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Here’s a pop quiz. You’re a nurse. You’ve just used an insulin pen on Patient A. Do you: (a) use the same pen on Patient B or (b) grab Patient B’s own pen? If you picked (a), please put down the syringe, because you have apparently never heard of a little thing called the germ theory of disease, which has been settled science since roughly the era of gas lamps and top hats. And yet, in Griffin Health Services Corp. v. Novo Nordisk Inc., 2026 WL 2140889 (D. Conn. Jul. 24, 2026), the court ruled that a jury needs to debate whether this risk was actually obvious to a hospital and its nursing staff. Spoiler: there was nothing left to debate. The CDC saw it. The FDA saw it. The Institute for Safe Medication Practices saw it. At least one of the hospital’s nurses literally asked the question out loud and got the right answer. Everybody saw it. The only place where this obvious risk somehow became a genuine jury question is in this opinion.

First, the facts. The manufacturer designed and sold prefilled insulin pen products used at the plaintiff hospital’s facility. The hospital’s own competency checklist, that nurses had to master before using the pens, included an instruction to return the pen to the patient’s individual medication drawer — which, if followed, would have prevented sharing altogether. Id. at *1. The manufacturer’s representatives ran five training sessions for the hospital’s nurses, but those sessions were voluntary, not mandatory, and did not reach all nurses. Id. The hospital’s own CEO testified that “strict” adherence to medication administration policy is “not possible” — a stunning admission for an institution now trying to blame someone else for its nurses sharing needles. Id. at *4. And it gets better (worse). When a nurse specifically asked a manufacturer trainer whether the pen could be used on more than one patient — she was told no, they cannot be shared due to the risk of cross-contamination. Id. at *2. So a nurse asked the question. Got the right answer. And some nurses at this hospital shared pens anyway. The hospital’s response to this fact pattern was to sue the pen maker.

Let’s talk about what the plaintiff hospital’s theory actually requires you to believe. It requires you to believe that the manufacturer had a duty to tell trained medical professionals that you should not stick a needle-adjacent device into one patient and then jab it into another. This isn’t esoteric medical knowledge. It’s Infection Control 101. Reusing anything that has touched a patient’s bloodstream on another patient is a bad idea for the same reason double-dipping your chip is rude — except with double-dipping, nobody ends up exposed to hepatitis.

The Centers for Disease Control and Prevention have been sounding this alarm for years in blunt, unambiguous language: “Never use insulin pens for more than one person,” because “blood may be present in the pen after use,” even when the needle is changed between patients. Ctrs. for Disease Control & Prevention, Considerations for Blood Glucose Monitoring and Insulin Administration. The Institute for Safe Medication Practices flagged the exact same cross-contamination risk from insulin pens back in March 2008 — and the court’s own recitation of the record notes that a 1998 study in the journal Diabetes Care had already identified the risk of biological material becoming trapped in insulin pen delivery systems, and the FDA and CDC both issued their own alerts on the subject in 2009 and 2012, respectively. Griffin, 2026 WL 2140889, at *2. In other words, this was published and republished information in the same professional literature that hospitals are supposed to be monitoring as part of, you know, being a hospital.

Despite the obviousness of the risk, the Griffin decision denied summary judgment on nearly everything. On design defect, the court found the insulin pen, like any prescription medical device, is “inherently unsafe,” meaning the manufacturer’s duty is to properly warn of dangers, and held that “a reasonable jury could find that [the hospital] was unaware of any risk, and that [the manufacturer] failed to warn or train users on the dangers of contamination.” Id. at *5-6. Read that again. A hospital. Unaware. Of the risk of cross-infection from reused injection equipment. After the CDC, the FDA, and the Institute for Safe Medication Practices all told anyone paying attention exactly what would happen.

On failure to warn, the court applied Connecticut’s learned intermediary doctrine — sort of. It first found that a genuine dispute existed over whether the manufacturer provided any warnings at all, then hedged by adding that even if the doctrine did apply, plaintiff’s claims were based on failure to warn the hospital itself, in the person of its doctors and nurses, who function as the learned intermediaries. That’s curious given that the evidence was that the manufacturer’s representatives affirmatively told trainees not to share the pens, explained the cross-contamination risk from backflow, and handed out package inserts containing the same warnings. Id. at *6. The court brushed this aside finding there was conflicting record evidence on the point. But that doesn’t change the fact that the underlying legal theory — that manufacturers must anticipate and spell out an infection-control risk this fundamental — should never have survived on the “obviousness” ground alone.

That’s what really bothers us about the design defect and failure-to-warn rulings — the court never squarely grapples with the obvious-risk line of learned intermediary cases that should have controlled this outcome. That line of authority doesn’t just say a warning can be less detailed when a risk is well known — it says there is no duty to warn of a risk at all once it is within the knowledge of, or obvious to, the average learned intermediary. This brings us to the second, equally basic principle the court seems to have simply skipped past. Prescription medical product manufacturers do not have a duty to instruct healthcare professionals on how to practice medicine. We’ve discussed both issues many times, and the caselaw on them is not close. Courts applying the learned intermediary doctrine have rejected, over and over, the argument that a warning must explain to trained professionals things they already know from their training.  Sharing an injection device between patients is precisely the kind of “obvious risk” that this line of cases says a manufacturer has no duty to spell out, because it is “within the knowledge of or obvious to the average learned intermediary.” Stahl v. Novartis Pharmaceuticals Corp., 283 F.3d 254, 266-68 (5th Cir. 2002) (see more authority here).

This is not a situation where the manufacturer is asking a court to assume some obscure clinical inference on the physician’s part. The specific, exact risk — cross-contamination and bloodborne pathogen transmission from reusing an injection device on more than one patient — had already been described in the peer-reviewed literature, flagged by multiple healthcare authorities, all before and during the years these pens were in use at the hospital. That is about as close to “universally known in the medical profession” as it gets. If the risk is universally known, the absence of a more explicit warning cannot be the legal cause of the resulting harm — a causation problem the Griffin court does not meaningfully address before sending the design defect and failure-to-warn claims to a jury.

Instead of confronting that body of law head-on, the court treated the “obviousness” of the risk as just another disputed fact for the jury, rather than as the threshold legal question — whether the risk was, as a matter of law, already within the knowledge of the average learned intermediary. A court that takes the obvious-risk doctrine seriously does not need a jury to tell it whether a nurse should already know not to reuse a blood-contaminated injection device on a second patient. That is precisely the kind of case this doctrine exists to take away from the jury, and it is the doctrinal gap that, in our view, is the real defect in this decision — not any close call on the summary judgment record, but the court’s failure to ask the right legal question in the first place.

Then there’s the “wrongful conduct” doctrine — what we usually call in pari delicto — which the manufacturer tried to invoke on the theory that the hospital was profiting from its own violation of drug-sharing statutes. No dice, said the court, because the doctrine only bars recovery for a plaintiff’s knowing participation in a criminal act, and none of the statutes the manufacturer cited actually covered insulin, since insulin is not a controlled substance. Griffin, at *4-5. Fair enough as a matter of statutory construction. But it’s still remarkable that a hospital’s institution-wide failure to enforce its own infection-control basics, gets no legal consequence at all, while the manufacturer that affirmatively told people not to share the pens gets dragged to trial.

If you thought it couldn’t get more galling, the court also let punitive damages go to the jury, reasoning that the manufacturer knew of similar issues at other hospitals. But punitive damages are supposed to punish conduct meaningfully worse than ordinary negligence, and it’s hard to square that with the facts here. Comparative fault isn’t a defense to strict liability, but a jury weighing “reckless disregard” ought to be allowed to reckon honestly with which party actually controlled whether its nurses shared needles day to day. That party wasn’t the manufacturer.

For dessert, the hospital lost roughly 150 completed nurse interview forms from its own internal investigation into the pen-sharing incidents — documents that presumably would have shed considerable light on how widespread and how known the risk was among its own staff. The court declined to draw an adverse inference because there was no evidence the documents were destroyed or altered rather than simply misplaced. Id. at *11-12.  Losing 150 witness statements documenting your own staff’s compliance failures, and then asking the manufacturer to eat the evidentiary consequences of your own paperwork problem is a lot to ask a reasonable jury to swallow.

We opened with a pop quiz, so let’s close with the answer key. Anyone who picks “reuse the pen” flunks basic infection control, whether they’re a first-year nursing student or a hospital defending a summary judgment motion. The germ theory of disease is not proprietary information belonging to medical device manufacturers; it is the shared inheritance of every trained healthcare provider since Pasteur. And a manufacturer that told trainees, in person, not to share its product, does not have an additional obligation to hold the hospital’s hand and make sure the hospital enforces its own policies. There really was nothing to see here, except apparently to the court, which decided a jury still needs to argue about it. Griffin kicks to a jury a question that shouldn’t have needed one— whether a hospital’s failure to train, monitor, and supervise its own nurses on a century-old, thoroughly-alerted infection risk can be laid at a manufacturer’s feet. We would love to see a “reasonable” jury actually buy that. We’re not holding our breath.

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Long ago, it seemed that large-scale drug or device litigation was usually spurred on by a recall, market withdrawal, or major labeling change describing a new risk or limiting the scope of product use.  The plaintiff lawyers these days seem to be more willing to put their energy into attacking currently marketed products without triggering events along these lines.  However, back when the rules on implied preemption for claims about prescription drugs were less settled—generally before the implications of Bartlett and Mensing for branded drugs had been recognized—some courts struggled with how a subsequent voluntary withdrawal from the market affected preemption and, more generally, product liability.  We detailed some of this in a long post about the Yates decision from the Sixth Circuit on the preemption of design defect claims as to a branded prescription drug.  Regardless of any recall, the temporal focus for whether failure to warn and design defect claims are preempted is not at some point in time after plaintiff stopped using the prescription drug.  Yet, there has been a tendency for some courts to get squeamish about the idea that a manufacturer can be “immune to” or “insulated from” liability if the drug is off the market by the time the motions are being decided.

Cosey v. Global Blood Therapeutics, Inc., No. 1:25-CV-09400, 2026 WL 2150348 (N.D. Ill. July 27, 2026), is a case where the court did the right thing on preemption despite a short time between plaintiff’s alleged injury from the drug and the decision by the manufacturer to withdraw it from the market.  The drug at issue in Cosey was, at the time of the use, one of the few approved medications (including gene therapy) available to treat sickle cell disease, a serious and potentially fatal genetic disorder.  One of the known significant complications of the disease is a vaso-occlusive crisis (“VOCs”) where blood flow is blocked by the accumulation of deformed hemoglobin molecules.  Plaintiff’s minor was first prescribed defendant’s medication for her sickle cell disease in January 2022, not very long after the medication was approved and had its indication expanded to cover use by younger children.  Id. at *1-2.  After more than two years of apparently safe and effective use, plaintiff’s minor allegedly suffered a VOC.  Within four months, on September 25, 2024, the manufacturer voluntarily withdrew the drug based on a possible increased risk of VOCs.  The Cosey decision identifies the basis of this decision as “the totality of the clinical data that indicated the overall benefit of [the drug] did not outweigh the risk in the approved sickle cell patient population [and the] data suggested occurrence of VOCs and fatal events that required further assessment.”  Id. at *1.  FDA’s website from which the court’s language appears to have been drawn adds that an increased risk of VOCs had been reported in postmarketing clinical trials.  Despite her VOC, plaintiff’s minor apparently kept taking the medication until the market withdrawal.  Relying in part on the tight timing, plaintiff sued the manufacturer and another entity and asserted the predictable product liability claims.  Predictably, the defendants moved to dismiss based on implied preemption and TwIqbal.

On the design defect claim, plaintiff argued that the manufacturer could have come up with a hypothetical safer drug and tried to get it approved instead of the drug it actually developed and got approved.  Citing only Bartlett, Cosey found this claim impliedly preempted.  Whether pre-approval or post-approval, “altering its composition” would not have resulted in a marketable drug without FDA approving the new drug.  So, there was no unilateral action that the defendants could take to sell a non-defective drug.  Id. at *3.  As far as we can tell, plaintiff did not argue explicitly that the recall negated preemption of the design defect claim, but the design defect allegations were not much more than the manufacturer’s statements in connection with the withdrawal.  Either way, this claim was dismissed with prejudice.

On failure to warn, which the court addressed along with express and implied warranty, Cosey took a deeper dive, citing the CBE regulations, Albrecht, Dolin, and some other decisions explaining that plaintiff has to do more than just say “CBE” to avoid implied preemption (as Levine misunderstood).  The complaint did not identify “‘newly acquired information’ that would have permitted unilateral modification to [the drug’s] label under the CBE regulation.”  Id. at *5.  The court was not fooled by plaintiff’s citation of the evidence the manufacturer said was new a few months after plaintiff’s alleged injury when it decided to withdraw the drug.  Nor were general allegations that there must have been something earlier sufficient. 

Plaintiff’s conclusory allegations that Defendants possessed “newly acquired information” about risks of [the drug], without identifying what that “newly acquired information” was or how it demonstrated a risk of a different type or greater severity than what the FDA already considered, does not suffice to undermine preemption. Since Plaintiff failed to identify any newly acquired information that shows Defendants were aware of an increased VOC risk, with sufficient time to initiate a label change before they withdrew the product, Plaintiff’s failure-to-warn claims fail.

Id. (emphasis added).  We pause on the italicized language to flag an issue that matters more in individual cases than in litigation-wide preemption motions.  Even where a CBE actually can be used to make a label change unilaterally, albeit temporarily, it still takes time.  We have seen cases where the allegedly newly acquired information that a plaintiff says should have led to a new warning was acquired a day or two before the last pre-injury prescription of the medication.  Under Cosey’s reasoning, the plaintiff would have to show the labeling change could have been effectuated in time for the prescribing physician to see it while it still could have affected the outcome alleged in the case. 

Plaintiff also included the sort of generalized negligence claim that is common in product liability cases, but typically does not implicate recognized duties to do more than design, manufacture, and warn about the product.  It appears that plaintiff did not actually contend there was some manufacturing issue specific to the pills that his minor took.  Instead, this was just a rehash of design and warnings claims the court already addressed.  Citing the Seventh Circuit’s Wagner decision we discussed here and here, the court found these repackaged claims preempted for the same reasons.

“For purposes of completeness,” Cosey also addressed what it called defendants’ argument that the warnings claims “are also preempted based on the learned intermediary doctrine.”  Id.  This, of course, is not a thing.  In Illinois, as in almost all states, the learned intermediary doctrine defines the duty to warn for the manufacturer of a prescription medical product.  The court’s conclusion that “Plaintiff cannot argue that, if properly warned, her physician would have altered her prescription, where her allegations make no mention of her physician at all” describes a failure to plead the elements of a state law claim consistent with TwIqbal.  Id. at *6.  In that context, it makes a bit more sense to give plaintiff another chance to plead a cognizable, non-preempted warnings claim.  Even if plaintiff uses the extra time the court gave him to amend to mention the prescribing physician by name, we doubt he can come up with factual allegations of newly acquired evidence from the right time period to avoid preemption of his warnings claims.

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Franco v. Chobani, LLC, 2026 WL 2150193 (7th Cir. July 27, 2026), is a food case, not a drug or device case, but it is vital reading for anyone who litigates over products regulated by the Food and Drug Administration (FDA).  In litigation involving regulated products, the fact of such regulation is usually a component of the defense. We defense hacks invoke regulatory compliance as both bona fides and bodyguards. We (and our clients) rely on what regulations say, and what regulators say about those regulations. 

Sometimes such reliance is misplaced.

Preemption is the apotheosis of a regulatory defense.  The recent SCOTUS opinion in the Roundup litigation (Durnell) explained the fundamental policy bases of regulatory preemption: consistency and uniformity. Companies making products that improve and extend our lives simply cannot carry on their business if they must conform to different, perhaps contradictory, rules set within different jurisdictions, and maybe even set by different juries within the same jurisdiction.  Moreover, whereas rule by regulation is driven by data, science, and experts, rule by litigation is driven by trial lawyer storytelling, cynicism, and faux morality tales of corporations elevating “dollars over lives.” Regulation balances risks and benefits; jury trials are crazy-quilt lotteries. Regulation imposes order; litigation exploits chaos. 

But what if the regulation succumbs to chaos? Franco is a festival of disillusionment.  This adverse decision by the Seventh Circuit in a food preemption case is more proof, if any was needed, that with the FDA under the control of a plaintiffs’ lawyer, the FDA is about as reliable as the Phillies bullpen.  The plaintiffs brought consumer deception claims on behalf of themselves and a putative class against Chobani over its “Zero Sugar” yogurt.  The plaintiffs alleged that they purchased the product advertised as “sugar free,” though it contained four grams per serving of allulose, a monosaccharide sweetener. The plaintiffs sought relief under various state consumer protection statutes. The district court dismissed the complaint under Rule 12(b)(6), deferring to FDA enforcement guidance and holding that the claims were preempted.

The plaintiffs appealed the ruling to the Seventh Circuit. The central issue was whether allulose is a “sugar” under 21 C.F.R. § 101.9(c)(6)(ii), which defines “total sugars” as “the sum of all free mono- and disaccharides (such as glucose, fructose, lactose, and sucrose).” Allulose is a “novel” sugar that differs from the not-so-novel sugars in terms of how it is metabolized and how it affects dental caries. Somewhere along the way, the FDA realized that its regulatory definition of “total sugar” (issued more than 30 years ago) had become outdated, given advances in materials science.  The FDA had in 2016 anticipated “future rulemaking” (that never occurred) to remove allulose from the definition of “total sugar” because it did not have the adverse physiological effects associated with ordinary sugars.  Rather than commence that rulemaking, in response to a citizen’s petition, in 2020 the FDA issued an allulose “guidance” that it would exercise “enforcement discretion” against prosecuting omission of this specific sugar from the declared quantities of total sugars.  That guidance was relied upon by the manufacturer in drafting the Nutrition Facts panel. It was also relied upon by the district court when it granted the motion to dismiss the Franco case.

During appellate oral argument, “both parties agreed that seeking the FDA’s perspective in this case would be helpful.” Given the regulatory history, especially the allulose guidance, one could see why the defendant would expect some help from the FDA in this case. But then the FDA filed an amicus brief and took the position that section 101.9(c)(6)(ii) was unambiguous and that total sugars as defined in that regulation included all monosaccharides, such as allulose. Talk about a reversal of fortunes! The district court had read section 101.9 to be ambiguous, and then deferred under Auer to the FDA’s Allulose 2020 guidance. (Chevron deference to an agency’s interpretation of statutes might be dead, but Auer deference to an agency’s definition of its regulations is not dead – yet.) But the FDA’s reversal of position led to the Seventh Circuit’s reversal of the district court. Relying on the regulation’s text and finding the FDA’s position in its amicus brief persuasive under Skidmore, the Seventh Circuit court concluded the sugar definition unambiguously includes all monosaccharides, and thus allulose is a sugar. Because foods labeled “sugar free” must contain less than 0.5 grams of sugars as defined by § 101.9(c)(6)(ii), the plaintiffs’ state-law claims, which mirror federal requirements, were not preempted. The court rejected the district court’s Auer deference to the FDA’s 2020 allulose guidance, characterizing it as enforcement discretion rather than a binding interpretation.

That last point is particularly disturbing. So much for settled expectations. The FDA took the position that its 2020 allulose guidance did not have the force of law, and therefore could not be considered preemptive.  The Seventh Circuit agreed.  Under the preemption requirements imposed by the Supreme Court in Albrecht, that may well be legally correct, but the independent preemptive effect of FDA enforcement discretion is nowhere mentioned.  For our purposes, the broader take away is that the RFK, Jr FDA can no longer be trusted to stand up for its actions when those actions would have supplied the bona fides and bodyguards referred to above.  According to the Seventh Circuit, the FDA allulose guidance was not a regulatory interpretation but merely “an announcement of the agency’s enforcement position.” The guidance was of no weight because it was not an agency “official position.” 

What about the defendant’s reliance interest?  The Seventh Circuit essentially said, tough. FDA regulated manufacturers are “sophisticated actors” that understand how mere FDA enforcement decisions “would not immunize the company” from product liability litigation.  To quote from another rotten ending, “Forget it Jake, it’s Chinatown.” Thus, regulated parties can no longer be content with ad hoc, FDA half-measures to resolve disputes, and should press for actual, legally binding regulatory changes.  Non-binding “guidance” is not enough, when the FDA can cut and run when called upon to give its views in litigation.  The less we say about the current FDA’s muddle-headedness’ and malevolent motives, the better.

Beyond that, the Seventh Circuit was content to allow a parenthetical – the “(such as glucose, fructose, lactose, and sucrose)” — in the original regulation to become a “redundancy” in light of the FDA’s position.  For the second week in a row, we consider a case involving the interpretation canon of noscitur a sociis. The notion of that canon is that a word is known by the company it keeps. Allulose is different in important ways from the sugars specified in the regulation. But the Seventh Circuit thought the defendant was making the “such as” do too much work.   

Our disappointment and indignation cannot surpass what was eloquently expressed in a recent article by Cory Andrews at the Washington Legal Foundation, “Guidance for Thee, But Not for Me: The FDA’s Bait-and-Switch in Franco v. Chobani.” (Link here.) Here is the conclusion of that article: “Franco tells every regulated business in the Seventh Circuit that FDA guidance is not a shield but a trap, and that the only safe course is to demand formal rulemaking the agency rarely and begrudgingly delivers. That is bad administrative law and bad policy.” At least one can always rely on WLF to get things right. Consistency and logic go a long way.

Addressing the defendant’s alternative Rule 12(b)(6) argument, the Seventh Circuit held that the complaint plausibly alleged consumer deception. The labels allegedly promised “sugar free” despite four grams per serving of allulose, and the court found it plausible that reasonable consumers could be misled by the absolute “sugar free” claim. Forget about whether allulose would not implicate any of the physiological effects that make consumers fret about the other sugars. The court held that “how reasonable consumers perceive Chobani’s labels and make decisions about its products are questions of fact that cannot be answered now.” Hello, discovery.

The only good thing about the decision is that the defendant gets to try again on different preemption grounds, based on the effect of FDA labeling approval after Durnell.   

The result in Franco is certainly bitter, not sweet. We remember when one could rely on the Seventh Circuit. (Okay, forget about Bausch for the moment. Let us momentarily wallow in our University of Chicago nostalgia over Posner, Easterbrook, and Wood.) We also remember when one could rely on the FDA.

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The California Supreme Court handed down its long-awaited decision in Gilead Tenofovir Cases yesterday, and as we hoped, the Court held that a drug manufacturer owes no duty of care when deciding whether and when to develop an allegedly safer alternative drug to replace an admittedly non-defective product.  The decision is a significant win for the pharmaceutical industry, and it puts an end to the novel “duty to innovate” theory of negligence liability that had been percolating in the lower courts.

And, yes, we can all agree now that prescription medications are not the same as chicken enchiladas, but put a pin in that.  We will come back to it later. 

We have been covering this litigation in California (here, here, here, and here) and elsewhere (e.g., here) for many years, and to provide the briefest of recaps, the plaintiffs in these cases allege injuries from taking TDF-based HIV antiretroviral medications.  They concede, however, that their TDF meds are not defective.  They allege instead that the manufacturer unreasonably delayed developing an alternative that plaintiffs allege was safer—TAF-based medications.  According to these plaintiffs, the manufacturer owed a duty to bring a different, allegedly safer medicine to market soon than it actually did.

The Court of Appeal bought it and created a newly minted tort—negligence based on a duty to innovate—in an opinion that we roundly criticized and named the worst drug and medical device opinion of 2024.  And deservedly so.  No court had ever recognized a tort duty to develop an alternative medicine faster, and imposing that duty would both impair innovation and punish a company for selling a non-defective product that saved thousands of lives.

The Supreme Court has now reversed, and its majority opinion acknowledges fully that the Court of Appeal’s new duty departed from existing California law in multiple ways and that the new duty was entirely unworkable.  Gilead Tenofovir Cases, No. S283862, 2026 WL 2223748 (Cal. Aug. 3, 2026) (slip op.) (to be published).

The Supreme Court first cast substantial doubt on whether a plaintiff can ever prevail in a product liability lawsuit (negligence or strict liability) without proving a product defect.  Generally speaking, the answer should be “no.”  The plaintiffs here argued that everyone is subject to a duty to avoid unreasonably causing harm to others.  But the Supreme Court explained that in the product liability context, the scope of any duty is limited to selling non-defective products:

In the products liability context, our decisions have generally defined a manufacturer’s duty under [California law] as the duty to design, manufacture, and market products that are free from defects.  Recognizing a broader duty under which liability may arise even absent a defect in the injury-producing product would create substantial tension with that body of law.

Id. at p.14-15.  That tension is because product liability law provides specific tests to determine whether a product is defective, and those standards both define potential liability and provide meaningful constraints.  The plaintiffs’ theory runs against this settled law: 

Plaintiffs’ theory risks circumventing these settled principles.  If manufacturers owed a broader duty to act reasonably to avoid all product-related injuries, plaintiffs could seek recovery for harms caused by concededly nondefective products merely by alleging the manufacturer acted unreasonably.  Questions currently governed by established defect tests would instead be left to a fact finder’s generalized assessment of reasonableness.

This problem is especially acute in the context of prescription drug development. 

Id. at p.15.  Echoing the defendant and multiple amici, the Supreme Court explained that an unconstrained negligence standard would invite juries to second-guess complex research and development decisions made decades ago under conditions of scientific uncertainty and incomplete information.  The contrast with established product liability principles was sharp.  “[P]roduct defect claims . . . are evaluated based on contemporaneous and relatively complete scientific evidence available at the time of the product’s distribution.”  The claims these plaintiffs asserted, by contrast, “would require retrospective assessment of inherently provisional judgments based on evolving scientific data.”  Id. at p.16.  In other words, products must be defective at the time of sale, not at some uncertain earlier time when their risks and benefits are still being researched.

The Court of Appeal’s attempt to deal with these factors resulted in an ineffective and unworkable standard.  The Court of Appeal pegged its new duty to whether an alternate product had already been “invented or developed,” but those terms were “ambiguous and, for that reason, are unlikely to act as meaningful constraints in practice.”  Id.  The Supreme Court was particularly critical of the Court of Appeal’s requirement that the manufacturer “know” the alternate medicine to be safer and equally as effective because

that conclusion rests 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.  . . . It also underscores the difficulty of imposing negligence liability based on preliminary and evolving safety assessments of an alternative drug still under development, rather than on a defect in the drug currently being sold.

Id. at p.17.  The Court of Appeal’s “knowledge requirement” was essentially unattainable.  Moreover, in a passage that was particularly satisfying for us, the Supreme Court faulted the Court of Appeal for comparing life-saving medications to a chicken enchilada with a stray chicken bone.  (See title of our post on the Court of Appeal’s opinion.)  As the Supreme Court held, “That context is far removed from prescription-drug development.”  Id. at p.20.  We agree. 

Here is the quote you will want to come back to:

For these reasons, we have substantial doubt that California law recognizes a general negligence duty requiring drug manufacturers to act reasonably in making drug development and commercialization decisions apart from their established duty to design, manufacture, and market products free from defects.  Products liability law has long tied a manufacturer’s duty of care to defects in the product placed into the stream of commerce, and plaintiffs identify no clear limiting principle for imposing liability absent proof of a product defect.

Id. at p. 20.  Expressing “substantial doubt” may not be a definitive holding, but this is the California Supreme Court.  Lower courts and federal courts making Erie predictions should pay heed.

In the end, the Supreme Court held that regardless of whether manufacturers could owe some duty beyond selling non-defective products, California tort law did not support creating the Court of Appeal’s duty to innovate in any event.  That the product was an FDA-approved prescription medicine was key.  Applying the factors enumerated in Rowland v. Christian, 69 Cal.2d 108 (1968), the Supreme Court held that the defendant owed no duty to develop and commercialize the alternate products—TAF-based medications—earlier than it actually did. 

In Rowland, the Supreme Court identified considerations governing duties of care—grouped into foreseeability factors and public policy factors.  The foreseeability factors weighed heavily against the plaintiffs’ proposed duty.  Almost any harm can be described as “foreseeable” in hindsight.  The question is whether the harm was reasonably foreseeable to the manufacturer at the time it was developing the alternate product.  As the Court already explained, the nature of drug development and the regulatory process make it difficult to establish what a manufacturer “knew,” let alone what it foresaw or should have foreseen:

Because a manufacturer cannot truly know of a drug’s safety and efficacy before phase III testing and FDA approval, it cannot reasonably foresee early in the development process that any delay in commercializing an alternative drug will harm users of an existing one.

Gilead, slip op. at p.26.  The Supreme Court also found that any connection between the alleged delay and the alleged injuries was “highly attenuated.”  Any such injury would depend on speculation regarding multiple independent third parties, including healthcare providers and regulators.  The connection would also depend on medical causation and uncertain outcomes of additional clinical trials.

The public policy factors likewise weighed against creating the new duty.  Here, we will emphasize two points.  First, while the Court of Appeal was quick to find the defendant “morally blameworthy” for allegedly delaying development of TAF-based drugs in order to increase profits, the Supreme Court took a more balanced view.  In deciding whether to continue developing an alternative medicine, a pharma manufacturer might consider profits, but that may be only one of several factors.  Plus, equating profit motive to moral blameworthiness would apply to “virtually every negligence action brought against a business,” which is not California law.  Id. at p.35. 

Second, the Court of Appeal’s duty to innovate would not prevent future harm, and might even contribute to harm by discouraging innovation.  As the Supreme Court explained:

Perhaps more importantly, such a duty risks creating perverse incentives that may undermine, rather than advance the goal of preventing future harm.  Decisions regarding whether to continue developing a promising drug, how quickly to advance it through clinical trials, and how to allocate finite research and development resources are inherently complex.  . . . [A] duty to develop and commercialize, without undue delay, a potentially safer alternative to a nondefective drug could distort those decisions . . . .

Id. at p.37-38.  A manufacturer could conclude, for example, that investing in development of alternative drugs is necessary to reduce litigation risk, while research into entirely new therapies carries no comparable incentive.  Early clinical studies could be curtailed for fear that study results could create a new class of tort plaintiffs.  The Supreme Court previously held in Brown v. Superior Court that tort law should encourage research into potentially beneficial medications, not discourage it.  The plaintiffs argued that these concerns are overblown and that juries can figure out whether these kinds of development decisions are reasonable or not.  But “[n]either the plaintiffs nor the dissent have identified a single case wherein a fact finder has been tasked with making such determinations.”  Id. at p.40-41. 

Much of the debate leading up to oral argument was around whether the Court of Appeal’s new duty would adversely impact innovation.  The Supreme Court recognized that risk, and not necessarily only in the pharmaceutical industry.  As the Court held,

For the reasons explained above, the duty threatens to skew innovation priorities in a manner that does not advance—and may ultimately undermine—public health and safety.  [¶]  Moreover, plaintiffs provide no legal basis for confining their theory of liability to the pharmaceutical industry.

Id. at p.44.  The Supreme Court reversed the Court of Appeal and remanded for entry of summary judgment for the defendant on all causes of action.

The Supreme Court’s opinion effectively shuts the door on the “duty to innovate” theory in California, and that is the correct outcome.  There was a dissenting opinion, from the one justice who clearly signaled alignment with plaintiffs during oral argument.  That justice broadly accused the Court of providing “sweeping immunity” for pharmaceutical manufacturers, but nothing could be further from the truth.  As we have said all along, the Court of Appeal’s new duty was completely gratuitous.  Patients taking TDF-based medicines have tort remedies against the product manufacturer—provided they can prove the elements of a product liability claim under California law, including the presence of a product defect. 

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We recently became aware of a legal podcast comment about the incompatibility of medical monitoring claims and the availability of equitable relief (at least in federal court) under Grupo Mexicano de Desarrollo S.A. v. Alliance Bond Fund, Inc., 527 U.S. 308 (1999).

Whodawhat?

That was our initial reaction.  But we took a look anyway, and it looks like there is something to it.  Grupo Mexicano has nothing whatever to do with prescription medical product liability litigation, or even product liability generally.  It was a creditors rights case.  For our purposes, the key holding concerns the inherent limitations of “equitable” relief in federal court.  The creditor plaintiff could not obtain equitable relief − an injunction against alienation of assets prior to any merits adjudication − because of the historical limitation on the federal courts’ equitable powers.  Those powers are limited to what existed in English courts of equity in 1789:

The Judiciary Act of 1789 conferred on the federal courts jurisdiction over “all suits . . . in equity.”  We have long held that the jurisdiction thus conferred is an authority to administer in equity suits the principles of the system of judicial remedies which had been devised and was being administered by the English Court of Chancery at the time of the separation of the two countries.  Substantially, then, the equity jurisdiction of the federal courts is the jurisdiction in equity exercised . . . in England at the time of the adoption of the Constitution and the enactment of the original Judiciary Act.  The substantive prerequisites for obtaining an equitable remedy as well as the general availability of injunctive relief are not altered by [the federal rules of civil procedure] and depend on traditional principles of equity jurisdiction.

Grupo Mexicano, 527 U.S. at 318-19 (citations and quotation marks omitted) (emphasis added).  “Long been the law“ is right. Under the Judiciary Act, “courts which are created by written law, and whose jurisdiction is defined by written law, cannot transcend that jurisdiction.”  Ex parte Bollman, 8 U.S. (4 Cranch) 75, 93 (1807) (construing that Act).

Obviously, for Grupo Mexicano to be relevant at all to medical monitoring litigation, such recoveries – by otherwise completely uninjured persons – would have to be considered “equitable” relief subject to the original 1789 grant of equitable powers to the federal courts.  So we looked at that.

It is immediately apparent that many, probably most, courts view “medical monitoring” awards to persons who have suffered no present injury as “equitable” in nature.  Indeed, Friends for All Children, Inc. v. Lockheed Aircraft Corp., 746 F.2d 816 (D.C. Cir. 1984), generally considered the first decision ever to recognize the recoverability of medical monitoring costs divorced from any present physical injury, solely invoked “equity” to justify its novel result.  Id. at 829-31 (e.g., “plaintiffs must show that they meet the traditional standards governing the award of equitable relief”).  Other decisions permitting non-injury medical monitoring claims do the same, particularly when recoveries are to be administered as court-supervised funds.  E.g., Exxon Mobil Corp. v. Albright, 71 A.3d 30, 80 (Md. 2013) (“many courts that award medical monitoring costs to do so by establishing equitably a court-supervised fund”); Hansen v. Mountain Fuel Supply Co., 858 P.2d 970, 982 (Utah 1993) (“Although trial courts have ample equitable powers to assure that this remedy is provided, we suggest consideration of a court-supervised fund”); Ayers v. Jackson Twp., 525 A.2d 287, 314 (N.J. 1987) (“a highly appropriate exercise of the Court’s equitable powers”); Petito v. A.H. Robins Co., 750 So.2d 103, 106 (Fla. App. 1999) (“the implementation of and supervision over a medical monitoring fund is well within a court’s equitable powers”); Burns v. Jaquays Min. Corp., 752 P.2d 28, 33 (Ariz. App. 1987) (following Ayers); Donovan v. Philip Morris USA, Inc., 2012 WL 957633, at *15-16 (D. Mass. March 21, 2012) (“the surest way for the Court . . . is to fashion relief through an injunction rather than a money damages award”).

We could go on, but the point is made.  Indeed, we often see plaintiffs urging that medical monitoring be treated as an equitable remedy when they seek class certification under Fed. R. Civ. P. 23(b)(2) – to avoid the predominance of common questions requirement – and some courts have been receptive.  See, Barnes v. American Tobacco Co., 161 F.3d 127, 142–43 (3d Cir. 1998) (court-ordered medical-monitoring programs could be characterized as final injunctive relief; denying (b)(2) certification on other grounds); Boughton v. Cotter Corp., 65 F.3d 823, 827 (10th Cir. 1995) (Rule 23(b)(2) certification for a medical-monitoring claim may be legally permissible; class lacked cohesion); In re Valsartan, Losartan, & Irbesartan Products Liability Litigation, 2023 WL 1818922, at *33-34 (D.N.J. Feb. 8, 2023) (actually certifying an equitable Rule 23(b)(2) medical monitoring class action).

At minimum, medical monitoring is a creature of equity in many jurisdictions.  In federal court – either on the basis of traditional diversity jurisdiction, or under CAFA – the recoverability of “medical monitoring” relief thus would seem to depend on whether English courts of equity back in 1789 allowed otherwise uninjured persons to recover for mere increased risk of future injury due to a defendant’s negligence.

We seriously doubt that any such 200+-year-old English precedent exists.  But we’re not going to do the other side’s research for them.  Instead, assuming that Grupo Mexicano would bar equitable relief, we will examine whether diversity jurisdiction provides an out.  Grupo Mexicano flagged, but did not address, that issue:

Although this is a diversity case, respondents’ complaint sought the injunction pursuant to Rule 65. . . .  Petitioners argue for the first time before this Court that . . . availability of this injunction under Rule 65 should be determined by the law of the forum State. . . .  Because this argument was neither raised nor considered below, we decline to consider it.

527 U.S. at 318 n.3 (Erie citation omitted).

We note that, for an Erie-based argument to have any traction, the equitable powers of the relevant non-federal jurisdiction would have to be considerably broader than those conferred on the federal courts by the Judiciary Act.  That may be the case, or it may not.  We note that Pennsylvania, a state that allows no-injury medical monitoring, has a statute similar to the 1789 federal Judiciary Act – only reaching even further back in time.  Pennsylvania has adopted the “common law and such of the statutes of England as were in force in the Province of Pennsylvania on May 14, 1776.”  1 Pa. Cons. Stat. §1503(a).  See Novatek Corp. v. Mallet, 324 F. Supp.3d 560, 568 (E.D. Pa. 2018) (§1503(a) precludes any Erie-based avoidance of Grupo Mexicano under Pennsylvania law).  Other states, particularly the original 13, may have similar statutes.

But even if a state court’s equitable powers are broader than a federal court’s under Grupo Mexicano, it is doubtful (albeit not conclusively determined) that plaintiffs could push an “equitable” medical monitoring claim past the Supreme Court’s Grupo Mexicano holding based on Erie principles.  “State law cannot define the remedies which a federal court must give simply because a federal court in diversity jurisdiction is available as an alternative tribunal to the State’s courts.”  Guaranty Trust Co. v. York, 326 U.S. 99, 106 (1945).  “Congress provided that the forms and modes of proceeding in suits of equity would conform to the settled uses of courts of equity.”  Id. at 104-05 (citation and quotation marks omitted).  Thus,

This does not mean that whatever equitable remedy is available in a State court must be available in a diversity suit in a federal court, or conversely, that a federal court may not afford an equitable remedy not available in a State court.  Equitable relief in a federal court is of course subject to restrictions:  the suit must be within the traditional scope of equity as historically evolved in the English Court of Chancery. . . .  That a State may authorize its courts to give equitable relief unhampered by any or all such restrictions cannot remove these fetters from the federal courts.

Id. at 105-06 (citations omitted).  That’s the Supreme Court speaking in a post-Erie decision.

Guaranty Trust means that, “since Erie, the Supreme Court has instructed that a federal court’s equitable authority remains cabined to the traditional powers exercised by English courts of equity, even for claims arising under state law.”  Sonner v. Premier Nutrition Corp., 971 F.3d 834, 840 (9th Cir. 2020) (citing Guaranty Trust).  The Supreme Court “has never held or suggested that state law can expand a federal court’s equitable powers, even if allowing such expansion would ensure a similar outcome between state and federal tribunals.”  Id. at 841-42.  Accord Rodgers-Rouzier v. American Queen Steamboat Operating Co., LLC, 104 F.4th 978, 987 (7th Cir. 2024) (“equitable remedies available in federal court for the violation of state substantive rights might continue to depend on federal law, even after Erie” and “are, in turn, based on” what was permitted in ‘the English Court of Chancery at the time of the separation of the two countries’”) (quoting Grupo Mexicano); Fidelity & Deposit Co. v. Edward E. Gillen Co., 926 F.3d 318, 326 (7th Cir. 2019) (“federal courts’ equitable powers are limited, not by state law, but to the traditional powers exercised by English courts of equity, even in diversity cases”); Davilla v. Enable Midstream Partners, 913 F.3d 959, 973 (10th Cir. 2019) (“the practice of borrowing state rules of decision does not apply with equal force to determining appropriate remedies, especially equitable remedies”).

There are lots more cases in the trial courts, but we believe that the above establishes that an argument that no-injury medical monitoring is simply not an available “equitable“ remedy in federal court under Grupo Mexicano regardless of what state law might allow (barring some weird ancient English precedent that we have no reason believe exists).  It would also bar even weirder “equitable” demands, like medical research funds or corrective advertising, that plaintiffs have occasionally demanded.

We caution that this argument seems never to have been tried before in the medical monitoring context.  We searched for any opinion in any court citing to either Grupo Mexicano or Guaranty Trust that also included the phrase “medical monitoring” and came up empty.  So the argument hasn’t been rejected, either.

So we say go for it − but pick your spots and make your arguments carefully and fully.  If you’re going to try it, don’t do it in a half-assed fashion, and save it for a judge who might be receptive.  Plaintiffs try new liability theories all the time; it behooves those of us on the defense side to be equally creative.

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Today’s post is from the Zimmer hip prothesis MDL, which appears to be winding down and which we’ve blogged about here. It’s a Rule 702 decision that excluded a treating surgeon who offered unsupported expert opinions about an alleged product defect. In re: Zimmer M/L Taper Hip Prosthesis Prods. Liab. Litig., 2026 WL 2111824 (S.D.N.Y. July 22, 2026).

Plaintiff claimed that his hip implant fractured six years after implant and caused injury. He offered the surgeon who performed his revision surgery as his expert witness. The surgeon offered opinions that (1) the modular neck component in the hip prothesis was defectively designed and manufactured, (2) the neck component was manufactured in a defective manner which caused it to “cold weld” into the stem, and (3) the component was defectively designed because it was not engineered to withstand “real-world biomechanical loads.” Id. at *2.  The defense moved to exclude the surgeon’s testimony under Rule 702.

The district court began its analysis under Rule 702 by citing the full text of the amended rule and included a footnote noting that the “2023 amendments clarified that the preponderance standard governs all admissibility criteria, thus reaffirming the importance of the court’s gatekeeping function.” Id. at * 2, n.1. We like that, but the court also cited to a pre-2023 amendment case for the proposition that the assumptions underlying an expert’s opinion go to weight rather than admissibility.  We don’t like that. As we’ve blogged about before, in amending Rule  702 in 2023 the Advisory Committee specifically stated:

[M]any courts have held that the critical questions of the sufficiency of an expert’s basis, and the application of the expert’s methodology, are questions of weight and not admissibility. These rulings are an incorrect application of Rule 702 and 104(a).

F.R.E. 702 advisory committee’s note to 2023 amendment. We will continue to call out pre-amendment citations that are contrary to the expressed intent of the 2023 amendments.   

Despite the reference that got us rankled, this expert didn’t stand a chance under any reasonable 702 analysis. The revision surgeon did not review, identify or cite any underlying data, literature or methodology in connection with his opinion that a defect caused the fracture. Nor did he cite or review any documents produced by the defendant related to the device. He also admitted that “he cannot speak to why the device fractured,” testifying in his deposition that “we will never know” why it fractured. Id. at *3. Although the court commended the surgeon for his candor in admitting that he did not know why the fracture occurred, that admission underscored the fact that his opinion was wholly unreliable and did not satisfy the requirements of Rule 702.

Plaintiff argued that the surgeon’s visualization of the device during the revision surgery constituted “direct surgical inspection” which should be considered the “gold standard” for why the fracture occurred. Id. Ha! Neither the expert nor plaintiff offered anything to suggest that the physician had any experience that would allow him to “reliably identify a defect by just looking at the device with his naked eye.” Id. Plaintiff also argued that the expert conducted a differential diagnosis. That went nowhere. The surgeon never referenced a differential diagnosis, and he made no effort to identify or rule out other potential causes of the fracture.  

The revisions surgeon’s opinions did not satisfy the requirements of Rule 702, and the court granted the defense motion to exclude his opinions. Since New York law requires expert testimony in “a complicated medical case,” the court also granted summary judgment in the defendant’s favor. Id. at *5.

Separately, the court held that summary judgment would be appropriate even absent the exclusion of plaintiff’s expert. Plaintiff’s only surviving claim was for negligence, and in recognition of the absence of sufficient evidence of a defect, plaintiff relied on a “malfunction theory.”  Id.  That theory requires that the incident causing the alleged injury be “[1] of a kind that ordinarily occurs as a result of product defects and, [2] that the incident was not . . . solely the result of causes other than the product defect existing at the time of sale or distribution.” Id. That theory didn’t work because the record clearly established that fracture is a known risk for artificial hip devices and that fractures can occur for reasons wholly unrelated to any product defect. The court held that constituted separate, independent grounds to grant summary judgment.

Overall, a very good result, and one we’ll gladly take as we head into the first weekend of August.

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News about the long‑running talc MDL has developed since, but the opinion we discuss today (In re Johnson & Johnson Talcum Powder Prods. Mktg., Sales Pracs., & Prods. Liab. Litig., 2026 U.S. Dist. LEXIS 162870, 2026 LX 335455, 2026 WL 2111340 (D.N.J. July 22, 2026)) is worth a look.  It is a prime example of an MDL court exercising its broad authority—nay, obligation—to confront proof problems head‑on.

As we posted a year ago, the term “case vetting order” is growing on us.  The term “Lone Pine Order” carries a lot of baggage, and it seems time to stop using the name of a 1986 New Jersey case to refer to a case management procedure for requiring plaintiffs to establish the factual bases for their claims. 

Whatever you call them, we have a cheat sheet of favorable orders of this type, and we post about them regularly. 

In the memorandum opinion in question, a magistrate judge granted the defendants’ motion for entry of an order to show cause (OSC) why all claims in the proceeding should not be dismissed with prejudice, covering all 69,000 plaintiffs in this MDL alleging that talc causes ovarian cancer.

The order does not itself dismiss any case, but it did declare the intent to force every plaintiff in this decade‑old plaintiff MDL to address a single, central question: Can she establish specific causation with admissible expert testimony under Rule 702?

Collapse of the Specific Causation Evidence in the Bellwether Cases

Earlier in this MDL, the court selected six bellwether cases for full fact and expert discovery and trial.  Those bellwether plaintiffs proffered two gynecologic oncologists, Drs. Judith Wolf and Daniel Clarke-Pearson, as specific causation experts.

At a hearing on Rule 702 motions to exclude these experts in May 2026, the wheels came off the bellwether case. 

During their testimony, Drs. Wolf and Clarke‑Pearson acknowledged there is no biomarker or reliable method to distinguish talc‑caused ovarian cancer from cancer caused by other risk factors or idiopathic causes, and that this was an “immutable limitation of scientific knowledge.” 

Drs. Wolf and Clarke‑Pearson also effectively conceded that “no qualified expert can reliably pinpoint the etiology” of a particular woman’s ovarian cancer, with Dr. Wolf admitting that she did not “know of any way” to rule in or rule out particular risk factors for a given claimant as a differential etiology would require. 

Indeed, with Drs. Wolf and Clarke‑Pearson frankly acknowledging that there was no basis for any expert to offer a specific causation opinion that talc caused a particular plaintiff’s cancer, these experts cast doubt on the legitimacy of every case in the entire MDL.

By June 8, 2026, the bellwether plaintiffs had withdrawn Drs. Wolf and Clarke‑Pearson as their specific causation experts, but that was not the end of it. 

Defendants filed a motion asking the Court to issue an OSC because the testimony showed that no MDL plaintiff could meet Rule 702 on specific causation, no matter what expert she proffered, and because all the MDL cases—bellwethers and non‑bellwethers alike—seemingly should be dismissed with prejudice for lack of admissible specific causation evidence.

The MDL Plaintiffs’ Steering Committee opposed the motion, no surprise there. It argued that, as to the ~68,994 remaining MDL plaintiffs, a global OSC/case vetting order would violate their due process rights to present individualized experts under their state’s applicable causation standard.  It argued that they intended to move to reinstate Drs. Wolf and Clarke‑Pearson as their specific-causation experts.  It argued the requested OSC would be a Lone Pine order that was “not an appropriate tool at this stage of the MDL”, and that case-by-case Rule 702 and Rule 56 motions for summary judgment were required.  In short, plaintiffs wanted endless expert witness do-overs.

The Court’s Authority to Vet Cases

The Court, however, agreed that an OSC was appropriate.  Its opinion began with the Third Circuit’s recognition that MDL courts have “broad discretion” and “significant latitude” to enter case betting orders to manage their dockets and reduce burdens on defendants and the court.  

Case‑management orders, including Lone Pine‑type orders and orders to show cause, are expressly aimed at separating meritorious from non‑meritorious claims and promoting just and efficient resolution, and therefore are supported by a surplus of authorities, including:

  • 28 U.S.C. § 1407(a) (MDL transfers must promote convenience and “just and efficient conduct”);
  • Rule 1 (mandating “just, speedy, and inexpensive” determinations); and
  • Rule 16(c)(2)(L) (authorizing “special procedures” in complex, multi‑party, or proof‑heavy cases).

The Court reviewed the factors often weighed in deciding whether a case vetting order is appropriate, from the nature and stage of the litigation, to case‑management concerns, to the availability of other procedures, and case complexity.

As for the “stage” of the MDL, if not now, when? After more than ten years and with more than 69,000 claimants, the talc MDL was anything but nascent; fact and expert discovery on the six bellwethers was fully completed; the record was expansive; and the specific‑causation problems of the Plaintiffs Steering Committee (PSC) only added to the procedural and substantive complexity. Indeed, recently enacted Fed. R. Civ. P. 16.1(a)(3)(B), which did not exist when this MDL was created, suggests that earlier MDL-wide case vetting would be appropriate in this context.

The PSC’s due process objection also met a swift and well-deserved end.  Due process requires notice “reasonably calculated” to apprise interested parties and an opportunity to present objections.  An order to show cause—indeed, any case vetting order—does exactly that.  The existence of other procedural mechanisms (Rule 702 motions, Rule 56 summary judgment, Rule 41 dismissals) is just one consideration, and those tools do not displace a court’s discretion to employ an order to show cause when common, complex issues need to be addressed efficiently and fairly.

At heart, the Court agreed an OSC was appropriate, because it agreed that there were “grave” and “concerning” doubts about whether any individual plaintiff could proffer specific‑causation testimony admissible under Rule 702 (and of course Rule 702 applies in federal court regardless of the applicable substantive state law).

Why An Order To Show Cause, And Why Now

The Court next turned to question of what case‑management mechanism was appropriate to the identified potential common causation problem.

On paper, the court acknowledged, individual Rule 702 and Rule 56 motions in each of the more than 69,000 cases would be theoretically possible, but in practice, that would be neither realistic nor fair.  About a decade had already passed with only six cases teed-up for trial.  The parties and the Court had invested countless hours and dollars litigating to that point, while hundreds of plaintiffs already had died and the years continued to pass. 

The Court was not prepared to leap from deficiencies in two specific-causation experts to the dismissal of the entire MDL, but instead chose a middle path: a global show‑cause process focused squarely on specific causation.

The Court thus granted the defendants’ motion for a show cause order, which the Court expressly characterized this as both equitable and efficient in treating all plaintiffs equally, giving each a chance to be heard, giving defendants a mechanism for challenging unsupported claims en masse, and giving the court a structured way to evaluate the viability of the litigation as a whole.  The Court reserved the specifics of the show-cause procedure for a separate, yet-to-come order.

Though the specifics of the show-cause procedure would be interesting to know, you don’t need more than this opinion to see why case vetting orders are so important. 

Lawsuits are easy to file, but the complaints on which they are built are little more than hypotheticals built on wishes and maybes.  MDL complaints are the most hypothetical and flimsy of all.  Whether the PSC in this talc MDL believed all the evidence eventually would line up close enough, or whether they were content to ignore known evidentiary gaps because 69,000 cases alone creates its own gravity, we will never know.  But the Court was right to decide to put these cases to the test. 

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Dressen v. AstraZeneca Pharmaceuticals LP, 2026 WL 2122898(10th Cir. July 23, 2026), extends to four weeks our streak of discussing favorable vaccine decisions – this time involving product liability.

In a well written, fully reasoned, reported decision, the Tenth Circuit reversed the worst Public Readiness and Emergency Preparedness (PREP) Act preemption decision to arise from the COVID pandemic.  We clobbered the trial court decision (the only one in the country to allow any liability theory against an actual vaccine manufacturer) here.  

The plaintiff in Dressen participated as a test subject in a Covid-19 vaccine clinical trial, signing an informed consent form (ICF), which among other things, disclosed federal limits on suits over the then-experimental vaccine. Alleging injury from the vaccine, the plaintiff sued, claiming a contract right to recover for the claimed injuries. She pointed to language in the ICF that she asserted amounted to a promise by the defendant to cover the costs of any medical care needed to treat injuries from the vaccine. 

The trial court held that PREP Act preemption did not extend to contract claims. It reasoned (if that’s what you want to call it) that the “administration” or “use” of a covered countermeasure cannot, by itself, cause a breach of contract, and the statute requires that a claim for loss be causally related to a covered countermeasure. 

The Tenth Circuit reversed, but before it could do so, it needed to ascertain whether the matter was appealable under the collateral-order doctrine. The three requirements of that doctrine are that the issue below had to have been conclusively determined below, that the issue to be resolved was important, and that it would be effectively unreviewable on appeal from a final judgment. The first two criteria were easily satisfied. More tricky was the third issue. If the defendant merely relied on its interest in avoiding trial to show an injury that could not be fixed on appeal from a final judgment, that would fall short. (What defendant would not prefer to avoid a trial?) But the PREP Act contained a form of congressionally created statutory immunity. That was a game changer:  “Once Congress has declared that an interest in avoiding trial is of sufficient importance to create an immunity from suit, we must defer to that assessment.” Accordingly, the Tenth Circuit had jurisdiction to consider, and reverse, the execrable decision below. 

Under the ICF, the plaintiff’s ability to sue over vaccine-related injuries was expressly subject to the in-force PREP Act declarations. Covid vaccines were the subject of such a declaration. The PREP statute provides immunity to the provision of covered countermeasures by covered persons.  The vaccine and its manufacturer obviously qualified. Further, the immunity expressly applied to clinical investigations and extended to all claims of “any type of loss,” not just tort claims.  “Any” means any. Given the statutory language, the Tenth Circuit saw “irony, if not chutzpah,” in the plaintiff’s attempt to create an extra-statutory contract exception that would allow recovery of the same damages. If Congress intended to exclude contract claims, it would have done so expressly.  

The plaintiff invoked various canons of statutory construction in an effort to read contract claims out of the PREP Act. In particular, the plaintiff relied upon ejusdem generis, negative implication, noscitur sociis, and the presumption against surplusage.  With a little help from Scalia/Garner’s excellent book, Reading Law: The Interpretation of Legal Texts, the Tenth Circuit swatted away the plaintiff’s effort to deploy those canons to rewrite the PREP Act. It is an impressive performance by the Tenth Circuit and, momentarily, reminded us of why we took Latin in high school. 

The court did not buy the plaintiff’s suggestion that PREP Act immunity could not reach claims, such as her contract claim, that did not explicitly reside on the vaccine compensation table. Further, given the expressed intent of Congress in the PREP Act, it was not “absurd” (as the plaintiff contended) to preclude contract claims arising from investigational countermeasures.  

In a footnote, the Tenth Circuit rejected the plaintiff’s argument that there should be a presumption against PREP Act preemption of state law claims because — and forgive us for the use of all caps, but there are enough recalcitrant courts out there such that hollering is warranted — THERE IS NO PRESUMPTION AGAINST EXPRESS PREEMPTION. SCOTUS has said so explicitly and clearly at least once, and the rest of its recent commentary on the issue has been death by silence.  Almost all appellate courts have renounced the presumption (except, sigh, our hometown Third Circuit).  And the silliness of the presumption has been decreed by the highest of all authorities — this blog. Please stop it with the out of date, unlawful presumption against express preemption. 

The plaintiff also urged the Tenth Circuit to apply the doctrine of constitutional avoidance. What constitutional issue needed avoiding? According to the plaintiff, PREP Act would be an uncompensated taking of contract rights in violation of the Fifth Amendment. The Tenth Circuit rejected that argument. “Statutory limits on liability are a commonplace,” and are not takings, so there is no legitimate constitutional issue to avoid.  Moreover, such avoidance makes no sense in the face of a clearly written statute that offers no special favor for contract claims.  

The plaintiff also argued that immunity should not apply because her injuries were not caused by the investigational vaccine but, rather, were caused by the defendant’s failure to live up to its promise. As we have already seen, that argument worked below.  It is undeniably clever, but also undeniably wrong. Applying the concept of but-for causation, the Tenth Circuit held that there can be multiple causes. Call the plaintiff’s injury the result of a breach if you want, but it was also allegedly the result of the vaccine. “Here, the vaccination was a necessary condition; it was therefore a but-for cause.” Hello PREP Act immunity, goodbye semantics. 

The only bone the Tenth Circuit tossed the plaintiff’s way was on the issue of whether the terms of the ICF might have equaled a waiver of PREP Act immunity. The trial court had not gotten to that issue, and the Tenth Circuit would not either: “We leave to the district court on remand to determine in the first instance whether PREP Act immunity can be waived and, if so, whether it was waived in this case.”

If you find vaccine litigation interesting, as we apparently do, you might want to refer to our PREP Act preemption scorecard and our posts, here and here, on the COVID PREP Act declarations.

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If you share your life with a dog, you know the drill. You call them by a hundred names. You talk to them like they understand every word (they might). You make decisions about their health with the same care — maybe more — than you would for yourself. So when a dog gets hurt after a medication, the instinct to find someone responsible is entirely human. We get it. But instinct is not a lawsuit. And a lawsuit, to survive, needs facts. Specific facts. Not just vibes, not just “the marketing was misleading,” and certainly not four rounds of amended complaints that keep making the same mistakes.

That brings us to Hartney v. Zoetis, Inc., 2026 WL 2104027 (D.N.J. Jul. 22, 2026), a putative consumer fraud and product liability class action against the manufacturer of a drug for canine osteoarthritis pain. After the fourth amended complaint, the court dismissed the case with prejudice. Four swings. Four misses. Game over.

The drug is a monthly injectable approved by the FDA in May 2023. Id. at *1. Eight named plaintiffs from across the country — Florida, Illinois, Texas, California, Missouri, Virginia, and New Jersey — brought claims on behalf of a nationwide class, alleging that the manufacturer misrepresented the drug’s safety, failed to warn veterinarians and pet owners about severe adverse events, and breached various statutory and common-law duties. Id. The plaintiffs’ stories are genuinely difficult. One dog was euthanized. Others suffered neurological symptoms, lameness, and organ problems. Id. at *2-3. We do not minimize any of that. But heartbreaking facts do not substitute for pleading facts, and pleading facts is exactly what these plaintiffs could not do.

Before getting to the merits, the court had to work through choice-of-law issues for both the consumer fraud and product liability claims. The outcome on choice of law alone eliminated most of the plaintiffs’ claims. On the consumer fraud side, plaintiffs tried to apply the New Jersey Consumer Fraud Act (NJCFA) to all class members. The court rejected that quickly. Applying New Jersey’s “most significant relationship” test, the court found that the relevant factors — where plaintiffs received and relied on the alleged misrepresentations, where their dogs received injections, and plaintiffs’ own domicile and residence — all pointed to plaintiffs’ home states outweighing that defendant was headquartered in New Jersey. Id. at *5-6. Therefore, only the New Jersey plaintiff could bring an NJCFA claim. Everyone else was out on Count 1 right there.

The product liability choice-of-law analysis ran the same way. Injuries happened in plaintiffs’ home states. Their veterinarians were in their home states. The fact that the defendant is headquartered in New Jersey is a “tenuous” connection that does not change the analysis. Id. at *9. So only the New Jersey plaintiff could proceed under the New Jersey Products Liability Act (“NJPLA”).

For the consumer protection claims, brought under the consumer fraud statutes of New Jersey, California, Illinois, Missouri, Texas, and Virginia, the court found that plaintiffs failed to adequately plead causation or reliance. The court put it plainly. The fourth amended complaint “sets forth generic assertions that fail to identify specific representations that were relied upon by their veterinarians or the named Plaintiffs.” Id. at *7. Plaintiffs did not allege what representations their veterinarians relied upon. They did not allege that they actually read the label. And critically, “other than generally alleging that Defendant’s marketing campaign was misleading, Plaintiffs do not allege that they viewed any marketing statements or materials that informed their decision to consent to [ ] injections for their dogs.” Id.

This is important. What plaintiffs saw, what their veterinarians told them, what materials were reviewed before the decision to use the drug — all of that is information entirely within plaintiffs’ control. It does not require defendant’s internal documents. It does not require discovery. Each plaintiff knows what happened at their own vet’s office. Each plaintiff knows what they read or did not read. These are facts that plaintiffs could have provided from day one. The failure to do so — even on the fourth try — is not a gap that could be cured with more time or more discovery. It is a fundamental pleading deficiency that goes to the heart of whether these claims can exist at all. Dismissal is not just appropriate here. It is required.

The court also addressed Rule 9(b)’s heightened pleading standard for fraud, finding that plaintiffs failed to allege “the who, what, where, and when of Defendant’s purported misrepresentations.” Id. The court held that plaintiffs cannot satisfy Rule 9 simply by referencing a representation on a website or in a campaign without alleging when and whether they were ever actually exposed to it. Id.

And then there is puffery. To the extent plaintiffs relied on the manufacturer’s “More Days of Play” marketing campaign, the court found that statements about helping dogs “move and play” and “improve overall quality of life” are classic puffery — broad, vague, commendatory language that no reasonable consumer could treat as a specific factual representation. Id. at *7-8. Puffery is not actionable under any of the consumer protection statutes at issue. Id. at *8.

For the New Jersey plaintiff specifically, the court addressed the NJPLA. Under New Jersey law, the NJPLA is the “sole basis of relief” for consumers injured by a defective product. Id. at *9. That means the New Jersey plaintiff’s NJCFA claim, negligence claim, and breach of implied warranty claim were all subsumed by the NJPLA. The plaintiff tried to dress up her failure-to-warn theories in consumer fraud clothing, but the court saw through it. The allegations were plainly about a defective product and inadequate warnings, which is product liability, full stop. Id. at *10.

On design defect, the court applied the well-established requirement that a plaintiff must allege the existence of a practical and feasible alternative design. Plaintiff offered nothing more than a conclusory allegation that “upon information and belief, safer, feasible, and practical alternative treatments for canine osteoarthritis pain were available.” Id. at *11. That is not enough. It was not enough the first time. It was not enough the fourth time. Plaintiffs apparently tried to correct this deficiency in their opposition briefs, but as the court reminded them, a complaint cannot be amended by a brief in response to a motion to dismiss. Id.

On failure to warn, the court took a sensible path. Rather than wading into the learned intermediary doctrine question — which the court noted is typically fact-bound and not resolved on a motion to dismiss — it decided the claim on warning adequacy. Id. at *11-12. The NJPLA provides that an FDA-approved warning label carries a rebuttable presumption of adequacy. Id. at *12 (citing N.J. Stat. Ann. § 2A:58C-4). Plaintiffs argued that adverse event reports and the January 2025 label change were enough to overcome the presumption. The court disagreed. The adverse event reports were publicly available. There was no deliberate concealment, no nondisclosure, nothing to rebut the presumption. Id. Therefore, failure to warn was dismissed.

One additional point worth highlighting. The court also addressed New Jersey’s direct-to-consumer (DTC) exception to the learned intermediary doctrine. Even setting aside whether the doctrine applied, plaintiffs could not invoke the DTC exception because — consistent with the Rule 9 and reliance failures above — they never actually alleged that they viewed any of the DTC marketing materials that supposedly informed their decision. Id. at *12 n.7. If you want to invoke the DTC exception, you have to allege you saw the DTC advertising. No allegation, no exception.

The court’s dismissal was with prejudice.  Plaintiffs tried to state a claim four times. The court had already dismissed without prejudice once. The fourth amended complaint did not meaningfully cure the pleading deficiencies. The differences between the third and fourth amended complaints, did “not suggest that Plaintiffs are progressing in the direction of an actionable claim.” Id. at *12. A fifth amendment would be futile.

Dog trainers say: you can teach an old dog new tricks, but only if the dog is willing to learn. Four amended complaints without curing the same basic pleading failures — the who, what, when, and where of specific misrepresentations; an actual alternative design; a rebuttal to the FDA’s presumption of adequacy — suggests these plaintiffs were not learning. Or perhaps the lesson is simpler — if you want to bring a case about what a plaintiff saw and relied on, you had better be prepared to say what that was. That information belongs to the plaintiff. It was available from day one. After four tries, the court ran out of patience. So did we.

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We first learned of the Washington Legal Foundations (“WLF”) back in the 1990s, when Bexis collaborated with WLF in pursuing what was then viewed as a rather radical proposition – that the First Amendment applied to FDA and other governmental constraints on off-label promotion of FDA regulated products.  Eventually, the Supreme Court specifically held that the First Amendment protects pharmaceutical promotion.  Sorrell v. IMS Health Inc., 564 U.S. 552, 557 (2011) (“Speech in aid of pharmaceutical marketing, however, is a form of expression protected by the Free Speech Clause of the First Amendment.”).

So, when the WLF opines on the First Amendment and product liability litigation, we listen.

Recently, we listened, and now we heartily recommend the new WLF working paper, “Public Nuisance & the First Amendment: Free-Speech Defenses to an Expanding Tort,” written by WLF’s General Counsel, Cory Andrews.  For many of the same reasons that the First Amendment protects truthful off-label speech, it also protects against governmental “public nuisance” claims that target the speech of product manufacturers.

In the past two decades, private plaintiffs and state-and-local governments began claiming that a manufacturer creates a public nuisance not only by making or selling a lawful product (bad enough), but by speaking about it − through advertising, sales representatives, scientific communications, and even policy advocacy − in ways said to encourage harmful use or play down risk.  With billions of dollars and nationwide policy in the balance, that move puts public nuisance on a collision course with the First Amendment.

Public Nuisance & the First Amendment (at probably the first page).

With ample citations to product liability-related precedent and restatement comments, the WLF article makes the following points:

  • Public nuisance claims challenging “product advertisements,” “a company’s scientific or policy advocacy,” and the “algorithmic design” of “social-media platforms” are all “inseparable from . . . speech.”
  • These public nuisance claims all “recharacterize[] protected expression as conduct the law may freely abate, simply by calling it a ‘nuisance.’”
  • Applicable First Amendment principles include: “the commercial-speech doctrine, the rule against compelled speech, the right to petition, the protection of editorial judgment, and the bedrock prohibition on prior restraints.”
  • These broad, non-traditional public nuisance claims are “without an established and recognized standard.”
  • “[P]ublic nuisance is not a roving commission to redress every social ill,” or a substitute for product-liability law, consumer-protection statutes, or [] regulatory regimes.”
  • Numerous examples of public nuisance attacks on speech, with “[e]ach iteration mak[ing] the same essential claim,“ that the purported nuisance is “how the defendant spoke about − or encouraged the use of − its lawful product.”
  • Supreme Court authority that governments may not use public nuisance to “abate speech.”
  • The “singular remedy” of public nuisance − “an injunction abating the offending activity—becomes a prior restraint the instant the activity is speech.”
  • Public nuisance claims are inherently “content”/”topic” and “speaker” based, and thus “presumptively invalid” so that “a jury verdict keyed to the content of a company’s speech is a content-based penalty by another name.”
  • “Promotion-based nuisance claims” necessarily target protected speech:  “sales promotions,” “scientific or policy statements,” and “contested positions” on public issues.
  • “Selectivity” – the targeting of manufacturers rather than other speakers” “is the tell.”  “What separates the defendant is not a different act but a disfavored identity.”
  • “The burden . . . is direct, not incidental; imposing damages for truthful promotion is not regulating inert behavior but penalizing expression.”
  • “To punish the manner of the speaking is to punish the speech.”
  • Post-hoc allegations that a manufacturer’s speech “‘unreasonably’ interfered with the public welfare” is both “ad hoc balancing” and “standardless,” in violation of the First Amendment.
  • “Product marketing, scientific debate, or advocacy” by commercial entities is “fully protected speech” not subject to mere “intermediate scrutiny.”
  • “Calling speech a ‘product,’ a ‘marketing practice,’ or a ‘nuisance’ does not” affect its First Amendment protection.
  • Public nuisance liability for mere silence makes no sense, and amounts to unconstitutional “compelled speech.”
  • “A disclosure that takes sides in a genuine scientific or policy debate is not uncontroversial and thus may not be forced.”
  • Another part of the First Amendment, the petitioning clause, prohibits public nuisance liability for a “defendant’s dealings with government itself.”
  • A detailed discussion of statutory and judicial precedents barring or restricting public nuisance claims.
  • While some speech is “commercial,” public nuisance claims “rarely stop “there,” so that the Bolger principle that full First Amendment protection applies to hybrid speech should apply.
  • Four states have presciently precluded product-based public nuisance by statute.

We wholeheartedly agree with WLF that the First Amendment should be raised and pursued as a defense to just about all product-based public nuisance claims.  Defense counsel should read the entire article, and act accordingly.

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FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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