Pain hurts. Pain sometimes hurts a lot, and chronic pain hurts for a long time. These self-evident truths explain why pain killers are a necessary presence in every doctor’s toolbox and why analgesics are critical in promoting health and well being. That is not to say that the world necessarily needs a wider variety of pain medicines than it already has. We don’t know. We do know, however, that when we depose plaintiffs who use pain medication and when we interact with primary care physicians and rheumatologists—doctors who treat chronic pain on a day-to-day basis—we are left with the impression that they want more options.
We also know that many people are vigorously opposed to newer opioid drugs that are currently being introduced in the U.S., mainly because of the risk of abuse. The FDA’s approval of an opioid analgesic called Zohydro ER in October 2013 is one example. Zohydro ER is an extended release version of hydrocodone, but it is the only hydrocodone analgesic on the market whose sole active ingredient is hydrocodone. Others contain acetaminophen, and removing that component mitigates the risk of liver damage for which acetaminophen is well known. Zohydro ER also is a time release product intended to dispense pain relief over a twelve-hour period. To our untrained eyes, Zohydro ER is “not right for everyone,” but it has properties that doctors might find useful for certain patients.
The governor of Massachusetts, however, has concluded that Zohydro ER is “not right for anyone,” and Massachusetts issued an emergency order on March 27, 2014, banning the prescription, ordering, dispensing, and administration of Zohydro ER—essentially a state-law order taking an FDA-approved drug off the market.
Such aggressive state regulation of prescription drugs fails the “you can’t do that” test, and the drug’s manufacturer sued for an injunction suspending enforcement of the ban. The case is Zogenix, Inc. v. Patrick, No. 14-11689-RWZ, 2014 WL 1454696 (D. Mass. Apr. 15, 2014), and the district court correctly ruled that the FDCA and the FDA’s drug-approval authority preempted the Massachusetts order.
This is not how we normally see preemption come up in prescription drug cases, but because even unusual sources of preemption precedent can be helpful, we decided to take a deeper dive. Starting with the proposition that “state and federal law conflict if state law ‘stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress,’” the district court quickly found that the state-law prohibition could not stand:
The FDA endorsed Zohydro ER’s safety and effectiveness when it approved the drug. When the Commonwealth interposed its own conclusion about Zohydro ER’s safety and effectiveness by virtue of [the] emergency order, did it obstruct the FDA’s Congressionally-given charge?
I conclude that it did. The FDA has the authority to approve for sale to the public a range of safe and effective prescription drugs—here, opioid analgesics. If the Commonwealth were able to substitute its own requirements, it would undermine the FDA’s ability to make drugs available to promote and protect the public health.
Id. at *2. Here at the Drug and Device Law Blog, we find the truth of this statement as self-evident as “pain hurts.” But Massachusetts tried to defend its ban anyway by arguing that Wyeth v. Levine rejected “obstacle preemption” and set federal drug regulation as a “floor, not a ceiling.” Id. We don’t think much of Levine, but even giving the opinion all due consideration, it lends no support to the Commonwealth’s position. Levine did not reject implied preemption, but held only that FDA-approval of prescription drug labeling does not necessarily preempt state-law tort claims alleging inadequate warnings.
The “floor-ceiling” analogy also does not apply where the state-law requirement is a complete ban of the product. The district court put it this way:
Wyeth assumed the availability of the drug at issue and analyzed whether stronger state labeling requirements obstructed the FDA’s objectives. Here, the obstruction is clearer because the drug Massachusetts wants Zogenix to adopt—Zohydro ER with an “abuse-resistant formulation”—has not been approved by the FDA. To satisfy the Commonwealth, [the manufacturer] would be required to return to the FDA and seek approval of a drug different from the one the FDA has already deemed safe.
Id. (emphasis added). This is a classic implied conflict preemption scenario, the flavor of implied preemption that most often applies in prescription drug cases: Sell the FDA-approved drug and violate state requirements; or meet the state requirements by selling a drug that the FDA has not approved, which would violate federal law. The only solution to this conundrum is for the state requirement to give way, as the district court ruled in Zogenix.
So physicians in Massachusetts can prescribe Zohydro ER to their patients who need it, but that is not why this order so piques our interest. The district court’s take on preemption calls to mind the Supreme Court’s opinion in Mutual Pharmaceutical Co. v. Bartlett, where the Supreme Court rejected the argument that state-law design defect claims do not conflict with federal law because a drug manufacturer defendant can comply with both state and federal law simply by removing its product from the market. In other words, it is no answer to implied conflict preemption to tell a drug manufacturer that it can just “stop selling” its product, despite the FDA’s license to do exactly that. The Zogenix order sounds a similar theme—a state-law order to “stop selling” a particular drug cannot coexist with federal law authorizing that same action.
The opioid battle is not over. Abuse of prescription pain medication remains an important issue, and newer opioid analgesics will continue to garner vocal opposition. Just the other day, an FDA advisory committee voted unanimously not to recommend approval of another new opioid pain medicine—Moxduo, a combination of two already-approved drugs, morphine and oxycodone. Again the concern is the potential for abuse. The FDA may or may not approve the drug, but if it does, and if states attempt to ban it as Massachusetts did with Zohydro ER, we can expect additional preemption rulings like Zogenix. Which goes to show that helpful preemption analysis can come from even unexpected places.