US district court judge, Timothy S Black (Southern Ohio, USA) has dismissed the accusation of several hundred plaintiffs that they have been treated off-label with Medtronic’s Infuse.
The plaintiffs were all former patients of Atiq Durrani (Cincinnati, USA), an orthopaedic surgeon indicted in 2013 for providing “medically unnecessary” spinal surgeries. Durrani’s hospital, West Chester Hospital, and its parent company, UC Health, settled allegations of violation of the False Claims Act with a payment of US$4.1 million. The hospital was accused of charging federal healthcare programmes for the “unnecessary” surgeries performed by Durrani. The surgeon now resides in Pakistan, following his indictment.
Medtronic received pre-market approval for the use of Infuse in single-level L4-S1 fusions using an anterior lumbar interbody fusion procedure in combination with the LT-cage. It was indicated as a treatment for degenerative disc disease. MedPageToday, however, reported that up to 80% of the product’s usage was likely to be off-label.
In this case, a number of plaintiffs had been treated without the use of LT-cage, while some had been treated posteriorly. Infuse had been used by Durrani in the cervical and thoracic spine, as well as across multiple levels.
In 2015, the bone morphogenetic protein received approval for three new indications; use in OLIF51 procedures with certain sizes of the Medtronic PEEK Perimeter Implant at a single level from L5-S1, use in OLIF25 procedures with certain sizes of the company’s PEEK Clydesdale Implant at a single level from L2-L5, and use in ALIF procedures with certain sizes of Medtronic’s PEEK Perimeter Implant at a single level from L2-S1.
According to Black, these off-label uses are not necessarily illegal. The plaintiffs had failed to provide sufficient evidence in court as to the harm caused by problems with the Infuse product.
The plaintiffs in this case attempted to argue both that Durrani had committed fraud, acting as an agent of Medtronic, because of his continued use of the Infuse product, in spite of his knowledge of its risks. The patients also argued, however, that Medtronic had itself committed fraud by failing to inform Durrani of the risks associated with the product, according to Black.
“Several courts throughout the country have examined this exact issue and have held that ‘the FDA established specific federal requirements for the Infuse device, even when the Infuse Protein is used alone,’” Black wrote, commenting that the FDA is not required by federal law to publish the adverse event data provided by Medtronic.
Medtronic’s Infuse product has been dogged by controversy since a number of employees failed to report over a thousand adverse events associated with use of the product to the FDA between 2006 and 2008. The adverse events—which included four deaths—were discovered in a retrospective chart review of the product. According to a Star Tribune report, staff failed to notify the FDA about the adverse events, shutting the study down in 2008. By the time news emerged of these unreported adverse events in 2013, most of the Medtronic staff involved in the scandal had left the company, causing confusion within the company itself.
Medtronic attempted to provide more adequate information regarding adverse events in a study run by Yale University, but this, too, has been the subject of some controversy.