Products Liability
The FDA has warned that power morcellators, a surgical tool used in laparoscopic hysterectomies, may help spread uterine cancer. Victims have already filed a lawsuit against Ethicon (Johnson & Johnson) and other morcellator manufacturers.
Miller & Zois is investigating product liability claims on behalf of women who have been diagnosed with uterine sarcoma, leiomyosarcoma, or any other cancer following the use of a morcellator to remove uterine fibroids. If you have uterine cancer and have had a hysterectomy, you may have legal options. To learn about those options, call 800-553-8082 or get a free on-line consultation.
Power Morcellators Can Spread Cancer Cells
Power morcellators are surgical devices with blades that have long, tube-shaped blades. These blades slice up uterine fibroids into small fragments so they can be removed though the patient’s stomach. Women often chose this procedure because it was less invasive and it did not leave a traditional surgical scar.
The problem is that doctors can’t check to see if uterine fibroids have cancerous cells. If a fibroid does contain cancer cells, the cutting of the uterus with the morcellator will cause cancer cells to spread throughout a woman’s abdomen and pelvic area which poses an extremely serious risk to a woman’s health.
A Warning of the Risk to Doctors and Patients Would Have Made a Difference
Doctors have known since the late ’90s that tissue fragments are left behind when using a morcellator. While they could have tried to contain the tissue using a surgical bag, surgeons never really believed it was worth the trouble because they have believed that the risk was low.
Had doctors and patients known of the risk, they might have considered a traditional hysterectomy because it completely removes the uterus and fibroids. A warning from the power morcellator manufacturers would have given doctors and patients a real choice.
But did the manufacturers know of the risks? They either knew of the cancer risk or should have. Johnson & Johnson certainly did. In 2006, a pathologist specifically wrote to J&J (through a subsidiary, Ethicon) and laid out everything we just did above and concluded that a classic hysterectomy was safer. So J&J knew.
Next question: if they had issued a warning would doctors and patients have listened or would they have continued to keep using morcellators? We have the answer to that now. After the FDA alert, hospitals dropped morcellators in droves.
The FDA Safety Alert in April, 2014
In April, federal regulators advised surgeons to stop using morcellators because of the risk of spreading cancer. In July, an FDA Advisory Committee will convene in Bethesda to figure out what further steps need to be taken. The FDA warned doctors that potentially 1 in 350 women get a hysterectomy using a power morcellator procedure and they might have had their undiagnosed cancer spread by the morcellator.
The FDA also had some important words for women who have had a hysterectomy or myomectomy for fibroids with a morcellator: make sure you have routine follow-ups with your doctor.
It is worth nothing that the FDA has been sleeping on this issue for years. What woke them up? According to the chief scientist at the FDA’s Center for Devices and Radiological Health, what woke them up was media articles. What? Our watchdogs are tracking epidemiological risk by reading the newspaper?
This is an important point because these morcellator manufacturers are going to hide behind “FDA approved” like it is some gold standard. But the FDA is clearly leading from behind on this issue, as it often does.
Actually, leading from behind might be a flattering characterization of the FDA in this case. You need to understand that the FDA has a database that catalogs problems with medical devices. They have thousands of entries for morcellators since the 1990s. But, get this, before December, 2013, there was not a single report of worsening of uterine cancer. Then, just five months later, the FDA advises against using morcellators. Unreal. The crazy thing is that the FDA acknowledges it knew all along that morcellators could spread uterine cancer but just did not think the risk was that grave. Seriously?
How Much Can You Expect for a Settlement or at Trial in These Cases?
Certainly, it is early to predict the settlement or the trial value these morcellator cases. There are just too many issues to figure out how much money a plaintiff can expect to receive. But one lens as to the trial value of these cases if there was a plaintiffs’ verdict would be to look at jury verdicts in uterine malpractice claims.
List of Potential Defendants
- Ethicon/Johnson & Johnson: which had 80% of the market share until they dicontinued supplying power morcellators on April 28, 2014
- Gynecare X-Tract
- Gynecare Morcellex Tissue Morcellator
- Morcellex Sigma
- Smith & Nephew – Trueclear Hysteroscopic Morcellator
- FemRx – Diva Morcellator
- Hologic – MyoSure
- Lumenis Inc. – VersaCut Morcellator
- Interlace Medical – Hysteroscopic Morcellator
- Olympus – PlasmaSORD
- Olympus – Gyrus PKS PlasmaSORD
- Nouvag – Morcellator TCM3000BL
- Blue Endo – MOREsolution Tissue Morcellator
- LiNA Medical – Xcise Cordless Laparoscopic Morcellator
- Karl Storz – Rotocut G1, G2, Steiner, and Sawalhell Supercut Morcellator
- Richard Wolf – Morce-Power 2306 Electronic Morcellator
Getting a Lawyer
If you believe you have an injury or wrongful death claim, you want to act quickly. Why? The statute of limitations in these cases might be complicated. So the sooner you assess your options, the better off you may be.
To speak to an attorney, call 800-553-8082 or get a free on-line consultation. There is no cost or obligation, the consultation is completely free. In fact, there is no cost or expense of any kind unless a recovery is ultimately obtained for you.