A patient's lawsuit alleging that Medtronic's ($MDT) Infuse bone growth implant injured her survived a challenge by the Minnesota medical device giant to dismiss the case.
The plaintiff, Christina Ramirez, can't sue Medtronic simply because doctors used Infuse as an off-label treatment. But the U.S. District Court judge, in his Aug. 21 order, allowed her claims of injury that trace her doctor's off-label use of Infuse to "Medtronic's off-label promotion" to survive.
"We are gratified that the Court rejected Medtronic's effort to close the doors to the courthouse on [Ramirez] and the many other patients that were implanted with the Infuse bone growth protein," Ramirez's attorney, Kent Klaudt of the law firm Lieff Cabraser, Heimann & Bernstein said in a statement.
Attempts to reach Medtronic on deadline were not successful.
Ramirez, who lives in Arizona, is suing the company based on problems she said she's faced from a lumbar fusion procedure in March 2009 for her back pain. Her lawsuit claims that the off-label use of Infuse led to uncontrolled bone growth and severe back pain. Doctors are allowed to use products off-label. But Ramirez's lawsuit claims the company didn't warn the FDA about severe-side effects stemming from Infuse's off-label use, and that Medtronic allegedly pursued aggressive, off-label uses of the compound in violation of federal law.
Medtronic continues to report solid financials, but controversy over Infuse could lead to increasing problems in the months ahead, as legal action escalates against the company from patients who say they've endured injuries from improper use of Infuse.
As of June, two independent reviews determined that Infuse performed no better than traditional bone graft and brought with it a higher risk of cancer, sterility and other side effects. And in late 2012, Senate Finance Committee investigators determined that Medtronic manipulated data about Infuse to help boost sales, though Medtronic at the time denied any wrongdoing and labeled the report as "misleading and unfair."
- read the plaintiff's release
- here's the court decision (PDF)