Mass Tort Litigation Blog

The Hon. Sam C. Pointer, Jr. (1934-2008)

Judge Sam Pointer passed away on March 15.  In his thirty years as a federal judge in Alabama, he made his mark in both civil rights and complex litigation.  Readers of this blog may know him best for his work as the MDL judge in the silicone gel breast implant litigation.  In that litigation, he took the path-breaking step of appointing a national science panel of court-appointed experts to weigh in on the question of medical causation.  Judge Pointer served as chair of the Advisory Committee on Civil Rules, and was a major author of the Manual for Complex Litigation.  Here's the Washington Post obituary and an announcement from Lightfoot, Franklin & White, where Judge Pointer practiced after he left the bench in 2000.

HME

FDA Proposes Guidelines for Drug-Coated Stents

Article in the Wall Street Journal -- FDA Proposes Stent Guidelines, by Jennifer Levitz.  Here's an excerpt:

The Food and Drug Administration proposed tougher clinical-trial guidelines for drug-coated stents in response to concerns about blood clotting in the artery-opening devices long after implantation.

The move is 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. Coated stents don't appear to increase deaths or blood clots overall; whether they increase late clots years after implantation is still debated.

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 new draft guidelines appear to codify standards that the FDA used to assess trials for new stents from Medtronic Inc. and Abbott Laboratories.

BGS

AEI Panel on Federal Preemption and the Supreme Court

The American Enterprise Institute has posted the audio and video for its panel presentation on February 21 on Federal Preemption and the Supreme Court.  AEI's Ted Frank moderated the panel, which included Michael Greve (AEI), Catherine Sharkey (NYU), Daniel Troy (Sidley Austin), and Brian Wolfman (Public Citizen).

BGS

Nagareda on Preemption in Riegel

Professor Richard Nagareda (Vanderbilt) comments in a Federalist Society SCOTUScast on the recent U.S. Supreme Court preemption decision in Riegel v. Medtronic. 

BGS

Supreme Court Embraces Medical Device Preemption

The Supreme Court today decided Riegel v. Medtronic, an important case concerning federal preemption of state law product liability claims.  Justice Scalia wrote for the 8-1 majority in favor of preemption, reasoning that experts at the FDA are better positioned than jurors to evaluate the risks and benefits of medical devices.  Justice Ginsburg dissented.  Here's a copy of the opinion on Findlaw.  And here's an excerpt from David Stout's story in the New York Times, Justices Make It Tougher to Sue Medical Device Makers:

In a case with huge implications for the health care-technology industry, the Supreme Court ruled on Wednesday that the manufacturer of a federally approved medical device cannot be sued under state law if the device causes an injury.

The 8-to-1 ruling in favor of Medtronic, the Minneapolis-based maker of cardiovascular devices, made it much more difficult for patients and their families to sue makers of medical devices that have been granted federal approval. ...

The Supreme Court upheld the lower federal courts on Wednesday, with Justice Antonin Scalia writing for the majority that Medtronic and other manufacturers were protected under the Medical Device Amendments of 1976, which in its section on pre-emption bars states from imposing on medical devices “any requirement which is different from, or in addition to, any requirement applicable under this chapter.”

But the justices’ ruling was hardly the last word on when F.D.A. approval bars patients from suing. They are already considering at least three cases involving drugs and drug-labeling.

HME

Supreme Court Grants Cert in Two Preemption Cases

The Supreme Court today granted cert in two preemption cases that will have significance for mass tort litigation.  In Wyeth v. Levine, No. 06-1249, the Court will decide whether the FDA's prescription drug labeling judgments preempt state law liability claims for failure to warn.  In a case involving Wyeth's anti-nausea drug Phenergan, the Vermont Supreme Court ruled that the FDA regs only provide a floor on labeling requirements, so states are free to enforce their own.  In Itria Group v. Good, No. 07-562, the Court is asked to decide whether federal law preempts state-law challenges to FTC-authorized statements in cigarette advertising about "light" or "low tar" cigarettes. 

You can see brief descriptions of these cases on ScotusBlog.  I'm sure more will follow from the defense perspective on the Drug and Device Law blog.  Public Citizen is a good resource for the consumer's perspective on this issue.

ADL

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.

BGS

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.

BGS

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.

BGS

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.

BGS

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.

BGS

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?"

HME

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.

BGS

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.

BGS

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.

BGS

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.

BGS

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.

BGS

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.

BGS

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.

BGS