publication date: Nov. 22, 2019

Robotic mastectomy surgeon sues Monmouth, alleging defamation, antitrust violations

By Paul Goldberg

Stephen A. Chagares, a New Jersey general surgeon who recently set off a national debate by using a robotic surgical device to perform mastectomies, has filed a lawsuit claiming defamation and violation of federal and state antitrust laws on the part of Monmouth Medical Center.

Earlier this year, as The Cancer Letter was writing a series of stories focused on robotically assisted mastectomies, Monmouth didn’t respond substantively to the reporters’ questions, and—the lawsuit now states—Chagares was expressly directed not to answer questions as the hospital went “radio silent” with respect to The Cancer Letter, the complaint filed at the Superior Court of New Jersey states.

“At all times relevant hereto, plaintiff was specifically instructed by MMC administration not to speak with any media regarding RNSM, including the publisher of The Cancer Letter, thereby depriving him of the ability to defend himself,” the complaint states. The directive also precluded Chagares from answering basic factual questions, such as whether his study was being conducted with IRB clearance.

Monmouth, a hospital with over 500 beds, is a teaching affiliate of the Rutgers Robert Wood Johnson Medical School and a member of the RWJBarnabas Health system.

While Chagares remained silent, another individual who was privy to relevant information on the controversy triggered by robotic mastectomies, speaking on background, told The Cancer Letter that Chagares had performed the procedures off-protocol and without IRB approval (The Cancer Letter, April 5).

Subsequent to publication of the story, Chagares informed The Cancer Letter that the claim that he was performing a study without IRB approval was untrue. The Cancer Letter immediately published a correction and started an investigation to examine the manner in which this large community hospital managed research risks—and the reliability and appropriateness of guidance it had provided Chagares.

Of course, it’s not nice to mislead and stonewall journalists, but in our view, the events at Monmouth presented an opportunity to pull back the curtain on the proliferation of minimally invasive technology, such as robotically-assisted mastectomies. Robots can be impressive, but using them to perform cancer-related surgery without evidence on long-term safety and efficacy is risky business, and events that played out at Monmouth could have played out elsewhere.

The Cancer Letter’s investigation turned up internal documents that, step-by-step, demonstrated that the hospital’s IRB had:

  • Given Chagares misguided directions on what is required to conduct a cancer-related study,

  • Failed to obtain an Investigational Device Exemption from FDA in order to conduct the study, and

  • Approved a surgical outcomes study that wasn’t designed to provide answers on the safety and efficacy of robotic mastectomy.

As approved by the Monmouth IRB and initiated by Chagares, the study measured patient satisfaction, stating to participants incorrectly that the question of safety and efficacy had been answered in prior studies.

An FDA advisory, published following questions from The Cancer Letter earlier this year, urges investigators to conduct long-term studies using clinical endpoints that are more informative than patient satisfaction.

“The FDA is issuing this safety communication because it is important for health care providers and patients to understand that the safety and effectiveness of using robotically-assisted surgical devices in mastectomy procedures or in the prevention or treatment of cancer has not been established,” the agency said in a statement at the time.

Device manufacturers looking to market surgical tools for use in the prevention or treatment of cancer may now be required to study long-term oncologic endpoints in surgical trials, according to FDA’s advisory.

The short-lived single-arm study, approved by the Monmouth IRB and initiated with Chagares as the PI, was far from meeting this bar.

In the process of reporting the Monmouth story, The Cancer Letter approached all parties, at one point sending 64 questions to the hospital. Pursuant to what the complaint now describes as the policy of radio silence, The Cancer Letter received no answers from Monmouth.

The institution didn’t acknowledge having received multiple requests for comment for this story.

According to Chagares’s just-filed complaint, the surgeon was urged not to answer questions from The Cancer Letter, which a hospital official described as “not well read.” Chagares was also told to stop follow-up on the two patients who had received robotic mastectomies while on his IRB-approved study—a woman with breast cancer, and a man with abnormal growth of breast tissue.

This directive from Monmouth’s administration violates the fundamental ethical precepts of the conduct of clinical trials, ethicists say (The Cancer Letter, May 31).

 

FDA: IDE was required; patients must be followed

The Cancer Letter has learned that its earlier coverage of the Monmouth imbroglio attracted attention from FDA.

An agency official has stated in an email to Chagares that Monmouth was, indeed, required to obtain an IDE for the study, and urged the surgeon to continue to monitor the patients he treated in the course of the study.

FDA officials said no formal investigation has been conducted.

The Cancer Letter has obtained an email from the FDA official who investigated the surgical study. In the email dated June 26, Adam Donat, the agency official, writes to Chagares:

Thank you for taking time to talk with me today. I appreciate you providing the protocol and IRB package for the closed study titled “An Observational Study Evaluating Patients’ Satisfaction After Robotic Nipple-Sparing Mastectomy.” As discussed, FDA’s review of this documentation found that the Da Vinci Surgical System is not approved for this use, and this constitutes a new intended use for a significant risk device (21 CFR 812.3(m)). Therefore, such a study would require an IDE application to FDA.

I understand that you had already closed the study and are continuing to follow up with the subjects, which is what FDA would request in this situation. In addition, we recommend working with your IRB to identify whether the informed consent document contained any incorrect language that subjects would need to be notified of.

If you plan to conduct a similar study in the future, you may contact the Division of Industry and Consumer Education (DICE) by telephone at (800) 638-2041, or by email at dice@fda.hhs.gov for questions related to IDE requirements. Also, please do not hesitate to reach back out to me directly using the contact info in my signature block if I can help in any way.

 

Sincerely,

Adam Donat

Deputy Director, Division of Clinical Evidence and Analysis 1

Office of Clinical Evidence and Analysis

Office of Product Evaluation and Quality

 

 

Patients who enrolled in the Monmouth study were told—incorrectly—that the robotic procedure had been found “successful” in breast cancer:

“You are being asked to participate in this observational study because you are planning to undergo a robotic nipple-sparing mastectomy (RNSM) either for preventative or therapeutic purposes. This procedure has been tested and found successful for the treatment or prevention of breast cancer. You will not be asked to participate in any experimental procedures.”

The Monmouth protocol was built on the foundation of a European randomized trial, with the control arm edited out. However, the person or persons who edited out the control arm apparently neglected to change one of the protocol’s primary hypotheses: that the use of a robotic device to perform a nipple-sparing mastectomy does not worsen the oncologic outcome of patients with breast cancer or BRCA mutation.

After being dismantled and reconstituted, the Monmouth protocol simply doesn’t provide the data for a hypothesis test.

As a result, Monmouth offered robotic surgery for an unapproved indication to patients without a safety and efficacy protocol, promised high-risk patients that the procedure is “successful” for use in said indication, and simultaneously enrolled patients in a data collection protocol to assess whether the procedure worsens oncologic outcomes.

As of May 2019, all cancer-related clinical trials in the RWJBarnabas Health system have been required to undergo review by the Rutgers Cancer Institute of New Jersey, said Steven K. Libutti, director of the Rutgers Cancer Institute, vice chancellor for cancer programs at Rutgers Biomedical and Health Sciences, senior vice president of oncology services at RWJBarnabas Health, and professor of surgery at Rutgers Robert Wood Johnson Medical School.

“All oncology protocols at RWJBarnabas Health will initially go through the Scientific Review Board at Rutgers Cancer Institute of New Jersey, the state’s only NCI-designated Comprehensive Cancer Center, to ensure scientific quality and study design before the study can proceed,” Libutti said to The Cancer Letter.

“We are in the process of centralizing the Institutional Review Board across the health system that will review and monitor all oncology clinical trials, keeping patient safety at the forefront of clinical research.”

 

Chagares urged to keep silent

After directing Chagares to duck calls from The Cancer Letter, Eric Carney, chief operating officer at Monmouth, assured the surgeon that the problem would soon blow over, the lawsuit states.

Carney is now a defendant in the suit.

The complaint describes Carney’s effort to convince Chagares to keep his mouth shut and—quid pro quo—Monmouth would publish a positive article about the surgeon in the hospital’s glossy magazine:

On or about April 13, 2019, plaintiff had a telephone conversation with defendant, Carney, regarding The First Article [in The Cancer Letter] during which Carney admitted that The First Article “was clearly not accurate.”

Carney further acknowledged that the Article did not present plaintiff in “a very good light” and that it “smeared” his reputation. [Erroneous information provided to a reporter was immediately corrected as soon as The Cancer Letter became aware of inaccuracy.]

Notwithstanding, MMC made a conscious decision from a public relations and legal perspective not to attempt to correct it, that MMC would go “radio silent” about the disparaging statements about plaintiff in The First Article with the expectation that it would blow over.

Additionally, [Carney] acknowledged that The Cancer Letter posed an additional thirty-two questions to MMC in an effort to clarify the contents of The First Article but, MMC opted not to provide answers to those questions.

Carney defended MMC/RWJBH’s decision not to attempt to correct The First Article, in part, by stating that it was an “old story” and that The Cancer Letter was “not a well-read, written article.”

Defendant, Carney, also represented to plaintiff in that telephone conversation that MMC had a strict media policy under which employees were not permitted to speak with the media without authorization and that a violation could result in termination. [Carney] further represented that he did not have the ability to determine who at MMC made the disparaging statements about plaintiff.

At the very end of the April 13, 2019, telephone conversation, defendant, Carney, offered to have a positive article published about [Chagares] in its magazine.

Plaintiff through counsel also contacted MMC’s general counsel and requested that MMC take action to correct the false and defamatory statements in The First Article. General counsel unequivocally stated that no such action would be taken by MMC/RWJBH.

 

 

“Safety concerns”

Chagares was told that his clinical study was stopped over “safety concerns.” As he pressed the institution to state formally what those concerns were and to get instructions on what he should tell his patients, he was told not to collect any additional data on the subjects already enrolled, the complaint states.

To date, hospital administrators have not provided written justification for the hospital’s decision to end the study—leaving surgeons, principal investigators, and patients in the dark as to what the alluded-to “safety concerns” might be.

“This is unacceptable,” Arthur Caplan, the Drs. William F. and Virginia Connolly Mitty Professor of Bioethics at New York University Langone Health and the founding director of the Division of Medical Ethics, said to The Cancer Letter earlier this year. “When you’re partnering with someone, you don’t abruptly end a study without explaining why, without explaining follow-up options, what’s going to happen. Are you going to track the people that were in the study, or are you just leaving them in the lurch?”

Such directives are harmful to physicians and patients, Rita Redberg, a cardiologist and professor of medicine at the University of California San Francisco, said to The Cancer Letter earlier this year.

“Wow. I cannot imagine that the hospital thought an Investigational Device Exemption from the FDA wasn’t required. I don’t understand that,” Redberg said. “They weren’t only throwing the surgeon under the bus, they’re throwing their patients under the bus, too.”

 

“Preferred Specialty Physician Referral List”

Chagares, who has practiced at Monmouth for 29 years, has an employment agreement to provide services as a general surgeon at the breast center. He is also a private sole practitioner at the hospital.

“At or around the time at which plaintiff complained about the termination of the RNSM study, defendants altered the MMC-BHMG Preferred Specialty Physician Referral List to take plaintiff out of alphabetical order and/or remove him completely from the list,” the complaint states. “Defendants annually supplied plaintiff with a fictitious Preferred Specialty Physician Referral List.”

The list is used by the hospital-owned practice to refer patients to outside specialists.

Chagares’s complaint argues that the hospital’s actions were “designed to exclude plaintiff from the breast surgery market, eliminate the competition that would be generated by RNSM and to capture the breast surgery market for their own financial benefit.

“Plaintiff had developed a national reputation for bringing RNSM to the United States and had already generated out of state patients at the time the procedure was terminated by defendants,” the complaint states. “The financial impact on fees to Medicare and other health care insurers as the result of defendants’ actions are substantial.”

The complaint is posted here.


Matthew Bin Han Ong contributed to this story.

Copyright (c) 2019 The Cancer Letter Inc.