News Tagged ‘MDSA

Hamburg hopes to create a culture in FDA where concerns are heard

hamburg 100x100President Barack Obama’s top pick for Food and Drug Administration (FDA) commissioner, Bioterrorsim expert and former New York City health commissioner Dr. Margaret Hamburg, says if confirmed she would “create a culture (at the agency) that would enable all voices to be heard,” according to Thompson, a human resources Web site. The comment was made during a question-and-answer exchange with Sen. Barbara Mikulski (D-Md) during the 1 ½-hour confirmation hearing.

Read the rest of this entry »

Alabama man injured by cardiac defibrillator sues manufacturer

Beasley Allen Law Firm attorneys P. Leigh O’Dell and Ted G. Meadows filed a lawsuit on April 29, 2009, on behalf of Patrick M. Lancaster of Alabama, alleging that the plaintiff suffered injuries as a result of having been implanted with a Sprint Fidelis Lead manufactured by Medtronic, Inc. The lawsuit names defendants Inc., Puerto Rico, Inc., and Puerto Rico Operations Co.

The complaint incorporates by reference the relevant portions of the Master Consolidated Complaint for Individuals on file with the Clerk of the Court for the United States District Court for the District of Minnesota in the matter In Re , INC., SPRINT FIDELIS LEAD PRODUCT LIABILITY LITIGATION.

Read the rest of this entry »

FDA meeting could compromise Medical Device Safety Act

The Food and Drug Administration (FDA) has planned an internal meeting today to discuss the strategic direction of the agency’s medical device center, adding fuel to concerns that the government agency carelessly approved medical devices and as a result put patients’ health and safety at risk, according to the American Association for Justice (AAJ).

Read the rest of this entry »