Ever since Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013), was decided, we’ve pointed out at every opportunity that its basic principle – that an immediate state-law “duty” is incompatible with an FDA pre-approval requirement, and therefore subject to impossibility preemption – should apply to any FDA (and probably other government agency) pre-approval requirement for any product, not just generic drugs.  

We’ve highlighted some success, see Thompson v. Allergan USA, Inc., ___ F. Supp.2d ___, 2014 WL 308794 (E.D. Mo. Jan. 28, 2014) (non-generic dosage claim preempted); Guenther v. Novartis Pharmaceutical Corp., 2013 WL 4648449 (M.D. Fla. Aug. 29, 2013) (non-generic black box, dosage, comparative labeling claims either preempted or probably preempted), but we hadn’t seen any case actually taking on a design defect claim in the non-generic context.  Now we have.  See Cassel v. ALZA Corp., 2014 WL 856023 (W.D. Wis. March 5, 2014).  While Cassel contains some hopeful signs, the bottom line was not good – preemption motion denied.  However, in order to avoid preemption, Cassel was forced to contort state law in novel ways that we don’t think most courts would countenance.

Cassel involved a peculiar sort of non-generic drug – at least that’s what we glean from the opinion – a fentanyl analgesic patch.  Such a product has some of the characteristics of a drug, in that there’s fentanyl in it, and that’s a substance that meets the observation in Bartlett that “as a matter of “basic chemistry,” “because of [the drug’s] simple composition, [it] is chemically incapable of being redesigned.”  133 S. Ct. at 2475.  On the other hand, the product’s mode of administration, being a patch, is capable of being redesigned, and in fact had been.  See Cassel, 2013 WL 4648449, at *1 (discussing 2009 design change).

Indeed, the plaintiffs in Cassel targeted this FDA-approved design change as creating a “defect” in the patch by eliminating a separate “rate-control membrane,” which they claim led to a fatal overdose.  Id.  The defendant manufacturer sought summary judgment against this design defect claim underBartlett/Mensing/Levine impossibility preemption, asserting the claim was barred due to the requirement of FDA approval for any change in design.  2013 WL 4648449, at *2.

The first thing Cassel did to wiggle out of preemption was create a never-before-seen three-part test that provided an escape route from “impossibility” preemption as found in Bartlett and Mensingleading back into the nearly-impossible-to-satisfy Levine “clear evidence” of FDA rejection standard:

First, the court must identify the steps a defendant should have taken to avoid liability under state tort law.  Next, the court must determine as a matter of law whether federal law expressly prohibited the defendant from taking these steps. If the answer to this second question is ‘No,’ the court must determine whether the defendant has presented ‘clear evidence’ that the regulatory agency would have stepped in and exercised its discretionary authority to prohibit the defendant from taking the necessary steps under state law.

2013 WL 4648449, at *3 (emphasis added).  In other words, when uncomfortable with what the Supreme Court decided, make up something new.  Under this new test, the objective, from an anti-preemption standpoint, is to ensure that the answer to the second question is “no.”  That’s precisely where Cassel went, although it had to chart a most unusual course to get there.

The “identification” prong of the test is where things get really interesting.  Remember, we’re supposedly dealing with a state-law (here, Wisconsin) product liability claim.  So what is the “step“ that the defendant manufacturer was supposedly under a state-law duty to take?  Something else we’ve never seen before:

plaintiffs were alleging a duty to design the patches differently before FDA approval (rather than to change the design after the fact)

Id. (emphasis added).

“Before FDA approval”?  Essentially Cassel is admitting that the defendant (and your DDL bloggers) are right about preemption of any claim involving a post-FDA-approval design change.  Such changes after a product is on the market would require FDA-pre-approval and thus would be preempted.  The response in Cassel to avoid preemption was to read such allegations out of state law.

Not so fast.

Wisconsin is no different from most states in that its product liability law determines defect at the time of sale, or alternatively when the product left the manufacturer’s hands.  “[T]he plaintiff must prove (1) that the product was in defective condition when it left the possession or control of the seller.”  Shawver v. Roberts Corp., 280 N.W.2d 226, 231 (Wis. 1979) (quoting Dippel v. Sciano, 155 N.W.2d 55, 63 (1967)).  Yeah, we know that Wisconsin recently enacted tort reform, but we don’t think that the statute changed something so fundamental as the defect-at-sale requirement, and there’s certainly no suggestion of any such change in Cassel.

Our principal response to this purported “duty“ is that it simply does not exist under any state’s product liability common law that we know of.  We are unaware of state having a “defect” standard that evaluates the product’s condition at any point before it was sold to the particular plaintiff.  Indeed, the Third Restatement categorizes all the usual product liability claims as involving “defects at time of sale.”  Restatement (Third) of Torts, Products Liability, Chapter 1.  That’s how fundamental the defect at sale element of product liability is.  The only other claims that the Restatement recognizes (in Chapter 2) are those based on:  (1)  misrepresentation (which is not defect-based), (2) post-sale duty to warn (which, involving matters occurring after sale, would not help a plaintiff on any Bartlett/Mensing/Levine preemption issue), and (3) duty to recall (which the Restatement rejects in the absence of prior government action).  There’s no such thing as a pre-sale design defect claim under state law.

Our secondary response is:  What is a “duty to design [a product] differently before FDA approval,” anyway?  First of all, it’s a direct attack on FDA approval.  The FDA approved this product.  The Agency found the design submitted to it safe and effective.  What is the basis of the state law duty?  Cassel is a product liability case, so the “duty” involved has to pertain to the safety of the defendant’s design.  Thus, the purported state law “duty” is a claim that, because the design wasn’t safe enough under Wisconsin common-law standards, the defendant should not have submitted it to the FDA, even though the FDA determined that it fully satisfied federal standards for “safety and effectiveness.” That’s no more, and no less, than a state-law attack on the FDA’s approval – and is therefore an independently preempted claim.  A state simply cannot interfere that deeply in the interactions between a regulated party and the regulating agency.  That’s one of the things Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), was about.  States have no authority over what an FDA-regulated manufacturer submits (or does not submit) to the FDA.

Moreover, the theory of liability in Cassel, “that defendants had a duty to employ an alternative design . . . before FDA approval,” 2013 WL 4648449, at *5, is just the unsuccessful Bartlett stop-selling argument all over again using different words.  The Supreme stated in Bartlett that “our pre-emption cases presume that a manufacturer’s ability to stop selling does not turn impossibility into possibility.”  Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466, 2477 n.3 (2013).

We reject this “stop-selling” rationale as incompatible with our pre-emption jurisprudence . . . .  [A]n actor seeking to satisfy both his federal- and state-law obligations is not required to cease acting altogether in order to avoid liability. Indeed, if the option of ceasing to act defeated a claim of impossibility, impossibility pre-emption would be all but meaningless. . . .  In every instance in which the Court has found impossibility pre-emption, the direct conflict between federal- and state-law duties could easily have been avoided if the regulated actor had simply ceased acting.

Id. at 2477 (citations omitted).

What, then, at this point – or at the time of sale, when product liability traditionally judges defectiveness − can/could the defendants do to avoid state-law liability under the novel theory of liability articulated in Cassel?  The only thing they can do is to stop selling their FDA-approved product.  They can’t take a time machine back to before FDA approval and somehow change what the FDA approved, so their only recourse to avoid liability is the very same stop selling alternative that the Supreme Court held was preempted in Bartlett.

So it looks like the court was bamboozled in Cassel.  First, the theory that the plaintiffs purported to pursue doesn’t exist under any state’s law, since states have never sat in judgment on federal approvals, but rather on defects at the time of sale. Second, even if such a theory could exist under state law, it’s preempted because it’s nothing more than old wine in a new bottle − the already-rejected demand that the defendant stop selling an FDA-approved product stated in a different way.

And what of the final complaint in Cassel?  The end of the opinion states:

Since defendants would find preemption wherever a manufacturer needs to ask for FDA approval before marketing, and since all new drugs require FDA approval before marketing, no drug manufacturer could ever be liable for a defectively designed product under defendants’ interpretation of the doctrine.

2013 WL 4648449, at *5.  That’s 100% correct.  That is precisely what the Supreme Court held in Levine, when it decided to use congressional silence as an unprecedented statement of affirmative congressional purpose in order to eliminate the possibility of preemption under the more nuanced analysis of purposes and objectives preemption, and then disposed of impossiblity preemption under a bright-line rule that anything not requiring prior FDA approval can’t be impossible.

As shown by Mensing and Bartlett, what’s sauce for the goose is sauce for the gander.  The converse is also true.  An FDA pre-approval requirement renders simultaneous compliance with an immediate state tort duty impossible.  All design changes to FDA-regulated products that could alter such products’ safety and effectiveness require FDA pre-approval and are therefore preempted under the test that originated in Levine.  Indeed,Cassel doesn’t – and couldn’t − deny this.  If it had, the plaintiffs wouldn’t have been running away full-tilt from traditional state “defect at sale”-based product liability law.

There’s really no way around this FDA-pre-approval requirement. Something’s either impossible or it’s not, and the Supreme Court has said (three times) that pre-approval is, since the defendant loses its ability to take independent action.  Nuances are for “purposes and objectives” preemption, but Levine took that out of the mix.  As the novel “duty” asserted in Cassel demonstrates, any design-related claim that doesn’t involve a post-approval change is just some slightly more convoluted way of saying “stop selling” the FDA-approved product altogether.  Once a plaintiff takes the position that the design as submitted to the FDA was somehow “defective,” then the outcome is necessarily functionally indistinguishable from the “stop selling” theory disposed of in Bartlett.