[Ip-health] US: Court Considers Protecting Drug Makers From Lawsuits

[Riaz K Tayob]

US: Court Considers Protecting Drug Makers From Lawsuits


by GARDINER HARRIS, The New York Times
February 26th, 2008

WASHINGTON =97 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 =93on
balance, going to save people or, on balance, going to hurt people?=94

=93An 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=92t see those who need the drug to cure them?=94 Justice Breyer asked.

Normally a member of the court=92s liberal wing, Justice Breyer came down
squarely on the industry=92s side when he answered his own question,
saying Congress left the role of policing the medicine market
exclusively to the Food and Drug Administration.

=93What worries me is, what happens if the jury is wrong?=94 he said.

If the justice=92s 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=92s 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which has since been withdrawn from the market.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=92s 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 =97 the same question it decided in device
makers=92 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=92s 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 =93very
seriously interfere with what the F.D.A. is doing?=94

Justice Anthony M. Kennedy asked whether the patients intended to argue
whether Rezulin =93should not have been on the market?=94

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, =93are the kind of thing that the F.D.A. would
want to police itself and not have state courts look into?=94

Allison M. Zieve, the lawyer for the plaintiffs, pointed out that
lawsuits against drug makers are still allowed in every state, pending
the court=92s 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.=92s 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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