United States District Court, D. Massachusetts
IN RE ZOFRAN (ONDANSETRON) PRODUCTS LIABILITY LITIGATION, This Document Relates To All Actions
MEMORANDUM AND ORDER ON PLAINTIFFS' MOTION TO
AMEND THE MASTER COMPLAINTS
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. 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
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.
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.
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.
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.
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
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.
otherwise noted, all facts are stated as set forth in the
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).
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).
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. ¶
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 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).
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).
Allegations of Misrepresentation in Current Master
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. Individual plaintiffs then
subsequently filed short-form complaints adopting a master
complaint with more detailed individual information
concerning their claims.
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).
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
(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). 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 ...