For most neurosurgeons, it is a rare day in the operating room when a product representative is not present to facilitate a procedure, introduce a new product, or review options for expanding existing product use. These representatives are often well-educated, highly trained and polished communicators who work to maintain neurosurgeons’ confidence. However, neurosurgeons must exercise great care in evaluating and acting on advice from these representatives regarding the use of their products. Consider the following summary of a true-life case.
Routine Surgical Case Goes Awry
A neurosurgeon removed a patient’s frontal meningioma. The case was routine and the tumor resection was complete. The bone flap was not replaced because of tumor invasion. The neurosurgeon decided not to use a cranial plating system or its titanium mesh cranioplasty alternative because he was concerned about scalp erosion. A product representative on the premises introduced an alternative cranioplasty product, describing it as a self-hardening hydroxyapatite material. The representative brought the product to the operating room and the neurosurgeon agreed to use it. After the material was prepared by the operating room staff with the guidance of the representative, it was applied to the cranial defect and the incision was closed. The patient had an uneventful postoperative course and made a good neurological recovery.
The patient later returned with wound puffiness and fullness. Imaging studies demonstrated breakdown of the cranioplasty material, and the incision was reopened. The wound was debrided and a new cranioplasty was created. The patient subsequently underwent three additional surgeries for closure of a cerebrospinal fluid leak, additional revision of the cranioplasty, and a final revision of the wound by plastic surgery. At no time did the patient suffer neurological injury, nor were there any infections or serious complications from these wound revision surgeries. The final cosmetic result was excellent.
The patient sued the manufacturer, alleging that the cranioplasty product was defective. The neurosurgeon was not named in the suit, and in fact, the patient had a great deal of respect for the neurosurgeon, liked him, and did not wish to sue him. However, in pretrial maneuvers, the company compelled the plaintiff’s attorney to include the neurosurgeon as a codefendant in the legal proceedings. As the case proceeded, a primary issue became the reasonableness of the neurosurgeon’s reliance on information and input from a product representative in the operating room.
Neurosurgeon’s Defense: A Product Rep in the OR Has a Duty to the Patient
In the jury trial that ensued, defense experts for the neurosurgeon asserted that a product representative’s advice in lieu of the product insert was reasonable given the circumstances, particularly since this representative had been intensively trained on this particular product prior to the events of this case. They further asserted that the manufacturer’s product representative in an operating room has a duty to the patient, including the duty to fairly represent the product’s positive attributes, negative attributes, and potential complications, and that this is especially true if the product is represented as a solution for a surgical problem that occurs during an operative case, when the physician clearly has not had an opportunity to study product materials. They also contended that a product representative has a duty to the patient to warn and, if necessary, strenuously object if a surgeon uses the product in a manner that may harm a patient.
Company’s Defense: Reliance on Product Rep’s Advice is Unreasonable
Attorneys and defense experts representing the company countered, asserting that it was unreasonable to rely on a product representative for advice; rather the surgeon should educate himself or herself, and should, if necessary, scrub out of surgery to read reference material and package inserts and telephone company engineers. They asserted that the product representative in the operating room does not have a duty to warn a physician if the product is being used in an improper fashion, even if there is a high likelihood that using the product in an inappropriate way would result in harm to a patient, and that a product representative cannot practice medicine and cannot be held responsible for any medical decision made by a physician.
Verdict: Neurosurgeon’s More Responsible
The trial lasted more than one week; the jury returned a plaintiff’s verdict for $1.75 million, with 75 percent apportioned to the neurosurgeon and 25 percent apportioned to the product representative’s company.
Because the number of innovative new products is expanding at a rapid pace, many of us frequently interact with product representatives. This case is worthy of our consideration because it illustrates that if there is an untoward consequence associated with a product, a congenial professional relationship with a product representative may not extend from the operating room to the courtroom.
Patrick W. McCormick, MD, MBA, FACS, is a neurosurgeon in private practice in Toledo, Ohio.