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When the proposed (soon to be approved) Fed. R. Civ. P. 16.1, concerning MDL practice was finalized last year, we gave it one cheer in our “New Rule 16.1 – Better Than Nothing, But Not by a Lot” blogpost.  We were, and remain, concerned that the provision concerning early vetting of MDL claimants will prove inadequate to address the serious problem created by huge numbers of meritless claims.  But we did point out that the section about exchanging information about the “factual basis” of claims was different from the other items on the rule’s topic list:  it used “how and when,” as opposed to “whether” or “if” – indicating that such early exchanges were viewed as mandatory (in some form).  This, we thought, gave the defense an opening for seeking serious early vetting of MDL claims.

That may already be happening.

Continue Reading Excellent MDL Early Vetting Order Raises Hopes for Rule 16.1
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Today, the summer solstice, is one of our favorite days of the year.  It’s the first official day of summer, and readers in the U.S. will have anywhere from 14-16 hours of daylight (the farther north, the more daylight). We hope you get to enjoy some of the summer sunshine today—or at least this weekend.  As the late, great, Brian Wilson put it, “Sunshine, can’t get enough sunshine, I’m following the sunshine, everywhere I go.”

Continue Reading Eighth Circuit Affirms Rule 702 Exclusion of Plaintiff Design Defect Expert
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When you write a few hundred or more posts for a legal blog devoted to the somewhat niche subject of drug and device product liability law, you look for themes or hooks to keep both the writer and presumptive readers engaged.  The themes may be fairly obvious based on the date of the post, the subject matter, or the name of a party.  A post may include hidden references or word play for specific readers, sometimes upon request.  Song lyrics, movie quotes, sports stuff, and events in the lives of the authors may also feature in posts.  Of course, according to the conventions of this Blog, we use plural pronouns even when referring to a singular author, and we have also referred to author’s offspring with sobriquets like Drug and Device Law Daughter or Drug and Device Law Rock Climber.  Whether these devices amuse readers may be revealed in occasional emails, texts, or other comments that we receive.  Most attempts at cleverness echo like the sound of a falling tree in a forest with no human around to hear it.

With that insight into our sausage making complete, we begin to employ a number of these devices in our present post.  We will not, however, attempt any link to Juneteenth, the day on which this post is being published, because that would be silly and demeaning.  Cordle v. Enovis Corp., No. 24-5958, 2025 WL 1570340 (6th Cir. June 3, 2025), is merely the unpublished affirmance on appeal of a dismissal of a knee brace product liability case originally brought in Kentucky federal court.  We could talk about bourbon or horseracing or even President Lincoln if we wanted an easy theme.  Nah.  This past Sunday, we attended the college graduation of the Drug and Device Law Engineer (a.k.a. Drug and Device Law Coxswain) on a beautiful day in a remote corner of New England.  Were we to go the song route, we might feature a sappy snippet from “Cat’s in the Cradle” or “Sunrise, Sunset” or perhaps an updated version of “We Didn’t Start the Fire” that started with the events of 2003, when she was born.  Again, nah.  We can take a more direct route to link the graduation to Cordle.  Back in the early 2000s, we spent a fair amount of time litigating diet drug cases all over the Commonwealth of Kentucky.  We had the win on medical monitoring in the Kentucky Supreme Court in Wood v. Wyeth.  We had the class action settlement in Northern Kentucky that ended with plaintiff lawyers in jail and/or disbarred, a judge kicked off the bench and disbarred, and the forced sale of one of the most successful racehorses of this century.  We even had cases down in Ashland, where Cordle would eventually be pending, that involved one of the most notorious “pill mill” prescribers of the era.  One of the main local lawyers with whom we worked on these cases was distantly related to both Secretary of State Henry Clay and abolitionist Cassius Marcellus Clay, the namesake for the boxer better known as Muhammad Ali, collectively some of the best known Kentuckians.

In a respite from all of this litigating in Kentucky, we took a family vacation to a Caribbean resort with a small Drug and Device Law Engineer in arms.  En route from our room to dinner one night, an elegant older woman approached and asked us to hold the elevator for her husband, who “would love to see your beautiful baby girl.”  We acceded to the somewhat unusual request.  The lady’s husband ambled slowly down the hall, clearly impacted by advanced Parkinsonian symptoms.  When Muhammad Ali got to the elevator, his face lit up as he played with the little DDLE’s toes and cheek and made cooing sounds to her delight.  Her brother got a plaintiff mock punch to the jaw.

Forgive us our long and indulgent detour to our recounting of an episode from more than twenty years ago.  We did not need to go back nearly so far to make a connection to Kentucky, knee braces, personal jurisdiction, or pleading foibles.  We did it in small part—the main reason was to fulfill our fatherly duty to offset filial accomplishment with a touch of embarrassment—to emphasize what we see as the real relevance of the Sixth Circuit’s decision in Cordle.  We have said many times that plaintiffs usually get too many chances to plead claims that survive motions to dismiss and that too many courts let vague allegations suffice even after TwIqbal.  The Cordle appellate decision got it right on both issues.  From filing to dismissal to affirmance on appeal, the case lasted less than twenty-one months.  We have seen way too many cases where plaintiffs are still amending their complaints, pursuing jurisdictional discovery, and generally fumbling around to plead factual allegations that state a claim two years or more into a case.

Below, the Cordle plaintiff amended her complaint in response to the initial motion to dismiss by the one of two defendants served in the case.  The initial motion argued that there was no personal jurisdiction over the movant and that plaintiff’s complaint was too vague to state any claims.  2025 WL 1570340, *1.  The amended complaint added some details and a third defendant, an entity related to the movant.  A second motion to dismiss by the same movant was denied on personal jurisdiction, but granted on 12(b)(6) because the complaint offered only conclusory allegations about defect and causation.  After the remaining defendants were served, they both moved to dismiss on multiple grounds.  Id. at *2.  They were both dismissed, one for both lack of personal jurisdiction and failure to state a claim and the other just for failure to state a claim.  Id.  Plaintiff was also not granted leave to file a third complaint because her proposed amendment would have been futile given its lack of allegations of conduct and causation specific to each defendant.  Id.  On appeal, plaintiff challenged only the latter personal jurisdiction ruling and the denial of leave to amend, implicitly accepting that the second complaint failed to state any claims against any of the defendants.

On personal jurisdiction, plaintiff argued below and on appeal that the defendant at issue was subject to specific personal jurisdiction because it registered to do business in Kentucky.  Registration is not enough under Kentucky cases (see here for Kentucky cases and other registration cases) and plaintiff had not offered factual allegations of the defendant’s conduct of business in the state related to the case.  Id. at *2.  She also offered the general argument that her allegations against another defendant over which the trial court exercised personal jurisdiction should be sufficient against its parent.  But the second complaint did not allege that relationship or anything that the parent did regarding the product at all.  This meant that there was not a “factual basis necessary to support personal jurisdiction” over the particular defendant.  Id. at *3.  Plaintiffs do need to plead facts, after all.  This failure also doomed plaintiff’s argument that she should have been provided an evidentiary hearing before dismissal.  The “threadbare jurisdictional argument” in her written submissions did not create any disputed issues of fact that would have made a hearing helpful.  Id. 

Next up was plaintiff’s argument that she should have been allowed a third chance at a pleading claims and personal jurisdiction before her case was dismissed with prejudice.  In evaluating futility, the Sixth Circuit looked at the proposed third complaint and saw that it “contains only vague assertions that all defendants caused her injury through defective design, manufacturing, and distribution of the knee brace.”  Id. at *4.  It neither alleged what each defendant allegedly did wrong nor facts “showing that defendants worked together.”  Id.  There was no reason to force another round of motions to dismiss, and the district court was correct not to allow plaintiff “yet another bite at the apple.”  Id.  While some wine, and perhaps some children, will improve with age, a product liability case that starts with vague allegations rarely does.  If we had them handy, we would toss our caps in the air to celebrate the work of both Cordle courts for giving plaintiff her day in court without letting the case drag on too long.  Instead, perhaps a sip of bourbon—no ice or water allowed—may have to suffice.

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Wouldn’t it be nice if all legal disputes could be sensible? But, alas, overreaching plaintiffs make work, make motions, and often make craziness.  Sometimes those overreaching plaintiffs can be the government, and that makes things even worse. 

In Hayek Medical Devices (N.Am.) v. Vermont, 2025 Vt. Super. LEXIS 117, 2025 LX 12055 (Vt. Super. May 9, 2025), it was Vermont – yes, the home of Ben & Jerry’s, Orvis, and fine maple syrup – that brought the crazy. 

Are there heroes and villains in this lawsuit? By all rights, this should be a straightforward commercial case.  The plaintiff medical device company sold 50 ventilators to Vermont during the early days of the COVID 19 pandemic. Vermont did not pay for the devices.  It sent them back.  The plaintiff would have preferred to have been paid what was promised. Time for a lawsuit. Fun fun fun. 

Vermont took the position that the ventilators were unsuitable and that the sale was infected with misrepresentations.  So far so sane. 

But farewell sanity, love, and mercy.  Vermont made bizarre and overreaching discovery demands. It sought two databases from the medical device manufacturer. Vermont contended that the databases might help to show that the device company had not mitigated damages.  

God only knows why the state could not have stopped there.  But thestate not only demanded ediscovery from the defendant’s product tracking databases, but further demanded that the plaintiff manufacturer “provide the resources necessary for the State to analyze the data to defend this case.”  Thus Vermont demanded not only production of the databases themselves, but also “the technical capability that would include a server, the software and technical expertise and any other resources that may be needed to analyze the data from the databases.”  In other words, the state was demanding that the plaintiff company pay for its analysis of the defendant’s electronic data.  Help me Rhonda. 

It is bad enough to seek burdensome discovery, and it is worse to do it again. After filing a motion to compel compliance with those broad demands, Vermont took a couple of depositions and then supplemented its discovery motion with a demand for appointment of a special master to oversee discovery.  

Now we get around to why this case, odd as it is, might matter to you. Although here we are talking about discovery demands made by the defendant, and a state at that, similar discovery demands could just as likely (maybe more likely) be made by personal injury plaintiffs against a prescription medical product manufacturer as a defendant in product-related litigation. 

But don’t worry baby. The overbroad, overly/intrusive, and overly-expensive discovery requests were denied.  “The State has failed to demonstrate any basis for such unconventional and extraordinary relief.”  

The court also shut down the state’s demands for production of a wide range of documents in connection with a deposition.  That request was denied because it was a transparent attempt to seek more document discovery after the relevant deadline had passed.  Indeed, the tardiness and evident gamesmanship of the discovery demands seem to have poisoned the well. The state’s demand that the documents be produced before, rather than at, the deposition further demonstrated the improper purpose animating the request.  

Part of the good vibrations we picked up from the Vermont superior court’s analysis was the extensive reliance on federal law, including federal rules and the “numerous” federal cases rejecting similar attempts to impose such vast and unusual discovery obligations. 

But there are some differences between federal and Vermont law, and those differences helped the device company fend off the state’s demands.  The court rejected the state’s request for the unilateral appointment of a special discovery master.  The state of Vermont had no rule allowing special masters.  The state could not force the plaintiff to pay for that, and special masters are allowed in Vermont state court matters only by agreement.  Moreover, the request was – again – late because discovery was mostly over and a summary judgment motion was pending. The state’s request for a special master just wasn’t made for these times.

The lesson is that when a litigation adversary makes crazy discovery demands, even if the adversary is a state, don’t back down. Be true to your school (and your fellow defense hacks).  

(The author of this post wrote it while lying in bed, just like Brian Wilson did.)

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Rouviere has been a long and storied litigation. We have shared many parts of that story here (Zoom depositions during Covid), here (turncoat experts), here (reflections on Rambo litigation), and here (summary judgment on statute of limitations).  After six years of litigation that ended in a summary judgment that was affirmed on appeal, we thought our post one year ago was the last we would be speaking about Rouviere. But no, there’s more. Plaintiff, proceeding pro se (without her attorney husband who previously represented her), tried to get a do over by claiming that not one, not two, but three judges who handled her original case should have been recused for various conflicts—the trial judge, the magistrate, and one of the appellate judges. Fortunately, when all that smoke settled the court saw the transparent last-ditch effort for what it was—a whole lot of nothing.

 If you don’t want to take our word for how the underlying proceedings went down (in the above-referenced posts), today’s decision sets out the history nicely. Rouviere v. DePuy Orthopaedics, Inc., 2025 U.S. Dist. LEXIS 112077, *2-9 (S.D.N.Y. Jun. 12, 2025). Which brings us to the alleged conflicts:

  • The Trial Judge: owned stock in defendant’s parent company while presiding over the case. Id. at *9-10.
  • The Magistrate: while presiding over the case, he received fixed annual payments from his former law former pursuant to a “nonemployee compensation agreement” and said law firm at some point “helped” and “advised” the defendant’s parent company, “among many other major clients.”  Id. at *10-11.
  • The Appellate Judge: her spouse is a partner at a firm who represented defendant in a separate case while the appeal was pending. Id. at *11.

Only one of these rose to the level of a conflict that warranted recusal—the trial judge. But since his decision was affirmed based on a de novo review, the decision did not need to be vacated.

Federal Rule of Civil Procedure 60(b) provides the bases on which final judgments can be vacated and includes a catch-all for “any other reason that justifies relief.” Rule 60(b)(6). That is the basis on which plaintiff brought her motion—another indication of its flimsiness. But motions under 60(b)(6) are not favored and can only be granted “upon a showing of exceptional circumstances” based on “highly convincing” evidence. Id. at *14-15. Plaintiff’s hook for her Rule 60(b)(6) motion was that the judges should have recused themselves under 28 U.S.C. §455(a) (where there is an appearance of impartiality or impartiality might be reasonably questioned) or §455(b) (where the judge knows of a financial interest that could be substantially affected by the outcome of the proceeding).

Applying those standards to the magistrate judge, the court concluded that his annual payments were “too remote to raise reasonable questions about his impartiality.” Rouviere, at *21.  Considering that a judge’s own prior representation of a party is not automatic grounds for recusal, his former law firm’s prior representation of a party is even more attenuated. Further it is “unrealistic to assume that every partner at [ ] a [large] law firm has a relationship—let alone an ongoing relationship—with every client that the firm has represented.” Id. at *22. Moreover, the fixed annual payments are not an interest affected by the outcome of the proceeding.  Even plaintiff had to concede that the outcome of this case was not going to bankrupt the magistrate’s former law firm.  Id. at *26.

While the trial judge’s stock ownership was grounds for recusal, it is not necessarily grounds for vacating the summary judgment order. “To reopen a case based on a violation of Section 455, a litigant must demonstrate that relief from judgment is appropriate under Rule 60(b).”  Id.at *28. Which—see above—is an extraordinary remedy. The court looks at three factors: a risk of injustice to the parties, a risk of injustice in other cases, and a risk of a hit to the public’s confidence in the judicial process. Id. The Second Circuit’s de novo review of the summary judgment ruling cuts against all three factors:

Plaintiff, accordingly, has already received what she is asking for on this motion: an independent review of her case by a different and unconflicted decisionmaker. Because there is no basis to conclude that yet another independent review “would lead to a more just outcome,” “[t]here is no reason to force the parties to relitigate the entire case, likely causing significant delay.”

Id. at *29 (citation omitted). Plaintiff tried to argue that Second Circuit’s review was not really de novo, but the court was bound by the appellate court’s order which explicitly stated otherwise. Id. at *29-30.

Which brings us to plaintiff’s final argument—that the appellate decision should essentially be disregarded because one member of the panel was conflicted. But the fact that a spouse’s law firm, not the spouse directly, represents a party in another matter is not grounds for recusal. Id. at *31-32. Even if it were, majority rules in a panel of three on the Second Circuit. So, the ruling of the other two members of the panel suffice to uphold the affirmance of summary judgment.  Id. at *32.  

We again would like to believe that we are finally saying good-bye to Rouviere, but we’ve already been fooled once. So we make no assumptions about this plaintiff who just doesn’t want to let go.

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States cannot take over enforcement of federal requirements when Congress has entrusted that enforcement exclusively to the FDA.  In Iowans for Alternatives to Smoking & Tobacco, Inc. v. Iowa Department of Revenue, No. 4:24-cv-00448, 2025 U.S. Dist. LEXIS 85732 (S.D. Iowa May 2, 2025), the state of Iowa enacted a law imposing penalties on manufacturers and sellers of vaping products that have not received marketing authorization from the FDA.  In addition, the law makes the shipping or receiving of non-compliant vaping products a violation of Iowa’s consumer fraud law and requires the appointment of an agent for service of process, thus serving up violators to the plaintiffs’ bar on a silver platter.  The law also benefited two large tobacco companies because it would have allowed the sale of their vaping products while simultaneously hindering unauthorized competition.  What again do they say about politics making strange bedfellows?

Here’s the rub.  Most vaping products on the market today are not authorized for marketing by the FDA, but the FDA allows them to remain on the market anyway.  That is because the FDA has exercised its enforcement discretion to recognize that immediately forcing most vaping products off the market could result in vape users reverting to more harmful products—i.e., traditional cigarettes.  That would be bad. 

It also means that if Iowa were allowed to enforce its new law, it would be penalizing the sale of unauthorized vaping products when federal regulators have allowed the sale of those same products.  That would be preemption—implied obstacle preemption to be precise.  That is the form of implied conflict preemption that occurs when state law “stands as an obstacle to the accomplishment and execution of the full purposes of Congress.”  Iowans for Alternatives to Smoking, at *11-*12.

To stop the Iowa law, a group of manufacturers, sellers, and users of unauthorized vaping products sued, claiming that the Iowa law violated the Supremacy Clause (implied preemption) and equal protection.  The district court ruled in their favor. 

At the outset, you might be wondering how this group had standing to sue.  If they were selling and using products that were unauthorized by federal law—i.e., they had no legal right to sell and use the products in the first place—what legal right did they possess that allowed adjudication in a court of law?  The district court ruled that this is the wrong question.  “The appropriate inquiry focuses not on whether the Plaintiffs’ activities fully comply with federal law, but on whether they have alleged a concrete injury that could be redressed by a favorable decision.”  Id. at *19.  Here, the FDA’s enforcement discretion created a “regulatory environment” under which market participants developed legitimate business interests that Iowa’s law placed at risk.  That is a “judicially cognizable interest” sufficient to confer standing.

On the merits, Congress placed the regulation of vaping products under the Food, Drug, and Cosmetic Act, and Section 337(a) of the FDCA “states unambiguously that all proceedings to enforce or restrain violations of the FDCA ‘shall be by and in the name of the United States.’”  Id. at *24-*25.  The Supreme Court’s Buckman opinion, moreover, recognizes Section 337(a) as clear evidence that Congress intended the federal government to be the exclusive enforcer of the FDCA.  Id. at *25. 

That is not to say that states lack any enforcement authority over vaping products.  The Tobacco Control Act reserves to the states the power to regulate the sale and possession of tobacco products, and some jurisdictions have, for example, permissibly banned all vaping products or all flavored products.  The Iowa law, however, goes beyond establishing general requirements for tobacco product sales.  “Rather, it creates a registration regime that explicitly incorporates federal premarket review standards as the determinative factor for market access.”  Id. at *33.  In other words, Iowa was asserting enforcement authority that belonged exclusively to the FDA: 

The statutory scheme effectively allows Iowa to bring enforcement actions in its own name against manufacturers and retailers based on compliance with the [Tobacco Control Act’s premarket tobacco product application] process—a federal requirement that Congress entrusted exclusively to FDA enforcement. . . .  The law’s operative effect is to create a state-level enforcement regime for federal premarket authorization requirements, with Iowa substituting its enforcement discretion for that of the FDA.

Id. at *33-*34.  The Iowa law therefore was “parasitic on the FDCA.”  And, while the Tobacco Control Act preserved significant state authority over tobacco regulation, Buckman reminds us that “savings clauses do not affect the ordinary working of conflict preemption principles.”  Id. at *35.  Implied preemption is, after all, grounded in the Supremacy Clause of the U.S. Constitution, not a federal statute. 

The Iowa law had to give way.  States cannot enforce the FDCA, and a scheme that conditions sales based on FDA authorization status “impermissibly intrudes on upon federal authority and contravenes congressional intent to centralize FDCA enforcement in the federal government.”  Id. at *38.  The district court thus preliminarily enjoined the implementation of the Iowa law. 

The court rejected the plaintiffs’ equal protection arguments, since the government presented rational bases for the various distinctions drawn by the statute.  But an equal protection challenge under rational basis review was always a longshot.  The story here is preemption.  Iowa and the vaping statute’s other supporters may be unhappy with the FDA’s enforcement discretion, but that is how Congress wrote it.  Thanks to Jim Fraser at Thompson Hine for bringing this order to our attention and getting this great result. 

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We weren’t expecting to find anything bloggable when we reviewed the Supreme Court’s recent unanimous decision in Smith & Wesson Brands, Inc. v. Estados Unidos Mexicanos, ___ U.S. ___, 2025 WL 1583281 (U.S. June 5, 2025).  But we were struck by the familiarity of the allegations of illegal marketing that the Court in S&W held could not be passed off as “aiding and abetting.”  These were the same tired and repetitive allegations of purported “illegal marketing” by independent actors in the distribution chain that we have seen in so many drug/device cases – sometimes masquerading as “public nuisance.”

We think our clients can use S&W against such allegations, at least by analogy.

Continue Reading Unanimous Supreme Court Slaps Down Familiar Sounding Marketing Allegations In Landmark Gun Decision
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On the internet, “because reasons” is the default when you don’t have the time or energy to explain why something is correct, but you are sticking with your viewpoint nonetheless.

It is the opposite of what our profession expects from lawyers and the courts:  We all are supposed to explain, with crystalline clarity, why our conclusion is exactly right.  If precedent sets out a multi-factor test for analyzing an issue, we all are supposed to march dutifully through those factors, applying law to the circumstances of our case with sound reasoning and thorough arguments, and only then arriving at our desired destination/outcome.

But haven’t you noticed that sometimes a particular hoary multi-factor test analyzed in every motion or opinion on a topic is not necessarily ideal?  The factors draw too fine a distinction, such that the discussion of one factor hardly varies from the others.  Some factors don’t matter at all, and so are hardly addressed and never outcome-determinative.  Maybe some of the factors fail to get to the root of the real, motivating concern for the test.  Or maybe there are too many factors, more than really needed to explain why a given outcome makes sense.  (Yes, we are looking at you, class certification.)

Anyway, a good multi-factor test ensures the parties and the courts don’t brush over important concerns, and articulate sound rationales at each step.  A bad multi-factor test is long, muddled, and results in a string of arguments that sound suspiciously like “because reasons”.

We thought about the problems that can crop up with multi-factor tests when writing our recent post about the Lone Pine factorial analysis in Conklin v. Corteva, 2025 U.S. Dist. LEXIS 92028, 2025 WL 1402696 (E.D.N.C. May 14, 2025).  It was a good outcome, and the analysis was commendable—but the points made by the court did not necessarily tie up with the Lone Pine factor headings they came under.

That got us thinking:  Are the Lone Pine factors most often listed the right ones?  Is there a better test?  

In fact, we probably should get away from talking about “Lone Pine orders” altogether.  The name is triggering for some, and the judicial remedies needed to cure frivolous litigation have long outstripped the one solution crafted by that one New Jersey state court judge in that one case, Lore v. Lone Pine Corp., 1986 NJ Super. LEXIS 1626, 1986 WL 637507 (N.J. Super. Ct. Nov. 18, 1986).  How about “Early Vetting Orders”? 

Let’s start with the purpose of this type of case management/early vetting order:

A Lone Pine order is designed to assist in the management of complex issues and potential burdens on defendants and the court in mass tort litigation, essentially requiring plaintiffs to produce a measure of evidence to support their claims at the outset.

In re Digitek Prod. Liab. Litig., 264 F.R.D. 249, 255 (S.D. W. Va. 2010). 

But that is not the only role of such case management orders.  For one, there are burdens on defendants in every litigation, although they most certainly weigh heaviest in mass torts.  But even in single plaintiff cases those burdens can be disproportionate where there is a threshold factual issue or two and reason to doubt that the plaintiff has the evidentiary support for them that Fed. R. Civ. Proc. 11 requires.  For another, in MDLs and other mass torts, sometimes there are burdens that could be addressed even at the pleading stage, when dodgy plaintiffs’ lawyers hide under “master complaints” without ever needing to specify that the relevant product was used or a plausible injury occurred.

As to commonly listed Lone Pine factors, these are:

(1) the posture of the action,

(2) the peculiar case management needs presented,

(3) external agency decisions impacting the merits of the case,

(4) the availability and use of other procedures explicitly sanctioned by federal rule or statute, and

(5) the type of injury alleged by plaintiffs and its cause.

See In re Digitek Prod. Liab. Litig., 264 F.R.D. 249, 256 (S.D. W. Va. 2010).  Not all of these clearly and directly speak to the stated goals for such case management orders, and the purpose of some of these factors is facially opaque.

If we were writing on a blank slate—which we can, because this is our (collective) blog—how would we frame the purpose of case management orders to weed out frivolous litigation, and what factors would make up an improved test?

Better yet, we understand the Federal Judicial Center is working on a Fifth Edition to the Manual for Complex Litigation last updated in 2004.  Wouldn’t it be great to have some guidance in there on this topic?  How about something like this:

Particularly in product liability MDLs, but in any civil action where threshold fact issues determine the viability of a claim or defense, the court should consider entering a pretrial case management order implementing procedures that will confirm the plausibility of the allegations and ensure the discovery burdens on the respective parties remain balanced throughout the litigation. 

For example, in a product liability MDL, consideration should be give to entering a pretrial order requiring plaintiffs to establish the factual basis for their claim, such as order requiring plaintiffs to produce evidence they took or used the product in question before any other discovery is propounded, or an order requiring plaintiffs to submit a limited expert report supporting the allegation that the product caused the plaintiff’s alleged injury well before other expert discovery takes place. 

Factors to be considered in entering this type of pretrial order include, but are not limited to:

  1. The requirements of Rule 11 when signing a complaint;The burdens imposed on the parties and the court if a complaint turns out to lack evidentiary support for basic and foundational factual contentions;
  2. The type of pretrial order that would be most appropriate given the posture of the action; 
  3. The relative burden on the plaintiff(s) of such an order, and the burden to the court and the parties of allowing an unvetted case to proceed that later is revealed to lack basic and foundational evidentiary support; and
  4. The likelihood that unsubstantiated claims have been filed, considering the prevalence of attorney advertising for claims of the type at issue, the involvement of litigation funders, scientific debate about the evidence of causation, and similar issues.

While we are dreaming, what about a change to the Federal Rules of Civil Procedure?  One issue commonly raised by plaintiffs in opposing requests for case management orders designed to weed out the mass tort wheat from the chaff is the absence of explicit authority in the Federal Rules of Civil Procedure for something called a Lone Pine order.  We are with the courts that say the broadly worded Rule 16 already provides federal judges with enough flexible authority to suffice.  But express language in the rules would convert such orders from relative rarities to commonplace occurrences.

For example, Rule 11(b) currently states that by signing a complaint, plaintiffs’ lawyers are “certif[ying] that to the best of [their] knowledge, information, and belief, formed after an inquiry reasonable under the circumstances” that “the factual contentions have evidentiary support or, if specifically so identified, will likely have evidentiary support after a reasonable opportunity for further investigation or discovery.” 

Yet Rule 11’s enforcement mechanism (found in Rule 11(c)) is clunky and little used because it involves imposing sanctions—something courts are loathe to do, even when appropriate.  So how about a new Rule 11(e) that authorizes orders designed to make a party “put up or shut up” with regard to the Rule 11(b) obligations?  It could provide something to the effect of:

The court may, and where doubt has been raised should, issue a case management order for the purpose of confirming a party’s compliance with Rule 11(b).  This provision operates independently of Rule 11(c) and is unrelated to the issue of whether sanctions should be imposed.

Add a few Advisory Committee notes explaining that this new subsection is about proactively weeding out unsubstantiated claims early on—unrelated to whether a given lawyer should be sanctioned for their deficient pleadings—and that its use it to be encouraged as a case management tool, and we would be off to the races.

Or maybe add Lone Pine considerations to the list of issues to be addressed at a Pretrial Conference pursuant to Rule 16(c)(2), such that an amended version could read, in relevant part (with our suggested addition underlined):

At any pretrial conference, the court may consider and take appropriate action on the following matters:

(A) formulating and simplifying the issues, and eliminating frivolous claims or defenses, including ordering parties to adduce prima facie evidence of essential facts;

* * *

(C) obtaining admissions and stipulations about facts and documents to avoid unnecessary proof, and ruling in advance on the admissibility of evidence;

* * *

(F) controlling and scheduling discovery, including orders affecting disclosures and discovery under Rule 26 and Rules 29 through 37;

* * *

(L) adopting special procedures for managing potentially difficult or protracted actions that may involve complex issues, multiple parties, difficult legal questions, or unusual proof problems;

* * *; and

(P) facilitating in other ways the just, speedy, and inexpensive disposition of the action.

For this hypothetical change to Rule 16, Advisory Committee notes also could explain that Rule 16(c)(2)(A)’s new language is well suited to situations where, for example, a plaintiff’s claim turns on whether he or she in fact took a given pharmaceutical product, and was diagnosed with a particular medical condition.  Requiring that plaintiff to come forward with some preliminary proof—a prescription or pharmacy record for the drug in question, and one measly medical record reflecting the diagnosis—should not be a big ask, and it might well clear out unmeritorious cases well before the parties and court slog through expensive discovery and summary judgment.

In federal courts, MDLs are where most of the bad cases hide out, so the forthcoming MDL Rule, Rule 16.1, is another opportunity for courts to consider proactive case vetting orders. 

Rule 16.1(a) already requires the assigned MDL judge to hold  “an initial management conference to develop an initial plan for orderly pretrial activity in the MDL proceedings” and Rule 16.1(b)(3) requires the parties’ report in preparation for that initial conference to cover topics that overlap with Lone Pine concerns, including “how and when the parties will exchange information about the factual bases for their claims and defenses” [Rule 16.1(b)(3)(B)] and “the principal factual and legal issues likely to be presented” [Rule 16.1(b)(3)(G)]. 

Rule 16.1 then contemplates entry of “an initial management order” addressing such concerns that will “control[ ] the court of the proceedings unless the court modifies it.”  Rule 16.1(c).  Given Rule 16.1’s terms, there should be no doubt that MDL courts can and should proactively consider what early vetting requirements are needed and implement them from the outset in the initial MDL management order.

Drug and Device Law Blog hive mind, what are your thoughts?  What other factors should a Lone Pine test involve?  Is “Early Vetting Order” a better name?  How else can the defense bar push courts to more regularly screen cases?

Frankly, we would take any approach that leads to the issuance of early, frequent, and even minimal Lone Pine-type orders.  The just, speedy, and inexpensive resolution of civil litigation certainly would be improved as a result.  Because reasons.

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Today we offer a peek at A. Twerski, “A Quarter Century after the Products Liability Restatement: Reflections,” 90 Brooklyn L. Rev. 1027 (Summer 2025).  The “Restatement” under discussion is the Restatement (Third), Products Liability, and the “A. Twerski” is, of course, Aaron Twerski, the sole surviving reporter for that Restatement. Professor Twerski has written this retrospective law review article, and it is well worth our attention. 

We dwell in a jurisdiction (Pennsylvania) where the Third Restatement has not quite gotten the traction that was expected by most and hoped for by some. But by Twerski’s account, the Third Restatement has had significant influence on the law. Twerski offers a nice distillation of what Restatements do:

“Restatements are a conglomeration of past, present, and future. Some issues have been well decided and are not controversial. A restatement may clarify them and shake out some cobwebs that have crept into the case law. For these noncontroversial rules, a restatement may set forth elements of a doctrine in a manner to make it easier for a court to apply. Other issues are the topic of some current controversy in the courts. An objective observer may well conclude that the law is moving in one direction and, for justifiable reasons, take sides on the issue. Still, other issues are the subject of great chaos and confusion in the courts.  A restatement may help in crystallizing the issues and in suggesting a new rule.”

Indeed.  Sometimes we defense hacks like the suggested new rules. Sometimes we do not. 

The article is short and focuses on areas of controversy and areas that might “benefit from additional clarity.”  Some interest us not at all, such as Section 16 on apportionment of damages in crashworthiness litigation. Some are interesting almost to the point of inspiring dread. For example, Section 3 permits plaintiffs to “draw a res ipsa-like inference of defect without proving a specific defect.”  Some might crop up in situations where our clients could be on either side of the issue, such as Section 12 successor liability and Section 13 post-sale failure to warn. Section 5 brings some clarity with respect to imposing liability on component part sellers where they have substantially participated in the integration of the component into other design of the product. 

The article addresses the significant controversy swirling around Section 2(B) Design Defect and the extent to which plaintiffs must show a reasonable alternative design (RAD). Most states require a RAD. (Pennsylvania does for negligence, but not for strict liability.) Even those allowing recovery based on disappointed consumer expectations have read that test narrowly. According to Twerski (and it does not get any more authoritative than that), “The Restatement’s position that one cannot warn oneself out of a design defect claim is now the rule in almost all jurisdictions. A manufacturer must maximize its product with a RAD, and only when risks cannot be ‘designed out’ of the product are warnings called for.”

For we Drug and Device Law drudges, Twerski’s discussion of §6, regarding drugs, is particularly interesting and relevant to what we do.  That “we” refers both to honorable defense hacks and predatory plaintiff lawyers.  

Here are a dozen key points regarding Section 6:

1. The learned intermediary rule (yes, Professor Twerski calls it a “rule,” as we do – it is not a “doctrine” or “defense”) is close to unanimous. We and the article cast a grim side-eye across the river at New Jersey. Twerski also notes that a “few jurisdictions will impose liability for not adequately warning the consumer directly when the Food and Drug Administration (FDA) requires that a warning be given in a pamphlet when the drug is dispensed.”

2. Comment k was a mess.  At least eight different interpretations were propounded. The state of the law “was simply incomprehensible.”  Thus, the Third Restatement did not try to restate it. 

3. Allegations of reasonable alternative design are “unwise and irrational” in light of the extensive FDA approval process.  Here, Twerski shows a keen understanding of the challenges and expense of drug development. “Scholars agree that basing a cause of action on a RAD is beyond the competence of courts.”  (Think about what this means for the execrable Gilead duty-to-innovate theory.)

4. “For an expert to state that the alternative drug that he or she proposes would attain FDA approval is sheer sophistry. Drugs are simply different.”

5. An alternative safer drug already approved could be meritorious, but “few if any drugs will meet that standard,” since competing drugs treating the same condition have different risk/benefit profiles.  

6. Pure risk/benefit balancing is beyond the competence of the courts and should be left to the FDA.  

7. Design defect claims involving drugs are mostly attempts to salvage cases barred by the learned intermediary rule.  

8. The Restatement exception for drugs too dangerous for “any class” of patients is narrow and should be.  (Should this be an exception at all, given FDA approval?)

9. “Defective design is, for the most part, not a workable theory for drugs.”  

10. A post-sale design defect based on a claim that a drug should have been redesigned is preempted.(But Twerski agrees with the dissent’s reading of New Hampshire law in the SCOTUS Bartlett case. Ugh.)

11. Pre-sale design defect claims are entirely speculative, given FDA approval requirements.  

12. Levine was a failure to warn case, and it does not apply to design defect claims.

The Twerski article is short and clear.  Even if you find yourself disagreeing with parts of it, you will have to consider the possibility that, given who the author is, you might be wrong.  In any event, you will be better informed for having read the article. 

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This is not the first time we have posted about Gallego v. Tandem Diabetes Care, Inc.  About six weeks ago we told you all about the excellent preemption decision that dismissed the entire case with prejudice except for a piece of the negligent design claim.  On that, plaintiff was given thirty days to file an amended complaint that sufficiently alleged both an FDA requirement and facts supporting a violation of that requirement.  On day twenty-eight, plaintiff moved for “pre-answer discovery” and an extension of the filing deadline.  Gallego, 2025 U.S. Dist. LEXIS 103545, *2 (E.D.N.Y. May 31, 2025). What plaintiff was actually asking for was “pre-complaint” discovery.  What the court said was: No.

Rather than file the more specific amended complaint the court ordered, plaintiff asked the court to compel defendant to produce no less than thirteen categories of documents ranging from broad policies and procedures to complaint reports to testing documents to the complete design files. Id. at * 4-5.  Perhaps putting the cart before the horse is too narrow an analogy.  This plaintiff was looking to fling open the corral doors and let all the horses run wild.  The scope of this “pre-complaint” discovery was virtually every type of document you would except a plaintiff to request after they pass TwIqbal—certainly not before. 

But scope barely factored into the court’s decision.  That is because it is a solidly established legal principle that “a plaintiff must allege facts supporting a plausible claim before being entitled to discovery.” Id. at *8 (citing numerous cases for this proposition).  Plaintiff’s complaint was dismissed for failure to state a plausible claim; therefore, he is not entitled to discovery unless and until that failure is remedied. While plaintiff claimed he could not “fully articulate” a claim without access to defendant’s documents, he cited no legal authority that circumvents the plausible pleading before discovery rule. 

While plaintiff tried to base his motion on “inconsistencies” in publicly available information, he neither specified the inconsistencies nor offered any explanation for why he believed the requested materials would resolve them.  Id. at *10-11.  He also argued there was information omitted from public reports, but again offered the court no specifics as to what was omitted or how it would aid in re-pleading his design defect claim.  Id. at *11.   In other words, plaintiff’s motion for “pre-complaint” discovery was just as vague as his original complaint. 

And yes, even if plaintiff had mustered a colorable argument for why discovery should be permitted, the proposed broad document requests were hardly tailored to be proportional to the needs of the case.  Id.  Indeed, it is difficult to understand how a court could apply the Federal Rules relevance and proportionality standards without a pending claim to know what the discovery is relevant and proportional to.

Plaintiff’s discovery requests were denied and he was given two weeks to file the amended complaint.  That two weeks is up soon. So, stay tuned to see if we have Gallego Part III.

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