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Last week we saw an article on a baseball website about batters who, through umpire forgetfulness or whatever, were not called out until strike four.  Then we read Comatov v. Medtronic, Inc., 2023 WL 2922830 (C.D. Cal. March 16, 2023), in which the court did not call a complete and final stop (like what the teenagers running the roller coaster tell you to wait for before attempting to exit the ride) to the lawsuit until the Fourth Amended Complaint.  (Is that four strikes or five strikes?) Mind you, we’re not suggesting there was any form of umpire forgetfulness in the Comatov case.  The judge who wrote the opinion is very smart, and he did not get the case until it had been amended four times. 

How did that happen? Well, Comatov was a bit of a roller coaster ride.  The claim was that the decedent died because a pacemaker malfunctioned.  After some ups and downs (mostly downs), the plaintiff tried to convert the case from medical malpractice to product liability.  As part of that conversion, the Fourth Amended Complaint added causes of action for strict liability due to a manufacturing defect, strict liability due to a failure to warn, negligence and negligence per se, and a survivor action under California law. Also as part of that conversion, the Fourth Amended Complaint dropped all California defendants (including the doctors), and thereby (perhaps inadvertently) creating diversity of citizenship and permitting the defendant to remove the case to federal court.  The C.D. Cal. wheel sent the case to a no-nonsense judge, and the roller coaster soon came to an abrupt stop. 

The pacemaker at issue had gone through premarket approval (PMA), which implicates our favorite defense, express preemption per the Medical Device Amendments (MDA) to the Food, Drug and Cosmetics Act (FDCA), which ousts state laws (including jury verdicts) to the extent they impose standards that are “different from, or in addition to” the federal regulatory regime. The Comatov court correctly rejected any presumption against express preemption, and quickly focused on the by now classic inquiry: is the plaintiff “suing for conduct that violates the FDCA (or else his claim is expressly preempted by section 360k(a)) … [or] suing because the conduct violates the FDCA (such a claim would be impliedly preempted under Buckman).”  (Emphases in original.) The answers to that inquiry turned out to be not so good for the plaintiff, whose claims were held preempted.

The warning claim was expressly preempted under the MDA.  The plaintiff alleged that the defendant failed to warn either the decedent or the decedent’s doctors about the device’s adverse events.  But, as the Comatov court pointed out, “the MDA requires only that Defendant report adverse events to the FDA.”  Thus, the plaintiff’s warning claim would impose a requirement that is “different from, or in addition to” federal law.  


The plaintiff’s remaining claims failed to “thread the preemption needle” via a parallel claim.  That failure was not for want of trying. The plaintiff set forth several federal regulations that the defendant allegedly violated.  But all the plaintiff did was recite a laundry list of conclusory FDA regulation violations (Quality System Regulations, failing to manufacture with a material meeting FDA requirements for hardness, durability, composition, and finish, etc.). Conspicuously missing were factual allegations supporting an inference of any actual violations.  

The plaintiff’s most specific alleged violation was the FDA’s issuance of a safety warning that at least three of the pacemakers had suffered from cracked capacitors that caused a sudden drain in battery level.  But the Fourth Amended Complaint did not allege that the cracked capacitor was at issue in the Comatov case, or that any specific manufacturing defect was attributable to a violation of FDA regulations.  Moreover, the court concluded that it was implausible to infer a manufacturing defect in plaintiff’s device from a general FDA safety communication.  Since the FDA already knew about the claimed problem, as demonstrated by its communication, no failure to report could possibly be causal.  Finally, FDA recalls or similar actions, by themselves, cannot create a presumption of a regulatory violation.  


Maybe our use of the word “finally” was premature.  The plaintiff engaged in what the court called a “last-ditch effort” to save the lawsuit by arguing that the inaccessibility of “confidential information” should relax the pleading requirements.  The Comatov court rejected this argument: “The near total absence of non-conclusory allegations is fatal to Plaintiff’s claims.” After four amended complaints, the court dismissed the case with prejudice.  The roller coaster ride was over, the batter was called out, and the case was done.

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Last year, the federal court decision to exclude plaintiffs’ general causation expert in the In re: Onglyza and Kombiglyze XR Products Liability Litigation, MDL 2809 (E.D. Ken.),took a spot in our top ten best of 2022 (original post on that decision here).  Without a general causation expert, it is not surprising that summary judgement followed shortly after.   In re Onglyza and Kombiglyze Prods Liab. Litigation, 2022 WL 3050665 (E.D. Ky. Aug. 2, 2022) (discussed here).  What we have not discussed is the parallel litigation pending in state court in California.  Until today.

Thirteen cases were coordinated in California and the California judge further coordinated with the MDL judge, including conducting a joint Rule 702/Sargon hearing.  After which, the California court reached the same conclusion as the federal court – plaintiffs’ general causation expert’s opinion was excluded because it did “not contain a reliable methodology for weighing the evidence but a shifting results-based methodology that fails to logically and consistently weigh all the relevant evidence.”  Onglyza Products Cases, — Cal.Rptr.3d –, 2023 WL 3001055 (Cal. App. Apr. 19, 2023).  Again, the next step was summary judgment based on a lack of expert evidence on general causation.  Now, the California trial court decision, both as to exclusion and summary judgment, has been affirmed by the appellate court.

The drugs at issue are in class used to treat diabetes.  Plaintiffs allege that the drug causes heart failure and related cardiac conditions.  At the request of the FDA, manufacturers conducted a cardiovascular outcomes study, a randomized controlled trial (“RCT”) with multiple cardiac endpoints.  The result of the trial was that there was no statistically significant difference between the drug and placebo for any primary endpoint (cardiac death, non-fatal heart attack, non-fatal stroke) or secondary endpoint except for hospitalization due to heart failure.  Id. at *1.  Following the cardiac trial, the authors of the study explained that heart failure finding was “unexpected and should be considered within the context of multiple testing that may have resulted in a false positive result.”  Id.  The authors cautioned that the outcome regarding hospitalization for heart failure warranted further investigation.  Id.  Further study was done in the form of observational studies and meta-analyses, none of which found an association between the drug and heart failure.  Id. 

Plaintiffs proffered two experts, a cardiologist who opined, based on the findings of the RCT and animal studies, that the drug was capable of causing heart failure; and a biostatistician.  Plaintiffs argued that the trial court overstepped in excluding the cardiologist’s opinion because the law allows the expert to place more weight on certain evidence, like the RCT, and less weight on other evidence, like everything else.  Id. at *5.  It may be one thing to place more weight on an RCT, it is another to conclude that “the finding from [the RCT] alone showed a causal link between [the drug] and heart failure.”  Id.   This conclusion is particularly flawed when the authors of the RCT concluded that the heart failure outcome “needs to be confirmed in other ongoing studies.”  A finding plaintiff’s expert agreed with.

A trial court does not abuse its discretion in excluding expert testimony on general causation when the expert’s opinion is based on a single study that provides no reasonable basis for the opinion offered.

Id. at *6.

Plaintiffs’ next argument was that their expert reliably performed the Bradford Hill analysis despite the trial court’s finding that the expert misapplied six of the nine Bradford Hill factors.  For example, one factor is “strength of association.”  The relative risk for hospitalization for increased heart failure was 1.27, but plaintiffs’ expert “could not say whether 1.27 was a strong association,” with “strong” being too subjective for him.  Id.  The court viewed this as the expert “refusing to engage with a factor of the Bradford Hill analysis on its terms.”  Id.  Another factor is consistency – “when the same finding is shown in multiple studies across different populations and settings.”  Plaintiffs’ expert, however, “disregarded inconsistent data from human studies and relied on data from preclinical animal studies,” to support this factor.  But, at the hearing, plaintiff’s expert conceded he was not qualified to interpret animal data, so instead he switched his position arguing that the RCT alone showed consistency because it examined 16,000 patients.  But the consistency factor requires an expert to see if different studies using different methodologies reached the same conclusion.  Plaintiffs’ expert’s cherry-picking of data shows the “unreliability of his shifting, results-based methodology.”  Id.  On the “analogy” factor, plaintiffs’ expert had to concede that heart failure studies done of other drugs in the same class likewise found no association.  So, instead, he analogized the drug at issue to drugs in a different class of diabetes medications where a link to heart failure had been found.  The trial court saw through the ploy:  the only reason to analogize to a different class of drugs was because it “supported his ultimate conclusion,” where the data on the drug at issue and its class did not.  Id. at *7.    

For all of these reasons, and more, the appellate court determined the trial court was well within its discretion in excluding plaintiffs’ expert based on its reasoned conclusion that the expert’s opinion was “shifting and unsound.”  Id. at *8.    

Plaintiffs also tried to argue that summary judgment was improper because expert causation evidence was not necessary.  That flies directly in the face of settled law that “in a personal injury action causation must be proven within a reasonable medical probability based upon competent expert testimony.”  Id. at *9.  Even if plaintiff had provided any authority that complex medical causation, such as heart failure, could be proven through non-expert evidence, the non-expert evidence plaintiffs relied on was insufficient to cross the summary judgment threshold.  The drug’s updated label that said consider the risks before using to treat patients at high risk for heart failure.  The RCT authors’ statement that the risk of heart failure needs to be further investigated.  FDA statements after the RCT that the drug may cause or increase the risk of heart failure.  All of these statements are based solely on the results of the RCT – which cannot support causation for all the same reasons plaintiffs’ expert’s reliance on the RCT alone could not.  [P]laintiffs cannot attempt to circumvent the shortcomings of [the RCT] by pointing to other evidence that merely relies on [the RCT’s] finding.”  Id. at *11.

Finally, the court did not abuse its discretion in denying plaintiffs’ request for additional time to designate a new expert.  Plaintiff chose to designate one causation expert, that was their strategic decision.  Asking for a do-over would prejudice defendants and tax the court’s resources as it would require additional expert discovery and another Sargon hearing.  Summary judgment was affirmed.

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Arbitration, if done right, is an effective, speedy, and low-cost alternative to civil litigation of all kinds, which is why the other side (or at least the lawyers representing them) hates it.  Unfortunately, with prescription medical products − and their necessary learned intermediary physicians – arbitration doesn’t come up very often in our line of work, although nothing inherent in personal injury litigation precludes mandatory arbitration.

But it might happen more, in the future.  In a think piece we published a couple of years ago, on software liability, we identified arbitration as one of the consequences in litigation where intermediaries (“learned” or otherwise) were out of the picture.  “In direct-to-consumer contexts, providers routinely seek to use contracts such as click-wrap licenses to allocate software-related liability including limitations on liability, forum selection clauses, compulsory arbitration and similar protective measures.”

But our clients might, at least in certain situations, be able to enjoy both the learned intermediary rule as well as mandatory arbitration.

Continue Reading Oye Cómo Va?  To Arbitration.
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Personalized medicine is the wave of the future.  Whether treating disease or prescribing medical devices (or both), medical practitioners are taking individualized patient characteristics into account more and more as they treat their patients.  Cancer therapy can now be targeted at the genetic level, and some medical devices can now be created to match patient imaging and other custom input.  The objective, of course, is better patient outcomes, but as defense lawyers we have wondered aloud multiple times what this all could mean for product liability when outcomes are not all rosy.  We wrote just a few weeks ago on how personalized medicine could impact duties to warn on genetic variations.  We mused on 3D printing for the first time more than eight years ago.  And we have gone back to that well multiple times over the years (here and here, for example), each time identifying potential issues and pitfalls.  Heck, Bexis and our colleague Matthew Jacobson even wrote a law review article on the topic a few years back. 

This is the backdrop against which we viewed a recent Nevada case reinstating product liability claims against dentists who allegedly designed, manufactured, and surgically implanted custom dental implants.  The case is Estate of John Cronin v. G4 Dental Enterprises, No. 84075, 2023 WL 2779206 (Nev. Ct. App. Apr. 4, 2023), and while the opinion does not disclose whether the implants were 3D printed, the opinion raises all the same questions.  The patient sadly passed away after having 23 teeth removed and replaced (for those keeping score, that is more than two-thirds of a normal human complement of teeth), and his family sued for medical malpractice and product liability.  Id. at *1.  The Nevada Court of Appeals held that they could sue for both. 

This is not your garden-variety medical device, product liability case.  The plaintiffs alleged that the dental implants were both a procedure and a product.  One of the dentists performed the surgery (the “procedure”), and he also allegedly invented a proprietary process involving the design and in-house engineering of the custom implants (the “product”).  He allegedly was the exclusive provider.  Id. at *7.  In other words (and in the language of product liability), the dentist “designed the implant, and manufactured and sold it to customers.”  Id. at *9.  From there, the Nevada court had no difficulty holding that the trial court should not have dismissed the plaintiffs’ product liability claims. 

We will see how the plaintiffs’ hybrid med mal/product liability lawsuit goes on remand.  But, in the larger scheme, we can foresee multiple issues that lawsuits like this will raise.  Courts have long seen healthcare providers as service providers to whom product liability law does not apply.  The introduction of in-house fabrication (known as “point-of-care” manufacturing) surely blurs the lines. 

We also need to revisit our prior discussions of the regulation of 3D-printed devices (again, we can’t tell whether the dental implants in this Nevada case were 3d printed, but still).  The FDA regulates medical devices, including 3d-printed medical devices when made by medical device manufacturers (see here for more information).  But point-of-care devices appear to still be a matter of regulatory discussion.  Who then are the relevant regulators for providers like our Nevada dentists?  The FDA, or state-level regulatory commissions, or plaintiffs’ attorneys applying tort law, or all of the above?  If FDA regulation applies (and maybe it does not if the subject devices did not cross state lines), providers may be subject to FDA’s Good Manufacturing Practices, which may (or may not) impact the applicable standards of care.  That would be especially true in states where regulatory compliance is a defense or partial defense. 

We wonder whether strict product liability should apply to devices designed and manufactured by healthcare providers.  Strict product liability is justified in part by a manufacturer or seller’s ability to spread the cost of risk over multiple users.  Moreover, in the case of unavoidably unsafe products (which includes all drugs and medical devices), strict liability is balanced by the obligation to provide warnings on known and knowable risks.  These paradigms are difficult to apply to healthcare providers, who operate under a different warnings regime that focused on informed consent. 

Which leads us to the learned intermediary doctrine, which holds in most every state that a prescription product manufacturer’s duty to warn runs to the prescribing healthcare provider (the learned intermediary), and not directly to the patient.  It makes perfect sense, unless the manufacturer and the provider are the same.  There is no intermediary!  (Pause here while your DDL bloggers recover from fainting.)  So maybe the manufacturer’s duty to warn and the physician’s duty to obtain informed consent merge.  Try instructing a jury on how that ought to work. 

Finally, we would not be the Drug and Device Law Blog if we did not mention federal preemption.  We are unaware of any point-of-care device approved under the FDA’s rigorous Premarket Approval process.  But if there are any—now or in the future—express preemption under the Medical Device Amendments should apply.  Implied preemption should be on the table, too.  How odd that will be when a healthcare provider asserts federal preemption as a complete defense. 

While this largely an issue-spotting exercise for us, the dental implant litigants in Nevada will have to proceed on remand for real.  We wish both sides the best of luck, and hopefully we have not heard the last of their case.

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Lawyers really like to be right.  This dive into the latest on reproductive rights in the context of challenges to FDA’s regulation of a prescription medication is an instance where we wish we had not been right with some of our predictions.  Back when the Dobbs decision had been leaked but not yet issued, we offered that the decision would open the door to a range of challenges to FDA-approved drugs for medical abortion and emergency contraception, along with a wide range of other regulated medical products.  Immediately after the decision came out, we did a more thorough analysis on the arguments for preemption of state actions against FDA-approved drugs for medical abortion.  The last ten months have seen a flurry of legislation, litigation, and executive and administrative actions related to medication abortion.  We will not attempt to recap that flurry; there are many resources that track it, along with other developments related to reproductive rights and reproductive health.

We cannot resist, however, addressing the case that is heading up the appellate chain the fastest.  The chain does not get higher than the Supreme Court, which has already weighed in with a temporary stay of a truly ridiculous decision purporting to invalidate a number of actions taken by FDA with regard to mifepristone, the only currently marketed approved medication for medical abortion.  The full cite for this mess is Alliance for Hippocratic Med. v. FDA, ___ F. Supp.3d ___, 2023 WL 2825871 (N.D. Tex. Apr. 7, 2023), stayed in part, ___ F.4th ___, 2023 WL 2913725, 2023 U.S. App. LEXIS 8898 (5th Cir. Apr. 12, 2023), temporarily stayed, FDA v. All. for Hippocratic Med., ___ S. Ct. ___, 2023 WL 2942266 (U.S. Apr. 14, 2023).  Because the appellate decisions are only on the issue of staying the district court’s decision and because there is a conflicting decision from another federal district court in Washington v. FDA, ___ F. Supp.3d ___, 2023 WL 2825861 (E.D. Wash. Apr. 7, 2023), clarified, 2023 WL 2941567 (E.D. Wash. Apr. 13, 2023), we will be seeing other appellate action soon.

If you were counting along, then you would have noticed five separate decisions in the course of one week.  A sixth issued on April 19, 2023, when the Supreme Court extended the stay by 48 hours.  We are going to focus on the Fifth Circuit’s decision assessing the likelihood that FDA and the other defendants will prevail on the merits.

The first thing to understand is that the plaintiffs in AHM (we briefly considered calling it Hippo. and drawing comparisons to the Escobar hippopotamuses causing havoc in Colombia) are individuals and private entities, so preemption is not as front and center as with more direct state action, like a legislative ban on an FDA-approved medication.  State action is lurking in plaintiff’s arguments and what they seek, but we will shelve the preemption discussion.  The Fifth Circuit certainly did not mention preemption, the Supremacy Clause, the Commerce Clause, or the dormant Commerce Clause, among a number of implicated constitutional issues.  Hell, it not even discuss Dobbs, except in a footnote referencing an obscure footnote on third-party standing.  Before we dive in, we suggest a thought exercise where the subject was a class of FDA-approved medications intended for the treatment of type 2 diabetes or obesity, for example, instead of for medical abortion.  Many of those drugs have REMS (risk evaluation and mitigation strategies) in place, have had citizen’s petitions calling for their withdrawal denied, etc.  Some individuals and private entities, or perhaps judges, might have beliefs that these conditions should not be treated, perhaps based on a religious viewpoint that they result from sinful gluttony.  There is no specific substantive due process right to medical treatment for these conditions, let alone one recognized when the Fourteenth Amendment was ratified.  Are you with us?  Even in that scenario, we cannot envision the sort of results-driven and shoddy analysis seen in the AHM decisions.  We also cannot imagine that an appellate court would use loaded language when purporting to give facts like the approved indication for the drugs.  (We will not dwell on the latter bit on disbelief, but compare the language in the AHM decisions with the terms used in the FDA documents, which are publically available.)

The district court decision in AHM “would have the practical effect of an injunction because it would remove mifepristone from the market.”  Even in the context of a veiled injunction, the bar for a stay is high, reserved for “extraordinary circumstances.”  The four factors are:

1) whether the stay applicant has made a strong showing that he is likely to succeed on the merits; (2) whether the applicant will be irreparably injured absent a stay; (3) whether issuance of the stay will substantially injure the other parties interested in the proceeding; and (4) where the public interest lies.

As to the first factor, FDA—which we use to cover all the stay applicants—argued only standing, the six-year statute of limitations for cases against the United States, exhaustion, and that FDA did not violate the Administrative Procedures Act.

Standing in the constitutional sense is a matter of a legally cognizable injury caused by the defendant that can be redressed in the lawsuit.  The Fifth Circuit held that the individual doctors had standing because of three purported injuries due to a perceived weakening of the REMS requirements over time.  (The entities also had standing because some of their members did.)  Not due to the approval itself.  It seemed that the post-suit change to the REMS that removed the requirement of in-person dispensing of the drug was considered fully in the standing analysis, which is supposed to look to standing at the time the suit was brought.  When you put it together, the plaintiffs who wanted to invalidate the drug’s approval had standing only because the current REMS was not strict enough.  That is unusual.  The identified injuries were even more unusual in light of the lack of standing to challenge approval.  The first injury was that the doctors would have to provide emergency care for some number of women because of “unsuccessful chemical abortions.”  (Yes, emergency care for complications during unintended pregnancies and “illegal” abortions will surely be required too.)  The second injury was stress to physicians from “treating these women.”  (Even our restrained comments do not fit in a parenthetical.)  The third and most ludicrous injury was “the irreconcilable choice between performing their jobs and abiding by their consciences.”  (See above.)  The court tried to disclaim that its broad interpretation of injury to find standing had the implications it obviously had:

We do not hold that doctors necessarily have standing to raise their patients’ claims. We do not hold that doctors have constitutional standing whenever they’re called upon to do their jobs. And we do not hold that doctors have standing to challenge FDA’s actions whenever the doctor sees a patient experiencing complications from an FDA-approved drug. Rather, we hold that on the record before us applicants know that hundreds of thousands of women will-with applicants’ own statistical certainty-need emergency care on account of applicants’ actions.

Here is one of the problems, and it ties to why doctrines like preemption and primary jurisdiction—also not discussed—exist.  FDA is charged by Congress with advancing public health.  Although the AHM court acknowledged that FDA has “the responsibility to ensure that ‘new drugs’ are ‘safe and effective,’” it missed the broader context of that responsibility.  Going back to our thought exercise, there is a statistical certainty that a significant number of one million people with type 2 diabetes will suffer complications requiring emergency medical care in the absence of effective treatment.  There is also a statistical certainty that a significant number of one million people with type 2 diabetes who take any approved diabetes medication will suffer complications requiring emergency medical care due to their treatment.  The FDA’s job is to balance risks and benefits on a population basis.  Individual healthcare providers are supposed to do that for each individual patient they have, but they tend not to be very good at appreciating the overall public health calculus.  FDA did this calculus when it approved mifepristone and each type 2 diabetes drug.  It does this calculus each time it considers imposing or updating a REMS.  That is why, with very narrow exceptions, a healthcare provider or patient declaring “I disagree with FDA on XYZ” should not bestow standing or form the basis of a lawsuit.

The discussion of the statute of limitations was better, mostly because it rejected weak arguments the district court accepted in allowing a challenge to the 2000 approval of the drug in a lawsuit brought in 2022.  Subsequent actions within six years of the suit, such as rejecting citizen’s petitions or revising a REMS, did not “reopen” the original approval.  Equitable tolling also did not apply because the plaintiffs could have brought the suit earlier.  (Here, Dobbs might have been raised by the plaintiffs as opening the door to the lawsuit they brought six months after the decision was issued.)  Because of the posture, though, the challenges to the 2000 approval and other older FDA actions are not out of the case for good.

We can dispense with the exhaustion analysis because we find it, well, exhausting, albeit it short.  The APA analysis is more interesting and focused on the non-time-barred actions by FDA.  Whereas a plaintiff in an APA suit has the burden of proving that an agency’s action were arbitrary and capricious, which has a very high bar, the AHM court viewed the burden in this context to be on FDA to show that its actions were not arbitrary or capricious.  Notably absent from the discussion of applicable law was Chevron deference, including the more recent decisions in Kisor and Am. Hosp. Ass’n.  With the burden flipped and no deference, the court quickly concluded that FDA had not carried its burden.  Again, without any consideration at all of the broader health implications, the court found that FDA had not evaluated the overall impact of its 2016 REMS change and adopted an “ostrich’s-head-in-the-sand approach” to adverse event reporting in that same REMS change.  None of the other timely challenged FDA actions were discussed, including the 2019 approval of the ANDA for the currently marketed version of the drug.  Put a pin in that.

The court found no irreparable harm to FDA in invalidating 2016 and later REMS changes because “the world operated under the 2000 Approval for sixteen years, apparently without problems.”  All of those years were with Roe and its progeny as the law of the land (but not the whole world).  By contrast, the same convoluted arguments that the plaintiffs were and would be injured under 2016 and later REMS were dispositive on the third factor.  The public interest factor was something of an afterthought given the other conclusions and included a punt on the implications of the Comstock Act.  It did include, however, an acknowledgement (“credit their showing”) that compelling FDA to remove mifepristone from the market—relief the court had already concluded was likely time-barred—would entail “injury to pregnant women, to public healthcare systems, and to the sense of order that governs FDA drug approvals.”  As we have noted, these considerations were noticeably absent from the rest of the decision.

The end result is that a stay of the district court’s decision was entered as to the 2000 approval of mifepristone, but not as to “FDA’s Major REMS Changes and all subsequent actions.”  If you follow the court’s analysis, though, it seems that only the challenge to the 2016 REMS and not to “all subsequent actions,” including the ANDA approval in 2019, checked all the boxes.  The temporary stays from the Supreme Court cover the entire district court order, but that does not mean an expansion of the stay will stick.  While we certainly think the entire lawsuit is without merit, FDA’s approval of an ANDA should not be second-guessed like this and the Fifth Circuit’s failure to stay the order as to that approval is a real problem.

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More than once have we taken note of the current plaintiff lawyer infatuation with enlisting “independent” (ha ha ha) laboratories that will manage to detect contaminants in any drug, cosmetic, or puddle of unicorn tears.  For example, see our coverage of the Zantac MDL magnum opus ruling where the court was less than impressed by lab tests (one of those labs being Valisure) purporting to find carcinogens in the medicine.  In addition, last November we reviewed a case holding that Valisure’s purported findings of benzene in antiperspirant were inadequate to prop up a product liability case under Louisiana law.  

Today, we take a brief look at Brief v. Idelle Labs, Ltd., 2023 WL 2860345  (D.N.J. April 10, 2023), which reached a similar result under New Jersey law. A plaintiff claimed that he suffered from leukemia as a result of benzene in his antiperspirant. The amended complaint alleged product defect under the New Jersey Products Liability Act, with  claims for manufacturing defect, design defect, and failure to warn. The amended complaint prayed for both compensatory and punitive damages. That prayer is unlikely to be answered.  

The defendant moved to dismiss the Brief case in its entirety.  (The defendant was not Procter & Gamble, but that fine company gets mentioned in the case because it was the original developer of the product. We mention such mentioning only because we were distracted by the court’s incorrect spelling of Procter as “Proctor.”  We have seen that misspelling often – from courts, plaintiff lawyers, and even defense lawyers.  But we never make that mistake, at least not since a former P&G employee taught us to remember that P&G products are bettER, not bettOR. With our brand loyalty to Tide, Cascade, Dawn, Braun, and many other products, that rubric rings true for us. Heck, P&G could hire us and pay the fees with Mach 3 blades.)

The plaintiff in Brief attempted to repel, evade, or delay the motion to dismiss by relying on extraneous materials and by urging the court to wait for discovery. Nice try. The Brief court refused to consider such extraneous materials and would not allow lack of discovery to excuse inadequate pleading.  

How was the pleading in the Brief amended complaint inadequate? The main problem was the amended complaint’s full-blown reliance on a finding by Valisure of benzene in three samples of the product from three specific lots, as well as a subsequent recall of the product. But a Valisure-inspired recall was not enough to make out an actual defect. The Valisure report identified “significant variability” of benzene from batch to batch. Nowhere near all the tested products were contaminated, so it could not be inferred that the plaintiff’s products necessarily were. Nor can a voluntary recall constitute an admission of defect — a point for which we will certainly be citing Brief in our briefs.  

Moreover, the plaintiff insufficiently pled causation. The plaintiff said that he “regularly” used the antiperspirant for “many years” (this formulation will sound familiar to veterans of the asbestos and talcum powder wars), but that rote recitation did not add up to facts showing “high levels” of benzene consumption.  In short, the Valisure test results were not a short cut to a valid lawsuit.  

Absent defect or causation, the Brief case needed to be slammed shut.  There were, to be sure, defects in the Brief case, but they resided in the causes of action, not the product.  Each one of the causes of action in the amended complaint suffered from a fatal flaw. 

First, the manufacturing defect failed because the plaintiffs pointed to no defect or deviation in the manufacturing process.  All that the plaintiff could plead was that benzene should not be in the product, so the presence of benzene must mean that something went wrong. But the plaintiff identified no “error or mishap” during manufacturing. Further, the plaintiff’s theory was internally inconsistent. The court held that “common sense dictates that a product cannot deviate from another identical product” when the plaintiff’s claim was that over the “many years of regular use” the products “suffered from the same inherent flaw.”  That clever point, using the plaintiffs’ exposure allegations to push the manufacturing defect claim right out the courthouse door, resulted in dismissal of the manufacturing defect claim with prejudice. 

Second, the Brief court held that the design defect claim failed because the plaintiff never made out a real defect or alternative design. The plaintiff relied on the Valisure testing, not only to show the presence of benzene in the product at issue, but also to show the lack of benzene in other, similar products.  According to the plaintiff, those other, benzene-free products suggested the availability of an alternative design. But, again, the Valisure testing was incomplete and nonspecific to the plaintiff.  Maybe the plaintiff could do a better job of pleading the design defect cause of action (we are skeptical), so the court dismissed this count without prejudice. 

Third, the failure to warn claim ran headlong into New Jersey’s presumption that FDA mandated drug warnings are adequate.  Antiperspirant spray products are regulated as drugs. The plaintiff did not plead any facts hinting that the defendant should have known, based on newly discovered information, of any link between the antiperspirant and leukemia, or that the defendant deliberately concealed risks. The plaintiff did not cobble together an allegation that any newly acquired information was withheld from the FDA. Thus, the court also dismissed the failure to warn claim, though it did so without prejudice.  

The plaintiff will need to put up or shut up.  One thing is sure (or, given the product at issue, Sure): the lab test results are not enough. We expect this lawsuit to have a brief lifespan.

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When this blogger thinks about the “Big Three” her mind goes to This is Us – Kevin, Kate and Randall.  Admittedly, that’s not the only “Big Three.”  Most people probably go to Great Britain, the United States, and the Soviet Union in World War II.  But that alliance certainly was shorter than the Pearsons.  Now, if you want longevity, ABC, CBS, and NBC are referred to as the Big Three in traditional broadcast television.  Being the Big Three prior to the 1990s might have not seemed like much, but still be considered the Big Three today in a field of over 1700 broadcast television stations in the United States is saying something.  Did you know there is Big 3 pro-basketball league founded by Ice Cube that pits former NBA and international players against each other in 3-on-3 basketball; that it is in its sixth season; and it airs on CBS?  This blogger didn’t.  And finally, if you are into astrology, apparently the Big Three are your sun, moon, and rising signs.  But that is about as far as we are willing to explore that particular trinity. 

So, while in historical, pop, and sports culture Big Three may have varied meanings, in products liability it is set in stone—design defect, manufacturing defect, and warning defect.  That’s what the court had to remind plaintiff in Schulze v. Ethicon, Inc., 2023 WL 2914381 (D. Utah Apr. 4, 2023). 

Plaintiff alleges she was injured following surgical implantation of pelvic mesh.  She brought claims for strict liability and negligence.  Her negligence claims included design defect, manufacturing defect, failure to warn (the Big Three) and “failure to test, inspect, train, study, and conduct adequate post-market vigilance or surveillance.”  Id. at *1.  The Big Four – in accounting maybe, in products liability no. 

During briefing plaintiff withdrew her manufacturing defect claim.  Id. at *4n.1.  That same briefing failed to provide any support for her independent claim of negligence based on a failure to test, study, or train.  Id. at *3.  Utah law recognizes the Big Three.  Other products liability tort claims are either invalid or subsumed within one of the Big Three.  For example, some courts have found that failure to test claims are subsumed under failure to warn.  In other words, if it exists, plaintiff can offer evidence of a purported failure to test, but it would be in support of one of the three recognized negligence causes of action, not it’s own independent claim.    

The court found additional support for the Big Three in the Restatement of Torts (Third) which only defines three activities creating products liability:  “liability for a manufacturing defect due to a defect in design, the manufacturing process, or in a failure to warn.”  Id.at *2 (citations omitted). 

Plaintiff also had a TwIqbal problem.  Her complaint failed to allege facts to plausibly support her failure to test, study, or train claims.  Plaintiff did not allege how defendant failed to test the product or train surgeons or how those failures purportedly caused her injuries.  So, even if recognized under Utah law, they would have been dismissed. 

The court limited plaintiff’s negligence claims to design defect and failure to warn only and denied a request for a second amended complaint.  It’s the Big Three for the win.

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At least try to do something different.

As we discussed before, because his prescription drug warning claims collided with federal preemption, the plaintiff in Roshkovan v. Bristol-Myers Squibb Co., 2022 WL 3012519 (C.D. Cal. Jun. 22, 2022), needed to plead what the FDA didn’t know, not what it did, to avoid dismissal.  His second try wasn’t any better than the first.

Continue Reading When at First You Don’t Succeed…
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This is a guest post by Kelly Jones Howell, of Harris Beach and it’s for a good cause.

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DRI’s Drug and Medical Device Committee will hold its annual Seminar on May 3-5, 2023, at the Hilton New Orleans Riverside, in New Orleans, Louisiana.  The Seminar is a preeminent program for practitioners who represent pharmaceutical and medical device manufacturers. The Seminar will feature a number of nationally recognized attorneys, both in-house and outside counsel, and other professionals, who will address cutting-edge topics that are relevant to all who practice in this area, whether they are associates, lead trial counsel, or in-house counsel.

This year’s program will offer a mixture of presentations, such as trial skills demonstrations, panel discussions and individual presentations from leaders in their practice areas, as well as a Young Lawyers Blockbuster. In addition to the outstanding program, there will be numerous networking opportunities, including a reception aboard the Creole Queen, small group networking/sightseeing tours and exploring New Orleans during Jazz Fest!
Seminar speakers will address key topics such as the latest developments in Rule 702, translating FDA approval into a jury-friendly defense, best practices for managing former employees, improv skills for lawyers, and changes in juror perceptions post-COVID. Those who attend may earn up to 9 hours of CLE, including 1.0 hours of ethics.

You can register for the event here.

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As our loyal readers know, the blog has been keeping a close eye on plaintiffs’ efforts to apply product liability law to software . This is of course an area of keen interest to medical device, software, and tech companies active or entering the digital health space.

The blog’s own Eric Alexander, with Reed Smith co-authors Gerry Stegmaier, Jamie Lanphear, and Michael Rubayo, has now written a very thorough chapter on this subject for the International Comparative Legal Guides’ fourth edition of its Digital Health guide. Titled “Predicting Risk and Examining the Intersection of Traditional Principles of Product Liability Laws with Digital Health,” the chapter is aimed at assisting device manufacturers and software developers in digital health in anticipating, preparing for, and responding to this potentially rapidly changing liability landscape.

Complimentary access to the article is available on ICLG’s website, and you can also download a complimentary PDF from ReedSmith.com.

Drug & Device Resources

Bexis’ Book

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.
Learn more about this book