Morcellation Media Monitoring 7/6/15

Client Attorney Privileged/Attorney Work Product/At Request of Counsel

Morcellation

1. Lawsuit Over Hysterectomy Tool Settled

   Jul 2, 2015 | The Wall Street Journal

   By Jon Kamp
   
   
   A federal lawsuit against a manufacturer of laparoscopic power morcellators that was expected to be the first to reach a trial has been settled for an undisclosed amount, an attorney for the plaintiff said Thursday. The case was filed against device maker Lina Medical ApS by Scott Burkhart, a Pennsylvania man whose wife, Donna, died in February 2013. The 53-year-old had a morcellator-aided hysterectomy 11 months earlier for heavy bleeding, according to the lawsuit. She learned after surgery that she had a hidden cancer called leiomyosarcoma.
2. Congressman Mike Fitzpatrick (R-PA): A call to federal arms in defense of public health

   Jul 2, 2015 | The Philadelphia Inquirer

   By Hooman Noorchashm, M.D., Ph.D. and Amy J. Reed, M.D., Ph.D.
   
   
   On June 17, 2015 a congressman from Pennsylvania delivered a five-minute speech before the general assembly on the floor of the United States House of Representatives. We ask that you watch this speech with care at this link. Congressman Mike Fitzpatrick, well recognized as a solid, pro-industry conservative, warned his colleagues in the United States congress of a severe public health hazard: the medical device industry is not being regulated by FDA with patient safety as its first and foremost priority.

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Client Attorney Privileged/Attorney Work Product/At Request of Counsel

Morcellation

1. Lawsuit Over Hysterectomy Tool Settled

   Jul 2, 2015 | The Wall Street Journal

   By Jon Kamp

   A federal lawsuit against a manufacturer of laparoscopic power morcellators that was expected to be the first to reach a trial has been settled for an undisclosed amount, an attorney for the plaintiff said Thursday.

   The case was filed against device maker Lina Medical ApS by Scott Burkhart, a Pennsylvania man whose wife, Donna, died in February 2013. The 53-year-old had a morcellator-aided hysterectomy 11 months earlier for heavy bleeding, according to the lawsuit. She learned after surgery that she had a hidden cancer called leiomyosarcoma.

   The Food and Drug Administration warned last year that power morcellators can spread and worsen these cancers, which can’t be reliably detected before surgery. The drill-shaped power tools use a rotating blade to slice up tissue for removal through small incisions.

   The lawsuit, filed in March 2014, was expected to reach trial later this year, ahead of at least 21 other federal suits. François Blaudeau, an attorney for Mr. Burkhart who represents other clients with morcellator claims, confirmed the settlement, which he said was reached last week and requires approval in the U.S. District Court for the Eastern District of Pennsylvania. There are also cases in state courts.

   The lawsuit alleged that Lina Medical failed to warn about the risk of spreading cancer. Attorneys for the device company couldn’t be reached for immediate comment.

   Mr. Burkhart said he was glad the case didn’t have to go to trial, and that his main goal was to make others aware of the risks.

   Publicity over the risks and the FDA’s intervention have sharply curtailed morcellator use. The FDA called for a “black-box” warning on morcellators and said they shouldn’t be used in the vast majority of women. Many hospitals and health insurers have banned or clamped down on use of the device, and former top manufacturerJohnson & Johnson voluntarily left the market last year.

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2. Congressman Mike Fitzpatrick (R-PA): A call to federal arms in defense of public health

   Jul 2, 2015 | The Philadelphia Inquirer

   By Hooman Noorchashm, M.D., Ph.D. and Amy J. Reed, M.D., Ph.D.

   On June 17, 2015 a congressman from Pennsylvania delivered a five-minute speech before the general assembly on the floor of the United States House of Representatives.  We ask that you watch this speech with care at this link.
   
   Congressman Mike Fitzpatrick, well recognized as a solid, pro-industry conservative, warned his colleagues in the United States congress of a severe public health hazard: the medical device industry is not being regulated by FDA with patient safety as its first and foremost priority.
   
   Fitzpatrick’s message to his congressional colleagues was clear. We take the liberty to paraphrase his sentiments: We have a problem. The American people have a problem. The legislation governing one of our federal agencies is creating a public health hazard.  He emphasized that the medical device industry is suffering from a lack of sufficient FDA oversight – despite the FDA’s being one of the largest federal public health agencies in the United States.
   
   Acting in response to this clear failure in federal regulation, he formally addressed the FDA, in writing, demanding an explanation. Four months have elapsed from the time of this congressional letter’s hand delivery to FDA - but there has been no response from that agency’s leadership. 
   
   Fitzpatrick recognizes his duty to the American people from his federal seat – and he is concerned.  He clearly and publicly stated: “…it’s becoming clear that the reporting system for faulty and deadly devices is broken…”.  Yet both the FDA and his colleagues in Congress remain silent thus far.           
   
   So we ask: Senator Alexander, Senator Casey, Senator Markey, Senator Toomey, Senator Warren, Congressman Pitts, Senator Schumer, Senator Gillbrand, all standing members of the United States congress – what will you do to secure the medical device regulatory space for the American people?
   
   Many have died unnecessarily or prematurely. Many more remain in harm’s way.
   
   We, again, remind the United States congress that the “power morcellator disaster” in women’s health is a bellwether case for public health and patients safety in the United States.
   
   Congressman Fitzpatrick of Pennsylvania has sounded the alarm clearly on the floor of the United States House of Representatives for all his colleagues to hear.  What remains to be seen is if our federal representatives find themselves capable of containing this severe legislative public health hazard – despite powerful industry forces to the contrary.
   
    Will congress act cogently and deliberately in light of the harm that has been done to many unsuspecting American families?  Congressional action, or lack thereof, on the “power morcellator” disaster will be telling of the state of affairs and purpose in our federal government.
   
   For now, our many thanks go to Congressman Mike Fitzpatrick of Pennsylvania for apparently being a lone voice of reason - standing in defense of patient safety and public health and calling his colleagues to arms.
   

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