Michael Carvin and Eric Murphy don’t know Jennifer McCann very well, and they don’t have much in common with her career-wise. Carvin is a well-known U.S. Supreme Court advocate at Jones Day, and Murphy is one of his proteges at the firm. McCann, on the other hand, is a young solo criminal defense lawyer in Long Island best known for her vigorous and at times controversial representation of Levi Aron, who confessed to a gruesome murder-kidnapping in Brooklyn last summer.
But in 2010, the unlikely trio of lawyers briefly joined forces. In a closely-watched case before the U.S. Court of Appeals for the Second Circuit, they argued that a pharmaceutical sales representative named Alfred Caronia had been wrongfully convicted of conspiring to misbrand a prescription drug—a misdemeanor offense under the Food Drug and Cosmetic Act.
Carvin, Murphy, and McCann prevailed, when a circuit panel, in a 2-1 opinion set aside Caronia’s conviction on First Amendment grounds, concluding that drug companies and their representatives have a constitutional right to promote prescription drugs for lawful off-label uses (NYLJ, Dec. 4).
More than a decade ago, the U.S. Food and Drug Administration approved a drug called Xyrem, made by Orphan Medical Inc., as treatment for sleep disorders. The FDA regulated Xyrem’s distribution closely, because its active ingredient is gamma hydroxybutyrate, sometimes called as the “date rape” drug. It served a niche market and generated only $25 million a year in sales.
One early proponent of the drug was Dr. Peter Gleason, a psychiatrist in Maryland. He touted it to his patients for off-label uses like pain relief and treating depression. Gleason’s enthusiasm didn’t go unnoticed by Orphan’s execs. They hired him to tour the country promoting Xyrem to other doctors. Caronia, a sales representative for Orphan Medical, served as one of Gleason’s contacts at the company.
The two men frequently attended promotional events together, and one afternoon in May 2006 Caronia drove Gleason to a train station in Long Island. When they arrived, half-a-dozen federal agents handcuffed Gleason and drove him to a local police station. Soon after, the doctor was charged with several federal felonies related to off-label promotion. Prosecutors likened him to a “snake oil salesman.” Caronia was also hit with similar charges.
Under FDA rules, doctors are free to prescribe drugs for off-label uses, so Gleason’s indictment drew strong criticism from some legal experts. Caronia, on the other hand, wasn’t much of a cause celebre at first. Both indictments were unusual, but Gleason’s was the more unique. To this day, he’s the only doctor to be indicted for drug misbranding under the Food Drug and Cosmetic Act.
Gleason’s public defender convinced prosecutors to drop the felony counts, but he eventually pleaded guilty before trial to a misdemeanor offense. Gleason served no jail time and tried to move on with his life, but the case appeared to haunt him. He committed suicide in 2010.
“We blame the prosecutor,” Gleason’s sister, Sally Goodson said in an interview. “My brother loved psychiatry. He was so good at it. And they crushed him. Can you imagine being a doctor all your life, devoting yourself to it, and then the government referring to you as snake oil salesman?”
Unlike Gleason, Caronia took his case to trial in 2009. He was represented by McCann and her Garden City, N.Y.-based mentor, Thomas Liotti. It was the first federal jury trial of McCann’s career. Caronia beat back some charges, but a jury convicted him on one misdemeanor conspiracy count. He paid a $25 fine, served a year of probation, and eventually found work as a carpenter.
An Offer of Assistance
Caronia’s conviction gained some attention from academics, and the business community eventually saw his appeal as a vehicle for pushing back against the Justice Department. Pharmaceutical companies have paid billions in fines over the years relating to off-label marketing. All the while, they’ve quietly questioned whether the prosecutions violated the First Amendment. No company ever pressed that argument in court, however, possibly out of fear of angering regulators. When McCann appealed Caronia’s conviction to the Second Circuit, more than 10 major makers of prescription drugs and medical devices hired Sidley Austin and Ropes & Gray to back the appeal.
Another amicus, the Washington Legal Foundation, made an offer to McCann: You handle the part of the oral argument pertaining to errors in the jury instructions, and our lawyers at Jones Day will handle the bulk of the First Amendment legwork.
How could McCann refuse? She’d only been practicing law a few years, and Carvin is a Supreme Court expert. “It would have been tough to take on something that massive on our own,” McCann said. “We were really appreciative of Jones Day’s help.”
Carvin led the brief-writing process, but he allowed Murphy—an associate in the firm’s Columbus, Ohio, office—to handle Jones Day’s portion of the oral argument. Murphy said he spent countless hours preparing. “I was very happy to have had the opportunity,” he said.
McCann said the collaboration with Murphy and Carvin was easy, noting that they discussed the case over a number of phone calls and emails. Nevertheless, both sides ended up writing their own briefs; McCann’s brief argued trial errors and commercial free speech issues while the amicus brief, which she called “wonderful” and “well-drafted,” solely took up questions of commercial free speech.
Oral argument was held in December 2010. McCann left Liotti’s firm to start her own practice shortly after December 2010 oral arguments on the Caronia case.
After a very long wait, the court not only vacated Caronia’s conviction; the majority produced this gem for Jones Day’s pharma industry clients: “We conclude simply that the government cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA for speech promoting the lawful, off-label use of an FDA-approved drug.”
The appellate court’s First Amendment bombshell “invalidates the current FDCA enforcement regime,” Carvin told Law Journal affiliate Litigation Daily. “It’s was very helpful to have a decision on the issue, because the federal government has been able to coerce pharmaceutical companies into settlements before the validity of the regime could ever be tested.”
However, the case may not be over. The FDA The government moved to extend the time when it could file a petition seeking a re-hearing from the panel, a re-hearing en banc or both options. It now has until Jan 16 to file its petition.
McCann wouldn’t say that the amicus involvement “tipped the scale” for her client, but “I think it drew more attention to the import of the decision.” The circuit was already attuned to the issues before it, she said, but the amici “alerted” the court that “the industry was watching.”
For herself, McCann said the case offered “an amazing opportunity to defend what this country was founded on.”