MASSDEVICE ON CALL — There may be "hundreds and hundreds" of patients with complaints against medical device giant Medtronic (NYSE:MDT) and a spinal surgeon accused of performing experimental surgeries without informed consent.
It’s the latest development in the dramatic saga of Medtronic’s controversial Infuse bone morphogenetic protein, which was at the center of a Justice Dept. criminal investigation that closed last year without evidence of wrongdoing.
Kentucky lawyer Eric Deters is representing 88 patients, 3 of them minors, who are suing Dr. Abubakar Atiq Durrani on the grounds that he "performed medically unnecessary, experimental spines surgeries on plaintiffs using falsely and improperly marketed Medtronic medical devices and drugs."
Deters has filed 15 additional complaints in the last calendar year and he suspects that many more may be waiting in the wings, Courthouse News Service reported.
"Since over 100 patients have contacted counsel and nearly 100 have claims, it is believed there are hundreds and hundreds more who have suffered at the hands of Dr. Durrani," according to the legal complaint.
The device giant has been batting back accusations about Infuse, which is used in spinal fusion surgeries, since a Spine Journal issue dedicated to highlighting serious concerns about the morphogenetic protein came out last summer.
The journal warned that off-label use of the product might increase a patient’s cancer risk nearly 5-fold after 3 years; others questioned the credibility of researchers who hid financial ties to Medtronic.
The ensuing clamor spurred federal investigations into allegations that Medtronic’s paid consultants may have concealed Infuse’s risks.
A U.S. Senate report issued in October 2012 blasted Medtronic over its handling of the Infuse kerfuffle, saying the company deliberately obscured evidence of adverse events, promoted off-label use of the product and paid out millions to the doctors who co-wrote positive studies, charges that the company denied.
"Medtronic vigorously disagrees with any suggestion that the company improperly influenced or authored any of the peer-reviewed published manuscripts discussed in the report, or that Medtronic intended to under-report adverse events," Medtronic said at the time.
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