Clinical Trial Activity Is Not an Exception to the Rule


Defendants and courts have seen a variety of arguments set forth in attempts to demonstrate specific personal jurisdiction. One argument seen with increasing frequency in medical products cases is that specific jurisdiction exists over an out-of-state defendant for the claims of non-resident plaintiffs because the defendant conducted clinical trials of the product at issue in the forum state. Courts have consistently rejected this argument.

For example, in Moore v. Bayer Corp., 2018 WL 4144795 (E.D. Mo. Aug. 29, 2018), three Missouri plaintiffs joined 95 non-Missouri plaintiffs to sue Bayer and four of its subsidiaries in Missouri state court. All plaintiffs alleged that they had suffered personal injuries as a result of being prescribed and implanted with the medical device Essure. The non-resident plaintiffs argued that specific jurisdiction existed because Bayer worked on the regulatory approval of Essure in Missouri. Plaintiffs alleged that “Missouri was one of eight principal sites in the United States chosen to conduct pre-market clinical trials of Essure. Missouri hospitals and physicians were used in these clinical investigations, and the Missouri study results were used to support the FDA approval process of Essure.” After analyzing Bristol–Myers Squibb Co. v. Superior Court of California, San Francisco County, 137 S. Ct. 1773 (2017) [BMS], the court held that “[t]he injury claims of the non-Missouri plaintiffs lack an adequate connection to Bayer’s activities in Missouri for specific jurisdiction. The non-Missouri plaintiffs were not prescribed Essure in Missouri, they did not have the device implanted in Missouri, and they were not injured in Missouri.” The court went on to state that “[t]he non-Missouri plaintiffs do not allege to have taken part in Missouri clinical trials nor do they allege to have personally reviewed or relied on the resulting data.”

More recently, in In re: Talc Liab. Litig., 2018 WL 4340012 (Del. Super. Ct. Sept. 10, 2018), the Delaware Superior Court rejected arguments that specific personal jurisdiction existed over out-of-state defendants in claims brought by non-resident plaintiffs simply because the defendant had tested samples of the product at issue in Delaware. The court stated that such in-state testing was insufficient to establish specific jurisdiction because “Plaintiffs have not alleged any fact linking [the] testing of talc samples in Delaware to the nonresident Plaintiffs’ claims.”

A number of other courts have similarly found that clinical trial activity in a forum state does not give rise to personal jurisdiction when the non-resident plaintiffs’ claims have no connection to Missouri. See, e.g., Dyson v. Bayer Corp., 2018 WL 534375 (E.D. Mo. Jan. 24, 2018); Jordan v. Bayer Corp., 2018 WL 837700 (E.D. Mo. Feb. 13, 2018); Johnson v. Bayer Corp., 2018 WL 999972 (E.D. Mo. Feb. 21, 2018); Schaffer v. Bayer Corp., 2018 WL 999980 (E.D. Mo. Feb. 21, 2018); Hinton v. Bayer Corp., 2018 WL 3725776 (E.D. Mo. July 27, 2018). Only a single judge in California and one pre-BMS court have concluded that in-state clinical trial activity is sufficient to establish specific jurisdiction over an out-of-state defendant for the claims of non-resident plaintiffs. M.M. v. GlaxoSmithKline LLC, 61 N.E.3d 1026 (Ill. App. 2016); Dubose v. Bristol-Myers Squibb Co., 2017 WL 2775034 (N.D. Cal. June 27, 2017) (Tigar, J.); Cortina v. Bristol-Myers Squibb Co., 2017 WL 2793808 (N.D. Cal. June 27, 2017) (Tigar, J.).

To date, the overwhelming majority of courts faced with this argument have rejected it. Those courts have properly followed the Supreme Court’s guidance in BMS and found that specific jurisdiction will not exist “without identifying an adequate link between the State and the nonresidents’ claims.” BMS, 137 S. Ct. at 1781.

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