Do as I say, not as I do. A crutch used by parents worldwide to justify their own bad habits while trying to ensure their children don’t repeat them. Technically, it’s being a hypocrite. Sure, parents should strive to set an example through behavior. But frankly, sometimes we’ll settle for hypocritical. Well, a federal court in Massachusetts just said the same applies to the FDA. We’ll explain.
A group of plaintiffs brought a putative class action against a group of pharmaceutical companies alleging that their prescription eye drops were intentionally designed to dispense more liquid than the human eye is capable of absorbing. Gustavesen v. Alcon Laboratories, Inc., — F. Supp.3d –, 2017 WL 4374384, at *1 (D. Mass. Sep. 29, 2017). Plaintiffs allege that therefore, medication is wasted and they are required to more frequently re-fill their prescriptions than is necessary to the financial benefit of the defendants. Id. Plaintiffs sought recovery under various states consumer protection statutes as well as for unjust enrichment and “money had and received.” Id. at *2. Defendants filed a motion to dismiss alleging multiple reasons why plaintiffs’ claims fail as a matter of law. The court opted not to consider anything beyond preemption finding that that precluded all of the alleged claims.
To begin its analysis, the court did a nice walkthrough of what it calls the Supreme Court’s trilogy of impossibility preemption decisions. First, of course, is Wyeth v. Levine, where the Court said failure to warn claims are not preempted because of a manufacturer’s ability to make certain labeling changes without prior approval of the FDA, unless there is clear evidence that the FDA would have rejected the change. Id. at *4. Next up was Pliva v. Mensing. A generic drug is required to have the same labeling as the brand-name version. Therefore, a generic drug manufacturer does not have the same ability to change its label as the brand manufacturer. Id. at *5. And, finally came Mutual Pharmaceutical v. Bartlett. Here the Supreme Court said that plaintiff’s design defect claim was preempted because any attempt by the manufacturer to change the design of the drug would have resulted in a new, unapproved drug that the manufacturer would have been prohibited from marketing. Id. Moreover, the court rejected plaintiff’s claim that defendant could have simply stopped selling the drug – defendant is not required to “cease acting altogether to avoid liability.” Id. Put the three cases together and you have the following framework. If FDA regulations allow a manufacturer to make a change without prior approval, no preemption unless clear evidence change would have been rejected. If “a party cannot satisfy a state law without first obtaining the discretionary approval of a federal agency, the state law is preempted.” Id. at *5.
Against that legal backdrop plaintiff’s argued that they had 2 theories of liability that were not preempted. First, they alleged that defendants could have changed the eye dropper tip to deliver a smaller drop and that this would have been prohibited by the FDA. Id. at *7. There are 3 categories of changes for approved drugs – major, moderate, and minor. Moderate changes are the type of labeling change discussed in Wyeth that do not need pre-approval. Major changes on the other hand must be submitted to the FDA before the drug is distributed. Id. To determine whether something is a major change, the court looked to FDA regulations and FDA guidances interpreting those regulations. In this case, that would include a guidance that for sterile products, like eye drops, any change to the container closure system is a major change. Id. The opinion goes more in depth on these regulations – but the conclusion is what is important. Plaintiff’s proposed design change would be a major change that would require prior FDA approval – therefore, the claim is preempted.
Now we come to the “do as I say” part. In response to defendants’ argument that the design change suggested by plaintiffs would be a major change, plaintiffs cited to three occasions where they claim the FDA allowed a container change without prior approval. As to 2 of the events, the documents relied on by plaintiffs don’t support their position. Id. at *9. As to the third:
At most, this is evidence of the FDA’s failure to follow strictly its own guidance. It does not cast doubt on the plain language of the 2004 Guidance deeming all changes to the size or shape of a sterile product’s container to be major changes requiring preapproval.
[P]laintiffs cite no law indicating that particular actions by an agency—as opposed to the agency’s official position—are relevant to interpreting a regulation. In fact, the Supreme Court has rejected invitations to apply the standards an agency follows in practice rather than the standards it officially promulgates.
Id. In sum, do as the FDA says, not as it does. The regulations and official guidances control over individualized instances where the FDA chose not to apply them. The court can’t be guided by internal decision-making processes in one-off situations.
Having found that a post-approval change of the eye drop container would have been a major change and therefore claims premised on that preempted, the court examined whether plaintiff could sustain a claim for a “pre-approval” design change. Meaning, could/should defendants have design the dropper tips differently before seeking FDA approval. This question was decided in defendants’ favor by the Sixth Circuit in Yates v. Ortho-McNeil-Janssen Pharm, Inc., 808 F.3d 281 (6th Cir. 2015) (see post here). After examining some other district court authority cited by plaintiffs, the court in this case decided Yates was more consistent with Mensing and Bartlett.
Going back to the trilogy – if a manufacturer can’t satisfy its state law duties without FDA permission, the claim is preempted. Well, it’s not possible for a manufacturer to market a re-designed drug because that drug “would require its own NDA to be marketed in interstate commerce.” Id. at *11. So, arguing that the defendant should have changed the design pre-approval runs straight into the same impossibility preemption as a post-approval design change. Moreover, arguing that the defendant should never have sold the product is virtually the same thing as arguing that it should have stopped selling the product – the theory rejected in Bartlett.
A nice preemption decision, especially the use of Mensing and Bartlett outside the generic realm.