As more medical device manufacturers offer autonomous robotic surgery to their surgeon customers, traditional lines of legal defense most often taken by companies may change, according to experts from Nutter.
David L. Ferrera and Melanie V. Woodward, NutterRobots in surgery are not new. Indeed robots have been assisting surgeons for years, giving surgeons more precision and control in the operating room. But medical innovation is on the cusp of a new development that would remove the surgeon from the operating room entirely: autonomous robotic surgery (ARS).
ARS is an advancement touted as providing myriad benefits to patients, including superior accuracy, shorter hospital stays and faster recovery time. As more medical device manufacturers offer this technology to their surgeon customers, traditional lines of legal defense most often taken by companies may change. Medical device manufacturers should reconsider potential product liability defense approaches to protect against litigation risks associated with these types of procedures.
What will be required to be communicated to patients?
Traditional product liability law holds that doctors are uniquely suited to advise their patients of the risks and benefits of a surgical procedure in response to the patient’s individual medical history and future needs. Given the medical complexities involved, medical device manufacturers typically are not expected to warn patients directly about surgical risks and benefits. Instead, the surgeon stands between the medical device manufacturer and the patient as a “learned intermediary” responsible for adequate warnings, because the surgeon has unique knowledge of the patient’s treatment options and the associated risks and benefits given current surgical practice. ARS arguably would remove the surgeon from this traditional equation, thus eliminating the learned intermediary. Without the learned intermediary defense, will companies who manufacture the robots now be responsible for communicating risks and benefits directly to patients?
We would argue no. ARS should not shift the existing legal landscape this dramatically. Although surgeons may be physically removed from the operating room, they will not be removed from the decision-making process. Surgeons will still play an important role in recommending ARS, explaining the pros and cons, and discussing alternative options. As the medical professionals responsible for helping patients make the decision about whether to undergo ARS, a surgeon should still be viewed as a learned intermediary, and ARS manufacturers should continue to receive this valuable defense in product liability litigation.
What will be the FDA regulatory pathway to market?
There are two regulatory pathways for medical devices to come to market following U.S. FDA review: so-called “510(k) clearance” for devices “substantially equivalent” to those already on the market, and “pre-market approval” for more innovative devices. Under traditional product liability law, medical devices that undergo pre-market approval obtain protection from many state law legal claims under a doctrine called “federal preemption.” In essence, preemption holds that a lay jury may not second-guess the safety assessments of FDA professionals. Although robotic-assisted surgery is not new, ARS is a significant technological advancement, likely to involve more complex hardware and software. Thus, autonomous robots should be subject to the FDA’s pre-market approval process, rather than 510(k) clearance. If that is the case, state law claims against manufacturers of FDA-approved ARS systems for defective design or inadequate warnings should remain ripe for early dismissal as preempted by federal law.
What is the “product”?
Because only “products” are subject to strict liability causes of action, defining the “product” is a key part of determining exposure to liability. Surgical robots are unique in that they require both hardware and software to operate. While hardware is certainly a “product,” most courts do not consider software to be a “product.” But, in 2016, the FDA issued draft guidance stating that software is a “medical device” subject to FDA regulation. Although this guidance is not legally binding, it echoes the holdings of some courts that software is a “product.”
The debate about what components of ARS constitute “products” is not academic. Rather, it highlights an inevitable issue that manufacturers will face in defending against lawsuits: was the patient’s injury caused by a defect in the robot or in the software that powers it? If different manufacturers collaborated to create the final ARS system, this issue could lead to finger pointing if the co-defendant manufacturers do not collaborate to present a unified front at the outset of a litigation.
Traditional legal rubrics such as the learned intermediary, preemption and co-defendant cooperation may be turned on their head in litigation involving ARS. Medical device manufacturers would be wise to stay abreast of the changing legal issues along with the changing technology.
David L. Ferrera is a partner and chairs the product liability litigation practice group at Nutter. Melanie V. Woodward is an associate in Nutter’s litigation department and a member of the firm’s product liability litigation, business litigation and environmental litigation practice groups.
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MedicalDesignandOutsourcing.com or its employees.
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