Bill Requires Physicians to Report Medical-Device Deaths

June 10, 2016

Citing the problem of occult uterine cancer spread by power morcellators, Rep. Mike Fitzpatrick (R-PA) introduced a bipartisan bill on June 8 that would require physicians to report deaths or serious injuries caused by medical devices to the US Food and Drug Administration (FDA).

The measure, called the Medical Device Guardians Act, also would give physicians some legal cover when they inform the FDA about a worrisome medical device.

US Rep. Mike Fitzpatrick (R-PA). (Source: US House of Representatives)

Fitzpatrick introduced another bill the same day that would allow patients injured by medical devices now exempt from state liability laws to sue the manufacturers.

Controversy over power morcellators supplied the impetus for the Medical Device Guardians Act. Surgeons use the devices in hysterectomies and myomectomies to shred uterine tissue for easy removal through laparoscopic incisions. However, power morcellators can disperse occult cancer in the abdominal cavity, advancing it to stage IV.

Power morcellators have been on the market since the early 1990s, but Fitzpatrick and bill cosponsor Rep. Louise Slaughter (D-NY) said in a press release that no one had informed the FDA about the devices upstaging occult cancers until anesthesiologist Amy Reed, MD, PhD, brought her own case to the attention of the agency. Dr Reed, a mother of six, underwent power morcellation for a hysterectomy to remove uterine fibroids in October 2013. She soon discovered that the procedure had dispersed an aggressive uterine leiomyosarcoma.

Since then, Dr Reed and her husband, heart surgeon Hooman Noorchashm, MD, PhD, have lobbied the FDA and Congress to ban power morcellators and tighten the FDA's 510(k) approval process. Under 510(k), a manufacturer only needs to demonstrate that its product is substantially the same as a device already on the market. The physician couple contends that this process can put patients in harm's way because it lacks premarket safety testing and mandatory postmarket monitoring for adverse events.

Dr Noorchashm and Dr Reed claim that hundreds, if not thousands, of women have lost their lives to dispersed uterine cancer after power morcellation for more than 2 decades.

"There were many physicians who knew about this problem," Dr Noorchashm told Medscape Medical News. "Cases existed in the medical literature. But not a single physician bothered to report it to the FDA (until Dr Reed)."

Dr Reed, who continues to receive treatment for metastatic cancer, works part-time at the Hospital of the University of Pennsylvania training critical care fellows, according to her husband. She was not available for comment.

GAO Investigation Under Way

Although power morcellators remain on the market, they have fallen into disfavor. In April 2014, the FDA warned against using the devices for hysterectomies or myomectomies in most women with uterine fibroids because of the risk of spreading occult uterine cancer, put at 1 in 350 women undergoing these procedures. Later that year, the FDA added a boxed warning to product labels. One manufacturer, Johnson & Johnson, voluntarily withdrew its morcellators from the market, major insurers have dropped or restricted coverage of the procedures, and fewer surgeons are using the devices.

The American College of Obstetricians and Gynecologists and some individual physicians, however, have argued for retaining power morcellators, saying that the risks of open surgery are far greater.

Besides sponsoring the Medical Device Guardians Act, Fitzpatrick along with 11 other members of Congress have instigated an investigation by the federal General Accountability Office into the FDA's original approval of power morcellators, and why it took so long for the agency to warn about their dangers.

Bill Mirrors AMA Ethical Code, Says Dr Noorchashm

Under current federal law, hospitals, ambulatory surgery centers, and other so-called device-user facilities must report any deaths linked to a medical device within 10 working days to the FDA as well as the manufacturer. The definition of device-user facilities excludes physician offices.

In the case of serious injury or illness, or any other significant adverse event, these facilities must immediately inform the manufacturer, and file an annual report about these mishaps, as well as any deaths, with the FDA. Such reports cannot be admitted into evidence or otherwise used in civil litigation unless the facility knew that the information in its report was false.

The Medical Device Guardians Act includes physicians and physician offices in the list of parties who must report device-related deaths and injuries. As with hospitals, any report filed by a physician can't be used in a lawsuit.

The bill mirrors a section of the ethical code of the American Medical Association that obligates physicians to report serious adverse events linked to a drug or medical device to the FDA, Dr Noorchashm noted.

Second Bill Inspired by Essure-Related Mishaps

The other bill introduced on June 8, called Ariel Grace's Law, would remove the legal immunity enjoyed by manufacturers of medical devices that have gone through the FDA's premarket approval (PMA) process, its most rigorous. Their manufacturers can't be sued in state courts when something goes wrong.

Fitzpatrick named the bill after an unborn child named Ariel Grace, whose death in the womb is blamed on Essure permanent contraception, a flexible metal coil inserted into a woman's fallopian tubes. Fitzpatrick contends that the device has led to the deaths of at least four women and almost 300 fetuses. Essure'smanufacturer, Bayer, is shielded from state lawsuits on account of the device's PMA status.

In an email to Medscape Medical News, Bayer said that the bill "upends the very carefully crafted balance established by Congress to promote medical device research and innovation, and could potentially delay or stifle significant health benefits such devices provide." The company also said that the vast majority of deaths that Fitzpatrick characterized as fetal deaths don't warrant that description, at least by the FDA's standards, because they involved ectopic pregnancies and miscarriages.

In February, the FDA proposed a boxed warning for Essure permanent contraception, as well as a patient checklist that highlights possible adverse events such as perforation of the uterus or fallopian tubes, device migration, hypersensitivity reactions, and persistent pain. However, the FDA said the device should stay on the market for now — provided women are apprised of the risks — because "it is extremely effective at preventing pregnancy when used correctly."

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