The Evolving Healthcare Delivery Model and Potential Further Erosion of the Learned Intermediary Doctrine

Courtney A. Stevens, Esq. | Senior Attorney, Loss Control | Medmarc

Last month, some members of Medmarc’s Loss Control Department attended the DRI Drug and Medical Device Seminar in Chicago, Illinois. Among the many insightful presentations was one delivered by Randall L. Christian of Bowman and Brooke LLP and Marc Fishman, in-house counsel at Novo Nordisk Inc, titled The Future of Drug Warnings: Rems, Medication Guides, and the (Potential) Erosion of the Learned Intermediary Doctrine.

Without regurgitating the entire presentation here, especially in light of the fact that we have persuaded the speakers to present a similar version to the Medmarc audience via webinar, I will include a few salient points below.

  • The average time of a patient actually spends with a doctor per doctor visit is now seven minutes. In this context, is it still reasonable to believe that doctors will communicate all the appropriate risk information to patients? Will knowledge of the evolving doctor-patient relationship (to shorter and arguably more infrequent visits) be imputed to manufacturers, such that some courts might believe it unreasonable for manufacturers to expect that doctors will adequately deliver safety and risk information to patients?
  • Further vulnerability to the learned intermediary doctrine might be seen in the form of the numerous tools manufacturers, particularly of drugs, have at their disposal to communicate directly with patients—counseling tools, medication guides, and, of course, direct-to-consumer advertising. Manufacturers engage in direct communication with patients
  • Studies have found that patients better understand and retain warning information that included imagery. There is some speculation that, as such, the FDA may require certain warnings to include imagery and, even in the absence of a law of regulation, failure-to-warn claims might be successful on the theory that warnings were ineffective for their lack of imagery.

 

The bottom line is that the learned intermediary doctrine—a long-time, effective defense for makers of prescription products—is in play, and manufacturers, and it is reasonable to expect its change in light of the evolving healthcare model.

Products Liability Implications of the DIY Healthcare Environment

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.

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