Federal appeals court denies FDA's request for rehearing in graphic tobacco label case

By Jessica M. Karmasek | Jan 23, 2013

WASHINGTON (Legal Newsline) -- A federal appeals court last month denied a request by the federal Food and Drug Administration to rehear a case involving graphic images on cigarette packaging.

In August, the U.S. Court of Appeals for the District of Columbia Circuit ruled that the FDA's new rule requiring the warnings -- images such as diseased lungs and a cadaver with chest staples -- is unconstitutional.

The decision is in conflict with the Sixth Circuit's ruling, setting up a likely appeal and judgment from the U.S. Supreme Court.

In response to the D.C. Circuit's ruling, the FDA filed a petition for rehearing and rehearing en banc in October.

"In sum, this case presents a question of exceptional importance," the federal government wrote in its 16-page request.

"The majority's reasoning is wrong and it conflicts with the Sixth Circuit's analysis of graphics in Discount Tobacco. We respectfully submit that the case should be reheard en banc."

In a Dec. 5 order, the D.C. Circuit denied the FDA's petition for panel rehearing. According to the single-page order, Judge Judith Ann Wilson Rogers was in favor of granting the petition.

In a separate order filed the same day, the federal appeals court also denied the FDA's request for a rehearing by the full court.

"Appellants' petition for rehearing en banc and the response thereto were circulated to the full court, and a vote was requested. Thereafter, a majority of the judges eligible to participate did not vote in favor of the petition," Court Clerk Mark J. Langer wrote.

"Upon consideration of the foregoing, it is ordered that the petition be denied."

Those judges in favor of a rehearing en banc included Rogers, David S. Tatel and Merrick B. Garland, according to the one-page order.

The court's 2-1 decision in August affirmed an earlier ruling by Judge Richard Leon that granted a preliminary junction. Oral arguments were held in April.

The Family Smoking Prevention and Tobacco Control Act of 2009 gave the FDA the authority to regulate the manufacture and sale of tobacco products. After new warning statements were implemented, the FDA proposed nine graphic images.

In addition to the two previously mentioned, images that were included were:

- A man exhaling cigarette smoke through a tracheotomy hole in his throat;

- Cigarette smoke enveloping an infant being kissed by its mother;

- A mouth filled with cancerous lesions;

- A man breathing into an oxygen mask;

- A crying woman; and

- A man wearing a T-shirt with a "no smoking" symbol and the words "I QUIT."

The images were supposed to take up 50 percent of the front and back portions of cigarette packaging. They also needed to be held to a higher First Amendment standard, Leon wrote.

Among the groups supporting the warning labels were 22 state attorneys general who joined in a brief that claimed Leon had failed to recognize the public health threat posed by smoking when he granted the preliminary injunction.

Leon also wrote that the images were misleading.

"(T)he graphic images are neither factual nor accurate," the judge wrote. "For example, the image of the body on an autopsy table suggests that smoking leads to autopsies; but the government provides no support to show that autopsies are a common consequence of smoking.

"Indeed, it makes no attempt to do so. Instead, it contends that the image symbolizes that 'smoking kills 443,000 Americans each year.' The image, however, does not provide that factual information."

The states that joined the brief are Alaska, Arizona, Arkansas, California, Connecticut, Hawaii, Illinois, Iowa, Maine, Maryland, Mississippi, Montana, New Hampshire, New Mexico, Ohio, Rhode Island, South Dakota, Utah, Vermont, Washington and West Virginia.

Judge Eric Clay wrote the Sixth Circuit's opinion in the related case.

"We return to where we began -- the lack of consumer awareness of tobacco's serious health risks resulting from the decades-long deception by tobacco companies," Clay wrote. "Ample evidence establishes that current warnings do not effectively inform consumers of the health risks of tobacco use and that consumers do not understand these risks.

"It is beyond cavil that adolescents are a target of the marketing expertise of tobacco companies, a targeting that exists precisely because of intertwined advantages -- or for the young, disadvantages -- the coupling of immaturity of risk perception with the evidence that the vast majority of regular smokers made the decision to begin smoking as an adolescent."

Clay continued, "It bears emphasizing that the risks here include the undisputed fact that plaintiffs' products literally kill users and, often, members of the families of users: Tobacco products kill up to one-half of the people who use them as they are intended to be used.

"Against this backdrop, the Act requires graphic and textual warnings that convey the factual health risks of smoking to provide consumers with truthful information as they make decisions about purchasing and using tobacco products."

From Legal Newsline: Reach Jessica Karmasek by email at jessica@legalnewsline.com.

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