Vaughan Estate of Vaughan v. Olympus Am., Inc.

208 A.3d 66
CourtSuperior Court of Pennsylvania
DecidedApril 10, 2019
Docket3101 EDA 2017
StatusPublished
Cited by11 cases

This text of 208 A.3d 66 (Vaughan Estate of Vaughan v. Olympus Am., Inc.) is published on Counsel Stack Legal Research, covering Superior Court of Pennsylvania primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Vaughan Estate of Vaughan v. Olympus Am., Inc., 208 A.3d 66 (Pa. Ct. App. 2019).

Opinion

OPINION BY McLAUGHLIN, J.:

*69 Decedent Janice Vaughan underwent medical procedures at Carolinas Medical Center in Charlotte, North Carolina, during which physicians used an Olympus TJF-Q180V duodenoscope (scope). The scope is designed for reuse on multiple patients and must be disinfected - or "reprocessed" - after each use. Allegedly, the scope used on Mrs. Vaughan was contaminated, and she developed a multi-drug-resistant infection and in May 2015, passed away.

Her widower, Freeman Maurice Vaughan, Jr., as administrator of her estate, instituted this suit in Philadelphia. Olympus Medical System Corp. (OMSC) filed preliminary objections seeking dismissal for lack of personal jurisdiction, which the trial court sustained. Because OMSC had contacts with Pennsylvania that were sufficiently related to the causes of action on which Vaughn is suing OMSC, it is subject to Pennsylvania's specific jurisdiction. We therefore reverse the order sustaining the preliminary objection to personal jurisdiction over OMSC.

Other defendants - Olympus America, Inc. (OAI), Olympus Corporation of the Americas (OCA), and Custom Ultrasonics, Inc. (Custom) - sought dismissal based on the doctrine of forum non conveniens . See 42 Pa.C.S. § 5322(e). In our view, the lower court abused its discretion when it found "weighty reasons" to disturb Vaughan's choice of forum. See Bochetto v. Dimeling, Schreiber, & Park , 151 A.3d 1072 (Pa.Super. 2016). Accordingly, we also reverse the order granting the forum non conveniens dismissal.

I. Factual and procedural background

According to the Complaint, OMSC redesigned the scope several years before Decedent's procedures but did not update the reprocessing procedures and instructions, known as the "reprocessing protocol." See Complaint, ¶¶ 1, 3, 22, 23. 1 As a result, end users were allegedly unable to sanitize the redesigned scope effectively. Id. , ¶ 3. Vaughan claims that OMSC failed to update the reprocessing protocol despite its allegedly receiving notice in 2013 of infections in patients involving scopes in the same product line as the subject scope, as well as in another line of scopes. Id. , ¶ 24.

The Complaint names three defendants: OMSC, OAI, and OCA. OMSC allegedly designed and manufactured the subject scope. Id. , ¶ 11. OMSC is a foreign corporation organized under the laws of Japan, and has its principal place of business in Tokyo. Complaint, ¶ 11. As a foreign manufacturer marketing a medical device in the United States, it must not only register with the Food and Drug Administration (FDA), but also must designate an agent in the United States to meet its statutory reporting requirements. See 21 U.S.C.A. § 360 (i)(1)(A)(ii) ; 21 C.F.R. §§ 803.58 , 807.40.

*70 OCA and OAI are New York corporations, and each maintains its principal place of business in Center Valley, Pennsylvania. OMSC's Preliminary Objections, ¶ 6. 2 It is undisputed that for FDA purposes, OCA is OMSC's agent. See OMSC's Memorandum of Law in Support of Preliminary Objections, at 12; Exhibit I to OMSC's Preliminary Objections, Affidavit of Laura Storms, ¶ 7. In addition, OCA and OAI are allegedly involved in the marketing, distribution, and post-marketing safety surveillance of the scope. Complaint, ¶ 9, 10.

Vaughan alleges that the FDA granted clearance for marketing the scope pursuant to a procedure known as "section 510(k) [ 3 ] premarket notification." See Complaint, ¶ 17. Under this procedure, certain classes of medical devices may be marketed if "the FDA concludes on the basis of the [section] 510(k) notification that the device is 'substantially equivalent' to a pre-existing device ...." Medtronic, Inc. v. Lohr , 518 U.S. 470 , 478, 479, 116 S.Ct. 2240 , 135 L.Ed.2d 700 (1996). Section 510(k) submissions must include, among other things, proposed labels, labeling, and advertisements sufficient to describe the device, its intended use, and the directions for its use. Buckman Co. v. Plaintiffs' Legal Comm. , 531 U.S. 341 , 345, 121 S.Ct. 1012 , 148 L.Ed.2d 854 (2001) (citing 21 CFR § 807.87 (e) ). After the FDA granted section 510(k) clearance, OMSC allegedly "remained directly involved with the dissemination of information about the device such as warnings, instructions, and other safety information within the U.S." Complaint, ¶ 17.

The Complaint also alleges certain of the regulatory duties of a medical device manufacturer such as OMSC. Id.

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Cite This Page — Counsel Stack

Bluebook (online)
208 A.3d 66, Counsel Stack Legal Research, https://law.counselstack.com/opinion/vaughan-estate-of-vaughan-v-olympus-am-inc-pasuperct-2019.