A St. Louis jury has begun hearing arguments in a lawsuit that claimed the popular antidepressant Zoloft caused birth defects in a California boy. The lawsuit is the first of its kind to make it to trial.
There are similar suits across the country in both state and federal courts alleging that when Zoloft is taken during pregnancy it causes birth defects. None of those lawsuits have yet been heard by a jury.
New York-based Pfizer, the maker of Zoloft, denies a link between the drug and birth defects.
Logyn Pesante was born with multiple heart defects, the most serious being transposition of the great arteries, also known as TGA, in which the two main arteries of the heart are in the wrong place. Since his birth Logyn has undergone 25 procedures and six operations and has a pacemaker.
His mother, Kristyn Pesante, took Zoloft during the first trimester of her pregnancy, according to the statements Thursday made before Circuit Court Judge Margaret Neill.
In opening statements Thursday, Pesante’s attorney Joseph Zonies of the Colorado law firm Reilly Pozner LLP, argued that Pfizer did not do enough to warn doctors about the potential risks of birth defects when taking Zoloft during pregnancy.
He claimed internal Pfizer documents highlighted the potential risks of birth defects but that information was not included on the label seen by doctors. He alleges the label did little to mention the potential for defects.
Once Zoloft hit the market after its approval for use in 1991, adverse events were reported by patients that included birth defects and fetal deaths, Zonies said during trial. But even then, he alleged Pfizer did not change its label or communicate to physicians when it learned of the adverse events.
“What would a reasonable drug company do?” Zonies asked, alleging the company did not do enough.
Attorneys for Pfizer argued that there is no evidence to prove Zoloft causes birth defects.
“No treating physician or medical records say Zoloft is a cause,” of Logyn’s condition, said Beth Wilkinson, attorney and partner with Washington, D.C., firm Paul Weiss Rifkind Wharton & Garrison LLP.
Wilkinson said the label does not need to reflect the risk of birth defects because
As the drug became widely available and sales increased there was no increased rate of malformations, or birth defects, Wilkinson said.
That wasn’t the case when the now notorious drug Thalidomide hit the market in the late 1950s. The drug was developed to combat morning sickness but caused severe birth defects in children.
As Thalidomide sales increased, Wilkinson showed during a courtroom presentation, so did the rate of malformations. That’s not the case with Zoloft, she claimed.
In a press release, Pfizer also pointed to a 2011 safety announcement by the Food and Drug Administration that advised physicians ‘not to alter their current clinical practice of treating depression during pregnancy’ when using antidepressants like Zoloft.
The FDA made the 2011 recommendation after it found conflicting findings studying a possible relationship between persistent pulmonary hypertension of the newborn, or PPHN, and antidepressant usage.
The suit in St. Louis was first filed in 2012 by a long list of plaintiffs that included mothers and their children, including some from the St. Louis region. It was later decided that Logyn, a minor with birth defects from California, would be the first case tried before a jury.
Zoloft was a blockbuster for Pfizer when it was launched in 1991. It became the company’s third-biggest product, with sales peaking at $3.4 billion in 2004. In mid-2006, the patent expired and cheaper versions, under the generic name of sertraline, grabbed market share. Last year, Zoloft represented $423 million in sales for Pfizer.
However, Zoloft and its generic equivalents are still the best-selling antidepressants on the market, according to Express Scripts’ data.