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Ethicon 7/14
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Endo International settles another clutch of AMS pelvic mesh cases
Jul 13, 2015 | Mass Device
By Brad Perriello
...Tens of thousands of product liability lawsuits ensued, filed against pelvic mesh makers including several Johnson & Johnson (NYSE:JNJ) divisions,... -
*New* Power Morcellator Controversy Spurs FDA Proposal – But Does it Go Far Enough?
Jul 13, 2015 | Mesh Medical Device News Desk
By Jane Akre
...Considering the harm done to pelvic mesh patients and those injured by the power morcellator, should medical device approvals really be made easier?...
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Endo International settles another clutch of AMS pelvic mesh cases
Jul 13, 2015 | Mass Device
By Brad Perriello
Endo International (NSDQ:ENDP) last week settled another batch of product liability lawsuits brought against subsidiary American Medical Systems Holdings over its pelvic mesh implants.
Last October the company agreed to put some 20,000 of the lawsuits to rest, saying it would increase the amount of money it had set aside to cover the claims from $1.2 billion to approximately $1.6 billion. In April 2014, Endo announced it reached agreements to settle up to approximately 21,700 additional mesh claims with separate plaintiffs’ law firms. In June 2013, it settled an undisclosed number of cases for $54.5 million.
Endo, which acquired AMS in 2011 for $2.9 billion, earlier this year agreed to sell the urology portion of that business to Boston Scientific (NYSE:BSX) for $1.65 billion.
Last week AMS said it and the plaintiffs in 167 of the cases settled all claims in the lawsuits, according to a filing with the U.S. District Court for Southern West Virginia, where Judge Joseph Goodwin is overseeing several multi-district litigations involving pelvic mesh products.
In 2008, the FDA notified transvaginal mesh manufacturers about reports of potential complications stemming from the devices. In 2012, the agency ordered AMS and other manufacturers to conduct post-market safety studies and monitor the rate at which adverse events were reported.
Tens of thousands of product liability lawsuits ensued, filed against pelvic mesh makers including several Johnson & Johnson (NYSE:JNJ) divisions, C.R. Bard (NYSE:BCR), Boston Scientific (NYSE:BSX), Coloplast (CPH:COLO B) and AMS. The devices are designed to treat female stress urinary incontinence and pelvic organ prolapse.
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*New* Power Morcellator Controversy Spurs FDA Proposal – But Does it Go Far Enough?
Jul 13, 2015 | Mesh Medical Device News Desk
By Jane Akre
The Wall Street Journal (WSJ) reports on Friday the House passed a bill that would improve the safety monitoring of medical devices. It was inspired by a gynecological device – the power morcellator.
The morcellator is a tool that is used to grind up growths in the uterus, however a woman has a one in 350 chance that the fibroid is masking a dangerous cancer causing it to spread. See background story here on Mesh News Desk.
The danger came to light over the very public prognosis last year of Dr. Amy Reed, who had the procedure. She and her husband, Dr. Hooman Noorchashm, MD, have taken to social media to call for a ban of the power morcellator.
One manufacturer, Johnson & Johnson has taken its device off the market but the morcellator remains on hospital shelves and it and other versions are still used by some hospitals and doctors despite the risks. The FDA added a black box warning but did not order a recall saying it could beappropriate for some patients.
The couple parent six children while they fight to have the technology abandoned. See theirChange.org petition. Meanwhile, her cancer has returned.
Dr. Reed continues to speak out about patient safety and the role the FDA fails to play. She and her husband have met with the FBI which is investigating what Johnson & Johnson knew about the risks of its morcellator back in 2006. Meanwhile, insurance giant Aetna has ended coverage for the power morcellator.
Bill Includes Unique Device Identifier (UDI)
The proposed improvement would include a bar code be added to medical devices. Two years ago the FDA proposed requiring the unique device identifier (UDI), not unlike a VIN number on your car. It allows the vehicle or device to be tracked if there’s a recall.
The FDA takes the “least burdensome approach in all areas of medical device regulation” (least burdensome on the manufacturer) and UDIs are not currently included in all electronic health records, making it virtually impossible to track any trends in patient harm can be tracked.
The bill does not appear to address the 510(k) approval process of the FDA which allows about 90 percent of medical devices, including the power morcellator and pelvic and hernia mesh onto the market with very little regulation. Long considered a hole in the patient safety net, the 510(k) allows manufacturers to exchange paperwork with the FDA while giving assurances its medical device is safe, without the burden of clinical trials.
21st Century Cures Bill
The amendment passed Friday is part of the so-called 21st Century Cures Bill, sponsored by Rep. Mike Fitzpatrick (R-Pa). It increases funding for patient safety, research and changes drug approvals.
It also uses words such as “streamlining the drug and device development process,” in other words making it easier to put devices on the market. The 510(k) approval process for manufacturers takes under $5,000 and under 90 days to approval with no clinical trials. Considering the harm done to pelvic mesh patients and those injured by the power morcellator, should medical device approvals really be made easier?
Rep Fitzpatrick said it was the power morcellator that moved his action. #
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