Your sales force is one of your most important assets. On the front line, they’re your company’s connection to the medical community and an important source of both profits—and potential product liability.
Developing appropriate policies regarding sales force liability exposures—and properly training and supervising representatives regarding these policies—can go a long way in reducing your risk of a sales force related product liability loss. The following practices are a good place to start.
Start with a solid sales force training strategy.
Liability prevention should be part of your marketing efforts from the start: Making sure your internal and external sales representatives understand legal theory, regulation and patient injury allegations is just as important as teaching them the science, product specifications and marketing strategies for your product.
Part of the hiring process as well as conducted periodically, this training should include:
- A brief overview of product liability legal theories to help reps understand the concept and how their behavior can affect liability.
- The risk paradigm inherent in the marketing of medical products.
- The sales rep’s role in avoiding and defending litigation.
Manage their marketing practices.
While you never want to dampen a rep’s enthusiasm, there are clear guidelines regarding what they can do to make a sale—and what they shouldn’t. Make sure each representative:
- Understands the regulations promoting “off-label” uses, including those governing disseminating articles detailing physicians’ research into off-label uses.
- Steers clear of over promotion such as overstating a product’s benefits—or minimizing its risks, misrepresenting safety claims or research into a product’s safety or claims of adverse events, or “watering down” written warnings in conversations with physicians.
- Adheres to spoliation mitigation practices and follows company retention policies for email, voicemail and text communications.
- Never distributes “homemade” materials to doctors. Regulators must approve all promotional materials distributed to physicians or patients.
- Avoids criticizing your company’s older products, which may suggest previous models are in some way defective.
Make sure they’re ready to respond to adverse events.
A sales rep can often be the first in your company to learn of a serious adverse event with your product. Make sure they’re ready. This should include training each representative on how to:
- Properly respond to an adverse incident, both from a regulatory and litigation standpoint. This training should include when and how to report the event, as well as to whom.
- Appropriately process and handle retrieved products, including how and when they should obtain the product, how it should be labeled and stored, as well as what to do if the product cannot be retrieved.
While not even a robust training program may be enough to avoid a claim or lawsuit, having a well-trained sales force is certainly a start. For more information about specific life sciences risk management strategies that can help your life sciences company, please contact Gary Lavery or Kevin Cominsky of Cook Maran & Associates.
Vice President, Commercial Insurance