Morcellation Media Monitoring 07/30/2015

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

Morcellation

1. Power Morcellator MDL Could Yield Big Damages, Lawyers Say

   Jul 27, 2015 | New Jersey Law Journal

   By Charles Toutant
   
   
   On the heels of warnings from the U.S. Food and Drug Administration about the risks of using power morcellators in uterine surgery, the Judicial Panel on Multidistrict Litigation has been asked to consolidate 21 federal suits against makers of the devices—and lawyers involved in the litigation predict that while the number of cases will not be large, their value could be significant. Plaintiffs in power morcellator cases tend to have major medical bills and most are within the peak earning years of 40 to 60, according to those lawyers.
2. Another act of gynecological maleficence: The Essure Female Sterilization Coil

   Jul 28, 2015 | The Philadelphia Inquirer

   By Hooman Noorchashm, M.D., Ph.D. and Amy J. Reed, M.D., Ph.D.
   
   
   On September 24, 2015 the Food and Drug Administration is planning to convene another hearing of the OB/Gyn Device Panel. Again, a harmful medical device in question is a gynecological one – a permanent female sterilization device, known as Essure. You can view the announcement here. Essure is a system manufactured by Bayer Healthcare - originally approved by FDA in 2002. It consists of a delivery system and nickel-containing permanent coil implants.
3. Morcellator Cancer Lawsuits Allege Two Pennsylvania Women Developed Cancer Due To Robotic Hysterectomy

   Jul 29, 2015 | Southern Med Law

   Morcellator cancer lawsuits contend laparoscopic power morcellators have the potential of spreading cancer when used during a hysterectomy or myomectomy (removal of uterine fibroids) and lawsuits continue to filed on behalf of women who have developed uterine cancer due to the morcellation device. The most recent morcellator cancer lawsuits to be filed were on behalf two Philadelphia women who assert that morcellator manufacturers, Olympus Corporation and its subsidiary, Gyrus ACMI, misrepresented their products as being safe to use and failed to warn of the cancer risks associated with power morcellators.

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

Morcellation

1. Power Morcellator MDL Could Yield Big Damages, Lawyers Say

   Jul 27, 2015 | New Jersey Law Journal

   By Charles Toutant

   On the heels of warnings from the U.S. Food and Drug Administration about the risks of using power morcellators in uterine surgery, the Judicial Panel on Multidistrict Litigation has been asked to consolidate 21 federal suits against makers of the devices—and lawyers involved in the litigation predict that while the number of cases will not be large, their value could be significant.

   Plaintiffs in power morcellator cases tend to have major medical bills and most are within the peak earning years of 40 to 60, according to those lawyers.

   Patients with undiagnosed uterine cancer who undergo a hysterectomy or removal of fibroids performed with a power morcellator risk spreading cancerous cells within their abdomen and pelvis, reducing their chances of long-term survival, the FDA announced in April 2014. Now, suits are being filed nationwide against the companies that made the morcellators by women who underwent such procedures, or by the survivors of women who died after their operations.

   Meanwhile, the Wall Street Journal has reported that the FBI has opened an investigation into Johnson & Johnson, which was the biggest maker of power morcellators, to determine what it knew about the tool's hazards before pulling it off the market.

   The JPML motion was filed in June on behalf of 21 plaintiffs who are suing four companies that made the devices. According to court documents, some suits named more than one defendant because it was unclear which company's device was used in the plaintiff's surgery. Sixteen of the suits were brought against Johnson & Johnson's Ethicon subsidiary, five against Karl Storz GmbH, and one each against Richard Wolf GmbH and Gyrus, a division of Olympus of Japan. About a dozen other morcellator suits are believed to be pending in state courts around the country, lawyers said.

   Two of the 21 cases cited in the JPML application are from New Jersey. A third New Jersey morcellator suit was filed July 22, raising medical malpractice claims against three physicians and a hospital as well as product liability claims against Karl Storz GmbH.

   A morcellator has spinning blades that grind up tissue so it can be removed through a small incision in the abdomen. They allow a hysterectomy and myomectomy for removal of fibroids to be performed with less pain and a faster recovery than the traditional, full abdominal incision.

   But approximately one in 350 women with fibroids also have uterine sarcoma, a form of cancer that cannot be reliably detected before surgery. When a morcellator spreads cancerous tissue in the abdominal cavity beyond the uterus, what was a localized (Stage 1) cancer can quickly be "upstaged" to a regional cancer (Stage II or III) or metastatic (Stage IV), the suits claim.

   The FDA's April 2014 announcement was followed in November by its requirement that makers of morcellators issue a stronger warning about the risks. The devices are still in use in some hospitals but in July 2014, Johnson & Johnson's Ethicon subsidiary, the largest maker of morcellators, instituted a voluntary recall.

   No morcellator cases have been tried, but Burkhardt v. Lina Medical U.S., filed in March 2014 in the Eastern District of Pennsylvania, was settled in June 2015, Johnson & Johnson said in papers filed with the JPML. Defendant Lina Medical is a U.S. subsidiary of a Denmark-based company. Lawyers in that case did not return calls.

   The July 22 New Jersey suit was brought by Viviana Ruscitto, who underwent a hysterectomy at Valley Hospital in Ridgewood in October 2014. She had no known evidence of cancer before the operation but since then she has suffered cancerous lesions in her abdomen, pelvis and lungs and her cancer is in Stage IV, the most advanced stage, according to her suit.

   Ruscitto's suit claims the doctors and hospitals are liable for malpractice and failure to obtain her informed consent. She also claims in the suit that Karl Storz's design of its morcellator was defective and that it failed to warn of the dangers of its product. In December 2014, she began an intensive chemotherapy regimen that is expected to continue until February 2016, according to court papers. But recently, Ruscitto's condition has taken a turn for the worse, said Demetrios Stratis, the Fair Lawn lawyer who filed her suit, and he is seeking to conduct her deposition as soon as possible. He said he's not sure how consolidation in a multidistrict litigation would impact the malpractice claims in his suit.

   "These cases have a lot of jury appeal. Everyone has someone close to them who was effected by cancer," Stratis said.

   The June JPML application was filed by Paul Pennock of Weitz & Luxenberg in New York, who sought to have the cases heard by U.S. District Judge Kathryn Vratil of the District of Kansas. An individual plaintiff, Timothy Schroeder, has responded with a request that the cases be moved to the U.S. District Court for the Southern District of Illinois and heard by Judge David Herndon.

   Johnson & Johnson asked the JPML to deny the motion to consolidate, citing the small number of cases and variations in the plaintiffs' medical circumstances. The company also said the District of Kansas and the Southern District of Illinois are inappropriate transfer venues because they have no connection to the case.

   Also opposing consolidation were Gregory Houser of Wuersch & Gering in New York, representing Richard Wolf GmbH; Robert Goodman, of Wilson Elser Moskowitz Edelstein & Dicker in Washington, D.C., representing Karl Storz GmbH; and Michael Weiss, of Carroll & Weiss in Atlanta, representing Gyrus ACMI,

   Andrew Sciolla of Pogust, Braslow & Millrood in Conshohocken, Pennsylvania, who represents one of the plaintiffs in the morcellator litigation, said the number of potential claimants was probably in the hundreds, but he added that such cases are "very difficult to locate—after the upstaging of the cancer, a lot of these women are in the battle of their lives."

   Sciolla said the morcellator cases are "extremely valuable" and called his own suit "an absolute tragedy of a case here. If it would get before a jury, there's no limit what they would award." He said the defendants' calculation of risk of harm to patients was "one in several thousand" but that turned out to be "terribly inaccurate."

   Michael Gunzberg, the New York lawyer who is co-counsel to Stratis, said the defendants' calculations of risks related to use of morcellators would be a major issue in the case, adding that the industry had represented that one in 10,000 patients in morcellator procedures was at risk, but "apparently it's much greater."

   But in some of the cases, defendants are likely to argue that the surgery didn't make a difference or that some plaintiffs didn't have cancer at all, said Hauser.

   "None of these cases are great cases—all involve women with serious medical issues. None of these are going to be a pleasant case for a jury to contemplate, if it gets that far. But it really varies a lot," Hauser said.

   A spokesman for the FBI in Newark, Mike Whitaker, said the agency does not confirm or deny what investigations it is conducting.

   A Johnson & Johnson spokesman, Matthew Johnson, said the company is “unaware of an active FBI investigation” concerning its morcellator devices. Johnson said the company opposes consolidating cases concerning morcellators made by at least five companies into a multidistrict litigation. “We will defend ourselves against the claims made in these lawsuits,” he said. 

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2. Another act of gynecological maleficence: The Essure Female Sterilization Coil

   Jul 28, 2015 | The Philadelphia Inquirer

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

   On September 24, 2015 the Food and Drug Administration is planning to convene another hearing of the OB/Gyn Device Panel. Again, a harmful medical device in question is a gynecological one – a permanent female sterilization device, known as Essure.
   
   Essure is a system manufactured by Bayer Healthcare - originally approved by FDA in 2002. It consists of a delivery system and nickel-containing permanent coil implants. The coils are placed into each fallopian tube without a skin incision, through the vagina. The nickel in Essure elicits an inflammatory response and tissue in-growth, in theory, over time, causing tubal occlusion leading to sterilization of the woman.
   
   Unlike the gynecological power morcellator, Essure was FDA approved through the Pre-Market Approval (PMA) mechanism. This approval mechanism for medical devices supposedly tests the device for safety and efficacy, prior to FDA approval for marketing. And because the device has supposedly undergone stringent safety testing and FDA review, federal law provides strong legal protections to the manufacturer against liability. In other words, any patients claiming harm by Essure can’t even take their claim to court.
   
   Bayer markets Essure as one the most effective, affordable and convenient means of birth control – ideal for the busy 21st century woman and mother. Of course, the American College of Obstetrics and Gynecology (ACOG) and a large majority of gynecological surgeons endorse this marketing message.
   
   But the trouble with Essure is that since obtaining FDA approval in 2002 it has become clear that beneath the nicely packaged and marketed gloss and convenience, severe hazards lurk.
   
   There are literally thousands of American women fallen to complications following placement of the Essure sterilization coils.
   
   The side-effects of Essure sterilization include severe joint pain, recurrent debilitating headaches, weight gain, chronic fatigue, hair loss, heavy, painful and irregular menstrual bleeding – to name only a few. And these complications are floridly debilitating to the mothers, wives, daughter and sisters who prior to Essure sterilization were healthy young women.
   
   In some cases the women with Essure coils in place have felt so catastrophically debilitated, they have been offered minimally invasive hysterectomies in hopes of removing the coils. Many of these women underwent morcellation as part of their hysterectomy operation. And when the Essure coil is morcellated, bits of nickel are spread all over the abdominal and pelvic cavity – like bits of shrapnel from a grenade.
   
   One would think that with thousands of sterilized women catastrophically debilitated, the ACOG would think twice about offering this potentially dangerous procedure to young and otherwise healthy women. But quite to the contrary, the ACOG endorses this procedure as an efficient and safe means of permanent sterilization.
   
   Here again, we have another example of gynecological surgeons and their major trade group committing maleficence against women.
   
   In many ways, endorsement of this practice by leading gynecologists is being defended and justified using the same arguments these surgeons used to defend the practice of power morcellation.
   
   Specifically, American gynecologists in the year 2015 seem to believe that any procedure with foreseeable harm is justifiable to perform on otherwise healthy women so long as: 1) the “majority benefits” and 2) “women’s right to choose” is preserved - no matter what the consequences to a minority subset of unsuspecting women might be.
   
   This line of reasoning by a group of American physicians is a fully egregious violation of a bedrock medical ethical principle, known as “non-maleficence”.
   
   Of course, gynecological leaders do not appear to see it this way. Many believe and have stated that tubal sterilization using Essure is safe.
   
   But, again we find ourselves asking why the specialty, charged with the health of women, in particular, is capable of accepting catastrophic collateral damage to a minority, unsuspecting and otherwise healthy subset of women.
   
   What is most striking is that the dangers of the Essure female sterilization device are being shielded by the rubric of “women’s reproductive choice”. But this abuse of a hard-won American social value by medical device manufacturers and captains of the gynecological industry in America is a blatant marketing crime.
    
   Of course, it is not difficult to see that the ethical corruption in the gynecological industry’s operation has effectively hijacked the progressive notion of “women’s reproductive health” in America for its business and corporate goals.
   
   So it is, again, that FDA’s Center for Devices and Radiological Health (CDRH) will find itself incapable of making the correct ethical decision to protect the minority subsets of unsuspecting women in harms way – as was the case with the power morcellator. The “fox guarding the hen house” is an apt analogy when it comes to that agency.
   
    So it is, again, that ACOG, and many leading gynecologists, will accept and defend severe harm to minority subsets of unsuspecting women, using the rhetoric of “benefit of the majority” and “patient choice”.
   
   So it is, again, that our federal representatives in congress mistake false-marketing and unethical medical practice by the gynecological industry as being indication of our society’s respect and valuation of “women’s choice”.
   
   We are now confident that a common, and corrupted, denominator underlies the “power morcellator disaster” and the severe harm done thousands of Essure sterilized women: An FDA more committed to industry and streamlined marketing than patient safety and a gynecological industry more committed to its corporate revenue stream than to women’s health.
   
   Why and how can our society tolerate such systemic maleficence committed against women?
   
   The only logical answer is that in the year 2015 the defense and propagation of corporate and industry interests, not the protection of American lives, dominates the practice of medicine, as well as our federal government and her agencies. And this simple fact has and will continue to compromise the health and wealth of our nation.
   
   But, very likely, it is too late for America’s spirit to save herself from corporate tyranny now.
   

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3. Morcellator Cancer Lawsuits Allege Two Pennsylvania Women Developed Cancer Due To Robotic Hysterectomy

   Jul 29, 2015 | Southern Med Law

   Morcellator cancer lawsuits contend laparoscopic power morcellators have the potential of spreading cancer when used during a hysterectomy or myomectomy (removal of uterine fibroids) and lawsuits continue to filed on behalf of women who have developed uterine cancer due to the morcellation device. The most recent morcellator cancer lawsuits to be filed were on behalf two Philadelphia women who assert that morcellator manufacturers, Olympus Corporation and its subsidiary, Gyrus ACMI, misrepresented their products as being safe to use and failed to warn of the cancer risks associated with power morcellators. The claims were filed separately but both are alleging that Olympus’ power morcellators spread undetected uterine cancer in their bodies and the companies failed to design its product to eliminate the cancer risks. The morcellation complaints further allege that Japan-based Olympus should have reasonably known of the dangers associated with their devices.

   “The risk of developing leiomyosarcoma is very real when a woman has a hysterectomy or myomectomy and the women who are filing morcellation lawsuits know all too well about the dangers involved in using power morcellators during these surgeries,” says Dr. François Blaudeau, who recently settled the first morcellator cancer lawsuit against morcellator makers, LiNA Medical APS, Kebomed AG & LiNA Medical US. The complaint was filed on behalf of Pennsylvania resident, Scott Burkhart, whose 53-year-old wife, Donna Burkhart, died of metastatic leiomyosarcoma cancer in 2013, one year after having a robot-assisted hysterectomy with uterine morcellation.

   The law firm notes that laparoscopic power morcellators are used to grind uterine tissue into small fragments during a hysterectomy or myomectomy for removal through small incisions in the abdomen. The morcellator can spread the uterine tissue fragments containing the unsuspected cancer cells into the abdominal and pelvic cavity where the cancer cells may be dispersed throughout a woman’s body. The U.S. Food and Drug Administration (FDA) conducted an analysis and found that the prevalence of unsuspected uterine sarcoma in women undergoing a hysterectomy or myomectomy to remove benign fibroids is 1 in 352 and the prevalence of unsuspected uterine leiomyosarcoma is 1 in 498. The FDA defines leiomyosarcoma as a rare and aggressive form of soft tissue cancer involving smooth muscle cells in the uterine and gastrointestinal areas.
   

   Due to the cancer risks surrounding laparoscopic power morcellators, the FDA issued a strong warning in November 2014 against using the devices for the majority of women who require a hysterectomy or myomectomy, including those who are going through menopause, about to enter menopause, or those who are good candidates for minimally invasive procedures that do not require the use of power morcellators. The FDA directed doctors to share this warning with their patients. The agency also directed power morcellator manufacturers to include a black box warning on their product labels about the cancer risks associated with their devices.

   Court documents indicate that the growing number of morcellator cancer lawsuits has prompted a petition to the U.S. Judicial Panel on Multidistrict Litigation (JPML) for consolidating morcellation complaints. Six plaintiffs involved in power morcellation lawsuits have asked the JPML to transfer 22 morcellator complaints filed in 16 different federal courts across the country, as well as all other subsequently filed morcellator complaints, to the U.S. District Court, District of Kansas for coordinated pretrial proceedings. Court records show that the 22 morcellator cancer lawsuits name Johnson & Johnson’s Ethicon unit as defendants. The JPML has scheduled oral arguments on the petition for October 1.

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