Matthews & Associates Law Firm is reviewing Laparoscopic Morcellator Lawsuits nationwide for women who were diagnosed with uterine cancer, including leimyosarcoma (LMS) or other types of cancer following a hysterectomy or fibroid removal which employed a power morcellator.
An estimated one of every 350 women undergoing a hysterectomy for removal of the uterus or uterine fibroids may have an undiagnosed sarcoma, which doctors cannot detect prior to the surgery. Additionally, they estimate that one in 500 women has an aggressive form of cancer called leiomyosarcoma (LMS). Laparoscopic power morcellators used in such cases can lead to serious problems.
Some doctors decry the latest FDA morcellator warning. At least 48 doctors decry an FDA morcellator warning for laparoscopic surgeries. The doctors – the self-described ‘Leiomyoma Morcellation Review Group’ – have proclaimed that the FDA erred in its warnings over power morcellators. In April 2014, the FDA first discouraged the use of power morcellators for minimally invasive surgery in women with uterine leiomyomas. The agency then wrote:
“Based on currently available information, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.”
Then FDA strengthened its power morcellator position to a warning on Nov. 24, 2014, writing:
“The FDA is warning against using laparoscopic power morcellators in the majority of women undergoing hysterectomy or myomectomy for uterine fibroids. Health care providers and patients should carefully consider available alternative treatment options for the removal of symptomatic uterine fibroids.”
A Mississippi woman filed a Bard IVC filter case in U.S. District Court in the Northern District of Mississippi, Oxford Division. Tonya Munson’s case against C.R. Bard was originally filed Dec. 31, 2014. (See: Munson v. Bard.) The plaintiff is from Sara, Mississippi, in Tate County.
Unlike the U.S., where industry calls the shots and regulators mostly abide with business, the Scottish government has moved to regulate transvaginal or pelvic mesh treatment options offered to women with pelvic organ prolapse and stress urinary incontinence.
The UK Daily Record reported this week that three of four mesh procedures used routinely in Scottish hospitals will no longer be recommended by doctors. Scotland seems truly interested in protecting women at the expense of mesh makers, rather than the other way around, U.S. style.
DALLAS – Mesh News Desk reported that plaintiff’s expert Dr. M (name withheld to avoid red herring arguments from defense counsel) continued to testify for a second day, September 29, 2015. It would be the final day of the Plaintiff’s case in Cavness v. Ethicon (Cavness v. Kowalczyk et al., case # DC-14-04220).
A California urogynecologist and mesh removal expert, Dr. M continued his testimony about the pelvic mesh implanted in the plaintiff. He opined that the pain she continues to experience three years after her April 2012 implant is the same chronic pain felt by thousands of other women with pelvic mesh implants.
Day 6 – Sept. 28, 2015 – of the latest trial against Ethicon in Dallas brought testimony from Dr. M (name withheld to prevent defense lawyers’ red herring arguments), a urogynecologist from the San Francisco bay area, double board certified in Ob-Gyn and Urogynecology. Dr. M testified that he has done more than 25,000 surgical procedures, including 5,000 to 6,000 for stress urinary incontinence and the rest – some 14,000 – related to POP (pelvic organ prolapse). He also performs about six surgeries a week to remove plastic mesh from women.
Note: Much of this story comes from Mesh News Desk.
Day two in the latest pelvic mesh trial in Dallas brought evidence from the plaintiff’s attorneys that Johnson & Johnson and Ethicon executives identified red flags during the development of the Prosima pelvic mesh, yet chose to put the product on the market anyway. It was later withdrawn after problems continued and the FDA called for safety testing.
Readers are cautioned and advised that the plaintiff’s lawyers get to present the plaintiff’s side first; then the defense gets to present its case. Defense attorneys made many objections to the release of the internal Ethicon emails below, which were entered into evidence in this case.
The Cook Group Inc. faces at least 100 lawsuits over its blood clot filters. Patients from around the country have filed lawsuits against the Bloomington, Indiana-based Cook. Lawsuits allege the company’s blood-clot filters have broken apart, migrated and/or perforated the inferior vena cava, the blood vessel in which where they are implanted. The inferior vena cava brings blood from the lower body back to the heart; the filter is designed to keep blood clots from reaching the lungs.
Begun in 2012, the Cook litigation has recently been consolidated in federal court in Indianapolis.
The Journal of the American Medical Association pointed out in March 2013 that IVC blood clot filters are widely used despite a dearth of efficacy evidence. Some 250,000 Americans get a Bard IVC filter or some other blood clot filter implanted in their chests each year, despite the fact that such implantations have shown evidence of harm without evidence of benefit.
JAMA asks, “How could a medical device be so well accepted without any evidence of efficacy?” Answers to that question show the deplorable state of medical device safety testing and monitoring in the U.S.