On April 17, 2014 the FDA issued a warning to MDs against using laparoscopic morcellators in hysterectomies due to an increased risk of spreading uterine sarcoma. While the FDA did not issue an outright ban of the use of power morcellators, some hospitals have already elected to stop using these devices.
According to Reuters, Johnson & Johnson (J&J), the largest maker of these devices, suspended sales of the morcellator device. Note: J&J has not recalled these devices. The Wall Street Journal reported that J&J wrote in a letter to customers that it is waiting for the FDA and medical community to further clarify the role of morcellation.
At least one lawsuit has already been filed against medical device manufacturers for the death of a 53-year-old woman who allegedly died of metastatic myelosarcoma following a hysterectomy with uterine morcellation. I have also started seeing advertisements by law firms seeking potential plaintiffs for morcellator lawsuits.
In that lawsuit, filed on March 14, 2014 (before the FDA’s warning) there are 27 allegations of negligence against the defendant manufacturers. The following are some of the allegations:
- Failing to conduct adequate and appropriate testing of minimally invasive gynecologic products, specifically including, but not limited to, products used for uterine morcellation;
- Putting products used for uterine morcellation on the market without first conducting adequate testing to determine possible side effects;
- Failing to respond promptly and appropriately to their own and other testing of, and information regarding products used for uterine morcellation, which indicated such products potential harm to human (sic);
- Failing to promptly and adequately warn of the potential for the metastases of cancer when using products used for uterine morcellation;
- Concealing from the FDA, National Institutes of Health, the general medical community and/or physicians, their full knowledge and experience regarding the potential that products used for uterine morcellation are harmful to humans.
The plaintiff also sued on a strict liability theory for failure to properly and adequately design and manufacture the products used. The plaintiff also sued for breach of express and implied warranties.
This emerging litigation is an opportunity for CLNC® consultants. Certified Legal Nurse Consultants interested in morcellator litigation should research (on the Internet) both the plaintiff and defense attorneys representing these cases. Morcellator cases will undoubtedly increase in number and will create a long-term legal nurse consulting opportunity.
Here are some examples of how you can apply your CLNC services to morcellator cases.
- Assess all relevant prior medical records for a detailed history of the plaintiff.
- Assess and provide a summary of medical records for evidence of uterine sarcoma and related injuries and damages.
- Research, summarize and create a “library” of all relevant, peer-reviewed articles on power morcellators for hysterectomies and their relationship to spreading uterine sarcoma. Avoid non-authoritative Internet services.
- Develop a plaintiff interview form to interview numerous plaintiffs quickly and consistently.
- Locate qualified gynecologic laparoscopist medical experts to testify to alleged defect, causation and damage issues. Communicate with experts on behalf of your attorney-client.
- Analyze and summarize all medical expert testimony for accuracy, and both favorable and unfavorable opinions.
Market your legal nurse consulting business with these six customized CLNC services for morcellator cases and attorneys will instantly see how you can save them time and money. Morcellator cases will be a hot topic for years to come. This is the time to jump in and be part of this very interesting litigation.
I’m Just Sayin’
P.S. Comment and share your experience with power morcellators and how you are going to get involved in morcellator litigation.