Pfizer wins first Zoloft birth defect case, Pesante v. Pfizer, Inc. On Friday, April 17, the verdict came in that mega-corporation Pfizer’s Zoloft anti-depressant was not the cause of plaintiff’s heart abnormalities. This is the first of over 1,000 such cases currently in the judicial system. The fact that Pfizer won will have widespread repercussions on the remaining cases.
Logyn Pesante’s mother took Zoloft while she was pregnant. He was born with a hole in his heart along with other congenital birth defects. Logyn, 11-years-old has had three open-heart surgeries, still deals with other problems related to the defects and may need a heart transplant at some point in the future.
The Pesantes sued under product liability for failure to warn of the possible risks of the drug. They asked for $2.7M to cover a medical expense related to the three surgeries, as well as the pacemaker that was put in when Logyn was only one month old.
The jury was not swayed by Pesante’s situation. Pfizer attorney, Beth Wilkinson, said in opening arguments that, “The science has never even suggested that birth defects were caused by Zoloft.” She went on to say that the company did include warnings on the label about using Zoloft while pregnant. The warnings were FDA-approved and the FDA has not requested any more specific warnings than those currently in place.
Summing up, Wilkinson said, “Sometimes, bad things happen to good people.” How comforting Logyn Pesante and his family must have found this statement.
Interestingly, the Zoloft suits are almost carbon copies of those filed against GlaxoSmithKline PLC regarding the anti-depressant Paxil. GSK agreed to pay over $1B in settlements and over $3B to resolve civil and criminal allegations that it ignored safety risks, withheld data from regulators and illegally marketed the drug. Considering how closely the two drugs are related, according to Dangerous Drugs & Medical Devices, the fact that GSK paid while Pfizer didn’t is odd.
To paraphrase Wilkinson, “Sometimes, good things happen to bad companies.”
It’s even more interesting that the jury didn’t seem to consider the fact that, in 1991, Pfizer researchers stated on Zoloft’s pre-release “Core Data Sheet” that women who weren’t using birth control should refrain from using the drug due to the risk of defects. Further, Pfizer’s own report stated that potential risks to newborns included: atrial septal defect, congenital heart disease and growth retardation. Logyn Pesante had an atrial septal defect. He, like all others born with it, had to have surgery to close the hole in his heart.
More risks were included omphalocele (the baby’s liver and intestines are outside the body after it’s born) and persistent pulmonary hypertension, high pressure in the lungs that causes a struggle to breath and can be fatal. Somehow, these warnings were never included on the final safety label.
According to Pfizer, it was because there weren’t any “credible” studies supporting the connection between Zoloft and birth defects. Odd, considering that a study was published in the New England Journal of Medicine (a respectable journal) in 2007 stating that the risk of birth defects doubled when expectant mothers took Zoloft.
In any case, Pfizer won the first round. That’s a big deal according to Prof. Carl Tobias of the University of Richmond in Virginia. “It’s always important to set the tone when you are facing thousands of cases. The first win casts doubt on the strength of these Zoloft cases.”
Pfizer’s own internal research, as well as a “credible” study, shows the dangers of Zoloft for unborn children. Let’s hope there’s an appeal and that justice prevails for Logyn and the many others in similar situations.
If you’d like to learn more about Zoloft birth defects, click here.