Morcellation Media Monitoring 06/15/2015

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

Morcellation

1. Power Morcellator Lawsuits on the Rise

   Jun 11, 2015 | The Legal Examiner

   By Steven Davis
   
   
   Litigation involving the power morcellator, a surgical tool used in hysterectomies and myectomies to remove fibroids from the uterus, continues to grow.
2. Insurer Bucks Trend, Lets Docs, Patients Decide on Morcellation

   Jun 15, 2015 | Outpatient Surgery Magazine

   By Jim Burger
   
   
   Insurance giant Health Care Service Corp. has done an about-face and decided not to join the stampede of health insurers restricting or eliminating coverage of procedures done with laparoscopic power morcellators.

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

Morcellation

1. Power Morcellator Lawsuits on the Rise

   Jun 11, 2015 | The Legal Examiner

   By Steven Davis

   Litigation involving the power morcellator, a surgical tool used in hysterectomies and myectomies to remove fibroids from the uterus, continues to grow.

   A husband alleging that his wife died from leiomyosarcoma less than a year after undergoing a hysterectomy involving morcellation filed the first power morcellator lawsuit in March 2014 in Pennsylvania, and at least six others have followed, including several brought in 2015:

   - In January 2015, a Michigan woman filed a claim against Karl Storz, a German company whose power morcellator allegedly caused the woman’s undiagnosed uterine cancer to spread to stage 4 cancer that has metastasized to her breasts and bones.

   - Also in January 2015, a California widower filed suit against Johnson & Johnson, claiming that his wife’s 2012 death was caused by a hysterectomy procedure in which J&J’s Gynecare Morcellex morcellator was used.

   - In March 2015, a Georgia couple filed suit against J&J over her leiomyosarcoma diagnosis after undergoing a hysterectomy in 2011.

   According to the National Women’s Health Network, hysterectomy is the second most common surgical procedure done on women of reproductive age, and by the age of 60, one in three women have had a hysterectomy.

   Power Morcellators and Cancer

   Until recently, power morcellators have been a common choice among surgeons who perform hysterectomies and myectomies to remove benign fibroids from the uterus. The device features high-speed blades that cut fibroid tissue into small pieces for removal through a small incision, but the ground up tissue is also spread throughout the abdomen and pelvic region by centrifugal force. Because there is no conclusive way to distinguish between benign fibroids and undiagnosed uterine cancer, power morcellators present a significant risk of spreading undetected cancer cells throughout the abdomen, leading to rapid upstaging of the disease.

   According to FDA researchers, as many as one of every 352 women who have fibroid removal surgery are also harboring undetected uterine sarcoma. The FBI is currently conducting aninvestigation of the power morcellator, allegedly focusing on J&J’s knowledge of the device’s risks.

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2. Insurer Bucks Trend, Lets Docs, Patients Decide on Morcellation

   Jun 15, 2015 | Outpatient Surgery Magazine

   By Jim Burger

   Insurance giant Health Care Service Corp. has done an about-face and decided not to join the stampede of health insurers restricting or eliminating coverage of procedures done with laparoscopic power morcellators.

   HCSC, the nation's 4th-largest health insurer, considered labeling morcellation "not medically necessary," but decided instead that whether to use the tool "is best determined through dialogue between the provider and the patient," spokeswoman Lauren Perlstein tells the Wall Street Journal.

   Last summer, Highmark, Inc., announced that it would stop paying for the procedure. UnitedHealth Group announced this spring that it would require physicians to obtain authorization for all hysterectomies that used morcellation, and last month, Aetna also stopped covering routine use of morcellators.

   The controversy surrounding the device, which gained widespread attention in 2013, stems from the revelation that it can spread undetected uterine cancer. The FDA issued a black box warning after conducting hearings, and has estimated that as many as 1 in 350 women may be vulnerable. Others say that estimate is much too high and argue that if morcellation is made unavailable, other complications, and deaths, will increase dramatically.

   Johnson & Johnson, which had the largest market share for the device, withdrew it from the market last year and asked customers to return their morcellators. Other companies' versions remain available, however.

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