February 21, 2012
The U.S. Court of Appeals for the Fifth Circuit recently ruled that some state law claims by a patient who had allegedly received a defective hip replacement survived federal preemption. See Bass v. Stryker Corp., No. 11-10076, 2012 WL 266985 (5th Cir. Jan. 31, 2012). The plaintiff sued the company that had designed, manufactured, and marketed a hip prosthesis that malfunctioned after it was surgically implanted into the plaintiff's body. He brought his action in the U.S. District Court for the Northern District of Texas under various theories, including strict products liability, negligence, breach of warranty, and violation of the Texas Deceptive Trade Practices Act. The defendant moved to dismiss, arguing that all of the plaintiff's claims were preempted under Medical Device Amendments ("MDA"), 21 U.S.C. § 360k(a), to the Food, Drug & Cosmetics Act ("FDCA"). The defendant asserted that the state law claims were preempted in light of the U.S. Supreme Court's interpretation of the MDA's preemptive reach in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008). The district court granted the manufacturer's motion to dismiss on the basis of preemption. The Fifth Circuit reversed in part, concluding that certain of the plaintiff's causes of action survived MDA preemption.
The court of appeals first noted that a state tort claim to recover for injuries allegedly caused by a medical device is preempted if (1) the federal government has established requirements applicable to the device, and (2) the claims are based on state law requirements that are different from or in addition to the federal requirements and that relate to safety and effectiveness. Devices that are approved through the premarket approval ("PMA") process of the Food and Drug Administration ("FDA") automatically satisfy the federal-requirements prong of MDA preemption. The court of appeals found that the district court had correctly determined that the hip replacement device at issue was subject to the PMA process and, for that reason, satisfied the federal-requirements element of preemption.
The court then noted, however, that the preemption provision of the MDA does not prevent a State from providing a damages remedy for claims grounded upon violation of the FDA regulations pertaining to a medical device. According to the court, state duties in such a case are parallel to, rather than in addition to, the federal requirements. In order to plead a valid parallel claim beyond the reach of MDA preemption, a plaintiff's allegations must be plausible within the meaning of the rules governing a motion to dismiss. The court concluded that the plaintiff had sufficiently pleaded parallel claims insofar as his claims were based upon manufacturing defects resulting from a violation of the FDA regulations. The court noted that the plaintiff had alleged that his injury had been caused by the hip replacement's failure to attach to his bone because the component at issue had been adulterated in violation of specific FDA regulations. The court explained that if a plaintiff pleads that a manufacturer of a Class III Medical Device, which are all subject to the PMA process, failed to comply with either the specific processes and procedures approved by the FDA or the Current Good Manufacturing Practices promulgated by the FDA and that such failure was the cause of the plaintiff's harm, then the plaintiff has pleaded a sufficient parallel claim for purposes of MDA preemption.
In light of this analysis, the court concluded that the only strict liability claims that survived MDA preemption were the plaintiff's manufacturing defect claims premised on the defendant's alleged violations of FDA regulations and requirements. The plaintiff's warning claims, by contrast, imposed a requirement in addition to those approved by the FDA, i.e., a duty to warn consumers if a device is adulterated. For the same reason, the court held that the MDA preempted the plaintiff's negligence causes of action to the extent that they were premised upon a failure to warn. However, insofar as the plaintiff alleged negligence in manufacturing the device, such allegations constituted parallel claims that did not impose requirements different from or additional to those imposed by the FDA, and, for that reason, they survived preemption.
As to the plaintiff's cause of action for breach of implied warranty, the court explained that such a claim is not preempted if a plaintiff alleges that the device manufacturer violated federal requirements and the plaintiff can demonstrate a causal nexus between that violation and the breach of implied warranty. If, however, a plaintiff alleges that the defendant breached the implied warranty despite its compliance with FDA requirements, then the claim is preempted by the MDA.
The court employed a similar analysis with respect to the plaintiff's cause of action under the state Deceptive Trade Practices Act. According to the court, the MDA preempted the plaintiff's cause of action to the extent that the plaintiff's claims relied upon misrepresentations by the defendant, in that such a cause of action is essentially one for a failure to warn, which is preempted by the FDA warning requirements. However, to the extent that the claim was based on a breach of the implied warranty, it would be permitted to proceed to the extent that it was founded upon violations of the federal requirements.