A federal judge in Texas has ruled that a lawsuit against a device maker can proceed, because preemption - as defined in a closely watched US Supreme Court ruling earlier this year - does not apply in this instance. And the decision suggests device makers may no longer be immune from some cases they have been unwilling to settle.
Here's some background: Last February, the US Supreme Court voted to 8-1 that patients can’t file lawsuits against device makers when their products were approved by the FDA. Medtronic successfully argued that the Food, Drug, and Cosmetic Act expressly preempts state law claims brought by patients who were hurt by devices that received premarket FDA approval.
The ruling gave device makers an eagerly anticipated defense in product-liability lawsuits and drugmakers are hoping for a similar ruling this fall when the court hears a case involving a Wyeth medication. [Preemption is the legal notion that FDA approval of a drug supercedes state law claims challenging safety, efficacy, or labeling. Drugmakers and the FDA argue that preemption exists by maintaining the agency’s actions are the final word on safety and effectiveness. Unlike medical devices, however, there is no statute providing for preemption for drugs.]
But in an 8-page ruling last week, US District Court Judge Barbara Lynn wrote that preemption does not preclude a family from pressing a lawsuit against Bionics over two Cochlear devices that were implanted in their son's ears in 2005. The family charged the implants were adulterated because Bionics failed to use an approved manufacturer for a component; failed to obtain premarket approval for design modifications and manufacturing processes didn't comply with FDA requirements. The FDA filed suit in 2006.
In her decision, Lynn noted that "the relevant issue here is whether plaintiffs’ strict liability and implied warranty claims impose duties on medical device manufacturers 'different from, or in addition to' those arising under the Medical Devices Amendments of 1976, triggering preemption." She went on to conclude that "plaintiffs’ strict liability claims are predicated solely on violations of federal law," and as a result, preemption is not warranted.