Medtronic Named in Lawsuit Over Spinal Graft Implant. Claim alleges “Off Label Use” for Neck Surgery Improper

The family of a California woman who died following neck surgery filed a lawsuit Tuesday against medical device maker Medtronic Inc.   According to the lawsuit, the woman’s death was caused by use of the Infuse spinal graft in her neck and a Medtronic representative encouraged the surgeon to use the implant for off-label uses prior to the surgery.   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.  Herndon Reston injury lawyer Doug Landau filed the first lawsuit in the country for the “off label use” of the diet drug combination “Phen-Fen” in the Alexandria Circuit Court.  The Virginia trial lawyer, along with Aaron Levine and Paul Rheingold alleged that the combination of these two drugs created an substantial risk of harm to the woman and caused her heart valve damage.  Drugs developed for one type of problem have been marketed, in an effort to increase their profitability, for other problems for which they may not have FDA or other regulatory approval.  If you have been injured by a defective drug or medical device, contact us at Abrams Landau, Ltd.  There are strict time limits in these kinds of claims.

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.  According to the Washington Post, shares of Medtronic rose 99 cents, or 3.4 percent, to $30.29 in afternoon trading. AP, The Washington Post  12/03/2008

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