In this age of rapidly developing technologies, medical device sales representatives fill a unique role. In the business of surgery, sales reps not only deliver medical devices to hospitals as needed, but they ensure that surgical teams know precisely when and how a device and its components are to be used. Often knowing more about their devices than the surgeons who use them, medical device sales representatives have therefore become commonplace in operating rooms across the United States. As a result, manufacturers have seen an increase in products liability claims based upon their sales reps’ alleged representations or actions during such procedures. There is a fine line that, when crossed, turns a sales rep from an asset to both manufacturers and surgeons into a potential liability for third-party claims.
Types of Claims Against Manufacturers and Commonly Asserted Defenses
Claims against manufacturers stemming from injuries sustained in the operating room no longer solely include conventional tort theories such as strict liability and negligence. Largely aimed at circumventing the defenses discussed below, recent claims against manufacturers as a result of sales reps in the operating room take a number of different forms. Theories of liability include: the sales reps’ failure to train, the sales reps’ failure to prevent misuse, the sales reps’ failure to provide further warnings, and negligent misrepresentations made by the sales rep (which may involve allegations of off-label promotion). Cases involving allegations of a sales reps’ unauthorized touching of a patient may also include claims for gross negligence or battery, both of which carry the possibility of punitive damages.
With the exception of the intentional tort of battery, all theories of liability above require the court’s finding of a duty of care. The following defenses have seen some success against plaintiffs’ artful pleadings designed to create new duties—to train, to prevent misuse, to provide further warnings—on behalf of manufacturers with sales reps in the operating room. However, ultimate liability for manufacturers typically turns on the role the sales rep plays in the procedure, i.e., the level of the sales rep’s responsibility and involvement.
Image Credit: Lisa Rice and Katie Stricklin/MD+DI