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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of the litigation seems to be that, as sympathetic as plaintiffs with cancer suing over a drug that FDA asked be withdrawn from the market can be, it was always based on bogus data and hype without an actual risk supported by good science.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  The plaintiff’s inevitable appeal led to the unpublished decision we are discussing here today.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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We spent much of the last six years opposing the government in civil litigation.  Sure, a few of the government lawyers had a certain swagger to them, but in most ways litigating against them was similar to litigating against private parties.  The government hired and collaborated with many of the same plaintiffs’ attorneys that we see in mass tort litigation.  They served discovery on us; we served discovery on them.  They requested every document under the sun, and they pushed hard to get them.  Good times. 

There was, however, one big difference:  The governmental entities on the other side of the aisle had discoverable documents.  Millions of them.  The plaintiffs that we typically see don’t usually have much of anything to produce, making the burdens of discovery astoundingly unbalanced. 

That dynamic changed with states, cities, and counties on the other side.  They had a major skin the discovery game just like we did, yet many of them were unprepared to handle it.  We can only speculate as to why.  Perhaps it was a function of government hubris and a feeling that the normal rules did not apply to them.  Maybe they and their outside counsel were just not accustomed to marshaling and producing documents in great numbers.  Or maybe they just underestimated the task and mishandled it.  We saw countless pretrial schedules slip because we could not get the documents.  One plaintiff was dropped from a bellwether trial group because it mishandled document discovery, and another lost a trial date that the court had said was firm and would not move. 

The lesson was that the rules apply to both sides.  That too is the lesson of United States ex rel. Plaintiff v. Novo Nordisk, Inc., No. 23-5459, 2025 U.S. Dist. LEXIS 115618 (W.D. Wash. June 17, 2025), where a federal district court ruled that a prescription drug manufacturer was entitled to an adverse inference jury instruction against the State of Washington because of the State’s culpable failure to preserve and produce documents. 

The State sued the manufacturer alleging violations of the False Claims Act and Anti-Kickback Statute through off-label promotion of a hemophilia treatment.  At the center of the State’s claims was its allegation that the State Medicaid program paid millions of dollars for a particular patient’s treatment.  Id. at *2-*3.  The State began to investigate in 2007, and multiple State employees reviewed records and participated in a “Hemophilia Working Group” in 2009.  Critically, the State Medicaid agency submitted a complaint to the Medicaid Fraud Unit in 2014 alleging that “extraordinary amounts” of the product were being shipped to the patient, raising concerns about waste or drug diversion.  Id. at *3.

This is the point of no return, as the State anticipated litigation no later than 2014.  The State did not, however, issue a litigation hold notice until two years later, and it took no further action to preserve the Medicaid agency’s records under March 2020.  The State did not place a legal hold on the mailboxes of some relevant document custodians until 2023—nine years after the Medicaid agency first made formal claims of fraud.  Id. at *4-*5.

To make things worse, the state did not disclose these facts to the defendant manufacturer until January 2025—after the close of discovery. 

The order does not say why the State finally came clean, but the defendant clearly challenged why the State failed to produce a single document from any of the record reviewers, the “Hemophilia Working Group,” or the author of the complaint to the Medicaid Fraud Unit.  Based on these failures, the defendant requested an adverse inference against the state that, if the documents were available, they would show that the State paid for treatments that were medically necessary.  Id.

The district court allowed the adverse interest instruction against the State.  The State’s duty to preserve documents arose no later than 2014, when it knew or should have known that documents relating to this patient, this product, and the State investigation were relevant to future litigation.  Moreover, it was reasonable to infer that, because the State paid for the patient’s treatment, at least some of the physician reviewers supported the prescriptions and that lost or destroyed records would have shown this.  This inference was bolstered by a State investigator’s testimony that she did not remember seeing evidence that the patient’s treatments were unnecessary. 

Finally, the State was culpable, and the defendant suffered prejudice.  The State did not take the necessary steps to preserve important records, and it created privilege logs anticipating litigation as early as 2014, yet waited years before following up to preserve records.  For its part, the defendant lost the opportunity to use the lost or destroyed records to prove that the treatment for which the State paid was medically necessary. 

The court could have done more, such as award attorneys’ fees, which it denied.  But still, this is a useful reminder that the government has to play by the rules, too.  With governmental entities increasingly active on the civil front, we’ll take that. 

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Skrmetti (upholding Tennessee statute forbidding gender dysphoria treatments for minors) was the SCOTUS case that got the most publicity last week, but we drug and device lawyers will always perk up most when we see the High Court issue a ruling regarding the Food and Drug Administration (FDA).  That is probably one reason (though surely not the only reason) why at parties the people with whom we are chatting invariably dart their eyes around the room, desperately searching for a more interesting conversation companion. 

Food and Drug Administration v. R.J. Reynolds Vapor Co., 606 U.S. —- (June 20, 2025), is not a product liability personal injury case, but it offers an interesting (to us, anyway) perspective on challenges to FDA actions.  Both our clients and our opponents sometimes have an interest in pursuing such challenges.   Does the R.J. Reynolds Vapor case offer a blueprint, contrast, or cautionary tale?

The R.J. Reynolds Vapor case concerned the FDA’s denial of approval of tobacco vaping products under the Family Smoking Prevention and Tobacco Control Act (TCA).  21 U.S.C. section 387j. The FDA determined that the vapor product had not been demonstrated to be “appropriate for the protection of the public health,” as required by the TCA.  21 U.S.C. section 387(c)(2)(A).  (We will not hearken back to our tobacco-law days, at least not too much, when we point out that this policy decision by the FDA is a subject of theoretical majesty. You might think that tobacco vaping products pose risks, but what if they are alternatives to riskier products? Must perfection be the enemy of better?) The key questions in the R.J. Reynolds Vapor appeal would seem to center on standing and venue, but the High Court insisted on talking about zones of interests rather than standing, and ducked the most interesting venue issue. The former was an exercise in statutory interpretation, while the latter was a matter of “prudence.” 

In reality, R.J. Reynolds Vapor is a case about persons and places, and it is about choosing the right persons to get to the right places. (Interpret that word “right” however you please.) Per statute, challenges to FDA actions can be brought in the District of Columbia or the challenger’s residence/principal place of business.  But who can be a challenger?

Obviously, the disappointed applicant can bring a challenge.  If not them, then who? In this case the manufacturer was located in North Carolina, which is in the Fourth Circuit.  Accordingly, the manufacturer had the choice of filing its challenge in either the DC or Fourth Circuit.  But prospects for overturning the FDA’s denial did not look good in those courts. By contrast, the odds of overturning the FDA’s disapproval looked a lot better in the Fifth Circuit.  (With a little help from Google you can catch up on developments explaining why that is so.) 

The manufacturer then did something clever.  It challenged the FDA denial in a joint petition with a Texas-based retailer and a trade association in Mississippi. (Critics of the R.J. Reynolds Vapor opinion like to characterize the retailer as a gas station. So what? It is still a retailer. Plus, we remember that during the interminable Engle trial – speaking of tobacco litigation – the best retail local wine selection was at a Miami gas station.)  Texas and Mississippi are both in the Fifth Circuit.  Even aside from the FDA/vaping developments referenced above, if you are even remotely sentient you know that the Fifth Circuit is perceived to be the most conservative, pro-business, anti-agency, etc., jurisdiction in the country.  That image might be simplistic or overblown, but there it is. There has been some legal and political controversy about litigants filing cases in one-judge divisions within the Fifth Circuit so as virtually to guarantee a favorable outcome.  It is an extreme and relentlessly successful form of forum-shopping. But the issue in R.J. Reynolds Vapor was who could file a challenge to the FDA’s denial of approval of the vaping products, and where could they do so. The only reason for the case being in the Fifth Circuit was the involvement of the retailer and trade association. But did they have any business being in the case?

A divided panel of the Fifth Circuit held that the retailer and trade association could bring the challenge and that, therefore, venue in the Fifth Circuit was proper.  The FDA filed for certiorari (a recent episode of the Advisory Opinions podcast entertainingly shows the remarkably different ways that word is pronounced by the Justices), and thus we have the SCOTUS opinion. Remember that while trial courts decide cases/controversies, SCOTUS decides legal questions. Here is the question teed up by the parties:  Whether a manufacturer may file a petition for review in a circuit (other than the U.S. Court of Appeals for the District of Columbia Circuit) where it neither resides nor has its principal place of business, if the petition is joined by a seller of the manufacturer’s products that is located within that circuit.  The majority decision in R.J. Reynolds Vapor was authored by the always intriguing Justice Barrett and the opinion affirmed the Fifth Circuit ruling. Justice Jackson, joined by Justice Sotomayor, dissented.  (It is interesting that Justice Kagan was with the majority on this case. Besides probably being the best writer on the Court, the former Harvard Law dean is wicked smart on procedural issues.  Recall that she dissented in Mallory. There is some speculation that Justice Kagan sided with the conservatives on recent cases in order to do some horse-trading on others.  That seems unlikely, but perhaps we shall see.)

The TCA is the main statute at issue in this case, along with the Administrative Procedure Act (APA). The TCA  sets forth the statutory zone of interest by permitting challenges to adverse FDA action by “any person adversely affected” by the FDA’s denial.  21 U.S.C. §§ 387l(a)(1).  That is the same language used in the APA, and the High Court majority interprets it the same way – to include anyone even “arguably” aggrieved by the action.  Therefore, it is not only the applicant who can sue, but in this case so can any retailers that could have sold the product for a profit.  They literally have “business” being in the case. We are all textualists now, right?  The Court cites A. Scalia & B.Garner, Reading Law (2012).  If you do not have that book on your shelf, you might want to get it. The Court points out that it would be passing strange to read the word “any” to mean “only one.”  If Congress had meant to limit standing to the applicant, it would have said so, as it has in other contexts. (More on that later.).   

The Court did not decide the interesting question of whether each petitioner must be in the correct venue. The FDA argued to the Supreme Court that even if the retailer and trade association can sue in the Fifth Circuit, a manufacturer from the Fourth Circuit should not be allowed to join in on the fun. But the FDA did not argue that position below, and SCOTUS would prefer to have that issue fleshed out below before deciding it. Too bad. There is a bit of a parallel between what happened in this case and the utilization by plaintiffs of (okay, we’ll say it: fraudulent) joinder of local defendants, often retailers, to steer a case away from federal court. There is real force to the FDA’s argument in this case, which was picked up by the dissent, that forum shopping is afoot.

While this action involves potential sellers of vaping products, could it also just as easily involve persons desiring to distribute drugs or vaccines or any other product (e.g., Ivermectin) that the FDA might refuse to approve for a particular use in the future? After all, just as with vaping products, there are retailers of drugs and vaccines who might realize profits.  What about PBMs?  What about patients who feel aggrieved by the unavailability of certain products? We plodding bloggers probably would have thought of those questions on our own but, to be honest, it was one of our faithful readers who first broached them to us.  And then he came up with a decent answer: it comes down to the relevant drug/device/vaccine language regarding standing to sue over approvals/rejections. The APA language is broad and, as the R.J. Reynolds Vapor majority points out, “not especially demanding.”  But it is likely not the only language at issue in any given case.  If the governing statute turns out to be the same as the TCA, you can expect the same answer. Find “any person adversely affected” by the denial, apply the “arguably” standard to determine who was adversely affected, and you’re off to the races. But first you must compare the governing language to what the Court construed here.  Notably, the opinion in R.J. Reynolds Vapor indicates that more narrow TCA statutory language applies to orders that a product be withdrawn, so withdrawals may not support such broad standing, er, zone of interest. The statutory language matters. It is, in fact, dispositive. 

To take just one example, for challenges to denial of a New Drug Application (NDA) under the Food, Drug, and Cosmetic Act, after exhaustion of administrative process, an “appeal may be taken by the applicant from an order of the Secretary refusing or withdrawing approval of an application under this section.  Such appeal shall be taken by filing in the United States court of appeals for the circuit wherein such applicant resides or has his principal place of business, or in the United States Court of Appeals for the District of Columbia Circuit….”  Section 505(h) (emphasis supplied by your friendly blogger). That “applicant” language is considerably narrower than “any person adversely affected.” Sorry, but there is no substitute for flipping through the statutes.   

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If Dante had practiced law, there’s a good chance he would have added a tenth circle of hell—discovery for defense attorneys. Imagine being slowly crushed under a mountain of PDFs, emails from 2007, and inexplicably sticky banker’s boxes. Let’s face it, some of us could update our bios to include—professional document archaeologist.

Discovery was theoretically designed to ensure fairness and transparency. In practice, it’s trying to figure out how to answer a 50-part interrogatory asking for every moment your client thought about the matter at issue since the Nixon administration. Then, only after countless weeks of negotiating a 32-page ESI stipulation covering every conceivable piece of metadata that could exist, comes document production.  The point at which you become your client’s part-time IT technician, therapist, and professional nag.  Which is followed by the 25,000 emails you have to comb through. Half of which are “Reply All” threads that devolved into inter-office lunch orders and passive-aggressive calendar invites. Still, you must review every single one because hidden among those chain emails is inevitably one relevant piece of information. . .followed by a dog GIF.

Which then brings us to the redaction rodeo. Where we redact things like phone numbers, addresses, and trade secrets. And plaintiffs assume we’re redacting anything that could conceivably give them the upper hand. Same goes for privilege logging.  All of which leads to the inevitable motions to compel.  It’s far from perfect; but it’s the system we’ve got and so we’ve got to work within it. Which means fighting the good fight when we need to, like the defendants did in State v. Optumrx, Inc., 2025 La. App. LEXIS 1167 (La. Ct. App. Jun. 20, 2025).

The State brought a lawsuit claiming that two Medicaid service providers inflated prescription drug prices charged to the Louisiana Medicaid program.  The State alleged that the providers “fraudulently concealed” the actual costs and failed to give the State contractually required access to records and data that would show the overpayments.  Id. at *4.   In discovery, the State sought to require defendants to turn over a huge amount of information about the defendants’ contracts and activities in other states. The trial court overruled the defendants’ relevance objections and sanctioned defendants when they refused to produce that material.  The sanction ruling created an appealable order.

Louisiana rules allow for discovery of “any matter, not privileged, that is relevant to the subject matter in the pending action.”  Id. at *10.  And while discovery statutes are “to be liberally construed” and trial courts are given “broad discretion,” that discretion is not absolute. So, the appellate court started with the subject matter of the suit: defendants’ provision of prescription drug coverage to Louisiana Medicaid recipients and whether defendants caused Louisiana to overpay for prescription drugs.  Id. at *11-12. The trial court allowed the out-of-state discovery finding that the State alleged defendants’ pricing scheme in Louisiana was part of a nationwide effort.  To which the appellate court said—not really and so what.

The State’s petition “vaguely alleges” problems with defendants’ pricing “as a whole.” But the suit is limited, as it must be, to allegations of improper price inflation in Louisiana. Moreover, defendants pricing structure with other states is governed by unique contracts with those states that were the subject of state-specific negotiations and concessions.  Therefore, the appellate court rejected “the speculative notion” that evidence of defendants’ pricing structures and contracts with other states—similar or different—was relevant or  would lead to the discovery of relevant information about how defendants administered Louisiana’s Medicaid program. Id. at *13-14. The trial court abused its discretion in ordering the out-of-state discovery.

The rest of the decision addresses various sanctions imposed on defendants regarding other discovery requests.  All but one sanction was overturned and most are case-specific. But we did want to point out that one of the sanctions was for failing to produce information that did not exist. Defendants proffered unrefuted affidavits from their in-house e-discovery director and one of their attorneys explaining that claims data from certain years did not exist because defendants did not provide services in those years.  Since defendants can only produce things that are in their “possession, custody, and control,” the appellate court found that the trial court “manifestly erred” in finding defendants had the data and abused its discretion by sanctioning defendants for not providing it.  Id. at *21. 

Discovery is a process. One filled with the constant fear that you’ve accidentally produced your client’s personal tax returns from 1998. Trial courts that order wildly disproportionate discovery that is wholly unrelated to the claims of the case and impose sanctions for failing to produce documents that don’t exist turn an already difficult and unpleasant process into a full-blown nightmare. Fortunately, this one had a happy ending, but discovery appeals are few and far between.   So, the next time someone tells you they want to go to law school to “argue in court,” take them aside and whisper softly: “Have you ever used Relativity?”

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When the proposed (soon to be approved) Fed. R. Civ. P. 16.1, concerning MDL practice was finalized last year, we gave it one cheer in our “New Rule 16.1 – Better Than Nothing, But Not by a Lot” blogpost.  We were, and remain, concerned that the provision concerning early vetting of MDL claimants will prove inadequate to address the serious problem created by huge numbers of meritless claims.  But we did point out that the section about exchanging information about the “factual basis” of claims was different from the other items on the rule’s topic list:  it used “how and when,” as opposed to “whether” or “if” – indicating that such early exchanges were viewed as mandatory (in some form).  This, we thought, gave the defense an opening for seeking serious early vetting of MDL claims.

That may already be happening.

Continue Reading Excellent MDL Early Vetting Order Raises Hopes for Rule 16.1
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Today, the summer solstice, is one of our favorite days of the year.  It’s the first official day of summer, and readers in the U.S. will have anywhere from 14-16 hours of daylight (the farther north, the more daylight). We hope you get to enjoy some of the summer sunshine today—or at least this weekend.  As the late, great, Brian Wilson put it, “Sunshine, can’t get enough sunshine, I’m following the sunshine, everywhere I go.”

Continue Reading Eighth Circuit Affirms Rule 702 Exclusion of Plaintiff Design Defect Expert

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FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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