Result: The court rejected PLAC's position on both issues addressed in PLAC's amicus brief.
The court affirmed the trial court's admission of evidence of eighty-five recalls involving Hyundai vehicles and components not related to the 2013 Elantra's driver's seat. PLAC argued that unrelated recalls do not rebut the presumption of non-defectiveness under Wis. Stat. § 895.047(3)(b). The court disagreed. Using a broad definition of relevance, the court held that when Hyundai relied on § 895.047(3)(b) and the 2013 Elantra's compliance with FMVSS to create a rebuttable presumption of non-defectiveness, Hyundai transformed compliance with FMVSS into a fact of consequence in the case. This, in turn, opened the door for plaintiffs to introduce unrelated Hyundai recalls to show that vehicles that comply with FMVSS could nonetheless have safety-related defects.
As to the admission of evidence of the later 2017 Elantra's seat design, the court found there was no abuse of discretion in admitting the evidence under the feasible alternative design exception to Wisconsin's prohibition of subsequent remedial measure evidence. PLAC argued that allowing evidence of a seat design that was still in development (later implemented in 2017 models) when the plaintiffs' Elantra was manufactured in 2013 rendered superfluous the statute's express language. The court held, however, that the 2017 model could have been practically adopted before Plaintiffs' vehicle was made in 2013 because of the 2017 model's similarity to other designs used by Hyundai before 2013.
As to the 2017 seat design, the court also rejected the argument that plaintiffs' introduction of the 2017 model seat design was an improper use of the impeachment exception to Wis. Stat. § 904.07. PLAC argued that the plaintiffs used evidence of the 2017 model as a backdoor to prove negligence under the guise of impeachment. The court, however, held that the evidence was relevant to impeached Hyundai's claim that the 2013 model was state-of-the-art, as well as the suggestion by one of the experts that the design could not have been improved upon. The court also concluded that even had there been an abuse of discretion in admitting the evidence, it would have been harmless.
Although much of the opinion was somewhat fact specific, the decision reflected the court's willingness to interpret the statutes concerning presumptions and admission of subsequent design changes in a way that fails to give protections to manufacturers that the plain language of the statutes would otherwise indicate as being appropriate.

Significance: This opinion is undoubtedly significant. This opinion might chill manufacturers' practical ability to offer evidence of compliance with governmental standards because of the risk that it will be seen as opening the door to an unlimited number of unrelated recalls. This risk is amplified by the fact that numerous jurisdictions have statutes that are textually similar to Wis. Stat. § 895.047(3)(b), expanding the scope of the consequences of this opinion beyond Wisconsin.
The court's decision to allow later-implemented design changes––either under the guise of impeachment or feasibility of alternative design––also may have broad effects. If those future designs are admissible merely because the manufacturer asserts, for example, a state-of-the-art defense, the rules against admission of subsequent remedial measure evidence (which is common to most jurisdictions) will become a nullity.
PLAC is supporting Hyundai's petition for review to the Wisconsin Supreme Court.

Background:
Volkswagen recalled plaintiff’s car, a 2011 Jetta, for a defect in the fuel line capable of spraying diesel fuel on the engine. One month after the recall and an associated stop sale order, the dealer sold the used Jetta to plaintiff without performing the recall repair. The fuel line failed on a long drive from Utah to Washington and had to be replaced. Plaintiff observed smoke and smelled fumes and experienced non-specific symptoms during the trip, and she was diagnosed with probable carbon monoxide (CO) poisoning. She alleged she was exposed to a toxic level of CO and that the exposure caused permanent brain damage. The jury had found the dealer liable for negligence and strict liability.
Following the jury verdict, the trial court granted the dealer’s motions for JNOV and a conditional new trial, finding plaintiff’s causation evidence insufficient and that it had improperly admitted expert testimony from two experts, mechanical engineer Peter Leiss (testimony that the leak could have caused the production of carbon monoxide, resulting in exposure) and physician Dr. Lindell Weaver (that plaintiff developed brain damage secondary to carbon monoxide poisoning during the trip). Leiss based his production opinion largely on a “fish tank test” conducted by a colleague using an aquarium and a hot plate, but devoid of any dynamic air flow and therefore not extrapolatable to conditions in a moving car. Weaver opined based on history, exam, and a differential etiology opinion, but he was not informed about a potential alternative cause – Smith had lived in her car for a period of time and was exposed to CO running the heater in the stationary car for long periods.
Issue: Plaintiff appealed the grant of the post-trial motions; the dealer cross-appealed the trial court’s rejection of additional arguments in support of the motions. PLAC briefed the following issues:

1. Whether Leiss’s production opinion was reliable and admissible.
2. Whether an expert opinion on specific causation in a toxic exposure case requires some expert evidence that the plaintiff was exposed to a dose capable of causing her injuries in order to be admissible and sufficient for a causation finding.
3. Whether an expert opinion on specific causation based on a temporal association between the exposure and plaintiff’s development of symptoms, and the fact of plaintiff’s injury, is admissible and sufficient to support a causation finding.
4. Whether a physician’s specific causation opinion based on a “differential diagnosis” methodology is “presumptively admissible” and whether Dr. Weaver’s analysis was reliable.
1. Leiss’s CO production opinion based on the fish tank test and his qualifications as a mechanical engineer should have been excluded and could not support a causation opinion or finding.
2. Evidence of the dose-response relationship, i.e., the dose of exposure needed to cause the injuries and the dose to which plaintiff was exposed, is ordinarily necessary to support a specific causation opinion in a toxic tort case. A prior opinion, Alder v. Bayer Corp., 61 P.3d 1068 (Utah 2002), had denied summary judgment despite the lack of dose evidence, but the exposure there was indisputably chronic, substantial, and toxic. PLAC argued that Alder was the exception rather than the rule, and more subtle and fleeting exposures like the one at issue necessitated some dose-response evidence
3. The temporal relationship between the exposure and the development of non-specific symptoms and the fact of the injury was insufficient to support a causation opinion or finding, and evidence that plaintiff sustained the injury after exposure is insufficient to infer that she was exposed to a harmful dose.
4. A specific causation opinion derived by the differential etiology methodology is not “presumptively reliable,” particularly in the absence of predicate dose-response evidence.
5. Weaver’s causation opinion lacked an adequate foundation in dose-response, improperly relied on temporal relationship, and his differential etiology analysis lacked scientific reliability because it failed to address prominent alternative cause (CO exposure from sleeping in the vehicle with the heater and plaintiff’s concurrent upper respiratory infection). It was therefore inadmissible and incapable of tying Smith’s CO poisoning and brain damage to the trip (and therefore the defect).

Result:

1. The Court held that plaintiff had presented legally sufficient evidence to prove causation. The Court rejected the notion that plaintiff had to prove each of the predicate facts to a causation conclusion (e.g., that CO as actually produced under the hood, and that Smith was exposed to an amount capable of causing the harm) by a preponderance of the evidence; rather, she only needed to prove the element of causation by a preponderance of the evidence. It was enough that Smith produced enough evidence of the material facts supporting causation to create a triable issue. And she did, based on the combination of the expert evidence and circumstantial evidence, including the temporal relationship, the development of symptoms, and observations of the leak itself.
2. The Court rejected the argument that plaintiff needed to produce evidence of the level of CO to which she was exposed in the Jetta passenger compartment during the trip. The Court characterized Alder as holding that “plaintiffs provide sufficient evidence of causation even where they do not have an expert who can quantify their level of toxic exposure, as long as the evidence that was presented provided a reliable basis from which the jury could reasonably infer that the alleged toxin was present and that it harmed the plaintiff.“ And invoking the concept of the “eggshell plaintiff,” the Court circularly observed that the harmful level of exposure is whatever exposure is needed to harm the plaintiff. The Court concluded that the evidence – including some evidence of the possible amount of plaintiff’s exposure, the association between CO and plaintiff’s symptoms, and plaintiff’s symptoms of CO poisoning themselves – was sufficient to permit the jury to find that plaintiff was exposed to a harmful dose of CO.
3. The Court did not reach the merits of the trial court’s conditional grant of a new trial, premised on inadmissibility of the expert opinions of Leiss and Weaver. There was a mismatch between the admissibility objections raised by the dealer and the trial court’s bases for ruling that the opinions should have been excluded. Consequently, a combination of the dealer’s failure to properly object and the trial court’s failure to give plaintiff an adequate opportunity to respond to its retroactive admissibility concerns precluded a new trial and obviated the need to address the merits of the trial court’s exclusion of the expert’s opinions.
4. The Court rejected the dealer’s cross-appeal. The Court agreed that temporal proximity is an insufficient basis to infer causation and that a differential etiology analysis is only admissible if grounded in sufficient facts or data. But it found that Weaver relied on more than temporal proximity, including a differential diagnosis analysis that was adequately supported by the evidence.

The Court’s Response to PLAC’s Arguments: The Court made several references to PLAC’s arguments.

1. In note 9 it acknowledged PLAC’s brief and generally described its position.
2. In note 14, after collecting various strands of evidence that supported a finding that CO was produced in the engine compartment, the Court rejected (and quoted) “PLAC’s argument that ‘Leiss’s opinion … was an essential predicate in the chain of causation’ – without which the district court ‘was right to find a failure of proof.’”
3. In note 16, again quoting a snippet of PLAC’s argument, the Court rejected the argument “that Alder is ‘the exception, not the rule,’ and that the exception carved out in that case should not apply here. The Court stated that Alder’s overarching principles applied here and the totality of the evidence supported a non-speculative finding of causation notwithstanding the lack of a “precise quantification” of the dose of exposure. [We disclaimed any argument that a precise quantification was necessary.]
4. In note 22 the Court noted PLAC’s argument that temporal proximity is an insufficient basis for finding causation, but replied that Dr. Weaver had additional support for his causation opinion. The Court also acknowledged PLAC’s position that use of differential diagnosis methodology does not per se make a causation opinion, and that the methodology must be grounded in sufficient facts and data. But it concluded the trial court had not abused discretion in finding Weaver’s analysis sufficiently founded.

Significance: There is substantial disagreement in the nation’s courts about the extent a dose-response foundation is necessary to support an admissible opinion and prove medical causation in a toxic tort case. The consensus view is that scientific evidence of the toxic threshold (the dose of exposure needed to produce the injury at issue) coupled with some reasonable evidence that the dose of exposure experienced by the plaintiff exceeded the threshold is required to support a causation finding, and that a causation opinion lacking this type of predicate is unreliable and inadmissible. The Alder case was an outlier based on a record of extreme [albeit unquantified] chronic exposure to known toxins. Our primary goal was to distinguish Alder and limit the case to its extreme facts. Our secondary goal was to get the Court to acknowledge the limits of temporality, and reject circular reasoning, as bases for causation opinions. We were largely unsuccessful in both pursuits, though we were hindered somewhat by the dealer’s and the trial court’s missteps that resulted in the Court avoiding addressing the merits of certain admissibility issues.

The brief addressed two issues on a certified question from the Second Circuit Court of Appeals: (1) Whether a cause of action exists under the negligence or failure-to-warn provisions of the Connecticut Product Liability Act (“CPLA”), or elsewhere in Connecticut law, based on a manufacturer’s alleged failure to report adverse events to a regulator like the FDA or to comply with a regulator’s post-approval requirements: and (2) whether the exclusivity provision of the CPLA bars a claim under the Connecticut Unfair Trade Practices Act (“CUTPA”) based on allegations that a manufacturer deceptively and aggressively marketed and promoted a product despite knowing that it presented a substantial risk of injury.
Background: The plaintiff alleged she was injured by defective artificial lenses manufactured and marketed by the defendants. The plaintiff brought negligence and failure-to-warn claims based on the defendant’s alleged failure to report adverse events to the FDA and to comply with FDA’s post-approval requirements. The plaintiff also sought leave to add a CUTPA claim based on the alleged deceptive and aggressive marketing of the artificial lenses. The U.S. District Court for the District of Connecticut dismissed the negligence and failure-to-warn claims based on federal preemption and denied leave to amend as futile because the CPLA bars CUTPA claims based on injuries caused by allegedly defective products.
On appeal, the U.S. Court of Appeals for the Second Circuit certified two questions to the Connecticut Supreme Court based on the absence of controlling authority. First, does Connecticut law recognize a tort claim based on the alleged failure to report information to a regulator? The Second Circuit certified this question because it is potentially dispositive of the preemption issue. Specifically, if the plaintiff’s claim does not exist under traditional state tort law principles, it would be preempted by the federal Food, Drug and Cosmetic Act (“FDCA”) because the claim would be based on federal law, not state law. Second, does the CPLA bar the plaintiff’s deceptive and aggressive marketing claim under CUTPA? Generally, the CPLA is the exclusive remedy under Connecticut law for product liability claims, subject to limited exceptions.
Result: On June 7, 2022, the Connecticut Supreme Court issued its decision holding, that the alleged failure to report adverse events to the FDA or to comply with the FDA’s post-approval requirements stated a cognizable claim under the CPLA. Typically, a manufacturer’s duty to warn under Connecticut law runs to the end-user of a product or, in the case of prescription drugs and medical devices, prescribing physicians. The Connecticut Supreme Court, however, concluded that the duty to warn embodied in the CPLA could run to other parties, including a regulator like the FDA, who stand in the best position to recommend precautions to the ultimate user. The Connecticut Supreme Court explained that this result was consistent with the broad, remedial purposes of the CPLA and general tort principles regarding the duty of care. PLAC had argued, among other things, that the Connecticut Supreme Court should not recognize a duty to warn the FDA because the FDA is not required either to publish or share those reports with the end user of the medical device. The Connecticut Supreme Court concluded that it was sufficient that the FDA might act on adverse event reports or communicate this information to the public. In addition, the Connecticut Supreme Court noted that this type of argument could still be made to the jury as part of disputing the foreseeability of plaintiff’s injuries and causation.
The Connecticut Supreme Court also held that the CPLA bars a deceptive and aggressive marketing claim under CUTPA for personal injuries caused by an allegedly defective product. Generally, the CPLA is the exclusive remedy for product liability claims under Connecticut law. The Connecticut Supreme Court previously recognized exceptions that permit a plaintiff to bring an unfair trade practices claims based on the sale of a product. These exceptions apply when the plaintiff does not seek a remedy for personal injury, death, or property damage, or where the plaintiff’s injury was caused by deceptive and aggressive marketing as opposed to a defective product. Because the plaintiff in this case sought damages for personal injury caused by an allegedly defective medical device, the CPLA’s exclusivity provision barred the claim. In a concurring opinion, one of the Justices expressed his doubt that the CPLA’s exclusivity provision bars any CUTPA claims but was compelled to agree with the majority because the plaintiff had not asked the Connecticut Supreme Court to reconsider its prior decisions.
Significance: The recognition of a duty-to-warn claim based on the alleged failure to report information to the FDA could expand the scope of state law claims in prescription drug and medical device cases that survive federal preemption by the FDCA. While the Connecticut Supreme Court did not decide the preemption issue, the Second Circuit seemed prepared to let the plaintiff’s claim proceed so long as it was cognizable under Connecticut law. This decision might also lead to new types of failure-to-warn claims in other product liability cases, with plaintiffs arguing that a manufacturer’s alleged failure to submit information to a regulator or comply with a regulatory requirement caused their injuries. On the other hand, the Connecticut Supreme Court’s construction of the CPLA’s exclusivity provision affirms, for now, that a plaintiff cannot allege an aggressive and deceptive marketing claim based on injuries caused by an allegedly defective product.

In the case, a plaintiff alleging an automobile design defect against GM sought to depose GM’s CEO, Mary Barra, based on general statements she made about the safety culture at GM and new safety programs. Ms. Barra attested she had no unique personal knowledge of the issues being litigated and sought a protective order pursuant to Georgia’s discovery code. The trial court and then the Court of Appeals denied the motion, ruling Ms. Barra could be deposed.
The Georgia Supreme Court granted review to decide whether Georgia rules support a version of the “apex doctrine,” which limits the circumstances in which a party may depose a high-level corporate executive. Although the Court stopped short of formally adopting the doctrine, it said the trial court must address the elements associated with the apex doctrine and, here, the trial court failed to do so. These elements include whether the executive’s high rank, lack of unique personal knowledge of relevant facts, and the availability of information from other sources demonstrate good cause for a protective order. The Georgia Supreme Court then remanded the case for reconsideration.
At bottom, this ruling is useful in that it requires trial courts to meaningfully assess the apex doctrine factors. Unlike in some other apex doctrine states, though, the factors are not dispositive. It will likely take time for jurisprudence to develop over how restrictive these factors will be in practice.

PLAC argued plaintiffs’ complaint described experiences indistinguishable from those of millions of owners of every complex consumer product sold in modern times: they had a problem with their products (laptop computers) after the express warranty expired and they had to pay for the necessary repairs (or replacements). Plaintiffs failed to distinguish the defect alleged in this case from the countless other defects that inevitably occur in all complex products and that are routinely repaired at the manufacturer’s expense (if they occur in the express warranty period) or at the consumer’s expense (if they occur after the warranty period). Binding decisions of Ninth Circuit and the California Court of Appeal squarely hold that there is no duty to disclose such defects unless they create an unreasonable safety risk. Williams v. Yamaha Motor Co., 851 F.3d 1015, 1025 (9th Cir. 2017); Wilson v. Hewlett-Packard Co., 668 F.3d 1136, 1142 (9th Cir. 2012); Daugherty v. Am. Honda Motor Co. 144 Cal. App. 4th 824 (2006), review denied, 2007 Cal. LEXIS 1472 (Feb. 7, 2007).

On May 19, 2022, the Ninth Circuit issued an unpublished decision agreeing with Apple and PLAC that its prior decisions were binding and that a duty to disclose an alleged defect arises only if it creates an unreasonable risk to safety. .