The Judicial Panel on Multi-District Litigation issued an order on April 17, 2012, establishing MDL No. 2342 styled In Re: Zoloft (setraline hydrochloride) Products Liability Litigation. This order will establish coordinated multi-district proceedings in the federal court in the Eastern District of Pennsylvania for lawsuits that have been filed on behalf of children who have suffered birth defects attributable to their mother’s use of Zoloft during pregnancy.
This initial order transfers more than 50 individual lawsuits against Pfizer and Greenstone (the manufacturer of a generic version of Zoloft), which had been pending in federal courts in New York, Mississippi, Missouri, and Ohio. Most of the cases that are part of this initial order were originally filed in federal court in Philadelphia or removed from state court in Pennsylvania. Many of the state court actions also included Wolters Kluwer Health as a party. This company writes the warning materials that are often included on pharmacy receipts for Zoloft. These abbreviated warnings, which are often the only warnings seen and relied upon by patients, are frequently antiquated and inaccurate, especially when the brand name drug manufacturer has failed to update its official warning label in a timely fashion as new drug-related safety issues have emerged. Pfizer had requested that the cases be transferred to a federal court in New York, rather than the Pennsylvania forum favored by the plaintiffs.
These cases will focus on the fact that the warning label for Zoloft does not adequately convey to pregnant women and their doctors that use of Zoloft during pregnancy may cause a number of birth defects. Zoloft was first approved by the FDA in 1991. The SSRI drug is approved for use in patients with obsessive-compulsive disorder (OCD), panic disorders, post-traumatic stress disorder (PTSD), pre-menstrual dysphoric disorder (PMDD), and social anxiety disorder (SAD). A generic form of Zoloft has been available since 2006.
There are growing concerns about the safety of use of all of the serotonin reuptake inhibitor (SSRI) drugs by pregnant women. This class of drugs also includes:
- Paxil CR
- Luvox CR
- citalopram (Generic formulation)
- escitalopram (Generic formulation)
- fluoxetine (Generic formulation)
- fluvoxamine (Generic formulation)
- paroxetine (Generic formulation)
- sertraline (Generic formulation)
- vilazodone (Generic formulation)
The FDA issued a safety alert on December 14, 2011, with regard to potential risks of Persistent Pulmonary Hypertension of the Newborn (PPHN) associated with use of SSRI drugs during pregnancy. PPHN is a serious and often life-threatening heart and lung condition. Unfortunately, there are conflicts in the data, such that the FDA was unable to provide clear guidance to patients and their obstetricians in weighing the risks versus the benefits of using SSRI antidepressants during pregnancy.
There is also evidence that use of anti-depressants during pregnancy may cause a number of other serious birth defects and conditions, including:
- atrial defects
- septal defects
- cardiac malformations
- autism spectrum disorder
- neural tube defects
- anal atresia
- cleft lip and cleft palate
- limb defects
- premature birth
At this time, only the package insert for Paxil includes an enhanced warning about potential risks to the fetus. Approximately 800 lawsuits involving Paxil were filed in state court in Philadelphia several years ago. It is reported that most of these cases were resolved as a part of a $1 billion settlement with GlaxoSmithKline. It is anticipated that additional cases will be filed against SSRI drug manufacturers Eli Lilly (Prozac), GlaxoSmithKline (Paxil), Forest Laboratories (Celexa and Lexapro), Pfizer (Effexor, Zoloft, and Pristiq), and others in the coming months.
Resources for additional information on the treatment of depression during pregnancy and the risks of SSRI drugs:
March of Dimes
Organization of Teratology Information Specialists
The Maternal & Child Health Library at Georgetown University
U.S. Department of Health and Human Services
Food and Drug Administration