Courtney A. Stevens, Esq. | Senior Attorney, Medmarc Loss Control
Mark Senak recently published an insightful post over at Eye on FDA on “The Growing World of Do It Yourself Health.” In it, he remarks how the advent of certain products and technologies are accelerating the “DIY” movement in healthcare. Among the factors he points to as underlying this movement are “Dr. Google” and the overall ability of individuals to self-diagnose and learn about their conditions via the internet; direct-to-consumer advertising educating patients on conditions and treatment options; the massive supplement industry that allows consumers to self-prescribe a combination of non-drug products to treat or prevent specific maladies; social media facilitating crowd-sourcing and the sharing of symptoms and treatment solutions and experiences; and wearable devices and health apps that make available to users constant readings of health information like heart rate, activity levels, blood pressure, and sleep patterns. Being that the blog is Eye on the FDA, Mr. Senak’s focus is on the regulatory implications of these changes. He notes that the FDA has been rather slow in addressing the change that these factors have precipitated and are, perhaps understandably, struggling to keep up with this area of such dynamic change.
Regulatory implications are not the only that today’s drug and device manufacturers need consider in the context of the evolving DIY healthcare environment, however. Patients’ increased involvement in their own healthcare and treatment decisions has significant import for products liability. I consider two such significant products liability considerations for drug and device manufactures below.
Erosion of the Learned Intermediary Doctrine
The learned intermediary doctrine (the doctrine which holds that makers of prescription products need only warn doctors about any health risks associated with their products, a strong defense to failure-to-warn claims) is on weaker footing in an environment in which (1) companies are undertaking direct communication (usually in the form of advertising) to patients about their products; and (2) social media and the internet may have replaced their doctors as patients’ principle source of health information. The principle justification for the doctrine—as prescribing physicians are in the best position to provide this information to their patients—is arguably eroded in this environment. At least three states (Arizona, New Jersey, New Mexico) already recognize a direct-to-consumer advertising exception to the learned intermediary doctrine, and several more will likely consider it in the near future.
Knowledge of Online “Talk” About Products Imputed to Manufacturers
Where information on the internet abounds, drug and device makers must take stock. The FDA has already cited companies for off-label promotion when they were merely the conduit (via their Facebook page, in one example) through which a consumer posted about an off-label use. Drug and device manufacturers should take note—you will now have some level or responsibility for what is being said about your product on the internet. Beyond the off-label implications, manufacturers should perform periodic trending and analysis of complaints or side effects voiced on message boards, online communities, etc. Some level of knowledge will surely be imputed to them should a claim or litigation arise for which a side effect widely posted on the internet forms the basis. The same is true for knowledge about a product’s use (or misuse). Once communication reaches some critical threshold, such a use will no doubt be held “foreseeable” to the manufacturer, and thus they will be accountable for designing it out or warning against its associated risks.
Surely the move to more of a patient-controlled healthcare environment will continue to reveal regulatory and products liability challenges, and drug and device manufacturers must do their best to undertake safety, quality, and communication strategies that appropriately account for the current and foreseeable future environment.