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Happy Valentine’s Day. To celebrate, we will discuss a court decision that we love.

Preemption and the Ohio Product Liability Act (OPLA) are two of the best friends a drug/device defense lawyer has.  Both show up in Groeschen v. Alcon Laboratories, Inc., 2024 Ohio Misc. LEXIS 2 (Ohio Ct. Comm. Pleas Feb. 2, 2024). As the Groeschen court explained, this case has a “lengthy history.”  In 2017, the plaintiff sued his eye doctor professionals and the manufacturer of contact lenses, claiming that the lenses caused him to suffer serious injuries, including vision loss.  The plaintiff alleged that the lenses malfunctioned as the result of some unspecified defective manufacturing process or chemical contamination, and that the defendants failed to warn him of the potential injuries.  

The manufacturer moved to dismiss the complaint, and then the First Amended Complaint.  In 2021, the court granted that motion to dismiss, in part, with preemption being the basis for dismissal. The court also ordered a more definite statement with respect to the manufacturing defect claim. That more definite (except it really wasn’t – more on that later) statement arrived in the form of a Second Amended Complaint.  The manufacturer again moved to dismiss. Meanwhile, discovery took place. The defendants met their discovery obligations.  The plaintiff … not so much.  The manufacturer then moved for summary judgment. The grounds for the summary judgment motion were fairly straightforward: the plaintiff had no evidence.  After the court denied the plaintiff’s request foradditional time to conduct discovery, the  plaintiff voluntarily dismissed the Second Amended Complaint. The court never ruled on either the motion to dismiss the Second Amended Complaint or the motion for summary judgment. 

Thus concluded Groeschen I

Now we get to Groeschen II.  In 2023, the plaintiff refiled the case. There was a Complaint.  Then there was a First Amended Complaint.  If you’re keeping count throughout the life of this case in its various iterations, we are now up to the fifth pleading overall.  And yet the claims were essentially the same, including the claims (negligence, products liability, breach of implied warranty) that were previously held to be preempted.  

Have you heard the definition of insanity as doing the same thing and expecting a different result?

The manufacturer moved to dismiss the latest (but not greatest) complaint.  We’re guessing that it was easy enough to dust off the old motion to dismiss and summary judgment motion, change a few dates, and then file and serve. There is nothing insane about doing the same thing and expecting the same result. 

The contact lenses were a class III medical device, meaning that they had gone through the rigorous Pre Market Approval (PMA) process, and meaning that any legal claim attempting to impose “any requirement” that “is different from, or in addition to” and FDA requirement would be preempted.  There was no getting around the fact that the plaintiff’s claims insisted that the medical device at issue – the lenses— should have been manufactured, designed, or labeled differently from the manner approved by the FDA. 

Well, maybe there was one possible way of getting around preemption, and by now almost all of you can predict that the plaintiff resorted to the Riegel parallel claim exception.  (Has any SCOTUS dictum visited more mischief? Inspired more frivolity by hapless plaintiff lawyers?  Made necessary more indignant blogposts?) If the plaintiff could point to a violation of FDA regulations that parallels a state law violation, his claims could conceivably squeeze through the “narrow gap” and evade preemption. But such parallel claims require more than conclusory violation claims. This was the issue that prompted the Groeschen I court way back in 2021 to ask the plaintiff to author a more definite statement. But in multiple complaints, the plaintiff failed to plead any violation of any particular federal specification.  Nor did the plaintiff identify particular Ohio state-law duties that parallel any FDA requirement.  Inevitably ineluctably indubitably, the Groeschen II court pushed the trap door button: “Plaintiff’s inability to allege the elements of a parallel claim capable of surviving preemption after five complaints in two cases over six years requires dismissal of all of Plainitff’s claims against [the manufacturer] as preempted.”

The court almost sounds exasperated. 

Maybe it was. We say that because, after hammering the plaintiff on preemption grounds, the Groeschen court held that even if preemption did not apply, the plaintiff’s claims for negligence, breach of warranties, and “common law tort claims for breach of implied warranty/strict liability” were abrogated by the OPLA, which precludes separate common-law claims.  The claims that otherwise could proceed via the OPLA still fail, because they fail to specify any particular design, warning, or manufacturing defect.  Moreover, the OPLA precludes consumer fraud claims in product liability cases. Lastly, the OPLA (bless it) bars punitive damages against FDA-approved products. 

The plaintiff lost, and the court’s reliance on multiple grounds makes an appeal by the plaintiff all the more difficult. 

Groeschen is a good decision that was a long time coming. We are grateful to our esteemed colleagues and friends at Greenberg TraurigMarcella Ducca and Greg Ostfeld — for bringing this case to our attention, and even more grateful for their excellent efforts in earning such a fine result. 

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We offer today’s case as a good recitation of Alabama warranty and fraud law.  Both have precise pleading requirements that plaintiff failed to meet in Morris v. Angiodynamics, Inc., 2024WL 476884 (M.D. Ala. Feb. 7, 2024). 

Plaintiff was implanted with a port used to deliver his chemotherapy treatments.  About five months after implant, plaintiff developed a pulmonary embolism and deep vein thrombosis.  When the port was explanted it was found to be clotted.  Id. at *1.  Plaintiff brought claims for negligence, breach of warranty, and fraud against the manufacturer; and defendant moved to dismiss the latter two categories.

Plaintiff brought three warranty claims – breach of express warranty, breach of implied warranty of merchantability, and breach of implied warranty of fitness for a particular purpose.  All three failed for two reasons.  First, Alabama law requires pre-suit notice to the seller as a pre-condition to any warranty claim.  Id. at*2.  Plaintiff’s first amended complaint alleged only that “upon information and belief” either he or his health care providers provided pre-suit notice.  But not only was that conclusory allegation missing the who, it was also missing the when, how, and to whom.  Id.  What it confirmed for the court was that plaintiff “has no knowledge personally or otherwise, that any pre-suit notice was ever provided.”  Id.  Plaintiff claimed this was information that would come out in discovery, however, a conclusory complaint does not throw open those doors.  Moreover, plaintiff should not need discovery to know whether he himself gave notice.  Without “some degree” of specificity or a factual basis to support a claim of pre-suit notice, plaintiff’s warranty claims had to be dismissed.

The second reason for dismissing the express warranty claim was TwIqbal.  Plaintiff failed to plead anything about where or how he received the alleged warranties or whether the defendant “communicated these affirmations to [plaintiff] directly.”  Id. Plaintiff apparently pointed to the device’s Indications for Use (“IFU”), but the IFU is not a warranty of safeness.  The IFU describes the device and its uses.  It also provides warnings and possible complications, including the risk of clotting.  Perhaps more importantly, the IFU is a communication from the manufacturer to healthcare providers; or the learned intermediaries.  Nowhere did the first amended complaint allege how the purported warranty passed from plaintiff’s prescribing physician to him.  Id. at *4.        

The second reason for dismissing the implied warranty claims is because Alabama law does not allow such claims for inherently dangerous products such as medical devices.  Rather, Alabama has decided that allegations of harm caused by medical devices and prescription drugs should be “addressed by claims under tort theories” rather than under the UCC.  Id. at *5. 

Moving on to fraud, plaintiff failed to plead these claims with the heightened specificity required by Fed.R.Civ.P 9(b).  Plaintiff left out of his complaint the “time and place” of the allegedly fraudulent statements, the content of the statements, and what he relied on that induced him to agree to the implantation of the device.  Id. at *6.  That warranted dismissal of his fraudulent misrepresentation claims.  Plaintiff also alleged fraudulent suppression.  Under Alabama law, a party who is obligated to communicate a material fact and does not do so can be liable for fraudulent suppression.  Id.  But the “duty to speak” depends on several factors including the relationship between the parties.  When parties deal with each other at arms’ length, there is no duty to disclose.  While plaintiff alleged defendants had a duty to disclose to his physician, he did not allege any “confidential or special relationship” between himself and the defendants.  Therefore, plaintiff’s fraudulent suppression claim was also dismissed.  Id.

Finally, plaintiff had already amended his complaint once in response to a prior motion to dismiss—with only minor changes and none that remedied the deficiencies in these claims.  The court was not inclined to give him another opportunity.  Id. at *7.  So, these claims are dismissed with prejudice.

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We’ve blogged several times already about the  Alliance for Hippocratic Medicine v. FDA litigation that is now before the Supreme Court.  Briefly, a Texas District Court, in a decision that we’ve already described as “results-driven and shoddy,” purported to invalidate more than 20 years of FDA regulation – back to and including the original 2000 agency approval – of the abortifacient drug mifepristone, which would have had the effect of immediately removing from the market nationwide the safest and most commonly used drug for medication abortions.  See Alliance for Hippocratic Medicine v. FDA, ___ F. Supp.3d ___, 2023 WL 2825871 (N.D. Tex. April 7, 2023) (“AHM I”).

On appeal, the Fifth Circuit overturned the District Court’s nullification of the FDA’s approvals of both branded and generic versions of mifepristone but affirmed that court’s voiding of both the 2016 risk evaluation and mitigation strategy (“REMS”) and 2021 non-enforcement decision that allowed telemedicine prescription of mifepristone.  See Alliance for Hippocratic Medicine v. FDA, 78 F.4th 210 (5th Cir. 2023) (“AHM II”).  We chastised both of these decisions for, on the one hand setting a very low bar for standing to challenge FDA drug approval decisions (mere stress to physicians from treating purported mifepristone adverse reactions being sufficient), and on the other for simultaneously dumbing down the previously rigorous “arbitrary and capricious” standard of review for FDA drug approval decisions (placing the burden on the agency to demonstrate the negative, for one).

We were hardly alone.  We quoted the FDA’s description of the decisions to overturn its regulation of mifepristone:

While FDA justified its scientific conclusions in multiple detailed reviews, including a medical review spanning more than 100 pages and assessing dozens of studies and other scientific information, the district court swept the agency’s judgments aside by substituting its own lay understanding of purportedly contrary studies, offering demonstrably erroneous characterizations of the record.

(quoting FDA appellate brief).  Another of our posts quoted similar concerns raised by our clients in the pharmaceutical industry as the matter was being successfully appealed to the United States Supreme Court:

The Fifth Circuit’s ruling threatens to stifle pharmaceutical innovation by disrupting industry’s reasonable investment-backed expectations.  Congress created an FDA approval process that is both rigorous and thorough, and pharmaceutical companies invest billions of dollars in research and development to meet FDA’s scientific standards.  Considering the rigorousness of this process and the due process interests of drug sponsors, Congress also mandated by statute a process for withdrawal or suspension of an FDA approval decision − a process the Fifth Circuit circumvented.  But if every FDA drug approval decision − and subsequent supplemental drug approval decision − can be retroactively invalidated by a court based on extra-statutory, judicially created requirements, biopharmaceutical companies will likely invest less in the advancement of new and existing medicines that benefit patients.

(Quoting PhRMA Amicus Brief, at 3-4).

Last week these concerns were graphically confirmed when two of the “purportedly contrary studies” mentioned by the FDA, and relied upon six times by the District Court in its unprecedented opinion, were withdrawn by the academic journal in which they were published − for apparently pervasive academic fraud.  See Health Services Research & Managerial Epidemiology retraction notice, available here.

The journal retracted the following three articles:

  • Studnicki J., Longbons T., Harrison D.J., et al., “A Post Hoc Exploratory Analysis:  Induced Complications Mistaken for Miscarriage in the Emergency Room Are a Risk Factor for Hospitalization,” 9 H. Servs. Res. & Man’l Epid’y. 1 (2022).
  • Studnicki J, Harrison D.J., Longbons T., et al., “A Longitudinal Cohort Study of Emergency Room Utilization Following Mifepristone Chemical & Surgical Abortions, 1999–2015,” 8 H. Servs. Res. & Man’l Epid’y. 1, (2021).
  • Studnicki J., Longbons T., Fisher J.W., Harrison D.J., Skop I., MacKinnon S.J., “Doctors Who Perform Abortions:  Their Characteristics & Patterns of Holding & Using Hospital Privileges,” 6 . Servs. Res. & Man’l Epid’y. 1 (2019).

The first two of these articles were cited no fewer than six times in the District Court’s decision.  See AHM I, 2023 WL 2825871, at *4 n.9 (“Longitudinal” for the proposition that “adverse events from chemical abortion drugs can overwhelm the medical system and place ‘enormous pressure and stress’ on doctors during emergencies and complications”), at *14 n.22 (both articles for the proposition that there are “‘many intense side effects’ and ‘significant complications requiring medical attention’” resulting” from FDA’s regulation of mifepristone), at *22 n.37 (one or both articles for the proposition that “chemical abortions are over fifty percent more likely than surgical abortion to result in an emergency room visit within thirty days”), at *23 n.45 (“Longitudinal” for the proposition that “over sixty percent of women and girls’ emergency room visits after chemical abortions are miscoded as ‘miscarriages’ rather than adverse effects to mifepristone”) (emphasis original).  AHM I thus relied on these retracted articles both to support its standing analysis and substantively to justify its injunction that would have removed mifepristone from the market.

Neither article, however, could have passed muster under Fed. R. Evid. 702 in product liability litigation.  Here’s why they were retracted.  The publishing journal’s investigation identified both disclosure and substantive scientific errors.  The journal determined, first, that the authors had undisclosed conflicts of interest:

[We] confirmed that all but one of the article’s authors had an affiliation with one or more of Charlotte Lozier Institute, Elliot Institute, and American Association of Pro-Life Obstetricians and Gynecologists, all pro-life advocacy organizations, despite having declared they had no conflicts of interest when they submitted the article for publication or in the article itself.

See Retraction Notice.  These undisclosed conflicts of interest tainted not only the articles themselves, but also their initial peer review – the publisher “became aware that a peer reviewer who evaluated” all three articles “for initial publication also was affiliated with Charlotte Lozier Institute at the time of the review.”  Id.  Thus, the publisher also “determined the peer review for initial publication was unreliable.”  Id.

These undisclosed conflicts of interest further affected the AHM litigation itself – the aforementioned American Association of Pro-Life Obstetricians and Gynecologists is one of the plaintiffs in  AHM.  The AHM I opinion contains no indication that the ties between the researchers in the cited articles and one of the plaintiffs was any more disclosed during the litigation than it was during the articles’ original peer review process.  AHM I thus relied, presumably unknowingly, on articles generated by one or more of the plaintiffs’ members.  Moreover, all three articles appear to have been covertly generated for litigation purposes, as the lead author for the articles has also acted as an “expert” witness in other abortion-related litigation.  See, e.g., Whole Woman’s Health Alliance v. Rokita, 2021 WL 650589, at *12-17 (Mag. S.D. Ind. Feb. 19, 2021) (admitting and excluding Studnicki testimony); Whole Woman’s Health Alliance v. Hill, 2020 WL 7129727, at *2-3 (Mag. S.D. Ind. Dec. 3, 2020) (addressing litigant’s attempt to correct various errors in Studnicki report).

Substantively, as well, the three articles cited in AHM I were junk science.  After learning of the conflict-of-interest problems with the articles’ original peer review, the publisher engaged “[t]wo subject matter experts” to conduct a second “post-publication peer review.”  See Retraction Notice.  Those unbiased experts determined:

In the 2021 and 2022 articles, which rely on the same dataset, both experts identified fundamental problems with the study design and methodology, unjustified or incorrect factual assumptions, material errors in the authors’ analysis of the data, and misleading presentations of the data that, in their opinions, demonstrate a lack of scientific rigor and invalidate the authors’ conclusions in whole or in part.  In the 2019 article, which relies on a different dataset, both experts identified unsupported assumptions and misleading presentations of the findings that, in their opinions, demonstrate a lack of scientific rigor and render the authors’ conclusion unreliable.


Thus, the attempted invalidation of over 20 years of FDA regulatory activity concerning mifepristone stands exposed as based in large part on junk science:  “fundamental problems” with “study design and methodology,” “unjustified or incorrect factual assumptions,” “material errors” of data analysis, “misleading presentations of the data,” “lack of scientific rigor” – all of which “invalidate the authors’ conclusions” and “render” those conclusions “unreliable.”  Those are not our words; they are the findings of the same scientific journal that was duped into publishing these articles.

If this outright repudiation of the claimed basis of an opponent’s litigation experts had occurred in the prescription medical product liability litigation in which we participate, it would have merited inclusion in our “stupid expert tricksblogposts.  But the scientific fraud that has evidently been perpetrated in the AHM litigation is far worse.  It is not about some plaintiff being awarded, or not, money for some claimed injury.  Rather these bogus articles have been employed in a political attack against the linchpin of prescription medical product regulation in this country – the congressionally conferred responsibility of the FDA to determine what medical products (here, drugs) are available in the American market and under what conditions.

No judge should have the power, as has been attempted in the AHM litigation, to overturn an FDA product approval on the behest of litigants who cannot possibly duplicate the FDA’s scientific expertise and comprehensive data review.  Biased litigants (and equally biased judges) cannot be allowed to second-guess FDA product determinations.  Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341, 351 (2001) (rejecting the “sort of litigation [that] would exert an extraneous pull on the scheme established by Congress”).  Nothing more graphically demonstrates that “[a] court is ill-equipped to second-guess” the FDA’s “scientific judgment” than what has been happening in AHMCytori Therapeutics, Inc. v. FDA, 715 F.3d 922, 927 (D.C. Cir. 2013) (Kavanaugh, J.).

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Dunn v. Sanofi-Aventis U.S. LLC, 2024 U.S. Dist. LEXIS 14111 (M.D. Alabama Jan. 26, 2024), involves yet another post-MDL attempt by a remanded plaintiff to amend her complaint.  This time the court rejected the amendment. 

Why was the amendment rejected?  We’ve been seeing over the last couple of years how SCOTUS has emphasized the centrality of “history, tradition, and text” in constitutional interpretation. Mind you, we’re not a hundred percent clear on the distinction between “history” and “tradition,” though we have a rough idea. (History is what the authors of the Constitution said, while tradition is how courts and society have dealt with the issue over the years). Maybe history, tradition, and text play roles in the Dunn court’s decision not to permit an amendment to the complaint. 

Here is some history: The litigation involved claims of Permanent Chemotheraoy Induced Alopecia. There were enough cases to warrant an MDL, and then MDL folklore and mythology took over, with a Master Complaint (which later evolved into a Second Amended Master Complaint) that contained general allegations, a Short Form Complaint that contained individual allegations, then bellwether trials, then remands. The plaintiff in Dunn filed her complaint in 2017, and the case was remanded in 2023. 

Here is some tradition (or is it more history?):  In 2019 the MDL court denied the Plaintiff Steering Committee’s proposed Third Amended Complaint, which would have described in greater detail how the defendant allegedly harmed the plaintiffs, and how the the defendant allegedly defrauded the plaintiffs. The MDL court held that the proposed amendment would have negated a significant amount of work done in the MDL and would moot earlier MDL rulings. The MDL court also denied amendments to short form complaints that would have buttressed the claims against statute of limitations defenses. The court reasoned that the amendments would have set off a new round of discovery and a revision of statute of limitations defenses.  

Here is something we feel pretty comfortable calling tradition: the law of the case.  Dunn was governed by Eleventh Circuit law, and the Eleventh Circuit recognizes that when a case gets transferred from one judge to another, that is not an opportunity to relitigate everything decided by the first judge. Maybe a litigant can persuade the second judge that the first committed clear error. But that’s a tough test. 

Here is some text: Federal Rule of Civil Procedure 15 provides that a “party may amend its pleadings once as a matter of course no later than … 21 days after serving it.”  But in “all other cases a party may amend its pleading only with the opposing party’s consent or the court’s leave.”  To be sure — and here maybe we’re back to tradition — leave to amend is “freely given when justice so requires,” while at the same time such leave will be denied if there is “undue delay, bad faith, or dilatory motive on the part of the movant” or an amendment would visit “undue prejudice to the opposing party.”  

Now that we have a handle on history, tradition, and text, we ask again, why did the Dunn court reject the plaintiff’s prooosed amendment?

First of all, the amendment was simply too late. The plaintiff failed to seek an amendment during the six years this case languished in the MDL.  The plaintiff attempted to excuse her inaction by arguing that the Short Form Complaint did not allow for the sort of allegations she wished to add, but the court did not buy that. Plenty of other plaintiffs were able to amend their Short Firm Complaints and add the type of allegations that the Dunn plaintiff wanted to add. 

Secondly, and no doubt related, the proposed amendment was functionally identical to the Third Amended Master Complaint that the MDL judge rejected.  The plaintiff in Dunn groused about the MDL court’s denial of the Third Amended Complaint, but there was no hint of clear error.  Hello, law of the case. Plus, the MDL court correctly believed that to allow the amendment would require reopening of discovery.  Who wants that?  (Well, besides the bad guys.) Moreover, the amendment was related to the statute of limitations issues in the MDL that arose when the plaintiffs shot themselves in the foot when they defined when their claimed injuries occurred.  

Thus, “Because the Plaintiff has failed to amend her complaint in the six years that this case has been pending with no justification beyond the difficulty of working within a text box and pursuant to the MDL’s orders, the Court finds that the Plaintiff engaged in undue delay in filing her motion.”  Done and Dunn

We defense hacks might not always adore MDL folk lore and mythology and the strange procedures they engender, but it is nice to see plaintiffs tripped up by such procedures.  

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As insightful and modest as the Blog can be, we are not infallible.  Every once in a while, two posts get written on the same decision, sometimes because we try to make sure a new post goes up every non-holiday weekday of the year.  Because of the aforementioned modesty, however, we are hesitant to deprive our readers of our insights.  So, we present two posts in one, the latter of which overlaps some with a prior post by a new Blog contributor.  As different as the two underlying cases and decisions are, there are some common themes between them.  For one, some types of litigation seem to last longer than you might expect with different plaintiffs trying the same thing over and over, regardless of success.  For another, even legal principles that seem like bedrock can erode, so results can change.  We start with the newer decision.

The More Things Change

Pelvic mesh litigation has been going on for more than a decade.  The MDL in which Hinton v. Boston Sci. Corp., — F. Supp. 3d –, 2024 WL 328873 (D. Mass. Jan. 29, 2024), would have been pending if filed sooner was opened back in 2012.  The pelvic mesh litigation was largely driven by regulatory actions related to pelvic organ prolapse devices, but most of the cases involve sling devices to treat stress urinary incontinence.  Even after it was clear that the slings had favorable evidence on risk-benefit and would not be subject to the same “up-regulation” as the pelvic organ prolapse mesh devices, the sling cases continued, in part because doctors kept using their best judgment to implant slings in patients.  In Hinton, the plaintiff’s sling was implanted in August 2019, after pretty much all the relevant FDA actions on pelvic mesh devices.  She allegedly suffered pelvic pain, had an explant within two months of implant, and sued in the defendant manufacturer’s local federal court within another four years.  As we have detailed many times (like here and here), the defendants have been doing better in these sorts of cases in the non-MDL courts, either on remand from an MDL or with direct filing post-MDL closure.

The Hinton plaintiff asserted the typical multiplicity of claims under Arkansas law.  Defendant’s motion to dismiss targeted only the manufacturing defect and warnings claims, probably because experience showed the other claims could survive, at least until summary judgment.  For manufacturing defect, Arkansas follows the same principle as many states in requiring that the plaintiff’s particular product “deviat[ed] from the norm,” which means that the released product was different than it was supposed to be per design and manufacturing specifications.  We are not saying plaintiffs in medical device cases can never plead a legitimate manufacturing defect claim, but attempts to push through repackaged design claims are far more common.  That was the case in Hinton and the court did not fall for it.  Saying the product’s design creates a propensity to malfunction is, at best, a design defect allegation.  Id. at *1.

Plaintiff also tried the old res ipsa loquitur argument that fails about as often.  As the court noted, citing an Arkansas Supreme Court case that follows the general rule, “Strictly speaking . . . res ipsa loquitur has no application to strict liability.”  Id. at n.1.  It sure does not apply to complicated allegations about mesh degradation—as made up and plainly inapplicable in a two-month implant case as they are—and other alleged mechanisms for pain with an implanted sling because res ipsa only applies when jurors can assess it based on their “everyday experience.”  Id. at *2.  Plaintiff also did not plead how her pain could only have been from a manufacturing defect.  Id.  In other words, plaintiff was done in by simultaneously over pleading general theories and under pleading specific facts.

On the warranty claims, Arkansas requires pre-suit notice and, of course, plaintiff did not provide any.  She tried to claim that the statutory pre-suit notice requirement applies to buyers, and she was a mere third-party beneficiary of a contract between the manufacturer and her physician.  Not surprisingly, her complaint had claimed she was the purchaser of the product and in privity with the manufacturer, another requirement that plaintiffs typically fail in implanted medical device cases.  Id.  In any event, Arkansas federal courts had already rejected the same arguments in hernia mesh cases.  Bringing the case away from Arkansas—perhaps expecting a more plaintiff-friendly venue—would not change the result.  Id. at *3 (noting that the forum shopping plaintiff “cannot expect that new trails will be blazed”).

Of Puppets And Standing

On this Blog, we have been known to quote all sorts of fictional characters, usually in a strained attempt to be funny or witty.  We have also tried to highlight when courts break from the typically staid language of written decisions to their own forays into humorous snark.  (A tip:  A judge’s joke is always funny in his or her presence.  Pro tip:  Laughing on the inside is typically insufficient to show an appreciation of the humor.)  However, we cannot recall a court’s deadpan delivery (as we read it) of statements about a puppet as if was an actual sentient being.  There are a few ironies in this discussion coming out of the Fifth Circuit’s decision in Children’s Health Defense v. FDA, No. 23-51067, 2024 WL 244938 (5th Cir. Jan. 23, 2024) (“CHD”), in the context of a ruling on standing.  For one, the Fifth Circuit made a mockery of standing in a well-publicized decision from August 2023.  For another, if we were to look for humor in a federal appellate decision, the Fifth Circuit might be the last place we look.  In addition, the decision affirmed the dismissal of a case against FDA over orders related to pediatric authorizations for two COVID vaccines.  Perhaps most importantly, the puppet being discussed is Elmo, decidedly the least funny of all Sesame Street characters.  Not to get too controversial here, but Oscar the Grouch, Cookie Monster, Grover, and even Snuffleupagus run comedic circles around Elmo. (Note that we wrote this before Elmo became a mental health advocate of sorts; that does not change our view of the character’s comedic abilities.)

A year ago, we marveled that litigation over COVID vaccine policies was still on-going.  CHD is more about non-existent policies than actual policies, but, over the course of two years, it meandered up to affirmance in the Fifth Circuit after dismissal in the Western District of Texas.  The named plaintiff was an entity apparently created by parents in Texas to bring the lawsuit, which was joined by some individual Texas plaintiffs and later some from North Carolina.  They sued FDA after the rejection of a May 2021 petition to FDA over what were then pretty limited pediatric vaccine authorizations.  In terms of legal particulars, the suit was grounded in the Administrative Procedures Act and standing was based on the alleged risk that the plaintiffs’ minor children would be vaccinated without their consent or feel marginalized by big red bullies like Elmo for not getting vaccines.  Under traditional standing principles articulated by the Supreme Court and the all the circuits, these plaintiffs had no real shot at standing.  But, in these courts, with this defendant, and with this subject matter, perhaps the standing bar might be lower.  Under other circumstances, the fact that the Fifth Circuit issued an unpublished per curiam decision affirming a dismissal while applying the typical personal jurisdiction standards would not merit a post.  Here, we think it did, in part because AHM (a.k.a., Hippo) was not mentioned in CHD.

After the declaration of a public health emergency for what would become the COVID-19 pandemic, FDA issued emergency use authorizations for a Pfizer/BioNTech vaccine for people sixteen and up and for a Moderna vaccine for people eighteen and up.  Some of the following dates are a bit fuzzy because of gaps in CHD, but this is the rough chronology of what followed in regards to the operative facts of CHD:  1) in May 2021, FDA expanded the Pfizer authorization to cover individuals twelve and up, 2) that month, the newly minted CHD petitioned FDA to undo the authorizations for the vaccines or at least the pediatric use portion of them, 3) FDA expanded the Pfizer authorization to cover individuals five and up, 4) FDA denied the petition, 5) CHD and some Texans sued in January 2022, and 6) in June 2022, FDA expanded both the Pfizer and Moderna authorizations to cover individuals six months and up.  Nowhere in that chronology is the enactment of a federal, state, or local law authorizing the vaccination of any of plaintiffs’ minor children—whose ages are not specified in CHD—without parental consent.  We have thus far omitted the key fact:  On a date not specified in CHD, Sesame Workshop “released a YouTube video announcing that Elmo had gotten the COVID-19 vaccine.”  2024 WL 244938, *2.

This video was part of plaintiffs’ claim that their children had an injury in fact, the key to standing.  Per the following footnote, it appears that the panel watched the video, although perhaps the plaintiffs did not.

Plaintiffs allege that Elmo sent the message that children will “get sick if [they] don’t take the COVID-19 vaccine.” In doing so, Plaintiffs rely on a video that suggests otherwise. See Sesame Street: Elmo Gets the COVID-19 Vaccine, Sesame Street, available at In the video, Elmo’s father states that: “I had a lot of questions about Elmo getting the COVID vaccine. Was it safe? Was it the right decision? I talked to our pediatrician so I could make the right choice. I learned that Elmo getting vaccinated is the best way to keep himself, our friends, neighbors and everyone else healthy and enjoying the things they love.” Id. Further, the video explains that “it’s okay to have questions about the COVID-19 vaccine for your kids. Get the latest facts by speaking with your pediatrician or healthcare provider.” Id.

Id. at n.3.  We hope that the thoughts of the panel watching the video, with or without the transcript feature, and a clerk typing “Elmo’s father states” tickle you as much as they do us.  More substantively, the idea that a video with puppets delivering a message that parents should talk to their children’s pediatricians in making a decision on vaccination helped create an injury in fact was laughable.  “[T]hat a third party might harass their children for being unvaccinated, [or] that their children may be exposed to pro-vaccine messaging” were “hypothetical dangers [] untethered to the law.”   Id. at *4.  Standing cannot be based on an alleged “psychological consequence produced by observation of conduct with which one disagrees.”  Id. (internal citation and punctuation omitted).  Without discussing anything in the In re: Social Media Adolescent Addiction/Personal Injury Products Liability Litigation MDL, we can say that taking offense at content on social media is part and parcel of social media and not a legitimate basis for standing.

Even if Elmo and pals created an injury in fact, it did not provide standing to sue FDA over its vaccine authorizations.  Id.  Recall that CHD’s petition to FDA, the denial of which spurred the suit, complained of authorizations that covered usage in people twelve and up.  Thus, plaintiffs’ minor children implicated by the authorizations presumably no longer watched Elmo videos or at least did so with a healthy dose of tween/teen skepticism.  Also, the Elmo video was apparently posted in June 2022 (per the internet, not the CHD decision).  It certainly could not have been a basis for standing when the suit was filed five months earlier.  The same disconnect was seen in plaintiffs’ other injury theory, which related to the possibility that their minor children might be vaccinated with their consent.  This could not possibly meet the standards articulated in Clapper v. Amnesty Int’l USA, 568 U.S. 398 (2013), that injuries in fact could not be based on “allegations of possible future injury” unless it is shown that a concrete injury is “certainly impending.”  Id. at *3.  Here, at best, the plaintiffs alleged that “some hypothetical third party might, at some hypothetical point in the future and through some hypothetical means, [] vaccinate their children against their wishes.”  Id. at *3.  Particularly given that the state law where these plaintiffs (and presumably their minor children) lived prohibited vaccination without parental consent, this was too speculative an injury to bestow standing.

Even setting aside suits like AHM, which may become more popular depending on what the Supreme Court does, ensuring the application of traditional, tight constitutional limits on standing matters to drug and device companies.  For one thing, they do use social media and even something called “television” to provide information about their products.  Someone who merely takes offense or claims to suffer “psychological consequence produced by observation of [the manufacturer’s information] with which one disagrees” should not have standing.  For another, a deterioration of the injury in fact requirement for standing could open the door to expanded litigation over “fear” claims, claims based on alleged risk of future injury, and other product liability theories without a tangible current physical injury.  It is nice to see the Fifth Circuit reiterate the traditional, pre-AHM standing standards.  The Sesame Street stuff was just a bonus.

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Today’s post is a short cautionary tale about Federal Rule of Civil Procedure 15(a)(1) and plaintiff’s “one free shot” at amending a complaint.  That rule provides:

A party may amend its pleading once as a matter of course no later than:

(A) 21 days after serving it, or

(B) if the pleading is one to which a responsive pleading is required, 21 days after service of a responsive pleading or 21 days after service of a motion under Rule 12(b), (e), or (f), whichever is earlier.

The rule is followed by Fed. R. Civ. P. 15(a)(2) which states that “[i]n all other cases, a party may amend its pleading only with the opposing party’s written consent or the court’s leave.” 

But what constitutes leave of court may not always be so clear, or so defendant learned in Coblin v. Depuy Orthopaedics, Inc., 2024 U.S. Dist. LEXIS 15120 (E.D. Ky. Jan. 29, 2024).  The case comes out of a hip implant MDL.  At issue was defendant’s motion to strike plaintiff’s third amendment complaint filed without leave of court and within 21 days of defendant having moved to dismiss the action.  Plaintiff claimed that her third amended complaint was actually her “one free shot.”  So, the court traced the history of the prior amendments. 

Plaintiff’s original complaint was filed in the Northern District of Texas.  While pending there, plaintiff filed her first amended complaint which defendant argued was done without leave of court.  However, that court had entered a Scheduling Order that stated “Plaintiff shall amend pleadings by September 30, 2022.”  Id. at *5.  Plaintiff filed her first amended complaint within that time frame, and not in response to a responsive pleading or within 21 days of service of the original complaint.  Therefore, the court concluded that the first amended complaint was only proper if it was made pursuant to leave of court.  Id. And that leave of court was the scheduling order. 

After the case was transferred to the Eastern District of Kentucky, plaintiff sought the court’s leave to file a second amended complaint, which the court granted.  Id. at *3.  So, despite the fact that it was plaintiff’s fourth attempt to plead her claims, her third amended complaint was her “one free shot.”  Id. at *6.  While it is more typical for plaintiff to use the “free shot” before requesting leave to amend, “there is no requirement that they do so; a party may amend under Rule 15(a)(2) before it amends under 15(a)(1).”  Id.  The motion to strike was denied.

What all this means is that because of the imprecise language of the scheduling order, language that is used frequently, plaintiff was able to bank her “one free shot” and use it two years into the litigation and after a sneak peek at defendant’s grounds for dismissalThe issue here was complicated by the court in Kentucky needing to interpret what the court in Texas intended by its scheduling order.  But, in MDLs it is not uncommon for transferee courts to have to do just that.  Nor is it uncommon to have case-specific Rule 12 motions filed late in the day–after generic rulings, after discovery, after plaintiff has seen the writing on the wall.  So, should defendants be thinking about asking courts to clarify that pleadings amendment deadlines are not de facto leave of court, but rather just the deadline by which if plaintiff wants to amend her complaint she needs to have taken the steps necessary to make that happen.  Including seeking leave of court under Rule 15(a)(2) if the terms of 15(a)(1) don’t apply.  

We leave you to ponder that question and with these words of caution–don’t assume the first amendment is the freebie. 

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When we last reported on Beaver v. Pfizer, the plaintiff’s complaint alleging that the FDA “suggested” that the defendant’s drug be removed from the market had been dismissed because it was a preempted “stop selling” claim.  In any event, as we also pointed out, the plaintiff did not claim the condition that had purportedly prompted the FDA’s suggestion.  The plaintiff’s warning claim had also been dismissed for ignoring the learned intermediary rule.

Since then, however, the Fourth Circuit cut the pro se plaintiff a break – affirming because there was “no reversible error,” but modifying “to reflect dismissal without prejudice.”  Beaver v. Pfizer, Inc., 2023 WL 4839368, at *1 (4th Cir. July 28, 2023) (citing King v. Rubenstein, 825 F.3d 206, 225 (4th Cir. 2016) (pro se dismissals “should generally be without prejudice”)).

A represented plaintiff would probably have followed up that appellate ruling with an amended complaint, but this pro se plaintiff instead filed a second action, in state court, “again alleging negligence.”  Beaver v. Pfizer Inc., 2024 WL 234725, at *1 (W.D.N.C. Jan. 22, 2024) (Beaver II).  It was immediately removed, and assigned to the same judge who had dismissed the first action.

So the Beaver plaintiff was on her second action.

This has not a been a good season for number twos – at least in NCAA Division I women’s basketball.  The pre-season #2, UConn, promptly lost to then unranked NC State.  Then Iowa became #2.  Iowa promptly lost to then unranked Kansas State.  After that, UCLA rose to #2, and held that position for several weeks, before losing to #9 USC (that is Southern Cal, not #1 South Carolina).  That brought Iowa back to #2, but not for long – the Hawkeyes promptly lost to #18 Ohio State.  So UCLA returned to #2, but only for a week, as they promptly lost to unranked Washington State.  That made Kansas State #2, but only for a week, as the Wildcats lost twice, to unranked Oklahoma and again to #12 Texas.  Thus, in thirteen weeks, six #2 ranked teams have lost seven times.

And so did plaintiff Beaver (the Oregon State Beavers are, as of this writing, ranked #18).  Beaver II points out, as did we, that the FDA did not act because of her condition – her only basis for causation was “because her doctor recommended that she stop taking [the drug] due to her disease,” and afterwards her condition allegedly improved.  2024 WL 234725, at *2.  The plaintiff apparently learned nothing from the initial dismissal, because she once again alleged that she would not have been injured if the defendant had removed the drug from the market.  Id.  This same allegation yielded the same result – preemption.

Plaintiff asserts a negligence/products liability claim, which is a state law claim.  However, any state-law duty Defendant may have to withdraw [the drug] from the market is preempted because the only way to comply would be to cease production of the drug altogether, the precise theory the Supreme Court rejected in Bartlett.  Moreover, allowing a state-law duty to foreclose the sale of an FDA approved medication . . . would also frustrate the purposes of the FDA’s regulatory scheme.  For these reasons, Plaintiff’s “stop-selling” theory does not state an actionable claim for negligence.

Beaver II, 2024 WL 234725, at *3 (citation omitted).

This time around, however, the plaintiff also argued that the defendant “should have never sold” the drug in the first place, because it was “negligently designed.”  Id.  Thus, Beaver II addressed the pre-approval design defect theory we have repeatedly criticized. Beaver II agreed with us.  The “‘should have never sold’ theory is inconsistent with the Supreme Court’s ruling in Bartlett.”  Whether before or after FDA approval, “a pharmaceutical company cannot be made to cease acting to avoid liability.”  Id.  Any form of don’t sell theory is at odds with the FDCA, “as the FDA is tasked with determining whether a drug may be sold in interstate commerce.”  Id. (citation omitted).

Further, to state a claim under North Carolina law, the plaintiff’s negligent design theory must either allege an alternative design or that the design was “so unreasonable” that no reasonable person would “use or consume” it.  Id. at *3-4 (quoting N.C. Gen. Stat. §§99B-6(a)(1)-(2)).  Plaintiff alleged no facts to support either prong.  “Plaintiff has not made any allegations regarding the existence of a reasonable alternative design for [the drug], nor has she alleged that the drug is so unreasonably designed that a reasonable person would not use it.”  Id. at *4.  “[E]ven a pro se plaintiff . . . must allege sufficient facts ‘to raise a right to relief above the speculative level.”  Id. (quoting the aforementioned King decision).  Thus “Plaintiff’s second attempt to state a claim against Defendant for negligence based on these same facts,” was dismissed “with prejudice,” id., and we defense counsel have another good decision for why stop-selling, and never-start selling, claims are preempted.

And later today, we’ll find out who is unfortunate enough to be #2 for Week 14.

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They say that in California everybody’s a star.  Or maybe, in today’s terms, everybody’s an influencer, has social media, a blog, or—in this case—an autobiography.  Today we discuss a discovery dispute in a California federal court that is somewhat unique, but that raises issues we see every day in drug and device cases. 

Continue Reading Lifestyle Discovery Fair Game Where Plaintiff Puts Quality of Life at Issue
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Of late, the Fifth Circuit has come in for some criticism over rulings involving science, the FDA, and medicines.  But apparently even it has its limits—and Article III standing is one.

In Children’s Health Defense v. FDA, No. 23-50167, 2024 U.S. App. LEXIS 1528, 2024 WL 244938 (5th Cir. 1/23/24), a non-profit and several parents challenged the FDA’s emergency use authorization (EUA) that permits the administration of COVID-19 vaccines to children.  In essence, the plaintiffs sought to have the FDA’s regulatory decision overturned on the ground that the Agency failed to follow the Administrative Procedures Act, and to enjoin the FDA from “marketing or promoting” COVID-19 vaccines.

So what was the alleged harm in Children’s Health Defense that might allow these plaintiffs to overturn an FDA regulatory decision?  How had the FDA’s issuance of an EUA during the COVID-19 pandemic caused a legally cognizable injury to these plaintiffs?

According to the plaintiffs, their injury was that they feared “a third party may vaccinate their children without their consent, that a third party might harass their children for being unvaccinated, and that their children may be exposed to pro-vaccine messaging,” such as a Sesame Street segment about Elmo getting vaccinated.     

You might be thinking that these alleged injuries sound pretty speculative, as well as attenuated from the FDA activity of issuing a COVID-19 vaccine EUA, and you would be right. 

In legal terms, the issue was whether these plaintiffs have standing, something required by Article III of the U.S. Constitution:

[T]o establish standing, a plaintiff must show (i) that he suffered an injury in fact that is concrete, particularized, and actual or imminent; (ii) that the injury was likely caused by the defendant; and (iii) that the injury would likely be redressed by judicial relief.

Children’s Health Defense, 2024 WL 244938 at *2.

As the Fifth Circuit acknowledged, speculation “that some hypothetical third party might, at some hypothetical point in the future and through some hypothetical means, [ ] vaccinate their children against their wishes” was neither a concrete nor an imminent alleged injury.  As to the exposure to a viewpoint with which the plaintiffs disagreed, the Fifth Circuit recognized it is not an injury in fact to allege a “psychological consequence produced by observation of conduct with which one disagrees.”  Id. at *4 (internal citation and quotes omitted).

In addition, the connection to the FDA was missing:  “Even if the alleged harms were plausible,” each would be “the result of a third-party action, not the FDA.”   In other words, even if there was an imminent risk that someone might help one of the plaintiff’s children obtain the vaccine against the parent’s wishes, the solution would be to seek an injunction against that person—it is not to try to upend the FDA regulatory decision authorizing the vaccine in the first place.

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Since honoring the Ninth Circuit’s decision in Nexus Pharms., Inc. v. Cent. Admixture Pharm. Servs., Inc., 48 F.4th 1040 (9th Cir. 2022), as being our third best decision of 2022, we have been waiting for (and expecting) a court to apply it to a food labeling case.  And now one has – Collyer v. Catalina Snacks Inc., 2024 U.S. Dist. LEXIS 9637 (N.D. Cal. Jan. 18, 2024). 

Plaintiff’s fraud claims in Collyer allege that the packaging of four keto-friendly cereals was misleading because the cereals do not contain an ingredient pictured on the package.  For example, the package for the Banana Chocolate cereal has real bananas pictured, but the banana taste comes from “natural flavors.”  Similarly, while the Apple Cider Donut cereal depicts both an apple and a donut, the product itself contains neither apple or cider with the “taste” again coming from natural flavors.  Id. at *2-3.

Before we get to the application of Nexus, the discussion of Collyer would be incomplete without acknowledging that these claims also failed the “reasonable consumer” standard under California’s Unfair Competition Law (UCL), False Advertising Law (FAL), and the Consumer Legal Remedies Act (CLRA).  The standard is whether a “reasonable consumer” would be misled by the product’s representations.  While this is typically a question of fact, in “rare situations” a court can determine that the alleged violations of UCL, FAL, and CLRA “are simply not plausible.”  Id. at *9.  This is such a situation.  First, plaintiff admitted that she did not believe the cereals contained whole bananas or apples.  Second, next to the images of apples, bananas, and donuts were the words “serving suggestion.”  Reasonable consumers understand that they are not getting whole fresh fruit in their box of cereal.  Third, no where on the packaging is there any misrepresentation of the ingredients or any assertion that the products are “made with” the “characterizing flavors.”  Finally, the court could not overlook that the cereals are described as “keto-friendly” and contain “0g sugar.”  A reasonable consumer, especially one shopping for a specialty product, would understand that the cereals do not contain apples, bananas or cider – all of which contain sugar.  Id. at *10-13.  Plaintiff is getting a chance to replead these claims to see if she can satisfy her pleading obligations, but given the heightened pleading standard for fraud claims, we are dubious.

That brings us to Nexus and preemption.  Plaintiff brought her UCL claim under all three of its prongs – that the labeling was unfair, fraudulent, and unlawful.  The unlawful claim is based on alleged violations of the Food, Drug, and Cosmetic Act (FDCA) as incorporated in California’s Sherman Law.  Id. at *14.  But claims based on violations of the FDCA are preempted by Buckman Co. v. Plaintiffs’ Legal Comm, 531 U.S. 341 (2001).  So, traditionally plaintiffs try to flip the equation.  They allege that their claims are for violations of the Sherman Law which incorporates the FDCA and therefore, they are bringing parallel state law claims.  That’s where Nexus comes in.  The Ninth Circuit held that false advertising claims that “would require litigation of the alleged underlying FDCA violation in a circumstance where the FDA had not itself concluded there was a violation” are preempted.  Id. at *16 (citing Nexus, 48 F.4th at 1048). Collyer also throws in a little language from Stengel v. Medtronic, Inc., 704 F.3d 1224, 1228, 1235 (9th Cir. 2013) (state law claims preempted where they are dependent on a violation of federal law).  Therefore, plaintiff’s claims based on the unlawful prong of the UCL are dismissed with prejudice.

We have been anticipating this expansion into food-related litigation since Nexus was decided.  California is a hotbed of food-related litigation thanks in most part to the Farm Fresh Salmon decision by the California Supreme Court which is essentially the antithesis of Nexus.   Nexus is not controlling in state court, but we are hopeful it can be used to cut back on the plethora of bogus food class actions in California federal court. Collyer may be the first, but we doubt it will be the last.