A California Appellate Court supported a trial court’s ruling that the Medical Device Amendments (MDA), Title 21 USC §360k(a), preempts any state law imposing safety requirements on manufacturers of a medical device. So even though the medical device did not pass all of the state’s safety requirements, in Blanco v. Baxter Healthcare Corp. the plaintiff’s claim was denied because the medical device in question met all the FDA requirements. As we see again and again, the MDA’s preemption claim is making it increasingly difficult to seek legal recourse for a faulty medical device. Of course, this would hold true for our cases in Chicago and around Illinois.
Claudia Blanco was diagnosed with mitral valve stenosis and needed to have her natural valve replaced with an artificial one. During surgery a bileaflet mitral heart valve manufactured by Baxter-Travenol Laboratories was inserted. A year after Blanco received the valve Baxter suspended marketing of its product due to reports of possible valve failures.
However, Blanco didn’t receive any notice of the valve problems for another five years. And while the notice advised her of the potential problems it did not advise her to have the valve removed or replaced. Less than ten years later Blanco’s artificial valve failed and she was rushed to the hospital for an emergency valve replacement, but died. After her death a representative from Baxter evaluated her valve and determined that the failure was in fact caused by a faulty valve.
But despite the evidence that the product was faulty Blanco’s claim was denied by both the trial and appellate courts. Because the medical device had passed a “rigorous” approval by the FDA it was protected from litigation for product liability. Also, because the device’s warnings were also approved by the FDA a claim cannot be brought for failure to warn.
The relevant Medical Device Amendment states that:
No state . . . may establish . . . any requirement (1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device . . .
When evaluating Blanco’s claim the appellate court reviewed the FDA requirements for the relevant medical device to determine whether the FDA had specific safety or warning requirements. The court decided that the FDA did have relevant standards, which the device had met. Therefore, if a jury entered a verdict in Blanco’s favor this would effectively impose new standards on the medical device that were above and beyond those imposed by the FDA. Because this would go in direct opposition to the MDA her claim was denied.
The only way to pursue a negligence claim against the manufacturer of a medical device is if the safety failure is not covered under a FDA requirement. However, because of the inclusive nature of the FDA approval process the chances of this are slim. Therefore, the user of a defective FDA-approved medical device is effectively denied legal recourse in any court, including here in Illinois.
Kreisman Law Offices has been practicing medical malpractice and Illinois medical device liability law for over 30 years in Cook County and the surrounding areas, including Buffalo Grove, Glenview, Melrose Park, and Southmoor.
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