Amid litigation over whether power morcellators can aggravate existing cancer, Johnson & Johnson subsidiary and morcellator manufacturer Ethicon has denied being aware of any reportable adverse events related to those devices until relatively recently.
In a statement to the website The Cancer Letter, a representative of Ethicon said the company first became aware of power morcellator adverse events in December 2013. Since then, Ethicon has reported all such events to the FDA that have come to the company’s attention, the representative said.
At issue is the potential of power morcellators to spread previously-undetected cancer. Power morcellators are surgical devices used to remove large masses of tissue during laparoscopic surgery. They work by cutting larger masses into pieces small enough to be removed through the small incisions used in laparoscopic surgery.
Using laparoscopic techniques for procedures like hysterectomy or uterine fibroid surgery offers the patient certain benefits, like reduced risk of infection and shorter recovery time.
According to a safety communication issued by the FDA in April 2014 and updated in November 2014, however, the use of power morcellators during some types of gynecological surgery may inadvertently cut up previously undetected cancerous tissue and spread it elsewhere in the body, causing a rapid and dangerous upstaging of that cancer.
The FDA estimates that as many as one in 350 women undergoing hysterectomy or uterine fibroid surgery may have a uterine sarcoma that went undetected prior to surgery. The agency says that there is currently no reliable way to detect a uterine sarcoma prior to surgery.
What Did Ethicon Know?
Ethicon’s statement to The Cancer Letter comes after a November 2015 U.S. House of Representatives committee hearing on the matter. In that hearing, Rep. Tim Murphy of Pennsylvania noted that Ethicon received a letter from Pennsylvania pathologist Dr. Robert Lamparter as early as 2006 expressing concerns about the possibility that power morcellators could spread cancer.
Ethicon told The Cancer Letter that Dr. Lamparter was only seeking advice on how to collect and evaluate specimens following power morcellation surgery. The company says that because the doctor did not report his experience as an actual event with a particular patient, his letter did not trigger Ethicon’s duty to report an adverse event.
Dr. Lamparter says the incident he wrote to Ethicon about was a “near miss.” The patient went in for a hysterectomy that was originally planned to be done laparoscopically.
When the surgery couldn’t be completed that way due to adhesions, it was completed abdominally. Dr. Lamparter says that when the uterus was removed intact, the surgeon found a cancer that would have been spread if the uterus had been morcellated.
After a series of email exchanges between Dr. Lamparter and Ethicon representatives, Ethicon closed its investigation of the issue. Today, Dr. Lamparter says his 2006 correspondence with Ethicon shows they were aware of the possibility of morcellator cancer years before the first such adverse event was reported to the FDA.
Johnson & Johnson has since recalled all Ethicon power morcellators from the market.
Morcellator Cancer Lawsuits
Meanwhile, several plaintiffs across the U.S. have come forward with morcellator cancer lawsuits. Generally, plaintiffs claim that power morcellators are unreasonably dangerous devices and that the manufacturers failed to adequately warn patients and physicians about the danger of morcellator cancer.
In October 2015, the federal Judicial Panel on Multidistrict Litigation transferred 28 of these claims to a federal court in Kansas for consolidated pretrial proceedings. Future morcellator cancer lawsuits will also be transferred into this multidistrict litigation.
Do YOU have a legal claim? Fill out the form on this page now for a free, immediate, and confidential case evaluation. The morcellation cancer attorneys who work with Top Class Actions will contact you if you qualify to let you know if an individual lawsuit or class action lawsuit is best for you. [In general, morcellator cancer lawsuits are filed individually by each plaintiff and are not class actions.] Hurry — statutes of limitations may apply.
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If you or a loved one were diagnosed with cancer in the uterus, pelvis or abdomen within two years of undergoing surgery for a myomectomy (removal of fibroids), hysterectomy (removal of the uterus), oophorectomy (removal of the ovaries), or salpingectomy (removal of fallopian tubes), you may have a legal claim. See if you qualify by filling out the short form below.
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- First Name*
- Last Name*
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- Approximately how long ago did you/your loved one have surgery to remove uterine fibroids?*
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1-2 years
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2-3 years
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3-5 years
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5+ years
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- What were you/your loved one diagnosed with?*
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Uterine cancer
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Endometrial cancer
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Ovarian sarcomas/cancer
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Parasitic myomas
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Leiomyomatosis
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Endometriosis
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Adenomyosis
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Fibroid/uterine tissue growth on other organs requiring surgery
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