There Is No Established Causation Between Acetaminophen and Autism

By Steven Boranian on October 8, 2025

“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.

Eleventh Circuit Shoots Down Plaintiff’s Request for a Mulligan

By Michelle Yeary on October 7, 2025

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 (11^th 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.

A couple of Interesting Links

By Bexis on October 6, 2025

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.

Hundreds of Non-Resident Zantac Plaintiffs Run Out of Connecticut

By Bexis on October 3, 2025

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).

PREP Act Immunity and Constitutional Challenges: Searcy v. Pfizer

By Lisa Baird on October 2, 2025

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.

E.D. Louisiana Dismisses IVC Case on TwIqbal Grounds

By Stephen McConnell on October 1, 2025

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.

Depo-Provera MDL Court Shoots Down Pharmacy Liability Claims Brought to Defeat Diversity

By Michelle Yeary on September 30, 2025

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!

What about Plaintiff Lawyer Advertising?

By Bexis on September 29, 2025

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.

The Best Test of Truth Is the Power of the Thought to Get Itself Accepted in the Competition of the Market

By Eric Hudson on September 26, 2025

The title of today’s post is from a quote by Justice Holmes in a dissenting opinion, Abrams v. United States, 250 U.S. 616, 630 (1919). Abrams involved a conviction under the Espionage Act based on the publication of leaflets that were distributed in New York during World War I. Among other things, the leaflets denounced President Wilson as a hypocrite and a coward, and lamented the “hypocrisy of the plutocratic gang in Washington and vicinity.” Id. at 620. In his dissent (joined by Justice Brandeis), Justice Holmes espoused the power of free speech in connection with our country’s experiment with its Constitution. Or, as Justice Holmes more eloquently put it: “It is an experiment. All life is an experiment. Every year if not every day we have to wager our salvation upon some prophecy based upon imperfect knowledge. While that experiment is part of our system[,] I think that we should be eternally vigilant against attempts to check the expression of opinions that we loathe and believe to be fraught with death . . . .” Id. at 630.

New California Ranitidine Litigation Order Makes A Huge Mess Of Everything

By Eric Alexander on September 25, 2025

This is from the non-RS side of the Blog.

We admit that the use of “everything” in our title may be excessive. The order in In re Rantidine [sic] Cases, JCCP 5150 (Cal. Super. Ct. Sept. 15, 2025) (“Cali Ranitidine”), slip op. here, did not cause climate change, poverty, hunger, air pollution, earthquakes, military conflicts, or any number of things that rational people typically want to avoid. It did not eliminate free speech, silly internet cat videos, pie, your favorite sports team, beautiful alpine sunsets, or many other things our readers might list as “good things.” In terms of helping to perpetuate a flawed litigation, throwing California product liability law into disarray, mucking up procedural norms, and misspelling “bellwether” and “Ranitidine,” though, it made a big mess.

Befitting the bizarreness of Cali Ranitidine, we will start with the third of these. Here are a few things that we did not think were in dispute about civil litigation, regardless of whether you are talking about an individual federal case, a federal MDL, a California JCCP, or some other variant. Pleadings come first. A complaint will number the counts asserted against the defendants, attempting to break them up by the particular legally cognizable causes of action asserted and how they apply to the different parties (e.g., count 1 against defendant X, count 2 against defendant Y, count 3 against both). The defendants can answer, move to dismiss, or move for a more definite statement. A motion to dismiss might argue, for instance, that count 1 lacks sufficient factual allegations of each element of the recognized cause of action or that there is no such cause of action recognized under applicable law. It could also argue that count 1 is preempted because the state requirements inherent in liability under that count would conflict with federal requirements. As we have said many times, when dealing with a challenge to whether a particular count states a valid claim and an argument that the claim would be preempted, a court has to evaluate the state law claim first, both on whether it exists and whether the allegations in the complaint support it. Regardless of how many rounds of amendment it might take, what counts are live should be sorted out before discovery starts. Among other things, the claims and defenses help to define the scope of discovery. Importantly, down the road, the defendants can move for summary judgment by arguing that plaintiffs failed to adduce enough admissible evidence to carry their burden to establish a prima facie case as to each live count. The defendants can also seek summary judgment based on having evidence to carry their own burden on a defense, such as preemption.

Part of why following this basic sequence matters is that the court’s consideration of summary judgment should not result in 1) an amendment of the complaint to add something new (although it could delete claims or parts of claims where plaintiffs caved or lost), 2) the recognition of a novel cause of action that is not in the live complaint at the time of the summary judgment ruling, 3) an expansion of claims one way or another beyond what was at issue in fact and expert discovery and any motions thereon, and/or 4) a court finding plaintiff failed to offer evidence to carry her burden on any claim that survives summary judgment. We recognize how tortured some of these may seem, but Cali Ranitidine violated each of these truisms.

We will not recap all posts on the larger litigation. The bottom line is that plaintiffs lost just about everything that mattered in the MDL, including on preemption and the exclusion of their general causation experts. An appeal is pending to the Eleventh Circuit, and defendants keep winning trials in Illinois state court. In general, there have been years of sturm and drang, starting with questionable lab “findings” and a cautious FDA, but there never was science supporting cancer from ranitidine use or liability for selling a drug that did not cause cancer. The national holdout has been the California JCCP, in part because the assigned judge has changed over time and in part because California is California.

This brings us to the decision in Cali Ranitidine, which resulted from a few rounds of briefing on a branded manufacturer’s summary judgment motion in a now former “bellweather [sic] trial” case that the court concluded should apply across the board. Frankly, the issue should have been very narrow and pretty easy. Defendant moved on the plaintiff’s manufacturing defect claim—count and allegations in the live Third Amended Master Complaint unspecified in Cali Ranitidine—after getting rid of all design defect claims as preempted. Of course, this was not a count asserting liability under an avowed “inherent defect,” “magic defect,” or “gobbledygook defect.” It was purportedly a “manufacturing defect” claim because everyone knows California, like most other jurisdictions, breaks up product liability into design defect, manufacturing defect, and warnings defect. See, e.g., Ramos v. Brenntag Specialties, Inc., 372 P.3d 200, 204 (Cal. 2016) (“California law recognizes three types of product defects for which a product supplier may be liable: manufacturing defects, design defects, and warning defects.”).

Last April, the JCCP held exactly that in connection with preempting all design defect claims; in our prior words: “And because ‘strict products liability’ is limited to the three traditional categories (design defect, manufacturing defect, and failure to warn), any ‘non-standard’ design defect claim would also fail.” Because California follows comment k under § 402A of the Restatement (Second) of Torts for prescription drugs, vaccines, and devices, the liability is not strictly “strict,” but there are still three basic subspecies. California does not recognize a duty to test, res ipsa for product liability, or some other possible variants. (Don’t get us started on Conte and the innovator liability nonsense.) In the multiple attempts at Master Complaints, the plaintiffs had asserted numbered counts under each of the three big subspecies against the defendants, no matter what other mud they threw at the wall. That was the focus of prior motions practice under the California equivalent of 12(b)(6).

Cali Ranitidine was supposed to address plaintiffs’ fourth attempt to offer a manufacturing defect claim that would be recognized by California law, not preempted, and supported by evidence adduced in discovery. We mention evidence because this was a decision on a summary judgment motion, although it may be the only summary judgment decision from an MDL, JCCP, etc., we have seen that does not identify the summary judgment standard or purport to apply it. That plaintiff had the burden to come forward with evidence sufficient to carry his burden on each element of the cause of action at issue is nowhere to be found. Instead, the only mention of burden is defendant’s burden to establish preemption, which was punted to another day. Slip op. at 20-21. What the Cali Ranitidine court did, completely out of place for the advanced stage of the litigation and procedural posture of the motion, was to engage in a theoretical analysis of whether plaintiffs could pursue, presumably in a fifth master complaint that would potentially reopen discovery, a novel claim for something between California’s design defect claim—preempted across the board—and California’s manufacturing defect claim—which the plaintiffs acknowledged they could not support. Id. at 3-4. In adopting a new “hybrid theory” that plaintiffs would have a chance to support, the court did not evaluate the applicable count in the live complaint, any of its allegations, whether it conformed to prior court orders, or whether there was sufficient evidence in the record to support the count. You know, what a court is supposed to do when entertaining a motion for summary judgment, even if it lapses back to the standards for a motion to dismiss. Years after the JCCP was formed in January 2021, the court’s frolic and detour into novelty was without procedural precedent.

It almost does not matter that the new “hybrid theory” was nonsensical and clearly fell within the court’s prior preemption ruling. Id. at 12. Creating a new cause of action simply because the established ones failed is bad. The court’s reasoning might be worse. We all know that the gist of a manufacturing defect claim is that the plaintiff’s particular product failed to meet the design specifications for the product and that the failure caused an injury. Plaintiffs in the JCCP admitted that they could never meet that standard for any case, so they wanted to establish a novel manufacturing defect claim based on the circular argument that every pill the defendant every produced was defective because the defendant failed to prevent those pills from having some uncertain amount of NDMA beyond the uncertain amount they would have had anyway. Legally speaking, that is nonsense, but it sounds most like the “non-standard” design defect claim the court had previously held preempted. In its selective tour of California product liability law over time to end up with the idea that having too much of a purported carcinogen in every pill ever made by the defendants could lead to non-preempted liability under an expanded understanding of design defect, the court made more mistakes than we can address here. We are not even counting simple sloppiness, such as the spelling and punctuation errors. Nor factual errors, such as asserting that FDA recalled all ranitidine products.

Fundamentally, the court misunderstood what the design of a product, particularly a drug, is by engrafting a concept of “intent” that matches better with absolute liability (which California expressly does not have) and certainly has nothing to do with strict liability (which looks solely to product “condition,” as opposed to manufacturer “conduct”). The tautology goes that no manufacturer intends for its drug, as manufactured, to have excessive levels of a carcinogen, so the entire manufacturing process could be seen as defective if it produced identically “excessive” levels of carcinogen in every pill released. Id. at 13. The court got here by concluding a deviation from design specifications was one way to establish a manufacturing defect and deviating from the amorphous concept of the “intent” of the manufacturer for a product was another. Id. at 14. This is quite silly because intent and design are different. Suppose that Drug Company X intends that its new drug will effectively treat medical condition A without excessive risks. That is not a design. The design of a drug includes the active drug ingredient and the rest of what gets pressed into the finished product. Hopes and dreams are not part of it.

Similarly, the intent of a widget—effectively performing its appointed widgetty task without undue risk of breakage from stress or fatigue, for instance—is not the same as its design. A manufacturing defect claim means the plaintiff’s particular product does not match the design, typically reduced to specifications and release criteria in the real world, not that the manufacturer failed to eliminate all risks or excessive risks whether from a contaminant, degradation product, or something else. Plaintiffs here did not have evidence of an actual specification that each pill was supposed to have no more than X% or Y ppm of NDMA and they were all released despite exceeding that specification. They certainly did not have admissible evidence that the amount by which the pills purportedly exceeded the non-existent specification was sufficient to cause cancer in any human and that it had done so for a specific plaintiff.

As we said, California follows comment k for prescription drugs. The court said it would apply comment k to OTC drugs too. Id. at 15. Comment k’s discussion of unavoidably unsafe products is certainly contrary to the court’s rationale.

The seller of such products, again with the qualification that they are properly prepared and marketed, and proper warning is given, where the situation calls for it, is not to be held to strict liability for unfortunate consequences attending their use, merely because he has undertaken to supply the public with an apparently useful and desirable product, attended with a known but apparently reasonable risk.

Section 2 of the Restatement (Third), which California appellate courts have cited with authority, says a product “contains a manufacturing defect when the product departs from its intended design even though all possible care was exercised in the preparation and marketing of the product.” It also limits strict liability to design, manufacturing, and warnings. California’s pattern instruction 1200 is similarly limited. Its notes include the following case quote, the second sentence of which negates Cali Ranitidine’s expansive interpretation of “design” in this context:

“A product has a manufacturing defect if it differs from the manufacturer’s intended result or from other ostensibly identical units of the same product line. In other words, a product has a manufacturing defect if the product as manufactured does not conform to the manufacturer’s design.” (Garrett v. Howmedica Osteonics Corp. (2013) 214 Cal.App.4th 173, 190 [153 Cal.Rptr.3d 693].)

Similarly, California’s pattern instruction 1202 states, “A product contains a manufacturing defect if the product differs from the manufacturer’s design or specifications or from other typical units of the same product line.” This is not supportive of the hopes and dreams expansion. We are sure that the defendant presented all of this authority and much more in arguing against the late expansion of California product liability law.

Instead of granting summary judgment, as it was required to do even if it had let plaintiffs shift to a novel hybrid theory that was not in a live complaint, Cali Ranitidine made up a roadmap of proof. The statements in the decision that should have led to summary judgment on manufacturing defect were legion. For instance:

“The evidence on this motion does not show that BI’s manufacturing of any pills deviated from its intended processes.” Id. at 3
“No evidence shows a meaningful distinction between the pills the plaintiffs ingested or the batch they came from and all the other BI manufactured pills.” Id.
That “a safer FDA-approved method [of manufacturing] . . . is not clear from the record on this motion.” Id. at 19.
Plaintiffs’ evidence of excess NDMA compared to other manufacturing processes was contradicted, not supported, by the work of their dubious lab, and none of their other evidence “meet[s] the evidentiary standard at this point.” Id.
Plaintiffs failed to cite “any evidence showing that the alleged ‘delta’ [of purportedly excessive NDMA] was a substantial factor in causing cancer.” Id. at 20.

Instead of summary judgment (or summary adjudication), plaintiffs got an opportunity “to marshal the evidence required under this Order,” which defendants could challenge in future, including on preemption. Id. at 20-21. While this may have some superficial appeal, it is the burden of the plaintiff facing a summary judgment motion to marshal evidence supporting a challenge claim/count, put it in the record, and show how it adds up to a prima facie case. Plaintiffs had plenty of chances to do that here. They were also the ones who argued a new theory at the hearing on the manufacturer’s summary judgment motion, apparently abandoning the briefed position and failing to support the new theory with evidence. Id. at 1. They submitted two extra briefs and had a second hearing, again failing to put evidence in the record to support the theory they espoused (that was not even supported by the live complaint). Id.

Lest there be any doubt, California Rule 3.1350(e)(3) requires the party opposing a motion for summary judgment or summary adjudication to file its “evidence in opposition” at the time it responds. Whatever evidence plaintiffs filed, it did not support the traditional claim for manufacturing defect or the hybrid claim they ultimately convinced the court to adopt. As such, that should have been the end of the claim for manufacturing defect, however framed. We still think the end result will be that hybrid manufacturing defect claims fail across the JCCP. It will just take more time and effort—and perhaps an appeal—to get there.

Drug & Device Law