Judge: Lawsuit against drug firms can continue
LINCOLN, Neb. (AP) -- A federal judge has refused to dismiss a lawsuit filed by the parents of an 11-year-old boy who committed suicide after taking antidepressant medications.
David and Debra Jackson of Omaha allege their son Jacob's 2002 hanging death was the result of side effects from the antidepressant drugs Zoloft and Effexor.
The lawsuit alleges that Pfizer Inc., the maker of Zoloft, and Wyeth Pharmaceuticals, which manufactures Effexor, failed to adequately test, evaluate and study the pediatric effects of Zoloft before marketing it to the public.
The lawsuit, filed by attorney Andrew Hilger, said Jacob began taking Zoloft on Sept. 9, 2002, on a doctor's recommendation.
Jacob's behavior worsened to include intensified agitation and suicidal desires, the lawsuit said.
Jacob's Zoloft dosage was increased three times between Sept. 17 and Oct. 2 on the recommendations of three doctors, the lawsuit said. On or about Oct. 8, one of the doctors advised a gradual decrease of the Zoloft dosage and prescribed the drug Effexor, the lawsuit said.
Two days later, Jacob was found dead in his parents' basement.
Hilger argued that Nebraska common law requires additional warnings than those given by the FDA relating to the risk of suicide.
U.S. District Judge Joseph Bataillon rejected arguments by lawyers for the drug companies that state law cannot pre-empt FDA regulations.
"Federal labeling laws are minimum standards; they do not necessarily shield manufacturers from state law liability," he said. "The primary purpose of ... the FDA's regulatory scheme is to protect the public. State-law protections reinforce and enhance this objective.
"Defendant's pre-emption argument ultimately fails because Congress has not expressed a specific intent to pre-empt state consumer-protection laws in the area of prescription-drug labeling," Bataillon said. "In the absence of Congress's express statement, defendant must overcome the presumption against implying congressional pre-emptive intent. It has not done so."