FDA’s Medical Device Approval Process Slammed during Senate Hearing

On April 13, 2011, the U.S Senate’s Special Committee on Aging convened for a hearing entitled “A Delicate Balance: FDA and the Reform of the Medical Device Approval Process.

During the two hour hearing, the Senate panel heard from seven witnesses commenting on both sides of the U.S. Food and Drug Association’s process currently in place for approving medical devices. The debate centered on how to foster medical technological innovation while ensuring the protection of patient safety. During the hearing, witnesses criticized the FDA’s fast-tracking 510(k) process that allows medical devices into the marketplace without having to undergo clinical trials or inspection. Senator Corker, who led the panel, summarized the hearing best when he stated that, “No one is particularly happy with the FDA.”

Testimony of DePuy ASR Hip Implant Recipient

Perhaps, the most illuminating testimony was given by the first witness, Katherine Korgaokar, a 41-year-old woman who received a DePuy ASR prosthetic hip at the age of 36. Based on the recommendation of her orthopedic surgeon, Ms. Korgaokar chose the DePuy ASR hip implant because it was “specifically designed for young active people [and] . . . that the metal-on-metal design was superior to other designs and that it should last at least 20 years or more.” However, four years later, Ms. Korgaokar was informed by her doctor that the DePuy ASR hip implant she received was recalled. Thereafter, Ms. Korgaokar underwent testing, and was informed that her chromium and cobalt levels were “about 1,000% higher than they should be.” This past January, she underwent a revision surgery, which has since caused her extreme pain. She also told the panel that she is concerned about what problems she will face down the road, including whether she will be able to ever have children.

Ms. Korgaokar also told the panel that she was “shocked” when she learned about the approval process that allowed the DePuy ASR on the market. Additionally, she informed the panel that she recently learned that the surgeon who recommended the DePuy ASR “received more than $600,000 from DePuy in ‘consulting’ income.’” This was never disclosed to her when she followed his recommendation and chose the DePuy ASR implant.

DePuy ASR Recall Hip Replacement Lawsuit

If you or a loved one has experienced any problems as a result of a DePuy ASR hip replacement implant, you may be able to file a lawsuit seeking compensation for your medical expenses, pain and suffering, lost wages and more. Contact one of our lawyers today for a free and confidential DePuy ASR recall lawsuit evaluation. The lawyers at Bernstein Liebhard LLP have extensive litigation experience and have recovered billions of dollars for their clients. In addition to being staunch advocates for your claim, our hip replacement injury lawyers also provide personal attention to guide you through the complex litigation process.