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Medtronic Denied Motion to Dismiss InFuse Lawsuit

Jul 25, 2013

Medtronic Inc.’s recent bid to dismiss a lawsuit brought over its bone graft product, InFuse, was denied by an Illinois state court judge. Lawsuit allegations include that InFuse led to complications that resulted in permanent disability and that the patient needing to undergo additional surgery.

Cook County Circuit Court Judge, Eileen Mary Brewer, just issued the hand-written order rejecting Medtronic’s motion of dismissal due to pre-emption. Claims include negligence, strict liability, breach of warranty, and willful and wanton conduct, according to Law360. In addition to the device maker, the litigation names—and cites negligence—Northwestern Memorial Hospital, Northwestern Orthopaedic Institute LLC, and Dr. Mark T. Nolden.

The physician allegedly diagnosed the plaintiff with problems in his cervical spine—such as cervical spondylosis, which is age-related wear in the neck's spinal discs—according to the lawsuit. Also, according to the complaint, the physician performed a posterior cervical fusion, which involves removing the affected disc and replacing that disc with bone growth material. Medtronic's InFuse product was used off-label in the surgery, according to the lawsuit, which notes that the U.S. Food and Drug Administration (FDA) has not approved InFuse for cervical spine procedures, according to Law360. The lawsuit also asserts that Medtronic's sales staff and its so-called “opinion leaders” touted, trained, and urged the surgeon named in this case, to use InFuse off-label.

The lawsuit also alleges that, after the surgery, the man developed a life-threatening complication that required emergency surgery; the plaintiff suffered partial paralysis and now has a permanent disability and pain that impacts him every day, according to Law360.

InFuse, a bone graft product marketed by Medtronic, is synthetic, or genetically engineered, recombinant human Bone Morphogenetic Protein (rhBMP-2). In 2002, the FDA approved InFuse for certain uses. Specifically, InFuse was designed to stimulate spine growth in individuals diagnosed with lower spinal degenerative disease; InFuse received approval for use in one type of spinal surgery and some dental procedures. InFuse has not been approved for use on the upper, or cervical spine, yet the bone graft product is widely used in off-label procedures. In fact, on July 1, 2008 the FDA issued a notification that warned about InFuse’s ties to serious complications when used in off-label in cervical spinal fusions.

It is illegal for any device or drug maker, including Medtronic, to advertise a product for unapproved, off-label uses. Physicians, however, may prescribe devices and drugs off-label, as they see fit.

Infuse has been associated with a number of adverse reactions, including:

  • Bone dissolution
  • Cauda Equina Syndrome (“Horse Tail” Syndrome)
  • Compressed airways
  • Cysts
  • Difficulty swallowing, breathing, and/or speaking
  • Gastrointestinal Problems
  • Excessive swelling in the neck
  • Increased cancer risks
  • Infections
  • Male infertility, sterility
  • Nerve injuries and nerve damage
  • Pain, chronic pain
  • Retrograde ejaculation
  • Swelling of the neck resulting in injury or death
  • Uncontrolled bone growth
  • Worsened back and leg pain

The way in which Medtronic marketed InFuse has been the focus of mounting controversy; there are also concerns over the way in which InFuse research was conducted, including that Medtronic funded the InFuse research. Medtronic has been accused of promoting InFuse off label, of downplaying InFuse’s risks, and of overstating InFuse benefits. These allegations led to a Senate probe, an FDA warning, and independent studies.

For the most part, patients and physicians are not aware of the notorious history associated with Medtronic’s InFuse, nor are they aware that traditional bone grafting, which utilizes bone harvested from the patient, is a safer option.

InFuse continues to remain on the market and be used in surgical procedures.

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