Hepatitis C Triad Prep Pads; Questions On The FDA Handling Of Problems

FDA knew of problems at plant that made tainted alcohol wipes
Documents show sterilization issues as early as 2009; dozens may have been sickened
'
"It also reported on a 55-year-old Tennessee man who contracted endomyocarditis, allegedly after using a Triad pad packaged with Genentech's peginterferon alfa-2a drug for hepatitis C. The man survived but required cardiac valve replacement surgery in December, the website indicated. He too has filed suit against Triad, with Genentech also named as a defendant".
'
By JoNel Aleccia Health writer
msnbc.com msnbc.com
updated 2/22/2011 8:38:13 AM ET 2011-02-22T13:38:13

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.

Since msnbc.com reported Feb. 15 about the death of Harrison Kothari , who was infected with the same type of rare bacteria that sparked the recall of tens of millions of pads and swabs, dozens of people have stepped forward to say they may have been sickened, too.
At the same time, government documents obtained by msnbc.com showed that federal Food and Drug Administration inspectors knew about problems with contamination and sterilization at a plant run by the Triad Group of Hartland, Wis., as early as July 2009.

“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.

In the last week, more than 50 people have contacted lawyers representing Sandra and Shanoop Kothari, who are suing the Triad Group for gross negligence in their son’s Dec. 1, 2010 death.
Skin infections, serious complications “We’re seeing a wide spectrum of complaints,” said Jim M. Perdue Jr.,the lawyer representing the Kothari family. Reported injuries range from superficial skin infections to serious complications, and even one claim of another death. None of the new infections has been confirmed, Perdue added.

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.
Triad officials did not respond to repeated e-mails and phone calls from msnbc.com.

Problems with sterilization, contamination Documents show that FDA officials expressed concerns following visits to the Triad plantfrom 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.

Triad failed to report complaints Further, inspectors reported that Triad failed to evaluate and investigate a complaint from a hospital about high rates of abnormal pap smear results tied to the sterile lubricating jelly. "Hospital lab confirms that the jelly was to blame," the report said. Triad had received six similar complaints between July 2009 and May 2010, investigators noted.

Investigators also said Triad failed to file proper forms documenting a complaint that alleged more than 30 women reportedly developed vaginal irritation after a doctor used the jelly during exams, with some developing problems that had to be treated with medication for up to three weeks or more. In December, Triad recalled specific lots of the jelly, saying they might not be sterile. The FDA re-issued the warning on Feb. 16.
According to FDA protocols, Triad could have received warning letters demanding corrections of violations. If the problems weren't fixed, the FDA could seize potentially tainted product, issue an injunction to stop business operations or force criminal prosecution that could lead to jail time or fines.

A search of FDA’s online warning letters database revealed no warning letters issued to H&P Industries or the Triad Group in 2009, 2010 or 2011.
Triad's response to the observations was listed only as: "Promised to correct," the documents showed.

Courtesy Of The Kothari Family
Harrison Kothari, 2, of Houston, died Dec. 1, 2010 from meningitis caused by a rare type of bacteria, Bacillus cereus. His parents say his infection was caused by Triad alcohol prep products which were used on Harrison. All lots of the wipes were recalled because of Bacillus cereus contamination.

The FDA inspection reports were first completed 16 months before 2-year-old Harrison Kothari developed meningitis caused by Bacillus cereus bacteria. He died on Dec. 1, 2010. The child was recovering well after the removal of a benign cyst and was scheduled to go home the day before the fatal infection flared up.
“This is confirming the Kotharis’ worst nightmare — that this was far more widespread than they thought,” said Perdue, the family’s lawyer.


Questions Raised About FDA Handling of Triad Problems

By John Gever, Senior Editor,

MedPage Today Published: February 23, 2011

Although FDA inspectors had reported a host of quality-control problems at Triad Group long before it recalled millions of contaminated alcohol-based prep pads, swabs, and jellies, the agency mysteriously took no corrective action, according an MSNBC.com report. Citing FDA inspection reports provided by an anonymous source, the website alleged that the agency knew about "shoddy sterilization practices" at Triad Group's plant in 2009, yet did not issue a warning letter or alert customers or physicians. On January 5 of this year, Triad announced a recall of all lots of isopropyl alcohol prep pads, swabs, and swabsticks -- labeled as sterile as well as non-sterile -- because of potential contamination by Bacillus cereus bacteria. The company cited a single case of non-life-threatening skin infection as the reason for the recall. The firm's products were sold under the Triad name and as house brands for Cardinal Health, CVS, Walgreens, and other retailers and distributors.

The recall was later expanded to include lubricating jellies sold by Triad as sterile. Firms such as Genentech that had packaged their injectable drugs with Triad prep products were then forced to issue their own alerts. But since the recall was announced, additional reports of infections associated with the products have come to light -- including at least one death, according to MSNBC.com. The website described a two-year-old Texas boy who died of meningitis attributed to B. cereus infection. The boy's parents are now suing Triad.

It also reported on a 55-year-old Tennessee man who contracted endomyocarditis, allegedly after using a Triad pad packaged with Genentech's peginterferon alfa-2a drug for hepatitis C. The man survived but required cardiac valve replacement surgery in December, the website indicated. He too has filed suit against Triad, with Genentech also named as a defendant.

The MSNBC.com report said that FDA inspectors had found "as early as July 2009" that sterilization procedures in Triad's plant in Hartland, Wis., were not being followed. The company had claimed to use gamma radiation to sterilize its products but the inspectors were unable to validate the process, MSNBC.com said. Inspectors reportedly also found that the company had shipped products that failed to meet specifications, and had failed to investigate complaints about faulty products from customers and to relay them to the FDA as required.

However, no warning letters or other follow-up action by the FDA ensued.

Contacted by MedPage Today, an FDA spokesman could not immediately confirm or deny the MSNBC.com report or answer other questions about Triad, but promised a response in due course. Officials at Triad Group could not be reached for comment.

The company's Internet homepage indicated its website had been taken down for maintenance. MSNBC.com quoted the FDA spokesman as saying the agency had not received any adverse event reports about Triad products prior to the recall. During the first month afterward, about 100 were filed, including 50 describing infections and one involving a fatality.

The spokesman said the number of reports was typical for publicly announced recalls. Only one report specifically identified B. cereus, according to MSNBC.com. He also told the website that another inspection had been conducted Jan. 7 that disclosed "deviations from our current good manufacturing regulations," but he did not provide specifics. An investigation is ongoing, he said. http://www.medpagetoday.com/Washington-Watch/FDAGeneral/25020