Case 1:14-cv-11689-RWZ Document 84 Filed 11/17/14 Page 1 of 7

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,
CANDACE LAPIDUS SLOANE, M.D., et al., in
their official capacities as members of the
MASSACHUSETTS BOARD OF
REGISTRATION IN MEDICINE,

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

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.

REPLY MEMORANDUM IN SUPPORT OF DEFENDANTS MOTION TO DISMISS

PLAINTIFFS VERIFIED THIRD AMENDED COMPLAINT
Jo Ann Shotwell Kaplan (BBO #459800)
Eric Gold (BBO #660393)
Anne McLaughlin (BBO #666081)
Julia Kobick (BBO #680194)
Assistant Attorneys General
One Ashburton Place, 20th Floor
Boston, MA 02108

Case 1:14-cv-11689-RWZ Document 84 Filed 11/17/14 Page 2 of 7

Zogenix now concedes that its claims are moot except with respect to the Boards final
regulations. See Mem. of Law in Opp. to Defts MTD Pltfs 3rd Am. Comp. (Opposition or
Opp.) at 2-3 n. 1. Those regulations do nothing more than impose reasonable restrictions on
medical and pharmacy professionals prescribing or dispensing any hydrocodone-only extended
release medication that is not in an abuse deterrent form. 243 CMR 2.07(25); 247 CMR
8.05(3).1 Designed to address the unique public health risks posed by Zohydro and any future
medication meeting this description, the regulations are intended to help prevent opiate misuse
and overdose. Mem. in Supp. of Defts MTD Pltfs Ver. 3rd Am. Compl. (Mem.), Exh. A at
3.2 The regulations prevent abuse of Zohydro by requiring prescribers to follow best practices
in diagnosing and treating patients, id., and by restricting the pharmacy personnel able to handle
the drug and therefore potentially divert it to improper use. See 247 CMR 8.05(3).
No matter how many times Zogenix repeats its conclusory assertions that the Defendants
are trying to prevent patients from accessing Zohydro, force Zogenix to reformulate it, or
creat[e] an effective ban, Opp. at 1, 3, 8, the assertions are refuted by the plain terms of the
regulations and the public rulemaking record. The regulations are neither intended to, nor could
by their terms, prevent legitimate patient access to Zohydro; and Zogenix was working on an
abuse-deterrent form of Zohydro as early as November 2013, well before Massachusetts officials
took any action at all. See http://goo.gl/CS9qYL. Defendants concern is not whether Zogenix
ever markets an abuse-deterrent Zohydro, but rather that the non-abuse-deterrent form not find
its way into the hands of those who would abuse it.3
1

It is beyond reasonable debate that the Boards have not regulated how Zohydro is designed or formulated, but
rather how it is prescribed and dispensed. Zogenix ignores both the nature of the Boards regulatory authority and
the plain terms of the regulations in suggesting to the contrary. See Opp. at 22, n. 5.
2
Zogenix continues to obscure the unique dangers of Zohydro, once again discussing potency, when the issue is
dosage, and misreading the Department of Justice Fact Sheet on hydrocodone. See Opp. at 16; TAC, 62. Zogenix
cites the Fact Sheet for the proposition that hydrocodone combination products, not single ingredient opioids, are
the most widely abused opioid drugs. Opp. at 16. What Zogenix fails to note is that, as of the preparation of that
fact sheet, the hydrocodone products on the market were [a]ll . . . combination products. See http://goo.gl/J5fCQc.
In other words, there was at the time no ability to compare Zohydro, with its far greater dose of hydrocodone, to the
hydrocodone-combination products. The relevance of the Fact Sheet is its confirmation that hydrocodone products
(of which Zohydro is now one) are the most abused opioid drugs.
3
The mere fact, if true, that Zohydro prescription volume continues to be low in Massachusetts, see Opp. at 1, does
not mean that the regulations are responsible. New Hampshire has no comparable regulations, and yet physicians

Case 1:14-cv-11689-RWZ Document 84 Filed 11/17/14 Page 3 of 7

Preemption. There is no such thing as a preempted purpose, and Zogenix cites no legal
support for such a preemption theory. Opp. at 3, 10. Nor does an alleged improper purpose for
a state law, or a complaint that the law singles out a party for regulation, have anything to do
with preemption doctrine. What matters instead, as Zogenix elsewhere acknowledges, see Opp.
at 4, is what the state law in fact does, Wos v. E.M.A. ex rel. Johnson, 133 S. Ct. 1391, 1398
(2013), and, given what it does, whether it stands as an obstacle to Congressional objectives.
This Court has already decided, and correctly so, that the BORIM and BOROPA
regulations (revised to eliminate the former other treatments have failed requirement) are not
preempted. See Mem. Dec. Vacating PI at 5-6 ([T]here is no conflict between state and federal
law, and thus, no preemption.). Zogenix completely ignores this ruling in its Opposition. It
instead quotes selectively from the transcript of the June 10 preliminary injunction hearing in a
futile effort to resurrect a preemption claim as to those regulations that is clearly barred by the
doctrines of waiver and judicial estoppel.4 But even if Zogenix were not foreclosed from now
there have said that they will not prescribe Zohydro. See http://goo.gl/suZ2Fx. And, despite Zogenixs stated
concerns about Zohydros limited period of exclusivity, Zogenix admits that it has effectively stopped marketing the
drug in Massachusetts, see Hawley Aff., Doc. # 64-1, 6, even though nothing in the regulations prevents the
company from doing so. If Zohydro sales remain low despite Defendants revision of their regulations, at Zogenixs
behest, to eliminate the other treatments have failed requirement and the restriction on pharmacy interns handling
Zohydro, it is now clear that those provisions of the former emergency regulations had nothing to do with the low
volume of Zohydro prescriptions in the state, just as Defendants suggested at the time. In any event, Zogenix has
been hugely successful in this litigation, defeating a conditional ban of Zohydro and securing what it repeatedly
characterized as by far the most important revision it needed to the regulations (elimination of the other treatments
have failed provision), together with half of what it sought regarding the pharmacy handling restrictions. If
Zogenix nonetheless remains disappointed by Massachusetts sales, the fault lies elsewhere than in the regulations.
4
Zogenix first quotes its counsel as having stated We would note that it seems unfair to us to single out Zohydro
Extended-Release from all of the other opioid medications that have contributed to what the Governor says was a
public health crisis before Zogenix got into prescribing [sic] Zohydro in Massachusetts. June 10 Tr. at 11:8-12;
Opp. at 9. What Zogenix fails to quote are the immediately preceding lines from the transcript, in which Zogenixs
counsel explained that this point went to its class-of-one equal protection argument, not its preemption argument:
We do not, your Honor. Although we would note and this is part of our equal protection argument. We would
note that it seems unfair to us to single out Zohydro. June 10 Tr. at 11:6-9. The omission is highly significant, as
is Zogenixs omission of lines from the transcript immediately succeeding the lines contained in the indented quote
on page 9 of its Opposition. What followed was the following colloquy: THE COURT: Now, assume for the
moment that the [BORIM] regulations include the letter of medical necessity without any reference to failed
treatments. Would there be a problem? MR. HOLLMAN: If the medical necessity is only the same as the
approved indication, which is to show that other which is to state that other medications are inadequate, that would
be supported by the clinical testing that was performed, supported by the approval that the FDA gave, and it would
be consistent with the FDAs approval. So, no, under those circumstances, no objection. Thats not what we have.
THE COURT: Well, I understand that. Im just trying to understand where the line might be. MR. HOLLMAN:
Thats the line, your Honor . . . . [T]hats the line of demarcation here, your Honor. June 10 Tr. at 14:16 15:12.

Case 1:14-cv-11689-RWZ Document 84 Filed 11/17/14 Page 4 of 7

asserting a preemption claim vis--vis the BORIM and BOROPA regulations, the Court has
already determined that the claim does not lie as to those regulations.5
Zogenix claims that the BORIP regulation preventing certified pharmacy technicians
from handling Zohydro effectively bans Zohydro in the Commonwealth. The suggestion defies
common sense. The provision does not regulate prescribers at all; and it leaves pharmacists and
pharmacy interns able to dispense the drug when presented with prescriptions. Zogenix still does
not assert (nor could it plausibly) that a single patient has been unable to fill a Zohydro
prescription in the Commonwealth because of this regulation. Without that allegation there
cannot be a determination that this restriction results in an effective ban on Zohydro or otherwise
stands as an obstacle to the drugs availability.
Contrary to Zogenixs claims, see Opp. at 7, Defendants have not argued that it is
irrelevant whether pharmacies are dispensing Zohydro. Defendants argue instead that it is
irrelevant whether pharmacies will stock Zohydro, provided they will order and dispense it upon
presentation of a valid prescription. It is Zogenix that confuses the analysis by discussing the
legally irrelevant question whether pharmacies will keep the drug in stock pending presentation
of prescriptions.6
Equal Protection. As expected, Zogenix still cites no case applying the class-of-one
equal protection theory to anyone other than a party actually subject to the challenged state law.
There being no such case, Zogenix argues instead that it is subject to the Boards regulations.
However, unless a state law imposes obligations or liabilities, or confers privileges, upon a party,
that party is not subject to the law. See Mem. at 6. And Zogenix is simply wrong that the
Boards regulations impose liabilities on it. There may be an economic impact on Zogenix, if the
5

Zogenix mischaracterizes Defendants arguments of waiver, law-of-the-case, and judicial estoppel when it treats
those arguments as having applied to the BORIP provision preventing certified pharmacy technicians from handling
Zohydro. See Opp. at 5. Defendants expressly indicated that this was the sole provision of the final regulations still
open to preemption challenge given those doctrines and the Courts prior rulings. See Mem. at 23.
6
Defendants have argued legal irrelevance; they have not attempted to exceed the bounds of a motion to dismiss and
make a factual argument about whether pharmacies are in fact choosing not to stock Zohydro. See Opp. at 7-8, incl.
n.2. And neither the Court nor Defendants are obliged to ignore for purposes of this legal argument the
commonsense distinction between stocking and dispensing drugs.

Case 1:14-cv-11689-RWZ Document 84 Filed 11/17/14 Page 5 of 7

regulations serve their purpose of preventing diversion and abuse of Zohydro. But the
regulations impose duties (and hence potential liability for breach of those duties) only upon
prescribers and pharmacies, not drug manufacturers. As a result, Zogenix has no answer to this
threshold requirement of a class-of-one equal protection claim and, as the Court has already
recognized, the claim is misplaced. July 8 Dec. at 4-5 n.3.
Zogenix also wrongly faults this Court for applying Engquist v. Or. Dept of Agric., 553
U.S. 591, 603 (2008), outside the public-employment context. While Engquists holding is
obviously specific to that context, numerous circuit court decisions, previously cited, have
applied its rationale outside that context. See Mem. at 7-8 incl. n. 9. And Defendants never
suggested that an agency is exempt from class-of-one scrutiny whenever it exercises any degree
of discretion. See Opp. at 10-12. But here Zogenix is unable to identify, as it must, any state
legislative or regulatory classification[ ] preceding the challenged regulations that created a
clear standard against which departures, even for a single plaintiff, could be readily assessed
and thereby constrained the Boards exercise of discretion. 553 U.S. at 602. Zogenix points
only to an absence of prior state regulation. Opp. at 13. Like the public employer in Engquist,
therefore, the Boards exercised broad discretionary authority based on individualized facts in
choosing to regulate hydrocodone-only, extended-release opioids not in an abuse-deterrent form,
as opposed to some larger category of opioids.7

Zogenix also misunderstands the significance of the emergency context in which the Boards were operating. The
point is not that the Boards lacked time to take deliberate action; their regulatory process was extensive and highly
deliberate, as required by law. The point is instead that public-health emergencies inherently involve novel
circumstances such that there is no prior baseline standard to apply. Moreover, Zogenix still does not clarify what
class it supposedly belongs to, variously describing the purported class as other similarly-situated opioid products
(without further definition), all opioids, or all extended-release/long-acting opioid products. Opp. at 14-15. And
Zogenix has no answer to the fact that it has itself made allegations clearly distinguishing Zohydro, the only
hydrocodone-only, extended-release, non-abuse-deterrent opioid currently on the market, from all other opioid
drugs, however classified. Case law clearly supports dismissal of a class-of-one claim where plaintiffs own
allegations reflect such distinctions. See Mem. at 9. Finally, Zogenix misstates the law of this circuit regarding the
need to allege facts demonstrating malice, or personal hostility. Tapalian v. Tusino, 377 F.3d 1, 6 (1st Cir. 2004).
Indeed, just this year the First Circuit confirmed that class-of-one claimants ordinarily must . . . show that the
defendants differential treatment of the plaintiff was motivated by bad faith or malicious intent to injure. Snyder v.
Gaudet, 756 F.3d 30, 34 (1st Cir. 2014) (internal quotation omitted). The earlier decisions cited by Zogenix, see
Opp. at 17 n. 4, are not to the contrary; they instead did not reach the question because the claims failed for other
reasons.

Case 1:14-cv-11689-RWZ Document 84 Filed 11/17/14 Page 6 of 7

Contracts Clause. In an attempt to save its undeveloped Contracts Clause argument,

July 8 Dec. at 4-5 n.3, Zogenix continues its pattern of setting up, and then dismissing,
arguments that Defendants never made.8 Defendants have been clear that a claimants status as
part of a regulated industry is especially important to, not necessarily determinative of, the
question whether any impairment of contract is sufficiently substantial. Mem. at 11. Where,
however, Zogenixs industry is subject to pervasive regulation and it was undeniably foreseeable
that there might be addition[s] to [that] regulatory regime, see id. at 11-13, any impairment is
insubstantial. Moreover, Zogenixs claim of impairment here derives from its facially
inaccurate suggestion that the Boards regulations constructively revoke[ ] its NDA approval.
Opp. at 18. They, of course, do nothing of the kind. Nor do they impose any liability on
Zogenix, let alone unexpected liability in potentially disabling amounts. Opp. at 18 (quoting
Allied Structural Steel Co. v. Spannaus, 438 U.S. 234, 246 (1978)). The Court need not entertain
evidence to reject these plainly insupportable descriptions of the Boards regulations. And
Zogenixs arguments to the contrary notwithstanding, see Opp. at 20, the Court should properly
defer, Energy Reserves Group, Inc. v. Kan. Power & Light Co., 459 U.S. 400, 412-13 (1983), to
the Boards judgment that their regulations are necessary and reasonable to prevent exacerbation
of a public health crisis.
DEFENDANTS, by their counsel:
_/s/ Jo Ann Shotwell Kaplan, AAG

Zogenixs Commerce Clause claim remains every bit as unpersuasive now as it was in July. See July 8 Dec. at 4-5
n.3. It accordingly warrants only a few brief points. First, Zogenix still can find no burden on interstate commerce,
as opposed to itself, or any way in which this case entails a lack of national uniformity [that] would impede the
flow of interstate goods. Opp. at 21 (quoting Exxon Corp. v. Governor of Md., 437 U.S. 117, 128 (1978)). There is
no national uniformity in how prescription drugs are regulated, id. at 21-22; to the contrary, there is extensive,
diverse state regulation of prescribing and dispensing practices. See Mem. at 11-13. And Zogenix is not even
subject to the regulations at issue here, so there is no prospect of it being subjected to a patchwork of state
regulations conflicting with those of Massachusetts. Nor is speculation about future, potentially conflicting state
regulations permissible to support a dormant Commerce Clause claim, in any event. See id. at 16. Finally, Zogenix
impermissibly and irrationally speculates that BORIPs limited restriction on Zohydro handling, affecting only one
category of pharmacy personnel, will somehow prevent national pharmacies from dispensing Zohydro in the future.
Opp. at 21-22. Even if that implausible result were to follow, however, it would burden only Zogenix, not an
interstate market.

Case 1:14-cv-11689-RWZ Document 84 Filed 11/17/14 Page 7 of 7

Certificate of Service
The undersigned counsel hereby certifies, this 17th day of November 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 non-registered parties so indicated on the NEF.
/s/ Jo Ann Shotwell Kaplan
Jo Ann Shotwell Kaplan