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Friday, October 24, 2008

Ind. Decisions - Federal Judge Hamilton's ruling in a drug-labeling case featured in ABA story

A lengthy feature article in the newly available this morning November issue of the ABA Journal, written by Tery Carter, begins:

In July, a federal judge in the Southern District of Indiana did something unusual on a motion to reconsider a controversial drug-labeling case: He reconsidered it in depth.

In fact, in what some saw as a jaw-dropping decision, U.S. District Judge David F. Hamilton reversed himself.

Ten months earlier Judge Hamilton had summarily dismissed Tucker v. Smith­Kline Beecham Corp., a lawsuit brought by the sister of a Catholic priest who committed suicide 22 days after he began taking the antidepressant drug Paxil. The suit alleged that the drug’s labeling had failed to warn patients and physicians of an increased danger of suicide.

In its defense, Smith­Kline (now GlaxoSmith­Kline) argued that the drug’s labeling was approved by the Food and Drug Ad­minis­tration—and the company could have faced criminal charges had it changed the label­ing to reflect an increased risk of suicide.

The judge said this issue of federal pre-emption had weighed heavily in his earlier decision. The drug company’s need to follow FDA labeling regulations, he had previously believed, outweighed any liability under state laws. Fed­eral rules rule.

But in shifting direction, Judge Hamilton said he had “failed to appreciate” the gritty details of the actual drug labeling process: That when a drug company has reasonable evidence that its product presents a serious hazard, FDA rules allow it to make changes without prior approval.

From early 2006 through Hamilton’s unexpected reversal, drug and medical device companies had been on an unprecedented courthouse roll—even in the wake of well-documented controversies over prescription drugs like Vioxx and Celebrex. Armed with a little-noticed expression of FDA policy, the deep-pocketed defendants found courts—especially federal courts—receptive to the pre-emption of state liability statutes in virtually every corner of the country, including the U.S. Supreme Court.

Here is the 28-page 7/18/08 "Entry on plaintiff's motion to reconsider."

See also this "Drug (and Vaccine) Preemption Scorecard" from the Drug and Device Law blog.

Posted by Marcia Oddi on October 24, 2008 10:15 AM
Posted to Ind Fed D.Ct. Decisions