Cook Medical Inc. and plaintiffs who have filed 400 lawsuits against it have agreed to bellwether cases that will be prepared for trial dates in September, 2016 according to news reports.
The cases will be tried in MDL No. 2570 IN RE: Cook Medical, Inc., in the Southern District of Indiana, assigned to Judge Richard L. Young and Magistrate Judge Tim A. Baker.
All federal product liability and personal injury lawsuits over complications with Cook Celect and Cook Gunther Tulip IVC filters have been centralized before U.S. District Judge Richard Young in the Southern District of Indiana, as part of an MDL, or multidistrict litigation.
The small, umbrella like devices are implanted for prevention of pulmonary embolism and they perforate the vena cava, migrated out of position or fracture, sending fragments or metal shards into the heart or lungs.
Court shoots down protective over
On May 12, Magistrate Baker denied Cook’s motion for a protective order. “Cook tries to distinguish Bard [Bard IVC Filters Products Liability Litigation, MDL 15-02641-PHX DGC (D. Ariz. April 1, 2016] on the basis that the defendant in that case had received an FDA warning letter, whereas Cook has not. This strikes the Court as the proverbial distinction without a difference. Warning letter or not, case law supports a finding that this information is relevant and discoverable,” he wrote.
The Court heard argument on Defendant Cook Medical’s motion for protective orderOn April 27, 2016. Cook sought to bar Plaintiffs from seeking discovery concerning Cook’s alleged failure to report adverse events associated with its IVC filters to the United States Food and Drug Administration.
Cook’s motion was premised in part on the Supreme Court’s holding in Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 348 (2001), that state law fraud-on-the-FDA claims conflict with, and therefore are impliedly preempted by, the Federal Food, Drug, and Cosmetics Act. The FDCA gives the FDA sole authority to enforce compliance with the FDCA’s disclosure and other provisions. Thus, Cook argues that since Plaintiffs cannot enforce compliance, Cook’s report submissions to the FDA are irrelevant and inadmissible.
More on point is the recent case of In re Bard IVC Filters Products Liability Litigation, MDL 15-02641-PHX DGC, which stated: The Court views discovery relating to under-reporting or non-reporting of problems with retrievable filters to be clearly relevant to this case. Actual failure rates will be relevant to Plaintiffs’ negligence and product defect claims. Evidence regarding representations made by Defendants concerning failure rates will be relevant to Plaintiffs’ claims for fraud and misrepresentation.
The Court agreed with the analysis in Bard. Plaintiffs allege that Cook knowingly presents false information regarding the safety profile of its filters to physicians and the public, 4 and uses this false information as a promotional tool and in the labeling of its IVC products. Similar to Bard, Cook’s actual reports to the FDA are relevant to Plaintiffs’ claims and examination of potential liability. Cook’s reports to the FDA are particularly relevant to analyze the learned intermediary defense because they are what an intermediary would have relied on.
“Cook’s argument of limited relevancy is not enough to overcome the broad standard of relevance applicable in discovery. Fed. R. Civ. P. 26(b)(1); see Bank of Am., N.A. v. Wells Fargo Bank, N.A., No. 12 C 9612, 2014 WL 3639190, at *3 (N.D. Ill. July 23, 2014).”