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Here at the DDL Blog, we love phrases denoting that two things are acting together or in close succession to produce a result.  We have written more than once on the “one-two punch” of causation and implied preemption, and who doesn’t appreciate a good “double whammy” in whatever context?  Cases with different outcomes are often the “yin” and the “yang” of the law, and we like it when defendants have the plaintiffs caught “between a rock and a hard place.”  And don’t forget the narrow gap between express and implied preemption. 

Yes, noteworthy things often come in pairs.  But what do you call it when a patient gets two vaccines on the same day and only one is entitled to statutory immunity, but no one knows which vaccine came first or whether one or the other caused the patient’s alleged injury?  You might call it a double fault, or strike two, or any other clever phrase you can come up with.

The Fourth Circuit called it “summary judgment.”  In Watts v. Maryland CVS Pharmacy, LLC, No. 23-2025, 2025 WL 1802385 (4th Cir. July 1, 2025) (to be published in F.4th), the plaintiff received two vaccines during the same visit in the same spot on her arm, but only one vaccine was subject to immunity under the National Childhood Vaccine Act.  Lo and behold, when the plaintiff sued for alleged injuries, she sought to hold the provider liable only for the non-immune vaccine.  She didn’t even mention the other vaccine in her complaint. 

That was a big mistake.  The plaintiffs’ expert reports made no mention of the other vaccine, and her causation expert attributed her injuries only to the one mentioned in the complaint.  It got awkward when both experts had to admit in their depositions that they had not known about the other vaccine when they wrote their reports and that although one vaccine or the other caused the plaintiff’s injuries, they could not say which one.  Id. at *2-*3. 

It got even more awkward when the causation expert served a “Notice of Errata” a month after his deposition purporting to add a sentence to his report stating that both vaccines caused the injury.  Id. at *3. 

That was out of bounds.  The rules allow an errata to correct misstatements or clarify existing answers, not to “materially change the answers or fully supplant them.”  This expert’s errata crossed the line.  He previously stated in report that he had “considered other potential causes” and that the one vaccine had caused the harm, but he now was attributing the plaintiff’s injuries to both vaccines.  The light is red, not green.  (For more on errata abuse see our post on the topic here.) 

On the merits, the parties debated “substantial factor” causation and “alternate liability” under Maryland law (remember the two hunters in Summers v. Tice from law school?).  But this case was governed by federal law—the Vaccine Act, under which the defendant was immune unless the plaintiff could prove that her injuries were caused by the non-immune vaccine and not the other.  That was a problem for the plaintiff because both her experts said that one vaccine caused her injuries, but neither could say which one.  Without evidence on which vaccine (if any) caused the harm, “a jury could do no more than ‘guess’ as to that crucial element.”  Id. at *4. 

Still further, even if the causation expert had been permitted to opine that both vaccines caused the harm, the defendant would still be entitled to summary judgment.  That is because the plaintiff would then be relying for liability upon the immunized vaccine “as a second, separate negligent act,” which the Vaccine Act bars.  This plaintiff alleged one set of indivisible injuries, and it was not possible to apportion the harm to one vaccine or the other.  The plaintiff certainly presented no evidence that would allow any jury to make that call. 

Plaintiff could have pursued claims under the National Vaccine Injury Compensation Program, but she chose not to, and now she is stuck.  Perhaps she was trying to kill two birds with one stone, or maybe dance a two-step through the litigation lottery.  For our two cents worth, this is the correct outcome. 

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Legal problems are often multi-faceted.  Turned one way, the problem looks like one issue.  Turn it around, and a different issue glimmers in your eye.

For example, in Saulsby v. Amphastar Pharm., Inc., __ S.E.2d ___, 2025 N.C. App. LEXIS 420, 2025 WL 1812450 (N.C. App. July 2, 2025), the North Carolina Court of Appeals affirmed summary judgment on contributory negligence grounds, but it just as easily could have relied on a warnings causation theory.

Saulsby is a product liability case involving, sadly and unfortunately, a death.  Nothing in the opinion discusses medical causation, and we have no basis to understand how this would be scientifically plausible, but the complaint alleged the decedent died after self-administering a single dose of an over-the-counter (OTC) asthma inhaler.   

The OTC inhaler been purchased by the decedent’s long-term boyfriend to alleviate her shortness of breath.  The product’s intended use was for “temporary relief of mild symptoms of intermittent asthma,” and it carried express warnings: “Do not use unless a doctor said you have asthma” and “Ask a doctor before use if you have . . . heart disease [or] high blood pressure.”

Contrary to those warnings, the decedent had not been diagnosed with asthma, and she did have multiple underlying health conditions including heart disease and high blood pressure.  In addition, no doctor was consulted.  The boyfriend allegedly asked a pharmacist whether the product was “good for breathing” but the question was posed without any context about the decedent’s health history or immediate medical need.

Moreover, the product’s warnings were not read by the boyfriend at the time of purchase, and there was no evidence the decedent read them prior to use either. 

North Carolina’s product liability landscape is one we generally like.  Here, the decedent’s estate sued the manufacturer for negligence (N.C. does not recognize strict liability) and breach of the implied warranty of merchantability.

After the trial court granted summary judgment, finding the decedent’s contributory negligence barred recovery under N.C. Gen. Stat. § 99B-4, the North Carolina Court of Appeals agreed that the decedent’s own negligence was clear and affirmed.

N.C. Gen. Stat. § 99B-4—a most useful statute—provides that a manufacturer or seller is not liable in a product liability action if:

(1) The use of the product giving rise to the product liability action was contrary to any express and adequate instructions or warnings delivered with, appearing on, or attached to the product or on its original container or wrapping, if the user knew or with the exercise of reasonable and diligent care should have known of such instructions or warnings; or

(2) The user knew of or discovered a defect or dangerous condition of the product that was inconsistent with the safe use of the product, and then unreasonably and voluntarily exposed himself or herself to the danger, and was injured by or caused injury with that product; or

(3) The claimant failed to exercise reasonable care under the circumstances in the use of the product, and such failure was a proximate cause of the occurrence that caused the injury or damage complained of.

The court rejected the plaintiff’s argument that this statute requires a determination of whether the decedent exercised reasonable care under the circumstances and whether the warning was adequate, because the statute pretty clearly uses the disjunctive or between its prongs. 

It also distinguished prior pharmacy cases that had chipped away at the statute (based on allegations the plaintiff was given the wrong product, or there were extenuating circumstances, or there were individualized warnings from a pharmacist).

The evidence established that both the decedent and her boyfriend either knew or should have known of the product’s express warnings, and in not reading them failed to exercise the care an ordinarily prudent person would have under similar circumstances, barring both the negligence claim and the implied warranty claim.

This conclusion tracks.  But even without the North Carolina statute, should a claim based on facts like these pass muster?  If the claim is for failure to warn, absolutely not. 

The idea behind a failure to warn claim is that if only the manufacturer had given a different, stronger, more adequate warning, then the harm never would have occurred—the prescription product never would have been prescribed or, with an OTC product, the consumer would have not taken the product or they would have followed the labeling. 

But on the facts of Saulsby, the flaw in that theory of liability is that it did not matter what the warnings said, because the decision-makers never read them.  In other words, the plaintiff cannot prove that the allegedly defective warning caused the harm, because the allegedly defective warning had no effect whatsoever.  (We have a comprehensive post on failure to read warnings and causation.)

Facts like those in Saulsby are one of the reasons we think the “heeding presumption” is nonsense.  Plenty of consumers take OTC medicines without much thought, after a quick trip to the store and maybe a cursory scan of the products on the shelves or an out-of-context question posed to someone behind the pharmacy counter.  These are the type of events that are entirely commonplace.  Maybe these are not the actions of an ordinarily prudent person when it comes to medications, but they are not rare.  States that use the heeding presumption tip the scales in plaintiffs’ favor by presuming (absent contrary evidence) that everyone always will read and heed a product label.  But we know people don’t, so the law should not ignore real life and presume that they will.

Anyway, this court came out the right way.  We just would like to think that failure to read facts like these would end in summary judgment even in states without North Carolina’s sensible contributory negligence statute.

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In Chock v. Stryker Corp., 2025 WL 1797933 (E.D. Cal. June 30, 2025), the plaintiff mounted a TwIqbal attack against the defendant’s affirmative defenses and largely lost. The court’s opinion is short and to the point, and offers lessons. The case is particularly useful, as many of the pleaded items at issue are common.  Most importantly, the court holds that TwIqbal does not apply to affirmative defenses. Instead, a lesser standard of “fair notice” does.  

The plaintiff alleged that a compression plate manufactured by the defendant had been implanted in her arm and then ruptured, causing serious injuries.  The defendant filed an answer with, as is typical, many affirmative defenses.  The plaintiff filed a motion to strike various affirmative defenses and to deem certain allegations in the complaint admitted. 

A motion to strike travels under Fed. R. Civ. P. 12(f), which permits a court to strike from an answer “an insufficient defense or any redundant, immaterial, impertinent, or scandalous matter.”  What makes an affirmative defense “insufficient”?  Are affirmative defenses subject to Twombly and Iqbal and their requirement for facial plausibility?

The Chock case was governed by Ninth Circuit law and, mirabile dictu, that law turned out to be pretty good for defendants on the issue of pleading sufficiency for affirmative defenses. The Ninth Circuit has not applied TwIqbal to affirmative defenses. Rather, the Ninth Circuit applies the “fair notice” standard to affirmative defenses. That makes sense.  After all, the plaintiff has the burden of proof and should be able to nail down plausibility before filing a complaint.  The poor defendant is merely playing … well, defense. 

The “fair notice” standard for affirmative defenses is a “low bar that does not require great detail,” but it does require a defendant to provide “some factual basis” for the defenses. Generally, “simply referring to doctrine or statute is insufficient to afford fair notice.”

Uh oh.  We have seen the answer/affirmative defense sausage being made many times, and it is seldom pretty.  As with interrogatory responses, the task of drafting answers and affirmative defenses is often assigned to the most junior lawyers.  For both tasks, lamentably, the usual modus operandi is to toss in everything, including the kitchen sink.  Why is that?  As Kierkegaard put it, “Fear and Trembling.”  Surplusage might be bad, but waiver is worse.  Insecurity and inelegance and inexperience usually result in long lists of affirmative defenses, some of which have only remote or tangential or wishful connection to the case. Common sense might not be quite dead when it comes to listing affirmative defenses, but it is at least incarcerated. 

Good thing for the defendant in Chock that its litany of affirmative defenses was not overly promiscuous. Good thing, too, that the Chock court spared the defendant from needing to satisfy TwIqbal pleading standards. Nevertheless, the court still insisted on something more than mere incantations of affirmative defenses. 

To wit:

  • An assertion of the statute of limitations as an affirmative defense requires identification of the particular statute being invoked.  The defendant in Chock did not refer to a particular statute of limitations, so the affirmative defense was stricken.   But the defendant was afforded the right to try again. 
  • Failure to state a claim is not an affirmative defense at all and was stricken.  There would be no right to take a stab at that one again. That is newsworthy.  We’re not sure we have ever seen an answer that did not list failure to state a claim as an affirmative defense.  Live and learn. 
  • Several other affirmative defenses in the Chock answer were “well-established” and, therefore, “do not require additional factual detail” beyond their identification.  “[A]t the pleading stage, it is difficult to conceive what additional facts could be offered.”  These affirmative defenses included comparative fault, mitigation of damages, release, and estoppel. Count us (and fellow defense hacks) relieved.  Feel free to tell your junior associates to go forth and endlessly list these affirmative defenses, like Homer’s catalogues in The Iliad. 
  • Even so, the court in Chock had a beef with the defendant’s “reservation” of unidentified “other” defenses. That reservation was not a proper affirmative defense and was stricken.  There is no point to it.  The Chock court observed that such a reservation “serves no purpose.”  It is like saying that, just in case we have not listed every conceivable defense under the sun, we want you to know we’ll continue to think of whether there are any more and, if we do, you’ll hear from us. Almost all of us do that, and it is wrong. 

Beyond affirmative defenses, the plaintiff in Chock also sought to have some of the complaint allegations deemed admitted when the defendant’s answer said that the documents referenced in the complaint “speak for themselves.”  The court held that such a formulation was an appropriate “conditional admission” whereby the defendant admitted that the documents existed but reserved the right to dispute the meaning of them as the litigation proceeds.  That response “satisfie[d] the requirements of” Rule 8.

The overarching lesson of Chock is that defendants might be free from the TwIqbal standard in authoring their answers, but they are not free from the requirement of giving some thought to the affirmative defenses.  We do not know if less is more, but more is not necessarily better. 

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Just because something is common doesn’t mean it’s predominate, and it definitely doesn’t mean it’s a good idea. Colds are common. So are traffic jams, mosquitos, and people who say, “Let’s circle back.” None of those things are dominant forces of greatness—they’re just annoyances we’ve sadly grown used to. Like plaintiffs seeking to certify products liability personal injury class actions by arguing: “Oh look, everyone got hurt by the same product. Let’s group them together and knock this out like a Netflix binge!” Fortunately, as evidenced by our cheat sheet, federal courts resoundingly say: No. Personal injury claims are simply too individualized to be redressed collectively.

Sure, products liability cases do share common issues—was the product defective, can the product cause the alleged injury? But commonality isn’t king. For a class action to work, the common issues have to drive the resolution of the case—not be drowned out by a flood of “but my situation is different” claims. Which essentially is what the court told plaintiffs in Candelaria v. Conopco, Inc., 2025 U.S. Dist. LEXIS 126314 (E.D.N.Y. Jul. 2, 2025).

Candelaria is about shampoo. But its applicability to the DDL world is apparent by the number of DDL cases cited in the opinion.  Plaintiff sought to certify a class pursuant to Federal Rule 23(c)(4) which allows a court to certify a class on “designated issues” even if the case or claims overall do not satisfy Rule 23’s class certification requirements. However, issue certification must “materially advance a disposition of the litigation as a whole to be warranted.” Id. at *8.  In other words, it does not matter if an issue is common if resolving that issue results in no efficiencies because individual trials would still be needed and the evidence on both common and specific issues is largely duplicative. Issue certification has to make the litigation “more manageable,” not less. Id.

The issues plaintiff wanted class treatment on were: general causation; defendant’s knowledge; duty to warn; breach of duty to warn; design defect; and reasonable alternative design. Id. at *6-7. But even she had to concede that addressing these issues would still leave open questions of both liability (proximate cause) and damages for individual trials. Id. at *12-13. Plaintiffs allege hair loss—a common condition with numerous alternative causes. Therefore, proximate cause “require[s] an analysis of each unique person, including their medical history, allergies, and prior diagnoses. Id. at *14. With those complex and particularized questions remaining, “the efficiency benefits of an issue class are removed.” Id. at *15.  Nor could plaintiff demonstrate judicial economy in this case because “the issue of specific causation is inextricably entangled” with the issue of the general causation.” Id. at *19.  In sum, plaintiff failed to prove that her proposed issue classes would materially advance the litigation.

Although that was enough to defeat class certification, the court went on to explain that plaintiff also failed to demonstrate that her issue classes were a “superior” method of adjudicating the case. Particularly, the court found the “likely difficulties in managing” the issue classes weighed against certification. The proposed class included at least 700 plaintiffs from 49 states and plaintiff conceded that each class member would be governed by the product liability law of the state where the injury occurred. Because product liability law is not ubiquitous, the differences in state law guaranteed that “certain of plaintiff’s Proposed Issues could not be decided in one fell swoop.” Id. at *22-23.  On design defect alone some states use the risk-utility test, some use consumer expectations, some take a hybrid approach, and others use an unreasonable danger-type standard. Plaintiff offered no “trial plan,” proposed jury instructions, or verdict forms to explain how these state law variations could be handled with a single jury. Id. at *24-26.        

Finally, product liability plaintiffs have an interest in controlling their own cases. Class actions are “most compelling” when the costs of pursuing an individual action exceeds the expected recovery. Id. at *26. That is not the case where plaintiffs individually allege damages greater than $75,000 and have retained counsel on a contingency basis. Moreover, several class members already filed individual actions, a few of which were pretty far along. Certifying the class requested by this plaintiff would raise issues relating to opt-outs and enjoining the other cases that cut against judicial economy. 

A class action requires common issues, but also common sense. The common issues have to predominate and handling them collectively has to move the litigation forward, not bog it down. In products liability cases, individual issues aren’t just side dishes—they’re the main course. So, you can’t use a one-size-fits-all solution.

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When a federal agency reverses course, the Supreme Court has a test to determine whether that agency action is impermissibly “arbitrary and capricious.”  FCC v. Fox Television Stations, Inc., 556 U.S. 502 (2009), set the current APA standard for review of federal agency flipflops.  While no “heightened standard” exists under the APA for reversals of position, such reversals must be accompanied by “a reasoned analysis for the change beyond that which may be required when an agency does not act in the first instance.”  Id. at 514 (citation and quotation marks omitted) (emphasis original).  That requires:

that an agency provide reasoned explanation for its action [which] would ordinarily demand that it display awareness that it is changing position.  An agency may not, for example, depart from a prior policy sub silentio or simply disregard rules that are still on the books.  And of course the agency must show that there are good reasons for the new policy.

Id. at 515 (citation omitted).  The agency reversal of position in Fox Television passed muster.  It was “forthrightly acknowledged,” explained in an “entirely rational” manner with a “context-based approach,” and based in part on “technological advances.”  In Fox Television, the agency course-change involved agency enforcement power, and that the agency “deci[ded] not to impose any . . . sanction” helped the Court decide that the new approach was not arbitrary and capricious.  Id. at 517-18.

In another agency change-of-course case, Encino Motorcars, LLC v. Navarro, 579 U.S. 211 (2016), the Court affirmed that the “basic procedural requirement[] of administrative rulemaking is that an agency must give adequate reasons for its decisions.”  Id. at 221.  The decision detailed what that meant in the context of a reversal of position:

Agencies are free to change their existing policies as long as they provide a reasoned explanation for the change.  When an agency changes its existing position, it need not always provide a more detailed justification than what would suffice for a new policy created on a blank slate.  But the agency must at least . . . show that there are good reasons for the new policy.  In explaining its changed position, an agency must also be cognizant that longstanding policies may have engendered serious reliance interests that must be taken into account.  In such cases . . . a reasoned explanation is needed for disregarding facts and circumstances that underlay or were engendered by the prior policy.  It follows that an unexplained inconsistency in agency policy is a reason for holding an interpretation to be an arbitrary and capricious change from agency practice.

Id. at 221-22 (citations and quotation marks omitted).  The Supreme Court held that the regulatory change in Encino “was issued without the reasoned explanation that was required in light of the Department’s change in position” and was arbitrary and capricious.  Id. at 222.  The agency “said almost nothing” about the “good reasons for the new policy.”  Id. at 223.  “[T]he Department did not analyze or explain why the statute should be interpreted” as it did.  Id. at 224.  The agency’s failure to offer a substantive explanation for the change meant that its actions were arbitrary and capricious:

It is not the role of the courts to speculate on reasons that might have supported an agency’s decision.  We may not supply a reasoned basis for the agency’s action that the agency itself has not given.  Whatever potential reasons the Department might have given, the agency in fact gave almost no reasons at all. . . .  [T]he Department’s conclusory statements do not suffice to explain its decision.  This lack of reasoned explication for a regulation that is inconsistent with the Department’s longstanding earlier position results in a rule that cannot carry the force of law.

Encino, 579 U.S. at 224 (citations and quotation marks omitted).

Most recently, the court applied what it called the “change-in-position doctrine” in our sandbox in FDA v. Wages & White Lion Investments, L.L.C., 145 S. Ct. 898 (2025).  Citing Fox and Encino, the Wages & White Lion Court stated that “[u]nder that doctrine, agencies are free to change their existing policies as long as they provide a reasoned explanation for the change, display awareness that they are changing position, and consider serious reliance interests.”  Id. at 917.  The doctrine applies whenever:

an agency acts inconsistently with an earlier position, performs a reversal of its former views as to the proper course, or disavows prior inconsistent agency action as no longer good law.

Id. (citations and quotation marks omitted).  That included “an agency’s divergence from a position articulated in nonbinding guidance documents.”  Id. at 918 n.5.  The doctrine requires – to avoid reversal as arbitrary and capricious – the agency to “offer good reasons for the new policy.”  Id. at 919.

But under current HHS/FDA management, arbitrary and capricious action has become, as we had feared, a new modus operandi.  We’re not the only ones who feel that way.  In State of New York v. Kennedy, ___ F. Supp.3d ___, 2025 WL 1803260 (D.R.I. July 1, 2025), mass layoffs at the FDA (and other parts of the larger Department of Health and Human Services) were held to be arbitrary and capricious.  Id. at *1 (“the Court concludes the States have shown a likelihood of success on their claims that the HHS’s action was both arbitrary and capricious as well as contrary to law”).  In that case, large-scale “reductions in force” were announced, not through ordinary proceedings, but by “press release.”  Id. at *12.  Reliance interests were simply ignored, and the plaintiffs were “unable to access previously available funds, guidance, research, screenings, compliance oversight, data, and, importantly, the expertise and guidance on which they have long relied.”  Id. at *13.  Thus, the court found blatant arbitrary and capricious behavior:

When looking to HHS’s explanation for its action, the Court must look to the grounds that the agency invoked when it took the action.  Review of the lone declaration provided by the Defendants . . ., and the various testimonies of Secretary Kennedy has not revealed a reasoned explanation for the agency action by the Defendants.  Instead of undertaking an intentional and thoughtful process for weighing the benefits and drawbacks of implementing the sweeping policy change, the Defendants hastily restructured the sub-agencies and issued RIF notices.  The Defendants have failed to demonstrate how the workforce terminations and restructurings made the sub-agencies more efficient, saved taxpayer dollars, or aligned with HHS’s priorit[ies]. . . .  In fact, the record is completely devoid of any evidence that the Defendants have performed any research on the repercussions of issuing and executing the plans announced.

Id. at *14.

And New York v. Kennedy is but one example of many – it’s just the first to have generated a judicial decision.  As we had feared might be the case, shortly after HHS ended notice and comment procedures concerning, inter alia, personnel matters, the entire membership of the Advisory Committee on Immunization Practices (“ACIP”) was purged and replaced by hand-picked administration choices, breaking a promise Kennedy had made during his confirmation hearing to “leave the government’s vaccine committee panels unchanged.”

Kennedy this week shocked the health industry when he dismissed all 17 members of the Advisory Committee on Immunization Practices, a panel that guides US policy on vaccine safety and effectiveness, and named new members weeks before their next meeting to review Covid-19 and other vaccinations.

The dismissal of the ACIP members Monday and the restocking of the panel on Wednesday delivered on proposals laid out in Kennedy’s 72-page “Make America Healthy Again” report.

Phengsitthy & Lopez, “RFK Jr.’s Rapid Vaccine Agenda Sets Stage to Chip Away at Shots” Bloomberg (June 12 2025).  Why should anyone care? Well, here’s what ACIP is supposed to do:

The ACIP holds weight because the Affordable Care Act and the Inflation Reduction Act tie coverage in the commercial and Medicaid markets to the committee’s recommendations, attorneys say. That committee also votes on whether vaccines should be added to the federal Vaccines for Children program, which provides vaccines to children who can’t to afford them.

Phengsitthy & Clason, “RFK Jr. Puts Health Insurers in Limbo by Dropping Covid-19 Shot,” Bloomberg (May 28, 2025).

And what about those replacement ACIP members?  Two of them have served as paid plaintiff-side expert witnesses in the largely unsuccessful Gardasil MDL (see our posts here, here, and here for why) and other antivax litigation.  In Gardasil the plaintiffs’ “speculative inferences” of vaccine-related harm were flatly rejected:

Federal law requires more than speculative inferences prior to adding dire warnings to lifesaving vaccines that discourage their use.  The law requires reasonable scientific evidence of a causal association between the vaccine and the alleged harm.  As described at length above, that evidence is lacking here.

In re Gardasil Products Liability Litigation, 770 F. Supp.3d 893, 920-21 (W.D.N.C. 2025).

So who now sits on ACIP?

Robert Malone, a scientist who has espoused debunked theories about the safety of vaccines, along with Martin Kulldorff, a Harvard-trained epidemiologist who has studied their side effects, were added to the [CDC’s] committee on immunization policy.  Both men have been hired by plaintiffs’ attorneys in the past to opine about Merck’s handling of its vaccines, court filings show.  Kulldorff racked up thousands of dollars in expert-witness fees working for plaintiffs alleging Merck hid the risks of its Gardasil vaccine aimed at preventing cancers tied to human papillomavirus, or HPV, according to court filings. . . .  Malone served as a $350-per-hour expert hired to prepare a report for plaintiffs in antitrust litigation accusing Merck of misleading regulators about the effectiveness of its vaccines for mumps, measles and rubella to protect its market share, the filings show.

Feeley, “RFK Jr.’s Vaccine Panel Includes Paid Witnesses Against Merck,” Bloomberg (June 12, 2025).  “While Kennedy said . . . that he would not appoint ‘anti-vaxxers’ to the [ACIP] panel, Malone said in a post . . . that he embraced the title two days before his appointment was announced.”  Zhang & Smith, “RFK Jr.’s New Vaccine Panel Includes Self-Proclaimed Anti-Vaxxer,” Bloomberg (June 11, 2025).  At least two other ACIP appointments, Vicky Pebsworth and Retsef Levi, are also reported to be avowed vaccine skeptics.

Also on vaccines – in a unilateral action announced by social media post – Secretary Kennedy reversed the Centers for Disease Control (“CDC”) and decreed that vaccination against COVID-19 was no longer recommended for well children and pregnant women.

The decision to back the immunization only for adults and those with existing health conditions reverses the Centers for Disease Control and Prevention ’s earlier stance that everyone six months of age and older get vaccinated.

Smith, “RFK Jr. Says Covid Shot Isn’t Recommended for Healthy Kids (2),” Bloomberg (May 27, 2025).  After the fact, HHS released a “COVID Recommendation FAQ” document (that no longer seems to appear on the HHS website, but we found a copy).  It fits a developing pattern of reliance on questionable studies – that document’s first two citations, Rose & Hulscher and Andrews, would not pass Fed. R. Evid. 702 muster.  The first now has an editorial “expression of concern” regarding “potential issues with the research methodology and conclusions and author conflicts of interest.”  The second is merely “a preprint and has not been peer-reviewed . . . and so should not be used to guide clinical practice.”  This is what happens when research is conducted for political rather than scientific purposes.

In yet another abrupt vaccine-related reversal of prior policy, the FDA “will no longer approve Covid booster shots for healthy adults and children without new studies,” that is, “randomized, controlled trial data.”  Prasad, et al., “An Evidence-Based Approach to Covid-19 Vaccination,” 392(24) N.E.J.M. 2484, 2485 (May 20, 2025).  The article is only two pages long, and is devoid of any scientific support for such a change.  Instead of science, the authors justify the reversal on the public being “unconvinced.”  Id.  See here for a more detailed critique.  This sudden change left would-be recipients and health insurers “in limbo”:

The change will likely curtail access to the Covid-19 vaccine for children and pregnant women if health plans drop coverage or increase cost-sharing after no longer being required to pay for the shots. That move would not only leave patients to start paying out of pocket for the vaccines, but place insurers in a tough spot with beneficiaries who are vulnerable to the virus or seeking to prevent it.

Phengsitthy & Clason, “Health Insurers in Limbo,” Bloomberg (May 28, 2025).  Leaving such interests “in limbo” is a textbook example of disregard for the “reliance interests” that the Supreme Court’s “change-in-position doctrine” seeks to preserve.

Portending reversal of an even longer FDA/CDC policy, Secretary Kennedy has also “threatened to ban government scientists from publishing in the world’s leading medical journals” – such as the New England Journal of Medicine (where, ironically, the Prasad article was published), the Lancet and the Journal of the American Medical Association.  He offered no reasoned explanation for this threat, only the kind of rhetoric we expect from P-side lawyers like Kennedy:

Kennedy justified his position by citing decade-old concerns from journal editors themselves about pharmaceutical influence, including former New England Journal of Medicine chief Marcia Angell’s 2009 warning that “it is simply no longer possible to believe much of the clinical research that is published” due to financial ties with pharmaceutical companies.

Hah!  Compared to how the sausage that passes for P-side medical literature gets made (see these posts), those journals are paragons of scientific excellence.  Instead, Kennedy wants “to launch government-run journals” to which federal employees willing to toe the administration line would be allowed to contribute.  This sort of government control over life sciences publication is antithetical to the scientific method.

Along the same lines, what little scientific justification has been provided to support Kennedy’s aforesaid “Make America Healthy Again” report turns out to be even worse than his “COVID Recommendation FAQ.”  The MAHA Report included downright fake, made-up citations – the same artificial intelligence-generated hallucinations that have also embarrassed a number of lawyers.  E.g., Wadsworth v. Walmart, Inc., 348 F.R.D. 489, 495 (D. Wyo. 2025).  It turned out to be rife with citations to things that don’t exist.  Here are a couple of press reports detailing the presence of hallucinated citations to purported “medical literature” were found in the MAHA Report:

  • LaChance, “RFK Jr.’s Disastrous MAHA Report Seems to Have Been Written Using AI,” Rolling Stone (May 31, 2025).
  • Gilbert, et al. “The MAHA Report’s AI Fingerprints, Annotated,” Washington Post (May 30, 2025)

In light of these glaring flaws, a “likely” conclusion is that the MAHA report “was not subjected to the rigorous review and quality control processes historically used by the US government for similar reports.”

Adding it all up, what we’re seeing is an extremely disturbing pattern of agency behavior from HHS, CDC, and FDA of sudden, dramatic, and unsupported policy reversals with the potential to threaten the public health.  About the only good thing we can say about any of this is that all of these actions are unlikely to satisfy the requirements of the Supreme Court’s “change-in-position doctrine” that we discussed at the beginning of this post.  Truly, it seems that, in the Kennedy HHS and its subagencies, arbitrary and capricious action has become a way of life.

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This is from the non-Dechert and non-RS portion of the Blog.

We used to post about defense wins in litigation over both branded and generic ranitidine fairly often.  The MDL in the Southern District of Florida systematically knocked down all of plaintiffs’ theories based on the lack of legal support (e.g., preemption) and lack of evidentiary support (e.g., admissible expert opinions on general causation) until there was nothing left but appeals and estoppel.  The reality of the litigation seems to be that, as sympathetic as plaintiffs with cancer suing over a drug that FDA asked be withdrawn from the market can be, it was always based on bogus data and hype without an actual risk supported by good science.  It also had massive problems with just about every variant of preemption applicable to product liability claims against drug companies.  Having fizzled out in federal court, the plaintiff lawyers have turned their attention to state courts to pursue perceived more lenient judicial treatment and force lucrative settlements.  They have found some favorable lower court audiences in venues predictable—California—and not-so-predictable—Delaware.

They presumably also sought a coordinated proceeding in Cook County, Illinois, due more to that venue’s pro-plaintiff reputation than its deep dish pizza, hot Italian beef sandwiches, or other potential sources of indigestion that might lead them to take ranitidine if could they find it.  Without recounting all the history that has been tracked on Law360 and other sites, the ranitidine plaintiffs have not done very well in Illinois state court.  In a case called Valadez, the trial court dismissed all the claims against generic manufacturers and retailers and some of the claims against branded manufacturers as preempted.  Later, a jury returned a defense verdict in favor of the branded defendants on all issues.  The plaintiff’s inevitable appeal led to the unpublished decision we are discussing here today.  Valadez v. GlaxoSmithKline LLC,  2025 IL App (1st) 241292-U (Ill. App. June 27, 2025).  By all appearances, the appeal was initially directed at the branded defendants who won the trial.  The other defendants were not on the caption for the notice of appeal, the order dismissing them was not identified in the notice of appeal, and plaintiff’s appeal brief did not cite the record appropriately.  Somewhere along the line, apparently, plaintiff decided to let her losses against the branded manufacturers go and direct her appeal to the preemption of her claims asserted against the non-brand defendants.  We are a bit surprised that the Appellate Court let all these gaffes go and proceeded to the merits, but it did.

The merits were pretty good, except for one part that is properly considered dicta (in an unpublished decision).  Plaintiff’s first two counts against the generic manufacturers and retailers asserted strict liability failure to warn and strict liability design defect claims, both of which Illinois state law recognizes.  After a review of Mensing and Bartlett, which collectively clearly articulated why these sorts of claims are preempted against generic drug manufacturers, the appellate court in Valadez followed both the trial court and the MDL court in finding these claims preempted against both the generic manufacturers and retailers.

Because it was impossible for the non-brand defendants to comply with the state-law requirements under [Section] 402A [of the Restatement (Second) of Torts] to provide a safer design and more complete warnings about the cancer risks, and with the federal law requiring that the design and warnings be the same as Zantac’s, counts I and II of plaintiff’s complaint are preempted.

In addition to the usual pretending that Bartlett had not nixed stop-selling arguments, plaintiff offered two additional arguments.  First, she claimed that Illinois and the FDCA both prohibit misbranding of drugs under 21 U.S.C. § 352(j), so she had a “parallel claim” under state law that is not preempted.  That argument entails such a butchery of preemption principles that it should fail on several grounds.  One was enough for the Valadez court:  these defendants still could not, consistent with the duty of sameness under federal law, change anything about the design or labeling of the drugs.  Of course, if plaintiff were trying to recover because of a purported violation of the FDCA, which is the only source for misbranding being prohibited anywhere, then that is an obvious Buckman problem.

Plaintiff’s second argument was to harken back to a truly bad Illinois state decision called Guvenoz that twisted itself in knots to find liability notwithstanding Bartlett.  Rather than having to declare its prior decision in Guvenoz wrong, the Valadez court found a distinction.  The plaintiff in Guvenoz alleged the generic drug plaintiff’s decedent took “should not have been sold at all, and there was no warning that could have cured the problem.”  (Yes, exactly the stop selling argument rejected in Bartlett and by so many courts—including Valadez—since.)  The plaintiff in Valadez, by contrast, “pleaded that alternative labeling and designs were available as remedial measures,” so Guvenoz did not apply.

The third count against the generic manufacturers and retailers that the trial court had found preempted was “for negligent transportation and storage.”  The appellate court in Valadez stated—without any accompanying analysis—that this purported claim was not preempted, but that statement was merely dicta because it was not necessary to the actual holding in the decision.  This is because plaintiff was estopped from asserting this claim against the non-branded defendants because of how she had tried and lost against the branded defendants.  The jury’s general verdict incorporated the finding that plaintiff was more than 50% responsible for her colorectal cancer due to her repeated refusal to undergo recommended colonoscopies that would have allowed for treatment to nip her cancer in the bud (or polyp).  Under Illinois law, the finding of contributory negligence means she cannot succeed on any negligence claim.  She had asserted essentially the same negligent conduct by all the defendants in failing to ensure storage and transportation at appropriate temperature and humidity levels.  So, her negligence claims against the non-branded defendants were estopped, whether by collateral estoppel or direct estoppel.

Even though dicta, we do want to rant for a bit on the blithe suggestion that the purported “negligent transportation and storage” claim “did not seek to change the labels and design of the ranitidine-containing products and thus did not conflict with federal law.”  To arrive at any conclusion, there would first need to be an analysis of whether this count contained sufficient factual allegations to state a cognizable claim for negligence under Illinois law.  Does Illinois impose a standard of care on ensuring specific temperature and humidity in transporting a product?  Would an allegation of violating that standard of care necessarily rely on a violation of a federal standard?  Because a strict liability claim under Illinois law focuses on the condition of the product “when the product left the manufacturer’s control,” then is this count really just a re-packaged design defect claim that was also preempted?  If it concluded that Illinois did recognize a claim for what plaintiff asserted in this count, then the court would need to examine if federal law imposed any requirements that conflicted with the state requirements.  Approval of ANDAs can impose a number of requirements on a generic manufacturer, and drug labeling often contains information about recommended storage conditions.  In short, a thorough analysis was required before the plaintiff’s facially novel claims could be said to pass muster.  When another state court actually did that analysis in 2022, it held that similar claims against generic manufacturers and retailers were not recognized by Maryland law and would have been preempted.  The MDL court had issued similar rulings about such claims against both retailers and generic manufacturers in 2021.  Those rulings covered claims asserted under Illinois law.  We could probably go on, but it should not be necessary for a relatively short rant on obiter dictum.

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What is the meaning of our brief time on Earth? is there life after death?  Is there a God?  If so, why would The Almighty permit so much wickedness and suffering in the world?  How can one explain the existence of contention interrogatories?

Unlike the Drug and Device Law Daughter, who attended Divinity School, we are ill-equipped to answer these profound questions. By scurrying into the legal profession, we managed to avoid both math and theology.  Or so we thought. It turns out that, every once in a while, the law is forced to contemplate Higher Things. 

Such was the case in Slattery v. Main Line Health, Inc., 2025 WL 1758616 (E.D.Pa. June 25, 2025), where the plaintiff, a physician, alleged that she was denied a COVID-19 vaccination exemption “based on her sincerely held religious beliefs as an Evangelical Christian.” The defendant medical practices had announced a mandatory Covid-19 vaccination requirement in 2021.  The plaintiff applied for a religious exemption by submitting a narrative statement and completing a required questionnaire. 

The plaintiff had taken other vaccines (including flu) before. Here, she claimed that the COVID vaccine utilized different technology. Perhaps that explained what to a neutral observer might appear to be the plaintiff’s contradictory, or at least situational, positions on vaccinations.  The plaintiff claimed that the vaccine permanently altered her genetic makeup – which “violates God’s intended design for [her] makeup.” 

The defendants’ Religious Exemption Committee declined the plaintiff’s request, determining that the plaintiff had not stated a basis why her religious belief required her to refuse the Covid-19 vaccination. 

The plaintiff filed a lawsuit under Title VII of the Civil Rights Act of 1964 and the Pennsylvania Human Relations Act for disparate treatment and for failure to accommodate based on her religious views.  The defendants moved for summary judgment. 

In COVID vaccination cases, most courts have shown deference to plaintiffs asserting “religious” objections to vaccination.  But what makes something “religious”?  Do courts even want to wade into such deep waters?  Sometimes, as in the Slattery case, they have to slip into their waders. In Slattery, the court called out the plaintiff’s religious objections for what they were – quibbles of a scientific, not religious, nature.  

The court reasoned that whether a belief is religious in nature depends on whether such belief “addresses fundamental and ultimate questions having to do with deep and imponderable matters” that are “comprehensive in nature.”  The plaintiff’s stated justification for an exemption was “scientific and/or medical in nature, not religious.”  Merely draping general religious terminology (the body is a temple, etc) over quarrels with particular medical mechanisms does not transform what is essentially a scientific distinction into a religious stand. Whether these beliefs were “sincerely” held was irrelevant, because they did not relate to any religious faith. (There is no more overrated ‘virtue’ than sincerity.)

Nor was a reasonable accommodation possible, since the plaintiff’s job required 40 hours a week of direct patient care.  While it might be all fine and good for the plaintiff to expose herself to increased COVID risk, the employer could reasonably refuse to permit her to pose an increased Covid-19 (and death) risk to the patients. That is a risk and cost to health and safety that was “immeasurable” and constituted an “undue hardship” for the employers. Such an undue hardship is, as a matter of law, a complete defense to a failure-to-accommodate claim.  

The disparate treatment claim went nowhere, too, because the plaintiff was “unable to distinguish which classes of people, or non-members, were treated more favorably than Plaintiff.”  

The court granted the defendants’ motion for summary judgment and dismissed the plaintiff’s complaint. The plaintiff’s case never had a prayer. 

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This post is not from the Reed Smith side of the Blog.

Welcome to the Garden State—where you can get cursed out in traffic, eat a pork roll (not a Taylor ham) sandwich that changes your life, and see a beautiful beach… all before 10 a.m. Where driving is both a sport and a trust fall exercise with strangers going 90 mph while drinking Dunkin’ or chowing down on a Wawa hoagie. North Jersey thinks it’s basically NYC (with better pizza and worse parking), while South Jersey swears it’s practically part of Philly (honestly, maybe?). Then there’s Central Jersey, which may or may not exist depending on who you ask and what time of day it is (it doesn’t). It’s got nature too.  The Pine Barrens are real, and they may or may not be haunted by a demonic flying goat. And you can’t beat the gorgeous shorelines, though if you call it “the beach” instead of “the shore,” someone will correct you with passive-aggressive enthusiasm. Diners on every corner, but you have to use jughandles to reach them. New Jersey is like that one weird uncle at Thanksgiving—loud, chaotic, unapologetically themselves, and full of stories you’re not sure are legal. But deep down–a total gem.

And if that’s a little confusing and contradictory—that was the point. Because so is today’s case: Hollenstein v. St. Jude Medical, Inc., 2025 U.S. Dist. LEXIS 121547 (D.N.J. Jun. 26, 2025). Plaintiff brought standard products claims against the manufacturer of his automatic implantable cardioverter-defibrillator alleging a “lead failure” caused the device to administer inappropriate shocks. The device was pre-market approved by the FDA, so you know we are going to be talking about preemption.  But before we get there, there is a personal jurisdiction ruling worth mentioning.

Plaintiff sued both the company that manufactured his particular device and that company’s successor.  The successor moved to dismiss on the grounds that the court had neither general nor specific personal jurisdiction. General jurisdiction didn’t exist because the company was incorporated in Delaware and its principal place of business is Illinois.  Id. at *17-18. Plaintiff argued in response to the motion to dismiss that the predecessor’s jurisdictional contacts, which are sufficient for specific jurisdiction, should be imputed to the successor. The court acknowledged that the question of “whether product line successor liability could support specific jurisdiction over a successor lacking minimum contacts” was a matter of first impression. Id. at *21. But it was also a question the court did not have to decide because nowhere did the complaint allege one defendant was the successor to the other. The successor was dismissed without prejudice.

Now we come to preemption.  All of plaintiff’s claims other than breach of express warranty are subsumed by the New Jersey Products Liability Act (NJPLA) and boil down to claims for design defect, manufacturing defect, and failure to warn.  The opinion starts off strong finding plaintiff’s design claim both preempted and insufficiently pleaded. Id. at *33-35.  Any state law challenge to the safety or efficacy of the device would be different from or in addition to the FDA’s approval and therefore the claim is preempted. Plaintiff also failed to plead that either the device’s risks outweighed its harm or that there was a “practical and feasible alternative design.” Id.

On manufacturing defect, the court went in the opposite direction.  It found the claim was not preempted because plaintiff alleged that defendants did not manufacture the device in accordance with enumerated PMA requirements. The court would not consider, at the pleadings stage, rulings by other courts on summary judgment that found no evidence of the purported PMA requirements. Id. at *35-36. For similar reasons, the court found the claim sufficiently pleaded, including pleading a causative connection between the alleged PMA violations and plaintiff’s injuries.  Id. at *37-38. 

Now we get to the confusing part—failure to warn.  Plaintiff’s warning claim is premised on allegations that defendant did not report adverse events to the FDA. We direct you to either our failure-to-report preemption round up or our 50-state survey on whether state law recognizes a failure-to-report. Both will show you that New Jersey courts have consistently held failure-to-report claims are either preempted or not recognized. Indeed, Hollenstein cites and relies on the New Jersey cases that “declin[e] to recognize a separate state law duty to the warn the FDA.” Id. at *44-45.

Here comes the twist. The court drew an inexplicable and unprecedented distinction between plaintiff’s claim based on (a) “[d]efendants fail[ure] to report newly acquired information to the FDA about the defects in the [device] after the initial PMA approval by the FDA,” id. at *44; and (b) [d]efendants’ alleged failure to disclose newly acquired information to the general public through the FDA’s Manufacturer and User Facility Device Experience (“MAUDE”) public, searchable database.” Id. at *45.

The court found the former was impliedly preempted, like the other New Jersey courts to have considered the issue. As to the latter, however, the court concluded it survived preemption as a parallel claim on the theory that it is a failure to warn the public claim. But that incorrectly assumes that manufacturers have any say in or control over what is reported in the MAUDE database. They don’t. The court blindly accepts the allegation “that had Defendants disclosed [event reports], it would have been published on the MAUDE database used by physicians.” Id. at *47.  MAUDE is an FDA database. No device manufacturer adds information to any FDA database–only the FDA does. And the FDA does not place all adverse events on the MAUDE database. So, this is just another way of alleging some sort of duty to report to the FDA. The court drew a distinction without merit that keeps failure to warn alive, for now. And has us wondering how plaintiffs are going to try to use this sideways ruling.

Plaintiff also brought a breach of express warranty claim that the court ruled might not be preempted if based on “voluntary” statements not regulated by FDA. But since plaintiff failed to plead the specifics of any actual statements made, the claim was dismissed without prejudice under TwIqbal.  On the facts, the claim seems weak, as the device functioned for 16 years, and thus met or exceeded the product’s expected useful life.

Just remember, Jerseyans don’t pump their own gas, will defend their favorite mall like it’s a football team, and say things like wudder, cawfee, and heum.  And we’ll complain endlessly about the state—but if you do, you’re an outsider. Only we get to make fun of our jughandles and toxic air.

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We get paranoid in our old age.  We know that our clients spend a great deal of effort and money on keeping their internal data safe from criminal hackers.  We assume that hospitals and other repositories of electronic medical records are doing the same.  However, once such data, such as corporate trade secrets and personnel files, are turned over during discovery, we have no confidence whatever that the other side is employing similarly robust data security measures.  Equally, if not more, problematic is the degree of data security maintained by expert witnesses and the plethora of other litigation-related vendors who may receive confidential material − translators, court reporting services, copying services, data processors, database and remote deposition hosts, coders, document reviewers, graphics producers, jury researchers, and trial preparation services.  Similar confidentiality issues exist, although less of a concern for us, concerning plaintiffs’ personal medical records after they are collected.

Is there any way we can require them to upgrade their security?

Continue Reading Using Protective Orders To Protect Against Data Breaches
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Readers of this blog know that we love preemption in all its forms, including preemption based in the Public Readiness and Emergency Preparedness (“PREP”) Act, 42 U.S.C. §247d-6d.

During the COVID-19 pandemic, a needlessly politicized public health emergency, the PREP Act provided important liability protections to health care providers, vaccine manufacturers, and others working hard to stem the death toll, treat those sickened by the virus, and invent novel treatments.

We have delved into the details of the PREP Act before:  The statute provides defenses to liability and preemption of state laws involving “covered persons” and “covered countermeasures”.  And we have covered numerous COVID-19 related opinions, both good and not-so-good.  Bexis even created a scorecard. 

Today’s PREP Act preemption opinion arose in the medical malpractice context, and comes from Puerto Rico: Marchese Torres v. Pro. Hosp. Guaynabo, Inc., 2025 PR App. LEXIS 1279; 2025 WL 1698806 (May 22, 2025 P.R. App.).

In Marchese Torres, the plaintiffs alleged the defendant doctors and hospital were responsible for negligence in the diagnosis and treatment of her husband.  The exact allegations are not terribly clear, but piecing together bits from the majority and dissenting opinions, it appears that plaintiff’s husband went to the emergency room, was given a COVID-19 test that came back negative, was sent home, and then at some point passed away.  The cause of death and its connection to the ER visit are not spelled out, but presumably the cause of death was COVID-19 related, and the theory was that earlier treatment would have prevented the death.

The trial court dismissed the case on both PREP Act and statute of limitations grounds, and the appellate court upheld on the PREP Act ground without reaching the statute of limitations issue (which is less interesting to us anyway).

According to the court, the physicians and hospital were protected by the PREP Act because

(1) the defendants were “covered persons”;

(2) the challenged actions involved “covered countermeasures” (in this case, the COVID-19 diagnostic test and associated clinical decisions);

(3) there was a causal relationship between the claim and the use of the countermeasure; and

(4) the events occurred during the public health emergency.

The court emphasized that the PREP Act displaces state (and territory) requirements related to COVID-19 countermeasures, including tort liability, and the only exception to immunity is where a death or serious physical injury is caused by “willful misconduct”—a high bar to reach, and one not alleged in this case.

This all seems straightforward, but there was a dissent.  In the view of the dissenting judge, the plaintiff’s case should not have been dismissed because there was conduct independent of a covered countermeasure.  In particular, the dissent viewed the only covered countermeasure to be the administration of the COVID-19 test, with the subsequent decision not to treat (and to send the husband home) as an instance of alleged negligence separate from that covered countermeasure. 

The dissent’s point—that failing to treat is not a “countermeasure”—has some surface appeal.  A “countermeasure” sounds like an action verb, like administering a vaccine, or manufacturing face masks, or intubating a patient whose oxygen levels have fallen dangerously. 

But lest we forget, the pandemic required those on the front lines to make tough choices in doling out care because everything was in short supply:  face masks, vaccines, hospital beds, even space to hold the deceased.  Not all who contracted COVID-19 fell seriously ill, fortunately, and resources often had to be allocated to those in most dire medical need.

Would it make good policy sense to impose liability for failure to treat, when that only would encourage health care providers to practice defensive medicine in the middle of a crisis?  It is not even useful to have doctors make clinical decisions based on malpractice concerns in ordinary times, much less during a pandemic, and we think the majority got the scope of the PREP Act right in affirming the dismissal.

As our scorecard shows, this is not the only opinion where a judge (like the dissenting judge here) has tried to cabin the sweeping immunity and preemption of the PREP Act to allow for more lawsuits than defendants might expect.  Fortunately, in the end the decision correctly affirms the robustness of the PREP Act’s liability protections.

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