United States v. Caronia – “A Tale Full of Sound and Fury”

By Ara B. Gershengorn
The author appreciates the assistance of Judith Gallant and Maria Amichetti in the preparation of this article.

In December 2012, the U.S. Court of Appeals for the Second Circuit vacated the conviction of Alfred Caronia, a pharmaceutical sales representative, for off-label promotion in a ruling that raised more questions than it answered.   For decades, the phrase “off-label promotion” has struck fear — and confusion — into the hearts of pharmaceutical companies everywhere, especially here in Massachusetts where a thriving life sciences industry operates in close proximity to an aggressive U.S. Attorney’s Office with substantial experience prosecuting healthcare companies for unlawful promotional activities.

Through the years, companies have paid hundreds of millions of dollars to settle both civil and criminal investigations involving off-label marketing.  In July 2012, GlaxoSmithKline paid $3 billion to settle civil and criminal charges relating in part to its unlawful promotion of Paxil and Wellbutrin.[1]  In December 2012, less than two weeks after the Second Circuit’s decision, Amgen agreed to pay $762 million as part of a guilty plea to marketing illegally its drug Aranesp.[2]   Settlements or pleas have come from nearly every major pharmaceutical company, including Pfizer,[3] Warner-Lambert,[4] Serono,[5] Schering-Plough,[6] Bristol-Myers Squibb,[7] Eli Lilly,[8] Cephalon,[9] AstraZeneca,[10] Merck,[11] and Novartis.[12]  Many of these investigations, including those of GSK and Pfizer, have been conducted by the U.S. Attorney’s Office in Massachusetts,[13] and even those pursued in other districts, such as the investigation of Amgen, sometimes received assistance from the federal prosecutors in Boston.[14]  As the Boston Federal District Court judge said at the sentencing of Merck in April 2012 (where she imposed a more than $300 million fine on the company for its off-label promotion and marketing of Vioxx), she had seen a “barrage” of off label marketing cases.[15]

Background on the FDCA

Off-label marketing is typically prosecuted as a violation of the Food, Drug and Cosmetic Act (“FDCA”).[xvi]  The FDCA sets out a regulatory scheme that requires drugs to be approved by the Food & Drug Administration before they may be introduced into interstate commerce.  In particular, the statute provides that “[n]o person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application, filed pursuant to subsection (b) or (j) of this section is effective with respect to such drug.”[xvii]  A “new drug” is defined in the statute as “any drug . . . the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof . . . .”[xviii]

The statute sets out the requirements for the application for a new drug, including reports of investigations into the safety of the drug; the components and composition; the methods used in, and the facilities and controls used for, the manufacturing, processing and packaging of the drug; and the indication of the drug.[xix]  Samples of the drug and the proposed labeling for the drug must also be submitted to the FDA.[xx]  When the FDA approves a drug, the approval is for an “approved” use (or uses), with particular labeling for each use.

Off-Label Use of Drugs

As the statutory scheme makes clear, the fact that a drug is approved and labeled for a particular use does not mean that its actual use is so restricted.  Instead, prescription drugs can lawfully be prescribed by physicians for both “approved” uses and unapproved — or “off-label” — uses.  Title 21 explicitly states, “[n]othing in this chapter shall be construed to limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease within a legitimate health care practitioner-patient relationship,”[xxi] and, as the Supreme Court recognized in connection with medical devices, off-label use “is an accepted and necessary corollary of the FDA’s mission to regulate in this area without directly interfering with the practice of medicine.”[xxii]   Nevertheless, the statute also recognizes that “[t]his section shall not limit any existing authority of the Secretary to establish and enforce restrictions on the sale or distribution, or in the labeling, of a device that are part of a determination of substantial equivalence, established as a condition of approval, or promulgated through regulations.  Further, this section shall not change any existing prohibition on the promotion of unapproved uses of legally marketed devices.”[xxiii]  Thus, as the courts have explained: “Although a doctor is free to prescribe drugs for off-label uses, FDA regulations forbid pharmaceutical companies from initiating discussions of such uses with physicians and from marketing a drug for anything other than an FDA-approved use.”[xxiv]

The government typically threads this needle by prosecuting “misbranding,” or “the introduction or delivery for introduction into interstate commerce of any . . . drug that is . . . misbranded.”[xxv]  A drug is “misbranded” if its labeling does not include “adequate directions for use.”[xxvi]  Adequate directions for use are “directions under which the layman can use a drug safely and for the purposes for which it is intended.”[xxvii]  FDA regulations define “intended use” by reference to “the objective intent of the persons legally responsible for the labeling of drugs,” which may be demonstrated by “oral or written statements by such persons or their representatives.”[xxviii]  It is on this misbranding theory that the government has investigated and prosecuted scores of cases, including one against Orphan Medical and its sales representative, Alfred Caronia.

Orphan Medical and Xyrem

The Caronia/Orphan Medical case revolved around the sale and marketing of the drug Xyrem.  Xyrem, manufactured by Orphan Medical, was approved with a first indication in July 2002 as a “central nervous system depressant” to treat symptoms of narcolepsy. [xxix]  It was initially indicated for the treatment of cataplexy (suddenly weak or paralyzed muscles when people who have narcolepsy feel strong emotions). [xxx]  The on-label indication was expanded in November 2005 to include excessive daytime sleepiness (EDS) in people who have narcolepsy. [xxxi]

Xyrem has serious side effects, including “difficulty breathing while asleep, confusion, abnormal thinking, depression, nausea, vomiting, dizziness, headache, bedwetting, and sleepwalking.”[xxxii]  Moreover, the active ingredient in Xyrem is gamma-hydroxybutryate, or GHB, commonly known as the “date rape drug.”[xxxiii]  The FDA required a “black box” warning for Xyrem, the most serious warning placed on medication labels.[xxxiv]

Orphan Medical hired Alfred Caronia in March 2005 as a Specialty Sales Consultant to promote Xyrem.[xxxv]  In July 2005, Caronia started Orphan Medical’s Xyrem “speaker programs” which enlisted physicians to speak to other doctors about the product’s on-label uses.[xxxvi]  Orphan Medical subsequently hired Dr. Peter Gleason, a psychiatrist, as one of its physician speakers.

In the Spring of 2005, the government began an investigation of Orphan Medical focusing on the off-label promotion of Xyrem.  Caronia and Gleason were recorded as they had off-label discussions with Dr. Stephen Charno, a physician cooperating with the government who posed as a potential Xyrem prescriber.  In one of the recorded conversations, Caronia, according to the government, promoted Xyrem for a variety of off-label conditions:

[Caronia]: And right now the indication is for narcolepsy with cataplexy . . . excessive daytime . . . and fragmented sleep, but because of the properties that . . . it has it’s going to insomnia, Fibromyalgia[,] periodic leg movement, restless leg, ahh also looking at ahh Parkinson’s and . . . other sleep disorders are underway such as MS.

[Charno]: Okay, so then so then it could be used for muscle disorders and chronic pain and . . .

[Caronia]: Right.

[Charno]: . . . and daytime fatigue and excessive sleepiness and stuff like that?

[Caronia]: Absolutely.  Absolutely.  Ahh with the Fibromyalgia.[xxxvii]

Caronia was also recorded discussing an unapproved subpopulation for Xyrem with physician-customers.[xxxviii]

In July 2007, the government charged Orphan Medical with misbranding Xyrem, claiming that “ORPHAN sales representatives and medical professionals retained by ORPHAN to speak in support of Xyrem, engaged in a scheme to expand the market for Xyrem by promoting the drug to physicians for ‘off-label’ medical indications, including fatigue, insomnia, fibromyalgia . . ., chronic pain . . ., weight loss, depression bipolar disorders and movement disorders such as Parkinson’s Disease.”[xxxix]  The Company pleaded guilty to felony misbranding, agreed to pay $20 million, and entered into a Corporate Integrity Agreement.

The government also charged David Tucker (a former Orphan Medical sales manager), Gleason, and Caronia with felony misbranding and other criminal violations.  Tucker pleaded guilty to a single felony misbranding count.  In August 2008, the government reduced its charges against Caronia and Gleason to misdemeanors.  Gleason pleaded guilty to one count of misdemeanor misbranding, while Caronia proceeded to trial on counts of misdemeanor misbranding and conspiracy.[xl]

In October 2008, Caronia was tried before a jury and convicted of conspiracy to commit misdemeanor misbranding.[xli]  He was sentenced to one year of probation, 100 hours of community service, and a $25 special assessment.[xlii]

Caronia appealed, arguing that he was convicted for his speech in violation of the First Amendment.  On December 3, 2012, the Second Circuit agreed and vacated his conviction by a 2-1 vote.

Second Circuit’s Decision

In vacating Caronia’s conviction, the majority opinion emphasized that the government had prosecuted Caronia for his off-label promotional speech.  “The government, in its summation and rebuttal, repeatedly asserted that Caronia was guilty because he, with others, conspired to promote and market Xyrem for off-label use. . . .  Thus, the government’s theory of prosecution identified Caronia’s speech alone as the proscribed conduct.”[xliii]

The court drew a distinction between the statutory offenses with which Caronia had been charged of misbranding (or conspiracy to misbrand) on the one hand, and off-label promotion on the other.  The former, the court noted, does not necessarily “criminalize speech,” whereas the latter would.  In order to avoid constitutionally invalidating a federal statute, the court construed the FDCA “as not criminalizing the simple promotion of a drug’s off-label use.”[xliv]  The statute itself, the court held, was not constitutionally infirm because it did not criminalize speech.  A prosecution for off-label promotion, on the other hand, which would criminalize speech, was constitutionally impermissible.

In so holding, the majority relied heavily on the recent Supreme Court decision in Sorrell v. IMS Health, Inc.[xlv]  In Sorrell, the Second Circuit noted, the Supreme Court had held that speech in aid of pharmaceutical marketing “‘is a form of expression protected by the . . . First Amendment.’”[xlvi]  Applying Sorrell, the Second Circuit determined that criminalizing off-label promotion would be both content-based and speaker-based restrictions of speech, meaning that a statute that criminalized off-label promotion would be drawing distinctions and thereby approving or disapproving speech based both on what the speaker was saying (because only on-label promotion but not off-label promotion was permissible) and who was speaking (because only manufacturers are so limited, whereas others, such as doctors, are permitted to discuss off-label uses).  Accordingly, the court found that the restriction was subject to a higher form of constitutional scrutiny.[xlvii]

The court then applied the four-prong test of Central Hudson.[xlviii]  The court found that the first two prongs — that the speech is not misleading and concerns lawful activity and that the government’s interest is substantial — were “easily satisfied.”[xlix]  The speech was not misleading in and of itself,[l] and the government’s interest in assuring drug safety and public health was substantial.  As to the third prong, however, (directly advancing the government interest) the court determined that regulating off-label speech did not directly advance the government’s interest.  To the contrary, the court found that prohibiting manufacturers from conveying truthful information about off-label uses might in fact hamper the government’s interest and “inhibit, to the public’s detriment, informed and intelligent treatment decisions.”[li]  “The government’s construction of the FDCA essentially legalizes the outcome — off-label use — but prohibits the free flow of information that would inform that outcome.”[lii]  Finally, the court found that the fourth prong (narrow tailoring) was also not satisfied.  The restriction consisting of a complete and criminal ban on speech was more extensive than necessary to achieve the government’s interest.[liii]

Because the FDCA defines misbranding in terms of whether a drug’s labeling is adequate for its intended use, the Second Circuit assumed, without deciding, that the government could prove intended use by reference to promotional statements made by drug companies and their representatives.  The court left open the possibility that prosecutors may use evidence of off-label promotion as a means of establishing the intended use of a drug.  Even if this use of evidence of speech were permissible, however, the Second Circuit determined that this was of little help to the government in this case because Caronia was not prosecuted on that basis.  “Rather, the record makes clear that the government prosecuted Caronia for his promotion and marketing efforts. . . .  [T]he government’s summation and the district court’s instruction left the jury to understand that Caronia’s speech was itself the proscribed conduct.”[liv]

After Caronia

The Second Circuit’s decision was quickly hailed by some as a sea change.  The New York Times declared it a “victory” for drug companies.[lv]  Bloomberg’s headline read “U.S., Barred From Prosecuting Off-Label Sales of Drugs.”[lvi]  Thomson Reuters asked “Seismic Fallout from Ruling on Drug Marketing and Free Speech?” and whether a “blockbuster ruling” by the Second Circuit would “turn off the spigot of false claims billions from the pharma industry?”[lvii]  Some waited anxiously to find if the FDA would seek further review of the ruling, either by an en banc court of the Second Circuit or by the Supreme Court.

But almost two months after the decision, on January 23, 2013, the FDA declared that it would not seek further review:

“FDA does not believe that the decision will significantly affect the agency’s enforcement of the drug misbranding provisions of the Food, Drug & Cosmetic Act. The decision does not strike down any provision of the FD&C Act or its implementing regulations, nor does it find a conflict between the act’s misbranding provisions and the First Amendment or call into question the validity of the act’s drug approval framework.”

Although perhaps surprising at first glance, the FDA’s decision not to appeal was actually quite predictable for a number of reasons.  Despite some of the hype immediately following the decision and the dire forecast of the dissent that “the majority calls into question the very foundations of our century-old system of drug regulation,”[lviii] the ruling arguably left in place a number of avenues for prosecution.  First, it left open the possibility that one can be prosecuted for conveying false or misleading information.  As discussed above, the majority opinion noted that the prosecution had not contended either at trial or on appeal that the promotion by Caronia was either false or misleading.  “[O]f course, off-label promotion that is false or misleading is not entitled to First Amendment protection.”[lix]  Thus, after Caronia, the government still can prosecute for false or misleading statements and arguably could claim that a statement that a drug is safe for off-label use could be found to be false or misleading if there is insufficient support (such as studies) to demonstrate such safety.[lx]

Second, the Caronia decision still permits the government to prosecute using evidence of off-label activities as evidence of intent.  The Caronia decision explicitly left open this possibility, although in a footnote, the court questioned how the government would identify criminal misbranding from communications between drug manufacturers and physicians who could prescribe drugs for off-label use.[lxi]

Third, the decision has limited reach.  The Second Circuit covers only Vermont, New York, and Connecticut, and therefore, the court’s decision is binding only on federal courts within those states.  Importantly, the decision does not bind either of two very active U.S. Attorney’s Offices – Massachusetts and Pennsylvania — neither of which, it is important to bear in mind, is limited to prosecuting companies in their own backyard.  Because of the wide reach of companies and their often national, if not global, sales and marketing practices, the U.S. Attorney’s Offices in both Massachusetts and Pennsylvania have prosecuted, and continue to prosecute, companies located across the country and the globe.

While some have contended that the Caronia decision’s limited geographic reach may have been a significant factor in the FDA’s decision to decline further review, it seems more likely that prosecutors, like the FDA itself, will not affirmatively argue that the decision is wrongly decided and should be limited to the Second Circuit, but will instead simply seek to construe it narrowly.  This view was expressed by the U.S. Attorney for the Eastern District of Pennsylvania, Zane Memeger, whose office, along with the District of Massachusetts, has been at the forefront of healthcare prosecutions.  “‘The Second Circuit decision is not binding on other areas, but it can be relied upon for guidance,’ Memeger said. . . . . Memeger said his prosecutors will continue to focus on finding evidence [of] misbranding, which remains illegal, and the more commonly understood term – lying.  ‘There is no right of a company or an individual to make false and misleading statements about the use of a drug,’ Memeger said.  ‘I don’t see a difference in prosecuting our cases as vigorously as we have.  You want to make sure you have proof and not just a simple statement.’”[lxii]

Finally, government prosecutions often involve not only misbranding but other accompanying allegations such as violations of the anti-kickback statute or the alleged filing of false claims neither of which have been narrowed through the Caronia decision.  The U.S. Attorney for the District of Massachusetts, Carmen Ortiz, noted this recently, speaking to attendees at the CBI Pharmaceutical Compliance Congress at the end of January of this year.  Ortiz stated “‘You should not view this decision as a green light to engage in conduct that could be in that gray area that may be covered. . . .   When I think of all the prosecutions we’ve done in my office, I can’t think of any that would be covered by the Caronia decision. . . .  I don’t think you want to test it.’”[lxiii]

This statement of course highlights the conundrum faced by companies that might want to challenge whether they fall into this gray area:  the risks for them, their boards of directors, executives, and shareholders are simply too great to “test it.”  For a time, Par Pharmaceuticals, faced with an investigation in New Jersey, raised a First Amendment challenge in a separate action it brought against the FDA in federal court in the District of Columbia.[lxiv]  Par sought a declaratory judgment that the FDA’s intended use regulations violate the First Amendment and run counter to the FDCA.  But in March 2013, Par reached a settlement with the Justice Department in which Par agreed to pay $45 million; enter into a five-year Corporate Integrity Agreement;[lxv] and, as a condition of the settlement, drop its lawsuit.[lxvi]

Given the extremely high stakes involved with fighting a prosecution and bringing a First Amendment challenge — criminal penalties, shareholder lawsuits, Medicare exclusion — it seems unlikely that any corporate defendants will be willing to find out whether the Caronia decision came in like a lion, but has gone out like a lamb.  For now, such tests will be left to individual defendants, like Alfred Caronia, if to anyone at all.

Ara Beth Gershengorn is a partner with Foley Hoag LLP with a practice focused on government investigations, data security and privacy, and complex civil litigation.  Ara has represented a variety of companies and officers in criminal, civil, congressional, and regulatory investigations against allegations involving whistleblower actions, such as the federal False Claims Act, healthcare fraud, including off-label promotion, kickbacks, and product safety, and antitrust, environmental crimes, and securities fraud.  Prior to joining Foley Hoag, Ara was an Assistant United States Attorney, where she successfully prosecuted federal criminal trials and conducted investigations of health care fraud, securities fraud, tax crimes, and education fraud.

[1] See “GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data,” Department of Justice (“DOJ”) Press Release, July 2, 2012.

[2] See “Amgen Inc. Pleads Guilty to Federal Charge in Brooklyn, NY.; Pays $672 Million to Resolve Criminal Liability and False Claims Act Allegations,” DOJ Press Release, December 19, 2012.

[3] See, e.g., “Justice Department Announces Largest Health Care Fraud Settlement In Its History,” DOJ Press Release, September 2, 2009; see also DOJ Press Release, “Pfizer Agrees to Pay $55 Million for Illegally Promoting Protonix for Off-Label Use,” December 12, 2012.

[4] See “Warner-Lambert to Pay $430 Million to Resolve Criminal & Civil Health Care Liability Relating to Off-Label Promotion,” DOJ Press Release, May 13, 2004.

[5] See “Serono to Pay $704 Million for the Illegal Marketing of AIDS Drug,” DOJ Press Release, October 17, 2005.

[6] See “Schering to Pay $435 Million for the Improper Marketing of Drugs and Medicaid Fraud,” DOJ Press Release, August 29, 2006.

[7] See Bristol-Myers Squibb to Pay More Than $515 Million to Resolve Allegations of Illegal Drug Marketing and Pricing,” DOJ Press Release, September 28, 2007.

[8] See “Eli Lilly Agrees to Pay $1.415 Billion to Resolve Allegations of Off-Label Promotion of Zyprexa,” DOJ Press Release, January 15, 2009.

[9] See “Pharmaceutical Company Cephalon to Pay $425 Million for Off-Label Drug Marketing,” DOJ Press Release, September 29, 2008.

[10] See “Pharmaceutical Giant AstraZeneca to Pay $520 Million for Off-Label Drug Marketing,” DOJ Press Release, April 27, 2010.

[11] See “U.S. Pharmaceutical Company Merck Sharp & Dohme to Pay Nearly One Billion Dollars over Promotion of Vioxx®,” DOJ Press Release, November 22, 2011.

[12] See “Novartis Vaccines & Diagnostics to Pay More Than $72 Million to Resolve False Claims Act Allegations Concerning TOBI,” May 4, 2010; see also “Novartis Pharmaceuticals Corp. to Pay More Than $420 Million to Resolve Off-label Promotion and Kickback Allegations,” DOJ Press Release, September 30, 2010.

[13] See supra, n. 3 (“The criminal case is being prosecuted by the U.S. Attorney’s Office for the District of Massachusetts and the Civil Division’s Consumer Protection Branch.”); supra, n. 5 (“This case was handled by the Justice Department’s Civil Division and the U.S. Attorney’s Office for the District of Massachusetts.”).

[14] See supra n. 4 (listing attorneys from offices including the District of Massachusetts).

[15]  See “U.S. Pharmaceutical Company Merck Sharpe & Dohme Sentenced in Connection with Unlawful Promotion of Vioxx,” DOJ Press Release, April 19, 2012.

[xvi] 21 U.S.C. § 331(a), et seq.

[xvii] 21 U.S.C. § 355(a).

[xviii] 21 U.S.C. § 321(p).

[xix] 21 U.S.C. § 355(b).

[xx] Id.; see also http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplic ations/NewDrugApplicationNDA/ (visited 4/10/2013).

[xx] 21 U.S.C. § 396.

[xxi] 21 U.S.C. § 396.

[xxii] Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 350 (2001).  The statement in Buckman has been applied to drugs as well as devices.  See, e.g., In re Neurontin Marketing and Sales Practices and Products Liability Litigation, 2010 WL 3169485 (Aug. 10, 2010), at * 4 (stating that “Doctors are permitted to prescribe drugs off-label” and indirectly citing Buckman).

[xxiii] 21 U.S.C. § 396.

[xxiv] United States ex rel. Carpenter v. Abbott Laboratories, Inc., 723 F.Supp.2d 395, 398 (D. Mass. 2010); see also United States ex rel. Poteet v. Lenke, 604 F. Supp. 2d 313, 316 n.3 (D. Mass. 2009) (“the federal government discourages off-label prescription use by imposing FDA restrictions on the dissemination of information about potential off-label therapies and by restricting Medicaid from reimbursing health care providers for off-label uses.”)

[xxv] 21 U.S.C. § 331(a).

[xxvi] 21 U.S.C. § 352(f).

[xxvii] 21 U.S.C. § 201.5.

[xxviii] 21 C.F.R. § 201.128.

[xxix] Caronia, 703 F.3d at 155.

[xxxi] Xyrem Medication Guide,  http://www.xyrem.com/images/Xyrem_Med_Guide.pdf (visited 4/11/2013).

[xxxii] Caronia, 703 F.3d at 155.

[xxxiii] Id.

[xxxiv] 21 C.F.R. § 201.57(c)(1); see also New Jersey Carpenters Pension & Annuity Funds v. Biogen Idec Inc., 537 F.3d 35, 42 (1st Cir. 2008) (describing the black box warning as the “strictest warning the FDA can require”).

[xxxv] Caronia, 703 F.3d 155-56.

[xxxvi] Caronia, 703 F.3d at 156.

[xxxvii] Id.

[xxxviii] Caronia, 703 F.3d 156-57 (“Caronia stating that “there have been reports of patients as young as fourteen using it and obviously greater than sixty-five.  It’s a very safe drug” when the black box labeling indicated that Xyrem’s safety and efficacy were not established in patients under 16 years and that the drug had “very limited” experience among elderly patients).

[xxxix] United States v. Orphan Medical, Inc., U.S.D.C., Eastern District of New York, Cr. No., 07-531 (ENV), docket entry 6 (Information) (July 7, 2007).

[xl] Caronia, 703 F.3d at 158.

[xli] Caronia, 703 F.3d at 159.  Caronia was acquitted of the other charges.

[xlii] Caronia, 703 F.3d at 160.

[xliii] Caronia, 703 F.3d at 158, 159.

[xliv] Caronia, 703 F.3d at 160.

[xlv] Sorrell v. IMS Health, Inc., 131 S. Ct. 2653 (2011).

[xlvi] Caronia, 703 F.3d at 161-62 (quoting Sorrell, 131 S. Ct. at 2659, 2667).

[xlvii] See Caronia, 703 F.3d at 161-63.

[xlviii] Central Hudson Gas & Elec. Corp. v. Pub. Serv. Comm’n of N.Y., 447 U.S. 557, 563-64 (1980).  Central Hudson established a four-prong test used in determining whether commercial speech is protected by the First Amendment.  See id. at 566.  (1) The speech must not be misleading and must concern lawful activity; (2) the government interest must be substantial; (3) the regulation must directly advance the government interest; and (4) the regulation must be narrowly drawn and may not be more extensive than necessary to serve the interest.”  Id.

[xlix] Caronia, 703 F.3d at 165.

[l] The court noted that the government was not contending either at trial or on appeal that the speech was misleading or false.  See id. n. 11.

[li] Caronia, 703 F.3d at 166.

[lii] Caronia, 703 F.3d at 167.

[liii] Caronia, 703 F.3d at 167-68.

[liv] Caronia, 703 F.3d at 161 (emphasis in original).

[lv] See, e.g., Katie Thomas, “Ruling Is Victory for Drug Companies in Promoting Medicine for Other Uses,” NY Times, Dec. 3, 2102

[lvi] Margaret Cronin Fisk, “U.S. Barred From Off-Label Sales of Drugs,” Bloomberg News,  http://www.bloomberg.com/news/2012-12-04/u-s-barred-from-prosecuting-off-label-sales-of-drugs.html

[lvii] Allison Frankel’s On the Case, “Seismic Fallout from Ruling on Drug Marketing and Free Speech?” December 4, 2013, Thomson Reuters News & Insight, http://newsandinsight.thomsonreuters.com/Legal/News/2012/12_-_December/Seismic_fallout_from_ruling_on_drug_marketing_and_free_speech_/.

[lviii] Caronia, 703 F.3d at 169 (Livingston, J., dissenting).

[lix] Caronia, 703 F.3d at 166.

[lx] In United States v. Harkonen, Nos. 11-10209, 11-10242 (9th Cir. March 4, 2013), 2013 WL 782354, submitted to the Ninth Circuit Court of Appeals mere days after the Caronia ruling and anxiously watched in the aftermath of Caronia, the Ninth Circuit upheld, in an unpublished decision, the conviction of a physician charged with wire fraud for issuing a fraudulent press release on the purported survival benefits of Actimmune.  Harkonen had claimed that the press release expressed a scientific view and that he should be protected under the First Amendment, but the court found that his statements were not protected by the First Amendment because the jury had determined that the press release was fraudulent.

[lxi] Caronia, 703 F.3d at 162 n.10.

[lxii] David Sell, “Philly U.S. Attorney: Caronia court decision won’t impact pharma prosecutions (locally, for now),” Feb. 12, 2013, http://www.philly.com/philly/blogs/phillypharma/Philly-US-Attorney-says-court-decision-wont-impact-drug-prosecutions-for-now.html.

[lxiii] Erica Teichert, “Drug Misbranding Investigations Remain Top Priority: DOJ,” Jan. 29, 2013,  http://www.law360.com/articles/411149/drug-misbranding-investigations-remain-top-priority-doj.

[lxiv] Par Pharmaceutical, Inc. v. United States, District of Columbia, District Court, No. 11-cv-01820.

[lxv] “Par Pharmaceuticals Pleads Guilty and Agrees to Pay $45 Million to Resolve Civil and Criminal Allegations Related to Off-Label Marketing,” DOJ Press Release, March 5, 2013, http://www.justice.gov/opa/pr/2013/March/13-civ-270.html.

[lxvi] Letter dated January 3, 2013, from Office of the U.S. Attorney for the District of New Jersey to John Nassikas, et al., re: Plea Agreement with Par Pharmaceutical, http://pharmarisc.com/wp-content/uploads/2013/03/Par-Pharmaceutical-Plea%20Agreement-1.pdf.



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