A German company that makes devices now under FDA scrutiny for their potential to spread sarcoma threatened legal action against the U.S. surgeon whose wife’s cancer cells were disseminated during routine surgery to remove fibroids.
Setting decorum aside, Hooman Noorchashm has been haranguing FDA, Congress, and the gynecology and oncology profession into partial abandonment of the procedure. Though he hasn’t sued anyone, several law firms are looking for women harmed by the procedure who would be willing to take part in litigation.
As an apparent result of this campaign by Noorchashm and his wife Amy Reed, top institutions—including Brigham and Women’s Hospital, where Reed underwent the procedure—are moving away from routine use of morcellation, and some insurers are refusing to pay for the procedure.
One of the largest manufacturers of these devices—Ethicon, a unit of Johnson & Johnson—recently voluntarily withdrew the devices, which cost between $1,500 and $3,000 each.
Power morcellation is performed on an estimated 100,000 women in the U.S. a year with a minimally invasive device that pulverizes a patient’s fibroids into fragments for easy removal through a small incision. The problems occur when power morcellators disseminate cells from undetected cancers.
The Karl Storz Group, the company that Noorchashm says made the device that was used in Reed’s surgery, is taking a different approach.
In a letter, the company said it wasn’t its device that made Reed ill; her sarcoma was present before the surgery.
And, citing Noorchashm’s emails, a Karl Storz official warned him to cease his campaign against power morcellation or face legal action.
“KARL STORZ insists that you immediately stop your campaign against the Rotocut morcellator, and any other morcellator device of KARL STORZ, and that you stop defaming the device and/or the KARL STORZ management in the medical world or on the market place,” the letter states.
“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 and/or other women’s uterine cancer, and/or aggravation of their cancerous situations, we would not hesitate to take appropriate legal actions to protect our good name and our rights.
“We trust that you understand our position and conclude by wishing you and your wife that you win your battle against the shocking illness which, nevertheless, cannot be attributed to any of our devices or acts.”
The letter, dated Aug. 22, is signed by Helmut Wehrstein, a member of the global executive committee of the company based in Tuttlingen, Germany.
Noorchashm says he has no plans to stop.
“This letter exemplifies an entire industry’s sentiments towards a deadly iatrogenic women’s health hazard—namely, upstaging of gynecological cancers using morcellators,” said Noorchashm, who is in the process of moving from Harvard to the Thomas Jefferson Medical College Department of Surgery. “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.
“Of course, almost all gynecological surgeons also recognized this avoidable peril, but seem to have accepted the collateral damage for the ‘benefit of the majority.’ Yet, none of the manufacturers or gynecological surgeons worldwide had reported this hazard to FDA until I did so in December of 2013, from my wife’s bedside, after she had undergone a major operation to remove the morcellated bits of leiomyosarcoma in her pelvic cavity.
“And now, I receive this bold letter in response to our appropriately loud alarm of public hazard, threatening legal action against me. How incredible! A Storz morcellator is used by a gynecological surgeon in Boston and causes my wife’s cancer to be spread inside her abdominal cavity, the company knows that this potentially deadly complication could occur, yet it continues to sell the product worldwide.
“And in response to my call to corporate responsibility and request that the company’s leadership act in the best interest of patient safety, I get a letter threatening legal action. Incredible!
“This specific example is why it 100% imperative that the United States Food and Drug Administration step up to the plate and regulate all these morcellator devices definitively. This specific example is also why the U.S. Congress must act to correct the 510(k) legislation governing medical device approval.
“Corporate responsibility works most of the time. It leads to innovation and progress most of the time. But when it fails, and it clearly has in the case of morcellators among a few other examples, the federal government must act, and act well, to protect the public.”
FDA has issued a safety communication and convened an advisory panel to solicit advice. Following J&J’s decision to withdraw its version of the device, two members of the Senate urged FDA to ask other manufacturers to withdraw the device pending outcome of additional assessment of risk.
“As the FDA prepares to make a final determination on the use of these devices, we urge you to seriously consider and not discount the testimony presented during the FDA’s July hearings by our constituents who devastatingly lost family members to cancer after a power morcellation procedure,” Sens. Kirsten Gillibrand (D-N.Y.) and Charles Schumer (D-N.Y.) wrote in a recent letter to FDA Commissioner Margaret Hamburg.
“KARL STORZ Insists That You Immediately Stop Your Campaign Against the Rotocut Morcellator”
The letter sent to Noorchashm follows:
Dear Dr. Noorchashm,
This refers to several emails which you addressed—amongst others—to Dr. h.c. mult. Sybill Storz, the CEO of the KARL STORZ Group.
In your emails, you requested Dr. Storz to “recall your Rotocut morcellator device from the market”, arguing that it caused harm to patients. You also urged Dr. Storz that she “must do right by all those who have been harmed” (21 May 2014) and you sent her (and other recipients) a collage of “30 women, some dead’; calling them “Your victims. Victims of your standard of care and using your robotic a power morcellator devices”. Again, in this email (24 June 2014) you imply that the power morcellator was the cause of some women’s deaths.
We know that amongst the 30 women displayed on the mentioned collage, is your wife. We also totally appreciate the shock and the suffering that you both must have had when the unsuspected uterine leiomyosarcoma was diagnosed on her after a laparoscopic treatment with power morcellation. In spite of this, and with a full understanding of your concern that power morcellation may potentially aggravate the cancerous status of a patient with hidden uterine sarcoma, one must distinguish between cause and effect. One thing is clear: Uterine sarcoma is not caused by power morcellation! To stop all morcellation today will not decrease the number of women carrying hidden, lethal uterine sarcomas. Women who happen to have the misfortune of a hidden uterine sarcoma are and have been seriously ill before laparoscopic surgery is or was applied to them. The illness has other causes and is by no means the result of a dangerous or malfunctioning device.
Furthermore, the risk of spreading an undetected cancer by minimal invasive surgery (MIS) must be measured against the benefits and risks of ubiquitous open surgery. The latter is generally associated with higher rates of morbidity and mortality.
MIS has many recognized advantages over open surgery such as: Reduced hemorrhaging (less need for blood transfusions), smaller incisions (reducing pain and recovery time, as well as post-operative scarring), reducing exposure of internal organs to possible external contaminants (thereby lowering the risk of acquiring infections), less pain, less post-operation medication and shorter hospital stay needed (often same day discharge), overall a faster return to everyday living. On the other end of the scale, there is the unquantified—but generally considered to be low—risk of inadvertently disseminating unsuspected malignant tissue in the body.
This may potentially result in the “upstaging” of a tumor and a worsening of a patient’s prognosis. But, again, as clearly came out during the recent FDA Obstetrics and Gynecology Devices Panel Hearing, held on 10th and 11th July 2014, it is not the (long tested) morcellator device that causes this problem, but the inability of today’s diagnostic medicine to detect, without invasive surgery, aggressive uterine sarcomas and to distinguish them from benign uterine fibroids.
You are assured that KARL STORZ will monitor the situation closely and will do its best to protect patients against any unnecessary risks. But, at the present stage, and considering the weak data on the specific risks attributable to the morcellation device itself (as opposed to the procedure), KARL STORZ considers it best to wait for the FDA’s final conclusions and recommendations and decided not to take a product from the market which, for hundreds and thousands of women, offers a safe and less invasive way for treating fibroids than by open surgery.
Based on the above, 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 in the medical world or on the market place. 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 situations, we would not hesitate to take appropriate legal actions to protect our good name and our rights.
We trust that you understand our position and conclude by wishing you and your wife that you win the battle against the shocking illness which, nevertheless, cannot be attributed to any of our devices or acts.
