Healthy Skepticism Library item: 13354

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Publication type: news

Harris G.
Court Considers Protecting Drug Makers From Lawsuits
New York Times 2008 Feb 26
http://www.nytimes.com/2008/02/26/washington/26drug.html?ex=1361682000&en=754f1b0bee6c11b6&ei=5088&partner=rssnyt&emc=rss

Full text:

WASHINGTON – Less than a week after issuing a sweeping ruling that bars most lawsuits against medical device makers, the Supreme Court heard arguments Monday in the first of two cases that could determine whether drug makers receive similar protection.

Justice Stephen G. Breyer said the fundamental question in the cases was who should make the decisions that will determine whether a drug is “on balance, going to save people or, on balance, going to hurt 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?” Justice Breyer asked.

Normally a member of the court’s liberal wing, Justice Breyer came down squarely on the industry’s side when he answered his own question, saying Congress left the role of policing the medicine market exclusively to the Food and Drug Administration.

“What worries me is, what happens if the jury is wrong?” he said.

If the justice’s view prevails, most lawsuits against drug makers, thousands of which have been filed in recent years and settled in some cases for billions of dollars, would be barred. But the Supreme Court is likely to wait until next year to answer Justice Breyer’s question completely.

That is because the question before the court Monday in Warner-Lambert v. Kent was in part restricted to the effects of a Michigan statute that bars personal injury suits against drug makers unless injured patients can show that the company deliberately withheld information from the F.D.A. that would have led the government to block the medicine from being sold.

The case was brought by 27 Michigan plaintiffs who claim they were injured as a result of taking a Warner-Lambert diabetes pill, Rezulin, which has since been withdrawn from the market. The plaintiffs claim the company withheld from the F.D.A. evidence of Rezulin’s dangers to the liver that would have led the agency to deny an approval.

But in a 2001 case involving the Buckman Company, the Supreme Court held that plaintiffs cannot sue based upon claims that a manufacturer defrauded the F.D.A.

Many of the arguments Monday concerned whether the court should strike down all of the Michigan statute or just the part allowing an exception for claims of fraud.

In October, the court will hear arguments in Levine v. Wyeth, a pharmaceutical case with no such state complications. In the Levine case, the court is being asked to decide whether F.D.A. approval bars personal injury lawsuits – the same question it decided in device makers’ favor last week.

Before the Bush administration, the F.D.A. argued that lawsuits provided patients with additional protection. Now, the administration says the lawsuits largely conflict with the agency’s ability to do its job, and several of the justices seemed to agree.

Justice Samuel A. Alito Jr. asked the lawyer for the Michigan patients to explain why their lawsuit should go forward given that it might “very seriously interfere with what the F.D.A. is doing?”

Justice Anthony M. Kennedy asked whether the patients intended to argue whether Rezulin “should not have been on the market?”

Even Justice Ruth Bader Ginsburg, the lone dissenter in the case decided last week that gave medical device makers broad protection against lawsuits, asked whether certain claims in the suit against Warner-Lambert, now Pfizer, “are the kind of thing that the F.D.A. would want to police itself and not have state courts look into?”

Allison M. Zieve, the lawyer for the plaintiffs, pointed out that lawsuits against drug makers are still allowed in every state, pending the court’s decision next year.

Carter G. Phillips, who represented Pfizer, said the Buckman case and the Michigan statutes allowed lawsuits to be filed against drug makers in Michigan only if the F.D.A. itself concluded that a company had committed fraud. Such a determination by the F.D.A. is exceptionally rare.

The government argues that the F.D.A. competently oversees the drug and device markets, and should not be second-guessed by courts. But the Institute of Medicine, the Government Accountability Office and the F.D.A.‘s own science board have all issued reports saying poor management and scientific inadequacies make the agency incapable of protecting the country against unsafe drugs, medical devices and food.