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FDA Warning on INFUSE Off-Label Use

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According to Consumer Reports, as many as one in five prescriptions is the US is for an “off-label” use. An off-label use is the use of a drug or medical device to treat an ailment not approved by the Food and Drug Administration (FDA). In order for a drug to be approved by the FDA, the drug company must prove that their drug is both safe and effective for a “main use.”

In the case of the Medtronic INFUSE Bone Graft, in 2002, INFUSEwas approved to fuse vertebrae in the lower spine. However, surgeons have very commonly used it off-label for neck surgeries, often at doses exceeding the approved amount. On July 1, 2008, the FDA issued a public warning cautioning doctors against off-label use of INFUSE, citing 38 reports of potentially fatal complications when used in the cervical region of the spine. Despite this warning from the FDA, physicians have continued use of INFUSE  in cervical surgeries.

Congress has made it clear that doctors, and not the FDA, are in the best position to determine how a drug or device is used and who should use. Once a drug has been approved for a single main use, manufacturers can pursue approval for other uses, but must back up their requests with clinical evidence. Drug manufacturers are highly motivated to get approval for new uses because they legally cannot advertise a drug for unapproved uses.  Additionally, many insurance companies, and Medicaid and Medicare will not pay for off-label prescriptions and procedures.

In June 2009, Medtronic admitted it paid nearly $800,000 to a former Army surgeon who fabricated a favorable study of Medtronic’s INFUSE Bone Graft in cervical surgeries.  The doctor was found to have forged signatures of four Walter Reed Army Medical Center doctors as co-authors.  All of the patients in the study were found to have been made up. Medtronic was also accused in 2008 of promoting off-label use for cervical vertebrae fusions. Medtronic is only approved for use in the lower, lumbar region of the spine.

Medtronic INFUSE Bone Graft Off-Label Use Lawyers

Although off-label use is legal, doctors have a responsibility to advise patients of the risks of off-label use. A large majority of the uses of INFUSE have been shown to be off-label. If you have suffered side effects or complications from the Medtronic Infuse bone graft spinal implants, or if a loved one has died, you may be entitled to compensation in a defective medical device lawsuit against Medtronic.

Free Consultation

From our offices in California, Estey Bomberger product liability lawyers are reviewing Medtronic infuse cases nationwide. Contact us today for a free consultation of your potential Medtronic Infuse bone graft lawsuit.  There is no cost or obligation to speak with a lawyer. Under our contingency agreement, we are only paid if we recover money for your case.