The Maryland Court of Special Appeals recently revived a medical device products liability case, ruling that the claim was not preempted by federal law.
The personal injury claims, brought by Steven McCormick together with his wife, arose from the so-called “off-label” promotion of a medical device, called the Infuse Bone Graft. Manufactured by defendant Medtronic, the device left McCormick disabled and unemployed allegedly due to this improper “off-label” use.
The Infuse Bone Graft was developed by Medtronic and was approved by the FDA in 2002. The three components of the device consist of:
The protein serves to spur the bone growth necessary to achieve fusion. The Infuse Bone Graft was created by Medtronic to replace the conventional method of performing spinal-fusion surgery.
The Infuse Bone Graft's label requires surgeons to utilize an anterior approach, during which the surgeon approaches the spine through the front of the body. The device cannot be used without a cage component, making the anterior approach the only safe and viable option for device implementation.
McCormick underwent spinal-fusion surgery conducted by defendant Dr. Rosner to relieve his persistent back pain. Dr. Michael K. Rosner, M.D., allowed a Medtronic sales representative, defendant Vincent Profitt, to be present in the operating room during McCormick's surgery.
Dr. Rosner used an inappropriate amount of the genetically-engineered protein component of the device and used a Medtronic cage that had not been approved by the FDA for use with the Infuse device. Dr. Rosner also took a posterior approach during his surgery.
Steven McCormick became permanently disabled in 2008, and in the spring of 2010, his physicians discovered a narrowing of the cervical disc space where the Infuse device had been implanted. McCormick underwent revision surgery to remove the “bony overgrowth” in the fall of 2010, during which his surgeon had to “chisel away the excess bone-growth” caused by the Infuse device.
McCormick learned approximately one year later that he had two nodules in his lungs that he must monitor to ensure they do not become cancerous.
According to the McCormicks, Medtronic engaged in an extensive and illegal effort to promote the off-label use of the device by means of a posterior approach without the required cage. Medtronic promoted this practice by providing physicians with information from consultants. Sales of the device exceeded $900 million dollars in 2010, of which more than 85 percent resulted from improper off-label procedures.
Additionally, the genetically-engineered protein component of the Infuse Bone Graft is a cancer-promoting substance, a fact the McCormicks claim Medtronic knew about and failed to inform the public or medical community. The Spine Journal, which is a medical periodical, devoted an entire issue in July 2011 to the concerns surrounding the use of the Infuse device. Journal discussed Medtronic's failure to report accurately adverse side-effects that occurred during clinical trials, as well as Medtronic's downplaying of the risks associated with the device.
The McCormicks brought their claims collectively against Medtronic, a Medtronic subsidiary, the Medtronic sales representative who was in the operating room during surgery, and Dr. Michael K. Rosner. The claims as against Medtronic were asserted for negligence, strict products liability, breach of warranty, fraud, and violations of the Consumer Protection Act.
The claim as against Dr. Rosner alleged his failure to obtain informed consent. The McCormicks, as husband and wife, then asserted a joint claim for loss of consortium. The circuit court dismissed the claims against Medtronic during the case's original proceedings but did not render a final judgment.
Congress passed the Medical Device Amendments (MDA) of 1976, which “swept back some state obligations and imposed a regime of detailed federal oversight.” The MDA expressly preempts certain state-law requirements with respect to federally regulated medical devices.
The MDA specifically preempts requirements that relate to the safety or effectiveness of the device and are different from, or in addition to, any requirement applicable under the MDA itself. This preemption of state-law claims only occurs when a manufacturer has complied with federal law, and not when the manufacturer has in some way violated federal law.
The Court, citing Greek mythology, determined that a plaintiff, such as Steven McCormick, can survive a state-law tort claim concerning an allegedly defective medical device only by steering between the Scylla of express preemption and the Charybdis of the implied preemption of claims that exist solely by virtue of the FDCA. This is a challenge the plaintiff must overcome by avoiding one obstacle without colliding with another, having the choice between two evils.
The court articulated this loophole by saying, “The conduct on which the plaintiff's claim is premised must violate the FDCA if the claim is to escape express preemption, but the conduct must also be the type of conduct that would traditionally give rise to liability under state law even if the FDCA had never been enacted.”
The Special Appeals Court reversed the trial court, specifically the trial court's conclusion that federal law preempts the claims for 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.