Paxil Birth Defects Trial Underway

Philadelphia, PAA Paxil birth defects lawsuit, alleging infants suffered serious Paxil side effects when they were exposed to the antidepressant prior to birth, is underway in Philadelphia. The lawsuit alleges GlaxoSmithKline knew about Paxil birth defects but failed to warn consumers about that risk.

According to Bloomberg (11/09/10), the lawsuit was filed on behalf of Anna Blyth, now 14 years old, who was born with a narrowed aorta. A lawyer for Anna alleged in her opening statement that Paxil caused Anna's birth defect. Furthermore, the lawyer alleged GlaxoSmithKline, maker of Paxil, had research from the 1980s that showed Paxil caused the deaths of offspring of animal test subjects but the company did not provide adequate warnings about those deaths.

As a result, the lawsuit argues, Anna endured two open-heart surgeries within nine months of being born. Marsha Blyth, Anna's mother, reportedly took Paxil for a short time while she was pregnant to help manage her depression.

In July 2010, GlaxoSmithKline reportedly agreed to settle approximately 800 Paxil birth defect cases for more than $1 billion. Those lawsuits also argued that the drug maker failed to properly warn doctors and patients about the risks associated with Paxil use while pregnant. Anna's case, however, was not part of that settlement.

GlaxoSmithKline is defending Paxil, saying genetics or the advanced age of Blyth's mother played a role in Anna's birth defects. The company also maintains that Anna has not experienced any long-term effects from her early heart problems. Finally, GlaxoSmithKline claims that in 1995, the year Marsha was pregnant, the warning label for Paxil contained all the knowledge GlaxoSmithKline had about the drug's risks for pregnant women.

Meanwhile, a different lawsuit related to Paxil birth defects was settled for an undisclosed amount. The lawsuit, filed by Jennifer Berg, alleged her use of Paxil while she was pregnant with her son resulted in his being born with persistent pulmonary hypertension of the newborn (PPHN). Nathan Berg died approximately six weeks after he was born.

GlaxoSmithKline recently agreed to pay $750 million to settle claims that deficiencies at one of the company's manufacturing plants resulted in adulterated Paxil tablets being sold to consumers. Other drugs affected by the manufacturing deficiencies reportedly included Bactroban and Avandamet. The plant was closed in 2009.

Among the violations found at the plant were a contaminated water system and an improper air system. According to officials, no patients appeared to have been injured by the manufacturing deficiencies.