89 F.4th 203
1st Cir.2023Background
- Edmund Ward, a Massachusetts resident with a rare genetic cholesterol deficiency, participated as the sole subject in a clinical trial involving ACP-501, developed by AlphaCore Pharma, LLC (ACP), a Michigan-based company.
- Ward was introduced to ACP and its principal, Bruce Auerbach (also Michigan-based), through his Massachusetts physician but received all ACP-501 injections at the NIH in Maryland, never in Massachusetts.
- The clinical protocol was drafted in part by ACP and Auerbach, but their specific roles were unclear; all drug supply and communication about the trial occurred outside Massachusetts.
- Ward filed suit in Massachusetts state court alleging fraud, lack of informed consent, unjust enrichment, and other claims, asserting that ACP and Auerbach fraudulently induced him to participate in the trial to facilitate the sale of ACP.
- The case was removed to federal court, where ACP and Auerbach moved to dismiss for lack of personal jurisdiction; the district court granted dismissal, finding insufficient contacts with Massachusetts.
- Ward appealed, arguing specific jurisdiction existed due to various alleged contacts.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Personal jurisdiction over ACP/Auerbach | ACP/Auerbach had purposeful, directed contacts with Mass. | ACP/Auerbach had no relevant Massachusetts contacts; all acts occurred elsewhere | No specific jurisdiction; contacts insufficient |
| Contact with Massachusetts-based physician | ACP/Auerbach contacted Dr. Schaefer in Massachusetts | Dr. Schaefer initiated contact; defendants did not target Mass. | Contact initiated by Mass. party does not create jurisdiction |
| Delivery of ACP-501 in Massachusetts | ACP/Auerbach sent drugs to Massachusetts for Ward | ACP-501 never sent to Massachusetts, only to NIH in Maryland | No drugs delivered to Mass.; claim unsubstantiated |
| Oversight of NIH protocol/data from Mass. | ACP/Auerbach oversaw protocol and obtained data from Mass. | Clinical trial directed from Maryland; no oversight or data tied to Mass. | No evidence of oversight/data collection from Massachusetts |
Key Cases Cited
- Int'l Shoe Co. v. Washington, 326 U.S. 310 (U.S. 1945) (establishing the "minimum contacts" standard for personal jurisdiction)
- Goodyear Dunlop Tires Operations, S.A. v. Brown, 564 U.S. 915 (U.S. 2011) (general jurisdiction requires defendant be "at home" in forum state)
- Burger King Corp. v. Rudzewicz, 471 U.S. 462 (U.S. 1985) (specific jurisdiction requires purposeful availment of forum)
- Walden v. Fiore, 571 U.S. 277 (U.S. 2014) (focus for specific jurisdiction is conduct of the defendant toward the forum)
- Ticketmaster-N.Y., Inc. v. Alioto, 26 F.3d 201 (1st Cir. 1994) (plaintiff must show specific facts for jurisdiction; conclusory allegations insufficient)
- Boit v. Gar-Tec Prod., Inc., 967 F.2d 671 (1st Cir. 1992) (prima facie showing of jurisdiction requires evidence, not unsupported allegations)