HOUSTON - Over the objections of women hoping to blame the maker of a birth-control medical device for their injuries, a federal judge has decided federal law preempts their claims.
Houston judge Drew Tipton on March 25 ruled against the complaints to magistrate judge Dena Palermo's March 6 report and recommendations that came from plaintiffs Giovanna Bulox and Lorena Ahiri Merlo. His adoption of the R&R grants summary judgment to several defendants, including Femcare, the maker of the device at issue.
Bulox's and Merlo's 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.
The problem with their case, she added, is that defendants like Femcare complied with FDA regulations, triggering federal preemption under the Medical Device Amendments of 1976.
"To avoid preemption under the MDA, a federal regulation does not need to be identical to, or have the exact same terms as, a state law claim," Simon Purnell of Griffin Purnell wrote for the plaintiffs.
"Rather, a state common law claim is preempted if it imposes requirements that are 'different from, or in addition to' those imposed by federal law. Texas product liability law... does not impose any additional requirements to those imposed by the MDA - both require parallel duties to ensure that Defendants' products are safe to use."
But Tipton found otherwise, claiming their failure-to-report claims were an attempt by private parties to enforce the FDA's power.
The MDA 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.
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.
The plaintiffs said Palermo ignored similar product liability claims brought under Texas state law.
"In instances where the product in question is a medical device regulated by the FDA, the most reasonable and practical method a manufacturer can use to warn of these risks is through the FDA," Purnell wrote.
"The FDA, in turn, can guide the manufacturer through the process of corrective action, including revising IFUs, marketing materials, product warnings, issuing recalls, etc.
"Because FDA reporting is logistically necessary in order for a medical device manufacturer to fulfil its duty to warn under Texas law, the duties and requirements imposed on manufacturers of medical devices by federal law and Texas product liability law are parallel."
Key to the case was the application of a 2011 ruling by the U.S. Court of Appeals for the Fifth Circuit. In Hughes v. Boston Scientific, the company allegedly failed to adhere to FDA medical device reporting requirements by not disclosing deaths or serious injuries.
Under a Mississippi products liability law no longer on the books, the Fifth Circuit said the duty to provide adequate warnings includes reporting "reasonable warnings" of risks.
"While the Hughes court did address claims brought under a previous Mississippi state law, attempts to distinguish the holding's applicability to the instant case are unpersuasive," Purnell wrote.
"The Hughes court analyzed a Mississippi state law that imposed a duty on manufacturers to provide 'reasonable warnings of risks.' Significantly, this is the same requirement Texas statutes impose upon a manufacturer in the context of a failure-to-warn claim."
Tipton disagreed. He found Palermo had the correct reading of the case, which allowed a jury to use a defendant's alleged violation of FDA reporting requirements as evidence it also violated the reasonable-warning requirement of the Mississippi law, he said.
"Thus, Hughes stands only for the proposition that if Plaintiffs could identify an independent and parallel source of liability in Texas law for noncompliance with federal reporting regulations, then federal law does not expressly preempt that claim," Tipton wrote.
"The Court agrees with Judge Palermo that Plaintiffs have not identified an independent and parallel source of liability in Texas law for violating federal reporting requirements."