A federal court in Massachusetts has issued a preliminary injunction in a challenge to the commonwealth’s regulation of a specific opioid analgesic— Zohydro—and denied the commonwealth’s motion to dismiss without prejudice. Zogenix v. Patrick, No. 14-11689 (U.S. Dist. Ct., D. Mass., decided July 8, 2014). Details about the court’s previous ruling enjoining a ban on the painkiller appear in Issue 76 of this Bulletin. Information about regulations the commonwealth imposed after the court enjoined the ban appears in Issue 77 of this Bulletin.
The court addressed the company’s preemption challenges to regulations requiring that (i) doctors or physician assistants certify that “other pain management treatments have failed” before prescribing the drug, and (ii) only pharmacists may handle Zohydro. In the plaintiff’s view, the commonwealth had attempted to limit access to a drug that the U.S. Food and Drug Administration had said should be available. According to the court, the challenged regulations are so vague that it is unclear whether they may be interpreted and enforced in a way that obstructs the federal law’s objectives. And without a record of enforcement, “it is unclear whether such an obstacle exists.” Still, the court determined that the “plaintiff should not bear the brunt of the defendant’s vague regulations, waiting for an adequate record of enforcement to develop while the clock ticks on its three-year exclusivity period.”
The court denied the defendants’ motion to dismiss, ruling that the plaintiff had stated a plausible claim for relief, and, in allowing the motion to preliminarily enjoin the regulation, the court further ruled that the defendants could seek to lift the injunction if they “provide adequate and constitutional guidance to physicians regarding the prerequisites for prescribing Zohydro in compliance with the regulation.” Finding that the plaintiff’s sealed declaration that pharmacies will not carry Zohydro was insufficiently detailed, the court ruled that it had not met its burden of proof on the “pharmacist-only regulation,” but denied its motion “without prejudice to renewal upon a more detailed submission.”