Zoloft (sertaline hydrochloride) is a selective serotonin reuptake inhibitor (SSRI) which has been used to treat anxiety and depression. The drug was first approved by the FDA in 1991 and it has since earned Pfizer hundreds of millions of dollars. According to the company’s annual report, it earned over $537 million in sales in 2011 alone (i). In recent years, SSRI antidepressants like Zoloft have been the subject of FDA warnings and lawsuits. The FDA has issued two warnings on the potential link between SSRIs and persistent pulmonary hypertension in newborns (PPHN). The first warning about this link was issued in July 2006 but the most recent warning in December 2011 stated that medical studies have neither conclusively confirmed nor denied this link. After looking at the data, the FDA found that two studies suggested an increased risk of PPHN with SSRI use in pregnancy while three studies did not support this conclusion (ii).
Some women who took this drug during pregnancy have talked to Zoloft attorneys resulting in hundreds of birth defect lawsuits. These proceedings were consolidated through multidistrict litigation (MDL) on April 17, 2012 in the United States District Court for the Eastern District of Pennsylvania. According to a July 10, 2013 report from the Judicial Panel on Multidistrict Litigation, there have been a total of 412 lawsuits filed and there are currently 370 legal actions pending in the case of In Re: Zoloft (Sertraline Hydrochloride) Products Liability Litigation – MDL 2342. These actions “involve allegations that Zoloft, a prescription medication approved for the treatment of depression and other ailments, causes birth defects in children when their mothers ingest the drug while pregnant” (iii).
The results of a recent medical study have suggested that patients who take SSRI drugs may face an increased risk of other adverse events. On April 29, 2013, the Journal of the American Medical Association for Internal Medicine published a study which looked at “whether perioperative use of SSRIs is associated with adverse outcomes of surgery in a national sample of patients.” The study looked at surgery outcomes from 375 hospitals and more than 534,000 patients who were taking SSRIs like Lexapro, Paxil, Prozac, and Zoloft, among others. It determined that these patients “had higher odds of in-hospital mortality, bleeding, and readmission at 30 days” (iv).
Attorney Paul d’Oliveira stated, “Depression is a very serious condition that doctors and manufacturers should approach appropriately. This means that doctors should tell patients about alternatives to prescription medicine and manufacturers should warn about the possible side effects of their drug. In my opinion, the medical industry has lost sight of the fact that they are treating real people. Treatment decisions need to be made on a person by person basis with the patient’s best interest in mind. Our law firm provides services with real people in mind and that is the reason that we have released our new informational graphic and video on Zoloft. We believe that awareness is an important step in empowering consumers.”
d’Oliveira & Associates has been investigating the safety of antidepressants, including SSRIs. The law firm is currently working with some of the more experienced Zoloft lawyers in the country who are handling these birth defect lawsuits. Contact the firm to receive a free legal consultation and there are no legal fees unless you receive a settlement or award. Call toll-free at 1-800-922-6878 or fill out a contact form in confidence.
- (i) Pfizer 2012 Annual Report.
- (ii) FDA Drug Safety Communication, December 14, 2011.
- (iii) Judicial Panel on Multidistrict litigation, Pending MDL Dockets.
United States District Court for the Eastern District of Pennsylvania.
- (iv) JAMA Internal Medicine, April 29 2013.