ZOGENIX2

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UNITED STATES DISTRICT COURT DISTRICT OF MASSACHUSETTS

ZOGENIX, INC., Plaintiff, v. DEVAL PATRICK, in his official capacity as the GOVERNOR OF MASSACHUSETTS, CHERYL BARTLETT, RN, in her official capacity as DEPARTMENT OF PUBLIC HEALTH COMMISSIONER, and CANDACE LAPIDUS SLOANE, M.D., et al., in their official capacities as members of the MASSACHUSETTS BOARD OF REGISTRATION IN MEDICINE, and KAREN M. RYLE, MS, R.PH, et al., in their official capacities as members of the MASSACHUSETTS BOARD OF REGISTRATION IN PHARMACY, and DIPU PATEL-JUNANKAR, PA-C, et al., in their official capacities as members of the MASSACHUSETTS BOARD OF REGISTRATION OF PHYSICIAN ASSISTANTS, Defendants.

CIVIL ACTION No. 1:14-cv-11689-RWZ

DEFENDANTS’ NOTICE OF PARTIAL MOOTNESS AND RESPONSE TO PLAINTIFF’S SUPPLEMENTAL SUBMISSION OF JULY 2, 2014

The Defendants hereby notify the Court that, in accordance with Mass. G.L. c. 30A, § 2,

the Board of Registration in Medicine (“BORIM”) and the Board of Registration in Pharmacy

(“BORIP”) have adopted final regulations that update the emergency regulations challenged in

this action. Emergency regulations in Massachusetts, the Defendants have previously explained,

Case 1:14-cv-11689-RWZ Document 65 Filed 07/03/14 of 9

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may only remain in effect for up to three months following their initial promulgation. See Mem.

in Support of Defts’ Motion to Dismiss, at 13, n. 13 [Doc. 45] (citing Mass. G.L. c. 30A, § 2);

Mem. in Opposition to Pltf’s Motion for an Expedited Briefing Schedule, at 7 [Doc. 35] (same).

Accordingly, over the past two-and-a-half months, BORIM and BORIP held public hearings and

invited public comment on whether and how the challenged emergency regulations should be

modified before they were made permanent. After considering this public input, BORIM and

BORIP revised the emergency regulations and promulgated a new set of final regulations.1

As explained below, these regulatory changes moot Zogenix’s preemption claim as to

BORIM’s requirements, moot Zogenix’s preemption claim as to BORIP’s requirement of a

Letter of Medical Necessity, and limit the scope of Zogenix’s preemption claim as to the

remainder of BORIP’s requirements. Since Zogenix’s preemption claim regarding BORIM is

now moot, Zogenix’s unauthorized supplemental submission of July 2 regarding purported

evidence of the effect of the emergency regulations on prescriber practice is now of no

relevance. And the purported evidence is not in fact probative of any relevant fact anyway, for

the reasons outlined below. In fact, the purported evidence is inconsistent with Zogenix’s claim

of a de facto, or effective, ban on the prescribing or dispensing of Zohydro.

I. The Final Regulations Partially Moot Zogenix’s Claims.

BORIM and BORIP’s final regulations modify their emergency regulations in two

relevant ways. First, under BORIM’s emergency regulation codified at 243 C.M.R.

§ 2.07(25)(d), physicians were previously required, before prescribing Zohydro ERTM

(“Zohydro”), to supply a Letter of Medical Necessity “that include[d] the patient’s diagnoses and

1 BORIM’s filing with the Massachusetts Secretary of State, which shows its final

regulations codified at 243 C.M.R. § 2.07(25), is attached as Exhibit A. BORIP’s final regulations codified at 247 C.M.R. §§ 8.01–8.07 and §§ 9.01-9.07 are attached as Exhibits B and C.


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treatment plan [and] verifie[d] that other pain management treatments have failed . . .” The final

regulation, however, only requires physicians to “[s]upply a Letter of Medical Necessity as

required by the Board of Registration in Pharmacy pursuant to 247 CMR 9.04(8)(c).” Ex. A, at

4, 5. That final BORIP regulation, in turn, has been revised to condition the dispensing of

Zohydro on the submission of a Letter of Medical Necessity “that includes the patient’s

diagnoses and treatment plan [and] verifies other pain management treatments are inadequate.”

247 C.M.R. § 9.04(8)(c) (emphasis supplied); Ex. C, at 6.

Thus, in final form, BORIM and BORIP’s regulations replace the language that required

the Letter of Medical Necessity to verify that other pain management treatment options “have

failed” with language requiring the letter to verify that other treatment options “are inadequate.”

243 C.M.R. § 2.07(25); 247 C.M.R. § 9.04(8)(c). This modification moots Zogenix’s claim that

the phrases “have failed” and “are inadequate” are substantively distinct, and that the former

requirement was preempted. See Mem. in Support of Pltf’s Motion for a Preliminary Injunction,

at 9 [Doc. 47]. Zogenix will surely agree: At the June 10, 2014 hearing, it explained to this

Court that a regulation requiring verification that other treatment options “are inadequate” would

not be preempted because the requirement would track the language in the Food and Drug

Administration’s label for Zohydro. Transcript of 6/10/14 Hearing, at 14–15. Furthermore, at

that same hearing, Zogenix conceded that its preemption claim with respect to BORIM’s

emergency regulations focused entirely on the Letter of Medical Necessity regulation. Id. at 9–

11. Because Zogenix embraces the language in the final version of that regulation and

challenges no other aspect of BORIM’s regulations, Zogenix’s preemption claim with respect to

BORIM’s regulations (as well as the Letter of Medical Necessity requirement of BORIP’s

regulations) is moot. See Am. Civil Liberties Union of Mass. v. U.S. Conference of Catholic


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Bishops, 705 F.3d 44, 52 (1st Cir. 2013) (challenges to “government regulatory schemes which

have expired or been effectively repealed” are moot);; New England Reg’l Council of Carpenters

v. Kinton, 284 F.3d 9, 18 (1st Cir. 2002) (“[Plaintiff] seeks only injunctive and declaratory relief,

not damages—and it would be pointless either to enjoin the enforcement of a regulation that is

no longer in effect or to declare its constitutional status.”).2

Second, while BORIP’s emergency regulation codified at 247 C.M.R. § 8.05(3)

prohibited pharmacy interns from handling Zohydro, the final regulation permits pharmacy

interns to handle the medication under the direct supervision of an approved registered

pharmacist. See Ex. B, at 5. This modification affects Zogenix’s sole remaining preemption

argument regarding BORIP’s regulations—namely, that prohibiting pharmacy interns, certified

pharmacy technicians, pharmacy technicians, and pharmacy technician trainees from handling

Zohydro is so unduly burdensome that it amounts to a de facto, or effective, ban of Zohydro. See

Mem. in Support of Pltf’s Motion for a Preliminary Injunction, at 9–10 [Doc. 47]; Transcript of

6/10/14 Hearing, at 11–13 (conceding that the only BORIP regulation Zogenix challenges

involved restrictions on the handling of Zohydro). Now, registered pharmacists and pharmacy

interns alike may unpack, stock, secure, and otherwise handle Zohydro, so long as the pharmacy

intern operates under the direct supervision of the pharmacist.

Pharmacy interns are comparable to medical interns; they have substantially more

education and experience than certified pharmacy technicians, pharmacy technicians, and

pharmacy technician trainees. See 247 C.M.R. §§ 8.01–8.04. And regulations in place well

2 Defendants expect that Zogenix’s preemption claim with respect to the emergency

regulations of the Board of Registration of Physician Assistants (“BOROPA”), which tracked BORIM’s emergency regulations, will also become moot. BOROPA will meet on July 10, 2014, to consider whether to adopt analogous modifications to its emergency regulations—modifications that would substitute the phrase “are inadequate” for “have failed” in the Letter of Medical Necessity regulation—in its final regulations.


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before BORIP’s emergency regulations at issue here already precluded pharmacy technicians (as

opposed to certified pharmacy technicians) and pharmacy technician trainees from handling any

Schedule II drug (a category that includes Zohydro), required that certified pharmacy technicians

do so under the “supervision” of a pharmacist, and provided that the “[a]ccountability for and

security of Schedule II controlled substances [are] the direct responsibilities of the pharmacist.”

See id. §§ 8.05(1), (2)(b). Thus, to the extent Zogenix persists with any preemption claim

regarding BORIP’s regulations, that claim is reduced to the untenable assertion that the

prohibition on certified pharmacy technicians handling Zohydro and/or the requirement that

pharmacy interns do so under the “direct supervision” of a pharmacist constitute such a change

from the pre-existing restrictions on the handling of all Schedule II drugs that either or both

provisions effectively ban the dispensing of Zohydro in the Commonwealth.

II. Zogenix’s July 2 Submission Is Not Probative Of Any Relevant Fact.

Because Zogenix’s sole remaining claim that Defendants’ actions constitute a de facto, or

effective, ban on the prescribing of Zohydro is now moot, Zogenix’s newly proffered evidence of

this supposed effective ban based on the number of Zohydro prescriptions filled since BORIM’s

emergency regulations issued is irrelevant to the remaining controversy (if there is one). As

noted previously, Zogenix’s preemption argument no longer pertains to restrictions on the

prescribing of Zohydro, but rather to restrictions on the handling of Zohydro by pharmacy

personnel. Moreover, the newly proffered evidence regarding Zohydro prescriptions in fact

demonstrates that the emergency regulations did not in application ban Zohydro prescriptions or

prevent pharmacies from dispensing Zohydro, because Zogenix’s affiant attests to actual filled

Zohydro prescriptions since the emergency regulations went into effect. See Supplemental

Declaration of Roger L. Hawley in Support of Plaintiff’s Motion for Preliminary Injunction


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(“Hawley Decl.”), ¶ 3. A mere reduced volume of Zohydro sales due to the emergency

regulations, even if such causation could be established, would not permit the relief Zogenix

seeks because, as has previously been briefed and argued at length, state regulatory restrictions

affecting the prescribing and dispensing of FDA-approved drugs are exceedingly common, well

within the historic police powers of the state, and plainly not preempted by federal law. See

Mem. in Support of Defts’ Motion to Dismiss, at 5–16 [Doc. 45]. Thus, with its newly proffered

evidence of filled Zohydro prescriptions in Massachusetts post-dating the emergency regulations,

Zogenix has disproven its own preemption claim.

It is equally irrelevant, if true, that Defendants’ two pharmacy affiants have not yet

stocked Zohydro. See id., ¶ 5. Zohydro is a very expensive medication that poses risks of

pharmacy theft (comparable to what occurred when there was a run of thefts on pharmacies

stocking non-abuse-deterrent Oxycontin). For these reasons, and because pharmacies do not

expect to be dispensing Zohydro on a daily basis, many pharmacists will procure, stock, and

dispense Zohydro only when they receive an actual prescription or are otherwise on notice that

they will need to dispense the drug.3 And in any event, not stocking Zohydro is distinct from not

dispensing it. Zogenix provides no evidence that Defendants’ prescriber and pharmacy affiants,

or any other Massachusetts prescribers or pharmacists, have declined to prescribe or dispense

Zohydro because of the former “other treatments have failed” requirement, the restrictions on

Zohydro handling by pharmacies, or any other aspect of the BORIM or BORIP emergency

regulations.

3 If the Court concludes that it should entertain Zogenix’s proffered evidence regarding

Massachusetts prescription history, despite the arguments contained herein, Defendants request leave to submit affidavits supporting this and other statements of fact herein, as well as other responsive evidence.


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If its preemption claim as to Zohydro prescriptions were not moot, Zogenix would have

to prove that there have been fewer Zohydro prescriptions as a result of the former “other

treatments have failed” requirement than there would have been otherwise for evidence of

prescription volume to have relevance. It is not enough to point to a relatively small number of

prescriptions because, as confirmed by evidence the Defendants have previously submitted,

many physicians have decided on their own not to prescribe Zohydro (e.g., all New Hampshire

physicians, see http://goo.gl/suZ2Fx, and affiant Alford, see Doc. #56, Ex. G, ¶ 7). And other

physicians, including affiants Shanahan and Leibschutz, see Doc. #56, Ex. C, ¶ 6; Ex. E, ¶ 7,

consider Zohydro a medication of last resort. In addition, Blue Cross/Blue Shield of

Massachusetts has declined to cover Zohydro prescriptions. See http://goo.gl/K13O4a. Thus,

there are likely to be numerous jurisdictions (perhaps especially in New England and other states

experiencing opioid addiction crises) where there are few, if any, Zohydro prescriptions

regardless of the existence of regulatory restrictions. At least as of June 8, for example,

Defendants understand there had been no Zohydro prescriptions in Rhode Island, which has

imposed no regulatory restrictions on Zohydro. There were only four Zohydro prescriptions in

Maine, which again has no Zohydro restrictions, during the month of June (the only month for

which data is now available to Defendants). And as of at least the end of May there had been no

Zohydro prescriptions in Vermont, where restrictions on Zohydro prescriptions do not employ

the “other treatments have failed” language, but rather require that “alternative treatment options,

including non-pharmacological treatments, are ineffective, not tolerated, or would otherwise be

inadequate to provide sufficient management of pain.” Rule Governing the Prescription of

Extended Release Hydrocodones Manufactured Without Abuse Deterrent Formulations, Doc.

#35, Ex. J, ¶ 4.3.


http://goo.gl/suZ2Fx

http://goo.gl/K13O4a

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It is, of course, not enough to point to national sales figures, because states that are not

experiencing similar crises in opioid addiction may have prescriber populations that are less

sensitized to the risks of abuse of Zohydro than are Massachusetts prescribers and, in any event,

may have no restrictions on Zohydro prescriptions or restrictions that differ from those of

Massachusetts in respects having nothing to do with the “other treatments have failed” and

“other treatments are inadequate” distinction. Any one or more of these differences renders

irrelevant the prescription experience of another state to even the now-moot previous dispute

regarding the impact of the former “other treatments have failed” provision of the BORIM

emergency regulations on Zohydro prescriptions. Indeed, a higher volume of prescriptions in

other states could even reflect substantial diversion and abuse of Zohydro in those jurisdictions.

But in any event, the only potentially relevant out-of-state comparison would have been to

prescription experience in a state experiencing a comparable crisis, with a comparable awareness

of Zohydro’s risks among prescribers, and comparable restrictions on Zohydro prescriptions but

for the sole challenged former provision.

For the reasons discussed herein, as well as those previously briefed and argued,

Zogenix’s most recent submission is to no avail and its claims should be dismissed.

Respectfully submitted, Defendants

By their attorneys,

MARTHA COAKLEY, ATTORNEY GENERAL


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/s/ Jo Ann Shotwell Kaplan Jo Ann Shotwell Kaplan (BBO #459800) Julia Kobick (BBO #680194) Eric Gold (BBO #660393) Anne Sterman (BBO #650426) Assistant Attorneys General One Ashburton Place Boston, MA 02108 (617) 963-2085; fax: (617) 727-5785

Dated: July 3, 2014 [email protected]

Certificate of Service

The undersigned counsel hereby certifies, this 3rd day of July, 2014, that this document was filed through the Electronic Case Filing (ECF) system and thus copies will be sent electronically to the registered participants as identified on the Notice of Electronic Filing (NEF); paper copies will be sent to any parties indicated on the NEF as non-registered participants. /s/ Jo Ann Shotwell Kaplan Jo Ann Shotwell Kaplan Assistant Attorney General


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