[Drug and Device Law] Happy Veteran's Day/In Praise of Free Speech and a SD Fla. Decision
Today is Veteran’s Day. This is a holiday that escapes the attention of too many people – until they stare at their empty mailboxes in puzzlement. It is a federal holiday, but most of us go about our usual business. Too bad. The holiday was originally designed for parades and gratitude. Veteran’s Day was Monday-ized between 1968-75, but right-minded people with a sense of history insisted that it be restored to traditional, date-specific status. Veteran’s Day is celebrated on November 11 because that is the anniversary of the World War I armistice. In 1918, the guns went silent on the eleventh hour of the eleventh day of the eleventh month. The meaning of that date is more important than creating yet another three day weekend to encourage folks to travel and spend. Odds are that you know of someone in your own family history who served this country in time of war. Maybe there is a legend about a great-great grandfather who huddled in Flanders’ fields in the Great War. Or a Marine who hit the beach at Iwo Jima. Or a soldier who flew helicopters in Da Nang but never wanted to talk about it. Or a college roommate who is grateful his time over in the sandbox was relatively short. Or a friend in the reserves who just last month was called to Afghanistan to help move some hardware home. Maybe you had a big lump in the throat when you shook hands good-bye.
Thanksgiving is three weeks away, but today is also a day for thanks.
President George H.W. Bush is a veteran. He was a navy aviator in World War II. On September 2, 1944 Bush piloted a Grumman TBM Avenger plane that attacked Japanese installations on Chichijima. Bush's aircraft was hit by flak and his engine caught on fire. Nevertheless, Bush finished the mission and released bombs over his target, scoring several damaging hits. With his engine ablaze, Bush flew several miles away from the island, where he and one other crew member bailed out. The other man's parachute did not open. Bush waited for four hours in a raft, until he was rescued by the lifeguard submarine USS Finback. According to Bush, while he floated in the Pacific, not knowing for sure whether he would make it, he thought about many things, including the Bill of Rights. Some ridiculed that story, but are we really so cynical as to discount the possibility that someone contemplating what they were fighting for might think it right and even a little noble to be on the side that favors freedom of speech? Thanks to that Greatest Generation, and thanks to all the great generations that followed who served to preserve our freedoms, including the freedoms of defense hack lawyers like us to scribble our silly blogs.
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Today’s case actually has something to do with freedom of speech. It is an off-label/first amendment speech with a twist – the plaintiff doctor sued a writer for criticizing his off-label use of a drug. The action was brought under both the Lanham Act and Florida common law. The issue was whether the speech in question was the type of commercial speech that might be susceptible to such claims (with all the requisite balancing) or whether it was noncommercial speech that was immune from attack. In Tobinick v. Novella, 2015 U.S. Dist. LEXIS 150083 (S.D. Florida Sept. 30, 2015), the court decided that the speech at issue was not actionable under the Lanham Act because it is not commercial speech, and that the Florida unfair competition claims failed as well because they rely on a similar theory of liability.
The claims were based on two articles written by the defendant and published online at sciencebasedmedicine.org. Both articles addressed the practice of the plaintiff, a doctor who provided medical treatment to patients with “unmet medical needs”. The first article, “Enbrel for Stroke and Alzheimer’s” appeared on May 8, 2013 in response to a piece published in the Los Angeles Times. It attacked the plaintiff’s practice of using Enbrel, an FDA-approved drug for the treatment of severe rheumatoid arthritis, for off-label indications, such as Alzheimer’s disease. The allegedly false statements in the first article concerned the viability of the off-label treatments, the scientific literature discussing those treatments, the size and locations of the plaintiff’s Institutes, and the categorization of the plaintiff’s practice as “health fraud.” The defendant then published the second article, entitled “Another Lawsuit To suppress Legitimate Criticism – This Time SBM” on July 23, 2014, after the plaintiff filed the lawsuit. The only statement in the second article that the plaintiff alleged was false and misleading was that there had been no double-blind placebo-controlled clinical trials of the treatment provided by the plaintiffs.
The defendant cried foul, arguing that his articles were not the sort of commercial speech that would be vulnerable to claims under the Lanham Act claim or common law unfair competition. How to classify speech that contains both commercial and noncommercial elements? Relevant considerations include whether: (1) the speech is an advertisement; (2) the speech refers to a specific product; and (3) the speaker has an economic motivation for the speech. In the Tobinick case, the articles proposed no commercial transaction. Moreover, they did not fall within the scope of the definition expounded in the U.S. Supreme Court’s Central Hudson decision: “expression related solely to the economic interests of the speaker and its audience." 44 U.S. at 561. Instead, both “articles clearly state their intent to raise public awareness about issues" pertaining to the plaintiff’s treatments. The articles were certainly not advertisements. The only products referenced in were the plaintiff’s treatments, and they were not being advertised. Quite the opposite.
The plaintiff argued that the articles were commercial speech because a for-profit company controlled by the defendant earned money by selling advertisements on its website advertisement in a podcast, membership, and goods such as t-shirts. That fact was not enough to transform the articles into commercial speech. Look hard enough, and you can find a potential economic dimension for almost anything. The court concluded that the existence of some economic interest alone should not deprive the speech of constitutional protection. Maybe the defendant might earn some money from an organization sponsoring or producing the speech, but it did not appear that there was a strong economic motivation for the speech. The defendant testified that the goal of his company was “to educate people in science and critical thinking,” which seemed consistent with the content of the articles -- raising public awareness of scientific issues, rather than promoting an economic interest. So scientifically-oriented articles remain fully protected speech. That conclusion not only took care of the Lanham Act claim, but also got rid of the Florida unfair competition claim, since that common law claim was premised on the same theory of false advertising that animated the Lanham Act claim. Thus, the defendant won summary judgment and free speech (even if it was speech that we might not agree with – have you read our posts on off-label use?) was vindicated.
Happy Veteran’s Day.
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Posted By Steve McConnell to Drug and Device Law at 11/11/2015 11:00:00 AM --
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