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Minnesota Plaintiff Overcomes Federal Preemption in Medtronic Infuse® Case: Judge Rules that Case Allowed to Proceed

The Star Tribune reports that a Minnesota judge has agreed to allow a Medtronic Infuse® bone graft case to proceed. In particular, Judge Laurie Miller will allow a Minnesota man to sue Medtronic over injuries he alleges was caused by Medtronic’s Infuse® bone graft product and to bring three charges of fraud and misrepresentation.

The Honorable Judge Laurie Miller, a district court judge in Hennepin County, had earlier refused to allow the case to proceed in light of U.S. Supreme Court rulings that typically exclude plaintiffs injured by federally approved medical devices from suing the manufacturers of such devices. However, after analyzing the more detailed allegations filed by plaintiffs’ counsel after her initial decision, Judge Miller chose to let the case proceed for the three charges of fraud and misrepresentation.

Judge Miller’s decision leads the plaintiff one step closer to a jury who could decide whether “Medtronic or its affiliates knowingly downplayed the dangers of Infuse® in convincing doctors to use the product in off-label ways, or those that have not been sanctioned by the FDA”, according to the Star Tribune. Judge Miller’s decision could have a huge impact on the 32 other Infuse® bone graft cases already on file in Minnesota, and could lead to the filing of new cases around the country.

Medtronic’s Infuse® Bone Graft is a bio-engineered bone graft product that is promoted as an alternative to traditional spine surgery, which entails harvesting bone from another area of the body or a cadaver. The Food and Drug Administration (FDA) only approved the Infuse® Bone Graft for use during limited spinal fusions, where the lumbar spine is approached frontally and the product is utilized in conjunction with a collagen sponge. FDA approval also mandates that the Infuse® Bone Graft be implanted within an “LT-Cage” to encourage bone growth between vertebrae.

Notwithstanding these criteria issued by the Food and Drug Administration, the Infuse® Bone Graft has been widely used by surgeons for “off-label” purposes, including neck surgeries. According to one report, researchers have alleged that Medtronic may have illegally promoted such off-label use of the Infuse® Bone Graft to encourage doctors to use the product in ways that the Food and Drug Administration had not approved.

However, off-label usage of Infuse® Bone Grafts during spinal surgery have been linked to severe and painful complications stemming from excessive bone growth around the spine. The bone overgrowth, in turn, can damage nerves around the spinal cord, causing intense pain, paralysis, spasms, and other serious complications. In fact, two independent studies published in the Annals of Internal Medicine have concluded that the Infuse® Bone Graft provides no benefits over traditional spine surgery and may expose patients to additional risks. The first study can be found here and the second study can be found here.

Although the Infuse® Bone Graft was once considered a groundbreaking means of replacing damaged or diseased bone by stimulating bone growth, the Infuse® Bone Graft is now the target of lawsuits alleging that the device causes life-threatening complications when used for such off-label purposes. According to a report based on an investigation launched in June 2011, the Senate Financial Committee has concluded that medical device maker, Medtronic, improperly influenced studies on its Infuse® bone grafts. Specifically, it is alleged that Medtronic participated in writing and editing these studies that appeared in journal articles – without disclosing its role in shaping these studies. These thirteen key studies as summarized in these articles, and financed by Medtronic, failed to mention serious risks associated with Infuse®, including male sterility, infection, and increased back and leg pain. It is also alleged that Medtronic paid study authors $210 million in consulting fees for unrelated work over the span of fifteen years. and a critical report from the Senate Finance Committee disclosing that Medtronic paid $210 million to doctors studying Infuse over a 15 year period.


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