Medical sales reps are trained to help surgeons in the operating room.
Dr. Ra’Kerry Rahman performed what was supposed to be a routine spinal operation on his patient, Cristina Martinez. However, in the middle of it, right after destabilizing her spine, the surgeon discovered the implant was larger than he wanted to use, and the company’s sales representatives didn’t have a smaller medical implants available. So, he finished the operation, and when Martinez awoke, she felt “pain and some numbness” almost immediately, according to a lawsuit on her behalf.
“When Rahman removed the plastic device four days later and replaced it with a smaller one, Martinez suffered nerve damage and loss of feeling in her left leg,” the lawsuit claims. Martinez is suing Dr. Rahman, Life Spine Inc. (the implant’s maker), and its distributor and sales reps. She has alleged that “their negligence led to her injuries because the right part wasn’t available during her first surgery.” All defendants have denied any wrongdoing and the case is set for trial in late fall.
Sales of spinal implants, artificial replacement knees and hips, and other devices used in these operations totaled approximately $20 billion in 2019. “At least 250 companies sell surgical hardware, and many more distribute it to doctors and hospitals nationwide,” according to industry data.
Manufacturers have sales forces which they train extensively to be able to make suggestions to those in the operating room. They pay surgeons to market their products, as well, at medical conferences, and use athletes for celebrity endorsements. However, sometimes these implants cause serious patient harm and lead to medical malpractice, negligence, product liability, and whistleblower lawsuits.
“In orthopedics, we are inundated with a multitude of new implants that debut each year,” said Dr. James Kang, chairman of the orthopedic surgery department at Brigham and Women’s Hospital. Kang added, “Surgeons often rely on industry reps in the operating room for guidance because it is usually burdensome and difficult for surgeons to know all of the intricate details and nuances of so many products.”
In Martinez’s court filing, Rahman said it was “appropriate for him to rely on the sales reps and hospital staff to inform him as to whether all materials and equipment needed for surgery were available.”
Stryker, one of the nation’s top spine implant manufacturers, confirmed it spends what it calls “a significant amount of time and money” to train reps. The company said, “When hired, they typically shadow other reps for three to six months, then attend a ten-day intensive Spine School and other training.”
Whistleblowers and government investigators with the Department of Justice (DOJ) have been targeting companies that engage in illegal kickback schemes for years. Some lawsuits, like Martinez’s, have also blamed sales reps and distributors for not voicing their concerns with product deficiencies they observed first-hand. The Food and Drug Administration (FDA) requires device makers to “advise the agency of information that reasonably suggests a device they sell may have caused or contributed to a death or serious injury or has malfunctioned.” However, with some much money changing hands, this often doesn’t occur. Aggressive oversight is lacking, and this can lead to very real consequences for patients.