Paxil Manufacturer Ordered to Pay Millions for Drug Defect

 

Jurors in state court in Philadelphia ordered GlaxoSmithKline Plc to pay a family $2.5 million over claims the antidepressant drug Paxil caused birth defects. The jury found the drug maker did not properly warn doctors and pregnant users of a potential risk. Compensatory damages were ordered to the family of a three-year-old whose heart damage is blamed on his mother taking Paxil. The jury more than doubled the $1.2 million they were seeking for past and future medical expenses and other damages caused by the boy’s heart defects.

The Pennsylvania case is the first one of 600 similar cases to come to trial. It’s also the first time a jury considered the claims that Glaxo knew Paxil caused birth defects and made an effort to hide the risk. Paxil whose generic name is paroxetine, was first approved in the US in 1992 and was about 2.1 percent of Glaxo’s sales, nearly $942 million, last year.

Jurors found ten to two that officials at Glaxo were negligent in failing to warn the mother’s doctor that Paxil could cause her unborn child harm and that the alleged defective drug was a “factual cause” in the boy’s heart defects. After the verdict was announced, one juror said he believes Glaxo did not examine certain “safety signals” like they should have and that the studies performed were inadequate.

In the past, Glaxo has had to pay millions of dollars over Paxil’s alleged defects. In 2004, the drug maker paid the state of New York $2.5 million to resolve claims that research was suppressed showing Paxil may increase the suicide risk in young people. In 2001, Glaxo was ordered to pay relatives of a man $6.4 million after he murdered his family then turned a gun on himself after taking Paxil in Cheyenne, Wyoming.

Glaxo is fighting other suits in the UK, Canada, and the US over claims Paxil increases suicidal and homicidal behavior. The company is also appealing the most recent verdict in Pennsylvania.