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Ideus v. Teva Pharmaceuticals USA, Inc.

United States District Court, D. Nebraska

May 6, 2018

STEPHANIE IDEUS, Plaintiff,
v.
TEVA PHARMACEUTICALS USA, INC., and TEVA WOMEN'S HEALTH, INC., Defendants.

          MEMORANDUM AND ORDER

          CHERYL R. ZWART UNITED STATES MAGISTRATE JUDGE

         Plaintiff's motion to compel, (Filing No. 69), is pending and fully submitted. For the reasons discussed below, the motion will be granted in part, and denied in part.

         STATEMENT OF FACTS

         Plaintiff Stephanie Ideus (“Plaintiff”) filed a lawsuit against Defendants Teva Pharmaceuticals USA, Inc. and Teva Women's Health, Inc. (“Defendants”), alleging she experienced complications during and after removal of ParaGard T-380 (“ ParaGuard”), an intrauterine copper contraceptive device manufactured by Defendants. As Plaintiff's physician removed the device in 2014, a piece broke off and became embedded in the myometrium of her uterine wall, necessitating a surgical extraction procedure. At present, Plaintiff's sole remaining claim alleges Defendants failed to warn of the possible breakage and embedment risks associated with the removal of Paragard.

         Defendants have raised a federal preemption defense to Plaintiff's failure to warn claim. Defendants argue-and this the court previously agreed-that federal regulations restrict a drug manufacturer's ability to change the drug labelling approved by the Food and Drug Administration (“FDA”). (Filing No. 56) (granting Defendants' motion for judgment on the pleadings on the basis of federal preemption but allowing Plaintiff a chance to amend her complaint). Thus, Defendants claim any state law warning and labelling requirements-as here proffered by Plaintiff-are preempted by federal law. (Filing No. 61).

         Plaintiff, in turn, argues that the FDA's “changes being effected” regulation allows for labelling changes when a drug manufacturer comes into possession of “newly acquired information” subsequent to a label's FDA approval. (Filing Nos. 64 and 69). And when evaluating Defendants' renewed motion for judgment on the pleadings, this court agreed, (Filing No. 66), finding Plaintiff had pleaded the existence of newly acquired information so as to overcome Defendants' preemption defense at the pleading stage) (emphasis added).

         Therefore, as this litigation enters the discovery phase, a central dispute is the existence, sufficiency and character of “newly acquired information” that Defendants may possess. Plaintiff's motion to compel requests an order compelling a response to Request No. 36, which seeks “all documents that concern any Complaint Investigation Process regarding Paragard T-380 A Copper IUD.”[1] (Filing No. 69 at CM/ECF p. 1). Despite the broad wording, Plaintiff concedes that Request No. 36 seeks only documents concerning “breakage and embedment” of ParaGard. (Id. at CM/ECF p. 2).

         To date, in response to Request No. 36, Defendants have produced only documents specifically related to the manufacturing “lot” in which Plaintiff's ParaGard device was produced. (Id). Plaintiff contends Defendants should be required to produce breakage and embedment information for all manufacturing lots of ParaGard spanning November 9, 2005 to present-not just for the lot specific to Plaintiff's device. (Id.).

         For the following reasons, Plaintiff's motion to compel will be granted in part, and denied in part.

         ANALYSIS

         Generally speaking, the Federal Rules of Civil Procedure allow for discovery of “any nonprivileged matter that is relevant to any party's claim or defense and proportional to the needs of the case.” Fed.R.Civ.P. 26(b)(1). Thus, the proper scope of discovery embraces information that is not only relevant but also proportionate to the litigants' needs.

         Relevancy[2], for the purposes of discovery, includes “any matter that bears on, or that reasonably could lead to other matters that could bear on, any issue that is or may be in the case.” Oppenheimer Fund, Inc. v. Sanders, 437 U.S. 340, 351 (1978). The proportionality analysis then requires the court to weigh “the importance of the issues at stake in the action, the amount in controversy, the parties' relative access to relevant information, the parties' resources, the importance of the discovery in resolving the issues, and whether the burden or expense of the proposed discovery outweighs its likely benefit.” Fed.R.Civ.P. 26(b)(1).

         Defendants argue against production, claiming the requested documents are not “newly acquired information” and are thereby irrelevant, unduly ...


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