The Tort Of Off-Label Promotion: US v Caronia - Just In Time For The Holidays, A Gift You May Not Be Able To Return

December 3, 2012, was a good day for Alfred Caronia, a sales representative for a drug manufacturer. It was three years to the day after his trial for off-label promotion resulted in a conviction for a misdemeanor and subjected him to a $25 fine and 100 hours of community service. Not happy was one of his co-defendants, Dr. Gleason, who settled before trial and, as a result of his federal criminal plea, spiraled downward, taking his own life. So why is this sad little case ripping the fabric of FDA enforcement of off-label promotion, and might it have impact on the emerging tort of off-label promotion?

Not unlike the iceberg that sank the Titanic or the stone that felled Goliath, seemingly small things sometimes present surprising outcomes. And by all accounts, Mr. Caronia's misdemeanor prosecution should have been a small thing. But, on December 3, 2012, two years to the day from hearing the case, the Second Circuit, in United States v. Caronia, ruled that the FDA's civil and criminal enforcement of drug companies violates the First Amendment, stating:

"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."

2012 U.S. App. LEXIS 24831, *8 (December 3, 2012). The Second Circuit Opinion was 2-1, and the deadline to seek en banc review was December 17, 2012 and we will not know if certiorari will be sought until after March 4, 2013 deadline. FDA did take action on December 17, 2012, FDA issuing a "Drug Safety Communication" concerning the product at issue in Caronia noting that "[m]any of the deaths occurred in patients who were prescribed Xyrem for unapproved uses such as fibromyalgia...." Notably, fibromyalgia was among the uses promoted off-label in Caronia.

The command of the Constitution is a mere ten words: "Congress shall make no law ... abridging the freedom of speech ..." In 1942, the United States Supreme Courtmade a profound and admittedly erroneous assumption that is taking decades for the Court to recognize and gradually walk back. In Valentine v Chrestensen, the Supreme Court held that, "[T]he Constitution imposes no such restraint on government as respects purely commercial advertising." 316 U.S. 52, 54 (1942). From that ruling grew generations of cases confounding the public beyond comprehension and leaving legal scholars pleasantly divided. It was not until the mid 1970's that the...