DECISION AND ORDER
VITALIANO, District Judge.
Defendant moves to dismiss the two-count misdemeanor information charging him with certain violations of the misbranding provisions of the Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C. § 301 et seq. The motion is denied in its entirety.
FACTUAL AND PROCEDURAL BACKGROUND
The following facts are taken from the superseding misdemeanor information filed August 19, 2008 and, for purposes of this motion to dismiss, are accepted as true.
Orphan Medical, Inc. ("Orphan"), now known as Jazz Pharmaceutical, was a specialty pharmaceutical company focused primarily on the development of drugs to treat pain, sleep disorders, and central nervous system disorders. Orphan manufactured the drug Xyrem, a powerful sleep-inducing depressant whose active ingredient was gamma-hydroxybutryate ("GHB").
Pursuant to the FDCA, manufacturers are restricted from marketing so-called "off-label" (i.e., non-FDA approved) uses of a drug. Such off-label marketing results in the drug being "misbranded" in violation of the statute.
In particular, the information alleges that, on October 26, 2005, Caronia promoted Xyrem to a physician "John Doe" for fibromyalgia, EDS, muscle disorders, chronic pain and fatigue, which uses were for off-label indications. The information further alleges that, on November 2, 2005,
The information supersedes a prior felony indictment against Caronia and Dr. Peter Gleason, who is the physician allegedly paid by Orphan to promote Xyrem for off-label uses. That indictment charged that Gleason and Caronia participated in a conspiracy with others to introduce a misbranded drug into interstate commerce with intent to defraud and mislead, 21 U.S.C. §§ 331 and 333(a)(2), and to make false statements in connection with the delivery of and payment for health care benefits, 18 U.S.C. §§ 1035(a)(1), (2). The indictment also charged a conspiracy to defraud public and private health care plans, 18 U.S.C. § 1349.
Gleason moved to dismiss the misbranding counts of the original indictment on various grounds, including that the misbranding provisions of the FDCA were unconstitutional restrictions of his right to free speech under the First Amendment and that they were unconstitutionally vague and overbroad. Caronia joined in Gleason's motion insofar as it applied to him and separately moved to dismiss the entire indictment on other grounds as well. Briefing on those motions was completed and the motions submitted for decision on May 12, 2008. While those motions were sub judice, on August 8, 2008, the government filed a superseding information against Gleason charging him with a single misdemeanor misbranding violation pursuant to 21 U.S.C. §§ 331(a) and 333(a)(1). Gleason pled guilty to that charge the same day and awaits sentencing. On August 12, 2008, the government filed a superseding information against Caronia containing a similar single misdemeanor misbranding charge. Then, on August 19, 2008, it filed this second superseding information, charging the two misdemeanor counts now at issue.
At that time, the Court requested supplemental briefing by Caronia and the government as to which portions of the original motion to dismiss still remained for the Court to determine and as to any new or modified grounds for dismissal. Recognizing the superseding information had rendered the pending motion moot, Caronia, essentially, reincorporated in the current motion Gleason's original arguments that the misbranding provisions of the FDCA as applied to the charged conduct are unconstitutional.
Procedurally, as a result of Gleason's guilty plea and the superseding information filed against Caronia, the original motions to dismiss filed by Gleason and Caronia are both denied as academic. The Court addresses now only the grounds, including those reincorporated, that Caronia raises on his new motion to dismiss.
Standard for Dismissal
Federal Rule of Criminal Procedure 12(b)(2) permits a criminal defendant to raise by pretrial motion "any defense, objection, or request that the court can determine without a trial of the general issue." A court faced with a motion to dismiss must ask, first, whether the information states an offense, and second, whether the information is sufficiently specific to provide notice and allow the defendant to plead double jeopardy in a subsequent case. United States v. Kramer, 499 F.Supp.2d 300, 305 (E.D.N.Y.2007); United States v. Sierra-Garcia, 760 F.Supp. 252, 258 (E.D.N.Y.1991). The court is limited to the face of the information and all the facts it alleges must be accepted as
Whether Caronia Misbranded Xyrem
Caronia argues that the allegations in the information actually establish that he did not misbrand Xyrem within the meaning of 21 U.S.C. § 331(k) and, therefore, that count two of the information must be dismissed.
He first claims that, at the time the information alleges he marketed Xyrem for off-label uses, the drug was not "held for sale ... after shipment in interstate commerce" within the meaning of § 331(k). In particular, he argues that Xyrem was dispensed only via a central pharmacy in Missouri and shipped directly to the consumer—which he claims, takes it out of the scope of subsection (k). See Kordel v. United States, 335 U.S. 345, 351, 69 S.Ct. 106, 110, 93 L.Ed. 52 (1948) (noting that § 331(k) is "restricted to cases where the article is held for sale after shipment in interstate commerce; and, unlike [§ 331(a)], it does not reach situations where the manufacturer sells directly to the consumer."). The government counters that the proof at trial will demonstrate Xyrem was manufactured in stages in Pennsylvania and South Carolina, then shipped to a Missouri company, SDS/Express Scripts, which, during the relevant time period, acted as a warehouse, centralized pharmacy and distributor for all Xyrem prescriptions nationwide.
Caronia next argues that, assuming the lawful reach of the FDCA, he did not misbrand Xyrem within the meaning of 21 U.S.C. § 352(f) because he administered adequate warnings to the cooperating physician in October and November 2005.
This argument is utterly without merit. It is well established that under the FDA's "intended use" regulations, the promotion of a drug for an off-label use by the manufacturer or its representative is prohibited regardless of what directions the manufacturer or representative may give for that use. See, e.g., Decision in Washington Legal Foundation v. Henney, 65 Fed.Reg. 14,286-01 (Mar. 16, 2000) (FDCA "generally prohibits the manufacturer of a new drug or medical device from distributing a product in interstate commerce for any intended use that FDA has not approved as safe and effective. . . . The intended use or uses of a drug or device may also be determined from advertisements, promotional material, oral statements by the product's manufacturer or its representatives, and any other relevant source."); Final Guidance on Industry-Supported Scientific and Educational Activities, 62 Fed.Reg. 64,074, 64,075 (Dec. 3, 1997) ("The courts have agreed with the agency that [21 U.S.C. § 352(f)(1)] requires information not only on how a product is to be used (e.g., dosage and administration), but also on all of the intended uses of a product.").
Caronia's third argument for dismissal is bolder still. He claims (without any support whatsoever) that warnings were unnecessary because the physician to whom he promoted off-label uses of Xyrem was a confidential informant who was not going to be a user or prescriber of the drug. Yet, as the government points out, the plain language of 21 U.S.C. § 331(k) requires only that the government show "that the [defendant] undertook some act with respect to the [drug] that [was] held for sale after shipment in interstate commerce, which act resulted in the [drug] being adulterated and misbranded." United States v. Torigian Laboratories, Inc., 577 F.Supp. 1514, 1526 (E.D.N.Y.1984). It is the mouth of the promoter not the ear or intent of the audience that controls. Promotion of off-label uses by a drug manufacturer's representative clearly falls within the broad statutory definition of the offense. Even assuming arguendo that the cooperating physician was not, and never intended to be, a user or prescriber of Xyrem, Caronia points to no authority, and the Court is unaware of any, that would exclude his alleged promotion of Xyrem to a cooperating physician for an off-label use from this statutory prohibition.
Finally, Caronia contends that he did not misbrand Xyrem in his conversations with the cooperating physician in October and November 2005. He attaches the government's transcripts of those conversations and claims that at no time did he actually promote Xyrem for off-label uses. On motion to dismiss, however, the Court must follow the well established rule that allegations of fact in the information be accepted as true and contrary assertions of fact by the defendant not be considered. See Blasius, 230 F.Supp. at 997; Goldberg, 756 F.2d at 950. The Court therefore declines to look beyond the facts alleged by the government in the information supporting the charge of Caronia's alleged misbranding. Such disputes are resolved by trial not motion.
For all these reasons and upon each of the grounds asserted on this branch of the motion, the Court denies Caronia's motion to dismiss count two of the information.
Constitutionality of the Misbranding Charges under the First Amendment
By reference to former co-defendant Gleason's motion to dismiss the prior indictment filed against Gleason and Caronia, Caronia argues on this second branch of his motion that the misbranding provisions of the FDCA as applied to his alleged conduct are an unconstitutional restriction of speech under the First Amendment. Reduced to its essence, Caronia's argument is that the government cannot restrict truthful, non-misleading promotion by a pharmaceutical manufacturer (or its employees) to a physician of the off-label uses of an FDA-approved drug. The government rejoins that the First Amendment does not apply to Caronia's activities as alleged in the information and that, if the First Amendment does apply, the FDCA's restrictions on promotion of off-label uses are constitutional.
Squarely, Caronia's constitutional attack calls into question America's regulatory regime for the approval and marketing of prescription drugs. The argument is founded on the unassailable fact that, under current law, while it is unlawful for a manufacturer to promote to physicians or consumers off-label uses of a prescription drug approved by the FDA for other uses, a physician may nonetheless lawfully prescribe that drug for any purpose, regardless of whether that purpose has been approved. See Washington Legal Foundation v. Henney, 202 F.3d 331, 332-33 (D.C.Cir.2000). It is generally recognized (even by the FDA) that off-label prescriptions can constitute a medically recognized standard of care and, therefore, that it is important for physicians to have access to accurate information about off-label uses.
The seminal case on the FDA's regulation of guidance relating to the off-label use of prescription drugs is Judge Lamberth's decision in Washington Legal Foundation v. Friedman, 13 F.Supp.2d 51, 74-75 (D.D.C.1998), order vacated as moot sub nom. Washington Legal Foundation v. Henney, 202 F.3d 331, 336-37 (D.C.Cir.
The constitutional cause was re-ignited in United States v. Caputo, 288 F.Supp.2d 912, 922 (N.D.Ill.2003), which rejected a First Amendment challenge to the misbranding provisions of the FDCA. On appeal, however, the Seventh Circuit, affirming the decision below on a nonconstitutional ground, noted in dicta and in contradistinction to the district court's opinion that recent Supreme Court commercial speech cases suggested that the provisions challenged below may be unconstitutional in at least some applications. See Caputo, 517 F.3d at 939 (citing Thompson v. Western States Medical Center, 535 U.S. 357, 122 S.Ct. 1497, 152 L.Ed.2d 563 (2002)). In short, the constitutional issues raised in Caronia's motion are very much unsettled, not only in this circuit but nationwide.
A. Whether the Information Alleges Speech or Conduct
As a threshold matter, the government argues here that the First Amendment is not implicated at all because the information alleges only "illicit conduct which is achieved, in part, through the use of commercial speech." Caronia's "speech" is used, the government says, only to establish the element of intent and to establish motive. The government compares this case to Whitaker v. Thompson, 353 F.3d 947 (D.C.Cir.2004). In Whitaker, the D.C. Circuit found that the FDA did not violate the First Amendment's restrictions on commercial speech when it determined that a certain dietary supplement had to be approved as a drug before it could be marketed as effective in the treatment of a disease. Id. at 952-53. Citing Wisconsin v. Mitchell, 508 U.S. 476, 489, 113 S.Ct. 2194, 2201-02, 124 L.Ed.2d 436 (1993), the D.C. Circuit held that it was permissible for the FDA to use the manufacturer's speech in its labeling to infer intent for purposes of determining whether the substance was a "drug" requiring prior approval before it could be marketed as proposed. Id. at 953; accord United States v. Gen. Nutrition, Inc., 638 F.Supp. 556, 562 (W.D.N.Y.1986). By its analogy to Whitaker, the government argues that Caronia's promotion, even if it was speech, can serve as evidence of Xyrem's "intended use" and establish criminal misbranding.
In line with these cases, it is clear to the Court that the promotion of off-label uses of an FDA-approved prescription drug is speech, not conduct. At the very least, Whitaker and similar cases may be confined to the particular context of restrictions on the marketing of drugs or medical devices that are not approved for any use, rather than the marketing of offlabel uses of drugs and devices that have been FDA-approved and can be prescribed by a health care practitioner with dispensing authority. Accord Caputo, 517 F.3d at 940 (avoiding the First Amendment question where medical device had not been approved for any use and thus "there were no lawful off-label uses to promote."). Simply stated, as the criminal information here alleges Caronia's promotion of offlabel uses of an FDA-approved drug, it cannot survive First Amendment scrutiny based solely upon the government's claim that the alleged activities constitute conduct as opposed to speech.
B. Whether the Information Alleges "Pure" or Commercial Speech
Caronia's instant motion to dismiss appropriates an alternative First Amendment argument advanced by Gleason prior to his guilty plea. Because he was a doctor expressing his opinions about a drug he could and did prescribe, Gleason argued that his promotional activities amounted to scientific and academic speech, which resides at the core of the First Amendment and, therefore, should receive the highest constitutional protection as pure speech. See, e.g., Keyishian v. Bd. Of Regents, 385 U.S. 589, 603-04, 87 S.Ct. 675, 683-84, 17 L.Ed.2d 629 (1967). Caronia, perhaps
Under the three-factor test set forth in Bolger v. Youngs Drug Products Corp., 463 U.S. 60, 66-68, 103 S.Ct. 2875, 2879-81, 77 L.Ed.2d 469 (1983), to determine whether a promotional activity is protectable as "commercial speech", a court must look to (1) whether the expression is an advertisement; (2) whether it refers to a specific product; and (3) whether the speaker has an economic motivation for speaking. In Friedman, Judge Lamberth found that manufacturer sponsorship of continuing medical education ("CME") seminars and distribution of reprints from peer-reviewed medical journal articles and commercially-available medical textbooks (so-called "enduring materials") was commercial speech. Friedman, 13 F.Supp.2d at 62-65. Noting the "commonsense" distinction between speech proposing a commercial transaction and other varieties of speech, Friedman found as to each of the Bolger factors: (1) that the materials and seminars were "advertisements" because they encouraged physicians to prescribe the drug; (2) that they referred to a specific product; and (3) that there was clear economic motivation behind the manufacturer's activities. Id. at 64. Furthermore, although the prescription drug industry presented a different context than traditional forms of consumer advertising, it was clear that the speech to doctors was intended to drive sales of the products because, "to the extent that physicians are the gatekeepers to sales, the marketing efforts must be directed at them." Id. at 63.
Here, the same analysis applies in spades to Caronia's speech as it is alleged in the information. Regardless what else might have been covered in his discussions, Caronia's alleged speech was made on behalf of the manufacturer and clearly (1) encouraged physicians to prescribe Xyrem, (2) referred to a specific product, and (3) was economically motivated. Any such promotion by Caronia to physicians on behalf of Xyrem's manufacturer of the drug's off-label uses would be commercial speech and be "entitled to the qualified but nonetheless substantial protection accorded to commercial speech." Bolger, 463 U.S. at 68, 103 S.Ct. at 2881.
Central Hudson Test
Finding that Caronia's alleged promotional activities in marketing Xyrem constitute commercial speech, the Court must now address his argument that his speech specifically is constitutionally protected. Central Hudson Gas v. Public Service Commission of New York, 447 U.S. 557, 100 S.Ct. 2343, 65 L.Ed.2d 341 (1980), which articulates a four-part test for determining whether commercial speech is protected by the First Amendment, is controlling. See Western States, 535 U.S. at 367, 122 S.Ct. at 1504. First, as a threshold matter, the Court must determine whether Caronia's commercial speech "concerns unlawful activity or is
1. The Speech Concerns Lawful Activity and Is Not Inherently Misleading
Under prong one of Central Hudson, the Court finds, in harmony with the analysis in Friedman and the district court's opinion in Caputo, that promotion of the off-label uses of a FDA-approved drug concerns lawful activity and is not inherently misleading.
First, promotion of off-label usage does not promote unlawful activity. Friedman, 13 F.Supp.2d at 66. "The proper inquiry is not whether the speech violates a law or a regulation, but whether the conduct that the speech promotes violates the law." Id. Here, the conduct that the speech promoted is the prescription of Xyrem for off-label uses, which the government concedes is lawful. As such, the promotional speech the information alleges Caronia engaged in concerns lawful activity under prong one.
Second, the Court finds that the alleged speech is not misleading. As noted in Friedman:
Id. at 66-67 (internal citations and quotation marks omitted). Promotion of off-label uses is not inherently misleading simply because the use is off-label. See id. at 67 ("In asserting that any and all claims about the safety, effectiveness, contraindications, side effects and the like regarding prescription drugs are presumptively untruthful or misleading until the FDA has had the opportunity to evaluate them, FDA exaggerates its overall place in the universe."). At this stage of the case, it is not clear what sorts of disclaimers and disclosures Caronia provided when promoting off-label uses; however and critically, the information does not allege that Carnonia claimed that the uses he was promoting were FDA-approved. Accord Caputo, 288 F.Supp.2d at 921. Further, adopting Judge Castillo's holding in Caputo and making it the finding here, "[Caronia's] speech was directed at physicians who are familiar with the FDA-approval process and able to independently evaluate the validity of their claims. Given the sophistication of the audience to whom the off-label uses were promoted, this Court cannot conclude, at this stage of the proceedings,
2. The Government Has a Substantial Interest in Restricting Manufacturer Promotion of Off-Label Uses
The question as to whether the government has a substantial interest in restricting manufacturer promotion of off-label uses was addressed at some length in Friedman, which held (1) that the government clearly had a substantial interest in promoting the health and safety of its citizens, and (2), in furtherance of that objective, the government had a substantial interest in compelling manufacturers to get off-label treatments on-label. Friedman, 13 F.Supp.2d at 69-71. The Friedman court rejected any claim, however, that speech restrictions could be justified based merely on the fear that physicians would misuse the information provided to them. Id. at 69-70. But, while a "paternalistic assumption that the public will use truthful, non-misleading commercial information unwisely cannot justify a decision to suppress it[,]" id. (citing 44 Liquormart, Inc. v. Rhode Island, 517 U.S. 484, 497, 116 S.Ct. 1495, 1505, 134 L.Ed.2d 711 (1996)), it also does not extinguish or diminish the government's substantial interest in subjecting off-label uses of a drug or medical device to the FDA's evaluation process. See id. at 70-71; accord Caputo, 288 F.Supp.2d at 921; Western States, 535 U.S. at 369, 122 S.Ct. at 1505 ("Preserving the effectiveness and integrity of the FDCA's new drug approval process is clearly an important governmental interest, and the Government has every reason to want as many drugs as possible to be subject to that approval process."). As with the first, the second prong of Central Hudson has also been satisfied.
3. Restricting Manufacturer Promotion of Off-Label Uses Directly Advances the Substantial Governmental Interest
The district court opinions in Friedman and Caputo help fashion this Court's conclusion with respect to the third prong. Those courts found that restricting manufacturer promotion of off-label uses directly serves the substantial governmental interest in requiring manufacturers to submit supplemental applications to obtain FDA approval for new uses of previously approved drugs.
Friedman, 13 F.Supp.2d at 72 (internal citations omitted; emphasis original); see Caputo, 288 F.Supp.2d at 921. In line with these authorities, this Court holds that the FDCA's prohibitions on commercial speech of the kind charged in the information filed against Caronia directly advance the government's interest in subjecting off-label uses of a drug like Xyrem to the FDA's evaluation process. Central Hudson's third prong is satisfied here as well.
4. The FDCA's Restrictions on Manufacturer Promotion of Off-Label Uses are Not More Extensive Than Necessary
With that the overture ends and the play begins. Enter on stage the essential question—can the government satisfy the fourth prong of Central Hudson?
Friedman is the well-spring; analysis starts there with Judge Lamberth's opinion which addressed the constitutionality of three FDA guidance documents that outlined factors the FDA would consider in deciding whether manufacturer (1) sponsorship of CME seminars and (2) distribution of textbook articles and article reprints from medical and scientific journals about off-label uses constituted unlawful off-label promotion. Friedman, 13 F.Supp.2d at 57-58. In considering prong four of Central Hudson, Judge Lamberth found that the FDA guidance documents at issue were more extensive than necessary to serve the government's interest in subjecting off-label uses to the FDA's evaluation process. Id. at 73. The court found further (and explicitly) that there were less-burdensome alternatives available to the FDA, including simply requiring full, complete, and unambiguous disclosure by the manufacturer of its involvement in the subject activities and the fact that the uses discussed were offlabel. Id. Significantly, however, the court also found that, even though the FDA guidance documents were themselves unconstitutional, there remained adequate incentives to compel manufacturers to get off-label uses approved. Id. For instance, the FDCA would still prohibit distribution by the manufacturer or its agents of internally-produced marketing materials to physicians concerning off-label uses, involvement with non-independent seminars, initiation of person-to-person-contact with a doctor about off-label use, and advertising off-label uses directly to the consumer. Id. Thus, the court observed: "Were manufacturers permitted to engage in all forms of marketing of off-label treatments, a different result might be compelled[,]" id. (emphasis original), that is, an acknowledgment of the possibility of a constitutionally permissible restriction on commercial speech promoting the off-label use of an approved prescription drug.
Caputo, by contrast, involved not a challenge to a specific FDA guidance document but, rather, the statutory misbranding provisions of the FDCA. The indictment in that case alleged misbranding violations arising out of the defendants' promotion of off-label uses of a medical device, similar to the charges at issue in this case. Caputo, 288 F.Supp.2d at 919. Unlike in Friedman, however, the Caputo district court found that the defendants' First Amendment challenge "strikes at the very heart of the FDA's ability to proscribe manufacturer promotion of off-label uses." Id. at 922. Citing the dicta in Friedman about the constitutionality of restricting some forms of off-label promotion, the court held that "permitting Defendants to engage in all forms of truthful, non-misleading promotion of off-label use would severely frustrate the FDA's ability to evaluate the effectiveness of off-label uses." Id. (emphasis original). More importantly, the Caputo court was unable to identify a less burdensome alternative that would advance the government's substantial interest. Id. Consequently, it held that the restrictions were not more extensive than necessary under prong four of Central Hudson, and refused to dismiss the misbranding charges of the indictment on constitutional grounds. Id.
On appeal, the Seventh Circuit affirmed the convictions of the Caputo defendants, but determined, based on the particular facts of the case, that—"fortunately"—it
Caronia's motion now demands answers to the questions raised but not resolved by the Seventh Circuit in Caputo. Building on the dicta in that case, he argues that Western States must be read to strike as unconstitutional any prohibition of a manufacturer's truthful promotion of off-label prescription drug usage. Caronia points out that in Western States, the Supreme Court struck down a ban on advertising by pharmacies of compounded drugs (drugs whose ingredients were tailored to the needs of individual patients) under the fourth prong of Central Hudson, despite the objective of Congress to draw a line between ordinary compounding (which was generally permitted as long as it was in response to a valid prescription) and largescale manufacturing done in the guise of compounding, which would effectively circumvent the FDA's new drug requirements. See Western States, 535 U.S. at 369-71, 122 S.Ct. at 1505-06. In a 5-4 opinion the Court found, however, that Congress could have chosen a number of alternative paths to achieving that goal which would not have restricted the commercial speech rights of manufacturers, that is, that the government had therefore failed to carry its burden under the final prong of Central Hudson. Id. at 371-73, 122 S.Ct. at 1506-07. By analogy, then, Caronia argues that the government cannot ban manufacturer speech about off-label uses in order to ensure that manufacturers will pursue formal FDA approval of new uses.
Caronia's motion is also denied.
D. First Amendment Overbreadth
Caronia argues further by reference to Gleason's earlier motion that the misbranding provisions of the FDCA are unconstitutionally overbroad. The argument is without merit. It is well established that the overbreadth doctrine generally does not apply in the context of commercial speech. See Bates v. State Bar of Arizona, 433 U.S. 350, 381, 97 S.Ct. 2691, 2707, 53 L.Ed.2d 810 (1977); see also Allstate Ins. Co. v. Serio, 261 F.3d 143, 153 n. 16 (2d Cir.2001). As the Court has already determined, there can be no question that such off-label promotion is commercial speech as opposed to "pure" speech. As a result, the overbreadth doctrine does not apply.
Even if the doctrine were to apply, however, the overbreadth of a statute must "not only be real, but substantial as well, judged in relation to the statute's plainly legitimate sweep. We will not topple a statute merely because we can conceive of a few impermissible applications." Massachusetts v. Oakes, 491 U.S. 576, 595-96, 109 S.Ct. 2633, 2644, 105 L.Ed.2d 493 (1989) (quoted in United States v. Rybicki, 354 F.3d 124, 130 n. 2 (2d Cir.2003)). The concerns raised by Gleason in his original motion rested largely on the term "representative"—in particular, whether doctors with financial connections to manufacturers would be chilled from otherwise permissible off-label speech for fear of provoking an "intended use" enforcement action. At most, however, the Court finds that such concerns amount only to a "few impermissible applications" that would rest largely on a strained interpretation of the term "representative". Given Caronia does not raise any other impermissible implications that might trigger overbreadth concerns, the Court finds that the misbranding provisions of the FDCA at issue in this information are not overbroad.
VI. Whether Caronia Conspired to Misbrand Xyrem
Finally, Caronia argues that, even accepting the factual allegations of the information as true, he did not conspire to misbrand Xyrem under either 21 U.S.C. 331(a) or (k) and, therefore, count one of the information must be dismissed. Caronia points out that he is accused of conspiring with Gleason to misbrand Xyrem and submits, therefore, that the Court must separately decide whether Gleason's own speech was protected or otherwise exempt under the FDCA. Stated differently, Caronia argues, if Gleason could lawfully promote off-label uses of Xyrem, then Caronia could not be guilty of conspiring with Gleason. Further, Caronia argues, he could not be guilty of conspiring with the cooperating physician under "Wharton's Rule", which holds that "[a]n agreement by two persons to commit a particular crime cannot be prosecuted as a conspiracy when the crime is of such a nature as to necessarily require the participation of two persons for its commission." See United States v. Bommarito, 524 F.2d 140, 143 (2d Cir.1975) (quoting 1 Anderson, Wharton's Criminal Law and Procedure § 89, at 191 (1957)). It is Caronia's contention that, under Wharton's Rule, he could not conspire with a government cooperator to misbrand Xyrem.
However, as the government points out, the conspiracy to misbrand Xyrem alleged in the information was among Caronia, Gleason, Orphan and other Orphan employees. See United States v. Hartley, 678 F.2d 961, 972 (11th Cir.1982) (corporation may conspire with its own agents, officers, and employees in violation of 18 U.S.C. § 371). Indeed, the government states that it intends to call at trial an Orphan supervisor who has already pled guilty to separate charges of misbranding to testify as to the conspiracy alleged in the instant information. Thus, given the multiplicity of alleged co-conspirators, the Court need not decide now whether any off-label promotion by just one of them, Gleason (who has also already pled guilty to charges of misbranding), is constitutionally protected to any degree greater than the speech of Caronia himself. Furthermore, although the Court doubts that Wharton's Rule would apply to a conspiracy between two persons to commit a misbranding violation,
For the foregoing reasons, Caronia's motion to dismiss each of the two counts of the information is denied in its entirety. The case is now ready for trial. Jury selection will commence September 29, 2008, upon consent previously given, before