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On June 17, 2008, the FDA announced that Chattem Inc. failed to inform officials about new warnings added to its Icy Hot heat therapy patches after getting more than 168 complaints, according to a recently released letter.

In a warning letter to the company, the U.S. Food and Drug Administration said Chattem did not tell the FDA it was changing the wording on the product’s label to help consumers avoid burns and other skin irritations after it received the complaints, the agency said in the letter dated June 6.

The company also did not report some complaints to the agency within the time period required by law, it said. It was not immediately clear how many consumers were seriously injured or otherwise harmed by the patch. FDA and Chattem officials did not return calls seeking comment.

Icy Hot is one of the companies biggest-selling brands, according to its 2007 annual report, which did not break down sales for specific products. The product line aims to help prevent muscle pain through the use of menthol a mint extract that produces a cooling sensation. The patches come in different shapes to adhere to the back and other sore body parts.

The FDA said Chattem did not have proper procedures in place to handle complaints and other problems.

It also said the product’s label did not properly explain its warnings or caution that certain users such as children should not use the patches.

“The duration of use of ‘up to 8 hours’ raises significant clinical concerns as this duration exceeds the established time at which a 2nd degree burn has been shown to occur on human skin at the target temperature of the patch,” the letter also said.

“The labeling needs to provide adequate directions for use with respect to the duration the device is to be applied to the patient’s skin,” it added.

The FDA’s letter follows an inspection of the company’s Chattanooga, Tennessee, plant Feb. 5 through Feb 8. Chattem recalled a variety of Icy Hot heat therapy products on Feb. 8, saying it had received consumer reports of burns and skin irritation.

FDA officials issue dozens of warning letters a year and can impose fines, product seizures and other penalties, although most are resolved without such measures.

The FDA said Chattem has 15 days to notify the agency about steps it was taking to correct problems. The agency acknowledged the company had sent an earlier response about some problems but said it was inadequate.

On June 20, 2008, the owner of a building that was badly damaged in a deadly new York City crane collapse that took place on May 30, 2008, has filed a $100 million lawsuit against the crane owner, contractor and others working on a new 32-story apartment tower across the street.

The company, First & 91 LLC, says in court papers filed in Manhattan’s state Supreme Court that it lost tenants and rent revenue, faces additional costs including repairs, and will suffer because the Upper East Side building has been “stigmatized.”

The lawsuit names crane owner New York Crane & Equipment, crane lessee Sorbara Construction, general contractor Leon D. Dematteis Construction and the owner of the building under construction, 1765 First Associates LLC.

The contractor declined to comment and other defendants did not immediately return calls. The crane operator and another worker died when the 200-foot crane collapsed and smashed into an apartment building at East 91st Street at First Avenue. The May 30, 2008 accident occurred 40 blocks north of the site where another crane collapse killed seven people on March 15, 2008.

The plaintiffs contend the crane in the second collapse was “improperly and hazardously welded” and that that was concealed from the city’s Buildings Department.

The investigation into the May 30, 2008 collapse has focused on a crane part called the turntable. Investigators say it was taken off another crane with cracks in it more than a year ago, rebuilt and installed about a month before the accident.

The 24-year-old Kodiak crane that was at the 91st Street site is a model that is out of production. Immediately after the collapse the city shut down four other sites that were using Kodiak cranes.

The Buildings Department said Friday that one 24-year-old Kodiak crane also owned by New York Crane was being dismantled this weekend after an engineer found two cracks in that crane’s turntable.

One of the three other sites where Kodiak cranes were operating was given the OK to resume operating. Tests are pending on the other two sites, the city said.

On June 19, 2008, the Veterans Administration responded to an ABC News/Washington Times investigation, and announced their plans to inform an estimated 32,000 veterans that they are using a drug linked to suicide or violent behavior.

The investigation revealed that the VA waited three months to notify veterans in a VA experiment of the possible side effects from the anti-smoking drug Chantix. All of the veterans enrolled in the Chantix study suffered from Post Traumatic Stress Disorder (PTSD) and had been recruited, with monthly $30 payments, for a behavioral study with the drug.

Veterans Affairs Secretary James Peake told Washington Times reporter Audrey Hudson on June 18, 2008, that he was personally sending new warning letters to the 940 veterans in the study and some 31,000 other veterans who have been prescribed Chantix by the VA.

“Our first responsibility is to our veterans,” said Peake, who said he has asked VA doctors to review “the communications process” involving all VA studies using veterans who are suffering from PTSD. Some 400,000 veterans are being treated for PTSD.

The Bush White House had initially defended the VA’s handling of the Chantix experiment.

“The VA is doing everything they can to be mindful of the safety of these veterans in all their programs and try to help them,” said Deputy White House Press Secretary Tony Fratto at a briefing on Tuesday after the ABC News report aired.

“This is the Veterans Administration, under wonderful leadership by Secretary Peake, who is interested in the health and safety of these veterans that are under his care, and every other member of that VA system is the same,” said Fratto.

In contrast, Secretary Peake said he “wished” the VA had not taken so long to warn veterans being used in the Chantix test.

One of the veterans in the Chantix study, James Elliott, of suburban Washington, suffered a mental breakdown and near-lethal confrontation with police, which he blames on Chantix.

VA doctors say there is no evidence Chantix was responsible.

Elliott’s incident with police occurred in February, after the VA knew of the possible risks, but before it had notified veterans.

Elliott said the failure of the VA to inform him of Chantix’s possible side effect made him feel like “a guinea pig, lab rat, and disposable hero.”

“It hurts me to have anyone think we would treat our veterans as lab rats,” Peake said.

Peake also revealed that there had been 26 “severe adverse effects” in the Chantix test group of veterans, including three cases of contemplated suicide.

Chantix has been linked to at least 40 suicides and 400 attempted suicides in the population at large, according to the FDA, which published its first, alert November 20, 2007. The FDA issued a second warning, and there was an alert from the drug’s maker, Pfizer, before the VA finally began to warn veterans in the study on February 29, 2008.

But even then, the VA omitted the word “suicide” from the cover letter sent to veterans.

Secretary Peake said the new VA warning letter he is sending will specify that suicide is one of the possible side effects of Chantix.

“I have no problem putting suicide in there, myself,” said Peake.

He said the VA would not hesitate to stop the study if needed, as some in Congress have demanded.

“We’re not enrolling new people in this study,” he said, but there are no plans to stop the current project.

“Chantix is an FDA-approved drug,” Peake said, “and we’re trying to find the best way to support smoking cessation.”

But Peake said there was no evidence to suggest the study should be stopped.