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Court in Pharmaceuticals Products Liability Case Grants in Part Plaintiff’s Motion to Compel Based on Relevancy

Posted on May 21st, 2018

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In Ideus v. Teva Pharmaceuticals USA, Inc., No. 4:16CV3086, (D. Nebraska May 6, 2018), Stephanie Ideus (“Plaintiff”) filed a motion to compel production of documents.

Plaintiff filed a lawsuit against Teva Pharmaceuticals USA, Inc. (“Defendant”) alleging she experienced complications during and after removal of ParaGard T-380 (” ParaGuard”), an intrauterine copper contraceptive device (“IUD”) manufactured by Defendants. Plaintiff’s remaining claim alleges Defendants failed to warn of the possible breakage and embedment risks associated with the removal of Paragard.

Plaintiff filed a motion to compel production of documents concerning any Complaint Investigation Process regarding Paragard T-380 A Copper IUD.  Teva Pharmaceuticals USA (“Defendant”) produced only documents specifically related to the manufacturing “lot” in which Plaintiff’s ParaGard device was produced. 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.

The law allows for discovery of any nonprivileged matter that is relevant to any party’s claim or defense and proportional to the needs of the case. Defendants argue against production, claiming the requested documents are not newly acquired information and are therefore irrelevant, unduly burdensome, and disproportionate to the needs of the case.

Discovery is sufficiently relevant if it appears reasonably calculated to lead to the discovery of admissible evidence. By narrowly focusing on whether these documents satisfy a federal regulatory definition, the parties employ too narrow a view of relevancy. The Court says the question is not whether the information requested will substantiate Plaintiff’s claim but should be whether the requests are reasonably calculated to lead to information that could bear an issue in the case.

The Court finds the files could lead to information or other admissible facts regarding whether Defendants received information warranting changing or expanding ParaGuard’s product labelling. The information known by Defendants as of January 11, 2010, when Plaintiff decided to have the ParaGuard device inserted, may be relevant in deciding what the label should have stated at that time. For the period of November 9, 2005 through January 11, 2010, as to all lot numbers, the documents are relevant. As to documents received after January 11, 2010, the documents requested are not.

The party fighting discovery may defeat a motion to compel information if that party establishes that production would constitute an undue burden or an unreasonable hardship, and are thus disproportionate to the needs of the case. In terms of access to the information, and the importance to the case, Plaintiff’s arguments are compelling. Defendants have exclusive access to these documents which will lead to information that could preclude Defendants’ federal preemption defense, an issue of paramount importance to the substance of this dispute. In carefully weighing the information regarding Defendants’ anticipated burden and expense, and the other factors of proportionality, the Court finds the hardships are not undue or unreasonable and the requested information is not disproportionate to the needs of the case. Therefore, the motion to compel is granted in part and denied in part.

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