Pfizer introduced the prescription drug Zoloft (sertraline chloride) to the market in 1991, and the drug became one of the most widely prescribed antidepressants in the U.S. Lawsuits accuse the multibillion-dollar drug company of promoting the drug to pregnant women even though studies linked Zoloft to birth defects. These defects include holes in the heart, cleft palate, club feet, spina bifida, skull defects and persistent pulmonary hypertension of the newborn (PPHN).
The latest Zoloft lawsuits claim the drug can lead to an increased risk of autism. The catalyst for Zoloft autism claims is the study led by Professor Anick Bérard of the University of Montreal.
Bérard and colleagues found women who used Zoloft and other SSRIs while pregnant had a 200 percent increase in the risk of having a child diagnosed with autism by age 7.
Plaintiffs say Pfizer failed to warn them of these side effects and marketed and sold a dangerous drug.
Zoloft product liability litigation has been slow moving, partially because Judge Cynthia M. Rufe — the presiding judge over consolidated federal cases in Philadelphia — ruled that plaintiffs have yet to prove the drug can cause birth defects. As a result, only a handful of federal cases remain.
In addition to individual state and federal lawsuits, there was also a Zoloft class action lawsuit that was dismissed in 2014. Despite the litigation setbacks, some attorneys are still accepting cases.
Zoloft Multidistrict Litigation (MDL) No. 2342
In 2012, the Judicial Panel on Multidistrict Litigation Zoloft consolidated birth defect cases in multidistrict litigation (MDL) in the U.S. District Court for the Eastern District of Pennsylvania under Judge Cynthia M. Rufe. There were more than 700 lawsuits in the MDL. As of August 2017, only 17 remained.
In addition to the MDL, there were several other lawsuits filed in state courts in Alabama, California, Illinois, Missouri, New York, Pennsylvania and West Virginia. About 25 adults who suffered birth defects after their mothers took Zoloft while pregnant filed lawsuits in West Virginia.
In 2015, Rufe ruled that a number of plaintiffs’ witnesses could not testify as experts. Barred experts included Dr. Anick Bérard, whose study found a link between autism and Zoloft, and Dr. Nicholas Jewell a biostatistics professor from the University of California at Berkeley. Jewell’s testimony provided data that linked Zoloft to birth defects, plaintiffs lawyers said.
In April 2016, Judge Rufe dismissed more than 300 lawsuits from the MDL without a trial. According to Rufe, plaintiffs failed to produce enough evidence — in part because of lack of expert witnesses — to link Zoloft and birth defects. Other plaintiffs chose to voluntarily dismiss their claims.
“The court recognizes that the final scientific verdict as to whether Zoloft can cause birth defects may not be delivered for many years,” Rufe wrote in her order. “Nevertheless, plaintiffs chose when to file their cases, and the court concludes that for the plaintiffs who have continued to pursue their claims, the litigation gates must be closed.”
In January 2017, the U.S. Court of Appeals for the Third Circuit heard arguments by plaintiffs’ attorneys against Rufe’s order excluding Dr. Jewell’s testimony. But, the appeals court upheld Rufe’s decision in June 2017.
“Courts are supposed to ensure that the testimony given to the jury is reliable and will be more informative than confusing,” Circuit Judge Jane Roth, a member of the appeals panel, wrote. “Dr. Jewell’s application of his purported methods does not satisfy this standard.”
Zoloft Class Action Lawsuit
In 2013, attorneys filed a Zoloft class action lawsuit. This class action is separate from the MDL. The lawsuit alleges Pfizer launched a massive marketing campaign designed to convince patients and doctors that Zoloft is effective and safe in treating depression, when the majority of clinical trial data does not prove its efficacy.
In September 2014, U.S. District Judge Lucy H. Koh granted Pfizer’s motion to dismiss the case with prejudice.
Lawyers filed the class action in the U.S. District Court for the Northern District of California, on behalf of Laura A. Plumlee. Plumlee’s lawyers also filed the lawsuit on behalf of consumers nationwide and in California who purchased Zoloft for the treatment of depression from 1991 to the present. According to the lawyers, the lawsuit is on behalf of “millions of consumers who were tricked into purchasing Zoloft.”
Unlike the multidistrict litigation, plaintiffs may opt to join a class action if eligible, but do not go to trial or seek settlement for their individual damages. According to the lawsuit, Pfizer withheld the truth about Zoloft’s lack of safety and effectiveness in treating depression.
The lawsuit claimed:
- Majority of clinical trials showed Zoloft was not superior to placebo
- Only two studies showed Zoloft was minimally better than placebo
- Pfizer manipulated clinical trial data
- Pfizer paid prominent doctors to say Zoloft was effective
- Pfizer purposefully hid negative Zoloft studies from patients and doctors
- The drugmaker purposefully deceived the public and made it impossible for prescribing physicians to adequately weigh the risks and benefits of the drug.
Zoloft Side Effects Claimed in Lawsuits
Plaintiffs in Zoloft birth defect litigation claim the antidepressant caused a variety of conditions, including autism. While various studies linked Zoloft to birth defects, the FDA only alerted the public about an increased risk of neonatal persistent pulmonary hypertension.
In its July 2006, the FDA wrote: “A recently published case-control study has shown that infants born to mothers who took selective serotonin reuptake inhibitors (SSRIs) after the 20th week of pregnancy were 6 times more likely to have persistent pulmonary hypertension (PPHN) than infants born to mothers who did not take antidepressants during pregnancy.”
Side Effects mentioned in lawsuits include:
- Atrial septal defects (ASD)
- Ventricular septal defects (VSD)
- Persistent pulmonary hypertension of the newborn (PPHN)
- Omphalocele (abdominal defects)
- Craniosynostosis (skull defects)
- Tetralogy of fallot (TOF) with pulmonary atresia
- Transposition of the great arteries
- Club feet
- Spina bifida
- Congenital heart defects
Plaintiffs are seeking compensation to help with medical bills, continuing care for their children, lost wages, pain and suffering, and other damages. In some cases, juries may award punitive damages to discourage drug manufacturers from exposing the public to these types of adverse effects.
Examples of Zoloft Lawsuits
Hundreds filed lawsuits against Pfizer claiming Zoloft caused birth defects in their children. The range of injuries claimed by each family varies in severity, and some children died because of multiple defects. Families of these children claim Pfizer failed to warn them of the risks.
“Prior to initial approval in 1991, Pfizer’s preclinical animal studies demonstrated significant harm to animal fetuses when Zoloft was administered during pregnancy, including increased mortality and birth defects,” according to lawsuits. “Pfizer knew about these adverse side effects, yet, without further testing, Pfizer began marketing and selling Zoloft to healthcare providers and the public.”
Eaton vs. Pfizer
Ryan and Justyne Eaton of Wisconsin filed their lawsuit in January 2013 over the wrongful death of their daughter, Aubrey. Justyne took Zoloft while pregnant with Aubrey, and she was born with multiple birth defects — including malformations of the brain, severe fluid buildup in the skull that damaged the brain, and lung defects. Aubrey died as an infant from these defects.
The Eatons claim that Pfizer knew or should have known that Zoloft posed an increased risk of birth defects. According to the lawsuit, the drugmaker “took no action to adequately warn or remedy the risks, but instead concealed, suppressed, and failed to disclose the dangers.”
Reese vs. Pfizer
Tyreke Reese, 21, of Boston filed a lawsuit in June 2012 against Pfizer after she suffered birth defects because her mother took Zoloft during pregnancy. Reese was born with multiple heart defects, including an atrial septal defect, which leaves a hole between the top two chambers of the heart.
Byington vs. Pfizer
A couple from Idaho, Jade and Jason Byington, sued Pfizer in July 2012. Their daughter, Sadie, was born with a malformed heart. The infant had an atrial septal defect, a ventricular septal defect and narrowing of the aorta.
Ciccone vs. Pfizer
Denise Ciccone of Pennsylvania took Zoloft during her pregnancy. Her daughter, Noelle, suffered birth defects, including clubbed foot and heart problems. Noelle was born in 2002, and the family filed the lawsuit in August 2012.
These and other lawsuits against Pfizer accuse the company of several counts of negligence, including:
- Producing, marketing and selling Zoloft, a dangerous drug
- Negligence for failing to warn the public, medical professionals and the FDA that Zoloft caused birth defects
- Failing to conduct post-marketing safety surveillance and report information to the medical community
- Failing to disclose the results of Zoloft studies
- Misrepresenting that Zoloft is safe for use by pregnant women
- Promoting and marketing the drug to pregnant women even when it knew studies linked it to increased risk of birth defects
- Failure to act responsibly and in the best interest of the public
Michelle Y. Llamas is a senior content writer. She is also the host the Drugwatch Podcast where she interviews medical experts as well as patients affected by drugs and medical devices. She has written medical and legal content for six years — including an article in The Journal of Palliative Medicine. Prior to writing for Drugwatch, she spent several years as a legal assistant for a personal injury law firm in Orlando. She obtained her Bachelor of Arts in English – Technical Communication from the University of Central Florida. She is a member of the American Medical Writers Association and the Florida Writers Association.