Judge Denies to Shrink Class Size in Paxil Birth Defect Suit

A Canadian appeals court rejected Paxil manufacturer GlaxoSmithKline Inc.’s attempt to limit the class period in a lawsuit alleging the drug company failed to warn patients and doctors that Paxil may cause birth defects.

The judge concluded that the company had knowledge that pregnant women should not take Paxil.

The plaintiffs in the class action alleged that after taking Paxil during pregnancy, they delivered babies with cardiovascular birth defects. In addition, the plaintiffs accused the company of failing to provide an adequate warning on the drug’s label when it was introduced to the market in 1993. A lower court had previously granted class certification covering women prescribed Paxil between 1993 and 2012. The drug company sought to limit the class size to include only individuals prescribed the drug between 2003 and 2005.

In a failed attempt to reduce the number of class members, GlaxoSmithKline (GSK) argued that because the plaintiffs did not demonstrate that GSK was aware of the birth defect risk prior to 2003, the company did not have a duty in years prior to 2003 to warn pregnant women not to take Paxil.

Disagreeing with GSK’s legal arguments, the judge overseeing the litigation ruled that the plaintiffs did not need to provide evidence of exactly when GSK first became aware that Paxil may cause birth defects. Citing information published by GSK in 2005 acknowledging that birth defects were twice as common in babies exposed to Paxil, the judge concluded that at some point prior to the publication of this report the company had knowledge that pregnant women should not take Paxil. The judge ruled that the burden is not on the plaintiffs to prove exactly when GSK first became aware of this fact.

One plaintiff in the lawsuit alleges that she was prescribed Paxil in 2002 and took the drug throughout her pregnancy. In 2005, she gave birth to a daughter with a heart defect and alleges the medical condition was a result of her use of the antidepressant during pregnancy. The class represents both children born with cardiovascular defects to women who took Paxil during pregnancy, as well as their mothers.