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Zogenix, Inc. v. Baker

United States District Court, D. Massachusetts

March 17, 2015

CHARLES D. BAKER, in his official capacity as GOVERNOR OF MASSACHUSETTS, et al.


RYA W. ZOBEL, District Judge.

In an effort to combat prescription drug abuse, the Commonwealth of Massachusetts, acting through defendant health officials who have been sued in their official capacities, has sought to regulate the use and handling of Zohydro™ ER ("Zohydro"), which is a Food and Drug Administration-approved opioid painkiller. Plaintiff Zogenix, Inc. ("Zogenix"), which markets and sells Zohydro, has challenged many of these regulations as preempted by federal food and drug laws. Last year, I enjoined the Commonwealth from enforcing two preliminary forms of its regulations. Docket ## 26, 66. The Commonwealth has now issued final regulations that largely conform to my previous orders, see Docket # 73 (lifting injunction), but Zogenix continues to challenge some of the restrictions, as well as the overall scheme, in its Verified Third Amended Complaint. Docket # 78. That complaint alleges in Count I that the regulations are preempted by federal food and drug laws; in Count II that they violate the Equal Protection Clause; in Count III that they violate the Contracts Clause; and in Count IV that they violate the Dormant Commerce Clause. Defendants now move to dismiss for lack of subject matter jurisdiction and failure to state a claim upon which relief can be granted. Docket # 81.

I. Background[1]

Hydrocodone, the active ingredient in Zohydro, is an opioid painkiller. Hydrocodone drugs have long been available in the United States, but they are usually sold as combination drugs with acetaminophen (which, for example, is the active ingredient in Tylenol®). Acetaminophen has high liver toxicity, so overuse of hydrocodone-acetaminophen combinations can cause liver damage. Zohydro, which does not include acetaminophen, is a pure hydrocodone drug-the only one on the market today.[2] Although it is formulated to provide pain relief over a twelve-hour period when used as instructed, users may immediately feel the full opioid high (without suffering ill effects from acetaminophen) by inhaling or injecting crushed Zohydro pills.[3]

Since the United States Food and Drug Administration ("FDA") approved Zohydro on October 25, 2013, it has been sold throughout the United States and in Massachusetts. It is subject to schedule II controls under both the federal and Massachusetts Controlled Substances Acts, which are the most restrictive controls available for an FDA-approved drug. Yet, because Zohydro contains no ingredients to deter abuse (i.e., it is not an "abuse resistant formulation"), Commonwealth officials have worried that these controls are insufficient to protect against further opioid abuse.

In the spring of 2014, Massachusetts Governor Deval Patrick declared opioid abuse and overdoses to be a public health emergency. With this announcement he authorized, and the Department of Public Health ("DPH") issued, an emergency order that banned the prescribing, ordering, dispensing, or administration of Zohydro. Zogenix sued, contending that federal law preempted the emergency order and seeking a preliminary injunction. On April 15, 2014, I enjoined enforcement of DPH's emergency order. See Docket # 26.

On April 22, 2014, the Commonwealth's Board of Registration in Medicine ("BORIM") promulgated an emergency regulation requiring an individually licensed prescriber to take certain steps before prescribing Zohydro, [4] including supplying a letter of medical necessity confirming that other pain management treatments had failed.[5] Similarly, on May 6, 2014, the Commonwealth's Board of Registration in Pharmacy ("BORIP") promulgated two Zohydro-related regulations. The first, which I will call the "pharmacist-only" regulation, stated that "[a] certified pharmacy technician, pharmacy technician, pharmacy technician trainee, or pharmacy intern may not handle [Zohydro]." The second contained a host of prerequisites a pharmacist must satisfy before dispensing Zohydro.[6] Zogenix again moved for injunctive relief from these regulations on federal preemption grounds. I allowed that motion in part, enjoining the letter of medical necessity requirements then codified at 243 CMR 2.07(25)(d) and 263 CMR 5.07(12)(d). Docket # 66 at 10. I denied the motion with respect to BORIP's "pharmacist-only" handling regulation, concluding that the record was not sufficiently developed to find that Zohydro had a likelihood of success on the merits. Id. at 11. I permitted Zogenix to renew its challenge to the BORIP regulations upon a more detailed submission.

On or about July 3, 2014 - nearly contemporaneously with my last injunction - BORIM, BORIP, and BOROPA issued new, "final" regulations concerning Zohydro. Among other changes, the new BORIM and BOROPA regulations omitted the troublesome language that formed the basis for my second injunction. Where formerly other pain management treatments must have "failed" before a physician or physician assistant could prescribe Zohydro, the new regulations merely required that other pain management treatments be deemed "inadequate." 243 CMR § 2.07(25)(a) (Docket # 65-1);[7] 247 CMR § 9.04(8)(c) (Docket # 65-3).[8] Defendants expressly conceded that this wording would not be preempted or problematic at the June 10, 2014 hearing. See Docket # 71 at 14-15. The new BORIP regulations changed the "pharmacist-only" handling regulation to allow both pharmacists and pharmacy interns to handle Zohydro.[9] Certified pharmacy technicians, however, were still prohibited from doing so. On the defendants' motion, I lifted the injunction on August 28, 2014. See Docket # 73.

On September 15, 2014, Zogenix filed a Verified Third Amended Complaint (the "Complaint"). Docket # 78. Although the Complaint takes issue with all of the final regulations, including the BORIM and BOROPA regulations, its focus is on the effect that the BORIP handling regulations will have on pharmacists' ability to distribute Zohydro. Compare Second Am. Compl. (Docket # 51) ¶ 11 ("Taken together, these requirements impose such draconian restrictions on physicians' ability to prescribe Zohydro ER that they amount to an effective ban of the drug in Massachusetts."), with Third Am. Compl. (Docket # 78) ¶ 13 ("Taken together, these requirements continue to impose draconian restrictions on pharmacists' abilities to stock or dispense Zohydro® ER that... amount to an effective ban of the drug in Massachusetts.") (emphases added). Defendants move to dismiss the Complaint for lack of subject matter jurisdiction and failure to state a claim upon which relief can be granted. Docket # 81.

II. Subject Matter Jurisdiction and Scope of Zogenix's Challenge

Defendants first challenge whether this court has subject matter jurisdiction over the Complaint, contending that some or all of Zogenix's claims are moot because the challenged regulations have expired or been superceded. Defendants also argue that Zogenix cannot challenge the gubernatorial public health emergency declaration because that declaration, standing alone, does not affect Zogenix. But Zogenix concedes that it is not asking the court to enjoin regulations that are no longer in effect or the gubernatorial declaration itself-it is challenging only the final regulations. Because those regulations are currently in effect, Zogenix's claims are not moot and this court has subject matter jurisdiction over the dispute.

There are now three sets of final regulations: the BORIM regulations that apply to doctors, the BOROPA regulations that apply to physician assistants, and the BORIP regulations that apply to pharmacies and pharmacists. Although Zogenix objected to previous versions of the BORIM and BOROPA regulations, the final versions are free from any previously challenged elements. Indeed, the final BORIM regulations use language to which Zogenix had "no objection" earlier in this case. See Docket # 71 at 14-15. And, at the hearing on this motion, Zogenix could not point to any specific provisions of the final BORIM and BOROPA regulations that it is challenging, naming only "the intended operation and effect" of "the entire regulatory scheme." Docket # 85 at 20:11-12. Zogenix has therefore waived any objections to the BORIM and BOROPA regulations specifically, and I construe its complaint to challenge only the final BORIP handling regulations.[10] Of course, to the extent that the history of the BORIM and BOROPA regulations informs the purpose and effect of the BORIP regulations, they remain relevant to this motion and this case.

III. Motions to Dismiss Under ...

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