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Medical Device Reps in the O.R.

medical devices

It is becoming increasingly common for medical device manufacturers to have representatives in the operating room during a procedure. However, the presence of the manufacturer representatives may create issues of liability for the pharmaceutical company or the medical device manufacturer or for the acts or omissions of their company representative while in the operating room. Several courts have dealt with this issue, including the United States District Court for the District of Utah, who recently addressed it.

Why Medical Device Reps are in the Room

Manufacturer representatives attend surgeries for the purposes of observing the use of the company’s product or ensuring that the product is used correctly by the surgeons. However, whether their presence and actions while in the operating room creates liability for the manufacturer comes down to the issue of duty. Specifically, some attorneys are alleging that either the manufacturer of the medical device had a duty to prevent the doctor from using the product or that the industry representative undertook the unauthorized practice of medicine, thereby assuming a duty of care to the plaintiff. In fact, the Utah Supreme Court has held that “[t]he long-recognized distinction between acts and omissions—or misfeasance and nonfeasance—makes a critical difference and is perhaps the most fundamental factor courts consider when evaluating duty.” B.R. ex rel. Jeffs v. West, 275 P.3d 228, 334 (Utah 2012).

A Matter of Opinion

Some courts have held that the mere presence of the representative in the operating room does not create liability for the manufacturer for the negligence of the healthcare providers. However, a different situation arises when the representative undertakes the unauthorized practice of medicine. Some courts have held that for liability to attach to the manufacturer, the representative must exercise medical judgment or participate in the actual treatment of the patient. In People v Smithtown General Hospital, et al., (402 NYS 2d 318 (NY 1978).) the Supreme Court of New York held that the surgeon at issue in that case “abdicated his role as surgeon in that operating room and permitted the judgment and skills of a layman to prevail” when he allowed the sales manager present in the room to remove the prosthesis from the plaintiff’s leg, implant the prosthetic device and treat his broken femur.

In McCartney v. United States of America, et al., the United States District Court for the District of Utah focused entirely on the issues of misfeasance and nonfeasance. The court notes that the issues can be resolved by determining what duties, if any, that the manufacturer owed to the plaintiff during two surgeries. In this case, the plaintiff underwent two surgeries involving the implantation of a spinal cord stimulator at the VA hospital in Salt Lake City, Utah. The plaintiff alleged the manufacturer had at least one representative present at both of the plaintiff’s surgeries. During the first surgery, the stimulator was implanted in the plaintiff’s back. A few months later the device failed, and the plaintiff underwent a second surgery at the VA to correct the problem. During the second surgery, the manufacturer’s representative, while present in the operating room, allegedly called plaintiff’s wife to inquire about the location of plaintiff’s pain. Plaintiff’s wife indicated she was unsure which leg was afflicted, and the stimulator was allegedly placed in an incorrect location. Plaintiff underwent a third surgery to replace the stimulator, which was successful, and the plaintiff subsequently filed two causes of action for negligence against both the manufacturer and the United States of America.

The issue in the first cause of action was whether the medical device representative who attended the plaintiff’s surgery owed a duty of care to the patient to ensure that the device was implanted properly. The issue in the second cause of action was whether the medical device representative affirmatively undertook a duty through the representative’s actions of calling the plaintiff’s wife during the surgery. The court disposed of both issues on the defendants’ motion to dismiss due to failure to plead with specificity. It also dismissed the second cause of action without prejudice to allow time for discovery to reveal facts sufficient to show that the plaintiff suffered harm because the physician relied on the manufacturer representative’s failure to exercise reasonable care.