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In re Zofran Ondansetron Products Liability Litigation

United States District Court, D. Massachusetts

April 24, 2017

IN RE ZOFRAN ONDANSETRON PRODUCTS LIABILITY LITIGATION, This Document Relates To: All Actions

          MEMORANDUM AND ORDER ON DEFENDANT'S MOTION TO DISMISS FRAUD-BASED CLAIMS

          F. Dennis Saylor IV United States District Judge

         This is a multi-district litigation (MDL) proceeding arising out of product-liability claims that the use of the drug Zofran by pregnant women caused birth defects. Plaintiffs allege, among other things, that defendants made false and misleading statements and omissions about the use of Zofran during pregnancy in their marketing, advertising, and product labeling, and in other oral and written communications.

         Defendant GlaxoSmithKline LLC has moved to dismiss plaintiffs' fraud-based claims for failure to plead with particularity as required by Fed.R.Civ.P. 9(b). For the reasons stated below, the motion will be denied. The allegations of the complaint are inadequate to state a claim for fraud based on GSK's alleged marketing and advertising campaign, and there are no allegations at all that any specific GSK representative made a false statement to a prescribing physician. Nonetheless, the allegations of fraud as to the product labeling of Zofran are sufficiently particular to satisfy the requirements of Rule 9(b).

         I. Background

         A. Facts Common to All Cases

         Unless otherwise noted, all facts are stated as set forth in the master complaints.[1]

         1.The Parties and Zofran

         GlaxoSmithKline LLC ("GSK") is a pharmaceutical company based in Wilmington, Delaware. (Master Long Form Complaint-Brand Zofran Use ("Compl.") ¶¶ 2-3). It is a subsidiary of GlaxoSmithKline PLC. (Id. ¶ 4). Until March 23, 2015, GSK was the sponsor of the new drug applications ("NDAs") for the pharmaceutical Zofran, or ondansetron. (Id. ¶ 6).

         Zofran is an anti-emetic-that is, a drug that prevents or treats nausea or vomiting. (Id. ¶ 17). In 1991, Zofran was approved for marketing in the United States. (Id. ¶ 23). It was approved for the prevention of nausea and vomiting induced by chemotherapy or radiation therapy and post-operative nausea and vomiting. (Id. ¶ 16). Generic ondansetron became available in the United States in 2007. (Master Long Form Complaint-Generic Use ("Generic Compl.") ¶27).

         Effective March 23, 2015, Novartis AG, a pharmaceutical company based in Switzerland, purchased the right to sell Zofran products in the United States. (Compl. ¶ 7). At that time, Novartis Pharmaceuticals Corporation, an American-based subsidiary of Novartis AG, become the NDA holder for Zofran. (Id.).

         The plaintiffs in this MDL proceeding are parents and guardians of children who allege that they were born with birth defects caused by prenatal exposure to Zofran and/or generic ondansetron. (Compl. ¶ 1).

         2. Alleged Effects of Zofran/Ondansetron on Embryonic Development

         Zofran is part of a class of anti-emetics referred to as selective serotonin 5-HT3 receptor antagonists. (Id.). Serotonin signaling in the body triggers nausea and vomiting. (Id. ¶ 19). The active ingredient in Zofran, ondansetron, is believed to alleviate symptoms of nausea and vomiting by inhibiting the body's serotonin signaling. (Id.).

         Serotonin signaling regulates developmental processes that are critical to normal embryonic development. (Id. ¶ 20). Inhibiting serotonin signaling during embryonic development can therefore increase the risk of birth defects. (Id.). 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. (Id. ¶ 43). The complaint alleges that subsequent scientific research has confirmed that Zofran also crosses the placental barrier during human pregnancies. (M¶44).

         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. (Id. ¶ 45). 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. (Id. ¶ 46).

         3. Alleged Off-Label Marketing of Zofran for Pregnancy-Related Nausea and Vomiting

         According to the complaint, beginning 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." (Id. ¶ 29). Among other things, GSK's Oncology Division directly created new relationships with obstetricians and gynecologists, and also partnered with GSK's Consumer Health Care Division, which already had established relationships with obstetricians and gynecologists. (Id. ¶ 32). The two divisions allegedly entered a "co-marketing agreement" in 2001 to market Zofran to obstetricians and gynecologists for use in treating pregnancy-related nausea and vomiting. (Id. ¶¶ 33-34). 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. (Id. ¶ 36).

         Since 1993, the prescribing information for Zofran has included the following statement concerning its use during pregnancy:

Pregnancy: Teratogenic Effects: Pregnancy Category B. Reproduction studies have been performed in pregnant rats and rabbits at IV. 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.

(Id. ¶ 50). 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." (Id. ¶ 51).[2] 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, " and misleading "because it states that Zofran should be used during pregnancy if it is clearly needed, without limiting that representation to situations where it is clearly needed for the prevention of chemotherapy-induced nausea and vomiting, radiation therapy-induced nausea and vomiting, or post-operative nausea and/or vomiting." (Id.).

         Count Two alleges a claim for negligent misrepresentation. It alleges generally that defendants "falsely and negligently misrepresented material facts on which plaintiffs and their healthcare providers acted, " and that defendants "also failed to disclose material facts regarding the safety and efficacy of Zofran to treat morning sickness." (Id. ¶¶ 72, 73). It further alleges that defendants "made misrepresentations through their advertisements, labeling, marketing, marketing persons, notices, product information, and written and oral information provided to patients and medical providers" about the safety of ingesting Zofran during pregnancy. (Id. ¶ 76). It then alleges:

77. Defendants negligently represented to the expectant mothers and the medical and healthcare community, including Plaintiffs and their healthcare providers, that:
(a) Animal studies of ondansetron showed no harm to fetuses;
(b) Zofran should be used during pregnancy if it is clearly needed, without limiting that representation to situations where it is clearly needed for the prevention of chemotherapy-induced nausea and vomiting, radiation therapy-induced ...

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