Another motion to remand has been granted in a Medtronic InFuse case, bringing the lawsuit back to the Circuit Court of the City of St. Louis.
InFuse is a type of artificial bone graft that uses a genetically engineered, synthetic, recombinant human Bone Morphogenetic Protein (rhBMP-2). The U.S. Food and Drug Administration (FDA) has only approved this product for several, very specific uses. Infuse is approved to stimulate bone growth in one type of spinal surgery and for some dental procedures. Using this product in any other manner is referred to as “off-label”.
Medtronic InFuse bone graft product has been widely used in off-label procedures, such as in the cervical spine (neck). On July 1, 2008 the FDA warned that there are serious, potentially fatal complications associated with using InFuse in cervical spinal fusions, including excessive swelling in the neck, compressed airways, swallowing and breathing difficulties and nerve damage. The agency reiterated that InFuse is not approved for this off-label procedure, and pointed out that it had received close to 40 reports of complications associated with off-label cervical spinal fusion that took place within two days to two weeks after the procedure. The FDA stated that “[w]hen airway complications occurred, medical intervention was frequently necessary. Treatments needed included respiratory support with intubation, anti-inflammatory medication, tracheotomy and, most commonly, second surgeries to drain the surgical site,”
Patients who have had InFuse implanted in their cervical spines should look out for signs of airway complications, including difficulty breathing or swallowing and/or swelling of the neck, tongue, mouth, throat and shoulders or upper chest area, the FDA said; these symptoms are most likely to occur two to 14 days after the surgery. If any of these symptoms do occur, medical attention must be sought immediately.
A number of InFuse patients have taken legal action against Medtronic over the off-label use of the product. Parker Waichman LLP, in collaboration with co-counsel The Drakulich Firm; Neblett, Beard and Arsenault; Holland, Groves, Schneller, Stolze; and The Lanier Law Firm are representing 99 individuals who allege that Medtronic illegally promoted InFuse for off-label procedures. The lawsuit alleges that InFuse “presents a potentially unreasonable risk of injuring patients”.
Medtronic tried to remove the lawsuit to federal court, accusing Parker Waichman LLP and their co-counsel of a legal move that tries to defeat diversity jurisdiction. In order for diversity jurisdiction to be maintained, individuals who are suing part cannot be from the same state as the party that is being sued. In this case, one out of 99 individuals lived in one of the same states as a Medtronic location. The InFuse patients suing Medtronic issued a remand order, which requests that the lawsuit be returned to state court. All of the individuals are suing due to the off-label use of Infuse and allege the same illegal marketing scheme. The court granted their remand, and stated that it was “appropriate”. These events help move the Medtronic InFuse lawsuit closer to trial.
InFuse has been a subject of controversy over it was marketed as well as questionable research studies funded by Medtronic. In 2012, the U.S. Senate Finance Committee reported on these early studies promoting InFuse, and took issue with them. According to the report, the authors of about 11 medical studies were paid $210 million in royalties and consulting feeds. Furthermore, the Senate report accused Medtronic of manipulating the studies to hide side effects.
Last year, two studies published in the Annals of Internal Medicine found that there is no difference between using InFuse compared to a traditional bone graft. The researchers found that the initial Medtronic-funded studies were biased and that the product may present a small increased risk of cancer or male infertility by causing retrograde ejaculation.