The Second Circuit Court of Appeals has overturned the conviction of a drug rep who was convicted of promoting off-label uses of an approved prescription drug.
Alfred Caronia was convicted in November 2009. He worked for Orphan Medical – now known as Jazz Pharmaceutical.
Orphan was a Delaware-incorporated pharmaceutical company that primarily developed drugs to treat pain, sleep disorders, and central nervous system disorders.
Orphan manufactured the drug Xyrem, a powerful central nervous system depressant.
Caronia was convicted of promoting the drug for off-label uses – that is, for uses not approved by the Food and Drug Administration (FDA).
Caronia argued to the Second Circuit that he was convicted for his speech – for promoting an FDA approved drug for off-label use – in violation of his right of free speech under the First Amendment.
In a 2-1 decision, the Second Circuit agreed.
“The government clearly prosecuted Caronia for his words –- for his speech,” the majority ruled in overturning the Caronia’s conviction. “A pharmaceutical representative’s promotion of an FDA-approved drug’s off label use is speech.”
Judge Debra Ann Livingston dissented from the ruling, arguing that “Caronia was convicted of conspiring to introduce a prescription drug into interstate commerce with the intent that it be used in ways its labeling neither disclosed nor described.”
“This intent was revealed. . .through his speech,” Judge Livingston wrote. “Because the First Amendment has never prohibited the government from using speech as evidence of motive or intent, I would affirm Caronia’s conviction. By holding, instead, that Caronia’s conviction must be vacated – and on the theory that whatever the elements of the crime for which he was duly tried, he was in fact convicted for promoting a drug for unapproved uses, in supposed violation of the First Amendment – the majority calls into question the very foundations of our century-old system of drug regulation.”
Big business think tanks jumped on the case and filed briefs in Caronia’s defense.
The Washington Legal Foundation was represented by Eric Murphy of Jones Day in Columbus, Ohio.
A group calling itself the Medical Information Working Group was represented by Joan McPhee of Ropes & Gray in Boston.
“The prosecutors never claimed that Mr. Caronia said anything false or misleading, or that anyone was harmed in any way,” Gregory Conko of the Competitive Enterprise Institute. “They prosecuted him simply because they did not approve of the content of his speech, and that is blatantly unconstitutional.”
Conko said that the FDA has interpreted pharmaceutical labeling laws very broadly to forbid manufacturers from speaking about uses of their products that the agency has not explicitly approved, and it has aggressively prosecuted companies for such speech.
Physicians may legally prescribe drugs for these so-called “off-label” uses, and an estimated one-fifth of all prescriptions are written for such uses. Doctors can even be held liable for malpractice if they do not use a drug off-label in certain circumstances, but the FDA has long forbidden manufacturers to tell physicians about such uses, Conko said.
“Other federal courts have previously concluded that speech about off-label uses is constitutionally protected, but the Second Circuit’s decision offers the clearest rebuke to prosecutors who have criminalized truthful speech,” Conko said. “The FDA should no longer be permitted to restrict the ability of doctors and patients to learn about important treatment options. And it cannot criminalize speech simply because it doesn’t like the speaker.”
But Patrick Burns of Taxpayers Against Fraud said that while one vote swung the court’s balance, “sadly, that one person’s opinion may cost human lives.”
“Remember, off-label marketing is not just about money – it’s also about poisoning for profit,” Burns said.
“What the justices do not seem to fully understand and weigh, but which is fundamental, is that FDA approval is not unconditional because drugs come with risks, and the risk-benefit analysis for every drug and every disease or condition is different,” Burns said.
“For example, Warfarin is a type of rat poison that is approved as a blood thinner for certain heart conditions, but it is not approved for upset stomachs, headaches, or as a breakfast cereal topping.”
“Do we want this drug marketed as a remedy for upset stomachs, headaches, and as a breakfast cereal topping?”
“Most medicines come with serious risks, and those risks have to be balanced against the benefits of treatment for specific diseases and ailments. The notion that a mere general practice doctor is able to adequately balance risk is pretty ridiculous on its face, but it is even more ridiculous when they are on the payroll of the drug company and their opinion is compromised by payola.”
“Some may argue that Xyrem was later approved for the use that Mr. Caronia was convicted of promoting it for, and so what’s the harm or the foul?”
“Of course, this argument simply underscores the point that the drug was not approved for that use when Mr. Caronia was promoting it. All Mr. Caronia knew for sure about the safety versus efficacy balance was that the check that the company had sent him had actually cleared the bank.”
“It’s a bit like going to an amusement park and riding the roller coaster and learning, only later, that the track was never inspected by the state. Does it make you feel better than it was inspected a week later and all was found to be OK? What if your children were on the track when the car shot off the rail?”