Morcellation Critic Dares Device Maker on Lawsuit Threat

September 05, 2014

A cardiothoracic surgeon says he will continue to advocate the recall of all laparoscopic power morcellators, including one made by Karl Storz, despite that manufacturer's recent vow to take legal action if he doesn't stop claiming that its product has caused uterine cancer and death.

"I'm not fazed at all," said Hooman Noorchashm, MD, in an interview with Medscape Medical News. "Let them sue me. No judge in his or her right mind will take this case."

Dr. Hooman Noorchashm and his wife, Dr. Amy Reed

Dr. Noorchashm has waged a high-profile campaign against gynecological morcellation ever since his wife, anesthesiologist Amy Reed, MD, PhD, underwent a hysterectomy in October 2013 for uterine fibroids at Brigham and Women's Hospital in Boston, Massachusetts . Her surgeon used Karl Storz's Rotocut morcellator to shred the fibroids, believed to be benign, into pieces that were extracted through tiny laparoscopic incisions. A week later, Dr. Reed's physicians told her that she had an aggressive uterine leiomyosarcoma, and that morcellation may have spread the previously unknown cancer throughout her abdomen, according to her husband. A subsequent operation confirmed that morcellation and its tissue-scattering action had advanced the cancer to stage IV, Dr. Noorchashm said.

In the ensuing storm of controversy, the US Food and Drug Administration (FDA) warned in April that, pending further investigation, laparoscopic power morcellators should no longer be used for hysterectomy or myomectomy in most women with uterine fibroids because of the risk of dispersing occult cancer. The agency estimated that 1 in 350 women undergoing the procedures to remove fibroids has an unsuspected uterine sarcoma such as leiomyosarcoma. One manufacturer — Johnson & Johnson's Ethicon division — announced in July that it was voluntarily withdrawing its morcellators from the market because of cancer "uncertainty."

Dr. Noorchashm, meanwhile, has pressed Karl Storz to pull its Rotocut device in a series of increasingly accusatory emails, some of which were copied to everyone from FDA commissioner Margaret Hamburg, MD, to the Wall Street Journal. Last month, the German device maker apparently had had enough. In an August 22 letter to Dr. Noorchashm, a member of the company's executive committee wrote 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."

The company "would not hesitate to take appropriate legal actions to protect our good name and our rights" if Dr. Noorchashm continued to publicly blame any woman's uterine cancer, including his wife's, "and/or any aggravation of their cancerous situations" on its device or the company's management team, wrote Helmut Wehrstein, the Karl Storz executive.

"Karl Storz insists that you immediately stop your campaign against the Rotocut morcellator, any other morcellator device of Karl Storz, and that you stop defaming the device and/or the Karl Storz management," Wehrstein said.

He wished Dr. Reed well in her ongoing battle with cancer, but stressed that "uterine sarcoma is not caused by power morcellation!" Wehrstein said that the "unquantified" but thought-to-be low risk of morcellation spreading unknown cancer stemmed not from the device itself, but "the inability of today's diagnostic medicine to detect, without invasive surgery, aggressive uterine sarcomas and to distinguish them from benign uterine fibroids."

The company intends to wait for further findings and recommendations from the FDA on power morcellation before it decides whether to withdraw its Rotocut device, "which, for hundreds and thousands of women, offers a safe and less invasive way for treating fibroids than by open surgery." It noted that open surgery "is generally associated with higher rates of morbidity and mortality," which must enter into the risk-benefit calculation for laparoscopic morcellation.

Karl Storz did not respond to several requests for an interview.

"Please Reflect on 30 Women, Some Dead"

Dr. Noorchashm and his wife, the parents of 6 children, have told their story to a wide audience through media outlets such as the Wall Street Journal and ABC News. On a personal level, the couple's story appears to be more hopeful than when the stage IV uterine cancer was first diagnosed. Dr. Reed had cytoreduction and hyperthermic intraperitoneal chemotherapy — the so-called Sugarbaker procedure — followed by 6 rounds of chemotherapy that ended in June. Subsequent MRI and CT scans for the cancer have come back negative.

"We are praying and keeping our fingers crossed so that she has a full recovery," said Dr. Noorchashm, an assistant professor of surgery at the Sidney Kimmel Medical College at Thomas Jefferson University in Philadelphia, Pennsylvania. "She probably will go back to work part-time in January."

Dr. Noorchashm highlighted his wife's plight in his first email to Karl Storz chief executive officer Sybill Storz in January 2014. He attempted to persuade the company to pull its Rotocut morcellator from the market with an appeal to shame and pride.

"I am sure that your company's honorable founder, Karl Storz, would not want his name to be associated with such a terrible and devastating complication in many unsuspecting women," he wrote. Withdrawing its product, he added, would be a "single powerful act of courage and corporate leadership" that other manufacturers would follow. "I thank you for your attention," he concluded.

Later emails to Storz and other company executives — shared with Medscape Medical News — were more confrontational. "This is how the Karl Storz Rotocut causes stage 4 cancer," Dr. Noorchashm said about a YouTube video that he shared in a February 12 email. In an April email, he warned that "legal battles are forthcoming from others, not us."

A month later, Dr. Noorchashm was hitting harder. "You and your company have and continue to exhibit profound negligence by not recalling this device from the marketplace," he wrote in a May 16 message. "That, Ma'am, is corporate negligence of the highest order. Because it caused innocent and unsuspecting deaths."

In June, Dr. Noorchashm copied Dr. Storz and other company executives on a brief, but especially provocative email with dozens of other recipients, including reporters and government officials. It came with an attached photo collage of Dr. Reed and 29 other women who underwent laparoscopic morcellation and then were diagnosed with advanced uterine cancer as a result. The Wall Street Journal had published a version of the collage in a recent story.

"Attached please reflect on 30 women, some dead," Dr. Noorchashm wrote. "Your victims."

"I'm Well Within My Rights"

In his interview with Medscape Medical News, Dr. Noorchashm described the August 22 letter from Karl Storz as an unprofessional and unethical attempt to intimidate him into silence.

"It's well within my rights as a citizen of the United States to express my opinion," he said. "And I'm well within my rights to be absolutely off-the-scale disturbed by the fact that these people knew about this hazard and allowed people, including my wife, to be subject to it."

Dr. Noorchashm said he agrees with Karl Storz that uterine cancer itself is not caused by morcellation. "But stage IV cancer, advanced stage cancer, is. When you have stage I cancer of the uterus that's contained, it's potentially curable by an appropriate surgery. When you use a morcellator and you upstage it, that's the morcellator causing an advanced-stage cancer.

"If they want to mince words with me, I'm happy to mince words with them in court or in the press."

He also took issue with the company's statement that the problem of laparoscopic morcellation dispersing occult uterine cancer was caused by the inability to spot the malignancy apart from invasive surgery.

"What an illogical piece of literature," he said. "If you can't tell [there is cancer], why in God's name would you morcellate? Why would you design a device and market it that you know would spread cancer?"

Dr. Noorchashm's battles are not just with morcellator manufacturers such as Karl Storz. He chides the FDA for not banning the devices.

"The question is whether the FDA will buckle to lobbyist pressure," he said. "They know what the risk is. They've pulled devices from the market with far less risk. Fundamentally, it all comes down to industry influence."

He also wants Congress to rewrite the law governing the FDA's 510(k) approval process for new devices, which requires that a manufacturer need only prove that its product is substantially the same as a device already approved by the agency. This expedited process, which has been used with morcellators, needs stronger regulatory teeth to ensure that hospitals, physicians, and device-makers report adverse events, according to Dr. Noorchashm. He said the first time that the FDA heard about the problem of laparoscopic morcellation spreading occult uterine cancer was when he reported his wife's case on the agency's MedWatch system.


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