Morcellation Media Monitoring 03/07/2016

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

Morcellation

1. Power Morcellation Lawsuits Expected to Keep Growing

   Mar 3, 2016 | LawyersandSettlements.com

   By Gordon Gibb
   
   
   While the number of Laparoscopic Power Morcellation lawsuits are not as yet substantial, attorneys close to the file estimate that before too long there could be upwards of 300 or more filings going forward. Given that some 650,000 women undergo hysterectomies in the United States each year due to uterine fibroids, 300 lawsuits appear to be a conservative estimate.
2. Rep. Mike Fitzpatrick Became An Advocate For Women’s Health

   Mar 4, 2016 | RightingInjustice

   By Jennifer Walker-Journey
   
   
   During his four terms in office, U.S. Rep. Mike Fitzpatrick has focused on policy issues like national security and taxes. But in recent years he’s become a champion for women’s health.

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

Morcellation

1. Power Morcellation Lawsuits Expected to Keep Growing

   Mar 3, 2016 | LawyersandSettlements.com

   By Gordon Gibb

   While the number of Laparoscopic Power Morcellation lawsuits are not as yet substantial, attorneys close to the file estimate that before too long there could be upwards of 300 or more filings going forward. Given that some 650,000 women undergo hysterectomies in the United States each year due to uterine fibroids, 300 lawsuits appear to be a conservative estimate.
   
   The US Food and Drug Administration (FDA) has yet to take the drastic step of ordering power morcellators off the market. However, the regulator’s 2014 safety advisory all but put the nail in the coffin of the once-popular medical device when, on April 17 of that year, the FDA recommended that doctors employ other options and made a point to discourage use of power morcellators for Hysterectomy.
   
   In its communiqué, the FDA cited data that suggested one in 350 women could be at risk for undiagnosed cancers in association with use of the device, which has been alleged to spread undetected cancer cells within the uterus, dramatically increasing a woman’s risk for Ovarian cancer and other cancers.
   
   A little more than three months after the FDA frowned upon the power morcellator (a device the regulator approved in the first place), Ethicon withdrew all of its power morcellators from the market.
   
   That withdrawal did not stop the multidistrict panel tasked with consolidating power morcellation lawsuits from limiting lawsuits within the MDL to those filed against Ethicon, which is a subsidiary of pharmaceutical and medical device giant Johnson & Johnson.
   
   Power morcellation is one of many treatments favored by doctors and the health care industry given the capacity to perform fibroid removal through a small incision, speeding healing and freeing up hospital beds. However, in recent years, several plaintiffs have alleged they emerged from a morcellation procedure with a cancer diagnosis when no risk factors were present prior.
   
   

   Three other manufacturers of power morcellators are facing lawsuits. However, the MDL was limited to Ethicon, Inc. (and Johnson & Johnson), given that laparoscopic power morcellation hysterectomy lawsuits against the latter outnumber those targeting their competitors.
   
   And even though Ethicon removed their devices from the market, the heat isn’t quite off yet. It has been reported that the Federal Bureau of Investigation (FBI) is involved, and Congress has requested that the US Government Accountability Office examine the file.
   
   As treatments for fibroids move away from the allegedly problematic power morcellator to more traditional procedures, attorneys observe that plaintiffs pursuing a laparoscopic power morcellation myomectomy lawsuit - or litigation stemming from a related procedure - would be well-served by representation through multidistrict litigation (MDL 2652, In Re: Ethicon, Inc., Power Morcellator Products Liability Litigation, before Judge Kathryn Vratil) with cases currently consolidated in Kansas.
   

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2. Rep. Mike Fitzpatrick Became An Advocate For Women’s Health

   Mar 4, 2016 | RightingInjustice

   By Jennifer Walker-Journey

   During his four terms in office, U.S. Rep. Mike Fitzpatrick has focused on policy issues like national security and taxes. But in recent years he’s become a champion for women’s health.

   Fitzpatrick’s focus changed in 2014, when was approached during a Christmas parade by cardiac surgeon Hooman Noorchashm and his wife, anesthesiologist Amy Reed. During their hour-long chat, Noorchashm and Reed told Fitzpatrick a disturbing tale about a medical device used to perform hysterectomies and uterine fibroid removals that had been linked to the spread of an aggressive form of uterine cancer. The couple was became aware of the problem after Reed was diagnosed with uterine sarcoma following a hysterectomy in which the now-controversial device – a power morcellator – was used.

   Power morcellators are fitted with a tube-like blade that shreds uterine growths or entire uteruses inside the body and removes the bits of tissue through a small incision in the abdomen. The procedure was favored over open surgery because it offered shorter recovery and less scarring.

   However, researchers have found that women with previously undetected uterine cancer were at greater risk for cancer spread after undergoing power morcellation, which made the disease more difficult to treat and worsened their odds of survival. Some uterine cancers, such asaggressive uterine sarcoma, are difficult to detect and diagnose prior to surgery.

   Fitzpatrick quickly became a leading voice in Congress about medical device safety and pressed the FDA to explain why it waited so long before warning doctors and patients of the cancer spread risk with power morcellation. The device now carries a black box warning.

   Last year, Fitzpatrick took aim at another medical device that has caused injuries to women – Bayer Healthcare’s Essure permanent birth control method. The implants were linked to complications such as migration and perforation of the fallopian tubes and uterus, as well as allergic reactions, chronic pain and infections. After more than 5,000 complaints, and pressure from Fitzpatrick, the FDA conducted a safety review of the Essure birth control device. Late last month, the agency recommended a black box warning be placed on Essure.

   Fitzpatrick says he will not run for another term, but he will continue to support more oversight with medical devices. “The issue is once the FDA has approved it and it is out there and you have found people who have been harmed, what is your process for dealing with that?” Fitzpatrick told Philly.com. “They are excruciatingly slow and ineffective in withdrawing something from the market.”

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