Artificial intelligence (AI), once little-known outside of academic circles and science fiction films, has become a household phrase. That trend will continue to expand as the public becomes more exposed to AI technology in everyday products, ranging from their cars and home appliances to wearable devices capable of tracking the metrics of their everyday routines. Perhaps no facet of AI has sparked observers’ imaginations more than machine learning (ML), which is precisely as it sounds: the ability of computer programs to “automatically improve with experience.” Machine learning lies at the heart of the kind of independent and superhuman computer power most people dream of when they consider AI.
While the public’s imagination is free to run wild with the promises of ML—creating an appetite that will no doubt be met with an equal and opposite response from businesses around the world—traditional policy and law-making bodies will be left with the task of trying to adapt existing legal and regulatory frameworks to it. Therefore it bears consideration how existing products liability norms might apply to AI/ML-based products, if at all, and what sort of uncertainties may arise for product manufacturers, distributors, and sellers. No enterprise better illustrates the careful balance between the endless potential of AI against the unique risks of products liability concerns than the medical device industry. This article discusses the uses and unique benefits of AI in the medical device context, while also exploring the developing products liability risks.
To read the full article by Duane Morris partner Matthew Decker, visit the MD+DI website.
On May 20, 2019, the Supreme Court of the United States issued a rare unanimous decision in Merck Sharp & Dohme Corp. v. Albrecht, et al., holding that judges, not juries, must decide whether state law failure-to-warn claims against brand-name drug manufacturers are preempted by the FDA’s labeling regulations. In so holding, the Court further clarified the preemption standard set forth in an earlier decision, Wyeth v. Levine, concluding that such claims are preempted where a drug manufacturer can show “that it fully informed the FDA of the justifications for the warning required by state law and that the FDA, in turn, informed the drug manufacturer that the FDA would not approve changing the drug’s label to include that warning.”
View the full Alert on the Duane Morris LLP website.
On June 28, 2018, the Supreme Court of the United States accepted for review Merck Sharp & Dohme Corp. v. Albrecht, an appeal from the Third Circuit Court of Appeals’ decision in In re Fosamax (Alendronate Sodium) Products Liability Litigation. At the marrow of the high court’s review lie the thorny questions of whether a state law failure-to-warn claim is preempted where the U.S. Food and Drug Administration has rejected a drug manufacturer’s proposed label warning about the health risks at issue, and, in making this determination, whether a jury, as opposed to the trial court, may be asked to look beyond the FDA’s rejection and decide if the FDA would have approved a differently worded warning had it been proposed by the manufacturer.
While the issue is a relatively narrow one, the Supreme Court’s analysis promises to shape the way courts around the country decide whether and how the decisions of regulatory agencies should be interpreted ― and here, predicted ― by juries.
How Did We Get Here?
The Fosamax litigation began in 2011, when the Judicial Panel on Multidistrict Litigation consolidated several thousand lawsuits in the United States District Court for the District of New Jersey. The common question raised by the plaintiffs was whether their use of Fosamax, a drug developed and manufactured by Merck for the treatment and prevention of osteoporosis, led to femur fractures and similar bone injuries, and further, whether Merck had properly warned of these potential risks.
To read the full text of this article by Duane Morris attorneys Alan Klein and Matthew Decker, please visit the Duane Morris website.