A Winnebago County couple has filed a lawsuit alleging that the side effects of Zoloft/sertraline use during pregnancy caused their infant to develop severe birth defects and die after birth.
Ryan and Justyne Eaton’s Jan. 3 complaint, pending in the U.S. District Court for the Eastern District of Pennsylvania, alleges that their daughter, Aubrey, was born with brain malformations, hydrocephalus and pulmonary hypoplasia, resulting in her death Jan. 6, 2010.
The 42-page pleading contains 12 counts, including strict product liability, failure to warn, defective design, negligence/malice, fraud, breach of warranties, a violation of the Wisconsin Consumer Fraud Act, and wrongful death. They seek compensatory and punitive damages.
Their lawsuit is one of about 270 that have been filed in federal court against the Zoloft’s developer and manufacturer, Pfizer, and the Greenstone LLC, the manufacturer of sertraline, its generic form.
The Eatons’ attorney, Ben Bertram of Bertram & Graf in Kansas City, Mo., said the mother had taken sertraline throughout her pregnancy.
Denying liability, Pfizer issued a written statement stating, “While we have great sympathy for all families dealing with birth defects, the Company stands by Zoloft and we intend to vigorously defend it.”
The statement emphasized that Zoloft is approved medicine by the Food and Drug Administration for the treatment of depression and other psychiatric conditions, and has been used by millions, including pregnant women.
Medical research suggests that 10-15 percent of women in their reproductive years suffer from major depression. SSRIs, which stands for “Selective Serotonin Reuptake Inhibitors,” are a class of drugs commonly used in treatment. Zoloft and sertraline are SSRIs.
Pfizer’s statement provides, “There is extensive science supporting the safety and efficacy of Zoloft, and the medicine carries accurate, science-based and FDA approved information on its benefits and risks. Considering the large patient population, very few cases have been filed to date.”
Last April, the Panel on Multidistrict Litigation consolidated the then-57 federal court actions before Judge Cynthia Rufe, observing that they involve common issues of fact, and that centralization will be convenient for parties and witnesses. The order reads, “Centralization will eliminate duplicative discovery; prevent inconsistent pretrial rulings; and conserve the resources of the parties, their counsel and the judiciary.”
By early spring, both sides will submit lists of cases for discovery, totaling 25. Discovery then will proceed, limiting the number of depositions for each case to eight. Depositions will be completed by the end of fall, before the submission of Daubert motions, to be heard next year.
The court then will select a handful of cases to be tried as “bellwethers,” or representative cases where the outcomes can be used to foster settlements of the remaining cases, or they may opt for trial as well. The first trial date is tentatively scheduled for Sept. 12, 2014.
The most significant hurdle for plaintiffs will be causation.
Bertram said the defense likely will probe for genetic or environmental factors causing the birth defects in the Eatons’ and other plaintiffs’ cases.
But research findings, expert opinions and government safety measures also will come into play.
An article in the Feb. 9, 2006, issue of the New England Journal of Medicine reported a significant association between the incidence of babies with Persistent Pulmonary Hypertension of the Newborn, or PPHN, a breathing disorder resulting in substantial morbidity and mortality, and their mothers taking SSRIs late in pregnancy.
In July 2007, the FDA issued an alert recommending “that physicians carefully consider and discuss with patients the potential risks and benefits of SSRI treatment throughout pregnancy, including late pregnancy.”
In 2008, the American College of Obstetricians and Gynecologists released guidelines recommending that treatment with SSRIs during pregnancy should be individualized. That recommendation hasn’t been altered.
However, in December 2011, the FDA followed up its previous alert with a safety announcement citing two studies that found an association between PPHN and SSRI use during pregnancy, and three that found no association. It concludes, “At present, FDA does not find sufficient evidence to conclude that SSRI use in pregnancy causes PPHN, and therefore recommends that healthcare providers treat depression during pregnancy as clinically appropriate.”
Pfizer’s written statement cited that same safety announcement.
“It is important to keep in mind that depression is a common but serious and potentially debilitating illness and there can be considerable risks if depression is left untreated, including during pregnancy. In fact, as recently as December 2011, the FDA revised its guidance regarding all SSRIs, the class of anti-depressants that includes Zoloft, advising health care professionals ‘not to alter their current clinical practice of treating depression during pregnancy.’ Indeed, the FDA warned that pregnant women who stop taking an SSRI are at risk of unwanted side effects or a relapse of depression.”
Moreover, in December the FDA approved labeling for Zoloft that doesn’t mention any increased risks of birth defects if taken during pregnancy. It advises them to notify their physician if they become pregnant or intend to become pregnant during therapy, and mentions the conflicted research advice.
Another central issue in the litigation, said Bertram, is the manner in which the drug manufacturers heavily marketed Zoloft to women of child-bearing years without warning of the potential outcomes if they became pregnant while on the drugs.
“The real issue here is allowing patient and the doctor to understand what they’re getting involved with when they embark on a treatment decision,” Bertram said.
“So if an infant is born with a general birth defect and neither the doctor or the patient never knew about the association between the drug and the possibility of having a child with a birth defect, then that’s taking the decision-making power away from the doctor and the patient. That’s a threshold issue that’s going to be present in every case.”
He noted that the Zoloft litigation merely is in its initial stages. Litigation regarding Paxil, also an SSRI, by comparison, is coming to a conclusion for the most part.
Milwaukee lawyer Jeff Pitman represents plaintiffs in dangerous drug cases.
“Cause is an obvious place for a pharma defendant to defend itself,” he said. “It seems like it will be a battle of the experts. It will be critical for the plaintiffs to boil their case down to some very simple concepts that a jury can understand.
“Only time will tell, along with jury verdicts, if the plaintiffs prove their cases,” he added. “Common sense would tell me, as a plaintiff lawyer, that the plaintiff attorney wouldn’t invest the substantial time and money required if she didn’t have the evidence and opinions to prove the case.”