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Morcellator deaths spur proposed Medical Device Guardian's Act

For decades the medical device known as a morcellator caused the death of hundreds, if not thousands, of women by spreading undetected cancer throughout their body. Despite these deaths, hospitals and physicians did not report these issues to the Food and Drug Administration (FDA). In fact, it was not until 2013, when physician Amy Reed's uterine cancer spread after a morcellation procedure, that the FDA was notified. In 2014, the FDA issued a "black box" warning on the morcellator. While this warning has severely limited the morcellator's use today, the damage was already done for many.

Two members of Congress have proposed a bill that would prevent these failures going forward. This bill, known as the "Medical Device Guardian's Act" was proposed by U.S. Representatives Mike Fitzpatrick (R., Pa.) and Louise Slaughter (D.,N.Y.). Congressman Fitzgerald has already played an instrumental role in bringing this systematic failure to the public's attention.

Bill would create a duty for doctors to report adverse events

Under current law, hospitals and medical device manufacturers have a duty to report deaths and injuries caused by medical devices to the FDA. If the Medical Device Guardian's Act becomes law, both physicians and physician's offices will be required to report adverse events as well. Under the bill, reports of adverse events could not be held against doctors in malpractice or other civil claims.

Clearly, both hospitals and medical device manufacturers failed in the case of the morcellator. This failure has led to litigation against Johnson & Johnson and other device manufacturers, as well as an investigation by the Government Accountability Office (GAO). If this bill becomes law, it will create one added layer of protection for patients and their families.

If you have been injured by a morcellator or another defective medical device, or if you were harmed by a doctor's negligence, it is important to work closely with a knowledgeable lawyer. Based in Washington, D.C., the lawyers of Fay Law Group, P.A., represent people across the country in a broad range of injury and wrongful death claims.

Source: Bill Would Require Doctors to Report Medical-Device Hazards, The Wall Street Journal, June 8, 2016, by Jennifer Levitz

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