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Will The FDA Criminally Investigate The Failure To Report Morcellator Deaths?

Hospitals are required under federal law to report patient deaths suspected to have been caused by defective medical devices to the Food and Drug Administration (FDA). Medical device manufacturers are under a similar obligation. Michael Fitzpatrick, a Congressman for Pennsylvania's 8th District, asked the FDA's Office of Criminal Investigations to look into why three hospitals and one medical device manufacturer failed to report deaths caused by a power morcellator.

This device, which was used for decades to remove uterine fibroids in hysterectomies, rapidly cuts body tissue into tiny pieces. The morcellator will also, unfortunately, cut cancer into small pieces, causing it to spread throughout the abdomen. Tragically, hundreds, if not thousands of women have died due to upstaged uterine cancer caused by the power morcellator.

A Member Of Congress Is Asking The FDA To Take Action

On December 18, 2015, Rep. Fitzpatrick sent a letter to George Karavetsos, the FDA's Director of Criminal Investigations. In this letter, Fitzpatrick asked the FDA to investigate why Rochester General Hospital, the University of Rochester Medical Center and Brigham and Women's Hospital in Boston failed to report patient deaths caused by upstaged cancer to the FDA. He also asked the FDA to investigate why Ethicon, a manufacturer of the power morcellator, failed to notify the FDA about deaths caused by its product.

Fitzpatrick's letter highlights four of the many deaths caused by this device. In April 2012, Erica Kaitz underwent power morcellation at Brigham and Women's Hospital. On December 7, 2013, Ms. Kaitz died due to upstaged uterine cancer (leiomyosarcoma). In 2009, Barb Leary went to Rochester General Hospital underwent a similar procedure. She died in September 2013 due to upstaged leiomyosarcoma. On October 21, 2013, Linda Interlichia underwent power morcellation at Rochester General Hospital, and died on October 31, 2014 of upstaged cancer. Brenda Leuzzi underwent power morcellation at the University of Rochester Medical Center in September 2012 and died on October 24, 2014 due to upstaged cancer.

Fitzpatrick also notes that Ethicon, a manufacturer of power morcellators, was aware of the risks associated with its product as early as 2006. In fact, in 2006, Ethicon changed its labeling to include a warning that the use of a morcellator "may lead to dissemination of malignant tissue." Changing labeling indicates that Ethicon was aware of these risks, yet it failed to report these risks to the FDA. Fitzpatrick is asking the FDA's Office of Criminal Investigations to look further into these failures.

The FDA has made public statements indicating that it had not received adverse reports of the use of the morcellator until late 2013. Ethicon and these hospitals appear to have violated federal law by failing to report these adverse outcomes. In 2016, we will closely watch this investigation.

Seeking Justice Through The Court System

Surviving family members who have lost loved ones due to upstaged cancer have brought a lawsuit against Ethicon. This case is being heard in federal court in Kansas City, Kansas, before Judge Kathryn Vratil. It is likely that more families will come forward as litigation progresses.

Contact Fay Law Group, P.A.

While based in Washington, D.C., our law firm works with families across the United States who have lost loved ones due to the negligent, reckless or intentional acts of others. We are currently representing families in the claim against Ethicon. We fully understand the legal and medical issues in the case, and are ready to help additional families recover compensation for their losses. Call 800-522-2715 to set up a free consultation.

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