A federal judge’s decision in a lawsuit over allegedly defective silicone breast implants highlights the preemption rules enshrined by the Supreme Court in Riegel vs. Medtronic (PDF).
In that case, the Supremes held that once a medical device has been approved by the Food & Drug Administration, product liability lawsuits based on state tort laws have no standing — in other words, the federal approval preempts state law.
Based on that precedent, Judge G. Murray Snow of the U.S. District Court for Arizona threw out Williams et al vs. Allergan. The Williams, Karen and Robert, sued one of Allergan and its corporate predecessors after her silicone breast implant ruptured.
The device, called a Style 110 implant, was approved only for reconstructive use, not for general plastic surgery; Karen Williams became eligible for the device after undergoing a left mastectomy in 1999. That implant was replaced with another Style 100 implant in 2004, as part of a clinical trial, but ruptured three years later and leaked silicone into Williams’ body.
The Williams alleged that the manufacturer of the second, leaky implant, Inamed (later acquired by Allergan), was liable for faulty and and negligent manufacture, development, design, production, assembly and merchandising of the device.
Allergan countered that the Williams’ claims were statutorily preempted; eventually, Judge Snow agreed and dismissed the case.
At first glance, the lawsuit highlights how the preemption doctrine stacks the decks against patients injured by a faulty device. Opponents of the statute say the possibility of litigation forced device makers to ensure the safety of their products. Removing that threat, they say, will lead to more and more unsafe devices in the marketplace.
Proponents counter that, in the vast majority of cases, it’s doctors’ mistakes that cause the problems, not inherent problems with the devices. They hold that allowing personal injury cases to be filed at the state level will be too costly for device makers, hampering innovation.
But a closer look at Williams et al v. Allergan et al shows that, even absent the preemption statute, the couple might still have lost. They accused the device maker of failing to follow FDA requirements, alleging that Karen Williams did not consent to be a member of the 2004 clinical trial. But they themselves produced the disclosure statement and consent form she signed (the Williams claimed she signed the form in 1999 and someone added in the 2004 date later, after everything went bad).
The Williams also accused the defendants of failing to follow other FDA rules, but couldn’t provide any evidence to support the allegation. And even if they had, Snow wrote, it might not have mattered.
“Even if Plaintiffs’ assertions were true, however, it is unclear why these facts would mean the [Medical Devices Act] does not preempt the negligence and strict liability claims alleged in the Complaint,” he wrote. “Whether Ms. Williams consented and whether Defendants followed every FDA requirement does not negate the fact that the FDA ultimately concluded the Style 110 implant was fit for public use.”
Another of the Williams’ claims, that the device makers “non-compliance with FDA requirements disrupted the approval process and contributed to the product’s lack of safety,” was also shot down by Snow.
“Even construing the Complaint broadly … Plaintiffs alleged no facts regarding FDA requirements, the premarket approval process, the study, or Ms. Williams’ consent. The Complaint also did not assert any of these arguments in either the count for strict liability or for negligence,” he wrote. “This is insufficient to assert a justiciable claim based on Defendants’ noncompliance with the MDA and FDA.”