When a federal appeals court invalidated on First Amendment grounds the conviction of a pharmaceutical sales representive for engaging in off-label marketing, it turned to a case spearheaded by a South Florida firm all the way to the U.S. Supreme Court.
Attorney Tom Julin, a partner at Hunton & Williams in Miami, also used a First Amendment argument in a case that centered on whether businesses and professionals have free speech rights.
The Dec. 2 ruling will have wide-ranging effects on the pharmaceutical industry, Julin said.
The decision undermines extensive FDA regulation of the industry as well as the many multi-billion dollar damage claims that have been brought against the companies that encouraged their sales representatives to engage in off-label marketing.
“There has been lots of class action litigation against pharmaceutical companies and billions of dollars in settlement claims on behalf of consumers,” Julin said.
Drugs, many of them used for psychological treatment, have been the subject of these lawsuits. They include Neurontin, Abilify, Zyprexa and Seroquel.
Julin was lead counsel in IMS Health Inc. v. Sorrell, representing data brokers challenging the New Hampshire law over the ban of the sale of pharmacy information listing doctors and medicines they practice.
The Supreme Court, in a 6-3 decision in June 2011, ruled the law was unconstitutional, resolving a split among appellate courts ruling on similar prohibitions in other states.
The current case in front of the U.S. Court of Appeals for the Second Circuit in New York City centered on Alfred Caronia, a former salesman for Orphan Medical Inc. who was convicted of conspiracy to introduce a misbranded drug into interstate commerce. He promoted the narcolepsy drug Xyrem for the off-label use of insomnia and fibromyalagia.
The three-judge panel overturned his conviction. “It relied heavily on the IMS Health decision,” Julin said.
“As the Supreme Court has held: ‘Speech in aid of pharmaceutical marketing … is a form of expression protected by the Free Speech Clause of the First Amendment,’” the appellate panel quoted from the High Court’s IMS Health ruling.
The Second Circuit, which encompasses Vermont federal courts, also decided the IMS case. Judge Debra Ann Livingston sat on both three-judge panels and dissented in both IMS and Caronia. In the most recent opinion, Livingston said the court’s decision will undermine the Food and Drug Administration’s authority under Federal Drug and Cosmetic Act.
“The majority calls into question the very foundations of our century-old system of drug regulation,” Livingston wrote in her dissent. “Determining a product’s ‘intended uses’ has long been a central concern of food and drug law.
But the majority opinion, written by Judge Denny Chin and agreed with by Judge Reena Raggi, stated, “We decline to adopt the government’s construction of the FDCA’s misbranding provisions to prohibit manufacturer promotion alone as it would unconstitutionally restrict free speech.”
Julin said the decision embraces the IMS Health decision restricting the government’s power to adopt any regulations that targets the content of speech. It again stated unequivocally that the right to free speech extends to companies that gather information from diverse sources and sell it to others for commercial purposes.
He said the salespeople charged for recommending off-label use of medications were simply passing on information from their companies.
“The other broad significance is how it will impact the pharmaceutical industry directly,” Julin said. “If it holds up, it will allow much more aggressive marketing of drugs for uses not approved by the FDA.”
Essentially, under the decision, the FDA will no longer have sole control over what is an appropriate use of a drug, he said.
Pilot program puts cameras in federal courtrooms
A handful of judges in the Southern District of Florida are participating in a three-year pilot program testing video recordings of civil proceedings.
Chief U.S. District Judge Federico Moreno said the parties and the judge have to agree on what case will be videotaped.
Senior U.S. District Judges Patricia Seitz, James Lawrence King and Paul Huck are participating, as are U.S. District Judges Donald Graham, Kenneth Marra and Donald Middlebrooks.
So far, proceedings have been videotaped in four Southern District cases since the pilot program started in January 2012.
“It started out slow, but we have had some hearings that have been recorded and uploaded,” said Steve Larimore, clerk for the Southern District.
There are several caveats to video recording federal proceedings. They must be civil cases and the judge, as well as both sides, must agree to use video. The recorded proceedings can viewed by attorneys and the public alike at www.uscourts.gov/multimedia/cameras/player.aspx.
One of the proceedings recorded before King was a final approval hearing of a $19 million settlement with the Bank of Oklahoma in the check overdraft multi-litigation case.
“As far as the philosophy or theory of it, I have always been for open hearings. I have never closed a courtroom knowingly,” King said. “It’s an open courtroom. The taxpayers paid for it.”
He said the downside is that sometimes judges in state courts have played to the camera “so their face will be on the 6 o’clock news,” but after a few days, the camera goes unnoticed.
JUDGE Robin ROSENBAUM on bench without robe, until now
Moreno, also, noted the pleasant investiture this month of U.S. District Judge Robin Rosenbaum.
The former federal magistrate has been on the bench since June, but the robing ceremony didn’t take place until Dec. 13 in Fort Lauderdale.
Judge Stanley Marcus of the Eleventh Circuit, was the keynote speaker. Rosenbaum clerked for Marcus.
Moreno noted for the gathering that when he swore Rosenbaum in as a magistrate five years ago, he failed to bring the oath and everybody scrambled to find it.
Others told stories of Rosenbaum’s great sense of humor. And when she worked for the Justice Department in Washington in the 1990s, she would roller skate to her office, the chief judge said.