Deadly harm: The result of regulatory failure by FDA

by Hooman Noorchashm, M.D., Ph.D. and Amy J. Reed, M.D., Ph.D.

Published Aug. 12, 2015, 12:34 p.m. ET

On Monday, August 10, 2015 a young mother, Viviana Ruscitto, lay dying at a New York Hospital - her abdominal cavity filled with inoperable cancerous tumors blocking her intestines. Her toddler's life was forever changed. You can read her account here.

She was another apparent victim of a gynecological device, known as a "power morcellator".

According to North Jersey's The Record, this woman's gynecologist, Dr. Howard H. Jones, used a power morcellator manufactured by Karl Storz Co. to mince up her uterus for the purpose of performing a minimally invasive operation. This technique most likely spread her contained, early stage cancer to an advanced disseminated stage IV cancer.

You can meet Dr. Howard H. Jones here.

The trouble is that this complication was not simply an unavoidable medical error. It was not an "oops" moment in surgical practice.

According to The Record, Viviana's surgery took place on October 17, 2014.

The tragic significance of this date is that it came a full year, to the day, after our family's well-publicized complication with this exact device at the Brigham and Women's Hospital in Boston. You can read this account here.

But it wasn't just that the doctor and hospital ignored the large-scale publicity between October 17, 2013 and October 17, 2014 in their decision algorithm.

In April 2014, the Food and Drug Administration put out a safety advisory to clinicians and doctors regarding the oncological risk of power morcellation.

In July 2014, the FDA held a well-publicized hearing to assess the dangers of power morcellation. And in the same month, the largest manufacturer of the power morcellator withdrew the product from the marketplace due to significant "safety concerns". You can read about these events here and here.

So Viviana's surgery was performed one full year after we, and the WSJ reporters Jennifer Levitz and Jon Kamp, presented the public and FDA with undeniable evidence of deadly harm from cancer upstaging by morcellation. Six months after the FDA released a warning that these tools should be used with extreme caution. And three months after Johnson & Johnson had withdrawn from the morcellator market.

This doctor, his hospital, Karl Storz Co. and the FDA all could and should have protected this young mother's life – and the many others who remain in harm's way.

Clearly, Dr. Jones and his hospital were either unaware of, or chose to ignore, the massive level of publicity, the FDA warning and J&J's action - but why?

Clearly, Karl Storz Co., the manufacturer of the power morcellator did not pay adequate attention. Even now they are continuing to manufacture and sell this product in the United States - but why?

Despite the overwhelming scientific and epidemiological data, the FDA's Center for Devices and radiological Health (CDRH) failed to ban this product from the market in November 2014.

There are only two possible explanations to "why" Viviana Ruscitto and her family are in the tragic position they are in: arrogance or ignorance on the professional and corporate levels.

As for the FDA's CDRH, Viviana Ruscitto's case should serve as a warning to all federal investigators and the United States Congress. Because this tragedy is what happens when our federal agencies fail at the due diligence they owe the public and its safety.

The CDRH's failure to ban power morcellators in November 2014, despite overwhelming evidence of harm, is demonstration of unacceptable "mission-corruption" at that agency. That agency's purpose is not to streamline with device manufacturers and medical professionals or to operate on the assumption that corporate entities are equal stakeholders with the public - it is ONLY to keep patients and the public safe.

In the end, our federal government must turn Viviana Ruscitto and others like her into icons and guardians defending and protecting others from deadly harm - from the forces of arrogance, ignorance and mission-corruption in our healthcare establishment, in our corporations and in our public health agencies.

Our prayers and respect go to Viviana Ruscitto and her family for their unsolicited bravery in the face of what can only be described as a case of unforgivable negligence.

Hooman Noorchashm and Amy Reed, husband-and-wife physicians, have campaigned to ban electric morcellators since December 2013, soon after Reed's unsuspected uterine cancer was spread by the device during a routine hysterectomy.