US District Judge F. Dennis Saylor IV shot down a defense motion and allowed fraud claims filed by 365 plaintiffs to proceed, charging that manufacturer GlaxoSmithKline (GSK) marketed Zofran to pregnant women, knowing it would cause birth defects.
The judge is overseeing litigation in In Re: Zofran (Ondansetron) Products Liability Litigation, MDL No. 2657 in the District of Massachusetts.
“[b]ecause plaintiffs adequately pleaded the content, time, and place of the allegedly false representations made in Zofran’s product labeling, the fraud-based claims premised on that misrepresentation satisfy the requirements of Rule 9(b),” the judge said. “Whether those representations were actually false is, of course, a question for another day.”
There are three categories of alleged misrepresentations in this case.
- The first category consists of statements allegedly made by GSK in its advertising, marketing, and promotional materials—in other words, statements made generally to the marketplace.
- The second category consists of specific statements made by GSK representatives to prescribing physicians, including statements made by sales representatives to physicians, or specific written materials provided to individual physicians.
- The third category consists of statements made in Zofran’s product labeling.
Serotonin receptor antagonist
The allegations are in either the master complaints or the individual short-form complaints. The plaintiffs are represented by Tobias L. Millrood of Pogust Braslow & Millrood LLC, Kimberly D. Barone Baden of Motley Rice LLC, M. Elizabeth Graham of Grant & Eisenhofer PA, and Robert K. Jenner of Janet Jenner & Suggs LLC and and Kimberly Dougherty of Andrus Wagstaff.
Zofran is an anti-emetic referred to as selective serotonin 5-HT3 receptor antagonists. Serotonin signaling in the body triggers nausea and vomiting. The active ingredient in Zofran, ondansetron, is believed to alleviate symptoms of nausea and vomiting by inhibiting the body’s serotonin signaling.
Serotonin signaling regulates developmental processes that are critical to normal embryonic development. Inhibiting serotonin signaling during embryonic development can therefore increase the risk of birth defects. According to the complaint, pre-clinical studies conducted by or on behalf of GSK in the 1980s revealed that Zofran ingested by mammals—in particular, rats and rabbits—during pregnancy crosses the placental barrier, exposing the fetus to the drug. The complaint alleges that subsequent scientific research has confirmed that Zofran also crosses the placental barrier during human pregnancies.
According to the complaint, animal studies conducted by or on behalf of GSK in the 1980s in Japan revealed clinical signs of toxicity, intrauterine fetal deaths, stillbirths, congenital heart defects, craniofacial defects, impairment of ossification (incomplete bone growth), and other malformations in fetuses exposed to Zofran during gestation. The complaint also alleges that from 1992 to the present, GSK has received reports—either directly or through studies published in medical literature—of birth defects in children exposed to Zofran or ondansetron during pregnancy.
GSK marketing scheme
Around 1997, GSK launched a marketing scheme to promote Zofran to obstetrics and gynecology healthcare practitioners and consumers as a safe and effective treatment for pregnancy-related nausea and vomiting.
According to the complaint, “[a]s a result of GSK’s fraudulent marketing campaign,” by 2002 Zofran had become the most frequently prescribed drug for treating pregnancy-related nausea and vomiting in the United States.
Since 1993, the prescribing information for Zofran has included the following statement about its use during pregnancy:
Pregnancy: Teratogenic Effects: Pregnancy Category B. Reproduction studies have been performed in pregnant rats and rabbits at I.V. doses of up to 4 mg/kg per day and have revealed no evidence of impaired fertility or harm to the fetus due to ondansetron. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
The complaint alleges that “[t]his statement is false and misleading because animal studies conducted by or on behalf of GSK outside of the United States have in fact revealed evidence of teratogenic effects due to ondansetron.” It further alleges that the statement is false and misleading “because [d]efendants failed to conduct post-market studies that were properly designed to identify Zofran’s true teratogenic risk.”