Medical device maker Medtronic Inc. said it did not encourage the unapproved use of its spinal implant, which a new lawsuit is blaming for the death of a California woman.
The lawsuit, filed by the woman’s family in Los Angeles, said her death was caused by use of the Infuse spinal graft in her neck. The device is approved only for use in lower-back surgery and some oral and dental procedures.
The woman’s surgery took place in August, a month after the Food and Drug Administration warned that use of Infuse for neck surgeries had led to problems swallowing, breathing and speaking.
The lawsuit alleges that a Medtronic representative encouraged the woman’s surgeon to use Infuse for neck surgery shortly before the procedure.
Doctors are free to use devices as they see fit. But medical device companies are prohibited by law from marketing for unapproved, or “off-label,” uses.
The lawsuit comes just weeks after the U.S. Department of Justice sent a subpoena to Medtronic as part of an investigation into unapproved uses of Infuse.
The Infuse graft uses a man-made version of a human protein to encourages bone growth.
In 2006 Medtronic reached a $40 million settlement with the U.S. Department of Justice to settle charges that it paid physicians millions in kickbacks to use its spinal repair products. Medtronic denied any wrongdoing.
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