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Earlier this week, we spoke of the impending birth of our soon-to-be standard poodle puppy.  We are delighted to report that the puppies are being born as we type this!   Eight are expected (e-mail us and we will send you a cool x-ray that shows all eight in utero – count the spines and skulls!), and one has arrived.  Dad is white and Mom is silver, and we are told that the litter will likely be a mix of blue (a dark steel grey) and white puppies.  (The genetics of all of this are way over our head – something to do with black plus a dilution factor and both parents carrying white.)  So far, one white girl has arrived.  We won’t know for a month or so which puppy will be ours, so we are beyond excited to see the array of possibilities.

“Excited” may overstate our reaction to today’s case, but we did read it with pleasure.  Nelson v. Bard, 2022 WL 3223188, ___ F.4th ___  (5th Cir. 2022), is a decision on the appeal of the District of Mississippi’s grant of summary judgment for the defendant in an IVC (inferior vena cava) filter case.   IVC filters are placed to prevent blood clots from traveling to the heart, lungs, and brain.  The plaintiff/appellant received his filter “as a prophylactic measure to prevent deep venous thrombosis and pulmonary embolism” when he temporarily stopped taking anticoagulants in preparation for a liver transplant.  Nelson, 2022 WL 3223188 at *2.  Fourteen years later, imaging revealed that the filter had fractured, with fragments penetrating the wall of the IVC and some migrating to other parts of the plaintiff’s body.   Most of the fragments were removed in the course of three surgeries, but one fragment remained in the pulmonary artery.  The plaintiff filed suit in the IVC filter MDL, asserting claims for design defect and failure to warn under the Mississippi Products Liability Act.  The case was remanded to the Southern District of Mississippi, and both sides moved for summary judgment.

The district court granted summary judgment for the defendant, holding that the filter’s warnings were adequate as a matter of law because the instructions for use (“IFU”) that accompanied the product “expressly warned” the plaintiff’s treating physician of the “very complications” the plaintiff suffered.  Id.  As we discussed then, the district court rejected at some length the plaintiff’s argument that the warnings were inadequate because they did compare the complication rates to those of the defendant’s predecessor filters and other manufacturers’ filters, holding that Mississippi law did not “support the conclusion that a failure to provide comparative-risk information renders a warning inadequate.” Id. at *3.   With respect to the design defect claim, the court held that the plaintiff had not adduced evidence linking the design defect his expert identified to the injuries he suffered, and that he had not identified a feasible alternative design.  The plaintiff appealed, resulting in today’s decision.

The Fifth Circuit affirmed the district court’s finding that the filter’s warnings were adequate as a matter of law, emphasizing that the IFU, “in no uncertain terms,” warned that fracture and migration, the “exact complications that allegedly caused [the plaintiff’s injuries,” were “known complications” associated with the filter.  And the plaintiff did not “persuasively argue” otherwise.  Id. at *5.   As the court explained, the district court’s holding was correct because the plaintiff did not “discuss, in any meaningful way, the warning language itself.”  Id.  He did not explain “why the text of the warnings was inadequate;” instead, he relied on the defendant’s internal documents to argue that the defendant knew of, and concealed, risk data, and thereby did not “warn physicians of high complication rates that it was aware of at the time.”   He argued that “the information that was concealed was so egregious that the IFU [was] per se inadequate.”  Id. at *6 (emphasis in original, internal punctuation omitted).  But, the court emphasized, Mississippi law requires failure-to-warn cases to be based upon “the warning label itself – its text and language – rather than internal documents.”  Id.  Because the plaintiff did not address “the language of the warning itself and how it was inadequate,” and because the warning label “warned in two different locations that filter fracture and migration were known complications,” the court held that the plaintiff failed to raise a genuine issue of material fact as to the failure to warn claim.  Id. 

With respect to the design defect claim, the court explained that the MPLA requires proof that the product was defective when it left the manufacturer’s control and that the defect proximately caused the plaintiff’s injuries.  The plaintiff’s expert testified that the filter was defective because it “tilted,” but the plaintiff failed to submit evidence that tied this supposed design defect to the fracturing and migration of the plaintiff’s filter.  In fact, the court pointed out, the expert’s report did explain how a “tilt” could cause the filter to fracture and perforate the IVC.  Since the plaintiff “failed to direct the district court’s attention” to this portion of the report, the appeals court could not consider it.   As the court stated, “Rule 56 does not impose upon the district court a duty to sift through the record in search of evidence to support a party’s opposition to summary judgment.”   (Because the court affirmed this holding, it did not need to address the “alternative design” holding.)

Lots of good stuff here.  We especially like the court’s rigorous application of good Mississippi precedent confining the warnings analysis to the text of the warnings themselves and leaving company documents – and conjecture based on them – out of the mix.  We also love the court pointing out the plaintiff’s sloppiness in failing to identify the portion of his expert’s opinion that might have saved the design defect claim.   Nelson is a well-reasoned opinion delivering a well-deserved victory for the defendant/appellee.  

Meanwhile, we are now up to three white girls, one white boy, and one blue boy!  We’ll give you the final tally when we next talk to you.  In the meantime, stay safe out there.

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Two weeks ago we reported on a case that refused to apply offensive non-mutual collateral estoppel, the doctrine that prevents a defendant from relitigating an issue that it lost in earlier litigation against a different plaintiff. Although we weren’t impressed by that decision’s analysis, its outcome was one we could endorse. Today we report on another case involving offensive non-mutual collateral estoppel, Freeman v. Ethicon, Inc., 2022 WL 3147194 (C.D. Cal. 2022). This time, we are neither impressed by the decision’s analysis nor happy with its result.

Indeed, Freeman illustrates why offensive non-mutual collateral estoppel is systematically unfair to defendants.

Alleging that they were injured by one of the defendants’ pelvic mesh devices, the Freeman plaintiffs moved for partial summary judgment, arguing that at trial the defendants should not be allowed to dispute certain factual findings entered by a state-court judge after a bench trial in earlier false-advertising and unfair-competition litigation.

In Parklane Hosiery Co. v. Shore, 439 U.S. 322, 330–31 (1979), the Supreme Court identified four non-exhaustive factors that federal courts should consider when determining whether application of offensive non-mutual collateral estoppel would be fair in a particular case:  (1) whether “the plaintiff had the incentive to adopt a ‘wait and see’ attitude in the hope that the first action by another plaintiff would result in a favorable judgment”; (2) whether the defendant had the incentive to defend the first suit; (3) whether one or more judgments entered before the one invoked as preclusive are inconsistent with the latter or each other, suggesting that reliance on a single adverse judgment would be unfair; and (4) whether the defendant might be afforded procedural opportunities in the later action that were unavailable in the first and “could readily cause a different result.”

In Freeman, the defendants argued that applying offensive non-mutual collateral estoppel would be inappropriate under Parklane and would violate their Seventh Amendment right to a jury. The court rejected the defendants’ arguments at every turn.

The court acknowledged that “[t]he existence of inconsistent prior judgments is perhaps the single most easily identified factor that suggests strongly that neither should be given preclusive effect.” 2022 WL 3147194, at *4 (quoting Wright & Miller, 18A Fed. Prac. & Proc. § 4465.2 (3d ed. Apr. 2022 Update)). The court also acknowledged that in the past decade there have been two dozen jury trials involving the defendants’ mesh products, with plaintiffs winning some and the defendants winning others. Nonetheless, despite the conflicting product-liability verdicts, the Freeman court thought it appropriate to give preclusive effect to the adverse findings entered in the false-advertising and unfair-competition litigation because, said the court, the findings of fact entered by the state-court judge at the conclusion of the bench trial in that case “were specific” while the verdicts for the defense in the product-liability trials did not contain “any specific” contrary findings of fact. Id. at *5. But juries often return general verdicts. Indeed, the Freeman court explained that in one of the product-liability trials resulting in a defense verdict the jury had no need to make particularized findings of fact because it concluded that, whatever the product’s characteristics, the defendants were not negligent in designing it. Yet rather than view the general defense verdict as weighing against application of offensive non-mutual collateral estoppel, the court considered its very generality a factor in favor of applying the doctrine to prevent the defendants from contesting certain elements of liability. In effect, the court concluded that the defendants should not be allowed to offer a defense because the earlier verdict in their favor had been too categorical.

The court also rejected the defendants’ argument that the state-court findings should not preclude relitigation of the factual issues because those findings rest on evidence that would not be admissible in federal court. The defendants argued that the state-court findings rest on expert testimony that was admitted under California’s Kelly-Frye standard but has been repeatedly excluded by federal courts applying the Daubert standard (or, as we like to say, Federal Rule of Evidence 702). This reality didn’t impress the Freeman court, which found that “the differences between the Kelly-Frye and Daubert standards do not rise to the level of procedural differences contemplated” by Parklane because, said the court, “the overlap of the two standards generally results in the same evidence being admitted.” 2022 WL 3147194, at *5.

Nor was the court impressed by the existence of new evidence that became available only after the state court that had entered the purportedly preclusive findings. Applying California law (because it was sitting in diversity), the court held that “even if new evidence was not previously available, collateral estoppel will still apply if the new evidence goes only to the weight of the evidence in support of the party who opposes preclusion.” 2022 WL 3147194, at *6 (cleaned up). In other words, in the court’s view, a prior weight-of-the-evidence determination is forever binding even when there is new evidence to be weighed in the balance.

The court also was not deterred by the Seventh Amendment. Citing numerous cases refusing to give preclusive effect to findings made in prior bench trials, the defendants argued that giving preclusive effect to findings made by a judge would deprive them of their right to a jury trial. None of the cases cited by the defendants were apposite, said the court, because the supposedly preclusive findings at issue in them “were made in prior federal court cases[,] whereas in this case, the findings were made in state court.” 2022 WL 3147194, at *6. That distinction was dispositive, the court asserted, because “[t]he Seventh Amendment is not applicable to the states.” Id. (internal quotation marks omitted). But that is irrelevant. The findings would be given preclusive effect in federal court, where the Seventh Amendment unquestionably applies. The question is not whether the defendants had a right to a jury trial in state court, but whether they can be denied that right in federal court. According to the Freeman court, they can be.

Summarizing its analysis, the Freeman court found that “issue preclusion in this case is fair under the Parklane factors.” 2022 WL 3147194, at *7. We have a very different notion of fairness.

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Two weeks ago we blogged about the Georgia Supreme Court’s not-quite embrace of the apex doctrine limiting depositions of organization big-shots.  In National Collegiate Athletic Association v. Finnerty, 2022 WL 2815848 (Indiana July 19, 2022), the Indiana Supreme Court did something similar.   The Finnerty case was brought on behalf of college athletes against the NCAA  for allegedly failing to implement “proper policies for preventing, diagnosing, or managing football head injuries.”  There are many such lawsuits and in many of them the plaintiffs sought to depose high-ranking NCAA executives.  

Those executives could have ended up doing nothing but depositions. Accordingly, those executives sought protective orders preventing such depositions because the executives possessed no unique knowledge and there were less intrusive means for discovering the information sought.  The trial court denied the protective order, the Indiana Court of Appeals held that the appeal from denial of the protective order was untimely, and the issue ended up in front of the Indiana Supreme Court.

The Indiana Supreme Court held that the appeal from the interlocutory order was timely, and proceeded to consider the NCAA’s request that Indiana adopt the apex doctrine, which limits depositions of executives who sit at the “apex” of a corporation’s hierarchy and who are consequently vulnerable to repetitive or harassing depositions.  In considering this issue, the Indiana Supreme Court had the benefit of excellent amicus briefing, including from the Product Liability Advisory Council and the U.S. Chamber of Commerce. (Full disclosure: we know the lawyers who authored these amicus briefs and we like and admire them.  We also like and admire what they wrote.  The briefs go through the need for and benefit of the apex doctrine, and also make the point that Florida had recently adopted it.)

As in the Georgia Supreme Court opinion we covered earlier, the Indiana Supreme Court in Finnerty declined to adopt the apex doctrine, but articulated a framework based on state discovery rules that captured most of the apex doctrine’s factors and operation.  The Indiana Supreme Court began its analysis by characterizing depositions as a “factual battleground where the vast majority of litigation actually takes place.”  (The Indiana Supreme Court actually borrowed that formulation from an E.D. Pa. case called Hall v. Clifton Precision.  Those of us who litigate frequently in E.D. Pa. are quite familiar with the Hall case, which sets out some terrifying rules about discoverability of conversations between deponents and their lawyers during deposition breaks.  Seriously, if you are defending a deposition in an E.D. Pa. case, read Hall.  And then be afraid.  Very afraid.)  

The Indiana Supreme Court had never before encountered the apex doctrine, and faced the issue of whether that doctrine could be squared with Indiana’s (sigh) “liberal” discovery regime.  On their face, Indiana trial rules do not “include heightened protections for any class of individuals.”  At the same time, Indiana courts are receptive to requests for protective orders that will prevent “annoyance, embarrassment, oppression, or undue burden or expense.”  But for the Indiana Supreme Court, explicit adoption of the apex doctrine was a step too far.  The Court saw federal application of it as “inconsistent” and its prevalence in state courts as “sparse.”  What the Indiana Supreme Court especially disliked about the apex doctrine was its “presumption – in conflict with [state court] discovery rules – that a high ranking official should not be deposed unless the requesting party first establishes a necessity for the deposition.”

What rule did the Indiana Supreme Court embrace, if not the full-blown apex doctrine?  First, the deponent must prove him or herself to be a true apex official.  The issue is anterior to the question of whether good cause exists for a protective order.  Because corporate organizational structures differ, it is impossible to lay out a bright line test based on, say, title.  Instead, it is a fact-sensitive inquiry focusing on the official’s “authority to exercise judgment and discretion when making executive decisions,” as well as the nature and scope of the executive’s duties and responsibilities.  The party seeking protection also bears the burden of demonstrating that the executive lacks personal knowledge of relevant information, that the information is available through less intrusive avenues, that the deposition would be unreasonably cumulative or duplicative, and that the hardship of the deposition would outweigh the benefit.  If that showing is made, the burden shifts to the requesting party to rebut either the deponent’s apex status or the good cause showing.  Such a rebuttal of apex status or good cause for protection requires “particularized factual support.”  Maybe the requesting party has evidence that the deponent really does have personal knowledge.  Or maybe the requesting party can show that any alternative means of discovery are “unavailable, inadequate, or already exhausted.”  If there is a genuine clash between the parties on these factors, the trial court “must use its discretionary authority to balance the parties’ needs and impose a protective order that (1) restricts the topical scope of the deposition or (2) requires the exhaustion of less intrusive discovery methods.”

Because the trial court in Finnerty summarily denied the NCAA’s motion for a protective order, there is no way to know whether it applied anything like this analytical framework.  Therefore, the Indiana Supreme Court remanded the case to the trial court to do the requisite balancing and decide whether the depositions were appropriate.  

This framework might not be precisely the same thing as the apex doctrine, but it seems at least apex adjacent.  The showing you’d put together if you were seeking to prevent or limit a deposition is pretty much the same as if you were in a jurisdiction that employed the apex doctrine.  Sure, it becomes a matter of discretion for the court, which means appellate review will be circumscribed, but at least it is clear in Indiana that a court must actually go through specified steps in exercising its discretion.  We predict that most depositions that would be blocked by the apex doctrine will also be blocked by Indiana’s new framework.  

We have long believed that the Indiana appellate courts are generally not a bad place to be for corporate defendants.  The Finnerty decision does not alter that belief.

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Today is sort of a twofer Tuesday.  We have two cases, but only one issue.  So, maybe it’s more of a two-for-one deal.  There is also one general takeaway – it pays to look at state-specific defenses to state-specific claims.  For example, the privity requirements in North Carolina make it extremely difficult to bring a breach of warranty claim in a prescription drug or medical device case.  As plaintiffs in Johnson v. Smith & Nephew, Inc., 2022 U.S. Dist. LEXIS 143203 (W.D.N.C. Aug. 11, 2022) and Cruise v. Smith & Nephew, Inc., 2022 U.S. Dist. LEXIS 143190 (W.D.N.C. Aug. 11, 2022) recently found out.

These are not related cases and they were not brought by the same plaintiff’s firm.  But both involve medical devices and breach of warranty claims, and both were pending before the same judge.  So, not surprisingly, they both had the same result.  There is really only one difference between the cases, an immaterial one at that.  In Johnson, plaintiff underwent hip replacement surgery and later suffered complications when the implanted device allegedly failed.  Johnson, at *1-2.  The plaintiff in Cruise likewise had hip surgery, but unbeknownst to her surgeon, part of a drill bit that was used in the surgery broke off and implanted in plaintiff’s hip.  Cruise, at *2. 

We’ll cite to Johnson for a discussion of breach of warranty law in North Carolina, but you can find the same discussion in Cruise.  First and foremost, to bring a breach of warranty claim under North Carolina law, you must have contractual privity with the defendant.  Id. at *6.  However, keeping with our two-for-one theme, North Carolina’s version of the Uniform Commercial Code (UCC) has two exceptions to the privity rule, and one common law exception.  The first exception provides that if the buyer of the product is in privity with the defendant, “any express or implied warranties made to the buyer inure to the benefit of the buyer’s family or household guests.”  Id.  So, your husband buys electric hedge clippers but you’re the one who is using them when they malfunction causing you injury – you have privity to bring a warranty claim. 

Exception number two under the North Carolina UCC provides that the privity requirement is removed when a “buyer” of the product involved brings a product liability action directly against the manufacturer for breach of implied warranty.  Id.  So, if you bought the clippers but through a distributor, you could bring your implied warranty claim directly against the manufacturer despite the lack of privity. 

The courts, likely stemming from exception two, have recognized “an exception for buyers who are not in privity wit the manufacturer when the manufacturer intends its warranties to be conveyed to a buyer through the retailer.” Id. at *7.  This time you bought the clippers at your local hardware store and they came with a manual that made representations about the product or Jimmy, your friendly hardware salesman made representations about the clippers based on what the manufacturer told him.  In this scenario you also could overcome the privity requirement and bring a warranty claim. 

But electric hedge clippers are not prescription medical devices and that changes everything.  Neither plaintiff was in privity with the manufacturer, so to bring their warranty claims they had to fit within one of the exceptions.  The first exception does not apply because even assuming the doctor or the hospital was the “buyer” of the hip implant or the drill bit, neither plaintiff is a family member or household guest of the hospital or doctor.  Id. at *11.  The second exception is only available to buyers, which neither plaintiff is.  Mr. Johnson did not purchase his hip implant from his surgeon.  As appellate courts in North Carolina have held, “medical professionals do not engage in the sale of ‘goods’ when they either issue a prescription for a drug, or [implant a medical device].”  Id.    Plaintiff Johnson argued that his insurance company paid for the hip implant and because he paid his insurance premiums, he should be considered they buyer.  But for plaintiff to be a buyer there must be a sale which involves the passing of title which did not occur.  And even if there was a sale of the hip implant, at best the insurance company would be the buyer not plaintiff.  Id. at *14.  If Mr. Johnson did not fit under the second exception, certainly neither did Ms. Cruise.  She did not buy the drill bit from her doctor or contract to buy the drill bit, so she was not a buyer under the UCC.  Cruise at *17.

As for the common law exception, it too fails. It is premised on the passing of representations made by the manufacturer through a retailer to the purchaser.  But in both cases plaintiffs do not allege that the manufacturer made any representations “aimed at” plaintiffs or relied upon by plaintiffs in deciding to undergo surgery.  Johnson, at *10.  The court here recognized that some other North Carolina district courts have found that a manufacturer’s representations to a doctor can inure to the benefit of the patient through an agency relationship.  The court deciding Johnson and Cruise, however, found such a conclusion “stretches the narrow privity exception and does not address the ‘buyer’ issue.”  Id. at *15.  See Cruise at *18 (the agency analysis “is outside the current legal framework, and the Court declines to stretch the narrow privity exceptions”).   

Without a privity exception, plaintiffs breach of warranty claims were dismissed.  That means both plaintiffs are left with only negligence claims because North Carolina does not recognize strict liability.  Two plaintiffs, two medical devices, but now only one claim. 

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We report, before we discuss today’s case, that we write in a state of high anticipation.  Regular readers of this blog may recall that we are huge dog show fans (we have had the same seats to the annual Westminster Kennel Club show – the one that is on TV – for 25 years).  We haven’t owned a purebred dog since 2011 when our last standard poodle died.  We have a house full of rescues, canine and feline, and are huge supporters of animal rescue – our tax accountant appreciates the “charitable donations” deduction this facilitates each year.  But we have always wanted one more standard poodle.  It has been a rough year, on both the “macro” and “micro” levels.  So, when our dear friend – and the breeder of our departed standards – offered us a chance to co-own a show puppy, we sent a bunch more money to rescues to assuage our conscience and gave ourselves permission to say “yes.”  Our puppy, and its siblings, are due to be born this Thursday.  When they are five or six weeks old, our friend will decide which is the most promising show dog (both parents are spectacular).  The puppy will come live with us a few weeks later, and it will begin its show career at six months old.  With us cheering from the sidelines.  By next time we post, we should have a birth announcement.

Now on to today’s case.  The decision – In re Taxotere Docetaxel Prods. Liab. Litig., 2022 U.S. Dist. LEXIS 132195 (E.D. La. July 26, 2002) – is short, and the discussion will be short, but we think the problem is big – the tip of a much-larger plaintiff-side MDL “iceberg.” The Taxotere MDL follows the typical model:  there is a master “long form” complaint on file, and each new plaintiff files a “short form” complaint that ticks off the claims (from the long form complaint) that plaintiff is incorporating.   The Taxotere long form complaint was filed in 2016, and the three plaintiffs in today’s decision filed their short form complaints in May 2017.   Under Fed. R. Civ. P. 4(m), the plaintiffs were required to serve their short form complaints within 90 days of filing.  Nearly five years after filing, none of the three plaintiffs had served the defendant with their short form complaints.  In January 2022, all three plaintiffs finally effected service, whereupon the defendant moved to dismiss all of the complaints. 

Fed. R. Civ. P. 4(m) provides;

If a defendant is not served within 90 days after the complaint is filed, the court . . . must dismiss the action without prejudice against that defendant or order that service be made within a specified time. But if the plaintiff shows good cause for the failure, the court must extend the time for service.

As the Taxotere court explained, “[t]he burden is on the plaintiff to show good cause as to why service was not effected timely, and the plaintiff must demonstrate least as much as would be required to show excusable neglect.”  In re Taxotere, 2022 U.S. Dist. LEXIS 132195 at  *3 (internal punctuation and citations omitted).  But, the court emphasized, Rule 4(m) afforded the court discretion “to extend the time for service even in the absence of good cause.”  Id. (citation omitted).  Moreover, the court explained, if claims dismissed for failure to effect service would be time-barred on re-filing, “the dismissal should be treated as a dismissal with prejudice under [Fed. R. Civ. P.] 41(b),” which requires a “clear record of delay or contumacious conduct by the plaintiff and a finding that lesser sanctions would not serve the best interest of justice.”  Id. (internal punctuation and citations omitted.

The three Taxotere plaintiffs made no attempt to establish good cause for their nearly-five-year failure to serve their complaints. Instead, they asserted that, under the “dismissal with prejudice” standard, the court should deny the Motions to Dismiss because the record “demonstrate[d] inadvertence, not clear delay or contumacious conduct.”  Id. at *4. 

And the court found that this more-stringent standard was not satisfied.  It held:

Although the delay in effecting service was indeed lengthy, it has not threatened the integrity of the judicial process. Each Plaintiffs’ case is in the same or substantially similar stasis as the thousands of other non-bellwether plaintiffs in this MDL.  Likewise, the record does not establish that Plaintiffs’ failure to effect service was the result of contumacious conduct. . . . [I]t is a party’s willful disobedience of a court order [that satisfies this standard]. There is no record of such conduct here. Rather, the evidence reveals that Plaintiffs discovered the deficiency on their own and cured it without the Court’s involvement.

Id. at *5-6 (internal punctuation and citations omitted).  The court concluded, “Because there is no clear record of delay or contumacious conduct, the circumstances of these cases do not justify dismissal with prejudice. This Court will, therefore, exercise its discretion under Rule 4(m) and extend the time for service nunc pro tunc to January 31, 2022.”  Id. at *6.

But here’s the problem:  this decision buys into the plaintiff-favoring herd mentality that, in our humble opinion, corrupts the MDL process. Because these cases were just getting dumped into a docket containing thousands of other cases, the plaintiffs were excused from complying with the service rules.  This is the same mentality that allows cases to languish for years, without any threshold showing of merit, in the hope of inclusion in a mass “settlement inventory” down the road.  Whether cases are consolidated or not, each plaintiff is an individual, with individual claims.  Each plaintiff should be required to comply with the applicable Rules and with the court’s orders or suffer dismissal.  And each plaintiff should be required to demonstrate, early in the pendency of a case, that he or she used the defendant’s product and suffered a requisite injury (we favor widespread implementation of Lone Pine orders). Sure, excusing these three plaintiffs from the service deadline may not seem like a big deal within the larger picture.  But rules are rules, and consolidation of large groups of cases should not operate to obfuscate individual plaintiffs’ rule violations. Moreover, overlooking plaintiffs’ intermittent service failures permits them to manipulate the docket, advancing cases they like and holding back cases they don’t.

We are scheduled to post again late in the week, and we hope to have puppy news (and maybe pictures!) by then.  In the meantime, stay safe out there.

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The world order has been restored.  The clouds have parted, and all today is in perfect resonant harmony.  Ok, we are exaggerating.  A lot.  But we are pleased to report that at least one federal district court has correctly interpreted and applied the PREP Act.  We are sure you are as relieved as we are. 

We reported two weeks ago on a federal district court that got the PREP Act completely wrong.  The law is remarkably straightforward.  Congress enacted the Public Readiness & Emergency Preparedness Act (“PREP Act”) in 2005 to ensure the availability of effective countermeasures in the event of 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). 

The misguided case on which we reported two weeks ago ruled that “exclusive” really means “non-exclusive,” and it allowed the plaintiff to pursue a state-law negligence claim based on a COVID vaccine reaction. 

Just days later, a federal court in New Mexico got it exactly right on very similar facts.  In Storment v. Walgreen, Co., No. 1:21-cv-00898, 2022 WL 2966607 (D.N.M. July 27, 2022), the plaintiff alleged that she got dizzy and fell after the defendant pharmacy administered a COVID vaccine.  Id. at *1.  These allegations fell directly within the Act’s preemptive scope, which includes “any claim for loss that has a causal relationship with the administration to or use by an individual of a covered countermeasure.”  Id. at *2 (emphasis in original, quoting 42 U.S.C. § 247d-6d(a)(2)(B)). 

It is difficult to imagine how the PREP Act would not apply to the plaintiff’s negligence-based claims, but the plaintiff tried anyway.  She argued that her injury (fainting at the pharmacy) could have occurred with or without a COVID vaccine and thus was not causally related.  Id. at *2.  She could not, however, get around her own allegations that the vaccine was the cause:

Plaintiff appears to argue that because her injuries could have resulted from any vaccination or other medical procedure . . . , the Court should find the PREP Act not applicable.  While it is true that other vaccinations or procedures might also leave customers dizzy, this does not change the fact that Plaintiff’s injuries actually resulted from administration of the COVID-19 vaccine.  The PREP Act therefore applies

Id. at *3.  The court included this additional pithy remark:  “Plaintiff provided no caselaw to support the it-could-have-been-a-different-vaccine argument . . . .”  This judge would make a good blogger.

This order is a true application of the “plain and unambiguous meaning” of a federal statute, and it provides a quintessential example of the PREP Act in action.  The court dismissed the case with prejudice. 

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An interesting issue recently arose (but was not resolved) in In re: Proton-Pump Inhibitor Products Liability Litigation, 2022 WL 2188038 (D.N.J. June 17, 2022) (“PPI”).  The ability of an FDA expert witness to testify was challenged under 18 U.S.C. §207, a federal conflict of interest statute.  We have never seen that statute invoked in connection with an ex-FDA witness before, and apparently neither has anyone else, since the opinion observes that “the fact pattern presented here is something of an unprecedented issue.”  Id. at *4 (citation and quotation marks omitted).  So we thought we’d alert our readers.

Continue Reading Regulatory Witnesses – Something Else To Watch
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In these dog days of summer, few things bring as much joy and relief as ice cream. What does ice cream have to do with drugs or medical devices?  Not much, we suppose.  Sure, ice cream can affect the brain and the body.  Our neurons vibrate with pleasure as they travel along a rocky road or groove with Cherry Garcia. Rumor has it that ice cream, like some antidepressants or antipsychotics, can result in a bit of weight gain.  (Color us skeptical, or at least stubbornly resistant, on that point.)  Ice cream can certainly seem addictive.  But we haven’t yet seen a lawsuit by someone complaining that they could not stop shoveling Chunky Monkey down their gullet. No, what makes ice cream — or, more specifically, ice cream litigation – relevant to our little corner of the law is the plaintiff strategy of claiming fraud when no one in real life was defrauded.

It is one thing to say a product is bad for you.  That plunges the jury into science. It is complicated. It is confusing. Intricate judgments must be made. But it is much simpler to accuse the defendant of lying.  Maybe the perfect product will never exist, but at least tell the truth about it.  Give consumers the facts so that they can make an informed judgment.  So the story goes, anyway. In some ways, ice cream litigation is more appetizing for plaintiffs than drug or device litigation. Drugs and devices are usually selected by doctors.   By contrast, there is no learned intermediary steering someone toward a pint of rum raisin. Let’s face it, ice cream is typically an impulse buy.   Still, ice cream consumer fraud cases raise the same issue that bedevils many of our DDL cases: what is a lie?

A little more than two months ago we blogged about a plain vanilla fraud case.  That is, the complaint in the case alleged that makers of vanilla ice cream were not honest about the source of the vanilla flavor.  The court correctly dismissed the complaint. No one was misled by the vanilla ice cream package. When it comes to ice cream, people care more about flavor than provenance or raw materials. (But don’t discount the possibility that some enterprising plaintiff lawyer will assemble an ice cream lawsuit around a Material Safety Data Sheet.  Ugh.)  Since we wrote that post, we learned that there is a plaintiff lawyer out there who calls himself the Vanilla Avenger. We’re not sure if he was the attorney in that vanilla case or the case we write about today.  We suspect he is not at all a Good Humor man.

When we talked with friends about the vanilla court’s tasty reasoning, what do you think was the most common comment we heard?  ‘I like chocolate better, anyway.’

Well, here comes a delicious opinion rejecting similar claims about chocolate ice cream.  In Yu v. Dreyer’s Grand Ice Cream, Inc., 2022 U.S. Dist. LEXIS 47043 (S.D.N.Y. March 16, 2022), the plaintiff filed a putative class action alleging consumer fraud about the ingredients in Haagen-Dazs Coffee Ice Cream Dipped in Rich Milk Chocolate, Almonds, and Toffee.  (If that product name doesn’t prompt you to race off to the frozen foods section of your local supermarket, you are made of considerably stronger stuff than we are. In fact, let’s lay our culinary cards on the table.  To prepare for this blogpost, the Drug and Device Law Daughter and this author sampled the Haagen-Dazs ice cream bars. The verdict:  extraordinarily scrumptious. We did not feel even a little bit defrauded. But we digress.)

The plaintiff alleged that the ice cream label was misleading under New York General Business Law because the representation that the ice cream was “dipped in rich milk chocolate” was false because the addition of vegetable oil “fundamentally changes the nature of the bar’s coating.”  The plaintiff also heaped on claims of breach of warranty, violation of the Magnuson-Moss Act, unjust enrichment, and common law fraud.  The plaintiff sought an injunction that would fix the label.  Interestingly, the plaintiff promised to resume purchasing the product “when she can do so with the assurance that the representations in its labeling are consistent with its ingredients.”

The plaintiff’s theory was that because the package “represents the product contains ‘rich milk chocolate’ without qualification, consumers expect that it only has chocolate ingredients, which is not the case.”  (We grit our teeth at that misplaced “only.”) Right away, and before we get to the court’s decision, we have three problems with this claim:  (1) we are frighteningly prolific consumers of ice cream, and we had no idea that vegetable oil is not a chocolate ingredient; (2) nor do we care; and (3) the Haagen-Dazs package has an ingredients list that includes vegetable oil. Fraud-schmaud.  

The defendant moved to dismiss the complaint.  It made several effective and winning arguments.  We like those arguments almost as much as we like the ice cream.  So, apparently, did the court, as it dismissed the claims.

First, the plaintiff premised its claim on alleged violations of our old friend, the Food Drug and Cosmetic Act (FDCA).  But the FDCA does not provide a private right of action.  Second, it was implausible to suggest that a “reasonable consumer would conclude that representations regarding chocolate on the Product’s label would imply that the Product’s coating did not contain any coconut or vegetable oil.”  The ingredient list was accurate and there was no reason to think that the “surrounding context” of the package somehow made that ingredient list disappear.  The plaintiff attempted to prop up her assertion regarding consumer expectations by alluding to what the court called a “mysterious” consumer survey.  It wasn’t clear who conducted the survey or what consumers were told.  In any event, the survey did not even remotely demonstrate that consumers would be surprised or disappointed by the presence of vegetable oil.  

More fundamentally, the court concluded that nobody buys chocolate ice cream “for health or nutritional benefits or satiety value.”  The label made no claims about those features.  Oddly, the complaint did not say that the plaintiff was disappointed by the taste of the product.  Remember, she said she’d happily buy more once the label was fixed (and, presumably, once she had won her suit and her lawyer had been paid).  Because there was no evidence that anyone was misled by the ice cream package, the plaintiff’s claims melted away.

To be sure, there were other problems with the plaintiff’s claims. The plaintiff did not plead facts showing that she had provided notice to the defendant, which New York requires for claims of breach of express warranty.  The claim for breach of the implied warranty of merchantability was a goner because the complaint “does not come close to alleging that the Product is ‘unfit to be consumed.’”  How could it?  Like the plaintiff, we intend to buy more of these fantastic ice cream bars.  Unlike the plaintiff, we do not require a rewrite of the package to nanny us with unnecessary and unread verbiage. The common law fraud claim flunks the particularity requirement of Fed. R. Civ. P. 9(b), the unjust enrichment claim is duplicative of and dependent on the others, and the plaintiff’s wish-washy statement of intention maybe to buy the product in the future was insufficient to confer standing on her to pursue this pointless lawsuit. 

All that being said, the court granted the plaintiff leave to amend her complaint to try again.  When it comes to ice cream, seconds or even thirds are frequently in order.  But here’s the bottom line or, if you will, the scoop: the Yu case represents much of what is wrong with civil litigation in this country. It is a clever lawsuit cobbled together by a lawyer to address a non-problem.  Meanwhile, we’re headed out to purchase another three-pack of the chocolate, almond, toffee ice cream bars.  It turns out that vegetable oil tastes great. And if we get an ice cream headache, that will be our own fault.

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They say the smartest people are the ones who are always learning something new.  Those who are open to new ideas and concepts.  People who are eager to acquire new information.  That’s a great way to live.  Long live enlightenment.  However, when it comes to federal preemption of a failure to warn claim involving a prescription pharmaceutical, the only new knowledge that counts is the FDA’s.

That’s essentially what the court told Plaintiff in Roshkovan v. Bristol-Myers Squibb Company, 2022 WL 3012519 (C.D. Cal. Jun. 22, 2022).  Plaintiff was prescribed defendant’s drug to treat his chronic myeloid leukemia.  He alleged that the drug caused him to suffer a loss of vision in his right eye due to hemorrhaging.  Id. at *2.  He brought failure to warns claims sounding in both negligence and strict liability.

The first thing defendant asked the court to do was take judicial notice of the drug’s labels from the FDA website.  The court granted that request on two grounds.  First, courts “regularly take judicial notice of materials prepared by government agencies.”  Id. at *5.  Second, the court was willing to consider the labels under the “incorporation by reference” doctrine.  Because plaintiff’s failure to warn claims were based on the content of the labels, and the labels were referenced and quoted in the complaint, defendant could incorporate them into their motion and the court could consider them in deciding the motion.  Id. 

The court next considered defendant’s argument that the drug’s warnings were adequate as a matter of law.  The labels included warnings about the risk of bleeding and hemorrhagic events and information about adverse events related to the eye and vision.  The label did not include the specific risk suffered by plaintiff—loss of vision due to retinal hemorrhage.  Id. at *8.  And because “California poses a high standard for ambiguous warnings,” the court was unwilling to find the warning adequate as a matter of law.  Id. at *9. 

That left open the question of the adequacy of plaintiff’s allegations regarding causation.  Here plaintiff did not fare as well.  Plaintiff alleged only that his physician prescribed the drug and the drug’s label was inadequate.  In other words, plaintiff simply alleged that that the inadequate warning caused his injury.  Under the learned intermediary rule, however, plaintiff bears the burden of proving that the inadequate warning “would have altered the prescribing physician’s decision to use the product.”  Id.  Therefore, to satisfy TwIqbal, plaintiff’s complaint must also so allege, and not in a conclusory fashion.  On this ground, plaintiff’s claims were dismissed.

But the court went on to consider defendant’s argument that the claims were also preempted.  This is where we get to who knew what when.  Failure to warn is not preempted if the defendant could have changed the label without FDA approval via the Changes Being Effected (CBE) regulation.  That regulation provides that a manufacturer can change its label to reflect “newly acquired information” that adds or strengthens a warning “for which there is evidence of a causal association” without prior FDA approval.  Id. at *10.  

Newly acquired information can be many things (studies, reports, new analyses), but first and foremost it must be information that was not previously submitted to the FDA.  Plaintiff in this case took great pains to set out all the information known to the FDA long before plaintiff ever took the drug – including that both the manufacturer and the FDA knew as far back as 2005 that the drug allegedly caused severe eye-related disorders.  Id.   So, plaintiff actually alleged “the opposite of what is required to overcome preemption.”  The only person plaintiff alleges “belatedly uncovered” this information was plaintiff:  “In September 2019, Plaintiff discovered …..”  Unless we are talking about the statute of limitations, what the plaintiff knew when doesn’t really matter.   And while not addressed in the opinion, it could be plaintiff was trying to plead around the statute of limitations and by doing so pleaded himself right into preemption.  Since the complaint, as currently pleaded, demonstrates that the manufacturer and the defendant were aware of the risk of vision loss and the drug’s labels were approved with this knowledge, the claims are preempted.  Id. at *11.  

Since the pleading deficiencies as to both causation and preemption could potentially be remedied, plaintiff is getting a second bite at the apple.  This time to survive plaintiff is going to have to move the focus off himself and onto his prescriber and the FDA.

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In our civil society, many non-governmental entities certify various things.  We’ve all heard of the Good Housekeeping Seal of Approval, which has been around for over a century.  Then there is Consumers Union/Consumer Reports – a magazine that does nothing but rate products, and recommends those it rates particularly highly rated or as providing a particularly good value.  There are a host of private standards testing organizations like the ASTM International, the American National Standards Institute, and the International Standards Organization, which in their respective fields create and maintain voluntary industrial standards for any number of commercially related operations.  These entities determine things such as what the “N95” in an N95 facemask means.  A myriad of other industry, medical, and online organizations certify and rate an almost endless variety of goods and services.  Heck, even lawyers get rated.

Continue Reading Suing the Certifiers – A Dangerous Undertaking

Drug & Device Resources

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