Will Nicholas Jewell, a renowned Ph.D. biostatistician, get his chance to testify in In re Zoloft Products Liability Litigation? More than 300 mothers in 45 states who charge that the antidepressant caused heart defects in their newborns hope he will.
It’s up to the Third US Circuit Court of Appeals, which will decide whether US District Judge Cynthia M. Rufe of the Eastern District of Pennsylvania erroneously excluded him as a causation expert last April. The judge also granted summary judgment to defendant Pfizer and effectively wiped out the caseload in MDL 2342.
Judge is “armchair scientist”
Calling the judge an “armchair scientist,” the plaintiffs argue that the court “superimposed its own standard of sound science,” and disregarded Jewell’s 40 years of experience.
The case is Jennifer Adams v. Wolters Kluwer, No. 16-2247 in the Third Circuit. Leading the effort to revive the litigation are plaintiff attorneys Mark P. Robinson, Jr. of Robinson Calcagnie, Inc. in Newport Beach, CA, Dianne M. Nast of Nastlaw LLC in Philadelphia, PA, and David C. Frederick, Derek T. Ho and Hilary P. Gerzhoy of Kellogg, Huber, Hansen, Todd, Evans & Figel, PLLC in Washington, D.C.
Jewell is highly qualified:
- He has been a professor of biostatistics (the statistical design and analysis of studies that investigate risk factors for disease) for nearly four decades, first at Princeton University.
- For the last 33 years, he has been a professor at the University of California (Berkeley).
- He authored a widely used textbook, Statistics for Epidemiology, and 160 peer-reviewed articles on biostatistics.
- He is also the editor of the Journal of the American Statistical Association, the country’s preeminent peer-reviewed statistics journal.
Zoloft triples the risk
Jewell reviewed multiple peer-reviewed epidemiological studies involving hundreds of thousands of women, and concluded that taking Zoloft (sertraline) during pregnancy can as much as triple the risk for having babies with serious, life-altering heart defects.
He employed a “weight of the evidence” methodology using established criteria developed by English epidemiologist Sir Austin Bradford Hill. This methodology has been generally accepted in the scientific community for decades.
However Judge Rufe ruled that a causation opinion must be supported by “repeated, consistent, statistically significant human epidemiological findings.”
In fact, four published peer-reviewed studies did find a statistically significant increased risk of cardiac birth defects with Zoloft use during pregnancy.
Further, the plaintiffs argue that the judge’s doubt about Jewell’s methodology usurps the role of the jury, and that questions about his analysis are properly left to cross-examination and trial.
For 30 years, the scientific community has been aware that serotonin reuptake inhibitiors (SSRIs), including Zoloft, are potential teratogens (i.e., agents that affect the development of eggs, sperm, or embryos and therefore increase the risk of birth defects).
In 1988, a Pfizer report warned that “[s]ertraline should not be administered to pregnant or lactating females.” In 1995, the Food and Drug Administration sent a letter to Pfizer that it was “necessary to change the pregnancy category of Zoloft® from B to C” (drugs that have caused or may be suspected of causing, harmful effects on the human fetus).
The four studies that the court disregarded include:
Colvin (2011). Lyn Colvin, et al., Dispensing Patterns and Pregnancy Outcomes for Women Dispensed Selective Serotonin Reuptake Inhibitors in Pregnancy, 91 Birth Defects Res. A Clin. Mol. Teratol. 142 (2011), a study including 123,405 pregnancies from 2002 to 2005 in Western Australia, found a positive association between Zoloft exposure and cardiovascular defects.
Ban (2014). Lu Ban, et al., Maternal depression, antidepressant prescriptions, and congenital anomaly risk in offspring: a population-based cohort study, 121 BJOG 1471 (2014), a study including 349,127 births from 1990 to 2009 in the U.K., found a positive association between Zoloft exposure and cardiovascular defects.
Huybrechts (2014). Krista F. Huybrechts, et al., Antidepressant Use in Pregnancy and the Risk of Cardiac Defects, 370 N. Engl. J. Med. 2397 (2014), a study that included 949,504 U.S. pregnancies from 2000 to 2007, found a positive association between Zoloft exposure and cardiac malformations.
Furu (2015). Kari Furu, et al., Selective serotonin reuptake inhibitors and venlafaxine in early pregnancy and risk of birth defects: population based cohort study and sibling design, 350 British Med. J. 1798 (2015), a study that included 2.3 million births in Denmark, Finland, Iceland, Norway, and Sweden from 1996 to 2010, found a positive association between Zoloft exposure and all cardiac defects.
“Under the correct legal standard, Dr. Jewell’s analysis easily clears Rule 702’s bar for admissibility,” the plaintiffs argue.