Two rulings within the past 24 hours should have attorneys representing prescription drug makers popping open something cold whether it be some champagne or a cola-cicco.
Sorry for the cheesy pun, but I couldn’t resist.
Late yesterday, a federal judge in a Paxil suicide case awarded GlaxoSmithKline (GSK) summary judgment based on the Third Circuit U.S. Court of Appeals’ ruling in Colacicco v. Apotex (2008 U.S. App. LEXIS 7463 [3rd Cir.]). Judge Michael M. Mihm of the Central District of Illinois wrote that even though the Seventh Circuit has yet to determine if Paxil suicide warning claims are preempted, the ruling in Colacicco was so “persuasive and compelling” that the Seventh Circuit would undoubtedly issue come to the same conclusion. Essentially, Judge Mihm agreed with every aspect of the Colacicco majority’s findings regarding the presumption against preemption, the level of deference the Food and Drug Administration’s view on preemption should be given and that there was insufficient evidence at the time of the decedent’s March 2003 suicide to support the addition of a stronger warning.
While Judge Mihm acknowledged that his ruling left William and Bonnie Mason without any legal remedy and that their daughter’s death was tragic, he so kindly explained that “not all tragedies have legal remedies, and the Court cannot ignore the law in order to achieve a more compassionate result.”
Ouch!
The case was Mason v. SmithKline Beecham Corp., No. 05-1252, C.D. Ill.)
The other ruling making defense attorneys’ day came out of the Fifth Circuit, which upheld a district judge’s finding that a widow’s claims against Wyeth were barred by the learned intermediary doctrine (Rozlyn Ackermann v. Wyeth, No. 06-41774 [5th Cir.]). Rozlyn Ackermann argued that Wyeth should have included a stronger warning about the risk of suicide in 2002, when her husband committed suicide and that the prescribing physician’s testimony about how he would have responded to a stronger warning was conflicting.
The panel rejected her claims, explaining that the 2002 Effexor label twice referred to the risk of suicide and that the physician maintained that his decision to prescribe Effexor would not have changed because he bases his decisions on his experience and the risks and benefits of the specific drug.
Full stories about these rulings will appear in Mealey’s Litigation Report: Antidepressant Drugs.