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FDA AND AMARIN REACH SETTLEMENT ON OFF-LABEL STATEMENTS IMPLICATING FIRST AMENDMENT ISSUES

Settling claims that drug maker Amarin promoted its fish-oil pills for unapproved uses, the FDA stresses the settlement does not signify a position on the First Amendment and commercial speech. It refused to acknowledge that the First Amendment allows a pharmaceutical manufacturer to promote off-label if the promotion is truthful. 

OVERVIEW
On March 8, 2016, the United States District Court for the Southern District of New York approved a settlement between the Food and Drug Administration (“FDA”) and drug company Amarin Pharma, Inc. in connection with Amarin Pharma, Inc., et al. v. U.S. Food & Drug Admin., et al. The case focused on a legal dispute concerning Amarin’s promotion of off-label claims for its fish oil product Vascepa®.[1]

In a prior decision, the district court had applied a 2012 decision by the U.S. Court of Appeals for the Second Circuit in the case of United States v. Caronia finding that pharmaceutical and medical device companies have a constitutionally protected right to provide truthful and non-misleading information regarding off-label uses of their products.[2] The previous Amarin decision, in a limited preliminary injunction context, ruled against the FDA and upheld the rights of Amarin to make truthful and non-misleading statements regarding off-label uses of its FDA-approved drug, including the right to make those promotional statements to healthcare providers through sales representatives. The court also held that truthful and non-misleading promotional statements do not alone form the basis of a prosecution for misbranding in violation of the Food, Drug and Cosmetics Act.

TERMS OF THE AMARIN SETTLEMENT AGREEMENT
Under the settlement agreement, the FDA agreed to be bound by the District Court’s preliminary injunction decision that Amarin may engage in truthful, non-misleading speech promoting off-label use of Vascepa® to treat patients with persistently high triglycerides. The FDA also agreed that the materials that provided a basis for the court’s preliminary decision, including disclosures and scientific information (as modified by court order) were truthful and non-misleading.

The settlement makes Amarin responsible for assuring that future communications to doctors regarding off-label use of Vascepa® are truthful and not misleading. The settlement also allows Amarin, at its discretion, to provide up to two communications regarding the off-label use of Vascepa® per year to FDA for comment and identification of objections. This may assist but cannot reasonably be said to guarantee that all of Amarin’s future off-label communications will be truthful and not misleading. The settlement agreement imposes time requirements on FDA to provide feedback to Amarin on its off-label communications and a set period for Amarin to respond to this feedback. It also allows the parties to submit a motion to the District Court to hear disputes as to whether particular off-label statements are misleading. The court review process will remain in place until 2020. The FDA insists the case is narrow and specific, involving a single drug and single company. In an agency statement, the FDA expressly stated “[t]his settlement is specific to this particular case and situation,” and “does not signify a position on the First Amendment and commercial speech.”[3]

IMPLICATIONS AND KEY TAKEAWAYS
Putting aside the merits of whether truthful off-label promotion should be permissible and enjoy First Amendment protection, the Amarin case and its predecessor Caronia inject substantial uncertainty into False Claims Act jurisprudence and liability for criminal misbranding. Since 2004, there have been at least 31 settlements by pharmaceutical companies to resolve allegations of off-label promotion of drugs. Many of these settlements involved significant civil damages under the False Claims Act and often involved guilty pleas to criminal misbranding in violation of the Federal Food, Drug and Cosmetic Act. Individual settlements have run into hundreds of millions, and in some cases, billions of dollars. Billion dollar settlements post-date Caronia.[4] In what was the largest pharmaceutical settlement in U.S. history at the time, Pfizer reached a $2.3 billion settlement with the Department of Justice to resolve criminal charges and civil claims under the False Claims Act for the alleged off-label promotion of Bextra, Geodon, Zyvox, and Lyrica. The Second Circuit is the only appellate court to currently hold that off-label promotion of drugs enjoys constitutional protection, and lower courts in other jurisdictions have sharply cabined Caronia, in some cases outright rejecting the decision and its reasoning regarding free speech.[5] Moreover, all courts to confront the issue have agreed that false or misleading off-label promotion does not enjoy constitutional protection, a position the Caronia court itself reiterated.

Pharmaceutical companies should view the Amarin decision and settlement with caution and should not view Caronia or its successors as providing free license to promote off-label. Companies face the risk that a court in another jurisdiction will reject the rationale of the Caronia majority, perhaps adopting the rationale set forth in the Caronia dissent, authored by Judge Debra Ann Livingston, which would have upheld bans on truthful off-label promotion as constitutionally viable. Along the lines of Judge Livingston’s dissent, the United States government could be expected – in another case – to argue that an outright prohibition on off-label promotion is the only reasonable means of achieving FDA goals because off-label promotion, by its nature, so inherently strays into being misleading that the concept of truthful off-label promotion is not possible to apply. Drug and device manufacturers also run the risk that promotion they view as being truthful could be found by a fact-finder to be false or misleading on the grounds that it overstates product efficacy, minimizes safety concerns, lacks fair balance, or for a myriad of other reasons. Nevertheless, Caronia and Amarin do provide one avenue for pharmaceutical companies accused of off-label promotion to avoid liability if they can convince a court to accept Caronia and Amarin‘s rationale and establish that the promotion at issue was truthful.

CONTACTS

If you have any questions or would like more information on the issues discussed in this LawFlash, please contact Justin Brooks at jbrooks@gbblegal.com.

GBB’s experienced team of attorneys assist qui tam relators and the United States government in prosecuting fraud and provide compliance counseling to companies wishing to avoid legal liability under the False Claims Act and other federal and state statutes.

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[1] Stipulation and Order of Settlement, Amarin Pharma, Inc., et al. v. U.S. Food & Drug Admin., et al., No. 15 Civ. 3588 (S.D.N.Y. Mar. 8, 2016).

[2] Amarin Pharma, Inc., et al. v. U.S. Food & Drug Admin., et al., 119 F. Supp. 3d 196 (S.D.N.Y., 2015) (applying U.S. v. Caronia, No. 09-5006 (2d Cir. Dec. 3, 2012).

[3] See https://www.washingtonpost.com/national/health-science/fda-settles-with-drug-company-on-promotion-of-fish-oil-pill-for-unapproved-uses/2016/03/08/0403a5ea-e57d-11e5-bc08-3e03a5b41910_story.html?postshare=7361457531156927&tid=ss_mail

[4] For example, in November 2013, Johnson & Johnson reached a $1.391 billion settlement to resolve false claims resulting from its off-label promotion of Risperdal, Invega, and Natrecor. Companies also entered into settlements in the hundreds of millions of dollars after the Second Circuit decided Caronia. In July 2013, Wyeth agreed to pay $257.4 million to resolve claims involving off-label promotion of the immunosuprressant drug Rapamune. In February 2014, Endo Pharmaceuticals agreed to pay $171.9 million to resolve civil liability under the False Claims Act for its off-label promotion of Lidoderm.

[5] E.g. Hawkins v. Medtronic, Inc., No. 13-00499, 62 F. Supp. 3d 1144 (E.D. Cal. Feb. 15, 2016); Beavers-Gabriel v. Medtronic, Inc., 15 F. Supp. 3d 1021 (D. Haw. 2014); McDonald-Lerner v. Neurocare Assocs., P.A., No. 373859-V, 2012 Md. Cir. Ct. (Md. Cir. Ct. Aug. 29, 2013).

 

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GBB files amicus on behalf of law professors in FCA case before Supreme Court

Congress intended the False Claims Act to apply broadly and reach all fraudulent attempts to cause the United States Government to pay out money. In Universal Health Services, Inc. v. United States ex rel. Escobar, a key case pending before the United States Supreme Court, the Petitioner has urged a counter-textual interpretation that would vitiate the False Claims Act and compromise Congress’ intent.  On behalf of a distinguished group of law professors, Guttman, Buschner & Brooks PLLC has filed an amicus brief in the matter.

The amicus brief proposes a comprehensive model, the application of which will ensure the Act continues to effectuate Congress’ intent.  As the brief explains, the starting point for determining whether conduct is fraudulent and should be captured by the Act begins by looking to principles of common law fraud. However, Congress expanded upon the liability available under the False Claims Act, specifically by eliminating traditional reliance and scienter requirements of common law. Application of the Act’s statutory provisions expanding liability, coupled with use of limiting principles of materiality – routinely applied to other fraud statutes to ensure minor violations are not cognizable – balances concerns of the Act’s over-expansion with its stated purpose to broadly reach all fraudulent or deceitful acts that cause the Government to pay out money.

The full amicus brief is available here: Universal Health Services Inc v US and Massachusetts, ex rel Escobar and Correa – Brief of Law Professors as Amici.

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Doctors promoting treatments on social media routinely fail to disclose ties to drug makers

by Sheila Kaplan (Statnews.com)

Washington – Physicians across the United States routinely offer medical advice on social media — but often fail to mention that they have accepted tens and sometimes hundreds of thousands of dollars from the companies that make the prescription drugs they tout.

A STAT examination of hundreds of social media accounts shows that health care professionals virtually never note their conflicts of interest, some of them significant, when promoting drugs or medical devices on sites such as Facebook, Instagram, and Twitter. The practice cuts across all specialties.

. . .

But Reuben Guttman, an attorney in Washington who specializes in food and drug law, said the system leaves patients vulnerable to misinformation.

“Doctors who accept these dollars and then turn around and promote on social media corrupt the market for honest medical information,” Guttman said. “And drug companies that pay these doctors are similarly poisoning the market for honest information.”

Read the full article at statnews.com.

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A Failure of Remedies: The Case of Big Pharma (An Essay)

By Paul J. Zwier and Reuben Guttman
Emory Corporate Governance and Accountability Review
Emory Law

This Article examines the U.S. pharmaceutical industry and the harms imposed on individual patients and healthcare consumers—including private and government third party payers—from practices proscribed by Federal and State laws regulating marketing and pricing. 1

The Article pays particular attention to the False Claims Act (FCA), which has become the government’s primary civil weapon against fraudulent and/or wrongful conduct causing the expenditure of government dollars.
Read the entire Essay at http://law.emory.edu/ecgar/content/volume-3/issue-2/essays/failure-remedies-case-big-pharma.html

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New Hampshire and Hillary’s $675k

Top trial lawyer Reuben Guttman reflects on the New Hampshire primary.

Every four years, candidates trudge through the snows of New Hampshire, courting voters to gain political legitimacy as measured by a solid showing in the nation’s first Presidential Primary. Front runners are expected to trounce the opposition and challengers must beat expectations to stay in the race. None of this is written; it is the common law of US Presidential elections as handed down by journalists, news commentators, and pundits.

From the towns of Exeter to Rochester, candidates knock on doors, and press the flesh at coffee shops, public schools, and shopping malls. They talk about those without health insurance; those who struggle under adversity to support families; and military veterans who have made personal sacrifices for their country. New Hampshire is an up close and personal experience for voter and candidate. It is also a political battle ground that has killed the hopes of front runners. President Lyndon Johnson had this experience in 1968, bowing out of a race for re-election after a poor New Hampshire showing. Four years later, New Hampshire ended the candidacy of Maine Senator Edmond Muskie when he seemingly showed weakness when tearing up during a speech in front the state’s largest newspaper, the Manchester Union Leader. Back then, the Union Leader’s Publisher, William Loeb, had political leverage exceeding his actual readership; a Union Leader endorsement was a coveted prize for those seeking New Hampshire success as a path to the Presidency.

This year marked another illustrious chapter in the history of this quintessentially American Presidential rite of passage. Hillary Clinton came into the 2016 New Hampshire primary after squeaking by her opponent, Vermont Senator Bernie Sanders, by less than a percentage point in the Iowa Caucus. She pressed the flesh in the coffee shops and on the streets as she did back in 2008 when she ran for President and scored a narrow New Hampshire Primary win over Barack Obama. Her target this time around was to win the approval of voters in a state whose median household income is $66,000. As she talked to working class families, she talked about those she met on the campaign trail and those with problems or issues that seemingly might resonate with voters. In trying to connect with voters, there is something she did not discuss; at least not on her own and not as part of her “stump speech.” She did not talk about another group of people she met on her journeys; the Wall Street bankers.

The banter between candidate Clinton and voters in the gritty New Hampshire terrain was undoubtedly in marked contrast to the banter between the former Secretary of State and the Wall Street bankers who paid her hundreds of thousands of dollars to speak at their outings. Go back in time to 2014 and the South Carolina resort city of Bluffton where Clinton was paid $225 thousand to speak at a Goldman Sachs event. That was one of three Goldman events which generated a combined $675 thousand for Clinton; three days’ “work” earned her ten times the median household income for a New Hampshire family.

From her perspective, Clinton says that she took the money because that is what Goldman paid her. No doubt this is true. But was Goldman paying to gain insight or influence?

Clinton claims that in accepting these speaking fees – and she was paid by Wall Street institutions other than Goldman — her votes or opinions were not influenced. Really? How can she be so sure? Lawyers, of course, understand the notion of conflict of interest. It is hard to really understand how monies or relationships influence human behavior and so – at least in the legal profession – conflicts of interest rules are rigid. It is no defense to maintain that although a conflict exists, “I have enough will power to resist any influence.” Of course, the legal profession not only concerns itself with actual conflict but also the appearance of conflict. People can only believe the system works if it has at least the appearance of integrity.

But do voters really care about these matters? Perhaps. The votes have been tallied; Hillary Clinton lost the 2016 New Hampshire Primary by more than 20 percentage points. Was it her speaking engagements that swayed voters? Will this resounding defeat be the death knell for a candidate who was all but coroneted? This is what makes New Hampshire so interesting; up close and personal politics just causes people to think hard and ask questions.

Reuben Guttman is a trial lawyer and founding partner at Washington, DC-based firm Guttman, Buschner & Brooks.