04/09/2008 - National Legal News

The 3rd U.S. Circuit Court of Appeals ruled Monday that the manufacturers of the antidepressants Paxil® and Zoloft® cannot be sued for their failure to warn consumers of the risk of suicide their drugs allegedly posed.

The 2-1 vote in a pair of cases reversed rulings handed out in lower courts and supported arguments made by drug makers who claim that because the U.S. Food and Drug Administration has not explicitly ordered such warnings, they cannot be held liable for suicides alleged to be connected to the use of their drugs.

In the ruling, Judge Dolores K. Slover, on behalf of the majority, wrote that the need for warnings was “without scientific basis” and that demanding such warnings would “therefore be false and misleading.”

The justices reiterated that their decision was limited to circumstances in which the FDA determined the need for a warning did not exist and which plaintiffs argued state law necessitated.

Lawyers for the plaintiffs argued that lawsuits represented a crucial check against the poorly funded FDA and provided injured victims with a final recourse for obtaining redress for their damages.

The cases that prompted Monday’s decision involved two individuals who committed suicide after taking antidepressants. Lois Colacicicco, 55, was a psychotherapist and breast-cancer patient who began taking the generic version of GlaxoSmithKline’s Paxil® antidepressant prescription medication. She committed suicide in her bathtub in October 2003. The second individual, Theodore DeAngelis, 64, began taking Pfizer’s Zoloft® on January 22, 2003. His psychiatrist increased the dose a week later, and DeAngelis committed suicide two days after that.

In October, the U.S. Supreme Court will hear Wyeth v. Levine, another case involving alleged inadequate drug labeling. It is the belief among some attorneys that that case could decidedly influence the future course of pharmaceutical litigation unless Congress becomes involved.