If you have been following along for a while, then you have surely run across our posts making some combination of the following points: 1) design defect claims rarely make sense for a drug because changing the design in some material way will usually make it a different drug, 2) such design defect claims, if recognized by state law, will usually be preempted because FDA approval of a different drug cannot be assumed, and 3) courts really should analyze conflict preemption by first determining that there is an actual state law duty that has been asserted or supported (depending on the procedural posture). One such post walked through why it took so long until a circuit court held that a design defect claim with a prescription drug was preempted. That case, Yates, has been followed a number of times, including on motions to dismiss, but there are still some glitches.
The decision in Young v. Bristol-Myers Squibb Co., No. 4:16-CV-00108-DMB-JMV, 2017 WL 706320 (D. Miss. Feb. 22, 2017), counts as a glitch on the preemption front even though the court dismissed (without prejudice) the design defect claim and eight of the nine other claims asserted. The plaintiff claimed to have suffered ketoacidosis and renal failure from taking a prescription diabetes medication right around the time FDA issued a Public Health Advisory about the risk of ketoacidosis for the class of medications, SGLT-2 inhibitors, to which it belonged. Several months later, the drug's label was revised to include warnings about ketoacidosis and urosepsis, a blood infection stemming from a urinary tract infection. Plaintiff claimed that the inherent design of the drug, like all SGLT-2 inhibitors, created a risk of ketoacidosis. When plaintiff sued, she asserted a wide range of claims and defendants moved to dismiss on various grounds. We will address only some of them.
Part of our point here is that the order can matter. We do not have the briefs, so all we can go off of here is the opinion. After the preliminary issue of whether common law claims are subsumed by the Mississippi Product Liability Act—the four here were—the court starts off the meat of the analysis with this: "The defendants argue that Young's claim for defective design must fail because Young has failed to plead a feasible design alternative and because federal law preempts the design defect claims." Id. at *5. So, what gets analyzed first? Preemption. (Remember, federal courts are supposed to try to resolve disputes on nonconstitutional grounds if they can.) In so doing, the court has to hold out as unresolved whether Mississippi law imposes the very duties that might create the conflict leading to preemption. As the court recognized at the end of its, to us, flawed preemption analysis:
If there is no state law duty, the state law cause of action must certainly fail but there can be no conflict so as to justify preemption. Put differently, the absence of a state law duty is fatal to a claim but not under the doctrine of conflict preemption.
Id. at *8. This logic suggests that the court needs to decide first whether there is a state law duty to do what the plaintiff urges was necessary. Because the court never determined that there was such a duty, the whole discussion of preemption seems like a bunch of dictum to us.
Plaintiff, of course, disputed that there can be a conflict between state and federal law when it comes to a drug's design. She argued "Federal law does not prohibit brand-name drug manufacturers from designing a reasonably safe drug before FDA approval, nor does it prohibit manufacturers from changing a drug's design post-approval to ensure it is reasonably safe." Id. at *6. Following the pre- and post-approval dichotomy, the court first followed the plain language of Bartlett to find that a post-approval change in design would be preempted, regardless of what it entailed. Id.
As for "pre-approval changes," the court followed the reasoning of the district court in Guidry v. Janssen Pharm., Inc., __ F. Supp. 3d __, No. CV 15-4591, 2016 WL 4508342 (E.D. La. Aug. 29, 2016), over that of the circuit court in Yates—citing only those two cases and Bartlett in the process. We find the concept of a "pre-approval change" something of a red herring when it comes to a new drug. The active ingredient in the drug here was a new molecular entity, meaning it had never been in a drug approved in United States until this drug was approved in 2014. That exact molecule had to be studied in various pre-clinical models before getting its first Investigational New Drug Application approved on its way to favorable results from years of Phase I, II and III clinical trials to include in a comprehensive New Drug Application. Any "change" in the active molecule here—presumably to another new molecular entity—at any step would almost always mean back to square one in terms of the approval process. (Changing the dosage, delivery system or maybe inactive ingredients might be different, but that just reinforces why the first step is to assess plaintiff's design defect claim and whether it flies under state law.)
With this in mind, the court's reasons for rejecting Yates appear to be pretty hollow. It endorsed Guidry's conclusion that "It is not too attenuated to assume that the FDA would approve a safer, alternative design of a drug that it has already approved." Id. at *8 (citation omitted). It is pretty attenuated to assume a drug based on a different new molecular entity would produce sufficiently favorable preclinical and clinical results to pass every regulatory hurdle. The vast majority of new molecules never make it to even the first phase of clinical trials. When it comes to a drug to treat type-2 diabetes, where there are many approved drugs with various modes of action and there is a long and active history of regulatory actions for classes of diabetic drugs, offering that a "safer"—presumably as to the risk of the injury that plaintiff claimed—drug would be approved is quite simplistic.
The court's rejection of the "stop selling" rationale that Yates took from Bartlett is also hard to understand. "The preapproval theory does not argue that a manufacturer should have stopped acting, just that it should have acted differently." Id. at *8 (emphasis in original). The different action here would be to not pursue the approval of the drug that FDA ultimately found to be safe and effective and then to sell it (with the approved labeling), but to try to come up with a different drug, research it, get it approved, and then sell it instead. Because a company can sell lots of different approved drugs, including multiple drugs for the same indication, this proposed different action would include stopping selling the approved drug. Bartlett and Yates correctly rejected this as argument for why there was not really a conflict.
Like we said, however, there was no real reason for any of this abstract analysis, because plaintiff's asserted design defect claim was not sufficient under Mississippi law, which requires plaintiff to prove a "feasible design alternative that would have to a reasonable probability prevented the harm." The court let it slide under TwIqbal that the plaintiff merely offered boilerplate allegations that there were diabetes drugs with a different mechanism of action that were safer than any in the SGLT-2 inhibitor class and that it was feasible for the defendants to provide one of them instead. Id. at *9. However, it held that "drugs which by their very nature perform a different function" are not alternative designs under Mississippi law. Id. at *11. We will skip the court's discussion of cases addressing the subject of what can count as a different design for a drug. Several among them probably merit inclusion the next time we do another " think piece"—a Bexis term—on this subject.
After the design defect analysis, the court walked through whether plaintiff had asserted enough facts for any of her other claims. Among them, only express warranty was good enough as is. Plaintiff, though, will get a change to re-plead all her claims, including design defect claims. It will be interesting to see if she can come up with a real alternative design and if that will be based on a state law duty to do something that really does conflict with federal law. We have our doubts.
This article is presented for informational purposes only and is not intended to constitute legal advice.
