A Word To The Wise – Locate Your FDA-Mandated Agents With Care

This message is directed primarily to our overseas readers, and those who represent non-United States drug and medical device companies. Under FDA registration regulations, non-United States manufacturers (and other regulated companies) that import their regulated products into this country are required to appoint a domestic "agent" for regulatory purposes:

(i) Registration of foreign establishments

(1) Every person who owns or operates any establishment within any foreign country engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or device that is imported or offered for import into the United States shall. . . .

(A) upon first engaging in any such activity, immediately submit a registration to the [FDA] that includes-

(i) with respect to drugs, . . . the name of the United States agent of each such establishment . . . who imports or offers for import such drug to the United States for purposes of importation; and

(ii) with respect to devices, . . . the name of the United States agent for the establishment . . . who imports or offers for import such device to the United States for purposes of importation. . . .

21 U.S.C. §360(i) (emphasis added). The corresponding FDA regulations are 21 C.F.R. §207.69(b) (for drugs), and 21 C.F.R. §803.58(a) (for devices).

Our advice is that, overseas manufacturers (and others required to register) ought to consider the product liability consequences of where they locate their FDA regulatory agents, in addition to all the other criteria that go into making these decisions.

The reason is personal jurisdiction, and the occasion for this advice is the recent decision in Vaughan v. Olympus America, Inc., ___ A.3d ___, 2019 WL 1549345 (Pa. Super. April 10, 2019), underscoring that the location of an overseas company's FDA-mandated agent is a place where such companies can, and will, be sued. Vaughn involved a duodenoscope described as being "designed for reuse on multiple patients" so that it "must be disinfected - or 'reprocessed' - after each use." Id. at *1. Various reusable devices have, in the last couple of years, been targeted by plaintiffs alleging sterilization-related claims.

Critically, for the overseas defendant in Vaughn, it used a Pennsylvania subsidiary as its FDA-registered "agent." From a personal jurisdiction standpoint, that a meant that the agent was indisputably "at home" in Pennsylvania. The relevant principal place of business was in Pennsylvania -...

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