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Lawsuit Claims Medtronic Infuse was Marketed Illegally | cialis online

Lawsuit Claims Medtronic Infuse was Marketed Illegally

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A surgical patient who received an Infuse Bone Graft is suing Medtronic, Inc. claiming the company illegally marketed the product for off-label uses.

April Cabana, 34, filed a lawsuit in the Superior Court of the State of California against Stryker Biotech and Medtronic, accusing both companies of fraudulently promoting their spinal fusion products for unapproved-use which resulted in her suffering serious injuries.

She now suffers from “exacerbated debilitating injuries, unwanted bone growth” and is on disability as a result of receiving both companies’ products.

In her complaint, Cabana says she underwent surgery and received a mixture of Stryker’s products Calstrux and OP-1.

OP-1 is a putty substance used to promote bone growth in certain spinal fusion procedures, while Calstrux is used for surgically created bone defects.

After receiving the two products, Cabana experienced excessive bone growth and migration in her lower back which caused nerve compression and severe pain.

She was required to undergo a second operation, where her surgeon “removed the bone of unknown origin,” and used Medtronic’s Infuse.

In 2002, the U.S. Food and Drug Administration approved Infuse for use in bone graft procedures but Medtronic marketed Infuse for various off-label procedures, says the complaint

The second surgery was unsuccessful and as a result, Cabana suffered extreme pain.

Cabana insists that her injuries are a prime example of when device manufacturers and pharmaceutical companies illegally promote their products for unapproved or untested uses.

Medtronic currently faces ridicule from a group of spine specialists who publically repudiated expert findings that said Infuse was beneficial and linked to low health risks.

In early June, a full issue of the Spine Journal was dedicated to exposing the highly debated issue of whether researchers overstated Infuse’s benefits and vastly understated its risks due to financial ties with Medtronic.

It has been revealed that several of these researchers received millions in royalties and other payments from the company. According to the Journal, “the median amount of Medtronic money received over time by researchers involved in some studies ranged from $12 million to $16 million, with most of that going to a few individuals.”

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