On October 6, 2014, the Court of Special Appeals of Maryland, which is Maryland’s intermediate appellate court (“the Court”), addressed the extent to which federal law expressly or impliedly preempts state common-law and statutory claims for personal injuries that result from “off-label” promotion of a medical device.
The Alleged Underlying Facts
The plaintiff alleged that in 2007, he underwent spinal-fusion surgery during which the defendant surgeon implanted Medtronic’s Infuse device in an “off-label” manner (in a manner other than the one for which it was approved by the FDA), which caused him to suffer serious complications that included excessive bone that required a second surgery and which left him disabled. The plaintiff alleged that Medtronic illegally promoted off-label uses of the device, including alleged misrepresentations concerning the risks of the off-label uses.
The Infuse Device
As the Court discussed in its 44-page opinion, the Infuse device approved by the FDA consists of three components: a genetically-engineered version of a naturally-occurring protein that stimulates bone growth; a collagen sponge; and a cage or hollow cylinder that holds the vertebrae in place and directs the development of bone growth. The genetically-engineered protein is applied to the sponge that acts as a carrier and scaffold for the protein. The surgeon implants the protein-infused sponge and the cage into the spine, where the protein evidently spurs the bone growth necessary to achieve the fusion. The device is intended to replace or supplant the conventional method of performing spinal-fusion surgery, which involves harvesting bone (either from the patient’s hip or from a cadaver) and implanting the harvested bone in the patient’s spine.
The plaintiff alleged that Medtronic promoted the off-label use of the Infuse device by giving financial incentives to physicians, by providing physicians with information from consultants and “key opinion leaders” whom Medtronic had targeted and paid, and by placing Medtronic sales representatives in operating rooms when surgeons were performing surgeries in which they used the off-label approach. As a result, the plaintiff alleged, Medtronic’s off-label promotion of the Infuse device resulted in sales of the device in excess of $900 million in 2010, of which more than 85% resulted from off-label procedures.
The U.S. Congress passed the Medical Device Amendments of 1976 (the “MDA”), 21 U.S.C. § 360c et seq., which provides, in part, “[N]o state or political subdivision of a State may establish or continue in effect with respect to a device intended for human use 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 under this chapter.”
Since 2008, numerous courts have recognized that the MDA expressly preempts state-law claims only when a manufacturer has complied with federal law, and not when the manufacturer has in some way violated federal law. However, even though a state-law claim may survive express preemption if it is based on a violation of federal law, it may be impliedly preempted if it is based solely on a violation of federal law or if the claim would not exist but for federal law (plaintiffs must show that a manufacturer has violated federal law to defeat express preemption, but the plaintiffs must also show that their legal theories predated the federal enactment or would exist independently of federal law if they are to defeat implied preemption).
Off-label use by members of the medical profession is permissible under the terms of the MDA, but off-label promotion by a manufacturer may constitute “misbranding,” a criminal violation of the Federal Food, Drug, and Cosmetic Act (the “FDCA”), 21 U.S.C. § 301 et seq. Nonetheless, the FDA has recognized a safe harbor that allows manufacturers of Class III devices to provide members of the medical profession with peer-reviewed articles or reference publications concerning the safety, effectiveness, or benefit of the off-label uses of the device.
The Court held that the MDA does not expressly preempt the plaintiff’s state-law claims that are based on a violation of the federal prohibition of false or misleading off-label promotion. The Court further stated that federal law does not preempt the plaintiff’s allegations concerning the failure to disclose material facts concerning the device and the failure to “fully disclose” the results of testing on the device, provided that those omissions occurred in the context of off-label promotion and that the omitted facts were necessary to make Medtronic’s other statements not misleading. However, the plaintiff’s negligence claim is expressly preempted to the extent that the plaintiff intends to challenge the adequacy of the FDA-approved warnings on the labeling: if such a claim were allowed to proceed, Medtronic would face liability under state law even though it had fully complied with federal law.
The Court reversed the lower court’s conclusion that federal law preempts the plaintiff’s claims for fraud, negligent misrepresentation, and violations of the Consumer Protection Act insofar as those claims are based on false statements of material fact that Medtronic may allegedly have made in voluntary communications with the public or members of the medical professions, in the context of off-label promotion of the Infuse device, and outside of the safe-harbor that permits the distribution of peer-reviewed articles or reference publications concerning the safety, effectiveness, or benefit of the off-label uses of the device.
The Court also reversed the lower court’s conclusion that federal law preeempts the plaintiff’s claims for the breach of any express warranties that Medtronic may have made in voluntary communications with the public or members of the medical professions outside of the context of the FDA-mandated and FDA-approved labeling for the device.
Source Steven L. McCormick, et ux. v. Medtronic, Inc., et al., No. 670, September Term, 2013.
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