Individuals who are suing Medtronic over the bone graft product InFuse are a step closer to trial. A number of individuals who are suing Medtronic over the bone graft product InFuse are a step closer to trial, as their motion to remand has been granted. The case will be brought from federal court back to the Circuit Court of the City of St. Louis. All of the individuals in the lawsuit are suing over the off-label use of Infuse, and are being represented by Parker Waichman LLP, in collaboration with co-counsel The Drakulich Firm; Neblett, Beard and Arsenault; Holland, Groves, Schneller, Stolze; and The Lanier Law Firm.
InFuse is a type of artificial bone graft that tries to stimulate bone growth by using a genetically engineered, synthetic, recombinant human Bone Morphogenetic Protein (rhBMP-2). It has only been approved by the U.S. Food and Drug Administration for several, very specific procedures, including one type of spinal surgery and for some dental procedures. Using InFuse in any other procedure is referred to as “off-label” use; it is illegal for companies to market products “off-label” although doctors can do this at their own discretion.
Parker Waichman and their co-counsel are representing 99 individuals who underwent off-label procedures
Parker Waichman and their co-counsel are representing 99 individuals who underwent off-label procedures with InFuse. In their lawsuit they allege that Medtronic illegally promoted InFuse for off-label uses and state that the product “presents a potentially unreasonable risk of injuring patients”.
Medtronic accused Parker Waichman LLP and their co-counsel of a legal move that tries to defeat diversity jurisdiction, and tried to have the lawsuit moved to federal court. Diversity jurisdiction dictates that individuals who are a suing party 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. They pointed out that 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.
The FDA has warned about life-threatening complications associated with InFuse. On July 1, 2008 the FDA said that using InFuse off-label in cervical spinal fusions could lead to excessive swelling in the neck, compressed airways, swallowing and breathing difficulties and nerve damage.
The agency emphasized that InFuse is not approved for this off-label procedure, and cited 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,”
The FDA said that patients who have had InFuse implanted in their cervical spines
The FDA said that 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. These symptoms are most likely to occur two to 14 days after the surgery and require immediate medical attention.
In 2012, a U.S. Senate Finance Committee report took issue with early studies promoting InFuse, pointing out that authors of about 11 medical studies were paid $210 million in royalties and consulting fees. Furthermore, the Senate report accused Medtronic of manipulating the studies to hide side effects.
In 2013, 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.