Facing Power Morcellator Lawsuit, Device Maker Threatens Legal Action Against Doctor”
Morcellator Manufacturer Threatens Doctor With Lawsuit
The Karl Storz group has threatened two doctors with legal action if they continue to speak to the public about the dangers of morcellation.
The Karl Storz Group has made it clear that they are taking a firm stance in the debate over the risks associated with power morcellators.
In a strongly worded letter which was sent to Dr. Hooman Noorchashm, the group stated that, “We will no longer tolerate unfounded and unproven allegations such as the ones contained in your previous emails and we will hold you responsible. Should we get to know further public statements from you that our device and/or management would be responsible for your wife’s or any other women’s uterine cancer, and/or any aggravation of their cancerous situation, we would not hesitate to take appropriate legal actions to protect our good name and our rights.”
Dr. Noorchashm and his wife, Dr. Amy Reed, launched a campaign to educate the public and the medical community about the dangers associated with the use of the power morcellator during gynecological surgeries. The pair had chosen to do so because Dr. Reed was diagnosed with leiomyosarcoma which metastasized to other areas of the body after undergoing a procedure to remove uterine fibroids. While the couple has decided to not file a lawsuit, they allege that Dr. Reeds leiomyosarcoma was spread by the use of a morcellator.
Other patients have filed a lawsuit against several morcellator manufacturing companies, including The Karl Storz Group. One of the companies, Ethicon, which is a subdivision of Johnson & Johnson, voluntarily withdrew their devices from the market in 2014, and urged doctors to return the device after the possible risk factors were made known to the public.
In response, Dr. Noorchashm has indicated he has no intentions of stopping his campaign. He stated “This letter exemplifies an entire industry’s sentiments towards a deadly iatrogenic women’s health hazard—namely, upstaging of gynecological cancers using morcellators. Clearly, almost all morcellator companies, including Storz, had recognized that their devices have the potential to spread and upstage cancerous tissues—many of their user’s manuals stated as such.”
The FDA’s Safety Warning About Power Morcellators
On November 24th, 2014, the U.S. Food and Drug Administration updated a safety warning that they had previously issued in April of 2014. The updated warning, which addressed the use of power morcellators during gynecological surgeries, reads, “If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s long-term survival. While the specific estimate of this risk may not be known with certainty, the FDA believes that the risk is higher than previously understood.”
The FDA estimated the number of women that had undiagnosed uterine cancer and were undergoing hysterectomies and myomectomies to be 1 in 350 where a power morcellator was used.