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Morcellation Media Monitoring 06/18/2015
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FBI Investigating Johnson & Johnson Over Morcellators
Jun 15, 2015 | KDKA (CBS, Pittsburgh, PA)
By Dr. Maria Simbra
The FBI is now investigating Johnson & Johnson over a device used to treat thousands of women for a common problem. -
Congress set to pass repeal of Medical Device Tax: American jobs trump American lives?
Jun 17, 2015 | Philadelphia Inquirer
By Dr. Hooman Noorchashm and Dr. Amy Reed
The House of Representatives is again set to vote on the medical device tax repeal today. This tax repeal is likely to stimulate the medical device industry, as it has been touted. And, on the basis of its economic benefits, it is likely to pass through Congress with relative ease. -
SC Couple Sue J&J for Power Morcellator Cancer
Jun 16, 2015 | Top Class Actions
By Amanda Antell
South Carolina plaintiff couple Andrea and Kevin P. are suing Johnson & Johnson, and its subsidiary Ethicon Inc., for allegedly causing Andrea to develop uterine fibroid cancer. The couple claims that the defendant’s power morcellator device, the Gynecare Tissue Morcellator, had ruptured an underlying uterine sarcoma in Andrea that resulted in her cancerous condition.
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FBI Investigating Johnson & Johnson Over Morcellators
Jun 15, 2015 | KDKA (CBS, Pittsburgh, PA)
By Dr. Maria Simbra
The FBI is now investigating Johnson & Johnson over a device used to treat thousands of women for a common problem.
The company pulled the device off the market last year after some patients were diagnosed with cancer and others died.
The question now is, did the company know the device could spread cancer and for how long?
“I had fibroids that were becoming increasingly problematic after my last pregnancy,” Dr. Amy Reed said.
A year-and-a-half ago, Reed, an anesthesiologist and mother of six, had a hysterectomy for uterine fibroids. They used a device called a morcellator which grinds the uterus into pieces so it can be removed through a small hole.
Little did she or her doctors know, she had cancer hidden in her uterus which was literally spread throughout her belly with the morcellation procedure, turning what was likely a localized disease into stage four metastatic cancer.
“This type of cancer, I said it’s like ink. Once you spill it, you can’t just go back and undo it,” Dr. Reed said.
Reed and her husband, Dr. Hooman Norchasm have been fighting to get morcellation banned.
“Morcellator was in the marketplace for 20 years and it was hurting people at a rate of 1 in 300 or 1 in 350 whatever that magic number is and no one knew about it. The FDA didn’t know about it and these folks would just go home and die,” Dr. Norchasm said.
Last year, the FDA issued strong warnings on the product label and a division of Johnson & Johnson, the largest maker of the device, advised doctors to stop using it and pulled it from the market.
Now, the Wall Street Journal reports that the FBI will investigate what Johnson & Johnson knew about the risks all along.
Reed is now 42 and her cancer recently returned. She’s had more surgery and radiation, but she and her husband worry about the future.
“Am I worried? Yes, daily. I’m worried every day. It’s like having a gun to your head. But, I also think that we will beat this thing,” Dr. Norchasm said.
“I think having kids forces you to be very forthcoming and very honest and they say what is it? Cancer. Will it kill you? And you say, I don’t know, which is the truth,” Dr. Reed said.
One of their concerns is that medical devices don’t undergo the same scrutiny as medications in this country and that doctors using them don’t always know what the risks are.
Though Johnson & Johnson pulled their morcellation device off the market, there are other companies that still make them.
As of August 2014, UPMC stopped using morcellators. Allegheny General and St. Clair hospitals aren’t using them either.
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Congress set to pass repeal of Medical Device Tax: American jobs trump American lives?
Jun 17, 2015 | Philadelphia Inquirer
By Dr. Hooman Noorchashm and Dr. Amy Reed
The House of Representatives is again set to vote on the medical device tax repeal today. This tax repeal is likely to stimulate the medical device industry, as it has been touted. And, on the basis of its economic benefits, it is likely to pass through Congress with relative ease.
However, the vote comes at a politically inopportune time for the members of the United States Congress. Because a very serious public health deficit in the legislations governing the medical device industry has been identified.
Many members of congress are now fully aware of this deadly public safety deficit in the medical device regulatory space – Senator Casey, Senator Warren, Senator Alexander, Congressman Fitzpatrick, among others.
The safety deficit in the medical device industry is a serious one that has led to the unforgivable loss of many unsuspecting American lives.
But when Congress passes this tax repeal to the medical device industry, in a setting where there are no real safety regulations protecting people’s lives, it will inevitably be stimulating “the good, the bad and the ugly”.
Repealing the medical device tax, at a time when the FDA is failing to effectively secure the industry, would be a very significant dereliction of congressional duty to the American people.
Our only question is whether the congressional representatives who know of this serious safety hazard can bring themselves to economically stimulate this industry before securing it for the people – Alexander, Casey, Warren, Fitzpatrick…
Today’s vote on the medical device tax repeal in the House of Representatives will be telling.
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.
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SC Couple Sue J&J for Power Morcellator Cancer
Jun 16, 2015 | Top Class Actions
By Amanda Antell
South Carolina plaintiff couple Andrea and Kevin P. are suing Johnson & Johnson, and its subsidiary Ethicon Inc., for allegedly causing Andrea to develop uterine fibroid cancer. The couple claims that the defendant’s power morcellator device, the Gynecare Tissue Morcellator, had ruptured an underlying uterine sarcoma in Andrea that resulted in her cancerous condition.
Background on Morcellation Cancer Lawsuit
Like millions of American women, Andrea had to undergo a myomectomy procedure and had opted to use the defendant’s robotic powered morcellator device. After reviewing the defendant’s power morcellator advertisements, the plaintiff’s physician had recommended the Gynecare Tissue Morcellator to be used in the laparoscopic surgery, as it was a far less invasive option.
On May 22, 2012, Andrea underwent the myomectomy procedure, which was needed due to dysfunctional uterine fibroid. During this procedure, the blades of the power morcellator had cut up of the uterine fibroid tissue and removed it though the small incision that was made in her abdomen.
Later on in September 2013, Andrea underwent another power morcellator procedure for a supracervical laparoscopic hysterectomy procedure, also using the Gynecare Tissue Morcellator. More uterine fibroids were found and removed during this procedure. It is important to note that prior to the first procedure, no leiomyosarcoma had been detected and no long-term consequences had been formed. The second procedure had been performed due to intense pain she felt in her abdomen and pelvic region, where the additional fibroids were found.
Unfortunately, sometime in 2014, the plaintiff was later diagnosed with leiomyosarcoma, or uterine fibroid cancer, after medical image testing found smooth muscle tumors of malignant nature. Andrea is now receiving medical treatment for her condition, and is expected to go through many rigorous sessions that will accumulate massive medical bills. At no point before or after her procedures did the defendants warn the plaintiff of the dangers attached to their device and provided no relevant studies. Therefore, Andrea and her husband are pursuing legal action against J&J and Ethicon for failing to protect her against the dangers of their device.
The plaintiff lawyers state that Johnson & Johnson had the civil responsibility of warning their clients and other power morcellator consumers of all possible side effects of their products. Andrea insists that she never would have used their power morcellator device if she had known about the possibility of spreading uterine sarcoma. For being allegedly responsible for manufacturing, selling, distributing, and marketing a dangerous product, Andrea and Kevin are suing Johnson & Johnson in this morcellation cancer lawsuit. The charges include negligence, false advertising, concealing information, and misrepresenting a product.
This Power Morcellator Lawsuit is Case No. 7:15-cv-02114-TMC, in the U.S. District Court for the District of South Carolina.
Overview of Power Morcellator Complications
Power morcellators are considered one of the greatest medical technological innovations of the 21st century. Use of this device provides a convenient alternative to the traditional laparoscopic surgery, which is highly invasive and requires a long period of recovery time. Every year, numerous hysterectomy procedures use power morcellators, with the promise of quick recovery. Unfortunately, it was not long after the release of these medical devices that problems were reported.
Medical experts explain that due to the process by which the uterine fibroids are destroyed, the morcellator blades may inadvertently rupture uterine sarcoma. Currently there is no way to diagnose uterine sarcoma before the procedure; the cancer is normally diagnosed soon after the surgery. This morcellation cancer problem became so apparent that in April 2014, the FDA announced that the agency was investigating the link between power morcellators and uterine cancer. It is estimated that one out of every 350 women undergoing power morcellator procedures may have undiagnosed uterine sarcoma.
An FDA advisory panel was recently held to evaluate the available data regarding the safety of the power morcellators, which resulted in the agency stating that there was no way to make power morcellators safer. However, the panel was divided between recommending that stronger warnings should be placed on the devices, or if they should be flat-out recalled. Ultimately, the FDA announced in November 2014 that it will allow power morcellators to remain on the market, albeit with significantly stronger warnings regarding the risk of power morcellators and uterine sarcoma.
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