The Supreme Court’s groundbreaking opinion in Bristol-Myers Squibb Co. v. Superior Court (BMS), 137 S. Ct. 1773 (2017), limited the reach of specific personal jurisdiction over out-of-state defendants. The BMS Court ruled that non-California plaintiffs could not establish jurisdiction in California to sue out-of-state pharmaceutical company Bristol-Myers Squibb for products-liability claims. The opinion detailed Bristol-Myers’s assorted contacts with California, including its relationship with in-state distributor McKesson Corp., in-state sales of the drug at issue, and in-state research facilities dedicated to developing other medicines. Though these California contacts were numerous, they had no connection to the plaintiffs’ out-of-state use of the drug. For that reason, the contacts did not support specific jurisdiction.
Jurisdiction Based on Clinical Trial Development Work
After BMS, practitioners and courts were left to sort out what, if any, in-state contacts would support specific jurisdiction over suits brought by out-of-state plaintiffs against out-of-state defendants, particularly in pharmaceutical tort cases that frequently play out nationwide. In the post-BMS world, plaintiffs have argued that a defendant’s clinical trials, or other product-development work, suffice to sustain jurisdiction in the state where that work occurred—even for suits brought by plaintiffs who admittedly used the product in another state.
Most courts reject this approach, holding that clinical trials or development work in a given state are insufficient, without more, to create jurisdiction there. Notably, some courts have made this determination as a threshold matter without the need for jurisdictional discovery. Most recently, a California state court overseeing a large group of pharmaceutical cases refused to allow plaintiffs to take any jurisdictional discovery concerning defendants’ in-state clinical trials, reasoning that “clinical trials . . . conducted in California [are] not sufficient to establish personal jurisdiction.” In re Xarelto Cases, No. 4862, 2018 WL 809633, at *10–11 (Cal. Super. Ct. Feb. 6, 2018). That opinion relied on a Missouri federal district court’s ruling in Dyson v. Bayer Corp., which likewise held that in-state clinical trials along with development of a national marketing campaign were “too attenuated from” the plaintiffs’ claims “to prove specific, ‘case-linked’ personal jurisdiction.” No. 4:17-CV-2584, 2018 WL 534375, at *4–5 (E.D. Mo. Jan. 24, 2018). Other courts have ruled similarly. See, e.g., BeRousse v. Janssen Research & Dev., LLC, No. 3:17-CV-00716, 2017 WL 4255075, at *4 (S.D. Ill. Sept. 26, 2017) (dismissing claims of 32 non-Illinois plaintiffs for lack of personal jurisdiction over out-of-state manufacturers).
The minority of courts exercising jurisdiction based solely on in-state drug development work have honed in on that work’s importance in bringing the product to market. For example, a Pennsylvania court recently exercised specific jurisdiction over an out-of-state pharmaceutical manufacturer who “supervised the design and manufacturing process of” the pelvic mesh product in Pennsylvania alongside a local company and “worked closely” with a local physician “in developing” that product. Hammons v. Ethicon, Inc., No. 1522 EDA 2016, --- A.3d ----, 2018 WL 3030754, at *8–9 (Pa. Super. Ct. June 19, 2018). Similarly, a California federal court exercised jurisdiction over an out-of-state pharmaceutical manufacturer where the plaintiff alleged that “nearly every pivotal clinical trial necessary for [the drugs’] approval involved studying of the . . . drugs throughout the State of California,” and that without these trials, “the drugs would not have been sold[.]” Dubose v. Bristol-Myers Squibb Co., No. 17-cv-00244, 2017 WL 2775034, at *4 (N.D. Cal. June 27, 2017).
- Plaintiffs may consider proactively stating facts in their complaints featuring the importance of any in-state clinical development work to the product in suit.
- Prior to pursuing jurisdictional discovery or opposing dismissal, plaintiffs should do their due diligence on the location of pivotal studies vis-à-vis their intended jurisdiction.
- Defendants may consider arguing, in their motions to dismiss, that permitting routine product-development work to confer specific jurisdiction risks inviting suits nationwide.
- In the course of resisting jurisdictional discovery or seeking dismissal, defendants should emphasize the lack of significance of any in-state development work to product approval.