A medical device used in a “safe” alternative to open surgery, the power morcellator has severely endangered women harboring undiagnosed uterine cancer. Entering surgery with no signs of the disease, these patients found themselves suddenly faced with the struggle of advanced cancer just weeks after their operations.
Some of these women and their families are standing up to device manufacturers by filing lawsuits. More than 20 power morcellator lawsuits are currently pending in 16 federal districts nationwide, and at least 300 additional cases are being evaluated.
FDA Issues Morcellator Warnings but Patients Already Affected
Power morcellators are surgical instruments that were frequently used in certain types of hysterectomies and myomectomies until the FDA issued serious warnings about the devices in 2014. According to medical experts, the spinning blade of a power morcellator can spread and “upstage” undetected uterine cancers, significantly worsening a patient’s prognosis.
Though many healthcare companies took action after receiving FDA warnings, thousands of patients had already been exposed to morcellator cancer risks.
Allegations from Morcellator Lawsuits
This exposure was unnecessary and preventable, according to pending morcellator lawsuits. Cancer patients accuse device manufacturers of ignoring 2 decades worth of research discussing the power morcellator’s adverse effects on undiagnosed cancer.
Manufacturers should have heeded the research studies by taking steps such as altering their product designs to increase safety, plaintiffs say. Most lawsuits also state that manufacturers did not sufficiently warn doctors and hospitals about the possible risks.
Patients claim that they were given little information or even misinformed regarding morcellator risk prior to undergoing surgery. Either they were given no indication of the potential of the cancer spreading or were given misleadingly low uterine cancer incidence rates, according to their allegations.
What Kinds of Lawsuits Are Patients Filing?
Most of the current morcellator lawsuits are framed as product liability suits, which means that manufacturers are held responsible for patient damages on the basis of actions or inaction that resulted in their products harming consumers.
In some unfortunate cases, the affected patient died from complications of advanced cancer contracted after power morcellation. In these instances, plaintiffs file “wrongful death” lawsuits, in which they ask for compensation for losses relating to their loved one’s death.
Another form of a lawsuit that morcellator cases can take is medical malpractice, where doctors or hospitals are blamed for the morcellated patient’s ordeal. A possible example where medical malpractice might be filed would be a case in which a patient was diagnosed with uterine cancer prior to a surgery and still received morcellation despite known risks.
Widower Gains Justice
The first federal power morcellator lawsuit was filed in 2014 by Pennsylvania widower Scott Burkhart against device manufacturer LiNA Medical.
Scott states that his late wife Donna had “no signs” of uterine cancer when she underwent a hysterectomy involving a LiNA Medical morcellator in March 2013, received no warning about possible risks, and was diagnosed with advanced uterine cancer shortly after the surgery, dying only 11 months afterward from the disease.
The lawsuit can be categorized both as a product liability and a wrongful death lawsuit. Scott holds LiNA Medical liable for multiple counts of negligence pertaining to the morcellator used in Donna’s surgery and alleges that her untimely death could have been avoided if the manufacturer had acted appropriately to protect patients from the risks of power morcellators.
This lawsuit was resolved in a settlement in June 2015, just before it was scheduled to go to trial. Scott Burkhart reported that he was “glad” to be done with the litigation, as he had mainly filed the suit to raise public awareness about the risks of power morcellators.
Multidistrict Litigation: The Next Step?
Plaintiffs of the 21 still pending power morcellator lawsuits have filed a request for consolidation via a procedure called Multidistrict Litigation (MDL).
MDL is a form of group litigation that can make the processing of multiple similar lawsuits faster and more efficient. Here, we’ll explore how MDL works and why it may be a good option for power morcellator litigation.
What Happens in MDL?
Multiple lawsuits filed in various districts nationwide can be grouped together under MDL if they share important similarities. For example, cases in an MDL might have a list of defendants and/or allegations in common with one another.
If a set of lawsuits are approved for handling under MDL, an MDL number is assigned and all individual cases are transferred to a single federal court for any necessary pre-trial procedures (one widely-known example being “discovery,” in which the plaintiffs and defendants obtain evidence from each other via interrogation and other methods.)
Such group handling of pre-trial events can increase efficiency, because when cases are handled individually, each court needs time to absorb basic background facts and details. But in MDL, the judge of the common court becomes solidly informed after considering several similar cases, saving time for all subsequent ones.
Constituent cases of an MDL remain separate lawsuits. That is, MDL lawsuits do not end in blanket settlement agreements or proceed to trial together. Each one is individually settled, dismissed, or sent to trial back in the court that it was originally filed in.
Is MDL Better for Morcellator Cases than Class Action?
Another common type of group litigation is a class action. In a class action, a single lawsuit is filed on behalf of all individuals who suffered through a situation similar to that described by the plaintiff filing. All potentially affected individuals are part of the class action unless they specifically opt out.
The plaintiff filing the claim is called the “lead plaintiff” and is responsible for representing all members of the class action lawsuit. If a settlement or court award is obtained, most of it generally goes to the lead plaintiff(s), some is reserved for legal fees, and the remaining is divided amongst the rest of the plaintiffs according to a court decision.
The seasoned attorneys at Banville Law consider MDL to be a more sensible choice for handling power morcellator litigation as it currently stands, for two main reasons:
- Power morcellator cases are varied enough that it would be difficult to appoint a lead plaintiff that would adequately represent them all. Examples of possible differences that could impact the ruling of a case include varying patient diagnoses and outcomes.
- The extreme physical, emotional, and financial hardship and loss that patients harmed by power morcellators experience requires significant compensation, which most individual plaintiffs are unlikely to obtain as part of a class action lawsuit.
If you or your spouse contracted an advanced stage cancer after undergoing a hysterectomy or myomectomy involving a power morcellator, you may be able to file a lawsuit and obtain compensation for your pain and suffering.
The best way to determine your eligibility is to schedule a free case evaluation with our skilled, dedicated lawyers. If your case is viable, we can work for you for a contingency fee, which means you owe no payment until we win you a settlement or court award.
Latest Power Morcellator News & Updates
By Laurence P. Banville
September 28, 2017 – Regulatory Decisions For Medical Devices Are Influenced By Patient Preferences
A recent FDA blog discussed their Patient Preference Initiative which was launched in September 2013 which was implemented to assist in the medical device decision-making. Contributors to the blog expressed how the FDA has seen increasing benefits by taking patient feedback. One of the most recent improvements they have seen is with giving more therapy options to kidney patients and strengthening the safe use of glucose monitors for pediatric Type 1 diabetes patients. One of the newest examples that the blog cited was called System One which is created to help determine and establish methods for estimating patient assessment of the benefits and risks of specific devices made for specific illnesses and conditions. This could help in the product review decisions.
August 18, 2017 – New Power Morcellator Clinical Study Draws Criticism For Olympus Inc.
A new 140 patient clinical study has been announced by Olympus Inc. to test the safety and effectiveness of the company’s new version of their power morcellator with a “contained tissue extraction system” to prevent cells from escaping and spreading previously undetected cancer. The new version of the device was developed after several reports and lawsuits were filed stating women developed aggressive and often times deadly cancer when the spinning blades of the morcellator spread previously undetected cancerous cells in patients’ abdomens. The FDA warned doctors and patients of this risk of spreading cancer and use of the original power morcellators decreased for gynecological surgeries. The company now faces criticism over their new study which will be led by gynecologists at the University of North Carolina but is not yet open. Many oppose the study and find it unethical and dangerous for women involved.
July 11, 2017 – JAMA Editorial Cites Power Morcellator Cancer Problem As Need For Better FDA Surveillance
An editorial was recently published in the Journal of the American Medical Association (JAMA) in which Dr. Rita F. Redberg described how she and many medical experts think the FDA needs to do a better job at gathering and using post-marketing surveillance data to ensure that medical devices are safe and effective for patient use. In the editorial, she cited the power morcellator cancer problem as a recent example of the need for improvement in the surveillance area. The fact that the problem wasn’t discovered until after hundreds of women had cancer cells spread when undergoing laparoscopic hysterectomies or uterine fibroid procedures was considered a failure of the FDA by many medical experts. The authors also state that many questions regarding morcellation are not resolved due to the FDA lacking a comprehensive system of data collection.
June 21, 2017 – Olympus Settles Power Morcellator Lawsuit
A power morcellator lawsuit filed by two plaintiffs over the medical device used during one plaintiff’s 2010 hysterectomy will be settled. The plaintiff in this settled case had alleged that use of the device caused her to suffer physical injury which could be permanent and/or fatal and that she could suffer from other diseases or conditions in the future. The lawsuit also cited the 1991 patent application that according to court documents, “describes the potential for laparoscopic power morcellators to disseminate and implant malignant tissue fragments in the body.” An Olympus subsidiary recently agreed to the settlement in which the terms are not disclosed.
May 24, 2017 – High-Risk Medical Devices Without Clinical Trials Are Defended In Editorial
On April 6 The New England Journal of Medicine published an editorial in which FDA officials defended the agency’s decision to allow more flexibility in gathering clinical data for certain medical device approval. The agency recently moved away from double-blind clinical trials to approval certain medical devices in an effort to streamline the approval process. This decision has been under much scrutiny from watchdog groups, and some medical professionals, who fear some medical devices may gain approval without any review. The FDA defended the “21st Century Cures Act” saying that the agency is not abandoning clinical trials but trying to find more flexibility in approving new devices.
April 7, 2017 – FDA May Loosen Regulations On Medical Device Approval Regulations
Early in March, the FDA released a notice which indicated the agency’s intention to allow certain medical devices in Class II to be approved without the need to undergo premarket notification requirements. Before the final determination is made the FDA will accept public comments for 60 days regarding the notice, which opened on March 14. Several patient safety and consumer advocates are concerned that this will make it easier for defective or dangerous products to be released onto the market putting patients at risk.
March 20, 2017 – Study Finds Active Surveillance Of Medical Devices Yields Better Results Than Adverse Event Reports
A new study was conducted, with funding from the FDA, in which the findings were published in the New England Journal of Medicine in January. The findings suggest that active surveillance of medical devices helps to more effectively identify problems rather than relying on the FDA Adverse Event Reporting System. The Data Extraction and Longitudinal Trend Analysis monitored clinical registries and other sources to monitor device called Mynx. By using this type of active surveillance risks were identified within 12 months of beginning the monitoring.
February 9, 2017 – GAO Releases New Report Critical Of Power Morcellators
The Government Accountability Office released a report which focused on the FDA’s approval of power morcellators. The medical devices have been linked to the death of several women who were diagnosed with dangerous cancers after undergoing hysterectomies that used laparoscopic power morcellators to remove uterine fibroids. Representative Louise Slaughter (D-NY) announced the release of the report on February 8th which was very critical of the medical devices. Rep. Slaughter is a part of a bipartisan group which investigated the devices and commissioned the report in 2015.
January 12, 2017 – Woman Who Had Power Morcellator Assisted Hysterectomy Passes Away At 57
A Pittsburgh-area woman who was diagnosed with cancer after undergoing a hysterectomy in 2012 which used a power morcellator has passed away at the age of 57 from the disease. The Brentwood, PA resident had undergone the procedure for the treatment of uterine fibroids and was diagnosed with leiomyosarcoma, a very aggressive and dangerous cancer, only six days later. Her experience is one that contributed to the end of health insurance coverage in three states for power morcellator assisted gynecological surgeries. The surgical tool has been linked to the possible spread of cancer when the tool’s blades shred the uterine tissue which could contain previously undetected cancer cells. The woman passed away in her home surrounded by her family.
December 12, 2016 – FDA Plans Meeting To Improve Reporting On Medical Devices
The FDA has planned a meeting on Monday to come up with different ways to improve the reporting system which hospitals should use to report when medical devices cause serious injury or death. The FDA stated that many hospitals do not file the required reports and this error was highlighted in a Wall Street Journal article in late 2013, revealing the dangers of using power morcellators which could spread undetected cancer cells. The FDA is looking to streamline and modernize the system.
November 15, 2016 – After FDA Morcellator Warning, Myomectomies Decline
The FDA issued a safety communication warning against the use of power morcellators during myomectomies and hysterectomies due to the risk of spreading previously undetected uterine cancer. A new study reported at the American Society for Reproductive Medicine 2016 Scientific Congress shows a steep decrease in both laparoscopic and abdominal myomectomies. Prior to the communication 1,823 women were reported to have undergone the procedure and after the communication only 659 women underwent the procedure, equaling a 63.9% overall decrease.
October 4, 2016 – Medical Device Safety Hearing Requested By Representative Mike Fitzpatrick
Representative Mike Fitzpatrick asked Congress on September 23rd for a medical device hearing with the hope of updating the current device safety laws. Laparoscopic power morcellators and permanent birth control device Essure are just two of the devices focused on in his mission to revise device safety laws which he states were mostly written in the 1970s. He stated “Many medical devices prove lifesaving, however, some devices are having devastating effects on patients. . . “
September 20, 2016 – Power Morcellator Lawsuit Filed In Wisconsin
A female plaintiff has filed a product liability lawsuit against Johnson & Johnson’s Ethicon in the U.S. District Court for the Eastern District of Wisconsin. The plaintiff’s complaint alleges that the power morcellator used during her laparoscopic hysterectomy disseminated previously undetected uterine sarcomas throughout her body causing the aggressive cancer to spread rapidly. The plaintiff’s surgery occurred in November 2008 and she claims that by April of the following year she had already completed several rounds of chemotherapy but developed three large masses in her abdomen and pelvis, indicating that the cancer had continued to rapidly spread. Her suit claims the manufacturers failed to adequately warn of the risk of developing cancer when the tool is used during a laparoscopic hysterectomy.
August 24, 2016 – No Increase In Hysterectomy Complications Found After Power Morcellator Use Declines
After several FDA warnings that power morcellator use in gynecological surgeries could spread previously undetected cancer and greatly advance the disease, the use of the medical devices drastically declined. In 2014, Johnson & Johnson, the largest producer of the products, suspended the sale of the devices. According to research published this week in the Journal of the American Medical Association, despite the decline in the use of morcellators, which were designed to create a minimally invasive surgery option for women, the number of hysterectomy complications has not risen. In fact, the total number of abdominal hysterectomies even rose without an increase in the number of complications.
April 29, 2016- Container Bag For Some Power Morcellator Procedures Approved By FDA
The Food and Drug Administration (FDA) has approved a first-of-its kind tissue container bag that is to be used in specific laparoscopic power morcellator procedures. The purpose of this container bag is to isolate uterine tissue that is not suspected to be cancerous. The approval comes through a de novo classification process.
March 31, 2013- The Beginning Of Power Morcellator Cancer Lawsuit Settlements
Johnson and Johnson has started to settle lawsuits filed by women who allege that the surgical device, power morcellator, manufactured by the company, spread undetected uterine cancer. There are about thirty-one morcellator lawsuits pending since March 15, 2016, in federal court against Johnson & Johnson’s Ethicon unit before Judge Kathryn H. Vratil in Kansas. A combination of these cases, as well as new cases that are waiting to be filed, moves the number to almost 100 power morcellator lawsuits.