Over the last decade, robotics have revolutionized healthcare. Surgical robots are rapidly making their way into many of our nation’s operating rooms, and are being used in a wide variety of surgeries ranging from gynecological to ocular procedures. Their popularity stems not only from their relative ease of use, but also from their potential for improved patient outcomes and decreased recovery time.
As with any device or product, however, surgical robots and the companies that make them have not been immune from product liability lawsuits. The leading maker of surgical robots has faced the brunt of these attacks from hundreds of plaintiffs. Though less than a handful of cases have actually gone to trial, the company has either spent or reserved over $100 million dollars to resolve these claims.
The plaintiffs in these cases have generally alleged a litany of purported injuries including damage to their bowel, blood vessels, arteries, ureters, bladder, vaginal cuff and nerves, de-vascularization of the vaginal cuff impeding healing, partial bowel thermal burns, post-surgical abscesses, tears, dehiscences, bleeding, hematomas, sepsis and fistulas.
They have attributed many of those injuries to a number of purported defects. For instance, some plaintiffs have taken issue with the device’s reliance on monopolar energy to cut, burn, and cauterize tissue, as opposed to bipolar or ultrasonic energy, which they contend would substantially reduce the risk of complications. Others have claimed that the device has inadequate insulation on its arms and that the insulation on its shafts often becomes torn and worn in places, allowing electrical current to pass into tissue outside the operative field.
In the general allegations sections of their complaints, many plaintiffs have also contended that the company:
- Failed to properly and thoroughly test the device before bringing it to market;
- Failed to report to the FDA, the medical community, and the general public data generated from pre-marketing and post-marketing tests which indicated risks;
- Failed to conduct adequate post-market monitoring and surveillance of post-surgical complications;
- Advertised the device directly to consumers, without adequate warnings regarding its risks;
- Failed to provide adequate and accurate training and information to healthcare providers and sales representatives;
- Failed to conduct or fund research into the development of safer robotic surgical instruments that would pose less risk of causing thermal injury; and
- Failed to maintain skilled technicians in the operating room or on emergency call.
Based on these and similar allegations, plaintiffs’ claims generally have focused on the following causes of action: design defect, manufacturing defect, failure to warn, negligent misrepresentation, fraud, fraudulent concealment, breach of express warranty, and breach of implied warranties. Some plaintiffs have also alleged violation of various state consumer protection statutes, negligent training, proctoring and certification, unjust enrichment, lack of informed consent, and even some more outlandish causes of action like battery.
There are a number of important takeaways from the lawsuits that we have seen thus far. For instance, emerging technologies, like robotic surgery, preset a unique context in which physician training may take on added importance. Companies should strive to develop comprehensive training programs for physicians and other relevant parties, like sales representatives and product specialists. As part of this effort, they should not hesitate to team up with outside companies specializing in medical education training to assess learning needs, develop, and refine their training curriculum. Companies should also make all reasonable efforts to tailor their training programs so that they are consistent with the prevailing expert views on the level of practice and repetition required before basic competency and proficiency are achieved on a particular system. Moreover, as plaintiffs’ lawyers have been known to question the effectiveness of surgical training that does not involve cadavers, wherever possible, hands-on cadaver training should be considered.
Privacy and data security should also rank high on a company’s priority list. Data collection and use of patient health information is an area ripe with potential legal landmines that should be evaluated in the early stages of product development and roll-out. A number of important questions that should be considered include, but are not limited to: What patient health information or other personal information is being collected? How is the patient health information being used? How is the information being stored and secured? Who is given access to the patient health information? Is the patient health information shared or disclosed outside the medical provider team? How long is the patient health information being retained? Is the patient health information being used for purposes other than providing medical care?
Some of the plaintiffs in the cases against the leading surgical robot manufacturer have also claimed that the company failed to adopt existing technology, which they contend could have prevented their injuries. To the extent such technology exists, all reasonable efforts should be made to adopt it. If, however, a decision is made to not implement such technology, the device’s history file should be updated to clearly document how and why that decision was made.
Finally, three issues have been repeatedly observed in cases where it is alleged that a system malfunction occurred: (1) The physician may have to revert to conventional surgery; (2) Due to the lengthened time of surgery, patients are exposed to anesthesia for a lengthened and potentially dangerous period of time; and (3) Patients may have larger post-operative scars and experience longer recovery times than expected. When possible—and permitted by the applicable regulatory guidelines—these potential risks should be clearly communicated to physicians so that they may inform their patients as they deem appropriate. Doing so would go a long way in blunting plaintiffs’ warnings-related attacks if these or similar issues arise during surgery.
Though this is by no means an exhaustive list of all the lessons that can be drawn from past or pending cases involving surgical robots, it includes some of the key points that companies should keep in mind. As new technologies—like artificial intelligence—start playing ever-increasing roles in the operating room, plaintiffs’ theories will evolve and additional issues may come into play. But by staying vigilant and paying close attention to emerging trends in pending litigation, companies can develop strategies to effectively limit or eliminate their liability.