On September 7, 2023, the federal court in South Carolina denied the Defendants’ respective motions to dismiss the Plaintiffs’ Filshie clips migration case. The federal court stated in its opinion, in part:

Plaintiffs bring claims against Defendants for (1) design defect; (2) manufacturing defect; (3) failure to warn; (4) strict liability; (5) negligence; (6) violation of the South Carolina Unfair  Trade Practices Act (SCUTPA); (7) gross negligence; and (8) punitive damages. The Court has diversity jurisdiction over the matter under 28 U.S.C. § 1332.

Pending before the Court are: Utah Medical’s and Femcare’s motions to dismiss for lack of personal jurisdiction, under Fed.R.Civ.P. 12(b)(2), Utah Medical’s and Femcare’s motions to dismiss for improper venue, in accordance with Fed.R.Civ.P. 12(b)(3); and Utah Medical’s, Femcare’s, and CooperSurgical’s motions to dismiss for failure to state a claim, pursuant to Fed.R.Civ.P. 12(b)(6).

Having carefully considered the motions, the responses, the replies, the supplements, the record, and the applicable law, it is the judgment of this Court each of Defendants’ motions to dismiss will be denied.

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In sum, Utah Medical, as the one with the nationwide distribution rights for Filshie Clips, and having marketed, sold, and distributed the Filshie Clips in South Carolina since 2019, has “purposefully established minimum contacts in [South Carolina] such that it should reasonably anticipate being haled into court [here].”

. . . .

As such, Utah Medical’s contacts with South Carolina after it obtained the nationwide distribution rights to the Filshie Clips in 2019 are relevant to some of Plaintiffs’ claims. Thus, Plaintiffs have satisfied the “arise out of” requirement to establish jurisdiction over Utah Medical.

. . . .

Accordingly, Utah Medical has failed to show how this Court exercising jurisdiction over it is constitutionally unreasonable such that it would “offend ‘traditional notions of fair play and substantial justice.’ “

. . . .

To recap, Utah Medical is currently doing business in South Carolina, and was doing business in South Carolina when Plaintiff’s above-mentioned claims arose. In its sharing information about the Filshie Clips purported safety and effectiveness, Utah Medical has purposefully availed itself of the privileges of doing business in South Carolina. And Utah Medical’s contacts relate to some of Plaintiffs’ claims, which concern allegedly misleading promotions about Filshie Clips’ safety and effectiveness.

In addition, Utah Medical has failed to establish the Court’s exercise of personal jurisdiction over it is constitutionally reasonable. Therefore, for all these reasons, the Court concludes it has personal jurisdiction over Utah Medical. Therefore, it will deny Utah Medical’s Rule 12(b)(2) motion to dismiss for lack of personal jurisdiction.

. . . .

Accordingly, the Court is unable to conclude Femcare’s contacts with South Carolina were random, fortuitous, or the result of a third party’s unilateral activity … Instead, Femcare’s contacts with South Carolina are the result of Femcare’s decision to sell its Filshie Clips throughout the United States, including South Carolina, through its distributors: first, CooperSurgical and now, Utah Medical. A manufacturer such as Femcare should be able to reasonably expect its medical device, Filshie Clips, would be sold in South Carolina when it entered into its exclusive distribution agreements with CooperSurgical and Utah Medical for the purpose of distributing its Filshie Clips throughout the United States. Those agreements failed to exclude South Carolina from the territories where its Filshie Clips would be sold.

Therefore, the Court concludes Plaintiffs have established Femcare purposely availed itself of the privilege of conducting activities in South Carolina.

. . . .

The Filshie Clips “arrived in [South Carolina] through [Femcare’s] purposeful shipment . . . through an established distribution channel.” Id. And, there is no dispute the Filshie Clips allegedly caused Plaintiffs’ purported injuries. Therefore, in light of the case law above, the Court easily concludes Plaintiffs’ claims arise out of to Femcare’s contacts with South Carolina. 

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In sum, Femcare is subject to this Court’s jurisdiction. It has purposefully availed itself of the privilege of conducting activities within South Carolina. It placed its product, the Filshie Clips, in the stream of commerce with the intent it reach the state of South Carolina; and it continues to conduct substantial business in South Carolina. 

Further, Plaintiffs’ claims arise out of Femcare’s contacts with South Carolina. And, Femcare is unable to show the Court’s exercise of personal jurisdiction over it would be constitutionally unreasonable. Accordingly, Femcare is subject to this Court’s jurisdiction.

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The Court concurs with those other courts holding it best to decide the preemption question after discovery. See eg., Shook v. Boston Scientific Corp., No. 1:20-cv-242-MOC-WCM, 2021 WL 1093637, at *3 (W.D. N.C. May 22, 2021) (“The Court has determined that, in light of the lenient pleading standards of Iqbal and Twombly, the Court will deny the motion to dismiss and allow the parties to proceed with discovery. In so holding, the Court makes no determination on federal preemption at this time. Rather, the Court has determined that Plaintiff has merely sufficiently pleaded enough facts to overcome a motion to dismiss as to the preemption issue.”).

Concerning the learned intermediary doctrine, “[u]nder this doctrine, the manufacturer’s duty to warn extends only to the prescribing physician, who then assumes responsibility for advising the individual patient of risks associated with the drug or device.” Odom v. G.D. Searle & Co., 979 F.2d 1001, 1003 (4th Cir. 1992). As per the doctrine, “the burden remains on the plaintiff to demonstrate the additional non-disclosed risk was sufficiently high that it would have changed the treating physician’s decision to prescribe the product for the plaintiff.” Id.

Discovery is necessary for Plaintiffs to attempt to meet this burden. As such, it would be inappropriate for the Court to decide the learned intermediation issue at this stage.

Accordingly, the Court will deny Defendants’ motion to dismiss for failure to state a claim.

Nedimyer v. CooperSurgical, Inc., Civil Action 3:22-1454-MGL.

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