Memo Introduced at Paxil Trial Suggests Drug Company May Have Buried Negative Studies

By September 16, 2009Dangerous Drugs

Pharmaceutical company GlaxoSmithKline discussed burying studies linking antidepressant Paxil (paroxetine) to birth defects, Bloomberg News reported Sept. 15. The revelation came in the opening phases of a lawsuit against GlaxoSmithKline by Michelle David and her three-year-old son, Lyam Kilker, who claim Paxil is responsible for Kilker’s life-threatening heart defects. The plaintiffs and their dangerous prescription drug attorney claim GlaxoSmithKline knew Paxil could cause birth defects and intentionally withheld that information in order to protect the drug’s sales, estimated at $942 million in 2008. According to Bloomberg, the case is the first of more than 600 claiming that GlaxoSmithKline knew Paxil causes birth defects, but continued selling it anyway without notifying consumers, doctors or regulators.
The memo in question was written in 1997 by GlaxoSmithKline executive Bonnie Rossello, about the possibility of doing animal studies on the drug. “If neg[ative], results can bury,” Rossello wrote. The plaintiffs also claim the manufacturer knew when it bought the drug’s patent in 1980 that the previous owner had found evidence that Paxil caused birth defects in rats. Nonetheless, they said, GlaxoSmithKline resisted doing a study on its drug for almost 20 years to see why the young rats in that study died. In 1998, the plaintiffs said, GlaxoSmithKline reviewed its reports of Paxil side effects and found a high number of birth defects — then deleted the relevant parts of the report and never notified the U.S. Food and Drug Administration. And in 2001, an internal report said birth defects in a patient’s fetus were “almost certainly” caused by Paxil use.
After a 2003 order from the FDA for more safety tests, the company acknowledged that Paxil increased the risk of birth defects. Nonetheless, a lawyer for the drug maker said at trial that it had not received reports of the specific defect Kilker has before he was born in 2005. Since 2003, several studies have shown that Paxil use during pregnancy increases the risk of heart defects in babies by 1.5 to 1.7 times. A study in the British medical journal The Lancet also found that babies born to mothers using Paxil had withdrawal symptoms, including convulsions. The drug’s labeling now warns of this risk, and the American College of Obstetricians and Gynecologists has recommended that pregnant women and women trying to become pregnant avoid Paxil.
As a defective prescription drug attorney, I will watch this and other Paxil cases closely. Heart defects in newborn infants are frightening and potentially life-threatening. Children with severe defects may need surgery or multiple-drug regimens to be well enough to live normal lives. This is a terrible challenge for any family to face — and juries will likely sympathize with children who are ill through no fault of their own. That may be particularly true if plaintiffs can prove that GlaxoSmithKline knew or should reasonably have known about the link between Paxil and infant heart defects earlier. If these plaintiffs can prove the claims outlined in the article, I think they have a strong chance.


The pharmaceutical liability lawyers at the Lowe Law Firm represent people around the United States who were severely injured by a medication or medical device. All manufacturers have a legal obligation to make sure their products are safe — and an obligation to disclose information suggesting otherwise. When they fail in that duty, especially if they intentionally withhold vital safety information, patients have a right to hold them legally responsible for the results. In a dangerous medication lawsuit, injured people and their families can claim all of the costs of their injuries as well as compensation for their injuries, pain and any disability or wrongful death. In some cases, they can also claim compensation for egregious misbehavior in the form of punitive damages.
If you believe a prescription drug caused you or a loved one to become seriously ill or injured, the Lowe Law Firm would like to help. To set up a free consultation, at which you can learn more about your rights and your options, please contact us through the Internet or call 1-877-678-3400 today.