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On its face, Osos v. Nuvasive, Inc., 2024 WL 3585092 (E.D. Mich. July 30, 2024), is a fairly routine medical implant product liability lawsuit, involving allegations of metallosis that have already been around the block quite a few times in hip implant cases.  Osos involves a somewhat different device, but the legal principles are no different.

But Osos involves Michigan law, and Michigan (as we first mentioned at the end of last year, and discussed more thoroughly here) only recently repealed a longstanding conclusive presumption of non-defectiveness based on FDA drug approvals.  That presumption, which “functionally foreclosed” most product liability claims against, such products, White v. SmithKline Beecham Corp., 538 F. Supp.2d 1023, 1029 (W.D. Mich. 2008), undoubtedly reduced litigation by Michigan plaintiffs.  See Our “Michigan Diaspora” post.  The repeal will equally undoubtedly cause Michigan prescription medical product litigation to rebound.

Continue Reading Possible Learned Intermediary Showdown in Michigan
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Today we discuss an excellent express preemption decision from the District of Arizona, Skinner v. Small Bone Innovations Inc., 2024 WL 3639296 (D. Ariz. Aug. 2, 2024).

This decision involved the Scandinavian Total Ankle Replacement device (“STAR”).  The STAR® Ankle is a Class III medical device subject to the Medical Device Amendments’ express preemption provision, 21 U.S.C. § 360k(a).  This was Plaintiff’s second bite at the apple:  The Court had already granted Defendants’ motion to dismiss but with leave to amend to attempt to state a parallel claim.  See Skinner v. Small Bone Innovations Inc., No. CV-23-01051-PHX-MTL, 2023 WL 6318014, at *6 (D. Ariz. Sept. 28, 2023).  After striking out in round one, Plaintiff fared no better in round two.

Continue Reading Slam-Dunk Express Preemption Decision from the District of Arizona
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We are unabashedly pro-science.  In our cases, we are usually on the side of good science against bad or no science.  In discussing large-scale product liability litigation, we have said many times how bad science and the risk of attendant litigation can negatively impact the development of new products.  Even if we were so naïve as to believe that good science always wins out in product liability litigation, it is clear that misleading legal advertising and uncritical media coverage can spread and emphasize bad science to the detriment of public health.  The FTC noted as much in 2019 when it took minimal steps to limit “deceptive” and “unfair” advertising from certain “legal practitioners and lead generators . . . that solicit clients for personal injury lawsuits against drug manufacturers.”  (If you think a government action from five years ago is ancient history, then just wait for the rest of the post.)  Of course, product liability litigation is not the only kind of litigation against medical product manufacturers that often relies on bad science and unscientific conclusions.  False Claims Act litigation can not only be high stakes, but it can take years to get from the filing of a sealed complaint by a relator to an ultimate conclusion.

When we think of litigation involving vaccines, a couple of things come to mind.  The first is how the widespread use of childhood vaccines was one of the great successes of science in the 20th century.  For instance, before the availability of vaccines for measles, mumps, and rubella, combined for decades into the “MMR” vaccine, many thousands died annually in the U.S. from these viruses and many multiples more were hospitalized or suffered permanent disabilities such as deafness from them.  Until some recent anti-science-driven drops in vaccination rates, serious complications from these diseases had become exceedingly rare in the U.S.  The second thing we think about with vaccine litigation is how the Childhood Vaccine Act created an alternative system for compensation for alleged vaccine-related complications for “table” vaccines such as MMR.    The flip side is that, under Bruesewitz, many product liability claims involving vaccines will be preempted.  We do not usually think about the False Claims Act with regard to vaccines, in part because the U.S. government, which has to receive a claim for payment to trigger the FCA, is so heavily involved with the common vaccines administered to children in the U.S.

Much like civil RICO and state consumer protection statutes, the FCA is widely overused by plaintiffs and plaintiff lawyers who initiate suits about medical products.  These suits routinely assert that FDA was somehow misled in fulfilling its regulatory function.  Because of the risk that the government will intervene in a case brought by a relator and the possibility that an adverse judgment will result in a bar from participation in government reimbursement programs, these cases present the manufacturer with the choice of settling for too much or expending significant resources in fighting this particular variant of blackmail.  While some FCA relators are legitimate whistleblowers relying on non-public information to expose a real issue, many more are anything but.  In U.S. ex rel. Krahling v. Merck & Co., Inc., No. 23-2553, 2024 WL 3664648 (3d Cir. Aug. 6, 2024) (unpublished), the relators did report information about an alleged impropriety to FDA back in 2001 and one of their counsel firms is named Whistleblower Partners, but the case itself seemed like a giant waste of time and resources particularly in light of the purpose of the old Lincoln Law.

Doing our best to summarize the highly technical stuff without misrepresenting it, the case involved certain lots of the MMR vaccine that may or may not have been purchased by the CDC before February 2000 and that FDA-approved labeling describing shelf-life and potency that were theoretically overstatements for some doses within those lots.  FDA was well-aware of the issues in with these lots based on an inspection and back-and-forth with the company in 2000 and 2001.  2024 WL 3664648, *2.  The FDA was also aware of the issue the relators raised in 2001, which related to the conduct of a clinical study (started before the lot issues) to change the label in relation to end-expiration potency.  Id. at *3.  So, the non-public information the relators had back in 2001 had at best a tangential relationship to the alleged falsity of the claims for payment from CDC.  Instead, the alleged falsity was based on information obtained in a decade of discovery about preliminary data from lot testing that had not been shared with FDA during the back-and-forth that resulted in the inspection observations being closed in April 2001 without adverse regulatory action.  What does any of that FDA history have to do with CDC’s decision to buy MMR vaccine from the company that was, at the time, the only manufacturer of an MMR vaccine approved in the U.S.?  Preciously little.  To link things up, plaintiffs would have had to allege that the vaccine was only on the market when CDC maybe bought some of the affected lots.  But plaintiffs did not allege any fraud on FDA, perhaps because that might have implicated the primary jurisdiction doctrine.  (Preemption applies to state law claims and the FCA is federal.)

In April 2010, nine years after the events above, plaintiff sued the manufacturer based on the claim that it misled the CDC.  After two years, the U.S. declined to intervene and the complaint was unsealed.  Over the next seven years, plaintiffs burdened not just the defendant but the government with discovery, only to turn up no evidence that CDC was misled by anything that the manufacturer allegedly misrepresented to or withheld from the government.  In FCA parlance, this is an issue of materiality, the standard for which the Supreme Court addressed a few years ago in Escobar.  The nine years that the case lingered until the defendant was able to move for summary judgment worked to the plaintiffs’ detriment, because they had insisted that FDA and CDC be informed of their allegations and evidence along the way.  Once the district court decided summary judgment, it had to look no farther than the lack of materiality to get rid of the case in a decision that was an honorable mention for our ten best list last year. 

Because a decision from a circuit court, even unpublished, carries more weight and because the appellate court’s review was de novo, Krahling merits a look.  Like the court below, the Third Circuit needed only to address materiality to conclude that the plaintiffs failed to establish a prima case.  In fact, none of the factors identified in Escobar supported that any purported misrepresentation or omission by the manufacturer was material to CDCs decision to purchase the only approved MMR vaccine.  First, there was no identified representation that was a condition of payment.  CDC did have conditions of payment, but they were all met even under plaintiffs’ view of the facts.  Id. at *7.  The plaintiffs’ allegations about vaccine potency and shelf life being misrepresented did not matter because the CDC did its own real-world research on efficacy and required a shelf life that was not longer than the alleged shortened shelf life indicated by the testing on the lots with potency issues.  Id.  Second, the identified alleged misrepresentations were minor and insubstantial given that CDC made its purchasing decisions based on advisory committee that did not rely on the alleged misrepresentations.  Third, the government did not change its practices upon learning the information at issue.  FDA knew about both issues identified by plaintiff back in 2001 and DOJ, CDC, FDA, and HHS knew about everything plaintiffs said mattered—in part because plaintiffs insisted on it.  Yet, CDC has never changed its purchasing practices or its position that the vaccine is effective, even once another MMR vaccine became available.  Id. at *8.

So, absent an unlikely reversal by the Supreme Court, the plaintiffs’ case is finally gone after a mere fourteen years.  The core issue was lots of an essential vaccine made more than twenty-four years ago that may have never resulted in doses lacking in potency being available for use after purchase by CDC.  Given the burden on the manufacturer and the U.S. government and the lack of any real public harm to redress, even if plaintiffs had been right about some aspect of the claims for payment from CDC for the vaccine being false, it does not seem like a good use of resources.  Perhaps such a case will not be allowed to linger so long and get so much leeway before getting kicked.  Deterring lawsuit abuse with sanctions, however, might be too much to expect.

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We are in the midst (at least we hope we are that far) of wrapping up an MDL settlement. As is typical, the settlement envisions a minimum participation rate  After all, why would a client fling a fat wad of cash at plaintiffs’ counsel, only later to fling not-quite-as-fat-wads at their own counsel to continue litigating an MDL that was supposedly put to rest?  The idea is to buy peace, not to subsidize adverse litigation.  Sadly, and, again, as is typical, now we hearing that hitting the participation rate might be hard because a considerable number of the plaintiffs cannot be found. Oh, and now it seems that plenty of those plaintiffs who can be found cannot find any proof of usage or injury. 

It is hard for us to resist hurling a great, big told-you-so at the court.  We knew the inventory was chock full of garbage.  We mentioned that more than once.  The judge and special master rolled their eyes. Just settle, they told us.  Just handle the inevitable infirmities on the back end, they told us. Of course, we would never have the temerity to complain to the court about how its refusal to vet cases early on led to this farce.  But maybe someday we will write an article about it.  Or a blogpost. 

How do plaintiff lawyers misplace their clients?  Sometimes plaintiffs move.  And sometimes they move on to the afterlife. When that happens, there is usually a requirement that their lawyers file a suggestion of death and substitute in a new plaintiff. That shouldn’t be so hard, right?  You’d be surprised. Or maybe, if you’ve been in this business a while, you wouldn’t be surprised at all. 

In the Bair Hugger MDL, plaintiffs’ counsel did not file timely suggestions of death under either the relevant pretrial order (PTO) or under the Fed. R. Civ. P. 25.  Indeed, it was the defendant who notified plaintiffs’ counsel of the deaths.  Nonetheless, plaintiffs opposed dismissals as a result of their own defaults. The plaintiffs asked for an extension of PTO 23’s 90 day deadline for filing a suggestion of death. The district court refused to amend the deadline, but acknowledged it might excuse tardiness where compliance was impossible or where plaintiffs’ counsel demonstrated diligent efforts.  

In the meantime, the district court granted summary judgment to the defendant (on substantive grounds not relating to the suggestion of death issue) and poured the plaintiffs out of court.  But then the Eighth Circuit reversed. The case came back to the district court. The parties agreed on a new schedule under PTO 23. 

And then would you believe that there were still cases where no timely suggestion of death was filed?  Yes, of course you would.  You would believe that because you are obviously intelligent (you are, after all, reading this blog), you probably have a J.D. degree, and you are a sentient being.  

The issue in In re Bair Hugger Forced Air Warning Devices Prods. Liab. Litig., 2024 U.S. Dist. LEXIS 138077 (D. Minn. Aug. 5, 2924), was whether the court would dismiss cases in which suggestions of death and/or motions to substitute parties had not been timely filed.  The answer, gladdening our flinty defense hack hearts, was mostly yes.  

The plaintiffs first tried and failed to eliminate the deadline entirely.  Under PTO 23, the deadline is excused for “detailed diligent & good faith efforts to comply.”  The court had the power to dismiss for violations of the PTO.  The plaintiffs are not entitled to ignore the deadline generally, either for lack of prejudice or generalized excuses.  The Bair Hugger court reasoned that the PTO 23 deadline was designed to “obligate counsel to ascertain whether or not their clients are alive and, if necessary, move for substitution. The process prevents deceased plaintiffs from populating and inflating the MDL docket and allows the Court and Defendants to know the true size of the MDL. This ultimately prevents court congestion and undue delay in resolving the MDL. These benefits justify dismissing plaintiffs who willfully disobey PTO 23.”  

The Bair Hugger court sounded a little exasperated with the plaintiffs’ shenanigans.  More to the point, it sounded ready to enter some dismissals.  

But before the court could do so, it first had to deal with further plaintiff shenanigans.  The plaintiffs contended that PTO 23 was unconstitutional in requiring plaintiffs’ counsel to contact next of kin, due to lack of representation of the next of kin.  To call that argument sophistry is to give it too much credit.  That reasoning, if you can call it that, would make the entire rule (both the federal rules and the PTO) toothless and let suggestions of death pend indefinitely.  The Bair Hugger court rejected the constitutional argument.  

Then the court got down to specific cases.  There were various permutations of nonfilings and late filings. And there were various forms of weak excuses, along the lines of the dog ate my homework, or the sun was in my eyes, or lawyering is hard. The court dismissed several individual cases for lack of any good cause for plaintiffs’ failure to file suggestions timely, or alternatively, untimely motions to substitute, or in many cases both.  That “nothing was happening” in the cases was not enough.  Periodic newsletters did not suffice.  

This order by the Bair Hugger court provides yet another example of plaintiffs’ counsel failing in MDLs to do even the absolute minimum to keep cases active.  One case was dismissed where the plaintiff died before the initial complaint was filed.  That sort of thing prompts a rueful shake of the head.  It is nonsense. But MDLs are often vast piles of nonsense. At least in the Bair Hugger case, it appears that the district court had run out of patience for such nonsense. 

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One of those experts was plaintiff himself—an emergency room doctor with a law degree.  We all know what they say about lawyers who represent themselves.  And that applies equally to doctors who try to act as their own causation experts.  Add to that destructive testing after telling defendant no product existed and four more unreliable experts, and you’ve got all you need for summary judgment.

This case is about certain of defendant’s aerosol sunscreens that were recalled, “out of an abundance of caution,” due to testing revealing “low levels of benzene” in sampled product.  Plaintiff claims he used defendant’s sunscreens every week for ten years and at least some of what he used was subject to the recall.  De Los Santos v. Johnson & Johnson, 2024 WL 3700205, *1 (N.D. Ala. Aug. 7, 2024).  The lawsuit blames this alleged benzene exposure for plaintiff’s lupus, Crohn’s disease, low blood cell counts, atrial fibrillation, bone marrow dysplasia, dysmegakaryopoiesis, and potentially hyperparathyroidism. 

In discovery, defendant requested that plaintiff identify the sunscreen he used, describe any tests conducted on the products at issue, and to produce all sunscreen containers still in his possession “whether or not [any such] containers contain any residual” sunscreen.  Id. at *2.   In verified interrogatory responses, plaintiff stated that he had “six empty containers.”  He did not produce them to defendant and he did not supplement his discovery responses.  Five months later, plaintiff retained an expert to perform destructive testing on the residual contents of those containers to determine the presence of benzene.  Id. at *3.  A month later, during a court teleconference, defendant learned for the first time that the “empty” containers had in fact not been “completely empty” and that the contents had undergone destructive testing.  Defendant sent three separate letters to plaintiff requesting the sunscreen containers.  When they were ultimately produced, defendant’s own experts determined there was not enough residual content to perform their own testing.  Id. 

Against this background, the court conducted a thorough spoliation analysis and concluded plaintiff acted in bad faith when he destroyed critical evidence through destructive testing, substantially prejudicing defendant and requiring sanctions.  Id. at *7-9.  While bad faith requires more than mere negligence, the conduct does not need to be malicious.  Here, not only did plaintiff have a duty to preserve the evidence, but defendant had requested it six months earlier.   Plaintiff served “incomplete or misleading discovery responses” and offered no excuse for failing to correct or supplement his responses—an obligation that was triggered at the latest when plaintiff became aware that there was enough residual sunscreen to allow testing to be done.  Far from a case of inadvertently lost evidence, “plaintiff ignored defendants’ requests to produce key evidence and allowed that evidence to be destroyed.”  Id. at *7-9.  Plaintiff used the testing he conducted to support his expert testimony, but defendant was precluded from conducting confirmatory tests.  “Such one-sided conduct fails to promote confidence that the process has uncovered the truth.”  Id. at *10 (citation omitted).

In deciding between the minimal sanction of excluding the test results and the most severe sanction of dismissal, the court found the choice “illusory.” 

Plaintiff’s claims require expert causation testimony, and his experts’ causation opinions all rely on the results of the [destructive] testing; thus, excluding the test results and the expert opinions relying on them results in the dismissal of Plaintiff’s claims.

Id. at *11.  While the court concluded that plaintiff’s behavior warranted dismissal, it went on to explain how plaintiff’s case failed even if it imposed the lesser sanction of preventing plaintiff from using the ill-gotten evidence. 

In a chemical exposure case, plaintiff must prove:  the chemical is capable of causing the alleged injuries (general causation); plaintiff was exposed to the chemical; he was exposed to enough to cause his injuries (toxic dose); and his exposure in fact caused his alleged injuries (specific causation).  Id. at *5.  So, the first fatal defect in plaintiff’s case is that with the exclusion of the test results, plaintiff had no evidence that he was exposed to any benzene from defendant’s sunscreen.  Id. at *12. 

But each of plaintiff’s experts had his/her own additional deficiencies.  For example, while plaintiff claimed to be an expert in “every area of medicine,”

he became an expert in benzene exposure after filing suit, despite having already concluded that benzene caused his medical issues upon [defendant’s] recall announcement—before filing suit.

Id. at *13.  This sort of “conclusion-oriented process” is not a reliable scientific methodology admissible under Rule 702.  Moreover, the only methodology he claimed to use was a differential diagnosis, but plaintiff started his differential diagnosis with an unsupported assumption that benzene exposure is capable of causing his alleged injuries and jumped from there to claiming benzene must be the cause for all his conditions because “coincidences” in medicine are rare.  Id. at *16.  Notably missing from plaintiff’s differential diagnosis is the core element of ruling out other possible causes, including idiopathic causes.  Id.  at *16. 

None of plaintiff’s other experts were any better.  Plaintiff proffered a radiation oncologist to testify that his conditions were not caused by radiation treatment, but then she over-reached by also opining that benzene was the likely cause.  Nor did this expert apply any reliable methodology, basing her opinions on the temporality of the diagnosis and alleged exposure.  Id. at *17.  Plaintiff also offered the opinion of his treating oncologist on causation.  This expert admitted that whether benzene is toxic is a “dose-dependent.” But he did not know the dose required to cause plaintiff’s injuries, the dose plaintiff was exposed to, and he did not perform a exposure analysis which he conceded he was unqualified to do.  Id. at *18.  This expert also tried to bolster his opinion by claiming that plaintiff absorbed benzene levels from defendant’s sunscreen at levels “exceeding federal limits.”  Even if the expert knew plaintiff’s exposure, which he does not, “regulatory agencies conduct risk-utility analyses involving a much lower standard than that which is demanded by a court of law.”  Id. at *19 (citations omitted).  In other words, exceeding regulatory limits has no bearing on the causal relationship between the chemical and the alleged injuries.

Plaintiff’s third additional expert was qualified to conduct exposure modeling to determine plaintiff’s total cumulative dose of benzene exposure—but he did not do so because he was not asked to.  Id. at *21.  That is not where this expert’s honesty ended.  At his deposition he conceded that on the “thin record” he had and without any evidence of dose response, “he could not opine that plaintiff’s alleged benzene exposure cause any disease.”  That left only the expert who conducted the destructive testing whose testimony was excluded as a spoliation sanction. 

Because plaintiff had no admissible expert evidence on general or specific causation or the toxic dose, plaintiff could not meet his burden and defendant was granted summary judgment.    

Congratulations to Robyn Maguire (Barnes & Thornburg) and the team of Nadine Kohane, Sarah Brown and Kaleb Gorman for this great win and excellent decision.

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By now everyone should be well aware of the amendments to Fed. R. Evid. 702, which became effective in December, 2023.  Last December we wrote a blogpost, “New Fed. R. Evid. 702 − Use This Stuff To Update Your Briefs,” with a collection of useful materials for litigators to prepare to take maximum advantage of the amended rule.  These included relevant excepts from not only the Committee Note explaining the 2023 amendments, but also from the Civil Rules Committee’s “Agenda Books” compiled during the amendment process concerning the widespread “incorrect” interpretations of prior Rule 702 that prompted the amendments.  The blogpost also included decisions addressing the precedential value of this committee material.

Now we have some more good stuff for you.  First, in May we blogged about Sprafka v. Medical Device Business Services, Inc., 2024 WL 1269226 (D. Minn. March 26, 2024).  As we noted, Sprafka was a final judgment and was likely to be appealed.  It has − to the Eighth Circuit, which was one of the most problematic courts under the prior rule.  On July 16, the Lawyers for Civil Justice – one of the organizations that most strongly advocated for the 2023 amendments – filed a thorough and persuasive amicus curiae brief in Sprafka, written by friend-of-the-Blog Lee Mikus.  The brief includes much of what was in our earlier blogpost, and more, and does so in rigorous, formal briefing style, as opposed to my breezier blog presentation.  Here are the relevant argument headings from LCJ’s Sprafka brief:

  • The Eighth Circuit Should Clarify That Federal Rule Of Evidence 702 Governs The Admissibility Of Expert Testimony.
  • Rule 702, Not Caselaw, Establishes the Admissibility Standard
  • Rule 702 Was Amended to Reject the Gatekeeping Characterizations that Plaintiff and the District Court Repeat
  • Plaintiff’s Interpretation of the Courts’ Gatekeeping Role Rests on Caselaw That Does Not Comport with Rule 702
  • The Rule 702 Factors Are Admissibility Determinations Courts Must Decide
  • Rule 702 Does Not Prefer Admission Over Exclusion
  • Admitting Opinion Testimony Under Rule 702 Requires an Affirmative Showing that the Rule’s Criteria Are More Likely Than Not Met

A second new, useful compilation is the published article, Eric Lasker & Joshua Leader, “New Federal Rule of Evidence Rule 702:  A Circuit-by-Circuit Guide to Overruled ‘Wayward Caselaw.’”  This article compiles, in circuit-by-circuit fashion, federal Rule 702 decisions from the bad old days that can now be challenged as “incorrect” applications of the Rule, according to the standards of the amended rule.  This reference will be helpful in spotting at a glance whether our opponents are relying on caselaw that is no longer valid (assuming it ever was) after December, 2023.  Or, as the article’s authors summarize its purpose:

While the product of extensive work and analysis, this guide is not exhaustive – the decades of judicial defiance of the Rule’s admissibility requirement would make any such effort unattainable.  And of course, practitioners using this guide must use their own judgment in explaining to courts why the identified decisions should no longer be followed.  But – we hope – the guide provides a quick reference that will help relegate this wayward caselaw to the dustbin of legal history and clear the field for the proper application of Rule 702 moving forward.

Circuit-by-Circuit Guide, at 5.

Finally this article, Erin Sheley, “Courts Must, As Recently Reminded, Follow The Law In Rule 702 Expert Testimony Determinations,” published in the Mealey’s Daubert (don’t say that) Report, contains useful recent Rule 702 case law, and some policy arguments, for helping courts get the amended Rule 702 right this time.

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The Vermont Supreme Court correctly applied the PREP Act last week to dismiss state-law claims arising from a COVID vaccine.  See Politella v. Windham Southeast School Dist., No 23-AP-237, 2024 WL 3545717 (Vt. July 26, 2024) (to be published in A.3d).  This was an easy case, and the PREP Act (aka the “Public Readiness & Emergency Preparedness Act”) is a remarkably straightforward federal statute supported by a clear and important public policy—to ensure the availability of effective countermeasures in the event of public health emergencies. 

So why is this case blogworthy?  Because while many courts have gotten the PREP Act right, a number of others have quizzically refused to apply it, allowing claims to proceed that should never have seen the light of day.  The worst offender is the Third Circuit, which essentially rewrote the statute to make an “exclusive” federal claim nonexclusive.  Then there was the California plaintiff who alleged that COVID medication resulted in wrongful death, a claim that the PREP Act squarely headed off.  The court allowed it because the plaintiff labeled the claim “fraudulent concealment.”  The only explanations for these orders are the general hostility that many courts display toward federal preemption and pro-plaintiff sentiment in cases with sympathetic facts.  We understand the latter, but you know what Justice Holmes said about hard cases.

The Vermont Supreme Court got it right.  To recap, Congress enacted the PREP Act in 2005 to encourage and protect the supply of countermeasures against public health emergencies, such as COVID-19.  The Act creates an administrative remedy for allegedly injured individuals, and it grants covered persons immunity from civil liability in connection with countermeasures, like vaccines.  There is only one exception:  The PREP Act provides “an exclusive Federal cause of action against a covered person for death or serious physical injury proximately caused by willful misconduct.”  42 U.S.C. § 247d-6d(d)(1) (emphasis added).  (You can see our PREP Act Preemption Scorecard here, and we gave you a more complete PREP Act primer here.) 

The Politella case in Vermont involved a COVID vaccine clinic set up in a school.  In a case of mistaken identity—the school allegedly put a name tag with the wrong name on a six-year-old—a student was vaccinated without parental consent.  Politella, at *1.  The child was not harmed, but the parents were upset and sued the State, the school district, the school, the principal, the school nurse, and everyone else in sight, alleging claims under Vermont state law. 

The PREP Act preempted all the state-law claims against all the defendants.  First, all the defendants were “covered persons” under the Act.  The plaintiffs cast a wide net, but the Act defines “covered persons” broadly, too.  It includes “Program planners,” which means “a State or local government, . . . a person employed by the State of local government, or other person who supervised or administered a program with respect to the administration . . . of a security countermeasure or a qualified pandemic or epidemic product.”  Id. at *3.  That covered all the defendants and not just the person who happened to roll up this particular student’s sleeve. 

Second, the claims were “causally related” to the vaccine’s administration.  In addition to the actual administration of the vaccine, the plaintiffs faulted the defendants for removing the student from class and mishandling consent.  But all of that was related to the vaccine and the vaccine program, such that the plaintiffs “have alleged only tortious conduct that is causally related to the administration of the vaccine.”  Id. at *4. 

Third, the vaccine was clearly a covered countermeasure (which the plaintiffs did not dispute).  And fourth, the Secretary of Health and Human Services had definitely declared COVID a health emergency in March 2020.  The plaintiffs emphasized that Vermont had not declared a public health emergency before their child was vaccinated, but that was irrelevant:  “True or not, this observation is immaterial. Nothing in the PREP Act turns on whether a state declaration is in effect.”  Id. at *6. 

Perhaps most notably, the plaintiffs cited authorities limiting or rejecting PREP Act preemption (see, e.g., wrongfully decided cases referred to above), and the Vermont Supreme Court distinguished and rejected them.  The PREP Act preempts all claims against covered persons, including state-law claims and not only claims for willful misconduct.  As the court noted, the PREP Act contains an express preemption provision, and “[o]ther state courts faced with similar facts have concluded that state-law claims against immunized defendants cannot proceed in state court in light of the PREP Act’s immunity and preemption provisions.”  Id.

These plaintiffs had two choices:  File an administrative claim under the PREP Act or file a lawsuit in federal court alleging willful misconduct.  They chose neither.  Case dismissed.  Easy. 

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As regular blog readers know, we love a clean grant of a motion to dismiss on preemption grounds.  They are relatively common, so it sometimes puzzles us that the plaintiffs’ bar keeps filing plainly preempted claims.

Perhaps some of these plainly preempted lawsuits get filed because the express preemption provision of the FDCA related to over-the-counter (“OTC”) medicines is somewhat less well known than the express preemption provision related to Class III, premarket approved medical devices. 

Whatever the reason, it is not unusual for plaintiffs to run to court with a putative economic loss class action attacking some aspect of an OTC drug:  its marketing or labeling, which allegedly deceived consumers; or the drug’s price, which allegedly should be partly or fully reimbursed for some reason, perhaps because the drug allegedly was less safe or less efficacious than represented.  And then a motion to dismiss gets filed, and far more often than not, those plaintiffs get promptly bounced back out of court due to OTC preemption.

To recap,  OTC medicines have an express preemption provision, 21 U.S.C. § 379r(a), providing that:

[N]o State or political subdivision of a State may establish or continue in effect any requirement −

(1) that relates to the regulation of a drug that is not subject to the requirements of [prescription drugs] of this title; and

(2) that is different from or in addition to, or that is otherwise not identical with, a requirement under this chapter [of the FDCA]. . . .

21 U.S.C. § 379r(a)(1). 

Unfortunately, OTC express preemption doesn’t reach personal injury/product liability claims, but—relevant here—it does apply to claims for fraud, consumer fraud, breach of warranty and the like. 

The putative class in Musikar-Rosner v. Johnson & Johnson Consumer Inc., No. 23-cv-11746-ADB, 2024 U.S. Dist. LEXIS 135171, 2024 WL 3596897 (D. Mass. July 31, 2024), sued over the defendant’s marketing of its OTC acetaminophen gelcaps as “rapid release”.  Like some plaintiffs before them, the putative class plaintiffs in Musikar-Roener contended the gelcap’s rapid release just wasn’t fast enough, and they sought recovery using claims for violation of Massachusetts General Laws Chapter 93A, breach of implied warranty of merchantability under Mass. Gen. Laws ch. 106, § 2-314, breach of express warranty under Mass. Gen. Laws ch. 106, § 2-313, unjust enrichment, and declaratory relief.

We always are heartened when a discussion of express preemption begins with the recognition that there is no presumption against preemption when Congress has expressly declared state law to be preempted, and that is how the analysis began in Musikar-Roener:

“In determining whether federal preemption applies, courts must start with the assumption that the historic police powers of the States were not to be superseded by the Federal Act.”  However, “where . . . [as in the instant case], Congress has expressly manifested its intent to preempt state law, no presumption against preemption arises.”  In such circumstances “[w]here a federal statute contains a clause expressly purporting to preempt state law, ‘[the Court] focus[es] on the plain wording of the clause, which necessarily contains the best evidence of Congress’ preemptive intent.’”

Musikar-Rosner, 2024 U.S. Dist. Lexis 135171, at *6 (citations omitted).  Rightly so.

With the presumption against preemption out of the way, the Musikar-Rosner judge turned to whether, and what, federal requirements applied to this OTC drug, and whether the state law claims would impose requirements different from, in addition to, or not identical with, those federal requirements.

On the federal requirement side of the equation, the FDA regulates OTC drugs through monographs, “which establish the parameters or conditions under which certain categories of OTCs may be marketed.”  The monograph system sometimes is a bit clunky.  It starts with notice of proposed rulemaking, then a “tentative final monograph”, prepared by an advisory review panel and published by the FDA for public review and comment.  Sometimes, the process stalls at this point for years (and years); sometimes the agency pushes ahead and promulgates a “final monograph” by publishing it in the Code of Federal Regulations.

The OTC regulatory history for acetaminophen and related medicines reflects some of that clunkiness, and a fair amount of rule-making activity by the FDA.  Most relevant for purposes of Musikar-Rosner, the FDA published a tentative final monograph (or “TFM”) in 1988 entitled the “Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use; Tentative Final Monograph.”  This TFM established the conditions under which OTC acetaminophen drug products are “generally recognized as safe and effective and not misbranded” and it incorporated a standard from the United States Pharmacopeia (“USP”) defining “immediate release” acetaminophen tablets as those dissolving by at least 80% in 30 minutes.

Then, Congress stepped in and itself moved the regulatory process along by deeming this tentative final monograph (and some others) to be a final administrative order in March 2020, via the COVID-19 pandemic-era Coronavirus Aid, Relief, Economic Security (“CARES”) Act.

Given the FDA’s monograph was a final order establishing federal requirement for OTC acetaminophen, the existence of federal requirements with preemptive effect would seem to be pretty darn obvious.

The plaintiffs, however, contended the monograph did not impose any federal requirement regarding “rapid release gelcaps” products in particular.  The Court disagreed. 

First, the monograph applied to acetaminophen tablets, and gelcaps were, by definition, gelatin-coated, capsule-shaped tablets, so plaintiffs’ argument there was no federal “gelcap” standard was unavailing.  Next, the monograph also set standards for tablet dissolution generally, so arguing there was no federal “rapid release” standard also was unavailing.   

The bottom line, the court found, was that the FDA had set federal standards, and the Musikar-Rosner plaintiffs’ claims were “different from or in addition to, or … otherwise not identical with” those federal standards.  Preemption applied, the defense motion to dismiss was granted, and another set of plaintiffs was promptly booted out of court.  Just the kind of result we like to see.

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We are not speaking for anyone else (clients, colleagues, our firm, etc.)  when we say that drug and device product liability cases should be patterned after the Vaccine Act (42 U.S.C. Section 300aa-1 et seq.).  It is faster, fairer, more predictable, and cheaper for everyone.  From the defense side, we like that actions under the Vaccine Act will not be decided by runaway juries.  And we suppose that is the main reason why plaintiff lawyers abhor the Vaccine Act and do whatever they can to avoid it.

In re Gardasil Products Liab. Litig., 2024 U.S. Dist. LEXIS 135736 (W.D. N.C. July 31, 2024), is a multidistrict litigation (MDL) that should never have existed. In this recent decision, yet another plaintiff effort to sidestep the Vaccine Act compensation system failed.  To our jaundiced, defense hack eyes, it appears that this is an entirely predictable instance of a vast plaintiff MDL client solicitation dredging up stale plaintiffs. The problem for the four plaintiffs at issue here is that filing a Vaccine Act claim in “Vaccine Court” is a prerequisite to any subsequent civil suit.  “[N]o one may bring ‘a civil action for damages’ against a vaccine manufacturer ‘for damages arising from a vaccine-related injury” unless she has first timely filed and exhausted a petition for compensation in the U.S. Court of Federal Claims.” You noticed that word “timely,” right?  One of the four plaintiffs never filed a claim in Vaccine Court at all, while the other three plaintiffs filed belated petitions with the Vaccine Court, which were thrown out on timeliness grounds.  The Vaccine Act requires that a petition for compensation must be filed within 36 months of “the date of the occurrence of the first symptom or manifestation of onset or of the significant aggravation of [a vaccine-related] injury.”

The plaintiff who never filed a claim in Vaccine court ended up giving up, and did not respond to the defendant’s motion to dismiss the MDL claim.  Adios. The other three plaintiffs did not go down without a fight.

To avoid the defense motions to dismiss, the three plaintiffs who had been bounced from the Vaccine court on timeliness grounds collaterally attacked the Vaccine Court judgments dismissing their cases. They also made the inevitable request for relief under a discovery rule, and made weak equitable tolling arguments that involved only general allegations with no direct contact between the defendant and the plaintiffs. 

The MDL court rejected the collateral attack on multiple grounds.  First, as a matter of procedure, the MDL court held that it had no power to second guess the Vaccine Court’s decision.  “[T]he decision as to the application of the Vaccine Act’s limitations period to petitioners in the Vaccine Court is properly decided by those Special Masters.”  Nothing in the Vaccine Act empowers courts in subsequent civil actions to review Vaccine Court decisions.  The plaintiffs pushed hard for de novo review. But they are separate proceedings.  Moreover, the MDL court reasoned that Vaccine Act timeliness should not turn on the vagaries of different states’ laws. In any event, there is no mechanism whereby a reviewing district court could remand a case to Vaccine Court.  All of which suggests that a collateral attack on Vaccine Court decisions is simply unavailable.

What the plaintiffs were really seeking here was a way to bypass the Vaccine Court altogether, in ex post facto fashion.  The MDL court was not having that. 

Then the MDL court did something smart.  After holding that it could not review the Vaccine Court’s determinations of untimeliness, it held that it would sustain the untimeliness finding even if it did conduct such a review.  The discovery rule does not apply to the Vaccine Act.  Then the court held that there were no circumstances external to the plaintiff’s own conduct that could justify tolling.  There was no showing of diligence and extraordinary circumstances.  Instead, the plaintiffs’ equitable tolling argument was premised on non-individualized, vague allegations of “fraud” and “concealment.”  In essence, the equitable tolling argument merely repackaged the discovery rule arguments under another name. “In sum, even if the Court were empowered to decide the issue of ‘equitable tolling’ de novo, it would reach the same conclusion that the Plaintiffs’ Vaccine Court petitions were untimely and dismiss their claims on that basis.”  Now, even if there is an appeal to the Fourth Circuit, and even if the Fourth Circuit disagrees with the determination of unreviewability, it can still affirm the dismissals.  

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This is our second go round with Vardouniotis v. Pfizer, Inc., Case No. 152029/2019 (N.Y. Sup.).  When we posted about the court’s decision on defendant’s motion to dismiss, we were resigned to shrug our shoulders and accept that “nothing’s perfect.”  It’s two years later and we’re still shrugging.

After the court allowed plaintiff’s negligence; gross negligence; willful, wanton and malicious misconduct; breach of implied warranty; and unjust enrichment causes of action to proceed, fact and expert discovery moved forward, including the production of plaintiff’s voluminous medical records.  Vardouniotis, 2024 WL 3345021, *4 (N.Y. Sup. Jul. 8, 2024).  Plaintiff claimed her 11-day use of Chantix caused her to develop a movement disorder.  The opinion details the treatment plaintiff sought for this condition including seeing ten different neurologists and undergoing multiple diagnostic tests like MRIs, EEGs, EMGs, and nerve conduction studies—none of which found a neurological basis for plaintiff’s abnormal movements.  Id. at *1-2.  Nor did any of plaintiff’s treaters diagnose a cause for plaintiff’s abnormal moments other than psychogenic or malingering.  Id. at *2.  Except one—the one she sought out because he had co-authored an article reporting two cases of movement disorders after use of Chantix.  The one who became plaintiff’s only causation expert.    

On general causation, plaintiff’s expert’s theory was that Chantix caused “excessive dopamine transmission” that can result in movement disorders.  Id. at *9.  His opinion was based on three studies, but none “draw a causal connection between” Chantix and any movement disorders.  Two of the studies do not address plaintiff’s claimed injury, and the third is about the risks of dopamine release caused by smoking, not by Chantix.  Id.  Moreover, “proof of a risk, even an increased risk, does not constitute proof of causation.”  Id. 

Plaintiff’s expert had “no controlled clinical studies, epidemiological data, or peer reviewed studies demonstrating a causal link” between defendant’s drug and any movement disorder.  Instead, he relied on five case reports.  However, “case reports are not generally accepted in the scientific community on questions of causation.” Id.   Indeed, three of the case reports here were “circumspect regarding causation,” and another attributed the patient’s movement disorder to stopping smoking, not to the effects of Chantix.  Id. at *10.  Finally, plaintiff’s expert cited an article summarizing post-market adverse event reports.  But the article itself did not reach any causation conclusion and specifically warned that “adverse event reports in themselves do not establish a causal link to the drug.”  Id.  Therefore, plaintiff’s general causation evidence was not based on a generally accepted methodology and was excluded. 

While the court’s ruling on general causation disposed of plaintiff’s expert’s specific causation opinion as well, the court conducted a separate specific cause analysis.  To reach his specific cause opinion, plaintiff’s expert relied on his own treatment and examination of plaintiff, and the medical records and testimony of her primary care doctor and her pain management doctor.  He chose not to review the medical records of the nine other treating neurologists, her multiple diagnostic tests, her numerous emergency room visits and hospitalizations, or any of her other medical providers.  Id. at *11.  All records that largely question whether plaintiff actually has any injury at all.  He disregarded “numerous and repeated notations by various treatment providers linking the plaintiff’s complaints of abnormal movements, and her efforts to obtain opioid medication as a treatment for her purported condition, to her suspected opioid use disorder and malingering.”  Id. 

Plaintiff tried to argue that the difference of opinion between her expert and her other treaters was an issue for the jury, but that missed the point.  “[T]he issue is not that other doctors reached a different diagnosis, but that [plaintiff’s expert] ignores and fails to specifically address those inconsistent diagnoses and the findings upon which they were based.”  In other words, plaintiff’s expert chose to ignore the overwhelming medical evidence that contradicted his litigation-driven opinion and made no attempt to rule out the findings of those other treaters as possible causes.  

And then plaintiff doubled down by submitting an affidavit from her expert asserting that he did not need to review the other treaters’ records because “those doctors are simply inferior physicians whose findings may be summarily discounted.”  Id. at *12.   Another mortal struck down by hubris. 

Without expert causation evidence, general or specific, defendant moved for summary judgment—which we think should have been a gimme.  And while the court agreed that plaintiff needs expert evidence on this type of complex causation issue, the court was unwilling to accept defendant’s assertion that the excluded expert was plaintiff’s only expert on causation.  Id. at *6, 12.  One would think that if plaintiff had such additional evidence, she would have proffered it in opposition to the motion.  So, while we are left shrugging our shoulders for now, we assume the dismissal on causation has merely been kicked down the road a bit.       

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.
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