Army Investigation Reveals Doctor Overstated Medtronic’s Success in Treating Injured Soldiers
May 13, 2009
An investigation conducted at the Walter Reed Army Medical Center found that Dr. Timothy Kuklo, a former surgeon at Walter Reed, made false claims and exaggerated the benefits of Infuse, a bone-growth product manufactured by Medtronic Inc. (“Medtronic”). Doctors at Walter Reed treated injured soldiers with Infuse. Kuklo’s study claimed to be a review of those soldiers who were given Infuse to treat lower-leg wounds with open fractures caused by explosions in the Iraq war from March 2003 to March 2005. However, the investigation found that Kuklo, a paid consultant for Medtronic, cited higher numbers of patients and injuries than the hospital could account for. Additionally, the investigation revealed that Kuklo forged the signatures of four Walter Reed doctors prior to submitting his article on the benefits of Infuse to a British medical journal. Kuklo conducted his study without seeking permission from the Army.
Concerns Surrounding Infuse
Infuse is commonly used in spinal surgeries and for the treatment of broken bones. Infuse was first approved by the Food and Drug Administration (“FDA”) in 2002 for use in the lower spine, and in 2004 for fractures of the shinbone. Since doctors are free to use Infuse for off-label purposes, surgeons at Walter Reed used Infuse to treat soldiers with far more severe injuries. Similarly, Infuse has not been approved by the FDA for use in the neck area. In July 2008, this other off-label use of Infuse prompted the FDA to issue a safety alert linking the use of Infuse in the neck area with potentially life-threatening complications.
Medtronic Under Investigation
Last year, the Justice Department commenced an investigation to determine whether Medtronic illegally promoted the off-label use of Infuse by paying doctors. A spokeswoman for Medtronic confirmed that it financially supported some of Kuklo’s research at Walter Reed. According to the Army’s investigation, Kuklo’s study “suggested a much higher efficacy of the product being researched in the article than is supported by the experience of the purported co-authors.” Kuklo’s study has since been retracted at the Army’s request.
If you or a loved one suffered injuries caused by Infuse, contact us today for a confidential and free case evaluation.