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We’re in New York this week for a legal conference that is always a good time.  But, truth be told (and we are officers of the court, after all), several years ago we attended a conference sponsored by plaintiff lawyers and it was in every way a delightful affair.  The judges did more than show up on one perfunctory panel. Rather, the plaintiff lawyers put the judges to work, installing them on panel after panel. Consequently, the audience was treated to more than the usual judicial bromides about how parties ought to work things out among themselves, etc. Further, the food at the plaintiff conference was superb. There was no rubber chicken in sight.  Most important, the plaintiff lawyers tossed around way more wisecracks than we typically hear at any of the three-letter conferences. Our favorite plaintiff lawyer, upon learning that one of the token defense hacks on a panel had argued the Daubert case, said it was like meeting Ebola patient zero. Good times. 

But is Daubert – er, sorry, we mean Rule 702 – really that much better for defendants than the former governing standard, Frye?  General acceptance is a pretty serviceable standard. Taken seriously, that standard would trip up most of the junk science masquerading as a plaintiff’s causation theory. The recent opinion in Wholey v. Amgen Inc., 2024 WL 4885723 (N.Y. Supreme Ct. Nov. 26, 2024), makes us nostalgic for a muscular Frye test. Wholey shows that the old Frye standard can sometimes have real teeth.  The Wholey opinion (which is on its way to publication) affirms summary judgment against a plaintiff who alleged that a drug she took to treat her rheumatoid arthritis had caused her to suffer from squamous cell cancer of the tongue.  The case fell apart because her medical causation experts flunked New York’s Frye standard — which turns out to be more stringent than Fed. R. Evid. 702 (at least as that rule is applied by timid federal judges).  

The plaintiff’s experts in Wholey admitted that “there were no clinical studies or medical literature to support their position.”  The plaintiff experts “also failed to establish that their reliance upon an individual case occurrence, as well as FDA warnings and adverse case reports related to the use of [the drug at issue] amounted to an acceptable methodology of determining a causal connection.”  

New York law had already established that “observational studies or case reports are not generally accepted in the scientific community on questions of causation.”  The plaintiff’s experts in Wholey were reduced to proposing a “stepping stone” methodology that has never been allowed by any New York court. Thus, the trial court did not abuse its discretion in determining that the experts did not offer generally accepted opinions.  

Goodbye, frail expert opinions. Goodbye, case.  Sometimes there really is something wonderful, even wholesome, about a New York state of mind. 

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We are all familiar with the phrase—the rules are the rules.  Meaning, rules should be enforced consistently, regardless of personal circumstances.  Essentially the opposite of—rules are made to be broken.  Meaning, exceptions to the rules abound.  The law is full of both the former (strict adherence rules) and the latter (loose adherence rules).  The difference between the two often being how much deference or latitude the court is given in applying the rules.  One rule with little wiggle room is Federal Rule of Civil Procedure 54(d)(1):  “Unless a federal statute, these rules, or a court order provides otherwise, costs—other than attorney’s fees—should be allowed to the prevailing party.”  As two Florida plaintiffs recently learned in Rebando v. Coopersurgical, Inc., 2024 U.S. Dist. LEXIS 213078 (M.D. Fla. Nov. 22, 2024) and Cunningham v. Sanofi-Aventis, U.S., L.L.C., 2024 U.S. Dist. LEXIS 215131 (M.D. Fla. Nov. 25, 2024).

In both cases, defendants were awarded summary judgment on products liability claims.  Both defendants then moved for costs.  The costs that a prevailing party are entitled to recover are set forth in 28 U.S.C. §1920 and include fees for serving subpoenas, fees for recorded transcripts necessarily obtained for use in the case, printing and witness costs, charges for copies of materials necessarily obtained for use in the case, docket fees, and costs for court appointed experts and special interpretation services.  While it is up to the party seeking costs to provide sufficient detail and documentation establishing the costs, if the losing party challenges the costs, the losing party bears the burden of showing the costs should not be awarded.  However, as both courts noted, there is a “strong presumption” that costs will be awarded to the prevailing party.

In Cunningham, defendants filed a bill of costs seeking approximately $7500 for video and stenographic deposition transcripts and approximately $2000 to collect medical records.  Defendants in Rebando sought approximately $26,000 for service of subpoenas and for video and stenographic deposition transcripts.  With respect to the deposition transcripts, plaintiffs in both cases argued that they should not have to pay for the video recordings because defendants failed to explain why both video and stenographic transcripts were needed.  But both courts found plaintiffs were too late in raising that objection:

when a party notices a deposition to be recorded by nonstenographic means, or by both stenographic and nonstenographic means, and no objection is raised at that time by the other party to the method of recordation pursuant to Federal Rule of Civil Procedure 26(c), it is appropriate under § 1920 to award the cost of conducting the deposition in the manner noticed.

Cunningham and Rebando quoting Morrison v. Reichhold Chems., Inc., 97 F.3d 460, 464-65 (11th Cir. 1996).

However, in Rebando, the court disallowed the videography fees for three depositions where defendants could not demonstrate that they were noticed as video depositions.  So, word of caution—if you are video recording a deposition, make sure your deposition notice clearly so states.  Rebando, at *22-23.

In Cunningham, plaintiffs also argued that transcripts costs must be “necessary” to be recoverable and that video was unnecessary because the footage was not used and plaintiff would testify live at trial.  Plaintiff misplaced the focus of the inquiry.  “It is not necessary that such videos be used.  The focus is on the need of the prevailing party throughout the case.”  Cunningham, at *5.  Both forms of transcripts were relied on by defendants in preparing their defense and in support of their summary judgment motion, so both were recoverable.  Id. at *6.    

Both cases also involved requests for costs associated with obtaining medical records.  And both plaintiffs complained about the number of times records were requested.  The Cunningham court had “little trouble concluding” that because plaintiff had put her health at issue, the collection of medical records, including getting updated medical records, was necessary “to understand Plaintiff’s claims and potential alternative causes.”  Id. at *8.  The Rebando court was likewise unpersuaded by arguments that defendants should not be allowed to recover for collecting medical records or subpoenaing witnesses that were not used in the summary judgment briefing.  Rebando, at *11-12.  In Rebando, the court did disallow a few claims that lacked supporting documentation and for a few subpoenas that appeared redundant.  But serving a medical facility at multiple business locations is not redundant and such costs were allowed. 

Each case had one additional unsuccessful argument by plaintiffs.  In Rebando, plaintiffs argued that their financial circumstances made them unable to pay the costs.  But financial status can be grounds to reduce a cost award only where the non-prevailing party provides “substantial documentation of a true inability to pay.”  Id. at *7.  In this case, plaintiffs offered general information about their total income, but provided “nothing beyond conclusory statements . . .  [that] fall far short of establishing that costs should either be denied or reduced.”  Id. at *8.  Plaintiffs offered to provide more, but the court admonished that they should have done so with their response or sought an extension of time to do so.  They did neither and therefore, financial status would not be taken into consideration.

In Cunningham, the court rejected plaintiff’s suggestion that awarding costs would have a “chilling effect” on future litigation.  Plaintiff cited no case law recognizing a “chilling effect” as a factor to be considered in awarding costs.  Cunningham, at *7.  And while we agree it should not be a factor on deciding the bill of costs, we wish Rule 54(d)(1) actually gave plaintiffs more pause in deciding whether to pursue meritless or marginal claims.  It isn’t fee shifting, but it isn’t nothing either.  Cunningham is a Taxotere case and Rebando involves an implant used in tubal ligation.  We’ve written about both litigations numerous times.  These are not one-off cases.  But despite defendants’ repeated successes, these plaintiffs took their iffy cases all the way through to summary judgment.  They lost.  They should pay.  The rules are the rules.

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In 2018, our blogpost on In re Johnson & Johnson Talcum Powder Products Marketing, Sales Practices & Liability Litigation, 903 F.3d 278 (3d Cir. 2018), was entitled “Money For Nothing?  No Standing This Time in the Third Circuit.”  There, it appeared that the Third Circuit had drawn an eminently reasonable bright line disallowing no-injury class actions by plaintiffs who used a product without incident, and then belatedly claimed that the product had some attribute that it supposedly should not have had.  J&J Talc held – “succinctly” – that “buyer’s remorse, without more, is not a cognizable injury” that provides constitutional standing in federal court.  Id. at 281.

What a difference six years – and a different panel – make.  Recently, in Huertas v. Bayer US LLC, ___ F.4th ___, 2024 WL 4703136 (3d Cir. Nov. 7, 2024), the same court rejected a standing argument on essentially identical facts.  The unsuccessful plaintiff class in J&J Talc alleged that the product at issue “can lead to an increased risk of developing . . . cancer,” and thereby caused them economic loss.  903 F.3d at 281.  Similarly, the plaintiff class in Huertas “s[ought] compensation for economic losses they allegedly suffered from purchasing products that they claim are worth less” because they were allegedly “contaminated” with “[b]enzene . . . a chemical that has been labeled a human carcinogen.”  2024 WL 4703136, at *1.

Thus, both cases shared not only economic loss claims alleging products that were supposedly “worth less” than what was purportedly “bargained,” but also the shared same reason for the claimed diminished value − an undisclosed, and entirely unrealized, cancer risk.  Neither product allegedly failed to do what it was supposed to do.  J&J Talc, 903 F.3d at 281 (plaintiffs did “not allege that [the product] failed to adequately perform any of these functions”); Huertas, 2024 WL 4703136, at *4 (no claim that the product “did not perform therapeutically as expected”).  How could the no-standing decision in J&J Talc possibly not be controlling of the claim in Huertas?

The only distinction Huertas offered was gossamer thin and factually irrelevant:

J&J is distinguishable because the Court explicitly recognized that it did “not involve allegations of a defective product.”  Here, however, [defendant’s] products were not supposed to contain benzene, and Plaintiffs plausibly alleged that the benzene contamination − the product’s defect − rendered it unusable, making it inherently worth less than if it had been manufactured properly.

2024 WL 4703136, at *4 (footnotes omitted).

So what was the alleged cancer risk in J&J Talc?  The majority didn’t bother to say, but the dissent mentioned “asbestos” almost immediately.  903 F.3d at 294.  The dissent also had no trouble calling the product “defective” despite the plaintiff not pleading that in so many words.  Id. at 295.  That raises the legal question whether the undisclosed presence of asbestos in a product can make it “defective”?  Well, duh.

Both J&J Talc and Huertas arose in New Jersey, and consulting Westlaw reveals that the New Jersey Supreme Court has used “asbestos” and “defect” or “defective” in the same sentence twelve times – for instance:

In this common law, strict-liability failure-to-warn action, plaintiff had to prove that . . . use of [defendant’s] asbestos . . . was dangerous − a product defect; [and that defendant] forwarded the asbestos bags . . . without adequate warnings − in a defective condition. . . .  [Liability] requires proof of two different forms of causation:  product-defect causation and medical causation.  For product-defect causation, the plaintiff must show that the defect in the product − the lack of warnings or adequate warnings − was a proximate cause.

Fowler v. Akzo Nobel Chemicals, Inc., 276 A.3d 1146, 1160 (N.J. 2022) (citations and quotation marks omitted).  All in all, no fewer than 90 New Jersey state and federal cases have used “asbestos” and some version of “defect” in the same sentence.  Under New Jersey law, it seems safe to say that asbestos-containing products can be considered “defective.”

To distinguish J&J Talc because, supposedly, an incompetent plaintiffs’ counsel simply failed to plead that the purported presence of asbestos made the product “defective” is to distinguish an otherwise controlling prior published opinion into oblivion, since all that any future plaintiff need do is remember to label the defendant’s product “defective” – which is easy, since it’s a legal conclusion rather than a fact.

Beyond essentially thumbing its nose at the Third Circuit’s stare decisis rules, Huertas strained mightily to analogize the “waste” of a partial tube of OTC fungicide (see 2024 WL 4703136, at *2 & n.6 (no plaintiff purchased more than one tube of an implicated product lot) with an earlier decision involving an expensive prescription drug – where the plaintiffs had quantified their damages as being in the hundreds or thousands of dollars.  See Cottrell v. Alcon Laboratories, 874 F.3d 154, 160 (3d Cir. 2017), cited in Huertas, 2024 WL 4703136, at *5.  In J&J Talc the named plaintiff sought damages for products bought over “approximately six decades.”  903 F.3d at 282 n.4.  Huertas is truly a money-for-nothing case, even worse than J&J Talc, where de minimis non curat lex.

That’s the bad part of Huertas – its resurrection of a bogus “benefit-of-the-bargain theory,” based on a product that “perform[ed] therapeutically as expected,” 2024 WL 4703136, at *4, and that a prior published opinion had definitively put to rest.  All one has to do is read the conclusion in J&J Talc to understand that its holding did not in any depend at all on the absence of a “defect” allegation in the pleading, but instead on fundamental flaws with this sort of economic loss theory:

[Named plaintiff] contends that other people have suffered health complications from using [defendant’s product].  Regardless of whether that serious allegation has merit, injuries suffered by others do not permit us to conclude that [plaintiff] has herself suffered an injury in fact.  The only injury that [plaintiff] alleges is purely economic in nature − that is, that had she known more about [the product], she would not have purchased it in the first place.  But [plaintiff’s] wish to be reimbursed for a functional product that she has already consumed without incident does not itself constitute an economic injury within the meaning of Article III.

903 F.3d at 293 (emphasis added).  These were the “reasons” that J&J Talc “conclude[d] that [the named plaintiff] does not have Article III standing,” id. – not that the plaintiff had a bad lawyer who failed to plead that an asbestos-containing product was “defective.”

However, while this aspect of Huertas was awful – and it was the most important part of the case – Huertas does have some silver linings that defendants should keep in mind going forward.

First, Huertas holds that a recall, by itself, does not establish product contamination:

Plaintiffs urge us to infer from [defendant’s] recall itself that Plaintiffs’ products were contaminated. . . .  [T]his was insufficient to establish that they purchased contaminated products.  The mere fact that a product was recalled would not nudge Plaintiffs’ claims across the line from conceivable to plausible.

2024 WL 4703136, at *6 (citation, footnote and quotation marks omitted).  That’s important, because these no-injury cases are all class actions, and this holding prevents contamination from becoming a dreaded “common issue” upon mere proof of a recall.

Second, the Huertas plaintiff was only able to establish that he purchased any contaminated product because of a factual quirk that is unlikely to recur in future cases of this ilk.  Plaintiffs had commissioned some rather spotty pre-complaint testing that the defendant contended with considerable force failed to establish that the claimed product contamination “was sufficiently widespread to plausibly affect any given [unit].”  Id.  However, the court’s “reservations” over plaintiff’s less-than-conclusive testing were counteracted by allegations the defendant made in a separate complaint filed in a supplier liability action while the Huertas matter was on appeal.  Id. at *7.  Those allegations – trumpeted by plaintiff at oral argument − prompted a remand to consider this “new” evidence.  Id.  Going forward, that unusual circumstance should be avoidable, such as by the use of arbitration clauses.

Third, even if the plaintiffs’ testing were enough to avoid dismissal, the scope of such testing – which (as here) will usually be minimal – limits the size of any recall-based class action.  “[N]either the recall itself, nor the . . . testing . . . have any relevance” to anyone (presumably including absent class members) who cannot establish use of a product from a lot that tested positive for contamination.  Id. at *8.  Those plaintiffs were all “properly dismissed . . . for lack of standing”:

To conclude otherwise would require an inference that all products sold during the recall window contained the specified prefixes, or that those prefixes dominated [defendant’s] sales during that time frame.  [Nothing] allege[s] facts that would support this inference.  Without any information to tie these Plaintiffs’ products to the recall other than the timeframe during which they made their purchases, these Plaintiffs’ allegations stop short of the line between possibility and plausibility.

Huertas, 2024 WL 4703136, at *8 (citations and quotation marks omitted) (emphasis added).

To us on the defense side, this last point is the most useful aspect of a rather dismal opinion.  Since proof of contamination cannot be based on the recall alone, as already mentioned, that means some sort of product testing is essential to fill that gap.  Thus, in a recall situation Huertas requires, as a prerequisite to standing, “sufficiently widespread,” id. at *6, testing – on a batch/lot by batch/lot basis – to establish that each plaintiff used a contaminated product.  Since standing is much easier to achieve than establishing liability, that also means that the requisite proof of use of a contaminated product will be an individualized issue that both limits the size of any putative class and ultimately should defeat class certification.

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There was a time when it seemed that half our posts were mixed bags of TwIqbal — product liability claims tested against the SCOTUS decisions in Twombly and Iqbal requiring pleadings to be substantive and plausible.  Then things settled down for a bit.  Did plaintiffs get smarter?  Did courts resume tolerance for bare bones complaints? Today’s case, Zamora v. AAP Implants, Inc., 2024 WL 48551352 (S.D. Fla. Nov. 21, 2024), is a mostly favorable TwIqbal magistrate’s decision.  It reminds us of the power and limitations of TwIqbal.

The plaintiff in Zamora claimed that a medical device (plate and screws) used to treat a fractured arm failed catatstrophically.  She alleged that the device “broke, snapped, split, and or cracked inside” her arm while she was “performing the simple movement of lifting her hand to her mouth.”  Her complaint included causes of action for failure to warn, design defect, manufacturing defect, and negligent “failure to test and inspect.”  

The defendant filed a motion to dismiss the complaint, which prompted the plaintiff to amend.  Then the defendant moved to dismiss the amended complaint, which prompted the plaintiff to file a second amended complaint.  Then the defendant moved to dismiss the warning, manufacturing defect, and failure to test/inspect causes of action.  That motion was teed up for the magistrate, except that the failure to test/inspect claim really was not at issue because the plaintiff did not respond to the motion to dismiss that claim. The court concluded that the plaintiff had conceded on the test/failure claim, and such concession made good sense because Florida law does not recognize an independent cause of action for negligent failure to test or inspect.  Thus, this case goes onto the failure to test cheat sheet for putting Florida on the nice, not naughty, list. 

The discussion of the warning claim applies the rationales for both of our recent TwIqbal posts on pleading the purported warning defect (“Plaintiff fails to allege the risks associated with the Device’s prescribed use”) and pleading physician-based warning causation (“allegations that explicitly claim that Plaintiff’s physician would not have used the Device if it were not for Defendant’s failure to warn”).  The plaintiff’s particularly poorly pleaded second amended complaint also failed to plead that the implanting surgeon, rather than the general public, should have been warned, so there are three pleading grounds for dismissing the plaintiff’s warning-related claims (“Plaintiff must clearly set forth the allegation that Defendant failed to warn her prescribing physician”).  Sadly, the court permitted the plaintiff to amend yet again.  Discovery was not yet closed, so why not take another shot at pleading an intelligible warning claim?  Grrrrr.  

Even more sadly, the plaintiff got away with a mashup of design and manufacturing defect allegations. The defendant argued that the manufacturing defect claim should be dismissed because it failed to allege that the device “deviated from all other Products or failed to meet a manufacturing specification” and because the plaintiff’s manufacturing defect claim was duplicative of her design defect claim. Indeed, to our jaded, defense-hack eyes, the defendant’s argument was absolutely correct.  As with most manufacturing defect claims, the one in Zamora was complete hooey, and complete TwIqbal bait.  

But the Zamora court seized upon the Bailey Eleventh Circuit case, which held that a plaintiff “should not be penalized for failing to possess and plead the specific facts involving the source of the defect that will likely come into her possession during the course of discovery.”  First, that “likely” is doing a lot of work.  Second, the proposition is unnecessary and silly.  Why not force plaintiffs to plead claims based upon actual known facts, and if discovery supports new theories, then the plaintiffs can add them?  But Bailey, Zamora, and way too many courts allow plaintiffs to plead claims based, not on facts or reasonable belief, but hope and cynicism. Consequently, the manufacturing defect claim, which will inevitably run aground on lack of evidence, lives on to clutter the docket.  Perhaps the court will be tougher minded when it comes to summary judgment.  

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We have reported on a few of these “non-drowsy” cough syrup cases.  The courts are split.  Some have put the cases to bed (here and here), but a few have given us nightmares (here).  Newport v. CVS Pharmacy, Inc., 2024 U.S. Dist. LEXIS 211026 (E.D. Mo. Nov. 20, 2024), unfortunately falls in the latter category. 

The allegations in Newport appear to be nearly identical to the other cases.  A common cough suppressant found in many over-the-counter cough medicines is dextromethorphan hydrobromide (DXM).  CVS sells its own brand of such a cough medicine.  The label on the cough medicine says “non-drowsy.”    Plaintiff alleges she relied on that statement in selecting the medicine, that she paid a “premium price,” and she in fact became drowsy after taking it.  She filed a putative class action alleging breach of warranty, breach of implied contract, unjust enrichment, and violations of various state consumer protection laws.  Defendants moved to dismiss all claims on several grounds.  Of chief interest to us is the court’s ruling on preemption. 

The FDCA has an express preemption clause for OTC drugs – requirements that are “different from or in addition to” or “not otherwise identical with” the FDCA are preempted.  Product liability claims have an exception, but this is not a products case.  Our first clue that this decision was headed in the wrong direction was the court’s resurrection of the presumption against preemption in an express preemption case, despite circuit court decisions (including the 8th Circuit) holding that such a presumption no longer exists.  Id. at *6. 

Because of the express preemption clause, this case should be focused on the federal regulations governing OTC medicines which are found in monographs promulgated by the FDA.  The monograph for cold and cough OTC medicines requires certain products in this class to carry a warning that the drug may cause drowsiness.  DXM is not one of them.  So, plaintiff’s case invites the court to hold the defendant liable for labeling the product as “non-drowsy” when such labeling complied with the FDA’s monograph.  Why then isn’t it preempted?

Indeed, both the court and plaintiff agreed that if plaintiff was seeking to add a drowsiness warning to the medicine; rather than merely seeking removal of the term “non-drowsy,” which she claimed was false and misleading—her claim would be preempted.  Id. at *8-9.  We don’t see the difference.  Claims of omission and claims of misrepresentation are two sides of the same coin.  No matter what you call it, the claim is premised on requiring something on the label that is “in addition to” what federal law requires, making it preempted. 

The court and plaintiff are correct that the FDA monograph does not explicitly address the term “non-drowsy,” but that is too narrow a focus.  It ignores for instance that the FDA’s expert panel considered scientific literature and data and concluded that DXM did not require a drowsiness warning.  Id. at *9.  Information that is available in the monograph’s regulatory history but which the court refused to consider because it lacks “force of law.”  Id. at *12.   It is undisputed that the FDA did examine whether certain products had to carry a “may cause drowsiness” warning and explicitly determined that DXM did not require it.  Therefore, the issue of drowsiness for DXM products was explicitly decided by the FDA. 

The ruling in Newport allows plaintiff to contradict the FDA’s conclusion that there was a lack of scientific evidence that this product causes drowsiness; precisely what Congress sought to prevent by enacting the express preemption clause.

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From our very first post back in early 2020 on preclusive power of the PREP Act, 42 U.S.C. §247d-6d, we were impressed by the scope of its combined preemption and immunity language.  There, we quoted the language from the HHS secretary’s emergency declaration:

[A] covered person shall be immune from suit and liability under federal and state law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration to or use by an individual of a covered countermeasure.

Quoting 85 Fed. Reg. 15198, 15199 (HHS March 17, 2020).

Continue Reading Deconstructing the PREP Act
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We consistently defend the ability of physicians to engage in off-label use. Bexis helped lay the scholarly foundation for courts to utilize the term “off label use,” and two of his law review articles remain go-to reads on the subject.  Not surprisingly, we follow medical malpractice decisions that address off label use.  Back in 2009, Mark Herrmann (the Blog’s co-founder with Bexis), published a law review article articulating the reasons why package inserts should not be admitted as standard of care evidence in medical malpractice actions. More recently, we wrote a comprehensive post collecting case law rejecting the admission of package insert evidence to establish a violation of the standard of care by physicians who used drugs or devices off label. Today’s case is a detailed opinion from the Iowa Supreme Court joining what is now the majority view—that package inserts should not be admitted as substantive evidence of the standard of care.

Continue Reading Package Inserts Are Not Admissible to Establish Standard of Care
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We have written many times, as recently as Tuesday, that the practice of plaintiff lawyers to include patently inapplicable claims among a laundry list of causes of action asserted in complaints is lazy, if not problematic.  It is rare to see a plaintiff self-regulate and cull down an overbroad pleading without a defense motion (or a conferral predicate to a motion).  We cannot recall a time when a plaintiff, evaluating the outcome of discovery, took the unilateral step to drop claims that were unsupported or to delete the sort of “on information and belief” assertions that often litter product liability complaints.  For example, medical device product liability complaints almost always assert one or more claims for manufacturing defect, yet discovery rarely uncovers support that a particular device did not meet specifications when it left the manufacturer’s control.  It is hard to imagine that a plaintiff lawyer has a good faith basis to assert a manufacturing defect claim after being presented with evidence that the lot that included plaintiff’s device met specifications and having nothing in the way of contradiction other than circular reasoning that the particular device must have been defective if it caused an injury to the plaintiff.  Another example common to drug and device product liability cases is where the complaint includes a number of allegations, whether or not tied to specific theories of recovery, that the defendant defrauded FDA, failed to report adverse events to FDA, and/or violated various FDA regulations.  If discovery showed that every single relevant adverse event was reported, then the unsupported (and arguably scurrilous) allegations about adverse events not being reported should be deleted at plaintiff’s initiative.  That does not happen, at least in the cases we see.

While plaintiffs in the TwIqbal era may pay some price for offering cookie-cutter complaints without detailed factual allegations, there is rarely a penalty for plaintiffs throwing as many muddy counts at the wall as they can and seeing what sticks.  When it comes to removal by a defendant, a recent case out of a hip implant MDL reminds us that there can be a benefit to the defendants doing something similar.  (This is certainly the case when it comes to asserting defenses in an answer and avoiding waiver down the road.)  Whether a case ends up in state or federal court can be outcome determinative and, as a result, we have discussed a number of decisions relating to removal and remand. We have never discussed the Supreme Court’s decision in BP P.L.C. v. Maor & City Council of Balt., 593 U.S. 230 (2021), before, which means it is a relatively obscure decision in our little corner of the blogosphere.  We offer Codman & Shurtleff, Inc., v. Medical Device Bus. Servs., Inc., No. 24-3737, 2024 U.S. App. LEXIS 28486 (6th Cir. Nov. 8, 2024), as something of a cautionary tale about the lessons of BP.

As often happens in MDLs, some cases are filed in state court with non-diverse defendants included as a means to block removal.  When removal happens, some of the plaintiffs will file motions to remand, which often get decided by the MDL court after transfer.  Even though removal can end up being determinative, decisions on remand motions are not “final decisions” and are not generally appealable under 28 U.S.C. § 1291.  Decisions granting remand motions are addressed by 28 U.S.C. § 1447(d), which makes clear that they are “not reviewable on appeal or otherwise, except that an order remanding a case to the State court from which it was removed pursuant to section 1442 or 1443 of this title shall be reviewable by appeal or otherwise.”  Of the two sections that serve as exceptions, § 1442 for federal office removal does come up in cases against drug and device manufacturers.  It is not often successful for various reasons, including that, notwithstanding our introduction, most experienced plaintiff lawyers in this space try to plead around it.  It does work sometimes, though.  In Codman, the defendants did not invoke § 1442 or § 1443 in their removal, and the MDL court issued an order granting the motion to remand.  2024 U.S. App. LEXIS 28486, *3.  The Sixth Circuit ruled that the denial of the motion to remand was not appealable. Id.

The lesson, however, comes from the holding in the BP case we mentioned above and Codman cited.  If either § 1442 or § 1443 is invoked in the removal, then the “remand order is reviewable in its entirety.”  Id.  That means, for our type of case, a removing defendant that wants the option of appealing an order remanding a truly diverse case should also offer a plausible basis for federal officer removal in its initial removal papers.  We say plausible because we do think Fed. R. Civ. P. 11(b) matters.  If the notice of removal can be signed consistent with that rule, though, then it should include an argument about federal officer removal to preserve an appellate option no matter how strong the argument for diversity jurisdiction may be.

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Back in our AUSA days we prosecuted many drug cases. That was a significant part of our job.  The defendants were uniformly unsavory and many were violent. That being said, the mandatory minimum sentences were often crazily high.  Sell 50.1 grams of crack and eat ten years.  If you had a prior drug conviction (hardly uncommon), you’re looking at twenty years. No wonder so many of these cases went to trial.  A guilty plea could not shave much off the sentence.   

Because we were in a big city office and drug deals were superabundant, we applied internal guidelines to manage the workload. The quantity of drugs sold had to exceed a certain amount before we would consider taking a case.  Small quantity cases would go stateside.  (After California passed a three strikes law, a comical side effect was that federal prosecutors had a weird piece of leverage: plead guilty or we’ll decline the case.) Even with the guidelines, we had plenty of work. 

Posturing politicians love to say they are tough on crime.  At least the crack-powder disparate treatment eventually went away. As we said, prosecuting these cases was part of our job.  But it was far from self-evident why a drug sale on a street corner in Los Angeles needed to be a federal case.  How can members of Congress who laud local control simultaneously insist that local drug crimes be prosecuted federally? Harsh treatment of marijuana (which is, ridiculously, a Schedule 1 drug) street sales seemed especially inappropriate, since casual marijuana use was far from anomalous.  And that was back in the 1990s. Federal prosecution of marijuana cases is really passing strange now, when most American downtowns smell like Amsterdam. 

All of which brings us to Cannabis Impact Prevention Coalition, LLC v. Hochul, 2024 N.Y. Misc. LEXIS 14151 (Sept. 30, 2024), in which opponents of New York State legalization of marijuana invoked the federal Controlled Substances Act (CSA – yeah, that abbreviation is more typically applied to something else, which makes the federalism implications even weirder) and the Food Drug and Cosmetics Act (FDCA) in an attempt to overturn state law.  They lost in this to-be-published decision.  

The New York law “allows for adults 21 years of age or older to use and possess marijuana in moderate amounts.”  Pursuant to that law, New York promulgated regulations that permit medical use of cannabis and affix various warnings to marijuana packaging/advertising, such as “cannabis can be addictive,” “cannabis can impair concentration and coordination,” and “there may be health risks associated with consumption of this product.”  Of course, as folks like to say in the comment sections, YMMV. 

The plaintiffs brought an action for a declaratory judgment and an injunction seeking to “put an end to Respondents’ unconstitutional ultra vires venture in violation of federal law and to compel [respondents] to perform their executive duties in accordance with federal law.”  Here is how the plaintiffs summarized their theory: “Respondents are attempting to orchestrate a marijuana trafficking operation utilizing taxpayer funds and public employees and resources. Their blatant disregard of every major objective embodied in federal marijuana law directly conflicts with, and otherwise stands as an obstacle to, Congress’s mandate that production, possession, and distribution of Schedule 1 drugs, including marijuana, be prohibited unless approved by federal law.”  That sounds less like a sober legal theory and more like a title card to the old Reefer Madness movie. 

The plaintiffs invoked the Supremacy Clause in arguing that the New York regulations were preempted by federal law.  

The respondents moved to dismiss the Governor because she was not a proper party to the action (granted) and moved to dismiss the action based on lack of standing (denied). Then we get to the respondents’ motion to dismiss the action for failure to state a cause of action. 

The issue boiled down to conflict preemption – a subject that has shown up in this blog every once in a while. The CSA’s classification of marijuana as a Schedule 1 drug represents a finding that marijuana has “no currently accepted medical use at all” and has a “high potential for abuse.”  That classification renders the manufacture, distribution, or possession of marijuana as a criminal offense.  (It might be high time to drop pot from schedule 1, but … politics. Here is a link to the DOJ’s pending proposal to down-classify marijuana.)

At the same time, the CSA expressly is not preemptive of state law.  It acknowledges the absence of Congressional intent “to occupy the field in which that provision operates, including criminal penalties, to the exclusion of any State law on the same subject matter which would otherwise be within the authority of the State, unless there is a positive conflict between that provision of this sub chapter and that State law so that the two cannot consistently stand together.”  

Is there a conflict? The New York State court concluded that there was no such conflict. In particular, while the federal CSA has been held to regulate “medical practice insofar as it bars doctors from using their prescription-writing powers as a means to engage in illicit drug dealing and trafficking as conventionally understood,” it does not purport to regulate the practice of medicine generally.  States have “great latitude” under their police powers to legislate protection of the health and safety of their citizens. Thus, the “structure and function of the CSA presume and rely upon a functioning medical profession regulated under the States’ police powers.”  So far, so good – we guess. But so what?

Nothing in the CSA requires a state to criminalize marijuana. Nor could Congress force states to enforce the CSA. Moreover, neither the CSA nor the FDCA allow private rights of action.  Most importantly for prescription medical product liability litigation is the holding that a plaintiff “may not circumvent a lack of a private right of action in one statute [the FDCA] by incorporating allegations of its violations into claims pleaded under another statute that does allow for a private right of action.”  Thus, the decision refuses to do to New York law what the California courts have done to California law — allow FDCA-based claims masquerading as ‘state-law’ claims. Since all of the plaintiffs’ asserted state statutory claims argued only violations of the CSA or FDCA, they were all dismissed. 

Would different/better pleadings survive a motion to dismiss?  Stay tuned. 

Photo of Michelle Yeary

So learned some plaintiffs in In re: Hair Relaxer Marketing Sales Practices and Products Liability Litigation, MDL 3060, 2024 U.S. Dist. LEXIS 206474 (N.D. Ill. Nov. 13, 2024).  While not a drug or device case, the problem it exhibits is common to many mass torts.  Plaintiffs’ counsels’ solicitations produce a rush to file complaints often without the requisite pretrial investigation that Rule 11 requires.  The result is usually hundreds of junk claims clogging up MDLs, costing defendants’ time and money to review and challenge, and often impeding settlement discussions because everyone knows the inventory is falsely inflated.  Or it can lead to problems like this.

Plaintiffs in In re: Hair Relaxer, filed a Master Long Form Complaint on behalf of all Plaintiffs and individual plaintiffs filed Short Form Complaints identifying the particular products used and alleged injury suffered.  The primary alleged injuries are ovarian, uterine, or endometrial cancer, but the Short Form Complaint includes an option to add “other” injuries.  Due to bankruptcy proceedings involving one of the defendants, plaintiffs making claims against that defendant had to file a proof of claim in the bankruptcy proceeding by April 11, 2023 and file suit in the MDL by September 14, 2023.  Id. at *155-156.  Thousands of plaintiffs filed suit by the September deadline.  All these months later, plaintiffs filed a motion for leave to dismiss without prejudice the cases of over 400 plaintiffs who have no confirmed diagnosis of ovarian, uterine, or endometrial cancer.  Id. at *156-157. Defendants opposed the motion arguing that the dismissals should be with prejudice.

The Seventh Circuit has a set of factors it considers in deciding whether to grant a plaintiff’s request for dismissal without prejudice.  First, the extent of defendant’s effort and expense in preparing the case.  Because very little case-specific discovery had gone forward, the court found this factor weighed in plaintiffs’ favor.  Id. at *159-160.

The second factor looks at whether plaintiffs “excessively delayed and lacked diligence in prosecuting their actions.”  Id. at *160.  Here the scales tipped against plaintiffs.  Plaintiffs argued that the complaints were filed in “good faith” based either on a misunderstanding of their medical condition or due to the “rush to file” created by the bankruptcy proceedings that prevented plaintiffs from confirming “these details.”  Id. at *161.  The court criticized the proffered excuses for the improper filings.  Whether a plaintiff has cancer is not a mere “detail,” but a “basic element” of her claim.  Id.  The bankruptcy was not a plausible excuse where plaintiffs had five months between filing a proof of claim and filing their lawsuits—sufficient time “for counsel to diligently investigate claimed injuries.”  Id.  Further, even if some plaintiffs “did not do their homework” before the filing deadline, that is no reason “for Plaintiffs who filed after September 14, 2023, to misrepresent a cancer diagnosis.”  Id. at *162. 

Plaintiffs also argued that the Master Long Form Complaint, Short Form Complaint, and Plaintiff Fact Sheet only encompassed the three types of cancer, seeming to suggest this led to confusion.  But both forms of complaints “expressly include non-cancer injuries.”  Id. at *162. And the court had reviewed Plaintiff Fact Sheets asserting non-cancer injuries.  So, “confusion” was no excuse for the “Plaintiffs moving to dismiss their claims [to] have not fulfilled even the minimal discovery obligation to complete a PFS.”  Id. at *163. 

The third factor the court considered was the explanation offered by plaintiffs for needing a dismissal without prejudice.  Which was—to preserve the right to re-file if they develop cancer in the future.  The court was sympathetic to this issue, leading to the final ruling that:  (i) claims of moving plaintiffs who alleged cancer and filed suit before the September deadline would be dismissed without prejudice; (ii) claims of moving plaintiffs who alleged cancer and filed suit after the September deadline would be dismissed with prejudice; (iii) the non-cancerous claims of any plaintiff moving to dismiss would be dismissed with prejudice.  Further, the court placed certain restrictions on plaintiffs who seek to re-file in the future.  They must file within six months of the date of diagnosis, can only refiled in federal court, and must serve a completed Plaintiff Fact Sheet and all authorizations within 10 days of re-filing.  In other words, if you are going to refile, this time you better have your homework done in advance.

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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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