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Litigation is about the subject at hand, of course.  Is the product really defective?  Did it really cause the alleged injury?  But litigation can also be about the litigation itself. It’s like that line in The Beatles’ Penny Lane: “And though she feels as if she’s in a play/She is anyway.” The process and its subject matter become self aware. But whereas Penny Lane was a joyful bit of pop artistry, litigation typically is bereft of joy or artistry. The discovery portion of litigation can be inordinately expensive and intrusive.  Sometimes – and maybe our cynical defense hack hearts are taking over at this point – it seems that plaintiffs will do everything possible to make discovery as expensive and intrusive as possible.  

In particular, as if the dinner bell was ringing with the commencement of discovery, plaintiff lawyers visibly salivate at the prospect of deposing every sales representative in sight (and maybe not even in sight).  Sales representatives who detail medical providers on the virtues of products must look like a tasty steak to a ravenous plaintiff lawyer.  Were those virtues oversold?  Were risks undersold?  And then there ensues the usual battle over whether sales rep depos are necessary, or how many are necessary, or how many antacids will be consumed as we wade through this dreary process. The process can get dreary because the process can get almost endless. And yet that need not be so.  Federal Rule of Civil Procedure 26 provides that a court, either on motion or on its own, “must” limit discovery if it finds that the discovery would be unreasonably cumulative, or could be obtained via a more convenient method, or is simply out of bounds.  

Baldwin v. DePuy Orthopaedics, Inc., 2023 U.S. Dist. LEXIS 54471 (N.D. Illinois March 30, 2023), is a useful magistrate discovery ruling applying Rule 26’s limiting principle and granting a protective order against depositions of a defendant’s detail representatives. The plaintiffs in Baldwin alleged that they were injured by a defective hip replacement medical device.  They contended that the defendant’s detail representatives had relevant information because they had “direct contact and communications regarding the device components at issue” with the plaintiff’s surgeons and because at least one of them attended each of the surgeries. The defendant filed a motion for a protective order prohibiting the depositions.


The court in Baldwin granted the protective order for the following reasons:  (1) The implanting surgeon had no recollection of receiving information about the device from those sources and “did not make clinical decisions for patients based on marketing material from device manufacturers” [you can get similar testimony from most doctors] and he could not recall any specific information he relied upon in selecting the device; (2)  All the information the sales rep would have come from the defendant, who had “already produced voluminous documents and witnesses for depositions [that is almost always the situation]; and 3) The presence of the sales reps during the surgery did not, without more, make their testimony relevant. 

On that last point, the plaintiffs tried to demonstrate a nexus between the sales reps’ presence in the operating room and the claims in the case by pointing to the testimony of surgeons in other cases regarding the same product.  But those other cases are, well, other cases.  The plaintiffs could not establish any relevant nexus in this case, so the Baldwin court had no hesitation in granting the protective order and shutting down the sales rep depositions. (By the way, this is not the first time that we have discussed a case involving the significance, or lack of significance, of sales rep presence in the operating room. See here, for example.)

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The recent decision of the Hawai’i Supreme Court in State ex rel. Shikada v. Bristol-Myers Squibb Co., ___ P.3d ___, 2023 WL 2519857 (Haw. March 15, 2023), isn’t all bad by any means – but it’s bad enough, and it carries with it the prospect of liability based on a virtually limitless number of individualized genetic traits, so you can bet we’re not very happy after reading it.

You’d be right.

Continue Reading Trouble in Paradise
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When last we spoke, we were about to deliver our beautiful standard poodle puppy, Luca (registered name Tivin Dreamcatcher), to his show handler, who would trim him and train him and launch his dog show career.  The transfer was accomplished without incident, if you don’t count mommy’s predicable reaction to the separation.  It also included a fun day of hanging around the dog show watching Luca’s beautiful white sister, Leah (Tivin Dreamweaver), who has already begun showing.  Luca responded to the strange setting and new people with the joyous confidence he has exhibited since he was a tiny baby.  Combined with the fact that he compares well to the exacting AKC conformation standard, we think that this “look at me” attitude will stand him in good stead as a show dog.  Luca’s first shows are next weekend, and we are beyond thrilled that we will be ringside. 

The federal court system also has exacting standards, and the plaintiff in today’s short decision failed to satisfy them.  In Richardson v. Tandem Diabetes Care Inc., 2023 U.S. Dist. LEXIS 38279 (W.D. La. Mar. 7, 2023), 2023’s first entry in our Twiqbal cheat sheet, the plaintiff alleged that his wife/decedent was fatally injured when the defendant’s insulin pump malfunctioned.  He asserted claims for design defect and “construction/composition defect” (a manufacturing defect claim) under the Louisiana Products Liability Act (“LPLA”).  The defendant moved to dismiss on two grounds:  PMA preemption and Twiqbal (failure to plead facts to support the LPLA theories of liability.)   The plaintiff did not respond to the Motion to Dismiss.

Addressing preemption first, the court explained that the insulin pump was a Class III medical device subject to the FDA’s full pre-market approval (“PMA”) process.  Under SCOTUS’s Riegel decision, as readers of this blog know, state-law product liability claims against manufacturers of Class III devices are preempted when they seek to impose “requirements with respect to the device that are different from, or in addition to, the federal requirements.”  Richardson, 2023 U.S. Dist. LEXIS 38279 at *6 (internal punctuation and citation to Riegel omitted).  In this case, as the court held, the plaintiffs only theories of liability were expressly preempted – the plaintiff did not even attempt to assert a parallel claim to escape preemption.

Given this, the court did not need to address the Twiqbal arguments, but it did.  The court explained that, in support of the design defect claim, the plaintiff alleged only that his decedent’s insulin pump was “reconditioned.”  The Complaint “fail[ed] to allege any . . . facts with respect to the design defect and/or whether there existed any alternative design for the insulin pump that was capable of preventing [the decedent’s] injuries.  Id. at *8.  Under the LPLA, these pleading failures were fatal to the design defect claim. 

With respect to the “defective construction/composition” claim, the court explained that, under the LPLA, a plaintiff must establish that, “at the time the product left the manufacturer’s control, the product deviated in a material way from the manufacturer’s specifications or performance standards for the product or from otherwise identical products manufactured by the same manufacturer.”  Id. at *9 (internal punctuation and citation to LPLA omitted).  The plaintiff’s complaint contained no such allegations – it did not even mention the specifications or performance standards for the insulin pump – and it failed to plead any causal connection between the alleged manufacturing defect and the plaintiff’s decedent’s injuries.  Like the design defect claim, the court held, the complaint did not allege sufficient facts to support the “defective construction/composition” claim.

And so the court dismissed the complaint on both preemption and Twiqbal grounds, a result that is no less satisfying because it was inevitable.  (Presumably because the plaintiff had previously been granted leave to amend, this dismissal was with prejudice.) We will talk to you soon with a report on our baby’s first dog show.  In the meantime, we wish happy celebrations to those who celebrate Passover and Easter.  Stay safe out there.

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Time and time again, we have opposed efforts by one side of a scientific dispute – typically involving a prescription medical product – to attempt to sue the other side of that dispute into silence.  We came to that position through the crucible of litigation, since plaintiffs in the Bone Screw litigation sought to sue a variety of medical societies because they supported the (at the time) off-label use of bone screws for pedicle fixation.  We have tried to be consistent.

Continue Reading Agree To Disagree – Don’t  Sue the Other Side of a Scientific Dispute into Silence
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About two months ago, we marveled at the notion that challenges to facially neutral state and local government vaccine requirements were still percolating through the legal system.  We probably should not have been surprised by the persistence of frivolous litigation.  After all, our day job entails defending litigations that can last years longer than they should after the science and merits have been pretty clearly decided, at least in our defense hack eyes.  We should not be startled to see that this flip side of COVID-era litigation also persists in 2023.  After the last several years, perhaps we should turn down our internal surprise-o-meter or risk a muscle strain from shaking our head so often at the things we find absurd.  We will risk a shake and hearty scoff at the law at issue in Stock v. Gray, No. 2:22-CV-04104-DGK, 2023 WL 2601218 (W.D. Mo. Mar. 22, 2023).  The result, at least on preliminary injunction, does restore a bit of our faith in the sanity of at least one portion of the federal system.

Stock involves a pharmacist’s First Amendment challenge to a patently ludicrous Missouri law.  This was not like cases we still see where neutral vaccine policies are challenged (unsuccessfully) on the basis that they interfere with free exercise of religion, another First Amendment right.  Instead, the Missouri law clearly picked a side.  The side it picked was against public health and the authority of FDA, which is charged by Congress with protecting public health.  As we have said so many times before, ivermectin is a veterinary drug that is not indicated for the treatment of any condition in humans and hydroxychloroquine is indicated to prevent or treat malaria in humans and to treat lupus and rheumatoid arthritis in humans.  No reputable medical authority supports using either one to prevent or treat COVID-19 in humans.  (To pile on, COVID-19 is a viral illness and malaria is caused by a parasitic protozoan.)  Throwing that aside for non-funny political theater, Missouri enacted a law in 2022 that limited the ability of pharmacists to react to prescriptions for human use of either of these drugs.  While pharmacists were made immune from disciplinary action from the state board of pharmacy for dispensing either drug on prescription, they were prohibited from “contact[ing] the prescribing physician or the patient to dispute the efficacy of ivermectin tablets or hydroxychloroquine sulfate tablets for human use unless the physician or patient inquires of the pharmacist about [their] efficacy.”  Id. at *4.  To initiate contact would create a risk of a range of disciplinary actions against the pharmacist.  That, dear readers, is what is known as a content-based restriction on free speech.  No legislator with even a modicum of knowledge of First Amendment law could think this would pass muster given what the Supreme Court had to say about state law content-based restrictions against speech concerning pharmaceutical products in Sorrell v. IMS Health, Inc., 564 U.S. 552 (2011), and especially in the months after the Supreme Court revisited the subject of content-based speech restrictions more generally in City of Austin v. Reagan Nat’l Adver. of Austin, 142 S. Ct. 1464 (U.S. 2022). 

Like we said, this seemed like political theater rather than legislation directed at protecting public health, so maybe passing constitutional muster was not part of the equation.  Stock’s challenge to the law contended her professional ethics required her to continue to dispute the efficacy of these medications for treatment of COVID-19, as she had been doing since March 2020, consistent with the advice of FDA, NIH, WHO, and an alphabet soup of public health entities, as well as manufacturers of these drugs.  She sought to enjoin the statute because it infringed on her free speech.  Within a few months, her motion for preliminary injunction and the defendant board of pharmacy’s motion to dismiss were ripe.

We will dispense with the challenge to plaintiff’s standing, which was weaker than the “evidence” supporting using ivermectin to treat COVID-19.  The first step in the preliminary injunction analysis was deciding whether plaintiff was likely to succeed on the merits.  She was.  Noting that the statute’s prohibition applies when the pharmacist tries to “express a particular view, namely, a view disputing the efficacy of the drugs,” but not to “tout, endorse, or acclaim the drugs,” it was easily seen as impermissible “viewpoint discrimination.”  Id. at *7.  The board tried to turn the phrase “dispute the efficacy” into something akin to “discuss the positives and negatives of its use, regardless of whether the pharmacist agreed with or disagreed with the prescription.”  The court rejected this argument because, well, it could read.  Id. at *7-8.  This meant the plaintiff was likely to establish that the statute was unconstitutional.  Under Eighth Circuit law, this finding meant the other requirements for preliminary injunction were automatically satisfied.  Id. at *8 (citing Rodgers v. Bryant, 942 F.3d 451, 456 (8th Cir. 2019)).

The Stock court noted that the board’s brief failed to cite Rodgers, “the controlling caselaw on the preliminary injunction standard,” and urged its counsel to cite “relevant controlling caselaw” going forward.  Id. at *6 n.4.  If that is how the case is being litigated by the board, then it will continue for a while.  There seems to be little hope that Missouri would repeal its ill-conceived and backwards law.  Doubling down on doltishness these days is no longer surprising.

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Hey, come closer. We’ve got a secret to share with you. We’ll whisper it in your ear. Ready?  Courts hate sealing filings.  It’s an administrative pain.  Plus, parties who claim confidentiality tend to be a bit promiscuous in that regard, labeling far more documents confidential than is warranted.  We’ve been on both sides of confidentiality disputes, and we get how risk aversion can drive one to slap a “Highly Confidential” sticker on way too many documents.  Better to err on the side of caution, right?  Well, maybe not always. You know that saying about how pigs get fat and hogs get slaughtered?  Parties who overdesignate documents as confidential can end up as bacon.  (By that we mean that they get fried, not that they are delicious). 

For an illustration of this reality, take a look at Thelen v. Somatics, LLC, 2023 U.S. Dist. LEXIS 47793 (M.D. Fla. March 21, 2023), a case that raises an unusual confidentiality issue.  The plaintiff brought a product liability suit against a manufacturer and a distributor of an electroconvulsive therapy (ECT) medical device. The plaintiff alleged that he sustained permanent neurological damage from the ECT device, that the defendants knew of  the risk of such injuries, and that the defendants failed to warn of those risks. The complaint included causes of action for negligence, strict liability, and breach of warranty.  

The issue in this decision involved the plaintiff’s request that all of his medical records (presumably largely psychiatric) should be filed under seal.  Despite the motion being unopposed, the plaintiff’s motion for sealing was denied.  That fact alone should tell you how much courts disdain the sealing process.  

The Thelen court began its analysis by observing that “Filing information under seal is disfavored.”  There must a showing of good cause to overcome the “presumption of public access.”  The plaintiff argued that his “privacy interest in maintaining the confidentiality of this sensitive material is compelling and outweighs the public interest in accessing court documents.” The Thelen court disagreed. The plaintiff, by bringing this product liability lawsuit, placed his health condition directly at issue.  The information in the medical records was central to the case, as opposed to being of only marginal relevance.  The plaintiff’s medical condition, including mental status before and after the ECT was front and center, and the court would need to address that issue in resolving pending summary judgment and Daubert motions. 

It appears possible that the plaintiff, as is typical, hurt his cause by over-designating what he wanted sealed.  According to the court, “The material proposed for sealing contains everything from general information about the Plaintiff’s medical history to very detailed information on his symptoms, medications, lifestyle, and interaction with and treatment by medical and psychological professionals.”  

But the very nature of the case put all of that information in play. Moreover, the plaintiff did not claim that the information in the records was unreliable. Indeed, much of it was self-reported.  In any event, the plaintiff would have the opportunity to “set the record straight in the lawsuit.”

Nevertheless, it is hard not to have some sympathy for the plaintiff.  The court certainly had sympathy: “While the Court understands why Plaintiff would wish to keep from the public record information concerning the details of his medical history, and his lawyers cannot be faulted for seeking to do so, in the end once a matter is brought before a court for resolution, it is no longer solely the parties’ case, but also the public’s case.” (Quotation and citations omitted.) 

Most of our readers either have faced or will face the dilemma of confidentiality designations. Plus, we do not mean to be cynical, but we’ve run across some plaintiff lawyers who weren’t particularly shy about using the threat of publicity to increase their leverage.  Underdesignate, and you might waive confidentiality or visit embarrassment on your client. Overdesignate, and you might provoke the judge into wholesale denial.  Your client might push you towards overdesignation. If that happens, you might need to push back. Otherwise, the judge will push your confidentiality/sealing motion right into the trash bin, and there is no pushing back on that. 

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We know the real quote attributable to Bill Gates is “content is king,”  But as communications continue to become shorter and more compressed, context can get lost in the shuffle; and context as much as content, drives our knowledge and interactions.  So, when the court in Henry v. Nissin Foods (U.S.A.) Co., opined that “context is crucial” in determining whether the reasonable consumer would have been misled, it caught our eye. 2023 U.S. Dist. LEXIS 45491, *15 (E.D.N.Y. Mar. 17, 2023).  While this particular case is about whether a food label was misleading, the issue has transportability to labeling and warnings for drugs and devices.  All too often our clients face allegations based on cherry-picked information – an isolated study or the always dreaded bad document.  Or, plaintiff’s counsel wants to focus on a portion of the labeling to the exclusion of the treating physician’s knowledge.  So, it’s our job to make sure the context is not lost. 

In this particular food case, plaintiff claimed the defendant’s label that stated “No Added MSG” misled consumers into believing that the product contained no MSG or glutamates.  But plaintiff failed to place that statement in the proper context.  On the front of the package, next to that statement was a disclaimer: “contains small amounts of naturally occurring glutamates.”  Id. at *16.  A disclaimer can defeat a claim of deception if it dispels the misleading impression given by the labeling statement at issue.  Id.  Here, the court concluded that the disclaimer “puts consumers on notice” of the possibility that the product has glutamates and therefore it “clarifies any misconception caused by the label.”  Id. at *20.  This was enough to defeat plaintiff’s various state consumer protection violation claims and breach of warranty claims. 

There is another way context was important in this case.  And that’s the difference between the context of FDA statements and state consumer protection laws defining “misleading.”  Because the context is different the court would not allow plaintiff to import FDA guidance and statements about MSG into her state-law cause of action.  In making her arguments, plaintiff relied heavily on two FDA documents (a proposed rulemaking and a backgrounder) containing statements about whether “No Added MSG” is misleading if placed on a product that contains ingredients that contain glutamates.  But, “misleading under the FDCA is not necessarily the same a “materially misleading” under state consumer protection statutes.”  Id. at *12.  For example, the FDCA definition of misleading does not include the “reasonable consumer” standard.  The FDA’s experience while germane to whether there has been a violation of the FDCA, does not extend to whether something is materially misleading under state law.  Therefore, the FDA’s statements about MSG are irrelevant to the legal issue before the court and would not be considered.   

While it does not exactly fit into our “context is king” theme – there was also a useful pleading-related holding.  “Mere allegations in a complaint that a statement would mislead a reasonable consumer do not satisfy a plaintiff’s burden at the pleadings stage.”  Id at *9.  So, maybe the tie in is plaintiff better have context rather than unsupported conclusions to withstand a TwIqbal challenge.

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We read a couple of recent articles in the local Philadelphia legal press questioning whether lawyers participating in depositions really had any idea what the “usual stipulations” for their depositions even were.  Between the two articles, they cited three cases.  The issue also prompted some discussion among us bloggers, with one of us commenting that, “for decades,” he has rejected reference to “usual stipulations” in depositions, in favor of the phrase “applicable rules and orders.”

Continue Reading What Are the “Usual Stipulations” for Discovery Depositions, Anyway?
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We reported nearly two years ago on a California trial court that dismissed claims against generic over-the-counter drug manufacturers under California’s notorious Proposition 65, on the basis that federal law preempted those claims.  You can read that post here, and you will see that we said at the end that an appeal was likely. 

Well, that easily foreseen appeal has come and gone, and the OTC defendants once again prevailed.  In Center for Environmental Health v. Perrigo Co., No. A163682, 2023 WL 2421132 (Cal. Ct. App. Mar. 9, 2023) (to be published), the California Court of Appeal held that federal regulation of drug warnings under the Food Drug & Cosmetics Act preempted Prop 65’s warnings requirements. 

To recap, Prop 65 is a voter-enacted law that requires businesses to warn Californians about significant exposures to chemicals that allegedly cause cancer or birth defects.  See Cal. H&S Code § 25249.5 et seq.  We can see why this passed a popular vote.  Who would vote against requiring warning about alleged cancer-causing chemicals?  In practice, however, Prop 65 has resulted in boilerplate warnings being posted in businesses of every kind all over California, making the warnings ubiquitous—and eminently ignorable.  That is why Prop 65 has become a poster child for ineffective and counterproductive over-warning. 

The primary beneficiaries of Prop 65 are attorneys who file lawsuits to recover generous statutory penalties and attorneys’ fees from businesses that do not provide Prop 65 warnings.  That was the purpose in Center for Environmental Health, where the plaintiff sued over the alleged presence of N-nitrosodimethylamine—known as NDMA—in certain generic OTC drugs.  The trial court ruled that federal law preempted a state-law action seeking to require Prop 65 warnings that were different from the FDA-approved drug labeling. 

The Court of Appeal affirmed the dismissal on the basis that the plaintiff could not identify any method by which the generic drug manufacturers could provide a Prop 65 warning while still complying with federal law.  That is implied impossibility preemption, i.e., when it is impossible to comply with both state and federal law, the state law requirements have to give way. 

How did the court get there?  The court started with interesting commentary on the odd nature of this lawsuit.  Prop 65 is intended to regulate toxic substances that are deliberately introduced into the environment.  By comparison, NDMA—if it actually exists in the subject drugs in the first place—is an alleged contaminant.  As a result, “A lawsuit seeking to require warnings that the products contain NDMA—which, again, is not supposed to be in them at all—seems a poor way to address the potential danger to consumer health.”  Id. at *6.  The court has a point.  This lawsuit is a square peg in a round state-law hole.

On preemption, recall that the FDCA contains a provision expressly preempting state-law requirements for OTC drugs.  Prop 65, however, is exempted from express preemption by a savings clause stating that express preemption does “not apply to a State requirement adopted by a State public initiative or referendum enacted prior to September 1, 1997.”  Id. at *5 (citing 21 U.S.C. § 379r(d)(2)).  Prop 65 is the only state enactment that falls within the exemption, which is surely no coincidence.  Id. at *5.  For its part, Prop 65 has its own exception, under which it does not apply to “[a]n exposure for which federal law governs warning in a manner that preempts state authority.”  Id. at *7 (citing Cal. H&S Code § 25249.10(a)). 

The Court of Appeal’s discussion of the two statutes is long and detailed, but it boils down to this:  Only implied preemption can apply, and even then, only if federal law governs warning in a manner that preempts state law governing warning.  The dispositive question then was “whether it is possible for the generic-drug defendants to provide warnings about their products that satisfy both Proposition 65 and federal law.”  Id. at *9. 

The court held that they could not and therefore that federal law impliedly preempted state law.  The FDA has not approved drug warnings like those required by Prop 65.  Moreover, under the Supreme Court’s opinion in PLIVA, Inc. v. Mensing, generic drug manufacturers have an ongoing duty to ensure that their drug labeling is the same as the innovator’s FDA-approved labeling.  Id. at *10.  Here, the plaintiff failed to identify any method by which the generic-drug defendants could give a Prop 65 warning without deviating from FDA-approved labeling and thus violating federal law.  Thus, implied preemption. 

The plaintiff argued that the generic-drug defendants had avenues to provide Prop 65 warnings while still complying with federal law, but the Court of Appeal rejected those arguments.  The plaintiff argued that the FDA had never stated that Prop 65 warnings regarding NDMA were inappropriate.  But that did not change the fact that the FDA has never approved such a warning and that it was impossible for the generic-drug defendants to seek such approval in any event (even assuming that the FDA would ever grant approval, and there is no indication that it would).  Id. at *15.  It also made no difference that the FDCA exempted Prop 65 from express preemption, since the issue here was implied preemption.  Id. 

The court rejected the argument that point-of-sale signs are not federally regulated “labeling,” relying on U.S. Supreme Court authority interpreting “labeling” broadly to include material “designed for use in the distribution and sale of the drug[s]” as part of “an integrated distribution program.”  Id. (citing Kordel v. United States, 335 U.S. 345, 349 (1948)).  The court likewise rejected the plaintiff’s reliance on a Ninth Circuit case interpreting warnings under the federal statute regulating fungicides more narrowly, finding “no basis for importing that focus into the [FDCA].”  Id. at *15-*16. 

Finally, the generic-drug defendants could not comply with Prop 65 through public advertising either.  Prop 65 requires that the warning be delivered so “as to render [it] likely to be seen, read, and understood by an ordinary individual under customary conditions of purchase or use.”  Id. at *16 (emphasis in original).  Any public advertising that met this standard would necessarily qualify as “labeling” under federal law.  Id. at *17. 

Our prediction of an appeal in this case required no particular insight, nor does it require clairvoyance to predict that the plaintiff will petition for review in the California Supreme Court.  We will report back with any further developments. 

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Stop us if you have heard us say “stop us if you have heard this before.”  Pelvic mesh cases on remand have often faced the harsh realities of procedural requirements and burdens of proof because transferee judges have treated them like individual cases rather than items in an inventory.  Decisions about the impact of failure to serve proper expert reports that cover the right topics at the right time, as well as the inevitable attempts to backfill, are not limited to pelvic mesh cases on remand.  However, these issues seem to be particularly prevalent in this particular species of lawsuit.  We detailed the trouble one of these, Donalds, had in federal court in the Old Line State.  Depending on the figurative route from the MDL court in West Virginia to its remand destination, Donalds passed a sign urging it to “Please Drive Gently.”  The typically gentle treatment from the MDL did not last and the plaintiff ended up with her sole case-specific causation expert excluded and her case tossed on summary judgment.  (Not to confuse things, but, a few months later, we covered the unsuccessful appeal of a somewhat similar pelvic mesh remand case called Donaldson.)

While some plaintiffs might pack it in or perhaps sue their own counsel, the Donalds plaintiff filed a motion to reconsider and, after that was denied, appealed.  In an unpublished decision, the Fourth Circuit affirmed.  Donalds v. Ethicon, Inc., No. 22-1737, 2023 WL 2446703 (4th Cir. Mar. 10, 2023).  We return to Donalds not only because we realized that we have questioned each of the four experts plaintiff named, but because cases presenting permutations of this same fact pattern are still percolating through the courts.  The facts and pertinent procedural history are fairly simple.  Plaintiff sued in the MDL over alleged injuries from defendant’s stress urinary incontinence sling after it was explanted (and later replaced by another of defendant’s stress urinary incontinence slings), she named experts about a year later, her case was remanded about two years after that, defendant moved for summary judgment, and the court requested briefing on the admissibility of the plaintiff’s only case-specific expert under Fed. R. Evid. 702.  That expert’s report was bare bones—much like many reports produced by a number of plaintiffs’ experts in those MDLs when their signatures were being affixed to ten or more reports on a given day.  Without addressing alternative causes, the report concluded “the complications [plaintiff] endured following implantation . . . were proximately caused by the erosion of the mesh product.”  Id. at *1.  In connection with the Rule 702 briefing more than three years later, plaintiff offered an affidavit from the expert to try to fix the obvious deficiencies in his report.  The court did not consider the affidavit in excluding the expert’s causation opinions and granting summary judgment.

On appeal, plaintiff offered a series of arguments, some of which she had waived along the way.  Up first was whether the expert’s disclosed causation opinion was properly excluded.  Citing Joiner and the Fourth Circuit’s strong decision in Sardis the Donalds panel tagged the expert’s opinion as merely ipse dixit.  The multiple failings included 1) not identifying a defect that allegedly caused the injuries (as required by Maryland law), 2) not addressing other possible causes, and 3) not identifying the reasons or methodology behind his opinion.  Id. at *3.  (The latter also posed an obvious problem under Fed. R. Civ. P. 26(a)(2)(B).)  So, no abuse of discretion in excluding it and, therefore, granting summary judgment.

The affidavit was evaluated as an untimely disclosure, so Fed. R. Civ. P. 37(c)(1) required plaintiff to show the non-compliance was “either justified or harmless.”  It was neither (or, rather, the district court’s conclusion was within its discretion).  It came more than three years after the deadline, even though defendant’s responsive expert pointed out potential alternative causes of plaintiff’s injuries and plaintiff’s expert’s failure to address them.  Plaintiff did not seek leave to supplement and “persistently argued only that presentation of the supplemental report was not a discovery violation at all.”  Id. at *4.  It was also not a timely attempt to supplement an incomplete or incorrect disclosure.  As one of the cited decisions put it, “Courts distinguish ‘true supplementation’ (e.g., correcting inadvertent errors or omissions) from gamesmanship, and have therefore repeatedly rejected attempts to avert summary judgment by ‘supplementing’ an expert report with a ‘new and improved’ expert report.”  Id. at *5 (quoting Gallagher v. Southern Source Packaging, LLC, 568 F. Supp. 2d 624, 631 (E.D.N.C. 2008)).  This should certainly be the line courts draw, regardless of whether the case is or once was in an MDL.

Plaintiff also argued that the trial court should have allowed her to offer expert causation testimony from the explanting physician, thus raising an issue of material fact to defeat summary judgment.  This was the gist of plaintiff’s Rule 59(e) motion for reconsideration.  The court below properly held this argument had been waived because it had not been raised in response to the motion for summary judgment.  Id. at *5.  There was also a clear Rule 26 issue, because the physician had been designated as a non-retained expert (as just about all implanting and explanting physicians were designated by plaintiffs in the pelvic mesh MDLs) but the designation did not mention a causation opinion.  So, there were two good reasons to not allow this end run.

There are possible good reasons to allow an expert to supplement a timely expert report or even name a new expert after the deadline has passed.  It would be nice, however, if what constitutes a good reason did not vary so much depending on whether it is the plaintiff or defendant seeking to supplement and whether the case is or once was pending in a large MDL.

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