Robert J. Boumis  |  September 17, 2014

Category: Legal News

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spinal surgeryThe practice of powered morcellation, a type of surgical procedure, has come under increasing scrutiny from the press, medical community, and government regulators. Within this climate of concern, the maker of one powered morcellator has made legal threats towards a vocal critic of its medical devices.

Morcellator Concern

Powered morcellators
are a type of surgical tool used in some laparoscopic surgeries. In laparoscopic surgery, the bulk of the surgery is performed in the patient’s body. This allows for shorter recovery times and fewer surgical complications when everything works as planned.

However, the smaller incision makes it harder to remove tissue and organs, as required in some procedures like hysterectomies. In a hysterectomy, the uterus is removed. To get the organ out with the small incision made during laparoscopic surgery, it must first be cut into smaller pieces to fit through the smaller incision. The cutting process is called morcellation, and the tool that does it is called a powered morcellator.

However, it is alleged that the process of using powered morcellators to cut up tissue during a hysterectomy can spread cancer if it is present in tissue being removed.

Some research indicates that as many as 1 in 350 women having a hysterectomy have undetected cancers, like uterine sarcomas and leiomyosarcomas, in their uterine tissues. Allegedly, morcellation can spread these cancer cells throughout the pelvis and abdomen. This could produce a very advanced state of cancer very quickly.

Since cancer is harder to treat once it spreads beyond its starting position, this scenario could produce a very poor prognosis.

Controversy

In response to these concerns, the U.S. Food and Drug Administration (FDA) issued a statement advising against the use of powered morcellators until more data can be analyzed. Along similar lines, the market leader in powered morcellators, medical giant Johnson & Johnson, issued a recall for their own morcellators. However, another company, Karl Storz has taken a different tact.

Much of the scrutiny focusing on powered morcellators has come from husband and wife doctors Hooman Noorchashm and Amy Reed.

Dr. Reed was diagnosed with an advanced case of leiomyosarcoma less than a week after having surgery with a powered morcellator. Since then, Dr. Noorchashm has issued emails to Karl Storz, government regulators like the FDA, and the media highlighting the alleged risk, accusing the company of “negligence of the highest order.”

Karl Storz, a German medical supply company and a manufacturer of their own model of powered morcellator, has apparently sent a letter to Dr. Noorchashm, insisting that the morcellator did not cause his wife’s cancer, and that his statements were defamatory, along with the statement that the drug company would “hold you responsible” of “unfounded and unproven allegations” made in his emails, which had been copied to the FDA and the The Wall Street Journal, among others.

The medical supply company has stated that the data at this point is not definitive and they would not make the decision to recall their brand of morcellator without stronger evidence. Dr. Noorchashm has welcomed the opportunity to defend his claims in court.

In general, morcellation cancer lawsuits are filed individually by each plaintiff and are not class actions.

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