Watters v. CooperSurgical, Inc.

• Decision Date: 13 February 2023
• Docket Number: 5:22-CV-223-D
• Parties: MELISSA MAE WATTERS, Plaintiff, v. COOPERSURGICAL, INC., etal., Defendants.
• Court: U.S. District Court — Eastern District of North Carolina

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MELISSA MAE WATTERS, Plaintiff, v. COOPERSURGICAL, INC., etal., Defendants.

No. 5:22-CV-223-D

United States District Court, E.D. North Carolina, Western Division

February 13, 2023

ORDER

JAMES C. DEVER III, UNITED STATES DISTRICT JUDGE

On June 2, 2022, Melissa Mae Watters (“plaintiff' or “Watters”) filed a complaint in this court alleging three claims under North Carolina law (i.e products liability, negligence, and violations of North Carolina's Unfair and Deceptive Trade Practices Act (“UDTPA”)) against defendants Cooper Surgical Inc. (“CSI”), The Cooper Companies, Inc. (“TCC”), Femcare LTD (“Femcare”), and Utah Medical Products, Inc. (“UTMD”) (collectively, “defendants”) [D.E. 1]. On August 23, 2022, defendants CSI, TCC, and UTMD moved to dismiss [D.E. 18] and filed a memorandum in support [D.E. 19]. On September 13, 2022, Watters responded in opposition [D.E 23]. On September 27, 2022, CSI, TCC, and UTMD replied [D.E 24].

On December 2, 2022, Femcare moved to dismiss due to lack of personal jurisdiction and failure to state a claim [D.E. 25] and filed a memorandum in support [D.E. 26]. On January 12, 2023, Watters responded in opposition [D.E. 31]. On February 9, 2023, Femcare replied [D.E. 34].

As explained below, the court grants TCC, UTMD, and Femcare's motion to dismiss for lack of personal jurisdiction. The court also grants TCC, UTMD, CSI, and Femcare's motion to dismiss for failure to state a claim. The court dismisses the complaint without prejudice.

I.

This complaint arises from alleged defects in Filshie Clip (“clip”) medical devices, which are titanium clips with a silicon rubber lining. See Compl. [D.E. 1] ¶ 20. Doctors use the clips for laparoscopic tubal ligation. See Id. In this procedure, the clip forces the fallopian tube to become necrotic and decrease in size by latching on and applying consistent pressure. See Id. at¶21.

Femcare, the clip manufacturer, sought and obtained conditional Premarket Approval (“PMA”) by the Food and Drug Administration (“FDA”). See id. at ¶ 24. The FDA classifies the clips as “Class in” medical devices. This classification means that the clips “present a potential unreasonable risk of illness or injury[.]” Id. at ¶ 25; see 21 U.S.C. § 360(c)(1)(c). Because the clips are Class III medical devices, the FDA only authorized the clips for commercial distribution on the condition that the FDA finds that there is a “reasonable measure” of the device's safety and effectiveness. See Id. at ¶ 27. Following conditional approval from the FDA in 1996, Femcare allegedly began marketing and selling the clips in the United States, including in North Carolina. See id. at ¶¶ 42-43.

During the FDA's study of the clips, defendants were responsible for providing the FDA with occasional safety updates regarding the product's performance. See id. at ¶ 47. Allegedly, the clips sometimes “migrate” while in position on the fallopian tube, which could cause significant injury and health risks. See id. at ¶ 45. Defendants allegedly underreported data to the FDA about the frequency of clip migration and the associated health risks. See id. at ¶ 51. Despite knowing the risks of clip migration, defendants allegedly continued to “tout the benefits of the [clip] over other available procedures.” Id. at ¶ 52.

In April 2013, Watters underwent a tubal ligation procedure using clips allegedly “manufactured, designed, and/or distributed by Defendants.” Id. at ¶¶ 56-57. The disclosure and consent form Watters read before the procedure allegedly did not contain warnings about the risk of clip migration or its potential side effects, and Watters's healthcare providers did not know of the risk. See Id. at ¶ 58. In February 2022, after Watters reported suffering from sharp pains and cramping, doctors discovered that Watters's clip had migrated. See id. at ¶ 62. Watters alleges that defendants had evidence of the clips' “propensity to migrate” but failed to warn the FDA, physicians, or patients of the damages stemming from clip migration. Id. at ¶ 67.

II.

Defendants TCC, UTMD, and Femcare move to dismiss for lack of personal jurisdiction. The court does not have personal jurisdiction over a nonresident defendant unless jurisdiction comports with North Carolina's long-arm statute and the Fourteenth Amendment's Due Process Clause. See, e.g., Mitrano v. Hawes, 377 F.3d 402, 406 (4th Cir. 2004). North Carolina's long-arm statute extends personal jurisdiction over nonresident defendants consistent with the Fourteenth Amendment's Due Process Clause. See Christian Sci. Bd. of Dirs, v. Nolan, 259 F.3d 209, 215 (4th Cir. 2001). Thus, the statutory inquiry merges with the constitutional inquiry. See id.; Atl. Corp, of Wilmington, Inc, v, TBG Tech Co., 565 F.Supp.3d 748, 759 (E.D. N.C. 2021).

Due process requires a defendant to have “certain minimum contacts with the forum such that the maintenance of the suit does not offend traditional notions of fair play and substantial justice.” Helicopteros Nacionales de Colom., S.A. v. Hall, 466 U.S. 408, 414 (1984) (alteration and quotations omitted). The minimum contacts analysis focuses on whether a defendant “purposefully directed his activities at residents of the forum” and whether the causes of action arise out of or relate to those activities. Burger King Corp, v. Rudzewicz, 471 U.S. 462, 472 (1985) (quotation omitted); see Ford Motor Co, v. Mont. Eighth Jud. Dist. Ct., 141 S.Ct. 1017, 1024-25 (2021). The analysis ensures that a defendant is not haled into a jurisdiction's court “solely as a result of random, fortuitous, or attenuated contacts.” Burger King, 471 U.S. at 475 (quotations omitted); see Ford Motor Co., 141 S.Ct. at 1025. The analysis focuses “on the relationship among the defendant, the forum, and the litigation.” Walden v. Fiore, 571 U.S. 277, 284 (2014) (quotation omitted); see Ford Motor Co., 141 S.Ct. at 1024-25; Bristol-Myers Squibb Co. v. Superior Ct, 137 S.Ct. 1773, 1781 (2017).

The extent of the contacts needed for jurisdiction turns on whether the claims asserted against a defendant relate to or arise out of the defendant's contacts with the forum state. See Ford Motor Co., 141 S.Ct. at 1025; Bristol-Myers Squibb, 137 S.Ct. at 1780; ALS Scan, Inc, v. Dig. Serv. Consultants, Inc., 293 F.3d 707, 712 (4th Cir. 2002). If the defendant's contacts with the state are the basis for the suit, specific jurisdiction may exist. ALS Scan, 293 F.3d at 712. In determining specific jurisdiction, the court considers: “(1) the extent to which the defendant purposefully availed itself of the privilege of conducting activities in the State; (2) whether the plaintiffs' claims arise out of those activities directed at the State; and (3) whether the exercise of personal jurisdiction would be constitutionally reasonable.” Id. (alteration and quotations omitted). Thus, the “constitutional touchstone” of specific personal jurisdiction “remains whether the defendant purposefully established minimum contacts in the forum State.” Burger King Corp., 471 U.S. at 474 (quotation omitted); see Bristol-Myers Squibb, 137 S.Ct at 1781-82; Walden, 571 U.S. at 284-91.

III.

Watters concedes that this court lacks general jurisdiction over TCC, UTMD, and Femcare. Watters, however, argues TCC, UTMD, and Femcare are subject to specific jurisdiction. As for TCC and UTMD, Watters argues that these defendants marketed and distributed the clips in North Carolina and thereby created specific jurisdiction in North Carolina. [D.E. 23] 16-27. TCC and UTMD respond that they had nothing to do with the clips used in Watters's April 2013 surgery and cite affidavits confirming that UTMD and TCC were not marketing clips in April 2013 when Watters underwent her initial surgery. See [D.E. 19-1,19-2]; [D.E. 24] 2-4.

Watters does not dispute the underlying facts in the UTMD and TCC affidavits. See [D.E. 23]. Nonetheless, Watters contends that UTMD's affidavit admits sufficient minimum contacts with North Carolina. See [D.E. 23] 17-21. Specifically, because the affidavit admits that UTMD has engaged in activities in North Carolina since 2019, Watters argues that UTMD purposefully availed itself of conducting activities in North Carolina. See Id. Essentially, Watters argues that UTMD's market participation in North Carolina since 2019 exposes it to personal jurisdiction in North Carolina for the April 2013 surgery. See id,

Watters's argument ignores that the facts establishing personal jurisdiction must be tied to the same underlying controversy that gave rise to the lawsuit. See Bristol-Myers Squibb, 137 S.Ct. at 1780 (holding that contacts not creating “the very controversy that establishes jurisdiction” are not sufficient to establish personal jurisdiction); Goodyear Dunlop Tires Operations, S.A. v. Brown, 564 U.S. 915, 931 n.6 (2011) (“[E]ven regularly occurring sales of a product in a State do not justify the exercise of jurisdiction over a claim unrelated to those sales.”); Burger King. 471 U.S. at 472-73 (holding that the “fair warning” requirement of the Due Process Clause is only satisfied if the litigation “arise[s] out of or relate[s] to” the activity defendant directed toward the forum). Watters's injury does not arise out of or relate to UTMD's post-2019 North Carolina market participation. Therefore, this court lacks personal jurisdiction over UTMD.

Alternatively Watters suggests that the relevant date for personal jurisdiction in this case is 2022, when Watters first discovered the alleged defect in her clip. See [D.E. 23] 19. In support, Watters notes that UTMD's marketing materials for their clips since 2019 “were likely one of the reasons why Plaintiff, her doctors and her healthcare teams were unaware of the Filshie Clips' propensity to migrate.” Id. at 20. ...