A recent court ruling from California strengthens the hand of medtech manufacturers against plaintiffs who might seek to argue they were injured because companies didn't properly train surgeons.
Robyn S. Maguire
In late April, the California Court of Appeals delivered a blow to plaintiffs who file lawsuits against medical device manufacturers based on an alleged "failure to train" physicians on how to use prescription medical devices. The decision in Glennen v. Allergan is significant because the field of available product liability claims against Class III manufacturers has narrowed considerably since 2008, when the United States Supreme Court held that lawsuits challenging the safety and efficacy of devices approved by FDA are federally preempted.
In that case -- Riegel v. Medtronic -- the takeway was that FDA alone has the authority to police the safety of devices, not lay juries. As a result of Riegel, plaintiffs have been persistent in developing theories that escape federal preemption and which are instead characterized as "parallel claims"--i.e., claims that align with, rather than add to, the requirements set forth in the federal Food, Drug, and Cosmetic Act (FDCA).
Lawsuits alleging a manufacturer's "failure to train" are appealing to plaintiffs, at least initially, because they seem to relate to facts and circumstances outside FDA's purview. These claims focus less on the manufacturer's conduct during research and development of a device (unquestionably within FDA's review), and more on the company's conduct after the product is brought to market. In short, they zoom in on what the product representative said, did, or failed to do, to make the physician familiar with the device before using it.
And therein lies the problem.
Stripped to its core, a lawsuit premised on a "failure to train" boils down to allegations that the company neglected its duty to provide physicians with important safety information about the device--the same elements of a so-called "failure-to-warn" claim. But because FDA's premarket approval process encompasses a review of device labeling and other warnings, those claims, whether couched as "failure to warn" or "failure to train" are, as the Glennen case confirms, preempted.
In Gomez v. St. Jude Daig Division, the alleged failure to train physician on how to use Angio-Seal product were preempted where FDA specifically reviewed the manufacturer's labeling and training materials.
Furthermore, as a court observed in the case of Sons v. Medtronic, even if a "failure to train" claim were not preempted, "it is well established that a medical device manufacturer is not responsible for the practice of medicine." That is, there is a critical point at which the manufacturer's duty to the physician ends and the physician's duty to the patient begins.
The court acknowledged both of these principles in Glennen.
In this case, the plaintiff alleged that defendant Allergan failed to adequately train physicians on how to use the Lap Band, a weight loss device used to limit food consumption in severely obese patients. The twist in the case was the way in which the plaintiff described her claim. Instead of alleging that Allergan was required, but failed to provide specific training to her doctor as part of the premarket approval process, she instead claimed that the physician made mistakes during surgery that evidenced inadequate training on behalf of the manufacturer.
This was a creative, but nevertheless defective, legal theory.
The court swiftly dismissed these allegations, holding that FDA's "[premarket approval] process does not obligate Allergan and like manufacturers to follow their products into the surgery room." It also found the plaintiff's attempt to create a parallel claim unconvincing. To that end, the plaintiff claimed that Allergan's alleged breach of FDA's Quality Systems Regulations (regulations that govern the procedures manufacturers must follow to safely design and manufacture medical devices) resulted in a failure to train physicians.
The Court held that there was "nothing in the language of these [regulations] to suggest that they are intended to address the quality of a manufacturer's physician training program." It refused to write a new provision into the FDCA requiring that "medical device companies who are required to provide training to physicians as a condition of premarket approval must insure such training is designed to satisfy the standard of care applicable to medical malpractice actions."
Although prior cases have rejected a naked "failure to train" claim as preempted, Glennen adds heft to these decisions by clarifying the potential field of parallel claims against Class III device manufacturers. Had the plaintiff alleged that Allergan failed to provide the training on which FDA conditioned its approval, she may have fared better in this case.
The creative, if not strained, allegations of her complaint, however, could not stand up to the robust Premarket Approval scheme. For now, Glennen confirms that a manufacturer's training, or the provision of information concerning how to use a Class III medical device, is protected under the doctrine of federal preemption, just as true failure-to-warn claims should be. Regardless of how they are alleged, failure to train claims appear to be off-limits in product liability lawsuits.
Robyn S. Maguire is a partner in Nutter's Litigation Department and a member of the firm's Product Liability and Toxic Tort Litigation and Business Litigation practice groups. She focuses her practice on complex civil disputes, with an emphasis on drug and medical device and land use litigation cases.