Mass Tort Litigation Blog

Richard Epstein Webcast on Riegel v. Medtronic

The Federalist Society has posted a webcast of Professor Richard Epstein discussing the recent U.S. Supreme Court case, Riegel v. Medtronic, which addresses possible preemption of state tort suits for FDA-approved medical devices.  Epstein says the Court might rule 9-0 in favor of preemption.

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FDA Preemption Cases

The Supreme Court heard oral arguments yesterday in Riegel v. Medtronic (06-179), the transcript is available on the Supreme Court’s website. Riegel presents the question of whether federal law preempts state lawsuits against FDA approved medical devices. The Riegels sued Medtronic, the manufacture of a balloon catheter, which burst during the dilation of Mr. Riegel’s coronary artery. The case raises federalism issues, asking whether federal agencies or state governments should make these types of health and safety decisions. Commenting on the case, the New York Times reports:

[I]n 2004, the Bush administration reversed the government’s position and began to take the manufacturers’ side, as it did before the justices on Tuesday in an argument by a deputy solicitor general, Edwin S. Kneedler. Explaining the change in policy, Mr. Kneedler said that in 2004, the F.D.A. "recognized that there would be a serious undermining of F.D.A.’s approval authority and its balancing of the risks and benefits if a state jury could reweigh those."

A question in this case, Riegel v. Medtronic Inc., No. 06-179, is whether the court will give the government’s position the usual deference it accords an agency’s interpretation of its basic statute.

The federal law at issue is the Medical Device Amendments of 1976, which in its section on preemption bars states from imposing on medical devices "any requirement which is different from, or in addition to, any requirement applicable under this chapter."

Beginning with a case in 1992 about warning labels on cigarette cartons, the Supreme Court has treated the word "requirement" as including not only obligations directly imposed by state laws and regulations, but also the award of damages by state tort systems.

For a jury to say, "Well, gee, it should have been done differently in this particular situation" is the equivalent of imposing a requirement in addition to federal approval, Theodore B. Olson, the lawyer representing Medtronic, told the justices.

"The F.D.A. is the right place for these decisions to be made and this balancing process to occur," Mr. Olson said, adding that while "nothing is perfectly safe," it would harm consumers to "discourage the marketing of products that might save our lives." Medtronic no longer makes the balloon catheter, called Evergreen, involved in the case.

In other FDA-related news, several amicus curiae filed their briefs in Warner-Lambert v. Kent (06-1498) on November 28, 2007. It doesn’t appear that the Supreme Court has scheduled oral argument yet. SCOTUSblog provides an overview:

Six years ago, in Buckman v. Plaintiffs’ Legal Committee, the Supreme Court held that state-law claims alleging that the manufacturer of orthopedic bone screws made fraudulent representations to the Food and Drug Administration ("FDA") were impliedly preempted by the Federal Food, Drug, and Cosmetic Act. On Tuesday, the Court granted certiorari in No. 06-1498, Warner-Lambert Co. v. Kent, to clarify the scope of its holding in Buckman: specifically, whether a state product liability statute that creates a general "safe harbor" from liability for FDA-approved drugs but carves out an exception for cases in which the approval was obtained through fraud is also preempted.

Under Michigan law, an FDA-approved drug cannot be deemed defective or unreasonably dangerous for product liability purposes unless the approval was obtained through fraud. Pursuant to this state statute, the respondents – all Michigan citizens – filed suit in Michigan state court, alleging that they were injured by Rezulin, a diabetes drug approved by the FDA but ultimately withdrawn from the market by Warner-Lambert. The case was removed to federal district court in Michigan and then subsequently transferred to the Southern District of New York by the Judicial Panel on Multidistrict Litigation. Warner-Lambert moved for judgment on the pleadings, arguing that under Buckman the claims were impliedly preempted, and the district court agreed.

ECB

Medtronic Feels Financial Effect of Recall of Sprint Fidelis Heart Leads, Mentions Ready for Litigation

An article in the Wall Street Journal -- Medtronic Net Slips on Recall, by Thomas M. Burton and Jon Kamp -- discusses the significant negative financial impact on Medtronic from its recent recall of Sprint Fidelis heart leads and mentions possible related litigation against Medtronic.  Here's an excerpt:

Regarding the potential for litigation linked to the recall, [Medtronic chief executive] Mr. Hawkins said it is too soon to say what the impact may be. "We're well-prepared financially and legally for any legal actions that come our way," he said.

***

Defibrillators are designed to correct potentially lethal racing heartbeats by dispatching a powerful jolt to the heart. A lead fracture can mean the electrical therapy doesn't get sent to the heart, and the patient can die. In the case of Sprint Fidelis, it has also meant that unnecessary shocks are sent to some patients' hearts. The company has said this phenomenon was at work in some of the five patient deaths that may have resulted from the fractured leads.

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Medtronic's Sprint Fidelis Cardiac Lead -- Problem Signs and the Role of the FDA

The Wall Street Journal has an extended article, Medtronic Recall Exposes Gaps In Medical Safety, by Thomas M. Burton and Anna Wilde Mathews, which provides an interesting description of the build-up of scientific warning signs for Medtronic's Sprint Fidelis cardiac lead, as well as the FDA's regulatory role.  Here's an excerpt from the lengthy article:

In late January, something unsettling happened at the Minneapolis Heart Institute. On two successive days, patients came to the clinic after their heart defibrillators had jolted them with huge, unnecessary and painful electric shocks. One 65-year-old woman said she'd been zapped 14 times in an hour.

Doctors checked the hospital's records and discovered four similar cases had occurred in recent months. Each stemmed from a broken wire -- called a lead -- that tells a defibrillator when to send an electric shock to a malfunctioning heart. All six cases involved the Sprint Fidelis 6949, manufactured by Medtronic Inc., a leading medical-device maker.

Within days, the Heart Institute concluded that the Sprint Fidelis wasn't safe enough, told the company of its concerns, and stopped using the product.

Across the country, physicians at leading hospitals from Chicago's Children's Memorial Hospital to Boston's Brigham and Women's Hospital came across similar problems and some took similar steps.

But it wasn't until this month that Medtronic of Minneapolis reached the same conclusion. On Oct. 7, Medtronic President and Chief Executive Bill Hawkins convened a meeting of top executives who decided that the company should suspend sales of the Fidelis leads. In one of the biggest recalls of a medical device, it pulled all Sprint Fidelis models from the market, citing five deaths in the devices' three years on the market.

The events surrounding the Medtronic recall expose a hole in the U.S.'s medical safety system: Medical devices are regulated under different standards from those applied to prescription drugs. The Food and Drug Administration requires that almost all new medications be tested in human trials before they go on the market. But some devices, like the Sprint Fidelis leads, are subject to lighter guidelines because they are considered modifications of earlier products. The FDA, in most cases, also doesn't mandate major studies of medical devices after they've hit the market.

As a result, both the federal agency and the company were handicapped in evaluating whether a widespread public health threat was emerging.

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Business Fallout from Stent Safety Concerns

As the Wall Street Journal reports, the after-effects of the heart-stent safety problems are causing much discussion among doctors who are meeting 30 years after the first balloon-angioplasty procedure.  Here's an excerpt from the article -- As Stent Sales Stall, Cardiologists Look to Reduce Safety Concerns, by Ron Winslow:

It was 30 years ago that pioneering cardiologist Andreas Gruentzig performed the first balloon-angioplasty procedure on a heart patient, giving birth to a specialty that has transformed treatment of coronary-artery disease in the past two decades.

But as interventional cardiologists toast their founding father at a big conference beginning this weekend in Washington, D.C., the glass-clinking will be muted by the sober state of their business -- in particular the status of its flagship device known as the drug-eluting stent.

Johnson & Johnson reported this week that sales of its Cypher stent plunged more than 40% in the third quarter from a year earlier; revenue for Boston Scientific Corp.'s Taxus stent, Cypher's only current rival in the U.S., fell 22%, and Boston Scientific announced a restructuring that includes laying off 2,300 workers.

The devices are tiny metal sleeves implanted to prop open diseased arteries; the drug-coated version minimizes chances that the stent will reclog within a few months, a problem that has required redo procedures for about 15% to 20% of bare-metal ones.

The Wall Street Journal also provides more in-depth treatment of the stent-related losses at Boston Scientific -- Boston Scientific Posts Loss As It Restructures, by Jon Kamp.

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Medtronic's Cardiac Leads & FDA Safety

Article in the Wall Street Journal -- Medtronic and FDA Face Scrutiny on Safety Issues, by Anna Wilde Mathews and Thomas M. Burton.  Here's an excerpt:

Medtronic Inc.'s decision to stop selling potentially defective defibrillator leads has prompted scrutiny of the devices and of how safety concerns about them were handled by the company and the Food and Drug Administration.

Plaintiffs attorneys, a consumer group and Iowa Sen. Chuck Grassley are examining the history of the Sprint Fidelis leads, which are electrical wires that connect the hearts of patients to the defibrillators implanted in their chests.

On Monday, Minneapolis-based Medtronic disclosed that the Sprint Fidelis wires have fractured in about 2.3% of the 268,000 models made, 235,000 of which are still implanted in people. The company said the fractures may have contributed to five deaths.

In early signs of the pressure likely to come for Medtronic and the FDA, Mr. Grassley, a Republican, last night sent letters to the company and the agency asking for more information about the leads. Separately, consumer group Public Citizen argued in a letter that the company and agency should have taken action sooner.

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Medtronic and the Deterrent Effect of Lawsuits

Deterrence, apparently, is in the eye of the beholder.  Medtronic recalled its Sprint Fidelis cardiac leads because of possible defects, and the company now finds itself a defendant in a putative class action.  Medtronic previously faced mass litigation over earlier defibrillator problems, and Guidant faced similar litigation.  The question:  Is this a story about a company that failed to learn from its mistakes, or is it exactly the opposite? 

According to the press release issued yesterday by plaintiffs' counsel Rheingold, Valet, Rheingold, Shkolnik & McCartney LLP, this is a case of a company that failed to learn its lesson from previous litigation.  The release quotes attorney Hunter Shkolnik:  "I believe that this new Medtronic litigation will follow the pattern of the previous litigation.  It is unfortunate that Medtronic did not learn a lesson from it and stop sales much earlier than it did.  The medical community published reports about this defect and Medtronic refused to act on it." 

Ted Frank at Point of Law sees it differently.  He describes the recall as "undertaken in an abundance of caution despite the lack of statistically significant evidence" and notes that "Medtronic's quick disclosure and recall contrasts favorably with the slower recall by Guidant three years ago."  He suggests that the budding Medtronic litigation will provide an interesting test case for members of the plaintiffs' bar who support tort liability as a deterrent:  "Will Medtronic be rewarded in the courtroom, or will they face the same degree of liability and litigation expense (or worse) as that of Guidant?  And if the latter, where does the supposed incentives of the modern-day product liability system come from?"

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Medtronic's Sprint Fidelis Cardiac Leads Not Semper Fidelis

Article in the Wall Street Journal -- Medtronic Defibrillator Patients Mull Options: Experts Advise Monitoring, But Say Fraction-Prone Wires Should Be Left Alone if Intact, by Thomas M. Burton and Anna Wilde Mathews.  Here's an excerpt:

It has long been an open secret among heart doctors: Flaws in the fragile wires, or "leads," connecting cardiac electrical devices to patients' hearts are far more frequent than malfunctions in the devices themselves.

Now that Medtronic Inc. has pulled its Sprint Fidelis leads from the market due to their risk of fracturing, hundreds of thousands of heart patients have been alerted to that reality. And they must decide how to respond.

The company, which says that 235,000 patients world-wide have a Sprint Fidelis attached to their hearts, recommends that patients see their doctors immediately. A cardiologist can reprogram a patient's defibrillator to heighten its ability to sense a defect in a lead so it can send out a warning beep if a problem is detected. Some doctors are also recommending that patients sign up for Medtronic's monitoring system, known as CareLink, which could alert patients to a possible fracture in the lead.

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Blog Roundup

Drug and Device Law Blog has posts on Tort Reform Works in Texas; Notes from the Scientific Underground; Preemption Scorecards; The Vanishing Trial; and Riegel Survives.

Food Law Prof Blog has posts on Cargill meat recall based on e.coli; Bush signs FDA Amendments Act of 2007; More on the Recall Process; CRS Report on Recall Authority; Roberts on Role of Regulation in Minimizing; Thinking About Recalls; and  Yet another meat recall -- this one enough for one picnic.

Point of Law has posts on Refik Kozic v. Merck; Absurd RI lead abatement plan developed; 
"Defendants See a Case of Diagnosing for Dollars"; and Zyprexa protective order enforcement VI: Egilman settlement.

Torts Prof Blog has posts on Topps Meat Recall: Let the Filing Begin; 9/11 Opt-Outers Settle; Lead Everywhere; Stent Safety and Patents;  USSC Denies Cert In Engle (Tobacco) Case; FDA Warns Against Use of Cold Meds by Toddlers; and Sebok's Part II on NJ Supreme Court's Vioxx Ruling.

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New Data Raises Safety Concerns for Medtronic's Endeavor Drug-Coated Stent

Article in the Wall Street Journal -- New Data Raise Questions About Medtronic's Stent, by Jon Kamp and Jennifer Corbett Dooren.  Here's an excerpt:

The Food and Drug Administration released new data for Medtronic Inc.'s Endeavor drug-coated stent that raise new questions about the heart device's performance and prospects, ahead of a regulatory review Wednesday.

Stents are small devices used to prop open heart arteries, and drug-coated stents use medication to slow renarrowing.

Avoiding stent-related clots has been Endeavor's calling card in a market that has been rattled by concerns about late-developing clots. While there are no new signs that Endeavor doesn't perform well over the long term, new data from the much-anticipated "Endeavor IV" study did show some earlier clots for Medtronic's stent.

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Heart Stents and Incomplete Scientific Evidence

Article on cnn.com -- Study: Drug-Coated Heart Stents May Not Be So Bad After All, from Dow Jones.  Here's an excerpt:

On Sunday, James and colleagues from Sweden presented follow-up results from data reported in December at the FDA safety hearing, and later published in the New England Journal of Medicine. They said that at that time, based on three years of data, patients with drug-eluting stents had an 18% increased chance of dying compared to patients with bare metal stents.

With more patients included and an extra year of data, the numbers now tell a different story.

After four years of tracking patients with drug-lined stents, James said that there was now no significant difference between patients who received the drug stents versus those who received the bare metal ones: patients with drug stents had only a 1% increased chance of dying. Newer drug stents are also better than earlier versions, some of which had to be recalled.

Experts are not entirely sure what might explain the research reversal, but more selective stent use might help explain the change, they said.

In the last year, use of drug stents has dropped dramatically. James said that in Sweden, only about 15% of eligible patients were now receiving them, compared to nearly 60% in previous years. And in the U.S., use has dropped from about more than 90% of eligible heart patients to about 70 percent.

The article also notes that the drop in stent use following the initial study results lead manufacturer Johnson & Johnson to cut 5,000 jobs. 

The change in stent study results is a cautionary reminder of the need to make informed policy judgments based on a complete scientific record.   The most egregious example in mass tort litigation is the silicone breast implant litigation, which lead to the bankrupting of a major company, Dow Corning, based on an incomplete scientific record.  When the  final scientific verdict was in -- too late for Dow Corning and other defendants -- the Institute of Medicine issued a report rejecting the medical causation that underlay plaintiffs' claims. 

But how do we know when the new study finding danger is accurate or inaccurate (as a result of confounding, chance, or bias)?  Phenylpropanolamine (PPA), the ingredient in cough-cold medications and appetite suppressants, was one of the most used drugs in the United States for decades, but a single epidemiological study (based primarily on the findings involving a subset of only a handful of individuals suffering stroke who took PPA in appetite suppressants) lead to the FDA's requesting the drug be voluntarily withdrawn from the market.  (For a critique of the study, see Download stier_hennekens_ppa_and_hs_in_the_hsp_annals_of_epidemiology_2006.pdf.)  What's worse, removing a drug from the market based on an incomplete record likely forecloses further research, which leaves litigants with a necessarily incomplete scientific record on which to base their claims.

So what's a judge to do?  I would argue that judges should continue to adhere strictly to Daubert's dictates that only expert opinions based on reliable science pass through the gates -- even if further studies do not appear to be forthcoming.  Justice requires that liability be fixed and payments required only where there is a solid basis for the claim, which includes medical causation.  But where the underlying science meets Daubert evidentiary standards, but may be incomplete, defendants need to be ready not only to present any cogent criticisms of the study, but also to point to examples where the preliminary science was wrong.  A glaring one: when the New England Journal of Medicine in 1981 published an article finding that coffee drinking may have been producing more than half of the cases of pancreatic cancer in the U.S. -- later studies failed to confirm those findings.  Starbucks, I'm sure, is happy the scientific record didn't remain incomplete.

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J&J Cuts Jobs Amid Safety Concerns for Stents and Anemia Drugs

Article in the Wall Street Journal -- J&J to Reduce Staff by 3% to 4%: Cuts Come Amid Slowdown In Stents and Expectation Of a Decline in Drug Sales, by Avery Johnson and Peter Loftus.  Here's an excerpt:

Johnson & Johnson is cutting costs and consolidating operations as the company braces for a downturn in drug sales and endures a sluggish market for drug-coated stents.

The company, based in New Brunswick, N.J., said it will reduce its global work force by 3% to 4%, or as many as 4,820 jobs. J&J pledged to consolidate some operations in its pharmaceutical group and combine medical-device businesses that make stents, the metal scaffolds that prop open arteries in the heart, legs and other parts of the body.

As of 4 p.m. composite trading on the New York Stock Exchange, J&J shares were at $60.50, up 43 cents.

The diversified health-products maker is in so many different businesses, from Band-Aids to biotech, that downturns in one area often are offset by gains in another. But J&J is now battling problems on an unusual number of fronts. The company faces patent expirations and safety concerns for some of its biggest sellers, ranging from anemia drugs to stents. Just two weeks ago, J&J tempered its 2007 sales outlook.

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Contact-Lens Solution Linked to Rare, Serious Eye Infection

Article in the Wall Street Journal -- Contact-Lens Solution Is Tied to Eye Infection, by Jon Kamp.  Here's an excerpt:

U.S. health investigators have linked a contact lens solution made by Advanced Medical Optics Inc. to the outbreak of a rare but serious eye infection that can cause blindness.

The news comes just a day after Advanced Medical Optics said it's interested in exploring an offer for rival Bausch & Lomb Inc., which was hurt from the world-wide recall of a lens solution last year amid links to a different infection. The Advanced Medical Optics product at issue is called Complete MoisturePlus, one of several all-in-one-bottle solutions on the market.

As of Thursday, in a probe that includes 35 states and Puerto Rico, the U.S. Centers for Disease Control and Prevention has identified 138 "culture-confirmed" cases and has interviewed 46 patients.

Research shows 36 of those people wore soft contact lenses, 21 reported using the Advanced Medical Optics product a month before symptoms, and 14 used it exclusively. That was enough of a link to a product with limited market share to spark a public announcement, said Sharon Roy, medical epidemiologist with the CDC's division of parasitic diseases.

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Drop in Use of Stents Following Study Showing Little Advantage Over Drug Therapy

Article in the Wall Street Journal -- Stent Implants Declined in April: Doctors Attribute Drop To Study Showing Drugs May Have Similar Benefits, by Keith J. Winstein.  Here's an excerpt:

The number of coronary stents implanted in the U.S. dropped sharply in April, according to a leading market researcher, in what doctors said was an unusually quick response to a study showing the devices provided little advantage over drug therapy in some patients.

The new figures are the latest evidence that the tiny scaffolds used to prop open arteries are no longer a powerful growth engine for the medical industry. Americans spent at least $14 billion on coronary-stent procedures last year, including surgical and hospital fees. World-wide sales of the devices totaled about $6 billion.

Doctors performed about 71,200 stentings in April, according to estimates from Millennium Research Group, a Toronto firm that surveys about 140 U.S. hospitals. That was down more than 10% from March and down more than 15% from a year earlier.

Boston Scientific Corp., one of the three main stent makers, said it believed that the effect would be temporary. Abbott Laboratories, of Abbott Park, Ill., said it hadn't seen a decline in its own market data, and Johnson & Johnson, based in New Brunswick, N.J., declined to comment on the new figures.

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Medicare Won't Cover Stents for Neck Arteries

Article in the New York Times -- In a Reversal, U.S. Says Medicare Won’t Cover Stents for Neck Arteries, by Barnaby J. Feder.  Here's an excerpt:

Responding to criticism from surgeons, the government has dropped its previously announced plans to expand Medicare coverage for the use of stents to prop open neck arteries to prevent strokes.

Instead, Medicare will stick with definitions that restrict eligibility for such stents to fewer than 10 percent of the 150,000 to 200,000 Americans who annually undergo surgery to clear blockages that restrict blood flow to the brain and raise stroke risks.

That is a far more conservative stance on stenting than has been taken by the Food and Drug Administration, which determines when a device is safe and effective enough to be sold commercially. And it is likely to slow the expansion of coverage among private insurers.

The decision, which Medicare regulators published online on Monday night, was an unexpected reversal for stent makers and many doctors who have promoted stenting as a less invasive alternative to neck surgery.

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More Debate About Heart Stents

Article in the New York Times -- First, a New Artery Stent Study; Now, Questions About What It All Means, by Barnaby J. Feder.  Here's an excerpt:

Is today the first in a new era for angioplasty and stenting, the artery-clearing technology that enchanted doctors while giving birth to a multibillion-dollar industry?

Many heart specialists at the annual scientific meeting here of the American College of Cardiology said it ought to be, based on a report Monday that found little additional value in giving stents to most heart patients as long as they received the right medicines.

“We were amazed at how well people did with medical therapy,” said Dr. William Weintraub, chief of cardiology at the Christiana Care Health System in Newark, Del., who is leading the analysis of the economic and quality of life data from the trial. The trial focused on patients with severe constrictions in their arteries that were causing angina chest pains or other symptoms but were not immediately life-threatening.

Device makers and some doctors, however, doubted that the trial would have broad impact. They noted several reasons to question the results, starting with the fact that only 3 percent of the stented patients in the trial received the latest drug-coated models. Those models were just reaching the market when enrollment in the study ended in 2004.

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Continued Debate Over Heart Stent Use

Article in the Wall Street Journal -- Debate Widens Over Stent Use In Heart Cases, by Ron Winslow and Keith J. Winstein.  Here's an excerpt:

Popular medical devices called stents proved no better than aggressive use of heart medicines in preventing heart attacks and death in a controversial study that is roiling the field of cardiology.

The findings add to a growing body of research suggesting that the tiny metal scaffolds -- which are implanted in about one million U.S. patients a year to prop open diseased coronary arteries -- are being used too often to treat disease that is stable or without symptoms. They are fueling a fierce debate between interventional cardiologists, who deploy the devices, and preventive cardiologists, who support the use of drugs and changes in health habits as front-line treatment.

At stake is how best to treat tens of thousands -- perhaps hundreds of thousands -- of patients with stable chest pain called angina who now undergo the risks and complications of having stents implanted but who might respond just as well or better by taking some pills.

Here's a link to the New York Times article -- In Trial, Drugs Equal Benefits of Artery Stents, by Barnaby J. Feder.

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Results of New Study on Heart Stents Expected This Week

Article in the New York Times -- Test Results Due Out Soon Are Crucial to Stents’ Future, by Barnaby J. Feder.  Here's an excerpt:

Physicians and Wall Street analysts are eagerly awaiting news next week about heart stents that could have big implications for patients and stent makers alike.

At a national cardiology meeting on Tuesday, researchers plan to share the results of a major clinical trial investigating whether heart patients with chronic chest pains actually benefit from getting stents placed in their clogged coronary arteries. Financial analysts say any negative findings could hurt the two companies that dominate the $3.2 billion domestic stent business: Boston Scientific and Johnson & Johnson.

Many Wall Street analysts say they expect the trial to show that while stents improve blood flow by propping open the arteries, the devices do not perform any better than drugs in helping such patients live longer or avoid heart attacks. Some analysts predict that such findings would make cardiologists more cautious about recommending stenting to patients.

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Risk of Blood Clots Leads to Continuing Drop in Use of Drug-Coated Stents

Article in the Wall Street Journal -- Market Share Slips for Drug-Coated Stents, by Keith J. Winstein.  Here's an excerpt:

The market share for drug-coated coronary stents slipped to 70.1% in February, marking the sixth straight month of decline, according to a survey by a market-research firm that surveys U.S. hospitals.

Doctors continued to pare back their usage in favor of plain, bare-metal stents over fears that the drug-coated variety can cause blood clots in some patients.

Last month, doctors in the U.S. used a drug-coated stent in only 72.5% of their procedures, according to Millennium Research Group, a Toronto research firm that surveys 140 U.S. catheterization labs where stenting procedures are typically performed. The share of stent procedures differs from the share of stents used because doctors often implant more than one stent at a time.

The share of procedures that use coated stents was the lowest since the stents were introduced in 2003 and 2004, and down from highs near 90% in early 2006.

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Questions Raised on Implant Recalls

Article in the New York Times -- History of Hernia Patch Raises Questions on Implant Recalls, by Barry Meier.  Here's an excerpt:

How do makers of implanted medical devices react when one of their products starts breaking?

One answer can be found in the case of a hernia repair device made by a subsidiary of C. R. Bard Inc. In late 2005, the company sent out a recall, urging doctors to stop using some versions of the product because a plastic component could break and cut through a patient’s internal organs and tissue.

At the time, Bard executives said they knew about some serious injuries potentially caused by the device, which is known as the Kugel patch. Since then, the Food and Drug Administration has received reports of more than 80 injuries and other problems possibly related to it, including several fatalities.

Bard officials said recently in a statement that they had not recalled the product sooner because complaints about failures were too few and unrelated to raise any alarms. The company also said that both it and the subsidiary, Davol Inc., had reacted responsibly.

But when F.D.A. officials inspected Davol in early 2006, they apparently found other reasons that company officials and the agency might not have been alerted earlier. For example, inspectors reported “discrepancies” and “inconsistencies” in how Davol tracked and analyzed device-related complaints.

And, in several instances, Davol also did not accurately report the possible severity of complaints to the agency, a copy of an inspection report obtained by The New York Times under the Freedom of Information Act shows.

Bard officials, who declined to be interviewed, said in a statement that they have since addressed the agency’s concerns, and agency officials said they are monitoring the company’s progress.

Still, at a time when the use of implanted medical devices is growing sharply, the episode of the hernia patch is an example of what some experts say is a far wider problem: that some major manufacturers, while contending that they carefully monitor product safety, are not as rigorous as they should be.

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