Prior to the coronavirus pandemic, sales reps for orthopedic device makers often had a presence in operating rooms. But as elective procedures pick up again, a wave of malpractice and product liability suits that take aim at companies and their marketing tactics are prompting calls to rethink the practice, according to an investigation by Kaiser Health News.

Several activities that fall under the rubric of marketing — from sales reps giving surgeons technical guidance in the O.R. on the use of their products to paying surgeons to tout their implants at medical conferences to having athletes offer celebrity endorsements – have been blamed for contributing to serious patient harm in thousands of medical malpractice, product liability and whistleblower lawsuits filed over the past decade, KHN found.

Some suits alleged patients were injured after sales reps sold or delivered wrong-size or defective implants, while others accuse device makers of misleading doctors about the safety and durability of their products. Others claim companies concealed and downplayed hardware defects or paid millions of dollars in illegal kickbacks to surgeons who agreed to use their products. 

Device makers, for their part, have denied the allegations and, in many instances, have settled under confidential terms. Moreover, the industry said these practices help ensure that patients receive the highest-quality care.

But some industry critics are calling for a rethink of the close ties between device makers and surgeons, from sales to tracking of injuries. They want to tighten restrictions on industry’s hospital access, including keeping reps out of O.R.s. 

The controversy comes at a moment when elective operations are getting going again after being shelved due to the COVID-19 pandemic. Some reps have expressed concerns that hospitals may take advantage of the pause to maintain those access limits.

Dr. Adriane Fugh-Berman, a Georgetown University Medical Center professor who runs PharmedOut, which examines industry influence on medicine, said hospitals should train staff to perform these functions. “Relying on sales reps in the O.R. is appalling. We need to come up with a better system,” she told KHN.

As the report notes, guidelines for “reentry” after COVID-19 issued by trade group AdvaMed and the American Hospital Association say medical device reps should deliver “services, information and support remotely whenever possible.” The guidelines advise hospitals to use videoconferencing gear when it “does not compromise patient safety or privacy.”

Critics said the current system drives up healthcare costs and exposes patients to risks, such infections traced to extra people in the O.R. Reps argued that their incomes have taken a hit from global purchasing arrangements that give hospitals greater leverage over prices for surgical hardware.

Orthopedic surgeons and neurosurgeons received a total of about $511 million in industry consulting fees from 2013 through 2019 and nearly $300 million more for “serving as faculty or speaker” at industry-sponsored events, a KHN analysis of government data found.

Meanwhile, pending injury lawsuits cite prominent surgeons who touted products that were later recalled or who helped train surgeons to use implants, including those paid by companies to serve as key opinion leaders, according to court filings. Patients are claiming injuries they blame at least partly on overly aggressive marketing.

Court records also show what KHN describes as a “hotly competitive” market for device reps, with veteran reps who influence which brands of hardware surgeons select commanding salaries and bonuses that can stretch into the low six figures and beyond.