Pliva, Inc. v. Mensing: Consumers lose right to pursue justice for injury caused by generics

Here's a communication I received as a member of the Leaders Forum for the American Association for Justice.

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Dear Colleagues,

As a Leaders Forum member, you are among the first to receive the latest update on the work of the Center for Constitutional Litigation.

In this last year since the Supreme Court of the United States ruled in Pliva, Inc. v. Mensing, the Center for Constitutional Litigation has worked on a number of cases that challenge the reach of that decision. As you know, in Mensing, the court ruled 5-4 that in most cases generic drug makers cannot be sued for failure to warn. The Court held that it was impossible for the generic manufacturers to comply with federal law—which requires generic labels to match brand-name labels—and state law—which may require a stronger warning.

In particular, among other issues, CCL is arguing that “impossibility preemption” does not apply to design defect cases. At this point, among the courts, there is a difference in opinion.

Thank you for your dedication and support of AAJ as a member of Leaders Forum.

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Mensing Does Not Preempt…

In the case of Bartlett v. Mutual Pharm. Co., Inc., the U.S. Court of Appeals for the First Circuit ruled that the Supreme Court’s decision in Mensing did not preempt state law design defect claims against the generic drug manufacturer.

In this case, CCL worked with the New Hampshire Association for Justice and filed an amicus brief in support of the plaintiff who used a drug called sulindac, which blinded her and caused much of her skin to burn off. The doctor had prescribed the brand name version of this non-steroidal anti-inflammatory drug, but the pharmacy dispensed the generic form, sulindac.

At trial, the district court told the jury that in order to find for the plaintiff, it must find that “sulindac’s design was in a defective condition unreasonably dangerous to consumers.” The jury decided in favor of the plaintiff and awarded her $21 million.

In his opinion for the court, Judge Michael Boudin wrote that, “…it is up to the Supreme Court to decide whether [Mensing’s] exception is to be enlarged to include design defect claims. Given the widespread use of generic drugs and the developing split in the lower courts…this issue needs a decisive answer from the only court that can supply it.”

Mensing Does Preempt…

One of the courts that concluded differently is the U.S. District Court, Eastern District of Kentucky. In a joint motion to dismiss filed by multiple defendants in In re: Darvocet, Darvon and Propoxyphene Products Liability Litigation, Judge Danny C. Reeves ruled that the Mensing decision applies to design defect and failure-to-warn claims.

One of the most compelling arguments for preserving these cases is that the clients took a generic form (propoxyphene) of Darvon/Darvocet which has been pulled off the market. The removal of the drug from the market bolsters the design defect argument that the drug’s risks outweighed its limited benefits.

CCL Senior Litigation Counsel, Lou Bograd, will handle the appeal of this ruling to the Sixth Circuit. Briefing in the Court of Appeals is scheduled to begin in August.

Critics blast feds' legal shields for manufacturers

On June 29, 2008, the Chicago Tribune published an article recapping Bridget Robb's horrific tale of being shocked 31 times in 13 minutes due to a faulty, Medtronic Sprint Fidelis Lead. The article is one of many discussing how injured people, like Ms. Robb, are many times are precluded from recovering for their injuries due to a legal doctrine called "preemption." In effect, injured individuals are precluded from recovering against a company for defects in a product's design and labeling.

Proponents of preemption argue that manufacturers are not insurers and the FDA always has the option of holding a product from the market. During the June 11, 2008 Senate Judiciary Committee hearing at which Ms. Robb testified, Senator Specter called the FDA a joke and said that it is ludicrous to have preemption by an agency that is dysfunctional.

Before the hearing abruptly came to a halt because of a 2-hour rule invoked by a certain Republican Senator, Senator Whitehouse discussed "Regulatory Capture" -- which is when an agency that purports to be a public agency is taken over by the groups it was meant to regulate. Senator Whitehouse believes that the FDA falls within this definition.

BRIDGET ROBB TESTIFIES BEFORE THE SENATE JUDICIARY COMMITTEE ABOUT INJURIES FROM DEFECTIVE MEDTRONIC SPRINT FIDELIS LEAD

On June 11, 2008, I had the pleasure of accompanying Bridget Robb, one of my clients, to Washington, D.C. to testify before the Senate Judiciary Committee, at a hearing entitled “Short-change for Consumers and Short-Shrift for Congress? The Supreme Court’s Treatment of Laws that Protect Americans’ Health, Safety, Jobs and Retirement.” Senator Patrick Leahy (D, Vt.) presided over the hearing. Witness testimony and the live hearing can be viewed at http://judiciary.senate.gov/hearing.cfm?id=3404

Ms. Robb courageously spoke about her harrowing experience with a Medtronic Sprint Fidelis lead in late 2007. Ms. Robb was shocked 31 times due to the defective cardiac lead, which had been recalled two months before her tragic incident. She never received notice of the recall. She described each shock as “if a cannon was being repeatedly shot at [her] chest at close range.” The event was made all the more terrible because our client’s telephone call to 911 was captured on tape, and the pain and agony of the numerous shocks is evident throughout the 7-minute call, which took place in the presence of her young child. Her experience was featured in a Good Morning America segment that ran on Wednesday morning before the hearing, which can also be viewed on the web at http://abcnews.go.com/GMA/OnCall/story?id=5044693&page=1

The hearing focused on how several recent decisions by the U.S. Supreme Court affected consumers’ health and safety, including preemption and ERISA.

Senator Leahy stated that he “called this hearing today to shine a light on how the Supreme Court’s decisions affect Americans’ everyday lives. Often, the Court’s rulings come into focus when they involve divisive cultural issues. Lately, however, many Court observers have noticed that business interests have been the big winners, over workers and consumers. In this worsening economy, mothers and fathers are struggling with health care coverage, the uncertainty of retirement, credit card payments and mortgages. Congress has passed laws to protect Americans in these areas, but in many cases, the Supreme Court has ignored the intent of Congress in passing these measures, oftentimes turning these laws on their heads, and making them protections for big business rather than for ordinary citizens.” During the hearing, Sen. Arlen Specter (R., Pa.) also spoke out forcefully on the failings of the FDA, calling the FDA "a joke."

Also testifying was Maureen Kurtek, a Harrisburg, Pennsylvania, resident, who offered personal testimony about how a recent ruling by the Supreme Court relating to ERISA preemption limited her right as a consumer to seek recovery for harmful practices by an HMO. Other witnesses include Andy Anderson, a lawyer with the law firm of Morgan, Lewis & Bockius LLP; Thomas O. McGarity, a law professor at the University of Texas School of Law; Richard M. Cooper, a partner with the law firm of Williams & Connolly LLP; and Robert Lawless, a law professor at the University of Illinois College of Law.

This hearing helped shed light on the profound effect that the failures of the Food & Drug Administration have on consumers, like Ms. Robb.

I am happy to answer any questions regarding the hearing or the recalled Medtronic Sprint Fidelis lead. Please contact me at (215) 790-7379 with any questions or to discuss your potential case. It is important that the horrible tragedy Ms. Robb experienced does not happen to others.

Riegel v. Medtronic -- Have You Lost the Right to Sue?

We represent multiple clients who have experienced unnecessary shocking due to Medtronic's faulty lead. One client, in particular, was shocked over thirty times.

What is more frightening is the fact that the Supreme Court recently held oral argument on whether federally approved medical devices are broadly shielded from product-liability lawsuits. If the Supreme Court agrees with this big business position, many people who are injured due to faulty medical devices will be left with no recourse. It seems that big business has bought the FDA since it recently admitted that it cannot keep up with advances in science! The report, from a subcommittee of the FDA's outside Science Board that included members and advisers from industry as well as academia, said the agency "cannot even keep up with the advances in science." An appendix to the report said the FDA conducted twice as many inspections of food facilities in 1973 as it did of all facilities -- including food, drugs and medical devices -- in 2006.

In Riegel v. Medtronic. The Riegel case was brought by a New York man, Charles Riegel, who was injured when a Medtronic catheter burst during a 1996 angioplasty procedure. Riegel, who died in 2004, asserted the catheter had design flaws and that labeling instructions for the device were misleading.

Allison Zieve, a Washington-based attorney representing Riegel, labored to convince the justices that federal law allowed Riegel to sue Medtronic over the device, which had received so-called premarket approval from the Food and Drug Administration.

"It is clear that Congress didn't want any additional requirements", Justice Antonin Scalia said, indicating he thinks Congress wanted the FDA to regulate medical devices without interference from state regulators or courts.

A majority of the Supreme Court appeared to support this view.

The BIGGER QUESTIONS - if the FDA has admitted that it can't protect the people and companies can avoid liability by having its products FDA-approved, what protections are afforded to the users of these products? What incentives do medical device companies have to protect the end user?

February 7, 2008 12:25 PM