The first Paxil lawsuit against GlaxoSmithKline over alleged birth defects caused by their antidepressant, is scheduled for trial to begin today in Philadelphia, in what is the first of about 600 similar claims involving heart defects and other injuries suffered by babies born to women who used Paxil.
The lawsuit, brought by plaintiff Michelle David, claims that her use of Paxil resulted in life-threatening heart defects in her three-year-old son, Lyam Kilker. The case is the first of three early trials that are likely to set the tone of plaintiff and defense strategies, and potentially create the basis for a future resolution of the Paxil birth defect lawsuits.
Paxil, known generically as paroxetine, is a selective serotonin reuptake inhibitor prescribed to treat depression. It was originally approved in 1992, and has become one of the most commonly prescribed drugs in the United States, with sales of just under $1 billion in 2008.
Plaintiffs claim that GlaxoSmithKline knew about the potential for Paxil to cause birth defects, but hid data and failed to warn users of the potential birth defect side effects. The FDA released an alert on December 8, 2005, that studies showed the drug could increase the risk of heart defects in infants when taken during the first three months of pregnancy. The agency also required the company to update Paxil label warnings to include the risk of birth defects.
GlaxoSmithKline has already settled several claims involving the antidepressant, including a $40 million settlement of a Paxil class action lawsuit brought by health insurers who claimed that the company withheld information that the antidepressant was much less effective on children and teens. The company also settled a lawsuit claiming it withheld safety information on increased suicide risks associated with Paxil brought by the New York Attorney General’s office.
GlaxoSmithKline officials say there is no conclusive evidence that Paxil causes birth defects, and intend to argue that the injury suffered by the plaintiff’s son was not caused by the use of Paxil. David’s son was born with holes in his heart that had to be addressed with multiple surgeries before he was six months old, which the lawsuit says is the result of her use of Paxil. David maintains that she would not have taken the drug if she had known of the potential risk to her then unborn child.
Plaintiff lawyers contend that the company knew of the potential risks years before the drug was approved, and allege they withheld and destroyed test data that indicated there was an increased risk of Paxil birth defects. Similar claims were made in the New York settlement regarding Paxil suicide risks.
Paxil settlement agreements forced the company to release a large amount of previously undisclosed test trial data on other drugs as well, which has led to findings of other side effects. An independent meta-analysis of data released involving clinical trials for GlaxoSmithKline’s diabetes drug Avandia was published in the New England Journal of Medicine in May 2007, leading to the discovery that Avandia side effects may increase the risk of heart attacks and death.
In March of this year, GlaxoSmithKline announced that it was changing company policies to ensure that all drug research data was released within 18 months of completion.