Yourlawyer.com (Blood Clots News) http://www.yourlawyer.com/topics/overview/blood_clots Sat, 21 Nov 2009 04:49:28 -0800 pixel-app en FDA Strengthens Safety Information for Erythropoiesis-Stimulating Agents (ESAs) http://www.yourlawyer.com/articles/read/12645 Fri, 09 Mar 2007 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12645
FDA and the manufacturer of these products have agreed on revised product labeling that includes updated warnings, a new boxed warning, and modifications to the dosing instructions. The new boxed warning advises physicians to monitor red blood cell levels (hemoglobin) and to adjust the ESA dose to maintain the lowest hemoglobin level needed to avoid the need for blood transfusions. Physicians and patients should carefully weigh the risks of ESAs against transfusion risks.

Recently completed studies describe an increased risk of death, blood clots, strokes, and heart attacks in patients with chronic kidney failure when ESAs were given at higher than recommended doses. In other studies, more rapid tumor growth occurred in patients with head and neck cancer who received these higher doses.

In studies where ESAs were given at recommended doses, an increased risk of death was reported in patients with cancer who were not receiving chemotherapy and an increased risk of blood clots was observed in patients following orthopedic surgery.

"The agency is in the process of re-evaluating the safety of Aranesp, Epogen, and Procrit on the basis of the results of recent clinical studies," said Steven Galson, M.D. director of FDA's Center for Drug Evaluation and Research. "The new studies provide significant new information for both prescribers and patients, and the new information applies to all ESAs, which share the same mechanism of action. The safety of these products will be discussed when the Oncologic Drugs Advisory Committee (ODAC) meets in May and further revisions to the labeling may occur after that meeting."

Safety concerns from earlier ESA studies were discussed during a 2004 meeting of the ODAC. Product labeling was previously revised in 1997, 2004, and 2005 to reflect new safety information.

The three drugs are approved to treat anemia in patients with chronic kidney failure and in patients with cancer whose anemia is caused by chemotherapy. Epogen and Procrit are approved for patients scheduled for major surgery to reduce potential blood transfusions and for the treatment of anemia due to zidovudine therapy in HIV patients. ESAs are not approved to treat the symptoms of anemia including fatigue in cancer patients, surgical patients, or those with HIV.

All three drugs are manufactured by Amgen Inc. of Thousand Oaks, California. Procrit is marketed and distributed by Ortho Biotech LP, a subsidiary of Johnson & Johnson.
]]> FDA Warns of Serious Side Effects Related to Popular Anemia Drugs http://www.yourlawyer.com/articles/read/12646 Fri, 09 Mar 2007 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12646
“Recently completed studies describe an increased risk of death, blood clots, strokes, and heart attacks in patients with chronic kidney failure when ESAs were given at higher than recommended doses,” the FDA said. “In other studies, more rapid tumor growth occurred in patients with head and neck cancer who received these higher doses.

“In studies where ESAs were given at recommended doses, an increased risk of death was reported in patients with cancer who were not receiving chemotherapy and an increased risk of blood clots was observed in patients following orthopedic surgery.”

This new labeling change marks the fourth time in the past decade that the products’ label warnings were forced to be updated. “The agency is in the process of re-evaluating the safety of Aranesp, Epogen, and Procrit on the basis of the results of recent clinical studies,” said Dr. Steven Galson, director of FDA’s Center for Drug Evaluation and Research. “The new studies provide significant new information for both prescribers and patients, and the new information applies to all ESAs, which share the same mechanism of action. The safety of these products will be discussed when the Oncologic Drugs Advisory Committee (ODAC) meets in May and further revisions to the labeling may occur after that meeting.”

The FDA is asking the drug makers to add a black-box warning, the agency’s most serious alert, that “advises physicians to monitor red blood cell levels (hemoglobin) and to adjust the ESA dose to maintain the lowest hemoglobin level needed to avoid the need for blood transfusions.”

According to the FDA, ESAs are “genetically engineered forms of the naturally occurring human protein, erythropoietin.” Erythropoietin is produced by the kidneys and increases red-blood-cell levels. Currently, the FDA has approved these drugs for treating anemia in patients with chronic kidney failure and in patients whose anemia is a result of chemotherapy. Combined domestic sales of the three drugs reached approximately $10 billion last year alone.

In January, Amgen sent a letter to medical professionals warning them of an elevated risk of fatalities associated with the use of Aranesp in cancer patients. Amgen conducted a clinical trial to test the safety and efficacy of Aranesp on patients whose anemia was caused by the cancer itself, not by chemotherapy. While the drug is not currently approved for this usage, corporate estimates say that approximately 10 to 12 percent of all Aranesp sales are for that exact off-label (unapproved) usage.

The safety of Epogen has also been questioned by the medical community. Last November, two studies in the New England Journal of Medicine cited the overuse of anemia drugs in the treatment of kidney patients. Scientists have found that anemic kidney patients are susceptible to heart problems or death when aggressively treated with these drugs. Epogen has also been under attack by Congress because of the strain it places on Medicare. Anemia drugs are currently Medicare’s largest drug expenditure.]]> Stent research alarms patients http://www.yourlawyer.com/articles/read/12604 Mon, 26 Feb 2007 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12604
Worried, the 78-year-old retired Bethlehem Steel Corp. accountant clipped the article and called his cardiologist. He wasn't alone.

Drug-coated stents tiny mesh tubes coated in chemotherapy drugs have been considered the best medicine had to offer, superior to the uncoated variety in their ability to keep scar tissue at bay and prevent coronary arteries from reclosing.

They've been inserted in 6 million heart patients nationwide, including 5,000 in the Lehigh Valley.

But heart specialists have been forced to reconsider their use since December, when new research showed they are more likely to cause blood clots than do the bare-metal variety and the clots can appear six months to years after the stents are placed.

Clotting is a natural reaction to injury, but studies conducted in the United States and Sweden found that blood clots were getting stuck inside the stents, cutting off blood flow and causing heart attacks and sudden death. Researchers put the risk of developing clots at about 1 in 200-500 people.

Area cardiologists said they've found blood clots in the drug-coated stents of patients who survived heart attacks. And they can only presume that some others have died from the complication as well. Without autopsies, they can't know for sure.

Rapid escalation of use of the devices has only added to the alarm. Since they went on the market four years ago, drug-coated stents have far surpassed bare metal, becoming the stent of choice in 80-90 percent of all cases.

''It's a huge amount,'' local cardiologist Bryan Kluck acknowledged. At Lehigh Valley Hospital-Cedar Crest, where Kluck practices, cardiologists inserted the devices in about 1,700 patients last year. Over the same time at St. Luke's Hospital-Fountain Hill, about 1,000 patients received one or more drug-coated stents. Another 500 or so received the devices at Easton Hospital in Wilson.

In response to the findings, the American Heart Association, American College of Cardiology and other medical groups in early January recommended that most patients with drug-coated stents remain on anti-clotting medicines, such as the prescription drug Plavix, and aspirin, for at least a year, possibly indefinitely.

Experts believe continued use of anti-clotting medicines is the best recourse because research shows that patients who stayed on the drugs for a year fared the best among those studied. The 3-5 percent increased risk of blood clots occurred primarily among patients who stopped taking the medicines after six months.

Patients were supposed to stay on the pills for one to six months, depending on the type of stent used. However, one study showed the average time patients took the blood-thinners was 45 days.

''The increased risk [of blood clots] is very small and likely to be overcome if patients stay on anti-clotting medicines,'' noted Dr. Deepak Bhatt, a cardiologist and researcher at the Cleveland Clinic, which analyzed 14 studies involving drug-coated stents.

Promising, but not perfect

Two brands of drug-coated stents are used in the United States: Taxus by Boston Scientific Corp. and Cypher by Johnson & Johnson's Cordis Corp.

Placed inside a blocked coronary artery on the end of a deflated balloon, the stents are locked in place when the balloon is inflated. They act as a buttress to keep fatty deposits pinned against the artery wall. They restore blood flow to patients in the throes of a heart attack or who have blockages.

When they first came on the market, the drug-coated stents were recommended only for patients at low risk, such as those with small blockages in single vessels. But because early results with such patients looked so good, doctors used them in more common and complicated cases and in sicker patients.

Doctors had hints of a clotting problem from earlier studies, but it wasn't until the release of more conclusive data in December, much of it produced by the Duke Clinical Research Institute in Durham, N.C., that concern reached a critical level.

A rare summit of international experts called days later by the U.S. Food and Drug Administration produced the recommendation that patients remain on anti-clotting medication for a year or more.

But Dr. Robert A. Harrington, a professor of medicine in the division of cardiology and director of Duke's Clinical Research Institute, said the recommendation puts doctors and patients in another predicament.

''Are we committing millions of patients to lifelong [anti-clotting medicine] with its attendant costs and risks?'' he asks in an editorial about the blood-clot problems in a December issue of the Journal of the American College of Cardiology.

Plavix generic name clopidogrel and other blood-thinners can cause life-threatening internal bleeding in some patients, such as those with ulcers. It also has been shown to be no better than low-cost aspirin at preventing a first heart attack.

The Cleveland Clinic's Bhatt, however, doesn't think the side-effects of blood thinners are reason enough not to continue using drug-coated stents.

''Everything has risks,'' he said.

Weighing the risks

Some patients were so upset by the research that they asked that the stents be removed something doctors generally don't do, considering it much riskier than leaving the mesh tubes in place.

Cardiologists hope they can quickly learn which patients, beyond the low-risk, are best suited to drug-coated stents from patient registries and continued research. Or that the next generation of stents won't cause blood clots. In the works are stents with different coatings and others made to dissolve over time.

Until they have more answers, local and national specialists are extending the use of anti-clotting medicine. They also are being more selective in using drug-coated stents, perhaps precluding patients with long blockages or blockages that extend beyond one artery, persons with diabetes, persons scheduled for lung or colon cancer surgery or persons who have trouble keeping up pill regimens.

''There was a time that I'd try any case I could to use drug-coated stents,'' said Dr. Gary Costacurta, chief of cardiology at Easton Hospital in Wilson.

Now, Costacurta said, he may use bare-metal stents for patients with long blockages or for patients with blood vessels that are large in diameter.

LVH's Kluck said being more selective may not be so easy especially in the emergency room.

About 20 percent of the patients who receive stents arrive in the ER with chest pains and signs of imminent danger to the heart. It's a scenario in which seconds can make a difference, he said, in how much damage occurs to the heart and whether or not the patient lives.

Such cases leave little time for a full patient history, Kluck said. What medicines the patient had been taking or stopped taking and whether they have had bleeding problems in the past might not be known. ''It's not clear if plain stents are better than drug-coated'' for such patients, he said. ''We must probe deeper to know.''

Dr. Peter Puleo, a cardiologist and medical director of the catheterization laboratory at St. Luke's Hospital in Fountain Hill, said he started telling his patients to stay on anti-clotting medicines for two years when he read early studies suggesting a problem.

Puleo said he uses bare-metal stents on patients with long blockages or larger blood vessels. He said he is less worried about patients bleeding from blood-thinners than he is about heart attack and death from blood clots. ''Death from internal bleeding is even more unusual than late-term thrombosis,'' Puleo said, using another term for blood clots. ''In cardiology, more people clot than bleed to death.''

''It makes people nervous about continuing [on the medicines], but you can get through it,'' Puleo said.

Dr. J. Patrick Kleaveland, medical director of the catheterization laboratory at LVH and co-director of the lab at Grand View Hospital in West Rockhill Township, Bucks County, said drug-coated stents are still safe and effective in reducing restenosis for patients with simple, straight-forward blockages.

Patients at higher risk may still benefit as well, Kleaveland said, if they can stay on anti-clotting medicines for at least a year without uncontrolled bleeding. ''The patients I've seen with the most devastating problems are those who stopped taking their medicines prematurely,'' he said.

Reasons patients stop taking anti-clotting medication range from not being able to afford the pills, which cost $3-$4 a piece, to not feeling well on them or having difficulty keeping up with the regimen.

But cardiologists warn that stopping, even for a few days, could prove fatal if the body throws blood clots at the braced vessels.

''The first sign of trouble could be the total blockage of a stent, artery and blood flow,'' Kluck said. In other words, a sudden, massive heart attack.

Lehigh County Judge Edward Reibman stopped taking his prescription blood-thinner months after receiving a drug-coated stent in 2005. He counts himself lucky he didn't develop blood clots.

''When I had the stent put in, I was prescribed Plavix and aspirin, but I felt lousy on them,'' Reibman said, remembering muscle and bone pain.

He stopped the Plavix, switched to another anti-clotting drug and after a few months stopped that, too. But he continued taking a baby aspirin a day.

At a checkup in December, when news broke of the risk of blood clots, Reibman's doctor told him to resume the Plavix.

The judge wonders what new risks will come with the prescription medicine, but said he isn't judging prior decisions.

''Everyone thought the stents were fine. No one knew about this late stent [blood-clotting] problem then,'' he said. ''You make decisions with the best information you have at the time, and as science develops, you learn more and hopefully make more decisions.'']]> Study: Contraceptive Patch Increases Risk of Blood Clots http://www.yourlawyer.com/articles/read/12605 Mon, 26 Feb 2007 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12605
The study looked at more than 98,000 women who’ve used transdermal (patch) contraception and compared them with more than 250,000 women who’ve used oral contraception; the median age was 25. According to the report, “There was a more than two-fold increase in the venous thromboembolism [blood clot] rate among transdermal contraceptive system users compared with oral contraceptives users.” Incidence of stroke and myocardial infarction was too low to produce any meaningful statistical connection.

Ortho-McNeil, makers of the controversial Ortho Evra birth-control patch, continues to deal with significant legal challenges. New York firm Parker & Waichman, LLP, announced in November that it had filed suit in the Superior Court of New Jersey on behalf of a 26-year-old woman who had suffered pulmonary emboli and will be forced to remain on a regimen of anticoagulent medication. The new suit marked the 100th filed by the firm in cases related to the patch.

Last fall, 43 women brought a suit against Ortho-McNeil, a subsidiary of Johnson & Johnson, and San Francisco-based distributor McKesson Corp., alleging that use of the Ortho Evra patch has led to blood clots and other serious health problems. In a separate complaint, plaintiffs want to hold the company responsible for the death of an otherwise healthy 25-year-old woman, Kelly Bracken of Maryland, who suffered fatal blood clots in her lungs and legs after using Ortho Evra. Roughly 400 women have now filed suit against the pharmaceutical company in complaints related to the safety of the patch.

The researchers at i3, a unit of Ingenix, relayed their results to the FDA last September, which led to the institution of new label warnings for the patch. Plaintiffs in the pending suits, as well as some watchdog groups and medical professionals, claim that Ortho-McNeil failed to undertake a comprehensive investigation of the safety of the drug and may have withheld or downplayed potentially damaging information about its side effects during the FDA approval process.

Ortho Evra was approved by the FDA in 2001. According to Parker & Waichman, “Evidence shows that the risk of blood clots, heart attack, and stroke associated with Ortho Evra is significantly higher than with oral contraceptive pills…. As of November 2005, the FDA had logged 9,116 reports of adverse reactions to the patch in a 17-month period, whereas Ortho Tri-Cyclen, a birth control pill, only generated 1,237 adverse reports in a six-year period. During a 12-month period, 44 serious injuries or deaths were associated with Ortho Evra, whereas only 17 such reports were linked to the birth control pill during a similar time period. The pattern is further magnified when usage rates are considered: Ortho Tri-Cyclen has six times the number of users as Ortho Evra.”
]]> Parker Waichman Alonso LLP Believes New Study Confirms Ortho Evra is Associated with Increased Risk of Venous Thromboembolism Compared to Oral Contraceptive Pills http://www.yourlawyer.com/articles/read/12600 Fri, 23 Feb 2007 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12600
Parker Waichman Alonso LLP currently represents hundreds of clients who were injured while using the Ortho Evra birth control patch. The firm has cases pending in state and federal courts against Ortho-McNeil Pharmaceutical, Inc, a division of Johnson & Johnson, Inc. (NYSE:JNJ). For more information on Ortho Evra, please visit www.orthopatchlawsuit.com and www.yourlawyer.com/topics/overview/Ortho_Evra_Patch .

It is alleged that Ortho-McNeil was aware of the increased medical risks associated with Ortho Evra before the drug was approved and that, once approved, the company failed to adequately warn patients about these risks. Several studies have revealed that the risk of blood clots, heart attack and stroke associated with Ortho Evra is significantly higher than with oral contraceptive pills. The incidence of embolisms and thrombotic injuries in Phase III trials of Ortho Evra was reportedly six times greater than the incidence of such events in oral contraceptives using the hormone levonorgestrel. The FDA has logged 9,116 reports of adverse reactions to the patch in a 17-month period, whereas Ortho Tri-Cyclen, a birth control pill, only generated 1,237 adverse reports in a six-year period. During a 12-month period, 44 serious injuries or deaths have been associated with Ortho Evra, whereas only 17 such reports were linked to the birth control pill during a similar time period. The pattern is further magnified when usage rates are considered: Ortho Tri-Cyclen has six times the number of users as Ortho Evra.

About Ortho Evra

Ortho Evra is an adhesive, transdermal birth control patch that users are instructed to apply to their upper torso, upper outer arm, buttock or abdomen. The patch is intended to release 150 mcg of norelgestromin and 20 mcg of ethinyl estradiol into the bloodstream every 24 hours. It is replaced once a week for three weeks, and no patch is worn during the fourth week during menstruation. The regimen is then repeated. Ortho Evra was approved by the FDA in November 2001, and over 4 million women have used Ortho Evra since its approval. Ortho Evra continues to be marketed aggressively to both consumers and physicians.

About Parker Waichman Alonso LLP

Parker Waichman Alonso LLP is a leading products liability and personal injury law firm that represents plaintiffs nationwide. The firm has offices in New York and New Jersey. Parker Waichman Alonso LLP has assisted thousands of clients in receiving fair compensation for injuries resulting from defective medications and medical devices. The firm is currently representing individuals injured by Kugel Mesh Hernia Patches, Fosamax, Vioxx, Bextra, ReNu with MoistureLoc, Guidant defibrillators, Risperdal, Seroquel and many other defective drugs and medical products. For more information on Parker & Waichman, LLP, please visit: www.yourlawyer.com or call (800) LAW-INFO.

CONTACT:

Parker Waichman Alonso LLP

David Krangle, Esq.

(800) LAW-INFO

(800) 529-4636

info@yourlawyer.com

www.yourlawyer.com]]> Exclusive: Women Claim Birth Control Patchs' Risks Undisclosed http://www.yourlawyer.com/articles/read/12539 Thu, 08 Feb 2007 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12539
A number of women told 7NEWS that the patch ruined their lives. They all made the choice to use the patch because they said they were told it was just as safe as other birth control.

Six Colorado women said they believe they were victims of a corporate secret. Three of the women had pulmonary embolisms and three had blood clots. All six said they never were informed about the greater risks associated with taking the Ortho Evra birth control patch.

"I just remember thinking that I was going to die," said Merlinda Maldonado, who used the Ortho Evra birth control patch.

"I was awakened by what I thought was a heart attack. I was in excruciating pain," said Carrie Grater.

"I had a blood clot that went from my ankle up to my knee," said patch-user Myndee Allen.

All of them thought they were at no greater risk with the patch than with the pill, saying that's what they were told.

But it's what the women said they were not told that raises questions about patchmaker Johnson & Johnson.

When it hit the market in 2002, women were not told the patch contained 60 percent more estrogen than the common 35 microgram oral contraceptive.

They were not told that the patch more than doubled their chances of experiencing problems with clotting, heart attacks, stroke and pulmonary embolisms.

"They didn't do enough testing and they ultimately didn't know how much estrogen the patch was going to deliver," said a Colorado attorney who represents some of the more than 4,000 women nationwide claiming they were injured by the Ortho Evra patch.

"Their lives have changed for the rest of their life because Johnson & Johnson and Ortho-McNeil told them, 'Change your contraceptive. It's more convenient,' without telling them, 'Oh, by the way, we're going to double your risk of getting blood clots, pulmonary embolisms, strokes and heart attacks.' It's outrageous," the plantiffs' attorney said.

Burg's accusation gets support in a recent legal filing from a doctor who worked for patchmaker Ortho-McNeil and Johnson & Johnson.

In a lawsuit over wrongful termination, Dr. Joel Lippman claims he warned the company of serious health concerns connected to the patch claims that Johnson & Johnson has denied.

In the lawsuit, Lippman said the patch "released dangerously high levels of estrogen into patients."

The complaint also said Lippman advised that the company should "conduct further research to understand the impact of the hormones released by the patch."

Lippman said in the legal filing that Ortho disregarded his concerns and launched the product.

"He had told them not to put it on the market and his suggestion was just ignored," Burg said.

Last September, the Food and Drug Administration required the maker of the patch to provide better warnings, but for the six former users who talked to 7NEWS, they said the warnings came too late.

They said the change to the label and the addition of a 98-word warning inside a 19,000-word insert are far too subtle, leaving women at risk.

7NEWS Investigator Tony Kovaleski asked the group of women if they believed Ortho Evra is properly informing women today.

They all said "no."

Ortho-McNeil declined 7NEWS' request for an on-camera interview, saying they cannot comment on ongoing litigation.

The company did say the patch is a safe and effective birth control choice when used as directed.]]> Some birth control may raise clot risk http://www.yourlawyer.com/articles/read/12509 Tue, 06 Feb 2007 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12509
All contraceptive pills carry a very low risk of blood clots that, even more rarely, can travel to the lungs and kill. It is a side effect of the pills' hormones, estrogen and progestin.

But "third-generation" oral contraceptives that contain a type of progestin called desogestrel can double that risk, the advocacy group Public Citizen said in a petition filed with the Food and Drug Administration that seeks to stop the sale of just those newer pills.

That means about 30 blood clots per 100,000 users, compared with 15 blood clots per 100,000 users of older "second-generation" birth control pills that are just as effective, Public Citizen said.

It's not a new issue: Labels of desogestrel-containing birth control pills already list that increased risk in fine-print warnings of side effects. And in 1995, Britain's drug regulators sparked a pill scare by issuing warnings about the same progestin, which sold overseas for years before hitting the U.S. market.

But Public Citizen contended that after years of research showing no extra benefit for desogestrel-containing contraceptives, it was time for users to switch to older, safer birth control pills. It was posting a video explaining the petition on YouTube to get that message to younger pill users.

"FDA will carefully review the petition," said agency spokeswoman Susan Cruzan.]]> Making Sense of Drug-Coated Stents http://www.yourlawyer.com/articles/read/12436 Mon, 01 Jan 2007 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12436 When the FDA approved the use of drug-coated stents on April 24, 2003, it was hailed as a landmark advance in the treatment of blocked arteries.

“Drug-coated stents will be the new standard of cardiovascular care essentially immediately upon their release,” Dr. Campbell Rogers, director of the Cardiac Catheterization Laboratory at Brigham and Women’s Hospital (BWH), said at the time. House and Human Services Secretary Tommy Thompson called the decision “a significant step forward in the treatment of heart disease” while Mark McClellan, FDA Commissioner during that period, added that “drug-eluting stents combine drugs with medical devices to provide more effective care for many patients with heart disease. FDA is working to make sure its regulatory procedures encourage the quick and efficient approval of such safe and effective combination products.”

Significantly, the FDA’s announcement also made the following claim: “The types of adverse events seen with the drug-eluting stent were similar to those that occurred with the uncoated stent.” However, only three and a half years later, that statement is being challenged by a growing number of medical professionals, researchers, and consumer watchdogs who fear that the drug-coated device brings with it a higher risk of blood clots that can lead to heart attacks and strokes. Today, the questionable safety of drug-coated stents threatens to shake up this multibillion-dollar industry, raising a myriad of medical and legal issues.

On December 7 and 8, the FDA held a public Circulatory System Devices Advisory Panel meeting to discuss the issue and delivered the kind of mixed message that is typical at the FDA: Drug-coated stents were deemed safe for a certain subset of the patient population, but were also associated with a higher risk of blood clots, heart attacks, and death in the majority of patients. The panel recommended that the FDA issue new warnings for doctors and patients to reflect the elevated risk. The panel also sought to reduce instances of “off-label” usage, which accounts for more than half of the drug-coated stent market. Yet they saw no compelling reason to pull the controversial devices off the market.

In the long run, however, this may not be good news for stent makers. “Increased incidents of injury and adverse events are always important factors to examine when assessing the liability case against the manufacturers of drugs or medical devices,” says Jason Mark, an attorney at Parker & Waichman LLP who runs the firm’s mass tort unit. “With safer alternative designs available to patients that pose less thrombotic risk, manufacturers who place these products into the stream of commerce do so at their own peril and, unfortunately, at the peril of unsuspecting patients.”

In 2003, the news was all good for Cordis Corporation, the division of Johnson & Johnson that developed the drug-eluting stent (DES). At the time, the only stents in use were bare-metal stents (BMS). These devices–a kind of wire-mesh scaffolding–were used to prop open clogged arteries after angioplasty and had met with much success. However, according to the FDA, roughly 15 to 30 percent of stent patients suffered from restenosis (re-clogging of the artery) within a year of the procedure and had to be treated again with another angioplasty or bypass surgery.

The drug-eluting stent was developed to solve the problem of restenosis. By releasing a drug to retard cell growth and stop scar tissue from forming within arteries that have been opened, the new device was designed to prevent the arteries from becoming blocked again. Cordis had funded a national clinical trial to test the device’s effectiveness, and it was lauded as highly successful. The combined occurrence of repeat angioplasty, bypass surgery, heart attacks, and death was 8.8 percent for drug-eluting stent patients and 21 percent for the uncoated stent patients. The FDA said the new device was found to “significantly reduce the rate of re-blockage that occurs with existing stents.” BWH’s Dr. Rogers, who had been involved in the New England-based part of the trial, noted, “When we tested the drug-coated devices versus the plain metal version on patients, the results were very compelling. In approximately 95 percent of patients receiving the drug-coated stents, restenosis was prevented.”

Patients and medical professionals were so excited about the drug-coated stent that angioplasty procedures were being delayed specifically to await the FDA’s approval of the Cypher, Cordis’ revolutionary Sirolimus-Eluting Coronary Stent. The FDA issued its blessing in April of 2003, and by June, the device was already in short supply as demand soared. Patients had heard the news about drug-eluting stents, and suddenly, nobody wanted a bare-metal stent anymore.

It didn’t take long for the mood to change. In early July of 2003, less than three months after it approved the Cypher stent, the FDA issued its first warning about the product. In a July 8 alert, the agency stated: “Since the product’s introduction it is estimated that over 50,000 patients have received a Cypher stent. To date, FDA has received 47 Medical Device Reports (MDRs) of stent thrombosis occurring at the time of implantation or within a few days of implantation.”

Cordis sent a letter to healthcare professionals that week, notifying them of the incidence of thrombosis and reminding them of four important considerations with regard to using the Cypher: selection of the appropriate stent size; selection of appropriate patients for implantation; use of an adequate antiplatelet regimen to reduce the risk of clot formation; and the use of the proper technique for stent deployment. The third recommendation–the one related to blood clotting–would become a key element in the implantation and maintenance of drug-coated stents.

The news only got worse. On October 29, 2003, the FDA felt compelled to issue a second warning about the new device. The agency had by then received nearly 300 reports of adverse effects, 60 of which resulted in fatalities. In addition, there had been 50 reports of hypersensitivity and allergic reactions including pain, rash, respiratory alterations, hives, itching, fever, and blood pressure changes; several of these events proved fatal as well. Only a month later, the FDA provided updated numbers. They’d received 75 new reports of thrombosis and 20 new incidents of hypersensitivity. Meanwhile, Cordis had distributed nearly 600,000 Cypher stents by that point, pumping them out at well more than 100,000 a month.

Doctors and patients proceeded with little caution over the next year, putting aside fears of thrombosis and other complications, and the popularity of the drug-eluting stent continued to grow. After gaining FDA approval in March of 2004, Boston Scientific introduced its own drug-coated stent, the Taxus, coated with paclitaxel. On October 18, 2004, a year after it issued its second DES warning, the FDA announced its conclusion that there was virtually no difference in the thrombosis risks of drug-eluting stents when compared to bare-metal stents.

“The Cypher stent,” said the agency, “when implanted in accordance with the approved indications for use, is not associated with an excess of SATs [sub-acute thromboses] compared to bare-metal stents. SAT remains a relatively rare event that occurs within the first 30 days following the stenting procedure.”

While the safety of the DES may still have been questioned, the efficacy of the product was almost universally accepted: Drug-coated stents were instrumental in reducing the need for second surgical procedures. By the end of 2005, more than 90 percent of all stents being implanted in heart patients were drug-eluting stents.

Medical professionals were so thrilled that drug-coated stents reduced the risk of restenosis, they were perhaps willing to overlook the fact that the risk of stent thrombosis may have been growing. Several studies released in 2006 have brought the safety concerns back to the forefront of the discussion.

The first significant study was the BASKET-LATE (Basel Stent Kosten Effektivitäts Trial-Late Thrombotic Events) trial, which was set up to assess rates of cardiac death and myocardial infarction (MI) in stent patients who stopped using clopidogrel, the anti-clotting drug sold under the brand name Plavix. The randomized observational study fitted 499 patients with a DES and 244 with a BMS. According to the study results, in the year after clopidogrel discontinuation, patients with drug-eluting stents were twice as likely to suffer late stent thrombosis as those with bare-metal stents. Researchers also concluded that the risk of cardiac death or MI with the use of drug-eluting stents was “significantly higher” than the risk with the use of bare-metal stents: 4.9 percent versus 1.3 percent in the year after clopidogrel discontinuation.

Dr. Matthias E. Pfisterer created quite a stir when he first presented these results in March of 2006 at the Annual Scientific Session of the American College of Cardiology in Atlanta, and since that point, the debate has only gotten more heated. In September, the issue commanded center stage at the European Society of Cardiology/World Congress of Cardiology meeting in Barcelona, Spain, when three separate European studies questioned the long-term safety of drug-eluting stents.

The major presentation was made by Dr. Edoardo Camenzind of the University Hospital in Geneva. Dr. Camenzind conducted a meta-analysis of nine clinical trials and more than 5,000 patients to determine the risks of the DES versus the BMS. Camenzind found that the incidence of death or heart attack was higher for DES patients than for BMS patients–and higher for Cypher patients than for Taxus patients. Cypher patients were as much as 30 to 40 percent more likely to suffer serious adverse events than those with bare-metal stents while Taxus elevated the risks roughly 5 to 10 percent.

A second meta-analysis came from Dr. Alain J. Nordmann of the University Hospital in Basel. In this study, researchers examined 17 randomized trials and found that the Cypher was associated with significantly higher rates of noncardiac death when compared to bare-metal stents. The ThoraxCenter of Rotterdam presented its own study, which tracked stent thrombosis rates in more than 8,000 patients. Dr. Peter Wenaweser reported the cumulative rate of thrombosis was 2.9 percent, not terribly significant, but the troubling news was that the risk of thrombosis did not seem to lessen over time. Instead, the risk associated with DES patients continued to increase at the same rate (roughly 0.6 percent) year by year.

The biggest bomb at the September conference in Barcelona was dropped by Boston Scientific itself. The stent manufacturer announced that its own internal research had found a slightly higher, statistically noteworthy risk of blood clotting in patients who received their Taxus drug-eluting stents when compared to those who’d been implanted with bare-metal stents. Their review looked at 3,500 patients and included four years’ worth of data to determine the risks of late stent thrombosis (blood clotting in the stent area from the period beginning six months after implantation). Their admission was the first of its kind by any of the stent makers.

Immediately following the Barcelona meetings, the FDA decided to issue a new statement regarding drug-eluting stents. “We are aware of recent data suggesting a small but significant increase in the rate of death and myocardial infarction (heart attack) possibly due to stent thrombosis (a blood clot in the stent) in patients treated with DES,” the agency said, specifically citing the BASKET-LATE trial and Dr. Camenzind’s meta-analysis. “The small but significant increase in the rate of death and myocardial infarction observed in these studies was noted in patients followed 18 months to 3 years after stent implantation.”

The agency stressed the need for further studies and noted the importance of effective Plavix regimens to prevent clotting in DES patients. They also announced December’s public meeting of the Circulatory System Devices Advisory Panel to discuss the issues in greater detail. But ultimately, the agency was quite clear when it said: “At this time, FDA believes that coronary drug-eluting stents remain safe and effective when used for the FDA-approved indications. These devices have significantly reduced the need for a second surgery to treat restenosis for thousands of patients each year.”

The issue gained momentum in October at the Transcatheter Cardiovascular Therapeutics (TCT) meeting in Washington, D.C. A highly anticipated presentation by Drs. Gregg W. Stone and Marty Leon further clouded the medical issues at hand. Yes, they said, drug-eluting stents were indeed associated with significantly higher rates of late stent thrombosis. Yet, notably, they also claimed that the mortality rates among DES patients were no higher than those of BMS patients. That was largely because BMS patients were more than twice as likely to suffer re-clogging of their arteries.

With the debate raging on and contradictory evidence mounting, the stage was set for the FDA’s public meeting in December. The fate of the $6 billion DES industry largely hung in the balance.

The FDA’s public meeting of the Circulatory System Devices Advisory Panel on December 8 and 9 was not without its own share of controversy.

For one thing, the FDA decided to use physicians with a monetary stake in the products they were reviewing on behalf of the agency. Six doctors on the advisory panel had financial links to stent makers Johnson & Johnson and Boston Scientific; the FDA granted conflict-of-interest waivers to all six of the physicians in question.

“The reality is that the FDA sees industry as its client,” notes Jason Mark, the Parker & Waichman attorney. “The interests of the FDA are too often aligned with the interests of industry, and it’s the patients who time and time again suffer the consequences.”

Considering who was chosen for the panel, perhaps it’s not surprising that the group recommended, for the most part, a wait-and-see, business-as-usual approach. The panel did recommend new label warnings highlighting the increase in the risk of sudden heart attack or death in DES patients. Yet, in its own inimitable way, the FDA managed only to complicate matters by adding fuel to both sides of the DES argument.

While some physicians feel the devices may be too risky for the marketplace, others feel that the new warnings may discourage potential DES recipients who would truly benefit. Meanwhile, new studies continue to emerge with regard to the increased risk of thrombosis in DES patients; a recent Cleveland Clinic review assessed the risk of thrombosis in DES patients as being four to five times greater than that of BMS patients.

With millions and millions of patients already having received drug-coated stents–some estimates put the total number of DES patients as high as 6 million–even a very small increase in the risk of thrombosis becomes all the more significant. Writing in Cardiosource, the website of the American College of Cardiology, Drs. Sanjay Kaul and George A. Diamond noted that, based on the available evidence, drug-eluting stents may be responsible for more than 2,000 additional deaths every year when you consider the fact that roughly 1 million Americans per year receive a DES.

“Our romance with new technology–DES being only the most recent instance–is entirely understandable,” Drs. Kaul and Diamond write. “Technological innovation accounts for much of the miracle in modern medicine. It is entirely understandable, then, that: 1) device companies should want to develop new technology and support clinical trials necessary for regulatory approval and marketing so as to profit from the sale of that technology in a capitalistic market; 2) medical investigators should want to perform and publish such studies as a way to advance their careers; 3) insurance companies should want to rely on this information to justify reimbursing hospitals and physicians for utilization of that technology lest they be charged with restricting access to care in return for reducing their costs; and 4) hospitals and physicians should want to employ such state-of-the-art technology, and that patients should demand its use–even before long-term outcome trials confirm the short-term promise of that technology.

“Together, all these individually understandable incentives conspire to introduce promising new technology too quickly into the medical marketplace and to encourage its rapid overutilization. It is not at all surprising, then, that conflicts should exist between clinical practice and its evidentiary support, and that many DES interventions are thereby insufficiently justified.”

While those two doctors don’t believe a recall or moratorium on DES is necessary, they do support further FDA review and the resulting labeling changes as well as “a more accurate, timely, and comprehensive post-market surveillance program.” They also believe the FDA should be doing more to curtail off-label uses, which still account for more than half of DES implantation. “Although the FDA does not have the mandate to impact medical practice,” they note, “it should nevertheless leverage its relationships with medical professional societies and device sponsors to collaborate on the development and implementation of new tools and programs that help mitigate unnecessary risk and promulgate best practice standards.”

If nothing else, the DES debate has assured that most healthcare professionals will be more vigilant and discerning when addressing the risks and benefits of DES usage. Based on the available findings, doctors should only recommend drug-eluting stents for patients with a high risk of restenosis or those patients who cannot or will not handle long-term antiplatelet therapy. Doctors should not be afraid to employ bare-metal stents in certain cases where the DES may prove too risky. (Since bare-metal stents can be three to four times cheaper than drug-coated stents, the issue may have financial ramifications as well.)

The use of clopidogrel (Plavix) has proven to be essential to the long-term health of DES patients. However, the FDA has not yet approved the drug for that usage, meaning that DES recipients must use the drug off-label. Mostly all parties agree that extending the antiplatelet therapy in DES patients may be necessary in order to prevent dangerous blood clotting.

As with any new drug, therapy, or device, long-term side effects may take years to reveal themselves. The hope is that the increased scrutiny facing drug-eluting stents will lead to better decisions by the medical community, further research by the manufacturers, and greater understanding and awareness on the part of patients themselves.

]]> Mother of Tenn. woman sues birth control patch company http://www.yourlawyer.com/articles/read/12366 Tue, 12 Dec 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12366
The lawsuit filed in San Francisco Superior Court names Ortho Evra's developer and manufacturer Ortho-McNeil Pharmaceutical Co., a Titusville, N.J.-based subsidiary of Johnson & Johnson; and San Francisco-based distributor McKesson Corp.

Approved by the U.S. Food and Drug Administration in 2001, Ortho Evra is a birth control patch that delivers the hormones estrogen and progestin directly into the bloodstream through the skin.

The lawsuit alleges that Ortho-McNeil knowingly deceived the public about the drug's risk of severe side effects, including stroke, blood clots, deep vein thrombosis and pulmonary embolisms.

The company doesn't comment on ongoing litigation, said Gloria Vanderham, a spokeswoman for Ortho Women's Health and Urology.

Celena Devault, 26 of Hollow Rock, died from a pulmonary embolism and blood clots in June 2003. She had begun using the patch in April 2003.

Celena Devault's mother, Mary Devault, is named as the plaintiff in the lawsuit.

Another lawsuit has been filed on behalf of 55 women suffering from blood clots and other serious illnesses which they allege were caused by the birth-control patch.

"We believe that Ortho-McNeil knew of the dangers of the Ortho patch sold in the U.S. and choose to ignore them," said an attorney, whose firm along with another, filed both suits.

"Patches sold in other countries, including Canada, actually contain a smaller, less dangerous dosage," one of the attorneys  said. "Now, young women across the country are suffering serious illness and even death."

In September, the FDA warned women that their risk of blood clots in the legs and lungs may be higher if they use the Ortho Evra birth control patch instead of the pill. The decision was based on one study showing higher risks for clots, although another study showed no increased risk.

An investigation last year by The Associated Press found that patch users die and suffer blood clots at a rate three times higher than women taking the pill. About a dozen women died in 2004 from blood clots believed linked to use of the patch, the AP reported. Dozens more suffered strokes and other clot-linked problems.]]> Hospitals revert to older stent models as FDA investigates new ones http://www.yourlawyer.com/articles/read/12361 Tue, 12 Dec 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12361
Drug-coated stents are implanted in more than a million Americans a year to keep arteries propped open. They are the next-generation of a metal mesh device inserted after angioplasty, a procedure where doctors use a balloon-tipped catheter to open pathways to the heart.

Arteries treated with the first bare metal stents had the tendency to close in some patients. The drug coating was designed to inhibit the development of scar tissue and stop the vessel from clogging again.

The promise of the new device was so impressed upon the medical community that doctors turned to the drug-coated version for most patients since they came on the market in 2003. Some hospitals used drug-coated stents in more than 90 percent of their patients.

But recent reports of clotting issues are causing doctors to think twice about using the newer models in some patients. A new report released last week, based on research led by the Cleveland Clinic, showed a four- to fivefold increased risk of clots compared to the bare metal variety.

Some hospitals have responded by cutting their use of drug-coated stents by 10 percent or more since reports of potential risks began surfacing last fall about so-called “late stent” clotting which develops after the device has been in patients for several months or longer.

“There is that nagging concern about late-stent thrombosis — that (clotting) concern is out there,” said Dr. Gary Schaer, director of the cardiac catheterization lab at Rush University Medical Center in Chicago.

At Rush, Schaer said the hospital routinely had been placing drug-coated stents in patients about 85 percent of the time, but recently that number has dropped to about 75 percent.

In its most recent two-month period, Rush said 68 percent of angioplasty patients received drug-coated stents. During the same period last year, 88 percent received the drug-coated variety. The hospital said it places about 600 coronary stents in patients annually.

Those types of numbers are bad news for stent manufacturers, including North Chicago-based Abbott Laboratories, which placed a huge bet on heart stents when it purchased Guidant Corp.’s cardiovascular business earlier this year for more than $4 billion. Abbott currently has a drug-coated stent in development for U.S. patients.

Currently, only two drug-coated stents are on the U.S. market: Boston Scientific Corp.’s Taxus, and Johnson & Johnson’s Cypher and both are losing sales. Although Abbott has a drug-coated stent in some European countries, analysts say J&J and Boston Scientific dominate a $6 billion worldwide market.

Drug-coated stents are big business. They can cost $2,200 or more, compared to $600 to $800 for the uncoated variety, hospitals say.

But the companies and some doctors maintain the risks are small, saying there have not been enough studies completed to warrant a return to bare metal stents. Even hospitals that have curtailed implanting the drug-coated version say they will stick with it for most patients.

At Loyola University Medical Center in west suburban Maywood, where the hospital implants more than 1,500 stents in more than 1,300 patients a year, doctors there say the risk is not enough to justify a retreat from drug-coated stents.

“There is no evidence that bare metal stents are any safer they were not as well scrutinized as drug eluting stents,” said Dr. Fred Leya, director of interventional cardiology at Loyola University Health System, parent of the medical center. While Leya said the risk of clotting in patients, or so-called “late-stent thrombosis” worrisome, he said clotting after the stent has been in the artery for several months or even longer than a year is “no more than 3 to 4 percent,” of patients. A widely reported study last month found a 2.9 percent risk of clotting after three years and the potential to rise.

Leya said the benefits of drug-coated stents outweigh risks, which include re-clogging of the arteries or having to re-implant bare metal stents as well as risks from angioplasty procedure itself.

The U.S. Food and Drug Administration has convened a special panel for this week to look at the clotting issue. The meeting is a regularly scheduled meeting to discuss heart devices, but the clotting issue of stents has prompted the FDA to call additional outside experts in to be a part of the discussion.

The FDA has not yet disclosed the list but leading experts in cardiology, drug and device safety are expected. The panel could recommend labeling changes to drug-coated stents. The FDA usually follows recommendations of its panels.

For its part, Abbott believes newer drug-coated stents like the Xience model it hopes to have on the U.S. market by 2008, could be safer.

An Abbott-funded study earlier this year showed Xience had a “thrombosis” rate of 0.5 percent at six months usage compared with 1.3 percent rate for Boston Scientific’s Taxus.

Abbott and doctors say all stents are different and should not be lumped in the same bucket when searching for a cause to the clotting issue. Stents have different drug coatings and are im

Until Abbott’s drug-coated stent hits, the market, analysts say the company could benefit in a return to bare metal stents, which it sells as part of its purchase from Guidant. “We have seen a small uptick in bare metal stents in the last few months,” said Morrison.

Leya said drug-coated stents reduced the tendency for arteries to re-clog to just 5 to 10 percent of patients, compared to 20 to 25 percent for the bare metal variety. By comparison, 30 to 50 percent of patients who simply had an angioplasty procedure eventually had their arteries re-clog, he said.

Although no one is certain about what causes the clotting issues, cardiologists think some of it may be due to patients not taking their medications to reduce the risk of clots.

The pills can cost $3 to $4 a day if they do not have drug coverage.]]> Panel weighs in on stents http://www.yourlawyer.com/articles/read/12350 Sat, 09 Dec 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12350
The panel said product labels for the stents should be revised to caution doctors and patients that off-label use carries an increased risk of blood clots, heart attack or death.

The devices, which are used to keep arteries open after blockages have been cleared, were approved in 2003 for use in patients with just one clogged vessel. But the stents are widely used off-label in sicker patients with multiple blockages or complicating illnesses, such as diabetes.

In the U.S., unapproved uses of the stents, made by Johnson & Johnson and Boston Scientific Corp., account for about 60% of sales.

These "patients should be warned they should not expect the same outcome" as healthier patients, said panel chairman Dr. William H. Maisel of Beth Israel Deaconess Medical Center in Boston.

The FDA called the panel meeting after a series of studies found the tiny mesh stents increased the risk of complications months and years after they were implanted. Several studies found the devices carried small but significant risk of heart attack or death.

The devices, known as drug-eluting stents, release drugs that prevent blockages caused by a buildup of scar tissue — a complication of bare-metal stents. But the drugs slow healing inside the artery, and that can lead to the formation of clots.

About 3 million people in the U.S. have the drug-coated stents, which generated worldwide sales of more than $5 billion last year.

The panel decided that the devices were safe and effective for the narrow group of patients for whom the devices were approved.

But panel member Dr. Norman S. Kato of Cardiac Care Medical Group in Encino said there is a shortage of conclusive medical research on the safety of the stents in other patients. He said off-label use of the stents could not be justified. He said the increased risk of death "makes me very, very nervous."

Panelist Dr. Eric Topol of Scripps Clinic in San Diego called for "more judicious" use of stents.

Despite the concerns, the panel of 21 experts said there is not enough evidence to restrict use of the stents.

Dr. Christopher J. White of Ochsner Clinic in New Orleans and a member of the advisory panel said it was not surprising to see an increase in complications in sicker patients. He noted that sicker patients who have bare-metal stents also have a higher rate of complications.

"Nothing I heard today is going to change what I do," White said.

The panel recommended those patients who use the stents for unapproved conditions should receive anti-clotting medicine for one year after their procedure. Currently, patients take the anti-clotting drug Plavix for three to six months.

Because the drug is expensive and can cause severe bleeding, the panel said, patients who cannot take the drug for 12 months should not receive coated stents.

The FDA isn't required to follow the panel's advice, but it typically does.]]> FDA Panel Seeks Warning That Stents May Be Unsafe http://www.yourlawyer.com/articles/read/12351 Sat, 09 Dec 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12351
Based on the finding, the special 21-member Food and Drug Administration panel recommended that the agency issue new warnings to doctors and patients that the devices' safety has not been established except for relatively low-risk patients, for whom the stents were originally tested and approved.

"If you use the device outside that indication, you're going to have a higher incidence of complications," said William H. Maisel of the Beth Israel Deaconess Medical Center in Boston, who chaired the panel.

The panel stressed that the tiny metal-lattice struts, known as drug-eluting stents, offer advantages over older bare-metal versions for some patients, with the benefits outweighing the risks for the relatively healthy patients for whom the devices have been tested.

It remains unclear whether the devices are causing the complications in other patients; the side effects could be occurring because these patients tend to be sicker. But panel members concluded that until that question can be answered, doctors and patients should be alerted about the potential risks. Several members said they hoped that would make doctors more cautious about using the devices.

"Let's be more judicious about this. Let's be less indiscriminate," said Eric J. Topol of the Scripps Clinic in San Diego.

The panel also recommended that patients who have the stents take anti-clotting drugs for at least a year.

More than 6 million people worldwide have gotten the drug-coated devices, including perhaps 3 million in the United States. At least 800,000 new patients get them each year, making the stents the most common device used to treat heart disease and one of the most common medical procedures of any kind. The panel's recommendations apply to at least 60 percent of those patients.

The FDA is not bound to follow the recommendations, but an official said the agency would respond rapidly.

"There may be things that can be done relatively quickly," the FDA's Daniel G. Schultz said, noting that the warning could take the form of changes in the devices' labels and letters to doctors and patients.

The recommendations came on the second day of a sometimes contentious two-day meeting the FDA urgently convened to determine whether the risks of the devices outweigh the benefits.

The panel concluded that although the devices, compared with older bare-metal versions, may increase the risk of blood clots, drug-eluting stents do not appear to increase the overall risk of heart attacks and strokes when used in the kind of patients for whom they were originally intended. But a majority of patients get them "off-label," or not as intended, and tend to be sicker and have more-complicated conditions, such as diabetes, multiple blockages and blockages in narrower arteries.

In a packed hotel room in Gaithersburg yesterday, the panel listened to presentations from researchers from California, Illinois, North Carolina, Rhode Island, Washington and elsewhere who analyzed the latest data from large registries of patients who had received the stents since they were introduced three years ago. Although the results were mixed, several analyses found an increased risk of blood clots, deaths and heart attacks.

"Do we have evidence that the safety-efficacy balance might be different in the off-label? I think we've heard enough to suggest that that's the case," said Steven Nissen of the Cleveland Clinic.

More than 1 million U.S. heart patients undergo procedures every year to have blocked arteries opened with tiny balloons, after which stents are implanted to keep the vessels open. Scar tissue often grows around the stents, however, narrowing the arteries again and requiring patients to undergo the procedure repeatedly or to have bypass surgery.

The newer stents are coated with a polymer impregnated with drugs that are released slowly, inhibiting scar-tissue growth. Because the devices were shown to be highly effective, they were hailed as a major advance and quickly replaced bare-metal versions for most patients, though the newer stents were tested on and approved for only low-risk patients.

The FDA called for the meeting after studies looking at patients outside tightly controlled clinical trials indicated that a year or more after implantation, patients with drug-coated stents faced increased risks compared with those with bare-metal models. Some researchers have estimated the newer devices might be causing thousands of heart attacks and deaths a year.

Some researchers, along with Boston Scientific Corp. and Johnson & Johnson, which make the two drug-eluting stents sold domestically, say any risks from the devices are offset by the reduced need for repeated procedures and bypass surgery, which carry their own risks.

Patients who get the stents had been advised to take aspirin and the drug Plavix for three to six months to reduce the risk of blood clots. Recent studies have indicated that patients may need to take the drugs longer, perhaps indefinitely. But Plavix is expensive and increases the risk of serious bleeding.]]> Safety of Drug-Coated Stents Spotlighted http://www.yourlawyer.com/articles/read/12335 Thu, 07 Dec 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12335
The companies, Boston Scientific Corp. and Johnson & Johnson, are in the hot seat as the Food and Drug Administration begins two days of meetings on Thursday to discuss the clotting risks associated with the devices.

Some people believe that clotting leads to an increased risk of heart attack and death a danger the FDA said is unknown.

Boston Scientific acknowledges a slight increase in clotting associated with its drug-coated stent, the Taxus. The company said it has seen no corresponding increase in heart attacks or deaths.

Johnson & Johnson said there is no significant difference in clotting, heart attack or death rates between its stent, the Cypher, and bare metal versions.

Both companies said use of the drug-coated stents reduces the need for follow-up surgeries to reopen clogged arteries when compared to bare-metal stents. That accounts for the widespread use of the drug-coated versions since their introduction in 2003.

The FDA is looking to an outside panel of experts for advice on a wide range of questions on the drug-coated stents, including whether to update the labels with new warnings, identify patients for whom they are not appropriate and perhaps change federal recommendations on how long people should take anti-clotting drugs such as Plavix and aspirin following stent surgery.

The agency also seeks recommendations for research on drug-coated stents on the market or pending approval.

"This is a public health issue of great importance," FDA devices chief Dr. Daniel Schultz told reporters this week.

Multiple studies have suggested the risk of blood clots, heart attack and death rises in patients who stop taking Plavix earlier than now recommended. Some doctors recommend patients stay on it indefinitely until more is learned.

But FDA staff said it is unknown how long patients should take the drug, distributed by Bristol-Myers Squibb Co. and Sanofi-Aventis SA.]]> Stents' Day in the Sun http://www.yourlawyer.com/articles/read/12338 Thu, 07 Dec 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12338
Specialists on the FDA circulatory system devices panel will meet Thursday and Friday to review safety data, conduct public hearings and determine whether the stent makers will be required to submit additional safety data on their devices.

Some stents, which are used to prop open arteries cleared of plaque, are coated with drugs designed to prevent regrowth of tissue in the area where the device is implanted. But recent studies have found that the polymers that enable the slow release of drugs remain after all active ingredients are absorbed. Scientists worry they could cause a reaction by the immune system, leading to tissue regrowth within the blood vessel.

At the meeting, panelists are expected to discuss whether FDA approvals or recommendations for stent use should be changed based on how severe a patient's condition is, whether the patient is diabetic or otherwise belongs to a high-risk group, according to briefing documents posted on the agency's Web site.

The panel is also expected to discuss how long patients should take blood thinners like Bristol-Myers Squibb (BMY) and Sanofi-Aventis' (SNY) blockbuster drug Plavix after stents are implanted, another measure that doctors use to prevent artery re-clogging.

"The panel could take some steps toward quantifying what the problem may or may not be and possible solutions," says Steve Brozak, health care analyst at investment research firm WBB Securities. On whether drug companies could benefit from greater use of their treatments as stent use potentially declines, he says, "This could be a game where you see a decline but you don't see someone else benefiting from the decline."

In order to determine what measures to take on stents, the FDA panel will consider data, and possibly request more, on whether the use of drug-eluting stents is associated with an increased rate of death compared with stents made of bare metal.

Another concern, which could have a short-term impact on the companies' stocks, is the question of whether safety concerns apply to both Johnson & Johnson's Cypher stent and Boston Scientific's Taxus. The companies are fierce competitors for stent market share and are in constant battle with data supporting that each company's stent is superior to the other's.

For example, study results presented at the Transcatheter Cardiovascular Therapuetics conference in October showed that, after a year, J&J's stent was associated with a 0.6% risk of artery reclogging compared with no risk for bare-metal stents, and Boston's device led to a so-called late-stent-thrombosis rate of 0.7% vs. 0.2% in bare-metal stents.

But regardless of which stent is shown to cause more of a risk of reclogging, and even if the FDA panel recommends the equivalent of a black box warning about the device's safety, "it's not so much what the panel is going to do. It's what the payers and managed care companies are going to do" in response to the meeting's outcome, says Les Funtleyder, health care analyst at institutional trading firm Miller Tabak. The FDA issues black box warnings when studies show that a drug carries a significant risk of serious, possibly life-threatening, side effects.

Funtleyder says managed care companies will take a closer look at data, specifically the health risk tradeoff between drug-coated and bare stents, to determine whether to change authorization requirements for use of the devices. The analyst expects to see decreased use of drug-eluting stents in favor of the bare devices, and notes that both companies' DES sales have already lost out to bare-metal stents by a few percentage points of market share.

At the panel meeting, "there will be a lot of rhetoric from people who believe they're more dangerous, which may weigh on the stocks," Funtleyder says. But he believes that for the most part, safety concerns are already priced in.

The meeting could remove some uncertainty surrounding the safety concerns, and eventually lead to a response from the FDA and managed care companies' responses, but ultimately, "getting it over with will be helpful to the stocks and the whole medical device group," the analyst says. "I don't see much of a negative coming out of the meeting, and in the absence of a negative, I suppose it would be a positive."]]> Feds questions experts on drug-coated stents http://www.yourlawyer.com/articles/read/12340 Thu, 07 Dec 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12340
The two manufacturers of the widely used devices say their benefits outweigh their risks, but the Food and Drug Administration believes patients could face a small but significant chance of blood clots.

The companies, Boston Scientific Corp. and Johnson & Johnson, were in the hot seat as the FDA began two days of meetings to discuss with a panel of outside experts the clotting risks associated with the devices.

Some researchers believe that clotting leads to an increased risk of heart attack and death in patients fitted with the devices - a danger the FDA said is unknown. The agency does believe the clotting risk is real, however.

"Are you certain of that conclusion?" asked panel member Dr. John Somberg, of Rush University Medical Center in Lake Bluff, Ill.

FDA medical officer Dr. Andrew Farb said yes, after acknowledging the difficulty of acting on that information.

"When we have rare events in relatively small numbers, to come up with sweeping conclusions can raise issues," Farb said.

The FDA asked panelists to assess the risk and then provide the agency with their recommendations, including whether to update the labels with new warnings or change guidelines on how long people should take anti-clotting drugs such as Plavix and aspirin following stent surgery.

"It is important to note FDA does not regulate the practice of medicine. However, FDA is responsible for any use of a device that raises a public health concern," FDA medical officer Dr. Takahiro Uchida told the panel.

Boston Scientific acknowledges a slight increase in clotting associated with its drug-coated stent, the Taxus. The company said it has seen no corresponding increase in heart attacks or deaths.

Johnson & Johnson said there is no significant difference in clotting, heart attack or death rates between its stent, the Cypher, and bare metal versions.

Both companies said use of the drug-coated stents reduces the need for follow-up surgeries to reopen clogged arteries when compared to bare-metal stents. That accounts for the widespread use of the drug-coated versions since their introduction in 2003. Today, more than 60 percent of the stents probably are implanted in higher-risk and other patients not studied before the devices gained FDA approval.

Multiple studies have suggested the risk of blood clots, heart attack and death rises in patients who stop taking Plavix earlier than now recommended. Some doctors recommend patients stay on it indefinitely until more is learned.

But FDA staff said it is unknown how long patients should take the drug, distributed by Bristol-Myers Squibb Co. and Sanofi-Aventis SA.

The FDA also seeks recommendations for research on the drug-coated stents on the market or pending approval. Both Medtronic Inc. and Abbott Laboratories hope to enter the more than $5 billion U.S. market for the drug-coated stents.]]> FDA Explores Safety of Heart Stents http://www.yourlawyer.com/articles/read/12339 Thu, 07 Dec 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12339
But the blood clot risk from the tiny metal mesh struts, known as drug-eluting stents, appears relatively low and it remains unclear whether it translates into an excess risk for heart attacks or deaths, according to the Food and Drug Administration analysts.

Nevertheless, because some studies have suggested the increased risk of blood clots, known as thrombosis, may be causing thousands of excess heart attacks and deaths each year, it is urgent that experts determine whether their use should be restricted and patients who already have them should be treated longer with anti-clotting drugs, the agency officials said.

"Since stent thrombosis is associated with high rates of death and [heart attacks], continued efforts to clarify the mechanisms of stent thrombosis and interventions to reduce the risk of its occurrence will have public health benefits," the FDA's Andrew Farb said.

The presentations opened a two-day meeting of a special 21-member panel the FDA urgently convened to evaluate the stents, which have quickly become the most commonly used devices for treating clogged arteries. The panel will address a long list of questions, including whether the risks of the devices outweigh their benefits. The FDA is not bound to adopt the panel's recommendations, but the agency usually does.

Hundreds of people packed a large meeting room in Gaithersburg, Md., just outside Washington, for the highly anticipated meeting, including representatives from Johnson & Johnson and Boston Scientific Corp., which make the two drug-eluting stents sold in the United States. Other medical device makers, heart specialists, reporters and patient advocates also attended the meeting.

The safety of the devices has garnered unusually intense attention because the number of people getting drug-coated stents has risen dramatically since they were introduced in 2003. Worldwide, an estimated 6 million people have them, including as many as 3 million in the United States. About 800,000 Americans are getting the stents each year. Worldwide sales are estimated at close to $6 billion.

More than 1 million heart patients each year undergo procedures to open blocked arteries with tiny balloons and then to install stents--hollow lattice tubes--to keep the passageways open. But scar tissue often grows around the stents, narrowing the arteries again and requiring patients to undergo the procedure repeatedly or to have bypass surgery.

The new generation of stents are coated with a polymer impregnated with drugs that filter out slowly, inhibiting the growth of scar tissue. Because the devices were shown to be highly effective they were hailed as a major advance, and most patients now get them.

But scientists began to become concerned that the slowed healing around the devices may prolong the risk of blood clots, which can also block arteries, causing heart attacks and death. Alarm intensified in recent months as studies began reporting that a year or more after implantation, patients with the drug-coated stents face a small but meaningful increased risk of clots, compared with those given bare-metal models, and possibly were experiencing a greater rates of heart attacks and deaths. The excess risk appears to be small, but could translate into thousands of heart attacks and deaths because of the large number of patients receiving the devices.

Patients who get the stents are advised to take aspirin and an anti-clotting drug known as Plavix for at least three to six months to reduce the risk. But recent new studies have also indicated that may not be long enough and they may need to continue taking the drugs, perhaps indefinitely. Plavix, however, is expensive and increases the risk of potentially serious bleeding problems.

The FDA summarized the existing data, concluding that the evidence indicates the devices do carry an increased risk for blood clots. But the agency's experts noted that the studies' design and size were not sufficient to reach any firm conclusions about whether that was translating into increased heart attacks and deaths. It also remained unclear whether extending Plavix use would be effective, the experts said.

The panel members began quizzing the FDA scientists about the findings, including whether the methods for identifying clots and assessing the risk were reliable.

"We think there is a small but significant increased risk in late-stent thrombosis," Farb said.

Boston Scientific and Johnson & Johnson, which have defended the safety of the devices, planned to present their analyses later in the day.]]> Drug-coated stents facing hard 2d look http://www.yourlawyer.com/articles/read/12327 Wed, 06 Dec 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12327
The topic of clots has headlined national medical conferences and filled the pages of medical journals. Now it will be discussed by 19 specialists during a two-day FDA hearing in Maryland.

Behind the clotting concerns, a second issue has emerged about drug-coated stents: A small but vocal group of doctors say the devices, which cost about $2,000 apiece, may be only marginally more effective than the cheaper bare-metal stents they replaced.

Some doctors and public-health experts have begun to see the tiny mesh tubes not just as an example of a profitable fusion of drug and medical device, but as a lesson in how doctors can be seduced by an appealing new idea backed by powerful salesmanship.

Cynthia Yock, a healthcare researcher at Stanford University who has analyzed the research on drug-coated stents, calls their popularity "a fantastic case study of the companies being able to expand the market in advance of the true clinical need."

Since their arrival in 2003, drug-coated stents have become the fastest-selling medical device ever. Doctors' confidence in their benefits helped Natick stent maker Boston Scientific Corp. generate more than $2 billion annually from stent sales, growing the company into one of the world's medical-device giants.

But as evidence mounts that drug-coated stents cause dangerous blood clots in a small number of patients, cardiology leaders are taking a hard look at the benefits that led them to choose them over the older generation of bare-metal stents.

Stents hold coronary arteries open after they have been cleared of a blockage. In the clinical trial that won approval for the first drug-coated stent, Johnson & Johnson showed that 21 percent of patients who got older bare-metal stents required a repeat procedure because their arteries had re narrowed. Drug-eluting stents brought that number down to 5 percent. Boston Scientific's approval trial showed a similar drop, from 15 percent in bare-metal stents to 4 percent in drug-eluting stents.

Some newer studies show older stents may not perform as badly as suggested by those earlier trials.

An analysis published in August of more than 17,000 patients treated at 17 hospitals in the United States found just 8 percent of patients who received bare-metal stents needed to return for an artery-clearing procedure.

"In current real-life practice, bare-metal stents aren't performing as poorly as we thought they performed, and it's a bit sobering to see that," said Deepak Bhatt, a cardiologist at the Cleveland Clinic who was not involved in the analysis.

A Boston Scientific spokesman said the benefits of its Taxus stent "have been maintained in real-world use," and the company plans to back its claims by giving the FDA panel data from a global registry of 7,000 stent patients.

Dr. Sanjay Kaul, a cardiologist at Cedars-Sinai Medical Center in Los Angeles, has emerged as a critic of the widespread use of drug-eluting stents. He said the original approval trials ultimately created an exaggerated picture of the risks of bare-metal stents. The models used for comparison in the trials weren't state-of-the art, Kaul said. More importantly, he said, all patients in the trials received a mandatory angiogram, a diagnostic procedure to measure blood flow. Doctors are more likely to re intervene after seeing some artery narrowing in an angiogram, even if the patient has no symptoms.

"It's a classic example of how you stack the deck in favor of your therapy in clinical trials," Kaul said.

The FDA panel will review numerous studies of stents and listen to presentations by doctors and stent manufacturers. Its chief goal is to determine how likely drug-eluting stents are to cause long-term blood clots, and what should be done. Bhatt last week published a study saying drug-coated stents are likely to trigger a blockage in about one in 200 patients five times the rate of clotting in bare-metal stents.

A paper released online yesterday by the Journal of the American Medical Association suggests patients can reduce their risk of clotting by staying on the blood-thinning drug Plavix, but blood-thinners have complications, including a higher risk of bleeding.

The FDA is also looking at whether drug-coated stents solve a major health problem. Studies consistently show patients are less likely to have re narrowed arteries with a drug-coated stent. But many doctors are questioning whether that is worth the risk of clotting, since re narrowed arteries rarely lead to serious problems such as heart attacks.

"You have a trade-off," said Robert Califf, a Duke University cardiologist, who was the lead author of yesterday's JAMA article. "You have a less frequent, more severe risk, and a more frequent, less important benefit."

For some cardiologists, the debate has triggered a re examination of why drug-coated stents were adopted before long-term safety data became available.

Fueled by high-profile early studies and a strong sales and advertising push by manufacturers, the stents quickly captured the market.

Within two years of introduction they were used in 90 percent of procedures, even though they were technically approved only for patients with relatively simple coronary artery problems.

"If I were to teach a course in marketing," said Kaul, "I certainly would use this as an example."]]> The heart of a stent debate http://www.yourlawyer.com/articles/read/12331 Wed, 06 Dec 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12331
Doctors could clear his three blocked coronary arteries by cracking open his chest and surgically bypassing them. Or they could clear them from within by inflating a tiny balloon and propping them open with wire-mesh stents, coated with a drug to keep the arteries from closing again.

But drug-coated stents can be risky, too. New studies show that people with drug-coated stents who stop taking their anti-clotting medication now recommended for just three to six months are prone to rare but potentially fatal blood clots for years.

Young, 62, was aware of the risks, but when his surgeon told him that the less-traumatic procedure would be "adequate," he decided that it was the way to go.

"I decided to put myself in the hands of my doctors," says Young, a real estate broker from Providence. He had two of his arteries treated Nov. 16. He's due to have the third fixed soon.

But even doctors are divided about the safety of the tiny devices now implanted in about 6 million people worldwide. The debate is so contentious, and doctors are so uncertain what to do, that the Food and Drug Administration will convene a panel of experts for a two-day meeting Thursday and Friday in Gaithersburg, Md., to determine whether the agency should revise its guidelines for the $6 billion-a-year stent market.

"The FDA is doing the absolute right thing," says cardiologist and stent expert Judith Hochman of New York University School of Medicine.

Mixed signals

The market has exploded in the past two decades, says Donald Baim, chief medical officer of stent manufacturer Boston Scientific. Today, about 1 million people a year have angioplasty, compared with 300,000 who have bypass operations. About 600,000 angioplasty patients receive stents, doctors say.

"We have a technology that has really changed the way medicine is practiced," says Daniel Schultz, director of the FDA's Center for Devices and Radiological Health. "We're also getting signals that there is, in fact, a risk that may be higher than we had seen in the initial clinical trials."

The problem is new and the studies are difficult to interpret, so doctors aren't sure how widespread it is.

An analysis by Deepak Bhatt of Cleveland Clinic published last week in the American Journal of Medicine suggests that the risk of developing a blood clot may be up to five times higher for patients with drug-coated stents than for those with bare-metal stents. A study released in October by Gregg Stone and Martin Leon of the Cardiovascular Research Foundation pegged the risk at about 0.5% a year — or five for every 1,000 drug-coated stent patients.

"There's continuing uncertainty as to what the true risk really is," says Robert Bonow, chief of cardiology at Northwestern University.

To reduce the risk of clots, the FDA recommends that patients stay on anti-clotting medicines, aspirin and clopidogrel (sold as Plavix), for three to six months after the stents are put in. Most blood clots appear months to years after the stents are in place, suggesting that patients should take the two medicines much longer.

As a precaution, some doctors, including Bonow and David Williams of Rhode Island Hospital, recommend patients take Plavix for a much longer period. But not everyone agrees. Although Plavix, the second-leading seller of all drugs in the USA, has been shown to be relatively safe, it can cause bleeding, especially in patients who have ulcers or have surgery, Stone says, and it's also costly.

"You've got 6 million patients worldwide, and the drug costs about $4 a day. That's about $24 million a day," he says. "On top of that, every year you're treating another million or so patients. It's not impossible to spend that kind of money, but we have to know that it's safe and it works. Right now we don't."

But the risks of not taking Plavix long-term may be higher, a study in today's Journal of the American Medical Association reports. In the study of more than 4,600 patients, researchers found that those who stopped taking Plavix from six months to a year after their drug-coated stents were put in place were more than twice as likely to die or have a heart attack than those who stayed on their medication.

"One of the striking things about our study is that we didn't see any point at which the risk diminished," says lead author Robert Califf of Duke University.

'Two sides to every story'

The irony is that drug-coated stents were developed to counter a side effect commonly seen with bare-metal stents: the regrowth of tissue within the artery that shuts it down again. Patients may find themselves experiencing the same symptoms that led to angioplasty in the first place. Some may need a repeat angioplasty or a bypass operation.

For the most part, some doctors argue, the symptoms of tissue regrowth are relatively benign, while a blood clot can cause a heart attack. "We're talking about significant heart damage that can be fatal," says Williams, who performed Young's angioplasty.

But there's disagreement here, too. Stone asserts that new studies suggest that, in 3% to 19% of cases, re-clogged arteries make themselves known by causing a heart attack. He argues that the risk of a blood clot and the risk of re-narrowing balance out. "As in everything in life," he says, "there are two sides to every story."

Hence FDA's decision to hold an advisory committee meeting. "We want to get all of the data that's currently available on the table in a neutral setting, where there isn't a bias one way or another."

The agency's recommendations, he says, "will depend on the level of consensus and where the discussion ends up taking us."]]> Controversy Swirls Around FDA Meeting on Stents http://www.yourlawyer.com/articles/read/12319 Tue, 05 Dec 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12319
In advance of the meeting, the FDA released documents today related to an FDA staff review that noted that the drug-coated stents “are associated with a small but significant risk of late-stent thrombosis.” Stents are wire-mesh devices used to unclog arteries. The drug-coated stents are intended to prevent scar tissue from forming in the arteries, but preliminary research has determined that the coated stents may increase the probability of adverse events, including heart attacks and strokes.

Agency critics are amazed and appalled that the FDA would allow panel members with significant ties to the companies whose devices are being reviewed. In a statement last month, Merrill Goozner of the Center for Science in the Public Interest said, “The scientists who advise the FDA should be free of all financial ties to firms whose products are under review. The public’s faith in the integrity of the process will be undermined by any reform legislation that allows physicians and scientists with conflicts of interest to continue serving on these committees.”

In response to the latest controversy, Goozner told the Newark Star-Ledger: “There are literally thousands of experts all over this country who are well-schooled in the details of this field. But instead of reaching out to that community to get a totally unbiased look at this question, the FDA appointed a committee on which a substantial fraction have conflicts of interest directly with manufacturers of products being evaluated. It’s almost impossible to have confidence in the outcomes of this kind of deliberation.”

According to Bloomberg News, one member of the advisory panel is Robert Harrington, who runs a Duke University research institute funded by both J&J and Boston Scientific.

Drug-coated stents have been used in 4 million patients and have sales in the $6 billion range annually. They are significantly more expensive than bare stents, but apparently they are more dangerous as well.
]]> FDA: Stent patients face blood clot risk http://www.yourlawyer.com/articles/read/12321 Tue, 05 Dec 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12321
Growing concern about the long-term safety of drug-coated stents comes to a head this week when the Food and Drug Administration convenes a two-day meeting to discuss clotting risks associated with the devices.

In documents released Tuesday, the FDA said it is unknown whether there is an increased risk of death or heart attack in patients fitted with the so-called drug-eluting stents. However, those patients do face an increased risk of blood clots a year or more after surgery compared with people fitted with bare-metal stents, the agency said in citing recent studies.

About 6 million people worldwide have one or more drug-eluting stents in their bodies.

The FDA is seeking advice on a wide range of questions on the stents, including whether to update the labels with new warnings, identify patients for whom they aren't appropriate and perhaps change federal recommendations on how long people should take blood thinners like Plavix and aspirin following stent surgery.

Plavix, also known as clopidogrel, can cost $1,400 a year.

The agency also wants advice on what research is needed, both on the drug-coated stents already on the market and others it has yet to consider approving.

"The single most important thing is to be able to provide the American public with the best current state of our knowledge with respect again to the risk and benefits associated with these products," FDA devices chief Dr. Daniel Schultz told reporters.

The miniature lattice-shaped tubes are coated with drugs that slowly dissolve or elute into the bloodstream to prevent regrowth of tissue that can clog arteries anew. Boston Scientific Corp. and Johnson & Johnson are the only two companies approved to sell the drug-coated versions.

Labels on those stents recommend patients take baby aspirin and Plavix for either three or six months, depending on the manufacturer, following surgery. Many patients remain on the drugs longer.

Multiple studies have suggested the risk of blood clots, heart attack and death rises in patients who stop taking those drugs early. The FDA staff said it is unknown how long patients should remain on the drugs to prevent life-threatening clots from forming.

In the new study, researchers found that patients who quit taking Plavix even six or 12 months after receiving a drug-coated stent faced more than twice the risk of premature heart attack or death as did patients who remained on the drug.

"The bottom line from our paper, for doctors and patients, is these results tilt the balance to the fact you should stay on clopidogrel if you have a drug-eluting stent indefinitely until further data tell us how long you should be on it," said Dr. Robert Califf, a Duke University cardiologist.

He estimates that 20 percent to 30 percent of people who have stents take Plavix for 12 months or more. That potentially puts tens of thousands worldwide at risk of heart attack or death each year, he said.

Details appeared Tuesday on the Web site of the Journal of the American Medical Association.

Califf and his colleagues also recommend a 10,000-patient, three-year study to determine whether long-term Plavix use is beneficial. One researcher questioned whether that would be useful, given rapid advances in stent technology and the time required to complete such a study.

"You're talking four to five years down the road and all these stents are going to be obsolete," said Dr. Spencer King, a cardiologist at the Fuqua Heart Center in Atlanta's Piedmont Hospital and past president of the American College of Cardiology.

Another suggested enrolling patients could be difficult if not downright unethical, since researchers would stop giving Plavix to some patients after a year or two and presumably switch them to placebo or dummy pills. Others would stay on the real drug for three years.

"I don't know many cardiologists or their patients who would want to be on the placebo end of that," said Dr. Robert Bonow of Northwestern University and a past president of the American Heart Association.

Boston Scientific has acknowledged a slight increase in clotting associated with its drug-coated stent, the Taxus, but said it's seen no corresponding increase in heart attacks or deaths. Johnson & Johnson said there's no significant difference in clotting, heart attack or death rates between its stent, the Cypher, and bare metal versions. Both companies said use of the drug-coated stents reduces the need for follow-up surgeries to reopen clogged arteries.

However, multiple studies have suggested the risk of blood clots, heart attack and death rises in drug-coated stent patients who stop taking Plavix and aspirin early.

Long-term risks of treatment with Plavix are unknown, the FDA cautioned. The drug, also known as clopidogrel, can cause major bleeding.

The FDA said the risk of blood clotting applies to the drug-coated stents when used as labeled. However, the agency acknowledges that more than 60 percent of the stents probably are implanted in types of patients not studied during the trials of the devices that led to their approval. That off-label use often involves more complex cases; those patients may well benefit more from the drugs in the coated stents but also face greater clotting risk, complicating the issue.

Doctors now implant stents in about 650,000 Americans a year. Since the first drug-coated stents gained FDA approval in 2003, they have gone on to capture 80 percent of the stent market. Doctors like them because there is less reclogging of the arteries in patients given drug-eluting stents.

Another significant question is whether that early benefit is outweighed by a later increased risk of clotting, heart experts said. Why that would be the case is unknown, although researchers have suggested a connection with the rate at which cells in the arteries grow back to envelop the stents. They're also looking at the polymers used to bind the drugs.

Meanwhile, Bonow and others suggested drug-eluting stents should be used more selectively and judiciously. In part that could depend on assessing the risk that a patient's arteries could clog again after surgery or how well they could tolerate or afford long-term use of Plavix.
]]> Controversy Swirls Around FDA Meeting on Drug Coated Stents http://www.yourlawyer.com/articles/read/12355 Tue, 05 Dec 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12355
In advance of the meeting, the FDA released documents today related to an FDA staff review that noted that the drug-coated stents “are associated with a small but significant risk of late-stent thrombosis.” Stents are wire-mesh devices used to unclog arteries. The drug-coated stents are intended to prevent scar tissue from forming in the arteries, but preliminary research has determined that the coated stents may increase the probability of adverse events, including heart attacks and strokes.

Agency critics are amazed and appalled that the FDA would allow panel members with significant ties to the companies whose devices are being reviewed. In a statement last month, Merrill Goozner of the Center for Science in the Public Interest said, “The scientists who advise the FDA should be free of all financial ties to firms whose products are under review. The public’s faith in the integrity of the process will be undermined by any reform legislation that allows physicians and scientists with conflicts of interest to continue serving on these committees.”

In response to the latest controversy, Goozner told the Newark Star-Ledger: “There are literally thousands of experts all over this country who are well-schooled in the details of this field. But instead of reaching out to that community to get a totally unbiased look at this question, the FDA appointed a committee on which a substantial fraction have conflicts of interest directly with manufacturers of products being evaluated. It’s almost impossible to have confidence in the outcomes of this kind of deliberation.”

According to Bloomberg News, one member of the advisory panel is Robert Harrington, who runs a Duke University research institute funded by both J&J and Boston Scientific.

Drug-coated stents have been used in 4 million patients and have sales in the $6 billion range annually. They are significantly more expensive than bare stents, but apparently they are more dangerous as well.
]]> New scrutiny for stents http://www.yourlawyer.com/articles/read/12314 Mon, 04 Dec 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12314
Also known as drug-eluting stents, the devices arrived on the medical scene with great fanfare in 2003 when they were approved by the FDA.

Now, a spotlight has been trained on coated stents because after three years on the market, doctors are finding that some of the 6 million patients with them worldwide are developing potentially dangerous clots. The FDA will determine whether the stents require further study or added warnings.

Word that clots were associated with drug-eluting stents first surfaced in September at an international meeting of cardiologists in Barcelona, Spain. There, researchers presented data showing that clots were occurring as late as three years after coated stents were put in place.

Burt Cohen, director of Angioplasty.org, a consumer advocacy group, said his Web site, which maintains a blog and posts reports about coated stents, has received 90,000 hits a day since September.

Doctors are noticing that patients are paying attention to the news. "It has changed my practice slightly," said Dr. Stephen Green, associate director of the catheterization laboratory at North Shore University Hospital in Manhasset. "But I talk to my patients, and for most of them the drug-coated stent is the stent of choice.

Green, citing federal statistics, estimates that only three to four people per every 1,000 receiving a coated stent will experience late-stage clotting.

When risks and benefits between drug-coated stents and the bare metal variety are weighed, Green said, the drug-coated devices still come out looking much better.

There are two brands of coated stents on the market. One is called the Cypher stent, manufactured by Cordis, a division of Johnson & Johnson. The other, the Taxus stent, is made by Boston Scientific Corp.

After placement of the Cypher stent, patients must take baby aspirin and the anti-clotting drug Plavix for three months; the Taxus stent requires six months of the medications.

"I don't think they'll go so far as a black box warning because there has not been a serious increase in deaths," said Dr. Kirk Garratt, clinical director of cardiovascular research at Lenox Hill Hospital in Manhattan. A black box warning is the highest level of FDA warning.

Dr. David Brown, chief of cardiovascular medicine at Stony Brook University Hospital, thinks a black box warning is out of the question. "My guess is that a couple of things will come out of the meeting: One would be to take Plavix for a longer period than currently recommended."

Dr. Robert Califf, a heart specialist at Duke University, who will provide one of the many scientific papers to be presented at the FDA meeting on Thursday and Friday, said the devices were implanted faster than scientists could collect data.

"As is frequently seen with new cardiac devices, a rapid increase in clinical adoption quickly outstripped what is known about the device from limited clinical trials," he said in a statement Friday.]]> FDA Probes Safety of Popular Heart Stent http://www.yourlawyer.com/articles/read/12312 Sun, 03 Dec 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12312
These gizmos, called drug-coated stents, worked so much better than plain old metal ones that 6 million people worldwide received them in the few years they have been available. It was a modern record for any medical device.

Now their long-term safety is in question.

Doctors think these stents may raise the risk of life-threatening blood clots months and even years later unless people stay on Plavix, an anti-clotting drug whose long-term safety in stent patients has not been established.

Thousands of people are being urged to take the $4-a-day drug until more is known.

Thousands of others each day who develop new blockages are being treated by doctors no longer sure of what to do. Many are returning to the old metal stents, and some are fundamentally rethinking when to use stents at all and are considering alternatives like bypass surgery or medications.

A Food and Drug Administration panel will meet on the issue Thursday and Friday. Medical journals are rushing studies into print, and powerful doctor groups are reconsidering treatment guidelines.

"It's such a huge public health issue with so many people involved," said Dr. Robert Califf of Duke University, who worked on one study to be presented to the FDA.

Doctors also worry about overreacting to a risk that appears small five or fewer clots in every 1,000 patients.

"The benefit of having a drug-eluting stent is tremendous," said Dr. Elizabeth Nabel, director of the National Heart, Lung and Blood Institute.

Stents are used in angioplasty. Through a blood vessel in the groin, doctors push a tube to a blocked heart artery, inflate a balloon to flatten the clog, and prop the artery open with a stent.

About 652,000 Americans had angioplasty in 2003 more than twice the 268,000 who had bypass operations, which are riskier, costlier and take far longer to heal. Angioplasty became more popular when the first drug-coated stent came out that year, virtually eliminating the procedure's main drawback: scar tissue requiring a repeat effort to reopen the vessel.

Two brands are sold in the United States Taxus, by Boston Scientific Corp., and Cypher, by Johnson & Johnson's Cordis Corp. Labels say patients should take baby aspirin and Plavix for three months with Cypher and six months with Taxus, based on how long the stents release medication and how long doctors believed it took for the artery to repair itself by forming a new lining. Many doctors prescribe Plavix for up to a year.

Now it seems the coated stents may keep this essential artery lining from forming for a long time, maybe permanently. Without the lining or Plavix, clots can form and stick to stents.

It happened in May to David Reinhart, a 41-year-old legal secretary in Manhattan who collapsed two weeks after finishing the year of Plavix his doctor recommended.

"I feel a bit of a guinea pig," he said of the stent situation. "It's obvious there's a lot they really don't know about it yet."

If it weren't for Swiss efficiency, the risk might not be known. Switzerland's government required a study to prove the new stents were worth their cost $2,200 to $2,700 versus $600 to $800 for old ones and to test how long Plavix should be taken. This produced the bombshell finding that patients with coated stents had double the risk of cardiac problems after stopping Plavix than those with plain metal stents.

"Everyone has been scrambling around looking in their databases" to see if it's true in their patients, said Dr. Christopher Cannon of Brigham and Women's Hospital in Boston, who consults for Sanofi-Aventis SA, which sells Plavix in the U.S. with Bristol-Myers Squibb.

Many such hospital registry studies have now been reported. Two presented at a recent American Heart Association meeting were provocative.

Dr. Joseph B. Muhlestein at the University of Utah found that deaths and heart attacks were higher with coated stents after three years and that their advantage for preventing artery reclosure disappeared by that time. Doctors in the Netherlands found that the devices were comparable after three years.

"It's led me to wonder maybe we're being too aggressive" in using the new stents, Muhlestein said.

Hospital registries help, but are not solid proof like randomized studies where similar patients are assigned to get one treatment or another. The best picture yet of risk may come from an analysis of pooled results from 14 randomized studies by Dr. Deepak Bhatt at the Cleveland Clinic. Published Wednesday in the American Journal of Medicine, it found that coated stents had five times the risk of clots as plain metal ones.

Some doctors say stents were approved based on studies that were too small, too short and in low-risk patients. Doctors also have used them for cases other than the types of blockages for which they were approved. Success is being further undermined by many patients quitting Plavix too soon.

"They just don't understand how important it is to continue," said Dr. Sidney Smith of the University of North Carolina, past president of the American Heart Association.

Longer Plavix treatment now is being urged "a little bit to get the doctor off the hook," said Dr. David Williams of Brown University. "We're saying indefinite for some patients even though we have no idea what that means" in terms of safety, he acknowledged.

"I find that a very unsettling recommendation," said Dr. Spencer King, a cardiologist at Fuqua Heart Center in Piedmont Hospital in Atlanta and past president of the American College of Cardiology.

Plavix carries a risk of serious bleeding, he noted. Requiring coated stent patients to take it indefinitely puts them at risk of a clot if they have to temporarily stop Plavix to prevent excessive bleeding before a hip replacement or other surgery. Already, there are reports of people suffering such clots when going off Plavix for colonoscopies.

Many people can't afford Plavix. Medicare doesn't cover it unless people have the supplemental drug benefit, and half of angioplasties are done in people over 65.

"In the whole saga, the most important thing comes down to whether the patient is going to take Plavix or not," said Dr. Samin Sharma of Mount Sinai Medical Center in New York.

More research is needed to clarify the drug's role, Cannon said.

"There's a risk that's there when you don't have (Plavix). What we don't have are studies that show what's the risk with it," he said.]]> FDA panel to probe clotting, new stents http://www.yourlawyer.com/articles/read/12304 Thu, 30 Nov 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12304
Drug-coated stents are implanted in nearly a million Americans a year to keep arteries propped open. They are the next generation of a metal mesh device inserted after angioplasty, a procedure in which doctors use a balloon-tipped catheter to open pathways to the heart.

Arteries treated with the first bare metal stents had a tendency to close in some patients. The drug coating was designed to inhibit the development of scar tissue and stop the vessel from clogging again.

The promise of the new device so impressed the medical community that doctors turned to the drug-coated version for most patients since they came on the market in 2003. Some hospitals used drug-coated stents in more than 90 percent of their patients.

But recent reports of clotting issues are causing doctors to think twice about using the newer models in some patients. A new report released Wednesday, based on research led by The Cleveland Clinic, showed a four- to fivefold increased risk of clots compared with the bare metal variety of stent.

Some hospitals have responded by cutting their use of drug-coated stents by 10 percent or more since reports of potential risks began surfacing last fall about so-called late stent clotting, which develops after the device has been in the patient for several months or longer.

"There is that nagging concern about late stent thrombosis that [clotting] concern is out there," said Dr. Gary Schaer, director of the cardiac catheterization lab at Rush University Medical Center in Chicago.

At Rush, Schaer said the hospital had been placing drug-coated stents in patients about 85 percent of the time, but recently that number has dropped to about 75 percent.

In its most recent two-month period, Rush said 68 percent of patients implanted with stents received the drug-coated version. During the same period last year, 88 percent received the drug-coated variety. The hospital said it places about 600 coronary stents in patients annually.

Those types of numbers are bad news for stent manufacturers, including North Chicago-based Abbott Laboratories, which placed a huge bet on heart stents when it purchased Guidant Corp.'s vascular business earlier this year for more than $4 billion. Abbott currently has a drug-coated stent in development for U.S. patients.

Big business

Only two drug-coated stents are on the U.S. market: Boston Scientific Corp.'s Taxus and Johnson & Johnson's Cypher. Both have lost sales. Although Abbott has a drug-coated stent in some European countries, analysts say Johnson & Johnson and Boston Scientific dominate the $6 billion worldwide market.

Drug-coated stents are big business. They can cost $2,200 or more each, compared with $600 to $800 for the uncoated variety, hospitals say.

But the companies and some doctors maintain the risks are small, saying there have not been enough studies completed to warrant a return to bare metal stents. Even hospitals that have curtailed implanting the drug-coated version say they will stick with it for most patients.

At Loyola University Medical Center in west suburban Maywood, where the hospital implants more than 1,500 stents a year, doctors say the risk is not enough to justify a retreat from drug-coated stents.

"There is no evidence that bare metal stents are any safer, they were not as well scrutinized as drug-eluting stents," said Dr. Fred Leya, director of interventional cardiology at Loyola University Health System, parent of the medical center.

While Leya said the risk of clotting in patients is worrisome, he said clotting after the stent has been in the artery for several months or even longer than a year affects "no more than 3 to 4 percent," of patients. A widely reported study last month found a 2.9 percent risk of clotting after three years and the potential to rise.

Leya said the benefits of drug-coated stents outweigh risks, which include re-clogging of the arteries or having to re-implant bare metal stents, as well as risks from the angioplasty procedure itself.

FDA intervenes

The FDA has convened a special panel for next week to look at the clotting issue. The meeting was scheduled to discuss heart devices, but the clotting issue has prompted the FDA to call additional outside experts in to be a part of the discussion. The FDA has not yet disclosed the list, but leading experts in cardiology, drug and device safety are expected. The panel could recommend labeling changes to drug-coated stents. The FDA usually follows recommendations of its panels.

For its part, Abbott believes newer drug-coated stents, like the Xience model it hopes to have on the U.S. market by 2008, could be safer. An Abbott-funded study earlier this year showed Xience had a thrombosis rate of 0.5 percent at six months' usage compared with a 1.3 percent rate for Boston Scientific's Taxus.

Abbott and doctors say all stents are different and should not be lumped in the same bucket when searching for a cause to the clotting issue. Stents have different drug coatings and are implanted with different systems.

"It's not just any one component of a drug-eluting stent that matters it's the whole system," said Abbott spokeswoman Kelly Morrison.

Until Abbott's drug-coated stent hits the market, analysts say the company could benefit in a return to bare metal stents, which it sells as part of its purchase of Guidant. "We have seen a small uptick in bare metal stents in the last few months," said Morrison.

Leya said drug-coated stents reduced the tendency for arteries to re-clog to just 5 percent to 10 percent of patients, compared with 20 percent to 25 percent for the bare metal variety. By comparison, 30 percent to 50 percent of patients who simply had an angioplasty procedure eventually had their arteries re-clog, he said.

Although no one is certain about what causes the clotting issues, cardiologists think some of it may be due to patients not taking their medications to reduce the risk of clots. .

Doctors say they encourage patients who have drug-coated stents to take aspirin and a common anti-clotting drug known as Plavix for up to six months or longer. The pills can cost $3 to $4 a day if they do not have drug coverage.

"A combination of aspirin and Plavix is extremely important," said Rush's Schaer. "We are more conservative about using the drug-coated stents in patients who are less compliant ."
]]> Cleveland Clinic Analysis Finds Patients With Drug-Eluting Stents Are at Increased Risk for Late Thrombosis http://www.yourlawyer.com/articles/read/12293 Wed, 29 Nov 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12293
Drug-eluting and bare-metal stents are commonly used to treat patients with coronary artery disease. There has been a growing body of evidence that drug-eluding stents, when compared to bare-metal stents, may increase the risk of blood clot formation long after they are implanted, potentially triggering a heart attack.

"Our analysis found there is a small, but real, hazard of late stent thrombosis with drug-eluting stents more so than with bare-metal stents, likely in the setting of discontinuation of anti-clotting drugs," said Deepak L. Bhatt, M.D., Associate Director of the Cleveland Clinic Cardiovascular Coordinating Center and one of the study's authors. "This does not, however, mean that drug-eluting stents should not be used, as other studies have shown that they do significantly reduce the need for repeat procedures compared with bare-metal stents."

Fourteen studies with 6,675 total patients were included in the analysis comprising nine sirolimus stent trials and five paclitaxel stent trials. Eight of the trials reported more than a year of clinical follow-up. The sirolimus trials mandated anti-clotting medication for at least two to three months and the paclitaxel trials required six months.

"The key to the controversy is likely careful patient selection," Dr. Bhatt said. "Further research is needed to determine how best to utilize drug- eluting stents and anti-clotting medications."

This analysis precedes an FDA Advisory Panel set to meet next week in Washington, D.C. The committee will discuss and make recommendations regarding issues related to stent thrombosis in coronary drug-eluting stents.

Cleveland Clinic Heart & Vascular Institute is the recognized world leader in diagnosis and treatment of cardiovascular disease. Cleveland Clinic has been ranked No. 1 in the nation for cardiac care by U.S. News & World Report every year since 1995. Cleveland Clinic has been ranked among America's Ten Best Hospitals every year since 1990 by U.S. News & World Report.

Cleveland Clinic, located in Cleveland, Ohio, is a not-for-profit multispecialty academic medical center that integrates clinical and hospital care with research and education. Cleveland Clinic was founded in 1921 by four renowned physicians with a vision of providing outstanding patient care based upon the principles of cooperation, compassion and innovation. U.S. News & World Report consistently names Cleveland Clinic as one of the nation's best hospitals in its annual "America's Best Hospitals" survey. Approximately 1,500 full-time salaried physicians at Cleveland Clinic and Cleveland Clinic Florida represent more than 100 medical specialties and subspecialties. In 2005, there were 2.9 million outpatient visits to Cleveland Clinic. Patients came for treatment from every state and from more than 80 countries. There were nearly 54,000 hospital admissions to Cleveland Clinic in 2005. Cleveland Clinic's Web site address is www.clevelandclinic.org.]]> Health Canada warning over birth control patch http://www.yourlawyer.com/articles/read/12283 Fri, 24 Nov 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12283
The department, along with drugmaker Janssen-Ortho Inc., issued the statement based on research that showed a U.S. formulation of the company's patch contraceptive may be associated with a higher risk of blood clots than oral birth control pills.

"We're taking the precaution of giving people an additional heads up that there's a risk of blood clots with the product," said Health Canada spokesperson Alastair Sinclair.

Janssen-Ortho's U.S. formulation is sold under the brand name Ortho Evra.

The Canadian product, sold as Evra, contains a lower dose of estrogen.

The advisory noted women who are obese are particularly at higher risk of blood clots.

It also points out there is a theoretical risk that exposing the patch to heat could lead to increased exposure of estrogen, so it recommends women wearing an Evra patch avoid saunas and hot tubs.

Sinclair said there have been 78 adverse events reported by Canadian users of Evra since the patch hit the market in 2004. Of those, 14 were cases of blood clots and one was a heart attack.]]> Birth control patch raises blood clot risk: Health Canada http://www.yourlawyer.com/articles/read/12281 Thu, 23 Nov 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12281
The patch sold in the U.S., which contains more of the ingredient ethinyl estradiol than those sold in Canada, has been linked to a higher risk of blood clots than oral birth control pills, the maker of the patch said.

However, both may carry the same risk of side-effects, Health Canada said.

"We're taking the precaution of giving people an additional heads-up that there's a risk of blood clots with the product," said Health Canada spokesperson Alastair Sinclair.

Women who are obese are at particularly high risk of blood clots, the safety alert said.

Canadian labels for Evra say it is important to stop using the medication at the earliest sign of blood clots.

Symptoms of blood clots may include:
  • Pain in the calf.
  • Shortness of breath.
  • Chest pain.
  • Coughing blood.
New information has been added to the drug information that describes the theoretical risk of unintentional increase in exposure to the hormone estradiol in patients with a fever.

Since the theoretical risk also exists if the patch application site is exposed to heat sources, women wearing an Evra patch should avoid saunas or whirlpool baths, the advisory said.

There have been 78 reports of side-effects in Canadian users of Evra since the patch hit the market at the beginning of 2004. Of those, 14 were cases of blood clots and one was a heart attack, Sinclair said.

The U.S. Food and Drug Administration released a similar warning in September.
]]> Health Canada warns of increased blood clot risks from birth control patch http://www.yourlawyer.com/articles/read/12282 Thu, 23 Nov 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12282
The department, along with drug maker Janssen-Ortho Inc., issued the statement based on research that showed a U.S. formulation of the company's patch contraceptive may be associated with a higher risk of blood clots than oral birth control pills.

"We're taking the precaution of giving people an additional heads up that there's a risk of blood clots with the product," said Health Canada spokesperson Alastair Sinclair.

Janssen-Ortho's U.S. formulation is sold under the brand name Ortho Evra. The Canadian produce, sold as Evra, contains a lower dose of estrogen. Still, Health Canada said it believes both products carry the same risk of adverse events.

The advisory noted women who are obese are particularly at higher risk of blood clots. It also points out there is a theoretical risk that exposing the patch to heat could lead to increased exposure of estrogen, so it recommends women wearing an Evra patch avoid saunas and whirlpool baths.

Sinclair said there have been 78 adverse events reported by Canadian users of Evra since the patch hit the market at the beginning of 2004. Of those, 14 were cases of blood clots, and one was a heart attack.

The U.S. Food and Drug Administration issued a similar warning about Ortho Evra in late September.]]> Millions face risk from drug-coated stents http://www.yourlawyer.com/articles/read/12272 Tue, 21 Nov 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12272 Millions of Americans could be walking around with tiny time bombs in their hearts.

The concern centers on devices called drug-eluting stents. Doctors implant them in the hearts of about a million Americans a year to treat coronary artery disease. They generate some $5 billion a year in sales for the two companies that make them. But they may be doing more harm than good.

Next month a panel of experts will try to advise the Food and Drug Administration on what to do about it. But many top doctors and scientists admit they are in uncharted waters with a frightening problem that was largely unanticipated. By one estimate the devices already kill 2,000 Americans a year and no one knows what the long-term danger will be.

To understand the potential hazard, it helps to look at the history of efforts to open the arteries to the heart when they get clogged with cholesterol-containing plaque. That blockage leads to shortness of breath and the chest pains called angina. If the artery closes completely the result is a heart attack with destruction of heart muscle and often death.

Beginning around 1980, doctors started using tiny balloons inserted on wires through the veins and guided by X-rays to push open the clogged arteries. This procedure, called angioplasty, often worked but with a problem. In about half the cases the artery would close up again within a few weeks or months, an outcome called restenosis. The re-shutting of the arteries occurs because the blood vessels respond to the treatment as if they suffered a slight wound. They try to heal by growing more cells which can clog the artery again.

Thwarting the body's own healing process

To solve the problem, starting in 1994, cardiologists put tiny pieces of wire mesh called stents around the balloons. These stay in place as a piece of scaffolding to try to keep the arteries open.

These helped, but not enough.

Cells still grew over the wire, and in 20 percent to 30 percent of the cases, the vessel clogged again.

Drug-eluting stents (DES) appeared as the next solution. These give off a drug that prevents  cell growth, and for that, they work well. The restenosis rate fell to about 5 percent. In 2003, soon after the FDA approved them, drug-eluting stents captured most of the market, even though they cost about $2,000 compared to $800 for the bare metal version.

Then a new hazard started to appear.

Doctors began seeing patients suffer from heart attacks that seemed to be triggered by the new stents. Because the drug-eluting stents are so effective at stopping the cell proliferation inside the arteries, the DES's end up as a piece of metal sticking out in the artery. That creates a perfect place for a blood clot to form and instantly block the artery. The result? A potentially fatal heart attack.

Dr. Jeffrey Moses of Columbia University, who conducted some of the original studies of the DES's, estimates the danger of a blood clot at 1 in 500 patients a year. For every million of the devices implanted, that would add up to 2,000 clots a year although not all of them would be fatal.

But an estimate from Drs. Sanjay Kaul and George Diamond from Cedars Sinai in Los Angeles, published on the Web site of the American College of Cardiology, estimates that deaths from the new devices exceed 2,000 a year. Studies from Europe regard the danger to be many times higher. Because the devices are so new no one knows how long the hazard persists.

Already, many cardiologists are cutting back from using the devices. Sales are dropping dramatically. The FDA panel may well recommend they not be used at all.

Companies are searching for alternatives, including balloons that give off the drugs and would be removed at the time of the procedure, as well as stents that dissolve a few weeks after they are implanted.

What's next?
The big question now facing the FDA is: What should the estimated 4 million patients who already have a DES do?

The devices cannot be removed safely or easily. One preventive measure is to keep the patient on the blood-clotting medication Plavix for months or even indefinitely. But that medicine can cause severe bleeding, including a type of deadly stroke, and it costs more than $1,200 a year.

DES manufacturers Boston Scientific and Johnson & Johnson could end up rivaling Vioxx maker Merck as targets of lawsuits from people who suffer heart attacks.

The origin of this terrifying problem is that medical devices, like drugs, get tested for a few months in a few hundred or at most a few thousand of people before the FDA approves them.

Many experts are clamoring for better methods of assuring safety before devices like these go into millions of people for a lifetime.

]]> Quebec court gives go-ahead for Vioxx suit http://www.yourlawyer.com/articles/read/12253 Sat, 11 Nov 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12253 Quebec is North America's first jurisdiction to allow a consumer class-action lawsuit against Merck & Co. Inc. over its painkiller Vioxx.

On Thursday, Quebec Superiour Court Judge Andre Denis authorized a class-action lawsuit by Quebec residents who suffered "damages caused by the use of the medication" between October 1999 and September 2004.

The number of Quebecers eligible to join the class-action suit isn't clear.

Merck says the class action is open only to Vioxx users who've suffered proven physical injuries because of the drug an interpretation of the term "damages" that would severely limit the number of eligible plaintiffs.

But a lawyer for the plaintiffs argued Quebecers who have suffered monetary "damages" linked to the drug's comparatively high price should also be included an interpretation that would potentially allow thousands of former users to participate.

On Sept. 30, 2004, Merck withdrew Vioxx a nonsteroidal anti-inflammatory drug related to ibuprofen after trial data showed the long-term use of the drug increased the risk of heart attacks and strokes.

Vioxx was used to treat the symptoms of arthritis, painful menstrual cycles and other types of acute pain. Merck has set aside more than $1.2 billion U.S. for Vioxx lawsuits.

On Wednesday, Merck chief executive officer Richard Clark said it could be several years before the company considers settling thousands of Vioxx lawsuits.

A lawyer for plaintiffs in Quebec and Ontario, said there have been more than 20 requests for class-action lawsuits filed across Canada over Vioxx. This is the first Vioxx class-action lawsuit that has received legal clearance to proceed.

Citing statistics by IMS Health Inc., a plantiffs attoreny said Quebecers consumed a disproportionate amount of Vioxx; between 1999 and 2004, 6.3 million prescriptions were written for the drug in Quebec, compared with 15.6 million for all of Canada.

"Given the number of people in Quebec who took Vioxx, it's a significant development," said a palntiffs attorney of the London-Ont. based Siskinds LLP.

The petition for a class action was filed by two plaintiffs, retired teacher Gerald Sigouin and Roger Ste-Marie, a car insurance adjuster. Both men, the court decision said, allege that they suffered heart attacks after using Vioxx for more than three years.

They said Merck "failed in its obligation to adequately inform consumers of (Vioxx's) side effects," a court document shows.

"If the consumers were adequately informed of the inherent risks in taking Vioxx, they wouldn't have taken it, or would have stopped taking it long before."

In his decision, Denis wouldn't allow family members and spouses of Vioxx users to participate in the class action.

Andre Payeur, attorney for Merck Frosst Canada, said the decision was a good one for the company as it limited participants to those who could prove they had been physically harmed by the drug.

"We're talking about very few people," he said.

Payeur defined "damages" as physical harm, as "this is a personal injury claim."

But in a legal squabble that could result in future court delays, plaintiffs attorney  said he defined "damages" as being both physical and monetary.

The plantiffs attorney argued that Merck justified charging more for Vioxx because the company claimed it was safer than other anti-inflammatories on the market. Plaintiffs, he said, could join the class action to seek monetary damages.

"It is surprising to us that Merck is seeking to characterize this as a victory," he said.

It's now up to the plaintiffs to initiate lawsuit proceedings.

Denis's decision isn't the first Vioxx-related class action to proceed in the courts.

In New Jersey, plaintiffs composed of insurance companies were given court authorization for a class action against Merck over the drug. Merck is appealing that decision, Payeur said.

In Quebec, Merck is not permitted to appeal the court's decision.

]]> Parker & Waichman, LLP Files 100th Lawsuit Against Ortho-McNeil Pharmaceutical, Inc.; Case Filed on Behalf of 26 Year Old Woman who Suffered Pulmonary Embolism after Using the Birth Control Patch for 9 Months http://www.yourlawyer.com/articles/read/12235 Mon, 06 Nov 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12235
To request a free Ortho Evra case consultation for yourself or a loved one, please visit www.orthopatchlawsuit.com or www.yourlawyer.com/topics/overview/Ortho_Evra_Patch .

Case Details:

On October 13, 2003, at age 26, the injured woman was taken to the emergency room at Kings’ Daughters’ Medical Center in Kentucky after experiencing shortness of breath. Diagnostic tests administered at the hospital revealed that the woman was suffering from pulmonary emboli. The victim was admitted to the hospital and received anticoagulant treatment. It is likely that the injured woman will need anticoagulant medication for a protracted period of time and potentially for the remainder of her life. Additionally, this condition may prevent the victim from using certain medications that may be necessary for her health in the future, including hormone replacement therapy.

About Ortho Evra:

In September 2006, an epidemiological study provided further evidence that Ortho Evra is unreasonably dangerous and should be recalled from the market. The study found that women using the Ortho Evra birth control patch are twice as likely to develop blood clots when compared with those using oral birth control pills. As a result of this study, The Food and Drug Administration updated Ortho Evra’s warning language to reflect that women using the patch face twice the risk of blood clots as compared to women on the pill. The FDA also asked Ortho McNeil to conduct a longer study of the contraceptive patch to evaluate the risks of blood clots, heart attack and stroke.

On November 10, 2005, Ortho McNeil, in conjunction with the FDA, modified its package insert to reflect that users of Ortho Evra are exposed to significantly more estrogen than women using oral contraceptives. In the November 10, 2005 label change, Ortho-McNeil admitted for the first time that women who use the patch will be exposed to up to 60% more estrogen than they would be exposed to if they were taking a birth control pill with 35 micrograms of estrogen. The patch is only intended to deliver 20 micrograms of estrogen. The FDA’s announcement on this warning can be found at www.fda.gov/bbs/topics/news/2005/NEW01262.html. It is widely understood that increased exposure to estrogen greatly increases the risk of blood clots, which can cause serious injury or death.

Pulmonary embolism is a sudden blockage in a lung artery, usually due to a blood clot that traveled to the lung from the leg, but clots can also form in the pelvic vein. Pulmonary thromboembolism can be fatal or may result in pulmonary arterial obstruction, pulmonary obstruction, pulmonary infarction, chronic pulmonary hypertension, dyspenea and tachypnea. Symptoms may include shortness of breath, difficulty breathing, anxiety, chest pain, fainting and convulsions. Treatment may include long term use of anticoagulant medications and/or surgery. Recent reports have indicated that the risk of developing blood clots, pulmonary thromboembolism, heart attack and stroke may be significantly higher with the Ortho Evra patch than with oral contraceptive use.

It is alleged that Ortho-McNeil was aware of the increased medical risks associated with Ortho Evra before the drug was approved and that, once approved, the company failed to adequately warn patients about these risks. Evidence shows that the risk of blood clots, heart attack and stroke associated with Ortho Evra is significantly higher than with oral contraceptive pills. The incidence of embolisms and thrombotic injuries in Phase III trials of Ortho Evra was reportedly six times greater than the incidence of such events in oral contraceptives using the hormone levonorgestrel. As of November 2005, the FDA had logged 9,116 reports of adverse reactions to the patch in a 17-month period, whereas Ortho Tri-Cyclen, a birth control pill, only generated 1,237 adverse reports in a six-year period. During a 12-month period, 44 serious injuries or deaths were associated with Ortho Evra, whereas only 17 such reports were linked to the birth control pill during a similar time period. The pattern is further magnified when usage rates are considered: Ortho Tri-Cyclen has six times the number of users as Ortho Evra.

Ortho Evra is an adhesive, transdermal birth control patch that users are instructed to apply to their upper torso, upper outer arm, buttock or abdomen. The patch is intended to release 150 mcg of norelgestromin and 20 mcg of ethinyl estradiol into the bloodstream per 24 hours. It is replaced once a week for three weeks, and no patch is worn during the fourth week during menstruation. The regimen is then repeated. Ortho Evra was approved by the FDA in November 2001, and over 4 million women have used Ortho Evra since its approval. Ortho Evra continues to be marketed aggressively to both consumers and physicians.

About Parker & Waichman, LLP

Parker & Waichman, LLP is a leading products liability and personal injury law firm that represents plaintiffs nationwide. The firm has offices in New York and New Jersey. Parker & Waichman, LLP has assisted thousands of clients in receiving fair compensation for injuries resulting from defective medications and medical devices. The firm is currently representing individuals injured by Vioxx, Bextra, Zyprexa, Ketek, ReNu with MoistureLoc, Guidant Defibrillators and many other defective drugs and medical products. For more information on Parker & Waichman, LLP, please visit: www.yourlawyer.com or call (800) LAW-INFO.

CONTACT: Parker & Waichman, LLP

Jason Mark, Esq.

Melanie H. Muhlstock, Esq.

(800) LAW-INFO

(800) 529-4636

info@yourlawyer.com

www.yourlawyer.com
]]> Women sue the makers of birth-control patch http://www.yourlawyer.com/articles/read/12224 Thu, 02 Nov 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12224
One lawsuit alleges that 43 women suffered from blood clots and other health ailments after taking Ortho Evra, one of the fastest-growing forms of contraception in the U.S.

A second complaint claims 25-year-old Kelly Bracken of Elk Ridge, Md., died of severe blood clots in her lungs and legs after she started wearing the patch.

The lawsuits, filed in San Francisco Superior Court, name as defendants the drug's manufacturer, Ortho-McNeil Pharmaceutical Co., a Titusville, N.J.-based subsidiary of Johnson & Johnson; and San Francisco-based distributor McKesson Corp.

Officials for Ortho-McNeil and McKesson did not immediately respond to calls seeking comment Wednesday.

Approved by the Food and Drug Administration in 2001, Ortho Evra is a patch that delivers the hormones estrogen and progestin directly into the bloodstream through the skin.

The lawsuit claims that Ortho-McNeil failed to properly investigate the product's safety and deceived the public about the severity of potential side effects, including strokes and severe blood clots.

In September, the FDA warned women that their risk of blood clots in the legs and lungs may be higher if they use Ortho Evra instead of the pill.]]> FDA warns of contraceptive patch dangers http://www.yourlawyer.com/articles/read/12217 Thu, 26 Oct 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/12217
The Associated Press reported this month that a young woman in Idaho has filed a lawsuit in federal courts against the companies manufacturing the birth control patch Ortho Evra made by Ortho-McNeil, a subsidiary of Johnson & Johnson.

The woman began using the patch at age 17 in 2004, and after using the patch for only one month, she was diagnosed with a blood clot disorder that can sometimes be fatal. She now has to take daily anticlotting medications, preventing her from ever taking medications containing estrogen, such as birth-control pills or treatments for menopause and hormonal imbalances.

Hundreds of lawsuits over the patch have been filed nationwide stating similar side effects,

according to company officials

The patch works by releasing synthetic estrogen and progestin into the blood. It is applied on a weekly basis and has more hormones than other forms of birth control.

Diane Zanto, Director of Student Health, said she has never seen any student on campus with these threatening issues from using the patch.

The patch has small risk factors along with other birth control methods, she said, but with the patch, the absorption rates are higher. Similar to taking the pill, there are increased risks of cardiovascular problems, and users should watch for minimal chest pains, shortness of breath and mild headaches.

The Ortho Evra patch, introduced in 2001, is the only FDA approved skin birth control patch. Since its release, the FDA updated the warning label on the patch after two separate epidemiology studies were conducted to evaluate its risk of serious side effects.

The FDA added information to the Ortho Evra label in November 2005 regarding the risk of increased exposure to estrogen seen in women who use Ortho Evra compared with oral contraceptives. In September 2006, the FDA announced an update to the label, notifying consumers of increased risks of blood clothing in legs and lungs.

The first study found that the risks of non-fatal, but serious blood clots from using the patch are similar to those accompanying oral contraceptive pills. The second study conducted by another group, shows a nearly two-fold increase in the risk of blood clotting in Ortho Evra users compared to users of other methods such birth control pills.

UW-Oshkosh alumna, Jessica Stern experienced side effects after only four months of using the Ortho Evra patch. “I realized that something wasn’t right,” she said. “As time went on, I had noticed that I was getting very emotional no matter what I was doing.”

Even though Stern didn’t experience any life-threatening side effects, she said that after awhile she was getting bad headaches, experiencing dizziness and feeling tired all of the time.

After these occurrences, her doctor recommended she stop wearing the patch. Eventually, she felt like she was “back to normal,” but was afraid of using another form of birth control because, “I never wanted to go through that experience again,” she said.

As for the recent FDA warning updates of the patch, Stern said she’s not really worried about the life threatening side effects. “I have looked at some of the Web sites and the main issues they are having with the patch,” she said. “I don’t have any thing that was listed, and as of right now, I am healthy according to my doctor.”

The patch is still being recommended by health officials and seen as an effective use of birth control, except to women who smoke or are over the age of 35. According to the makers of the patch, side effects of the patch are not serious and those that are occur infrequently.

]]> Heart Stents Reconsidered by Medical Community http://www.yourlawyer.com/articles/read/12356 Wed, 25 Oct 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/12356
Recent evidence points to an increased risk of fatal blood clotting associated with a particular type of stent, the drug-coated stent. Drug-coated stents were virtually non-existent as recently as five years ago, but now they command more than 85 percent of the stent market. The FDA has scheduled meetings for this coming December in order to discuss the issue in more detail and perhaps call for further studies.

This week, an FDA official urged Boston Scientific and Johnson & Johnson, the two largest stent producers, to conduct further research into the matter. “The real question is how to expand the knowledge base for many thousands of patients being treated ‘off-label,’” said Bram Zuckerman, director of the FDA’s division for cardiac devices.

The debate over the use of stents has divided the medical community. Most agree that the use of stents–mesh tubes used to hold open clogged arteries–have been instrumental in saving thousands of lives. Beyond that, other questions remain: Are too many doctors recommending the stenting process rather than more traditional treatments such as medication or surgery? Are the more expensive drug-coated stents more dangerous than cheaper non-coated ones? Are the safety risks connected to the method and accuracy of implantation, rather than the product itself?

Several studies this year have pointed to long-term risks of clotting associated with the drug-coated stents in particular. The coated stents are used to prevent tissue from reforming in the arteries. What seems most alarming about them, according to recent studies, is that the risk of clotting has not diminished over time, forcing some patients to remain on anti-clotting medication for extended periods.

Last week, a New England Journal of Medicine study reported that the risk of stroke or death was more than two times higher for patients receiving stents than it was for patients who are treated by endarterectomy (an invasive surgical treatment). That study specifically regarded patients suffering from carotid artery blockage. In a commentary in the same issue of the NEJM, Dr. Anthony J. Furlan said, “The benefits of surgery in reducing the long-term risk of stroke need to be weighed against the immediate risk of death or stroke as a complication of the surgery.” He also said that, based on current FDA guidelines, stenting should be reserved for those patients with a significant (more than 70 percent) blockage who have displayed stroke symptoms and are at a high risk of surgical complications.
]]> Data: Drug-coated stents carry clot risk http://www.yourlawyer.com/articles/read/12208 Tue, 24 Oct 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/12208
The data, presented at the Transcatheter Cardiovascular Therapeutics meeting, revealed that the drug-coated stents, manufactured by Boston Scientific Corp. and Johnson & Johnson, carry a statistically significant higher risk of blood clots that could lead to major heart attacks, The Wall Street Journal reported Tuesday.

The data were taken from 1,800 patients implanted with Boston Scientific Corp.'s Taxus stent and 3,500 patients implanted with Johnson & Johnson's Cypher stent. Analysis of the data revealed that the Taxus stent caused a 0.4-percent risk of blood clot, while the Cypher stent caused a 0.6-percent risk. While the percentages are small, experts said they are statistically significant. The experts said stent blood clots have a 70-percent chance of causing major heart attacks and deaths.

A Johnson & Johnson spokesman said the numbers "are subject to interpretation by a number of methodologies, some of which may yield significant differences at certain time points."]]> Warning added to birth control patch http://www.yourlawyer.com/articles/read/12145 Sat, 23 Sep 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/12145
The Food and Drug Administration said it updated the label on the Ortho Evra birth control patch to reflect the results of one study that found women using the patch faced twice the risk of clots than did women on the pill.

However, a second study found no difference in risk between the two forms of birth control.

"Even though the results of the two studies are conflicting, the results of the second epidemiology study support FDA's concerns regarding the potential for Ortho Evra use to increase the risk of blood clots in some women," the FDA said in a notice published on its Web site.

Initial results of the two studies were made public in February by the patch's manufacturer, Ortho Women's Health & Urology. The Raritan, N.J.-based company is owned by Johnson & Johnson.

Last year an investigation by the Associated Press, citing federal death and injury reports, found higher rates of blood clots in women using the patch.

The FDA recommended that women with concerns about clots and use of the patch talk to their doctors.

"We cannot conclude there is in fact a greater risk," Shames said. "We are however concerned enough about this information and we think it is important enough information that it should be given to consumers and to health care providers so they can make better choices."

In November, the FDA updated the label on Ortho Evra to alert women that using the patch exposes them to about 60 percent more estrogen than using birth control pills.

Johnson & Johnson previously has said clots remain rare and that they have been reported as a potential risk of all hormonal contraceptives.

Dr. Daniel Shames, of the FDA's Center for Drug Evaluation and Research, said the studies, which rely on insurance claims information on upward of 500,000 women, would last another 18 to 24 months.

The company also said it would continue to provide new information to the FDA.

The company reported in filings made last month that Ortho Evra sales have declined significantly following the previous label revision and a spate of media coverage of the clot issue.

Since the patch went on sale in 2002, more than 4 million women have used it.

The company disclosed that about 500 people have filed lawsuits or made claims related to injuries they allegedly suffered from over the Ortho Evra patch.]]> Parker & Waichman, LLP Believes New Study On Ortho Evra Provides Further Evidence That the Birth Control Patch is Associated With Higher Rates of Blood Clots http://www.yourlawyer.com/articles/read/12141 Thu, 21 Sep 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/12141 Parker & Waichman, LLP (www.yourlawyer.com) announced that it believes a new study provides further evidence that Ortho Evra is dangerous and should be recalled from the market. The study found that women using the Ortho Evra birth control patch were twice as likely to develop blood clots compared with those using oral birth control pills. Parker & Waichman, LLP currently represents hundreds of clients who were injured while using the Ortho Evra birth control patch. The firm has cases pending in state and federal courts against Ortho-McNeil Pharmaceutical, Inc, a division of Johnson & Johnson, Inc. (NYSE:JNJ). For more information on Ortho Evra, please visit www.orthopatchlawsuit.com and www.yourlawyer.com/topics/overview/Ortho_Evra_Patch.

As a result of this study, The Food and Drug Administration updated Ortho Evra's warning language to reflect that women using the patch faced twice the risk of blood clots as women on the pill. The FDA also asked Ortho McNeil to conduct a longer study of the contraceptive patch to evaluate the risks of blood clots, heart attack and stroke. The FDA warning came despite a second study, which did not show an increased risk of blood clots with Ortho Evra compared to oral birth control pills. Parker & Waichman, LLP believes the data from this second study is fundamentally flawed for several reasons, including its failure to properly analyze the medical records of Ortho Evra patients.

This is not the first time there have been changes made to the warnings about Ortho Evra's risks. The first warning about the increased risks of blood clots associated with Ortho Evra was issued on November 10, 2005. In that warning, Ortho-McNeil admitted for the first time that women who use the patch will be exposed to up to 60% more estrogen than they would be exposed to if they were taking a birth control pill with 35 micrograms of estrogen. The patch is only intended to deliver 20 micrograms of estrogen.

Parker & Waichman, LLP believes the evidence about Ortho Evra's increased safety risks strongly supports the need to have the drug permanently recalled from the market. "The notion that periodic warnings of Ortho Evra's increased risks is sufficient to protect the health of women is misguided. There are many safer alternative forms of hormonal contraception than the patch. This is not a last resort, life saving medication. The product needs to be withdrawn from the market so that it can no longer cause harm," said Jason Mark, an attorney at Parker & Waichman, LLP who heads the firm's mass tort department.

It is alleged that Ortho-McNeil was aware of the increased medical risks associated with Ortho Evra before the drug was approved and that, once approved, the company failed to adequately warn patients about these risks. Evidence shows that the risk of blood clots, heart attack and stroke associated with Ortho Evra is significantly higher than with oral contraceptive pills. The incidence of embolisms and thrombotic injuries in Phase III trials of Ortho Evra was reportedly six times greater than the incidence of such events in oral contraceptives using the hormone levonorgestrel. The FDA has logged 9,116 reports of adverse reactions to the patch in a 17-month period, whereas Ortho Tri-Cyclen, a birth control pill, only generated 1,237 adverse reports in a six-year period. During a 12-month period, 44 serious injuries or deaths have been associated with Ortho Evra, whereas only 17 such reports were linked to the birth control pill during a similar time period. The pattern is further magnified when usage rates are considered: Ortho Tri-Cyclen has six times the number of users as Ortho Evra.

Ortho Evra is an adhesive, transdermal birth control patch that users are instructed to apply to their upper torso, upper outer arm, buttock or abdomen. The patch is intended to release 150 mcg of norelgestromin and 20 mcg of ethinyl estradiol into the bloodstream per 24 hours. It is replaced once a week for three weeks, and no patch is worn during the fourth week during menstruation. The regimen is then repeated. Ortho Evra was approved by the FDA in November 2001, and over 4 million women have used Ortho Evra since its approval. Ortho Evra continues to be marketed aggressively to both consumers and physicians.

About Parker & Waichman, LLP

Parker & Waichman, LLP is a leading products liability and personal injury law firm that represents plaintiffs nationwide. The firm has offices in New York and New Jersey. Parker & Waichman, LLP has assisted thousands of clients in receiving fair compensation for injuries resulting from defective medications and medical devices. The firm is currently representing individuals injured by Vioxx, Bextra, Zyprexa, Ketek, ReNu with MoistureLoc, Guidant defibrillators and many other defective drugs and medical products. For more information on Parker & Waichman, LLP, please visit: www.yourlawyer.com or call (800) LAW-INFO.

CONTACT:  

Parker & Waichman, LLP
Jason Mark, Esq.
Melanie H. Muhlstock, Esq.
(800) LAW-INFO
(800) 529-4636
info@yourlawyer.com
www.yourlawyer.com

 

]]> GALS' PATCH PERIL http://www.yourlawyer.com/articles/read/12142 Thu, 21 Sep 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/12142
The new warnings came months after a manufacturer settled dozens of lawsuits involving the patch and more than two years after a Manhattan fashion student collapsed and died after using one.

The move by the Food and Drug Administration follows a series in The Post which detailed the dangers associated with the trendy contraceptive and uncovered dozens of women who had died or been crippled after wearing the device.

The Post also revealed evidence that the manufacturer's chief researcher was hired in 2000 after faking hormone data in previous scientific studies for another company in the mid-1990s.

The FDA said it updated the label on the Ortho Evra birth-control patch to reflect the results of a recent study that said women using the patch faced twice the risk of clots as women on the pill.

The patch, which is worn on the skin, delivers pregnancy-blocking hormones. It's replaced once a week and is viewed as more convenient than daily pills.

In April, 2004, aspiring model Zakiya Kennedy collapsed on a Midtown subway platform and died from a blood clot in her lung.

The medical examiner blamed the patch, which the 18-year-old had worn briefly.

Kennedy's family filed a multimillion-dollar wrongful-death suit which is still pending against the manufacturer's parent company, Johnson & Johnson, and Mount Sinai Hospital, where a doctor prescribed the patch. They applauded the new label.

"That's a good thing that they updated it," said Kennedy's grandmother, Roberta Alloway. "That should help get the message across that it's a dangerous product."

Alloway said her ultimate goal is to get the product off the market entirely. In the meantime, she said she hopes the new label is easy to read and understand.

"Unfortunately, my granddaughter had to die to bring it to the forefront," Alloway said.

The FDA said it was issuing the updated label despite conflicting results from another study that there was no added risk in using the patch instead of the pill.

"Health-care providers need to balance the risk of higher estrogen exposure with Ortho Evra with the risk of pregnancy if the pill is not taken daily." said Dr. Daniel Shames of the FDA.

Researchers believe estrogen may promote coagulation of the blood, which can result in clots that cause heart attacks or strokes.
]]> Birth-Control Patch Label Warns of Risk http://www.yourlawyer.com/articles/read/12135 Wed, 20 Sep 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/12135
The Food and Drug Administration said it updated the label on the Ortho Evra birth-control patch to reflect the results of one study that found women using the patch faced twice the risk of clots than did women on the pill. However, a second study found no difference in risk between the two forms of birth control.

"Even though the results of the two studies are conflicting, the results of the second epidemiology study support FDA's concerns regarding the potential for Ortho Evra use to increase the risk of blood clots in some women," the FDA said in a notice published on its Web site.

Initial results of the two studies were made public in February by the patch's manufacturer, Ortho Women's Health & Urology. The Raritan, N.J.-based company is owned by Johnson & Johnson.

Last year an investigation by The Associated Press, citing federal death and injury reports, found higher rates of blood clots in women using the patch.

The FDA recommended that women with concerns about clots and use of the patch talk to their doctors.

In November, the FDA updated the label on Ortho Evra to alert women that using the patch exposes them to about 60 percent more estrogen than using birth-control pills.

Johnson & Johnson previously has said clots remains rare and that they have been reported as a potential risk of all hormonal contraceptives.

Ortho Women's Health & Urology said in a statement that data will continue to be collected for both studies. The company also said it would continue to provide new information to the FDA.

The company reported in filings made last month that Ortho Evra sales have declined significantly following the previous label revision and a spate of media coverage of the clot issue. Since the patch went on sale in 2002, more than 4 million women have used it.

The company also disclosed that approximately 500 people have filed lawsuits or made claims related to injuries they allegedly suffered from the Ortho Evra patch.

The investigation by The Associated Press found that patch users die and suffer blood clots at a rate three times higher than women taking the pill. About a dozen women died in 2004 from blood clots believed linked to use of the patch, the AP reported. Dozens more suffered strokes and other clot-linked problems.

Health officials warn that women who smoke should not use the patch, since smoking increases the risk of stroke and heart attack.
]]> Parker & Waichman, LLP Files Lawsuit Against Ortho-McNeil Pharmaceutical, Inc. on Behalf of Ortho Evra Victim - JNJ http://www.yourlawyer.com/articles/read/12194 Tue, 19 Sep 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/12194
On August 24, 2004, the injured victim was taken to the emergency room at St. Mary's Medical Center in Wisconsin after experiencing lightheadedness, shortness of breath and chest pain. Diagnostic tests taken at the hospital revealed bilateral pulmonary emboli. The woman was hospitalized and received Heparin and Coumadin anticoagulant therapy. It is likely that the injured woman will need anticoagulant medication for a protracted period of time, potentially for the remainder of her life.

Last month, an epidemiological study provided further evidence that Ortho Evra is unreasonably dangerous and should be recalled from the market. The study found that women using the Ortho Evra birth control patch are twice as likely to develop blood clots compared with those using oral birth control pills. As a result of this study, The Food and Drug Administration updated Ortho Evra's warning language to reflect that women using the patch faced twice the risk of blood clots as compared to women on the pill. The FDA also asked Ortho McNeil to conduct a longer study of the contraceptive patch to evaluate the risks of blood clots, heart attack and stroke.

On November 10, 2005, Ortho McNeil, in conjunction with the FDA, modified its package insert to reflect that users of Ortho Evra are exposed to significantly more estrogen compared with women using oral contraceptives. In the November 10, 2005 label change, Ortho-McNeil admitted for the first time that women who use the patch will be exposed to up to 60% more estrogen than they would be exposed to if they were taking a birth control pill with 35 micrograms of estrogen. The patch is only intended to deliver 20 micrograms of estrogen. The FDA's announcement on this warning can be found at www.fda.gov/bbs/topics/news/2005/NEW01262.html. It is widely understood that increased exposure to estrogen greatly increases the risk of blood clots, which can cause serious injury or death.

Pulmonary embolism is a sudden blockage in a lung artery, usually due to a blood clot that traveled to the lung from the leg, but clots can also form in the pelvic vein. Pulmonary thromboembolism can be fatal or may result in pulmonary arterial obstruction, pulmonary obstruction, pulmonary infarction, chronic pulmonary hypertension, dyspenea and tachypnea. Symptoms may include shortness of breath, difficulty breathing, anxiety, chest pain, fainting and convulsions. Treatment may include long term use of anticoagulant medications and/or surgery. Recent reports have indicated that the risk of developing blood clots, pulmonary thromboembolism, heart attack and stroke may be significantly higher with the Ortho Evra patch than with oral contraceptive use.

It is alleged that Ortho-McNeil was aware of the increased medical risks associated with Ortho Evra before the drug was approved and that, once approved, the company failed to adequately warn patients about these risks. Evidence shows that the risk of blood clots, heart attack and stroke associated with Ortho Evra is significantly higher than with oral contraceptive pills. The incidence of embolisms and thrombotic injuries in Phase III trials of Ortho Evra was reportedly six times greater than the incidence of such events in oral contraceptives using the hormone levonorgestrel. The FDA has logged 9,116 reports of adverse reactions to the patch in a 17-month period, whereas Ortho Tri-Cyclen, a birth control pill, only generated 1,237 adverse reports in a six-year period. During a 12-month period, 44 serious injuries or deaths have been associated with Ortho Evra, whereas only 17 such reports were linked to the birth control pill during a similar time period. The pattern is further magnified when usage rates are considered: Ortho Tri-Cyclen has six times the number of users as Ortho Evra.

Ortho Evra is an adhesive, transdermal birth control patch that users are instructed to apply to their upper torso, upper outer arm, buttock or abdomen. The patch is intended to release 150 mcg of norelgestromin and 20 mcg of ethinyl estradiol into the bloodstream per 24 hours. It is replaced once a week for three weeks, and no patch is worn during the fourth week during menstruation. The regimen is then repeated. Ortho Evra was approved by the FDA in November 2001, and over 4 million women have used Ortho Evra since its approval. Ortho Evra continues to be marketed aggressively to both consumers and physicians.

About Parker & Waichman, LLP

Parker & Waichman, LLP is a leading products liability and personal injury law firm that represents plaintiffs nationwide. The firm has offices in New York and New Jersey. Parker & Waichman, LLP has assisted thousands of clients in receiving fair compensation for injuries resulting from defective medications and medical devices. The firm is currently representing individuals injured by Vioxx, Bextra, Zyprexa, Ketek, ReNu with MoistureLoc, Guidant Defibrillators and many other defective drugs and medical products. For more information on Parker & Waichman, LLP, please visit: www.yourlawyer.com or call (800) LAW-INFO.

More information on this and other class actions can be found on the Class Action Newsline at www.primezone.com/ca.

CONTACT:  Parker & Waichman, LLP
          Jason Mark, Esq.
          Melanie H. Muhlstock, Esq.
          (800) LAW-INFO
          (800) 529-4636
          info@yourlawyer.com
          www.yourlawyer.com]]> Drawbacks of drug-coated stents surfacing http://www.yourlawyer.com/articles/read/12315 Wed, 13 Sep 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/12315
The era of the coated devices, which are known technically as drug-eluting stents, was ushered in amid fanfare just three years ago as doctors anticipated a more effective way of treating coronary artery disease. Drug coatings thwart the encroachment of immune system cells that can cause blood vessel scarring and replugging. Coated stents replaced bare metal ones, which left the patient vulnerable to re-blockage.

Two reports in today's New England Journal of Medicine document problems with coated stents, suggesting a return to the bare metal type for some newly diagnosed patients.

Last week a team of European doctors at the World Congress of Cardiology in Barcelona reported problems with dangerous blood clots, which appeared several years after patients had been implanted with a drug-coated device. And Boston Scientific, maker of a stent coated with the cancer drug paclitaxel and sold as the Taxus stent, acknowledged that their own data demonstrates a potential for abnormal clotting with the device.

"This is a classic kind of thing," said Dr. David Brown, chief of cardiovascular medicine at Stony Brook University Medical Center. "Every time we have a technological breakthrough, we invent a new disease along with it. In this case, it's late-stage thrombosis ."

Stenting became an option in the 1980s with the development of bare metal devices. In addition to Taxus, the Cypher stent, by Cordis, a division of Johnson & Johnson is coated with sirolimus, which also beats back cellular forces that lead to re-clogging. An estimated 6 million coated stents have been implanted worldwide

Dr. Steven Nissen, president of the American College of Cardiology and chairman of cardiovascular medicine at the Cleveland Clinic, said it's time to conduct a large-scale clinical trial to determine the risk for heart attacks, strokes and death with the coated devices. He underscored that the clinical trials leading to approval of the devices were not long enough.

"It's all about risks and benefits," Nissen said. "In this case, the late-stage thrombosis with drug-eluting stents is an unintended consequence. We're now beginning to get the big picture."

Even though Nissen told Newsday two years ago that stents would become passe as better drug treatments evolved, he said the newly identified problems are not a sign stents are fading out of favor. "These devices are still very important," in the treatment of heart patients, Nissen said.

Both he and Brown say one way to cope with drug-eluting stents is to extend the amount of time patients are on dual blood-thinning therapy aspirin and the drug Plavix. Even though all heart patients must take aspirin for life, they are weaned from Plavix. Patients with drug-coated stents may have to remain on the drugs longer.

"The decline in bypass surgery nationally occurred as a result of better medical therapy, so I don't think we'll see a shift from a percutaneous treatment to a surgical treatment," Dr. Kevin Marzo, chief of interventional cardiology at Winthrop-University Hospital in Mineola, said.]]> Study: Blood-clot risks higher in drug-coated stents http://www.yourlawyer.com/articles/read/12121 Fri, 08 Sep 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/12121
The medical device maker reported the finding of its own new study to the U.S. Food and Drug Administration shortly after completing an analysis in late June, and met with the agency Aug. 1 to discuss the finding, company spokesman Paul Donovan said.

The Natick, Mass. based company reviewed previous clinical data involving 3,500 patients to compare rates of clotting in patients with its Taxus stent compared with older stents that are not coated with drugs.

The drug coatings are intended to help prevent formation of scar tissue that can form new blockages after surgery to implant stents, which are metal-mesh tubes that prop open coronary arteries. But recent studies, including findings released Sunday at the World Cardiology Congress in Barcelona, Spain, have indicated drug-coated stents carry a higher risk of rare instances of potentially fatal blood clots.

Boston Scientific's review confirmed that a higher risk exists in Taxus, the company's top-selling product and one of just two drug-coated stents on the U.S. market. While the stents are often credited with helping prevent heart attacks and bypass surgery, the review found a statistically significant higher rate of so-called "late stent thrombosis," or clotting, with Taxus in a period beginning six months after surgery compared with bare-metal stents.

"We have seen a slight increase in late stent thrombosis, which a number of studies have clearly shown to be a class effect common to drug-eluting stents," Donovan said. "The important point is we have seen no increases in heart at tacks or deaths."

Nearly 6 million people worldwide now have the drug-lined ver sions from the two dominant drug- coated stent makers, Boston Scientific and Johnson & Johnson's Miami Lakes, Fla.-based Cordis unit.

New Brunswick-based J&J has said it sees no statistically significant risk of late thrombosis in Cy pher.

Some of the blood-clotting concern stems from the fact that bare- metal stents allow heart cells to naturally grow to cover the stent after surgery, providing a natural biological lining. Drug-coated ver sions can prevent tissue growth, which helps prevent blockages but apparently leaves exposed metal that can act as a clot magnet.
]]> Boston Scientific confirms small risk of blood clots forming in drug-coated stents http://www.yourlawyer.com/articles/read/12120 Thu, 07 Sep 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/12120
The medical device maker reported the finding of its own new study to the U.S. Food and Drug Administration shortly after completing an analysis in late June, and met with the agency Aug. 1 to discuss the finding, spokesman Paul Donovan said.

Its shares fell 2.3 percent in midday trading.

Boston Scientific develops and makes the stents in Maple Grove and has a stent-making plant in Ireland.

The Natick, Mass.-based company reviewed previous clinical data involving 3,500 patients to compare rates of clotting in patients with its Taxus stent and those with older stents that are not coated with drugs.

The drug coatings are intended to help prevent formation of scar tissue that can form new blockages after surgery to implant stents, which are metal-mesh tubes that prop open coronary arteries. But recent studies, including findings released Sunday at the World Cardiology Congress in Barcelona, Spain, have indicated drug-coated stents carry a higher risk of rare instances of potentially fatal blood clots.

Boston Scientific's review confirmed that a higher risk exists in Taxus, the company's top-selling product and one of just two drug-coated stents on the U.S. market. While the stents are often credited with helping prevent heart attacks and bypass surgery, the review found a statistically significant higher rate of so-called late stent thrombosis," or clotting, with Taxus in a period beginning six months after surgery compared with bare-metal stents.

"We have seen a slight increase in late stent thrombosis, which a number of studies have clearly shown to be a class effect common to drug-eluting stents," Donovan said. "The important point is we have seen no increases in heart attacks or deaths."

The results will be published once complete data are available, he said. The finding was reported in The Wall Street Journal's Thursday editions.

Nearly 6 million people worldwide now have the drug-lined versions from the two dominant drug-coated stent makers, Boston Scientific and Johnson & Johnson's Miami Lakes, Fla.-based Cordis Corp. unit.

The Journal reported J&J has said it sees no statistically significant risk of late thrombosis in Cypher.

Shares of Boston Scientific fell 40 cents to $16.87 in midday trading on the New York Stock Exchange, near the bottom of the stock's 52-week range of $15.46 to $27.82.

Shares of New Jersey-based J&J fell 53 cents to $63.39 in midday trading on the NYSE.

Some of the blood-clotting concern stems from the fact that bare-metal stents allow heart cells to naturally grow to cover the stent after surgery, providing a natural biological lining. Drug-coated versions can prevent tissue growth, which helps prevent blockages but apparently leaves exposed metal that can act as a clot magnet.]]> Concerns increase on drug-coated heart stents http://www.yourlawyer.com/articles/read/12113 Mon, 04 Sep 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/12113
Studies released yesterday at the World Cardiology Congress in Barcelona raised new concerns about the risks that might accompany the drug-coated stents, which were introduced in 2000 as an improvement on bare-metal stents.

Nearly 6 million people worldwide now have the drug-lined versions. The devices are intended to keep arteries open after having been cleared of fatty deposits and are often credited with saving patients from future heart attacks or bypass surgery.

The drug-coated stent market last year was estimated as being worth more than $5 billion, and it is dominated by Boston Scientific Corp., based in Natick, and Johnson & Johnson. Drug-coated stents are also far more profitable, selling for about $2,300 each compared to the cheaper $700 bare metal versions.

A Swiss-Dutch study tracked 8,146 patients and found that recipients of drug-coated stents were at increased risk of thrombosis, or blood clots, that can occasionally result in death.

Two other Swiss studies, analyses of presented and published information discussed at the cardiology conference, also found that first-generation drug-coated stents had higher links to thrombosis compared to bare metal stents.

In bare metal stents, heart cells naturally grow to cover the stent, providing a natural biological lining. But in the drug-coated versions, the drugs prevent tissue growth which is both their intent and their possible downfall.

Drug-coated stents were previously viewed as a great advance since the drugs they emitted prevented cells that could block the arteries from growing. A thick growth of cells is undesirable, but a thin layer of cells lining the artery is essential. In some instances, drug-coated stents have prevented this minimal protective cell layer from growing, leaving exposed metal, which essentially can act as a clot magnet.

``This is potentially explosive information," said Dr. Steven Nissen, president of the American College of Cardiology and director of cardiology at the Cleveland Clinic.

``It certainly makes me pause with substantial concern," said Nissen. He said there is already a shift in the United States away from using drug-coated stents in favor of their uncoated predecessors.

Doubts about drug-coated stents were initially raised in March by a small-scale Swiss study, although there have long been naysayers about their potential adverse effects.]]> Parker & Waichman, LLP Files Suit Against Ortho-McNeil Pharmaceutical, Inc., Additional Suits to be Filed in Coming Months - JNJ http://www.yourlawyer.com/articles/read/12092 Thu, 24 Aug 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/12092
On August 24, 2004, the injured victim was taken to the emergency room at Eastern Idaho Regional Medical Center after experiencing headaches, shortness of breath and right anterior pleuritic chest pain. Diagnostic tests taken at the hospital revealed large pulmonary embolus in right upper lobe involving a secondary order vessel that extended into two third order vessels. The woman was hospitalized for six days to receive anticoagulant therapy. It is likely that the injured woman will need anticoagulant medication for a protracted period of time, potentially for the remainder of her life.

On November 10, 2005, Ortho McNeil, in conjunction with the FDA, issued a warning about the increased risks of blood clots associated with Ortho Evra. In the new warning, Ortho-McNeil admitted for the first time that women who use the patch will be exposed to up to 60% more estrogen than they would be exposed to if they were taking a birth control pill with 35 micrograms of estrogen. The patch is only intended to deliver 20 micrograms of estrogen. The FDA's announcement on this warning can be found at www.fda.gov/bbs/topics/news/2005/NEW01262.html. It is widely understood that increased exposure to estrogen greatly increases the risk of blood clots, which can cause serious injury or death.

Pulmonary embolism is a sudden blockage in a lung artery, usually due to a blood clot that traveled to the lung from the leg, but clots can also form in the pelvic vein. Pulmonary thromboembolism can be fatal or may result in pulmonary arterial obstruction, pulmonary obstruction, pulmonary infarction, chronic pulmonary hypertension, dyspenea and tachypnea. Symptoms may include shortness of breath, difficulty breathing, anxiety, chest pain, fainting and convulsions. Treatment may include long term use of anticoagulant medications and/or surgery. Recent reports have indicated that the risk of developing blood clots, pulmonary thromboembolism, heart attack and stroke may be significantly higher with the Ortho Evra patch than with oral contraceptive use.

It is alleged that Ortho-McNeil was aware of the increased medical risks associated with Ortho Evra before the drug was approved and that, once approved, the company failed to adequately warn patients about these risks. Evidence shows that the risk of blood clots, heart attack and stroke associated with Ortho Evra is significantly higher than with oral contraceptive pills. The incidence of embolisms and thrombotic injuries in Phase III trials of Ortho Evra was reportedly six times greater than the incidence of such events in oral contraceptives using the hormone levonorgestrel. The FDA has logged 9,116 reports of adverse reactions to the patch in a 17-month period, whereas Ortho Tri-Cyclen, a birth control pill, only generated 1,237 adverse reports in a six-year period. During a 12-month period, 44 serious injuries or deaths have been associated with Ortho Evra, whereas only 17 such reports were linked to the birth control pill during a similar time period. The pattern is further magnified when usage rates are considered: Ortho Tri-Cyclen has six times the number of users as Ortho Evra.

Ortho Evra is an adhesive, transdermal birth control patch that users are instructed to apply to their upper torso, upper outer arm, buttock or abdomen. The patch is intended to release 150 mcg of norelgestromin and 20 mcg of ethinyl estradiol into the bloodstream per 24 hours. It is replaced once a week for three weeks, and no patch is worn during the fourth week during menstruation. The regimen is then repeated. Ortho Evra was approved by the FDA in November 2001, and over 4 million women have used Ortho Evra since its approval. Ortho Evra continues to be marketed aggressively to both consumers and physicians.

About Parker & Waichman, LLP

Parker & Waichman, LLP is a leading products liability and personal injury law firm that represents plaintiffs nationwide. The firm has offices in New York and New Jersey. Parker & Waichman, LLP has assisted thousands of clients in receiving fair compensation for injuries resulting from defective medications and medical devices. The firm is currently representing individuals injured by Vioxx, Bextra, Zyprexa, Ketek, ReNu with MoistureLoc, Guidant Defibrillators and many other defective drugs and medical products. For more information on Parker & Waichman, LLP, please visit: www.yourlawyer.com or call (800) LAW-INFO.

More information on this and other class actions can be found on the Class Action Newsline at www.primezone.com/ca

CONTACT:  Parker & Waichman, LLP
          Jason Mark, Esq.
          Melanie H. Muhlstock, Esq.
          (800) LAW-INFO
          (800) 529-4636
          info@yourlawyer.com
          www.yourlawyer.com
]]> Merck Suffers 2 Setbacks in Vioxx Cases http://www.yourlawyer.com/articles/read/12068 Thu, 17 Aug 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/12068
In New Orleans, the jury found that Merck "knowingly misrepresented or failed to disclose" information about Vioxx to retired FBI agent Gerald Barnett's doctors. It said Barnett, of Myrtle Beach, S.C., should get $50 million in compensatory damages. And it added $1 million in punitive damages, saying Merck "acted in wanton, malicious, willful or reckless disregard for the plaintiff's rights."

In New Jersey, state Superior Court Judge Carol Higbee ruled evidence uncovered since the November verdict showed that Merck withheld information showing heart attacks could come with use of Vioxx for less than 18 months, said one of the plantiff attorneys.

The New Jersey attorneys represented Frederick "Mike" Humeston, of Boise, Idaho, who had a heart attack in September 2001.

"Merck consistently said throughout the trial that you had to be on Vioxx for 18 months to be at increased risk of a heart attack, Humeston attorney said. "And that was false. They had data that people were having heart attacks within weeks."

Merck said it would appeal the New Orleans verdict and was considering its options in the New Jersey case.

"Both the finding and the amount of damages were totally uncalled for in this case because Merck acted appropriately in providing information to the medical, scientific and regulatory communities in a responsible and appropriate manner," Kenneth C. Frazier, a senior vice president for Merck, said of the New Orleans verdict.

As for the New Jersey case: "We have a significant disagreement with the court's decision because the evidence presented to the jury during the course of a seven-week trial in 2005 showed that Merck behaved appropriately with respect to Vioxx and also that Vioxx was in no way related to Mr. Humeston's heart attack," Ted Mayer, of Hughes Hubbard & Reed, a member of Merck's national defense team, said in a news release.

Ruling from the bench in Atlantic City, Higbee based her decision on new depositions and an editorial published in the New England Journal of Medicine asserting that Merck withheld "very important heart attack data from the public, and also that they didn't correctly state the data in the trial," Seeger said.

Mayer said the facts behind the editorial "were known to the plaintiff long before the trial, and the jury was aware of the issue because it was presented by the plaintiff's expert."

Mayer also said that the company intended to maintain its policy of trying every Vioxx case.

The lawsuits are among more than 16,000 Vioxx-related suits against Merck in state and federal courts.

David Logan, dean of Roger Williams University School of Law in Bristol, Rhode Island, said the New Orleans verdict would put pressure on Merck to consider settling cases.

"How long can Merck carry the cost of these verdicts?" Logan asked. "None of these cases are coming back small."

He said the cost of litigation and the management time devoted to overseeing the Vioxx cases remove resources that Merck should be spending on developing new products. "This is a drag on Merck going forward," he said. "it is an enormous tax on the company moving forward."

Jon LeCroy, an analyst with Natexis Bleichroeder, said there is no reason for the company to settle and every reason for it to continue to try each case, stretching out the process as long as possible so it doesn't have to dole out a lot of money at once and wearing down plaintiffs so some may go away.

"Clearly it is costing them a lot to fight the cases but that will go up ten fold if they announce a settlement", he said, noting a settlement usually triggers more lawsuits.

Barnett's lawyer, had asked for $25 million in punitive damages, arguing that it would send a message to drugmakers that they should not rush pharmaceuticals to market. Merck's lawyer, Phil Beck, argued that no further awards were needed to punish the drugmaker.

"My guess is that you have already awarded punitive damages. You sent a message loud and clear and the people at Merck heard that message," Beck said.

Outside the courtroom, Barnett said little, only that he was "very happy" with the verdict. Robinson said he was not disappointed with the relatively small punitive award, saying he wanted punitive damages added as a symbolic gesture to deter drug companies from putting unsafe drugs on the market.

On its verdict sheet, the jury had the chance to assign percentages of fault to Merck and various physicians, but assigned blame only to Merck.

The first federal trial had to be held twice. The first jury deliberated 18 hours over three days, but deadlocked over whether Vioxx was to blame for the death of a Florida man who had taken the drug for less than a month. The second jury in that case came back in less than four hours with a verdict for Merck.

In state courts, before Thursday, Merck had won four cases in New Jersey and California. It had lost two cases in Texas and one in New Jersey.

The New Jersey ruling removes one of Merck's state wins.

In federal court, the company now has one win and one loss.

The jurors who decided the Barnett case have at least two things in common with the plaintiff: All eight are men and they're all getting older.

Beck pointed out in closing arguments Wednesday that both are risk factors for heart attacks, and neither can be controlled.
Counsel for Barnett emphasized that his 62-year-old client, who underwent a quintuple bypass after a heart attack at the age of 58, was careful to keep his risks as low as possible with daily exercise, a healthy diet and drugs to control his cholesterol.

He told the jury that the problem was Vioxx, which Barnett took for 31 months before his heart attack in July 2002. He continued to take the painkiller for another two years, stopping one week before Merck pulled it from the market in September 2004, after a study showed it increased the risk of heart attacks and strokes.

Logan said that jurors may have empathized with Barnett. "Plaintiff lawyers want jurors to think `There but for the grace of God goes me.'" he said.]]> Parker & Waichman, LLP Files Suit Against Ortho-McNeil Pharmaceutical, Inc. on Behalf of 36-Year-Old Woman http://www.yourlawyer.com/articles/read/12062 Wed, 16 Aug 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/12062
On August 25, 2005, the injured woman was taken to the emergency room at Roane Medical Center in Tennessee after experiencing shortness of breath and chest pain. Diagnostic tests taken at the hospital revealed extensive pulmonary emboli bilaterally. The victim was transferred to Methodist Medical Center to receive anticoagulant therapy. It is likely that the injured woman will need anticoagulant medication for a protracted period of time, potentially for the remainder of her life.

On November 10, 2005, Ortho McNeil, in conjunction with the FDA, issued a warning about the increased risks of blood clots associated with Ortho Evra. In the new warning, Ortho-McNeil admitted for the first time that women who use the patch will be exposed to up to 60% more estrogen than they would be exposed to if they were taking a birth control pill with 35 micrograms of estrogen. The patch is only intended to deliver 20 micrograms of estrogen. The FDA’s announcement on this warning can be found at www.fda.gov/bbs/topics/news/2005/NEW01262.html . It is widely understood that increased exposure to estrogen greatly increases the risk of blood clots, which can cause serious injury or death.

Pulmonary embolism is a sudden blockage in a lung artery, usually due to a blood clot that traveled to the lung from the leg, but clots can also form in the pelvic vein. Pulmonary thromboembolism can be fatal or may result in pulmonary arterial obstruction, pulmonary obstruction, pulmonary infarction, chronic pulmonary hypertension, dyspenea and tachypnea. Symptoms may include shortness of breath, difficulty breathing, anxiety, chest pain, fainting and convulsions. Treatment may include long term use of anticoagulant medications and/or surgery. Bilateral pulmonary embolism occurs when blood clots block both pulmonary arteries. Recent reports have indicated that the risk of developing blood clots, pulmonary thromboembolism, heart attack and stroke may be significantly higher with the Ortho Evra patch than with oral contraceptive use.

It is alleged that Ortho-McNeil was aware of the increased medical risks associated with Ortho Evra before the drug was approved and that, once approved, the company failed to adequately warn patients about these risks. Evidence shows that the risk of blood clots, heart attack and stroke associated with Ortho Evra is significantly higher than with oral contraceptive pills. The incidence of embolisms and thrombotic injuries in Phase III trials of Ortho Evra was reportedly six times greater than the incidence of such events in oral contraceptives using the hormone levonorgestrel. The FDA has logged 9,116 reports of adverse reactions to the patch in a 17-month period, whereas Ortho Tri-Cyclen, a birth control pill, only generated 1,237 adverse reports in a six-year period. During a 12-month period, 44 serious injuries or deaths have been associated with Ortho Evra, whereas only 17 such reports were linked to the birth control pill during a similar time period. The pattern is further magnified when usage rates are considered: Ortho Tri-Cyclen has six times the number of users as Ortho Evra.

Ortho Evra is an adhesive, transdermal birth control patch that users are instructed to apply to their upper torso, upper outer arm, buttock or abdomen. The patch is intended to release 150 mcg of norelgestromin and 20 mcg of ethinyl estradiol into the bloodstream per 24 hours. It is replaced once a week for three weeks, and no patch is worn during the fourth week during menstruation. The regimen is then repeated. Ortho Evra was approved by the FDA in November 2001, and over 4 million women have used Ortho Evra since its approval. Ortho Evra continues to be marketed aggressively to both consumers and physicians.

About Parker & Waichman, LLP

Parker & Waichman, LLP is a leading products liability and personal injury law firm that represents plaintiffs nationwide. The firm has offices in New York and New Jersey. Parker & Waichman, LLP has assisted thousands of clients in receiving fair compensation for injuries resulting from defective medications and medical devices. The firm is currently representing individuals injured by Vioxx, Bextra, Zyprexa, Ketek, ReNu with MoistureLoc, Guidant Defibrillators and many other defective drugs and medical products. For more information on Parker & Waichman, LLP please visit: www.yourlawyer.com or call (800) LAW-INFO.

Contact Information
Jason Mark
Esq.
Parker & Waichman, LLP
(800) 529-4636
info@yourlawyer.com]]> Kentucky woman sues maker of birth control patch, Ortho Evra http://www.yourlawyer.com/articles/read/12049 Wed, 09 Aug 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/12049
Tonya Dingess, 36, who works as an emergency medical technician for the city of Paintsville, filed suit Monday against Ortho-McNeil Pharmaceuticals and its parent company, Johnson & Johnson. Dingess, who lives in Louisa, may be the first Kentuckian to file a lawsuit related to the birth control patch.

Last summer, Dingess experienced blood clots in her legs, spleen and lung, which started about five weeks after she began using the patch.

"She came within hours of dying from this," said the attorney representing Dingess. Dingess was in excruciating pain for nearly two weeks, then was hospitalized for six days so blood thinners could begin to eliminate the life-threatening clots.

"It's amazing I ever lived through it," Dingess said, adding that other women did not.

An Associated Press report last year identified about a dozen young women who died in 2004 from blood clots presumed to be linked to the birth control patch. They analyzed 16,000 FDA reports of adverse events related to the patch and found that patch users were three times more likely to suffer blood clots and die, compared with women taking birth control pills. Millions of women have used the patch since it first arrived on the market in 2002.

In November, the FDA announced a new warning about Ortho Evra. The warning said that women who use Ortho Evra may be exposed to 60 percent more estrogen than women who take a typical 35 microgram estrogen birth control pill. The FDA also said that higher levels of estrogen could put some women at higher risk of getting blood clots.

More than 100 women around the nation have filed suit against the drug company.

"We can't comment on any ongoing litigation," said Gloria Vanderham, communications manager for Ortho Women's Health & Urology, the maker of Ortho Evra.

In February, the makers of Ortho Evra released results of two studies related to the patch. One of the studies found that the risk of developing blood clots in the leg or lungs was similar for users of the patch and those who used birth control pills that contain 35 micrograms of estrogen. The second study found a two-fold increase in the risk of developing blood clots in the legs or lungs in women who use the patch, compared to birth control pills. That's still a "relatively rare event," according to the company's press release, and it noted that further evaluation is ongoing.]]> Raloxifene averts breast cancer, at a risk http://www.yourlawyer.com/articles/read/11976 Thu, 13 Jul 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/11976
Doctors have been testing this drug as an alternative to tamoxifen for preventing breast cancer and as a way to lower heart disease risks.

Based on the new study's results, "most people would decline taking raloxifene" unless they have a high risk of breast cancer, said Dr. Linda Vahdat, director of breast cancer research at Weill Cornell Medical College.

Dr. Marisa Weiss, a Philadelphia breast cancer specialist who founded the consumer Web site breastcancer.org, agreed.

"The cardiac benefit wasn't there. The side effects were," and breast cancer is more treatable than life-threatening blood clots and strokes, she said.

Neither doctor took part in the study, which involved 10,101 postmenopausal women in the United States and 25 other countries. Results were published in Thursday's New England Journal of Medicine.

Many of the authors consult or work for Indianapolis-based Eli Lilly & Co., which makes raloxifene and paid for the study. The drug is sold as Evista for treating the bone disease osteoporosis, but the company is seeking approval to market it for breast cancer prevention.

A similar drug, tamoxifen, has long been used to prevent breast cancers whose growth is fueled by the hormone estrogen. A big federal study reported last month that raloxifene was equally effective at preventing the most serious types of breast cancer and with fewer side effects, although some doctors disagree on how large the differences in side effects really are.

That study, called STAR, directly compared the two drugs in women at higher-than-usual risk of developing breast cancer. The new study involved a different group of women those at high risk of heart problems and tested whether raloxifene was better than dummy pills at reducing breast cancer and heart-related risks.

Participants either had clogged arteries or multiple heart risk factors, such as advanced age, diabetes, smoking, high blood pressure or high cholesterol. About 40 percent also had elevated risk of breast cancer, mostly because of their age, but this was not the main reason they were in this study their heart risk was.

Roughly half were given daily raloxifene pills and the others, dummy pills. Neither they nor their doctors knew who was taking what.

After an average of five years on the pills, deaths and major heart problems were about the same in both groups. Raloxifene users had one-third fewer cases of breast cancer and about half the number of invasive breast cancers benefits seen previously.

However, 59 of the 5,044 raloxifene users had fatal strokes; only 39 of the 5,057 on dummy pills did, translating to a 49 percent greater risk for those taking the drug.

Blood clots in veins, which can be life-threatening if they travel to the lungs, formed in 103 women on raloxifene but only 71 of the others.

The "moderate" breast cancer prevention benefits "do not seem to justify the risks" of raloxifene for women already prone to heart problems, Marcia Stefanick, a disease prevention researcher at Stanford School of Medicine, wrote in an editorial in the medical journal.

However, the murky results make it important for women to talk about risks with their doctors, said Dr. Lori Mosca, one of the authors and director of preventive cardiology at New York Presbyterian Hospital in New York.

"Even though the study overall appears to be a wash, it's important that every woman understand that the tipping point for her may be different. Every woman has a unique risk for breast cancer, for cardiovascular disease," she said.

None of this changes tamoxifen's status as the drug of choice for breast cancer prevention before menopause. Raloxifene's safety and effectiveness in that situation is unknown.
]]> Parker & Waichman, LLP Files Suit Against Ortho-McNeil Pharmaceutical, Inc. on Behalf of Estate of 26-Year-Old Woman Who Died After Using Ortho Evra for 7-1/2 Months - JNJ http://www.yourlawyer.com/articles/read/11979 Thu, 13 Jul 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/11979 Parker & Waichman, LLP (www.yourlawyer.com) announced that it has filed suit against Ortho-McNeil Pharmaceutical, Inc., a division of Johnson and Johnson Inc. (NYSE:JNJ), on behalf of the estate of a 26-year-old woman. The decedent died from an acute pulmonary embolism after using the Ortho Evra birth control patch from November 26, 2002 to July 8, 2003. The suit was filed in the United States District Court for the Eastern District of Michigan. For more information on Ortho Evra and this case, please visit www.orthopatchlawsuit.com or www.yourlawyer.com/topics/overview/Ortho_Evra_Patch

On July 8, 2003, the decedent experienced difficulty breathing and collapsed in her home. Paramedics arrived and found the woman in acute respiratory distress. She was taken to the emergency room at St. John Macomb Hospital in Michigan, where emergency room doctors noted she was cyanotic (blue lips and skin) and in severe respiratory distress. The decedent did not respond to CPR and other life-saving measures and was pronounced dead that evening. An autopsy revealed the cause of death as an acute pulmonary embolism.

On November 10, 2005, Ortho McNeil, in conjunction with the FDA, issued a warning about the increased risks of blood clots associated with Ortho Evra. In the new warning, Ortho-McNeil admitted for the first time that women who use the patch will be exposed to up to 60% more estrogen than they would be exposed to if they were taking a birth control pill with 35 micrograms of estrogen. The patch is only intended to deliver 20 micrograms of estrogen. The FDA's announcement on this warning can be found at www.fda.gov/bbs/topics/news/2005/NEW01262.html . It is widely understood that increased exposure to estrogen greatly increases the risk of blood clots, which can cause serious injury or death.

Pulmonary embolism is a sudden blockage in a lung artery, usually due to a blood clot that traveled to the lung from the leg, but clots can also form in the pelvic vein. Pulmonary thromboembolism can be fatal or may result in pulmonary arterial obstruction, pulmonary obstruction, pulmonary infarction, chronic pulmonary hypertension, dyspenea and tachypnea. Symptoms may include shortness of breath, difficulty breathing, anxiety, chest pain, fainting and convulsions. Treatment may include long term use of anticoagulant medications and/or surgery. Recent reports have indicated that the risk of developing blood clots, pulmonary thromboembolism, heart attack and stroke may be significantly higher with the Ortho Evra patch than with oral contraceptive use.

It is alleged that Ortho-McNeil was aware of the increased medical risks associated with Ortho Evra before the drug was approved and that, once approved, the company failed to adequately warn patients about these risks. Evidence shows that the risk of blood clots, heart attack and stroke associated with Ortho Evra is significantly higher than with oral contraceptive pills. The incidence of embolisms and thrombotic injuries in Phase III trials of Ortho Evra was reportedly six times greater than the incidence of such events in oral contraceptives using the hormone levonorgestrel. The FDA has logged 9,116 reports of adverse reactions to the patch in a 17-month period, whereas Ortho Tri-Cyclen, a birth control pill, only generated 1,237 adverse reports in a six-year period. During a 12-month period, 44 serious injuries or deaths have been associated with Ortho Evra, whereas only 17 such reports were linked to the birth control pill during a similar time period. The pattern is further magnified when usage rates are considered: Ortho Tri-Cyclen has six times the number of users as Ortho Evra.

Ortho Evra is an adhesive, transdermal birth control patch that users are instructed to apply to their upper torso, upper outer arm, buttock or abdomen. The patch is intended to release 150 mcg of norelgestromin and 20 mcg of ethinyl estradiol into the bloodstream per 24 hours. It is replaced once a week for three weeks, and no patch is worn during the fourth week during menstruation. The regimen is then repeated. Ortho Evra was approved by the FDA in November 2001, and over 4 million women have used Ortho Evra since its approval. Ortho Evra continues to be marketed aggressively to both consumers and physicians.

About Parker & Waichman, LLP

Parker & Waichman, LLP is a leading products liability and personal injury law firm that represents plaintiffs nationwide. The firm has offices in New York and New Jersey. Parker & Waichman, LLP has assisted thousands of clients in receiving fair compensation for injuries resulting from defective medications and medical devices. The firm is currently representing individuals injured by Vioxx, Bextra, Zyprexa, Ketek, ReNu with MoistureLoc, Guidant Defibrillators and many other defective drugs and medical products. For more information on Parker & Waichman, LLP please visit: www.yourlawyer.com or call (800) LAW-INFO.

More information on this and other class actions can be found on the Class Action Newsline at www.primezone.com/ca

CONTACT:  Parker & Waichman, LLP
          Jason Mark, Esq.
          Melanie H. Muhlstock, Esq.
          (800) LAW-INFO
          (800) 529-4636, Toll-free
          info@yourlawyer.com
          www.yourlawyer.com

]]> Vioxx Bextra Celebrex Cox-II Inhibitors Blood Clot Injury Attorney http://www.yourlawyer.com/topics/overview/blood_clots Thu, 13 Jul 2006 00:00:00 -0700 http://www.yourlawyer.com/topics/overview/blood_clots Blood Clots

On November 10, 2005 Johnson & Johnson's Ortho McNeil unit issued a warning that the Ortho Evra contraceptive patch contains higher levels of a hormone known to cause blood clots than average birth control pills. Women who use Ortho Evra are exposed to 60 percent more estrogen than those who use the pill, the FDA said in a statement. The warning comes after several investigative reports by The Associated Press and CBS News highlighted the risks of Ortho Evra.

The Associated Press reported that it appears that the risk of dying or suffering a survivable blood clot while using the Ortho Evra birth control patch was about three times higher than while using birth control pills. The AP found that the FDA and and Ortho-McNeil were aware of the increased risk of blood clots associated with the patch even before it was approved. According to FDA reports obtained by the Associated Press, a dozen women died last year from blood clots believed to be related to the Ortho Evra patch.

FDA records show that seventeen patch users between the ages of 17 and 30 have suffered fatal heart attacks, blood clots and possible strokes since August 2002. Blood clots are masses of thickened blood. Clotting is a means used by the body to end bleeding.

The first stage in clotting is adhesion of platelets, which are fragments of blood cells that travel in the blood, to the cut edges of a damaged blood vessel. As a result, a platelet plug is formed and external bleeding stops. Next, small molecules, called clotting factors, cause strands of materials, (fibrin) to stick together and seal the inside of the wound. Eventually, the cut blood vessel heals and the blood clot dissolves after a few days. A blood clot can become dangerous when it blocks an artery or vein and stops blood flow.

The blood clot is then called a thrombus. Although a thrombus may occur in any blood vessel, it most commonly develops in the veins of the leg and can travel through the major blood vessels of the pelvis and lung where it can be fatal. A thrombus in the leg or pelvic vein is called a deep vein thrombosis (DVT). A thrombus that breaks free and travels within the bloodstream it is called an embolus. As it travels, it compromises blood flow and may become lodged in a smaller blood vessel, causing blockage.

For example, if an embolus blocks an artery in the lung, it is called a pulmonary embolism. Common symptoms of a pulmonary embolus include: shortness of breath, chest pain and coughing up blood. Common signs of a DVT include: pain in the calf or leg muscle, swelling, tenderness, prominent veins and discoloration.

Less common symptoms may include: back , shoulder or upper abdomen pain; dizziness; fainting; painful respiration; wheezing;  new heart arrhythmias. An embolism can also travel to the heart, eyes, or brain. An em-bolus in the brain can cause strokes. An em-bolus blocking an artery in the heart can cause heart attacks. An em-bolus may cause sudden blindness in one eye. An em-bolus that blocks an artery is a life- threatening condition. There are many factors that increase the risk of blood clots: Atypical Antipsychotic Drugs, HRT Drugs, Ortho Evra contraceptive patch, bed rest, chemotherapy, deep vein thrombosis, fractures, birth control pills, smoking and cancer.

If you or a loved one has taken HRT drugs, COX-II Inhibitors or used the Ortho Evra Patch and been diagnosed with Blood clots, please fill out the form at the right for a free case evaluation by a qualified defective drug attorney.

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