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The saga over the illegality defense in Kansas appears to have run its course, and as in previous chapters, the defense has prevailed.  The Tenth Circuit has ruled that the defense of illegality exists under Kansas law and that it applies to product liability claims.  As we reported here and here, this is the first case applying illegality (aka in pari delicto) as a defense to product liability claims under Kansas law, and the Tenth Circuit ruling is the first appellate opinion to so hold.

To recap, the decedent in Messerli v. AW Distributing, Inc., No. 23-3241, 2025 WL 2525275 (10th Cir. Sept. 3, 2025) (to be published), sadly passed away allegedly as a result of inhaling intoxicating fumes (or “huffing”) from computer dusters, those cans of compressed air you use to blow away dust.  As we wrote here, a federal district court in Kansas granted a motion to dismiss on the basis that the decedent had engaged in illegal conduct, which supported a complete defense.  That was because Kansas’s illegality defense bars claims arising from a plaintiff’s illegal conduct, and huffing is a crime in Kansas under laws against “the unlawful abuse of toxic vapors.”

The Tenth Circuit affirmed, noting at the outset that Kansas has outlawed toxic vapor abuse for good reason, citing the addictive and dangerous nature of certain inhalants and the multiple emergency room visits associated with them. 

In coming to its conclusion, the Tenth Circuit’s reasoning was threefold.  First, the court held that the illegality defense exists under Kansas common law that that the Kansas Product Liability Act did not abrogate it.  The KPLA merges all product liability theories into a single product liability claim, but where the Act is silent, common law fills in the gaps.  The KPLA did not expressly abrogate the illegality defense, and multiple recent Kansas cases confirm that the illegality defense is still available under the common law in tort actions.  The same is true in multiple other states.

Second, Kansas’s adoption of comparative negligence in 1974 did not overrule the illegality defense, either.  On this point, the plaintiff argued that the decedent’s illegal acts should not bar recovery completely, but should reduce the recovery by an amount to be determined by a jury.  The Tenth Circuit, however, rejected this argument on the basis that Kansas courts have continued to apply the illegality defense since the legislature adopted comparative fault.  Moreover, and we think more importantly, comparative fault and illegality are horses of a different color.  Unlike comparative fault, the illegality defense does not aim to apportion fault, but instead prevents injured parties from benefiting from their own illegal behavior.  This is a policy choice.  The Restatement (Second) of Torts recognized that “the public policy behind this rule is that a court should not lend its aid to a [person] who founds [a] cause of action upon an immoral or illegal act.”  Messerli, at *7.  And the Tenth Circuit agreed with other courts holding that plaintiffs should not be compensated for injuries that “involve a substantial violation of law.”  Id. 

Third, the Tenth Circuit affirmed the district court’s Erie determination that the Kansas Supreme Court would apply the illegality defense in product liability cases.  The Kansas Supreme Court has long endorsed a preference that juries allocate fault based on “comparative degrees of causation.”  Id. at *8.  The illegality defense, however, is different because

the policy argument behind the illegality defense is not based on allocating fault, but on the principle that the courts should refuse to allow a plaintiff to benefit from his own illegal act.  The degree of the injured party’s culpability is not at issue.  We are concerned only with whether we should aid a plaintiff who violated the law. 

Id.  The key is that Kansas common law, like the law other states, has always applied the illegality defense for reasons separate and independent from contributory negligence and comparative fault.  As a result, the defense applies to tort claims generally and likewise to product liability claims under the KPLA. 

From there it was a short path to affirming the dismissal.  The complaint alleged that the decedent huffed dusters and that toxic vapor intoxication caused his death.  Because the complaint squarely alleged that illegal acts allegedly caused the death, the illegality defense barred the plaintiff’s claims. 

The Tenth Circuit’s opinion is useful not only because it is the first of its kind, but also because of the clarity of its reasoning.  A plaintiff’s product misuse is one thing; a plaintiff’s attempt to base a civil action on his or her own illegal conduct is quite another.  File this opinion away for future use. 

Thanks to Scott Kaiser, Stephen Nichols, and Holly Pauling Smith at Shook Hardy for bringing this opinion to our attention and for attaining this result.

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The preemption case du jour is Gregory v. Boston Sci. Corp., 2025 U.S. Dist. LEXIS 164801, 2025 WL 2452382 (E.D.N.Y. Aug. 25, 2025), in which the Eastern District of New York granted summary judgment on federal preemption grounds.

Every time we see a case that does that—upholds preemption on summary judgment—we wonder why the court didn’t uphold preemption at the pleading stage, on a motion to dismiss.

As the Supreme Court recognized in Riegel v. Medtronic, Inc., 552 U.S. 312, 330  (2008), when Congress enacted 21 U.S.C. § 360k(a) as part of the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act, it did not just intend to protect manufacturers of Class III, premarket approved (“PMA”) devices from litigation judgments–it hoped to protect manufacturers against the costs of discovery as well.  In other words, federal preemption is most effective in carrying out congressional intent when it is enforced at the outset of the case, not after years of expensive litigation.

So we checked the Gregory docket. 

Three years ago, in 2022, the defendant filed a preemption motion to dismiss, and (sensibly) asked the court to stay discovery until that pleading-stage motion was decided.  The Court denied the stay and ordered discovery to proceed. And then, basically, the Court just sat on the motion to dismiss until case events and the passage of time rendered it moot: 

  • After more than a year had passed without a decision on the motion to dismiss, discovery closed. 
  • Then two years passed, and defendant filed its summary judgment motion. 
  • Then three years passed. 
  • Finally, the Court granted the motion for summary judgment, which brings us to the opinion that is the subject of our present post.  After it does so, the clerk administratively closes the motion to dismiss in the process of closing the case, meaning that first motion to dismiss was never heard and never decided. 

So much for the prohibition against plaintiffs “unlocking the doors” to discovery with an inadequately-pled or legally-barred claim. 

We are frustrated just recounting these facts, because we do not think this is anyone’s idea of the swift and efficient administration of justice.  Sadly, we have been in this situation ourselves, with preemption motions pending unheard as the months and years click by.

This situation also reminded us of the pair of preemption motion to dismiss denial/preemption summary judgment grant opinions we wrote about in this post. 

Setting our frustrations aside, we now turn to the opinion at hand, which would have been a perfectly acceptable preemption decision had it been issued three years earlier on motion to dismiss.

The plaintiff in Gregory had been implanted with a urinary control device, a Class III medical device approved by the FDA through the PMA process.  This is a product liability case, so of course alleged device failures and a revision surgery were involved.  The plaintiff asserted the usual assortment of claims—strict liability, negligence, breach of express and implied warranties—and he threw in a few extras, like a New York General Business Law claim alleging deceptive representations related to the device.

As you would expect, the court’s analysis centered on the express preemption provision, 21 U.S.C. § 360k(a), which prohibits states from imposing requirements “different from, or in addition to” federal requirements applicable to medical devices, and Riegel.  The court reiterated that state law claims are preempted unless they are “parallel” to federal requirements—i.e., premised on a state law claim that involves a parallel federal duty, rather than a state law claim that would impose additional or different obligations beyond the federal requirements in effect for the device.

Strict Liability, Negligence, Strict and Negligent Infliction of Emotional Distress

Plaintiff’s claims for strict products liability and negligence were found to be preempted, as were the related claims for negligent or intentional infliction of emotional distress.

Although “Plaintiff [did] assert, albeit in conclusory fashion, that Defendant’s manufacturing process violated federal requirements…. Plaintiff does not explain how Defendant’s manufacturing process violated federal law.”  Moreover, “to survive MDA preemption, a plaintiff cannot simply demonstrate a defect or a malfunction and rely ‘on res ipsa loquitor’.”

Given that plaintiff never identified any particular manufacturing-related PMA violation on summary judgment, you can bet his complaint never articulated what that alleged violation was either.  So, good on the court for recognizing that conclusory assertions of noncompliance are insufficient, but that was a light bulb that should have gone off three years earlier. 

Implied Warranty

The court likewise dismissed the implied warranty claim, because the FDA had granted premarket approval and plaintiffs cannot used implied warranty to demand a different, allegedly safer design.  As the court acknowledged,

“[t]o do so would impose different and additional requirements to federal law. And again, Plaintiff’s allegations in support of this claim are scant. Plaintiff has not identified a particular defect in the device or a particular FDA requirement Defendant allegedly violated.” 

Really?  Bet that was true at the pleading stage as well. 

Express Warranty

The express warranty claim was preempted to the extent it was based on FDA-approved representations and, in any event, there was no evidence the defendant made any express warranty to plaintiff, either directly or through his physician, anyway.  (And also, promises the plaintiff’s doctor allegedly made about the device’s longevity were not attributable to the defendant manufacturer, as the doctor was not the manufacturer’s agent.)

Deceptive Business Practices

Plaintiffs’ New York deceptive business practices claim was also preempted to the extent it challenged FDA-approved promotional materials. The court further found that, even if the claim were not preempted, plaintiff failed to provide evidence of any materially misleading statement by the defendant regarding the device’s expected lifespan.

So, there you have it.  The decision in Gregory reaffirms the formidable barrier that federal preemption poses to state law claims involving PMA-approved Class III medical devices. Plaintiffs must plead and prove specific violations of federal law to avoid preemption; generalized allegations of defect or malfunction are insufficient. 

Eventually.

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Some litigations are gifts that keep on giving. A big chunk of DDL work product consists of commentary on a couple of mass torts. Maybe it is a version of the 80-20 rule, or how a huge percentage of crimes are committed by a relatively small group of career criminal recidivists. For a while, Aredia-Zometa cases consistently supplied grist for our mill. The pelvic mesh gave us a lot of rulings (mostly lousy) by the MDL courts, and a lot of rulings (mostly good) by the remand courts. More recently, it looks like the Bair Hugger MDL will never stop issuing interesting decisions. Early on, those decisions were not so good.  But lately, the courts (often the remand courts, so that pattern in itself is noteworthy) have been reassuringly sane. 

One of the most basic elements of product liability is product identification. The very name “product liability”suggests as much. The plaintiff had to be injured by the defendant’s product.  That fundamental requirement was lacking in Prichard v. 3M Co., 2025 WL 2586388 (N.D. Ga. Aug. 19, 2025), a decision in a case remanded from the Bair Hugger MDL.  

Recall that the Bair Hugger is a medical device used to regulate patient body temperature during surgery. Recall, also, that plaintiffs claimed infections due to contaminants from the device.  The Prichard complaint was a dreaded MDL short-form complaint, which is often a vehicle for sloppiness or outright fraud. Prichard’s complaint was ridiculously overpleaded (originally 19 separate causes of action) in typical MDL style. But none of those causes of action can survive absent product identification. There simply cannot be, say, causation, without product identification.  

MDL courts are too often too lax about requiring product identification.  That is why MDL’s have grown to a point where they constitute a gargantuan percentage of the civil docket.  Rather than police bloated inventories by insisting on some proof of product identification (and injury and causation), some MDL judges devote all their time to dreaming up ways to force settlement.  But once a remand court is facing the prospect of trial, that court becomes less interested in social engineering and more interested in not wasting judicial resources and jury time on garbage cases.  At that point, courts pay more attention to such niceties as product identification. 

Prichard reminds us of a bank robbery case in which the teller identified the FBI case agent as the crook. (That actually happened to one of our colleagues.  We had a jolly time taping trial transcript pages on his door.) In Prichard, the plaintiff’s medical records listed only a serial number identifying the device used during surgery. When the hospital was subpoenaed, it turned out that the number identified a device that wasn’t a Bair Hugger at all. 

Did the plaintiff realize he was mistaken and try to get his lawsuit right?  He did not.  Rather, the plaintiff’s convenient testimony, first appearing in his fact sheet, was that some unidentified nurse gave him something she called a “Bair Hugger” during surgical prep.  Unfortunately for plaintiff, that “evidence” (how many times have plaintiffs tried to fill in an essential evidentiary gap with a purported oral statement made by an unidentified employee?) did not prevent summary judgment, because it was blatant hearsay. Remember that inadmissible hearsay cannot defeat summary judgment.  The plaintiff had not attempted to identify the nurse, nor did he, personally, know what a Bair Hugger looked like.  

Beyond that, evidence that the hospital had purchased several of the defendant’s products more than a 15 years before the plaintiff’s surgery was not enough, given the positive identification of a different product in his medical records.  The hearsay and the sometime use of the product by the hospital might have been enough to survive lax MDL plaintiff vetting, but it could not prevent summary judgment in the remand court.  

Moreover, that one of the defendant’s heating devices was used during surgical prep did not mean that it was used during the surgery itself, where the claimed injury took place.  

The plaintiff attempted to exploit the defendant’s answer to the complaint, which admitted that the plaintiff’s “medical records indicate that the Bair Hugger may have been used in this procedure.”  That was then and this is now.  Allowing for a possibility means little, especially when there was “now evidence to the contrary, which cannot be supplanted by the parties’ earlier speculation.”  (Still, this sort of thing lends credence to the Roy Cohn school of litigation: deny everything.) 

By now, most of you can guess what the plaintiff’s last ditch argument against summary judgment was: more discovery, please. But discovery was closed, and that actually mattered to this court. In any event, a plaintiff cannot oppose summary judgment with “vague assertions” about what additional discovery might reveal. The court granted the defendant summary judgment, and denied the plaintiff’s request for further amendment of the complaint. 

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Today’s guest post is from Dechert’s Brooke Meadowcroft who brings us her take on an unfortunate learned intermediary ruling out of Illinois. As always, our guest posters deserve 100% of the praise (and any of blame) for their posts. Not that we expect the latter. 

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The learned intermediary doctrine is the elegant legal principle that says when it comes to prescription drugs and medical devices, the manufacturer satisfies its duty to warn by informing the prescribing doctor—not the patient—because, well, four years of medical school and three years of residency trump three hours on WebMD. But apparently, some courts think that when a plaintiff brings a consumer fraud claim (as opposed to a failure to warn claim), the learned intermediary doctrine need not apply. And with that, the curtain falls on logic.

Ignoring state court decisions interpreting the Illinois Consumer Fraud and Deceptive Business Practices Act (“ICFA”) on this very issue, the Northern District of Illinois, in Swieczkowski v. BillionToOne, Inc., recently ruled that the learned intermediary doctrine was not a bar to the plaintiffs’ ICFA claim. 2025 WL 2483345, at *3 (N.D. Ill. Aug. 28, 2025).

In Swieczkowski, the plaintiffs brought various claims against the defendant, which produced a non-invasive prenatal test that allegedly screened for chromosomal abnormalities and is only available by prescription. Id. at *1. The “Unity Complete Test” (“Unity Test”) included a screening for Trisomy 18, a fatal chromosomal disorder. Id. Plaintiffs allege their physician was marketed the Unity Test by the defendant and shown advertising materials that included a representation that the test had a 99.9% sensitivity rate. Id. The plaintiffs’ physician recommended the plaintiffs undergo the test, which they did. Id.

The results of the Unity Test showed that the fetus’s risk of having Trisomy 18 was less than 1 in 10,000. Id. at *2.However, when the plaintiffs’ child was born a few months after the test was administered, a blood test revealed that the child had Trisomy 18. Id. The child later passed away from complications from the condition. Id.

The plaintiffs alleged that the Unity Test’s results were misleading and false because the 1 in 10,000 risk calculation failed to account for the risk of a false negative, and the defendant’s own study allegedly revealed a false negative rate much higher than .0001. Id. The plaintiffs also asserted that the 1 in 10,000 figure was also false and misleading as it indicated that the Unity Test was diagnostic, when it was actually just a screening tool. Id. The plaintiffs alleged violations of the ICFA and common law claims of fraud and negligent misrepresentation in their lawsuit against the company. Id. at *1.

The defendant, in its motion to dismiss the plaintiffs’ suit, alleged that the plaintiffs’ claims were barred under the learned intermediary doctrine because the limitations associated with screening tests are well known in the medical community. Id. at *2.

The court denied the defendant’s assertion that the learned intermediary barred the plaintiffs’ claims. First, the court stated the defendant did not cite any caselaw where an Illinois court applied the doctrine to an ICFA claim (more on this later). Id. at *3. The court differentiated between the defendant’s cited caselaw, which focused on applying the doctrine when evaluating product liability actions based on a failure to warn theory, versus the plaintiffs’ claims, which relied on a fraud/misrepresentation theory. Id. Thus, the learned intermediary doctrine couldn’t apply here as the plaintiffs weren’t claiming that the Unity Test posed safety/use risks. Id. While the court later denied the defendant’s motion to dismiss, finding that the plaintiffs’ claims were sufficiently supported by the alleged facts, id. at *6, the real absurdity of Swieczkowski is its conclusion that the learned intermediary doctrine is completely irrelevant in the context of the ICFA (and other state consumer protection laws).

The distinction between consumer fraud and failure to warn in the prescription product context is a legal fiction so thin, it would make a Hollywood scriptwriter blush. The whole point of the learned intermediary doctrine is that in the prescription drug universe, manufacturers communicate warnings and representations to doctors, not patients. Whether those representations involve risks or benefits, side effects, or odds of success, the target audience is the same: the learned intermediary. The patient is not relying on representations by the manufacturer, something which is a core element of causation in any fraud claim. But rather, the patient relies on the physician to apply his/her training, experience, and knowledge to interpret the information provided by the manufacturer, among other sources of data. The learned intermediary breaks the causal nexus.

Rest assured, Swieczkowski does state that in cases involving products liability actions, the doctrine will be more applicable than in a pure fraud/marketing misrepresentation case. So drug/medical device manufacturers can breathe a sigh of relief knowing that at least the doctrine is alive and well in Illinois for failure to warn claims. But in so ruling, the court completely overlooked decisions both by Illinois state courts and federal courts applying Illinois law that have already applied the learned intermediary doctrine to ICFA claims, as we’ve discussed and cited here before. In so doing, Swieczkowski violates a fundamental rule of diversity jurisdiction: federal courts cannot alter the state laws they’re applying, as doing so would run afoul of the Erie doctrine. Which, as much as lawyers would like to avoid Erie and its many complexities, is unconstitutional. Allowing otherwise would let federal courts completely rewrite state laws, creating a Wild West of forum shopping and judicial activism for state consumer protection laws.

So really, there should be no battle on this issue. It has been decided. Unfortunately, by pretending that consumer fraud claims in the context of prescription products are meaningfully different from failure-to-warn claims, Swieczkowski has turned the Land of Lincoln into a land of legal opportunism. It incentivizes artful pleading over honest lawyering where plaintiffs who know they can’t outrun the learned intermediary doctrine, slap a consumer fraud label on their claim and are back in business. If semantics are allowed to override substance, we risk turning the learned intermediary doctrine into the ignored intermediary doctrine, and that’s just bad law.

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Have you ever heard of the “Presentment Clause” to the United States Constitution?  U.S. Const. Art. I §, cl. 2.  While we can’t say that we had never heard of it – we are aware of presidential vetoes, pocket vetoes, and such – we had never had occasion to consider it in the context of the legal work we do defending prescription medical product liability litigation.  That changed with In re Gardasil Products Liability Litigation, ___ F.4th ___, 2025 WL 2535105 (4th Cir. Sept. 4, 2025), which we recently discussed, here.

Continue Reading Presenting the Presentment Clause
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Several of our Reed Smith bloggers are planning to be in New York on December 3–4 for ACI’s 30th Annual Conference on Drug and Medical Device Litigation. We’re looking forward to hearing Bexis’ participation on a 30-year retrospective panel and other insightful content, while also enjoying valuable networking opportunities and hopefully the chance to connect with some of our loyal readers.

We’re also pleased to share that ACI has invited the Blog to serve again as a media sponsor this year. As part of that, they’re offering our readers a special 10% discount on conference registration. Just be sure to use the code D10-999-DDLB26 when you sign up. Book before the September 19th early bird deadline and save even more!

You can register here. We hope to see you in New York!

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We’ve blogged recently about good preemption decisions in the Filshie Clips litigation from the Southern District of Texas (per Bexis, “as good a PMA medical device preemption decision as a defendant has a right to expect”) and the Northern District of Georgia. Today we add another preemption win in the same litigation from the Middle District of Florida.  Rebando v. Coopersurgical, Inc., 2024 WL 6816971 (M.D. Fla. Sept. 3, 2024).  As a quick refresher, Filshie Clips are medical devices that underwent the FDA’s premarket approval process. The defendants have been successfully relying on the express and implied preemption provisions under the Medical Device Amendments to the Food Drug and Cosmetics Act. Rebando follows that trend. It’s a short and sweet decision flatly rejecting claims based on alleged failures to report adverse events.

Plaintiffs in Rebando premised their failure to warn claim on allegations that the defendants failed to submit adverse event reports to the FDA.  But the Eleventh Circuit has directly addressed these types of “failure to report” claims and held that they are impliedly preempted. Mink v. Smith & Nephew, Inc., 860 F.3d 1319 (11th Cir. 2017).  Rather than trying to distinguish Mink, plaintiffs suggested that their “artful drafting” of the complaint to avoid preemption—which got them past the defendants’ motions to dismiss—should be enough to get them past summary judgment. Not so, said the court:

The Court agrees that Plaintiffs artfully drafted their Complaint to avoid dismissal—as evidenced by the fact that Defendants’ Motions to Dismiss were denied—however, this case is no longer at the motion to dismiss stage. At this point, Plaintiffs must actually present evidence that their failure to warn claims consist of more than a failure to report adverse events to the FDA. Plaintiffs have failed to do so.

Id. at *4 (which makes us think it’s a shame that defendants have to spend significant resources defending against preempted claims past the motions to dismiss stage based on “artful drafting” of initial pleadings).  

Plaintiffs also argued that the Eleventh Circuit got it wrong on implied preemption. The court disagreed and held that failure to report claims are impliedly preempted.  Since plaintiffs did not present any evidence to support their claims other than allegations of failure to report, the court granted summary judgment on the failure to warn claims.

Like their failure to warn claim, the plaintiffs design defect claim was premised on alleged failures to report adverse events. Plaintiffs claimed the defendants failed to disclose adverse events to the FDA when they were obtaining premarket approval and that proper disclosures would have resulted in the FDA requiring a design change. But this is “precisely the type of fraud-on-the-FDA claim that the Supreme Court determined was preempted.” Id., citing Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 343-44 (2001). Plaintiffs also tried to rely on their claim that defendants failed to submit post-market adverse events, claiming that would have resulted in the FDA requiring a design change. But the court recognized that for what it was—a failure to warn claim repackaged as design defect. The court’s reasoning for granting summary judgment on the failure to warn claim applied equally to the repackaged version characterized as design defect.

Plaintiffs remaining claims all sounded in either failure to warn or design defect, so the court entered judgment in favor of the defendants. We’ll gladly take another preemption decision rejecting failure to report claims (and as a reference, here’s a link to the blog’s prior, 50 state survey on failure to report claims).

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As we have riffed on before, staying apolitical when discussing the science and law implicated by our posts can be harder than one might expect.  That has become increasingly true with regard to litigation over alleged injuries from vaccines, to say nothing of vaccine mandates for public health.  It was not terribly long ago that we would have said that the importance of vaccines in reducing communicable disease and mortality, helping to extend the percentage of people who survive childhood and the average lifespan of humans, was nearly universally accepted.  Similarly, we would have said that the role of the Vaccine Act in reducing the burden of litigation on vaccine manufacturers/developers while providing a no-fault compensation program for “vaccine-related injuries” was also widely accepted by people who follow such things.  The non-acceptors were largely within the plaintiffs’ bar, whose positions we generally see as motivated by profit motive more than an honest reading of the science or a genuine concern about public health.  We are not immunologists or public health experts, so the foregoing was presented as the historic views of lawyers who tend to be on the right side of the v.  Regardless of whether we viewed those who tend to be the other (wrong?) side of the v. as being equally smart and honest on the science, we would not place much stock in what lawyers who make a living advocating say about what the science shows.

Both sides should be able to agree, however, that cancer is bad and medical efforts directed at reducing the incidence of potentially fatal cancers should be supported.  According to this webpage from the CDC from July 2024, presumably from true experts in immunology and public health, in less than two decades of use, the use of vaccines for human papillomavirus (“HPV”) have been associated with a major reduction in the incidence of cervical cancer and the infections that cause most of it.  This is an indisputably good thing.  Does that mean the manufacturers of HPV vaccines have not been subject to lawsuits claiming injuries?  Of course not.  Indeed, litigation led to the creation of the first MDL for a vaccine on the Vaccine Injury Table.  Since its inception in 2022, the Gardasil MDL has produced a number of favorable rulings, one of which was recently affirmed by the Fourth Circuit.  In re: Gardasil Prods. Liab. Litig., — F. 4th –, 2025 WL 2535105 (4th Cir. Sept. 4, 2025).  One of the issues in that decision, the rarely presented Presentment Clause, got us thinking and will be the subject of a deeper dive in the coming days.  With that teaser hanging, we will discuss the whole of the In re Gardasil appellate decision here.

The appeal involved both the order dismissing three particular plaintiffs and two broader “bellwether” orders from the MDL.  Essentially, the three plaintiffs had sought compensation in the Court of Federal Claims under the Vaccine Act for unspecified (in this decision, at least) “vaccine-related injuries” from the use of the HPV vaccine, but admittedly did not do so within the statutory period.  Id. at *2.  The vaccine court’s special master rejected the claims as untimely and not entitled to equitable tolling.  Rather than pursue appeal options under the Vaccine Act, the plaintiffs pivoted to suing the vaccine manufacturer in the MDL.  The MDL dismissed the cases for failing to comply with the statutory predicates and being untimely.  Id.  The MDL had previously ruled that certain counts asserted by the bellwether plaintiffs were preempted and should be applied to all the plaintiffs.  See generally here on vaccine preemption.  Along the way, the MDL court rejected the non-bellwether plaintiffs’ argument that the addition of vaccines like the HPV vaccine to the Vaccine Injury Table provided for in the Vaccine Act violated the Presentment Clause, even though Congress later took action to adopt the additions and impose an excise tax.  Id. at *3.  If that argument has been accepted, then the Vaccine Act would impose no requirements before a product liability lawsuit could be brought.

The Presentment Clause argument on appeal attacked both the Secretary of HHS’s addition of the Gardasil HPV vaccine to the Vaccine Injury Table in 2007 and the Secretary’s general authority to amend the specified injuries and timeframes on the Table for the covered vaccines.  The latter argument was not preserved below, so it was waived.  Id. at *7-8.  It also has no logical connection to why plaintiffs lost in the Court of Federal Claims and the MDL, other than as a backdoor way to challenge the constitutionality of the entire Vaccine Act.  The Fourth Circuit did not engage in overkill and address the merits of second argument.

The analysis of the merits of the first argument was straightforward.  The CDC had already recommended HPV for routine administration to eleven and twelve year old females and Congress had already passed an excise tax on the vaccine, so the Secretary’s addition of the vaccine to the Vaccine Injury Table was compelled by the Vaccine Act.  Id. at *6.  A case from way back, decided by largely the same Court that decided Plessy v. Ferguson four years later, made clear that an action by the executive branch that was pursuant to direction in a law passed by Congress was not a violation of the Presentment Clause.  See Marshall Field & Co. v. Clark, 143 U.S. 649, 693 (1892).  The addition of Gardasil to the Vaccine Injury Table by part of the executive branch “when conditions built into the statute [were] satisfied” did not usurp Congress’s authority to pass laws and then present them to the President for signature.

The three plaintiffs also challenged their dismissal below based on the argument that the MDL should have independently evaluated compliance with the Vaccine Act’s requirements and found their cases timely is equitably tolled.  In other words, the Fourth Circuit was urged to find that the federal court entertaining a tort suit against the vaccine manufacturer can ignore the procedural requirements of the Vaccine Act when it chooses simply because the civil suit—as opposed to the claim against the Secretary of HHS pursuant to the compensation program—is characterized in the Vaccine Act as “de novo.”  This is a creative, if not fanciful, argument given the actual language of the Vaccine Act.  The Vaccine Act imposes both statute of limitations and exhaustion requirements before the manufacturer can be sued.  The Vaccine Act also empowers special masters to decide timeliness and other requirements for compensation.  Moreover, it provides for review of a special master’s decisions by the Court of Federal Claims and later the Federal Circuit, not by other courts.  Id. at *9.  “If a special master finds a petition untimely, the claimant can only seek relief from that decision in the Court of Federal claims and, subsequently, the Federal Circuit.”  Id.  The characterization of a suit against the manufacturer as de novo means any “findings of fact and conclusions of law” from the proceeding against the Secretary of HHS are not admissible in the civil lawsuit against the manufacturer, “[b]ut it doesn’t require courts facing tort suits to disregard Vaccine Act proceedings.”  Id.

In addition to a district court—even a mighty MDL—having no authority to second-guess the special master’s decision on timeliness, the plaintiffs would be precluded from relitigating the issue they lost in the vaccine program and elected not to challenge within its confines.  Id. at *10. 

The special master who decided Plaintiffs’ Vaccine Act petitions concluded that their petitions were untimely. Plaintiffs didn’t pursue review of that determination in the Court of Federal Claims and, therefore, that ruling stands. Thus, Plaintiffs can’t sue Merck. It also means that Plaintiffs aren’t entitled to discovery in this case to allow them to establish equitable tolling with respect to their petitions.

Id. at *11.  All in all, this was a firm rejection of attempts to moot the requirement of the Vaccine Act so that the plaintiffs could proceed unfettered.  This decision was consistent with the clear intent of Congress that there should be protections for the manufacturers of important childhood vaccines and a no-fault option for compensation for claimants.  We know the plaintiff lawyers play games within the vaccine compensation program.  In an appeal from an MDL where the basis for plaintiffs’ claims has been lacking, it is good to see the continuing gamesmanship fail again.

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Whenever we see a class action in which the named plaintiffs suffered no injury, we throw up our hands and think that the invention of class actions was a wrong turn in American legal history. But when we see a case like Klosowski v. FPG Labs, LLC, 2025 WL 2532500 (D. Del. Sept. 3, 2025), we calm down a bit, reminded that there are tools courts can employ to cabin the madness. 

In Klosowski, nine individuals sued companies that provided genetic testing designed to increase the effectiveness of the IVF implantation process.  The defendants represented that their testing was more “than 98% accurate, increases the chance of pregnancy, decreases the chance of miscarriage, leads to higher chance of a healthy pregnancy, and reduces the time to pregnancy.”  The plaintiffs alleged that these representations were false, and brought claims for violations of various state consumer protection statutes, common law fraud, breach of warranty, and unjust enrichment.  They sought certification of a nationwide class, as well as several state subclasses. 

The defendants moved to dismiss the complaint for lack of standing and failure to state a claim.  Why?  None of the named plaintiffs alleged that the genetic testing they bought failed to work for them. 

One wonders what these plaintiffs and their counsel were thinking.  None of the class representatives could possibly have suffered the solely economic injuries that the complaint raised.  “In essence, Plaintiffs claim they overpaid for a product that did not work as it was supposed to — despite Defendants’ representations that it did. This is known as the benefit of the bargain theory.” But as far as we or the court can tell, the tests worked and the plaintiffs got what they paid for – the full economic benefit of their bargain.  

The court wasted little time in dismissing the complaint for lack of standing. The complaint cited studies purporting to undermine the scientific efficacy of the genetic testing.  So what?  “Allegations that a product is [flawed] as to others are not relevant to determining whether named plaintiffs have standing themselves.”  

Plaintiffs themselves must suffer an actual injury, not some generalized interest.  None of the risks that the plaintiffs alleged came to pass for them.  Indeed, as the Klosowski court pointed out, “some of these adverse outcomes are directly in conflict with and mutually exclusive of one another.”  

Purchasing something that was purportedly “improperly marketed” is not a cognizable injury in and of itself.  The class allegations purported to bring claims on behalf of everyone who ever purchased the product “with no mention of harm whatsoever.”  Such allegations are bereft of any concrete injury-in-fact that could support standing.  The Klosowski court relied on two Third Circuit cases we have discussed before. 

The court did not reach the issue of whether plaintiffs had standing to assert claims outside their home states, but urged the plaintiffs to consider that issue if they chose to amend the complaint.  Any class claim was foreclosed under Louisiana law, so at least that part of the complaint was dismissed with prejudice. 

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It’s twenty-four years post-Buckman and here we are still talking about the dismissal of cases premised on allegations that a manufacturer made misrepresentations to the FDA. Which means plaintiffs are still filing them.  We thought Buckman was the legal equivalent of a big red “STOP” sign. But it seems not everyone got the message.  So here it is again.  The federal Food, Drug & Cosmetic Act (“FDCA”) doesn’t have a private right of action, which means you can’t sue someone just because they violated FDA regulations. It’s the FDA’s job to enforce the FDCA. It has investigators, auditors, warning letters, and lots of fun acronyms. If a manufacturer actually misrepresented something, the FDA can handle it. It doesn’t need a tort suit from New York or California or any parts in between to tell it how to do its job. If that wasn’t clear enough, try this. If your claim is that the manufacturer misled the FDA, that claim exists solely by virtue of the FDA’s regulatory scheme. In other words, if the FDA didn’t exist, your lawsuit wouldn’t either. That makes it 100% federal territory and 100% impliedly preempted.

So, what if –hypothetically speaking– plaintiffs brought a putative class action against the manufacturer of a cochlear implant system alleging that the device fails to perform as expected and that they were misled into purchasing the devices. And let’s assume that the sole foundation for their claims is an allegation that the defendant provided fraudulent test results to the FDA during the pre-market approval process. One would assume that between PMA-preemption and Buckman preemption such a lawsuit should not exist. Unfortunately, Gibson v. Advanced Bionics, LLC, 2025 U.S. Dist. LEXIS 170605 (C.D. Cal. Sep. 2, 2025), isn’t hypothetical, those were the allegations, and defendant did have to spend the money to get it dismissed. But dismissed it is.  

Before we get to the preemption analysis, we should note that plaintiffs are residents of Arizona and defendant is a California company, but the complaint alleged a nationwide class. The court found plaintiffs only had standing to pursue claims under the laws of Arizona and California, all claims under any other state’s law were dismissed. Id. at *9-10.  

That didn’t really matter here because the entire case was dismissed as preempted. Plaintiffs’ fraud claims were both expressly and impliedly preempted. To the extent plaintiffs tried to argue defendant had a continuing duty to disclose, that is asking the court to impose a requirement that is “in addition to” what the FDCA requires and therefore the claim is expressly preempted. Id. at *14-15. So too are challenges to FDA-approved statements. As part of the PMA process, the FDA reviews the manufacturer’s promotional materials. Plaintiffs did not allege that defendant went beyond those approved statements, so any finding that those statements are fraudulent would impose a requirement “different from” those imposed by federal law. Id. at *15-16.

Such claims also are impliedly preempted. Any duty to provide test results or communicate with the FDA exists solely because of the FDCA. Furthermore, the FDA was aware of plaintiffs’ allegations and took no action against the manufacturer.  It’s up to the FDA to investigate potential violations of the FDCA, not private plaintiffs. Id. at *16-17.

Plaintiffs’ express warranty claim was likewise based on statements made in the device’s FDA-approved labeling and therefore was likewise expressly preempted.  Id. at *18-19.  So too was plaintiffs’ implied warranty claim since it challenged statements made in promotional materials that were reviewed and approved by the FDA. Id.at *19-20. And while plaintiff also tried to bring a breach of contract claim, it suffered from the same problems as it was based on the same FDA-approved statements. Id. at *20-21.

Since leave to amend would be futile, the dismissal was granted with prejudice.

If Buckman was a STOP sign, plaintiffs should read the twenty-four years of further legal precedent as steel bars bearing a federal seal and a very clear sign that says: “Private Enforcement Not Allowed. Go Home.”

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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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