A bill expected to be introduced today in the U.S. House of Representatives would require doctors to tell the FDA about problems they encounter with medical devices.
The “Medical Device Guardian’s Act,” co-sponsored by Reps. Mike Fitzpatrick (R-Pa.) and Louise Slaughter (D-N.Y.), would amend the Food, Drug & Cosmetic Act “to require physicians and physician’s offices to be treated as covered device users required to report on certain adverse events involving medical devices.”
The FDCA only requires hospitals and medical device makers to report adverse events to its Manufacturer & User Facility Device Experience database, known as MAUDE.
The measure was spurred by the 18-year gap between the FDA’s approval of laparoscopic power morcellators and the safety watchdog learning that the devices can spread malignant cancers in the abdomen. The devices use small, rotating blades to break up large tissue masses into fragments, and are commonly used to remove benign uterine fibroids in women. However, if the device is used on a patient with undetected cancer, it can strew cancerous cells throughout the abdomen. Although the FDA approved morcellators in 1995, it wasn’t until 2013 when a Massachusetts physician, Dr. Amy Reed, exposed the risk after undergoing a hysterectomy at the Boston hospital where she worked.
“After that initial report from Amy, 100s of other safety reports began to flow into the FDA,” Fitzpatrick and Slaughter wrote in a letter to colleagues introducing the bill, according to the Wall Street Journal.
By April 2014 the FDA had issued a warning about the cancer risk and convened an advisory panel to consider the use of power morcellators in fibroid removal. The agency’s Obstetrics & Gynecology Devices committee failed to come to a clear consensus on the cancer risk from laparoscopic power morcellators, despite outraged testimony from dozens of attendees; in November of that year the FDA ordered so-called “black box” warnings for the devices. Last September, the Government Accountability Office said it would investigate potential safety and regulatory issues with the morcellators. Early this year, Fitzpatrick called for the FDA to open a criminal probe into several deaths associated with morcellators.
The furor prompted Johnson & Johnson (NYSE:JNJ) to recall its morcellators in July 2014, after pulling them from the market in April of that year. J&J is now looking to settle 100s of product liability and wrongful death lawsuits brought over the Ethicon devices.
“In retrospect, it should not have fallen on patients to get the FDA’s attention,” the legislators wrote, averring that “everyone in the chain of care” ought to be on the hook for reporting adverse events to the agency.
Boston’s Brigham & Women’s hospital, where Reed’s myomectomy was performed, confirmed that cancers in Reed and another, earlier patient were spread by power morcellation, the newspaper reported. The hospital said it initially deemed it unnecessary to report the incidents because the morcellator “functioned as expected and was used in the way it was intended, although with unintended and tragic consequences,” a Brigham spokeswoman told the Journal, noting that the Brigham has since reported both cases to the FDA.
Dr. Rita Redberg, a cardiologist at the University of California San Francisco Medical Center, said the bill would be a “huge step forward” because doctors are likely to be most aware of adverse events. For its part, the FDA told the paper that the MAUDE database has “important limitations” and asked Congress and the medical device industry for help in building a new system that would add patient care data into the mix.
Fitzpatrick and Slaughter are also expected to introduce “Ariel Grace’s Law,” which would open Bayer (ETR:BAYN) to even more liability lawsuits over its Essure female sterilization device, according to Morning Consult.
