In recent years, it has become more common for medical device sales representatives to be named in product liability lawsuits. Lawsuits, traditionally, have stemmed from claims that sales representatives were a part of the “chain of distribution.” However, several new “duty of care” implications have seemingly come out of left field. These include being sued for the following:
- Promotion of a product for off-label use.
- Prohibiting or advising a surgeon against using a product for off-label use.
Breach of duty
- Improperly teaching a practitioner on how to use a prescription medical device.
- Preventing the practitioner from using the device improperly.
Plaintiff’s attorneys allege that these duties fall under the common-law negligence theory, but courts are just learning how to apply the law, as these novel issues are presented in courts across the United States. In some cases, this application of the law doesn’t seem to coexist with black letter law on longstanding tenets.
The main question seems to be “Is it a sales representative that owes a duty to the patient?” Among the shades of gray that seem ubiquitous here, the courts are struggling to reconcile this both practically and legally. Sales representatives are not doctors. Often, they have little medical background. How could the court expect them to owe, independent of the physician and facility, a duty to a patient they have likely never met? Sales representatives are experts on their products, not the procedure.
One sticking point seems to be the immeasurability of rapport and influence. Since sales reps have attended more procedures, using their product, than any single practitioner, it is not uncommon for advice to be solicited regarding some nuance of the procedure itself. Even more common is the inclination for a sales representative to interject advice that they know is integral to the success of the procedure. This is exactly what happened in the case of Medtronic, Inc. v. Malander, 996 N.E.2d 412 (Ind. Ct. App. 2013). An Indiana court found that a representative who provided “technical” advice to the practitioner concerning a possibly defective cardiac ventricular lead, did assume a duty (to the patient). The sales representative was found to have breached this duty when he did not insist that the cardiologist replace the faulty lead. This inaction or omission, said the plaintiff’s attorney, resulted in the patient’s death.
Completely avoiding liability may be close to impossible but the following practices can reduce exposure.
- Follow the guidelines for conduct, provided by the manufacturer.
- Repeat the warnings and instructions for use.
- Offer to contact an expert at the company for more sophisticated questions.
- Strictly observe protocol in the surgical suite. Especially, standing outside the sterile field.
- Generally, stick to what you know best—the product.
- Avoid any advice that encroaches the area of treatment or is patient specific.
Some jurisdictions have adopted a “Captain of the Ship” doctrine that in essence makes the surgeon or practitioner responsible for any actions or omissions that occur during the procedure. The loophole that plaintiff lawyers will attempt to exploit, in order to broaden liability, is to expose the possibility that another party temporarily usurped the role of “Captain.” Once a lawsuit has been filed the questions that arise will be in an effort to determine what actually happened during the procedure. Keep records of all procedures. Understand that your best defense is your “routine.” Maintaining the position of trusty “crew member” as a daily practice is the best way to make certain those, often-times, blurred lines are never crossed.
Please contact us if you are a commercial leader within a biotech or medical device company seeking your next great hire, or career advice for yourself. We look forward to the opportunity to help you excel in the future!
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