Paxil Birth Defects Lawsuit - GSK Ordered to Turn Over Emails

Philadelphia PA"If neg, results can bury", so wrote GlaxoSmithKline (GSK) executive Bonnie Rossello in a 1997 memo. Rossello was referring to what action the pharmaceutical giant should take if it became necessary to do animal studies with Paxil, their blockbuster antidepressant, known generically as paroxetine.

The memo was read in opening statements during the bellweather Paxil birth defects lawsuit which began in Philadelphia this week.

The lawsuit is brought by the family of 3-year-old Lyam Kilker. His mother, Michelle David, alleges that her use of Paxil during her pregnancy caused Lyam to suffer life-threatening heart defects.

The suit alleges that officials at GSK withheld important safety information regarding the use of Paxil during pregnancy and lobbied researchers to withhold information regarding it's safety from inclusion in a paper that stipulated GSK's "core safety philosophy" for the drug.

In a report published by Bloomberg.com Sept 15, Sean Tracey, the attorney representing Lyam Kilker and Michelle David, told the court that GSK hid problems related to Paxil to protect its profits. "They said if there's any doubt, take it out. They do not want to scare anybody. It's a very competitive marketplace. It's a multibillion-dollar industry," he's quoted as saying.

Did GSK Hide Paxil Birth Defect Data?

In an effort to answer that question, Judge Nancy Gertner ruled Tuesday that the company must turn over its emails and correspondence between itself and the research facility that tested Paxil. This ruling came in connection with a second case centering around the death of 1-year-old William Seale in 2004 following 3 surgeries to try to correct heart defects. William's mother had taken Paxil while pregnant.

Early data on Paxil, which was gathered from rat studies done by the Danish developers of the compound, reportedly show that low-dose paroxetine killed young rats. According to Bloomberg's report, Tracey told jurors that one researcher noted in internal documents dated from 1980 that the rat data suggested Paxil could be a cause of birth defects.

Additionally, Tracey said that documents would be presented during the trial that had never seen the light of day. He cited an internal review of existing Paxil-related side effects data from 1998 in which officials found "an alarmingly high number" of birth defect reports. However, the report was not handed over to the FDA, and "the alarming language" was deleted from the text.

According to Tracey, it wasn't until 2003 when the FDA ordered pharmaceutical companies to do more safety studies on their respective antidepressants that GSK acknowledged there was an increased risk of birth defects associated with Paxil.

Those birth defects include cardiac defects ranging from septal defects to complete deformation of the heart. Paxil has also been associated with cranial and abdominal defects, as well as neural tube malformations, more commonly recognized as spina bifida and anencephaly.

In 2007, a study published in the New England Journal of Medicine showed that the use of antidepressants in the first 3 months of pregnancy more than doubles the risk of craniosynostosis (premature closure of the connections between the bones of the skull before brain growth is complete), omphalocele (the child's abdomen does not close properly allowing intestines and other organs to protrude outside the body), and anencephaly (birth without forebrain).