The Oklahoma City Thunder forward “used a controversial bone-graft material that is not FDA approved for use in the foot” to promote growth, according to the article, which later indicates the star’s procedure had utilized the Infuse bone graft protein.
According to Medtronic’s site, the Infuse bone graft is only approved for spinal fusion procedures, open tibial shaft fractures and oral-maxillofacial procedures.
“They stuffed some bone-graft thing in, and they pasted over the top of the area. That healed up in a couple of weeks. But then they stuck something else in there just to smooth it out and make sure it was thick. They did a lot,” Durant told the BleacherReport.
Approved in 2002 for use in spinal fusion surgery, Infuse at 1 point had annual sales of nearly $1 billion. The bone-grafting product has since been linked to abnormal bone growth, certain cancers and male reproductive problems. Medtronic has been accused of not only downplaying the product’s risks but also promoting it for off-label use.
In May, A federal appeals court said it would not re-hear a product liability lawsuit Medtronic won over the off-label use of its controversial InFuse protein.
In a brief order, the U.S Court of Appeals for the 10th Circuit declined plaintiff Patricia Caplinger’s bid for an en banc re-hearing of a 2-1 decision dismissing the case. Caplinger had argued that her claims survived preemption because the device was used in a manner not approved by the FDA.
The appeals court in April found that Caplinger’s claims relied on dubious grounds – that state laws parallel federal statutes, which would cut off preemption.
Last May, Medtronic said it had agreed to settle approximately 950 product liability lawsuits for $22 million, but admitted no wrongdoing.
A month later, health insurer Humana (NYSE:HUM) leveled a racketeering lawsuit against Medtronic, accusing it of rigging the presentation of Infuse scientific data and of pushing its use in off-label procedures.