Plaintiffs in a Multi District Litigation (“MDL”) filed complaints against Cook Medical Inc. (“Cook”) and alleges that Cook knowingly presented false information regarding the safety profile of its IVC filters to physician and the pubic, and used this false information as a promotional tool and in labeling its IVC products.
Plaintiff sought to discover the reports Cook made to the Food and Drug Administration (“FDA”). Cook moved for Protective Order, asking the Court to bar Plaintiffs from seeking discovery concerning Cook’s alleged failure to report adverse events associated with its IVC filter to the FDA. Cook’s motion relied in part on Buckman Co. v. Plaintiff’s Legal Comm., 531 U.S. 341, 348 (2001), in which the Supreme Court held that state law fraud-on-the FDA claims conflicts with, and therefore are implied preempted by the Food, Drug, and Cosmetic Act (“FDCA”).
Cook argued that because the FDCA gives the FDA sole authority to enforce compliance with the FDCA’s disclosure, Plaintiffs cannot enforce compliance and Cook’s report submissions to the FDA are inadmissible and irrelevant. To support it’s argument, Cook also cited to In re Incretin Mimetics Prods. Liab. Litig. 2014 U.S. Dist. LEXIS 142227 [S.D. Cal. Oct. 6, 2014], in which the plaintiffs compelled production of documents discussing adverse event reports to whether the defendant misrepresented or under-reported information to the FDA for its drug at issue. Relying in part on Buckman, the Increntin court denied the plaintiffs’ motion to compel.
Judge Baker, the Magistrate Judge assigned to the MDL, however found Buckman and Incertin do not support Cook’s position because unlike those cases, Plaintiffs in this MDL are not asserting fraud-on-the FDA claims and preemption is not at issue.
Judge Baker also held that while the Incretin court’s holding was based on a finding that production of source documents and databases would unduly burdensome, Cook made only a one- sentence reference to the burden and expense. As a party moving for a protective order, the burden was on Cook to establish facts supporting undue burden, Judge Baker noted, and Cook’s passing reference to expense comes nowhere close to establishing undue burden.
Finally, Judge Baker found while the defendant in Incretin denied misrepresenting or under reporting information to the FDA, this is not the situation.
“As Plaintiffs pointed out, discovery revealed that Cook only reported device complains to the FDA (and therefore to the MAUDE database) for filters marketed in the United States and withheld complaints for the same products marketed outside the country. Cook does not dispute this, though it does dispute that such reporting constitutes an irregularity,” Judge Baker noted.
Judge Baker denied Cook’s efforts to bar Plaintiffs in the IVC filter MDL from seeking information concerning the manufacturer’s alleged failure to report adverse events to the FDA.