Filshie Clip Migration Claims Proceed Against CooperSurgical And Femcare: Filshie Clips are silicone-lined titanium medical devices that are attached to a woman’s fallopian tubes during a tubal ligation procedure. The clips work by exerting continuous pressure on the fallopian tubes, eventually blocking them and acting as a form of long-term birth control. The Filshie Clip is designed to remain permanently attached to the fallopian tube at its placement location. Femcare obtained conditional premarket approval (PMA) from the Food and Drug Administration (FDA) for the manufacturing and commercial distribution of the Filshie Clip within the United States in 1996. The device remains on the market today.
Jackie Dianna Mack and Frankie Mack filed a personal injury lawsuit against The Cooper Companies, Inc. (TCC) and its subsidiary CooperSurgical, Inc. (CooperSurgical); and Utah Medical Products, Inc. (UMP) and its subsidiary Femcare, LTD (Femcare) concerning migration of the Filshie Clips that allegedly caused injury to Mrs. Mack. The Defendants were alleged to have manufactured, marketed, and distributed Filshie Clips. The Macks claimed that the Defendants’ failures, along with the Defendants’ related breaches of various duties imposed on manufacturers and distributors of medical devices, caused Mrs. Mack’s injuries. The Macks brought state law claims against the Defendants for: (1) design defect; (2) manufacturing defect; (3) failure to warn; (4) strict liability; (5) negligence; (6) “violation of consumer protection laws”; (7) gross negligence; and (8) punitive damages.
The Macks alleged that migration of Mrs. Mack’s Filshie Clips was not an anomaly, as it was occurring in over 25% of patients. Despite this high rate, the Defendants neither warned nor adequately informed the Macks nor their healthcare providers of how frequently these migrations actually occurred or the severity and permanency of the potential injuries. The Defendants allegedly failed to provide any warning “even though [they] had received adverse reports and knew or should have known Filshie Clips had a significant propensity to migrate.” And problematically, Femcare had listed the migration rate at 0.13% in its application for premarket approval even though “the risk of migration was significantly higher [than 0.13%] and continued to increase from year to year.” Still, the Defendants “failed to address the Filshie Clips’ safety issues, even though adverse event reports did or should have alerted them to a product defect causing the device to cause injuries.” The Defendants also allegedly failed to report these adverse events to the FDA and to update their marketing materials to reflect the actual risk of clip migration, and the Defendants allegedly breached their duty to continually monitor and test their product to ensure its safety and to adequately warn consumers of the dangers inherent in the use of Filshie Clips. The Defendants moved to dismiss all claims against them.
Personal Jurisdiction
In its Memorandum Opinion And Order dated March 23, 2023, the United States District Court for the Middle District of Alabama Southern Division (“federal court”) stated: “The Court finds that Femcare has sufficient minimum contacts in Alabama to be subject to personal jurisdiction in this Court. Femcare is alleged to manufacture and knowingly distribute Filshie Clips to residents of Alabama. Femcare is also alleged to have entered into an exclusive distribution agreement with CooperSurgical who exclusively sold Filshie Clips throughout the United States without limitation, including the state of Alabama, two of which were implanted into Mrs. Mack. As such, Femcare’s contacts with Alabama are not random, fortuitous, or the result of a third party’s unilateral activity … Femcare should have reasonably anticipated being haled into court in Alabama for claims arising out of its contacts with Alabama … the Macks have sufficiently established that this Court may exercise personal jurisdiction over Femcare.”
Federal Preemption
With regard the the Defendants’ preemption claims, the federal court stated: “As currently pled, the Macks’ state law claims are not impliedly preempted. Although the MDA impliedly preempts “state-law fraud-on-the-FDA claims,”
Buckman, 531 U.S. at 348, it generally does not impliedly preempt “traditional state tort law causes of action that predated the federal enactments[] and did not implicate a duty owed to the FDA,” Mink, 860 F.3d at 1330 (citing Buckman, 531 U.S. at 353). For example, here the Macks’ design defect and manufacturing defect claims are based on their contentions that (1) the Filshie Clips used in Mrs. Mack were “defective in design” because their “risk of harm exceed[s] their claimed benefits,” specifically as it relates to the device’s alleged migration from the implantation site,
(Doc. 1 at 14); and (2) the Filshie Clips were “unreasonably dangerous” and “failed to perform as safely as the ordinary consumer would expect, causing injury,” (id. at 16). Additionally, the Macks’ failure to warn claim is based on their contention that the Defendants had a continuing duty to warn the Macks regarding the Filshie Clips’ “unreasonable risk of migration” but failed to do so. (Id. at 17–18.) The Macks thus rely on “traditional state tort law which had predated the federal enactments,” see Buckman, 531 U.S. at 353, and their claims do not “implicate a duty owed to the FDA” … Femcare and CooperSurgical’s focus on the allegations regarding the failure to report to the FDA ignores the other allegations that do not implicate a duty owed only to the FDA: that the Defendants owed common law duties to the Macks to not negligently design, manufacture, or fail to warn the Macks about the alleged dangers of the Filshie Clips. Reading the Complaint as a whole and construing it in the light most favorable to the Macks, the allegations regarding the failure to report to the FDA do not render the Macks’ claims impliedly preempted at this stage.”
Express Preemption
“The Macks’ state law claims are also not expressly preempted. This Court finds the district court’s decision in Blevins-Ellington v. CooperSurgical, Inc., No.1:22-CV-00197-LMM, 2023 WL 2111346, at *13 (N.D. Ga. Jan. 17, 2023), which reaches a similar conclusion as to Defendants’ liability under state law for injuries caused by Filshie Clips, persuasive and instructive on this point. Alabama law permits negligence and strict liability claims against product manufacturers and distributors that rest on common law duties owed to individuals … the Macks assert that the Defendants owed them a duty to prevent manufacturing and design defects, to warn of the risk of harm, and to exercise ordinary care, each of which the Macks connect to parallel federal requirements—for example, the requirement that the Defendants “obtain[] approval for changes in the design, manufacture, and warnings/marketing approved by the FDA” … Thus, based on the Complaint as currently pled, the MDA does not expressly preempt the Macks’ state law tort claims for injuries Mrs. Mack allegedly suffered from her Filshie Clips.”
The federal court stated: “Viewing the Complaint and all reasonable inferences in the Macks’ favor, the Complaint sufficiently pleads facts establishing a causal connection between the Defendants’ actions and the claims against them. According to the Macks, they assert their claims against the Defendants collectively because of the “intertwined business relationship and intertwined facts in the case”—specifically, because the Defendants all allegedly “developed, manufactured, distributed, marketed, and/or sold Filshie Clips during the time they were implanted in Ms. Mack.””
The federal court therefore denied the motions to dismiss filed by both CooperSurgical and Femcare.
Source Mack v. CooperSurgical, Inc., Case No. 1:22-cv-54-RAH.
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