Image: JoNel Aleccia
By JoNel Aleccia Health writer
updated 3/31/2011 1:45:34 PM ET 2011-03-31T17:45:34

Two U.S. senators on Thursday asked the federal Food and Drug Administration to answer for its handling of investigations into millions of recalled medical prep products tied to serious infections and death.

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Sen. Michael F. Bennet, D-Colo., and Sen. Lamar Alexander, R-Tenn., sent a letter to FDA Commissioner Margaret Hamburg asking her to explain the agency's actions regarding H&P Industries Inc. and the Triad Group of Hartland, Wis., whose products have been blamed for serious illnesses in the senators' states.

As reported this week , the FDA on Monday asked H&P Industries and its sister company, the Triad group, to voluntarily shut down production of its drug products. So far, Christy Maginn, a spokeswoman for the firm, will not say whether the company intends to comply, stating only that officials are in discussions with FDA and plan to meet next week.

Maginn said H&P Industries officials had not seen a copy of the letter to Hamburg and could not immediately comment.

But the senators have questions about reports that the FDA knew about problems at the plant much earlier.

"We are particularly concerned by media reports that suggest that the FDA was aware as early as July 2009 of manufacturing sterility and contamination problems at Triad Group, yet no public action was taken until physicians at the Children's Hospital in Denver, Colorado, alerted the FDA to a link between patient infections and Triad Group products in November 2010," the letter states.

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H&P Industries and Triad Group, two firms run by Wisconsin brothers David Haertle and Eric Haertle and their sister, Donna Petroff of Antioch, Ill., have been under scrutiny since last fall, when The Children's Hospital investigated unusual bloodstream infections in two young patients and detected Bacillus cereus contamination in two-thirds of Triad alcohol wipes tested.

The findings led to an FDA inspection and ensuing recalls of lubricating jelly and millions of alcohol prep wipes. This month, the firm also recalled povidone iodine prep pads because of different bacteria. This week, Michael C. Rogers, the FDA's acting director of the Office of Regional Operations, said that a new inspection has revealed a variety of additional pathogens.

At least three lawsuits have been filed in connection with the recalls, including one by a 55-year-old Tennessee man who said he developed a serious heart infection and required surgery after using contaminated wipes. The parents of a 2-year-old Houston boy who died after an infection caused by Bacillus cereus also blame the wipes.

This week, a 31-year-old Colorado woman with multiple sclerosis filed a lawsuit in U.S. District Court claiming she developed a life-threatening infection after using Triad wipes packaged with her vital medication. Jayme Maestas, of Lakewood, developed the infection after using the wipes which were packaged as sterile, said her lawyer, Paul J. Komayatte. However, her infection did not test positive for bacteria found in the Triad wipes, he noted.

In addition, the parents of one of the two children whose cases prompted the Colorado hospital's investigation have said they intend to sue. A 10-year-old boy had entered the hospital for leukemia treatment when he developed a life-threatening infection, his parents said.

Company officials on Thursday emphasized that there's no confirmed link between the infections and death cited in the lawsuits and particular Triad Group products.

The Triad Group recalls cover hundreds of millions of products widely used in hospitals and clinics and sold by pharmacies and other health care providers, the senators noted.

In a statement, Bennet and Alexander asked the FDA to take strong action.

"We urge the FDA to carefully review its oversight of medical product manufacturing to ensure that manufacturers comply with the voluntary compliance measures suggested by FDA inspectors," it read.

A spokesman said the senators hope to hear back from Hamburg as soon as possible. The senators are both members of the Senate Committee on Health, Education, Labor and Pensions. 

Shelly Burgess, an FDA spokeswoman, said that the agency would respond directly to the senators involved.

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