HOUSTON - Two women who experienced complications from an implant used to prevent pregnancy shouldn't be able to sue the maker of Filshie Clips because it complied with federal regulations, a magistrate judge says.
Magistrate judge Dena Palermo issued her report and recommendations March 6 in a lawsuit against Femcare and others, and it will now be up to district judge Drew Tipton to consider her thoughts in the case filed by Ahiri Merlo and Giovanna Bulox.
Their Filshie Clips migrated from their fallopian tubes, a threat recognized by the product's maker and the Food and Drug Administration. Even though the plaintiffs claim the disclosed figures undersold the danger, they still can't file state-law claims like design defect and gross negligence, Palermo wrote.
"Texas courts generally reject arguments that reporting statutes give rise to common-law causes of action under Texas law," Palermo wrote.
"Accordingly, because there is no 'parallel' state requirement under Texas law, Plaintiffs' contention that Defendants' failure to warn via failure to report adverse event complaints is 'simply an attempt by private parties to enforce' FDA reporting requirements..."
The 1976 Medical Device Amendments grant the FDA the power to regulate medical devices and includes a preemption provision that keeps states from establishing different or stronger standards for devices.
Part of the approval process with the FDA has the device-maker informing it of adverse event reports and of new research concerning the device.
Femcare makes the Filshie Clip, which was sold by CooperSurgical until 2019. When Utah Medical bought Femcare, it also acquired distribution rights from Cooper. All three were named as defendants.
Femcare's FDA approval process began in 1992. It reported the Filshie Clip migrated from fallopian tubes in 0.13% of patients and stuck by that figure in the following years.
In 2007, an academic article claimed migration rates could actually be 25% or higher. It reported the article to the FDA, but the agency did not order a change to the 0.13% rate told to doctors and patients.
Femcare's own report in 2019 said that none of the migrations in the previous 10 years were life-threatening or caused serious injury.
However, Bulox said after nine years with the clip, she experienced pain caused by a clip that migrated and penetrated her intestine. Merlo's migrated too, but doctors never found where.
They sued for design defect, failure to warn, strict liability, negligence, gross negligence and violations of consumer protection laws. The complaint argued the clips weren't as safe as they expected.
"However, Plaintiffs do not plead that the Filshie Clips used in their surgeries or otherwise currently distributed were designed in a manner other than as the FDA approved," Palermo wrote.
The plaintiffs said the FDA-approved design was dangerous, which the defendants said doomed their arguments because the FDA is responsible for enforcing device law.
"Because Plaintiffs have not alleged that the product in question was designed in violation of federal standard they have failed to plausibly state a claim for design defect that would avoid preemption under the MDA," Palermo wrote.
Daniel Griffin and Simon Purnell of Griffin Purnell represents the plaintiffs. Several firms represent the defendants - Burbridge Mitchell of Utah, Holm Bambace of Houston and Mayer LLP in Houston.