After reports that their clinical trials might have been tainted by corruption, the United States Senate Finance Committee has launched a probe investigating the medical product Infuse Bone Graft as well as its manufacturer, medical technology company Medtronic, Inc.

Committee chairman Senator Max Baucus of Montana and senior member Chuck Grassley of Iowa have asked Medtronic to hand over extensive documents, communications, and financial information regarding Infuse Bone Graft, a medical product that is used by surgeons instead of real bone in a number of grafting procedures. A number of reports have surfaced recently stating that complications related to the bioengineered protein were never reported by surgeons involved in the Medtronic-sponsored medical trials—perhaps because many medical professionals involved were being paid as consultants during the tests.

The Senate Finance Committee hopes to answer the following questions during their investigation of Medtronic:

  • Were doctors conducting medical trials with Infuse Bone Graft being paid by the medical product’s manufacturer during the studies?
  • Were all complications related to the use of Infuse Bone Graft during Medtronic human trials reported by surgeons?
  • What is the nature of Infuse Bone Graft’s off-label uses, and are they safe for patients?
  • Why did doctors allegedly overlook complications during clinical trials?

 

Infuse Bone Graft was approved by the Food & Drug Administration (FDA) in 2002 for use in lower spine surgeries. Since that time, it was been used in 500,000 surgeries and in a number of off-label operations. Since its approval, many have reported complications from the product, including abnormal bone growth, swelling, and male sterility.

Kentucky medical injury attorneys
 
Controversy is nothing new for Medtronic or Infused Bone Graft. Complications from the grafting material have been reported since 2004, while the company has also battled lawsuits from shareholders and injury victims. If you or a loved one has suffered harm because of a Infused Bone Graft procedure—and if you believe that the injury was due to the negligence of Medtronic—you may wish to speak with an attorney about your possible lawsuit. Call the Infused Bone Graft lawyers at Gray & White today and get your questions answered. 
Matthew L. White
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Founder & Partner of Louisville Personal Injury Law Firm Gray & White Law
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