Nearly a decade ago we published the blogpost “Pre-Approval Design Defects – No Such Thing.” As we discussed, “pre-approval” design (later joined by warning) claims were a transparent preemption dodge. No such claims had ever been advanced before the Supreme Court’s holdings in the generic drug preemption cases (Mensing/Bartlett) that actions requiring FDA prior approval – which includes all design changes affecting safety – were necessarily preempted because the defendants could not unilaterally make those changes purportedly required by state law. Our prior post wasn’t really about preemption, but rather the incompatibility of “pre-approval” defect claims with accepted state law:
The reason that [the case we discussed] was “unable to conceive of” a state law pre-approval duty is because such duties do not exist. Design defects under Restatement (Second) of Torts §402A (1965) . . . [are] limited to products that are defective at sale. “The rule stated in this Section applies only where the product is, at the time it leaves the seller’s hands, in a condition . . . which will be unreasonably dangerous” to the ultimate consumer. Restatement (Second) of Torts §402A, comment g (1965). In the Third Restatement, this time in the black letter, . . . all “categories of product defect” are likewise determined “at the time of sale or distribution.” Restatement (Third) of Torts, Products Liability §2 (1998).
That “pre-approval” defect claims are contrary to state law (and therefore aren’t available ab initio as a preemption dodge) was strongly reinforced by the California Supreme Court’s recent decision in Gilead Tenofovir Cases, ___ P.3d ___, 2026 WL 2223748 (Cal. 2026) (which we discussed generally, here). Since Brown v. Superior Court, 751 P.2d 470 (1988), California has not allowed strict liability design claims against prescription medical products, so plaintiffs had to pitch the “duty to innovate” claims that the Gilead court rejected as “negligence.”
Plaintiffs in Gilead had every opportunity to pursue standard defect allegations in that litigation, but they declined to do so. Instead, they pursued their novel theory that, regardless of any defect, they the defendants were negligent when they elected to delay pursuing FDA approval of an allegedly “safer” version of their breakthrough anti-HIV drug, in favor of successfully obtaining FDA approval of a related drug – the drug the undoubtedly saved most of these ingrate plaintiffs from slow and inevitable death from AIDS. But for our purposes, Gilead also illustrates why the law unanimously restricts defect allegations, and any other kind of tort claim, to conditions existing at the time of product manufacture and sale, as opposed to speculative pre-FDA-approval allegations.
Gilead recognized that, in California as elsewhere, product-based negligence “claims still require proof that the manufacturer’s negligence resulted in a defective product.” Id. at *5 (citations omitted). Divorcing negligence from product defect (what the Gilead plaintiffs advocated) “would create substantial tension with that [product liability] body of law.” Id. at *6. That’s because “products liability law employs specific tests to determine whether a product is defective.” Id. Such specificity is particularly necessary when the plaintiff’s allegations attack prescription medical product development:
Unlike product defect claims, which are evaluated based on contemporaneous and relatively complete scientific evidence available at the time of the product’s distribution, evaluating the reasonableness of drug-development decisions would require retrospective assessment of inherently provisional judgments made based on evolving scientific data.
Id. (citation omitted) (emphasis added). Such development is a “multistep, highly regulated process.” Id. at *7. FDA approval matters. It prevents speculative and conjectural claims.
The plaintiffs’ claims in Gilead were based “on a flawed premise; namely, that a drug can be sufficiently developed, and its safety and efficacy sufficiently known, before completion of phase III clinical trials and FDA approval.” Id. Similarly, “pre-approval” defect claims assert that same false premise – that “defects” can be determined prior to a product’s FDA approval.
That premise is inconsistent with the statutory and regulatory framework governing drug [and medical device] development. It also underscores the difficulty of imposing negligence liability based on preliminary and evolving safety assessments of an alternative [design] still under development, rather than on a defect in the [product] currently being sold.
Id.
“[D]efinitive judgments regarding” yet-to-be approved products’ “risks and benefits ordinarily cannot be made before completion of phase III trials and FDA approval.” Id. at *8. For that same reason, state law provides no basis for alleging “pre-approval” defects. Instead, the common-law limits product liability defect claims to those in existence at the time that the product at issue was sold. Gilead recognized that “[p]roducts liability law has long tied a manufacturer’s duty of care to defects in the product placed into the stream of commerce.” Id.
In particular, Gilead held that sufficient knowledge of the risks and benefits of FDA-regulated products for those risks to be “foreseeable” does not exist “before completing phase III clinical trials and obtaining FDA approval.” Id. at *9. “[T]he difficulty of making comparative judgments, the structure of the [FDA]-approval process, and the governing statutory and regulatory framework demonstrate that such knowledge ordinarily cannot be established at earlier stages of development.” Id. “[O]nly about one-third of drugs evaluated in phase II clinical trials yield results promising enough to proceed to phase III testing,” and “fewer than one out of eight will obtain FDA approval.” Id. at *10, 11. (citations omitted). Thus, as a matter of law, Gilead held that “a manufacturer cannot truly know of a drug’s safety and efficacy before phase III testing and FDA approval,” making such risks unforeseeable. Id. at *10.
Any such injury [to a plaintiff] would depend on speculation regarding the independent conduct and discretionary decisions of multiple third party actors, as well as the uncertain outcomes of additional clinical trials and scientific research required to develop, approve, and market the new drug.
Id. at *11. No outside “assessment of a drug’s safety and efficacy” can “make FDA approval certain.” Id. (citation omitted). Pre-approval risk/benefit assessment is, as a practical matter, impossible:
[B]ecause of this high failure rate, . . . drug manufacturers must make complex strategic decisions about where to devote finite resources based on limited information. These decisions are often provisional, iterative, and contingent on preliminary laboratory or clinical studies that may later prove incorrect. As a result, they do not readily lend themselves to retrospective evaluations of reasonableness armed with the benefit of hindsight.
Id. at *16.
For these reasons, prescription medical product liability claims are not evaluated prior to FDA approval. Rather, like all product defect claims, defect are only measured “at the time of manufacture and distribution.”
Product defect claims are judged based on contemporaneous and relatively complete scientific evidence available at the time of manufacture and distribution. . . . [A] retrospective inquiry creates a substantial risk that hindsight will supplant the manufacturer’s contemporaneous judgment, even when its decisions were reasonable when made.
Id. at *17 (emphasis added). For this reason, the “novel theory” in Gilead that would have required a jury’s evaluation of a defendant’s pre-approval conduct and information was rejected:
That inquiry asks fact finders to reconstruct years of research and development decisions made in the face of evolving scientific evidence and uncertain outcomes, rather than to evaluate the safety of a product that actually reached the market. Neither the plaintiffs nor the dissent have identified a single case wherein a fact finder has been tasked with making such determinations.
Id. (emphasis added). Gilead emphasized that product liability is limited to those prescription products “that are already on the market,” not “decisions made long before a drug is approved or marketed.” Id. at *20 (emphasis original), 21.
Although the plaintiffs stayed away from the term “defect,” Gilead involved a “pre-approval” design defect claim. To avoid preemption, such claims propose to shift the defect inquiry from the time that a drug or device was actually manufactured and sold, to some indeterminate time before FDA approval, when some alternative, purportedly safer, unapproved design was theoretically possible without FDA review. Evaluating purported design defects prior to any FDA approval is a bad idea for all of the reasons Gilead discussed – which is why no state’s common law that we know of allegations of “defects” to any other time than traditional requirement of defect at sale.
And, as Gilead noted, plaintiffs in that high-stakes litigation were unable to cite “a single case” supporting a “defect” existing prior to FDA approval.
“Pre-approval” defect claims are figments of plaintiffs’ perfervid imagination, lacking any basis in existing tort law. They are alleged solely for the purpose of avoiding preemption. The doctrine of constitutional avoidance counsels against reaching constitutional arguments when non-constitutional issues are dispositive. Defense counsel should respond to such made-up claims by establishing that they have no legal support in the relevant jurisdiction.
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