A Medical Device Daily
A patient who allegedly was seriously injured by Medtronic (Minneapolis) Infuse Bone Graft implant in an off-label surgical procedure promoted by the company has sued the company, according to James A. Dunlap Jr. & Associates LLC and Page Perry, LLC.
The firms, along with co-counsel Lieff, Cabraser, Heimann & Bernstein, LLP, filed suit in New York federal court on behalf of Paul and Susan Antonelli, of Amsterdam, New York. The suit alleges that Mr. Antonelli was injured during a failed January 2006 procedure at a New York hospital to fuse vertebrae in his spine.
The complaint alleges, among other things, that Medtronic improperly promoted its Infuse Bone Graft product for a cervical lumbar surgery procedure, when the product was not approved by the FDA for that use. The Infuse Bone Graft product may cause severe swelling in the neck and throat that restricts breathing and can lead to suffocation of the patient if used off-label for unapproved uses, particularly spinal surgery performed from the back.
The FDA has received more than 200 reports of significant side effects resulting from off-label use of the medical device, particularly in the cervical spine, a number of which have led to serious and potentially life-threatening complications.
The lawsuit alleges that Antonelli's post-operative period was marked by increasingly severe pain, selling of the neck, mental status changes, difficulty swallowing, and difficulty breathing during which he nearly suffocated. He then required an emergency bedside tracheotomy after a few of his front teeth were knocked out in an effort to intubate him.
Medtronic's Infuse Bone Graft product has been the subject of a recent whistleblower lawsuit brought by former Medtronic employees who alleged that doctors received more than $8 million in 2006 in "sham" consulting fees for using and promoting the Infuse Bone Graft product. Medtronic's marketing and promotion of the device for off-label uses is being investigated by the U.S. Department of Justice.
In addition, the U.S. Senate is conducting hearings into the matter. Medtronic previously settled for $40 million with the Justice Department on another whistleblower action alleging that, between 1998 and 2003, Medtronic's spinal products division paid kickbacks to doctors in a number of forms, including sham consulting agreements, sham royalty agreements and lavish trips to desirable locations.