Medtronic may not be a big fan of the Appellate Court these days, and with good reason. The company is back to facing a negligence lawsuit because of an off-label use of their product Infuse. The situation goes like this; a male patient underwent spinal surgery. The surgeon used Infuse. The patient went numb. A lawsuit arose. A demur was filed. The trial court sustained the demur. The Appellate court reversed it.
The heart of the matter, however, is based in the off-label use. The Food and Drug Administration (FDA) had approved Infuse for certain kinds of surgery – specifically, ones where the incision during the surgery was made in the abdomen. In the case discussed here, the surgeon made the incision elsewhere, and the patient suffered post-surgery with pain and numbness. When the patient-turned plaintiff filed suit, Medtronic demurred stating that the grounds under which he filed (a California state law which requires that patients be warned about potential adverse side-effects) was preempted by the federal Medical Device Act, which allows doctors to use devices in an off-label manner but prohibits manufacturers from advertising them for such uses.
This case could have far-reaching repercussions in how manufacturers promote their products, especially to the FDA. We could see far more negligence and liability cases in the future, if they don’t.