Yesterday, Judge John Fullam (Eastern District of Pennsylvania) denied Wyeth’s preemption-based summary judgment motion in a number of Effexor SSRI suicide cases. See Baumgardner v. Wyeth Pharm., Case No. 2:05-cv-05720-JF (Aug. 31, 2010). The opinion is short, which we suppose is a blessing in disguise, because at least the court didn’t take this opportunity to comment at length about the vitality (or lack thereof) of the preemption defense in post-Levine SSRI suicide cases. That’s about the only good news in this opinion. In short order, the court concluded that the plaintiffs’ failure to warn claims were not preempted, because Wyeth had not presented “clear evidence” supporting its defense. Slip Op. at 2 (quoting Levine).
The plaintiffs claimed that Effexor’s warning was inadequate because it failed to warn of the danger that “those taking the drug might try to harm themselves or others.” Id. at 1-2. What evidence did Wyeth offer to establish preemption? First, Wyeth provided evidence that the FDA had rejected three citizens’ petitions that sought the removal of antidepressants (including Effexor) from the market or otherwise sought a revised, “strengthened” suicidality warning. Id. at 2-3. The FDA’s Psychopharmacological Drugs Advisory Committee had also concluded that “the connection between antidepressants and suicide was not scientifically supportable.” Id. at 3. The court found that none of this was sufficiently “clear evidence” that the FDA would have rejected additional warnings had Wyeth proposed them. See id. at 3 (characterizing Wyeth’s argument as an impermissible “attempt[] to, in effect, shift the responsibility for its labeling decisions onto the FDA”).
More important, Wyeth presented evidence that it had proposed a change to Effexor’s pediatric label in 2003. That proposed label change warned of increased hostility and suicidality, but it was not adopted by the FDA. Id. at 3-4. The court disagreed with Wyeth’s interpretation of Effexor’s labeling history, concluding, “the FDA did not reject the defendant’s proposed labeling change, but let the defendant’s then-existing label stand until early 2004 when the FDA decided to issue a different, and arguably more comprehensive warning to Effexor users and their families and prescribers of the drug.” Id. at 3-4.
We’ll be frank: the court’s interpretation of the labeling history, as well as its handling of the regulatory history of Effexor generally, is not good news for the preemption defense.