Paxil Lawsuit Remanded to PA State Court

The drug giant GlaxoSmithKline (GSK) is facing legal action regarding their selective serotonin reuptake inhibitor (SSRI) Paxil. Removed from Philadelphia County’s Court of Common Pleas and submitted to the U.S. District Court for the Eastern District of Pennsylvania on June 26, the Paxil lawsuit alleges the antidepressant caused the plaintiff’s daughter to be born with a congenital birth defect, a condition that ultimately resulted in her death.

The plaintiff claims her use of the drug during pregnancy was directly responsible for her daughter’s death, and that GSK showed a “reckless disregard” for public safety by failing to warn consumers of the risk. The original complaint was filed in 2010, and remanded to the state court shortly afterwards.

The Paxil lawsuit involves allegations made against numerous SSRIs, which studies indicate carry an increased risk of fetal complications when taken during pregnancy.

Reports of fetal side effects of SSRI use during pregnancy include:

•  Heart defects and malformations
•  Low birth weight
•  Birth defects

One of the most commonly cited complications relating Paxil and other SSRIs is persistent pulmonary hypertension of the newborn (PPHN). Lawsuits claim GSK concealed the PPHN risk during marketing.

Paxil PPHN risk

A study published in a 2012 edition of the British Medical Journal suggested the risk of PPHN was more than doubled by SSRI use during pregnancy. The results of the study appeared to support a 2006 investigation, published in the New England Medical Journal, which assessed the risk for PPHN following exposure to SSRIs.

The study showed that children born to mothers who took SSRIs after the 20th week of gestation were 6 times more likely to have PPHN than infants whose mothers had not taken antidepressants. After the research was published, the FDA issued the following warning:

“Physicians should consider the benefits and risks of treating pregnant women with SSRIs, alternative treatments, or no treatment late in pregnancy.”

However, the FDA has since retracted its warning, as it believes the data remains unclear regarding the risk of taking SSRIs during pregnancy. They also noted that women who discontinued their use of antidepressants during pregnancy had a 68% chance of relapsing into a major depression, compared with 26% of women who kept taking their medication.

SSRIs are the most frequently-prescribed antidepressant in the United States. Their precise mechanism is not fully understood, but they are known to be an effective treatment for severe depression.

Paxil lawsuit claims GSK was ‘negligent’

Since its FDA approval in 1992, Paxil has been at the center of numerous court cases. There is evidence that GSK was aware of a link between Paxil and birth defects as early as the 1980s – well before it hit the market. The drug went on to generate $11.7 billion for GSK in the U.S.

In 2009, a major Paxil lawsuit resulted in a $2.5 million award to a three year old boy and his family, after the jury found his birth defects were caused by the drug. By 2010, GSK had paid out over a billion dollars to settle more than 800 claims, and in 2011, settled a Department of Justice investigation into deceptive marketing tactics for over $3 million.