Today, major healthcare companies are investing heavily into various AI-powered devices. For example, Zimmer Biomet and the New York City-based Hospital for Special Surgery recently inked a three-year deal to create the HSS/Zimmer Biomet Innovation Center for Artificial Intelligence in Robotic Joint Replacement. “The collaboration aims to develop decision support tools—powered by data collection and machine learning — to assist surgeons planning and predicting outcomes for robotic-assisted joint replacements.” Additionally, Johnson & Johnson have gone on record saying that they see “a huge opportunity to harness data, machine learning and artificial intelligence to help drive decision-making at all levels of healthcare.” As artificial intelligence starts playing a larger role in the modern healthcare space, a critical question will need to be answered: Are AI-powered solutions products or services?
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Design Defect Claims
Defeat Design Defect Claims Before They’re Filed
During product development, it’s not unusual to discover certain failure points in a surgical robot’s design. For example, certain components, like nuts or bolts or screws, may become brittle when exposed to various substances or gasses commonly found in operating rooms. Similarly, prolonged use may cause cables and wires to become overstressed. Such component degradation may result in unwanted changes in the robot’s movement patterns or even complete structural failure. Issues like these, if not immediately addressed during product development, can become low-hanging fruit for plaintiffs’ lawyers.
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The Risk of Clinical Data Collection Biases In Fully Autonomous Medical Robots
Recently, an artificial intelligence-guided robot successfully performed a laparoscopic surgery to connect two ends of an intestine in four pigs, without any human intervention. And according to the researchers involved, the robot surgeon produced “significantly better” results than humans. Though such an accomplishment is astonishing and signals the inevitable rise of fully autonomous medical robots, it is important to remember that the results generated by artificial intelligence are only as good as the information used to train it.
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The Healing Touch: Haptic Feedback and the State-of-the-Art Defense
As more and more surgical robots make their way into operating rooms, companies are learning valuable lessons about how their devices function in the real world. Though many existing design features are proving highly effective, physician response suggests that current systems should evolve to include additional capabilities, like “haptic feedback.” While discussing what it’s like to perform surgery without it, a UCLA associate professor of electrical engineering recently explained, “You can see what you’re doing, but imagine trying to tie your shoes without having a sense of touch.”
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Emerging Trends in Surgical Robotics Product Liability Litigation
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.
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Can Robot-Assisted Surgery Be a Pain?
Recently, my colleague Amy Foust made some really good points about a subject that is rarely discussed. Over the years, a number of patients have claimed that they were injured by surgical robots defective by design or manufacture. A recent study from Johns Hopkins University may now allow some to argue that surgical robots are also injuring surgeons.
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Aubin v. Union Carbide—A Year Later
In January, I posted regarding the impact of the Florida Supreme Court’s decision in Aubin v. Union Carbide Corp., 177 So. 3d 489 (Fla. 2015). In that post I explained that even after Aubin, the consumer expectations test should not be applied in all design defect strict product liability cases because it is still up to the individual trial court judges to decide whether the consumer expectations and risk-utility tests should be given alternatively or together depending on the individual circumstances presented in each case. Some of the reasons for this conclusion included that the standard jury instructions remain unchanged; that numerous courts have ruled some products are too complex for the application of the consumer expectations test; that cases subject to the learned intermediary doctrine by definition involve a product too complex to permit the application of the consumer expectations test; and that the risk-utility test traces its roots to the Restatement (Second) of Torts, not the Restatement (Third) of Torts which was rejected in Aubin.
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Following Aubin v. Union Carbide, Will Complex Medical Device Manufacturers Face an Uphill Battle in Defending Against Strict Liability Design Defect Claims in Florida?
In Florida, there are two tests that a jury may apply in determining whether a product is defectively designed under a strict liability theory: the “consumer expectation test” and the “risk-utility test.” Plaintiffs usually prefer the consumer expectation test because it is generally easier for them to prove, while defendants prefer the “risk-utility test.” Late last year, the Florida Supreme Court issued its opinion in Aubin v. Union Carbide Corp., 177 So.3d 489 (Fla. 2015). Almost immediately, a number of commentators argued that Aubin spelled the end of the exclusive application of the risk-utility test in all Florida cases involving strict liability design defect claims. But is that really true?
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