publication date: Dec. 18, 2015

 

 

How Medical Devices Do Harm 

Friends call him The Hoomanator, a darkly comical conflation of his first name, Hooman, and morcellator, the medical device he has aggressively campaigned against.

Enemies—who are great in number—call him much worse.

Over the past two years, Hooman Noorchashm, a cardiac surgeon at Thomas Jefferson University Hospital, has been accused of launching a “campaign of distortions,” threatened with legal action, subjected to security searches and publicly chastised.

Over a two-year investigation, The Cancer Letter tracked Noorchashm and his wife, Amy Reed, as they challenged FDA, Congress, hospitals, the gynecology profession and manufacturers of medical devices. Their struggle began with a routine hysterectomy, during which a device called a power morcellator disseminated Reed’s undetected sarcoma. Today, as Amy’s aggressive disease spreads, the couple continues to draw public attention to the blind spots in the U.S. medical device regulatory system.

Reed and Noorchashm’s campaign reveals how the system works and how it fails. As a direct result of the outcry stirred up by the couple, FDA has restricted the use of power morcellators, finding that one in 350 women undergoing hysterectomies or myomectomies have an unsuspected uterine malignancy.

The couple and their supporters argue that the lives of this minority of women are being sacrificed for the convenience of the majority. Critics say the controversy was blown out of proportion by the media, and as a result, women are more likely to be harmed by more invasive open surgeries that FDA’s restrictions have made the standard of care for most women. However, in a statement to The Cancer Letter, FDA said it stands by its guidance.

On Dec. 18, Rep. Mike Fitzpatrick (R-Pa.) sent a letter to the FDA Office of Criminal Investigations, requesting an investigation of the “failure” of FDA’s Medical Device Reporting regulations with regard to specific hospitals and manufacturers.

“As you may be aware, hundreds, if not thousands, of women are dead because of a medical device known as a laparoscopic power morcellator,” Fitzpatrick wrote. “Despite the long history of this device on the market, only recently has the FDA put out guidance that the use of laparoscopic power morcellator increases the risk of spreading unsuspected cancers.

“It appears that these patient safety regulations may not be working as intended, leaving patients in danger.”

Fitzpatrick’s letter can be downloaded here.

The questions that remain extend beyond power morcellators, encompassing the entire landscape of medical device regulation. Patients can be harmed and never learn that the device is to blame. Doctors, hospitals, and manufacturers can, as a practical matter, conceal the fact that a device has caused harm. No one will catch them, because no one is looking.

Here is what The Cancer Letter’s investigation shows:

• FDA doesn’t assess the risk posed by the vast majority of medical devices. Instead of focusing on risk, FDA’s Class II 510(k) process clears products for the market based on “substantial equivalence” to comparable devices that are already on the market. The power morcellator is one example where preemptive risk assessment by the agency might have gauged the potential for harm to a subset of women, experts said to The Cancer Letter.

• Hospitals and manufacturers are required to “self-report” adverse outcomes to FDA, but the agency doesn’t actively look for those that don’t. The agency says it focuses on “encouraging” more reporting, which means that manufacturers and hospitals can often get away with not reporting adverse outcomes. This matter has become the focus of probes by Congress, the FBI, and the Government Accountability Office.

FDA doesn’t have a postmarket surveillance system for tracking all medical devices available in the U.S. Experts say the agency does not have a system analogous to the National Drug Code Directory, which assigns unique identifiers to each drug product. Without a data system that can be used for active safety surveillance, FDA, manufacturers, providers, and patients cannot quickly identify potential safety issues. Unique device identifiers exist, but investment is needed before payers, providers and hospitals can report UDIs in claims data and electronic medical records.

• Manufacturers of the highest-risk medical devices are shielded from product liability lawsuits. The 1976 Medical Device Amendments—along with a 2008 Supreme Court ruling—sharply limit the types of recourse patients might have for injuries from medical devices. This applies to Class III products, which go through premarket approval, FDA’s highest bar for demonstration of safety and effectiveness.

Lawsuits can be filed for injuries caused by Class II devices, which include power morcellators. At least 50 such suits have been filed in the U.S. since Reed and Noorchashm brought the issue to light. The couple has filed their own lawsuit claiming medical malpractice on the part of the device manufacturer, Karl Storz, and Brigham & Women’s Hospital, the institution that performed Reed’s surgery. Hospital officials declined to comment on the lawsuit.

2015 was a rough year for Reed. The 42-year-old mother of six has had three surgeries, chemotherapy, and three runs of stereotactic radiation for five metastases of leiomyosarcoma in her spine, lung and pelvis. The latest occurrence was removed on Dec. 16.

The Cancer Letter’s video interview with Reed and Noorchashm is posted here.

Driven to obtain justice for Reed, as well as to protect future patients from unnecessary harm, Noorchashm took on the entire establishment.

“We have to find a way out of this hole. I’m committed to doing whatever it takes to figure out a way,” Noorchashm said. “But I fear that my best may not be good enough.” 

 

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