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Editor: Robert Binstock
Profession: Paxil Side Effect Attorney

Category: Paxil Suicide

This week the 3rd U.S. Circuit Court of Appeals heard arguments that could play an pivotal role in the future of product liability litigation. The cases against GlaxoSmithKline (GSK), the makers of the antidepressant Paxil, and Apotex, the makers of the generic version of the same drug, have been seen in opposite lights by two previous lower court judges. Both cases involve suicide warnings or lack thereof for these powerful antidepressants.The issue here is whether plaintiffs' lawsuits against these companies can be pre-empted due to approved labeling by the FDA.

One side argues that the since the FDA has never required a suicide warning and has explicitly decided not to include this warning that cases stemming from the alleged mislabeling must be pre-empted. The reasoning is that the FDA is responsible for regulating prescription drugs and the labeling of those drugs; a power granted to them by Congress, therefore letting the manufacturers off the hook if the FDA has approved the label.

The other side of the argument places the blame squarely on the shoulders of the drug makers, claiming that drug makers are empowered by the FDA to enhance warnings as new dangers are discovered. If this is the case then lawsuits against manufacturers like GSK and Apotex should not be pre-empted.

In nearly two hours of oral argument on Monday, the three-judge panel appeared inclined to rule in favor of the drug manufacturers on the grounds that the FDA has explicitly rejected the plaintiffs' proposed warnings for Paxil, Zoloft and Prozac -- antidepressant drugs known as "selective serotonin re-uptake inhibitors," or SSRIs.

Plaintiffs' attorneys have made every effort possible to convince the panel to decide in their favor and I believe it is important to point out that in the past drug product liability lawsuits have not been pre-empted. Which ever way the panel decides on this issue, it will extremely large repercussions throughout the legal field and set a president for the future of prescription drug litigation.