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Vallejo v. Amgen, Inc.

United States District Court, D. Nebraska

May 20, 2016

JAN VALLEJO, Individually and As Personal Representative of Steve Vallejo; Plaintiff,



         This matter is before the Court on the Objection to Magistrate Judge Zwart’s Order (Filing No. 88) (“Objection”), filed by Plaintiff Jan Vallejo, individually and as personal representative of Steve Vallejo (“Plaintiff”). For the reasons discussed below, the Objection will be overruled.


         Plaintiff alleges that Steve Vallejo developed myelodysplastic syndrome (“MDS”), as a result of taking the prescription drug Entranercept, trade named Enbrel (“Enbrel”), ultimately causing his death. (Filing No. 83 at 1.) MDS encompasses a group of related clonal disorders affecting the bone marrow’s ability to produce certain cells in healthy amounts. MDS can progress to anemia, leukemia, thrombocytopenia, pancytopenia, and severe marrow failure. Enbrel is an injectable prescription drug that neutralizes certain tumor necrosis factors (“TNFs”), which are proteins made by the body’s immune system. (Id.) On February 17, 2014, Plaintiff filed this action against Defendants Amgen Inc., Pfizer Inc., and Wyeth LLC (collectively “Defendants”).[1] (See Filing No. 1.)

         On May 5, 2015, Judge Zwart ordered phased discovery, with the first phase devoted to general medical causation, i.e., whether Enbrel can cause MDS (“Phase I”). (Filing No. 55.) After the Parties were unable to comply with Judge Zwart’s order that they submit a joint outline of discovery issues, Judge Zwart held a hearing on December 9, 2015 (“December Hearing”), at which an expert witness testified on behalf of Plaintiff regarding Plaintiff’s discovery needs. (See Filing No. 79.) Judge Zwart ordered the Parties to submit briefs in support of their arguments, and on March 28, 2016, Judge Zwart entered an order (Filing No. 83) (“Order”) setting the bounds of discovery for Phase I.

         In the Order, Judge Zwart ruled on Plaintiff’s request for discovery in three areas at issue in this objection: (1) reports concerning Enbrel and related symptomology of MDS; (2) reports concerning non-Enbrel TNF blockers and MDS; and (3) the methods by which Plaintiff may attempt to locate information and documents within Defendants’ possession. (See id.)

         I. Discoverability of Reports Concerning Related Symptomology

         The Parties disputed whether Plaintiff was entitled to studies concerning only MDS or, instead, all symptoms related to MDS. (Id. at 6.) Because MDS is not a specific disorder, but rather a spectrum of disorders, Plaintiff argued that she should be given reports beyond those only mentioning “MDS, ” including those referencing a host of medical terms proposed by Plaintiff.

         Plaintiff’s proposed search terms conformed to the standardized hierarchy of adverse effect terminology within the MedDRA’s Standardized MedDRA Query (“SMQ”). Each SMQ contains a five-level hierarchy of terms. (Filing No. 83 at 7.) At the lowest, most specific level are Low Level Terms (“LLTs”). In ascending order of breadth, the remaining levels are Preferred Terms (“PTs”), High Level Terms (“HLTs”), High Level Group Terms (“HLGTs”), and System Organ Classes (“SOCs”). (Id.)

         Judge Zwart noted that “Plaintiff requests reports and studies that mention every SMQ term as it may relate to MDS” and that “the SMQ designates 206 LLTs for MDS.” (Id.) Judge Zwart found these terms to be overly broad and ruled that “any discovery of adverse event reports and Enbrel studies be limited to the PT ‘MDS’” and its corresponding fifteen LLTs.[2] (Id. at 9.)

         II. Discoverability of Reports on other TNF blockers

         Plaintiff also sought to require Defendants to identify any studies that relate any TNF blocker to MDS or its symptoms; determine if anyone associated with the Defendants supplied any information for those studies; and produce all such information. (Id. at 9-10.) Judge Zwart noted in her Order that such information’s relevance was tenuous, given that non-Enbrel TNF blockers operate via different mechanisms and are prescribed for different purposes than Enbrel, and that Plaintiff’s request would require Defendants to “email and search the files of approximately 100, 000 employees[3] for information that may not exist . . . .” (Id. at 10.)

         For these reasons Judge Zwart noted that sustaining Defendants’ objection to the request would be appropriate, but because the case was “languishing, ” Judge Zwart ordered a limited set of information to be disclosed. (Id.) To wit, the Order required Defendants “to answer or produce discovery regarding studies on the causal relationship, if any, between Enbrel[] and MDS and produce such studies or reports within any Defendant’s custody or control that are not available in the public domain.” (Id.)

         III. Custodial ...

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