Akerman v. GlaxoSmithKline, LLC (In re Zofran (Ondansetron) Prods. Liab. Litig.)
| Decision Date | 04 August 2017 |
| Docket Number | Case No. 1:16-cv-10199-FDS, Case No. 1:16-cv-11748-FDS, Case No. 1:16-cv-10665-FDS, Case No. 1:16-cv-12213-FDS,Case No. 1:16-cv-12471-FDS, Case No. 1:15-cv-13749-FDS,MDL No. 1:15–md–2657–FDS |
| Citation | 261 F.Supp.3d 62 |
| Parties | IN RE: ZOFRAN (ONDANSETRON) PRODUCTS LIABILITY LITIGATION, This Document Relates To: Akerman v. GlaxoSmithKline, LLC Case No. 1:16–cv–12471–FDS; Easterly v. GlaxoSmithKline, LLC Case No. 1:15–cv–13749–FDS; Green v. GlaxoSmithKline, LLC Case No. 1:16–cv–10665–FDS; Gulick v. GlaxoSmithKline, LLC Case No. 1:16–cv–12213–FDS; Perham v. GlaxoSmithKline, LLC Case No. 1:16–cv–10199–FDS; Rice v. GlaxoSmithKline, LLC Case No. 1:16–cv–11748–FDS. |
| Court | U.S. District Court — District of Massachusetts |
MEMORANDUM AND ORDER ON DEFENDANT'S CONSOLIDATED MOTION TO DISMISS FOR FAILURE TO PLEAD USE OF ITS PRODUCT; DEFENDANT'S SUPPLEMENTAL CONSOLIDATED MOTION TO DISMISS; AND PLAINTIFFS' MOTION TO CERTIFY QUESTIONS OF LAW TO STATE COURTS
This is a multi-district litigation ("MDL") proceeding arising out of claims that the use of the drug Zofran
by pregnant women caused birth defects. Plaintiffs allege, among other things, that defendant GlaxoSmithKline LLC ("GSK") negligently and fraudulently promoted Zofran
to treat pregnancy-related nausea and vomiting despite its knowledge of risks associated with taking the drug during pregnancy and its failure to adequately study and warn of that risk.
Certain plaintiffs also allege that GSK should be liable for injuries caused by the ingestion of the generic formulation of Zofran
, due to the widespread off-label promotion of Zofran by GSK for use to treat morning sickness. In other words, those plaintiffs allege that GSK may be held liable even though it did not manufacture or sell the product that caused their injuries.
GSK has moved to dismiss the claims of various plaintiffs who allege that they ingested only the generic formulation of the drug.1 Plaintiffs have opposed those motions and, in the alternative, have moved to certify the following question to the highest courts of the relevant states:
Is a brand-name drug manufacturer immunized from liability under this state's misrepresentation laws even when the brand-name drug manufacturer's misrepresentations created a market for the drug for an unapproved use in an untested population, resulting in injuries to consumers who ingested a generic version of the drug for that unapproved use?
(Pl. Mot. to Certify at 1). For the reasons stated below, defendant's motion to dismiss will be granted, and plaintiffs' motion to certify will be denied.
A.Factual Background
GlaxoSmithKline LLC 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).
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).
/Ondansetron on Embryonic Development
is part of a class of anti-emetics referred to as selective serotonin 5–HT3 receptor antagonists. (Id. at ¶ 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).
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 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).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. ).
The complaint alleges claims for, among other things, negligence, fraudulent misrepresentation, the violation of state consumer protection laws, wrongful death, and loss of consortium. The crux of all of the claims is that defendants failed to perform an adequate study of the safety of ingesting Zofran
during pregnancy and promoted Zofran for use during pregnancy despite knowing of its teratogenic risks. As is particularly relevant here, the generic master complaint alleges that defendants' liability extends to those plaintiffs who ingested only generic ondansetron because it was reasonably foreseeable that promoting Zofran for use during pregnancy would result in patients being prescribed its generic alternative, once available. (See, e.g. , Generic Compl. ¶¶ 69, 91, 101, 117).
On October 13, 2015, the Judicial Panel on Multidistrict Litigation transferred individual cases alleging birth defects due to ingestion of Zofran
or ondansetron filed across the country to this Court for consolidated pretrial proceedings. In response to this Court's order dated May 18, 2016, plaintiffs filed a brand-name master complaint and a generic master complaint on May 31, 2016. Individual plaintiffs then subsequently filed short-form complaints adopting a master complaint with more detailed individual information concerning their claims.
The brand-name master complaint asserts 13 causes of action against defendants GSK and Novartis: negligence (Count 1); negligent misrepresentation (Count 2); negligent undertaking (Count 3); negligence per se (Count 4); failure to warn (Count 5); breach of express warranty (Count 6); breach of implied warranties (Count 7); fraudulent misrepresentation and concealment (Count 8); violation of state consumer protection laws (Count 9); wrongful death (Count 10); survival (Count 11); loss of consortium (Count 12); and punitive damages (Count 13). The...
To continue reading
Request your trial