Important Lessons for Medical Providers from Case Against Surgical Device Manufacturer Accused of Faulty Design
By Damian D. Capozzola, Esq.
The Law Offices of Damian D. Capozzola
Los Angeles
Jamie Terrence, RN
President and Founder, Healthcare Risk Services
Former Director of Risk Management Services
(2004-2013)
California Hospital Medical Center
Los Angeles
News: A federal court in Florida recently allowed claims to proceed against a surgical device company after the death of a patient whose doctor used the instrument on her during the surgery. The plaintiff, diagnosed with colon cancer, filed a lawsuit against the manufacturer of the device, claiming that the injury resulted from a defect in the device’s insulation. The woman’s estate claimed that the Food and Drug Administration (FDA) received numerous reports of problems with the device and that the manufacturer, which also was named in 93 similar lawsuits, failed to warn the medical community and underreported adverse events to the FDA.
The court partially granted the manufacturer’s motion to dismiss, but it allowed the plaintiff’s manufacturing defect claim to proceed. Following the court’s decision on the motion to dismiss, the case was dismissed by agreement of the parties due to a confidential settlement.
Although arising in the context of products liability, this case also contains valuable lessons for medical providers, who often are joined as defendants in such lawsuits. The case underscores the need for rigorous due diligence by doctors and hospitals when adopting new medical technologies. Independent evaluations, thorough training, and stringent monitoring protocols are essential to ensure patient safety. Additionally, doctors and hospitals should be aware that indemnity agreements with manufacturers can mitigate legal and financial risks in the event of surgical device failures.
Background: The plaintiff was diagnosed with colon cancer in June 2021. In September 2021, she underwent surgery, which was performed by a physician using the da Vinci XI Surgical System. During the surgery, an electrical spark from the da Vinci robot caused a perforation in the plaintiff’s small intestine. This injury required multiple follow-up medical procedures and extensive care, including the insertion of a feeding tube and rehabilitation. Following the surgery, the plaintiff was transferred to a rehabilitation facility because of her deteriorating condition.
Despite the initial successful removal of the cancerous tumor, she suffered severe complications from the thermal injury caused by the surgical robot.
The plaintiff claimed that she endured significant abdominal pain, severe physical and mental distress, and was unable to eat solid foods again. She died five months later after the surgery. The plaintiff’s estate filed a lawsuit against the manufacturer of the surgical device, alleging that the thermal injury resulted from a defect in the insulation of the da Vinci robot. The complaint alleged that prior to the plaintiff’s surgery, literature available to the manufacturer showed that the insulation on the electrosurgical instruments used by the robot insufficiently prevented electricity from leaking into the body. The manufacturer of the device also had been named in 93 other product liability lawsuits, including lawsuits involving patients’ deaths because of the device.
The FDA also had received thousands of injury and defect reports related to the use of the da Vinci robot, many describing burns to internal organs caused by stray electrical currents. The plaintiff brought several claims against the manufacturer, alleging that it failed to adequately warn the medical community, including the plaintiff’s healthcare providers, about these known dangers, and that it systematically underreported adverse events to the FDA. The defendant manufacturer filed a motion to dismiss the plaintiff’s complaint, which the court partially granted. The court dismissed the plaintiff’s strict liability claim for failure to warn. The court found that the plaintiff’s claim relied heavily on the defendant’s failure to report adverse events to the FDA but that this claim was preempted by the Food, Drug, and Cosmetic Act.
However, the court allowed a manufacturing defect claim to proceed against the surgical device company. It found that the plaintiff had sufficiently alleged a defect in the monopolar curved scissors of the da Vinci robot that caused the thermal injury. The court also allowed most of the plaintiff’s negligence claim to proceed as well, based on the plaintiff’s allegations that the device was negligently designed and negligently manufactured, and that the company failed to warn the medical community. The court also found that the plaintiff had sufficiently alleged the manufacturer’s negligence in failing to conduct adequate intra-operative surveillance, post-operative complication studies, and provide adequate training to healthcare providers.
After the court’s decision came down, the parties agreed to dismiss the case on confidential terms.
What this means for you: This case highlights critical considerations for doctors and hospitals when adopting new medical technologies. Healthcare providers increasingly integrate sophisticated devices, such as the da Vinci XI Surgical System at issue in this lawsuit, into their practices and patient care. However, there are inherent risks and liabilities associated with such technologies, which should be addressed at the outset.
Prior to adopting new technologies for patient use, healthcare providers should comprehensively evaluate the technology’s safety and efficacy independent of the manufacturer’s representations. Several of the plaintiff’s allegations in this case centered on the fact that the manufacturer failed basic safety standards in warning providers of the device’s defects and potential problems. The plaintiff was able to point not only to her own experience of a thermal injury caused by an electrical spark from the device, but she also obtained information that the FDA had received thousands of reports of similar malfunctioning. Independent studies, peer reviews, and clinical trials provide essential corroborative evidence that healthcare providers should consider to ensure patient safety. Information the manufacturer has regarding complications from the device also is relevant and should be demanded by healthcare providers. In this case, it was not clear from the plaintiff’s allegations if the doctor and hospital were aware of the many FDA complaints and dozens of other lawsuits against the manufacturer, and the doctor and hospital were not named as defendants in the lawsuit, either. To mitigate the risk of that from the outset, healthcare providers should make a demand for all information a medical device manufacturer has involving complaints of defects and misuse of a device. Independent evaluation can be key for healthcare providers to keep them from being named as defendants in lawsuits.
Training is another crucial aspect of due diligence to ward off potential lawsuits. The plaintiff here alleged that the defendant manufacturer failed to properly train the hospital staff on the correct use of the device. Healthcare providers can and should demand from any manufacturer proper and extensive training of all their healthcare personnel, including surgeons and operating room staff, on any new technologies. This training need not end when the device is purchased, either. The misuse or mishandling of the device and defective design in this case were alleged to have resulted in dozens of other lawsuits and thousands of complaints to the FDA. Healthcare providers can proactively request updated information and training to avoid finding themselves named as a defendant in lawsuits involving the use of surgical devices.
Healthcare providers also should establish stringent monitoring protocols to track the performance of new technologies and promptly report any adverse outcomes, even after they are trained on the device. Effective monitoring and reporting systems enable timely interventions and corrective measures, reducing the likelihood of harm to patients. Equipment malfunction and patient burns in the operating room and — even operating room fires — are not rare. Because they are not rare, healthcare facilities and the healthcare providers have several avenues available to them that probably could have mitigated damages and loss.
The FDA and the manufacturer have the responsibility and the ability to recall defective products. Recall notices must be noted and logged by receiving hospitals and providers through their risk, patient safety, or compliance officers. These officers must assure that those who use, clean, maintain, and store medical equipment and devices are made aware of the recalls and return, remove, render inoperable, or destroy the recalled items. Most reputable manufacturers request that the product be returned and issue refunds or replacements for the returned items.
If and when an injury occurs that involves any medical device or equipment, hospitals and physician practices have avenues available to them that are specifically designed to quickly notify product monitoring agencies that can report these events to the FDA and will even, as appropriate, assist with the investigation of the incident, especially if patient harm or a patient death has resulted from a product’s use.
The failure of the healthcare provider or facility to follow through with these reporting activities is partially the reason that multiple failures of equipment under similar circumstances go on unbeknownst to manufacturers and regulatory agencies, leaving patients at risk for harm. Equipment failures happen. Just like an automobile with so many new systems requiring frequent maintenance, newer more sophisticated medical devices also are becoming more complex to use and maintain. Healthcare regulatory agencies and licensing organizations mandate product safety activities and have access to a facility’s monitoring and reporting practices and will question a low number of reports in high-volume facilities.
To mitigate potential liabilities associated with new technologies, doctors and hospitals should seek indemnity agreements from manufacturers of new medical technologies. These agreements offer several benefits. First, indemnity agreements transfer some of the legal and financial risks associated with the use of new technology from healthcare providers to manufacturers. In this case, had there been an indemnity agreement, the manufacturer could bear primary responsibility for any claims arising from device failures, protecting providers from significant liabilities. Second, indemnity agreements establish clear lines of accountability between healthcare providers and manufacturers. This clarity is crucial in legal proceedings, where determining responsibility can be complex and contentious. Third, indemnity agreements provide financial protection for hospitals and doctors, covering costs related to legal defense, settlements, and damages. Given the high stakes involved in medical malpractice and product liability cases, this financial safeguard is essential.
For attorneys involved in medical malpractice lawsuits, the case also is a reminder to carefully draft complaints in a way that will survive a motion to dismiss brought by the defendants’ counsel, and for defendants’ counsel to carefully review the pleadings so that they can see all avenues of attack. For instance, in this case, the district court found that one of the plaintiff’s claims was preempted by a federal law, the Food, Drug, and Cosmetic Act. Federal laws essentially can replace certain state-law claims if the federal laws specifically govern that area of law. Here, the manufacturer argued that the plaintiff’s claims based on the manufacturer’s failure to warn were preempted because they essentially enforced duties owed to the FDA, and the Food, Drug, and Cosmetic Act stipulates that duties owed to the FDA ware enforceable only by the government, not by private litigants.
Finally, this case also underscores the need for thorough vetting, training, and monitoring when adopting new medical technologies. Additionally, it highlights the importance of securing indemnity agreements from manufacturers to mitigate potential liabilities. By taking these steps, doctors and hospitals can better protect their patients and themselves, ensuring that the integration of innovative medical technologies enhances rather than compromises patient care.
Reference
- Decided on July 11, 2024, in the United States District Court for the Southern District of Florida, Case No. 24-cv-80137.
A federal court in Florida recently allowed claims to proceed against a surgical device company after the death of a patient whose doctor used the instrument on her during the surgery. The plaintiff, diagnosed with colon cancer, filed a lawsuit against the manufacturer of the device, claiming that the injury resulted from a defect in the device’s insulation.
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