Medtronic reported that about 700 lawsuits have been brought by 1,000 patients in state and federal courts over its bone morphogenetic protein-2 (BMP-2) product, Infuse. Infuse is a biologic agent that stimulates bone growth and has been used in over 1 million spine surgeries. In some cases, Infuse may cause the growth of unwanted bone.
In June 2011, an entire issue of Spine Journal devoted its pages to exposing problems with growth proteins, including Infuse. Federal investigations ensued and a U.S. Senate Finance Committee report accused Medtronic of deliberately obscuring evidence of adverse effects, paying millions to doctors who co-wrote favorable studies of Infuse, and promoted off-label uses of the protein. In 2013, two independent reports also raised questions about the benefits of Infuse over methods used in traditional spinal fusion surgery and whether the product could be linked to serious adverse events including cancer and sterility in men.
As many as 85% of Infuse's use has been off label, leading to speculation that a substantial portion of the lawsuits may involve patients who experience excess bone growth after an off-label surgery. The lawsuits are still in the early stages and none have resulted in a finding of liability against Medtronic. While these cases wind their way through the courts it is expected that more lawsuits are coming.
[1] Fauber, John, "Medtronic Sued by 1,000 Infuse Patients," Milwaukee Journal Sentinel/MedPage Today (March 4, 2014).
[2] Sarvestani, Arezu, "Medtronic tallies 700 patient lawsuits over Infuse", MassDevice.com (March 5, 2014).
In June 2011, an entire issue of Spine Journal devoted its pages to exposing problems with growth proteins, including Infuse. Federal investigations ensued and a U.S. Senate Finance Committee report accused Medtronic of deliberately obscuring evidence of adverse effects, paying millions to doctors who co-wrote favorable studies of Infuse, and promoted off-label uses of the protein. In 2013, two independent reports also raised questions about the benefits of Infuse over methods used in traditional spinal fusion surgery and whether the product could be linked to serious adverse events including cancer and sterility in men.
As many as 85% of Infuse's use has been off label, leading to speculation that a substantial portion of the lawsuits may involve patients who experience excess bone growth after an off-label surgery. The lawsuits are still in the early stages and none have resulted in a finding of liability against Medtronic. While these cases wind their way through the courts it is expected that more lawsuits are coming.
[1] Fauber, John, "Medtronic Sued by 1,000 Infuse Patients," Milwaukee Journal Sentinel/MedPage Today (March 4, 2014).
[2] Sarvestani, Arezu, "Medtronic tallies 700 patient lawsuits over Infuse", MassDevice.com (March 5, 2014).
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