The FDA's Center for Biologics Evaluation and Research (CBER) regulates human cell, tissue, and cellular and tissue-based products (HCT/P) such as bone, skin, corneas, ligaments, tendons, heart valves, stem cells, oocytes and semen. The Health Resources Services Administration (HRSA) oversees the transplantation of vascularized human organs such as kidney, liver, heart, lung or pancreas.
Medtronic Agrees To Settle 950 Lawsuits for $22M Over Its Infuse Bone Growth Product
As part of a settlement, Minneapolis-based MedTronic has agreed to pay $22 million to plaintiffs in an estimated 950 lawsuits filed over its Infuse bone growth product, but does not admit to any wrongdoing. An additional 750 cases brought by 1,200 plaintiffs are pending and more claims are expected to be brought.
Infuse contains recombinant human Bone Morphogenetic Protein (rhBMP), which is a genetically engineered version of a protein found in the body. Use of the protein causes bone growth in specific areas of the spine. The FDA approved its use in 2002 as an alternative to conventional spinal fusion. However, approval was limited to treat degenerative disc disease, open fractures of the tibia, sinus augmentation, and localized alveolar ridge augmentation.
Worldwide, more than one million people have received an Infuse implant. Plaintiffs allege Medtronic promoted Infuse to spinal surgeons for off-label uses that caused patient injuries. According to a report by the Senate committee investigating the product, the company's undisclosed manipulation of information through the medical literature included overstating its benefits and downplaying concerns about serious complications. Over the last 15 years, Medtronic reportedly has paid $210 million in royalties and other payments to a group of 13 doctors and two corporations linked to doctors to promote the off-label use of Infuse.
Legal News: Controversial Infuse Bone Growth Protein Targeted in Lawsuits
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.
 Fauber, John, "Medtronic Sued by 1,000 Infuse Patients," Milwaukee Journal Sentinel/MedPage Today (March 4, 2014).
 Sarvestani, Arezu, "Medtronic tallies 700 patient lawsuits over Invuse", MassDevice.com (March 5, 2014).
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