Healthy Skepticism Library item: 14523

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Publication type: news

Mundy A.
In Drug Case, Justices to Weigh Right to Sue
The Wall Street Journal 2008 Oct 27
http://online.wsj.com/article/SB122506300017470355.html

Full text:

For nearly a century, Americans have been able to sue drug companies for deaths or injuries caused by medicines. Now the pharmaceutical industry and other big businesses are hoping the Supreme Court will sharply curb that right.

In a case called Wyeth v. Levine, which the court will hear next week, a Vermont guitarist named Diana Levine lost an arm to gangrene caused by an improperly administered nausea drug. A Vermont jury awarded her $6.7 million in damages from Wyeth, accepting her argument that the drug maker should have put stronger warnings on the label.

In its appeal of the verdict, the drug maker says the drug’s label was approved by the Food and Drug Administration, and it argues the federal regulator’s judgment should trump state law on issues of product safety. Many lawsuits are based on state consumer-safety regulations that often are stronger than federal standards.

“This case is worth tens of billions to the pharmaceutical industry,” said Richard Rubin, Ms. Levine’s lawyer.

The Chamber of Commerce, the nation’s largest business lobby, has called the battle — with some hyperbole — the business case of the century. The Bush administration has long promoted the idea that federal law pre-empts state lawsuits. It has included the notion of pre-emption in regulations for dozens of products, ranging from suntan lotion to seat belts, and has weighed in on Wyeth’s side before the Supreme Court.

The business lobby isn’t hiding its anticipation that the current Supreme Court, one of the most pro-business ones in 50 years, will rule in Wyeth’s favor. In January, the court ruled in favor of pre-emption in a medical-device case involving Medtronic Inc. of Minneapolis.

In another drug case recently heard by the court, Justice Stephen Breyer, part of the court’s liberal wing, strongly supported the FDA’s pre-eminence in determining safety standards.

In a testy burst, Justice Breyer asked the plaintiff’s lawyer whom she would rather have deciding whether a drug would hurt or save people: “an expert agency, on the one hand — or 12 people pulled randomly for a jury role who see before them only the people whom the drug hurt, and don’t see those who need the drug to cure them?”

The details of the Wyeth case give both sides hope. Ms. Levine, who lost her livelihood, and her story are likely to arouse sympathy. She went to a clinic with a migraine and received medicine to stop her accompanying nausea. The injection was carried out incorrectly, and within days her right hand turned black because of gangrene.

Two surgeries later, Ms. Levine lost her arm. The clinic reached a settlement with her. Mr. Rubin said Wyeth offered a settlement of less than $2 million, which Ms. Levine turned down because her medical expenses and expected lost wages were higher.

But Wyeth points out the case doesn’t involve any allegations that the company deliberately sold a drug it knew was dangerous. “We’re the ones who brought [this case] forward,” not the tort bar, said Wyeth’s lead outside lawyer, Bert Rein, referring to the company’s appeal.

Wyeth says it complied with FDA guidelines on how to label the nausea drug. It didn’t strengthen its warning label to comply with stronger Vermont state law.

“The data show that the number of reports of gangrene amputation is infinitesimally small, and the successful administration has occurred in a huge number of patients over the last 50 years,” said Joseph Camardo, head of global medical affairs for Wyeth.

The company argues that it can’t rush to the FDA for talks on changing the label every time an issue arises in one of the 50 states, and it also believes it can’t change the label on its own.

“It would be a chaotic system if you can relabel anything as long as you mumble safety,” said Mr. Rein. But he confirmed he knew of no instances on record in which the FDA had punished a company for amplifying its label warnings.

Ms. Levine’s lawyers say Congress never intended to stop drug makers from proactively toughening warnings to doctors and consumers. They say FDA guidelines are the floor, not the ceiling, when it comes to safety standards.

The Chamber of Commerce, which has underwritten a multimillion-dollar lobbying campaign supporting pre-emption, has said the outcome of Wyeth v. Levine could affect many questions — for example, whether states could set their own standards on the environment and vehicles’ fuel efficiency. Liability suits involving products such as cars would be more directly affected.

The most immediate impact of a ruling would fall on the drug industry. While details differ, pre-emption would have given drug makers a stronger position in many lawsuits in recent years that involved drugs used in accordance with FDA-approved labels.

Johnson & Johnson just paid $68 million to settle cases involving its Ortho Evra contraceptive patch. Settlements over the anti-psychotic drug Zyprexa have cost Eli Lilly & Co. more than $1 billion. Merck & Co.‘s Vioxx litigation has cost it $4 billion so far, and the price tag for Wyeth’s fen-phen-related diet pills has reached $20 billion.

Consumer groups cite such cases in arguing that the FDA makes mistakes and companies hide information. They say patients’ right to sue — in state court if necessary — is the only deterrent to corporate misbehavior. The New England Journal of Medicine has published an editorial in Ms. Levine’s favor making these points.

Mr. Rein, the Wyeth attorney, acknowledged that victims would have a harder time getting compensated for medical costs and lost wages if the Supreme Court rules in Wyeth’s favor. He said Congress should consider establishing a fund to help such victims, as it has for vaccine-related injuries.

However, Congress may have other ideas. If it swings heavily Democratic in this year’s elections, which take place the day after the court hears the Wyeth case, some Democrats say they will push forward bills to undo pre-emption and guarantee the right to sue for damages.

Ms. Levine says she was stunned when the FDA joined in the case against her and when the Justice Department’s solicitor general filed a brief.

Her daughter, Jessamine, is also a musician and wrote a ballad called “Mr. Solicitor General,” which included the lyrics: “What you’re dealing with isn’t just statistics — this is real, son.”

Write to Alicia Mundy at alicia.mundy@wsj.com