Judging from the details of the Medtronic bone graft lawsuit, the relief imposed by the Court of Special Appeals of Maryland is about the only “relief” that plaintiff Steven McCormick could look forward to.
But first, a brief synopsis of the Medtronic Infuse bone graft system that was approved by the US Food and Drug Administration (FDA) in 2002. Infuse is characterized by the application of a synthetic, genetically engineered protein that stimulates bone growth. One can imagine, given the robust nature of bone once growth is stimulated, that strict parameters are required in order to ensure against overgrowth or bone stimulation in the wrong place - potentially posing dire consequences to the patient.
To that end, the FDA approval of Infuse was based on a strict set of criteria: among them, access to the spine was required from the front (anterior) rather than the back (posterior). Also, the specific use of a recommended cage in order to direct the bone growth along a specific pathway.
However, that didn’t appear to happen for plaintiff Steven McCormick, who underwent spinal fusion surgery to relieve chronic back pain. According to court documents, the surgeon is alleged to have used a Medtronic cage that had not been approved by the FDA. What’s more, the surgeon approached the patient’s spine from the back (posterior) rather than the front (anterior), and is alleged to have used an excessive amount of the Infuse protein.
In other words, the surgery became a Medtronic off-label situation.
McCormick is reported to have become permanently disabled as of 2008, and required revision surgery in the fall of 2010 in order to address Medtronic complications described as “bony overgrowth.” Surgeons had also found when McCormick was examined the previous spring that the cervical disc space where the Medtronic Infuse bone graft had been implanted had narrowed.
The Medtronic Guy was in the operating room…
McCormick and his wife jointly sued Medtronic and various other parties. Amongst the allegations was the alleged promotion of Medtronic for off-label use. While a doctor or surgeon has the legal, moral and medical authority to use a product for indications not approved by the FDA (off label), a manufacturer cannot be seen as promoting a medical device for uses beyond those sanctioned by the regulator.
According to the Medtronic lawsuit brought by the McCormicks, a Medtronic sales rep was present in the operating theater when the surgeon performed the procedure.
Claims were brought against Medtronic, and a Medtronic subsidiary, for negligence, strict products liability, breach of warranty, fraud and violations of the Consumer Protection Act. The attending surgeon, Dr. Michael K. Rosner, was cited for alleged failure to obtain informed consent. Medtronic sales rep Vincent Profitt, who was allegedly present when the surgery occurred, was also named in the lawsuit.
The trial court dismissed the charges against Medtronic, concluding that federal law preempts the claims for breach of any express warranties that Medtronic may have made in voluntary communications with the public or members of the medical professions outside of the context of the FDA-mandated and FDA-approved labeling for the device.
READ MORE MEDTRONIC INFUSE BONE GRAFT LEGAL NEWS
In other words, the preemption of state law claims is limited to when a manufacturer has duly complied with federal law, not when the manufacturer has been seen or is alleged to have violated federal law in some fashion.
About a year following his revision surgery, plaintiff McCormick learned about the presence of two nodules in his lungs that require monitoring to ensure they are not cancerous. Medtronic Infuse bone graft has been linked to cancer.
The case is Steven L. McCormick, et ux. v. Medtronic, Inc., et al.,. Case No. 670, in the Court of Special Appeals of Maryland.