Did you participate in a Norian clinical trial for spinal fracture in which Synthes bone cement was used? Discuss your situation with our lawyer.
Synthes bone cement is not approved for use on spinal fractures. Please contact our lawyer for a free lawsuit review via the form below.
On Tuesday, June 16, 2009, Norian Corporation, Synthes, Inc., and four top Synthes executives, were charged by a federal grand jury for allegedly scheming to conduct clinical trials using a bone cement on spinal fractures without the approval of the Food & Drug Administration.
According to a press release from the U.S. Department of Justice, the indictment charges that from May 2002 until fall 2004, Norian conspired with others, including Synthes and the four named executives, to conduct unauthorized clinical trials of Synthes’s medical devices, Norian XR and Norian SRS,2 in surgeries to treat vertebral compression fractures of the spine, a painful condition commonly suffered by elderly individuals.
These surgeries were allegedly performed despite a warning on the FDA-cleared label for Norian XR against this use, and in the face of serious medical concerns about the safety of the devices when used in the spine.
Read the Department of Justice press release, June 16, 2009.
According to the New York Times, prosecutors charged Synthes and Norian with running an unauthorized trial of the bone filler in spinal procedures known as vertebroplasty and kyphoplasty.
The Food and Drug Administration has received injury and death reports about such episodes and in 2002 issued a warning about the risks.
The filler was approved in 2002 by the F.D.A. for use in general bone repair, but regulators insisted that Synthes not promote its use for spinal procedures.
If you or a loved one suffered an injury or death as a result of a suspected use of Norian bone cement in spinal surgery, please complete the form below to get a free review of your possible lawsuit.
A representative of our firm will be in touch shortly.
see also:
Background
Preeminent NYC law firm accepting cases involving Norian bone cementWin compensation for misuse of Norian bone cement on spine, law firm
Injury Reports
Possible Synthes Bone Cement Lawsuit for Norian Trial Participants.Free bone cement lawsuit review of injury stemming from Synthes filler
Stryker Hip Implants
FDA Issues Warning on Stryker Hip Implants. Free Lawsuit Review.Stryker Hip Implants: Get latest news and a case review from lawyers
