Round one to Pfizer in Zoloft lawsuit battle

pharmafile | April 20, 2015 | News story | Sales and Marketing Pfizer, Zoloft, antidepressant, birth defects, law suits, legal, sertraline 

Pfizer’s Zoloft did not cause a young boy’s birth defects, a jury has ruled, in the first of a thousand lawsuits the company is defending accusing it of cover up.

The lawsuits allege that Pfizer bosses knew Zoloft (sertraline) caused potentially fatal birth defects. They also claim that despite company researchers being aware that women who weren’t using contraception shouldn’t take Zoloft because of the risks of defects – this information didn’t appear in the safety warnings issued to doctors or patients.

The plaintiff in the first case, heard by a state jury in St Louis, Missouri, is Kristyn Pesante. She took Zoloft during the early stage of her pregnancy and later had a son Logyn, now 11, who was born with severe congenital birth defects, including a hole in the heart that has required several surgeries.

Pesante filed for $2.7 million to compensate for the costs of the surgeries, but the jury dismissed this. It did not rule on the plaintiff’s causation or failure to warn claims, finding simply that “on the claim by plaintiff Logyn Pesante for compensatory damages for personal injury against defendant Pfizer, we find in favour of Pfizer”.

Pfizer faces many more trials brought by parents of children with birth defects, but argues that although there is a 3-5% background risk of birth defects in the general population, this cannot be linked to the drug. At one point, Zoloft was the most popular antidepressant in the US, and earned $2.6 billion back in 2005.

“The decision is particularly significant as the plaintiffs’ lawyers selected this case for their first trial, and after all the evidence was heard, the jury found in favour of Pfizer,” a Pfizer statement says. “Equally significant, some of the same plaintiff’s experts and theories, which the Pesante jury found unpersuasive, have been put forth in other pending Zoloft cases.”

“While we have great sympathy for families affected by birth defects, this verdict affirms that Zoloft did not cause the conditions alleged in this case,” adds Neha Wadhwa, a Pfizer spokeswoman, in a further statement.

A second trial is scheduled for May in Philadelphia and a multi-district litigation is due to be heard in January 2016. Pfizer stands to lose billions if claims are successful; in 2010 GSK paid out $1 billion to settle more than 800 claims its antidepressant Paxil (paroxetine) caused birth defects.

GSK also paid out a further $3 billion, including a $1 billion fine, to settle civil and criminal claims that it illegally promoted prescription drugs such as Paxil and failed to properly report safety data to regulators.

Lilian Anekwe

 

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