In the spring of 2012, a multidistrict litigation was filed against Pfizer pharmaceuticals, the maker of the antidepressant Zoloft (Sertraline Hydrochloride), alleging the drug causes birth defects in babies born to mothers who took the drug while they were pregnant. The MDL now includes over 500 cases. Following is an update on the status of the Zoloft MDL:
• The Zoloft MDL was created by Order of the United States Judicial Panel on Multidistrict Litigation (“MDL Panel”) on April 17, 2012. A typical case involves claims by a plaintiff from anywhere in the United States against defendant Pfizer, Inc., and may name other defendants as well.
• The MDL Panel noted that the 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.” Pfizer and the other defendants deny these allegations. The Panel further found that “[c]entralization will eliminate duplicative discovery; prevent inconsistent pretrial rulings; and conserve the resources of the parties, their counsel and the judiciary.”
• Also in April 2012, the MDL Panel centralized the MDL in the Eastern District of Pennsylvania, for reasons of convenience of the parties and witnesses.
• US District Judge Cynthia Rufe, of the Eastern District of Pennsylvania, is presiding over the case.
• In October 2013, Rufe named Dianne Nast, who is also on that plaintiffs’ steering committee, to be liaison counsel to the Zoloft MDL.
• Earlier this year, Rufe told lawyers from Pfizer’s defense team and the plaintiffs’ steering committee that the pace of the Zoloft birth defects litigation must improve. “If we are going to determine true issues of science, of liability, and then of damages, I would hope that we would be speeding along. It’s time to speed,” Rufe said.
• Lawyers in the Zoloft MDL are hoping to have a verdict by Thanksgiving 2014.
What is an MDL?
• An MDL is more practical for both the plaintiffs and the judicial system, as it allows for trying all cases on an individual basis. An MDL is a special federal legal procedure that speeds up the process of handling complex cases such as complex product liability lawsuits. An MDL can take place when civil actions involving one or more common questions of fact are pending in different districts. Additionally, MDLs reduce the likelihood of duplicative discovery and conflicting pretrial rulings from different judges.
About alleged Zoloft birth defects
• Some research has suggested serious Zoloft side effects, including an increased risk of heart defects. The link between Zoloft and heart defects has some people concerned that pregnant women should not take the medication.
• SSRIs such as Zoloft have also been linked to an increased risk of Persistent Pulmonary Hypertension of the Newborn (PPHN).
• Although research has not yet established a link specifically between Zoloft and coronary birth defects (it would be a violation of medical ethics to perform studies on pregnant women), it is known that other antidepressants increase the risk of heart birth defects when taken during pregnancy. Paxil (paroxetine), which is in the same group of SSRIs as Zoloft, is known to cause heart birth defects in babies when taken during pregnancy.
• There is a link between other SSRIs and congenital malformations, including cardiac malformations.
• A study conducted at Aarhus University Hospital, Denmark, revealed that the risk of pregnant women giving birth to babies with birth defects, including heart defects, was increased among women who had prescriptions for SSRIs filled in the 30 days before conception through the end of the first trimester, compared with those who had no SSRI prescriptions filled during the same period.
About Zoloft
• Zoloft belongs to the group of antidepressants known as Serotonin Reuptake Inhibitors (SSRIs).
• Zoloft (known generically as sertraline) is a drug used to treat depression, obsessive-compulsive disorder, panic disorder, post-traumatic stress disorder (PTSD) and premenstrual dysphoric disorder.
• The SSRI was approved by the Food and Drug Administration (FDA) to treat depression in 1992. Currently, it is among the most widely prescribed SSRI antidepressants in the United States.
• In November 2006, concerns arose when the FDA added a warning to the prescribing information noting that women who took the drug after 20 weeks of pregnancy had a six times greater risk of their newborn having PPHN.
• A September 2009 study published in BMJ (the British Medical Journal) found that Zoloft taken in the first trimester increased the risk of heart defects.
• The FDA currently categorizes Zoloft as pregnancy Category C. This label means that it is possible animal studies have indicated fetal harm from maternal use of the drug, but human trials have not yet determined that the risks of using Zoloft during pregnancy outweigh the drug’s intended benefits.