FDA regulators asked AMS to address concerns un-validated manufacturing processes for slew of devices, including components for the AMS 800 artificial urinary sphincter and the AMS 700 inflatable penile prosthetic. The federal watchdogs also cited AMS for failing to conduct "adequate risk analysis" and respond properly to an apparent increase in failure rates associated with the AMS 800 device.
AMS and Endo were given 15 days from the receipt of the FDA warning letter, dated April 10, 2014, to respond to the citations.
The companies announced earlier this year that they’d received word of a "Form 483" warning, in which FDA regulators noted procedural violations observed during a February inspection of a Minnetonka, Minn., facility.
"These observations, previously self-identified by AMS, were being addressed through a corrective action plan which AMS originally expected to complete beyond 2015," according to an Endo filing.
Some of the devices mentioned in the FDA’s latest letter were also cited in a warning released last year by Australian regulators.
The Australian Therapeutics Goods Admin. in April 2013 issued a safety advisory late last month on certain lots of AMS’s 800 urinary control systems, warning that the devices were released on the market on the market without meeting the company’s own product release criteria.
That’s more bad news for AMS and Endo, which are also mired in the high-profile nationwide lawsuits over pelvic mesh devices. They and others are facing thousands of product liability lawsuits in state and federal court.
Hundreds of cases involving Boston Scientific (NYSE:BSX), Johnson & Johnson (NYSE:JNJ), Secant Medical, C.R. Bard(NYSE:BCR), Endo Health Solutions (NSDQ:ENDP), Cook Medical and Coloplast (CPH:COLO B) have been consolidated into multi-district litigation under Judge Joseph Goodwin of the U.S. District Court for Southern West Virginia. In February, more cases were consolidated by Judge Arnold New, director of the Complex Litigation Center at the Philadelphia Court of Common Pleas. Earlier this month plaintiffs whose cases were removed to the U.S. District Court for Eastern Pennsylvania filed motions to have their suits moved to the court in Philly as well.