publication date: Jul. 21, 2017

Anti-morcellation advocate files “wrongful death” suit against Karl Storz and Brigham & Women’s Hospital

By Matthew Bin Han Ong

Hooman Noorchashm, the cardiac surgeon who, with his late wife, ran a campaign against power morcellation, is stepping up his family’s legal complaint against Karl Storz and Brigham & Women’s Hospital.

The “wrongful death” filing comes less than two months after Noorchashm’s wife, Amy Reed, died from complications of abdominal sarcomatosis (The Cancer Letter, May 26).

Reed died on May 24. She was 44.

Reed, formerly an anesthesiologist at Beth Israel Deaconess Medical Center and the Hospital of the University of Pennsylvania, underwent power morcellation at BWH in 2013. The procedure, which was performed with a Storz morcellator, contributed to the dissemination of her undetected cancer in her abdomen and pelvis (The Cancer Letter, Nov. 21, 2014).

Noorchashm’s lawsuit, filed on July 12, amends earlier medical malpractice and product liability claims against the defendants to add claims for wrongful death and punitive damages. The complaint also names Michael Muto, associate professor at Harvard Medical School and director of the Gynecologic Oncology Fellowship Program at BWH, and Karen Wang, an assistant professor at Johns Hopkins Medicine who, at the time, was Reed’s surgeon at BWH.

Reed and Noorchashm had made an unusual precondition for any possible settlement: they said that they would not discuss settlement unless Storz, a German company, pulls its power morcellators off the market. Noorchashm said his July 11 deadline was not met and the case was therefore amended to include a wrongful death claim.

“Withdraw from the power morcellator line of products by July 11 at the close of the business day and we will provide you with the opportunity to negotiate a private settlement—do not comply with this requisite condition and we will proceed with filing ‘Wrongful Death’ charges and a private settlement will be unlikely,” Noorchashm said in a statement to the press.

Noorchashm’s complaint can be downloaded here.

In April 2014, FDA issued an advisory, concluding that the risk for dissemination of occult uterine sarcoma via morcellation was one in 350—almost 30 times higher than the rate touted by pro-morcellation advocates and gynecology professional societies.

Ethicon, the Johnson & Johnson subsidiary that manufactured nearly three-quarters of laparoscopic power morcellators on the market, requested a withdrawal of the controversial devices in July 2014 (The Cancer Letter, Aug 1, 2014). The Wall Street Journal reported in March 2016 that J&J has settled nearly 70 of the estimated 100 legal claims that the devices harmed women by spreading undetected cancer.

About 50 suits related to harm caused by Storz morcellators have been filed in Los Angeles, according to Sean Tracey, a Texas personal injury lawyer. At least thirteen of those cases are going to trial, he said.

According to Noorchashm, the defendants filed a motion to withhold internal documents related to the power morcellation problem from the plaintiff, citing concerns that Noorchashm would violate confidentiality and leak those documents to the press.

In an email July 10 to the defendants’ counsel, Noorchashm wrote:

“You, your firms and the other attorneys on your side have put yourselves in the unfortunate position of defending clients whom, I know you would not forgive if you yourselves or your loved ones were on the receiving end of their carelessness and negligence—as my family is.”

It is highly unusual for plaintiffs to directly communicate with or seek to influence defendants and their counsel. On July 20, after reviewing Noorchashm’s email, a Boston judge granted Storz and BWH the right to withhold internal documents from Noorchashm.

“Of course! I would share any information that would be relevant to these corporations’ wrongdoing to the public,” Noorchashm said to The Cancer Letter. “This was a public health hazard that damaged a lot of families around the world—including mine. Frankly, the fact that these defendants even filed this motion demonstrates that they have something sinister to hide.

“I am stumped by the idea that a judge would endorse such corporate protectionism in the state of Massachusetts—I mean, really, to withhold critical information to a case from the plaintiff? Talk about the sanctity of the judicial process!

“The defendants know that vocal transparency and publicity has been at the core of the anti-morcellation campaign from the beginning, and so should the judge. There is nothing wrong with transparency when it comes to people’s lives in harm’s way.

“With this latest shenanigans from the defendants, it’s unlikely that I would submit to a private settlement—unless STORZ publicly withdraws their product from the global marketplace. I suggest the defendants take this promise very seriously.”

Storz officials did not respond to an email from The Cancer Letter.

“If you do not fight to achieve this Storz market withdrawal, your culpability will be formally demonstrated to the public in court,” Noorchashm wrote in an email July 12 to BWH leadership. “Let me assure you that with Amy’s death, there is no way that my children and I will settle privately with you so long as the deadly instrument that killed Amy in your physician’s hands is on the market harming others.”

BWH officials declined to comment, citing pending litigation.

The text of Noorchashm’s July 11 press statement follows:

Members of the Press,

This statement is to inform you that tomorrow morning, our attorneys at Greene LLP in Boston will be formally amending “Wrongful Death” charges to our legal complaint against the Brigham and Women’s Hospital (BWH), Dr. Michael Muto, Dr. Karen Wang and the Storz company.

This escalation has come about for two reasons.

First, the immediate cause of my wife’s death on May 24, 2017, was abdominal sarcomatosis resulting from her incorrect pre-operative work-up and subsequently the inappropriate use an unsafe power morcellator device manufactured and negligently marketed in the United States, and worldwide, by the German company, Storz.

Second, in February 2017, prior to Dr. Reed’s death, the defense counsel, unsolicited, approached our lawyers in an attempt to seek a private settlement. Dr. Reed and I responded by demanding a specific precondition to any settlement discussions. Namely, that the Storz company permanently remove the morcellator line of products from its repertoire of over 1,500 medical devices—as was done by J&J’s Ethicon subsidiary in 2014 following an FDA hearing, which demonstrated the severe hazard to women’s health. This precondition was met with silence from the defense at that time. Following Amy’s death on May 24, 2017, and per my wife’s instructions, I delivered an ultimatum to Storz executives and defense counsel via our attorneys at Greene LLP:

Withdraw from the power morcellator line of products by July 11 at the close of the business day and we will provide you with the opportunity to negotiate a private settlement—do not comply with this requisite condition and we will proceed with filing “Wrongful Death” charges and a private settlement will be unlikely.

As the set deadline has now passed, our lawyers and I have proceeded with amending charges of “Wrongful Death” to our lawsuit against BWH, its physicians and the Storz company.

As we proceed with prosecuting our case against Dr. Reed’s BWH physicians and the BWH and Storz corporate entities over the next year we aim to publicly demonstrate that the physicians and the BWH and Storz corporate defendants are guilty of negligence while violating federal law, state statute, the principles of medical ethics and safe surgical practice leading to the wrongful death of my wife, Dr. Amy Josephine Reed – mother of 6, wife, daughter, physician, scientist and advocate for women’s health – and others. Additionally, given the limited malpractice insurance coverage of the BWH physicians in “Wrongful Death” cases, we are prepared to seek punitive damages from all involved physicians personally.

It is simply an astonishing fact that a multinational conglomerate supposedly committed to health and safety of patients, Storz, finds itself unable to withdraw a product from the marketplace in the face of undeniable, forgivable and totally avoidable harm—and in a setting where its largest competitor did so over three years ago. Very certainly, it is an ominous sign for the corporation when this company’s risk managers and lawyers are neither capable of moving quickly to protect women in harm’s way, nor of effectively abrogating their corporate clients’ liability exposure in the marketplace.

Moreover, it is difficult to understand how the Storz co-defendants at BWH, who are no longer offering morcellation operations at their institutions, have not publicly voiced their professional opposition and recommendation to Storz, and the wider GYN community, that the company and the specialty withdraw from the power morcellator line of products. These facts will serve to severely damage the defendants as the case is prosecuted. We specifically aim to demonstrate that these two corporate entities, their doctors, their executives and their insurers are jointly and publicly liable for negligently causing my wife’s wrongful death, as the case moves forward in court now.

Sincerely,

HN.

Copyright (c) 2017 The Cancer Letter Inc.