Healthy Skepticism Library item: 17329

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Publication type: news

Marek L
7th Circuit Finds Paxil Manufacturer Didn't Meet Burden to Pre-empt
The National Law Journal 2010 02 26
http://www.law.com/jsp/nlj/PubArticleNLJ.jsp?id=1202444598749

Full text:

A lawsuit against SmithKline Beecham Corp. over the suicide of 23-year-old Tricia Mason, who ended her life two days after taking the antidepressant Paxil, can go forward, the 7th Circuit ruled this week.

In a unanimous Tuesday decision reversing the lower court, the appeals court said that the drug manufacturer now known as GlaxoSmithKline didn’t meet its burden of showing with “clear evidence” that the Food and Drug Administration would have rejected a change in the drug’s labeling to warn about the enhanced possibility of suicide in young adults.

The “clear evidence” standard was set last year with the U.S. Supreme Court decision in Wyeth v. Levine. In that case, the high court found that Wyeth also did not meet the burden of showing that a label change would have been rejected by the FDA. The Court let stand a Vermont Supreme Court ruling that upheld a jury verdict against Wyeth over deficient labeling related to the IV push injection of Phenergan. Both cases revolve around the issue of whether compliance with FDA regulations pre-empts state court litigation.

In finding that the drug manufacturer did not meet its burden of clear evidence, the 7th Circuit decision, written by Judge Terence Evans, pointed to the “extensive showing” required by Wyeth v. Levine. “Consequently, the plaintiff’s claims are not preempted.”

Bijan Esfandiari of Baum, Hedlund, Aristei & Goldman in Los Angeles argued for the Mason estate. He called the 7th Circuit ruling “excellent” and noted that it was the first appellate decision to apply the “clear evidence” standard, aside from a short 8th Circuit ruling a few months ago.

“It sets the bar very high for what a manufacturer needs to prove to establish pre-emption,” Esfandiari said. “Pre-emption in prescription drugs is a relic of the past.”

GlaxoSmithKline said in a statement: “We are disappointed and respectfully disagree with the decision.” Daryl Joseffer, a partner with King & Spalding in Washington, D.C., represented the company in oral arguments.

Tricia Mason’s death is not the only suicide to trigger a Paxil lawsuit. With regard to those suits and others related to drug labeling, Wyeth v. Levine reversed an earlier FDA assertion that federally approved drug labeling pre-empted state court lawsuits alleging a failure to warn.