July 22, 2015 – – On July 10, 2015, the US House of Representatives passed the 21st Century Cures Act, a sweeping healthcare reform bill intended to accelerate innovative medical research. But critics representative of a growing movement, one devoted to ending the use of power morcellators, have roundly criticized the loss of several key amendments inspired directly by the morcellator crisis.
Sean Tracey, Esq., lead partner at Tracey & Fox, says the so-called Fitzpatrick Amendments promised to reform the way in which medical devices were approved and monitored after approval, but were dropped from the Act before its passage. “Only now that morcellator cancer lawsuits are being filed and public outcry has brought this tragedy to the nation’s attention, are we getting a true picture of how many women’s lives have been cut short by power morcellators. The damage done over twenty years is unimaginable,” Tracey says, “but it’s even more shocking that American legislators have failed to pass these necessary reforms.”
Amy Reed, MD, PhD and Hooman Noorchashm, MD, PhD have become vocal leaders in the effort to ban power morcellation completely. After undergoing a hysterectomy in which a power morcellator was used to grind “fibroid” tissue, Reed, an anesthesiologist in Philadelphia, was diagnosed with uterine cancer. She quickly learned that morcellation had spread her leiomyosarcoma, a cancer that develops in soft tissue, worsening her prognosis. Boston’s Brigham and Women’s Hospital, where Reed’s procedure took place, publicly acknowledged the role morcellation played in “upstaging” her cancer, and agreed to stop using the dangerous devices in 2014.
Eventually, the US Food & Drug Administration would caution surgeons to avoid using power morcellators in the majority of women undergoing fibroid removal procedures. In a statement sent to ABC News, the agency recognized Reed for having brought the safety risks of morcellation to their attention. As hospitals began to limit or stop utilizing morcellators, and health insurers restricted coverage for procedures involving the device, Reed’s advocacy appeared to be spearheading a real shift in the healthcare industry.
“21st Century Cures” was to be the next step, an Act intended to reform the FDA approval process. Introduced to the House of Representatives on May 19, 2015, the Act contained several amendments written by Mike Fitzpatrick, a Republican congressman from Pennsylvania and cancer-survivor himself. Noting major deficiencies in the FDA’s medical device approval process, and citing the continued use of power morcellators as a case example, Fitzpatrick urged the House to support a “modernized” system for medical device postmarket surveillance, that would “allow [industry and government] to catch issues like the power morcellator faster.”
In a statement delivered before the House of Representatives on June 17, 2015, Fitzpatrick continued: “Unfortunately, it’s becoming clear that the reporting system for faulty and deadly devices is broken.” He noted a Wall Street Journal investigative report that found Johnson & Johnson, once the world’s largest manufacturer of power morcellators, had been alerted to the device’s severe risks as early as 2006. “It took the FDA and industry nearly a decade to come to the same conclusion.”
Fitzpatrick’s full statement before the House can be found here.
But on July 8, one day before the House was set to vote on “21st Century Cures,” all but one of the Fitzpatrick Amendments were rejected. In a Hearing of the House Rules Committee, Congressman Michael Burgess, a Republican from Texas and former gynecological surgeon, framed the morcellation crisis as a problem caused not by inadequate FDA oversight, but by inadequate physician education. While Fitzpatrick agreed that physicians should have used morcellators more cautiously, he took issue with the FDA’s 510(k) Approval Process.
510(k), what Fitzpatrick referred to as an “expedited” process, allows the FDA to approve new medical devices quickly if a substantially similar “predicate” device has already been approved. Fitzpatrick noted that the first power morcellator had been approved twenty years ago, when the risk of a woman harboring an unsuspected uterine cancer was estimated to be approximately 1 in 10,000. “That number was wrong,” Fitzpatrick testified, “the number that’s being discussed today is 1 in about 350 […] Once we determine it’s doing more harm than good, how is the public notified? How’s the FDA notified? And what’s the process to reach back and say that one particular [predicate] device needs to be recalled?”
Reed and Noorchashm, in an editorial published by the Philadelphia Inquirer, say that Fitzpatrick’s call to action fell on deaf ears, noting that 7 out of the Congressman’s 8 amendments failed to pass. Sean Tracey continues to offer free legal consultations to women who believe that a power morcellator procedure spread an undetected uterine cancer. He routinely advises patients injured by dangerous medical devices on their legal rights and options. For more information, call 713-495-2333.
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Sean Tracey
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