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In re Zofran Ondansetron Products Liability Litigation

United States District Court, D. Massachusetts

May 21, 2018

IN RE ZOFRAN ONDANSETRON PRODUCTS LIABILITY LITIGATION, This Document Relates To Farrington
v.
GlaxoSmithKline, LLC, Case No. 1:16-12290-FDS; and Varrichione
v.
GlaxoSmithKline, LLC, Case No. 1:15-cv-13899-FDS.

          MEMORANDUM AND ORDER ON DEFENDANT'S MOTION FOR JUDGMENT ON THE PLEADINGS

          F. Dennis Saylor IV United States District Judge.

         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.

         Defendant 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.[1] 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.

         I. Background

         On 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.

         On 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 remain:

Plaintiff

Case Number

Relevant State

Buker

17-10062

Connecticut

Farrington

16-12290

New Jersey

Varrichione

15-13899

Oklahoma

         II. Legal Standard

         A Rule 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).

         On a 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).

         III. Analysis

         As 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).

         As the 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).

         Since 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.

         Plaintiffs 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 ...


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