Another Filshie Clip Migration Federal Court Partial Preliminary Win

Filshie Clip Migration Preliminary Win: The Filshie Clip, created by Marcus Filshie in the late 1970s, is a component of the “Filshie Clip System” for laparoscopic tubal ligation, which involves applying a titanium clip with silicone rubber lining around each fallopian tube. In short, the clip exerts continuous pressure on the fallopian tube, prompting necrosis and decreasing the tube’s size, eventually leading to fibrosis. The Filshie Clip is designed to remain permanently attached to the fallopian tube at its placement location, thus providing a long-term form of birth control.

In 1996, the FDA authorized the Filshie Clips’ commercial distribution after granting the device premarket approval. Subsequently, the Filshie Clip System was marketed and sold throughout the United States, including in Ohio.

In early 2003, Plaintiff underwent a tubal ligation procedure using Filshie Clips. Prior to this procedure, Plaintiff received a Disclosure and Consent detailing the related risks and hazards. The Disclosure and Consent did not, however, inform Plaintiff of the risk that the clip could migrate and the appurtenant damages entailing such a migration. In March of 2003, shortly after the tubal ligation, Plaintiff began experiencing pain and discomfort in her lower abdominal and pelvic region. This pain developed over the next 20 years, when, in January of 2022, Plaintiff’s doctor identified a migrated Filshie Clip as the cause of her suffering. As of the time Plaintiff filed her complaint, she was in the process of scheduling a surgery to remove the clips.

As set forth in Plaintiff’s Amended Complaint, Filshie Clips have subjected numerous unsuspecting women to significant injuries, stemming from the clips’ propensity to migrate after implantation on the fallopian tubes. Whereas Defendants represented a .13% migration rate when seeking premarket approval, the actual rate, according to Plaintiff, is over 25%. Despite this high rate, Defendants neither warned nor adequately informed Plaintiff or her healthcare providers how frequently these migrations occur or the attendant injuries that may accompany such migration. This is so despite Defendants having received adverse reports concerning clip migration. Rather than disclose the actual migration risk to the FDA, Defendants instead continued to market and promote the Filshie Clip System over other available procedures. Defendants’ actions allegedly breached their duty of reasonable care in the development and promotion of Filshie Clips and their duties as manufacturers and distributors of medical devices to continually monitor and test their product, thus subjecting Defendants to liability under the FDCA and Ohio product liability law.

Plaintiff asserted that, had Defendants complied with FDA regulations and Ohio product liability law, Plaintiff’s injuries could have been avoided. Plaintiff therefore brought the following state law claims against all Defendants: (1) strict products liability for design defect, (2) strict products liability for manufacturing defect, and (3) strict products liability for failure to warn. Defendants each separately moved to dismiss Plaintiff’s Amended Complaint in its entirety.

In its Opinion and Order filed on July 10, 2013, the United States District Court Southern District of Ohio Eastern Division stated:

“TCC’s Motion to Dismiss Plaintiff’s First Amended Complaint is GRANTED for lack of personal jurisdiction. (ECF No. 44.) TCC is DISMISSED without prejudice;

Femcare’s Motion to Dismiss Plaintiff’s First Amended Complaint is DENIED without prejudice regarding personal jurisdiction (ECF No. 59);

Plaintiff’s request for limited jurisdictional discovery as to Femcare is GRANTED. (ECF No. 60.) Plaintiff and Femcare shall have sixty (60) daysfrom the date of this Opinion & Order to engage in limited jurisdictional discovery. Such discovery must be limited to jurisdictional issues raised in or relevant to Femcare’s motion to dismiss for lack of personal jurisdiction. Two weeks after the close of the limited discovery period, Plaintiff may supplement its memorandum in opposition to Femcare’s motion to dismiss for lack of personal jurisdiction. Two weeks after Plaintiff files a supplemental brief, Femcare may file a reply in support of its motion to dismiss for lack of personal jurisdiction;

Femcare’s Motion to Strike Plaintiff’s Exhibits Offered in Opposition to Femcare’s 12(b)(6) Motion to Dismiss is DENIED as moot (ECF No. 66);

Femcare’s Motion to Dismiss Plaintiff’s First Amended Complaint under Rule 12(b)(6) is GRANTED in part and DENIED in part. (ECF No. 59.) The motion is GRANTED as to Counts I and II of Plaintiff’s Amended Complaint on the basis that Plaintiff’s claims are preempted. The motion is DENIED as to Count III of Plaintiff’s Amended Complaint;

CooperSurgical’s Motion to Dismiss Plaintiff’s First Amended Complaint is GRANTED in part and DENIED in part. (ECF No. 43.) The motion is GRANTED as to Counts I and II of Plaintiff’s Amended Complaint on the basis that Plaintiff’s claims are preempted. The motion is DENIED as to Count III of Plaintiff’s Amended Complaint; and

UTMD’s Motion to Dismiss Plaintiff’s First Amended Complaint is GRANTED in part and DENIED in part. (ECF No. 45.) The motion is DENIED to the extent UTMD asserts that the Court lacks personal jurisdiction over UTMD. The motion is GRANTED as to Counts I and II of Plaintiff’s Amended Complaint on the basis that Plaintiff’s claims are preempted. The motion is DENIED as to Count III of Plaintiff’s Amended Complaint.”

In explaining its holding with regard to the preemption issue, the District Court stated: “Simply put, Plaintiff has failed to allege a factual basis for her design defect claim that is independent of Defendants’ alleged failure to make certain disclosures to the FDA. Under Sixth Circuit precedent, this claim is impliedly preempted … [however,] Unlike Plaintiff’s claims for design defect and manufacturing defect, the Court finds that Plaintiff’s failure to warn claim evades preemption … Plaintiff carefully drafted her Amended Complaint to avoid alleging that Defendants failed to provide warnings “beyond” those required by the FDA—that is, Plaintiff’s Amended Complaint strictly limits her FDCA failure-to-warn allegations to those that parallel Ohio’s product liability laws.”

With regard to the Plaintiff’s manufacturing defect claim, the District Court stated: “allowing Plaintiff to proceed on this claim, given the absence of any allegation that Defendants failed to produce the Filshie Clips used in Plaintiff in accordance with FDA specifications per the PMA, “effectively results in a holding that an FDA-approved manufacturing process could nevertheless be legally insufficient and expose defendant to liability” … such a permissive decision would “encroach[] on federal regulatory authority that 21 U.S.C. § 360(k) was specifically designed to prevent.” 209 F. Supp. 3d at 1008. Accordingly, § 360k(a) expressly preempts plaintiff’s manufacturing defect claim.”

Arnold v. CooperSurgical, Inc., Case No. 2:22-cv-1951.

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 who may 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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