Inspector failed to flag salmonella-linked plant

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Posted on 5th March 2009 by Gordon Johnson in Uncategorized

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Date: 3/5/2009

By DANNY ROBBINS
Associated Press Writer

DALLAS (AP) — A Texas agriculture inspector failed to note that a peanut plant at the center of a national salmonella outbreak was operating without a state health department license despite at least three visits in the years before hundreds of people got sick, according to interviews and documents obtained by The Associated Press.

The inspector responsible for certifying the plant to process organic products noted after each visit that the plant had such a license when it didn’t. Health officials said problems at the plant operated by Peanut Corp. of America might have been flagged years ago had the inspector, who has since been fired, reported the plant’s failure to obtain the required license.

When the plant was finally inspected earlier this year, Texas health officials found dead rodents, rodent excrement and bird feathers in a crawl space above a production area, leading them to order a recall of all products the plant had shipped since 2005.

Tests have since shown that ground peanuts at the Plainview plant were contaminated with the same strain of salmonella that sickened more than 650 people, is suspected of causing at least nine deaths, and led to one of the largest product recalls in U.S. history. Salmonella has also been detected in peanut samples from a Georgia plant operated by Peanut Corp., which has filed for bankruptcy amid fallout from the outbreak.

Texas Department of Agriculture spokesman Bryan Black said if the lack of a license had been properly noted, the department would have denied it organic certification and notified the Department of State Health Services. The inspector, Gaylon Amonett, was fired on Feb. 13, the day after state health officials ordered the recall.

“We trust our inspectors to do their jobs,” Black said. “Any time they do not follow the protocol, it is inexcusable.”

Because the Plainview plant was not licensed, state health officials have said they had no record it existed and never sent their own inspectors to the facility to check for possible food safety problems. All food manufacturers in the state are required to obtain a license from the state health department.

Amonett, a 22-year TDA employee who worked out of the agency’s Lubbock office, acknowledged that he checked “yes” to the question of whether the Plainview plant had records showing it was in compliance with health codes on worksheets he completed for inspections in 2005, 2006 and 2008.

The reason he checked “yes” the first time, he said, was because a plant manager told him an application for state health department licensing had been completed and was in the hands of Peanut Corp. officials at the company’s headquarters. He said he continued to check “yes” in succeeding years because he assumed that the license was granted.

Amonett said the matter was his “only mistake” in his years as an inspector. Agriculture department records show that he received a merit raise on Jan. 1.

“It’s an inadvertent mistake, and I’m sorry for it,” he said.

Jack McCasland, environmental inspector for the Plainview-Hale County Health Department, said plant officials led him to believe the licensing process was under way when he visited the facility before it opened.

“To be honest, I never really thought to follow up on it,” McCasland said. “It just never occurred to me that they wouldn’t be (licensed).”

Organic certification allows companies to market products as organically grown or produced. Processors must meet standards set by the U.S. Department of Agriculture and are monitored by a USDA-accredited entity. The Texas Department of Agriculture has served as a certifying agency since 2002.

In a memo about the Plainview matter, TDA assistant general counsel Jim Pollard wrote that Amonett was trained as an organic inspector in 2004. Under agency rules, inspectors are required to make sure a company’s licenses and other records are complete and current. The memo, obtained by the AP through a request under the Texas Public Information Act, cited the three inspections by Amonett.

TDA declined to release the inspection reports, contending that they are exempt from disclosure under the information act.

Although food safety is technically not part of the organic certification process, the salmonella outbreak has prompted the USDA to direct organic certifying entities to report any health or safety violations to the appropriate government officials.

“While we do not expect organic inspectors to be able to detect salmonella or other pathogens, their potential sources should be obvious from such evidence as bird, rodent and other animal feces or other pest infestations,” the directive stated.

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Associated Press writer Betsy Blaney contributed to this report from Lubbock, Texas.

Copyright 2009 The Associated Press.

Warning: Don't wear medication patches during MRI

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Posted on 5th March 2009 by Gordon Johnson in Uncategorized

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Date: 3/5/2009

By LAURAN NEERGAARD
AP Medical Writer

WASHINGTON (AP) — Need an MRI scan? Tell the doctor if you use a nicotine patch or any other medication patch — or you’ll risk a burn during the MRI.

Patches that ooze medication slowly through the skin are becoming more popular, from over-the-counter nicotine patches to prescription patches that deliver estrogen, pain medication, Alzheimer’s or Parkinson’s drugs, even an anti-nausea drug for chemotherapy recipients.

But the Food and Drug Administration just discovered that some are missing a key safety warning about MRI compatibility.

More than a quarter of the 60 different drug patches sold contain traces of aluminum or other metals in their backing, the part that makes them stick to the skin, estimated Dr. Sandra Kweder, the FDA’s deputy drug director.

You can’t see the metal; the patch even may appear completely clear. But affected patches contain just enough metal to conduct electricity, meaning a patch worn during an MRI scan can overheat and cause a skin burn similar to a bad sunburn.

The FDA recently learned of a few patients who suffered patch burns, none severe. In January, tracking the source of one burn, officials found that Teva Pharmaceuticals’ fentanyl painkiller patch lacked the MRI warning. The FDA then found a variety of other drug patches also lacked the warning.

On Thursday, the FDA issued a public health advisory: Tell your doctor about any medication patches, so the professional can decide which should be removed before an MRI, how soon before the scan, and when it can be reapplied.

“If there’s any uncertainty, just don’t wear it in the machine,” Kweder said. “It’s just the smart thing to do.”

As for patch makers, FDA is reviewing every product’s label to be sure ones that are supposed to carry the safety warning do. Some may be missing because a patch was reformulated to add metal after its label was written; other times FDA acknowledged it just didn’t ensure the warning was present in the first place.

Now the agency is considering having an MRI warning somehow be put on the individual patch, not just the box it comes in.

“We have to look at the different configurations of these patches and what’s going to be practical to allow for this,” Kweder said.

Copyright 2009 The Associated Press.

Dems move to overturn shield for device makers

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Posted on 5th March 2009 by Gordon Johnson in Uncategorized

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Date: 3/5/2009

By MATTHEW PERRONE
AP Business Writer

WASHINGTON (AP) — A day after the Supreme Court decided that federal rules do not protect drugmakers from state lawsuits, Democrats in Congress moved to overturn a decision that has shielded medical device companies from similar legal action.

On Wednesday the court turned away Wyeth’s claim that it could not be sued in state courts for its drug Phenegran, because it had already been approved by the federal Food and Drug Administration. The ruling upheld a $6.7 million award to a Vermont woman who lost her arm after she was improperly injected with the company’s nausea medication.

Seizing on the decision, Democrats on Thursday reintroduced a bill that would allow similar lawsuits against companies that make heart devices, catheters, hip replacements and other devices.

“Yesterday the Supreme Court rightfully upheld a patient’s right to legal recourse after sustaining an injury from a pharmaceutical product,” said Rep. Frank Pallone, D-N.J. “Today, we introduce legislation that gives patients that same right when injured by a medical device.”

The idea that corporations are shielded from state liability claims by federal rules is relatively new and was pushed aggressively under the Bush administration.

Last year, the Supreme Court agreed with the pre-emption policy in a case involving medical devices, ruling a patient injured by a catheter from Medtronic could not sue under state laws. That case turned on a provision of federal law prohibiting states from imposing their own requirements on the devices. There’s no similar provision for drugs.

Since then thousands of lawsuits against Medtronic and other device companies have been dismissed by lower courts, citing the Supreme Court’s decision.

But Pallone and other Democrats said Thursday that decision ignored decades of precedent, in which lawsuits brought by patients in state courts helped bolster safety regulation at the federal level. The bill to restore liability claims against device makers is co-sponsored by Rep. Henry Waxman, who chairs the Energy and Commerce Committee. He is expected to hold hearings on the issue in coming weeks.

The device industry’s chief lobbying group quickly slammed the effort, saying it will “produce a chilling effect on medical innovation, create more lawsuits and ultimately result in higher health care costs for all Americans.”

The Advanced Medical Technology Association, or AdvaMed, said the legislation would allow state courts to second-guess medical experts at the FDA and create a “patchwork of inconsistent and confusing guidance.”

Despite opposition from industry, the Medical Device Safety Act enjoys support from a broad range of interest groups, including consumer advocates, trial lawyers and AARP. With companion legislation introduced by U.S. Sen. Ted Kennedy, D-Mass., many analysts have already predicted the measure will become law.

Earlier in the day AdvaMed rolled out its first-ever advertising guidelines for companies like Medtronic Inc., Johnson & Johnson and Boston Scientific Corp. Among other things, the guidelines urge companies to state the risks of their implants clearly and concisely when advertising them to consumers.

The device industry has begun attracting new scrutiny from lawmakers as companies increasingly pitch their implants to consumers via TV and magazine advertisements.

Copyright 2009 The Associated Press.