A legally complex and incredibly compelling case out of the U.S. District Court for the Middle District of Florida raises some very important issues for certain folks in the Sunshine State.
The case involves cardiac defibrillator lead implants manufactured by California-based Pacesetter, Inc. and Minnesota-based St. Jude Medical, Inc. The defibrillator lead implants — in this case, the model 1582 Riata lead — connect an implantable cardioverter defibrillator (ICD) to the heart in order to monitor heart rhythms. These ICDs detect life-threatening or irregular heartbeats. In the case of an irregular heartbeat, the ICD delivers an electrical shock to return the heart to a more normal rhythm. ICD leads usually have layers of insulation that protect electrical conductor wires inside. The model 1582 Riata lead is a Class III medical device as designated under the Medical Device Act (MDA), 21 U.S.C. §360c, and must be approved by the Food and Drug Administration’s (FDA) premarket approval (PMA) process prior to commercial distribution. This classification is given to medical devices that support or sustain human life or can present a high risk of injury and, as a result, must undergo the rigorous approval process. Once the FDA grants approval to a device, the manufacturer must inform the FDA of incidents where the device may have caused or contributed to a patient’s death or serious injury.
But there was trouble with the model 1582 Riata lead implants. Back in late 2011, St. Jude Medical recalled them, citing insulation failure. While most lead implants are expected to have a shelf life of roughly 10 years, the Riata implants were experiencing premature erosion of the insulation surrounding the electrical conductor wires attached to the ICDs. For patients, that meant the lead implants could oversense, undersense, or deliver inadequate amounts of high-voltage therapy. Because of this problem, the manufacturer ultimately stopped selling the 1582 Riata lead implants model. But by the time the manufacturer did so, more than 227,000 of the units had been distributed worldwide with as many as 80,000 still implanted in patients even a year later.
Enter the case of Marmol v. St. Jude Medical Center, the plaintiff, Delio Marmol, claimed he began to experience unnecessary electrical shocks from his implant that were unrelated to his heart condition. Informed by his doctor of an FDA recall of the Riata lead implants, Marmol attempted to have his replaced. But his surgery was unsuccessful and the implant could not be removed. As a result, Marmol brought Florida state law claims of strict liability for a manufacturing defect, negligence, and a failure to warn. The defendants sought to dismiss Marmol’s claims on four bases: (1) he failed to assert a prima facie claim for a manufacturing defect, (2) his manufacturing defect claims were preempted under the MDA, (3) no private action could be brought for violations of FDA requirements under Florida law, and (4) his failure to warn claim was also preempted under the MDA.
In regard to Marmol’s manufacturing defect and negligence claims, it’s important to understand the concept of preemption. Under the MDA, any state law that contradicts, is different from, or adds to the requirements of a device governed by it is preempted. The Supreme Court established a two-part test for preemption. First, the federal government must have established requirements on the particular device and, second, the state law claims concerning the device must be based on requirements that are “different from or in addition to” the federal requirements governing the safety and effectiveness of the device. In the case of Marmol, the first prong was automatically satisfied because the model 1582 Riata lead implants, as a Class III medical device, underwent the rigorous requirements of the FDA-mandated PMA process. However, the court was stuck on the second-prong question of whether Marmol’s state law manufacturing defect and negligence causes of action would impose requirements that are “different from or in addition to” the MDA requirements. The defendant claimed they did because Marmol was claiming a defect or negligence on a basis that went beyond the requirements of the PMA process. But the court saw some persuasiveness in Marmol’s argument that other federally imposed standards – other than those required in the device-specific PMA — could be considered to find that his cause of action was not “different from or in addition to” the requirements of the MDA. In the end, however, the court realized it did not need to answer this question of preemption because Florida law does not allow private causes of action for violations of FDA requirements and dismissed Marmol’s manufacturing defect and negligence claims.
In regard to Marmol’s state law failure to warn claim, the court found there was implied preemption and dismissed this claim as well. Marmol claimed the defendants breached their duty to warn about the defects of the model 1582 Riata lead implant by failing to provide timely post-PMA reports about its safety concerns and other potential hazards to the FDA. But while Florida law recognizes the duty of medical device manufacturers to warn consumers directly or through their physicians prior to use, it does not require them to notify the FDA of any potential problems after granting PMA. Without such a duty – and because federal law does not allow for a private cause of action for failure to comply with FDA requirements – the court found Marmol’s failure to warn claim to be impliedly preempted.
While the courts and lawyers haggle over intricate and complex legal concepts such as preemption, the takeaway is this: Suing a medical device or pharmaceutical manufacturer can be very difficult and these claims should be thoroughly evaluated by an experienced attorney before filing suit.
