Lawyers Weekly USA (8/30/12) reported that the plaintiff had received the Medtronic infuse bone graft in her back in an attempt to escape debilitating back pain. Instead of improving her situation, the plaintiff alleged in her lawsuit that her condition worsened as a result.
In her Medtronic lawsuit, the unidentified plaintiff alleged that her surgeon had used the Medtronic device in a manner not originally approved by the US Food and Drug Administration (FDA).
Therein lay a common thread in many examples of Medtronic litigation: the use of Medtronic off label.
The FDA granted Medtronic approval for Infuse in 2002 primarily for use in the lower lumbar region of the spine. Specifically, use of Infuse would resolve for the surgeon the challenge of having to harvest bone from other parts of the body. On paper, Medtronic Infuse presents as an inspired product: a genetically engineered copy of a protein that resides naturally in the body and fosters the growth of bone. Infuse allows surgeons to use the recombinant human Bone Morphogenetic Protein (rhBMP) in specific areas of the spine where the growth of bone would need to be carefully controlled.
However, beyond additional procedures for sinus augmentation and localized alveolar ridge augmentation (certain oral and dental procedures), Infuse was not approved for any other purpose by the FDA.
While surgeons and doctors retain the moral, legal and ethical authority to employ drugs and devices for uses not specifically approved by the FDA, manufacturers are not allowed to market their products as such.
It is alleged by plaintiffs, however, that Medtronic actively marketed and promoted Medtronic off label towards doctors and surgeons for use of Infuse in the neck, or cervical spine, causing risk for Medtronic complications ranging from restriction of air passageways, to difficulty swallowing or speaking. Medtronic, it has been alleged, not only promoted Infuse for such uses, but also provided training for these unapproved procedures and allegedly paid millions of dollars to doctors to promote such Medtronic off label use on Medtronic's behalf, through oral presentations and the authoring of professional articles in medical journals.
READ MORE MEDTRONIC INFUSE BONE GRAFT LEGAL NEWS
Not so, said the Court, which noted the plaintiff's claim "is not based on allegations that Medtronic's device violated state tort law notwithstanding compliance with the relevant federal requirements. In contrast, the plaintiff here is alleging that Medtronic promoted the use of its device in violation of federal requirements. Accordingly, Riegel is not authority that plaintiff's claims against Medtronic are preempted here."
The FDA maintains Medtronic infuse bone graft is safe and effective, with a positive risk / benefit profile when used in accordance with those indications expressly approved by the regulator.