FDA lacks evidence for case against Triad

FDA lacks evidence for case against Triad

September 19th, 2011 // 12:33 pm @

Federal regulators have found no firm link between contaminated alcohol wipes made by a Wisconsin company and hundreds of reported ailments, from rashes to at least eight deaths, the U.S. Food and Drug Administration said this week.

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There may be a connection between the wipes made by Triad Group and the incidents, the agency said, but investigators lacked key evidence to establish such a link in the cases they examined. Those reported incidents were prompted by the January recall of the wipes, which the agency found were contaminated with the Bacillus cereus bacterium.

“Missing data and lack of genetic fingerprinting precluded us from tracing the clinical cases back to exposure to the suspect Triad products and determine if bacterial contamination of Triad products served as the source for the infection-related adverse events,” the FDA’s Division of Pharmacovigilance wrote in a statement to the Journal Sentinel, adding no further action is expected by the regulators.

The FDA would not say how much investigating was done on the more than 200 reports of health complaints in which Triad products were cited as the culprit. A spokeswoman listed potential actions investigators may take but would not disclose what was done in any of the cases involving Triad.

“A hands-on review of the AERS (Adverse Events Reporting System) cases by a trained professional is needed to interpret the information in these case reports, and make conclusions,” FDA spokeswoman Shelly Burgess wrote in a statement, without elaboration.

It doesn’t appear the FDA delved deeply into the details of at least one death.

The agency did not call the family of a 2-year-old Texas boy who died from an infection from the same bacterium found on Triad wipes, according to the family’s attorney.

“The FDA has not contacted us or reviewed any medical records. I invite the FDA to contact me. I would be more than happy to talk to them,” said Don Kidd, one of the attorneys for the family of Harrison Kothari, who died in January.

A Journal Sentinel investigation this year found that the FDA – the federal agency in charge of protecting public health – had known about critical issues at the company for at least a decade but failed to take any enforcement action.

At least six federal lawsuits, including one by the Kothari family, contend that Triad Group and its sister company, H&P Industries, knowingly distributed the contaminated alcohol wipes.

The FDA effectively shut down the Hartland plant in April after U.S. marshals seized $6 million worth of products. The company is barred from operating for now, and to reopen, it must follow strict guidelines and scrutiny as laid out in a consent decree filed in federal court. There are signs the company is preparing to reopen – it has paid a $4 million penal bond and has hired a new top executive.

A spokeswoman for the company did not return a call to comment. Triad previously strongly denied any connection between its products and illnesses or deaths.
January recall

Triad and H&P voluntarily recalled all the alcohol wipes and swabs in January after the FDA found that some lots were contaminated with Bacillus cereus, a bacterium responsible for killing the Houston boy. Last month, H&P and Triad recalled all lots of Povidone iodine swab sticks, prep solutions, scrub solutions and prep gels because the iodine-based products were not properly tested.

Triad, one of the nation’s largest distributors of alcohol wipes, sold products to a variety of private-label companies, such as CVS, Walgreens, Cardinal Health and Leader.

The FDA has been examining reports of eight deaths that may be connected to the company’s products. Only two – the Houston boy and a 66-year-old man – cited the bacterium directly, an agency document shows. Not included in that total is Ruby Hutcheson, 68, of Alabama. Hutcheson died just days before she was scheduled to give a deposition in her lawsuit against the company.

In the first six months of this year, more than 200 reports had been received by the FDA that cited problems potentially connected to the wipes. The reports were received by the FDA’s Adverse Event Reporting System, designed to alert regulators to potential safety concerns and evaluate a company’s compliance, according the FDA website.

However, the agency cautioned that a complaint filed with the system does not mean a product was to blame for an ailment or death.

The FDA’s Division of Pharmacovigilance, which evaluates the safety of marketed drugs and may recommend actions against companies, wrote that it expects to take no new action against Triad.

“As the Triad products have all been recalled and their manufacture and distribution have been prohibited by a consent decree of condemnation, forfeiture, and permanent injunction against the manufacturer, no further regulatory action is indicated from the perspective of DPV II,” the statement said.

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