A manufacturer of medical devices manufactured and sold a device used in surgery to strengthen the spines of individuals with degenerated vertebral discs. The device consisted of an absorbable collagen sponge, a manufactured version of a protein found in small quantities in the human body, and a titanium threaded fusion cage. Generally, during surgery the doctor infuses the collagen sponge with the liquid protein and inserts the sponge into the cage to both stabilize the spine and maintain spacing between the vertebrae during the fusion process.
The FDA granted the device premarket approval for use in certain types of spinal fusion surgeries, including anterior lumbar interbody fusion (anterior fusion), where the surgical incision was on the patient's abdomen. Posterior lumbar interbody fusion (posterior fusion) was an alternate form of spinal fusion surgery that approached the spine through an incision in the patient's back. Posterior fusion was considered an off-label use of the device because the FDA had only approved it for use in anterior fusion.
After premarket approval, applicants must report adverse events to the FDA. Adverse events are incidents in which the device may have caused or contributed to death or serious injury, or malfunctioned in a manner that would likely cause or contribute to death or serious injury if it recurred. Applicants must also report new clinical investigations or scientific studies concerning the device of which the applicant knew or reasonably should have known. The FDA may withdraw premarket approval based on newly reported data or existing information; it must withdraw approval if it determined that a device is unsafe or ineffective under the conditions in its labeling. The FDA has an established procedure a manufacturer must follow if it wants to change the intended use for a device. FDA regulations prohibit a device manufacturer from promoting the use of a device in a manner inconsistent with the premarket approval.
The medical device manufacturer sponsored a clinical trial to explore the use of the device in posterior fusion but halted the trial because early results showed unwanted and uncontrolled bone growth in more than 70 percent of patients. Nonetheless, over a period of thirteen years, the medical device manufacturer entered into consulting and royalty agreements with physicians promoting the device through presentations and medical journal articles. Studies funded by the medical device manufacturer omitted discussion of bone growth in the spinal canal as an adverse event and instead reported no adverse events. The medical device manufacturer, however, was aware that adverse events or complications had been reported in between 20 and 70 percent of cases when the device was used in posterior fusion. The medical device manufacturer also provided information and instructions for off-label surgeries by placing sales personnel in hospital operating rooms. The medical device manufacturer’s promotional activities increased the use of the device in posterior fusion. At the same time, various investigations by the media, the Department of Justice, and Congress raised questions about the safety of the device and about payments from the medical device manufacturer to physicians.
Ten years after the clinical trial of the use of the device in posterior fusion was halted, a man underwent posterior fusion surgery of his L3 through L5 vertebrae. His surgeon used the device in an off-label manner. The man began suffering numbness and pain after the surgery. CT scans showed the collagen sponge had leaked the liquid protein and unwanted bone growth had encased the nerves in the man's spine.
The man sued the medical device manufacturer for negligence and strict liability. The suit alleged that the medical device manufacturer defectively manufactured the device, promoted off-label uses of the device without adequately warning of the associated risks, and failed to take available steps to warn the man of the risks of these uses. The medical device manufacturer filed a demurrer arguing that all of the man’s claims were preempted by the Medical Device Amendments (MDA) to the federal Food, Drug, and Cosmetic Act (FDCA). The Superior Court of Los Angeles County sustained the medical device manufacturer’s demurrer without leave to amend.
California’s Second District Court of Appeal, Division 5, affirmed in part, reversed in part, and remanded. The court held that the patient's failure to warn claim for the manufacturer’s failure to file adverse event reports, negligence per se claim for failing to file adverse event reports, and negligence per se claim for promoting off-label uses were not preempted. Moreover, the patient’s manufacturing defect claim was adequate to overcome a demurrer on the ground of preemption. However, the patient's failure to warn claim for promoting off-label uses was preempted.
The court explained that state law causes of action that provide a damages remedy for claims premised on a violation of FDA regulations are not expressly preempted by the MDA if they parallel, rather than add to, the federal requirements. In order for a state requirement to be parallel to a federal requirement, the plaintiff must show that the requirements were genuinely equivalent, which requires that a manufacturer could not be held liable under the state law without having violated the federal law. A state law cause of action for violation of the FDCA is barred under the doctrine of implied preemption if it is cognizable only by virtue of the provisions of the FDCA itself, rather than traditional state tort law. For a state law cause of action for violation of the FDCA to survive implied preemption by the FDCA, the conduct on which a claim is based must be the type of conduct that would traditionally give rise to liability under state law, and that would give rise to liability under state law even if the FDCA had never been enacted.
The patient's failure to warn claim for the manufacturer’s failure to file adverse event reports was not expressly or impliedly preempted. Federal law requires manufacturers of Class III devices to file adverse event reports whenever the device may have caused or contributed to death or serious injury, or malfunctioned in a manner that would likely cause or contribute to death or serious injury if it recurred. California law imposed a parallel requirement under the common law strict liability tort of failure to warn. The device manufacturer can be found liable if it did not adequately warn of a particular risk that was known or knowable in light of the generally recognized and prevailing best scientific and medical knowledge available at the time of manufacture and distribution. California's common law strict liability tort of failure to warn imposed a requirement parallel to the federal requirement to file adverse event reports. A medical device manufacturer's state law duty to warn of a particular risk that was known or knowable in light of the generally recognized and prevailing best scientific and medical knowledge available at the time of manufacture and distribution should not be so narrowly defined as to exclude a requirement to file adverse event reports with the FDA if that was the only available method to warn doctors and consumers.
The patient's negligence per se claim for failing to file adverse event reports was not expressly or impliedly preempted. California's common law tort of negligence per se imposed a requirement parallel to the federal requirement to file adverse event reports. California recognizes the applicability of negligence per se in a broad range of scenarios, including violation of federal law. The incident was a proper basis for negligence per se liability under California law, since the FDA regulations requiring adverse event reports are designed to limit the risk inherent in Class III medical devices, and the patient is in the class of persons the regulations were meant to protect.
The patient's negligence per se claim for promoting off-label uses was not expressly or impliedly preempted. A manufacturer's state law duty of reasonable care paralleled the federal duty to comply with the regulations prohibiting misbranding and adulteration. The court reasoned that the manufacturer of a medical device owed a duty of reasonable care to the consumer of such a device even in the absence of FDA regulations. The doctrine of negligence per se simply directed the trier of fact to the federal requirements to establish the applicable standard of care.
The patient’s manufacturing defect claim was adequate to overcome a demurrer on the ground of preemption. If a plaintiff pleaded that a manufacturer of Class III medical device failed to comply with either specific processes and procedures that were approved by the FDA or Current Good Manufacturing Practices (CGMP) under the FDCA and that this failure caused the plaintiff’s injury, the plaintiff would have pleaded a parallel claim, for purposes of preemption analysis. Here, the complaint generally alleged that the implanted device was defective because it failed to comply with the manufacturing specifications required by the device's premarket approval and CGMP as they related to leakage from the device. The issue of preemption would necessarily be addressed after the man had some opportunity to conduct discovery. At the pleading stage, the court could only conclude that the complaint alleged sufficient facts to state a cause of action for manufacturing defect.
However, the patient's failure to warn claim for promoting off-label uses was expressly preempted. Strict liability failure to warn under California law imposed a requirement to warn of a particular risk that was known or knowable in light of the generally recognized and prevailing best scientific and medical knowledge available at the time of manufacture and distribution. Federal regulations prevent device manufacturers from promoting off-label use of FDA-approved devices. Any duty for the medical device manufacturer to warn the patient and the patient’s doctors about the risks of off-label use would be different from, and in addition to, the federal requirements.
The appellate court affirmed in part, reversed in part, and remanded the trial court’s grant of the medical device manufacturer’s demurrer.
See: Coleman v. Medtronic, Inc., 2014 WL 286096, 14 Cal. Daily Op. Serv. 1001 (Cal.App. 2 Dist., January 27, 2014), as modified (Feb 03, 2014) (not designated for publication).
See also Medical Law Perspectives, April 2012 Report: Using Medical Devices Off-Label: False Claims, Overpromotion, Malpractice, and Other Dangerous Territory