Yourlawyer.com (Heart Attacks News)

Antidepressants Linked to Sudden Cardiac Death in Women

Wed, 11 Mar 2009 00:00:00 -0700

A new study has concluded that women with no history of cardiac problems but who use antidepressants are at an increased risk for sudden cardiac death (SCD). HealthDay News reports that the reason for the link remains unknown, according to the researchers whose findings were published in the Journal of the American College of Cardiology.

"We suspect that their use is a marker for people with worse depression," explained the study’s lead author Dr. William Whang, an assistant professor of clinical medicine at Columbia University Medical Center in Manhattan. "The elevated risk seems more specific for antidepressant use, but that use may well be a marker of more severe symptoms," quoted HealthDay News. Whang noted that the link seemed to be physiological saying, “We found that women who had worse depressive symptoms had higher rates of risk factors such as hypertension, diabetes, and smoking.” As a matter-of-fact, the report indicated, said HealthDay News, women with clinical depression were at a two-fold risk of experiencing SCD.

The researchers looked at over 63,000 American women in the Nurses Health Study, said HealthDay, with no history of previous stroke or heart disease from 1992 to 2004, said Natural News, and found a link between depression and heart risk; however, the link between SCD and antidepressants was significantly more pronounced. Also, antidepressant use was not linked with an increased risk of cardiac arrest over fatal heart disease, only with the increased risk of SCD, reported HealthDay News. Prior research established the link between depression and an increased risk of death for those with heart disease, explained Whang, who noted, "But this was a group of women without heart disease, and that makes it different," said HealthDay News.

Natural News pointed out that the study found women with the highest risk for SCD and fatal coronary heart disease (CHD) expressed the most severe depression symptoms or were on antidepressant therapy. "We can't say antidepressant medications were the cause of higher risk of sudden cardiac death. It may well be that use of antidepressants is a marker for worse depression," said Whang, reported Natural News. "The biggest clinical implication is that management of coronary heart disease risk factors may be especially important for those with depressive symptoms. Taking care of those risk factors can modify the risk for coronary disease," warned Whang, according to HealthDay News.

To determine which women suffered from depression, the team reviewed their self-reported depression symptoms and use of antidepressants, for instance, Prozac, said Natural News. A link was clearly present with serious heart rhythm problems, which include those causing sudden death, said HealthDay News. The American Heart Association explained, said Natural News, that SCD causes sudden death from an unexpected loss of heart function.

SSRI antidepressants, such as Prozac, Lexapro, Zoloft, and Paxil have been described as safe for the heart; however, a number of cardiovascular side effects, such as irregular heart rhythms and potentially lethal arrhythmias, are known to occur in some taking these medications, said Natural News, noting that Prozac maker, Eli Lily, lists a variety of adverse cardiac symptoms on the official package insert for physicians.

Late Treatment with Stents Questioned

Thu, 19 Feb 2009 00:00:00 -0800

Cardiac stents have been the subject of much controversy in recent months and, now, two emerging studies have found that patients do not fare better over medications and other treatments than with stents following heart attacks.

Stents are tiny wire-mesh tubes used to prop open arteries after doctors clear them of blockages. Some stents have a drug coating meant to keep vessels from re-clogging following such procedures.

Reuters said that the studies found that stents, when used following an untreated heart attack, offer no better treatment than other protocols. One study found, said Reuters, that one in three heart attack cases do not receive immediate stent treatment following a heart attack because, for instance, patients might not seek treatment in the immediate hours or days following the crisis. By the time patients seek help, the heart muscle is already likely damaged, points out Reuters.

"Our study specifically addresses the question of whether, with a complete blockage, there is any benefit, now that the dust has settled after the acute heart attack, to opening the artery anyhow," said Dr. Daniel Mark of the Duke University Medical Center in North Carolina, quoted Reuters. Dr. Mark led the international study. "I think our comprehensive answer to that is the benefit is very small and it's not worth the extra cost of doing the procedure," he added.

Bloomberg News said that medications and heart bypass offered greater protection over angioplasty and stents—both of which open arteries. Initial findings from the Occluded Artery Trial (OAT) revealed that four years following heart attacks, the death rate, incidence of heart failure, or a follow-up heart attack were not minimized by a so-called “late attempt” at removing heart blockage, said Reuters. Dr. Mark told Reuters that “the heart muscle where that artery is blocked is pretty much dead, and it's not going to help it out by opening the artery."

The findings also indicated that one year following stent implantation, patients were as unable to climb stairs as those not implanted, said Reuters. Also, while 477 stent patients received hospital bills about $7,000 higher than nonstent patients, their quality of life was shorter—after two years—than those patients treated with medications only.

Authors of the “Syntax” study led by Patrick Serruys, a cardiologist at Rotterdam’s Erasmus University, said that heart bypass should remain “the standard of care” though its advantages must be balanced against stroke risk, which can occur following bypass, and longer surgery recuperation times over stent implantation, reported Reuters.

Bloomberg noted that both studies were published online, today, in the New England Journal of Medicine, adding that, in the U.S. doctors performed no less than 800,000 angioplasties last year for a total cost of $10 billion. Of these, Duke University concluded that about half could have received comparable treatment via drugs, diet, and exercise, with less risk of re-clogging. The researchers said that the results of both studies “adds only a modest early advantage with regard to symptoms and functional status, and this advantage is not maintained,” reported Bloomberg.

Stent makers include Boston Scientific Corporation, Abbott Laboratories, Johnson & Johnson, and Medronic Inc.

FDA Asks Novartis to Suspend Marketing of GI Drug Zelnorm

Mon, 02 Apr 2007 00:00:00 -0700

The U.S. Food and Drug Administration (FDA) notified Novartis Pharmaceuticals Corporation that the company must cease its marketing of Zelnorm (tegaserod), a prescription drug used in the treatment of constipation and irritable bowel syndrome (IBS). According to the FDA, Zelmorm has been associated with an “increased risk of serious cardiovascular adverse events (heart problems).” Novartis has agreed to voluntarily suspend its marketing of Zelnorm.

Zelnorm was first approved by the FDA in 2002 to treat constipated women with IBS, and the approval was expanded two years later to treat chronic constipation in both men and women younger than 65. However, recent randomized trials conducted by Novartis have called into question the drug’s safety, and the FDA now says that “for most patients the benefits of this drug no longer outweigh the risks.” According to the data, “the risk of serious cardiovascular adverse events (e.g., angina, heart attacks, and strokes) associated with use of Zelnorm is higher than with placebo treatment.”

“This decision reflects the FDA’s commitment to continuously monitor approved drugs throughout their marketing life, and take action when we believe the risks exceed the benefits,” said Dr. Douglas Throckmorton, deputy director for the Center for Drug Evaluation and Research. “Here, a potential risk of very serious harm to patients who have this non-life-threatening condition was recently identified, making this action necessary.”

The FDA recommends that Zelnorm patients who experience severe chest pain, shortness of breath, dizziness, difficulty walking or talking, or other symptoms of a heart attack or stroke should contact their doctors immediately.

Zelnorm is taken off the market

Sat, 31 Mar 2007 00:00:00 -0700

A widely prescribed drug for severe constipation is being taken off the market after it was linked to a higher risk of heart attacks and strokes, federal regulators said.

Doctors said the voluntary withdrawal of Zelnorm by its manufacturer would leave few options for patients who suffer from a type of irritable bowel syndrome that affects about 12 million Americans, mostly women.

"This is really a sort of one-of-a-kind drug," said Dr. Bennett Roth, chief of gastroenterology at UCLA Medical Center. "It doesn't work for everybody, but in those for whom it works, it gets pretty good results. There are going to be a lot of unhappy patients."

The Food and Drug Administration said it asked for the withdrawal of Zelnorm after an analysis of 29 studies involving more than 18,000 patients found that those who took the medication had significantly higher rates of cardiac problems than those who were given a sugar pill.

Patients taking Zelnorm should call their doctors to discuss alternative treatments, the agency said. Options include laxatives. Any patients who experience chest pain, sudden weakness or other symptoms of heart attack or stroke should immediately go to the emergency room.

The drug's maker, Novartis, said it was complying with the FDA request but did not believe the drug was to blame.

A consultant who reviewed the data for the company said the rates of heart problems in patients taking Zelnorm roughly corresponded with the expected rates in the population.

But Dr. John Jenkins, head of the FDA's Office of New Drugs, said the differences between patients on Zelnorm and those given a sugar pill were significant.

Jenkins said 13 patients taking Zelnorm suffered heart attacks, chest pain or strokes, and one died. Of those taking a sugar pill, one had symptoms of a stroke that went away without further problems. None died.

Although the overall rates of problems were low 0.1% for those taking Zelnorm, compared with 0.01% for those on the sugar pill, the disparity between the two groups got the FDA's attention.

"We found the signal worrisome enough that we thought the benefit of the drug no longer outweighed the risk," Jenkins said.

Zelnorm ranked among the top 200 brand-name prescriptions last year, according to the Internet site drugtopics.com, which monitors the drug industry.

More than 2.6 million prescriptions were written for the medication in 2006, a 25% increase from the previous year.

Novartis said its sales of the drug approached $490 million in 2006. "The product was growing quickly," said spokeswoman Sherry Pudloski. It was approved in the United States in 2002.

Novartis, headquartered in Switzerland, said it would continue talking with the FDA to see whether the medication could remain available to a limited number of patients under tightly controlled conditions. The FDA followed a similar approach a few years ago with another drug for irritable bowel problems, Lotronex.

The discovery of possible heart risks followed a 2004 request from Swiss regulators for a closer look at the data. Novartis submitted the findings to the FDA beginning in February.

Swiss regulators have decided to keep Zelnorm on the market in that country with stronger warnings, Pudloski said. And Novartis is discussing the drug's future in Canada with regulators there.

Peter Lurie, deputy director of Public Citizen's Health Research Group, said his calculations indicated that those taking Zelnorm would face a seven- to eight-fold increase in risk of cardiac problems.

"When you remember that a number of patients taking this drug are younger, otherwise healthy people, the tolerance for serious side effects should be very low, even if they are rare," Lurie said.

Irritable bowel syndrome is estimated to affect up to 20% of Americans, most of whom do not seek treatment. But some patients suffer from continuing bouts of sharp abdominal pains and bloating. About a third have constipation, another third have diarrhea and the remainder alternate between the conditions.

The causes of the syndrome are not fully understood.

Novartis to stop constipation drug sale

Fri, 30 Mar 2007 00:00:00 -0700

Swiss pharmaceutical maker Novartis AG will stop selling a drug to relieve constipation after it was linked to a higher chance of heart attack, stroke and worsening heart chest pain that can become a heart attack, federal health officials said Friday.

Novartis agreed to withdraw Zelnorm at the FDA's request, the agency said in a public health advisory.

Zelnorm, also called tegaserod maleate, is a prescription medication approved for short-term treatment of women with irritable bowel syndrome with constipation and for patients younger than 65 with chronic constipation, the FDA said.

Doctors who prescribe Zelnorm should work with their patients and transition them to other therapies as appropriate, the FDA added.

Earlier this year, Novartis gave the FDA the results of new analyses of 29 clinical studies of Zelnorm for treatment of a variety of gastrointestinal tract conditions. The analyses showed 13 of 11,614 patients given Zelnorm had serious and life-threatening cardiovascular side effects, while just one of the 7,031 patients given dummy pills did, the FDA and Novartis said in separate statements.

The FDA has told Novartis it would consider allowing a limited reintroduction of Zelnorm "if a population of patients can be identified in whom the benefits of the drug outweigh the risks," the agency said.

Novartis said it believes the drug provides unique benefits.

"Although we have complied with the FDA's request and are collaborating with the agency, we continue to believe that Zelnorm provides important benefits for appropriate patients," said Dr. Stephen Cunningham, vice president and head of U.S. clinical development and medical affairs for Novartis.

The FDA first approved Zelnorm in 2002.

Jury awards $47.5 million in Vioxx case

Tue, 13 Mar 2007 00:00:00 -0700

Merck & Co.'s painkiller Vioxx contributed to an Idaho postal worker's heart attack, a jury in Atlantic City ruled Monday, reversing the verdict in the man's first trial and hitting Merck with a total of $47.5 million in damages.

In one of Merck's biggest losses over the drug so far, the jurors awarded the man and his wife $20 million in compensatory damages Monday morning, then later said Merck should pay $27.5 million in punitive damages.

The verdict in the case of Frederick ''Mike'' Humeston, who was granted a second trial in light of new evidence, means Merck has now won nine cases and lost five in the mushrooming litigation over its former blockbuster arthritis pill.

Humeston, 61, of Boise, Idaho, suffered a heart attack in September 2001, several months before Merck under pressure from federal regulators put a stronger warning about the cardiovascular risks of Vioxx on the drug's detailed package insert.

Humeston, a decorated Vietnam veteran, had taken Vioxx intermittently for knee pain from a shrapnel wound.

The five-man, three-woman jury ruled on March 2 that Merck was negligent and did not provide adequate warning about those risks before Humeston's heart attack. That set the stage for a second phase of the trial, with the jury last week hearing evidence on whether Vioxx contributed to Humeston's heart attack, entitling him to damages.

The jurors, after deliberating for about five hours over two days, awarded Humeston $18 million in compensatory damages for pain and suffering and gave $2 million to his wife, Mary. Then, after brief arguments over punitive damages, the jury deliberated briefly late Monday afternoon and decided to assess $27.5 million in punitive damages against Merck.

''This is why you keep fighting,'' said Humeston's lawyer. ''A little guy from Idaho took on Merck and beat them big time.''

If the verdict and damage amounts are upheld, it could be the biggest hit to Merck so far. In the only Vioxx case with a larger verdict - $51 million awarded last August to Gerald Barnett of Myrtle Beach, S.C. - U.S. District Judge Eldon E. Fallon in New Orleans ordered a new trial on the amount of damages, calling the total ''grossly excessive.''

The palntiff's attorney said Idaho caps on damages won't apply to Humeston because the jury found Merck's conduct ''was intentional and reckless.''

The palntiff's attorney said Humeston was floored by the verdicts. He left the courthouse soon after the punitive damages were announced to spend some time alone with his wife.

Hope Freiwald, a member of Merck's defense team, said the company would pursue all avenues of appeal.

Humeston lost his first trial against the pharmaceutical giant in 2005, but New Jersey Superior Court Judge Carol Higbee granted him a second trial because new evidence surfaced that short-term Vioxx use could also be risky; Humeston took the drug on and off for about two months. Merck insists Vioxx didn't increase cardiac risks until after 18 months of use, but many doctors say research disproves that.

Whitehouse Station, N.J.-based Merck pulled Vioxx from the market in September 2004 after its own research showed the drug doubled the risk of heart attack and stroke.

During the eight-week trial, Merck lawyers contended Humeston had several risk factors for heart disease, including being overweight and sedentary and having high blood pressure and cholesterol levels.

In the unusual, two-phase court proceeding in Atlantic City, jurors were initially asked to only consider Merck's conduct in marketing and disclosing risks of Vioxx. Merck had opposed that format, saying that if jurors found Merck's conduct negligent as jurors did they would be biased against the company in any damages phase.

''We believe the result is not supported by the evidence in this case,'' Freiwald said late Monday. ''We think the verdict in this case reflects the fact Merck didn't have a chance to tell the jury the entire story before the jury formed its conclusions.''

Judge Higbee chose the two-phase arrangement to try to speed up Vioxx trials. She is overseeing all Vioxx lawsuits filed in New Jersey more than half of the roughly 28,000 lawsuits Merck faces. Merck has been fighting them one by one.

The same jurors ruled March 2 that Merck was not negligent in the case of a second plaintiff in the case who died of a heart attack after the stronger warning on the drug's risks.

Vioxx Jury Awards $20M to Idaho Couple

Mon, 12 Mar 2007 00:00:00 -0700

Merck & Co.'s painkiller Vioxx contributed to an Idaho postal worker's heart attack, a jury in Atlantic City ruled Monday, reversing the verdict in the man's first trial and awarding him and his wife $20 million in damages.

The verdict in the case of Frederick "Mike" Humeston, who was granted a second trial in light of new evidence, means Merck has now won nine cases and lost five in the mushrooming litigation over its former blockbuster arthritis pill.

Humeston, 61, of Boise, Idaho, suffered a heart attack in September 2001, several months before Merck under pressure from federal regulators put a stronger warning about the cardiovascular risks of Vioxx on the drug's detailed package insert.

Humeston, a decorated veteran, had taken Vioxx intermittently for knee pain from a Vietnam War shrapnel wound.

The five-man, three-woman jury ruled on March 2 that Merck was negligent and did not provide adequate warning about those risks before Humeston's heart attack. That set the stage for a second phase of the trial, with the jury last week hearing evidence on whether Vioxx contributed to Humeston's heart attack, entitling him to damages.

The jurors awarded Humeston $18 million in compensatory damages and gave another $2 million to his wife, Mary.

The jury, which deliberated for about five hours over two days, also decided Humeston should be reimbursed for his out-of-pocket costs for Vioxx.

A third phase of the trial will now begin, with jurors considering whether they should assess punitive damages against Merck.

Humeston lost his first trial against the pharmaceutical giant in 2005, but New Jersey Superior Court Judge Carol Higbee granted him a second trial because new evidence surfaced that short-term Vioxx use could also be risky; Humeston took the drug on and off for about two months. Merck insists Vioxx didn't increase cardiac risks until after 18 months of use, but many doctors say research disproves that.

"It's been a long battle. I'm just happy that justice finally prevailed," said Humeston's lawyer.

Whitehouse Station, N.J.-based Merck pulled Vioxx from the market in September 2004 after its own research showed the drug doubled the risk of heart attack and stroke.

During the eight-week trial, Merck lawyers contended Humeston had several risk factors for heart disease, including being overweight and sedentary and having high blood pressure and cholesterol levels. The company's lawyers noted he sometimes took large doses of ibuprofen, another pain reliever linked to heart attack risk.

"We certainly hoped for a different result," Hope Freiwald, a member of Merck's defense team, said in a statement. "The last time a jury had a chance to look at all the evidence at one time, it found that Merck acted appropriately."

Merck's lead attorney, Diane Sullivan, who had won the first Humeston case, did not immediately comment.

In the unusual, two-phase court proceeding in Atlantic City, jurors were initially asked to only consider Merck's conduct in marketing and disclosing risks of Vioxx.

Judge Higbee chose the two-phase arrangement to try to speed up Vioxx trials. She is overseeing all Vioxx lawsuits filed in New Jersey more than half of the roughly 28,000 suits Merck faces. Merck has been fighting the suits one by one.

The jurors ruled on March 2 that Merck was negligent in the case of Humeston, but not in the case of a second plaintiff in the trial, the sister of Brian Hermans of Waupaca, Wis. He died at age 44 after having a heart attack in September 2002, after the stronger warning was issued.

Because the jury found Merck violated New Jersey's consumer fraud law by omitting or giving misleading information about Vioxx in its marketing, the Hermans family is entitled to be reimbursed for three times the amount he spent on Vioxx. His attorney can also be reimbursed for his fees and costs. Higbee is to rule on those issues later.

Merck Slapped with $47 Million Verdict in Vioxx Case

Mon, 12 Mar 2007 00:00:00 -0700

On Monday, pharmaceutical giant Merck & Co. was ordered to pay $47.5 million in damages after a New Jersey jury decided that the company’s Vioxx medication was responsible for an Idaho man’s heart attack. The jury awarded $20 million in compensatory damages to Frederick Humeston and his wife and then tacked on an additional $27.5 million in punitive damages after deciding unanimously that Merck’s actions were “willful and reckless.”

“The verdict today finally achieves justice for Mr. Humeston and his family, who were among the many thousands of unsuspecting users of this very dangerous product,” said the plaintiff's attorney in a statement. “The jury recognized the very serious heart risks of Vioxx, risks that Merck went to great lengths to conceal from doctors and the public.”

In the first phase of the trial, jurors found that Merck not only violated consumer-fraud laws, but also failed to provide adequate warnings prior to the plaintiff’s Vioxx regimen. Humeston had lost his first trial against Merck. However, that previous verdict was tossed out and a retrial was ordered by Judge Carol Higbee after new evidence came to light.

Today’s verdict concluded the second phase of Humeston’s trial, which was to determine whether or not the drug led directly to his heart attack, which he survived. Jurors decided that Vioxx was indeed responsible for the man’s heart attack, and they also claimed that Humeston’s physician may have chosen alternative treatment had proper warnings about the drug been issued. Humeston’s heart attack occurred in September of 2001 before updated Vioxx product warnings appeared on the label. Therefore, jurors decided, the company was liable for both punitive and compensatory damages.

Merck Slapped with $47 Million Verdict in Vioxx Case

Mon, 12 Mar 2007 00:00:00 -0700

Merck Slapped with $47 Million Verdict in Vioxx Case

Mon, 12 Mar 2007 00:00:00 -0700

FDA Strengthens Safety Information for Erythropoiesis-Stimulating Agents (ESAs)

Fri, 09 Mar 2007 00:00:00 -0800

The U.S. Food and Drug Administration (FDA) today issued a public health advisory outlining new safety information, including revised product labeling about erythropoiesis-stimulating agents (ESAs), widely-used drugs for the treatment of anemia. The drugs affected by the safety update are darbepoetin alfa (Aranesp) and epoetin alfa (Epogen and Procrit). (ESAs are genetically engineered forms of the naturally occurring human protein, erythropoietin. Natural erythropoietin is made by the kidney and increases the number of red blood cells).

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

Fri, 09 Mar 2007 00:00:00 -0800

FDA Warns of Serious Side Effects Related to Popular Anemia DrugsThe U.S. Food and Drug Administration (FDA) has issued a new warning about erythropoiesis-stimulating agents (ESAs), which are drugs that are used to treat anemia. The warnings relate to darbepoetin alfa (Aranesp) and epoetin alfa (Epogen and Procrit). All three of the drugs are made by Amgen Inc., although Procrit is distributed and marketed by a Johnson & Johnson subsidiary.

“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.

Verdict Reached in Two Vioxx Cases

Fri, 02 Mar 2007 00:00:00 -0800

Jurors in a New Jersey courtroom decided today that Merck misled medical professionals and consumers about the risks associated with Vioxx, the company’s discredited pain medication, and in one of the cases did not provide adequate warnings about the potentially severe side effects.

In the case of Messerschmidt v. Merck, the jury ruled that Merck’s misleading marketing materials violated the state’s consumer-fraud laws although they also ruled that Merck had provided sufficient warnings before doctors had prescribed Vioxx to Brian Hermans. Hermans died of a heart attack at age 44 after taking Vioxx.

In the second case, Humeston v. Merck, jurors found that Merck not only violated consumer-fraud laws, but also failed to provide adequate warnings prior to the plaintiff’s Vioxx regimen. Frederick Humeston survived his heart attack, but lost his first trial against Merck. However, that previous verdict was tossed out, and a retrial was ordered. The next phase of Humeston’s trial will determine whether or not the drug led to his heart attack.

Humeston’s heart attack occurred in September of 2001 before the updated Vioxx product warnings appeared on the label. Therefore, the company may be liable for punitive and compensatory damages in that case. However, Hermans suffered his heart attack a year later, after the FDA’s mandated label change had taken place and therefore is not eligible for punitive or compensatory damages.

Meanwhile, Merck’s Vioxx replacement, known as Arcoxia, is slated to be reviewed by the FDA’s Arthritis Drugs advisory committee in an April meeting. Arcoxia is also part of the class of drugs known as cox-2 inhibitors, and it would be the first drug of the class to be approved in the U.S. since Vioxx and Pfizer’s Bextra were pulled from the market due to safety concerns.

Study: Contraceptive Patch Increases Risk of Blood Clots

Mon, 26 Feb 2007 00:00:00 -0800

According to a study published this month in the journal Obstetrics & Gynecology, women who use contraceptive patches, such as Ortho Evra, may be more than twice as susceptible to blood clotting as women who take oral contraception. The study was conducted by researchers at the i3 Drug Safety group.

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.”

ADHD drugmakers must tell of risks

Fri, 23 Feb 2007 00:00:00 -0800

Federal officials told the makers of Ritalin, Adderall, Strattera and all other drugs for treatment of attention deficit hyperactivity disorder, or ADHD, on Wednesday to come up with new pamphlets to explain the potential risks of the drugs to patients and parents.

The announcement came almost a year after panels of Food and Drug Administration advisers recommended that informational guides be provided to consumers. There are 15 drugs to treat ADHD, including extended-release, patch and chewable versions.

The panels made the recommendation after reviewing reports of young children hearing voices or having hallucinations while on the medications, some reporting they could see snakes or bugs or worms, and there were other reports of heart complications, including sudden death.

An agency review found a slightly increased risk, about one per 1,000 patients for adverse psychiatric reactions. A separate review of reports of serious cardiovascular adverse events found reports of sudden death in patients with underlying serious heart problems or defects, and reports of stroke and heart attack in adults with certain risk factors.

The new patient guides would supplement the information already included on the drugs' labeling and would be given out in booklet or pamphlet form with each prescription.

Dr. Mark Epstein, a specialist in the treatment of ADHD and medical director of the Miami Children's Hospital Dan Marino Center in Weston, Fla., said the concerns first surfaced about two years ago and that he got calls from many parents of his patients who take the drugs.

"Parents are very scared when they hear about a risk for sudden death," Epstein said. But after he explained that the risk is no higher for children on the drugs than for the general population, and that the deaths occurred in patients with known heart problems or a family history of such problems, only one or two parents insisted their children be taken off the drugs, he said.

"When the appropriate diagnosis is made and the medications are prescribed properly, they are exceedingly safe," Epstein said, but he recommended that patients and parents talk with their own doctors if they have concerns.

ADHD affects an estimated 3 percent to 7 percent of school-age children and about 4 percent of adults. The three main symptoms are inattention, hyperactivity and impulsivity.

Parker Waichman Alonso LLP Believes New Study Confirms Ortho Evra is Associated with Increased Risk of Venous Thromboembolism Compared to Oral Contraceptive Pills

Fri, 23 Feb 2007 00:00:00 -0800

Parker Waichman Alonso LLP (www.yourlawyer.com) announced today that they believe the results of a new study, which appears in the February edition of Obstetrics & Gynecology, confirms that the Ortho Evra transdermal contraceptive patch is more dangerous than oral contraceptive pills. The study, which analyzed United Healthcare insurance claims from April 2002 to December 2004, found a more than 200 percent increase in the rate of venous thromboembolism among women using Ortho Evra compared with those using a typical oral contraceptive pill.

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

Government wants further ADHD drug warnings

Thu, 22 Feb 2007 00:00:00 -0800

The makers of Ritalin, Adderall, Strattera and other drugs treating attention-deficit hyperactivity disorder were advised by the government Wednesday to give patients and their parents an additional warning that those medicines could cause serious psychiatric and heart problems, including sudden death.

Patients would receive with their prescriptions two-page "medication guides" that warn about possible side effects and urge them to notify doctors immediately after any sign of heart or psychiatric problems, such as chest pain, shortness of breath, fainting or hallucinations.

Dr. Thomas Laughren of the Food and Drug Administration emphasized that the move was precautionary and should not frighten patients away from taking the drugs, which he said were safe. He expected the manufacturers of the 15 drugs to comply with the request within 30 days.

An estimated 3.3 million children and 1.5 million adults take ADHD drugs, whose sales exceed $3.5 billion a year. Their use has been dogged by concerns about overuse in children and side effects, prompted by scattered reports of children dying suddenly. Some of the children were later determined to have had heart defects.

The latest action expands upon a move the government made last year, when the FDA asked manufacturers to revise ADHD drug labels to alert prospective patients with heart problems and warn of hallucinations in one out of 1,000 children.

Dr. Richard L. Gorman, a pediatrician who served on an FDA advisory panel that recommended the ADHD drug warnings, said the medication guides were "in line with" what the committee recommended. Gorman said parents must pay close attention to their children's reactions to the drugs because children might take them for years.

Laughren said it took until now to work out the wording of the medication guides, which are more simply worded than drug labels. Companies may tweak the language that the FDA proposed, he added.

More than 2,500 children who took ADHD drugs went to emergency rooms in 2004, and about a quarter of them had serious heart or blood pressure problems, the Centers for Disease Control and Prevention reported last year. Twenty-five deaths, 19 involving children, linked to the drugs were reported to the FDA from 1999 to 2003. Fifty-four strokes, heart attacks and other heart issues were also reported; some of those patients had previous heart conditions.

Drug makers to add warnings to ADHD pills

Wed, 21 Feb 2007 00:00:00 -0800

Drugs prescribed to treat attention deficit hyperactivity disorder will include guides to alert patients and parents of the risks of mental and heart problems, including sudden death.

The Food and Drug Administration said Wednesday that it directed the manufacturers of Ritalin, Adderall, Strattera and all other ADHD drugs to develop the guides. In May 2006, the agency told manufacturers to revise the labels of the drugs to reflect concerns about the cardiovascular and psychiatric problems.

Draft versions of the guides posted on the FDA Web site include discussion of reports of increased blood pressure and heart rate in ADHD patients, as well as cases of sudden death in some who have heart problems and heart defects. In adult patients, the reported problems also include stroke and heart attack.

The alerts also cover psychiatric problems, such as hearing voices, unfounded suspicions and manic behavior, of which there is a slightly increased risk in patients who take the drugs, the FDA said. The guides also tell patients and their parents of precautions they can take to guard against the risks.

Wednesday’s announcement came roughly a year after two panels of FDA advisers recommended that the drugs include such patient medication guides. The announcement covers 15 drugs, including extended-release, patch and chewable versions of some of them.

Ritalin is manufactured by Novartis Pharmaceuticals Corp. and in generic form by other companies; Adderall is made by Shire Pharmaceuticals Inc.; Strattera by Eli Lilly & Co.

ADHD affects an estimated 3 percent to seven percent of school-age children and four percent of adults, the FDA said.

ADHD Drugs to Get New Warnings

Wed, 21 Feb 2007 00:00:00 -0800

The U.S. Food and Drug Administration (FDA) announced today that it is ordering all manufacturers of attention deficit hyperactivity disorder (ADHD) medication to develop Patient Medication Guides to warn patients of potentially serious side effects. The most significant warnings will be related to adverse psychiatric symptoms and to cardiovascular risks.

“Medicines approved for the treatment of ADHD have real benefits for many patients but they may have serious risks as well,” said Dr. Steven Galson, director of the FDA’s Center for Drug Evaluation and Research (CDER). “In our ongoing commitment to strengthen drug safety, FDA is working closely with manufacturers of all ADHD medicines to include important information in the product labeling and in developing new Patient Medication Guides to better inform doctors and patients about these concerns.”

According to the agency, “An FDA review of reports of serious cardiovascular adverse events in patients taking usual doses of ADHD products revealed reports of sudden death in patients with underlying serious heart problems or defects, and reports of stroke and heart attack in adults with certain risk factors. Another FDA review of ADHD medicines revealed a slight increased risk (about 1 per 1,000) for drug-related psychiatric adverse events, such as hearing voices, becoming suspicious for no reason, or becoming manic, even in patients who did not have previous psychiatric problems.”

In May of 2006, the FDA’s Pediatric Advisory Committee and the Drug Safety and Risk Management Advisory Committee directed the drug makers to revise their label warnings, and the new directive for Patient Medication Guides is the next step in that process. There are 15 medications subject to the new warnings: Adderall, Adderall XR, Concerta, Daytrana, Desoxyn, Dexedrine, Focalin, Focalin XR, Metadate CD, Methylin Oral Solution, Methylin Chewable Tablets, Ritalin, Ritalin SR, Ritalin LA, and Strattera.

The FDA says that approximately 3 percent to 7 percent of children and 4 percent of adults suffer from ADHD, which has three main symptoms: inattention, hyperactivity, and impulsivity. They recommend that any patient considering using any of these drugs “develop a treatment plan that includes a careful health history and evaluation of current status, particularly for cardiovascular and psychiatric problems (including assessment for a family history of such problems).”

According to drafts of the medication guides posted on the FDA’s website, the warnings include information about adverse events including “heart-related problems” and “mental (psychiatric) problems.” The heart-related problems cited include sudden death in patients who have heart problems or heart defects; stroke and heart attack in adults; and increased blood pressure and heart rate. The psychiatric problems facing all patients include new or worse behavior and thought problems; new or worse bipolar illness; and new or worse aggressive behavior or hostility. For children and teenagers, there are added warnings about new psychotic symptoms (such as hearing voices, believing things that are not true, unfounded suspicion) or new manic symptoms.

FDA orders warning 'guides' for ADHD drugs

Wed, 21 Feb 2007 00:00:00 -0800

Pharmacists will soon begin handing out consumer-friendly "medication guides" about cardiovascular and psychiatric problems linked to widely prescribed attention deficit/hyperactivity disorder drugs, the Food and Drug Administration announced Wednesday.

Tom Laughren, director of the FDA's Division of Psychiatry Products, said makers of the 15 products approved to treat ADHD have 30 days to finalize the language in the medication guides. Meanwhile, drafts written by the FDA are posted online at www.fda.gov/cder/drug/ infopage/ADHD/default.htm.

About 3% to 7% of school-age children and about 4% of adults have attention disorders, the FDA says. In 2006, U.S. sales of ADHD drugs totaled about $3.5 billion, according to IMS Health, a health care information company.

Laughren said the new guides reflect changes ordered last May in the warnings section of the drugs' physician labeling. Two FDA advisory committees a year ago recommended adding information about new data on cardiovascular and psychiatric problems in children and teens who took the ADHD drugs.

From 1993 to February 2005, the FDA received 27 reports of unexpected death in patients under 18 who had taken one of the medications, Laughren said. It's not clear whether the deaths were the result of the ADHD drugs or underlying cardiovascular problems, he said.

In addition, since 2000 the agency has received hundreds of reports of psychosis or manic behavior, particularly hallucinations, in patients who had no known risk factors, according to an agency memo given last year to one of the advisory committees.

Also, a pooled analysis of trials that compared an ADHD drug with a placebo found a higher rate of hallucinations, delusions and mania in patients who were given the medication, Laughren said, putting the risk for such problems at one in 1,000 patients.

"Despite this new warning language in the medication guides; we continue to view ADHD as an important illness that benefits from treatment," Laughren said.

FDA Directs ADHD Drug Manufacturers to Notify Patients about Cardiovascular Adverse Events and Psychiatric Adverse Event

Wed, 21 Feb 2007 00:00:00 -0800

The U.S. Food and Drug Administration (FDA) today directed the manufacturers of all drug products approved for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) to develop Patient Medication Guides to alert patients to possible cardiovascular risks and risks of adverse psychiatric symptoms associated with the medicines, and to advise them of precautions that can be taken.

"Medicines approved for the treatment of ADHD have real benefits for many patients but they may have serious risks as well," said Steven Galson, M.D., Director, Center for Drug Evaluation and Research (CDER). "In our ongoing commitment to strengthen drug safety, FDA is working closely with manufacturers of all ADHD medicines to include important information in the product labeling and in developing new Patient Medication Guides to better inform doctors and patients about these concerns."

Patient Medication Guides are handouts given to patients, families and caregivers when a medicine is dispensed. The guides contain FDA-approved patient information that could help prevent serious adverse events. Patients being treated with ADHD products should read the information before taking the medication and talk to their doctors if they have any questions or concerns.

ADHD is a condition that affects approximately 3 percent to 7 percent of school-aged children and approximately 4 percent of adults. The three main symptoms are inattention, hyperactivity, and impulsivity. People with ADHD may have difficulty in school, troubled relationships with family and peers, and low self-esteem.

An FDA review of reports of serious cardiovascular adverse events in patients taking usual doses of ADHD products revealed reports of sudden death in patients with underlying serious heart problems or defects, and reports of stroke and heart attack in adults with certain risk factors.

Another FDA review of ADHD medicines revealed a slight increased risk (about 1 per 1,000) for drug-related psychiatric adverse events, such as hearing voices, becoming suspicious for no reason, or becoming manic, even in patients who did not have previous psychiatric problems.

FDA recommends that children, adolescents, or adults who are being considered for treatment with ADHD drug products work with their physician or other health care professional to develop a treatment plan that includes a careful health history and evaluation of current status, particularly for cardiovascular and psychiatric problems (including assessment for a family history of such problems).

As part of the Agency’s ongoing regulatory activity, in May 2006 the FDA directed manufacturers of these products to revise product labeling for doctors to reflect concerns about adverse cardiovascular and psychiatric events. These changes were based on recommendations from the FDA Pediatric Advisory Committee and the Drug Safety and Risk Management Advisory Committee. To help patients understand these risks, an additional part of this revised labeling process is the creation of a Patient Medication Guide for each individual product.

The medicines that are the focus of the revised labeling and new Patient Medication Guides include the following 15 products:

Adderall (mixed salts of a single entity amphetamine product) Tablets
Adderall XR (mixed salts of a single entity amphetamine product) Extended-Release Capsules
Concerta (methylphenidate hydrochloride) Extended-Release Tablets
Daytrana (methylphenidate) Transdermal System
Desoxyn (methamphetamine HCl) Tablets
Dexedrine (dextroamphetamine sulfate) Spansule Capsules and Tablets
Focalin (dexmethylphenidate hydrochloride) Tablets
Focalin XR (dexmethylphenidate hydrochloride) Extended-Release Capsules
Metadate CD (methylphenidate hydrochloride) Extended-Release Capsules
Methylin (methylphenidate hydrochloride) Oral Solution
Methylin (methylphenidate hydrochloride) Chewable Tablets
Ritalin (methylphenidate hydrochloride) Tablets
Ritalin SR (methylphenidate hydrochloride) Sustained-Release Tablets
Ritalin LA (methylphenidate hydrochloride) Extended-Release Capsules
Strattera (atomoxetine HCl) Capsules

Heart surgery drug linked to death risk

Wed, 07 Feb 2007 00:00:00 -0800

A drug widely used to prevent excessive bleeding during heart surgery appears to raise the risk of dying in the five years afterward by nearly 50 percent, an international study found.

The researchers said replacing the drug aprotinin, sold by Bayer AG under the brand name Trasylol with other, cheaper medications for a year would prevent 10,000 deaths worldwide over the next five years.

The findings were more bad news for Trasylol: The same scientists found the drug raised the risk of kidney failure, heart attacks and strokes in a study published last year. Most of the deaths in the new study were related to those problems.

Bayer said in a statement that the findings are unreliable because Trasylol tends to be used in more complex operations and the researchers' statistical analysis did not fully account for the complexity of the surgery cases.

Nevertheless, the drug company said it will "work with regulatory agencies and external experts in the field to further evaluate the findings."

The study, published in Wednesday's Journal of the American Medical Association, intensifies questions about how best to track the safety of drugs after they have gone on the market. The Food and Drug Administration approved aprotinin in 1993.

Last year's study and other research led the FDA to review Trasylol's safety and order stronger warning labels in December. But that action wasn't strong enough, said Dr. Dennis Mangano of the nonprofit Ischemia Research and Education Foundation, lead author of both studies.

The FDA is already reviewing aprotinin's safety. The new study is an important contribution to that review, which could result in additional warnings, said Dr. Dwaine Rieves, deputy director in the FDA's Division of Medical Imaging and Hematology Products.

The drug works by blocking enzymes that dissolve blood clots, and Mangano speculated that clotting problems caused the deaths.

Mangano advised patients to ask their doctors what drug, if any, they will be given to slow bleeding during heart surgery and about the risks. Past patients should find out if they have been given aprotinin so their doctors can watch for problems, he said.

"I believe that for the vast majority of coronary bypass patients the drug should not be used," Mangano said. But he said the drug should remain on the market because some very high-risk patients may benefit from it.

Dr. Brett Sheridan, a heart surgeon with the University of North Carolina Health Care System who was not involved in the study, said several years ago he quit giving aprotinin almost entirely because he had seen more kidney damage in patients who got the drug.

"It's not a perfect study, but the data are compelling enough that we have to use aprotinin judiciously," Sheridan said of the new research.

The study followed 3,876 patients who had heart bypass surgery at 62 medical centers in 16 nations. Researchers compared patients who received aprotinin to patients who got other drugs or no anti-bleeding drugs. Over five years, 20.8 percent of the aprotinin patients died, versus 12.7 percent of the patients who received no anti-bleeding drug.

When researchers adjusted for other factors, they found that patients who got Trasylol ran a 48 percent higher risk of dying in the five years afterward.

The other drugs, both cheaper generics, did not raise the risk of death significantly.

Cost varies depending on dosage and length of surgery, but a two-hour bypass surgery might require $792 in Trasylol, compared with $7 to $35 for one of the generics.

The study was not a randomized trial, meaning that it did not randomly assign patients to get aprotinin or not. In their analysis, the researchers took into account how sick patients were before surgery, but they acknowledged that some factors they did not account for may have contributed to the extra deaths.

Aprotinin joins the painkiller Vioxx, drug-coated stents and other drugs and devices where safety concerns arose after the products were on the market.

"We don't know enough about what happens with drugs and devices once they go into the public domain," said Dr. Bruce Ferguson of East Carolina University, who wrote an editorial accompanying the new study. Drug companies will have to help pay for a better system of post-market safety research because the government can't afford to do it alone, he said.

Similarly, Mangano said: "I would love to see something change as a result of this."

Last week, FDA officials announced plans to assess safety in the first 18 months a drug is on the market.

The earlier study prompted at least two lawsuits against Bayer, including one from 78-year-old Tennessee resident Ada Williams, who was given the drug during heart surgery in 2004.

"She has to live the rest of her life on dialysis three days a week to keep her alive," said her attorney.

International study: Five-year death rate higher in heart surgery patients who are given aprotinin

Wed, 07 Feb 2007 00:00:00 -0800

Patients who are given a widely used drug to prevent excessive bleeding during heart surgery are at increased risk of dying within five years following their operations, medical researchers have found in the largest study of its kind.

Results from an international analysis that focused on a drug called aprotinin, sold under the brand name Trasylol, revealed the risk of death increased by nearly 50 percent in patients given the drug during bypass operations. The medication, made by Bayer AG, was federally approved in 1993.

"I think something radical needs to be done," Dr. Dennis Mangano of the nonprofit Ischemia Research and Education Foundation in San Bruno, Calif., said, calling for a change in how the FDA approves drugs.

As lead investigator of the international research, Mangano found 20.8 percent of patients given aprotinin died of complications, which he said, could be directly traced to the drug. In the control group, only 12.7 percent of patients died. More than 3,800 patients at 62 medical centers in 16 countries were involved in the study.

Aprotinin obstructs the activity of enzymes that dissolve blood clots and thus affects numerous biological pathways involved in clotting. Because it affects so many pathways, Mangano said, the effects of the drug do not diminish after surgery. Vessels throughout the body continue to be affected, including the complex labyrinth of vessels throughout the kidneys. Mangano discovered last year that kidney failure can be a consequence. In this study, he found that patients were vulnerable to heart failure, heart attacks and strokes.

"The thrombosis takes months to years to manifest in death," he said.

In a statement yesterday, Bayer lambasted Mangano's study, which is published in today's issue of the Journal of the American Medical Association. The pharmaceutical giant labeled data in both of Mangano's studies "unreliable." Bayer officials said they "will work with regulatory agencies and external experts in the field to further evaluate the findings."

Even though aprotinin is not a household name, it has been given to an estimated 4 million patients. Not long after its approval, reports of liver toxicity began surfacing, doctors say.

"This is a very important study," said Dr. Stephen Lahey, chief of cardiovascular surgery at Maimonides Medical Center in Brooklyn. He said that while at Harvard University a decade ago, he and colleagues abandoned use of aprotinin after noticing complications.

Issues involving aprotinin are "unbelievably politically charged," Lahey said, "because the company that makes it is a very, very big company and it has a lot of literature saying aprotinin is fine." He was not involved in the research.

Mangano said if surgeons globally used either of two cheaper and less potent medications for a year, 10,000 lives would be spared over five years.

Merck Suffers Potential Legal Setback in Vioxx Case

Wed, 17 Jan 2007 00:00:00 -0800

In what may be a devastating blow to drug maker Merck, a New Jersey appeals court overturned a lower court’s decision to dismiss a proposed class-action suit against the company. In a unanimous ruling, the three-judge panel declared that the lower court “prematurely terminated plaintiffs’ opportunity” for legal recourse and must reconsider the case.

The proposed class-action suit seeks to hold Merck financially responsible for coronary testing of former Vioxx patients including those who haven’t yet shown signs of adverse reactions. That group may very well include hundreds of thousands of former Vioxx patients.

Merck pulled Vioxx off the market in 2004 after discovering that the arthritis drug doubled the risks of heart attack and stroke. The company is currently facing more than 27,000 personal-injury lawsuits in addition to 265 potential class-action suits.

The original ruling in the case, now overturned, was handed down by New Jersey Superior Court Judge Carol Higbee. Higbee is still in charge of roughly 15,000 Vioxx-related cases, including two that are going to product-liability trial next week.

If Merck is held responsible for medical monitoring of former Vioxx users, their legal bill may skyrocket. Some estimates have placed the total potential damages as high as $50 billion.

Vioxx Decision Upheld, Award Reduced by Texas Court

Tue, 26 Dec 2006 00:00:00 -0800

The good news for Felicia Garza: A Texas judge certified the ruling of a state jury that held the pharmaceutical company Merck & Co. liable for the Vioxx-related death of her husband. The bad news: The same judge decided that the initial damages awarded--to the tune of $32 million violated state law and therefore reduced the award considerably, to $8.7 million.

Leonel Garza passed away in 2001 after suffering a heart attack that plaintiffs believe was caused by him taking the controversial painkiller Vioxx. This past April, a Texas jury ruled against Merck and awarded the deceased’s family $32 million in damages: $7 million in compensatory damages and $25 million in punitive damages. However, Judge Alex Gabert ruled that the award violated a 2003 state law that set strict limits on punitive and compensatory damages.

Still, the big news for other Vioxx plaintiffs was that the original ruling was upheld, meaning that the courts accepted the premise that even short-term use of Vioxx may have led to severe side effects including heart attacks and strokes. Well more than 27,000 lawsuits have been brought against Merck, which pulled Vioxx from the shelves in September of 2004 after a study disclosed that long-term use of the drug could double a patient’s risk of a coronary event.

However, a New Orleans federal judge rejected appeals by the plaintiffs to form a class action, saying that each individual case was too distinct to be tried as a group. Merck has emerged victorious in the majority of the cases heard to this point.

A financial relationship between Felicia Garza and one of the jurors in the Texas trial has called the legitimacy of the original verdict into question, and Merck plans to seek a new trial because of the alleged improprieties. The lengthy appeals process may delay payment to the Garzas for many years to come.

FDA Panel Seeks Warning That Stents May Be Unsafe

Sat, 09 Dec 2006 00:00:00 -0800

New drug-oozing stents widely used to prop open clogged arteries are associated with an increased risk of blood clots, heart attacks and death for the majority of patients receiving the devices, an expert panel concluded yesterday.

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.

Panel weighs in on stents

Sat, 09 Dec 2006 00:00:00 -0800

A divided Food and Drug Administration advisory panel Friday said cardiac patients should be warned they face a higher rate of life-threatening complications from unapproved use of drug-coated stents.

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.

Analysis: Panel urges warning on stents

Fri, 08 Dec 2006 00:00:00 -0800

A Food and Drug Administration advisory panel recommended new warnings Friday for popular medical devices used in millions of patients with cardiovascular disease.

Experts said the two brands of drug-coated stents available in the U.S. should carry new warnings that the devices may increase the risk of sudden heart attack or death in many patients.

Stents are mesh tubes used to hold arteries open after physicians clear away blockages, usually with an inflatable balloon angioplasty. Approximately one million Americans receive stent implants each year.

The devices are made either of bare metal mesh or a newer, coated metal that steadily releases a drug into artery walls to prevent formation of scar tissue. Two drug-coated stents, Taxus, made by Boston Scientific and Cypher, made by Cordis, a division of Johnson & Johnson have exploded in popularity since they came on the market in 2003 and 2004.

Stents are credited with providing a non-surgical alternative to heart bypass operations for many patients with artery disease. But new data released earlier this year suggested that drug-coated versions may increase the risk of heart attacks and sudden deaths by as much as 0.5 percent per year, starting a year after implantation.

The data and resulting press coverage prompted FDA to organize a hastily-convened two-day expert panel to decide how the agency should react. Friday's conclusions came one day after the panel informally voted that the benefits of drug-coated stents outweigh the risks for average patients.

Studies leading to the approval of Taxus and Cypher tested the devices in patients with single, smaller artery blockages. But doctors quickly started using them in patients with blockages in multiple vessels and in those with larger blockages or co-existing diseases like diabetes.

Today, more than six in ten of all drug-coated stent implants are done "off-label," or used beyond their approved indication, according to FDA.

Experts said Friday that the devices' label inserts should now carry a warning that use in more complicated patients increases the risk of dangerous blood clots, heart attack and sudden death.

"If (doctors) use the device in an off-label manner they're not going to get the results that they see in the label," said William Maisel, a cardiologist at Beth Israel Deaconess Medical Center in Boston and chair of the advisory panel.

Experts also said physicians should be urged to extend the use of the blood-thinning drug Plavix in patients who receive drug-coated stents off-label. Current recommendations advise patients to take Plavix along with aspirin for three to six months after implantation, although experts said that should be extended to one year.

The recommendations was not made by a formal vote but were the consensus of panel members. FDA does not have to follow advisory panels' advice, but usually does.

FDA officials said they would move to communicate the recommendations to the public, although the method of that communication is yet to be decided. The agency could choose to add warnings to drug-coated stent labeling, communicate directly with physicians about the risks, or do both.

At the end of the day what I heard loud and clear is that we need to do better job..,communicating to patients and communicating to doctors the best and the latest information," said Dan Schultz, MD, director of FDA's Center for Devices and Radiologic Health. "This meeting needed to happen," he said.

News of the potential for increased risk sparked anxious press reports and worry among many U.S. patients. Experts stressed Friday that there was little need for patients using drug-coated stents to have them removed. Suspected clots and heart attacks blamed on the stents are still thought to be relatively rare. Patients who take blood-thinning drugs according to physician recommendations reduce their risk.

Some experts described the two days of FDA meetings as a kind of reality check on the use of drug-coated stents by U.S. doctors.

"I think we've got to come back to Earth here," said Steven Nissen, chair of cardiovascular medicine at the Cleveland Clinic Foundation and one of the FDA advisors.

There was dissent among panel members. Some worried the issuing new warnings would further frighten patients and physicians away from using stents.

"I haven't seen anything today that's going to change my practice on Mon morning when I go back," said Christopher J. White, chairman of cardiology at the Ochsner Clinic Foundation in New Orleans, and a member of the FDA panel.

In an interview, Ralph G. Brindis, MD, a stent researcher at Kaiser Permanente of Northern California, predicted that the FDA hearings would lead physicians to "more conservatism" in their use of drug-coated stents. He said doctors may now be less likely to use the devices in diabetic patients with multiple blockages or diabetes, instead opting for traditional bypass surgery.

"I think doctors will get the message that rather than using multiple drug-eluting stents, that they'll be a modest swing back to that procedure," said Brindis, who is also chief medical officer of the American College of Cardiology.

Mark Turco, MD, a researcher at Washington Adventist Hospital in Washington, DC, said that drug-dispensing stents were greeted by "unbridled enthusiasm" that outpaced scientific proof for many patients. He said recent news of increased risks then swung public perception to one of near panic over the dangers.

"Hopefully we will soon move to a realistic application where the data will far outweigh the perceptions," he said.

Health Canada warning over birth control patch

Fri, 24 Nov 2006 00:00:00 -0800

Health Canada is warning Canadian women that the use of a birth control patch may increase their risk of developing blood clots in the legs and lungs.

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.

Millions face risk from drug-coated stents

Tue, 21 Nov 2006 00:00:00 -0800

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

Sat, 11 Nov 2006 00:00:00 -0800

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

Mon, 06 Nov 2006 00:00:00 -0800

Parker & Waichman, LLP (www.yourlawyer.com) announced that it has filed a lawsuit against Ortho McNeil Pharmaceutical, Inc., a division of Johnson and Johnson Inc. (NYSE:JNJ), on behalf of a 26 year-old woman. The suit, which was filed last week in the Superior Court of New Jersey, Law Division, Middlesex County, was the 100th lawsuit filed by Parker & Waichman, LLP on behalf of Ortho Evra victims. Parker & Waichman, LLP has been retained by hundreds of additional women who were injured after using the Ortho Evra birth control patch and will continue to file suits against Ortho McNeil throughout the remainder of 2006 and 2007.

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

FDA Statement Regarding New Trasylol Data

Fri, 29 Sep 2006 00:00:00 -0700

Since January, 2006, the Food and Drug Administration (FDA) has been conducting a safety review of Trasylol (aprotinin injection). The review was triggered by the results of two published research studies: one that reported an increase in the chance of kidney failure, heart attack and stroke in patients treated with Trasylol compared to those treated with other similar drugs, and the other that reported an increase in kidney dysfunction compared to another drug. On September 21, 2006, FDA held a public meeting of the Cardiovascular and Renal Drugs Advisory Committee to discuss the safety and overall risk-benefit profile for Trasylol. At that meeting, the committee discussed the findings from the two published observational studies, the Bayer worldwide safety review, and the FDA review of its own post-marketing database.

On September 27, 2006, Bayer Pharmaceuticals told FDA that it had conducted an additional safety study of Trasylol. The preliminary findings from this new observational study of patients from a hospital database reported that use of Trasylol may increase the chance for death, serious kidney damage, congestive heart failure and strokes. FDA was not aware of these new data when it held the September 21, 2006, Advisory Committee meeting on Trasylol safety. FDA is actively evaluating these new data and their implications for appropriate use of the drug.

While FDA conducts its evaluation of this new safety study, we recommend the following to healthcare providers:

Physicians who use Trasylol should carefully monitor patients for the occurrence of toxicity, particularly to the kidneys, heart, or brain, and promptly report observed adverse event information to Bayer Pharmaceuticals, the drug manufacturer, or to the FDA MedWatch program, by phone (1-800-FDA-1088), by fax (1-800-FDA-0178), or by the Internet at http://www.fda.gov/medwatch/index.html.
Physicians should consider limiting Trasylol use to those situations where the clinical benefit of reduced blood loss is essential to medical management of the patient and outweighs the potential risks.

These recommendations are similar to those provided in a February 8, 2006, FDA Public Health Advisory and information sheets for health care professionals and patients which were based on the published studies mentioned above. See http://www.fda.gov/cder/drug/infopage/aprotinin/default.htm.

Trasylol works to slow or prevent bleeding, and is used to reduce blood loss and the need for blood transfusion during some types of heart surgeries. Trasylol is made from the lung tissue of cattle.

In the published studies and the recently supplied Bayer study, patients were not assigned at random to receive various treatments, but rather had their treatment chosen by their physician as part of their standard medical care. Consequently, in these safety studies, patients receiving Trasylol may have had a higher chance for serious complications to begin with as compared to patients receiving no treatment or treatment with another drug intended to decrease bleeding. This possibility complicates the assessment of whether the available studies show that Trasylol treatment, rather than other factors, increased the chance for serious kidney or heart complications.

The new study was done for Bayer by a contract research organization. Existing hospital data from 67,000 records of patients undergoing coronary artery bypass graft surgery were examined. 30,000 of the patients were treated with Trayslol and 37,000 were treated with alternate products. Using complex epidemiological and statistical methods, the report suggested that patients receiving Trasylol were at increased risk for death, kidney failure, congestive heart failure and stroke.

Healthcare providers and patients are encouraged to report adverse event information to FDA via the MedWatch program by phone (1-800-FDA-1088), by fax (1-800-FDA-0178), or by the Internet at http://www.fda.gov/medwatch/index.html.

GALS' PATCH PERIL

Thu, 21 Sep 2006 00:00:00 -0700

Labels on a popular birth-control patch will be updated to warn women that the danger of blood clots in their legs and lungs are higher for them than for women using the pill, federal officials said yesterday.

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.

Parker & Waichman, LLP Files Lawsuit Against Ortho-McNeil Pharmaceutical, Inc. on Behalf of Ortho Evra Victim - JNJ

Tue, 19 Sep 2006 00:00:00 -0700

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 a 25 year-old woman. The woman was diagnosed with bilateral pulmonary emboli after using the Ortho Evra birth control patch for six months. The suit was filed in the Superior Court of New Jersey, Law Division, Middlesex County (midl-8005-06), earlier this month. Parker & Waichman, LLP continues to evaluate new Ortho Evra injury cases, and plans to file a significant number of additional cases against Ortho-McNeil Pharmaceutical, Inc. throughout the remainder of 2006. To request a free Ortho Evra case consultation, please visit www.orthopatchlawsuit.com or www.yourlawyer.com/topics/overview/Ortho_Evra_Patch.

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

Wed, 13 Sep 2006 00:00:00 -0700

Doctors have begun to consider the drawbacks of coated stents, the tiny mesh devices implanted to prop open clogged arteries, in light of emerging studies revealing a risk of blood clots that can lead to heart attacks and strokes.

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.

Parker & Waichman, LLP Files Suit Against Ortho-McNeil Pharmaceutical, Inc., Additional Suits to be Filed in Coming Months - JNJ

Thu, 24 Aug 2006 00:00:00 -0700

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 a 34 year-old woman. The woman was diagnosed with a severe pulmonary embolism after using the Ortho Evra birth control patch less than two years. The suit was filed in the United States District Court for the District of New Jersey earlier this month. Additionally, Parker & Waichman, LLP announced that it plans to file a significant number of additional cases against Ortho-McNeil Pharmaceutical, Inc. throughout the remainder of 2006. For more information on Ortho Evra and this case, please visit www.orthopatchlawsuit.com or www.yourlawyer.com/topics/overview/Ortho_Evra_Patch

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 found negligent in Vioxx case

Thu, 17 Aug 2006 00:00:00 -0700

Merck was found negligent in the latest Vioxx case, as a jury in New Orleans federal court found that the drugmaker misrepresented the risks of the arthritis painkiller.

Jerry Barnett, 62, a former agent for the Federal Bureau of Investigation and a former Vioxx patient, had sued Merck, blaming the drug for his non-fatal heart attack. He is fourth plaintiff to successfully sue the company.

Merck pulled its arthritis painkiller Vioxx off the market in 2004, after a Merck-funded study found that the drug increased the risk of heart attacks and strokes. Since that time, some 14,200 cases have been filed against the New Jersey-based drugmaker from former Vioxx patients and their families.

Merck has consistently denied all allegations of wrongdoing, saying that Vioxx did not kill anyone, and has vowed to fight each case individually.

Before Thursday's verdict, Merck was leading the fight with five courtroom wins and three losses. Merck won the most recent case in a Los Angeles state court Aug. 2, when a jury found that Vioxx did not cause a plaintiff's non-fatal heart attack.

Merck Suffers 2 Setbacks in Vioxx Cases

Thu, 17 Aug 2006 00:00:00 -0700

Merck & Co. was stung with two major legal setbacks over the withdrawn painkiller Vioxx on Thursday when a federal jury ordered the drugmaker to pay $51 million to a heart attack victim, and a state judge in New Jersey overturned a November verdict favoring the company.

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.

Merck found liable in another Vioxx case: reports

Thu, 17 Aug 2006 00:00:00 -0700

A jury on Thursday said Merck & Co. Inc. has to pay $50 million in compensatory damages to a former FBI agent who suffered a heart attack after taking the company's painkiller Vioxx, according to media reports.

The jury in a federal court in New Orleans reportedly ruled that Merck & Co., Inc. was negligent for failing to adequately warn doctors of about the risks associated with the drug. The jury also found that Merck "knowingly misrepresented or failed to disclose" information about Vioxx to the doctors of 62-year-old Gerald Barnett, the reports said.

Barnett suffered a heart attack in September 2002; he took Vioxx for 33 months, according to The Wall Street Journal.

Barnett's doctor said that if Merck had disclosed the drug's risks earlier, he would never have prescribed it for his patient, The Wall Street Journal reported on its Web site, citing court papers. Barnett reportedly kept taking the drug even after the heart attack, and until a few weeks before it was pulled from the market in September 2004.

The jury is scheduled to deliberate punitive damages in the trial later today.

Whitehouse Station, N.J.-based Merck is involved in more than 14,000 lawsuits over Vioxx, according to the Journal. With this latest verdict, the drugmaker has now won five trials and lost four.

There was no one at the company immediately available for comment.

Parker & Waichman, LLP Files Suit Against Ortho-McNeil Pharmaceutical, Inc. on Behalf of 36-Year-Old Woman

Wed, 16 Aug 2006 00:00:00 -0700

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 a 36 year-old woman. The woman was diagnosed with bilateral pulmonary emboli after using the Ortho Evra birth control patch for two months. The suit was filed in the United States District Court for the District of New Jersey earlier this week. For more information on Ortho Evra and this case, please visit www.orthopatchlawsuit.com or www.yourlawyer.com/topics/overview/Ortho_Evra_Patch.

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

Cruise ship's sudden tilt not an isolated incident

Sun, 23 Jul 2006 00:00:00 -0700

The sudden tilt that threw passengers across the deck of a cruise ship last week appears to be the most severe of a half-dozen similar incidents over the past year.

The accidents occurred on ships run by three major cruise lines, including Princess Cruises, which operates the month-old Crown Princess, which injured 93 people Tuesday when it lurched to one side about 11 miles off Port Canaveral, Fla.

The incidents, described on a cruise Web site and confirmed by some cruise line officials, raise the issue of whether such accidents are more frequent than industry trade groups contend.

"The recent listing of the Crown Princess is an uncommon occurrence for cruise ships," the International Council of Cruise Lines said Wednesday in a statement.

But earlier this year, 27 passengers were hurt on a Princess Cruises ship after a sudden list caused by the captain. In another case, a computer glitch on the Carnival Legend last July caused the ship to list 14 degrees to the side, an angle similar to the list on the Crown Princess. There were minor injuries, Miami-based Carnival Corp. said.

One reason for uncertainty about the number of such incidents is that no one keeps an official count of them. Cruise lines aren't required to report them, said Coast Guard spokeswoman Jennifer Johnson, except if they cause serious injuries or property damage.

Ships are designed to roll in the waves, but when a tilt endures for more than five or 10 seconds, it becomes a list. It signifies that the ship is moving forward with the deck at a stable angle, rather than level.

When it happens abruptly, things go flying. That occurred July 13, 2005, on the 2,680-passenger Carnival Legend as it left Tortola, in the British Virgin Islands.

According to a passenger who left an account on an Internet message board, a hard left turn combined with a strong wind pushed the ship into the 14-degree list.

"(It) felt like the ship was going to turn over; pool water and debris streamed past our window. Crew members said they had never experienced a list of that degree," said the account, on the Web site Cruisejunkie.com, which is run by a Canadian professor who has written two books about cruising.

In a statement issued last July, Carnival blamed a computer malfunction that affected the propulsion system.

That also is suspected as the cause of the Crown Princess accident, although no firm conclusion has been made. Steering, including the autopilot on the bridge, is one subject of the investigation under way by the National Transportation Safety Board.

Although keeping an officer at the ship's controls would seem the best policy, human error also causes listing incidents. In February, a passenger on the Grand Princess had a heart attack and the captain decided to return to Galveston, Texas.

He turned hard at cruising speed. "It was a sharper turn than should have been undertaken," said Princess spokeswoman Julie Benson. Glassware, ornaments and TV sets went airborne, according to an account in the Galveston County Daily News. Twenty-seven passengers and 10 crew members were treated for sprains, cuts and bruises.

Searching for Explanations

One question about last week's Crown Princess mishap is why it caused so many more injuries than other recent listing incidents.

Ron Butcher, a former Coast Guard inspector who recently wrote a book on cruise passenger safety, said the cause of the list may be different than other incidents, such as a mistake in keeping the ballast in the ship's holding tanks in proper alignment.

Butcher also said he wonders whether investigators may conclude the list on the ship was more acute than is currently thought.

"A 15-degree list, while serious, I don't see as consistent with the amount of damage that occurred," Butcher said.

Raloxifene averts breast cancer, at a risk

Thu, 13 Jul 2006 00:00:00 -0700

Women with heart disease or a high risk for it would trade one set of odds for another if they took the drug raloxifene to try to prevent breast cancer, a new study suggests. The drug helped prevent cancer, but raised the risk of blood clots and fatal strokes. It also didn't lower the risk of death, hospitalization or heart attack, as some had hoped it would.

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

Thu, 13 Jul 2006 00:00:00 -0700

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
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Testimony: Feds not told about tests that exposed Vioxx dangers

Fri, 30 Jun 2006 00:00:00 -0700

Merck & Co. did not inform federal authorities about two clinical trials in which users of the painkiller Vioxx were more likely to die than people given a placebo, jurors in the first Vioxx liability case to go to trial in California were told Wednesday.

Dr. Edward Scolnick, the former head of Merck & Co.'s research laboratories, said in a videotaped deposition that he did not believe the numbers were coincidental.

"It's not likely due to chance," he said.

Scolnick's testimony was shown to jurors on the second day of Stewart Grossberg's products liability lawsuit against Merck.

The 71-year-old plaintiff alleges the painkiller caused him to have a heart attack in 2001 and that Merck & Co. marketed it without warning consumers of its potential problems.

Merck & Co. said there's no proof Vioxx caused the Southern California man's heart ailments.

Grossberg's lawsuit is one of more than 13,000 such claims against Merck nationwide. Some 2,000 of the lawsuits were filed in California and consolidated in Los Angeles Superior Court by Judge Victoria G. Chaney.

Scolnick testified that people who took Vioxx died at a rate four times higher than those who didn't receive the drug in one of the clinical trials, and 2 1/2 times higher in the other. Both trials were done in 2001 to see if Vioxx could help Alzheimers patients.

Merck & Co., however, did not turn over trial results to the U.S. Food and Drug Administration when company officials met with agency representatives in April of that year, Scolnick said.

He said he was not aware of the clinical trial results at the time.

Merck put Vioxx on the market in 1999 as a treatment for arthritis and acute pain in adults. The company pulled the drug from the market two years ago, citing research that showed Vioxx doubled risk of heart attacks and strokes with long-term use.

Merck Scientist Testifies Vioxx Caused More Heart Attacks Than Aleve

Fri, 30 Jun 2006 00:00:00 -0700

People who took part in a clinical trial of the pain reliever Vioxx had heart attacks at a rate four times higher than those taking an older painkiller, a health data analyst for Merck and Co. testified today.

Deborah Shapiro, director of clinical biostatistics for Merck and Co. which marketed Vioxx from 1999 to 2004 said in a videotaped deposition shown to a jury that half of the 8,000 patients in the study took Vioxx and the other half naproxen, known by the brand name Aleve.

"The data was unfavorable to Vioxx, and of course that was a matter of concern," Shapiro testified.

The clinical trial, called Vioxx Gastrointestinal Outcomes Research, took place in 1999, Shapiro said.

Shapiro's videotaped deposition, which is being used in place of courtroom testimony, was shown on the third day of the trial of Stewart Grossberg's products liability lawsuit against Merck.

The retired Northridge construction manager's case in Los Angeles Superior Court case is the first against Vioxx and its manufacturer to go before a California jury.

Grossberg was 66 when he had a non-fatal heart attack in September 2001, more than two years after he began taking Vioxx, according to his court papers. He and his attorneys allege the heart attack was substantially related to his use of Vioxx.

Jurors were shown a copy of a December 1999 memo Shapiro co-signed and gave to Dr. Alise Reicin, a VIGOR study author and a top Merck scientist who had long defended Vioxx's safety. In the memo, Shapiro and another Merck researcher stated there were "serious vascular adverse experiences in the Vioxx program."

Shapiro said she does not know what Reicin did with the memo.

"I don't know who she shared the letter with," Shapiro said.

Shapiro testified that although she told various Merck officials about her concerns, she did not try and influence them with her feelings.

"I tried to avoid giving my opinion because it was their opinion that ruled the day," Shapiro said.

However, one Merck scientist asked her to "do additional analysis to explore the data because the trends were disconcerting," Shapiro testified.

Merck's attorneys have said there is little evidence that Vioxx caused heart attacks in Grossberg or plaintiffs in other cases.

The company's scientists have said the results of the VIGOR study can be explained by the success of naproxen in preventing heart attacks in those patients who took the drug.

Plaintiff says Merck knew of potential dangers with Vioxx

Wed, 28 Jun 2006 00:00:00 -0700

Merck & Co. knew of potential harmful side effects of its drug Vioxx and failed to notify doctors, a lawyer for a man who claims the painkiller caused his heart attack said Tuesday in opening statements of the first Vioxx liability case to go to trial in California.

"Merck knew of these potential side effects and never told a soul," said the attorney, who is representing the plaintiff.

The Whitehouse Station-based drug manufacturer, which says there's no proof Vioxx caused the Southern California man's heart ailments, was to present its opening statement later in the day. The drug was taken off the market two years ago amid concerns it increased the risk of heart ailments.

The plantiff's attorney, said that testing inadequacies such as excluding patients with a history of heart disease clouded the experiments and that the company had a "careless disregard" for patients for not warning doctors of the potential for heart attacks.

Company memos dating to 1996 showed that Merck was aware of the potential side effects, he said.

The company nevertheless hired 3,000 sales people and trained them to downplay the risks when talking with doctors, Girardi said.

The palntiff's suit is one of more than 13,000 such claims against Merck nationwide. Some 2,000 of the lawsuits were filed in California and consolidated in Los Angeles Superior Court by Judge Victoria G. Chaney.

Merck put Vioxx on the market in 1999 as a treatment for arthritis and acute pain in adults. The company pulled the drug from the market, citing research showing that Vioxx doubled risk of heart attacks and strokes with long-term use.

In pretrial briefs, the plantiff, 71, contends that Vioxx is unsafe and alleges that Merck misled consumers with advertising that didn't acknowledge the drug posed a risk of heart problems. He is seeking unspecified damages on the grounds that the company was negligent and failed to warn users of the drug, among other allegations.

Merck counters that it is the victim of frivolous lawsuits sparked after the pharmaceutical company withdrew Vioxx voluntarily in 2004. In court documents, the company has argued there is no proof Vioxx caused the palntiff's heart ailments and instead points to his family history and preexisting conditions as the main factor.

'Journal' suggests Vioxx risk may appear earlier

Tue, 27 Jun 2006 00:00:00 -0700

Pharmaceutical giant Merck's contention that its Vioxx painkiller raised the risk of heart attack or stroke only after 18 months' usage was contradicted Monday by the New England Journal of Medicine.

Correcting the results of a Merck-sponsored study it previously published, the Journal suggested the increased health risk started earlier for Vioxx patients, but didn't specify a time frame.

The correction escalated the debate about Vioxx, the drug Merck pulled off the market in September 2004 after the study found the elevated health danger. The company faces more than 11,500 lawsuits over the drug, and has won half of the six cases in the court trials completed so far.

The Journal reported that the original article about the study used a faulty statistical analysis, which Merck itself disclosed earlier this year. But while company experts contended the mistake didn't affect conclusions about when the danger risk begins, the Journal disagreed.

"Therefore, statements regarding an increase in risk after 18 months should be removed," from the article that reported the study results, the Journal said.

Lawyers suing Merck on behalf of Vioxx patients or their survivors argued that the Journal correction significantly undercut Merck's legal contentions.

"I think that judges are almost required now to grant new trials in the cases where Merck has won, because the linchpin of Merck's defense has always been the 18-month argument," said a Texas attorney who won a $253 million Vioxx verdict against the firm last year. "It turns out that 18 months is bogus, and it's bogus because of Merck's own internal mistakes."

A New York attorney who last year lost a Vioxx case in which shorter-term usage of the drug was an issue, said he plans to add the Journal correction to his legal arguments seeking a new trial.

"This removes a major hurdle to getting verdicts against Merck," Seeger said.

But Dr. Peter Kim, president of Merck Research Laboratories, said the Journal correction "centered on the description of a single statistical method" and did not change the data in the Vioxx study "or its results."

He reiterated that "the increased relative risk was observed beginning after 18 months."

The Journal also released letters from two doctors critical of that claim. In counterpoint, two of the Vioxx study authors wrote that an analysis of the long-term experience of Vioxx users tested in the study is now underway.

Merck general counsel Kenneth Frazier said the debate "in no way changes our commitment to defending the Vioxx litigation on a case-by-case basis."

Vioxx study's correction links drug to earlier risk

Tue, 27 Jun 2006 00:00:00 -0700

A correction published Monday by a medical journal to a key study on withdrawn painkiller Vioxx reveals the risk of heart problems was elevated throughout the time people took the drug and did not develop only after 18 months of use as the drug's maker, Merck & Co., has contended.

The correction in the New England Journal of Medicine supports many doctors' contention that risks showed up with as little as four months of use.

Heart attacks and strokes occurred more frequently after people had been on the drug for at least 18 months, but the actual harm might have occurred much earlier, said Dr. Jeffrey Drazen, editor-in-chief of the journal, who worked with the authors to correct their original findings of the APPROVe trial, published in March 2005.

"It's a subtle but very critical point," Drazen said, comparing the situation to health problems being detected months after exposure to excessive radiation.

Cleveland Clinic cardiologist Dr. Steven Nissen, who has challenged the study's conclusions in the past and did so again in a separate letter also published by the medical journal on Monday, agreed.

"A key legal defense in the liability cases has been the suggestion that there was no risk until patients had taken the drug for 18 months," he said. Now, with the correction, "the authors have removed any claim that there was a delay in risk."

The main authors, Dr. Robert Bresalier of the University of Texas' M.D. Anderson Cancer Center and Dr. John A. Baron of Dartmouth Medical School, could not be reached for comment but acknowledge in a letter released by the journal that their statistical analysis had been flawed.

Merck, which paid for the study and helped conduct it, acknowledged the flawed analysis last month but claimed it did not change the results.

On Monday, Whitehouse Station-based Merck posted on its Web site what it called "an open letter to the scientific community," saying it stands behind the original results of the study.

Merck faces new Vioxx setback

Mon, 26 Jun 2006 00:00:00 -0700

Merck, the US pharmaceutical group, on Monday received a fresh blow to the defence of its painkiller Vioxx.

The New England Journal of Medicine, one of the world's most prestigious medical journals, published a correction arguing that the risk of heart problems was elevated throughout the period that patients took the drug.

The journal took the rare step of issuing an online change to the pivotal Approve study for Vioxx it had previously published.

The study had only highlighted heart problems developing for patients with lower bowel tumours after 18 months of treatment with the drug.

The findings had been interpreted by some as suggesting that Vioxx was safe for short-term use, although critics of the drug had claimed instead that risks emerged with as little as four months' use.

Merck took the surprise step of withdrawing Vioxx in September 2004, largely on the basis of a three-year study showing a heightened risk of heart attack and strokes for those on the drug for more than 18 months. In a letter in the journal, Dr Robert Bresalier of the University of Texas and Dr John Baron of Dartmouth Medical School, who wrote the original Merck-funded Approve study, conceded that there had been statistical errors in their analysis showing a difference between the drug's use up to and beyond 18 months.

They stressed that their original article's conclusion remained unchanged, notably that there was an increased risk of heart problems in patients taking Vioxx if they had a history of lower bowel tumours. The new analysis suggests health problems may have begun earlier but only become evident after 18 months.

Monday's news failed to depress Merck's share price, which rose slightly. But it comes at a sensitive time for the company, which is fighting more than 11,500 lawsuits brought by patients and families who claimed health problems linked to Vioxx.

Critics of the Approve study, such as Dr Steven Nissen from the Cleveland Clinic, who wrote a separate letter in the latest issue of the journal, said that Merck had used the claim of no risk until 18 months after usage began in their defence in the litigations.

Kamran Abbasi, editor of the journal of the Royal Society of Medicine and former acting editor of the British Medical Journal, said: "These findings affect the interpretation of the Approve study. The episode shows once again the limits on how much medical journals can do to police the system. The reality is that journals are at the whim of powerful companies and their research departments."

Merck on Monday said it stood by the original findings of the study.

Prempro Vioxx Heart Attack Inury Lawyer

Mon, 26 Jun 2006 00:00:00 -0700

Heart Attacks

More than 1 million Americans suffer heart attacks each year. A heart attack happens when the blood supply to part of the heart muscle itself; the myocardium is severely reduced or blocked. The medical term for heart attack is myocardial infarction. The reduction or obstruction occurs when one or more of the coronary arteries providing blood to the heart muscle is blocked. This is frequently caused by the buildup of plaque (deposits of fat-like substances), a process called atherosclerosis. The plaque can at some point burst, rip or come apart, creating a snag where a blood clot forms and blocks the artery. This leads to a heart attack. A heart attack is also sometimes called a coronary thrombosis or coronary occlusion.

If your blood supply is cut off for more than a few minutes, muscle cells suffer permanent injury and die. Depending upon how much of the heart muscle is damaged, the victim could be disabled or killed. The heart muscle requires a constant supply of oxygen-rich blood to nourish it. The coronary arteries provide the heart with this critical blood supply. If you have coronary artery disease, those arteries become narrow and blood cannot flow as well as it should. Fatty matter, calcium, proteins and inflammatory cells build up within the arteries to form plaques of different sizes. The plaque deposits are hard on the outside and soft and mushy on the inside.

Symptoms of a heart attack include: discomfort radiating to the back, jaw, throat or arm; fullness; indigestion or choking feeling (may feel like heartburn); sweating; nausea; vomiting; dizziness; extreme weakness; anxiety or shortness of breath; rapid or irregular heartbeats and discomfort; pressure; heaviness or pain in the chest, arm or below the breastbone.

Many of today’s prescription drugs cause heart attacks. Cox-II Inhibitors (Bextra, Celebrex and Vioxx) and HRT drugs (Premarin, Premphase and Prempro) are the most common drugs that cause heart attacks.

If you or a loved one has suffered a Heart attack as a result of taking HRT drugs or COX-II Inhibitors, please fill out the form at the right for a free case evaluation by a qualified defective drug attorney.