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In re Zofran Ondansetron Products Liability Litigation

United States District Court, D. Massachusetts

January 22, 2016

IN RE ZOFRAN ONDANSETRON PRODUCTS LIABILITY LITIGATION, MDL This Document Relates To: All Cases MDL Order No. 9

MEMORANDUM AND ORDER ON DEFENDANT’S MOTION TO DISMISS ALL CLAIMS ON PREEMPTION GROUNDS

F. DENNIS SAYLOR IV UNITED STATES DISTRICT JUDGE.

This multi-district litigation arises out of claims that the use of the drug Zofran (ondansetron) by pregnant women caused birth defects. Defendant GlaxoSmithKline, LLC has moved to dismiss all complaints on the grounds that any state-law failure-to-warn claims are preempted by federal law under Wyeth v. Levine, 555 U.S. 555 (2009), and that any remaining claims are preempted under Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001).

On October 13, 2015, pursuant to 28 U.S.C. § 1407, the Judicial Panel on Multidistrict Litigation transferred twelve cases to this Court for consolidated pre-trial proceedings as MDL No. 2657. Since that time, at least 196 additional cases have been added by follow-on transfer orders. The Court appointed lead counsel for the plaintiffs on November 18, 2015, and appointed a plaintiffs’ steering committee on December 16, 2015.

GSK filed this motion to dismiss on December 11, 2015, before the start of discovery. Plaintiffs oppose the motion on the merits and on the ground that the motion is not procedurally ripe at this stage of the litigation. The Court first requested briefing from the parties only as to the latter issue, and it is that issue-and not the merits of the motion-that is the subject of this memorandum and order. For the following reasons, defendant’s motion to dismiss will be denied without prejudice to its renewal at a later time.

I. Background

Unless otherwise noted, the following facts do not appear to be in dispute for the purposes of this motion.

Defendant GlaxoSmithKline manufactures the drug ondansetron under the brand name “Zofran.” Zofran was first approved in 1991 for the prevention of post-operative nausea and vomiting associated with anesthesia, and for nausea and vomiting caused by radiotherapy and chemotherapy. In addition to those approved uses, GSK is alleged to have marketed Zofran “off-label” for pregnancy-related nausea and vomiting, otherwise known as “morning sickness.”

Plaintiffs allege that Zofran was in fact unsafe for use in pregnant women, and that in utero exposure to Zofran caused birth defects in children born to mothers who took the drug. GSK characterizes plaintiffs’ legal claims as falling into one of two categories: (1) claims that GSK failed to provide adequate warnings of the dangers of Zofran use by pregnant women; and (2) claims that GSK failed to comply with Food and Drug Administration regulations by either marketing Zofran off-label or by withholding information from the FDA. (Def. Mem. 4-5).

GSK has moved to dismiss all claims in all cases, regardless of the applicable state law. In substance, GSK contends that plaintiffs’ failure-to-warn claims are preempted in their entirety by federal law in accordance with Wyeth v. Levine, 555. U.S. 555 (2009). GSK further contends that any other claims, including those for unlawful off-label marketing activities and concealing safety information from the FDA, are preempted under Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001).

In January 2013, an individual named James Reichmann submitted a “citizen petition” to the FDA.[1] The petition requested, among other things, that the FDA reclassify ondansetron from pregnancy risk category B to pregnancy risk category C, D, or X “after evaluation of ‘new safety information.’” (Def. Mem. Ex. D).[2] Had the FDA approved the petition, the reclassification of ondansetron would have required new, stronger language in the drug’s labeling warning of the potential risks associated with its use by pregnant women. See 21 C.F.R. § 201.57(c)(9)(i)(A)(3-6) (2006).[3]

The FDA, however, rejected that request in a response issued October 27, 2015. (Def.

Mem. Ex. A). The FDA’s response was 20 pages long and included, among other things, a review of various studies and scientific literature. It concluded as follows:

Based on our review of the Petition, supplements, additional submissions to the docket, and the scientific literature, as well as our review of other pertinent data and information, including published literature not referenced in the Petition, supplements, or docket, and adverse event reporting information, we deny the requests in the Petition for the reasons discussed above.
Although we have denied your requested actions, we nevertheless appreciate the information you provided. We will continue to monitor information regarding the use of ondansetron during pregnancy. As with all drug products, we will continue to engage in postmarketing surveillance and review ...

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