Paxil Birth Defects: When Important Data Is Allegedly Pushed through the Cracks

Philadelphia, PAWith a pivotal Paxil side effects trial set to start in May, a focus will be placed on what Paxil manufacturer GlaxoSmithKline knew about the risk and potential for heart defects in newborns with Paxil use during the first trimester, and an alleged failure to disclose such risks to the medical community and the population at large.

The trial could also put a focus on the relationship between the pharmaceutical company and the doctor (in generic terms), as it relates to the sharing of important data with a doctor who has the moral, medical and legal authority to prescribe drugs off-label.

There will likely be no suggestion in this forthcoming Paxil lawsuit—or any subsequent lawsuit—that Paxil was prescribed off-label. Paxil is an antidepressant that affords important therapy for individuals suffering from clinical depression. The issue here is when the patient is female and becomes pregnant. Then the wisdom of Solomon must come into play, to determine the best course of action when weighing the various risk factors against one another.

To wit, would stopping a needed medication serve as a greater risk to the mother than the baby? Or do risk factors favor stopping Paxil during the most critical times of a pregnancy in an effort to reduce the risk factors that a baby would be born with Paxil heart defects that may affect a child over his lifetime?

Back to the doctor, who has the ultimate responsibility here. He has to weigh the pros and cons with the best information at his disposal in order to make the most appropriate recommendation for the individual patient. A doctor has tremendous power, together with tremendous responsibility. Most patients are inclined to follow the recommendations of their doctor, to their ultimate benefit or downfall.

The Paxil trial scheduled for May will allege that GlaxoSmithKline dropped the ball when it came to sharing information with regard to Paxil. Legal representatives for the plaintiff have stated that in their view, evidence will show that GlaxoSmithKline ignored clinical studies showing Paxil causes Paxil birth defects, and failed to properly warn doctors of the risks for serious, life-threatening Paxil defects.

The US Food and Drug Administration (FDA) requested GlaxoSmithKline include increased risk for congenital heart defects in newborns with regard to Paxil use during the first trimester. The new Paxil FDA label appeared in December 2005. Since then there have been two Paxil trials alleging birth defects. The first resulted in a $2.5 million verdict for the plaintiff in late 2009.

A second trial last year alleging Paxil birth defects was halted when the defendant was granted summary judgment. The doctor who prescribed Paxil to plaintiff Marsha Blyth, Dr. Claud Hackney, died in 2001. His medical records were also destroyed. The judge in the case granted summary judgment for the defendant because plaintiffs suing prescription drug manufacturers are required to show under the learned intermediary doctrine that the manufacturers failed to provide adequate warnings to the prescribing physician. In the absence of admissible evidence pertaining to the habits and practices of the late doctor, it would be impossible to prove what the doctor might have done in light of a different warning.

All eyes are on the Paxil lawsuit in State court in Philadelphia in May, as it may set a tone for future lawsuits.