With claims related to warnings, design, and recall all preempted, plaintiffs seeking to sue makers of generic drugs don’t have many options. After all, as we’ve discussed before, if state common law can’t require changing a defendant’s warnings, changing the design, or making the defendant stopping selling the product altogether, there’s not much left for a plaintiff to allege.
So, who ya gonna call?
One straw that generic drug plaintiffs have grasped at is the footnote in Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013), “not address[ing]” the issue of “parallel claims” – faciallydictum about something not raised in Bartlett:
We do not address state design-defect claims that parallel the federal misbranding statute. The misbranding statute requires a manufacturer to pull even an FDA-approved drug from the market when it is “dangerous to health” even if “used in the dosage or manner, or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof.” 21 U.S.C. § 352(j). The parties and the Government appear to agree that a drug is misbranded under federal law only when liability is based on new and scientifically significant information that was not before the FDA.
Because the jury was not asked to find whether new evidence concerning [the drug] that had not been made available to the FDA rendered [it] so dangerous as to be misbranded under the federal misbranding statute, the misbranding provision is not applicable here.
Id. at 2477 n.4 (other citations omitted).
Plaintiffs tried to slime the defendants with that footnote in one of our favorite cases, In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, 756 F.3d 917 (6th Cir. 2014), but they hadn’t pleaded anything of the sort, so the court held they couldn’t change their theories on appeal. Id. at 930 (regardless of anything else, “the house [of cards] collapses based on their deficient pleading”). Darvocet pointed out that the Supreme Court’s footnote musings didn’t mean either that such claims existed or that they escaped preemption:
Academics, commentators, and even the parties to this case are not clear on what precisely Footnote 4 means and what its impact might be. . . . InBartlett, the FDA argued in an amicus brief that . . . “pure” design defect claims . . . are preempted unless they “parallel the FDCA’s drug ‘misbranding’ prohibition”. . . . It is not clear whether this [Supreme Court footnote] implies that an exception for “parallel misbranding” claims actually exists.
Id. at 929 (citations omitted).
We’re pleased to report that, although generic plaintiffs recently took another shot at Bartlett footnote 4 in a different MDL, they once again drew back a nub. The decision is In re Yasmin & Yaz (Drospirenone) Marketing, Sales Practices & Products Liability Litigation, 2015 WL 7272766 (S.D. Ill. Nov. 18, 2015), and while it likewise avoided a definitive pronouncement on whether a footnote four claim actually existed in the first place, it significantly narrowed the scope of any such hypothetical phantasm.
Here’s how Yasmin/Yaz busted the “parallel claim” ghost. First, it recognized the questionable provenance of any implied preemption exception at all for “parallel claims.” That’s express preemption terminology and “the background of Footnote 4 raises a legitimate question as to whether Bartlett indicates an exception for ‘parallel misbranding’ claims actually exists.” 2015 WL 7272766, at *4. The court did not need to answer that question, however, because it agreed with the defendant’s “position as to ‘pure’ design defect claims.” Id. That position was that plaintiffs were not – and could not – assert such a “pure” version of design defect.
The problem was that Illinois design defect claims did not come in one if the pre-chosen forms. No “pure” design defect claim was available under Illinois law because that state follows Restatement (Second) of Torts §402A, comment k (1965):
Illinois has adopted comment k of the Restatement (Second) of Torts § 402A, whereby a drug is not defectively designed if it is “unavoidably unsafe and is properly prepared and there are adequate warnings.” Accordingly, the viability of plaintiff's design defect claim necessarily turns on the adequacy of the subject drug's labeling. The Supreme Court has held that a claim of this nature is preempted.
Yasmin/Yaz, 2015 WL 7272766, at *4. Comment k’s “unavoidably unsafe” defense is inextricably interlinked with the the adequacy of a manufacturer’s warnings because even where a risk is unavoidable and can’t be designed out of a product, liability may still attach, regardless of design, if the warnings about that risk are inadequate. Even if called a “design” claim, in practice under comment k the allegations depend on warnings. Therefore, “[b]ecause the plaintiff's design defect claim necessarily turns on the adequacy of [the] product labeling, the claim is preempted.” Id.
That’s a big deal because almost every state follows comment k in some way (the Erie-ignoring Mesh MDL notwithstanding). Some states apply comment k on a case-by-case basis, others across the board, but they all recognize the concept of “unavoidably unsafe” products with risks that can only be warned about. We discussed this at length back in 2011, and our 50-state survey concluded that only Alaska, Wisconsin, and maybe Nevada outright reject comment k. A few other places (Delaware, Puerto Rico, Vermont, Virginia, and the Virgin Islands), haven’t ruled one way or another about comment k – in the case of Delaware and Virginia because they never adopted §402A strict liability in the first place.
Every other state follows comment k in one way or another (and we’re not sure what’s going to happen in Wisconsin post-tort reform). Thus, under the Yasmin/Yaz rationale, even the ghostly cause of action hinted at in Bartlett’s footnote four can’t even haunt preemption in the vast, vast majority of generic drug cases.
That’s the big news about Yasmin/Yaz. There’s some little news, too. For the sake of completeness, we’ll also go through that. Negligent misrepresentation, fraud, express warranty, and consumer fraud were “all premised on alleged misrepresentations or inaccuracies in [the drug’s] labeling.” Id. at *5. Cue the electric shocks, they’re preempted. Id. Plaintiffs didn’t have a scrap of evidence of any manufacturing defect, so the court refused plaintiff’s request for a fishing expedition. Id. at *6.
Barring supernatural activity, this decision should sound the death knell for generic drug-related claims in the Yasmin/Yaz. Preemption came, saw, and you know…. prevailed.