Morcellator Cancer Lawsuit Filed By Southern Med Law Contends That Ethicon Inc. Failed To Warn The Plaintiff’s Wife And Her Doctor About The Cancer Risks Associated With The Surgical Device.
Southern Med Law, which is representing women in uterine morcellation lawsuits, has filed a wrongful death complaint on behalf of a South Carolina man whose wife died allegedly as a result of having uterine morcellation surgery. According to the complaint, the woman underwent a total laparoscopic robotic hysterectomy and cystoscopy for menometrorrhagia and fibroid conditions on October 2, 2012. All reasonable and standard procedures for detecting cancer were performed prior to the surgery and no cancer was detected in her, the complaint said. A morcellator, made by Johnson & Johnson’s Ethicon unit, was used in the surgery, and after the surgery, the woman was diagnosed with leiomyosarcoma cancer, according to the complaint. The morcellation lawsuit claims that the morcellator upstaged the leiomyosarcoma cancer; the woman died from the injury on September 25, 2014. The morcellation complaint, which names Ethicon as a defendant, purports that the company failed to properly warn of the cancer risks associated with the surgical tool. (6:15-cv-00516, U.S. District Court, District of South Carolina)
“As the lawsuit states, Ethicon had a duty to provide the plaintiff’s wife and her doctors, as well as other women and their physicians, true and accurate information regarding its power morcellator. As a result of the defendant’s breach of duty, the morcellator was unsafe to use and she died because of it,” says Southern Med Law’s founder, Dr. François Blaudeau, who filed the first morcellation lawsuit in the United States. Dr. Blaudeau is serving as Plaintiff’s Lead Counsel in a case in which a 53-year-old Pennsylvania woman died of metastatic leiomyosarcoma cancer in February 2013, one year after having a robot-assisted hysterectomy with uterine morcellation. (Case No. 5:14-cv-1557, U.S. District Court, District of Pennsylvania)
As stated in court documents and by the U.S. Food and Drug Administration (FDA), laparoscopic power morcellators are used in minimally invasive surgeries, such as hysterectomies or to remove uterine fibroids. According to the FDA, morcellation refers to dividing the uterine tissue into smaller pieces to make it easier to remove the tissue through small incisions in the abdomen. Unsuspected cancer cells spread the tissue when it is removed through the incision sites.
The FDA estimates that about 1 in 350 women undergoing hysterectomy or myomectomy for the treatment of fibroids is found to have an unsuspected uterine sarcoma, a type of uterine cancer that includes leiomyosarcoma. Additionally, there is no reliable method for predicting or testing whether a woman with fibroids may have a uterine cancer, according to the FDA.
[fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm424443.htm, November 24, 2014]
Southern Med Law notes that national health insurance companies have stop covering hysterectomies and myomectomies that use power morcellation. Aetna Inc. was the latest health insurer to announce in May that it would end routine coverage of the gynecological procedures due to the cancer risk associated with power morcellators. Additionally, UnitedHealth, the nation’s largest health insurer, decided earlier this year to restrict coverage of uterine morcellation surgeries. Under the policy that took effect in April, the health insurer will not provide coverage for laparoscopic or abdominal hysterectomies unless doctors get preauthorization. Doctors who do not receive preauthorization will have their claim denied and they will not be allowed to bill patients for the surgery, according to the new policy.
[money.cnn.com/2015/02/27/news/companies/unitedhealth-hysterectomies/, CNN February 27, 2015]
The law firm explains that the health insurance coverage changes were made in the wake of warnings by the FDA about using laparoscopic power morcellators in minimally invasive procedures. The FDA issued its strongest warning in November 2014 when it said that laparoscopic power morcellators should not be used for the vast majority of women who require a hysterectomy or myomectomy (fibroid removal), 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.
About Southern Med Law
Southern Med Law is a patient and consumer advocacy organization providing legal representation to the victims of negligent personal injuries, medical malpractice, dangerous drugs, faulty medical devices and defective products. Led by Dr. François Blaudeau, an attorney and a practicing obstetrician/ gynecologist, 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 advocacy that assures success.
Southern Med Law
Southern Institute for Medical and Legal Affairs
2224 1st Ave., North
Birmingham, AL 35203
Phone: (205) 547-5525
Fax: (205) 547-5526