Manufacturer buried Paxil birth defect reports, jury told

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October 8, 2009

Manufacturer buried Paxil birth defect reports, jury told 

Susan Heylman

In the first Paxil birth defect case to go to trial, jurors heard testimony late last month that manufacturer GlaxoSmithKline (GSK) was aware of reports of birth defects from mothers who took the antidepressant while pregnant but withheld the information from the FDA and consumers. (Kilker v. SmithKline Beecham Corp., No. 070201813 (Pa., Philadelphia Co. Com. Pleas filed Feb. 20, 2007).) The trial is ongoing in Philadelphia this week.

In his opening statement, Sean Patrick Tracey of Houston told the jurors that they would see internal GSK documents that would show the company had reports of Paxil-related congenital abnormalities that go back to the drug’s entry into the market in 1993. These were documents previously under seal that “the FDA hasn’t seen, the United States Congress hasn’t seen, and that no jury has ever laid their eyes on before,” he said.

Tracey said one of the documents would show that a GSK official discussed “burying” negative studies linking Paxil to birth defects. Another would show that GSK told officials to avoid disclosing the risks. “GSK said if there is any doubt, take it out,” he told the jury.

Plaintiff Michelle David blames the Paxil she took during her pregnancy for her son Lyam’s life-threatening heart defect. Lyam was born in 2005 with two holes in his heart and underwent multiple surgeries within six months of birth.

More than 600 Paxil birth defect cases have been filed against GSK. Lyam’s lawsuit is the first of three bellwether cases being tried in Philadelphia this fall. (Susan Heylman, New Paxil Suits Allege Birth Defect Risk, TRIAL 14 (Mar. 2007).)

During the trial's first week, the plaintiff’s expert neuropsychopharmacologist, David Healy, testified that Paxil can induce birth defects. He based his opinion on his review of animal studies, human epidemiological studies, and internal GSK documents.

A former FDA doctor, Suzanne Parisian, testified that GSK documents introduced by the plaintiff showed that company scientists were “alarmed” by the finding that, as of November 1997, there was a 13.3 percent rate of incidence for congenital abnormalities in pregnant women taking Paxil. The information was never submitted to the FDA, she told the jurors, when under FDA rules, it should have been.

The jurors also heard from a former GSK drug safety executive, Jane Nieman, who said in a videotaped deposition that GSK officials noted in company files in 2001 that they were “almost certain” that a rare heart defect in the fetus of a woman taking Paxil was linked to the drug.

Tracey finished presenting the plaintiff’s evidence on September 24. “We proved everything we said we would prove in the opening statement,” he said. Closing arguments are scheduled for today.

Update: On October 13, the jury awarded the plaintiff $2.5 million in compensatory damages. GSK said it will appeal.

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