Ties to Power Morcellator Manufacturer Prompt Doctor To Step Down from FDA Panel

Published on August 25, 2014 by Sandy Liebhard

A specialist in minimally-invasive gynecological surgery stepped down from a U.S. Food & Drug Administration (FDA) advisory panel after it was disclosed that he had served as a paid consultant to a major manufacturer of power morcellators. However, the doctor did serve on the same advisory panel when it met nearly three years ago to discuss the risks associated with transvaginal mesh.

According to a report from New Brunswick Today, a company owned by Dr. Andrew Brill was paid over $150,000 by Johnson & Johnson’s Ethicon, Inc. unit over the past few years for consulting services. Ethicon was the nation’s largest manufacturers of power morcellators, which are used to carve up tissue in minimally-invasive hysterectomies and fibroid removal procedures. The FDA issued a warning in April discouraging doctors from using the devices, after it determined that they could cause undiagnosed uterine cancers to spread throughout a woman’s body.

Potential Conflicts of Interest

As part of its review, the FDA convened a meeting of its Medical Devices Advisory Committee/Obstetrics and Gynecology Medical Devices Panel in July, which was tasked with making recommendations on the use of power morcellators in uterine surgery. Just days before the meeting, Dr. Brill stepped down from the panel.

“During the course of the agency’s review and in consultation with Dr. Andrew Brill, it was determined that the financial information he disclosed was just above the threshold established for panel members to participate in one of our meetings,” an FDA spokeswoman told the Wall Street Journal at the time.

According to New Brunswick Today, Dr. Brill was subject to the “Ethics in Government Act,” which precludes so-called “special government employees” from receiving more than $50,000 in consulting fees.

Because Johnson & Johnson’s figures are incomplete for 2010, it’s not known how much AIB Consulting, Dr. Brill’s company, had received from Ethicon when he served as a non-voting member of the same FDA panel in September 2011. That month, the panel was convened to discuss the risk associated with transvaginal mesh. Ethicon manufactures a number of the pelvic mesh products that were the subject of that meeting.

Ethicon Morcellator Recall

Just weeks after the FDA held its most recent advisory panel meeting, Johnson & Johnson announced a power morcellator recall for devices manufactured by Ethicon. The company’s products are also named in a number of morcellator lawsuits filed on behalf of women whose cancers were allegedly spread by the surgical tool.