Morcellation Media Monitoring 10/5/2015

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

Morcellation

1. Our Personal Meeting with the FDA Leadership, 10/1/2015

   Oct 2, 2015 | Change.org

   By Hooman Noorchashm
   
   
   Yesterday, 10/1/15, Amy and I met with the FDA's director for the Center for Devices and Radiological Health (CDRH). The following is a letter we sent the CDRH and FDA leadership following the meeting. Please read with care:
2. Ethicon Plaintiffs' Attys Grilled On MDL Consolidation

   Oct 1, 2015 | Law360

   By Cara Salvatore
   
   
   A panel of federal judges grilled plaintiffs’ lawyers Thursday about the benefits of consolidating product liability lawsuits over a gynecological medical device, saying their decision could have serious consequences for patients who may not live through the end of their trials.
3. Power Morcellator Lawsuit Update: MDL Debated In Court

   Oct 2, 2015 | The Legal Herald

   By Laurence Banville
   
   
   A panel of federal judges will determine if power morcellator plaintiff's motion to consolidate is the right course of action. On October 1st, 2015 a panel of federal judges listened to arguments from both plaintiffs and defendants in numerous power morcellator lawsuits. Ultimately the panel will decide whether or not all federally-filed complaints should be consolidated into a Multidistrict Litigation (MDL).
4. Morcellator Cancer Lawsuits Await Courts Decision To Consolidated Uterine Cancer Claims

   Oct 1, 2015 | Southern Med Law

   Attorneys for Southern Med attended a hearing for morcellator cancer lawsuits today. The hearing was to decided whether to consolidate the 22 power morcellation complaints. The morcellator cancer lawsuits were filed women or their surviving family members involved who believe they developed advanced leiomysarcoma or uterine cancer after undergoing laproscopic hysterectomies or myomectomies using morcellation that caused the cancer to spread.
5. GAO to Investigate Dangers of Power Morcellators

   Oct 1, 2015 | The Legal Examiner

   By Steven Davis
   
   
   The U.S. Government Accountability Office (GAO) has announced that it plans to begin an investigation into power morcellators, the controversial medical devices that shred uterine fibroid tissue for easy removal through laparoscopic incisions. Critics of morcellators say they endanger women’s lives and therefore should be banned because they also spread and worsen hidden cancers.
6. The Growing Scope of the FDA Warnings about Power Morcellators

   Oct 2, 2015 | US Recall News

   The FDA first issued a warning about the use of power morcellators in hysterectomy and myomectomy procedures in April 2014 and then expanded and clarified it in Sept 2014. Since that time there have been growing voices of disquiet against the devices, with the first lawsuits being filed in Pennsylvania in March 2014, and up to two dozen cases pending in federal court as of July 2015, according to Trial Magazine.

Full Text of Stories Below

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

Morcellation

1. Our Personal Meeting with the FDA Leadership, 10/1/2015

   Oct 2, 2015 | Change.org

   By Hooman Noorchashm

   Yesterday, 10/1/15, Amy and I met with the FDA's director for the Center for Devices and Radiological Health (CDRH).

   The following is a letter we sent the CDRH and FDA leadership following the meeting. Please read with care:

   Dear Mr.Desta, Dr. Lurie and members of the CDRH,

   On behalf of myself, my wife and our two daughters, Nadia and Ava, please accept our thanks for organizing our meeting yesterday with CDRH director Dr. Shuren.

   It was unfortunate that Dr. William Maisel, CDRH's chief scientist, was unable to join this meeting given his key role in the FDA action taken regarding the power morcellator.

   We've had some time to reflect on Dr. Shuren's comments and outlook on the CDRH regulatory process vis a vis patient safety and the medical ethical duties owed to every patient in the United States.

   Based on Dr. Shuren's comments yesterday, it was abundantly clear that the CDRH director does not believe there to be a patient safety concern with the agency's predominant regulatory mechanism, the 510(k). Furthermore, director Shuren appears satisfied that the action taken following the morcellator disaster's public revelation is sufficient proof that the FDA process is "working well".

   But, as we asked pointedly "How can you say it is working and it is safe if for over twenty years a device is harming and killing people and FDA does not even know about it?"

   We came to the unfortunate and inevitable conclusion that the CDRH director is not seeing the public health hazard posed by 510(k) and that he is, at best, approaching the problem he confronts theoretically and from the perspective of industry's needs to get "innovative and life-saving devices" into market efficiently. But, as we have mentioned before, the FDA is a federal agency whose only purpose is to protect the health of the people of the United States, not the health and lubrication of industry.

   You motto is "Protecting and Promoting YOUR health". It is NOT "Protecting and Promoting Industry Health and Streamlining".

   On the basis of our observations, and many other patient advocates', we look forward to Dr. Shuren's voluntary resignation as director of the CDRH in the near future - because we know that his complacency on the severe patient safety hazard posed by the CDRH process will lead to more unsuspecting American casualties with a FDA labels attached.

   Of course, we understand that this is a difficult perspective for Dr. Shuren to accept - however, we hope not to have to demonstrate the CDRH's systemic failures that have led to the loss of life across the United States in an upcoming public forum in congress. We are poised to do so, and vocally, if and when necessary.

   Next, we wish to reiterate the need for FDA to immediately investigate the violation of section 803 of CFR 21 by the Brigham and Women's Hospital (Boston, MA), by Johnson & Johnson's Ethicon subsidiary and by Karl Storz Company.

   Next, we wish to reiterate that the FDA must immediately move to ban the power morcellator device in light of the complication and death of Ms. Viviana Ruscitto (NY) and Ms. Avelina Greenfield (IL).

   Next, we wish to reiterate that there is no way to ethically subject a morcellation containment bag to a clinical trial. We ask that the CDRH seek the guidance of third party public health experts and bioethicists in determining if such safety testing to demonstrate the oncological safety of morcellation bags is feasible in people. We do not believe such trials will pass ethical muster.

   Next, we wish to inform the CDRH that suspension of the PMA status of the Essure coils is an immediate responsibility of your agency. This PMA was issued without adequate safety testing regarding the potential allergic and hypersensitivity reactions to Nickel. Moreoever, there is some rather clear evidence of data tampering in some subjects. As such, the PMA status of this device is invalid (and potentially fraudulent), yet it is functionally eliminating the "Essure harm" women's civil right to seek justice in courts across the United States.

   Finally, we recognize that this is a rather difficult time in CDRH history - but you are confronted with two severe points of failure (Power morcellators and Essure). These cannot be ignored any longer, nor is it sufficient for anyone at the CDRH helm to claim that reactive measures in the case of these devices are evidence that the agency is functioning adequately. The power morcellator was harming and killing for over twenty years and the Essure coil have been harming women for over 10 years.

   Mr. Desta, Dr.Lurie and members of the CDRH, enough is enough. It is time for the CDRH leadership to be reformed so our congress can get an accurate picture of how public health is being threatened by one of our own federal government's agencies.

   Yours sincerely,

   Hooman Noorchashm MD, PhD

   Amy J. Reed MD, PhD.

   Return to headline | Return to top

2. Ethicon Plaintiffs' Attys Grilled On MDL Consolidation

   Oct 1, 2015 | Law360

   By Cara Salvatore

   A panel of federal judges grilled plaintiffs’ lawyers Thursday about the benefits of consolidating product liability lawsuits over a gynecological medical device, saying their decision could have serious consequences for patients who may not live through the end of their trials.
   
   Paul Pennock, a plaintiffs’ lawyer representing 29 women who say the power morcellators made by Ethicon Inc. and others may have actually spread cancer around their bodies, asked the Judicial Panel on Multidistrict Litigation in a Manhattan courtroom hearing to group the suits together in a multidistrict litigation in the interest of efficiency.
   
   But lawyers for Ethicon and smaller manufacturers Karl Storz Endoscopy America Inc. and Gyrus ACMI LP, which are also defendants in some of 38 total suits that could be consolidated, said they involve vastly different issues by a number of metrics, and the judges seemed to agree.
   
   “You’ve got 29 women in 29 surgeries, you don’t even know what product was used in lots of them,” U.S. District Judge Catherine Perry said.
   
   “Do you expect similar experts for all of the devices?” U.S. District Judge Ellen Huvelle asked a minute later. The answer was no.
   
   Still later, U.S. District Judge Lewis Kaplan nodded to the many ways of dividing the suits, asking incredulously if attorneys were aiming to “slice the MDL according to the way the defendants are going to defend.”
   
   Meanwhile, JPML chair Sarah Vance, a federal judge in Louisiana, returned again and again over the course of the panel’s 45 minutes with the morcellator cases to the risk that plaintiffs would die while waiting for an MDL to progress. The group under consideration for consolidation does involve some patients that don’t have cancer.
   
   “What’s going to happen if we form an MDL? All those benign cases are going to end up in that case,” Judge Vance said. “If you have cancer, you want to get a jury verdict as soon as possible.”
   
   The U.S. Food and Drug Administration in November 2014 put out a guidance warningthat laparoscopic power morcellators may spread cancer and shouldn't be used in gynecological surgery that involves cancer or fibroids.
   
   The communique was a sharp warning against the morcellators, gynecological tools used to perform hysterectomy or uterine fibroid removal. The FDA said that uterine tissue may contain unsuspected cancer and that using the morcellators may spread the cancer and decrease long-term patient survival.
   
   The controversy over the tool's danger prompted Johnson & Johnson unit Ethicon to execute a worldwide recall of its Morcelex brand devices in July 2014 after suspending sales of the devices that April.
   
   Morcellators break targeted tissue into fragments that can be removed through an incision in the stomach, according to the FDA.
   
   Of the 500,000 hysterectomies performed every year, about 11 percent are done using this method, according to the FDA.
   
   Although uterine fibroids are common and usually benign, about 1 in 350 women undergoing a hysterectomy or fibroid removal have an unsuspected uterine sarcoma, a type of uterine cancer, according to the agency.
   
   In May 2014, Ethicon was hit with the first suit over the product in New York federal court. Plaintiffs Brenda Leuzzi and George Leuzzi claim that Brenda Leuzzi was diagnosed with cancer after undergoing a robot-assisted hysterectomy with morcellation in 2012 and that the company did not adequately test its Morcelex product for potentially dangerous side effects.
   
   Later, Peggy Paduda of Florida sued Karl Storz after doctors used a morcellator to remove fibroids from her uterus, which allegedly spread endometrial stromal sarcoma, a type of cancer, throughout her abdomen.
   
   The case is In re: Power Morcellator Products Liability Litigation, MDL Number 2652.
   

   Return to headline | Return to top

3. Power Morcellator Lawsuit Update: MDL Debated In Court

   Oct 2, 2015 | The Legal Herald

   By Laurence Banville

   A panel of federal judges will determine if power morcellator plaintiff's motion to consolidate is the right course of action. On October 1st, 2015 a panel of federal judges listened to arguments from both plaintiffs and defendants in numerous power morcellator lawsuits. Ultimately the panel will decide whether or not all federally-filed complaints should be consolidated into a Multidistrict Litigation (MDL).
   
   Why Consolidate?

   The plaintiffs are arguing that allpower morcellator lawsuits should be moved to the U.S. District Court for the District of Kansas under the Hon. Kathryn H. Vratil. The motion to consolidate indicates that the request is being made because “the complaints all assert product liability claims against Defendants based on allegations that the use of a Power Morcellator device during a laparoscopic hysterectomy or myomectomy for the removal of uterine fibroids can and did cause the dissemination and upstaging of occult cancer or the development of recurrent parasitic fibroids,”. 
   
   The motion also argues that it will save each plaintiff and their families time and money because without consolidation each discovery will be on an individual basis and essentially duplicate.
   
   The Argument Against Consolidation

   Four morcellator manufacturers have filed responses to the motion to consolidate: Johnson & Johnson, Karl Storz GmbH, Richard Wolf GmbH, and Gyrus ACM. These companies are arguing that consolidation would not actually expedite the process since there are so many manufacturing companies named in the lawsuits. 
   
   The Power Morcellator

   Around 30 lawsuits have been filed at this time against power morcellator manufacturers, each one alleging that the use of a morcellator during a gynecological surgery spread undetected uterine cancer.
   
   The investigation into the risks associated with morcellation has gained momentum ever since the first morcellator lawsuit was filed in March 2014. The U.S. Food and Drug Administration released a safety warning soon after this complaint was filed, urging surgeons to reconsider using the morcellator on women being treated for uterine fibroids.
   
   The FDA reported that they had estimated 1 in 350 women undergoing hysterectomies or myomectomies to treat uterine fibroids would also have undiagnosed uterine cancer. Due to the encapsulating nature of the fibroids, there is still no testing available that can accurately determine if a fibroid contains uterine cancer. 
   
   Recently the U.S. Government Accountability Office announced that it would be performing an investigation into the process through which the FDA approved the power morcellator in 1991.
   

   Return to headline | Return to top

4. Morcellator Cancer Lawsuits Await Courts Decision To Consolidated Uterine Cancer Claims

   Oct 1, 2015 | Southern Med Law

   Attorneys for Southern Med attended a hearing for morcellator cancer lawsuits today. The hearing was to decided whether to consolidate the 22 power morcellation complaints. The morcellator cancer lawsuits were filed women or their surviving family members involved who believe they developed advanced leiomysarcoma or uterine cancer after undergoing laproscopic hysterectomies or myomectomies using morcellation that caused the cancer to spread.

   The attorneys at Southern Med Law has been fighting for the rights of women who are believed to be morcellator cancer victims even before the FDA acted to warn the public about its potential danger. The Firm’s founder, Dr. François Blaudeau, serves as Lead Counsel in what was the first morcellator cancer lawsuit filed in a U.S. court. The lawsuit was filed against LiNA Medical APS, Kebomed AB & LiNA Medical US on behalf of a Pennsylvania widower and was scheduled to go to trial this November in the U.S. District Court, Eastern District of Pennsylvania, but was recently settled for an undisclosed amount. (Case No. 5:14-cv-1557, E.D. Pa., Allentown)

   “The U.S. Judicial Panel On Multidistrict Litigation heard oral arguments today on consolidating power morcellator lawsuits for coordinated pretrial proceedings but it will be two weeks before we know the panel’s decision,” says Dr. François Blaudeau of Southern Med Law, who attended the hearing.

   Laparoscopic power morcellators have spinning blades that shred uterine tissue into fragments so the tissue can be removed through small incisions in the abdomen. The tissue, however, may contain undetected cancer cells. These cancer cells can travel to various parts of a woman’s body if the morcellated fragments are left in the abdominal and pelvic area or attach to surrounding organs. Once implanted, the morcellated fragments begin to grow. The FDA estimates that approximately 1 in 350 women undergoing a hysterectomy or myomectomy for fibroids have an unsuspected type of uterine sarcoma, that includes leiomyosarcoma, a rare and aggressive form of cancer. According to the FDA, the prevalence of unsuspected uterine leiomyosarcoma is 1 in 498.

   In April 2014, the FDA issued the first of two warnings regarding uterine morcellation and advised doctor not to use power morcellators for uterine surgery. The FDA also recommended that morcellator manufacturers add a black box warning that states using laparoscopic power morcellators during fibroid surgery may spread cancer and decrease the long-term survival of patients. Shortly after the FDA’s warning, Johnson & Johnson, the largest manufacturer of laparoscopic power morcellators, suspended sales of new morcellators and pulled its devices off the global market. According to the Wall Street Journal, Johnson & Johnson sent letters to its customers asking them to return the morcellators. The FDA issued a stronger warning in November 2014, that all but banned the use of laparoscopic power morcellators in the majority of women undergoing a hysterectomy or myomectomy.
   [wsj.com/articles/johnson-johnson-to-call-for-voluntary-return-of-morcellators-1406754350, July 30, 2014]
   [fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm424443.htm, November 24, 2014]

   The firm continues to offer free legal evaluations to women and their families who have developed leiomysarcoma or uterine cancer after undergoing a laparoscopic hysterectomy. Contact Southern Med Law today to learn more about your legal rights and filing a power morcellator lawsuits. Call the office directly at 205-547-5525 or visit www.southernmedlaw.com for more news and information.

   Southern Med Law is a full service law firm representing men and women across the country. Led by Dr. François Blaudeau, the legal staff at Southern Med Law possesses a deep understanding of the complex medical and legal questions at issue in all manner of product liability and personal injury claims. They’re not afraid to take on the nation’s largest corporations in their pursuit of justice, and are committed to ensuring that all victims have access to the type of aggressive legal representation that assures success.

   Return to headline | Return to top

5. GAO to Investigate Dangers of Power Morcellators

   Oct 1, 2015 | The Legal Examiner

   By Steven Davis

   The U.S. Government Accountability Office (GAO) has announced that it plans to begin an investigation into power morcellators, the controversial medical devices that shred uterine fibroid tissue for easy removal through laparoscopic incisions. Critics of morcellators say they endanger women’s lives and therefore should be banned because they also spread and worsen hidden cancers.

   FDA Warnings Regarding Morcellators – What Took So Long?

   In April 2014, the U.S. Food and Drug Administration (FDA) issued a warning against using power morcellators for hysterectomies and myomectomies in most women with uterine fibroids because of the risk of spreading undetected cancer present in 1 of every 350 women undergoing these procedures. In October 2014, the FDA ordered that a Black Box warning be added to morcellators.

   Last month, 12 congressmen sent a letter to the GAO, asking the agency to investigate why the FDA took so long to issue these warnings, given that morcellators have been on the market since 1991 and numerous studies have established the high risk they pose for spreading uterine cancer. The lawmakers are also questioning whether the expedited 510(k) approval process used by the FDA to clear the power morcellator missed the cancer risk of the device before it was approved. The FDA has said that the magnitude of the risk associated with morcellation wasn’t known until the issue came to light in late 2013, when the agency began researching how the devices could harm women.

   Morcellators Falling Out of Favor, But Still Used

   Since the FDA issued that first warning about power morcellators in 2014, use of the device has fallen, and one manufacturer, Johnson & Johnson, voluntarily pulled its morcellators off the market. Many major insurers have either dropped or restricted coverage of procedures involving morcellation, and as a result, fewer surgeons are using the devices. The power morcellator is blamed for hundreds of deaths and is the subject of numerous lawsuits pending across the U.S.

   Return to headline | Return to top

6. The Growing Scope of the FDA Warnings about Power Morcellators

   Oct 2, 2015 | US Recall News

   The FDA first issued a warning about the use of power morcellators in hysterectomy and myomectomy procedures in April 2014 and then expanded and clarified it in Sept 2014.

   Since that time there have been growing voices of disquiet against the devices, with the first lawsuits being filed in Pennsylvania in March 2014, and up to two dozen cases pending in federal court as of July 2015, according to Trial Magazine.

   It is worthwhile to re-visit the two original FDA warnings to see how the scope expanded even in just the six months between the two dates when they were issued, to get a flavor for how this issue is likely to mushroom over the coming years.

   The first key difference is in the audiences to which the warnings were targeted. The original April 2014 update targeted the following medical specialties: Internal Medicine, Pathology, Obstetrics/Gynecology, Nursing and Oncology. While the September warning added in Obstetrics/Gynecological Surgery and also, crucially, General Surgery into the mix.

   General Surgery is a specialty that focuses on the content of the abdomen, including the liver, stomach, pancreas, esophagus, small bladder, bile ducts and gall bladder. As well as some diseases of soft tissue, breast and skin. In effect then it covers a massive amount of medical ground. According to CDC statistics, for example, there were 6,027,000 operations carried out on the digestive system in 2010, which is over 12 times the number of hysterectomies. So its inclusion on the September 2014 FDA warning would seem to indicate that the FDA is anticipating the issue of the safety of power morcellators to spread much more widely than they had originally anticipated.

   This ‘upgrading’ of the potential risk is also evident when you compare the stated ‘purpose’ of the two warnings.

   In April 2014 the FDA had the statement as:

   “Based on currently available information, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.”

   But by September 2014, this had been upgraded to:

   “The FDA is warning against using laparoscopic power morcellators in the majority of women undergoing hysterectomy or myomectomy for uterine fibroids.” (My highlights)

   The scope of the problem has clearly been considerably expanded in the eyes of the FDA, despite the fact that the original figures of 1 in 350 women undergoing those two procedures being affected has remained unchanged.

   This concern though is understandable, given that both of these procedures are very common, with around half a million hysterectomies performed every year in the United States, of which 11% are said to have been performed with the help of a power morcellator. So even a very low statistical number of problems, can equate to potentially thousands of women being adversely affected in the real world.

   The September warning also added in two new contraindications that hadn’t been mentioned in April. As well as a new box warning for the devices to say that uterine tissue could contain unsuspected cancer.

   More recently, in August 2015, 12 members of Congress sent a letter to the Comptroller General of the United States, Gene Dodaro, requesting further investigation. They opened up their letter with this line:

   “Hundreds, if not thousands, of women in America are dead because of a medical device known as a laparoscopic power morcellator.”

   We have not heard the last of this issue.

   Return to headline | Return to top

Full Text of Stories Below