Wednesday, June 07, 2006

Preemption: Another Read on the Paxil Litigation "Halted"

From, this report:

The widower of a woman who committed suicide after taking a generic version of the anti-depressant drug Paxil may not pursue product liability claims premised on an alleged failure to warn of suicide risks because the Food & Drug Administration strictly controls the content of such warnings and did not demand it at the time, a Pennsylvania federal judge has ruled.

The decision is Colacicco v. Apotex Inc.. Judge Michael M. Baylson found that the Plaintiffs' state law tort claims are pre-empted by the federal Food, Drug & Cosmetic Act.

Judge Baylson ruled that the defendants are entitled to dismissal of all claims against them because the FDA controls the content of warnings and because the Hatch-Waxman amendments to the FDCA explicitly require generic manufacturers to use the same labeling as approved for the drug's innovator.

Because the 3rd U.S. Circuit Court of Appeals has never squarely addressed the question, Baylson asked the FDA to submit an amicus brief.

In response, the FDA's lawyers filed a brief that urged Baylson to rule in favor of the manufacturers and dismiss the suit.

There is an Atlanta connection to this decision - GSK's lawyers include Thomas Bayman, Erica M. Long and S. Samuel Griffin of King & Spalding in Atlanta.

Baylson's ruling addresses the threshold issue of pre-emption, and "whether regulations of a federal agency, promulgated pursuant to a federal statute, and implementing that statute, require the court to dismiss this pharmaceutical products liability suit based on common law tort principles alleging that inadequate labeling of a prescription drug led to the suicide of plaintiff's wife." (See opinion).

Baylson answered "Yes." He did write that he found "many conflicting court decisions on this topic," but that a series of decisions from the U.S. Supreme Court "point this court in the direction of deference, and require dismissal of this case."

Baylson also found that the FDA's view, as expressed in its amicus brief, was "critical to this court's analysis" because U.S. Supreme Court precedent dictates that an agency's interpretation of the statute and regulations it administers is entitled to deference.