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We’ve been defending drug and device litigation for a long time, and we’ve seen many plaintiffs who experienced real injuries. Those of us at the blog, our colleagues at other defense firms, and our clients are genuinely sympathetic to injuries a plaintiff actually experienced. Many plaintiffs we’ve encountered also endured terrible circumstances earlier in their lives. Some of those can be heartbreaking. Defending cases on the basis that our clients’ products did not cause the injury or that the injury was a known and warned of risk doesn’t mean the defense bar looks askance at plaintiffs and their experiences.  But, when we see a case involving a syringe needle purportedly propelled into a plaintiff’s derrière, some of us might exhibit a moment of minor moral weakness and include the above title in a blog post. Mea culpa.

Today’s case, Rudzinskas v. Retractable Techs., Inc., 2025 U.S. Dist. LEXIS 191860 (S.D. Ga. Sept. 29, 2025), involves a type of syringe that automatically retracts once the plunger handle is fully depressed.  Plaintiff’s husband regularly administered vitamin B-12 shots to her and had been doing so for six or seven years. Plaintiff claimed that, on one of those occasions, the needle from defendant’s syringe “shot into [her] like a slingshot.” Id. at *4.  Plaintiff went to the hospital and an ultrasound suggested the needle was embedded in the plaintiff’s buttock. Plaintiff underwent surgery to have the needle removed, but the surgeon was not able to extract it. 

Continue Reading A Real Pain in the  . . .
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Not too long ago, we tried to extrapolate from a doctoral thesis on quantum dots to lessons for litigation.  That “[q]uantum dots are between one-billionth of a meter and one-hundred-millionth of a meter in size” emphasized that “appreciating the scope and scale of what is being discussed can be critical.”  In the spate of litigation over alleged contaminants and degradation products in a variety of over-the-counter and prescription drugs, it seems rare that the plaintiffs want to talk about scale beyond that a particular chemical can be detected at all.  Not us.  Trace chemicals in a sample are often discussed in terms of parts per million (“ppm”).  The amount of a chemical that is known to be harmful (e.g., carcinogenic) in a particular organism might be discussed in terms of grams of exposure per kilogram of body weight of the organism, sometimes with a frequency included.  The number of molecules in a mole of a substance is about 602,214,076,000,000,000,000,000.  The number of molecules in a gram of substance depends on the molecular weight of the substance, but it will typically be in the sextillion range.  For a little context, 1 ppm would be one person out of ten stadiums full of 100,000 people each.  If that person weighs 75 kg, then a risk threshold (or lowest observable effect level) of 1 gram per kilogram of body weight per day would require 75 grams per day.  If we are talking about 200 mg of an NSAID, then that person would need to take 375 of them per day.  If we are talking about a trace contaminant or degradation product that occurs at 2 ppm in that NSAID, then that person would need to take 187,500,000 of those NSAIDs per day to hit that threshold.  We could probably go on discussing the number of molecules, the molecular weight of benzene, or other math-adjacent stuff that would make Thomas Dolby proud.  We will not, but this exercise is actually relevant to a case based on a claim that the medical product at issue has a detectable trace amount of benzene or some other contaminant or degradation product in it.

This week, we have two separate purported class actions for consumer protection over different OTC drugs that were dismissed by two very different courts on preemption grounds.  Kouyate v. Harvard Drug Grp., LLC, No. 1:24-cv-6223-GHW, 2025 U.S. Dist. LEXIS 190152 (S.D.N.Y. Sept. 26, 2025), concerned an acne face wash that contained benzoyl peroxide.  Leonard v. CVS Pharmacy, Inc., No. 5:24-cv-06280-EJD (N.D. Cal. Sept. 29, 2025), concerned cold and flu medicines that contained guaifenesin.  Although we used the past tense above, each plaintiff was given the chance to replead non-preempted claims.  Each also based his/her claims on the purported presence of small but unspecified amounts of benzene in their respective products and the respective manufacturer’s failure to deviate from the FDA-required labeling to describe the purported benzene.  We think that these decisions are close enough to discuss together, adding to our many prior posts about similar claims, including with these same drugs.  See here, here, and here for a sampling.  Kouyate came out first and has a more extensive preemption discussion, so we will address it first.

The plaintiff in Kouyate bought his OTC acne wash knowing it had benzoyl peroxide and purportedly believing it did not have any benzene in it.  (The complaint actually alleged that plaintiff filled a prescription, but that seems like the same sloppiness the court noted from the lawyer re-using complaints.  2025 U.S. Dist. LEXIS 190152, *9 n.3.  This is an OTC product.) He alleged that benzoyl peroxide can degrade into benzene over time, and that an “independent laboratory” found his acne wash had “unsafe levels of benzene” in it.  Id. at *1.  Based on this, he brought a class action under New York law for false advertising, common law fraud, and negligence per se based a state criminal statute banning misbranded and adulterated drugs.  To us, these allegations scream preemption, both express preemption and under Buckman.  Yet, the court offered a careful analysis of the preemption issues, an analysis that we think would have supported not giving plaintiff a third shot to plead non-preempted claims.  We also think that the court’s conclusions that plaintiff had not pleaded the false advertising claim—which required an affirmative misrepresentation—or a common law fraud claim—which required the basic fraud elements pled with particularity—also supported not giving plaintiff another shot on those claims.  Id. at *47-56.  (Evaluating the adequacy of pleading first, as we usually advise, also might have helped.)  It also should have been pretty clear that any attempt at negligence per se, even though based on a violation of state law, would be preempted because it amounted to a stop selling claim.  We are getting a little bit ahead of ourselves, though.

The product at issue in Kouyate was governed by a monograph that set out specific requirements for the labeling of a benzoyl peroxide containing acne wash, including the percentage of benzoyl peroxide, a list of inactive ingredients, specific warnings, and directions.  The monograph does not require or otherwise address any disclosure of the possibility that some small amount of benzene might be created by the degradation of the benzoyl peroxide.  The labeling for defendants’ products uncontestably complied with the monograph requirements and did not include any affirmative misrepresentations (e.g., “This has no benzene,” “None of the ingredients will ever degrade into another chemical substance at all.”).  Keeping in mind that the plaintiff did not assert any product liability claims that would have been exempted from the express preemption provision for OTC drugs, the simple conclusion was that any change in labeling plaintiff claimed was required to avoid violating the state false advertising statute and/or common law fraud requirements was going to be “different from or in addition to [or] otherwise not identical with” the FDCA requirements imposed through the monograph.  Id. at *24-26.  Relying heavily on the Second Circuit’s decision in Critcher, which evaluated the express preemption provision for cosmetics in the context of a case about the labeling of the amount of skin cream in a container, the court rejected the argument that the FDA requirements were insufficiently specific to preempt plaintiff’s claims about additional labeling language.  Id. at *27-31.  Indeed, benzene, whether present at 2 ppm or more, is not “an active or inactive ingredient that needs to be disclosed in the label” because it was not “a purposefully added component of the drug.”  Id. at *27.  (Not long ago, we discussed a decision that postulated that a quasi-manufacturing defect claim could exist because the allegedly harmful substance was not purposefully added to the product.)

Not long before plaintiff bought his acne wash, FDA had advised that benzoyl peroxide products with more than 2 ppm of benzene should not be sold.  However, the monograph had not yet changed, and the acne wash complied with current requirements.  That did not change the analysis.  Nor did the related argument that the manufacturer should have updated its labeling through the same CBE mechanism that confounded the Supreme Court in Levine.  But Kouyate recognized that monograph drugs like the acne wash could not use the CBE regulations.  Id. at *34.

That left the negligence per se claim, which was designed to avoid preemption based on the carveout from preemption under 379r(f) when state requirements identical to FDCA requirements are the basis for liability.  Plaintiff argued that the same labeling issues preempted under his other theories were not preempted because the drug was misbranded under state law; he also argued that the drug was adulterated under state law because having benzene above 2 ppm rendered it harmful, worthless, and illegal to sell.  The problem for plaintiff was that trace benzene from the degradation of benzoyl peroxide does not make the acne wash misbranded or adulterated under the FDCA.  Id. at *38-41.  If, as plaintiff claimed, degradation into benzene is a known, inevitable process, then no acne wash could contain benzoyl peroxide.  Yet, FDA considers these benzoyl peroxide drugs, otherwise compliant with the monograph, to be safe and effective.  Id. at *40.  The mere allegation that the trace amount in plaintiff’s particular product exceeded 2 ppm does not matter because the monograph does not impose any such limit.  The only sources of any such limit are FDA guidances and other non-binding authority.  Id. at *40-43.  Plaintiff’s other arguments, which did not really tie to recognized state law anyway, were unavailing.  We do think that plaintiff’s theories of liability sounded like the stop selling arguments rejected in Bartlett and many cases since.  So, it is hard for us to see how plaintiff can plead non-preempted non-products claims based on the mere presence of benzoyl peroxide and labeling compliant with the current monograph.

The preemption analysis in Leonard was shorter, but no less correct.  The generic OTC drug had an approved ANDA, but it also had monographs relevant to plaintiff’s theory that the defendants had to disclosure that an inactive ingredient, carbomer, was manufactured with benzene.  Like Kouyate, there was certainly no FDA requirement to disclose how the carbomer was made or to refrain from using carbomer made with benzene.  The regulatory requirements were also in some flux when plaintiff purchased her medication in July 2024.  At that time, per FDA guidances, carbomers used as inactive ingredients in drugs were supposed to be in the process of transitioning from a monograph limit of “up to 5,000 ppm” of benzene to a limit of no more than 2 ppm.  Any new requirements, however, were not effective until August 2026.  Unlike in Kouyate, the plaintiff in Leonard did not allege specific testing of benzene in her particular products, just that its choice of carbomer allowed for the possibility of benzene at some level.    She also did not claim that the products failed to comply with actual FDA requirements.  Based on the Dougherty case from the same court, which involved similar claims about a similar product, that meant that any claims based on alleged adulteration or misbranding were preempted.  Id. at *5.  Plaintiff tried to use the decidedly bad decision from the same court in Holley, but the Leonard court recognized that impossibility preemption and express preemption are different.  Id. at *6.  The plaintiff’s claims ran afoul of express preemption by trying to impose requirements different than what the FDCA imposed.  The court also rejected the argument that plaintiff’s claims under California’s version of the federal Sherman Act were automatically parallel claims not subject to express preemption.  But the challenge to “the FDA-approved content and label as adulterated and deceptive” under any claim did attempt “to impose a requirement that is different from or in addition to the federal requirement.”  Id.  As long as plaintiff continues to assert non-product liability claims, it is hard to see how they will not be preempted in Leonard as in Kouyate. 

Given how many times we have written about the preemption of claims based on alleged benzene in FDA-regulated products, including those containing benzoyl peroxide and guaifenesin, we doubt that these will be the last two complaints asserting slightly different versions of the same preempted claims.

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“To be clear, while an association between acetaminophen and autism has been described in many studies, a causal relationship has not been established . . . .”  That is not your DDL bloggers speaking (although we did add the emphasis).  It is not a drug manufacturer speaking, nor any particular doctor or researcher speaking.  It is not even an expert retained by the defense in litigation speaking. 

No, this is the position of the United States Food & Drug Administration, as stated two weeks ago in a Notice to Physicians.  The Notice also said that “there are contrary studies in the scientific literature” and that “acetaminophen is the safest over-the-counter alternative in pregnancy among all analgesics and antipyretics.”  We are also told by people who know that the FDA updated its website less than two months ago to say, “To date, FDA has not found clear evidence that appropriate use of acetaminophen during pregnancy causes adverse pregnancy, birth, neurobehavioral, or developmental outcomes.” 

So there you have it.  The federal government’s position is that acetaminophen used during pregnancy has not been shown to cause autism.  Yet, we as a nation were treated to our President holding a press conference to inform pregnant women that acetaminophen “can be associated with a very increased risk of autism” (which is not true) and telling them “don’t take Tylenol” unless they “can’t tough it out” (which no doctor would say). 

We do not cover politics, but we do cover prescription drugs, and we write today to remind you that we have been through this before.  Plaintiffs in the acetaminophen MDL have been claiming that acetaminophen use during pregnancy causes autism since before that MDL was created in 2022.  More to the point, the district judge presiding over that MDL ruled nearly two years ago that the plaintiffs had presented no reliable expert opinion that prenatal exposure to acetaminophen can cause autism spectrum disorder or ADHD.  In re Acetaminophen ASD-ADHD Prods. Liab. Litig., 707 F. Supp. 3d 309 (S.D.N.Y 2023). 

It was a detailed and exceptionally thorough order, which we covered here and here.  The plaintiffs’ expert epidemiologist was superbly qualified (currently Dean of the Harvard School of Public Health).  But even the best of us cannot make chicken salad out of chicken feathers, and there simply is no accepted causal relationship between prenatal acetaminophen and autism.  As the MDL judge noted, acetaminophen use by pregnant women is common, and autism and attention deficit/hyperactivity disorder are prevalent in U.S. children.  Search hard enough, and you might find some association. 

Causation is different.  We won’t overly rehash what we wrote before, but the court concluded that it was not reliable to draw a causal inference from a mere association.  The vast majority of the published analyses did not find any increased risk of autism or ADHD, and many studies that did find increased risks suffered from problematic data collection and other methodological limitations.  The FDA conducted multiple reviews, and it concluded in 2022 and 2023 that study results did not support a determination of causality. 

The plaintiff’s expert employed a “transdiagnostic evaluation” that applied the Bradford Hill criteria to multiple associations at once.  But that approach only obscured the limitations in the scientific literature, and by blending multiple associations together, it resulted in analysis of questionable relevance.  Even worse, the court found that the plaintiffs expert engaged in classic cherry picking, under which his treatment of a study depended on whether it supported his opinions.  Overall, the court was not impressed: 

In sum, Dr. Baccarelli failed to sufficiently explain the appropriateness of conducting a single Bradford Hill analysis for NDDs [neurodevelopmental disabilities] which included ASD and ADHD, selectively analyzed the consistency of the literature and the issue of genetic confounding, repeatedly pressed conclusions that study authors were not willing to make, and disregarded studies that do not support his opinion due to limitations that he did not view as disqualifying in studies that did support his opinion. Together, these deficiencies demonstrate that his opinion does not “reflect[ ] a reliable application of the principles and methods to the facts of the case.” Fed. R. Evid. 702.

Id. at 356 (quoting Fed. R. Evid. 702).  Having excluded the plaintiffs’ general causation experts, the court granted summary judgment a few months later. 

We are revisiting these developments because the issue was recently headline news.  Moreover, the MDL judge’s order excluding the plaintiffs’ experts is currently on appeal, and the plaintiffs filed a Rule 28(j) letter in the Second Circuit submitting an HHS press release, the FDA’s statements, a transcript of the press conference, and an unsworn statement from their expert as supplemental authority. 

The Second Circuit will not be impressed either.  As we stated at the start of this post, the FDA’s position (“to be clear”) is that a causal relationship between prenatal acetaminophen exposure and autism or ADHD has not been established, and the information that the plaintiffs submitted to the Second Circuit reflects exactly that.  Even worse, the plaintiffs’ 28(j) letter quotes the FDA Commissioner, who himself purported to quote the plaintiffs’ expert Dr. Baccarelli as stating that “there is a causal relationship.”  That is wrong.  In his written statement, Dr. Baccarelli actually reported “the possibility of a causal relationship” and that further research is required “to determine causality.” 

Think about that.  The plaintiffs submitted supplemental “authority” to a United States Court of Appeals prominently citing a misquote of an unsworn statement from an expert who has written time and again that causation has not been established.  Sheesh. 

As far as we can tell, nothing has changed in the science since the MDL judge excluded the plaintiff’s expert’s unreliable causation opinions.  Earlier this year, Dr. Baccarelli and co-authors published a review of studies on acetaminophen and neurodevelopmental disorders, but they found nothing new.  They reported an association between prenatal acetaminophen use and neurodevelopmental disorders, but admitted—as they had to—that “observational limitations preclude definitive causation.” 

The FDA’s statements and the President’s remarks will likely generate more wasteful litigation, which we will be watching.  Also imagine the women who may now be scared away from the standard-of-care treatment for pain and fever during pregnancy, which themselves pose significant risks to fetal health.  This is not the promotion of public health.  We are disappointed. 

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You know it’s going to be an interesting ride when the appellate brief reads like a conspiracy theory starter pack. Which is how we read the issues raised on appeal in Thelen v. Somatics, LLC, — F4th –, 2025 WL 2749888 (11th Cir. Sep. 29, 2025):  erroneous entry of summary judgment on design defect, erroneous merging of strict liability and negligent failure to warn, erroneous jury instruction on proximate cause, improper statement in closing arguments, and abuse of discretion on excluding fact and expert testimony. It’s a kitchen sink approach to be sure. And the appellate court hit the garbage disposal.

Plaintiff suffered from severe depression and other mental health issues, including multiple suicide attempts.  His physician recommended plaintiff undergo electroconvulsive therapy (“ECT”). Over two years, plaintiff received nearly 100 ECT treatments. Thereafter plaintiff was diagnosed with severe memory loss and neurocognitive disorder. He filed suit against the manufacturer of the device used to administer the ECT alleging the usual slate of products liability claims, all of which were premised on defendant’s alleged failure to warn.  Several claims were dismissed pretrial, leaving only negligent and strict liability failure to warn. The jury found the warnings that accompanied the product to be inadequate but also concluded that the absence of adequate warnings was not the proximate cause of plaintiff’s injury. On appeal, the Eleventh Circuit had to sort through plaintiff’s laundry list of reasons they should get a mulligan.

First, plaintiff argued that the district court should not have granted summary judgment on his design defect claim. We aren’t sure why the case was filed in Florida, but there was no dispute that Nebraska law applied. Nebraska uses a consumer expectation test for design defect—does the product have “a propensity for causing physical harm beyond that which could be contemplated by the ordinary user or consumer.” Id. at *6. The alleged design defect was that the defendant did not warn the product might cause “brain damage.” However, the labeling did warn of risks to the brain, such as permanent memory loss and prolonged seizures, among many other serious risks including death. Id. So, while the term “brain damage” was not used, plaintiff did not offer any evidence that a “reasonable consumer” would not understand that the risk of “brain damage” is encompassed in the risk of permanent memory loss. One of plaintiff’s own experts even equated the two. Nor was it sufficient for plaintiff, his parents, and his physician to claim they did not understand the product could cause “brain damage.” Plaintiff had to present objective evidence that the ordinary patient would not have understood the risk. His subjective expectations are irrelevant. Id. at *7.

Moreover, “brain damage” is a pretty broad term. But it’s also vague. If the labeling warned of brain damage, one can imagine lawsuits where plaintiffs complain the warning was not specific enough. What does that mean? Memory loss? Seizures? Cognitive decline? So, where the label already warns about those exact things, what more is the company supposed to say? At some point, common sense has to kick in.

Next, plaintiff argued the district court erred in merging his strict liability and negligence claims because both were premised on failure to warn. Nebraska recognizes the “merger of doctrines” that allows the court to adopt a “single theory approach.” Id. Therefore, because the claims are factually identical, the court did not err in merging them. Plaintiff tried to argue that his negligence claim was also based on a failure to test and failure to investigate, but his counsel acknowledged that both theories required proving a failure to warn in order to succeed.  Id. at *8.

Plaintiff’s next contention was that the court erred in instructing the jury that to establish proximate cause the plaintiff had to prove “that his prescribing physician would have altered his conduct had adequate warnings and instructions been provided.”  Id. Plaintiff tried to argue that the court was wrong to apply the learned intermediary doctrine to causation, as it is only applicable to duty. But plaintiff had no Nebraska authority to support this argument, and federal courts interpreting Nebraska law have concluded the opposite. Id. at *9. Further, during the charge conference, plaintiff’s counsel conceded that the instruction was correct. While later argument technically preserved the issue for appeal, the appellate court found the concession suggestive that the district court was not mistaken and that regardless, plaintiff was not prejudiced by it.  Id.

Relatedly, plaintiff argued that defense counsel incorrectly stated the legal standard for proximate cause in his closing argument and that the district court failed to give a curative instruction.  Defense counsel said that for plaintiff to succeed he would have to prove that his physician “would not have prescribed ECT” if the warnings included the term “brain damage” instead of “permanent memory loss.” Id. Apparently plaintiff thought there was a significant difference between “would have altered his conduct” and “would not have prescribed.”  But what other “altered conduct,” could even be at issue? Again, we are left looking for common sense.  But even if there was some error, plaintiff’s counsel failed to object to the statement until after the jury had started its deliberations.  So, the issue was waived. Id. at *10.

Which brings us to plaintiff’s challenges to excluded evidence.  Plaintiff wanted to introduce a patient consent video featuring his prescribing physician. The district court excluded it finding its probative value outweighed by the potential to mislead and confuse the jury. The video was evidence of the physician’s knowledge, which was already in evidence via his testimony. But, in a learned intermediary case, the focus is on what the defendant disclosed to the doctor, not what the doctor told his patient. Because the video was duplicative and only tangentially relevant to the main issue, the court did not abuse its discretion in excluding it. Id.

Finally, plaintiff argued that the court abused its discretion in excluding the expert testimony of plaintiff’s treating neuropsychologist on medical causation. The expert was not a medical doctor and therefore not qualified to offer a medical causation opinion.  Id. at *11.  He even conceded his lack of qualifications at his deposition.  Further, he did not employ a sound methodology because he failed to rule out alternative causes. Plaintiff’s last-ditch attempt was to argue that as a treater, the witness should have been allowed to offer his opinions as a lay witness.  As the court noted, the cause of a neurocognitive injury is not the same thing as “observing a broken jaw or broken arm.” Id. at *12. This is a classic example of a court forcing an expert to stay in his own lane.  Not every doctor is that type of doctor. 

The bottom line is, that plaintiff was trying to hold defendant liable for not using a vague headline term like “brain damage” which is not a failure to warn. And when both the court and the jury so ruled, plaintiff filed an overreaching appeal that boiled down to “we demand a do-over.” Spoiler: That’s not how litigation works.

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We recently received a couple of links from old friends that we thought we’d pass along.  Decades ago, Bexis and some of our other bloggers worked with Peter Grossi – then a senior partner at Arnold & Porter – defending fen-phen cases in Philadelphia and elsewhere.  Peter is retired now, but he still teaches law part time at UVA.  And he is still thinking important thoughts.

He recently sent us an SSRN link to his forthcoming law review article, “An Outline on How Adding Autism to the National Vaccine Compensation Program Would Likely Destroy It,” which validates – with hard numbers – something Bexis always suspected:  that attempts to add “autism” to the Vaccine Act’s vaccine injury table, using the same junk science that already failed under the Act would really be an effort to bankrupt the Act’s compensation system altogether.  Here’s an excerpt from Peter’s abstract:

Secretary Kennedy and his colleagues at HHS/CDC may soon officially declare that one or more of the childhood vaccines cause autism.  This article outlines the impact of such a sea-change on the docket, and then the very survival, of the National Vaccine Injury Compensation Program (VICP) − a federal “no fault” system which Secretary Kennedy has long opposed as a brake on state tort litigation.

Using CDC data (published before Secretary Kennedy’s appointment), we show that the number of “profound” autism claims that could immediately be filed in the VICP would exceed the total number of all claims processed by the Program for all injuries from all vaccines over the Program’s entire 40-year history.  And that massive number of new claims will then bankrupt the Program.

By all means, read the entire article.

Our second link is from the Blog’s co-founder, Mark Herrmann, now also retired.  He still writes semi-regularly for another blog, “Above the Law.”  His latest piece is entitled, “Does Tylenol Give Mass Tort Defense Lawyers A Headache?”  It also points out something that we’ve been wondering about – “Where do mass tort defense lawyers stand now?”  Many in the prescription medical product liability litigation defense bar “were hardcore Republicans.”  But with Republicans orchestrating the administration’s recent theater of the absurd concerning Tylenol and discredited autism claims, how can we defend that?

Might now be the time to break your inherited allegiance to the Republican Party and move on to sanity?

Doesn’t Tylenol, at long last, give you a headache?

Again, read the entire post here.

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Add Connecticut to the list of Zantac multi-plaintiff losses, following the Florida multidistrict litigation (our “Zantac Chronicles” series of posts, and the Delaware Supreme Court).  Only this time the several hundred Connecticut plaintiffs that were dismissed never even reached the absurd causation allegations that doomed the MDL and Delaware cases.  Rather, these Connecticut plaintiffs didn’t even have a means to establish personal jurisdiction over the non-Connecticut defendants they sued.  Bacher v. Boehringer Ingelheim Pharmaceuticals, Inc., 2025 WL 2463143 (Conn. Super. Aug. 22, 2025).

Continue Reading Hundreds of Non-Resident Zantac Plaintiffs Run Out of Connecticut
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The intersection of the PREP Act federal immunity statute and constitutional law continues to shape the landscape of COVID-19 vaccine litigation.  In Searcy v. Pfizer, Inc., __ F. Supp. 3d __, 2025 U.S. Dist. LEXIS 186682, 2025 WL 2713736 (M.D. Ala. Sept. 23, 2025), the Middle District of Alabama addressed a wrongful death action brought by the estate of a plaintiff who died following administration of a COVID-19 vaccine.  The estate asserted state law tort claims, and challenged the constitutionality of the Public Readiness and Emergency Preparedness Act (“PREP Act”), 42 U.S.C. §§ 247d-6d, 247d-6e.

As you may recall, the PREP Act was enacted to encourage rapid development and deployment of medical countermeasures during public health emergencies by providing broad immunity from suit and liability to “covered persons” for claims “caused by, arising out of, relating to, or resulting from” the administration or use of “covered countermeasures.”

The Act’s only exception is for willful misconduct, which is a claim that: (1) must be brought exclusively in the United States District Court for the District of Columbia;  (2) requires pleading with particularity and a complaint supported by a verification under oath, a doctor’s affidavit, and certified medical records; (3) requires conduct more culpable than negligence or recklessness; (4) can be pursued only after the plaintiff first pursues an administrative claim; and (5) must be proven by clear and convincing evidence.  42 U.S.C. §§ 247d-6d & 247d-6e.

The Act also establishes a no-fault administrative compensation program (the Countermeasures Injury Compensation Program, or “CICP”) for individuals allegedly injured by covered countermeasures.

The Lawsuit

The complaint alleged the decedent was “mandated, coerced, and fraudulently induced” to receive a COVID-19 vaccine as a condition of employment at a hospital (presumably one of the named health care defendants, although the complaint did not explicitly say), and that he died as a direct result of a “vaccine-induced condition” called spontaneous pneumothorax.  

The estate asserted twelve Alabama state law claims in Alabama state court, including wrongful death, failure to warn, negligence, fraud, and conspiracy, and sought both damages and a declaration that the PREP Act is unconstitutional.

But the complaint named a broad array of defendants—including vaccine manufacturers, healthcare providers, and federal officials—so the manufacturer removed.  Because of the federal defendants, 28 U.S.C. § 1442(a)(1) provided federal officer/federal agency jurisdiction, an unusual twist in our tort law world.

All of the defendants then filed motions to dismiss, asserting various arguments about PREP Act immunity, failure to state a claim, and the lack of merit to the estate’s asserted constitutional challenges.

PREP Act Immunity

The court found that all defendants were “covered persons” under the PREP Act, that COVID-19 vaccines are “covered countermeasures,” and that the estate’s claims arose from the administration of a covered countermeasure. To get there, the court had to address the estate’s challenge to the Department of Health & Human Services’ issuance of an Emergency Use Authorization (“EUA”) for the defendant manufacturer’s vaccine.  Issuance of an EUA is “committed to agency discretion” and such discretionary actions are exempt from review under the Administrative Procedures Act, however, so that pretty much was that.

The only real remaining out from PREP Act immunity was the willful misconduct exception, but the estate affirmatively disclaimed any willful misconduct argument.  The estate also argued that wrongful death claims are exempt from PREP Act immunity, but that isn’t in the statute so the court had little difficulty concluding that wrongful death claims are only permitted if they fit within the narrow willful misconduct exception.  

Constitutional Challenges

The battery of constitutional arguments, including alleged violations of procedural due process, the Takings Clause, the Seventh Amendment, the Commerce Clause, and the nondelegation doctrine, took a little more time to address, but the court applied the “presumption of constitutionality” due all federal statutes, and systematically rejected each challenge:

  • Due Process: Congress’s legislative determination to provide immunity for certain state law claims afforded all the process that was due.   
  • Takings Clause: Nobody has a protected property interest in any common-law rule, and the estate’s causes of action did not vest prior to the PREP Act’s enactment in any event.  So, no unconstitutional taking.
  • Seventh Amendment:  Elimination of common-law claims does not violate the right to jury trial, nor do administratively-run compensation schemes like the CICP.
  • Commerce Clause: Remember how the pandemic brought the economy to a screeching halt?  So yes, the PREP Act regulates economic activity that substantially affects interstate commerce.
  • Nondelegation Doctrine and Separation of Powers: The PREP Act provides an intelligible principle to guide agency action and thus does not constitute an impermissible delegation of legislative authority.

And That’s Not All

Even if the PREP Act did not bar the claims, the court found that the federal defendants were entitled to sovereign immunity, as the Act expressly preserves such immunity and Congress did not unequivocally waive it.  

And product identification also required dismissal of the claims against the named vaccine manufacturer.  The complaint alleged that three COVID-19 vaccines were available, but never identified the one the decedent purportedly received, much less specify that it was the one manufactured by the manufacturer defendant it named.  

COVID-19 vaccines work, and we remain grateful for them and the other COVID-19 counter-measures developed by the life sciences industry during a harrowing world-wide crisis. Fortunately, Searcy further cements the PREP Act’s role as a shield for manufacturers, healthcare providers, and federal actors in the context of pandemic response.  We have added it to our PREP Act scorecard.

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This week we could not resist writing about a good result from an always interesting jurisdiction (Louisiana) involving one of our all-time favorite defense lawyers (Hi, Lori Cohen). 

In McGuire v. B. Braun Med. Inc., 2025 U.S. Dist. LEXIS 184172, 2025 WL 2689205 (E.D. Louisiana Sept. 19, 2025), the district court granted the defendants’ motion to dismiss an IVC complaint on several TwIqbal grounds. Laissez les bon temps rouler!

The claim in McGuire will sound familiar to most of you. IVC devices are designed to trap and filter blood clots before they travel to the heart and lungs. The plaintiffs claimed that sometime after implantation of the device it failed “when it tilted, penetrated, perforated, and fractured” inside the plaintiff, causing him injuries. He and his wife filed a complaint that alleged two causes of action: one asserted a couple of theories under the Louisiana Products Liability Act (the LPLA – one of our favorite things from the Pelican State, just after etouffee and the Preservation Hall Jazz Band), and one under “redhibitory defect” (we like that rather less – sort of like how we feel about the New Orleans Saints and Huey Long). The plaintiffs ended up withdrawing their redhibitory claim. Bless their hearts for that. 

The first ground for dismissal was that the plaintiffs’ boilerplate allegation of injury was insufficient.  The complaint lacked “allegations regarding actual concrete harm,” did not claim that the device failed in its intended purpose, or that it caused any particular medical treatment, alleged no “specific pain or impairment of bodily function,” no pain in relevant body parts, or even what led to the medical test that revealed the alleged malfunction.   There is no reason for the plaintiffs not to know all these facts: “This information is within plaintiffs’ own knowledge or control, and plaintiffs should be able to articulate the nature of any injury, if one exists. As it stands, plaintiffs have failed to plead an actual injury.”

To establish a claim for “defective construction or composition” under the LPLA, plaintiffs must establish that “at the time the product left it’s manufacturer’s control, the product deviated in a material way from the manufacturer’s specifications or performance standards for the product or from otherwise identical products manufactured by the same manufacturer.” The McGuire court held that the defect allegations were conclusory and circular.  Those allegations essentially amounted to saying that the bad result showed a construction defect.  That is not good enough.  Moreover, the plaintiffs did “not allege how the unidentified defect caused plaintiffs’ alleged injuries.”  

The design claim was also, er, defective. It did not identify any particular “safety feature” that the product lacked and did not allege how the device failed. Should the device have been made out of different materials or deployed a different mechanism.  Who knows?  The plaintiffs didn’t seem to, and that consigned the design claim to oblivion. 

Now we get to the claim of failure to warn. Louisiana applies the learned intermediary doctrine, and that is bad news for the McGuire plaintiffs. Their warning claim failed to allege what different thing the surgeon would have done (such as decided against implanting the IVC) had he received what the plaintiffs asserted would have been an adequate warning (e.g., that the device could migrate, collapse, fracture, etc.).  The complete failure to allege warning causation doomed the warning claim.   

And as is almost always the case, the plaintiffs’ express warranty claim did not state the actual language of the purported warranty, nor was any fact supporting reliance pleaded.  Merely saying that the plaintiffs would not have purchased the device if they had known it was “faulty” did not cut the mustard (or remoulade).  And so, to use a term that is both French and always our first Wordle guess, the court bid “adieu” to the complaint.  (But since the court granted the plaintiffs’ motion to amend, maybe “au revoir” would be more accurate.)

The McGuire case has been added to the DDL Blog’s TwIqbal cheat sheet. 

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It’s MLB playoff season and once again the Milwaukee Brewers are at the top of the field. They, along with the Philadelphia Phillies and the Chicago Cubs, have all secured a home-field advantage in the playoffs. That means those teams have the tactical edge of getting the final at-bat in each inning and overall. They also play on their own field, usually in front of their own fans–where they feel more comfortable. Simply put, historically, home teams win more. So, it’s not surprising that in litigation too, everyone wants home-field advantage. Plaintiffs want to stay in state court with sympathetic juries, while defendants prefer the cool neutrality of federal court. And yet, time and again, plaintiffs try to thwart federal jurisdiction by naming local pharmacies or hospitals as defendants to defeat diversity.

The plaintiff in today’s case did just that. But the court was having none of it. First, the decision finds the pharmacy was fraudulently joined because Illinois does not recognize either failure to warn (with a limited exception) or strict liability claims against pharmacies. Second, when faced with dismissal of the non-diverse defendant, plaintiff tried to pull a jurisdictional bait-and-switch: seeking leave to amend her complaint to add another non-diverse entity as a defendant. An entity she knew about at the time of filing her complaint but didn’t sue until the case had made its way to federal court and she was facing denial of her motion to remand.  Baseball is a game, litigation is not. The court did not entertain plaintiff’s gamesmanship. 

In In re Depo-Provera Products Liability Litigation, 2025 U.S. Dist. LEXIS 186000 (N.D. Fla. Sep. 22, 2025), the court was presented with an individual plaintiff’s motion to remand her case which she brought against the manufacturer of the drug and the local pharmacy where she filled the prescription. The removal argued that the pharmacy was fraudulently joined.  

Plaintiff’s first argument in favor of remand was that removal was improper under the forum defendant rule which provides that a case cannot be removed if any properly served and joined defendant is citizen of the state where the action is brought.  But since a fraudulently joined defendant cannot be “properly” joined, fraudulent joinder is an exception to the forum defendant rule.  Id. at *7-8.

Plaintiff next argued that joinder of the pharmacy was not fraudulent because she had a valid failure to warn claim. But the law is clear: “Illinois pharmacies have no duty to warn patients/consumers or doctors of the adverse effects of the prescription drugs they dispense, absent one narrow circumstance.” Id. at *9. The underlying rationale is that it is the doctor who knows the patient best and should be making prescription and treatment decisions, not the pharmacist.  The narrow exception to the rule, absent here, is when the pharmacy knows a customer is susceptible to adverse consequences of the drug—such as a known allergy or known contraindication. But the courts have made clear that pharmacists have no duty to investigate or learn about such conditions, only that if known they should act in accordance with that knowledge.  Id. at *9-10.  Here, not only did plaintiff plead no facts showing the pharmacy had specialized knowledge, the complaint alleged that plaintiff returned to her physician to administer the injectable drug. “Given these facts, there is no question that interjecting a duty to warn on the part of [the pharmacy] in this case could interfere with the prescribed treatment and disrupt the physician-patient relationship.”  Id. at *14.

Plaintiff next argued that her strict liability design defect claim was also viable against the pharmacy because Illinois law imposes liability on every entity in the distributive chain. To which the court responded:

After a thorough review of the case law on this issue, the [court] is convinced that Illinois law does not recognize a claim for strict liability design defect against a dispensing pharmacy for a prescription drug. . . . Indeed, under Illinois law, there is a decades-long recognition of the need to shield healthcare providers who ‘pledge[] to protect human life and health,’ in part by implementing a public policy that ‘dictates against the imposition of strict liability’ in order to avoid a diminution in those protections.   

Id. at *16-17 (citations omitted).

In other words, public policy dictates a “special standard” for prescription drugs that necessitates an exception to the general rule that would impose strict liability in the marketing chain. Id. at *18.  The policy exception has routinely been extended to pharmacies recognizing that holding a pharmacy strict liability for injuries allegedly caused by ingestion of the drugs it dispenses “would impose on the retail druggist the obligation to test, at its own expense, new drugs” and in turn the “costs to society which needs and values the pharmaceutical products sold by druggists, would be unduly high.” Id. at *19.

Accordingly, because Illinois would not recognize either a failure to warn or a strict liability action against the pharmacy, it was dismissed.  Thereby establishing complete diversity and proper federal jurisdiction. But plaintiff tried one more trick—moving to amend her complaint to add another non-diverse defendant, Planned Parenthood, at which plaintiff also received the drug and related treatment. 

Federal courts, under 28 U.S.C. § 1447(e), have the discretion to deny joinder of non-diverse defendants after removal. And thank goodness they do. Otherwise, we’d be watching a nonstop circus of plaintiffs dropping non-diverse defendants into complaints like surprise party guests. Adding non-diverse parties post-removal to manufacture a remand is forum shopping dressed up as due diligence.  The court’s discretion under § 1447(e) is guided by four factors: plaintiff’s motive, the timeliness of the request to amend, whether denying amendment will significantly injure the plaintiff, and any other “relevant equitable considerations.” Id. at *20-21.   

As to both motive and timeliness, pharmacies/health care providers aren’t exactly covert operatives. They don’t sneak under the radar. If you’re filing a product liability lawsuit about a prescription drug, you know where you filled the prescription. You were there.  In fact, in this case, plaintiff’s original complaint contains allegations about Planned Parenthood’s role in providing the drug to her, but she did not seek to name it as a defendant until 5 months after filing, 3 months after removal, and 1 month after defendant’s motion to dismiss.  Id. at *23.  Suspicious timing indeed.

Nor is plaintiff at risk of being significantly injured if amendment is denied. The statute of limitations has not run.  While perhaps not the most convenient, plaintiff could separately pursue her claims against Planned Parenthood in a parallel state court action. Id. at *24. The court found no other relevant equitable factors worthy of consideration and therefore denied the motion to amend. 

The decision is great on both Illinois pharmacy law and fraudulent joinder.  Now, let’s go Phils!

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As we’ve discussed earlier several times, there is a lot of lawyer advertising on television and in other media, and it can have adverse effects.  A lot of it also is of questionable accuracy, giving “the false impression that they reflect medical or governmental advice,” using phrases such as “consumer medical alert,” “health alert,” “consumer alert,” or “public service health announcement” to disguise their solicitation, “display[ing] the logo of a federal or state government agency in a manner that suggests affiliation with the sponsorship of that agency,” and calling something a “recall” although that “product that has not been recalled by a government agency.”  Recht v. Morrisey, 32 F.4th 398, 406 (4th Cir. 2022) (affirming constitutionality of state legislation prohibiting these practices).

However, we recognize that attorney advertising is First Amendment protected commercial speech.  E.g., Zauderer v. Office of Disciplinary Counsel, 471 U.S. 626, 651 (1985).  It is also big business – as discussed in the recent ATRA publication, “Legal Services Advertising in the United States”:

Trial lawyers and aggregators increasingly spend large sums of money on advertising to recruit new clients for class action lawsuits.  In 2024, it is estimated that more than $2.5 billion were spent on more than 26.9 million ads for legal services or soliciting legal claims across the United States. When compared with the same time period in 2020, spending on these ads increased more than 32%.

Id. at Introduction & Background (unnumbered page 2).  Our current Secretary of HHS certainly knows this, as he formerly worked at Morgan & Morgan, which is by far the most prolific plaintiff lawyer advertiser of all.  Id. at p.8 (M&M spent almost 4 times as much on advertising as any other p-side firm).

Marketing of prescription medical products is also widespread.  As the Supreme Court held in Sorrell v. IMS Health Inc., 564 U.S. 552 (2011) (our post here) – “Speech in aid of pharmaceutical marketing . . . is a form of expression protected by the Free Speech Clause of the First Amendment.”  Id. at 557.  Sorrell held a state statute that attacked pharmaceutical marketing unconstitutional as a content-based speech restriction.  That statute “disfavor[ed] marketing, that is, speech with a particular content.  More than that, the statute disfavor[ed] specific speakers, namely pharmaceutical manufacturers.”  Id. at 564.  That pharmaceutical marketing was also “commercial speech” didn’t matter where the government attempted suppress it on a “viewpoint”-related basis:

[The statute] imposes more than an incidental burden on protected expression.  Both on its face and in its practical operation, [the] law imposes a burden based on the content of speech and the identity of the speaker.  While the burdened speech results from an economic motive, so too does a great deal of vital expression.  [The] law does not simply have an effect on speech, but is directed at certain content and is aimed at particular speakers.

Id. at 567 (citations omitted).

The FDA recently sent out a flood of vague, nearly identical form “warning letters” that attacked a particular type of pharmaceutical marketing – direct-to-consumer (“DTC”) advertising – as supposedly “misleading” without identifying any particular advertisement run by the recipient or any particular “misleading” attribute of any such advertisement.  This is a dramatic change from FDA practice, with warning letters previously being directed at specific ads, specific allegations of violations, and proposing specific remedial action.  Moreover, the accompanying  FDA “news release” does not does not read like any regulatory document that we’ve ever seen, but rather like a plaintiffs’ lawyers diatribe, calling DTC advertising that has been legal (and not tortious) for decades as a “pipeline of deception” and vaguely attacking “deceptive practices” and “increasingly lax” FDA enforcement in order to “hold the pharmaceutical industry accountable.”  That’s not even-handed regulation; that’s a p-side closing argument  Id.  And there’s more.  The FDA even threatens high-tech surveillance of pharmaceutical advertising:

Going forward, the agency will aggressively deploy its available enforcement tools.  The FDA is already implementing AI and other tech-enabled tools to proactively surveil and review drug ads.

Id.

This blunderbuss approach is every bit the sort of viewpoint-based attack on pharmaceutical advertising, and in particular on DTC advertising, that was held unconstitutional in Sorrell.  The same sort of intent to suppress pharmaceutical free speech that was present in Sorrell (“preventing [drug] detailers − and only detailers − from communicating . . . in an effective and informative manner,” 564 U.S. at 564), practically oozes from every pore of the FDA’s broad and vague attack.  Indeed, this action is probably more violative than Sorrell of the First Amendment, since its broad and vague threats of enforcement and surveillance smack of both a prior restraint and a blatant attempt to chill pharmaceutical free speech (except for plaintiffs’ lawyers) generally.

So both lawyer advertising and pharmaceutical advertising are big business.  The current HHS regime – now run by a plaintiff’s lawyer – plainly seeks to tilt the playing field so that plaintiffs’ lawyers have free reign, while suppressing speech from the other side.  That would have the effect of making the media even more dependent on lawyer money for its revenue than it is now.  We don’t think that’s fair, or constitutional.  As we said over eight years ago:

The bottom line is this:  Lawyer advertising holds no preferred position among types of commercial speech.  Indeed, there are no “types” of commercial speech – it’s all the same constitutionally.  So when attorneys on the other side advocate bans on truthful manufacturer speech, because supposedly even truthful off-label information is a threat to the public health, they should remember that the same thing can be said about truthful attorney advertising.

We’re quite willing to apply the same standards to both sides.

We’ve detailed the FDA’s very checkered history when it comes to the First Amendment and suppression of manufacturers’ truthful scientific speech.  We fully expect to see another round, and assuming current precedent holds, to see the FDA take it on the chin once again.

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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