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Pennsylvania Couple Brings $5 Million Lawsuit Over Infuse Bone Graft Risks

John and Lori Shambaugh of Pennsylvania have filed a $5 million lawsuit against Medtronic Inc., the manufacturers of the Infuse bone graft, for failure to warn them about serious health risks related to the use of their product. Lori Shambaugh had the Infuse bone graft implanted in her spine using techniques involving a posterior approach and without an LT-Cage, both of which were not approved by the Food and Drug Administration. Following the surgery, the plaintiff suffered from debilitating pain in her right leg, which has limited her ability to function and dramatically reduced her quality of life.

This Medtronic Infuse lawsuit was filed in the U.S. District Court for Middle Pennsylvania and seeks damages for pain and suffering, medical costs, loss of earnings, legal fees and punitive damages.

Infuse bone graft risks

The Infuse bone graft was developed by Medtronic Inc. as an alternative to bone grafts used from harvested bone from patients or cadavers. Infuse utilizes rhBMP-2, a manufactured protein that stimulates the growth of bone, in a procedure to fuse the vertebrae. By using a manufactured protein, Infuse reduces risks to patients who would have to provide bone material from their hip or spine.

Infuse was approved by the FDA for use in spinal fusion procedures, but only in conjunction with an abdomen approach and the use of a LT-Cage. The FDA had received evidence of Infuse bone graft risks during its investigations of the product, and had only approved its use in Anterior Lumbar Interbody Fusion (ALIF) surgeries. The FDA and Medtronic had knowledge that the rhBMP-2 protein could leak out if not properly contained within a LT-Cage and produce injury.

Basis for Medtronic Infuse Lawsuit

This lawsuit brought by the Shambaughs alleges negligent and fraudulent practices perpetrated by the manufacturers of the Infuse bone graft. Despite numerous reports of Infuse bone graft complications—including ectopic bone growth, which could produce spasms, chronic pain, paralysis and, at least in one case, death when Infuse was used in unapproved procedures—Medtronic continues to represent Infuse as a safe alternative to other bone grafts.

Medtronic purportedly engaged in deceptive practices which resulted in almost 1,200 adverse incidents which should have been reported to the FDA, but never were. Medtronic also did not disclose the Infuse bone graft risks to physicians, who were encouraged to use Infuse in off-label procedures. Not only did Medtronic promote the use of Infuse bone grafts in procedures unapproved by the FDA, but it specifically trained the Ms. Shambaugh’s physician in such surgical techniques.

Deceptive practices by Medtronic

The debilitating injuries detailed by Ms. Shambaugh in her Medtronic Infuse lawsuit are alleged to have resulted from the deceptive practices of Medtronic Inc. The company is alleged to have paid $210 million to researchers, who were supposed to provide an independent evaluation of Infuse bone graft risks. Many of those studies have since been called into serious question. Medtronic also paid hundreds of thousands of dollars to consultants to downplay warnings by the FDA concerning off-label uses of Infuse.

Several studies by reputable medical groups have shown that Infuse bone grafts can produce risks of complications similar to or worse than those Ms. Shambaugh experienced.