Caronia- Former Drug Rep

Drug and Device Law
Friday, May 07, 2010
A First Amendment Showdown in the Second Circuit
If you’ve been reading us for a while, you know how worked up we get about how the FDA’s overbearing and paternalistic regulatory scheme infringes on the free speech rights of manufacturers. And if you haven’t been reading us for a while (or just want a refresher), click on the “First Amendment” link to the right (or at the end of this post) and you’ll see our collection of Greatest Hits on the topic – some short and some long (hey, we warned you, we can get worked up about free speech).

One of those posts was about United States v. Caronia, a case where the government chose to prosecute a sales rep for promoting Xyrem off-label. Way back in 2008, we railed against the District Court’s decision to reject the defendant’s First Amendment arguments and deny a motion to dismiss, allowing this criminal case to go forward. Turns out we were right to be miffed; ultimately, the case went to a jury, which convicted the sales rep on the charge of conspiracy to misbrand Xyrem.

After a tortuous post-trial and sentencing process – one year probation, 100 hours community service, and a $25 fine in case you’re wondering – Mr. Caronia was finally able to appeal his conviction to the Second Circuit. The appellant’s opening brief and the Washington Legal Foundation’s (“WLF”) amicus brief were filed a couple of weeks ago, and we’ve had a chance to take a gander – and we’ve also seen this informative Legal Pulse piece from our friends at WLF, laying out WLF’s read on the case.

First things first. As we were perusing the briefs, a few facts struck us as either interesting or significant:

1) Mr. Caronia was convicted of promoting Xyrem to combat “excessive daytime sleepiness,” an off-label use at the time (Xyrem was approved at the time for the treatment of cataplexy in narcolepsy patients). But here’s the crazy part – FDA approved Xyrem for “excessive daytime sleepiness” very shortly after the off-label discussions took place. In fact, the government did not claim that the statements were false or misleading, and withdrew its original charge that Mr. Caronia engaged in fraud. So the speech at issue here was truthful and non-misleading – and it was speech about a lawful use of Xyrem. That didn’t matter to the government, though – in FDA’s eyes, a drug is “misbranded” solely because the promotion is for an off-label use, regardless of whether the information imparted is true or not. Talk about overbroad and not narrowly tailored to further a substantial interest…but we’re getting ahead of oursleves a bit.

2) The particulars of the government’s “sting” and the speech at issue are also significant. Mr. Caronia was encouraged to use his co-defendant, Dr. Gleason, as a promotional speaker on Xyrem. Back in 2005, Mr. Caronia received calls from Dr. Charno, a confidential government informant who asked for information about Xyrem. In response, Mr. Caronia brought Dr. Gleason to Dr. Charno’s office, where Dr. Gleason talked about an off-label use of Xyrem while Mr. Caronia sat quietly and listed. (According to appellant’s brief at p. 9, the informant repeatedly asked off-label questions pursuant to training he received from the feds). So now you have doctor A telling doctor B about a lawful off-label use largely because he was being pumped by doctor B, the information being provided is truthful and non-misleading, and the speech relates to a use for which the drug was approved shortly after. And yet the government still pressed this prosecution. Weird. And paternalistic. But we’re getting ahead of ourselves again.

3) Even weirder is that the government insisted on continuing to pursue Mr. Caronia even after the manufacturer of Xyrem took a plea bargain. In fact, the Vice President of Jazz Pharmaceuticals, the maker of Xyrem, testified at trial that she knew a conspiracy to misbrand Xyrem existed within the company, but had no knowledge of Mr. Caronia’s specific participation.


It will be interesting to see the government’s spin on these facts, because from where we’re sitting, this case is a real headscratcher. Why waste FDA resources, court time, and taxpayer dollars pursuing this case? And, coincidentally, put at risk the (unconstitutional) regulatory scheme that the government usually jealously guards – remember, after all, that these are the same guys who routinely try to moot constitutional challenges by approving a drug for the off-label use at issue (after the lawsuit’s been filed, of course. The WLF and Allergan challenges are two of the better-known examples of this tactic.). Or did the government think it could sneak away with a ruling against some poor guy in an obscure criminal prosecution? If so, that strategy has failed.

On the law, both the appellant’s brief and the amicus get it right – this is an unconstitutional speech ban unsupported by a sufficient government interest. First of all, there was nothing misleading about the truthful communication here. In fact, as WLF points out, Dr. Gleason was permitted to use Xyrem to combat “excessive daytime sleepiness.” He was also permitted to talk to patients about that use. And he was permitted to suggest that use to other doctors – at least until he was paid by the manufacturer. And even after he became a paid speaker, Dr. Gleason was still permitted to talk to other doctors about the off-label use in response to an unsolicited request for information. See WLF Brief at 5-6. This kind of speaker-based discrimination runs afoul of the First Amendment, particularly where that speech is about core scientific information affecting public health (nice turnabout, WLF – the public health mantra is usually the government’s justification for restricting this speech). Indeed, this is bizarro paternalism, allowing a doctor to say “use this stuff” to (mostly) medically uneducated patients, but not allowing a doctor (or the manufacturer, for that matter) to make the same suggestion to a sophisticated health care professional. See WLF Brief at 7.

Turning to the speech restriction at issue, both briefs hammer home the point that Central Hudson’s commercial speech test wasn’t satisfied here, because under that test, the government may regulate speech only if it proves that the government has a substantial interest, that the speech restriction directly advances that interest, and that the restriction is no more extensive than necessary. App. Brief at 38, WLF Brief at 9. Remember – the government’s position in the court below was not that the speech was factually inaccurate or misleading – rather, the government urged and got a conviction for truthful, non-misleading speech. See, e.g., WLF Brief at 22. So the speech ban had to be narrowly tailored to directly advance the government’s purported interest – a test that FDA’s regulatory scheme flunks:

1) With respect to FDA’s purported interest in ensuring that physicians receive “complete” or “accurate” information about a particular drug, it is absurd to suggest that a speech restriction about an off-label use pending FDA approval furthers that goal. In fact, it is paternalistic and antithetical to that goal, because it deprives doctors of valuable information. See WLF Brief at 24-25, App. Brief at 40-41.

2) With respect to FDA’s purported interest in encouraging manufacturers to seek approval for off-label uses, prohibiting speech is a curious and blunderbuss way to accomplish that goal. Both briefs catalog a number of alternatives short of a total speech prohibition that would incent manufacturers to seek approval. And manufacturers have plenty of encouragement to seek approval for widespread off-label uses. And, of course, this purported interest makes no sense where, as here, the manufacturer has already sought approval and is within days of getting that approval. But now we’re just piling on, so we’ll stop.

We’ll have to wait to see the government’s response to all of this, but based on what FDA’s been saying in Allergan, we have a pretty good hunch that we’ll be hearing more about the horrors of off-label use gone awry, and perhaps more “trust us, we would never use our vague regulatory scheme to infringe your rights.” Although it’s pretty hard to make that second argument on these facts. Here’s to the hope that the Second Circuit rejects those arguments and sees the First Amendment light (although we should note that the Second Circuit could dodge the issue if they accept the appellant’s alternative argument that the verdict sheet was erroneous). As always, stay tuned and we’ll let you know what happens.

 

Jennifer L. McCann said...

The title of the above article evokes images of John Wayne wearing an FDA badge in place of his typical sheriff’s star, but to Alfred Caronia and our small Long Island firm, which represented Mr. Caronia from the inception of this case, it has been a battle of David and Goliath. The omnipotent FDA prosecuted a new sales representative for failing to interrupt doctors discussing clinical uses of the drug beyond his comprehension and training. The pharmaceutical company pleaded guilty to conspiring to misbrand their own drug, implicating my client and every other Jazz employee by virtue of an ambiguous allocution.

It was a year after his indictment before the Government conceded that Mr. Caronia had not participated in any fraudulent misbranding. Finally, the felony charges against Mr. Caronia were reduced to non-fraudulent misdemeanors. Then, the real issue arose: was it unconstitutional to restrict non-fraudulent commercial free speech?

The empathy of the Caputo court for the future judge, who would determine this issue, was shared by the undersigned.

Fortunately, we need not decide today whether a seller of drugs or medical devices has a constitutional right to promote off-label uses.” See U.S. v. Caputo, 517 F.3d =35, 940 (7th Cir.2008). While I disagree with the lower court’s decision, I can affirmatively state that my respect for the Honorable Eric N. Italiano, United States District Court for the Eastern District of New York, has grown significantly as a result of his commitment to the seriousness of this case and the Constitutional issues within it.

Thank you to Washington Legal Foundation and Jones Day for their eloquent amicus brief in this case. I look forward to arguing this issue before the United States Court of Appeals for the Second Circuit. I sincerely hope the Circuit Court is able to see the imprudence and unconstitutionality of 21 U.S.C. § 331(k).

Jennifer L. McCann
Law Offices of Thomas F. Liotti
Attorneys for the Defendant-Appellant, Alfred Caronia

 

Hope Jazz is still paying for his defense. This whole case was junk from the very beginning. Jazz never should have pled guilty to anything. They acted like scared rabbits and caused a lot of damage to good peoples' reputations. For Shame!

 

Jazz never paid a dime for Al's defense

 

Only paid for Bill's funeral

 

Are you sure? Say it isn't so? Do you mean that Jazz walked away from their own employee from the very beginning? I thought Jazz paid for his defense through his original trial and now were paying for his appeal. Please update.

 

walked away... only paid for drunk tucker

 

Wow! If I am looking for loyalty while working for this crew, I better buy a dog.

 

No need. The idiots on patrol here, show how incredibly stupid they are. The only part that really bothers The Family, is trying to cover their incompetentcies. They should all be out within the next 6 months! We're working on it.

LaToya Jazz
Asst. Dir Sales& Board Member

 

This company's higher-ups and their attorneys bent-over for the fda and the justice department because a power-hungry prosecutor wanted to make a name for himself (and get a better job).The company paid a pittance amount of cash in comparison to the average fine for their guilty plea. The company's lack of spine hurt the good name of a physician-speaker and destroyed a company rep who had only been working for the company for 3 months. The prosecutor got his new job. The whistleblower got her dough. The CEOs went back to Palo Alto as if nothing had happened. None of these punks (the company, the fed's, and the whistleblower) lost a night of sleep for what they did and for what they did not do. But three outstanding lives were hurt for a life-time (since company rep Bill C's death in Arizona has never been satisfactorily explained either.)

 

Van Der Sloot Blunt Trama B.C. Blunt Trama

 

Drug and Device Law
http://druganddevicelaw.blogspot.com/
Thursday, September 02, 2010
Medical Device Preemption And Fraudulent Joinder
One of the things we really like about blogging is that it puts us in touch with smart defense lawyers all over the country. Sometimes, when we know who’s litigating certain issues in particular mass torts, well give him/her a call to check if s/he knows anything new on that point. Other times, somebody will call us to see what we might know on a particular topic. We try to be of assistance where we can.


Occasionally, we’ll have this sort of conversation, and it’ll turn out that neither of us knows anything much about a topic.

That kind of result that usually turns into a blog post.

As here.

The issue is this. As we’ve posted before, we don’t like the joinder of corporate sales reps in product liability cases. There shouldn’t be any separate claim against them, as long as they’re acting as the agent of a disclosed principal (their employer), anything a sales rep does is something that the manufacturer of the prescription medical product at issue has to deal with – for better or worse.

But as we noted in our prior post, sales reps are being named as defendants with increasing frequency, almost always as a ploy to destroy diversity, and therefore keep cases out of federal court. The legal doctrine that’s developed in response to baseless claims against non-diverse (in-state) parties is called “fraudulent joinder” – that there’s no possible state-law claim against the in-state defendant, so that defendant’s citizenship can be ignored for jurisdictional purposes.

Our thought isn’t a complete fix by any means. Rather, it’s strictly limited to manufacturers of pre-market approved (“PMA”) medical devices that are subjects of the preemption defense recognized in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008). Express preemption under Riegel bars any tort claims that are “different from or in addition to,” 21 U.S.C. §360k(a), FDA regulations pertaining to PMA medical devices.

We think that, if a given claim against a manufacturer is preempted under Riegel (which is most of them, except some “parallel violation” claims, see our scorecard), then a similar claim would be likewise be preempted under Riegel when brought against a manufacturer’s paid sales representative.

The statute’s “different from or in addition to” language suggests one real question in this regard: Does the FDA regulate the conduct of sales reps, so that there would be a state-law tort claim would be “different from or in addition to” that FDA regulation?

Umm … sure the FDA does. If you don’t believe us just ask, for instance, the unfortunate sales rep Mr. Caronia, who was prosecuted (we’d say – and WLF is arguing – in violation of the First Amendment) for supposedly promoting off-label uses. See United States v. Caronia, 576 F. Supp.2d 385 (E.D.N.Y. 2008). Obviously, in Caronia, the FDA was found to have authority over what a company’s sales rep says (allegedly “promot[ing] [a product] to a physician ‘John Doe’ for . . . off-label indications”) and does (allegedly “introduc[ing] another physician, who was paid by[the manufacturer], to ‘John Doe’”). 576 F. Supp.2d at 389-90.

We haven’t looked beyond the off-label promotion scenario, but we expect we’d find quite a few other examples of FDA regulation of a manufacturer’s sales representatives if we searched the statute, regulations, and FDA guidances. More power to anyone who does.

Given that the FDA regulates certain aspects of sales representative conduct and speech, then a purported state-law duty that a sales rep say (such as give specific warnings to either doctors or patients) or do (such as stay out of an operating room altogether) something else would be “different from, or in addition to” that rep’s obligations established by the FDA.

That, in turn, means that the allegations are plainly preempted under Riegel – where they don’t involve any claim that the rep violated FDA regulations, or where the violation claim isn’t pleaded properly under Twombly/Iqbal. See, e.g., Horowitz v. Stryker Corp., 613 F. Supp.2d 271, 284 (E.D.N.Y. 2009) (requiring pleading the specific PMA requirement allegedly violated); Hughes v. Cook, 452 F. Supp.2d 832, 841-842 (W.D. Tenn. 2006) (same).

Completing the circle, if the claims are preempted, then it’s impossible to recover against the sales rep, and the strict “no possibility of a claim” standard for fraudulent joinder should be met - where Riegel applies. That being the case, the sales rep should be ignored for diversity purposes and the action belongs in federal court.

A PMA medical device defendant pursuing this line of fraudulent joinder would need to take care in casting the preemption argument so that it’s limited to the sales rep defendant and is not a generalized attack on the merits of the case against, inter alia, itself – the so-called “common defense” exception to fraudulent joinder. See, e.g., Hunter v. Philip Morris USA, 582 F.3d 1039, 1045-47 (9th Cir. 2009); Smallwood v. Illinois Central Railroad Co., 385 F.3d 568, 574-75 (5th Cir.2004) (en banc); Collins v. American Home Products Corp., 343 F.3d 765, 768-69 (5th Cir. 2003); Green v. R.J. Reynolds Tobacco Co., 274 F.3d 263, 269 (5th Cir. 2001). For this reason, it may turn out in practice that preemption-based fraudulent joinder in the medical device area is most useful where, there are no facts pleaded to tie the sales rep defendant plausibly to any “parallel” FDCA violations alleged against the manufacturer.

We’d like to say more on this subject, but we ran really comprehensive Westlaw and Lexis searches trying to find any cases addressing the impact of medical device preemption on fraudulent joinder of sales representatives – or indeed any kind of fraudulent joinder – and came up empty. If there are medical device manufacturers out there using Riegel to protect their sales reps from preempted claims, we’re not seeing it, at least not at the fraudulent joinder stage. We found one pre-Levine drug case, where an analogous preemption argument (involving a distributor, not a sales rep) was made, but the court did not find the case for preemption strong enough to support fraudulent joinder. In re Fosamax Products Liability Litigation, 2008 WL 2940560, at *7 (S.D.N.Y. July 29, 2008). But where preemption is concerned, we all know that medical devices and drugs are very, very different. Unlike Fosamax, after Riegel, we think that the case for preemption in PMA medical device cases is strong enough to meet the fraudulent joinder standard.

Anyway, that’s our idea of the day.
Posted by Bexis at 4:16 PM

 

Caronia why? Must we say good-bye?

 

there for the grace of Judas go you is why we don't say bye Feddie

 

Drug and Device Law
Friday, January 21, 2011

Caronia Update: What Went Down At The Oral Argument

We’ve blogged about United States v. Caronia before. In fact, some might say we’re a bit obsessed by it, and with good reason; the First Amendment’s a big deal to us, and Caronia represents an opportunity for a Court of Appeals to pass on the constitutionality of FDA’s draconian and convoluted off-label promotion rules. As a reminder, Mr. Caronia is the poor sales rep that was convicted of conspiring to misbrand Xyrem by promoting it for off-label uses.

Now we’ve gotten our hands on an unofficial transcript of the oral argument before the Second Circuit Court of Appeals (thank you Rick Samp, over at WLF), and here’s what happened:

The panel was Judge Denny Chin, Judge Debra Ann Livingston, and Judge Reena Raggi. Interestingly, Judges Raggi and Livingston were recently on a panel in another First Amendment case, where the court ruled that Vermont’s restriction of religious vanity license plates violated the Free Speech clause (that case is Byrne v. Rutledge, 623 F.3d 46 (2d Cir. 2010), if you’re interested).

The Caronia panel was a hot bench. In particular, Judge Raggi challenged all of the advocates – especially the government attorney, Douglas Letter. A few themes emerged:

1) We previously speculated that the Second Circuit could dodge the constitutional question because the defendant argued in the alternative that there was an inconsistency in the verdict sheet. The panel didn’t seem at all inclined to do that. It gave the verdict sheet issue pretty short shrift, and quickly homed in on the Constitutional issues raised by the appeal, so it’s looking likely that the decision will tackle the First Amendment issues head-on.

2) Jennifer McCann and Eric Murphy (WLF) argued on behalf of the defendant. They made clear that this case presents an overbreadth challenge. The FDA’s off-label regulatory scheme is unconstitutional as applied here, where approval for the off-label use is pending. That’s a rather limited, but particularly sympathetic fact pattern – but you know what they say about camel’s noses and tents. Thus, the defendant argued, the regulatory scheme is not narrowly tailored to achieve the government’s stated goals; although FDA says it restricts off-label speech so as to incentivize manufacturers to go through the rigorous approval process, in this case, the manufacturer was seeking approval for the off-label use. Judge Raggi asked Murphy whether there is a reasonable distinction between restricting the speech of company scientists or doctors, which she suggested would lead to an overbreadth problem, and restricting the speech of a sales rep, which could be viewed as a reasonable limitation consistent with the government’s regulatory purposes (i.e., limiting uninformed discussion by someone whose interest is simply to “tout” the drug).

3) Douglas Letter’s argument on behalf of the government started where you’d expect: First Amendment? We don't need no stinkin’ First Amendment. We’re punishing conduct – the introduction of a misbranded drug into interstate commerce – and the speech at issue is simply evidence of intent. Reading tea leaves, that argument isn’t going anywhere. Judge Raggi and Judge Chin both challenged Letter extensively on this point, in the process repeatedly underscoring that doctors may lawfully prescribe drugs for off-label purposes. So, asked Judge Raggi, since a doctor could prescribe Xyrem off-label, and the Xyrem that hypothetical doctor prescribed would carry an identical label to Xyrem being prescribed for an approved use, the only thing making the off-label Xyrem “misbranded” (and thus giving rise to criminal sanctions) is the speech “touting” the off-label use. Ergo, the government’s punishing speech, not seeking to use it as evidence of intent. When Letter tried to dodge this, Judge Livingston asked Letter whether a manufacturer violates FDA regulations where the manufacturer knows the prescriber is going to use Xyrem for an off-label use, but nonetheless ships the Xyrem to the prescriber without saying anything about that off-label use. Letter didn't really have a good answer to this; he dodged and said there would not be a violation because the hypothetical presented a scenario where the manufacturer had “subjective intent” as opposed to “objective intent.” Huh? Judge Livingston called him on this, asking what else a manufacturer might do that would be evidence of “objective intent.” Ultimately, Letter had to concede that he knew of no off-label case where the government proved misbranding without relying on evidence of off-label speech.

4) In a related argument, Letter repeatedly stressed that “promotion is not a crime.” Yet Judge Raggi said she was “really concerned that this case went to the jury with the understanding that what was proscribed here was drug promotion.” When she asked whether the First Amendment would require reversal if the jury was instructed that promotion is illegal, Letter responded (naturally) that there was no need to reverse because the regulations passed intermediate scrutiny under the Central Hudson test for restrictions on commercial speech.

5) On the core First Amendment issue, the judges expressed concerns about the vagueness of the regulatory scheme, as well as the seeming disconnect between the government’s stated purpose and the sweeping scope of that scheme. Right out of the box, Judge Raggi was all over Douglas Letter, asking where someone can look for clear guidance as to what a sales rep can or can't do. The government’s answer: the guidance put out by FDA “makes clear what manufacturers can do.” Judge Raggi followed up by questioning how that is a “standard” by which courts can decide whether a crime has been committed. A fine question, we might add, and one that the government tried to dodge by falling back on the “promotion is not a crime” mantra. And on the disconnect between the government’s stated interests and the regulatory scheme at issue, Judge Raggi again pushed Letter hard. If the government is concerned about a manufacturer “dilly-dallying” in its efforts to seek approval for an unapproved use, FDA could “put timetables” on the manufacturer. But, Judge Raggi said, “[t]he concept of completely precluding speech is one we look at with some concern. And so I’m not sure why this can't be much more narrowly tailored.” When Letter responded with the bugaboo of past experience – the horror story of widespread off-label use leading to “public health disasters” – Judge Raggi cut that argument off immediately, explaining that in such a situation, FDA could stop the sale of the product entirely, or otherwise limit its use. “But as long as you’re allowing the physician to prescribe it for off-label purposes… I think you have to agree that there’s a concern that more speech is generally better than less speech.” The government’s response to that? “Absolutely, Your Honor, I couldn't agree more.” We agree too.

So what’s going to happen in Caronia? A long time ago we learned that you can get burned when you try to predict an outcome based on questions asked at oral argument, but we'll give it a shot. Based on the transcript, we’d venture to say that the panel will reach the First Amendment issues, will reject the government’s argument that the First Amendment isn't implicated at all, and will tackle the overbreadth and vagueness problems pervading FDA’s regulatory scheme. We’d give an edge to the defendant on those arguments, but you probably could have guessed that by now. Stay tuned.

 

I see noone has responded to what Jazz did to Al. If this company's employees are looking for friends at the CEO level, buy a dog.

 

Al is as innocent as was Dr. Gleason.
Fuck you all for not caring.

 

Re: Caronia- Former Drug Rep WON

Ruling Is Victory for Drug Companies in Promoting Medicine for Other Uses

By KATIE THOMAS

In a case that could have broad ramifications for the pharmaceutical industry, a federal appeals court on Monday threw out the conviction of a sales representative who sold a drug for uses not approved by the Food and Drug Administration. The judges said that the ban on so-called off-label marketing violated the representative’s freedom of speech.
The 2-to-1 decision by a three-judge panel of the Court of Appeals for the Second Circuit in Manhattan addresses a long-running and costly issue for the industry, which has paid billions of dollars in penalties to the federal government in recent years after being accused of marketing blockbuster drugs for off-label uses.
In July, for example, the British drug maker GlaxoSmithKline agreed to pay $3 billion in fines, in part for promoting antidepressants and other drugs for unapproved uses; a month later, Johnson & Johnson announced that its pharmaceutical unit had reached a $181 million consumer fraud settlement with 36 states and the District of Columbia over its marketing of Risperdal, an antipsychotic drug.
“Most if not all of these cases have been based on a central premise: that it is unlawful for a company and one of its employees to be promoting a drug or a medical device off-label,” said John R. Fleder, a director at the law firm Hyman, Phelps & McNamara who represented the F.D.A. while working at the Justice Department. “And this decision hits at the heart of the government’s theory.”
The ruling, in United States v. Caronia, involved the conviction of Alfred Caronia, a former sales representative for Orphan Medical, which was later acquired by Jazz Pharmaceutical. Mr. Caronia was selling Xyrem, a drug approved for excessive daytime sleepiness, known as narcolepsy. He was accused of promoting it to doctors as a treatment for insomnia, fibromyalgia and other conditions. He became the target of a federal investigation in 2005 and was caught on an audiotape discussing the unapproved uses of the drug with a doctor who was a government informant. He was convicted by a jury in 2008.
Mr. Caronia appealed the conviction, arguing that his right to free speech under the First Amendment was being illegally restricted. The appellate court decision applies only to the Second Circuit, which comprises New York, Connecticut and Vermont, but some lawyers said that the government was likely to appeal and that the case could find its way to the Supreme Court.
Under the Food, Drug and Cosmetic Act, which gives the F.D.A. the authority to regulate drugs, selling a “misbranded drug,” or one that is intended to be used for purposes not listed in the label, is illegal. Doctors, on the other hand, are free to prescribe a drug for any use. The agency has argued that off-label promotion of drugs is evidence that a sales representative or company intended to sell misbranded drugs.
In its decision, the court said this view violated the First Amendment and cited as precedent a 2011 Supreme Court decision, Sorrell vs. IMS Health. In that case, the high court, citing freedom of speech, overturned a Vermont law restricting pharmaceutical companies from using prescription data for marketing purposes.
“The government clearly prosecuted Caronia for his words — for his speech,” the majority wrote, concluding later “the government cannot prosecute pharmaceutical manufacturers and their representatives under the F.D.C.A. for speech promoting the lawful, off-label use of an F.D.A.-approved drug.”
The lone dissenting judge, Judge Debra Ann Livingston, vigorously disagreed, arguing that by throwing out Mr. Caronia’s conviction “the majority calls into question the very foundations of our century-old system of drug regulation.” She argued that if drug companies “were allowed to promote F.D.A.-approved drugs for nonapproved uses, they would have little incentive to seek F.D.A. approval for those uses.”
Gerald Masoudi, a former chief counsel of the F.D.A., said the ruling made a distinction between truthful discussion of off-label uses of drugs, many of which are considered legitimate by the medical community, and those that are misleading or false. He noted that “anyone on the planet” could discuss off-label uses of drugs, except for pharmaceutical companies.
“It’s very significant,” he said, “because it’s going to make F.D.A., in its promotion cases, focus on the kinds of speech that are more likely to harm consumers, such as false or misleading marketing versus something that is not approved.”
In a statement, the trade group for the pharmaceutical industry, Pharmaceutical Research and Manufacturers of America, said it was pleased with the ruling.
“PhRMA believes that truthful and nonmisleading communication between biopharmaceutical companies and health care professionals is good for patients, because it facilitates the exchange of up-to-date and scientifically accurate information about new treatments,” the statement said.
A spokeswoman for the F.D.A. said the agency did not comment on active litigation.
Lawyers said the government would most likely ask for a rehearing before the circuit court’s full panel of judges and after that, it could be taken up by the Supreme Court.
Because pharmaceutical companies market their drugs nationally and the ruling applies only within the Second Circuit, the ruling is not likely to lead drug makers to change their marketing policies. Rather, some said, the F.D.A. will be unlikely to pursue convictions in similar cases until the legal issues are resolved.

 

Bill and Dr. Gleason died for not

 

Freedom of speech wins! Now tell me how the court can stick with the constitution and a company still restrict speech? Its ok for a drug company restrict my speech? Even if it violates my freedom of speech? What a headache for the lawyers! I'm sure they will bill for there time.