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At the time, it seemed like the perfect fit — the right doctor for the right job at the right company.

The doctor, a cardiac surgeon and immunologist, was a well-known public advocate for improved oversight of the medical device industry — a role developed after painful personal experience.

The job was medical director and safety monitor.

The company was Franklin Lakes-based Becton, Dickinson and Company, one of the world’s largest makers of medical devices, which prides itself on encouraging employees to “speak up.’’

But Dr. Hooman Noorchashm says that when he did speak up, BD fired him.

Noorchashm started at BD in February, nearly five years after his wife’s death from cancer spread by a device used during her gynecologic surgery. Her illness had set them both on a crusade to prevent other women from suffering as she did — work he carried on after her death.

Noorchashm says he saw the BD position as an opportunity to work from the inside to make health care safer. “I’ve been fighting the industry for so long,” he told NorthJersey.com in a recent interview. “I saw it as a transformative moment for myself — and the company.”

In six months on the job, Noorchashm:

  • raised concerns about potential cancer recurrences caused by a mesh product that BD hoped to sell for use in reconstructive surgery on breast cancer patients;
  • insisted that federal authorities be notified of potential safety breaches in containers manufactured by a company that BD had acquired and that are used to sterilize surgical equipment for millions of operations;
  • alerted executives to a previous licensure problem involving a BD vice president for medical affairs.

Now, the 50-year-old Yardley, Pennsylvania, resident and widowed father of six has filed a whistleblower lawsuit in state Superior Court in Bergen County — a suit that BD says it will oppose. The court filing lays out one man’s allegations against a behemoth in America’s $177 billion U.S. medical technology industry, offering a glimpse of the internal workings of a high-stakes medical business.

The suit alleges that BD retaliated against Noorchashm after he raised his alarms by terminating his employment in violation of state law. Noorchashm was protected under New Jersey’s Conscientious Employee Protection Act, the lawsuit says, when he told his supervisors he objected to company actions that he believed violated the law and public policy and would undermine quality patient care.

“I definitely was the right person for that job,” Noorchashm said in his interview with NorthJersey.com and the USA Today Network New Jersey. “But I don’t think they wanted me to do the job. I think they wanted to look good and hire someone who’s a big medical device safety person. …  At the end of the day, I posed too much liability risk to them. “

A spokesman for BD said the company looks forward to “vigorously” defending itself in court.

“Dr. Noorchashm’s characterization of his dismissal from BD is not correct,” said Troy Kirkpatrick, vice president of public relations and reputation management at BD. “In fact, an important part of BD’s culture is our emphasis on ‘speaking up.’  We encourage our associates to voice their opinions and concerns, so the company can address them openly and transparently.”

He added that Noorchashm’s allegations are inaccurate and “mischaracterize BD’s actions” regarding the sterilization containers and tissue-reconstruction products. “Patient safety is at the heart of the products we make and the patients we serve,” Kirkpatrick said.

Two months after Noorchashm was fired, BD issued a voluntary recall of the sterilization devices. A planned international clinical trial of the breast-reconstruction product was suspended by BD after he spoke up, the lawsuit says, and the doctor about whom he raised concerns no longer works there. The company did not respond to questions about those moves.

Grim experience led to advocacy

Noorchashm’s reputation as a patient-safety advocate was born in tragedy.

In 2013, Amy Reed, an anesthesiologist and the mother of their six children, underwent surgery to remove her uterus because of fibroid tumors. Her surgeon used a power morcellator, a device with a spinning blade that shreds tissue to make it easier to suction out through a small incision. Such small-incision, or minimally invasive, procedures are generally thought to be safer, with shorter recovery times, than opening the abdomen. 

But the fibroid tumors contained previously undetected cancer cells, which the power morcellator spread in Reed’s abdomen.

Reed’s cancer returned again and again, eventually affecting her lungs and spine. To treat it, she underwent additional surgeries, chemotherapy, radiation, immunotherapy and experimental therapy. She died in May 2017 at the age of 44.

In their outrage, the couple launched a campaign to ban the use of power morcellators, and to alert the public to their risk.

They wrote to the Food and Drug Administration, device manufacturers, hospitals, doctors and lawmakers. They gave interviews to newspapers and network television. And they partly succeeded: In 2014, the FDA recommended that the device not be used for “the majority” of women in the removal of uterine fibroids, and subsequently warned that it should be used only with a containment bag to catch the pulverized tissue. One manufacturer took its device off the market. Use of the devices in hysterectomies fell significantly.

Complications like Reed’s were underreported, the couple believed, and they reached out to other women with the same experience, or to their survivors. Noorchashm even attended the 2015 funeral of Viviana Ruscitto in Nyack, New York, who had died a year after a power morcellator procedure at The Valley Hospital in Ridgewood. A Government Accountability Office report in 2017, prompted by their efforts, faulted the FDA’s system of gathering reports of cancers spread by the device.

When Reed died, the couple’s quest and her death were reported in The New York Times and other major newspapers. “My public profile,” Noorchashm said ruefully, “is hard to miss.”

Headquartered in Bergen County, syringe maker to the world

BD, one of the world’s largest manufacturers of needles and syringes, was instrumental in the vaccination of billions of people during the COVID pandemic. It received one of the first emergency use authorizations for its in-home COVID test.

An international company with 77,000 employees — nearly 5,000 of them in New Jersey — it has originated such ubiquitous products as Foley urinary catheters, single-use IV lines, blood collection tubes and medication-dispensing cabinets. In 2021, it reported more than $20 billion in revenue.                                     

The company’s products can mean life or death to patients. They are used in nearly every country and are part of the toolbox of health care workers worldwide as they cope with global pandemics and treat everyone from premature infants to cancer patients.

In a message on the company’s website, CEO Tom Polen says BD operates on the principle that “We do what is right.” The company’s “Global Speaking Up Policy,” described on the website, aims to foster a culture in which all employees feel free to raise concerns and ask questions. “BD associates are obligated to report any suspected violations of laws, industry codes, the BD Code of Conduct, or BD policies,” the policy says.

For those who do speak up, “BD does not tolerate any form of retaliation against any person who in good faith reports an actual or suspected violation or cooperates in BD investigations,” the code of conduct states.

Noorchashm said that when he joined BD, he aimed to bring both his personal experience and his professional training to his work there. Even now, despite his firing and the subsequent lawsuit, he said he holds the company in high regard.

“BD is a reputable company that creates a lot of useful and mission-critical devices in health care,” he said. But he believes a combination of lax federal oversight of medical devices and inadequate self-reporting of problems by the device industry puts patients at risk. “BD needs to set a stellar example of safety and patient advocacy,” he said.

A device for women who have had breast cancer

Among the assignments Noorchashm took on at BD was a safety review of products with a vast potential market in reconstructive surgery for women who have undergone mastectomies.

The products use filaments like suture threads that can be reabsorbed into the body. In one product, the threads are woven into a mesh, and in another they are knitted into a scaffold to support soft-tissue repair and stimulate tissue growth.

The material in the threads, a polymer called P4HB, is produced through a biologic fermentation process.

Although P4HB had been used safely in hernia repair and soft-tissue surgeries, Noorchashm saw its use in breast reconstruction for cancer patients as problematic. During its reabsorption, he said, studies sponsored by BD showed that P4HB might provoke a cellular response that actually causes cancer. He also thought the product might interfere with imaging studies used to monitor women for cancer recurrences after surgery.

Based on his wife’s experience, “I’m very tuned in to what medical devices can do in the cancer space with women’s health,” he said in the interview. “These are very vulnerable women, whose lives have been devastated. … This could represent predatory marketing.” 

BD planned a large-scale clinical trial of the product as part of the FDA pre-approval process. The lawsuit says Noorchashm objected because the clinical trial was based on what he considered an inadequate safety study, done without an FDA exemption to use an investigational device in that way and without reports to the FDA about three cancer recurrences that occurred among its 50 participants. The study, which had been conducted by a private physician in Florida, constituted “human experimentation … on women with breast cancer,” he said.

He insisted to company executives that the recurrences be reported to the FDA and more safety studies be done before the clinical trial, he said.

In addition, he said, the trial was designed to measure how the reconstructed breasts looked and how satisfied the patients were, without focusing on the more important indicator of cancer recurrence. 

His lawsuit says Noorchashm’s concerns were downplayed. He was told the cancer risks already had been adequately assessed, and that he was “yelling fire.”

Despite pushback, he escalated his concerns to BD’s general counsel and its vice president of medical safety, the lawsuit says.

The planned international clinical trial was suspended shortly after he raised his concerns, the suit says.

But the dispute had also become more personal.

According to the lawsuit, Noorchashm discovered that the vice president of medical affairs leading the project to commercialize P4HB for breast reconstruction had surrendered his medical license 13 years earlier in California, “due to criminal activity.” Records reviewed by NorthJersey.com from the Medical Board of California show that the man had been arrested twice and charged with drunken driving, and had been reported to the board for having stolen a prescription pad and written himself prescriptions for controlled substances.

Concerned that the man had misled BD and was also retaliating against him, Noorchashm brought the California action to the attention of BD’s executive team, general counsel and human resources department, according to the lawsuit. In August, the lawsuit says, the man’s employment was terminated. BD did not respond to a question about the doctor’s status.

Concealing data about safety failures?

There was conflict in a third area, as well, involving what Noorchashm considered a decade-long, illegal concealment of safety failure data with a line of sterilization containers. Safety breaches that potentially allowed the contamination of surgical instruments could have put millions of surgical patients at risk, the lawsuit says.

BD acquired CareFusion, the company that held the patent for the Genesis Sterilization Containers, in 2015. Noorchashm’s lawsuit alleges that CareFusion “deliberately concealed” safety failures in the device starting in 2011, when the containers received FDA approval. When the same issues resurfaced at BD this year, upper management “seemed to have no plans to inform consumers or the FDA of the [device’s] safety failure,” the lawsuit says.

“The Genesis Containers were the straw that broke the camel’s back,” Noorchashm said of his insistence on reporting the safety failures to federal authorities and the role that recommendation played in his firing.

As medical director, he was a member of the BD committee that received reports of adverse events, or problems reported by physicians or hospitals with devices used in surgery. When the committee became aware that certain containers failed an “aerosol challenge,” his lawsuit says, its members and a high-ranking executive discussed BD’s response, which should have included notification to the FDA and to consumers, a recall, or replacement of the devices.  

After Noorchashm objected to the lack of a reporting plan at a committee meeting on Aug. 8, he wrote two emails and sent them to BD’s senior leadership, demanding they “correct the omission,” according to the lawsuit.

The next day, the lawsuit says, BD terminated his employment, “effective immediately, without warning, cause or severance.”

The BD spokesman, Troy Kirkpatrick, said this characterization is “not correct,” but “as this matter is the subject of pending litigation, we will not comment further at this time.”

BD subsequently issued a voluntary recall for 17 product lines of the Genesis sterilization devices that were manufactured and distributed between April 2011 and August 2022. They had not consistently met the “aerosol challenge testing,” which meant they “might lead to transmission of infectious pathogens to the surgical patient,” an Oct. 4 letter to customers said.

It noted that no adverse events had been reported.

Advocating from outside the industry, again

Since his firing, Noorchashm again finds himself on the outside, fighting the medical device industry.

He has waged a zealous campaign to convince the U.S. government to investigate his safety and ethics concerns about BD. Given his previous experience fighting to redeem his wife’s death, he knows where the levers of power are.

Two weeks after he lost his job, he met with FDA regulators via Zoom to discuss BD’s “poor and dangerous public health conduct,” according to an agenda and summary he circulated to them. There followed a stream of detailed emails about BD.

On Nov. 1, he filed a citizen petition with the FDA to reclassify the P4HB products as “biologics” rather than “medical devices” — a change that would make them subject to more stringent safety and efficacy testing, especially in cancer patients. BD said through its spokesman that “we do not believe the petitions that Dr. Noorchashm filed with the FDA have merit.”

On Nov. 11, he submitted a fraud alert to the Securities and Exchange Commission alleging that BD had deliberately concealed information from the FDA, consumers and BD’s investors about the potential safety defect in the sterilization devices, in violation of federal law. On Nov. 15, he contacted the Veterans Affairs inspector general to warn of the use of the Genesis sterilization devices in VA facilities.

Over recent months, he has shared information and correspondence through emails and texts with reporters, sometimes late at night and on weekends, until advised recently by his attorneys to reduce such communication.

He signs some of his emails, “In defense of public health, Hooman Noorchashm.”

His dismissal from BD has been “extremely painful,” Noorchashm said. He would like his job back.

“I’d like to be part of the solution,” he added. “I think medical devices are a necessary part of the health care landscape. The issue is, how do we make them safe?”

Lindy Washburn is a senior health care reporter for NorthJersey.com. To keep up-to-date about how changes in health care affect you and your family, please subscribe or activate your digital account today.

Email: [email protected] 

Twitter: @lindywa