Are Sales Reps in the OR Responsible When Devices Fail?

Article from Outpatient Surgery, landmark case if the Medtronic rep is found culpable,  med device reps might need to carry rep liability insurance.  1099 reps need to place close attention, in this time of a lawsuit prone society a 1099 med device rep is especially vulnerable.

 Another avenue for lawyers and insurance to make money. The notion that a  patient plaintiff is suing  a medical rep for a failed product is unprecedented.  What's next, bring a lawsuit against a medical rep for a patient contracting a post -operative infection because the rep scrubs were not supplied by the hospital and maybe he/she came from a prior case from another hospital or wore the same scrubs the day before. 

Below is the text of an article that was published in Outpatient Surgery this month.

Sales reps have become fixtures in operating rooms across America, sometimes knowing more about their products than the doctors who use them do. But are they at fault when those devices malfunction? A lawsuit circulating through the Louisiana court system could provide the answer.

The dispute centers on the case of James Wells, who went to Tulane Medical Center in New Orleans in May 2014 to undergo anterior spine surgery. The procedure, performed by orthopedic surgeon John A. Davis Jr., DDS, MD, involved the Atlantis Translational Anterior Cervical Plate System, a titanium implant manufactured by Medtronic. When Mr. Wells returned 2 months after the surgery for a routine check-up, X-rays revealed the implant had cracked in half.

Sales rep Hudson Higgins, who was trained to work with surgeons who use Medtronic's spinal products, supplied the Atlantis System to Dr. Davis. Operative notes show Mr. Higgins was present for both Mr. Wells's initial surgery as well as the subsequent procedure to remove the faulty implant.

The lawsuit alleges that sales reps aren't passive observers of surgery, but highly trained professionals who are present during cases to advise surgeons on which implants to use and how to assemble and insert them correctly. Sales reps serve as liaisons between device manufacturers and surgeons, and are responsible for relaying critical information about their company's devices, contends the lawsuit.

Dr. Davis was certainly knowledgeable about the device, the lawsuit states, but obtained most of that knowledge from Mr. Higgins. And even though Mr. Higgins was not the manufacturer of the Atlantis System, the lawsuit says he helped Dr. Davis choose the device, which was known to be defective and not suitable for Mr. Wells. Mr. Higgins is accused of failing to warn Dr. Davis of the inherent risks of using the implant in the case.

In an affidavit, Mr. Higgins claims he had to no knowledge of alleged defects in the Atlantis System. Medtronic's defense attorneys argue that he had absolutely no input in Dr. Davis's decision to use the implant, which they say Dr. Davis had been using before Medtronic employed Mr. Higgins, who has been a sales consultant at Medtronic Spine & Biologics since February 2013, according to his LinkedIn profile. They also argue that legal precedent shows the responsibility to warn surgeons about the risks posed by medical devices lies solely with the manufacturers, not sales reps.

The case is headed for a jury trial in a state court if the parties don't reach a settlement. Attorneys for both sides did not respond to requests for comment. A voicemail left for Mr. Higgins was not returned.