Medtronic, founded in Minneapolis, Indiana in 1949, is the world’s largest standalone medical technology company, credited with the invention and distribution of several cardiovascular products, diabetes supplies, and spinal materials. Medtronic’s controversial INFUSE bone graft is a protein bio-engineered to be implanted in the spine or vertebrae to encourage healthy bone growth. INFUSE procedures are common in patients who wish to reduce back pain by fusing spinal vertebrae. The procedure was approved by the FDA in 2002, and “life threatening issues” were publicly acknowledged by the FDA in 2008 after 38 cases of injury were reported by doctors between 2004 and 2008. These potential life threatening issues include paralysis, severe back pain, sterility, and death.
The FDA approved uses of INFUSE originally involved only one procedure called “anterior lumbar interbody fusion surgery,” which is performed on one specific area of the lower back (lumbar region). Medical law experts are arguing that Medtronic not only funded misleading research of the product, but promoted off label uses of INFUSE and encouraged doctors to perform unapproved procedures, such as posterior lumbar interbody fusion, upper back surgery, and multi-level spine surgery.
Medical reports show that in 2011, more than 85 percent of INFUSE operations were for off label uses and unapproved procedures. Evidence of Medtronic’s false advertising of their product was uncovered in an investigation conducted by the United States Senate Finance Committee, who found that the medical company paid more than two million dollars in “consulting fees” to the authors of the misleading studies. In 2011, the Senate Finance Committee published a letter written to the leading doctors at Medtronic highlighting the company’s questionable financial ties and faulty studies, writing,
“…the Milwaukee Journal Sentinel reported that a Medtronic-funded study published in 2004 found that 75% of bone morphogenetic protein 2 (BMP-2) patients experienced ectopic bone growth, where potentially harmful bone growth occurs outside of the fusion area. The authors, who had financial ties to Medtronic, “concluded that ‘although not desirable,’” the ectopic bone growth “did not appear to have an ill effect on the patients.” However, in a separate 2008 study conducted by physicians without financial ties to Medtronic, “neurological impairment occurred” in five patients who had the same ectopic bone formation.” – (Senate Finance Committee, 2011)
It is estimated that 100,000 INFUSE bone grafts are performed annually in the United States, even after the warnings issued in 2008, and the investigation conducted by the Senate Finance Committee. Clearly there are issues with Medtronic’s practices, and, while many patients may have received an INFUSE procedure with no adverse effects; a growing number of patients who were harmed by the product are filing lawsuits. In 2014 alone Medtronic settled over 950 INFUSE cases for $22 million, and reportedly set aside over $100 million to deal with 3,800 other damage claims. The number of cases being filed against Medtronic currently is rising and may soon be centralized through multi-district litigation and may bring about a new round of mass settlement.
Grounds for joining litigation include damages relating to severe back pain, paralysis, or sterility resulting in personal trauma or loss of wages.
The attorneys and staff at Jones Brown are committed to helping victims of medical malpractice receive settlements for medical expenses and pain and suffering. It is important to understand that the plaintiff’s personal doctor is not held responsible for any damages in lawsuits relating to Medtronic’s devices and procedures. If you or someone you love has been damaged by an unapproved INFUSE procedure, fill out our brief questionnaire to find out if you qualify to file a case