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In re Zofran (Ondansetron) Products Liability Litigation

United States District Court, D. Massachusetts

May 18, 2018



          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. In their master long-form complaints, plaintiffs alleged claims of misrepresentation in addition to more standard product-liability claims such as negligence and breach of warranty. Specifically, the master complaints alleged that defendant GlaxoSmithKline LLC 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. Based on those allegations, they asserted claims for negligent misrepresentation, fraudulent misrepresentation, and violation of state consumer-protection statutes.[1]

         On April 24, 2017, the Court dismissed the claims based on allegedly fraudulent marketing and advertising for failure to comply with the heightened pleading standards of Fed.R.Civ.P. 9(b). It did not, however, dismiss the claims for misrepresentation arising out of the FDA-approved label.

         Plaintiffs have now moved to amend the master complaints to reassert claims of misrepresentation based on marketing and advertising and other “off-label” representations. In substance, plaintiffs contend that discovery has revealed the existence of a widespread and fraudulent marketing scheme by GSK representatives that was intended to promote the use of Zofran notwithstanding its dangers. They contend that the evidence derives from internal GSK documents, and that those documents could not reasonably have been discovered prior to filing suit.

         Plaintiffs seek to amend the master complaints to assert claims for misrepresentation only in general terms, identifying particular misrepresentations that were allegedly made by GSK representatives over the years. Individual plaintiffs would then adopt those allegations that apply to their particular circumstances. Defendant GSK has opposed the motion to amend on grounds of futility and undue delay.

         The Court agrees that the motion is untimely and will deny it on that basis, without reaching the issue of futility. To begin, a motion to dismiss has been granted on the very same issue; as a general matter, plaintiffs are not permitted to amend a complaint after dismissal to try to cure problems pointed out by the court. Here, however, plaintiffs contend that discovery has produced new evidence, and that the amended complaint could not have been brought in its present form before that information was uncovered.

         The basic problem with that argument is that it conflates the evidence of the representations made by GSK representatives with the evidence of the alleged falsity of those representations. The representations at issue have not been hidden from view: to the contrary, they were allegedly made to plaintiffs' physicians (who, plaintiffs say, relied on them). The representations were largely made openly-in fact, according to plaintiffs, they were made as part of a huge marketing campaign, and were published or broadcast to thousands of physicians nationwide. Thus, that information has been actually or constructively available to plaintiffs from the very beginning. What has been hidden, if at all, is evidence that those representations were false, or part of a widespread scheme.

         Regardless, Rule 9(b) requires that claims of fraud be pleaded with specificity. Such claims are not to be made in general terms, with the details of the alleged misrepresentation to be filled in once discovery has occurred. Accordingly, and for the reasons set forth below, the proposed amendment of the master complaint to add new misrepresentation claims is untimely, and the motion to amend will therefore be denied.

         I. Background

         Unless otherwise noted, all facts are stated as set forth in the master complaints.[2]

         A. 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).

         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. (Id. ¶ 1).

         B. 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. ¶ 17). 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. (Id. ¶ 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).

         C. Allegations of Misrepresentation in Current Master Complaint

         In response to this Court's order dated May 18, 2016, plaintiffs filed a brand-name master complaint and generic master complaint on May 31, 2016.[3] Individual plaintiffs then subsequently filed short-form complaints adopting a master complaint with more detailed individual information concerning their claims.

         According to the current master 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 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.

(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).[4] 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 ...

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