Medtronic Infuse Bone Graft Victims Sue for "Off Label" Use

June 17, 2013

2798019336_e7895053e8.jpgDangerous device attorneys at Pintas & Mullins report that patients implanted with Medtronic Inc's Infuse Bone Graft device are now suing the company for illegally promoting the device for uses not approved by the FDA.

About 300 lawsuits have already been filed against Medtronic, all of which allege off-label marketing of the Infuse device; according to the American Association for Justice, around 900 more cases are in the midst of the investigation stage. The Infuse Bone Graft uses a collagen sponge, soaked in genetically engineered proteins to enhance bone growth, to treat degenerative disc disease in patients' lower spines.

The FDA granted Medtronic limited premarket approval for the device in 2002, placing limits requiring the genetically engineered proteins be used along with a titanium cage. Furthermore, the FDA noted that the Infuse was to be used only in a specific type of spinal surgery, which is performed through the abdomen, opposed to through the back or other entry points.

In order to circumnavigate a 2008 Supreme Court ruling protecting similar medical devices from personal injury lawsuits, patients must prove that Medtronic knowingly promoted and marketed the Infuse Bone Graft System for uses not outlined by the FDA.

The 2008 decision (Riegel v. Medtronic) prohibits most state law claims over a medical device that successfully went through the FDA's safety review process for premarket approval. The federal court did, however, leave an opportunity for plaintiffs to file lawsuits if the alleged state law violations are the equivalent or parallel to federal law requirements.

In other words, plaintiffs may not sue Medtronic if they were injured by the Infuse Bone Graft if it was first soaked in genetically engineered proteins, used in conjunction with a titanium cage, and was implanted through the abdomen. Plaintiffs may sue, however, if any part of the procedure deviated from these requirements, as the dangers of using the device for "off-label" purposes were not disclosed.

For example, one patient from Missouri, Patricia Caplinger, had the Infuse Bone Graft implanted through her back in a 2010 procedure to correct a degenerative disc disorder. Because the entry point was located on her back, rather than her abdomen, Caplinger contends that it caused problematic bone growth around her spinal cord, which compressed her nerves and required additional surgeries. She was able to sue Medtronic in 2012, accusing the manufacturer of numerous violations, including the failure to warn about the potential dangers of off-label use.

Other plaintiffs are filing Medtronic Infuse malpractice lawsuits claiming the bone graft surgeries they underwent using the device were medically unnecessary. In one case, a woman was not told until after the procedure that the Medtronic device was used in ways not intended on the label.

About a year after her surgery, this woman developed chronic pain in her leg and now has to live in painkillers. CT scans show nerve damage to her L4 and L5 vertebrae, which were the two fused with the Medtronic Infuse. She is now facing additional spinal cord implant surgeries to alleviate the pain. She claims she's lost about two inches in height since the procedure, has had to switch to a desk job, and is unable to lift her 20 pound grandson or lean forward for any period of time.

Other plaintiffs are alleging that Medtronic falsely promoted the device as approved for use in cervical and thoracic spine surgeries, and that side effects associated with the Infuse include cancers, spinal stenosis, male sterility, and problems breathing. In 2008, one woman went into respiratory arrest and passed away after a Medtronic device procedure. Her family filed a wrongful death lawsuit alleging her death was due to implanting the Infuse Bone Graft device on her neck.

Medtronic Infuse Bone Graft lawyers
at Pintas & Mullins will continue to report on legal developments, studies, and reports relating to this device. If you or a loved one was seriously injured by a Medtronic device, or any other defective or dangerous medical device, you have important legal rights, and may be entitled to significant compensation through a lawsuit against the manufacturer.