Survey Of FDA Workers Reveals Concerns About Corporate Interests In Device Approval Process
Bernstein Liebhard LLP, a New York law firm nationally recognized for its consumer protection and mass tort practices, reports on the results of a 2011 survey conducted by the Union of Concerned Scientists (“UCS”) that showed that workers in the U.S. Food and Drug Administration’s (“FDA”) medical device approval section were concerned about the influence of special interests on device approval decisions. The study, released on March 7, 2012, revealed that some workers felt pressured to approve devices even when they harbored doubts about the devices’ safety. One in four of the participants answered yes to the question: “Have you ever been pressured to approve or recommend approval for a device or product despite reservations about the safety, efficacy or quality of the product?” This is especially alarming given the recent attention surrounding the FDA 510(k) device approval process, which allowed allegedly dangerous devices such as vaginal surgical mesh and certain metal hip implants to be marketed without clinical testing.
FDA Scientists Are Troubled Over Business Interests For Medical Devices
The UCS survey questioned 997 FDA employees, 158 of whom worked in the FDA center for devices. “FDA scientists expressed concern on several fronts, including their right to publish research and communicate with the public, the degree of corporate and political influence on regulatory decisions, and the overall transparency and accountability of the agency’s decision making,” a summary of the survey results from the UCS blog noted. Forty percent of the participants felt that business interests that influence regulatory decisions were “too high.” Some participants were worried about the FDA’s ability to monitor the devices after they hit the market. One in four participants was uncertain that the FDA could assure patient safety from defective medical devices that malfunction after they’re sold. The latest recall of certain metal hip implants and the controversy surrounding the safety of vaginal surgical mesh implants highlight the grave dangers of allowing medical device manufacturers to market their products without proper testing.
Litigation Continues Over Dangerous Devices Like Vaginal Surgical Mesh And Metal Hip Implants
The lawyers at Bernstein Liebhard are actively involved in numerous litigations concerning allegedly defective medical devices, including vaginal surgical mesh and metal hip implants. The firm has filed dozens of cases in In re Pelvic Mesh/Gynecare Litigation, No. 6341-10 (N.J. Super Ct.), and In re Pelvic Mesh Litigation/Bard No. L-6339-10 (N.J. Super. Ct.), which are two consolidated actions of all the vaginal surgical mesh lawsuits filed in New Jersey state court. The Firm is also actively filing cases on behalf of individuals who received metal hip implants manufactured by DePuy in the following actions: In re: DePuy Orthopaedics, Inc. ASR Hip Implant Products Liability Litigation (“MDL No. 2197”), which is currently underway in the U.S. District Court for the Northern District of Ohio and In re: DePuy Orthopaedics, Inc. Pinnacle Hip Implant Products Liability Litigation (“MDL No. 2244”), which is currently underway in the U.S. District Court for the Northern District of Texas.
Those who have experienced complications from vaginal surgical mesh or metal hip implants may be entitled to compensation for medical expenses, pain and suffering, lost wages and other injuries. For more information about filing a lawsuit, contact an attorney at Bernstein Liebhard LLP at (877) 779-1414 or at firstname.lastname@example.org.
About Bernstein Liebhard LLP
Bernstein Liebhard LLP is a New York-based law firm exclusively representing injured persons in complex individual and class action lawsuits nationwide since 1993, including those who have been harmed by dangerous drugs, defective medical devices and consumer products. The firm has been named by The National Law Journal to the “Plaintiffs’ Hot List,” recognizing the top plaintiffs’ firms in the country, for the past nine consecutive years. Only two firms in the country have been selected for the Hot List nine years in a row.
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