Lawyer Accuses Drug Company of Ignoring Paxil Risks

Philadelphia, PAGlaxoSmithKline ignored evidence about Paxil birth defects, according to a lawyer involved in a lawsuit regarding Paxil heart defects. The lawyer told the jury that Glaxo told scientists to avoid making public the risks of Paxil defects when the antidepressant was used by pregnant women.

According to an article in The Philadelphia Inquirer (September 16, 2009), the lawsuit was filed on behalf of a woman who alleges that the use of Paxil during her pregnancy caused her son's heart problems. During opening statements for the court case, the lawyer argued that early tests on Paxil showed rats that were given the drug were more likely to have pups that did not live longer than four days.

Internal Paxil Memos

A document provided by the plaintiff's attorney involved a warning from a Glaxo scientist, who stated that there was a possibility that Paxil could cause birth defects at higher doses. The lawyer argued that a Glaxo executive said in 1997 that if animal studies were necessary, the company could "bury" negative results.

The attorney also alleged that Glaxo received a letter in 2001 from a woman who said she used Paxil during her pregnancy but decided to abort her fetus after testing showed birth defects. The attorney said that an internal Glaxo report showed that Glaxo officials were "almost certain" that the birth defects were linked to the mother's Paxil use, but did not turn over those findings to the FDA.

Finally, he argued, Glaxo destroyed data from Paxil animal studies in 1993 and in 1996, 1998 and 2000 withheld safety reports about adverse reactions regarding mothers who took Paxil.

The boy involved in the lawsuit, Lyam Kilker, was born with two holes in his heart. He was kept in the hospital for five months after he was born and underwent surgery to repair his heart. His attorney said that he will eventually need further surgery.

An attorney for Glaxo said that there is no evidence that Paxil caused the young boy's heart issues and said that any sign of problems with Paxil were reported to the proper authorities. Furthermore, the attorney said that Glaxo did not target pregnant women in its marketing.

The Inquirer article notes that there are more than 600 lawsuits alleging that Paxil knew about the risks associated with the use of Paxil while pregnant but hid those risks to maximize profits. This particular lawsuit is the first to be tried and could set the precedent for all the other lawsuits.

Paxil is a in a class of drugs known as Selective Serotonin Reuptake Inhibitors (SSRIs). It is used to treat depression. According to Bloomberg (September 11, 2009), GlaxoSmithKline Plc is the world's second biggest drug maker. Bloomberg notes that Paxil generated approximately $940 million in sales in 2008