Archive for the 'Medical Device' Category

Army doctor forged Infuse study

Thursday, June 11th, 2009

Yet another scandal involving the Walter Reed Army Medical Center has surfaced. Apparently Dr. Timothy R. Kuklo, a former surgeon at Walter Reed, may have falsified his study of Medtronic Inc.’s Infuse Bone Graft.

During his time at Walter Reed, Kuklo conducted, published, and promoted a study in which he claimed that soldiers’ leg injuries healed faster when Infuse was used.

However, major news agencies such as the Wall Street Journal and the New York Times have reported that Kuklo lied about the number of patients and injuries treated, did not obtain the Army’s permission to conduct the study and forged the signatures of his co-authors.

Kuklo is currently an associate professor at the Washington University medical school in St. Louis. He is a paid consultant for Medtronic and even gave speeches on Medtronic medical devices while at Walter Reed.

His position at Medtronic may cause legal problems for both of them since Kuklo employed an off-label use for Infuse in his study and pharmaceutical companies are forbidden from promoting off-label use of their products.

FDA told to toughen medical device reviews

Tuesday, February 10th, 2009

The Food & Drug Administration (FDA) neglected to conduct appropriate medical device reviews, a new report by the Government Accountability Office (GAO) says.

According to Dow Jones, the GAO report involves some high-risk medical devices. This shocking news follows the revelation earlier this month that FDA scientists wrote to President-Elect Obama’s transition team looking to end corruption at the agency

The FDA is responsible for making sure that drugs, medical devices, and other products are safe to the American public.

It seems it has failed again and continues to put untold citizens who have been fitted or implanted with sensitive and high-risk medical devices in jeopardy.  The GAO’s report charges the FDA to immediately work to ensure high-risk medical devices be thoroughly reviewed as a opposed to it merely providing clearance, said Dow Jones.  Of note, external cardiac compressors are among the types of devices that do not receive thorough review.

If you or a loved one was injured because of a defective medical device, it is important to contact an attorney experienced in medical malpractice law.

FDA Told to Toughen Medical Device Reviews

Tuesday, January 20th, 2009

The Food & Drug Administration (FDA) neglected to conduct appropriate medical device reviews, a new report by the Government Accountability Office (GAO) says.

According to Dow Jones, the GAO report involves some high-risk medical devices. This shocking news follows the revelation earlier this month that FDA scientists wrote to President-Elect Obama’s transition team looking to end corruption at the agency

The FDA is responsible for making sure that drugs, medical devices, and other products are safe to the American public.  It seems it has failed again and continues to put untold citizens who have been fitted or implanted with sensitive and high-risk medical devices in jeopardy.

The GAO’s report charges the FDA to immediately work to ensure high-risk medical devices be thoroughly reviewed as a opposed to it merely providing clearance, said Dow Jones.  Of note, external cardiac compressors are among the types of devices that do not receive thorough review.

If you or a loved one has been harmed by a defective drug or defective medical product, seek the advice of an experienced defective drug attorney. You could be entitled to financial compensation.