Insights

On April 2, 2025, the U.S. Supreme Court extended the reach of Section 1964(c) of the Racketeer Influenced and Corrupt Organizations (RICO) Act by holding that a plaintiff may seek treble damages for a business or property loss resulting from a personal injury.[1] The 5-4 decision has resolved a 3-2 circuit split over whether the RICO statute precludes relief for losses stemming from a personal injury.

Many medical device companies are accustomed to defending product liability litigation, and the applicability of product liability law to traditional medical devices is not usually questioned. But as an increasing number of medical devices are themselves software or include some software-based function – from clinical decision support tools to robotic surgery machines – an important question becomes: is medical device software a “product” within the meaning of product liability law? This threshold issue has the potential to be claim or even case dispositive for defendants facing allegations of defective device software.

In Brown v. GlaxoSmithKline, LLC and Providence Health System – Oregon, 323 Or. App. 214 (Ct. App. Or. 2022), the Oregon Court of Appeals recently found that a hospital could be a “seller” of pharmaceutical drugs under Oregon law, subjecting it to strict products liability for alleged drug defects.  This decision contravenes—and thus threatens to upset—the overwhelming consensus among U.S. courts that hospitals are not strictly liable for allegedly defective drugs or medical devices used in the course of providing medical care to patients. 

Cyberattacks have become an omnipresent threat in our society, affecting every industry. On Friday, July 2, the biggest ransomware attack on record hit thousands of victims in at least 17 countries, including at least 200 companies in the United States. Hackers demanded $70 million in cryptocurrency to provide a decryption key. This attack followed on the heels of two high-profile ransomware attacks on U.S. infrastructure: the May Colonial Pipeline attack and the June attack on JBS, the world’s largest meat processing company.

At the close of 2020, the Supreme Court of Florida amended Florida Rule of Civil Procedure 1.510 to adopt the federal summary judgment standard, noting that the federal “standard is more rational, more fair, and more consistent with the structure and purpose of [Florida’s] rules of civil procedure.”1 In doing so, Florida joins thirty-eight states that have embraced, in whole or in part, the federal summary judgment standard.

The U.S. Food and Drug Administration (FDA) has again postponed the enforcement of certain requirements under the Drug Supply Chain Security Act (DSCSA), this time by three years. 

Counterfeit medical devices—medical devices that are falsely represented to be produced, packed, or distributed by another device manufacturer, packer, or distributer—are reportedly increasing in volume and sophistication. Recent reports of counterfeit diagnostic COVID-19 tests and N-95 masks demonstrate that the demands associated with the COVID-19 pandemic have only exacerbated supply chain vulnerability to counterfeit medical devices. In addition to putting patients at risk, counterfeit medical devices harm manufacturers and distributors of genuine devices in myriad ways: by damaging the reputation of the genuine devices, imposing costs to remove counterfeit product from market, and even posing potential product liability risks under certain circumstances.

Both the United States Environmental Protection Agency (EPA) and plaintiff’s lawyers have been targeting the chemical ethylene oxide in recent months. In December 2019, EPA published an advance notice of proposed rulemaking to gather information about the use of ethylene oxide in commercial sterilization and fumigation businesses for future Clean Air Act regulations. One week later, EPA published a proposed rule under the Clean Air Act that would seek to reduce emissions of ethylene oxide from storage tanks, process vents and equipment leaks at manufacturing facilities. These actions followed on the heels of two class action lawsuits filed in a West Virginia federal court on behalf of individuals who lived in the vicinity of two different facilities that manufactured ethylene oxide and, according to the complaint, emitted the chemical into the environment, allegedly causing harm to the plaintiffs. These actions may lead to additional interest in ethylene oxide among plaintiff’s lawyers and state regulators.

As artificial intelligence (AI) decision-making begins to equal or surpass that of physicians, the potential for increased reliance on AI could also mean that liability traditionally assigned to physicians through malpractice suits shifts to AI companies. It is critical that companies developing this technology consider potential liability as they position the technology for market. 

On May 20, 2019, the U.S. Supreme Court announced that application of “impossibility” preemption to bar failure to warn claims against drug manufacturers presents a question of law to be decided by trial courts, not juries. While the Justice Breyer-authored decision resolved a decade of disagreement among the lower courts and settled the issue of whose decision governs (judge or jury), concurring opinions by Justices Thomas and Alito demonstrate that this decision raises even more challenging questions as to the scope and availability of impossibility preemption. These issues will be, for now, left to the lower courts to work out. Their resolution will likely determine the ongoing viability of this defense.

In a statement released on March 15, 2019, the United States Food and Drug Administration (FDA) announced new efforts to evaluate the long-term safety and efficacy of materials used in the manufacture of implantable medical devices. 

For years, class action litigation has raged over advertisements claiming that foods are "natural." Seizing on ambiguity in the public's understanding of that term, the plaintiffs' bar has rushed to fill a void left by regulators, who have thus far refrained from offering a standard definition. The U.S. Food and Drug Administration (FDA) has repeatedly declined to wade into the controversy. On Tuesday, however, the agency finally responded to "consumers who have requested that the FDA explore the use of the term 'natural.'" Acknowledging "the changing landscape of food ingredients and production," the agency announced that beginning on November 12, it will accept public comments on use of the term in labeling of human food products.

Pharmaceutical manufacturer Amarin Pharma Inc.'s momentous win in New York federal court affirms a drug manufacturer's First Amendment right to truthfully promote non-FDA—approved uses of its product. On August 7, 2015, Judge Paul Engelmayer of the Southern District of New York issued the first known affirmative protection of off-label promotion of a specific prescription drug. Amarin Pharma, Inc. et al. v. U.S. Food & Drug Admin., et al., Opinion & Order, No. 1:15-cv-03588 (S.D.N.Y.). The court granted preliminary relief that permits Amarin to engage in truthful and non-misleading speech promoting the off-label use of its triglyceride-lowering drug Vascepa to treat patients who have lower levels of triglycerides than the patients for whom the FDA approved its use. Critically, the court went even further and held that truthful and non-misleading speech may not form the basis of a prosecution by the Food and Drug Administration (FDA) for misbranding. The court's decision rested heavily on the Second Circuit's 2012 decision in United States v. Caronia, 703 F.3d 149 (2d Cir. 2012), and indicated for the first time how district courts might entertain offensive uses of Caronia by drug manufacturers.