“Off-label” uses for drugs and medical devices have been in the news lately. What is “off-label” use? Essentially, when the Food and Drug Administration (FDA) approves a drug or medical device, the specific conditions for which the drug or device is approved are listed. Some drugs and devices, however, can provide positive benefits to patients if used for conditions or symptoms that have not yet been investigated and approved by the FDA. Only licensed medical doctors are allowed to use and prescribe drugs and medical devices in ways and for conditions not approved by the FDA, if based on sound medical judgment, the “off-label” use of the drug or device can help a patient. Even so, a physician can be held liable if the “off-label” use is unreasonable and not based on good medical judgment. However, drug companies and medical device manufacturers (and particularly the sales reps that promote the use of the drugs and devices to physicians) are not allowed to advertise their products for uses not approved by the FDA.
Lawsuits against drug manufacturers alleging that the company promoted the off-label use of its drugs or medical devices often include the allegation that the doctors also received secret inducements to prescribe the drug in a manner not intended by the FDA. Clearly, if a physician is accepting payments or incentives to use a drug or device in an unapproved manner, the basis for such a decision is subject to scrutiny.
In an unusual case the Department of Justice is investigating Medtronic Inc. for the off-label use of its Infuse Bone Graft. The Infuse Bone Graft was approved by the FDA for use in the lumbar (low back) spine area. Infuse Bone Graft, if used properly in the lumbar region, would cause bone growth that fills in the gap between the vertebrae and replaces damaged discs. The FDA, however, only approved the use of this bone grafting material in a small area of the lower lumbar spine.
A number of patients have complained that they were injured when the Medtronic Infuse Bone Graft was used in an off-label manner. In July the FDA issued a safety alert about the off-label use of the Infuse Bone Graft in the neck or cervical region of the spine. Some of the complications that occurred when the Infuse Bone Graft was used in the cervical region included severe breathing problems and difficulty swallowing. Using the Infuse Bone Graft in the cervical region has caused some patients to lose the ability to breath or to swallow resulting in tracheotomies in order to breathe, while others had to have feeding tubes installed.
Medical malpractice lawyers in Texas need to investigate all potential causes of injuries, especially in light of the $250,000.00 cap on non-economic damages when suing medical providers. The cap on damages would not apply to suits against the medical device manufacturer if the manufacturer promoted its product for an off-label use and the off-label use caused injury. If off-label uses, and perhaps incentive payments to physicians, have caused serious or catastrophic injury, a manufacturing company can be held to fully compensate a patient.