Today we offer a peek at A. Twerski, “A Quarter Century after the Products Liability Restatement: Reflections,” 90 Brooklyn L. Rev. 1027 (Summer 2025). The “Restatement” under discussion is the Restatement (Third), Products Liability, and the “A. Twerski” is, of course, Aaron Twerski, the sole surviving reporter for that Restatement. Professor Twerski has written this retrospective law review article, and it is well worth our attention.
We dwell in a jurisdiction (Pennsylvania) where the Third Restatement has not quite gotten the traction that was expected by most and hoped for by some. But by Twerski’s account, the Third Restatement has had significant influence on the law. Twerski offers a nice distillation of what Restatements do:
“Restatements are a conglomeration of past, present, and future. Some issues have been well decided and are not controversial. A restatement may clarify them and shake out some cobwebs that have crept into the case law. For these noncontroversial rules, a restatement may set forth elements of a doctrine in a manner to make it easier for a court to apply. Other issues are the topic of some current controversy in the courts. An objective observer may well conclude that the law is moving in one direction and, for justifiable reasons, take sides on the issue. Still, other issues are the subject of great chaos and confusion in the courts. A restatement may help in crystallizing the issues and in suggesting a new rule.”
Indeed. Sometimes we defense hacks like the suggested new rules. Sometimes we do not.
The article is short and focuses on areas of controversy and areas that might “benefit from additional clarity.” Some interest us not at all, such as Section 16 on apportionment of damages in crashworthiness litigation. Some are interesting almost to the point of inspiring dread. For example, Section 3 permits plaintiffs to “draw a res ipsa-like inference of defect without proving a specific defect.” Some might crop up in situations where our clients could be on either side of the issue, such as Section 12 successor liability and Section 13 post-sale failure to warn. Section 5 brings some clarity with respect to imposing liability on component part sellers where they have substantially participated in the integration of the component into other design of the product.
The article addresses the significant controversy swirling around Section 2(B) Design Defect and the extent to which plaintiffs must show a reasonable alternative design (RAD). Most states require a RAD. (Pennsylvania does for negligence, but not for strict liability.) Even those allowing recovery based on disappointed consumer expectations have read that test narrowly. According to Twerski (and it does not get any more authoritative than that), “The Restatement’s position that one cannot warn oneself out of a design defect claim is now the rule in almost all jurisdictions. A manufacturer must maximize its product with a RAD, and only when risks cannot be ‘designed out’ of the product are warnings called for.”
For we Drug and Device Law drudges, Twerski’s discussion of §6, regarding drugs, is particularly interesting and relevant to what we do. That “we” refers both to honorable defense hacks and predatory plaintiff lawyers.
Here are a dozen key points regarding Section 6:
1. The learned intermediary rule (yes, Professor Twerski calls it a “rule,” as we do – it is not a “doctrine” or “defense”) is close to unanimous. We and the article cast a grim side-eye across the river at New Jersey. Twerski also notes that a “few jurisdictions will impose liability for not adequately warning the consumer directly when the Food and Drug Administration (FDA) requires that a warning be given in a pamphlet when the drug is dispensed.”
2. Comment k was a mess. At least eight different interpretations were propounded. The state of the law “was simply incomprehensible.” Thus, the Third Restatement did not try to restate it.
3. Allegations of reasonable alternative design are “unwise and irrational” in light of the extensive FDA approval process. Here, Twerski shows a keen understanding of the challenges and expense of drug development. “Scholars agree that basing a cause of action on a RAD is beyond the competence of courts.” (Think about what this means for the execrable Gilead duty-to-innovate theory.)
4. “For an expert to state that the alternative drug that he or she proposes would attain FDA approval is sheer sophistry. Drugs are simply different.”
5. An alternative safer drug already approved could be meritorious, but “few if any drugs will meet that standard,” since competing drugs treating the same condition have different risk/benefit profiles.
6. Pure risk/benefit balancing is beyond the competence of the courts and should be left to the FDA.
7. Design defect claims involving drugs are mostly attempts to salvage cases barred by the learned intermediary rule.
8. The Restatement exception for drugs too dangerous for “any class” of patients is narrow and should be. (Should this be an exception at all, given FDA approval?)
9. “Defective design is, for the most part, not a workable theory for drugs.”
10. A post-sale design defect based on a claim that a drug should have been redesigned is preempted.(But Twerski agrees with the dissent’s reading of New Hampshire law in the SCOTUS Bartlett case. Ugh.)
11. Pre-sale design defect claims are entirely speculative, given FDA approval requirements.
12. Levine was a failure to warn case, and it does not apply to design defect claims.
The Twerski article is short and clear. Even if you find yourself disagreeing with parts of it, you will have to consider the possibility that, given who the author is, you might be wrong. In any event, you will be better informed for having read the article.