Yourlawyer.com (Defective Medical Devices News)

Heart Device Patients Often Unaware of Recalls

Fri, 16 May 2008 00:00:00 -0700

It seems that many patients who have been implanted with heart devices are not aware of recent recalls and do not understand the dangers they might face, this according to two new surveys. Although the surveys are small, they do indicate a lack of understanding among doctors and patients about heart disease and the devices used to treat it, said Dr. Bruce Wilkoff, director of cardiac and tachyarrhythmia devices at Cleveland Clinic Wilkoff, who is familiar with the surveys. "There are fundamental problems with even the physician's understanding of the situation and an appropriate focus on accurate information," Wilkoff added. One of the new surveys found that nearly one in five heart patients didn't know about recent recalls of their devices.

Meanwhile, recent recalls of implanted defibrillators have forced some patients to have them removed. Spefically, defibrillator lead wires—especially those in the Medtronic Sprint Fidelis and St. Jude Riata devices—have fractured, perforated patient heart walls, or caused device failure. In some, these malfunctions led to additional cardiac procedures or complications and even death. Implantable defibrillators are meant to keep the heart beating regularly and to shock the heart back to its proper rhythm in the event the heart stops. A defibrillator lead is a thin wire attached to the heart wall that delivers an electrical impulse via the defibrillator. When a defibrillator wire detaches or breaks, the device will fail leaving a patient at risk for death because the device does not sense the need for a shock, is unable to deliver the shock, or delivers an unnecessary shock. If the wire perforates the heart wall, the heart can bleed into its pericardial sac causing cardiac tamponade, a lethal condition where pressure builds around the heart preventing it from beating effectively. Unfortunately, heart perforation is generally discovered after the wire has made its way through the heart wall.

The findings are planned to be released at the Heart Rhythm Society's annual meeting in San Francisco and involved 61 randomly selected patients at the University of Maryland and the Baltimore VA Medical Center who were asked about recalls between October 2006 and April 2007. Eighteen percent didn't know about any pacemaker or defibrillator recall, about half learned about recalls through the media, 24 percent heard through their doctor, and over half said they'd be very worried if their device was recalled.

"We need to do a little better of a job and find better means of talking to our patients," said survey lead author Dr. Timm-Michael Dickfeld, director of electrophysiology at the Baltimore VA Medical Center. "They seem to like to have the physicians talk to them more, and explain these things more, and not leave it up to the media or the TV to inform them."

A second survey, conducted by doctors at the University of Oklahoma, asked 165 patients with a variety of heart devices whether they'd want them removed if there was a recall or safety advisory. Five percent reported they'd want the device removed immediately if there was a "recall" and 2.5 percent said they'd want it taken out if there was a "safety advisory."

Cypher Stent Ad Criticized

Thu, 15 May 2008 00:00:00 -0700

A 60-second television ad for the Cypher drug coated stent—made by the Cordis subsidiary of Johnson & Johnson—is under fire. It seems the ad failed to fully warn consumers about the potential dangers of receiving a stent, according to an article published by The New England Journal of Medicine. The Journal says the ad promotes the Cypher stent’s potential benefits but minimizes its risks and this may be deceptive and should be reviewed by federal regulators.

The ad uses the tag line “life wide open,” a play on words. Stents are an important element in heart-disease treatment. Tiny wire-mesh tubes, stents prop open arteries once doctors clear them of blockages. Stents are implanted to maintain arterial blood flow and there is long, ongoing debate over drug-coated versus bare metal stent use.

“We believe that the Food & Drug Administration (FDA) should perform a critical post-release review of the ‘Life Wide Open’ campaign to assess whether it meets the basic regulatory requirements for non-deceptive advertising,” the Journal’s article said. The article also questioned the validity of advertising such high-risk procedures directly to the public.

Cordis defended the ad, saying its content and message had been reviewed by the FDA prior to the ad’s release last Thanksgiving Day, during a popular NFL game broadcast. “The goal of the ‘Life Wide Open’ campaign is to foster an informed, balanced conversation between patients and physicians about treatment options for coronary artery disease, which kills millions of Americans each year,” Cordis said. Cordis spokesman Christopher Allman, said the ad was no longer running nationally but was being broadcast in Baltimore.

The article comes as pressure mounts on the FDA to limit consumer medical advertising or at least increase its oversight. The US is one of the few industrialized countries that permit such advertising. Tomorrow, an FDA advisory committee plans to discuss whether TV ads for prescription drugs should include a statement encouraging consumers to report negative side effects to a toll-free number operated by the FDA, a requirement currently in effect for print ads. There is no such requirement for medical devices ads, which are not as closely monitored.

During a Congressional hearing last week on drug advertising, the chairman of the House Energy and Commerce Committee, John D. Dingell (Democrat-Michigan), pressed several drug company representatives on whether they would support the proposed ads. “They said they couldn’t tell us, so we’re communicating with the CEOs of the companies,” said Dingell who also said he supported the requirement, “But understand one thing, it might not be enough.” Dingell said the committee found systemic violations of advertising requirements by drug companies. “Some ads appear to be misleading and others appear to be downright deceptive,” Mr. Dingell said.

The chairman of the House subcommittee investigating drug advertising, Representative Bart Stupak, said that Congress should consider banning drug ads aimed directly at consumers.

Although the FDA currently does not scrutinize advertising for medical devices as closely as for prescription drugs, it does regulate ads for so-called high-risk medical devices, including stents.

Lawmakers Want More FDA Oversight of Imported Medical Devices and Cosmetics

Thu, 15 May 2008 00:00:00 -0700

Democratic lawmakers say the US Food and Drug Administration (FDA) has insufficient funding and power to maintain appropriate oversight and regulation of imported products, especially medical devices and cosmetics. "While the market for these products becomes increasingly global, the FDA has no requirement to inspect foreign establishments manufacturing medical devices," said Representative Frank Pallone (New Jersey-Democrat) who led a US House of Representatives Energy and Commerce panel Wednesday.

Lawmakers continue to work toward legislation that would require drug and device makers, food manufacturers, and cosmetic companies to register with the FDA and pay for mandatory inspections of foreign factories. The proposed bill follows a flood of tainted goods imported from China, including poisonous pet food, tainted toothpaste, and contaminated medications, such as the blood thinner heparin. Currently, the FDA inspects foreign makers of heart defibrillators and other high-risk devices about once every six years; makers of hearing aids and less risky devices once every 27 years; and US device facilities once every three to five years, according to the Government Accountability Office (GAO).

Some Republicans feel industry fees are like an added tax that would burden manufacturers. Representative Joe Barton—Texas-Republican—said imported devices did not pose the same risks as other products. "We've had major problems with food imports from China, we've had major problems with drug imports from China, but I'm not aware that we've had major problems with medical device imports from China," he said.

Device makers also argue that increased inspections for low-risk products, like contact lenses and glucose meters, would delay those products from reaching patients. "Requiring FDA to conduct pre-approval inspections ... would bring the approval process to a grinding halt," said Steven Ubl, head of the Advanced Medical Technology Association, in testimony to Wednesday’s panel. Also, industry groups questioned more inspection fees for device companies, which already pay the FDA to review products for approval. FDA officials said they are working to increase inspections and create agency offices in other countries.

Stephen Sundlof, head of the FDA's Center for Food Safety and Applied Nutrition, which oversees cosmetics, urged lawmakers to focus on risky products and better use of private inspections. Democrats said the FDA has even less power over cosmetic products, which have gone largely unregulated for decades—the industry is overseen by rules enacted 70 years ago and the FDA has only reviewed 11 percent of related ingredients and banned or restricted 10 types that posed safety risks. About $62 billion in personal products are sold in the US annually and the number of imported products has tripled since 2000 and is expected to grow, said Sundlof who also acknowledged that regulating cosmetics has become a challenge as more products "straddle the line between cosmetics and drugs."

"I think improving oversight authority of cosmetics is long overdue," said Representative Jan Schakowsky (Illinois-Democrat). Sundlof acknowledged only one-third of all US cosmetic makers are registered with the FDA and said companies are responsible for ensuring safety before marketing products. Unlike drugs or devices, cosmetics are not approved by the FDA prior to being placed on the market.

Immucor Gets FDA Warning Letter

Wed, 14 May 2008 00:00:00 -0700

Immucor, a maker of blood-testing supplies, has received a warning letter from the Food & Drug Administration (FDA) because of problems with its manufacturing procedures. The letter, dated May 2, said Immucor had 15 working days to make corrections. Should it fail, the FDA warned Immucor it could face license suspension and/or revocation, seizure and/or injunction.

The warning letter stems from an FDA inspection of Immucor in Norcross, Georgia, between January 8 and January 17, 2008. The FDA warning letter says the company allowed products into its inventory that had previously tested positive for microbial growth and were put on hold by the FDA. The blood reagent products were allegedly allowed back into Immucor's inventory before the FDA could complete its investigation. The FDA also claims Immucor "failed to establish and maintain procedures for implementing corrective and preventive action, including requirements for investigating the cause of nonconforming product and identifying the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems."

The FDA acknowledged that it received written responses from Immucor that address the violations found during the January inspection. However, the agency said those responses did not provide sufficient detail to fully assess the adequacy of your corrective actions. For example, the FDA said the responses failed to discuss implementation of adequate quality assurance oversight to ensure prompt identification, correction, and follow up to problems associated with the manufacture of Immucor products.

Immucor Chief Executive Officer Gioaccino De Chirico said in a press release that the company was working to make sure it was in compliance with the FDA. "We take our regulatory responsibilities very seriously and are working diligently to respond to the FDA as soon as possible," De Chirico said. The press release also noted that the FDA had not recalled any Immucor products, or placed any limitations on the manufacture or distribution of any of our products.

Senate Guts Bill to Regulate Industry Gifts to Doctors

Wed, 14 May 2008 00:00:00 -0700

A Senate bill under revision would require drug makers and medical device makers to publicly report gifts over $500 annually to doctors; the previous bill was more stringent and required all gifts valued over $25 be reported. Penalties for drug and device makers were reduced to fines of between $1,000 and $50,000 per violation, a change from the earlier proposal released last year with higher penalties from $10,000 to $100,000 per violation. The new version pushes back when the bill would go into effect, from 2008 to 2011 and also includes several changes sought by industry, including having the federal law preempt state laws requiring gift disclosure.

The bill would require drug and device makers to submit an annual report to the federal government, which would post it on the Internet. It is unclear if similar legislation would be introduced in the House.

Extravagant gifts given to doctors by industry, such as golf vacations and expensive dinners, have long been criticized as influencing doctors' prescribing habits. Industry says such gestures are part physician education; however, critics say these practices sully independent decision-making. "Transparency brings about accountability and benefits everyone, consumers most of all," said Senator Chuck Grassley, an Iowa Republican. Grassley is sponsoring the bill with Democrat Senator Herb Kohl of Wisconsin.

Some consumer groups disagree. “It is absolutely unacceptable. The whole idea of the registry is it provides a gift-by-gift annotation," said Peter Lurie, deputy director of Public Citizen's health research unit, who testified at an earlier hearing on the topic. "Penalties need to be significant otherwise these companies will treat it as a cost of doing business," Lurie said.

The Pharmaceutical Research and Manufacturers of America, a trade group for big drugmakers, had not taken a position when the first bill was announced, but now says it hopes any legislation not "inadvertently imply that these transactions are inappropriate" and is concerned about the burden placed on doctors and companies to report.

Last year, five medical device makers settled a U.S. Justice Department investigation over gifts and payment practices. Four of them—Zimmer Holdings Inc,, Johnson & Johnson's DuPuy Orthopedics, Smith & Nephew, and Biomet Inc.—agreed to pay a combined $311 million as part of the settlement. The fifth company, Stryker Corporation agreed to change its practices and was not fined.

Meanwhile, there is a growing movement underway among healthcare facilities to ban gifts to doctors by drug companies in an attempt to remove conflicts of interest during the prescription-writing process. SMDC Health System, the Duluth-based operator of four hospitals and 17 clinics across northeastern Minnesota and northwestern Wisconsin purged its facilities of all promotional trinkets with logos from drug companies. It took 20 shopping carts to remove all the products and SMDC plans on shipping the 18,718 items to the West African nation of Cameroon to the health system of the Evangelical Lutheran Church of Cameroon, which has three hospitals and several rural health centers where the advertised drugs are not available. Also, Kaiser Permanente, the country’s largest HMO, Veterans Affairs hospitals, and medical centers at several universities have recently adopted strict conflict-of-interest policies, such as gift bans.

Stryker Corp. Trident Hip Replacement Blamed for Epidemic of Squeaky Hips

Mon, 12 May 2008 00:00:00 -0700

A growing number of hip replacement patients - especially those with Stryker Corp's Trident components - are experiencing squeaky hips. It seems that such artificial hips made with ceramic materials and touted as being more durable, are prone to squeaking, even during light walking. One study in the Journal of Arthroplasty found that 10 of 143 patients who received ceramic hips from 2003 to 2005 developed squeaking. No squeaks occurred in a control group of 48 who received metal and plastic hips. “There is something amiss here,” said Dr. Douglas E. Padgett, chief of adult reconstructive and joint replacement service at the Hospital for Special Surgery in Manhattan.

Most artificial hips consist of a socket implanted in the pelvis, into which a spherical head is fitted. The head is attached to a spike anchored into the thigh bone. Durability is critical as no one wants to outlive their artificial hips and undergo a second, more extensive surgery when older and less able to handle surgical trauma. Ceramics—which have been in use since the 1960s—were promoted as lasting longer than the 15 years for traditional steel and plastic joints; however, each joint type has known or suspected problems. Metal-on-metal devices slowly shed tiny ionized particles some feel promote cancer and the newest plastics are not as durable as other materials, raising worries that fragments can lead to bone-destroying inflammations.

Over 250,000 Americans receive total hip implants yearly in a procedure that costs close to $45,000. While any artificial hip can occasionally make any number of noises, it wasn’t until Stryker Corp. began marketing Trident ceramic hips in the United States in 2003 that the previously rare squeaking began. Tens of thousands of hips have been replaced by Stryker and other makers and now people are complaining that their squeaking hips are interfering with daily life. No one really understands why this is occurring, and now there are concerns the noises might be pointing to more serious problems and malfunctions.

Investigators reviewing the problem report that while the reason is unclear, squeaking appears to be linked with extreme flexing of the ceramic implants and some surgeons are afraid the ceramic material might shatter, leaving a patient with so many inflammatory shards that a doctor could never find them all. “Catastrophic failure has been a concern in the past, with older ceramic components,” said Dr. James M. Bried, a surgeon in Poway, California. Patients and surgeons are concerned squeaking points to premature wearing down, something that could force a second surgery and doctors who have removed ceramic hips say they find dark stripes indicating accelerated wear on the ceramic heads. Dozens are undergoing a second surgery and have sued Stryker.

Stryker was the pioneer and market leader in ceramic joint replacement, but now doctors say Stryker has not taken patients’ concerns seriously. Last fall, the Food and Drug Administration (FDA) issued a warning to Stryker, saying it had failed to take steps needed to prevent squeaking and other problems. Also, last year Stryker recalled ceramic hip parts made at its Cork, Ireland, factory when it determined some parts failed to meet its sterility specifications.

Atrium Recalls Heparin-Coated Hydraglide Catheters Amid Contamination Concerns

Mon, 12 May 2008 00:00:00 -0700

Another medical device maker is recalling a heparin-coated product amid fears that the drug could be contaminated. Earlier today, Atrium Medical Corporation announced that it was initiating a voluntary and precautionary recall of selected lots of Hydraglide Brand Heparin-Coated Thoracic Drainage Catheters. The recalled catheters are used for autotransfusion during cardiopulmonary bypass surgery.

Tainted heparin has been of concern since January, when Baxter International recalled nearly all its heparin injections in the US after some patients experienced extreme - and in some cases fatal - allergic reactions, including difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that was life threatening after being administered the products. There have been similar recalls by other manufacturers of Chinese-sourced heparin in 11 other countries, including Denmark, Italy, France Germany and Japan. In the US, heparin has been associated with the deaths of more than 100 people since early 2007, according to the Food & Drug Administration (FDA). Of those, the vast majority - 81 to be exact - were associated with contaminated batches of heparin.

In March, the FDA confirmed that it had found oversulfated chondroitin sulfate in samples of the active ingredient used in Baxter heparin. The FDA said the chondroitin sulfate was molecularly changed to mimic heparin’s blood-clotting properties. That ingredient was supplied to Baxter by Changzhou SPL, a Chinese plant partially owned by Wisconsin-based Scientific Protein Laboratories LLC. Since then, researchers have been able to show that chondroitin sulfate can cause reactions like those seen among patients treated with tainted heparin.

In speaking with reporters after a Senate hearing last month, FDA Commissioner Andrew von Eschenbach said that while the agency has no specific evidence that the chondroitin sulfate contamination was intentional, “the concern is that it had to be by design.” It costs a fraction of the ingredient usually used in heparin, and producers may have used it in an attempt to cut costs.

According to an Atrium press release, its heparin-coated Hydraglide Thoracic Catheters were manufactured with heparin found to have been contaminated with oversulfated chondroitin sulfate. Atrium said in the release that the patient risk associated with the presence of the contaminant in heparin-coated medical devices is not known at this time. Customers with affected lots are advised to immediately discontinue use of these devices and obtain replacement catheters from Atrium. So far, Atrium has not received reports of any heparin-related injuries arising from any use of the Hydraglide Thoracic Catheters

The Atrium Hydraglide recall follows last week's medical device recall by Medtronic. That recall involved a variety of disposable medical devices, used during cardiac bypass surgery, that are made with Medtronic’s Carmeda BioActive surface, which includes heparin. Both recalls were initiated because of an April 8 recommendation by the FDA that medical devices made be subjected to a new method of testing to insure that the drug was not contaminated with chondroitin sulfate.

Drug Coated Stent Debate Yet to be Resolved

Mon, 12 May 2008 00:00:00 -0700

Experts continue to disagree on the usefulness and safety of drug coated stents. Stents are an important element in heart-disease treatment. Tiny wire-mesh tubes, stents prop open arteries once doctors clear them of blockages. Some stents have a drug coating meant to keep vessels from re-clogging following balloon angioplasty procedures. Bare-metal stents tend to re-clog more often than drug-coated stents, so physicians are quick use drug-coated stents, even in those patients with complex heart disease, not the patients in whom the devices were tested. In either case, stents are implanted to maintain arterial blood flow.

Scar tissue causes stents to re-close in about one in five patients, who then require a follow-up procedure to remove and replace the device. Without the procedure, the patient can suffer a heart attack, said Dr. Laura Mauri, an assistant professor of medicine at Harvard Medical School and Brigham and Women's Hospital, in Boston. New stents approved by the U.S. Food and Drug Administration (FDA) in 2003 are drug-coated to prevent too much scar tissue from forming; however, research indicates that the drug can increase the risk of too little scar tissue forming and a blood clot appearing in the stent. "If not enough scar tissue forms to cover the stent, the metal can create a blood clot on its own," said Dr. Jack Tu, a senior scientist at Canada's Institute for Clinical Evaluative Sciences and a professor with the University of Toronto. "It's a fine balance. You want some scar tissue to form around the stent, but you don't want too much to form."

In December, the FDA announced that it is preparing to issue new drug-coated stent testing requirements. The revised rules are expected to be more stringent and to specify the numbers of patients on whom new drug-coated stents can be tested and for how long. The rules also offer a recommended length of time patients should take anti-clotting drugs following implantation.

Drug-coated stents are recommended for patients with an increased risk of suffering from reclosure, Tu said, such as those with diabetes, smaller-than-normal blood vessels, or long lesions left by heart disease. Drug-coated stents have been quite successful in preventing repeat procedures, Mauri said and, “have medication on them. The medicine releases slowly over time and prevents cells from building up that could lead to a blockage." But, even those who favor drug-coated stents note that they have risks, such as that medications must be taken with them—a strict regimen of anti-clotting medications for at least one year following the procedure. "Patents who are unable to comply with this regimen should be treated with bare-metal stent implantation," said Dr. Murtuza J. Ali, an interventional cardiology fellow at the Boston University Medical Center. If the patient isn't diligent about taking the anti-clotting drugs, a heart attack could result over time, Mauri said. "We know if these medicines are stopped early, there are risks of blood clots forming inside the stent," she said.

Medical Devices Made with Tainted Heparin Recalled by Medtronic

Thu, 08 May 2008 00:00:00 -0700

Medtronic Inc. is recalling some medical devices because they may be coated with tainted heparin, a drug linked to 81 deaths in the US. The disposable medical devices, used during cardiac bypass surgery, are made with Medtronic's Carmeda BioActive surface, which includes heparin. No injuries have been reported in relation to the Medtronic devices, but the recall underscores the enormous scope of the problems involving contaminated heparin.

Tainted heparin first garnered attention earlier this year, when Baxter International recalled nearly all its heparin injections in the US after some patients experienced extreme - and in some cases fatal - allergic reactions, including difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that was life threatening after being administered the products. There have been similar recalls by other manufacturers of Chinese-sourced heparin in 11 other countries, including Denmark, Italy, France Germany and Japan. In the US, heparin has been associated with the deaths of more than 100 people since early 2007, according to the Food & Drug Administration (FDA). Of those, the vast majority - 81 to be exact - were associated with contaminated batches of heparin.

In March, the FDA confirmed that it had found chondroitin sulfate in samples of the active ingredient used in Baxter heparin. The FDA said the chondroitin sulfate was molecularly changed to mimic heparin’s blood-clotting properties. That ingredient was supplied to Baxter by Changzhou SPL, a Chinese plant partially owned by Wisconsin-based Scientific Protein Laboratories LLC. Since then, researchers have been able to show that chondroitin sulfate can cause reactions like those seen among patients treated with tainted heparin.

In speaking with reporters after a Senate hearing last month, FDA Commissioner Andrew von Eschenbach said that while the agency has no specific evidence that the chondroitin sulfate contamination was intentional, “the concern is that it had to be by design.” It costs a fraction of the ingredient usually used in heparin, and producers may have used it in an attempt to cut costs.

Medtronic says the Carmeda BioActive surface is used on blood oxygenators, reservoirs, pumps and other disposable products that are used during the bypass surgery. According to Reuters, Medtronic initiated the recall because of an April 8 recommendation by the FDA that medical devices employing heparin be checked with newly-developed tests to make sure the heparin is not tainted. Chondroitin sulfate cannot be identified with the tests normally used to inspect batches of heparin.

A separate Medtronic line of disposable bypass-surgery products covered with a different biosurface called Trillium will remain on the market because they incorporate far smaller amounts of heparin.

Medtronic Announces Job Cuts, Restructuring

Wed, 07 May 2008 00:00:00 -0700

Still struggling in the wake of last year's Sprint Fidelis Defibrillator Lead recall, medical device maker Medtronic Inc. says it plans to cut 1,100 jobs worldwide as part of a restructuring plan. Medtronic's business has been hurt, not just by the Sprint Fidelis recall, but by the declining worldwide demand for implantable defibrillators, which has been shrinking since Medtronic and competitors recalled faulty products in 2005.

Medtronic suspended sales of the Sprint Fidelis Leads in October 2007 after receiving reports of 5 fatalities linked to lead fractures. A lead is a wire that connects an implantable defibrillator to the heart. When it breaks, the defibrillator can emit a massive and painful shock. And in the worse case scenario, the fractured lead can prevent a defibrillator from sending a necessary, lifesaving shock to the heart. Replacing a lead is not an easy procedure, as the invasive surgery can cause the tissue of the blood vessels and heart to tear. In fact, replacing a defibrillator lead is so risky that patients with Sprint Fidelis Leads are being told to leave the defective components in place unless they fracture.

Last November, Medtronic said the Sprint Fidelis recall hurt revenue in its Cardiac Rhythm Disease Management unit by $130 million, and it also absorbed $31 million in costs to write off the Sprint Fidelis leads recalled during the quarter in which the recall occurred. Medtronic's revenue grew 12 percent in its most recent quarter, though revenue in the cardiac rhythm disease management unit rose just 3 percent.

According to Reuters, as part of the restructuring effort, Medtronic will move its endovascular manufacturing operations to Galway, Ireland, from Santa Rosa, California. The endovascular division makes stent grafts to treat aortic abdominal aneurysms. It also intends to relocate the diagnostic and monitoring portion of its cardiac rhythm disease management business to Minneapolis from the Netherlands.

This is not the first time Medtronic has been forced to make job cuts. Last year, the company eliminated a total of 900 jobs in its cardiac rhythm management, cardiovascular, and Physio-Control external defibrillator businesses.

Medtronic faces many lawsuits over the defective Sprint Fidelis Lead, as well as some of its other defective medical devices. Last December, the company agreed to pay out $114 million to settle product liability lawsuits filed as the result of injuries cased by its malfunctioning Marquis line of implanted cardiac defibrillators.

Late last month, Medtronic announced it had reached an agreement with Food and Drug Administration (FDA) over quality system improvements for its external defibrillators. The agreement addressed concerns raised by the FDA during inspections and outlined actions Medtronic’s Physio-Control subsidiary must take to resume unrestricted distribution of the portable electronic devices. Physio-Control stopped U.S. shipments in January 2007 due to quality problems.

Women Tells of Mentor ObTape Horrors

Tue, 06 May 2008 00:00:00 -0700

Mentor’s ObTape Vaginal Sling is a medical device meant to stop the uncontrollable flow of urine as a result of urinary stress incontinence, a medical condition affecting about two million American women. Patients with urinary stress incontinence are no longer able to control or stop urine flow, which often happens in the years following childbirth. Approximately 35,000 women were implanted with Mentor Corporation’s ObTape and, now, women are reporting that the tape has deteriorated in their bodies and is making them ill and causing severe pain and other complications.

ObTape is a piece of mesh that is inserted as a type of sling that tapes up the bladder to prevent leaking. The Mentor ObTape Vaginal Sling is designed to replace eroded or weakened muscles in the urethra and is essentially a hammock for the vaginal wall. The vaginal sling technique has been around for about 100 years and is considered the “gold standard” in stress urinary incontinence treatment. Generally, the minimally invasive treatment can be done on an outpatient basis.

Meanwhile, one woman who has filed a lawsuit against Mentor Corporation, reports that following implantation of the mentor ObTape Vaginal Sling, the tape moved out of place and started to disintegrate inside her. When she became ill, doctors removed the sling, piece by piece, which left her with a large leg wound. Also, a medical study examined 67 patients and found that over 13 percent of patients experienced similar complications as well as impaired healing, vaginal extrusion, and urinary tract erosion that causes extreme vaginal pain, discharge, and infections, not to mention that the sling did not correct the original problem in many of the woman. Another eight developed a chronic vaginal discharge and one patient developed an abscess of the left thigh that tracked to the incision site. The study compared these patients to 56 others who had received another brand of vaginal sling. None of those patients experienced the complications seen with the Mentor ObTape Vaginal Sling.

Some believe Mentor misled the Food & Drug Administration (FDA) when it applied for what's called 510K status, which means it claimed that its product was so similar to ones already on the market it didn't need complete testing. Many believe the FDA was not as diligent as it should have been with the Mentor ObTape Sling.

Dr. Jaime Sepulveda is a national expert in pelvic floor medicine and reports he has always been skeptical about Mentor's ObTape because, unlike similar products on the market, it had different dimensions and hole sizes and it should have received separate Food and Drug Administration (FDA) approval. The non-woven design of the Mentor ObTape Vaginal Sling blocked much-needed oxygen and nutrients while woven vaginal slings produced by other companies allow oxygen and nutrients to pass through.

Currently, there are a variety of lawsuits against the Mentor Corporation as more women come forward claiming that ObTape migrated inside their bodies, disintegrated, and required surgical removal. Mentor no longer makes ObTape and within three years of the Mentor ObTape Vaginal Sling going on the market in 2003, the defective medical device was removed.

Stryker Gets Another FDA Warning Letter

Mon, 05 May 2008 00:00:00 -0700

Stryker Corp. has been hit with another Food & Drug Administration (FDA) warning letter, the medical device maker's second since last November, and the third in a little over a year. This time, the FDA took Stryker's biotech division to task for quality systems and compliance issues at its Hopkinton, Massachusetts, location. One of the issues cited by the FDA warning letter involves falsification of hospital-approval documents used under an FDA rule that allows device sales on a very limited basis.

The past year or so has been a rough one for Stryker. In January, Stryker recalled some of its hip implant components made under the popular Trident line because of possible contamination issues. The Stryker Hip Implant component recall involved two hip replacement cups – the Trident Acetabular PSL Cup and the Trident Hemispherical Cups – made at the Stryker facility in Cork, Ireland. Acetabular Cups are used in the socket portion of replacement hip components. The PSL version is the most commonly used Stryker cup in the U.S.

The recall came after Stryker received two FDA warning letters about conditions at the Ireland plant, as well as a factory in New Jersey that also makes hip implants. The first, a seven-page letter dated March 15, 2007, cited several violations at the Ireland plant, including missed deadlines to fix failures in following procedures for testing problematic products and documenting risk. The heavily redacted letter referred to an earlier voluntary recall of “hip fracture stems” which appeared to be related to the problems. It also cited several instances where the “root cause” of problems that caused that particular recall was not determined.

Then Stryker received another letter regarding the New Jersey facility. That letter, dated November 28, 2007 said that the deficiencies uncovered during an inspection at the Mahwah, New Jersey facility had contributed directly to the manufacture of faulty hip implants. The FDA letter described a range of deficiencies, including “clusters” of Staphylococcus bacteria, the pathogen that causes staph infections, that was found throughout the plant. The November 28 letter states repeatedly that Stryker “failed to perform corrective and preventive actions in order to prevent the recurrence of nonconforming product or other quality problems.” For instance, in regards to the bacterial contamination, the letter states that Stryker “has not identified the root causes of the microorganism contamination and has not executed corrective and preventive action to prevent recurrence.”

This third warning letter involves the company's biotech division, a small segment of Stryker's business that makes products to promote bone growth. The letter concerns observations made during an inspection that began in September 2007. The letter cites issues relating to the division's handling of a past clinical study, its quality system, including medical device reporting procedures, and the falsification of hospital Institutional Review Board documentation used to approve implantation of Humanitarian Use Device. No products have been recalled as a result of the letter.

Stryker says it is taking the FDA warning "very seriously" and has already taken steps to deal with the problems. The small number of field sales employees behind the falsified documents are no longer with the company, Stryker said. The company said it also launched a company-wide 'quality action plan' aimed at strengthening oversight.

Insulin Pumps Linked to Injuries, Deaths

Mon, 05 May 2008 00:00:00 -0700

A review by the US Food and Drug Administration (FDA) just revealed that insulin pumps can be risky and have been linked to injuries and deaths. Insulin pumps are generally used by teenagers with Type I diabetes and the FDA, while not suggesting parents find alternate treatments, suggest they exercise increased vigilance. The FDA is also calling for additional studies to review and respond to safety issues in teenagers and children using insulin pumps.

Type 1—juvenile—diabetes comprises between five and 10 percent of all diabetes cases, affecting 12 to 24 million people globally and involves the body attacking insulin-producing cells in the pancreas. Type 2 diabetes is far more common, usually affects adults, and is generally linked to obesity. Insulin regulates blood sugar levels and if blood sugar levels go too high, heart disease, blindness, and kidney damage can result.

The insulin pump was developed for Type 1 diabetes patients and is popular because it allows patients to dose themselves, as needed, discreetly and in public. Pumps give patients an alternative to multiple daily injections and some may include a glucose monitor, which reduces blood sugar testing by pricking a finger. It’s estimated about 100,000 teenagers may be using insulin pumps globally.

The federal study reviewed use of the insulin pumps over the course of the decade from 1996 to 2005 and revealed 13 deaths and over 1,500 injuries based on reports from patients aged 12 to 21. Some of the problems were related to insulin pump malfunction and others due to carelessness or risk-taking by the patient. Device problems such as a blocked tube can quickly cause dangerous high blood sugar levels. "In a matter of a few hours, all the insulin in the body disappears. Metabolically, the child starts to spiral out of control," said Dr. John Buse, the American Diabetes Association's president for medicine and science, adding that patients need to be aware of the pump’s risks, monitor their sugar levels, and inject themselves, if needed

Some of the teenagers studied did not understand how to correctly use the insulin pumps, had dropped the pumps, or were negligent in their care of the devices. At least two possible suicide attempts were made by teenagers who overdosed themselves with insulin. Reports were not always clear about cause of death or injury. The study is published in the May issue of the journal Pediatrics.

Insulin pumps are about the size of a mobile phone and can be worn on a belt or pocket. The pump deploys the insulin into the body through a plastic tube with a small tip that inserts under the skin and is taped in place. Insulin pumps cost about $6,000 and related supplies cost an additional $250 a month; most insurers cover the bulk of the cost. Devices deliver a continuous low level of insulin and patients also tell the device how much insulin to dose before each meal, based on the meal’s estimated carbohydrates,

"Without appropriate glucose monitoring, the pumps can increase the risk of getting sick more quickly compared to injections," Dr. Christina Luedke of Children's Hospital Boston, said.

Medtronic Unit Agrees to Consent Decree

Mon, 28 Apr 2008 00:00:00 -0700

An agreement has been reached by a unit of Medtronic Inc. on a consent decree with the U.S. Food and Drug Administration (FDA) over quality system improvements for its external defibrillators. The agreement—which is subject to court approval—addresses concerns raised by the FDA during inspections and outlines actions Medtronic's Physio-Control subsidiary must take to resume unrestricted distribution of the portable electronic devices. Physio-control is a maker of external defibrillators,

Automated external defibrillators, or AEDs, are becoming more and more available in office buildings, schools, and other public venues for use by bystanders to help a person suffering from sudden cardiac arrest. Physio-Control stopped U.S. shipments in January 2007 due to quality problems. Medtronic said shipments to meet critical customer requirements and certain specified public health needs will continue; however, in September, Medtronic announced plans to eliminate about 200 jobs in the Physio-Control unit. The consent decree agreement requires court approval.

Meanwhile, last October, Medtronic announced it was suspending sales of the Sprint Fidelis lead, a vital component in its implantable defibrillators.   According to Medtronic, the Sprint Fidelis lead, a wire that connects the Medtronic defibrillator to the heart, could fracture inside a patient’s blood vessel, delivering a massive electrical jolt.   This malfunction can cause extreme pain, or—in the worse case scenario—death.   At least five deaths were linked to a malfunctioning Sprint Fidelis lead used with an implantable Medtronic defibrillator.

The Sprint Fidelis lead has been used in implantable Medtronic defibrillators since 2004; most patients who received the devices since then have the faulty leads.   Sprint Fidelis leads were used only in cardiac defibrillators—or complex devices with defibrillation capacity—not conventional pacemakers. Some patients with congestive heart failure use devices that included this defibrillation ability, and those were among the machines that use the Sprint Fidelis lead.

A company review of 30 months of data indicated the defibrillator lead had a continuing fracture problem.   According to the company’s own estimates, approximately 2.3%, or 4,000 to 5,000 people with a Sprint Fidelis lead will experience fracture within 30 months of Medtronic defibrillator implantation.   Patients whose Sprint Fidelis lead fractures will require a dangerous surgical procedure to replace the wire.

Implantable defibrillators are meant to keep the heart beating regularly and to shock the heart back to its proper rhythm in the event the heart stops. A defibrillator lead is a thin wire attached to the heart wall that delivers an electrical impulse. When a defibrillator wire detaches or breaks, the device will fail, leaving a patient at risk for death because the device does not sense the need for a shock, is unable to deliver the shock, or delivers an unnecessary shock. Lead fracture can cause the device to beep, alerting the patient to seek immediate medical attention; however, the fracture can also cause a massive electrical shock resulting in extreme and sudden chest pain. Worse, the fracture can deplete the battery, rendering the defibrillator unable to deliver a necessary, life-saving shock to the heart. If the wire perforates the heart wall, the heart can bleed into its pericardial sac causing cardiac tamponade, a lethal condition where pressure builds around the heart preventing it from beating effectively. Unfortunately, heart perforation is generally discovered after the wire has made it through the heart wall.

Why the Rush to Approve Drug Coated Stents?

Fri, 25 Apr 2008 00:00:00 -0700

The new Xience heart stent out-performed the more popular Taxus heart stent in a one-year trial; however, experts disagree on whether stent science is moving too fast and doctors are concerned over the recent discovery that blood clots can form at the site of drug-coated stents long after implantation.

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 balloon angioplasty procedures. Bare-metal stents tend to re-clog more often than drug-coated stents, so physicians are quick use drug-coated stents, even in those patients with complex heart disease, not the patients in whom the devices were tested.

Xience is a new stent with a new drug coating that—in a one-year clinical trial—performs better and seems safer. While some are looking to the FDA to approve the device, others argue that more testing time is needed. Manesh Patel, MD, assistant professor of cardiology at Duke University, urges caution saying, "We want a durable result with the device we use. That is the conundrum in a rapidly moving science. We have new devices that may be safer and more effective, but we need time to see how well they reduce long-term events."

Gregg W. Stone, MD, director of cardiovascular research and education at the New York Presbyterian Hospital/Columbia University's Center for Interventional Vascular Therapy, led the 1,002-patient study of the new stent and says it's already known that drug-coated—or drug-eluting—stents generally work better than bare-metal stents.

"Physicians have to use their judgment, based on what they know and on the studies that have been done, to decide whether the use of a drug-eluting stent is in the individual patient's best interest. I don't think this new stent is going to markedly change how doctors use stents. It will just convert doctors who have used earlier stents to this one because the outcomes look safer and more effective," Stone said

The new Xience stent is coated with a different drug than is used in other stents and in comparisons to the more popular Taxus stent, showed less re-clogging of the arteries and fewer heart attacks or repeat procedures over a year of follow-up. "Compared to the most widely used stent in the world, the outcomes for the new stent, in some regards, appear safer and more effective," Stone says. "We anticipate FDA approval over the next several months."

Patel continues to urge caution, "What happens next is critical," he says. "Will we have learned from the two main lessons of the past: Will doctors show restraint, and put these stents only in the type of patients who have been studied? And will we do the longer studies to show they work?"

Stone’s study and Patel’s editorial appear in the April 23/30 issue of The Journal of the American Medical Association. Abbot Vascular, maker of the Xience stent, sponsored and funded the study. Stone, a senior investigator in many clinical trials, received research support and/or honoraria from Roche Vascular and other stent manufacturers.

More Kid-Sized Medical Devices Needed

Thu, 24 Apr 2008 00:00:00 -0700

More and more, physicians are realizing that children should not be fitted for adult-sized medical devices. According to Dr. David Staffenberg, a metal plate improperly lodged in a young boy's skull showed him how very dangerous traditional devices—generally made to fit adults—can be when implanted in children. In the case of Staffenberg’s patient, the plate was implanted to help stabilize the boy's skull but ended up resting on his brain. Staffenberg safely removed the titanium plate; however, that did not resolve the overarching issue that the vast majority of medical devices are made for adults. Apparently, doctors work around the problem by “jury-rigging” devices to suit their patients’ needs; however, this practice has limits and patient risk can be high. Also, problems exist not because children are smaller, but because they are also growing and their metabolism is quicker.

Now, lawmakers and doctors are pushing the medical device industry to design a new class of “kid-friendly” equipment and President Bush signed a law in September offering financial incentives to those companies that design child-sized devices. The law also provides regulators with additional power to both analyze the use of adult-sized devices in children and requires device makers to swallow the cost of such tracking.

Industry is not happy about this nor is it happy that there is a decidedly smaller market for child-sized devices—children tend to be healthier than adults—which presents limited profit potential and experimental kid-sized devices can legally be sold without full federal approval only if used to treat rare diseases. "The pediatric market is a mere fraction of the market for adults," said Paul Citron, who recently retired as vice president of technology at Medtronic Inc., a medical device maker. The U.S. market for medical devices is estimated at nearly $90 billion; however, health care experts agree pediatrics is a mere fraction of that. Also, with device makers like Medtronic and Boston Scientific Corp. already under fire for problems with pacemakers, stents, and other adult devices, it is not expected that they will look to expand their market to children.

Some issues fitting children with devices made for adults include heart valves that quickly deteriorate in growing bodies; pacemakers that cause infection, stroke, and death in smaller patients; surgical cameras that are too big for children and cause tissue damage; pacemaker batteries that cannot keep up with children’s faster heartbeats; and oversized oxygen masks. And the Food and Drug Administration (FDA), which regulates devices, has limited information on the frequency with which adult devices are used in children; the one large-scale study, conducted in 2005 by the Institute of Medicine, gave no estimate on related deaths or injuries.

After thousands of doctors complained, the American Academy of Pediatrics increased its lobbying budget over 100 percent to $362,500 in 2007 to help pass legislation on pediatric-device development, but manufacturers say they lack the technology to meet this need. The device bill proposed $30 million in research grants over five years; however, nothing has yet been set aside in the federal budget.

FDA Warns Philips Medical Systems Over Manufacturing Procedures

Wed, 23 Apr 2008 00:00:00 -0700

Philips Medical Systems Inc. has been warned by U.S. health regulators about a wide variety of problems with its manufacturing procedures at an Ohio plant. According to a letter released by the U.S. Food and Drug Administration (FDA), one of the problems cited includes Philips Medical’s failure to oversee proper medical device design. Philips Medical System is a unit of Philips Electronics NV.

FDA inspectors visited Philips' Cleveland, Ohio plant this past September and October 2007 and found more than one dozen production problems at the facility. Philips Medical manufactures computed tomography (CT) and nuclear medicine devices. Among the production problems cited were an inadequate system to manage production changes as well as problems with software to check device and also said Philips Medical Systems did not properly maintain certain investigative records and failed to set up proper procedures to handle complaints. The FDA cited these issues in an April 1 letter to Philips Medical Systems, which is also quoted as saying, “Your procedure does not require systematic evaluation to determine if an event is ... reportable.”

According to the FDA, Philips Medical has taken some steps to correct the problems since the inspection; however, Philips Medical has yet to address them all. Philips spokesman, Arent Jan Hesselink, said Philips has resolved 10 out of the 14 FDA complaints. “On the remaining four, we are still working with them. It is a matter of implementing some changes, in some cases simply a matter of providing the FDA with documentation,” the spokesman said adding, “We take it very seriously and will do everything we can to make sure that any issues seen by the FDA are solved.”

The FDA issues dozens of warning letters each year and while the majority are resolved without issue, the FDA can impose fines, injunctions, and other civil penalties.

Philips' shares were off 44 cents—over one percent—at $37.87 in late morning trading on the New York Stock Exchange and were down about 1 percent on the Amsterdam exchange.

Meanwhile, in February, researchers from the University of California, San Francisco (UCSF) argued that medical devices are not subject to the same rigorous review process as pharmaceuticals and this needs to change to improve health outcomes and found once a device receives FDA approval, an independent technology review could help identify which devices are beneficial. According to the team, this data would improve health professionals' awareness of the potential promise and pitfalls of new technology. Sometimes, the only information on a device is what the manufacturer provides.

The UCSF analysis evaluated the federal review process, how devices come to market, how scientific literature reports on clinical trials involving medical devices, and the effectiveness of independent review boards in improving a technology's medical benefit. Out of thousands of medical technology applications submitted annually to the FDA, less than 100 undergo the type of scrutiny required for new drugs. Most new applications are approved through an expedited FDA process that considers new devices similar to those already approved. Also, the FDA relies on manufacturers and clinical investigators to initiate recalls and failure reports when a technology is not beneficial or is potentially harmful to patients.

Tanning Bed Research Funded by Industry Group

Fri, 18 Apr 2008 00:00:00 -0700

In a climate where taking money from the medical device industry is being met with increased rancor and where questions over potential conflicts have been growing at medical journals, a Boston University researcher who wrote a piece in the New England Journal of Medicine is under fire. Dr. Michael Holick conducted some work and wrote on a recommendation on the moderate use of tanning beds for treatment or to avoid vitamin-D deficiency. Holick received research monies from an organization funded and controlled by the tanning-bed industry. While this link between industry and Holick's work wasn't spelled out in the piece, a note at the end of the article stated that Holick's research was partly funded by the UV Foundation; no foundation information was included.

According to its Website, the nonprofit foundation is financed by the Indoor Tanning Association tanning-bed equipment makers with a board of directors composed entirely of tanning-bed-industry officials. Boston University was the top recipient of grants from the foundation from 2004 through 2006--the most recent three years of the group's Internal Revenue Service filings; the university received $162,014 in that time. On its Website, the UV Foundation said it "has made a commitment of $150,000 over three years to Boston University, to continue the efforts of Dr. Michael Holick, a Vitamin D expert" adding that the foundation "is dedicated to exploring the positive effects of UV light and to increasing public awareness about those benefits."

Two weeks ago, the New England Journal of Medicine issued a correction after embarrassing disclosures of financial links between the authors of a lung-cancer study and two large companies—General Electric and Vector Group, Ltd.—the journal published a correction, a clarification, and an editorial that called for the transparent disclosure of funding sources. The lung-cancer study, which was published in 2006, has been controversial and suggested an annual screening with a CT scan could reduce the death rate from lung cancer, the top cancer killer. Critics said the study revealed that screening could detect cancers earlier—not that screening could avert deaths. GE is a big CT scanner maker and Vector is part of the Liggett Group, a large cigarette maker. The correction acknowledges the study's lead authors, Claudia Henschke and David Yankelevitz of Cornell University's Weill Medical College in New York City, received royalties from GE for pending patents on ways to manipulate and interpret CT scans and other medical images.

Current New England Journal of Medicine policies for review articles requires authors "not have major research support" from relevant companies; a spokeswoman for the journal said Holick’s amount was within guidelines. Holick's article did not report new research but made recommendations based on a review of published studies. In the piece, tanning beds were cited as a "recommended" vitamin D source when used in moderation which concerned cancer specialists who say studies have shown ultraviolet rays used in indoor tanning are linked to an increased cancer risk. "I was surprised that the New England Journal, a very prestigious journal, would run the article this way," said Martin Weinstock, a Brown University dermatology professor who also expressed surprise the journal would run an industry-funded piece.

Some Physicians, Scientists Choose to Refuse Industry Money

Thu, 17 Apr 2008 00:00:00 -0700

There is a small group of prominent academic scientists who no longer accept payments from food, drug, and medical device companies. In this unprecedented trend, some physicians no longer accept payment for speaking at meetings or for sitting on advisory boards. Although they may still work with these companies—because they feel it is important for scientists to assist these companies in their work with these studies—they work for free. The scientists involved say their decisions were private and difficult. For instance, one scientist will experience significant financial sacrifice. Regardless, the group feels that they are now able to provide decisions based on science and with no connection to money.

This group is acting in response to accusations of ethical conflicts. According to Dr. Jerome P. Kassirer, a professor at the Tufts School of Medicine and who wrote a book on conflicts of interest, this group’s actions renounce decades of industry influence. Five years ago, “nobody paid any attention to taking money from industry. They just took it. In some instances, I think people thought they were suckers if they didn’t.”

Even last year, the Food and Drug Administration (FDA) decided it could not totally ban researchers from its advisory boards who accepted industry consulting fees. But Kassirer says he keeps finding experts who are rejecting the money, “I don’t think there’s any question that the atmosphere has changed,” he said. Kassirer attributes this change to publicity about conflicts and the public shame when researchers’ conflicts are published. “Finally, it’s gotten to people,” he said.

One such example is that of Dr. Peter Libby, chief of cardiovascular medicine at Harvard’s Brigham and Women’s Hospital, who said he began receiving offers from drug companies in the early 1980s. “When you start emerging as an opinion leader or as a researcher who has knowledge and expertise, the pharmaceutical industry takes an interest in either having you consult to help them with their research or to speak,” he said. Libby felt it was his duty to consult with drug companies to help develop therapies and set up studies. Although he never owned stock in companies for which he consulted, he always disclosed the fact that he consulted and spoke for companies. Because he was so prolific, he felt he was free from accusations of conflicts of interest. Libby spent four years working without pay to help create a public television series, “The Mysterious Human Heart,” a project he felt would educate the public about heart disease and how to prevent it. He was immediately scorned for having consulted for manufacturers of pharmaceuticals and medical devices, “They said we were biased. What I thought was four years of public service was impugned. That was a wake-up call for me. I was singed in the blogosphere.” Libby decided to continue speaking at forums sponsored by the pharmaceutical industry and consulting for companies, but not for payment. “I want to speak out about the beliefs I am passionate about regarding prevention and medical advances that I think can reduce disease and save lives,” he said. “It is not worth it to be under suspicion.”

Senate Panel Assails FDA Funding

Wed, 16 Apr 2008 00:00:00 -0700

According to this week’s bipartisan Senate panel meeting, the US Food and Drug Administration (FDA) does not have adequate funding “to adequately protect the nation's increasingly global supply of food and drugs.” The lawmakers confirmed that the FDA needs millions more dollars than the $2.4 billion the Bush administration requested for 2009 to keep up with the much-needed inspections of overseas manufacturing plants and to monitor drug side effects and food contamination. "There is no new money for food safety, medicinal products safety or anything else," said Herb Kohl, a Wisconsin Democrat and chairman of a Senate appropriations subcommittee. "I find that troubling."

These discussions follow the most recent drug scare, over contamination of a raw ingredient made in China and a component of Baxter International Inc.'s blood thinner heparin as well as numerous reports of tainted pet food and bacteria-laced peanut butter, spinach, and lettuce. Heparin was linked to dozens of deaths and adverse reactions in over 700 patients. Millions take heparin annually to avoid potentially life-threatening blood clots.

Senator Robert Bennett of Utah, the panel's top Republican, did defend the FDA's overall performance, but added, "The budget that has been submitted by the administration appears to me to be inadequate to meet those challenges." The panel is currently reviewing how much taxpayer money will be needed for the FDA for fiscal year 2009, which starts in October. External experts assembled by the FDA said the agency needs an additional $375 million to improve its oversight of those products that comprise about 25 percent of the US economy.

FDA Commissioner Andrew von Eschenbach, whom President George W. Bush appointed, said the FDA would have trouble using such a large sum in one year, but could use $100 million and would use some of the funding to create new FDA offices overseas, including in China. Meanwhile, the FDA is creating a temporary facility in Beijing next month, hoping to make it official by September. Two other FDA offices are planned in Shanghai and Guangzhou for a total of 13 employees in China and the FDA is hoping to have five offices overseas and is looking at setting up offices in India, the Middle East, Latin America, and Europe. Additional funding could also go toward upgrading the agency’s antiquated systems, von Eschenbach added.

The FDA focuses on domestic companies, with about 1,200 inspections conducted annually in the US; however, only about 300 foreign facilities are inspected annually. In November, the Government Accountability Office found the FDA didn’t know how many foreign firms are actually subject to inspection and the FDA could not confirm how many foreign firms have never been inspected. The agency has a list of 3,249 firms, but at the current rate of inspection, it would take the FDA over 13 years to go through each firm on its list. Today, approximately 80 percent of all active drug ingredients come from abroad. Worse, many of these drug-manufacturing plants are in developing countries that don't have infrastructure that meets U.S. safety standards.

Medical Device, Drug Makers Seek to Head Off Regulation by Disclosing CME Grants, Other Donations

Tue, 15 Apr 2008 00:00:00 -0700

Medical device makers and drug companies, facing increasing scrutiny from Congress, have decided to come clean about donations and grants they provide to fund medical education programs, patient advocacy organizations and other groups. Drug maker Eli Lilly already has such a program, and , Medtronic Inc., a maker of among other things, implantable defibrillators and defibrillator components, has announced it will disclose such funding on its website starting May 1. Other drug and medical device makers recently told one lawmaker they intend to start similar disclosure programs. While some patient advocates have praised such plans, others fear that the proposed disclosure efforts are simply an attempt by drug and device makers to end a push in Congress towards legislation that would require public disclosure of their giving.

The move to be more forthcoming about funding efforts comes on the heels of a letter written in February by Sen. Charles Grassley (R-Iowa) to 15 of the nation's biggest drug and device companies. Grassley asked if the companies planned to start publishing grant information on their websites, in the way Eli Lilly began last year. Grassley, a member of the Senate Finance Committee, said he was particularly interested in grants the companies used to fund Continuing Medical Education (CME) programs for physicians.

Physicians must attend CME conferences in order to keep their licenses, and many drug and medical device makers "generously" fund such events. In fact, in 2006, pharmaceutical companies alone spent over $1 billion on CME courses. Unfortunately many of these courses are thinly disguised marketing ploys. Last summer, a Finance Committee found that drug companies were actually using CMEs to influence clinical practice guidelines and Medicaid formularies.

The Accreditation Council for Continuing Medical Education (ACCME) has rules spelling out who is allowed to pay for CME courses, and drug companies and device makers are not allowed to directly fund such programs. But "directly" is the operative word here. There is nothing in the rules that prohibits the manufacturers from paying a third party to design and promote courses. And that's exactly what they do. Very often, the course materials designed by consultants for these programs exaggerate the benefits of the sponsoring company's products, and downplay side effects and other safety issues. And it is not unusual for these conferences to include information on off-label uses of drugs and devices, something which manufacturers are legally barred from doing directly.

Congress has recently been threatening to legislate disclosure requirements for drug and device makers. In his February letter, Grassley wrote, "If your company does not yet have any efforts or plans in place, please explain why not." The answers have been positive, with most agreeing to disclose CME funding, and many volunteering to publicize payments to patient advocacy groups such as the American Heart Association. In addition to Medtronic, AstraZeneca has plans to start posting its funding efforts to its website by August 1. Merck, Amgen and Abbot Labs all said they are working on developing plans to disclose funding programs,. Only Schering-Plough rebuffed Senator Grassley, saying "We do not publish or have plans at the moment to publish a list of charitable contributions or educational grants that medical organizations have received from us."

While Grassley said he was happy with the results of his letter writing campaign, others were more cautions. Dr. Peter Lurie of the consumer group Public Citizen told the Associated Press that drug and device makers' voluntary disclosure efforts could be little more than an effort to ward off legislation that would require more comprehensive disclosure. "If they were doing this out of the goodness of their heart, they would have done so decades ago," Lurie said.

Hearing Aid Lawsuit Dismissed Due to High Court Pre-emption Ruling

Fri, 11 Apr 2008 00:00:00 -0700

A recently-dismissed lawsuit against the maker of a defective hearing aid provides a window into the a recent US Supreme Court decision will affect people injured by defective medical devices. That decision gave medical device makers protection from state product liability lawsuits in cases where a device has been approved by the Food & Drug Administration (FDA). Because of that decision, the Arkansas Supreme Court on Thursday reinstated the dismissal of a lawsuit filed against Soundtec, a maker of hearing aids, by a man who claimed he suffered ear damage after having a hearing device implanted in his right ear in 2002.

In February, the US Supreme Court ruled in favor of medical device makers that the Medical Device Amendments of 1976 to the Food, Drug, and Cosmetic Act that require FDA approval of medical devices preempt product liability lawsuits in state courts. That law clearly says that states can’t maintain requirements that are different from federal standards. But Congress didn’t specify if those federal standards preempted state common law claims. Medtronic, which had brought the case before the Supreme Court, and the Bush Administration asserted that allowing state personal injury lawsuits against the makers of defective medical devices amounts to a state “requirement” different from FDA requirements because such complaints are based on state laws.

Eight members of the Supreme Court agreed. In his majority opinion, Justice Antonin Scalia wrote that permitting state juries to impose liability on the maker of an approved device “disrupts the federal scheme,” under which the FDA has the responsibility for evaluating the risks and benefits of a new device. Justice Scalia wrote that state tort law amounted to such an additional requirement. He said the 1976 law “speaks clearly to the point at issue,” regardless of the federal government’s previous or current positions.

While the US Supreme Court ruling will nullify some medical device product liability lawsuits currently making their way through state courts, it is unclear how great an affect it will really have, because most medical devices on the market today went through a different approval process than the one at issue in this case.

One lawsuit the ruling apparently did nullify was Gary Depain's claim against Soundtec. In 2004, Soundtec successfully argued federal law pre-empted state law in the matter, and the state court therefore had no jurisdiction. Despain's attorneys appealed, and the Arkansas Supreme Court agreed in February that federal law did not pre-empt state law. Despain's lawsuit was returned to the lower court for trail. But less than two weeks later, the US Supreme Court handed down the pre-emption decision. Soundtec's lawyers asked the Arkansas Supreme Court to reconsider its earlier decision, and the panel reinstated the dismissal, citing the High Court decision in doing so.

The lawyer representing Despains said in February his client remains unemployed and disabled from the device, which caused severe ringing in his ear and later was removed. Gary Despain worked at Franklin Electric Co., where welding machines produced electromagnetic fields that aggravated the problem.

Group Pushes FDA to Announce Medical Device Tracking Program

Fri, 04 Apr 2008 00:00:00 -0700

The Food & Drug Administration (FDA) is taking too long to announce and implement a program to track medical devices, a coalition of health care advocacy groups said. Implementation of an identification system that assigns a medical device unique number will mean quicker and more reliable recalls and better tracking of outcomes in patients who have implanted devices, the group says.

Every year, dozens of medical devices are recalled due to dangerous defects. One of the challenges of such medical device recalls is informing patients with implantable devices that they are the subject to a recall. A standardized medical device tracking system would help streamline this process.

The Food and Drug Administration Amendments Act of 2007, which passed in October, included legislation requiring the implementation of a unique identification system for devices but did not specify a time frame in which such a system must be in place. Known as unique device identification, such a system will enable bar coding and other electronic tracking systems for medical devices. Advocates of such a system say it is critical to improving patient safety, reducing medical errors, enhancing medical device recall processes and improving device adverse event reporting. The FDA has been consulting with industry stakeholders on such a rule since 2005 and in recent months has come under pressure to finish the task.

In a letter to the FDA dated March 26, the Advanced Patient Safety Coalition - made up of hospitals, patient advocacy groups, and clinicians - called unique medical device identification “a crucial factor” in improving patient safety and reducing the frequency of medical errors.

“We need to be able to track medical devices like we can track any other product,” Blair Childs, senior vice president at Premier Inc., of Charlotte, N. C., and a member of the coalition, told GovernmentHealthIT.com. “We can track spinach that has E. coli back to the field where it was grown, but we can’t track a recalled medical device because there is no unique numbering system.”

Child's said there has been a growing sense of urgency among advocates of the medical device tracking system because the FDA has given no indication as to when such a tracking system might be implemented. Even once the FDA announces the new system, it will take time for it to become a reality. Once the proposed rule appears in the Federal Register, it must go through a 60-day comment period and potential FDA adjustments.

Medtronic Study Shows CRT Devices Provide Little Help to Patients with Mild Heart Failure

Thu, 03 Apr 2008 00:00:00 -0700

Cardiac-resynchronization therapy (CRT) devices don't do much for patients with mild heart failure, according to a just completed clinical trial. The clinical trial, called REVERSE, was funded by Medtronic Inc. in the hope that it could expand the market for its CRT devices to patients with mild heart failure. As it stands now, CRT devices are only approved for people with severe heart failure.

About 5 million Americans have hearts so weak they don't pump enough oxygen-rich blood to fuel the body. CRT devices are typically implanted in patients diagnosed with severe heart failure, where the heart cannot pump enough blood through the body. CRTs are often designed to provide shocks when hearts get dangerously out of control. Such devices are known as CRT-Ds, as they also have a defibrillator function. They cost around $32,000, more than a typical high-end defibrillator.

The results of the REVERSE study were presented Tuesday at the American College of Cardiology annual meeting in Chicago. According to Bloomberg.com, REVERSE was designed to see if patients who received an implanted rhythm-management device in addition to heart medication fared better than those on drugs alone. All 610 patients in the study had the CRT devices surgically implanted, though 191 didn't have them turned on.

The CRT study missed its primary goal on a measure of disease progression, but some patients saw their conditions improve. In the group with the devices on, 16% of patients worsened, versus 21% worsening in the group that left the device off. Researchers did not deem the difference between the groups to be statistically significant.

However, Medtronic and advocates for expanded CRT device use did find encouragement in some of the findings. The study did find that CRT devices triggered some improvements to enlarged hearts in less-sick patients. Patients with the device also were 53 percent less likely to be hospitalized for the condition.

According to The Wall Street Journal, in December, a study funded by St. Jude also failed to find a benefit for CRT-Ds, in that case among patients whose hearts were beating mostly in sync. Still, Medtronic is not giving up on expanding the use of its CRT devices. David Steinhaus, medical director of Medtronic's cardiac-rhythm unit, told The Wall Street Journal that the company believed "there's enough in this study" to start a dialogue with the Food and Drug Administration on expanding approved uses.

FDA Releases Drug Coated Stent Guidelines

Thu, 27 Mar 2008 00:00:00 -0700

Drug coated stents should be subject to more stringent clinical trials before approval, and makers of such devices should conduct long-term follow-up studies after drug coated stents are brought to market, according to the Food & Drug Administration (FDA). Those recommendations were part of the FDA's proposed guidelines for drug coated stents that were released yesterday. While the proposal is not binding, companies often seek the FDA's advice during product development, and will follow such guidelines in order to ensure approval of medical devices.

Stents are lattice-like devices that act like scaffolding to hold a blood vessel open. According to the FDA, each year in the United States, approximately 1 million patients undergo procedures to treat coronary atherosclerosis, also known as hardening or blockages of the heart arteries -- a condition that can cause angina and heart attacks. Some 650,000 patients are treated with drug-eluting stents that are coated with a medication that prevents the growth of scar tissue. Currently, Johnson & Johnson, Boston Scientific Corp and Medtronic Inc make the drug-coated stents now on the market. Abbott Laboratories Inc also is expected to receive approval for a new drug-coated stent.

In 2006, the safety of drug coated stents was called into question when the Cleveland Clinic published an analysis of fourteen stent studies covering more than 6,000 patients that found those with drug coated stents were four to five times more likely to suffer from blood clots than those implanted with bare metal stents. Since then, use of the drug coated stents has dropped dramatically.

According to The Wall Street Journal, the proposed drug coated stent guidelines would mark the first concrete change since the FDA held a two-day meeting in December 2006 about whether such stents increase the risk of clots compared with bare-metal stents years after the procedure. The guidelines aren't expected to affect drug coated stents already on the market, but cold delay stents in development.

According to Bloomberg News, the draft guidance calls for drug coated stent makers to undertake new testing to identify the medicines used and show how the drugs break up in the body. The tests need to be done before trials in humans start, the FDA said. The agency also recommended longer human studies, larger safety databases and continuing studies of patients after devices reach the market.

Under the proposal, instead of assessing patients' progress and health in trials nine months after a stent is implanted, the agency will now require companies to submit trial data on patients' health one and two years after the procedure, before stents can be approved. The FDA said that after a drug coated stent is approved, companies should continue monitoring, preferably for five years after implantation, for blood clots, heart attack or other complications.

"Medical Device Safety Act" Seeks to Overturn Supreme Court Ruling on Defective Device Lawsuits

Wed, 26 Mar 2008 00:00:00 -0700

Lawmakers in Congress are getting closer to passing legislation that would overturn a Supreme Court decision that barred people injured by defective medical devices from suing in state courts if the device was approved by the Food & Drug Administration (FDA). Two members of the House of Representatives say they are drafting a bill to overturn the decision that should be ready sometime next month.

In the case considered by the Supreme Court, Medtronic Inc, the maker of the faulty Sprint Fidelis Defibrillator Lead and other defective devices, had argued that the Medical Device Amendments of 1976 to the Food, Drug, and Cosmetic Act that require FDA approval of medical devices preempt product liability lawsuits in state courts. That law clearly says that states can’t maintain requirements that are different from federal standards. But Congress didn’t specify if those federal standards preempted state common law claims. Medtronic and the Bush Administration asserted that allowing state personal injury lawsuits against the makers of defective medical devices amounts to a state “requirement” different from FDA requirements because such complaints are based on state laws.

Eight members of the Supreme Court agreed with Medtronic. In his majority opinion, Justice Antonin Scalia wrote that permitting state juries to impose liability on the maker of an approved device “disrupts the federal scheme,” under which the FDA has the responsibility for evaluating the risks and benefits of a new device. Justice Scalia wrote that state tort law amounted to such an additional requirement. He said the 1976 law “speaks clearly to the point at issue,” regardless of the federal government’s previous or current positions.

But U.S. Reps. Frank Pallone, D-N.J., and Henry Waxman, D-Calif. disagree with the Supreme Court's interpretation, and want to clarify the law in broader terms. To that end, they plan to introduce the " Medical Device Safety Act" that would state that existing federal law governing medical device approvals does not "modify or otherwise affect" lawsuits brought in state courts. As it stands now, the bill would apply to any civil action pending or filed on or after the date of enactment. A spokeswoman for Pallone told the Pioneer Press that the bill is expected to be introduced shortly after Congressional leaders return from break Monday.

It’s not clear how many current state medical device lawsuits might be barred if the Supreme Court's ruling is allowed to stand, but it does not ban all of them. According to The New York Times, most medical devices now available reached the market through a different process than covered by the decision, under which the FDA found them to be “substantially equivalent” to those marketed before the 1976 law took effect. The Supreme Court ruled in 1996 that this approval process does not pre-empt state damage suits against manufacturers. The decision also does not ban state lawsuits against medical devices that are not manufactured according to FDA specifications, and lawsuits can still be brought under state laws that mirror federal laws.

Probe into Medical Device Kickbacks Now Targets Doctors

Mon, 24 Mar 2008 00:00:00 -0700

Federal investigators looking into kickbacks in the orthopedic device industry have apparently set their sites on another target - doctors who received these illegal incentives. The physician investigation is just the latest chapter in the government's ongoing probe of the financial arrangements often made between medical device makers and the doctors who use their products. So far, the kickback investigation has uncovered excessive consulting agreements, lavish trips and other perks the makers of hip and knee implants handed out as rewards to surgeons who used their products.

A recently completed New Jersey Attorney General’s Office probe alleged that orthopedic device companies paid U.S. physicians lucrative fees for nominal services between 2002 and 2006. One, Stryker Orthopedics, cooperated with prosecutors and escaped a fine, but agreed to federal monitoring for 18 months. The other companies, Zimmer Holdings Inc., Depuy Orthopaedics Inc., Biomet Inc. and Smith & Nephew Inc. agreed to a $311 million settlement with the Justice Department and the U.S. Department of Health and Human Services.

According to The New York Times, Lewis Morris, the chief counsel in the federal office that pursues civil complaints of Medicare fraud, told an audience of hundreds of doctors, company representatives and investors this month in San Francisco at the annual meeting of the American Academy of Orthopedic Surgeons that the government will now be taking a hard look at doctors who are "soliciting kickbacks” from the makers of hip and knee replacements.

Although industry executives told The New York Times that they have heard that some doctors have received subpoenas, none have been publicly identified. According to the Times, the government has not argued that any of the kickbacks led to unnecessary knee or hip surgery or maltreatment of any patients. Nor has it established a direct link to higher Medicare costs. However, doctors can be convicted of violating Medicare’s antifraud statutes simply for submitting a bill for a procedure linked to a kickback, whether or not the procedure was necessary.

During a hearing last month before the Senate Special Committee on Aging, Assistant inspector general Gregory Demske told lawmakers that four makers of artificial hips and knees paid doctors more than $800 million in royalties and fees in four years to influence their choice of implants. While he did not identify these companies, Demske said that together they controlled three-quarters of the $9.4 billion worldwide market for hip implants and knee replacements. Demske and other witnesses told the panel such payments have enriched doctors and distorted the market by bolstering sales of lower-quality devices. Demske said such payments are difficult to regulate, because it is hard for investigators to determine which are legitimate, and which are kickbacks.

China to Crack Down on Medical Device Makers

Fri, 21 Mar 2008 00:00:00 -0700

China will revoke the licenses of those manufacturers producing unqualified medical devices that cause disastrous results, according to a draft on the administration of medical device recalls. The Chinese government will assign compulsory recalls and levy penalties of three times the amount of the medical device value to those manufacturers which do not voluntarily recall products that pose a potential safety hazard.

According to the rules, medical device producers should maintain minutes on the handling of recalled products and report to the regulator of the Food and Drug Administration. Also, when destroying unqualified medical devices, producers must have a drug regulator on hand to witness the process. Manufacturers should closely track and handle recalled, embedded medical devices and bear relevant expenses resulting from the process. The administration regulations were drafted by the State Food and Drug Administration, which was just incorporated into the Ministry of Health when it concluded its annual session of the National People's Congress.

Meanwhile, in the United States, researchers from the University of California, San Francisco (UCSF) argued that medical devices are not subject to the same rigorous review process as pharmaceuticals and this needs to change to improve health outcomes. The team found once a device receives US Food and Drug Administration (FDA) approval, an independent technology review could help identify which devices are beneficial. According to the team, this data would improve health professionals' awareness of "the potential promise and pitfalls of new technology.” Feldman, professor of medicine at UCSF said, "These days, patients are asking their doctors for the newest technologies from genetic tests to specific radiation treatments and many physicians don't know where to turn for the latest evidence-based information. Sometimes, the only information out there is what the manufacturer provides."

The UCSF analysis evaluated the federal review process, how devices come to market, how scientific literature reports on clinical trials involving medical devices, and the effectiveness of independent review boards in improving a technology's medical benefit. Out of thousands of medical technology applications submitted annually to the FDA, less than 100 undergo the scrutiny required for new drugs. Most new applications are approved through an expedited FDA process that considers new devices similar to those already approved. Also, the FDA relies on manufacturers and clinical investigators to initiate recalls and failure reports when a technology is not beneficial or is potentially harmful to patients.

"FDA approval should be the start of the process toward clinical application, not the end," Feldman said. "Physicians and patients just aren't aware of the limitations of the FDA process of initial assessment and oversight of new medical technologies. Assessments by objective entities are a necessary addition to FDA approval, so that deficiencies in clinical evidence, and patient safety issues that may arise after approval, are recognized before widespread adoption into clinical practice." The purpose of independent review organizations is to provide transparent, objective evaluations, Feldman said. Eventually, the authors suggest, independent review boards should summarize their findings into uncomplicated take-home messages that patients can easily find on their own.

Class I Recall for Medtronic SynchroMed and IsoMed Infusion Systems

Thu, 20 Mar 2008 00:00:00 -0700

Medtronic Inc.'s January communication regarding problems with its SynchroMed and IsoMed infusion systems has now been deemed a Class I recall by the Food & Drug Administration (FDA). A Class I recall indicates a situation in which there is a reasonable probability that use of the product will cause injury or death. Medtronic said the classification from the FDA does not change the recommendations made to physicians in the January 2008 letter and there is no new action required of physicians or patients in regards to the defective SynchroMed and IsoMed infusion systems.

Medtronic’s SynchroMed and IsoMed intrathecal drug delivery systems consist of an implantable pump and catheter that deliver small quantities of drug directly into the intrathecal space in the spine. These devices are used to treat chronic, intractable pain and for the management of severe spasticity of cerebral or spinal origin.

On January 16, Medtronic sent a letter to healthcare providers informing them of an increase in the rate of reported inflammatory mass cases in patients who have received intrathecal drug delivery through its SynchroMed and IsoMed implantable infusion systems. This letter was an update to two previous communications on this topic that Medtronic issued in 2001 and 2003. The risk of inflammatory mass formation has been included in the labeling for Medtronic’s SynchroMed and IsoMed implantable drug infusion systems as either a Warning or Precaution, since 2001 and in the prescribing information for Infumorph (preservative-free morphine sulfate for microinfusion pumps) since 2003.

Inflammatory mass is a chronic inflammatory or granulomatous mass at or near the tip of intrathecal catheters and has been reported with the infusion of morphine, baclofen and other physician-prescribed drugs and/or mixtures, including pharmacy-compounded drugs. In the January letter, Medtronic noted an increase in reported cases of inflammatory mass associated with intrathecal drug delivery from 0.1 percent reported to date in 2001 to 0.5 percent reported to date in 2007. The company said that the actual incidence was likely higher than stated due to under-reporting. Medtronic said it has received FDA approval to update the SynchroMed and IsoMed labeling to include this new data.

According to Medtronic's press release, the most frequently reported symptoms of inflammatory mass are decreased therapeutic response, pain, and neurological deficit/dysfunction. Serious reported symptoms include paralysis and other neurological impairments. To date, there have been no reported deaths associated with this issue. Medtronic said the development of inflammatory mass was associated with a wide range of doses and concentrations of opioids. The risk of inflammatory mass occurrence also appeared to increase over time and with higher concentrations of opioids

In the January letter, Medtronic cautioned clinicians to utilize the lowest effective dose and concentration of opioids and to monitor patients closely for early clinical symptoms of inflammatory mass. The letter also recommended diagnostic steps for physicians to consider for patients who have new neurological symptoms aimed at preventing more severe outcomes.

Medtronic said patients with questions should talk to their physician or contact Medtronic Patient Services at 1-800-510-6735, Monday – Friday, 8 a.m. to 5 p.m. CDT. Physicians with medical questions related to Medtronic therapies should contact Medtronic at 1-800-328-0810, Monday – Friday, 8 a.m. to 5 p.m. CDT.