Healthy Skepticism Library item: 13106

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Publication type: news

Fisher D.
Product Liability Preemption Pullback
Forbes 2008 Mar 3
http://www.forbes.com/2008/03/03/scotus-fda-torts-biz-healthcare-cz_df_0303s

Full text:

After delivering medical-device manufacturers an unqualified victory against
tort lawyers last month, the U.S. Supreme Court pulled back when it came to
lawsuits over Warner-Lambert’s anti-diabetes drug Rezulin.

In a 4-4 tie, the court refused to overturn a decision by a New York federal
appeals court allowing Rezulin cases to proceed under a law that requires
plaintiffs to first prove the company misled the Food and Drug
Administration. Chief Justice John Roberts abstained because of stock
investments in Warner-Lambert.

The Supreme Court’s non-decision, entered without comment, halts what some
thought was gathering momentum in favor of so-called “preemption,” a legal
concept that bars traditional tort-law suits over drugs and devices that
have been approved by the FDA.

The court applied this doctrine to medical devices last month in a case
called Medtronic v. Riegel, involving an FDA-approved balloon catheter that
popped after the physician inflated it past its recommended pressure. But in
that case federal law specifically precluded such lawsuits; with the Rezulin
suits, Warner-Lambert could only argue that public policy favored allowing
the FDA to do its job without conflicting verdicts from juries applying
state tort law.

“A lot of people were thinking about busting out the champagne after Riegel,
but this is going to be a long process,” said James Beck, a lawyer of
counsel with Dechert LLC who co-authors the Drug and Device Law Blog.

The court’s unwillingness to offer blanket protection against tort suits
might bode poorly for another closely watched case scheduled to be argued
this fall, Wyeth v. Levine. In that case, Wyeth is trying to overturn a $6.8
million Vermont ruling on behalf of a woman who lost part of her arm after
being injected with the anti-nausea drug Phenargan. The drug had at least
three warnings against injecting the drug into an artery, but the plaintiffs
argued the FDA-approved label didn’t go far enough.

The Rezulin litigation has a confused history. Plaintiffs sued after the
drug was found to cause liver damage and Warner-Lambert removed it from the
market in 2000. Michigan, where the drug company is based, passed a law
prohibiting traditional tort suits over FDA-approved drugs unless the
plaintiffs can show the company misled the agency during the approval
process.

Subsequent to that, the Supreme Court appeared to ban such “fraud-on-the-FDA
suits,” saying the states had no business second-guessing federal decisions.
A federal appeals court in Michigan used the decision to throw out some
Rezulin cases, but then the New York appeals court came to the opposite
conclusion over another collection of suits.

The 4-4 tie probably reflects the court’s unwillingness to eliminate any
possibility of traditional tort suits over FDA-approved drugs, Beck said. If
it had eliminated the fraud-on-the-FDA exception in the Michigan law, “this
is a case where there would be no possibility of a claim, and I think the
court had trouble with that,” he said.

But the 4-4 split leaves the law unsettled. Plaintiff lawyers will likely
jockey to get their cases into the Second Circuit, based in New York, and
avoid the Sixth Circuit, based in Michigan, Beck said. Meanwhile drug
companies will reassess their chances of winning the long-sought protection
in Wyeth v. Levine.