Recently, the U.S. Food and Drug Administration (“FDA”) has been repeatedly criticized by the media, experts and congressmen for its medical device approval process. Calls for regulatory reform have been become commonplace given the wave of medical devices approved by the FDA that have since proven to be unsafe. Many have suggested that the FDA is failing to safeguard and protect the welfare of the public. Two commonly cited examples of the agency’s flawed approval process involve the recalled DePuy ASR hips and transvaginal mesh implants. Until recently, flaws in the FDA’s approval process have been made public by medical experts, lawyers and patient advocates. However, a recent lawsuit filed by six FDA staffers provides an insider’s perspective that not only supports outsiders’ claims that the approval process is inherently flawed, but also suggests that agency officials actively concealed these flaws from the public.

Staffers Sue FDA Over Emails Questioning Safety Of Medical Device Approval Process

On January 30, 2012, the Washington Post reported that six current and former employees of the FDA filed a lawsuit in the U.S. District Court for the District of Columbia, alleging that the FDA monitored emails sent from their personal Gmail and Yahoo accounts from their work computers for more than two years. According to the lawsuit, the emails included messages to congressional staff and drafts of whistleblower complaints. The FDA began monitoring the emails of six doctors and scientists after they warned Congress that the FDA was approving medical devices that posed unacceptable risks to patients. In addition, the FDA allegedly used spyware to take electronic snapshots of staff computer screens. The plaintiffs, who worked for the FDA’s Office of Device Evaluation, allege that the monitoring began three years ago, after nine FDA employees signed a letter to President Obama’s transition team claiming that there was agency misconduct in the approval of medical devices.

Transvaginal Mesh And Metal-On-Metal Hips Support FDA Staffers Concerns

Although the FDA staffers highlighted cancer-screening devices as unsafe in their 2009 warning letter to Congress, other FDA-approved medical devices have also been the subject of widespread criticism. Recently, House Democrats requested that congressional hearings be held to review the safety of medical devices implanted into patients as well as examine the FDA approval process. In support of these requests, the congressmen cited problems associated with transvaginal mesh implants, as well as metal-on-metal artificial hips, such as the DePuy hip replacement. Medical device manufacturers, such as Johnson & Johnson, utilized the FDA’s fast-track 510(k) process in order to receive market approval for both transvaginal surgical mesh and metal-on-metal hip implants. The expedited 510(k) process only requires manufacturers show that their medical device is substantially similar to others already on the market. Under the 510(k) process, medical devices do not have to go through rigorous clinical testing or trials in order to receive market approval. According to the congressmen, the serious injuries caused by defective medical devices such as pelvic mesh and the DePuy metal-on-metal recalled hip replacement implants demonstrate the need for regulatory reform.

Medical Device Defects Spur Artificial Hip And Transvaginal Mesh Lawsuits

If you or a loved one has experienced complications as a result of being implanted with a defective medical device such as transvaginal mesh or a metal-on-metal artificial hip, you may be able to file a vaginal mesh lawsuit or a hip replacement 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 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 lawyers also provide personal attention to guide you through the complex litigation process.

Published February 10, 2012 by