Court Lets Two CVS Stores Sell Controlled Drugs

By Anna Yukhananov

Florida - A appeals court ruled that CVS Caremark Corp may continue selling potentially addictive prescription drugs at two Florida pharmacies, blocking a Drug Enforcement Administration order to suspend shipments.

The U.S. Court of Appeals for the District of Columbia Circuit issued an order on Wednesday temporarily lifting a February 4 DEA suspension that was issued because of concerns that CVS was not adequately watching for prescription abuse.

The DEA said the two CVS pharmacies in Sanford, about 30 miles south of Orlando, were inappropriately filling prescriptions for the painkiller oxycodone, which can be highly addictive. They also had suspicious sales of other controlled substances.

CVS said the DEA had acted in an "arbitrary and capricious" manner in ordering sales suspended, and that remedial steps taken by CVS were sufficient. It said it would suffer irreparable harm if forced to stop filling prescriptions at the pharmacies.

Initially a federal district court judge blocked the DEA order but on Tuesday agreed to let it take effect. CVS appealed the decision.

The appeals court in Washington on Wednesday granted CVS's request and issued a stay pending further proceedings. The court ordered CVS to file a response by March 19 and the DEA to file its response by March 21, according to the court docket.

The litigation stems from the DEA's battle against prescription drug abuse, which has surged in the United States to eclipse abuse of most illicit drugs including heroin and cocaine.

The DEA said in court documents that about 7 million Americans abuse pharmaceuticals made with controlled substances for purposes not related to medicine and that Florida is the center of the growing epidemic.

The CVS appeal comes on the heels of a similar stay order issued to Cardinal Health Inc after the DEA tried to prevent it from selling any controlled substances from its facility in Lakeland, Florida. The DEA said four of Cardinal's customers, including the two CVS stores, filled illegitimate prescriptions.

The case is Holiday CVS LLC v. Justice Department et al in the U.S. Court of Appeals for the District of Columbia Circuit, No. 12-5072.

DOJ Asks Court To Keep Secret Any Partnership Between Google, NSA

By Mike Scarcella

United States - The Justice Department is defending the government's refusal to discuss—or even acknowledge the existence of—any cooperative research and development agreement between Google and the National Security Agency.

The Washington based advocacy group Electronic Privacy Information Center sued in federal district court here to obtain documents about any such agreement between the Internet search giant and the security agency.

The NSA responded to the suit with a so-called “Glomar” response in which the agency said it could neither confirm nor deny whether any responsive records exist. U.S. District Judge Richard Leon in Washington sided with the government last July.

A three-judge panel of the U.S. Court of Appeals for the D.C. Circuit is scheduled to hear the dispute March 20.

EPIC filed a Freedom of Information Act request in early 2010, noting media reports at the time that the NSA and Google had agreed to a partnership following the cyber attacks in China that year against Google.
EPIC asked for, among other things, communication between the NSA and Google about Gmail and Google’s “decision to fail to routinely encrypt” messages before Jan. 13, 2010.

The NSA’s response to the request for records noted that the agency “works with a broad range of commercial partners and research associations” to ensure the availability of secure information systems. The agency, however, refused to confirm or deny any partnership with Google.

The security agency said it routinely monitors vulnerabilities in commercial technology and cryptographic products because the government relies heavily on private companies for word processing systems and e-mail software.

“If NSA determines that certain security vulnerabilities or malicious attacks pose a threat to U.S. government information systems, NSA may take action,” DOJ Civil Division lawyers Catherine Hancock and Douglas Letter said in a brief in the D.C. Circuit in January.

DOJ’s legal team said that acknowledging whether NSA and Google formed a partnership from a cyber attack would illuminate whether the government “considered the alleged attack to be of consequence for critical U.S. government information systems.”

NSA said it cannot provide documents—or confirm their existence—because the information would alert adversaries about the security agency’s priorities, threat assessments and countermeasures.

DOJ said media reports about the alleged Google partnership with NSA do not constitute official acknowledgement.

The Washington Post and The New York Times both reported that Google contacted the NSA after the Jan. 2010 cyber attack, which the company said was rooted in China and targeted access to accounts of Chinese human rights activists. The Wall Street Journal said NSA’s general counsel worked out a cooperative research and development agreement with Google.

EPIC’s attorneys, including Marc Rotenberg, the group’s president, said in court papers that the document request includes records that are not relevant to the NSA’s information assurance mission.

“The NSA mischaracterizes EPIC’s FOIA Request by stating that responsive documents would reveal ‘information about a potential Google-NSA relationship,’” Rotenberg said.

The crux of the records request, Rotenberg said, is Google’s switch to application encryption by default for Gmail accounts soon after the cyber attack. Google in 2008 began allowing users to encrypt mail passing through the company servers, EPIC said in its brief, but encryption was not provided by default.

EPIC’s brief said the failure of the NSA to conduct a search for records “deprives the court of the ability to meaningfully assess the propriety” of the agency’s response that it can neither confirm nor deny the existence of responsive records.

“Without first conducting the search, not even the agency can know whether there is a factual basis for its legal position,” Rotenberg said.

EPIC said its records request does not seek documents about NSA’s role to secure government computer networks. “Google provides cloud-based services to consumers, not critical infrastructure services to the government,” Rotenberg said.

Tobacco Health Labels Unconstitutional: U.S. Judge

By Jeremy Pelofsky

United States - A U.S. judge sided with tobacco companies on Wednesday, ruling that regulations requiring large graphic health warnings on cigarette packaging and advertising violate free-speech rights under the U.S. Constitution.

Cigarette makers challenged the U.S. Food and Drug Administration's rule requiring companies to label tobacco products with images of rotting teeth, diseased lungs and other images intended to illustrate the dangers of smoking.

"The government has failed to carry both its burden of demonstrating a compelling interest and its burden of demonstrating that the rule is narrowly tailored to achieve a constitutionally permissible form of compelled commercial speech," U.S. District Judge Richard Leon said in the ruling.

The judge granted a preliminary injunction last year blocking the new label requirement from taking effect in 2012, a decision the Obama administration has already taken to the U.S. Court of Appeals for the District of Columbia Circuit.

The government is also likely to appeal the new ruling.

While educating the public about the dangers of smoking "might be compelling, an interest in simply advocating that the public not purchase a legal product is not," Leon wrote in a 19-page ruling.

Further, Leon noted the warning labels were too big to pass constitutional muster and that the government has numerous other tools at its disposal to deter smoking such as raising cigarette taxes or including simple factual information on the labels rather than gruesome images.

Congress passed a law in 2009 ordering the FDA to adopt the label regulation, which requires color warning labels big enough to cover the top 50 percent of a cigarette pack's front and back panels, and the top 20 percent of print advertisements.

The FDA released nine new warnings in June to go into effect in September 2012, the first change in U.S. cigarette warning labels in 25 years. Cigarette packs already carry text warnings from the U.S. Surgeon General.

Tobacco companies, including Reynolds American Inc's R.J. Reynolds unit, Lorillard Inc, Liggett Group LLC, Commonwealth Brands Inc, which is owned by Britain's Imperial Tobacco Group Plc, and Santa Fe Natural Tobacco Co Inc challenged the rule, arguing it would force them to engage in anti-smoking advocacy against their own legal products.

"Unfortunately, because Congress did not consider the First Amendment implications of this legislation, it did not concern itself with how the regulations could be narrowly tailored to avoid unintentionally compelling commercial speech," Leon wrote.

A spokesman for the Justice Department, which represented the FDA in the case, had no comment. Representatives for the tobacco companies involved in the litigation were not immediately available for comment.

Tobacco companies have said it would cost them millions of dollars to comply and also argued the graphics offer no information that could not be accomplished through messages similar to warnings already on cigarette packages and ads.

The Centers for Disease Control and Prevention estimates some 45 million adults smoke cigarettes, which are the leading cause of preventable deaths in the United States.

The ruling "ignores decades of First Amendment precedent that support the right of the government to require strong warning labels to protect the public health," Matthew Myers, president of the Campaign for Tobacco-Free Kids said in a statement.

The case is R.J. Reynolds Tobacco Co et al v. FDA, U.S. District Court for the District of Columbia, No. 11-1482.

Odd Stories: License Plate

Nebraska - An attorney is taking the state of Nebraska to court so he can have a license plate reading “NE 420”.

Frank Shoemaker asked for the plate from the state's motor vehicle department and was told he wasn't allowed to have it. Beverly Nerth, the director, said the 420 numerals “were used to promote marijuana use, an illegal drug in the state.” She added the combination may also be assumed to represent Adolf Hitler's birth (April 20, 1889), and Colorado's Columbine High School massacre which happened on April 20, 1999.

The American Civil Liberty Union, who is representing Shoemaker, said nothing about the plate is obscene or offensive about the license plate and it's a political statement.”

License plates can be used to express a personal or political statement according to the 8^th Circuit U.S. Court of Appeals, said ALCU's Tracy Hightower-Henne.

Update: Frank Shoemaker has been allowed to get the plate he desired.