Call Us: 1.800.873.5297

By

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.

 

The choice of a lawyer is an important decision and should not be based solely on advertisements. The cases discussed do not predict outcomes in future cases. Past results afford no guarantee of future results and every case is different and must be judged on its own merits.

000-017   000-080   000-089   000-104   000-105   000-106   070-461   100-101   100-105  , 100-105  , 101   101-400   102-400   1V0-601   1Y0-201   1Z0-051   1Z0-060   1Z0-061   1Z0-144   1z0-434   1Z0-803   1Z0-804   1z0-808   200-101   200-120   200-125  , 200-125  , 200-310   200-355   210-060   210-065   210-260   220-801   220-802   220-901   220-902   2V0-620   2V0-621   2V0-621D   300-070   300-075   300-101   300-115   300-135   3002   300-206   300-208   300-209   300-320   350-001   350-018   350-029   350-030   350-050   350-060   350-080   352-001   400-051   400-101   400-201   500-260   640-692   640-911   640-916   642-732   642-999   700-501   70-177   70-178   70-243   70-246   70-270   70-346   70-347   70-410   70-411   70-412   70-413   70-417   70-461   70-462   70-463   70-480   70-483   70-486   70-487   70-488   70-532   70-533   70-534   70-980   74-678   810-403   9A0-385   9L0-012   9L0-066   ADM-201   AWS-SYSOPS   C_TFIN52_66   c2010-652   c2010-657   CAP   CAS-002   CCA-500   CISM   CISSP   CRISC   EX200   EX300   HP0-S42   ICBB   ICGB   ITILFND   JK0-022   JN0-102   JN0-360   LX0-103   LX0-104   M70-101   MB2-704   MB2-707   MB5-705   MB6-703   N10-006   NS0-157   NSE4   OG0-091   OG0-093   PEGACPBA71V1   PMP   PR000041   SSCP   SY0-401   VCP550  

Legal Disclaimer & Privacy Policy
This web site is designed for general information only. The information presented should not be construed as legal advice and does not form the basis for an attorney/client relationship.

The choice of a lawyer is an important decision and should not be based solely on advertisements.
This web site is not intended to be advertising, and Schlichter Bogard & Denton LLP does not desire to represent anyone desiring representation based upon viewing this web site in a jurisdiction where this web site fails to comply with all laws and ethical rules of that jurisdiction. Materials on this web site may only be reproduced in their entirety (without modification) for the individual reader's personal and/or educational use and must include this notice.

We will not disclose, sell, or rent any of your identifiable personal information to any third party, unless approved by you, or required by law.