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Zogenix vs Deval Aug28 2014 Memorandum of Decision

Zogenix vs Deval Aug28 2014 Memorandum of Decision

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Published by kevgo
Plaintiff has constitutional standing to sue.
Defendants’ motion to vacate the preliminary injunction (Docket # 68) is

Zogenix vs Deval Patrick
Plaintiff has constitutional standing to sue.
Defendants’ motion to vacate the preliminary injunction (Docket # 68) is

Zogenix vs Deval Patrick

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Published by: kevgo on Aug 28, 2014
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Defendants also argue that my July 8, 2014 memorandum was moot–at least in part–becausethe old regulations had expired before it was issued. I need not address that argument given today’smemorandum.
et al.
MEMORANDUM OF DECISIONAugust 28, 2014ZOBEL, D.J.On July 8, 2014, I preliminarily enjoined two Massachusetts regulations whichrequired that a licensed prescriber write a “letter of medical necessity” certifying “thatother pain management treatments have failed” before prescribing Zohydro ER
(“Zohydro”). Docket # 66 at 10 (citing 243 CMR § 2.07(25)(d); 263 CMR § 5.07(12)(d)). I invited defendants, Commonwealth health officials sued in their official capacities, tomove to lift the injunction if they “provid[ed] adequate and constitutional guidance tophysicians regarding the prerequisites for prescribing Zohydro.” Id. Defendants haveaccepted the invitation and so moved, arguing,
inter alia 
 that the Commonwealth haspromulgated new regulations which no longer offend the Supremacy Clause of theUnited States Constitution. Docket # 68; see U.S. Const. art. VI cl. 2. I agree and lift
Case 1:14-cv-11689-RWZ Document 73 Filed 08/28/14 Page 1 of 6
2the injunction. First, however, a preliminary word about standing.
A. Standing
In my prior memorandum, I stated that defendants had “waived” their standingargument because they failed to develop the argument in their memorandum in supportof their motion to dismiss. Docket # 66 at 10 n.4. Defendants claim this was error. It istrue, of course, that standing implicates subject matter jurisdiction and may not bewaived. United States v. AVX Corp., 962 F.2d 108, 116 n.7 (1st Cir. 1992). Here,though, defendants raised their standing challenge in a single perfunctory paragraphon the last page of their memorandum in support of their motion to dismiss, Docket # 45at 20, but, rather perplexingly, developed the argument in an altogether separatedocument filed two weeks later: their memorandum in opposition to plaintiff’s motion fora preliminary injunction. Docket # 56 at 16-20. In so doing, defendants did not complywith our Local Rules. See U.S. Dist. Ct. Rules D. Mass, Local Rule 7(b)(1) (“A partyfiling a motion shall at the same time file a memorandum of reasons, including citationof supporting authorities, why the motion should be granted.”). The First Circuit recently reiterated that “[w]hen an issue implicates subject-matter jurisdiction, a federal court is obliged to resolve that issue even if the partieshave neither briefed nor argued it.” Merrimon v. Unum Life Ins. Co. of Am., ___ F.3d ___, Nos. 13-2128, 13-2168, slip op. at *2 (1st Cir. July 2, 2014). It is debatablewhether this precept applies issues which
 briefed, but are briefed improperly. Assuming,
, that it does, and appreciating my “unflagging obligation to notice jurisdictional defects and to pursue them on [my] own initiative,” Espinal-Dominguez v.
Case 1:14-cv-11689-RWZ Document 73 Filed 08/28/14 Page 2 of 6
3Puerto Rico, 352 F.3d 490, 495 (1st Cir. 2003), I address defendants’ standingchallenge.The judicial power of the federal courts extends only to actual cases andcontroversies. U.S. Const. art. III, § 2, cl. 1. “A case or controversy exists only whenthe party soliciting federal court jurisdiction . . . demonstrates ‘such a personal stake inthe outcome of the controversy as to assure that concrete adverseness which sharpensthe presentation of issues upon which the court so largely depends.’Katz v. Pershing,L.L.C., 672 F.3d 64, 71 (1st Cir. 2012) (quoting Baker v. Carr, 369 U.S. 186, 204(1962)). To establish that personal stake, a plaintiff must satisfy “each part of a familiartriad: injury, causation, and redressability.” Id. (citing Lujan v. Defenders of Wildlife,504 U.S. 555, 560-61 (1992)). Defendants challenge the first two of these three parts.First, they contend that plaintiff’s claimed injury is impermissibly premised onspeculation about future events, rather than on a harm it has already suffered. Docket# 56 at 16-17. The injury plaintiff alleges must be “concrete and particularized” and“actual or imminent, not conjectural or hypothetical.” Lujan, 504 U.S. at 560 (internalquotation and citation omitted). Plaintiff must demonstrate only “an objectivelyreasonable possibility” that it will be injured in such a way. Osediacz v. City ofCranston, 414 F.3d 136, 143 (1st Cir. 2005). Here, plaintiff has alleged injury to itseconomic well-being in that the regulations restrict the availability of Zohydro andtherefore reduce the size of the market for its product. And it has alleged damage to itsreputation from the publicity that has accompanied the regulations. These allegationsare just as strong, if not stronger, than those in cases where courts in this Circuit have
Case 1:14-cv-11689-RWZ Document 73 Filed 08/28/14 Page 3 of 6

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