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?”
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.
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.
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
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pill, Rezulin, which has since been withdrawn from the market.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
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
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?”
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.
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.
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