Appeals court vacates FDA's rescission of ReGen's MenaFlex implant
September 29, 2014 by Brad Perriello
ReGen Biologics won a round in its long battle with the FDA over its MenaFlex knee implant last week when a federal appeals court vacated the watchdog agency’s move to rescind clearance for the collagen mesh implant and ordered “further proceedings” for the device.
The Hackensack, N.J.-based company declared bankruptcy in 2011, a year after the FDA’s Center for Devices & Radiological Health pulled its 510(k) clearance for the Menaflex device. ReGen sued in the U.S. District Court for the District of Columbia to overturn the rescission, calling it “arbitrary and capricious, an abuse of discretion, not in accordance with law, and in excess of statutory jurisdiction, authority and limitations.” Read more
Masimo wins $467m verdict in patent spat with Philips
October 2, 2014 by Alexander Soule
Masimo yesterday won a $467 million patent infringement verdict over Royal Philips in a long-standing battle over pulse oximetry technology.
Although Philips stipulated that it did infringe the patents, it argued that the infringement was moot because the patents are invalid. The jury disagreed, denying Philips’ claim that 2 Masimo patents are invalid and finding that Masimo did not infringe a 3rd Philips patent. Read more
Endo reaches deal to end remaining U.S. lawsuits over mesh
October 1, 2014 by MassDevice
Endo International said yesterday that it reached agreements to settle up to 20,000 legal claims from women who said they were harmed by transvaginal mesh devices, ending nearly all of the U.S. cases against it and its American Medical Systems unit.
Endo, which did not admit liability, said it would increase the amount of money it had set aside to cover vaginal mesh claims from $1.2 billion to approximately $1.6 billion in connection with the latest agreements, according to a regulatory filing from the company. Read more
Judge halves $74m pelvic mesh verdict against Boston Scientific
October 3, 2014 by Brad Perriello
A Texas state judge yesterday reportedly halved the damages levied against Boston Scientific last month in a product liability lawsuit over its Obtryx pelvic mesh, rolling back $50 million in punitive damages.
Judge Ken Molberg of the Dallas County District Court invoked a Texas cap on damages, Law360 reported, cutting the $50 million to $11.2 million but leaving in place $23.5 million in actual damages. Read more
Judge tosses FDA whistleblowers lawsuit
October 3, 2014 by Brad Perriello
A federal judge last week tossed a lawsuit brought by 6 of the so-called "FDA 9" whistleblowers accusing the government of violating their constitutional rights with surveillance of their private email accounts.
The staffers alleged that the FDA spied on the private email accounts they accessed using their government-issued computers, after they warned Congress and the president that unsafe medical devices were being allowed onto the U.S. market. Read more
