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Torts and Personal Injury Law Center
Current Focus: Federal Preemption in Drug and Device Cases
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Emerging Drugs & Devices
5/8/2009 5:02:03 PM EST
Tom Moylan
Uncle Sam Takes A Powder On Drug Preemption
Posted by Tom Moylan
LexisNexis Torts Law Center Staff

The FDA served notice last month that it will no longer hold the drug industry’s coat during the drug preemption fight.

What a difference five months — and a new administration — makes. In November, during the waning days of the George W. Bush administration, the U.S. Solicitor General stood before the Supreme Court and argued in favor of preemption. On March 4, on a surprising 6-3 vote, the court rejected preemption in the case of Diana Levine.

Along with preserving Levine’s $6.7 million verdict, the high court ruling had a domino effect on three other cases involving drug preemption. Days after, the high court vacated preemption rulings in three cases and sent them back to the Third Circuit. Would the Third Circuit re-hear arguments or send the case down? It asked for briefs on Levine and the results were predictable: the plaintiffs said their claims aren’t preempted, the defendants said they still are.

Then the U.S. Justice Department weighed in through a letter, rather than a brief: the federal government was no longer taking a position in the case. And it was withdrawing amicus briefs that were submitted in support the Levine drug defendants. If there was any doubt there was a new sheriff in town, that letter extinguished it. The feds aren’t going to take sides, at least in this fight.

The letter didn’t shut the door on preemption of drug claims, but it made it clear that the FDA and the U.S. wasn’t going to get in the ring as it had for the past four years.

What a change from 2003, when then-FDA Chief Counsel Daniel Troy invited attendees at the Defense Research Institute Drug and Device annual meeting to send amicus briefs along to him, if they cared to. And how the industry responded! The U.S. strategically submitted briefs in drug liability cases, and when it couldn’t write a fresh one, it submitted ones from other cases. The FDA topped it off with the Preamble to the Final Rule, the so-called preemption rule, which was written into the final version of long-pending drug labeling regulation. The Preamble got well-worn in various courtrooms in its three-year lifespan.

But while the Supreme Court’s Levine ruling may have left the door open to preemption of some drug claims, the Preamble took one between the eyes: the majority noted that the rule wasn’t opened for comments and that it wasn’t authorized by Congress.

Drug preemption as an issue lives: plaintiffs and defendants are already arguing over Levine’s applicability. The Supreme Court majority didn’t close the door, and the defendants are already putting their shoulders into it And if history is any guide, that could take another 10 years to get a consensus — or another Supreme Court ruling … by another Supreme Court … under another administration. But for now, it’ll only be plaintiffs and defendants only in the ring; Uncle Sam’s sitting this one out.

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