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Two U.S. Senators Call for Increased Oversight of Medical Products

Two U.S. Senators have asked the U.S. Food and Drug Administration (FDA) to increase their oversight of medical product manufacturers following product recalls at Triad Group.  On April 1, 2011, Sens. Michael Bennet (D-Colo.) and Lamar Alexander (R-Tenn.), both members of the Senate Committee on Health, Education, labor and Pensions, submitted a letter to the FDA in which they expressed their concern that the FDA was aware of manufacturing sterility and contamination problems at Triad Group as early as July 2009, but failed to take appropriate action to protect the public until late 2010.  In their letter, the Senators urged the FDA to review its oversight procedures with respect to medical product manufacturing to ensure that manufacturers comply with recommended safety measures.

According to a Milwaukee Journal Sentinel article, Triad has been sued by a Texas couple who allege that the company’s alcohol wipes were the cause of a bacterial infection that caused the death of their 2-year-old son. In January 2011, Triad recalled all of its swabs and wipes due to suspected contamination with the bacteria Bacillus cereus, which can lead to life-threatening infections in at-risk populations, including surgical and immune-suppressed patients. According to Triad, the recall was being done out of an "abundance of caution" and was not linked to an illness or death.

According to the Journal Sentinel, on March 29, a Colorado hospital confirmed that two-thirds of the Triad-made alcohol prep pads it tested were contaminated with Bacillus cereus and a recent FDA inspection report revealed numerous issues at the Triad plant, including employees packing acne pads into product containers with their bare hands and children's multi-symptom cold medicine made without a necessary active ingredient.

Earlier this week, the FDA asked Triad Group to voluntarily stop production of its drug products. The company has not said whether it would comply with the request.

According to Sen. Bennet’s communications director, Adam Bozzi, “the Senators are hoping the FDA will shed some light on what they knew about the problem and review both the agency's and the company's role in oversight, manufacturing practices and enforcement of compliance measures. They also hope to find ways moving forward that this type of incident does not happen in the future.”

Steinberg Goodman & Kalish  (www.sgklawyers.com) is dedicated to protecting victims and their families.  We handle medical malpractice, product liability, personal injury, wrongful death, auto accidents, professional negligence, birth trauma, and railroad law matters. Contact us at (800) 784-0150 or (312) 782-1386.