United States District Court, D. Massachusetts
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
Dennis Saylor IV United States District Judge
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.
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
Facts Common to All Cases
otherwise noted, all facts are stated as set forth in the
Parties and Zofran
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).
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).
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.
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).
Alleged Effects of Zofran/Ondansetron on Embryonic
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.
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).
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).
Alleged Off-Label Marketing of Zofran for
Pregnancy-Related Nausea and Vomiting
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.
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
(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. ¶
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.).
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