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Today’s guest post is by Howard Dorfman, a old friend of the Blog, who is now continuing to think important thoughts as an Adjunct Professor at Seton Hall Law School. This post concerns potential product liability implications of the FDA’s decision to release so-called “complete response letters (“CRLs”), apparently as a matter of future routine. We hadn’t written about that topic, and were more than pleased when Prof. Dorfman indicated his interest in doing so. As always, our guest posters deserve all the credit (and any blame) for their work.

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On September 4, the Food and Drug Administration (FDA) announced its intention to release future Complete Response Letters (CRLs) “promptly” following their being sent to drug sponsors. That day, the agency also released 89 previously unpublished CRLs issued from 2024 to the present related to pending or withdrawn New Drug Applications (NDAs) and other drug filing applications. According to the FDA, each of released CRLs details specific deficiencies in the drug filings relating to safety and efficacy identified by the agency that prevented approval of the application.

At the same time, the FDA released 89 new CRLs, adding to the more than 200 CRLs that were previously made public in July, ostensibly designed to allow third parties greater access to the reasoning behind the agency’s review process. However, the previous release of CRL letters only included rejection letters for drugs that were eventually approved. The September release represented the first time the agency had released such documents for non-approved drug submissions. Further, the FDA indicated it would henceforth release CRLs as they are issued, that is at the same time sent to the drug sponsors.

The September 4 pronouncement was not the first time FDA expressed its intentions regarding release of CRLs. On July 10, the agency announced its intention to embrace what it referred to as “radical transparency” by publishing more than 200 CRLs issued to a sponsor when it does not approve a New Drug Application, Abbreviated New Drug Application or Biologics License Application.

CRLs are official documents issued by the FDA to sponsors when the agency does not approve their submitted drug/biologic applications. It is important to recognize that a CRL is an intermediate step, not representing an outright rejection of the application. Rather, the CRL provides detailed feedback, often regarding safety, efficacy, or manufacturing issues, focusing the applicant’s attention on the application’s shortcomings and highlighting what would be needed for eventual approval.

CRLs often contain confidential and critical information regarding the feasibility of drug development, clinical trials, or manufacturing issues, including details that many companies choose not to publicly disclose. While the FDA touted its publication as a major “transparency” initiative, the 200 published letters did not reveal much to the public because they were for drugs that had already been approved. As a result, the relevant approval packages — including CRLs — were already publicly available and, in the end, only 22 of the 200 letters had not actually been published previously.

In the abstract, it is difficult to argue against greater transparency into government activities, particularly as pertaining to deliberations and decisions made that affect the availability of prescription drugs and biologics. However, the expansion of the process whereby CRLs are released has gone from limiting the release to CRLs for products that eventually obtained approval by the agency to those issued for submissions that have not yet been approved, including CRLs relating to applications that are voluntarily withdrawn or even abandoned. These latter documents had not previously been released by the agency, as it left to the discretion of the sponsor whether to communicate about rejected applications, including to indicate the reasons given for the rejection. Pharmaceutical companies generally release such information through press releases and/or in SEC-mandated filings.

It is well-established that pharmaceutical companies’ press releases can significantly increase their product liability exposure, particularly if the information can be characterized as false and misleading or failing to disclose important information. Historically, press releases have been considered a form of promotion and are subject to the same strict standards imposed by FDA regulations pertaining to promotional oversight by FDA for prescription drugs. 

The most significant issue impacting pharmaceutical companies’ liability is that immediate and unrestricted FDA release of all categories of CRLs is that the applicants have no time to react to the deficiencies that the FDA identifies. A successful regulatory response requires a thorough analysis of the FDA’s stated reasons presented for denial of marketing approval.  Such responses rarely can be developed and submitted to the agency within a relatively short period of time. In the interim, the CRL has been made public, where it can serve as an unwarranted imprimatur of FDA support for unsubstantiated causation allegations in future or current product liability litigation. The letters have the potential to serve as a source of expert opinion alleging product defect or company failure to undertake adequate clinical trials in support of their drug applications.

As recent litigation has shown, a CRL from the FDA can be a potent piece of evidence for plaintiffs’ experts in product liability litigation. By detailing what the FDA sees as deficiencies in an application, a CRL can support claims that a manufacturer failed to ensure a product was safe, effective, or properly manufactured before bringing it to market. Historically, plaintiffs’ experts have relied upon CRLs as a component of their testimony in litigation brought against a drug or biologic manufacturer.

Establishing evidence of a manufacturer’s negligence: Because CRLs frequently address deficiencies in the drug manufacturer’s manufacturing process, plaintiffs’ experts often use CRLs to make arguments that the manufacturer was aware of the product’s safety, efficacy, or quality issues and, despite this knowledge, continued to develop and sought regulatory approval. Moreover, an expert could compare the deficiencies cited in the CRL with the company’s public statements to investors in the form of press releases or in SEC-required disclosure documents or in its promotional materials and claim supposed discrepancies that in their opinion suggest negligence or fraudulent conduct.

Establishing causation: If a CRL documents a specific safety concern, identifies a problem in a clinical trial (such as criticizing its statistical analysis or sample size) or indicates the need to develop a robust Risk Evaluation and Mitigation Strategy (REMS) program, the applicant can expect to see expert reports parroting those statements as opinions that the individual or collective failures cited in the CRL were the most likely cause of the resulting injury.

Manufacturing defects: CRLs frequently cite deficiencies related to “Current Good Manufacturing Practices” (CGMPs), such as insufficient process validation or problems at a manufacturing facility. Even when such problems have been corrected, an adverse manufacturing expert witness can be expected to reference these findings to support a claim that the product was negligently made, which could have led to contamination or other harmful issues.

Labeling and “Failure to warn” claims: Labeling issues are frequent reasons for a CRL. A plaintiff-side expert will utilize labeling issues in a CRL to make claims that the manufacturer’s initial labeling was inadequate and failed to provide proper warnings about the product’s potential risks. The failure to warn allegations would no doubt follow the drug, beginning with approval process through marketing and throughout the product’s life cycle.

Of course, the defense will counter that notwithstanding statements made in a CRL, the most significant and definitive response to any allegations made by the plaintiff’s expert remains the fact that the reasons for the CRL were fixed, as demonstrated by the FDA’s eventual approval of the application. Final FDA approval, after any CRL problems were corrected, provides the most definitive evidence that the product is indeed safe and effective. Nonetheless, plaintiffs can – and do − point to the existence of a CRL to raise questions regarding the agency’s initial concerns with the product’s application and the approved product, thereby indicating that the company’s initial submission upon which the subsequent filing was based, was flawed and open the application and the approval process to scrutiny and remains relevant.

It is impossible to foresee how a trial or appellate court will view these arguments at the pretrial, trial and appellate levels – but the ongoing Fosamax litigation underscores how different courts have reached different conclusions about the same CRL.

Summary

Transparency appears to be the new “mantra” for FDA as demonstrated by the updated and expanded policies developed pertaining to the CRL process. While most of the discussion has focused on the impact on its impact on SEC disclosures and SEC litigation implications, an overlooked and equally important consideration for pharmaceutical companies is the potential impact on product liability litigation. In these circumstances, mere disclosures already part of SEC disclosure obligations may be insufficient in mitigating liability exposure for the pharmaceutical developer. As “radical” disclosure expands, companies will have to focus on existing policies and procedures in numerous aspects of the internal drug review and approval process to limit, if not to avoid, this increased risk.

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We have been mulling over Loper Bright Enterprises v. Raimondo, 603 U.S. 369 (2024) and federal preemption. 

Yes, we need a life, but let’s put that aside for the moment.

In particular, we’ve been reviewing a rash of complaints where plaintiffs contend that the FDA’s decisions about whether to grant or deny premarket approval deserve no deference—and indeed should be invalidated—because the Agency made the wrong call and Loper Bright says they should be ignored.  Further, according to plaintiffs, an invalid PMA means manufacturers cannot assert a preemption defense, and they are off to the races with their tort claims faulting the FDA-required warning label, the mandated device design, and the scrutinized and approved manufacturing process. 

Loper Bright does not allow plaintiffs’ lawyers to overturn an exercise of FDA discretion in carrying out its assigned function in deciding whether to grant a PMA or PMA Supplement. Loper Bright recognizes that “[w]hen the best reading of a statute is that it delegates discretionary authority to an agency, the role of the reviewing court” is pretty much limited to “ensuring the agency has engaged in reasoned decisionmaking.”  Loper Bright also says nothing about agency policymaking or factfinding, which get very deferential review.  (See our post here.)

But more than that, these plaintiffs’ lawyers have the whole thing entirely backwards.  Loper Bright doesn’t undermine express medical device preemption, it gives manufacturers and defense lawyers a chance to re-set and expand how medical device preemption works.

Loper Bright involved the National Marine Fisheries Service and a federal law from 1976 (the Magnuson-Stevens Fishery Conservation and Management Act) that had something to do with the Atlantic herring fishery.  Something about the herring needing paid chaperones?  Or maybe the fishing boats?  (We are trying to care about the details, and failing.) 

Anyway, the National Marine Fisheries Service had issued regulations based on its interpretation of the statute, and the question was whether the Supreme Court had to defer to the agency’s interpretation of that statute or not.  Given that it is called the Supreme Court, you will not be shocked to learn that the Justices on said court decided that, while it is fine for a federal agency to exercise its discretion when Congress has authorized it to do so, interpreting federal laws is the job of the federal courts and they do not need the agency’s help with that, thank you very much.

Stated another way, Loper Bright got rid of a rule (Chevron deference) which had required courts to defer to “permissible” agency interpretations of the statutes those agencies administer, even when the reviewing court read the statute differently.  It freed federal courts from having to pay heed to an agency’s interpretation of a federal statute, and allows them to figure out the statute’s meaning on their own.

Ok, now let’s look at another federal law from 1976:  the Medical Device Amendments to the federal Food, Drug, and Cosmetic Act, and in particular the express preemption provision for medical devices, 21 U.S.C. § 360k(a). 

The first Supreme Court decision to interpret Section 360k(a) is one of our all-time bottom ten cases, Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996).  It is just a mess.  A plurality decision with no cogent rationale and conclusions that suggest the court perhaps forgot to read the statute it was interpreting.

How did Lohr get so off track?  Maybe it is because Lohr’s interpretation of 21 U.S.C. § 360k(a) was constrained by the FDA’s attempt to interpret that statute, 21 C.F.R. § 808.1(d). 

Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), tells us that: 

In Lohr, a majority of this Court interpreted the MDA’s pre-emption provision in a manner “substantially informed” by the FDA regulation set forth at 21 CFR § 808.1(d)….That regulation says that state requirements are pre-empted “only when the Food and Drug Administration has established specific counterpart regulations or there are other specific requirements applicable to a particular device.”

* * *

Informed by the regulation, we concluded that federal manufacturing and labeling requirements applicable across the board to almost all medical devices did not pre-empt the common-law claims of negligence and strict liability at issue in Lohr. 

* * *

Even though substantial-equivalence review under § 510(k) is device specific, Lohr also rejected the manufacturer’s contention that § 510(k) approval imposed device-specific “requirements.”

Riegel, 552 U.S. at 322 (emphasis added).

What Riegel is telling us is that because the Supreme Court in Lohr relied on an agency interpretation of a federal statute, it issued a cockamamie opinion.  One that said that general federal requirements aren’t “federal requirements”, and that device-specific 510(k) review doesn’t impose device-specific federal requirements.  Lohr made little sense, because the Agency’s interpretation of the “federal requirement” part of the statute made no sense.

Compare that with how the Supreme Court in Riegel handled the “state requirement” prong of 21 U.S.C. § 360k(a) after it concluded it was not constrained by the Agency’s statutory interpretation of 21 C.F.R. § 808.1(d).  (Yes, the Court has been throwing shade at deference to agency statutory interpretation for some time.)

The particular question for the Court in Riegel was whether “state requirements” include only positive enactments (statutes or regulations) or “state requirements” also encompass duties imposed tangentially, by imposing liability through common-law tort claims.

The FDA’s regulation said that “state requirements” in the federal statute only meant laws or regulations, not tort claims.  But the Court in Riegel didn’t agree, so it ignored the regulation and interpreted the statute as it wished:

All in all, we think that [21 C.F.R.] § 808.1(d)(1) can add nothing to our analysis but confusion.  Neither accepting nor rejecting the proposition that this regulation can properly be consulted to determine the statute’s meaning; and neither accepting nor rejecting the FDA’s distinction between general requirements that directly regulate and those that regulate only incidentally; the regulation fails to alter our interpretation of the text insofar as the outcome of this case is concerned.

Riegel, 552 U.S. at 329-30.

We would all have been better off if Riegel ignored all portions of the Agency’s statutory interpretation regulation, both this state requirement bit and the federal requirement bit that Lohr had mangled.

But now that Loper Bright is here, maybe federal courts can start the statutory interpretation process over again based in the text of 21 U.S.C. § 360k(a), and free from the shackles of Lohr as tainted by the misguided regulation.  Bexis certainly thinks so.

If express preemption analyses started with the language of the statute, and Riegel instead of Lohr,we could revisit the question of whether the 510(k) process imposes device-specific federal requirements (it does), particularly in its modern, more enhanced form.  And we could revisit the question of whether federal requirements are “federal requirements” even though they apply to all devices and not just a particular device (they do).

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As mentioned last week, we’re having an odd moment in our practice when virtually all our cases involve feverish battles over whether the cases belong in state or federal court.  Care to guess which side of the argument we’re adopting? (Hint: we prefer judges who will actually pay attention to dispositive motions and might even occasionally grant them.)

Speaking of odd, today’s case, Riddley v. Coopersurgical, Inc., 2025 U.S. Dist. LEXIS 215830, 2025 WL 3062996 (N.D. Texas Nov. 3, 2025), reached an odd result in an odd way. It might even be a first as far as we can tell. We hope not to see its like again. 

Riddley is yet another case in which the plaintiff sought to recover for injuries she allegedly sustained from the use of Filshie Clips, a federally regulated tubal ligation device.  The plaintiff filed her lawsuit in Texas state court against the manufacturer, the manufacturer’s parent company, and a distributor. The defendants removed the case to federal court based on diversity. After discovery closed, the plaintiff and the defendants filed motions for summary judgment. So far, so normal.

And then the magistrate-judge in Riddley sua sponte remanded an obviously diverse case at the summary judgment stage because there was no summary judgment-quality evidence of one defendant’s citizenship.  The evidence of citizenship – that the defendant in question “admitted” (in its answer) to diverse citizenship –supposedly wasn’t good enough at the summary judgment stage.  The decision brands that admission as a “stipulation between the parties” that could not establish diversity/subject matter jurisdiction.  “At the summary judgment stage particularly, the requirement is for evidence, and there is no record evidence in this case on which a reasonable jury could base a finding as to [the defendant’s] citizenship.” 

Since admissions are used routinely to establish all sorts of facts at trial, this ruling does not seem to make much sense. Nor, in light of the admission, does citizenship seem to be a “disputed” issue for purposes of Rule 56. Think about how much oxygen is expended by judges imploring the parties to agree on things. And now here, where the parties agree on something about as basic as can be, the court blows a raspberry at the parties and points them to the exit sign.

To our eyes, the magistrate-judge was standing hard on ceremony. The court emphasized how the scheduling orders directed the parties to Fifth Circuit precedents on subject matter jurisdiction and instructed the parties that any brief supporting summary judgment must be accompanied by “evidence sufficient to support a reasonable jury finding on any relevant jurisdictional facts.”  It seems as if the magistrate-judge wanted to teach the parties a lesson – a very hard lesson.  Another judge might have, after the scolding, permitted the parties to rectify the technical error/omission.  Not this magistrate-judge.  The case was remanded to state court.  Adios. 

But no matter how wrong we might think the Riddley decision is, it suggests a potential trap for the unwary.  After reading this blogpost, you are no longer unwary. 

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This post comes from the non-Butler Snow side of the blog.

Today’s case gives us two cautionary tales. First, there are many ways to make friends with a court. Dumping thousands of exhibits onto its doorstep and saying, “You figure it out,” is not one of them. Second, taking documents stamped CONFIDENTIAL or HIGHLY CONFIDENTIAL and casually using them in another case as if those words were decorative is sanction bait.

Heinrich v. Ethicon, Inc., 2025 U.S. Dist. LEXIS 216989 (D. Nev. Nov. 4, 2025), is a long-running pelvic mesh case—filed in 2013 in the MDL and remanded in 2020. A trial on statute of limitations only resulted in a plaintiff verdict. After which both sides sought additional discovery. Plaintiff’s request to re-depose the implanting surgeon was denied. However, plaintiff had a collateral state court action pending against the surgeon asserting breach of fiduciary duty and fraud. So, plaintiff took his deposition in that case. But here’s the rub—at that deposition, plaintiff showed the doctor confidential and highly confidential documents produced by defendant in the MDL. Defendant moved for sanctions.

In its motion, defendant claimed that plaintiff had violated the MDL protective order with respect to over 200 documents. In response plaintiff claimed that most of the documents had been publicly disclosed or de-designated prior to the deposition. After argument on the motion, the court ordered plaintiff to file a supplemental brief and specifically directed plaintiff not to include any additional argument and not to file any additional documents, but rather to only identify which documents she believed were not subject to the protective order and why.  Id. at *4-5.

Not only did plaintiff include additional argument in her filing, she attached 5,890 pages of exhibits and asked the court to figure out which were confidential and which were not. To nobody but plaintiff’s surprise, the court was not interested in playing “Where’s Waldo?” with confidential materials. It was plaintiff’s (really her counsel’s) job to sort through the documents. Instead, plaintiff violated the court’s order—which is never a good look—and asked the court to be an ”archaeologist” or “pig, hunting for truffles.” Id. at *6. We are all aware of the discovery strategy of burying your opponent in a mountain of paper and hoping they give up. Spoiler: judges don’t give up. They have long memories and limited patience for document dumps masquerading as compliance. So, the court struck everything except the portion of the supplement that contained a spreadsheet which attempted to show which documents had been previously disclosed. Id. at *7.

On the merits of the motion, the court found that as to twenty-five documents, plaintiff had violated the MDL protective order by using them in the state court litigation. As to those documents plaintiff “dumped” on the court exhibits, exhibit lists, hearing transcripts, and court orders from other cases and “speculated” that the documents may have been disclosed in the “hodge podge.” But again, the court was unwilling to “excavate masses of papers in search of revealing tidbits.” Id. at *18 (citation omitted). Because the MDL protective order explicitly limited the use of confidential materials to that litigation only, plaintiff violated the court order.

Nor could plaintiff demonstrate that the violation was “substantially justified.” Plaintiff easily could have put defendants on notice of the state court deposition and her intention to use the confidential documents. While the MDL protective order did not address this particular situation, it contained provisions for other situations where a party may want to use confidential information, calling for advance notice. Id. at *20-21. “Such notice would have given plaintiff a safe harbor, protected defendants, and brought about the confidentiality issue for resolution before the proverbial horse was out of the barn.” Id. at *22.

And this is most definitely why sanctions are warranted. The defendant did not find out until after the fact. The barn door was supposed to be locked, subject to notice and a chance to object—not flung open in the name of creative litigation strategy. Defendants shouldn’t be left chasing hoofprints and damage control. Courts have to reinforce that confidential actually means confidential. Here, that meant plaintiff was prohibited from using the state court deposition of the surgeon in the federal case, was prohibited from using the 25 confidential documents in any other action, including the action against the surgeon, and had to pay reasonable attorneys’ fees and expenses in connection with bringing the sanctions motion. Id. at *22-23.  

Between the data dump and the protective order violation, this case was fraught with procedural mischief and disrespect for the court. So, the morals of the cautionary tales—follow the court’s orders. The court — and your credibility — will thank you.

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Back in the bad old days of the Bone Screw litigation, we had to fight our way through a thicket of scurrilous allegations about how our clients supposedly promoted off-label use through continuing medical education seminars that the Bone Screw plaintiffs claimed were used to reward surgeons who regularly used our clients’ products with excessive speaker fees.  Back then – in the mid 1990s – the plaintiffs’ preferred avenues for asserting such allegations were state-law based:  negligence per se, fraud on the FDA, and conspiracy.  By the time that the infamous Franklin False Claims Act (“FCA”) decisions came down (United States ex rel. Franklin v. Parke-Davis,147 F. Supp.2d 39 (D. Mass. 2001), and United States  ex rel. Franklin v. Parke-Davis, 2003 WL 22048255 (D. Mass. Aug. 22, 2003)), we had won Buckman (and a lot of other things), so Bone Screw-related promotion allegations were never the subject of FCA litigation.

But the Bone Screw promotional allegations were close enough to what has been subsequently alleged ad nauseum in FCA litigation that we’ve followed similar FCA litigation ever since.  Today’s case, United States v. Gilead Sciences, Inc., 2025 WL 2627686 (E.D. Pa. Sept. 11, 2025), does not involve off-label use, but does involve allegations of kickbacks – through speaker programs and donations to charitable organizations.  We’re happy to say that the entire action was dismissed – on both sets of facts.  We’re even happier to recommend the discussion in Gilead as providing useful guidance for how pharmaceutical companies can manage both types of programs in compliance with applicable law.

Continue Reading FCA Dismissal Illustrates Pharmaceutical Promotion Done Right
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We’ve blogged a lot recently about preemption and the dismissal of complaints alleging that certain over the counter products, including acne medications, sunscreens, antiperspirants, expectorants, and shampoos contain benzene.  Almost a year ago we blogged about the dismissal of an OTC case involving medicated shampoo that allowed plaintiff leave to amend. Today’s decision, Pineda v. Lake Consumer Products, Inc., 2025 WL 2698991 (E.D. Pa. Sept. 22, 2025), is a mixed bag that addresses plaintiff’s amended complaint. It’s about coal-tar shampoos, which are known to include benzene and are subject to an FDA monograph that recognizes the naturally occurring presence of benzene in coal tar. Yet, shockingly, plaintiff filed a class action claiming she would not have purchased the shampoos had she known they contained benzene.

Continue Reading OTC Preemption Letdown in the Eastern District of Pennsylvania
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This post is from the non-Dechert and non-RS side of the Blog.

Depending on the time, issue, and players, the supposed epithets of “judicial activism” or “activist judge” can be thrown in just about every juridical direction.  If we were to try to parse out the most common reason for the use of these terms, we might identify a judge or panel of judges establishing law that should have resulted from legislation.  There is also the variant where the judge or judges establish new law that really should come from another court, such as the highest court of the relevant state.  While we recognize that many decisions from courts could be said to “establish new law” whenever a non-rote issue is being decided, there is a difference between interpreting existing law in connection with deciding a live issue in a particular case and establishing new law.  Under the principle of stare decisis, controlling precedent is to be respected with logical applications of the precedent to novel sets of facts, which can lead to “extensions” or “corollaries” of existing law.  (Obviously, stare decisis does not prevent the Supreme Court or state supreme courts from reversing decades of established law, like Brown v. Board of Ed. undoing Plessy v. Ferguson or Dobbs undoing Roe.)  When a federal court sits in diversity and has to utilize Erie restraint in applying state law, these dynamics become more than mere semantics.

In a federal diversity case where the highest court of the state whose law is being applied has not ruled on the specific issue in the case, in which direction does restraint pull?  As lawyers defending companies that get sued, our first thought on this is that federal courts sitting in diversity should not establish new state law causes of actions.  We concede that they also should not establish new state law defenses to causes of action.  In many cases, however, the fight is about whether a broad or vaguely defined state law cause of action encompasses the relief plaintiff seeks for the defendant’s allegedly culpable conduct.  For instance, a state’s recognition of a cause of action for negligence does not cover conduct as to which the state imposes no duties.  Reporting to a federal agency, such as FDA, would be an example.  Also, if the state’s product liability law has recognized distinct theories for strict liability failure to warn, design defect, and manufacturing defect, then making up a hybrid theory to fit the plaintiff’s needs in the particular case would be an expansion.

In City of Huntington v. AmerisourceBergen Drug Corp., 609 F. Supp. 3d 408 (S.D. W. Va. 2022), the district court presented its Findings of Fact and Conclusions of Law after a long bench trial.  The trial court found that plaintiffs had failed to carry their burdens on a number of the elements of their public nuisance claims asserted against the three main U.S. prescription drug distributors related to the purported connection between their distribution of prescription opioids and the local impacts of abuse of prescription opioids and various illegal drugs of abuse.  This defense win in a marquee opioid litigation trial—the plaintiff jurisdictions were considered some of the strongest plaintiffs because of the volume of prescriptions dispensed in them compared to their populations and the extent of the local problem—garnered quite a bit of attention.  Predictably, it also garnered an appeal.  Last week, the Fourth Circuit reversed.  City of Huntington v. AmerisourceBergen Drug Corp., — F. 4th –, 2025 WL 3009526 (4th Cir. Oct. 28, 2025).  Our introduction was not subtle in signaling that we think one of these courts got it wrong in large part because of not following Erie.

We have made no secret of our view that public nuisance should not be extended to the sale or distribution of products, especially prescription medical products.  We have been saying this since long before the Restatement (Third) of Torts: Liability for Economic Harm § 8 cmt. g (A.L.I. 2020), stated that “the common law of public nuisance is an inapt vehicle for addressing” alleged harms related to products.  We also think the municipal cost recovery rule is a problem for the opioid litigation claims, as they are premised on shifting the increased costs of government functions to purported tortfeasors/lawbreakers.  Part of the issue with the proposed expansions of public nuisance is that the tort of nuisance—since its roots in thirteenth century England—has always been focused on the use or enjoyment of real property.  As private nuisance expanded to public nuisance, both through common law and statute, the connection to real property has become somewhat more opaque but is still present.  The remedy has always been abatement, an equitable remedy, not monetary damages for past injury.  Even the term “abatement” derives from the term for cutting down a tree, which definitely relates to property.  Before opioid litigation pushed the limits of public nuisance to try to encompass liability for marketing, selling, and distributing products, perhaps the most famous litigation seeking to impose broad liability for a purported public nuisance was the Rhode Island lead paint litigation.  While that had a much closer link to real property rights—the allegedly harmful paint was on the walls of residences where children lived and consumed paint chips—it still fell in the Rhode Island Supreme Court because there was an insufficient connection between the defendants’ sale of their products and the creation of a dangerous condition at a specific location that affected an indivisible public resource.  As the Rhode Island Supreme Court said there, “Expanding the definition of public right based on the allegations in the complaint would be antithetical to the common law and would lead to a widespread expansion of public nuisance law that never was intended[.]”  State v. Lead Indus. Ass’n, 951 A.2d 428, 453 (R.I. 2008).  By any measure, using public nuisance as a vehicle for governmental entities to obtain damages related to the marketing, distribution, or sale of a product would be an expansion of public nuisance, not a failure to restrict it.

This brings us back to the issue of Erie restraint.  The Huntington district court, at the start of its analysis of West Virginia law on public nuisance, wrote:

This court should “‘respond conservatively when asked to discern governing principles of state law’ and take care to avoid interpreting that law in a manner that ‘has not been approved’” by the West Virginia Supreme Court of Appeals.

609 F. Supp. 3d at 472.  This sentence cited Knibbs v. Momphard, 30 F.4th 200, 213 (4th Cir. 2002), and its own quotation of Rhodes v. E.I. du Pont de Nemours & Co., 636 F.3d 88, 96 (4th Cir. 2011).  The Fourth Circuit echoed the same exact Knibbs and Rhodes citations after the following sentence, but without any hint of the need for restraint or a conservative response:  “Because there is an absence of controlling state law, we are charged with predicting what the State Supreme Court would conclude based on that state’s existing law.”  2025 WL 3009526, *10.  The actual cited/quoted language from Knibbs and Rhodes (in order below without citation) supports the district court’s approach:

We “respond conservatively when asked to discern governing principles of state law” and take care to avoid interpreting that law in a manner that “has not been approved” by the Supreme Court of North Carolina.

            * * *

In the absence of such action by the highest state court in West Virginia, our role in the exercise of our diversity jurisdiction is limited. A federal court acting under its diversity jurisdiction should respond conservatively when asked to discern governing principles of state law. See Day Zimmermann, Inc. v. Challoner, 423 U.S. 3, 4, 96 S. Ct. 167, 46 L. Ed. 2d 3 (1975) (per curiam). Therefore, in a diversity case, a federal court should not interpret state law in a manner that may appear desirable to the federal court, but has not been approved by the state whose law is at issue. See id. Mindful of this principle, we decline the plaintiffs’ invitation to predict that the West Virginia Supreme Court of Appeals would adopt the specific provisions of the Restatement advanced by the plaintiffs.

While both the Huntington district and appellate court recognized that the West Virginia Supreme Court had not ruled on the direct issue of whether West Virginia public nuisance law covered damages (not just traditional abatement) for harms allegedly caused by the distributors’ distribution of prescription opioids to pharmacies in the plaintiff jurisdictions, they came down on opposite sides of these issues.  It is clear to us that the district court applied the proper restraint against expansion counseled by the Supreme Court and prior Fourth Circuit decisions—both as to the scope of conduct and the scope of remedies.  The Fourth Circuit, which repeatedly framed its approach as refusing to restrict West Virginia’s common law on public nuisance, did not.  The rest of the decision reversing and remanding the case for further proceedings was essentially a foregone conclusion.

Mind you, the Fourth Circuit had done the right thing by referring a certified question to the West Virginia Supreme Court and was put in an unusual, awkward position when the West Virginia Supreme Court denied its request on the grounds that it could not give an advisory opinion.  That meant that an Erie prediction—with proper restraint, hopefully—was back on the Fourth Circuit’s plate.  Of course, had it answered the question, the West Virginia Supreme Court very well could have expanded public nuisance to the extent needed to help out the case brought by a West Virginia county and city against out-of-state companies.  After all, this is the same court that adopted medical monitoring without present injury in Bower v. Westinghouse Electric Co., 522 S.E.2d 424, 427 (1999), and rejected the learned intermediary doctrine for prescription drug product liability cases State ex rel. Johnson & Johnson v. Karl, 647 S.E.2d 899 (W. Va. 2007).  The political pressure to provide such novel remedies in Huntington would surely have been substantial.  But the Fourth Circuit, in its role on a diversity case, should not have “interpret[ed] state law in a manner that may appear desirable to the federal court, but has not been approved by the state whose law is at issue,” which was clearly the case here.

We could walk through the rest of the Fourth Circuit’s decision to highlight instances of questionable conclusions and suspect analysis throughout.  Surely, others will, including on the likely cert. petition to the Supreme Court.  Rather than do that, we will focus briefly on two interrelated recurring issues. 

First, the district court, after recounting lots of evidence and many findings from bench trial, went ahead and addressed whether plaintiffs carried their burden as to the elements of public nuisance, assuming it encompassed products and monetary damages.  The district court’s decisions, as factfinder, established layers of alternative grounds for affirming even if the Fourth Circuit disagreed on the scope of public nuisance.  It was obvious from the opinion below that each factual determination that the Fourth Circuit revisited was supported by substantial evidence in the record.

Second, although questions of fact are supposed to be reviewed on a clear error standard, 2025 WL 3009526, *9 (“[T]his is a deferential standard, and we will not disturb the district court’s factual findings if they are plausible in light of the record reviewed in its entirety.”) (citation omitted), the Fourth Circuit appeared to undertake a de novo review of some of the district court’s many factual determinations.  The Fourth Circuit held that a number of these factual determinations, such as the existence of multiple, fatal holes in plaintiff’s proximate cause case, “were based, at least in part” or “rested, in part” on purported legal errors in interpreting the distributors’ duties under the federal Controlled Substances Act.  Even if the district court was wrong on that issue—it relied on plaintiffs’ witnesses’ testimony on those federal duties—this holding was quite a stretch.  The Fourth Circuit did not identify improperly excluded evidence, hold that any factual determinations were not supported by substantial evidence in the record or were contrary to the weight of the evidence, or explain how there could be proximate cause given the many undisturbed factual determination on causation.  For instance, this finding from the district court seems untouched by the Fourth Circuit’s criticisms and negates causation under the causation theory it resurrected:

Plaintiffs rely on a breach of a no-shipping duty to prove diversion and creation of an opioid epidemic. To the extent they also rely on the reporting requirement, plaintiffs failed to show that any alleged violations based upon a failure to report suspicious orders by defendants contributed to the volume of opioids distributed in Cabell/Huntington. Put another way, plaintiffs did not show that had defendants reported more suspicious orders that the DEA would have closed any of the pharmacies that defendants serviced in Cabell/Huntington.

609 F. Supp. 3d at 449 n.5.  There are more examples, but we will leave it there.

Whether this goes to the Supreme Court or goes to the district court to redo its Findings of Fact and Conclusions of Law in light of the Fourth Circuit’s expansion of West Virginia public nuisance law, it is still far from a foregone conclusion that plaintiffs will win this case with the obvious holes in the evidence they offered at trial.  As John Adams famously said, and some plaintiff lawyers like to quote:

Facts are stubborn things; and whatever may be our wishes, our inclinations, or the dictates of our passions, they cannot alter the state of facts and evidence.

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Today’s case, Clayton v. Zimmer United States, Inc., 2025 U.S. Dist. LEXIS 213345 (S.D. Ohio Oct. 29, 2025), marks two weeks in a row where we discuss good (for the defense) court decisions coming out of Ohio.  Meanwhile, in our non-blogging-but-actually-paying part of our job, we’re on something like our fifth week in a row fighting against plaintiffs in several cases who are doing everything possible to stay out of federal courts.  Why do some plaintiff lawyers shun the wisdom, life-tenure, non-elected, well-resourced majesty of federal courts?  We don’t mean to be unkind, but we take this fear of the federal to say nothing good about those lawyers or their cases.

In Clayton, the plaintiff was an Ohio citizen who claimed that an implanted knee device fractured and caused her serious injuries. She filed suit in Ohio state court under the Ohio Products Liability Act (the OPLA) against the manufacturing companies (not Ohio citizens) and a local supplier called Mid-Ohio which was – you guessed it – an Ohio citizen.  The defendants removed the case to federal court, invoking diversity jurisdiction. Obviously, at first blush it looked like Mid-Ohio’s presence defeated diversity. But the defendants argued that the federal court should retain jurisdiction over the case because Mid-Ohio was fraudulently joined. The plaintiff’s response was that Mid-Ohio was legitimately in the case because it was derivatively liable as a supplier of the device implanted into her knee.

The federal court began its analysis by reminding us that fraudulent joinder is a pretty tough test for defendants to meet.  There must be “no colorable cause of action” against the non-diverse party. It helps the removing party that it “can present evidence beyond the pleadings to make this showing,” but it hurts the removing party that the standard for fraudulent joinder is “akin to that of a Rule 12(b)(6) motion to dismiss,” with perhaps even more deference to the plaintiff. 

As we have seen more than once, Ohio’s substantive product liability law, the OPLA, is remarkably sane. Under that law, the plaintiff’s claim against the local supplier could not survive, even under the loose fraudulent joinder standard. Ohio’s product liability statute limits “derivative” liability to when “the supplier in question is owned, or when it supplied that product, was owned, in whole or in part, by the manufacturer of that product[.]” Ohio Rev. Code § 2307.78(B)(4). No such ownership interest existed here, so the fraudulent joinder standard was met and, given this quirk of Ohio law, removal to federal court was successful.  

The plaintiff tried to support her claim against the local supplier by alleging that her surgeon spoke to a “local Zimmer representative” about the device and that Mid-Ohio is listed on the Zimmer website. But Mid-Ohio submitted undisputed evidence that it “does not own, is not owned by, nor has it ever been owned by Zimmer US, Inc., Zimmer Biomet Holdings, Inc., or Zimmer, Inc.” Accordingly, the federal court found that the plaintiff failed to assert a colorable claim against Mid-Ohio and that Mid-Ohio was fraudulently joined in this action.

In our eyes, the OPLA is just as undefeated as the Ohio State Buckeye football team.

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In the 1980s, when a wave of complicated, expensive, and hard to prove lawsuits against the vaccine industry threatened to drive many manufacturers out of the market and subsequently cause a public health crisis, Congress stepped in and enacted the Vaccine Act which created the National Vaccine Injury Compensation Program. It is designed to strike a balance. It keeps vaccines available by shielding manufacturers from constant litigation and provides an accessible, less adversarial way for injured individuals to be compensated. Claimants don’t have to prove fault like in regular tort cases, and even if they lose, they can sometimes get their attorneys’ fees paid as long as their claim was brought in good faith and on a reasonable basis.

But here’s the catch: “reasonable basis” has to actually mean something. If you’re going to bring a claim in the Vaccine Court, you need some evidence to back it up—medical records, a doctor’s note, a little something beyond “I just feel like it was the vaccine.” That was the issue the court had to deal with in Stratton v. Secretary of Health and Human Services, 2025 WL 2955287 (Fed. Cl. Ct. Aug. 22, 2025).

Plaintiff filed her Vaccine Act petition alleging that her HPV vaccine caused her to develop POTS and autonomic dysfunction. The petition “acknowledged outright” that she only filed the petition because she was statutorily compelled to do so before she could pursue litigation against the manufacturer. Id. at *4. Not surprisingly then, plaintiff did a minimal amount of work and then immediately withdrew her claim at the 240-day mark—the deadline by which if a claim is not resolved, the claimant can withdraw it and move forward in federal court. However, even when a claim is withdrawn, plaintiff can file a motion for attorney’s fees and costs for work performed up to the time of withdraw. Here the claim was for almost $11,000. Notably, this is just one of over 300 HPV vaccine claims initiated and then withdrawn by the same counsel, so Stratton has broader implications.

Attorney’s fees should not be handed out like participation trophies.  Even though “[r]easonable basis is an extremely lenient standard,” it is not non-existent. It requires objective evidence. Id. at *6. Here, the plaintiff’s medical records detail multiple symptoms of POTS experienced by plaintiff long before receiving the vaccine and “no contemporaneous evidence that she experienced a close-in-time reaction or worsening of her pre-vaccination symptoms.” Id. at *8. Moreover, the Vaccine Program has a long history of rejecting contentions that the HPV vaccine is capable of causing POTS.  The opinion cites to a series of rulings issued before plaintiff’s claim was filed that should have put her counsel on notice of the weakness of the claim. Id. at *9. Allowing attorneys to get paid in cases like these would send the wrong message: that the Vaccine Court is an ATM for anyone willing to type “vaccine injury” into a form.

There is also a fundamental problem with plaintiffs using the Vaccine Act program as nothing more than a waiting room; a place to kill time until they can march off to federal court and start the “real” lawsuit. That’s missing the whole point. The Vaccine Act wasn’t designed as a bureaucratic obstacle course before you can sue the government. It was meant to resolve disputes efficiently—give claimants compensation when it’s deserved and protect vaccine manufacturers (and the vaccination system itself) from endless litigation. If you just sit back and let the 240 days tick by without engaging, you’re not participating in that process—you’re gaming it (as we discussed here).

And worse, if people keep doing this, it turns the Vaccine Court into a rubber stamp. The system depends on claimants actually trying to resolve their cases there. When people skip that step, it wastes time, money, and judicial resources. So yes, if a claimant does nothing during those 240 days—or flat-out says, “I’m only here because I have to be”—they shouldn’t get to turn around and say, “Okay, my time’s up, let’s go to federal court!” The Vaccine Act isn’t a formality; it’s a process with a purpose. If you want to use the Vaccine Act, use it. If not, don’t pretend you did.

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Not long ago we published a blogpost, “New California Ranitidine Litigation Order Makes A Huge Mess Of Everything” about a California trial court decision that created, out of whole cloth, what it called a “hybrid theory” of strict liability that jumbled together elements of the long-established – and long separate – concepts of design and manufacturing defect, while sprinkling in the negligence concept of intent.  See In re Rantidine Cases, 2025 WL 2796831 (Cal. Super. Sept. 15, 2025).  As a result, the court allowed a “manufacturing” defect that was uniform across all units of the product, because it construed plaintiffs’ attack on the defendants’ manufacturing processes as a manufacturing defect.

In this post we will attempt to describe just how far out of bounds this “hybrid theory” really is.

Continue Reading California Design vs. Manufacturing Defects – Neer the Twain Shall Meet

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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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