Is Medical Device Software a “Product”?

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.

The FDA has been regulating software that meets the Food, Drug & Cosmetic Act definition of a medical device for several years. FDA’s policies towards software regulation are “independent of the platform on which [the software] might run, are function-specific, and apply across platforms.”[1] In other words, software may meet the definition of a medical device for purposes of FDA regulation whether it is itself a medical device or is used in the function or control of hardware devices, mobile platforms, or other general-purpose computing platforms. For purposes of product liability litigation, on the other hand, it is possible software may be treated differently based on its platform, function, or other characteristics. But to our knowledge, the question of whether medical device software constitutes a “product” has not been addressed in a published decision.

Recent litigation in the social media context, however, illustrates a potential “non-product” argument. Last month, several leading technology companies filed a joint motion to dismiss the complaint in In re: Social Media Adolescent Addiction / Personal Injury Products Liability Litigation (MDL No. 3047), a multidistrict product liability litigation pending in the United States District Court for the Northern District of California in which plaintiffs allege that defendants’ social media platforms caused addiction and mental health problems in adolescent users. Defendants argue that their social media platforms are not “products” subject to product liability law but rather are “services” and plaintiffs’ alleged injuries flow from intangible information and ideas expressed through those services. Defendants’ position in the Social Media Adolescent Addiction litigation is supported by recent precedent in which courts have uniformly held that social media platforms are not “products” for purposes of product liability law. Among other reasons, social media platforms function as communication tools, they are publishers of third-party content, and they are not tangible. While medical devices may or may not share all of these characteristics, it is an argument worth considering where a plaintiff brings product liability claims aimed at medical device software functions.

Whether a defendant should raise a “non-product” defense will depend on individualized facts, circumstances, and goals, but classification as a “product” or not could have important implications. Among other things, strict liability is available in most jurisdictions for claims against “products,” but is not available for claims related to services, ideas, or information. And “products” do not have the same First Amendment protections that ideas and information do. On the other hand, certain defenses such as potential preemption of tort liability under the Medical Device Amendments to the Food, Drug and Cosmetic Act, the component parts doctrine, and the learned intermediary doctrine, may be available in product liability actions, but likely do not apply to the extent software is treated as a service, idea, or information.

We will continue to follow the social media litigation to see how some of these threshold issues are resolved for purposes of the Social Media MDL and are available to advise clients regarding the developing case law in this space.