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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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The order certifying a class of third-party payors in the long-running Avandia MDL was the wrong result for the wrong reasons, and the Third Circuit has now vacated that order in an opinion that is well worth the read.  In In Re: Avandia Marketing, Sales Practices and Products Liability Litigation, No. 25-2278, 2026 WL 2093904 (3d Cir. July 21, 2026) (to be published in F.4th), the Third Circuit held that the district court erred in ruling that common issues predominated over individual issues on the key issue that has undone the vast majority of pharma-related class actions—causation/reliance. 

For anyone who hasn’t been following along, the FDA approved Avandia to treat Type II diabetes in 1999, and the MDL got going in 2007, after a widely publicized, but ultimately disproven meta-analysis purported to show an increased risk of heart attacks.  That was almost 20 years ago.  In that time, the FDA required a black-box warning and a REMS program, but then determined that neither was justified because there really was no increased risk.  An MDL for a cardiac risk that never actually existed.

All that is left in the MDL is a third-party payor class action, where health plans allege that they paid for more Avandia prescriptions because the manufacturer fraudulently misrepresented Avandia’s cardiac risks—not because the medication increased cardiac risk (the original, bogus theory that the FDA repudiated), but because it supposedly did not reduce that risk.  Causation is the Achilles heel for third-party payor class actions, and it should have been here, too.  The district court, however, ruled that the plaintiff payors could prove causation on a class-wide basis and certified a nationwide class.  We gave you our dim view of that order here, and the order came in as our fifth worst drug and device decision of 2025.

We knew where the Third Circuit was headed when we read the opinion’s first sentences:

We do not presume in law that x caused y merely because x happened first.  The connection might be causal.  But it might be coincidental.  Or some z might be responsible for x and y alike.  As statisticians emphasize, correlation alone does not prove causation.

In re Avandia, at *1.  Correlation alone does not prove causation.  We have heard it time and time again, and the Third Circuit made it the centerpiece of its opinion.  The plaintiffs’ RICO causation theory was that the defendant’s alleged fraud caused physicians to rely on misrepresentations in prescribing decisions, which caused TPPs to pay for prescriptions they wouldn’t otherwise have reimbursed. The plaintiffs thus needed to show that physicians’ reliance could be proved on a class-wide basis.

On this score, the district court got it wrong.  First, the district court ruled that evidence of “a common scheme to deceive” justified an inference of class-wide reliance.  The Third Circuit, however, rejected that:  “[O]ur cases do not support a broad, uniform rule that courts may infer class-wide reliance any time plaintiffs propose to prove the defendant committed fraud. . . . [And] we have also warned, in a case where the proof of the violation came from common evidence of a common scheme, that ‘reliance is nearly always an individualized question.’”  Id. at *12.  Moreover, “there is no fraud exception” in proving predominance, and a court should not “relax its certification analysis.”  Id.  Here, dozens of factors bear on a physician’s prescribing choices, and the Third Circuit faulted the district court for unjustifiably oversimplifying those decisions.  The court pointedly noted that the district court’s “portrayal of prescribers’ decision-making process did not cite a single page of the several-thousand-page record” and did not represent “the ‘rigorous analysis’ required for class certification.”  Id. at *13. 

Second, district court found class-wide proof of causation from “statistical evidence,” namely the manufacturer’s internal studies showing that some of its marketing campaigns caused prescriptions to increase.  Id. at *13-*14.  But that was wrong too, because those internal studies did not purport to isolate the purportedly fraudulent messaging.  Taken at face value, the internal studies could show the impact of marketing generally, but not the alleged fraud. 

The plaintiffs therefore fell back on evidence that a decline in Avandia prescriptions correlated with the 2007 publication of the same disproven meta-analysis that started this whole MDL.  So (the argument goes) if those same facts (even if false) had been disclosed earlier—say, 2005, the start of the class period—prescriptions would have dropped then, too.  Voilà: causation.

The Third Circuit was having none of that:

[W]e are not aware that any court has permitted a putative class of TPPs to prove providers’ reliance by class-wide evidence without statistical evidence the defendant’s conduct caused the injuries.  The Plans could have cleared the bar if they had introduced statistical evidence of causation, like a regression analysis.  They tried.  But the District Court struck that evidence after a Daubert hearing.  Without it, the Plans have only statistical evidence of correlation and circumstantial evidence of causation. . . .  That is not enough.

Id. at *15.  There it is again—correlation is not causation.  That is not to say that plaintiffs can never prove causation on a common basis, but the standard is rigorous.  Following a long discussion of authorities in other circuits, the Third Circuit concluded as follows:

[W]e hold that TPPs in a pharmaceutical fraud RICO action may prove but-for causation with class-wide statistical evidence so long as that evidence is sufficiently rigorous to show causation, not just correlation.  Statistical evidence has such rigor if, like a regression analysis, it can distinguish the causal significance of the variable at issue and justify the rejection of competing explanations. 

Id. at *19.  The payor plaintiffs here did not have this level of proof.  The district court already excluded much of their statistical evidence as unreliable (which the plaintiffs wisely did not appeal), and what they had left fell well short of proving causation on a class-wide basis, or any basis.  Importantly, the court vacated class certification and remanded rather than outright denying certification.  The plaintiffs therefore may get another shot at developing new evidence—including discovery if the district court allows it—although we don’t understand why the Third Circuit has given the plaintiffs yet another chance after 19+ years of litigation that hasn’t proven anything. 

So the saga continues, but the path back to class certification is considerably steeper now.  Plaintiffs can use statistical evidence to prove class-wide causation, but it has to be reliable, admissible statistical evidence that isolates the effect of the fraud from everything else.  Bare correlation—even striking temporal correlation—isn’t enough.  A “common scheme to deceive” standing alone isn’t enough.  And, after Avandia, “our marketing studies show marketing works” won’t cut it either.  We will keep you posted. 

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As we have said before, the Blog is unabashedly pro-science.  There is a difference between good science and bad science, and reliance on the latter to make any important decision—be it in everyday life, litigation, or public policy—is not smart.  We are also unabashedly in favor of strict application of the Rules of Evidence, the 700 series and otherwise.  It may be overly simplistic to say that plaintiff lawyers in our kind of cases tend to want limited application of the Rules of Evidence or even no rules at all and the defense lawyers want the opposite.  It may not be.  At the same time, we appreciate whenever we have the chance to aid a jury’s consideration of competing reliable expert opinions with vigorous cross-examination by both sides.  It certainly can be the case that reliable competing expert opinions can be presented in the same case with a mutually strict application of Rule 702.  However, the existence of vigorous cross-examination and the notion that juries can do a good job weighing competing expert evidence, regardless of its relative reliability, are not substitutes for strict application of Rule 702.  Correcting that misimpression was part of what was emphasized in the 2023 amendment to Rule 702.  We, of course, knew better than to assume that the amendment would correct all misapplications of Rule 702 by federal judges and appellate panels.  We have tracked how it has gone since.  See, e.g., here, here, and here.

One thing that we have seen courts get tripped up on is temporality.  We are not talking about the concern, urged extensively by many plaintiffs in the years after Daubert and rejected by the famous Rosen observation that “law lags science,” that there could be support for a plaintiff’s expert causation opinion created after the fact so it would be unfair to ding an expert for not having support for her “inspired” “scientific guesswork.”  It would not be.  We are also not talking about the temporality criterion of the Bradford Hill Criteria, which is usually the easiest one to analyze and meet.  (We digress somewhat to note that it will often be hard to establish this temporality when it comes to a claim that gestational exposure caused a developmental disorder absent clear evidence on when the developmental disorder actually starts; some teratogens are known to have relatively small exposure risk windows.)  Instead, we are talking about the issue of when the three aspects of Rule’s 702’s reliability requirement—whether it “is based on sufficient facts or data,” “is the product of reliable principles and methods,” and “reflects a reliable application of the principles and methods to the facts of the case”—should be measured.  The right answer is that the opinion has to be reliable when formed, which correlates to the period of time leading to when the expert report is signed (for a retained expert).  Under Fed. R. Civ. P. 26(a)(2)(B), the report must include, inter alia:  “(i) a complete statement of all opinions the witness will express and the basis and reasons for them; [and] (ii) the facts or data considered by the witness in forming them.”  Consistent with the Rule 702 focus on methodology, these requirements point back to the time when the opinion is formed before the report is signed.  Not when the trial court decides a Rule 702 challenge.  Obviously, a bad methodology with an insufficient basis cannot be saved by post hoc work.  (In theory, an initial report could be withdrawn and a better report swapped in, but then the opinions being tested on a Rule 702 motion would be the ones in the superseding report.)  A few years later, when an appellate court looks at whether the opinion met Rule 702, is certainly not the time.

Another thing courts still get wrong is how burden works.  Rule 702’s amendment in 2023 was intended to clarify that the proponent of the expert opinion evidence bears the burden of establishing by a preponderance of evidence the relevance/fit and three reliability criteria.  That is clear from its formatting as well as the advisory committee notes.  We have emphasized this issue before and noted how whether a court refers to “burden” or what the proponent established can be a tell in how it will rule on expert opinion admissibility.

Unfortunately, these issues featured in Rutledge v. Walgreen Co., — F.4th –, 2026 WL 2015284 (2d Cir. July 13, 2026), where a really thorough and impactful Rule 702 decision by an MDL judge was undone by a really misguided appellate decision.  This, of course, is the Second Circuit’s reversal of the key rulings on general causation experts that led to mass summary judgment for the defendants.  We are sure there will be more to say about this decision, which also included a punt on a back-up expert in another case and a short and sloppy affirmance of an early and sloppy preemption denial.  We are going to focus on the reversal of the exclusion of three experts, the central epidemiologist and two experts whose function was to help the epidemiologist pass the “biological plausibility” criterion under Bradford Hill.  We set aside the affirmance of the exclusion of two other plaintiff experts, including whether the appellate court’s reasoning is consistent.

On the timing issue we noted, we give the Rutledge court some credit for disclaiming that political posturing since the MDL court issued its rulings played any role in its decision.  Id. at *1.  We hope that is true.  However, the temporal framing of the inquiry throughout was a bit off.  We might be nitpicking on tense and phrasing, but the timing does matter.  Another plaintiff expert coming up with a plausible biological mechanism does not help the plaintiff establish that the epidemiologist’s opinion was reliable unless the epidemiologist relied on it in forming his opinion.  Similarly, if studies came out or the consensus of professional bodies shifted in favor of causation in the years since an epidemiologist signed his report, that also would not help plaintiffs prove reliability.

The prior observation ties to our second issue above.  Other than initially quoting the “if the proponent demonstrates to the court that it is more likely than not” language from the flush language of Rule 702, Rutledge never returned to the concept of plaintiffs’ burden as proponents of the evidence.  By contrast, the failure of plaintiffs to carry their burden on a number of aspects of reliability and relevance was a key part of the MDL’s decision.  As with a summary judgment decision, burden needs to be a meaningful part of the court’s analysis.

Strangely, other than quoting them up front, the Second Circuit also seemed to ignore Rule 702(a), (b) & (d), focusing solely on qualifications (uncontested) and 702(c).  In other words, the court focused on whether (without the concept of burden) “the testimony is the product of reliable principles and methods,” but not helpfulness/fit or the other reliability provisions: “whether the testimony is based on sufficient facts or data” and whether “the expert’s opinion reflects a reliable application of the principles and methods to the facts of the case.”  Whether the expert purports to apply a reliable methodology—i.e., the Bradford Hill Criteria versus the Cherry-Pick Flim-Flam method—is different than whether she applies it reliably and has sufficient supporting evidence to form an opinion that general causation exists.  We find Rutledge’s reversal of the epidemiologist’s exclusion to be overly focused on his claims that other epidemiologists also use the Bradford Hill Criteria to explore different exposures and different diseases in a similar way to how he says he used them here.  Those claims, if credited, may help to satisfy 702(c) but not 702(b) or 702(d), each of which is an independent requirement.

For instance, one of the main failings of the epidemiologist’s methodology according to the MDL court was his use of a “transdiagnostic evaluation,” essentially lumping together different outcomes to manufacture the appearance of a strong association from epidemiological studies.  This sort of data dredging is roundly decried when done in individual studies.  Per the MDL court, plaintiffs failed to show it was reliable to do it for the very different conditions of autism spectrum disorder and attention-deficit/hyperactivity disorder (and other things he lumped in when it suited him).  Without the lumping, he could not offer an opinion that prenatal acetaminophen use causes either condition.  In Rutledge, the court did not require such a specific showing tied to the facts of the case, only that the epidemiologist was “using a methodology that epidemiologists routinely use.”  Id. at *11.  That is an incomplete analysis of the issues.  It is also hard to reconcile with the court’s later disclaimer that:

We do not mean to suggest that all Bradford Hill analyses that simultaneously examine multiple outcomes, or that use symptomatic as well as diagnostic endpoints, are reliable and admissible under Rule 702. We can imagine, for example, conditions which are sufficiently distinct so that a single, joint, analysis could not be performed in a reliable manner.

Id. at *12.  You can only make that distinction if you look at whether the proponent carried its burden to show the lumping was reliable for the particular issues in the case as required by Rule 702(d), which Rutledge did not do but the MDL court did.

More generally, the appellate court found the MDL court overstepped its gatekeeping function by “substitut[ing] its own definitions of certain Bradford Hill factors for those of other epidemiologists, and (ii) penaliz[ing the expert] for drawing plausible conclusions well within “the range where experts might reasonably differ.”  Id. (citations omitted).  The examples of overstepping, however, sound an awful lot like not just taking the plaintiff’s expert’s word for it that his opinion was reliable and actually testing whether the record showed the plaintiffs carried their burden to establish each element of Rule 702.  We could go on with the details, but we will end our discussion of the epi’s reinstatement by noting that Rutledge’s conclusion should only make it harder for district courts:

While the district court’s reasoning was considered and extensive, its analysis frequently overstepped its gatekeeping function by substituting its own judgments about the requirements of causality and the persuasiveness of various studies for those of scientists operating in the field.

Id. at *19.

On the other two experts whose opinions were held to have been wrongly excluded, they were, as we noted, offered solely on biological plausibility.  If the epidemiologist’s opinion was excluded, theirs would not be helpful to the jury as mechanism hypotheses alone could not possibly carry the plaintiffs’ causation burden.  Relatedly, the district court had noted that one of the mechanism experts “plays a critical role for the plaintiffs [who] rely on [him] to give his imprimatur to the transdiagnostic Bradford Hill analysis of causation applied by their other experts. His reports do not do so.”  It then explored in detail how his opinion did not provide what the epidemiologist needed to establish biological plausibility.  Rutledge deemed this an “unduly narrow definition of relevance.”  Id.  Had the appellate court considered the developed law on the “fit” requirement under Daubert and Rule 702, which it never discussed, it might have found the MDL court’s approach appropriate gatekeeping.

As to the other mechanism expert, Rutledge questioned the MDL court’s finding that the expert’s reliance on animal studies showing the opposite of his hypothesized mechanism unreliable.  Eschewing its own guidance not to “substitut[e] its own judgments about the requirements of causality and the persuasiveness of various studies for those of scientists operating in the field,” Rutledge accepted the expert’s own “counterintuitive” explanation that “[a]ny behavioral evidence of neurodevelopmental change attributable to acetaminophen supports the conclusion that acetaminophen disrupts neurodevelopment.”  Id. at *20.  Even ignoring that “neurodevelopment” is a really broad umbrella term, a study showing a decreased risk of a certain negative outcome would not be reliable support for an opinion that there is an increased risk simply because it showed some change.  That is not how this all works.

The resurrection of an MDL with such a shaky causation footing is good for plaintiff lawyers, but maybe for nobody else.  And maybe not for long.  The MDL’s denial of preemption on warnings claims at the pleadings stage was flawed, in part because the CBE regulation was not available to change the label of these monograph OTC drugs back when they were being used in the individual cases.  On summary judgment, plaintiffs will have to show that the branded manufacturers, generic manufacturers, pharmacies, and retailers could each have unilaterally changed the OTC drug labels to add specific warnings on specific risks during the relevant time of use during pregnancy based on newly acquired information.  Here, temporality favors the defendants.  The weak evidence of general causation should get weaker as you go back in time.  And it should be clearer that then-existing regulations and regulatory environment would not have permitted unilateral labeling changes by most, if not all, of these defendants.  We will be watching to see how it plays out.

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By taking a look at Akerlund v. Atlas Air, Inc., 2026 WL 1993146 (11th Cir. July 10, 2026), that makes this the third straight week in which we are pleased with a sensible vaccine decision. In this published case, the Eleventh Circuit affirms that an airline’s COVID-19 vaccination mandate did not subject its employees who resisted vaccines on various grounds to a hostile work environment.

The plaintiffs were employees in a commercial airline business. They objected to their companies’ pandemic era policies on masks, testing, and vaccines. Employees were required to get vaccinated against COVID 19, unless they obtained a religious or medical exemption, in which case they had to undergo periodic testing and wear a mask on the job.

The employees sued both the commercial airline and the company the airline used to staff the flights. The causes of action included hostile work environment under Title VII, a Federal Food, Drug, and Cosmetics Act (FDCA) violation, federal constitutional deprivations, tortious invasion of privacy, negligent disclosure of private medical information, and infliction of emotional distress. 

The district court dismissed all claims against the staffing company and some claims against the airline for want of personal jurisdiction, and the remaining claims against the airline for failure to state a claim.  

The Eleventh Circuit affirmed. First, the court held that there was no personal jurisdiction over the staffing company.  That company was not incorporated in Florida, where the lawsuit was filed, nor did it have its principal place of business there. The only connection the staffing company had with Florida was that it occasionally sent employees to Miami for training, but that did not make the company “at home” in Florida, so forget about general jurisdiction. Nor did any of the claims in the case “arise out of or relate to” those training sessions, so forget about specific jurisdiction, as well. 

But while the staffing company exited the case completely based on absence of personal jurisdiction, there could be personal jurisdiction over the airline to the extent some of the plaintiff-employees worked in the airline’s Florida facilities. Consequently, the Eleventh Circuit, like the district court, needed to address the substantive claims against the airline. 

The hostile workplace claim was a goner because the plaintiffs were offered an accommodation (masking and testing), but refused it.  Though the plaintiffs alleged that the airline was showing hostility to the employees’ religious beliefs, it turned out that the employees’ objections to the accommodation were “political and logistical,” not religious.  Moreover, the plaintiffs came across with no allegations of discriminatory intent or motive.

As flight attendants mutter as you disembark, “buh bye.”

The FDCA were grounded in the allegation that the airline “unlawfully required its employees to take medical products authorized for emergency use” (citing 21 U.S.C. section 360bbb-3). But that FDCA claim failed for the usual reason – there was no private FDCA right of action. As the court held, “they cannot sue to enforce such claims; only the federal government can bring enforcement actions under that statute.”

Prepare doors for arrival and cross-check — because you are about to get out.  

The plaintiffs’ constitutional claims purported to travel under either section 1983, which applies to state action, or the Bivens theory, which applies to federal employees. But a private airline is neither a state nor federal employee. It would have been a stretch to characterize the airline as a governmental actor just because it was complying with a Biden executive order, and courts are not inclined to stretch to permit Bivens claims. 

Look out the window. Do you see that piece of luggage being rudely tossed twenty feet in the air, missing the conveyor belt entirely? Those are your constitutional claims.

Various state-law privacy claims in Akerlund failed for lack of any information being publicly disclosed. Communications within the company referring to employees’ vaccination status remained strictly internal. Under Florida law, except in cases of physical invasion, a tort of invasion of privacy must be accompanied by publication to the public in general or to a large number of people. Not so, here. 

The employer vaccine mandates in Akerlund came nowhere close to conduct that would support intentional infliction of emotional distress.  Such vaccine requirements did not “exceed  bounds of decency.”

Do you know what does exceed the bounds of decency? Filing silly claims. Oh, and the flounder meal option, too. That was pretty bad.

Now for dessert. As a legal cherry on top, the plaintiffs’ counsel – a notorious antivax lawyer – was sanctioned for submitting multiple “filings … riddled with citations to nonexistent, ‘hallucinated’ cases.”  The court was plainly exasperated by the AI slop: “Whatever the merits of artificial intelligence, it is no substitute for actual intelligence.”  It is bad enough for the plaintiff lawyer to lose the case entirely, but it turned out so much worse for him. The Chief Judge of the Eleventh Circuit referred the plaintiff counsel to the relevant disciplinary committee. Ouch. That has to hurt much more than any vaccine shot. 

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There is a well-worn saying in electrical engineering — if you want to break a circuit, you can cut the wire or trip the breaker. Plaintiffs in several consolidated spinal-cord stimulator cases recently tried something more creative — they attempted to rewire the entire regulatory grid by suing the FDA itself, hoping to knock out the device manufacturer’s preemption defense before the defense could do its job. It was an audacious gambit that did not work. The court in Keys v. Medtronic, Inc., 2026 WL 2030069 (D. Minn. July 14, 2026), dismissed all but a sliver of the plaintiffs’ claims, and the novel APA strategy fizzled on the launchpad.

Keys is actually four cases decided together.  All four plaintiffs were implanted with defendant’s spinal-cord stimulator, a Class III medical device that first obtained PMA in 1984 and has since been the subject of more than 400 PMA supplements. Id. at *2. The plaintiffs’ core theory was that post-2017 PMA supplements had so significantly altered the device’s design that it had become a materially different product from what was originally approved. Id. at *3. On that foundation, the plaintiffs constructed an unusual two-track attack — standard product-liability claims against the device manufacturer, and a simultaneous APA challenge against the FDA itself.

The obvious problem with suing the FDA over a PMA decision is Buckman, which forecloses private FDCA enforcement suits. Plaintiffs tried to sidestep Buckman by styling the claim as an APA “arbitrary and capricious” challenge rather than a direct FDCA enforcement action. Clever — but the court was not impressed.

The plaintiffs needed to explain what injury gave them standing to bring this FDA suit in the first place. Their theory was that the injury was the manufacturer being able to assert a preemption defense in the product-liability cases. That is, the “harm” was not anything the FDA did to plaintiffs physically — plaintiffs expressly disclaimed that theory in briefing — but rather the availability of a legal defense in a different lawsuit. Id. at *4.  Standing, however, requires an injury in fact that exists at the outset of the litigation. But by plaintiffs’ own account, the “injury” they suffered — defendant invoking preemption — did not occur until defendant filed its motion to dismiss. That happened after the complaints were filed. So at the moment each plaintiff filed suit, the asserted injury did not yet exist. No injury, no standing. The APA claims were dismissed for lack of jurisdiction. Id.

The court also addressed the merits, finding the APA claims would fail regardless. Plaintiffs leaned heavily on 21 C.F.R. § 814.39(a), claiming it required a new PMA whenever cumulative changes were sufficiently significant. The court read the regulation and found that it does exactly the opposite of what plaintiffs claimed — § 814.39(a) governs when a PMA supplement is required (as opposed to a mere report to the FDA), and says absolutely nothing about when a new PMA, as opposed to a supplement, might be required. Id. at *4-5. Plaintiffs cited no statutory or regulatory provision that identifies any such threshold. Zero. The merits ruling was swift and conclusive.

The court then turned to the products liability claims.  The four plaintiffs were from either Kentucky or Tennessee, states with one-year statutes of limitations for personal injury and product-liability claims. Making nearly every claim dead on arrival on timeliness grounds. 

The plaintiff from Kentucky was implanted in May 2018, developed severe complications, and was advised to turn off his device by mid-2019. One of the Tennessee plaintiffs was advised to turn off her device by mid-2019; and another experienced shock-like symptoms and urinary incontinence within two weeks of her February 2020 implantation.  They all filed suit in 2025. 

The court found all of their claims time-barred on their face. Id. at *5-7. The fourth plaintiff brought claims related to a 2019-implanted device, which was time-barred on the same logic; but had a second device implanted in March 2024.  His claims relating to the 2024 device survived the statute of limitations and moved on to preemption analysis.

Here, the court applied the familiar Riegel/Buckman framework: a parallel state-law claim must allege conduct that violates the FDCA, but the claim cannot be premised on the FDCA violation itself. The gap is narrow, and the court found it swallowed most of plaintiff’s claims.

Indeed, the lone survivor was manufacturing defect. Plaintiff alleged that his device deviated from defendant’s design specifications and included specific allegations regarding improper assembly. This is the archetypal parallel claim. Further, the Eighth Circuit has counseled leniency in dismissing manufacturing-defect claims given plaintiffs’ limited access to PMA manufacturing data. So, it is hardly surprising that the court found plaintiff had done enough for this claim to survive a motion to dismiss. Id. at *9.

Nothing else did.  Plaintiffs alleged that the defendant marketed the device as safe and effective while concealing adverse events and post-market modifications. But they never alleged that defendant failed to disclose anything the PMA required it to disclose. That omission was fatal. On that ground the court dismissed several information-based claims (consumer protection, failure to warn, fraudulent concealment).  Id. at *8-9.

Plaintiff’s negligence-per-se theory based on alleged failures to submit adverse-event reports was impliedly preempted under Buckman. To the extent the claim was based on failing to update labeling, it survived Buckman but failed on pleading because plaintiff never identified any specific labeling language required by the FDA that defendant omitted. Finally, to the extent plaintiff was relying on an alleged cGMP violation, it did not support a negligence per se claim, but the court left open the possibility that, if properly developed, a cGMP violation could support the manufacturing-defect claim. Id. at *9-10.

Plaintiff’s safety-and-effectiveness warranty claims were conflict preempted because a jury verdict finding the device not safe and effective would directly contradict the FDA’s PMA determination. The remaining warranty allegations failed because plaintiff never alleged that defendant warranted anything beyond what the PMA required — expressly preempted. The claims also would have failed independently for lack of pre-suit notice under Tennessee’s UCC. Id. at *10.

Finally, plaintiff made two sales representative claims.  He alleged that defendant was negligent in using unlicensed field representatives to influence intraoperative decisions without ensuring informed consent. While defendant’s representatives were present during the surgery, the court dismissed the claim because plaintiff did not allege that field personnel failed to disclose anything required by the PMA. Id. at *11. Preempted.

Plaintiff’s most unusual claim alleged that defendant’s representatives committed negligence per se by violating Tennessee’s statute prohibiting the unauthorized practice of medicine. Defendant argued there is no private right of action under that statute. Plaintiff did not respond. Under Tennessee law, the burden falls on the plaintiff to establish a private right of action exists. Silence equals concession. Claim dismissed. Id.

Plaintiffs asked for leave to amend but failed to follow the district’s local rules for doing so and — more fundamentally — identified no additional facts that would save their claims. The court, unsurprisingly, declined to let them take another swing. Id.

While manufacturing-defect claims continue to be the gap in the PMA preemption armor, the novel APA strategy that was supposed to short-circuit preemption entirely got unplugged before it ever got started.

Drug & Device Resources

Bexis’ Book

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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