Criminal probe begins into who knew what about deadly medical device

Last year I told you about a dire warning from the FDA that laparoscopic power morcellators — a medical device used to grind uterine fibroids and perform hysterectomies — could spread aggressive cancer.

One of the device’s largest manufacturers, Johnson & Johnson’s billion-dollar Ethicon division, even promised to pull their morcellators off the market.

But our government isn’t going to be sending a letter of commendation to Ethicon any time soon.

It may end up sending a criminal indictment instead.

The FBI has opened an investigation into what Ethicon and other device makers knew about the cancer risks of power morcellators — and exactly when they knew it.

One small-town Pennsylvania doctor says that he has proof that Ethicon knew about the cancer risks of morcellators for nearly a decade. And he just may have a smoking-gun e-mail that could bring down a billion-dollar medical giant.

A criminal cover-up?

If you’ve heard of Dr. Hooman Noorchasm, you know he’s a man on the warpath.

It’s been two years since his wife, Dr. Amy Reed, had a morcellation surgery to chop up what were described as benign uterine fibroids. Just days later she learned that the morcellator had spread a previously undiagnosed cancer throughout her entire abdomen and pelvis.

And she wasn’t alone. As Dr. Noorchasm — a Harvard-trained surgeon — began researching morcellation, he learned that it was an open secret in the medical community that the procedure could spread previously undetected cancer cells.

“It was very clear to us that we needed to do everything in our power to stop this,” he said in an interview with Medscape.

Dr. Noorchasm took to the airwaves to warn the public and demanded that the FDA ban morcellation. He even appears to be behind a recently confirmed criminal investigation opened by the FBI.

And right now, that investigation seems to be focused on one retired hospital pathologist in the small town of Lewisburg, PA.

You see, federal law requires that when a company or health professional becomes aware of adverse events, either from a drug or medical device, it must be reported. And Dr. Robert Lamparter, who was a pathologist at a small hospital in Lewisburg, claims he knows for a fact that Ethicon was aware of the cancer risk from morcellators since at least 2006.

After all, he’s the one who warned the company.

Dr. Lamparter’s hospital was regularly seeing cases of unexpected uterine cancers. And as a disease expert, he understood right away what would happen if a morcellator — which literally tosses cells throughout your abdominal cavity — was used on tissue that was harboring undetected cancer cells.

So he sent an email to Ethicon in 2006 warning of the risk and claiming that “if a morcellation is done, the patient’s survival is jeopardized.”

Ethicon admits that it received Dr. Lamparter’s email, and claims it added a warning in the instructions for the device. But Dr. Lamparter called that tiny change nothing more than a “legal fig leaf’ the company was using to hide behind.

Now the FBI is asking whether Ethicon and other device makers did enough to alert the FDA and to warn doctors and patients. But given the thousands of morcellations performed using Ethicon devices since 2006, the answer to that question seems obvious.

And Dr. Lamparter’s revelation could be just the tip of the iceberg. Dr. Noorchasm, through his own investigation, concluded that device makers and surgeons may have known about morcellation’s cancer risks for at least 20 years.

They simply decided that the risk was manageable and, according to Dr. Noorchasm, proceeded to spread cancer in up to five American women a day. It’s just a reminder that “acceptable risk” depends on which side of the doctor’s desk you’re sitting at.

Shockingly, power morcellators are still on the market. Ethicon stopped selling its brand last year, but other companies have not.

And while the FDA stepped in last November adding a black box warning to the devices, Dr. Noorchashm calls that meaningless. It’s a warning that surgeons don’t bother to look at and that patients never see.

So it looks like women still need to be careful about making sure that any hysterectomy or fibroid surgery is not done using this electronic chopping device.

Because until it’s totally banned, it will still pose a deadly risk.

Sources:

“F.B.I. investigates whether harm from surgical power tool was ignored” Denise Grady and Katie Thomas, May 27, 2015, The New York Times, nytimes.com