Filshie Clip Litigation Early-Stage Victory! — In its Order filed on January 17, 2023, the United States District Court for the Northern District of Georgia DENIED the Filshie clip Defendants’ Motions to Dismiss.

Background

Plaintiffs are three women and one of their spouses who allege that Defendants designed, manufactured, and advertised defective “Filshie Clips,” which caused significant physical injuries when the clips migrated. Defendants are The Cooper Companies, Inc. (“Cooper Companies”); Cooper Surgical, Inc. (“Cooper Surgical”); Utah Medical Products, Inc. (“Utah Medical”); and Femcare, Ltd. (“Femcare”), Utah Medical’s United Kingdom subsidiary.

Filshie Clips are a birth control device used in tubal ligation procedures. They are small titanium clips lined by silicone rubber that are meant to be attached to the fallopian tubes. When they function properly, Filshie Clips exert continuous pressure to block the fallopian tubes and serve as a long-term form of birth control.

Defendant Femcare, a manufacturer, received conditional premarket approval (“PMA”) for Filshie Clips from the Food and Drug Administration (“FDA”) in 1996 as a Class III device, the most dangerous and most rigorously tested class of medical devices. 21 U.S.C. §§ 360c, 360e. At that time, Defendants reported that Filshie Clips had a .13% migration rate. Plaintiffs argue that the risk of migration was significantly higher than that number and has continued to climb since 1996, today reaching an estimated 25% migration rate. Stated succinctly, Plaintiffs’ suit alleges that Defendants designed and manufactured a defective product and failed to warn both consumers and healthcare providers about this risk of migration — of which Defendants were or should have been aware — and that with proper disclosures of the migration risks, Plaintiffs’ injuries would have been avoided.

Plaintiffs brought seven substantive counts against all Defendants, plus pleas for punitive damages (Count 8) and attorney’s fees (Count 9). The seven substantive counts are as follows: Count 1: Design Defect, Count 2: Manufacturing Defect, Count 3: Failure to Warn, Count 4: Strict Liability, Count 5: Negligence, Count 6: Violation of Consumer Protection Laws, and Count 7: Gross Negligence.

All four Defendants moved to dismiss Plaintiffs’ Complaint on various grounds. Defendants Cooper Companies, Utah Medical, and Femcare first argued that (a) the federal District Court cannot exercise personal jurisdiction over them and that (b) venue is improper. Alternatively, Cooper Companies and Utah Medical argued that (c) they cannot be held liable for their subsidiaries’ conduct, even if they are subject to this Court’s jurisdiction. Next, all Defendants contended that (d) federal law preempts Plaintiffs’ claims, that (e) the learned intermediary doctrine precludes liability here, and that (f) the applicable statute of repose bars one Plaintiff’s strict liability claim.

In short, Defendants made various arguments for dismissal that can be labeled as follows: (A) personal jurisdiction, (B) venue, (C) parent company liability, (D) preemption, (E) learned intermediary doctrine, and (F) statute of repose. Defendants Cooper Companies and Utah Medical argued all six points (A–F), and Defendant CooperSurgical joined them in arguing the final three issues. Defendant Femcare argued all but (C) parent company liability. Plaintiffs challenged all of these arguments except for (F) the statute of repose.

Federal Court’s Ruling

The federal District Court determined that it may exercise personal jurisdiction over Defendant Utah Medical because of Utah Medical’s contacts with the forum state. Utah Medical did not challenge its status as the sole distributor of Filshie Clips in the United States, and it does not dispute Plaintiffs’ allegations that it currently does business in Georgia. By advertising Filshie Clips online and sharing information about their purported safety and effectiveness, Utah Medical has purposefully availed itself of the privileges of doing business in Georgia, and these contacts relate to Plaintiffs’ claims, which concern misleading promotions about Filshie Clips’ safety. “Therefore, Utah Medical is subject to this Court’s jurisdiction, and Utah Medical’s Motion to Dismiss [25] is DENIED as to personal jurisdiction.”

The federal District Court held:

“[T]he Court GRANTS Plaintiffs’ request for limited jurisdictional discovery regarding Defendant Cooper Companies. Thus, Defendant’s Motion to Dismiss [24] for lack of personal jurisdiction over Cooper Companies is DENIED without prejudice.”

“Based on the facts presented, Plaintiffs have shown that personal jurisdiction over Femcare may be proper, depending on additional facts available only from Femcare itself … Accordingly, the Court GRANTS Plaintiffs’ request for limited jurisdictional discovery regarding Defendant Femcare. Thus, Defendant Femcare’s Motion to Dismiss [55] for lack of personal jurisdiction is DENIED without prejudice.”

“Plaintiffs assert claims under Georgia state law, and no party has indicated another forum where venue may be more appropriate based on a substantial portion of the related events taking place in that district. Therefore, Plaintiffs have made a sufficient showing that venue is proper in this District. Therefore, the Court finds that venue is proper under 28 U.S.C. §1391(b)(2) and need not address the parties’ arguments regarding § 1391(b)(3) or 18 U.S.C. §1965. Defendants’ Motions to Dismiss for improper venue are DENIED.”

“The Court has determined that is has personal jurisdiction over Utah Medical and will determine jurisdiction over Cooper Companies after limited discovery. Whether either of these companies is liable for its subsidiary’s conduct is a question of the merits of Plaintiffs’ case, to be determined at a later stage in the litigation and after discovery. At this stage, the Court finds Plaintiffs’ pleadings sufficient. Thus, Defendants Cooper Companies and Utah Medical’s Motions to Dismiss on parent company liability grounds are DENIED.”

Congress passed the Medical Device Amendments of 1976 (“MDA”) to the Food, Drug, and Cosmetic Act, 21 U.S.C. § 360c et seq, to create a uniform regulatory scheme for medical devices. To gain Class III status, Filshie Clips passed the FDA’s “rigorous” premarket approval (“PMA”) testing. The FDA has authority to withdraw PMA based on new or existing information, and it “must withdraw approval if it determines that a device is unsafe or ineffective under the conditions in its labeling.” Thus, manufacturers granted PMA for their devices must comply with specific regulations promulgated by the FDA, as necessary to sustain approval.

To ensure nationwide standardization, Congress included an express preemption provision in the MDA. To avoid having his claims preempted, a plaintiff must carefully plead a claim that implicates the safety or effectiveness of a federally regulated medical device. Express preemption will bar state-law claims that impose on the medical device a requirement different from or additional to federal requirements. And implied preemption prohibits state-law claims that seek to privately enforce duties owed to the FDA.

Thus, MDA preemption leaves “a ‘narrow gap’” for pleadings to avoid preemption: “a plaintiff has to sue for conduct that violates a federal requirement (avoiding express preemption), but cannot sue only because the conduct violated that federal requirement (avoiding implied preemption). Eleventh Circuit precedent indicates that the MDA does not expressly preempt all state law tort claims for injuries suffered from dangerous medical devices.

In light of such, the federal District Court stated: “Plaintiffs’ claims here would simply provide them with a damages remedy for existing violations of federal regulations through this state common law avenue because of the state law duties owed to Plaintiffs … Therefore, the Court finds that Plaintiffs’ claims are not expressly preempted.”

“Plaintiffs specifically allege that Defendants violated FDA requirements regarding their ongoing duty to report to the FDA, Dkt. No. [17] ¶ 102; their duty of truthfulness to the FDA and the obligation to receive FDA approval for any changes to the device … and their failure to comply with FDA manufacturing regulations … These allegations are sufficiently specific to avoid preemption, especially at this stage of litigation and without the benefit of discovery.”

“In short, Defendants’ preemption arguments must fail. The Eleventh Circuit has consistently held that the MDA does not preempt state tort claims like Plaintiffs’, especially at the pre-discovery dismissal stage. Thus, the Court finds that Plaintiffs’ pleadings are sufficient to survive Defendants’ Motions to Dismiss. Therefore, Defendants’ Motions to Dismiss on preemption grounds are DENIED.”

“The Court does not decide whether the learned intermediary doctrine will ultimately apply in this case. The Court only finds that Plaintiffs’ failure to warn (Count 3) allegations are adequate to survive Defendants’ Motions to Dismiss on these grounds. Defendants’ Motions to Dismiss are DENIED as to the learned intermediary doctrine.”

WE ARE CURRENTLY INVESTIGATING FILSHIE CLIP MIGRATION CLAIMS THROUGHOUT THE UNITED STATES.

If you or a loved one suffered injury or other harm from Filshie clip migration, or other Filshie clip issues, in the United States, you should promptly find a lawyer who may investigate your Filshie clip claim for you and represent you or your loved one in a Filshie clip case, if appropriate.

Visit our website or call us toll-free in the United States at 800-295-3959 to find Filshie clip attorneys who may assist you with your Filshie clip claim.

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