Sometimes the DDL blog is ahead of the curve.  On more than one occasion we’ve advanced the idea that lack of personal jurisdiction should be a good defense to innovator liability in a post-BMS world.  After all, BMS held that there was no specific jurisdiction over a plaintiff’s claim just because the defendant allegedly sold the drug at issue to other, in-state residents, causing similar injuries:

The mere fact that other plaintiffs were prescribed, obtained, and ingested [the drug] in California − and allegedly sustained the same injuries as did the nonresidents − does not allow the State to assert specific jurisdiction over the nonresidents’ claims.  As we have explained, “a defendant’s relationship with a . . . third party, standing alone, is an insufficient basis for jurisdiction.”

Bristol-Myers Squibb Co. v. Superior Court, 137 S. Ct. 1773, 1781 (2017). (quoting Walden v. Fiore, 134 S.Ct. 1115, 1123 (2014)).  Rather, “case-linked” personal jurisdiction requires case-linked conduct by the defendant within the jurisdiction.  Under BMS, where does the “case-linked” conduct of the branded defendant take place in an innovator liability case?  That conduct does not include sale of a product.  The defendant did not sell the allegedly injurious product, but only a different bioequivalent product with the same risks.  Sale of a different product to different people, even if those other people are in-state residents, can’t support specific, “case linked” personal jurisdiction.

Now, we have a case that puts those ideas into practice – Henry v. Angelini Pharma, Inc., 2020 WL 1532174 (E.D. Cal. Mar. 31, 2020).

Plaintiff, a California resident, was prescribed and ingested generic trazodone for insomnia.  He alleges that the trazodone caused him to experience priapism, a prolonged penile erection, lasting over 24 hours and he is now impotent.  Id. at *1.  Plaintiff brought claims for strict liability, negligence, breach of implied and express warranties, negligent misrepresentation, negligence per se, and punitive damages against the manufacturer of the generic trazodone as well as companies involved with its branded competitor.  On the brand side, one of the defendants was an Irish company with a U.S. headquarters in Pennsylvania who was the successor to the original brand manufacturer.  The other brand defendant was the current brand NDA holder, a Delaware corporation headquartered in Maryland.  Plaintiff alleged the brand label had an inadequate warning which in turn was used by the generic manufacturer.  Brand defendants moved to dismiss for lack of specific jurisdiction.

The Ninth Circuit uses a three part test to determine whether specific jurisdiction exists:  (1) defendant must have purposefully availed itself of the privilege of conducting activities in the state by an affirmative act or conduct; (2) plaintiff’s claim must “arise out of or result from” those activities; (3) the exercise of jurisdiction must be reasonable.  Plaintiff bears the burden of proof on the first two prongs.  Id. at *2.

Defendants’ argument was correctly centered on the lack of a connection between the state, plaintiff’s alleged injury, and any activity on their part.  Plaintiff’s opposition focused solely on the fact that according to LinkedIn, five years before plaintiff was prescribed trazodone, defendants employed a sales representative to market the brand drug in California.  Id. at *4.  Plaintiff further theorizes that the brand rep “almost certainly” misrepresented the risk of priapism to healthcare providers in California.  Id.

The court’s analysis begins as it ought to:  “Plaintiff’s claim arises from taking a drug in California that was not manufactured by [brand defendants].”  Id.  Hence, it is an innovator liability claim.  “The trouble with this attenuated legal theory is that there is nothing that ties Plaintiff’s claim to Defendant’s activities in California.”  Id.  As for the lone sales rep:

Plaintiff fails to explain how the actions of a single salesman in California, marketing and selling a drug Plaintiff did not take to an unknown number of practitioners, four to five years before an injury that was caused by a different drug manufactured by [a different defendant], has anything to do with Plaintiff’s claims.

Id.  That is BMS, except BMS involved the same product, not a bioequivalent generic.  Selling a drug the plaintiff did not take, here the brand version, to others in the state does not satisfy specific jurisdiction.

In an attempt to avoid dismissal, plaintiff requested a transfer to Maryland.  But a case can only be transferred to a court with subject matter jurisdiction that is a proper venue and where defendant is subject to personal jurisdiction.  And where there are multiple defendants, the personal jurisdiction and venue requirements must be satisfied as to all defendants.  Id. at *5.  As noted above, one of the brand defendants had a principal place of business in Maryland.  As to the other brand defendant and the generic manufacturer, plaintiff argued that their FDA-related interactions in the form of ANDA filings (generic manufacturer) and submission of the drug’s warning (brand defendant) were jurisdictional contacts conferring jurisdiction in Maryland.  Id. With no Ninth Circuit law on point, the court found Zeneca Ltd. v. Mylan Pharm., Inc., 173 F.3d 829 (Fed. Cir. 1999) persuasive.  Allowing government contacts to serve as jurisdictional contacts “would be contrary to the policy against the creation of national supercourts in Maryland and may offend due process.”  Henry, at *5 (quoting Zeneca).

Plaintiff is a California resident who was prescribed [ ] generic trazodone by his physician in California, the drug was dispensed and ingested in California, and the resulting injury occurred in California. The Court declines to find that [defendants] are subject to specific jurisdiction in Maryland based on nothing more than their FDA filings and the unsubstantiated possibility that [generic defendant] also sold its drug in Maryland. Based on the limited information before this Court, it is not clear that Maryland can exercise personal jurisdiction over all Defendants.

Id.  Plaintiff gets to continue its case against the generic defendant in California.  But, we know how those cases usually go.

Henry now gives us precedent to cite to support our previously posited position that the lack of case-related in-state conduct means that there can’t be specific personal jurisdiction over a branded defendant sued for no reason other than the plaintiff being injured in a state recognizing innovator liability.  Branded defendants sued outside their home states on innovator liability claims should raise personal jurisdiction as a defense.  Don’t forget it’s a waivable defense.