Evidence-Based. Clearly Delivered.
Evidence-Based. Clearly Delivered.
Pharmaceutical sales representatives who provide “details” to physicians, including approved scientific information, benefits, side effects etc. are also known as detail representatives and are becoming a new target in products liability and medical malpractice cases. They have been named as defendants alongside manufacturers or identified for deposition or trial testimony. Their job functions include arranging appointments with medical professionals to educate and spread awareness of medical devices the company is manufacturing. Courts in many jurisdictions have found that detail representatives owe no legal duty to patients or physicians under a medical malpractice negligence theory. The first element of a medical malpractice complaint is a professional duty owed to the patient. Detail representatives do not form a traditional physician relationship. They do not manufacture nor sell medical equipment. In addition, they are not required to train physicians because the FDA warning that comes with the device is sufficient. Therefore, they have no duty to patients on whom the medical equipment is used.
The following cases support the premise that detail representatives do not have a legal duty to patients nor to physicians. For example, in Wolicki-Gables v. Arrow International, 641 F. Supp. 2d 1270, 1291 (M.D. Fla. 2009), the court ruled against the plaintiff who alleged that the detail representative failed to instruct the surgeon how to connect the medical device in the middle of the surgical procedure. Although present at the surgery, the representative was there merely to carry ‘back up’ products in their sterile packages to have available for the surgeon’s use, if necessary, and to observe preparation of the products.” Id. at 1291. The detail representative did not “scrub in” to the surgery or otherwise interact with the physician during the surgery. An appeals court in Illinois also noted that providing a pacemaker and leads and attending a surgery does not create a duty to a patient to ensure that the product is used properly. Kennedy v. Medtronic, 851 N.E. 2d 778 (Ill. App. Ct. 2006).
Next, in Hall v. Horn Medical, Civ. Action No. 11-1032, 2012 WL 1752546, at *3 (E.D. La., May 16, 2012), the physician argued that he relied on the detail representative’s statements with respect to the use of a cage device during a spinal surgery. The court found it “unreasonable as a matter of law” that “a seasoned neurosurgeon [would] rely on a sales representative’s opinion about the type of procedure that should be employed in operating on a patient’s spine.”
In summary, detail representatives usually do not have individual liability for medical malpractice and product liability.
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