United States District Court, D. Massachusetts
IN RE ZOFRAN ONDANSETRON PRODUCTS LIABILITY LITIGATION, This Document Relates To Farrington
GlaxoSmithKline, LLC, Case No. 1:16-12290-FDS; and Varrichione
GlaxoSmithKline, LLC, Case No. 1:15-cv-13899-FDS.
MEMORANDUM AND ORDER ON DEFENDANT'S MOTION FOR
JUDGMENT ON THE PLEADINGS
Dennis Saylor IV United States District Judge.
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
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
has moved for judgment on the pleadings to dismiss the claims
of three plaintiffs who allege that they ingested only the
generic formulation of the drug. On August 4, 2017, the Court
granted a motion to dismiss six individual complaints based
on similar arguments. For the reasons stated below, the
present motion to dismiss will also be granted.
October 13, 2016, GSK filed a motion to dismiss the claims of
six individual plaintiffs who alleged that they ingested only
the generic formulation of the drug. Plaintiffs opposed those
motions and, in the alternative, moved to certify a question
to the highest courts of the relevant states. On August 4,
2017, the Court granted the motion to dismiss, finding that
the relevant states, which included Oklahoma, would not
impose liability on a brand-name manufacturer for injuries
caused by ingestion of generic drugs. It also denied the
request for certification.
October 27, 2017, GSK moved for judgment on the pleadings on
the claims of seven additional plaintiffs who alleged that
they ingested the generic version of the drug. As a result of
voluntary dismissals, only three cases subject to the motion
12(c) motion for judgment on the pleadings “is treated
much like a Rule 12(b)(6) motion to dismiss.”
Perez-Acevedo v. Rivero-Cubano, 520 F.3d 26, 29 (1st
Cir. 2008). It differs from a Rule 12(b)(6) motion primarily
because it is filed after the close of pleadings and
“implicates the pleadings as a whole.”
Aponte-Torres v. Univ. of P.R., 445 F.3d 50, 54-55
(1st Cir. 2006). Because a Rule 12(c) motion “calls for
an assessment of the merits of the case at an embryonic
stage, the court must view the facts contained in the
pleadings in the light most favorable to the nonmovant and
draw all reasonable inferences therefrom to the
nonmovant's behoof.” R.G. Financial Corp. v.
Vergara-Nunez, 446 F.3d 178, 182 (1st Cir. 2006).
motion to dismiss, the Court “must assume the truth of
all well-plead[ed] facts and give . . . plaintiff the benefit
of all reasonable inferences therefrom.” Ruiz v.
Bally Total Fitness Holding Corp., 496 F.3d 1, 5 (1st
Cir. 2007) (citing Rogan v. Menino, 175 F.3d 75, 77
(1st Cir. 1999)). To survive a motion to dismiss, the
complaint must state a claim that is plausible on its face.
Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570
(2007). That is, “[f]actual allegations must be enough
to raise a right to relief above the speculative level, . . .
on the assumption that all the allegations in the complaint
are true (even if doubtful in fact).” Id. at
555 (citations omitted). “The plausibility standard is
not akin to a ‘probability requirement, ' but it
asks for more than a sheer possibility that a defendant has
acted unlawfully.” Ashcroft v. Iqbal, 556 U.S.
662, 678 (2009) (quoting Twombly, 550 U.S. at 556).
Dismissal is appropriate if the facts as alleged do not
“possess enough heft to show that plaintiff is entitled
to relief.” Ruiz Rivera v. Pfizer Pharm., LLC,
521 F.3d 76, 84 (1st Cir. 2008) (alterations omitted)
(internal quotation marks omitted).
discussed in the Court's opinion of August 4, 2017, a
person injured by a generic drug cannot normally sue either
the manufacturer of the product (that is, the generic
manufacturer) or the creator of the label (that is, the
brand-name manufacturer). Such a person therefore may not
have a legal remedy. (August 4, 2017 Mem. at 8-9).
Court also noted, plaintiffs have sought to avoid that result
by proceeding under a variety of theories, under the laws of
different states, under which brand-name drug manufacturers
could be held liable for injuries caused by generic drugs
manufactured by a different company. (Id. at 9).
Most, although not all, of those efforts have been rejected.
The majority view is that plaintiffs injured by generic
products cannot recover against brand-name manufacturers.
See, e.g., In re Darvocet, 756 F.3d at 938. The
minority view permits recovery, at least under some
circumstances. See, e.g., Conte v. Wyeth, 168
Cal.App.4th 89 (2008).
the issuance of the Court's opinion on August 4, 2017,
three state supreme courts (in California, Massachusetts, and
West Virginia) have issued opinions on that topic. See
T.H. v. Novartis Pharm. Corp., 4 Cal. 5th 145 (2017);
Rafferty v. Merck & Co., Inc., 479 Mass. 141
(2018); McNair v. Johnson & Johnson, 2018 WL
2186550 ( W.Va. May 11, 2018). Two of those opinions
(California and Massachusetts) follow the minority view, and
one (West Virginia) follows the majority view.
in the three cases at issue here are likewise seeking to
impose liability on a brand-name manufacturer for injuries
caused by a generic product. As set forth below, plaintiffs
seek to proceed on what is essentially a theory of
intentional or negligent misrepresentation or negligent
undertaking. The theory is based on the allegation that GSK
“created a market” for the drug's use to
treat pregnancy-related ...