Paxil and preemption: last stand of a defense argument By Sylvia Hsieh Staff writer Published: September 25, 2009 Federal preemption - a favored defense argument to defeat state tort suits - has been on life support since the U.S. Supreme Court decided Wyeth v. Levine six months ago. Now, a trilogy of cases in the federal courts of appeals will either resuscitate the argument in certain pharmaceutical cases, or put the final nail in the coffin. These cases will decide whether the makers of popular antidepressants like Paxil and Effexor can be sued in state court for failure to warn about the risk of suicide, or whether those claims are preempted by the federal regulatory scheme. In case after case, defense lawyers have withdrawn their preemption argument in drug products liability cases in light of the Supreme Court’s holding that a state failure-to-warn claim did not conflict with the FDA because the manufacturer could have strengthened its label without FDA approval. But there is one exception: defense attorneys continue to pursue preemption in a line of cases alleging that antidepressants in the class of SSRIs (selective serotonin reuptake inhibitors) cause suicide. “The big battle is in SSRI antidepressant cases,” said Jim Beck, a defense attorney with Dechert LLP in Philadelphia who co-authors a drug and device law blog . “If they can’t get preemption there, they won’t get it anywhere.” The first of the three cases, Mason v. GlaxoSmithKline , will be argued on October 5 before the 7th Circuit. The two others, Dobbs v. Wyeth and Miller v. GlaxoSmithKline , have been briefed for the 10th Circuit and will be argued in November at the earliest. Long paper trail In the first major test of the scope of Wyeth , these cases will clarify how much FDA scrutiny is enough to create conflict-preemption. Defense lawyers say the extensive FDA record in these cases is on their side. Mark Herrmann, a partner with Jones Day in Chicago, represents Wyeth Pharmaceuticals in one of the pending 10th Circuit cases brought by the wife of a 53 year-old Oklahoma man who committed suicide after he was prescribed Effexor in 2002. Herrmann will argue that the FDA has monitored and assessed antidepressants and their links to suicide since the 1990s, including rejecting three citizen petitions to add a black box warning. “SSRIs are the perfect example of where the FDA was dictating exactly the terms of labeling. … You will not find a stronger case of the FDA looking at an issue than with SSRIs and suicidality,” he said. Under Wyeth , he contends, a defendant need only show that the FDA would have rejected a warning label, not that it actually rejected a warning the manufacturer proposed. “There’s no obligation for a manufacturer to say to the FDA, ‘Please slap me. I want to do something I know you will say no to,’” said Herrmann. But plaintiffs’ lawyers say Wyeth requires more than a hypothetical. Derek Braslow of Pogust & Braslow in Conshohocken, Pa., argues that Wyeth requires “clear evidence” that the FDA would have rejected a warning. “Clear evidence to me is the drug manufacturer asking for a strengthened warning and the FDA saying ‘No, that warning isn’t valid.’ Anything less than that would not be considered clear evidence of a rejection,” he said. David C. Frederick, a partner with Kellogg, Huber, Hansen, Todd, Evans & Figel in Washington, D.C. who represented the plaintiff in Wyeth v. Levine , suggested that the preemption defense requires a “far more precise” argument than what defendants have argued in the SSRI cases. “The FDA did not consider and reject the warning that would have made those drugs safe,” he said. The pending 7th Circuit case was brought by the family of a 23 year-old college student who committed suicide after taking Paxil. Their attorney, Bijan Esfandiari of Baum Hedlund Aristei & Goldman in Los Angeles, will argue that warning letters GlaxoSmithKline sent to doctors in 2006 for patients of all age groups proves that the FDA did not reject additional warnings. Mark Brown, a partner with King Spalding in Washington, D.C., who represents GlaxoSmithKline, did not get approval from the company to comment for this article. More cases A number of rulings by trial courts have rejected the preemption defense in antidepressant-suicide cases since Wyeth, and dozens more are pending. This could be a bad sign for the future of the preemption doctrine, or it could mean that trial courts are skittish after Wyeth and there is still room for the law to be shaped in the appeals courts. One early federal appeals court case that addressed preemption in the SSRI arena pre-Wyeth was Colicicco v. Apotex Inc. In Colicicco , the 3rd Circuit dismissed failure-to-warn claims against the drug makers based on federal preemption. A petition for certiorari was filed with the Supreme Court, but the case was remanded to the 3rd Circuit after Wyeth . The 3rd Circuit in turn remanded the case to the U.S. District Court. Colicicco will test another preemption argument, namely whether generic drug manufacturers are bound by the warning labels of brand drug makers or whether they can make label changes in light of federal requirements that generic drug labels be the “same” as brand labels. The case is now in “preemption discovery” mode in anticipation of a defense motion raising a preemption defense, said Braslow, who represents the plaintiff. Questions or comments can be directed to the writer at: sylvia.hsieh@lawyersusaonline.com Close this Window Bookmark and Share This Page Save to Browser Favorites / Bookmarks Email This to a Friend Copy HTML: If you like this then please subscribe to the RSS Feed. More » © Copyright 2009 Lawyers USA. All Rights Reserved.