Bernstein Liebhard LLP, a nationwide law firm representing clients injured by transvaginal mesh implants and all metal hip implants reports on the discussion at the inaugural U.S. Food and Drug Administration (“FDA”) Patient Network Annual Meeting, which took place on May 18, 2012. The meeting featured presentations from FDA experts and open discussions with patients and advocacy groups regarding the FDA drug and medical device approval processes. Speakers from numerous FDA departments outlined FDA processes and goals, and solicited audience input with questions and answers at the end of each presentation. One attendee asked about how the FDA determines classification levels for medical devices and how the FDA tests the devices to see if they are safe. The FDA has recently come under fire given the widespread controversy over its expedited 510(k) approval process, which granted market approval for both transvaginal mesh implants and all metal hip implants.

FDA Wants To Better Monitor Patient Feedback

Bernstein Liebhard LLP is encouraged that the FDA opened discussion on its drug and device approval policies and solicited patient input for these important issues, especially in light of the recent DePuy hip recall and FDA warnings concerning vaginal mesh implants. The lawyers at our firm represent hundreds of patients alleging injuries stemming from these and other defective medical devices.

Peper Long, associate director of External Relations for the Center for Devices and Radiological Health (“CDRH”), said that the FDA relies on patients to report adverse events to the agency in order to monitor the safety of medical devices and identify problems. “We want and need more information in those reports,” Long said. She explained that a central strategy for the FDA this year is to create a national post- market strategy to better monitor patient feedback. Patient advocacy attendees also weighed in on the issue and suggested that patients would be more likely to provide feedback and report adverse events if a more effective system is implemented.

Defective Product Lawsuits Mounting

The safety of various medical devices is being challenged in federal and state courts around the country. Thousands of lawsuits have been filed concerning the August 2010 DePuy ASR hip recall and problems stemming from vaginal mesh implants. Learn more by watching these transvaginal mesh implants and all metal hip implants videos, or by visiting our website,

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.

Bernstein Liebhard LLP 10 East 40th Street New York, New York 10016 (877) 779-1414

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Contact Information: Felecia L. Stern, Esq. Bernstein Liebhard LLP

Published May 31, 2012 by