An Iowa woman has filed a lawsuit in the US District Court for the Eastern District of Pennsylvania, alleging that the manufacturer of the antidepressant Zoloft is responsible for her child’s heart defects. The lawsuit alleges that Pfizer, Inc. knew about the risk of congenital birth defects associated with its antidepressant drug.
Hundreds of Zoloft lawsuits related to birth defects have been filed over the past few years. The lawsuits allege that Pfizer marketed its drug to pregnant women, and failed to warn consumers and healthcare providers of the potential risks to developing fetuses. Plaintiffs claim that Pfizer marketed its selective serotonin reuptake inhibitor (SSRI) antidepressant to pregnant women despite being aware of evidence of congenital abnormalities in clinic trials.
In addition to Zoloft, lawsuits have been filed against the manufacturers of other SSRIs, including Paxil, Celexa, Effexor, Lexapro, Pristiq, and Prozac. SSRIs are widely prescribed in the US for symptoms such as depression, anxiety, and other mental health conditions. The drugs have been marketed as safe and effective.
Drug manufacturers frequently come up with new uses for their SSRI drugs in order to hold on to their patents. “Every year there might be a new syndrome pushed forward by the company,” said attorney Kim Adams, a shareholder with the Levin, Papantonio law firm, who practices in the areas of personal injury and product liability. “Every 3 to 5 years when the patents come up, in order for companies to hold on to that brand drug, we see new symptoms for which the drugs can be prescribed.”
The use of SSRIs by pregnant women has been associated with multiple severe birth defects including heart defects, some of which can be fatal, pulmonary hypertension (abnormally high blood pressure in arteries and lungs), intestinal defects, cranial defects, cleft palate, club foot, and more.
“We believe these drugs should be established as category D by the FDA, meaning there is evidence this drug can cause harm to your fetus. Most of these drugs are classified by the FDA as category C, which means ‘We don’t really know what the risk is,’” Ms. Adams continued. “We need women to understand the true risk associated with these medications and the risk to their fetuses.”
In 2011, Harvard Medical School reported that the rate of antidepressant use in the United States increased by almost 400% between 1988 to 1994 and 2005 to 2008, according to a study by the National Center for Health Statistics. The study also found that women are two and a half times more likely to be taking an antidepressant than men.
The most recent lawsuit against Pfizer will be added to the Zoloft multidistrict litigation, which was established in 2012. In 2005, before Pfizer’s Zoloft patent expired, Zoloft drug sales totaled $3.3 billion. That same year, Pfizer, the largest drug manufacturer in the world, raked in $51.3 billion in revenue.
Recently, the company has been hit with a string of lawsuits by women taking Pfizer’s Lipitor. The drug, which is widely prescribed to regulate cholesterol and blood pressure, has been associated with an increased risk for type 2 diabetes. The drug has also been linked to musculoskeletal injuries and diseases.
In filing a Lipitor lawsuit, Plaintiffs allege that Pfizer withheld information about the risk for type 2 diabetes associated with their drug. The FDA approved a warning label change for Lipitor in February 2012, which includes an increased risk for developing type 2 diabetes.