FDA knew of problem yet tainted alcohol pads still caused serious problems

Blurbs from an MSNBC article discussing the harms associated with products released from a plant run by Triad Group.  The products include such materials as alcohol pads used for sterilization, creams and ointments, lubricating jelly, swabs, etc: Link

The death of a 2-year-old Houston boy from a rare infection blamed on contaminated alcohol wipes may be only the first casualty tied to allegedly shoddy sterilization practices by a Wisconsin medical products firm….

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“Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed,” officials wrote in inspection reports. But there’s no record that the FDA sent warning letters typically used to force firms to comply….

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Reported injuries range from superficial skin infections to serious complications, and even one claim of another death….

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Another 100 reports of problems with alcohol prep pads have been logged by the FDA since the Jan. 5 recall of Triad products because of potential contamination with the bacteria Bacillus Cereus, an agency spokesman said.

And a Tennessee man has filed his own $30 million lawsuit against Triad, claiming he developed an infection from Bacillus Cereus from the wipes and had to undergo open-heart surgery as a result.

“That was the most scared I’ve been in my life,” said Donovan Joseph Postich, a 55-year-old ironworker from Madisonville, Tenn., who is permanently disabled after the surgery. “They told me about the tainted pads and you just kind of put two and two together.”

Triad’s recall covers all lots of its alcohol prep pads, wipes and swabs, totaling perhaps hundreds of millions of products sold in the U.S., Canada and Europe.

H&P Industries, which does business as the Triad Group, is among the largest providers in the U.S. of generic medical products often sold under private labels of grocery stores such as Safeway and Kroger and drugstores such as CVS and Walgreens….

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Problems with sterilization, contamination
Documents show that FDA officials expressed concerns following visits to the Triad plant from July 15 to July 17, 2009, and again from April 19 to May 18, 2010. Inspectors reported that the company could not validate the processes used to ensure quality or sterility not only of alcohol prep pads and wipes, but also other products used for intimate care.

Those include hemorrhoid creams, infant and adult glycerin suppositories and sterile lubricating jelly widely used in homes, as well as in clinics and hospitals for medical exams.

The inspection documents, known as FDA Form 483s, were obtained by msnbc.com from a confidential source and confirmed by FDAzilla.com, an independent Web site that monitors the FDA. Copies of the documents were sent to the FDA for review; the agency did not deny their authenticity.

In the documents, inspectors cited Triad’s sterilization process for alcohol prep products, questioning dosages of the gamma radiation process that ensures sterility.

“Specifically, there is no validation of the gamma radiation sterilization process for the Alcohol Swabsticks labeled as sterile,” the report said.

In addition, shipments of Triad Plus BZK prep pads that failed to meet specifications were released for distribution, inspectors said.

The documents did not mention specific contamination of the swabs or pads with Bacillus Cereus.

However, inspectors said Triad’s processes “may not be adequate to sterilize” the lubricating jelly and charged that Triad had failed to address “high microbial bioburden levels” previously detected in the purportedly sterile jelly. Information about the specific type of contamination was redacted in the documents.Inspectors reported worn and broken manufacturing equipment, misidentified batches of hemorrhoid cream, and instances where if a single batch of hemorrhoid ointment or glycerin suppositories failed quality standards, others weren’t tested for the same problem and were released for distribution.

In one case, inspectors noted that a batch of lubricating jelly failed viscosity tests on Jan. 28, 2010, but was released anyway with the specific consent of Triad’s president, David Haertle. A week later, the decision to release the jelly per Haertle’s authority was revised and cases of the jelly were scrapped, but some already had been distributed, according to the report.

“No action was taken on the distributed cases,” inspectors wrote.

Overall, officials concluded the company had no procedures in place for reporting or acting on manufacturing problems….

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Before the recall, FDA had received no reports of adverse events related to Triad alcohol prep products, Kelly said. From Jan. 5 to Jan. 31, the company received about 100 reports of problems with alcohol prep products, which Kelly said was typical of the number of reports received after most recalls are posted. They included about 50 reports of infection and one death, which could not be tied to contaminated wipes.

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If you or someone you know thinks they have been injured by one of Triad’s products, please advise them to contact their doctor immediately to discuss their situation.  After the health concerns are taken care of, please CONTACT us immediately for a free case consultation.  The Ronan Law Firm has over 25 years of litigation experience.  The Ronan Law Firm has successfully represented clients all across the nation in pharmaceutical cases such as Vioxx, Fen-Phen, Avandia and more. Why let uncertainty prevent you from obtaining proper recovery for your injury?  CONTACT the Ronan Law Firm with any questions or concerns that you may have.