Infuse Lawsuits Begin: Negative Coverage Could Cost Medtronic Millions

Laura Dyrda -  
A barrage of lawsuits regarding off-label use for Medtronic's Infuse bone morphogenic protein product may be right around the corner, according to various news sources.

While Infuse is cleared by the Food and Drug Administration for very specific use, some surgeons have used it in off-label applications and experienced subsequent complications with the product. A study published last month in The Spine Journal found that the 13 company-sponsored studies of the product reported potential complications during the approval process, but often failed to mention them in the data released to the public.

The device and royalties paid to the surgeons who participated in the study are currently the subject of a Senate investigation. A report in the Star Tribune suggests an increase in class-action lawsuits by patients could be headed Medtronic's way, and Infuse sales may decrease by 50 percent. The company could lose a projected $750 million per year in Infuse sales, according to the report.

Preparation for the lawsuits began this week. Houston-based law firm Williams Kherkher released a statement encouraging patients who received Infuse for off-label use, such as cervical spine surgery, and suffered complications to contact them for legal assistance.

Related Articles on Infuse:
To Infuse or Not to Infuse: The Feud Between Spine Surgeons Continues

Dr. Thomas Zdeblick Defends Relationship With Medtronic, Disputes Inappropriate Reporting Claims

NASS to Companies: Stop Inaccurately Promoting Bone Growth Factors

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