1

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
PLAINTIFFS 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 l:l4-cv-ll689-RWZ Document 65 Filed 07/03/l4 Page l 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 Pltfs 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.
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As explained below, these regulatory changes moot Zogenixs preemption claim as to
BORIMs requirements, moot Zogenixs preemption claim as to BORIPs requirement of a
Letter of Medical Necessity, and limit the scope of Zogenixs preemption claim as to the
remainder of BORIPs requirements. Since Zogenixs preemption claim regarding BORIM is
now moot, Zogenixs 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 Zogenixs claim
of a de facto, or effective, ban on the prescribing or dispensing of Zohydro.
I. The Final Regulations Partially Moot Zogenixs Claims.
BORIM and BORIPs final regulations modify their emergency regulations in two
relevant ways. First, under BORIMs emergency regulation codified at 243 C.M.R.
2.07(25)(d), physicians were previously required, before prescribing Zohydro ER
TM
(Zohydro), to supply a Letter of Medical Necessity that include[d] the patients diagnoses and

1
BORIMs 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. BORIPs final
regulations codified at 247 C.M.R. 8.018.07 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 patients
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 BORIPs 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 Zogenixs claim that
the phrases have failed and are inadequate are substantively distinct, and that the former
requirement was preempted. See Mem. in Support of Pltfs 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
Administrations label for Zohydro. Transcript of 6/10/14 Hearing, at 1415. Furthermore, at
that same hearing, Zogenix conceded that its preemption claim with respect to BORIMs
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 BORIMs regulations, Zogenixs preemption claim with respect to
BORIMs regulations (as well as the Letter of Medical Necessity requirement of BORIPs
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 Regl Council of Carpenters
v. Kinton, 284 F.3d 9, 18 (1st Cir. 2002) ([Plaintiff] seeks only injunctive and declaratory relief,
not damagesand it would be pointless either to enjoin the enforcement of a regulation that is
no longer in effect or to declare its constitutional status.).
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Second, while BORIPs 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 Zogenixs sole remaining preemption
argument regarding BORIPs regulationsnamely, 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 Pltfs Motion for a Preliminary Injunction, at 910 [Doc. 47]; Transcript of
6/10/14 Hearing, at 1113 (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. 8.018.04. And regulations in place well

2
Defendants expect that Zogenixs preemption claim with respect to the emergency
regulations of the Board of Registration of Physician Assistants (BOROPA), which tracked
BORIMs 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 regulationin its final regulations.
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before BORIPs 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 BORIPs 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. Zogenixs July 2 Submission Is Not Probative Of Any Relevant Fact.
Because Zogenixs sole remaining claim that Defendants actions constitute a de facto, or
effective, ban on the prescribing of Zohydro is now moot, Zogenixs newly proffered evidence of
this supposed effective ban based on the number of Zohydro prescriptions filled since BORIMs
emergency regulations issued is irrelevant to the remaining controversy (if there is one). As
noted previously, Zogenixs 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 Zogenixs affiant attests to actual filled
Zohydro prescriptions since the emergency regulations went into effect. See Supplemental
Declaration of Roger L. Hawley in Support of Plaintiffs 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 516 [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 Zogenixs 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.
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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 Zohydros 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,
Zogenixs most recent submission is to no avail and its claims should be dismissed.
Respectfully submitted,

Defendants

By their attorneys,

MARTHA COAKLEY,
ATTORNEY GENERAL

Case l:l4-cv-ll689-RWZ Document 65 Filed 07/03/l4 Page 8 of 9
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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 JoAnn.Kaplan@state.ma.us

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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