Two House measures introduced earlier this week aim to strengthen federal requirements for reporting adverse outcomes caused by medical devices and to increase access to legal recourse for patients harmed by Class III high-risk devices.
Sponsored by Reps. Mike Fitzpatrick (R-Pa.) and Louise Slaughter (D-N.Y.) and introduced June 8, the bills address harm to patients from two high-profile medical devices:
• The power morcellator, a Class II minimally invasive gynecological device known to spread undetected uterine cancer during hysterectomy and myomectomy, and
• And Essure, a Class III permanent sterilization device inserted in the fallopian tube. FDA has received nearly 10,000 reports from patients about complications resulting from the nickel-based metal coil, which has been known to perforate uterine walls and abort pregnancies.
The Medical Device Guardians Act was created in response to lapses in FDA’s regulatory system for medical devices, which mandates reporting of adverse outcomes by hospitals and device manufacturers.
This means that only institutions, not individual practitioners, are liable, removing the incentive for physicians to report adverse outcomes.
The second bill, Ariel Grace’s Law, would allow patients harmed by Class III devices to file lawsuits against manufacturers. The 1976 Medical Device Amendments, along with a 2008 ruling by the Supreme Court, sharply limit the types of recourse patients might have for injuries from medical devices. This applies to Class III products such as the Essure device, which go through premarket approval, FDA’s highest bar for demonstration of safety and effectiveness (The Cancer Letter, Dec. 18, 2015).
“I’m eternally grateful for all the families that have worked with Congressman Fitzpatrick and me to prevent more people from going through the tragedy that they’ve endured,” Slaughter, the highest ranking Democratic member of the House Committee on Rules, said in a statement. “These bills are about saving lives. We’ve seen firsthand how devastating it is when a medical device has an unintended, adverse consequence.
“It’s time for Congress to make commonsense changes to protect patients and give them the information that could help save lives.”
In the case of the power morcellator, FDA said it did not receive any reports of adverse outcomes from manufacturers and hospitals prior to December 2013. (The Cancer Letter, Nov. 19, 2015).
In November 2014, The Cancer Letter first reported on Brigham’s role in upstaging a patient’s leiomyosarcoma via power morcellation performed in 2012. Erica Kaitz, the patient, died on Dec. 7, 2013. In October 2013, another patient, Amy Reed received her cancer diagnosis at Brigham. Reed subsequently led a campaign against widespread use of the procedure (The Cancer Letter, Nov. 21, 2014).
In a study by Brigham physicians Michael Muto and Michael Seidman published November 2012 in PLOS ONE, the authors identify four patients—out of 1,091 patients—who showed evidence of peritoneal dissemination of leiomyosarcoma after undergoing power morcellation. Three of the four patients died, with an average post-diagnosis survival of 24.3 months.
It is not publicly known where the four patients were treated.
Ethicon—a subsidiary of Johnson & Johnson, and the largest manufacturer of the devices—said it didn’t know of the dangers of power morcellators prior to December 2013, when Reed and her husband Noorchashm filed a Medical Device Report to FDA. Whistleblower Robert Lamparter, a retired pathologist from central Pennsylvania, disagreed, and produced documents from 2006 proving that he had reported to J&J a near-miss case as well as risk estimates similar to FDA’s numbers (The Cancer Letter, Nov. 20, 2015).
In 2015, Fitzpatrick, Slaughter and 10 members of Congress commissioned a Government Accountability Office investigation on who knew what, and when.
The GAO joins three other federal agencies in looking into potential violations of statutory requirements for hospitals and manufacturers to report adverse outcomes: the Federal Bureau of Investigation, the FDA Office of Criminal Investigations and the Subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce.
“While many medical devices prove lifesaving, we know that some can cause harm and have devastating consequences for patients,” Fitzpatrick, vice chairman of the Subcommittee on Oversight and Investigations, said in a statement June 8. “I think everyone would agree that when a medical device is found to be unsafe, there needs to be an effective process in place to track these failures, to remove devices from the market, and provide legal recourse for those impacted. Currently, that process is failing us, and our constituents are paying the price.
“It’s time we reform the FDA, its processes and procedures to allow for maximum innovation and maximum safety. Agencies, physicians and lawmakers should all be committed to this common cause, and open to these bipartisan solutions.”