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Back in 2008, when Blog was less than two years old, we wrote a practical post entitled “Defense Amici – One Stop Shopping.”  It arose from blogposts we wrote examining the arguments made by defense-side amici curiae in the Riegel, Kent, and Levine (twice) cases then pending in the United States Supreme Court (yes, it’s been that long).  Describing the various amici arguments started us thinking about how could we get in touch with these resources should we ever be in the situation should we become party to an ultra-high profile appeal.

We did that because defense-side amici in big cases put together arguments that the rest of mere mortal defense counsel can use to a client’s benefit.  But how do mere mortals get these amici, should we need them?

That’s what this (updated) post is about.

Suppose that defense counsel – representing, say, a small medical device company (which recently happened in Himes) or a non-target defendant in some multi-district litigation morass (as in Buckman) – ends up grabbing the tiger by the tail.  Counsel obtains a major win (yay!), or worse, takes a significant hit (boo! – but it does happen).  The case goes up on appeal raising a significant issue.  Maybe it even goes to the United States Supreme Court.

Boom!  Lightning strikes.

The Supreme Court takes the case.  It can happen – it did happen to Pamela Buckman.

All of a sudden, the case is a very big deal.  All of a sudden, so-so opposing counsel disappears, and the plaintiff is now represented by the Public Citizen Litigation Group or some similar appellate specialist.

The defense needs amicus curiae support.

Counsel doesn’t want to get slimed.  So….  Who ya gonna call?

In this business, it ain’t Ghostbusters.

That’s what this post is all about.  Just like in 2008, we’ve reached out to major national defense-side amicus groups to get the basic information that defense counsel in such a situation need to bring a case to their attention.  And these are just the national groups.  If you’re in a state appellate court, also consider state-specific defense-side groups.  Moreover, some of the groups listed below have state affiliates.

One piece of general advice – near and dear to Bexis’ heart particularly, since he writes briefs for some of these groups:  Don’t waste any time making contact.  Any amicus group needs (and, as importantly, likes) sufficient time to consider the merits of a case, to make a decision, to engage a brief writer, and to get a persuasive brief written.  The timing for amicus briefs is (in most jurisdictions, but there are notable exceptions) tied to the due date for the principal brief filed the side being supported.  That means, especially when appealing a loss and having to go first as appellant, defense counsel needs to get the client on board, contact these groups, and submit the case to them as soon as possible after the matter has been accepted for further appellate review.

We can’t emphasis the importance of timing enough.  The likelihood of getting amicus support is very much inversely related to the time available to get a brief approved, written, and filed.

With that, here are the amicus players in the drug and device area that we know enough about to ask, and here’s what they need when considering whether to appear as amici in any given case.

AAM (Ass’n for Accessible Medicines):  AAM is the major trade association for manufacturers and marketers of generic drugs and biosimilars.  AAM’s primary focus is on patent, antitrust, and (most relevant to product liability) preemption issues related to generic drugs and regulatory issues involving approval of generic drugs and generic exclusivity.  The contact person for submitting a case to AAM is Karin Hessler (  Cases are submitted to AAM’s board of directors, and they have three weeks to decide whether AAM will appear as amicus.  Cases submitted with less than three weeks’ notice must be “extraordinary” to be considered, so act quickly.  AAM has no particular submission form to complete; a letter explaining the matter and the reasons why it should participate is sufficient.  Applicants are expected to submit whatever information they believe AAM’s board reasonably needs to evaluate the case.  Submitters are typically AAM members, but membership is not required.

AdvaMed – the medtech association (Advanced Medical Technology Ass’n):  AdvaMed is the world’s largest association of medical technology manufacturers, so medical technology cases are the primary focus of its amicus activity.  AdvaMed primarily appears in federal appellate courts, but will consider other courts (e.g., state high courts) if the case is important enough.  The contacts for submitting a case for AdvaMed’s consideration are Patrick Fogarty, Deputy General Counsel, ( and Christopher White (  There are no particular forms to fill out.  A detailed email with the opinion and relevant pleadings attached will suffice.  AdvaMed has a dedicated review committee  and prefers six weeks lead time to consider a case.  It will not consider a case submitted with a less than three weeks lead time.  AdvaMed may join another amicus brief or file its own as the needs of the case require.  It helps, but is not essential, for the client to be an AdvaMed member.

ALF (Atlantic Legal Foundation):  ALF’s relevant core issues are:  individual liberty, free enterprise, limited and responsible government, and sound science in judicial and regulatory proceedings.  Counsel seeking ALF amicus support in an appellate case need to complete this Amicus Support Request form and submit it to ALF Executive Vice President & General Counsel Larry Ebner (  ALF can rarely file an amicus brief anywhere with less than 30 days advance notice, and at least 45 days in the Supreme Court.  ALF has no “members” and does not consider possible financial contributions in deciding whether to appear as amicus.

ATRA (American Tort Reform Ass’n):  ATRA’s signature issue is tort reform, however, it’s branched out lately and will file briefs on other important tort law issues.  You (or your client) must be an ATRA member for any request to be considered.  Contact people for submitting a case for ATRA’s consideration are Tiger Joyce ( or (Lauren Sheets Jarrell at  ATRA has no specific turnaround time requirements.  There’s no set form to fill out, and ATRA will tell you what it needs in any given case.

BIO (Biotechnology Innovation Organization):  BIO will consider appearing as amicus curiae in any case with broad implications for the biotech industry, particularly where biotechnology is affected differently than the pharmaceutical or medical device industries.  BIO has two points of contact for amicus brief requests:  For health issues, including pharmaceutical reimbursement, FDA regulatory, antitrust (FTC, pharma M&A), and product liability contact John Delacourt (  For IP issues, including patentability standards, PTO and PTAB procedures, artificial intelligence, and FDA Orange Book listings, contact Hans Sauer (  The longer lead time BIO has to consider a case, the better.

DRI (Defense Research Institute)/DRI Center for Law and Public Policy (the Center):  At the recommendation of its Amicus Committee, the Center files amicus curiae briefs in cases presenting issues important to civil litigation defense lawyers, their clients, and the civil justice system.  The Center primarily participates in U.S. Supreme Court cases, at both the certiorari and merits stage, and occasionally in federal courts of appeals cases.  Amicus participation in state appellate courts requires consultation with relevant state or local defense organization (SLDO).  The Center usually files amicus briefs in its name only.  Criteria for participation are:  that the Center can add something new and meaningful to the arguments; the importance of the case or issues; and consistency with DRI’s overall mission and goals.  Requests to the Center must be made via its online Amicus Request Form at least 45 days before the requested amicus brief is due (except in extenuating circumstances).  Requests should be made by counsel for the party seeking amicus support.

LCJ:  (Lawyers for Civil Justice):  LCJ’s amicus program is focused on litigation involving amendments to federal rules.  This program is integral to LCJ’s overall mission of supporting reform of procedural rules to further the just, speedy, and inexpensive determination of every action and proceeding.  As amicus curiae, LCJ brings this experience and perspective to bear to support sensible interpretations of civil rules.  These include Fed. R. Evid. 702 (expert witness admissibility), Fed. R. Civ. P. 26(b) (scope and proportionality of discovery); and Fed. R. Civ. P. 37(e) (spoliation of electronic information).  Unlike many amicus organizations, LCJ will participate in important trial court briefing.  LCJ’s submission form is here.  The contact person for making a submission is Alex Dahl (  LCJ requires at least a month before any brief would be due to evaluate a case and arrange for a brief to be written.

MDMA (Medical Device Manufacturers Ass’n):  MDMA is a major trade association for medical device manufacturers, so medical device litigation is the primary focus of its amicus activity. To submit a case for MDMA’s consideration, contact Mark Leahey (  MDMA prefers a month’s notice for any case submission.  There are no forms to fill out; an email with a description of the issue will suffice as an initial submission.  If MDMA needs additional information or documentation, it will inform the submitter.  MDMA has no separate amicus committee, and where necessary uses its board for that function.  MDMA frequently joins other organizations’ amicus briefs.  It helps:  (1) if the client is a MDMA member, and/or (2) the submission includes an offer by an outside lawyer (not, of course, retained by a party) to do the actual writing.

MIWG (Medical Information Working Group):  Since 2006, MIWG has sought clarity in the FDA regulatory scheme for dissemination of truthful and non-misleading information about prescription drugs, biological products and medical devices (that is, First Amendment protection), and to improve the federal regulatory framework and enforcement climate affecting manufacturer dissemination of information regarding those products (including products in development and new uses of marketed products (that is, off-label use)) .  On these issues, MIWG regularly files amicus briefs at all levels of litigation, including federal district, circuit, and Supreme Court levels, as well as making FDA regulatory submissions.  Prior MIWG filings may be viewed here.  Litigants interested in submitting a case for MIWG consideration may contact any of:  Kellie Combs (; Torrey Cope (; Doug Hallward-Driemeier (; and/or Jaime Jones (  No particular format is necessary.

NAM (the National Ass’n of Manufacturers):  The NAM is interested in all issues of broad importance to product manufacturers, tort and product liability litigation among them.  To submit a case for the NAM’s consideration contact Erica Klenicki ( or Michael A. Tilghman II (  The NAM prefers as much time as possible consider a case and prepare a brief, but has no amicus committee and is capable of responding quickly if the case warrants it.  There are no forms to fill out, and the NAM will tell you what documentation it wants.  Although not dispositive, the NAM typically limits amicus participation to cases that will have a significant impact on its members.

PhRMA (Pharmaceutical Research & Manufacturers of America):  PhRMA is the major trade association for the country’s leading innovative biopharmaceutical research companies (non-generic prescription drugs), so the primary focus of its amicus activity concerns cases involving product liability, fraud and abuse, civil justice fairness, antitrust, and intellectual property-related issues that may be of unique concern to the research-based pharmaceutical industry. The contact person for submitting a non-IP related case to PhRMA is Melissa Kimmel ( and for IP-related matters is David Korn (  There are no specific forms to fill out, however, PhRMA appreciates receiving a short memo or letter regarding the request for amicus support that explains the procedural posture of the case, the legal issues involved and the potential significance of the legal questions to PhRMA’s members.  PhRMA appreciates as much lead time as possible to send requests for amicus support through its member vetting process.  Any additional information needed would be  requested on an ad hoc basis.

PLAC (Product Liability Advisory Council):  PLAC’s range of interest extends to any issue that affects the litigation of cases against product producers and sellers.  The contact person for submitting a case to PLAC is Rita McConnell ( or  Submitted cases are considered by a Case Selection Committee that meets the first Thursday of each month.  To be considered, requesting parties must complete PLAC’s Amicus Questionnaire and submit it, along with the documentation requested in the questionnaire, at least ten days before the monthly meeting, and ideally at least six weeks before a brief would be due.  Cases submitted with less than ten days lead time for committee consideration, or less than thirty days before a brief is due, are significantly less likely to be accepted.  PLAC considers requests from both members and non-members but priority is given to member requests. See PLAC’s Amicus FAQs.

United States Chamber of Commerce Litigation Center:  The Chamber’s Litigation Center fights for business and free enterprise in the courts.  It is interested in issues of broad importance to the business community – tort and product liability litigation among them.  To submit a case for the Chamber’s consideration, please fill out this form, and, once completed, email it to  The Litigation Center prefers to receive the opinion being appealed and other relevant briefs. The Litigation Center has its own membership and frequently contacts members when considering whether to file an amicus brief.  As always, it is best to provide as much lead time as possible, ideally at least a month.  Consideration can be expedited if the circumstances demand it.

WLF (Washington Legal Foundation):  Founded in 1977, WLF promotes free enterprise, individual rights, limited government, and the rule of law.  WLF is an active amicus participant, especially at the U.S. Supreme Court and the federal courts of appeals.  To submit an amicus request, contact WLF’s General Counsel and Vice President of Litigation Cory Andrews (  WLF has a Litigation Review Board that approves all amicus work.  While there are no forms to complete, WLF is most receptive to amicus requests that are:  (1) accompanied by a concise amicus memo detailing the case and the legal issues WLF might cover, and (2) received, at minimum, four to six weeks prior to the amicus deadline.  WLF generally avoids participating in business-to-business litigation.  WLF welcomes requests that come with a pro bono offer by an expert attorney (not, of course, retained by a party) to do the actual writing. WLF has no “members” and does not consider possible financial contributions in deciding whether to appear as amicus.

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For design defect claims, a key issue is whether the relevant jurisdiction requires evidence that a suitable alternative design existed that would have allowed the plaintiff to dodge the alleged injury.  This blog has posted at length about alternative design requirements and their nuances.  These posts address everything from the existential question of “What is an alternative design?” to a 50-state survey about the alternative design requirement for negligent design defect claims

But the new news on alternative design is that the West Virginia Supreme Court has decided Shears v. Ethicon, Inc., 2024 W. Va. LEXIS 272, 2024 WL 2932375 (W.Va. June 11, 2024), and definitively held that in West Virginia, a plaintiff cannot prevail on a strict liability design defect claim without proof that an alternative, feasible design, existing at the time the subject product was made, would have substantially reduced the risk of the specific injury suffered by the plaintiff. 

This is a decision that has been a long, long time coming. 

To recap:  More than a decade ago, in 2013, the Shears mesh product liability lawsuit was filed, and made part of an MDL.  See Shears v. Ethicon, Inc., 64 F.4th 556, 559 (4th Cir. 2023).  In 2015, the MDL court consolidated the cases of 37 West Virginia plaintiffs for a single trial under the caption Mullins v. Ethicon, Inc., 117 F. Supp. 3d 810 (S.D. W. Va. 2015). 

As the cases progressed, the MDL court ruled that West Virginia did not require proof of a safer alternative design, then backtracked on that decision in 2016 after “the Supreme Court of Appeals of West Virginia published its West Virginia Pattern Jury Instructions for Civil Cases: Instructions on the Law in Plainer Language (2016 ed.)”.  See Mullins v. Ethicon, Inc., 2016 U.S. Dist. LEXIS 170445, 2016 WL 7197441 (S.D. W. Va. Dec. 9, 2016).

Pattern Instruction § 411 (“Design Defect — Necessity of an Alternative, Feasible Design”) was the key to the course-correction in Mullins.  It provides:

There are many designs which, although they may eliminate a particular risk, are not practicable to produce. To prove that a design is defective, [name of plaintiff] must prove that there was an alternative, feasible design that eliminated the risk that injured [him/her].

Years passed, the MDL slowly chugged along.  In November 2020, the MDL court remanded 9 cases, including Shears, back to their home districts for trial.  For Shears, home was the Northern District of West Virginia.

Eventually the Northern District of West Virginia considered the alternative design issue, in the context of a defense motion to exclude a plaintiffs’ expert.  The expert had opined that there were two alternatives to the design of the “TVT mesh” at issue, namely “polyvinylidene fluoride” and “Ultrapro”, and these alternatives would have reduced—but not eliminated—the risk of injury that plaintiff allegedly experienced.  See Shears v. Ethicon, Inc., 64 F.4th 556, 562 (4th Cir. 2023). 

Understanding Pattern Instruction § 411 as requiring proof of an alternative design that would have eliminated—not just reduced—the risk, the Northern District of West Virginia excluded the expert’s testimony as inapposite to strict liability design defect.

The Shears case then went to trial, and the jury found for the defendant on the sole remaining claim for negligent design defect.[1] (see below).

The plaintiffs’ appeal landed in the Fourth Circuit last year, and the Fourth Circuit was not at all convinced that Pattern Instruction § 411 was a correct statement of West Virginia law regarding alternative design, going so far as to declare:

[W]e are satisfied that “there is no controlling appellate decision, Constitutional provision or statute” of the State of West Virginia that resolves the question of whether Section 411 sets forth a correct statement of law — nor is there sufficient authority that would permit us to reasonably guess how the Supreme Court of Appeals of West Virginia might resolve that question

Shears v. Ethicon, Inc., 64 F.4th 556, 563 (4th Cir. 2023) (emphasis added).

Given that West Virginia’s supreme court had published the pattern instructions, and stated in the preface that “[a]lthough these instructions are not binding, they have gone through multiple edits and revisions after extensive research and editing by the reporters, the review committees, Judge Alsop, and Justice Ketchum,” it is interesting that the Fourth Circuit felt there was insufficient authority for it to even guess at how West Virginia would decide the legal question.  So many times, federal courts happily make expansive Erie guesses based on far less authority (or none at all).

Believing itself to be without guidance for an Erie guess, the Fourth Circuit punted the question to the state, by certifying the issue to the Supreme Court of Appeals of West Virginia.  Bexis was not amused by this turn of events. 

The Fourth Circuit at least was clear in what it wanted:

It is of importance to us, however, that at no point has the Supreme Court of Appeals definitively stated — in a signed, published opinion — “one way or the other whether a design defect claim requires proof of a safer alternative design of the allegedly defective product.”

Which brings us to the present day, and Shears v. Ethicon, Inc., 2024 W. Va. LEXIS 272, 2024 WL 2932375 (W.Va. June 11, 2024).  In it, the Supreme Court of Appeals of West Virginia, more or less, responded:  “Ok, fine, here is your signed, published opinion.  For a strict liability design defect claim, West Virginia law requires proof of the existence of an alternative, feasible product design existing at the time of the subject product’s manufacture.”

Of course, having taken on the certified question, the Supreme Court of Appeals of West Virginia put a finer point on the issue.  The court concluded that Pattern Instruction § 411 did not correctly state the plaintiff’s burden with respect to the alternative design requirement, because the plaintiff must prove the alternative, feasible design “would have substantially reduced the risk of the specific injury suffered by the plaintiff” whereas § 411 required the alternative design to “eliminate the risk.”

Analyzing the risk reduction standard for the proposed alternative design, the court turned to its seminal product liability decision in Morningstar v. Black & Decker Manufacturing Co., 162 W. Va. 857, 253 S.E.2d 666 (1979) and “the general test for establishing strict liability in tort” being “whether the involved product is defective,” meaning “not reasonably safe for its intended use.”

Viewed in the context of an alternative design, this means that an appropriate alternative, feasible design should be, at least, “reasonably safe.” See [Morningstar, 162 W.Va. 857] (holding, in part, that “[t]he standard of reasonable safeness is determined not by the particular manufacturer, but by what a reasonably prudent manufacturer’s standards should have been at the time the product was made.” (emphasis added)). Morningstar‘s use of the term “reasonably” signifies that a product is safe if it meets “fair or sensible standards.”

Because of this “reasonably safe” standard, the plaintiff must have prima facie evidence the alternative design would “substantially reduce” the risk, not just be “safer”:

While some jurisdictions require only that the alternative, feasible design be “safer,” we find this criterion is too vague and does not meet Morningstar’s “reasonably safe” standard for an alternative design. Because a product could be safer than a defective product yet remain defective or “not reasonably safe,” this standard is an ineffective guide for what a reasonably prudent manufacturer should have produced.

Indeed, because West Virginia’s high court concluded that a mere “safer” alternative design was not sufficient, it also rejected the Restatement (Third) of Torts: Prod. Liab. § 2 approach to alternative design as too lax.  The Restatement (Third) of Torts: Prod. Liab. § 2 requires an alternative design that “could have reduced” the foreseeable risks of harm posed by the product.  As a result, Ford Motor Co. v. Tyler, 2023 W. Va. App. LEXIS 337, 2023 WL 8588042 (W.Va. Ct. App. Dec. 8, 2023)—which we discussed at West Virginia Appellate Court Requires Safer Alternative for Negligent Design Defect Claims)—was overruled to the extent it adopted the Restatement’s design defect standard. Thus, West Virginia now indisputably imposes an alternative design element in design defect cases. While not quite as pro-defense as the formulation in the pattern jury instruction, Shears‘ “substantially reduce” standard is more demanding than either the Third Restatement or the alternative design standards of many states, so it is a favorable development overall.

With West Virginia having answered the certified questions posed by the Fourth Circuit, the case returns to federal court for the Fourth Circuit to now decide the still-pending appeal (perhaps after requesting further briefing from the parties). We will keep you posted when they do.

[1] Plaintiffs also put on evidence of a “malfunction” theory of strict liability—in other words, that a malfunction occurred and would not ordinarily have happened in the absence of a defect.  However, because the plaintiffs’ own evidence established that the alleged injury was a known risk of any pelvic surgery involving mesh, it was something that could ordinarily happen regardless of defect, and the trial court granted judgment as a matter of law for the defense on that claim. 

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We are trying hard not to fall into the current fashion of catastrophizing everything.  But the SCOTUS opinion in Mallory might have been the worst recent High Court ruling for corporate defendants.  This blog has spilled a lot of tears and ink on Mallory (including here, here, and here, and several other posts.) Last week, we discussed some post-Mallory developments that might furnish cause for optimism.

In Mallory the Court held that, despite the Court’s decisions in Daimler and BMS limiting personal jurisdiction over corporations, such limitations vanished if a state made acceptance of general personal jurisdiction a condition of a corporation’s registration to do business in that state.  Thus, an employee not a citizen of Pennsylvania, claiming an injury that did not occur in Pennsylvania, could sue his employer, which was not incorporated in Pennsylvania and did not have its principal place of business there — but had registered to do business in Pennsylvania and thereby consented to general jurisdiction, even in a “foreign-cubed” case.  

Pennsylvania is the one state that explicitly imposed that condition on corporate registration.  But if there are other states that want to enliven their decaying downtowns by luring litigation tourists, perhaps we will see widescale replication of the practice.  One shudders.

The Mallory decision was a bolt from the blue.  After the oral argument (we commented on it here), most commentators thought the corporate defendant had the better of the dispute, and that only two of the Justices would side with the plaintiff.  The Pennsylvania courts in the Mallory case had held that the Pennsylvania corporate registration statute was not consistent with the due process analyses in Daimler and BMS, and the smart money was on a High Court affirmance.

The smart money was wrong.  In a strange 5-4 (or 4-1-4) outcome, the court held that Daimler and BMS had not overruled the ancient Pennsylvania Fire (1917) case, which had blessed general jurisdiction by consent.  Never mind that Pennsylvania Fire was from the Pennoyer v. Neff bad old days, and the territorial view of personal jurisdiction was supposedly superseded by the fairness analysis in the International Shoe (1945) case. (The tension between the territorial and due process analyses gave rise to one of the really lame examples of legal humor, as scholars said they waiting for the other International Shoe to drop.)  And never mind that the last couple of court terms have not exactly been marked by fidelity to precedent.  And never mind that the Pennsylvania statute seemed like a classic case of an unconstitutional condition.

Justice Gorsuch authored the majority opinion in Mallory, in which Justices Thomas, Sotomayor, and Jackson joined.  Justice Alito concurred in the result, but wondered whether the consent statute might flunk the dormant commerce clause even if it satisfied due process. Put a pin in that issue.  Justice Barrett wrote the dissent, in which Chief Justice Roberts, and Justices Kagan and Kavanaugh joined.  Note that the voting breakdown does not fit any sort of ideological theme.  Note also that the two Justices who once upon a time taught Civil Procedure (Kagan and Barrett) would have struck down the consent statute.  

This is all old news.  Why are we harping on it today?  Last week a new article visited our inbox: Sachs, Dormant Commerce Clause and Corporate Jurisdiction, 2023 The Supreme Court Review 213 (2024).  Sachs had been an active commentator and blogger (The Volokh Conspiracy) on the Mallory case.  He submitted an amicus brief in the case.  Sachs is considered a prominent conservative/originalist legal scholar.  

We were hoping that the article would furnish support for the dormant commerce clause.   We were disappointed. But perhaps we should not have been surprised.  Originalists are, by and large, not huge fans of the dormant commerce clause.   Sachs pointed out that Justice Alito’s concurrence referred to the “so-called” dormant commerce clause.  Nevertheless, Alito made it pretty clear that he thought the Pennsylvania statute would flunk the Pike v. Bruce Church balancing test for the dormant commerce clause.  Pennsylvania simply had no legitimate interest in having its courts resolve disputes between two non-citizens over a matter having nothing to do with Pennsylvania.

We are not blind to the fact that the most recent SCOTUS pronouncement on the dormant commerce clause, National Pork Producers Council v. Ross, 598 U.S. —, 2023 WL 3356528 (U.S. May 11, 2023), rejected application of the clause.  That case upheld California humane animal husbandry rules even those rules imposed enormous costs on pork producers outside of California due to the great difficulty in segregating pork products sold in one large state.  Like Mallory, National Pork Producers had multiple opinions (five), with Justice Gorsuch authoring the controlling opinion.  The Court held that significant extraterritorial impacts of state law do not invalidate the law without proof of an intent to discriminate against out-of-state economic interests to the advantage of in-state interests. In National Pork Producers, there was no such discrimination.  The plurality opinion also suggested that the compliance costs of revamping pork production were insufficient to require a court to weigh those costs against the moral benefits California voters wanted via mandating humane animal husbandry.

But at least California would realize such benefits.  What is the benefit to Pennsylvania of dragging in foreign corporations on foreign matters?  Maybe some lawyers and court personnel would enjoy the heightened local litigation activity, but from the perspective of the state overall, clogging the court system cannot be a net plus.  

Sachs looks at the Mallory ruling and its implications in a different way.  He sees Mallory as a triumph of “very old doctrines of personal jurisdiction,” and a coda to the tug of war between territorial and due process analyses that resulted in “a complex and contradictory body of case law.”  Well, we have to agree with that, having felt that way since we first read Pennoyer and International Shoe back in our first year of law school.  Personal jurisdiction law, particularly with respect to corporations, has long been a mess.  But Daimler and BMS were clear, consistent rules, appearing to rescue us from the mess.  

If all that Sachs said was that corporate personal jurisdiction law was sloppy, we’d nod our head in agreement and move on with things.   But Sachs goes on to examine the “Dormant Commerce Clause on Original Grounds.”  The “Founding-era picture was that corporations had no right of their own to operate in other states.”  They needed permission from other states, and those other states could impose conditions. The notion was that a corporation carried on activities in a state only by grace of that state’s permission. Then as corporations became more important in carrying on interstate commerce, they claimed greater rights (even though they lacked the privileges guaranteed to citizens under Article IV), and the dormant commerce clause carried the day, “rendering incoherent both the theory and practice of corporate jurisdiction.” It’s sort of a materialist (though not Marxist) account. It’s also radical.  (Remember that Sachs has also argued against Erie v. Tompkins.) The consent theory got stomped on by International Shoe.  SCOTUS “began to phrase its theory in terms of ‘presence’ or ‘doing business’ rather than ‘consent.’”

So Sachs sees modern corporate jurisdiction doctrine as a mess, mostly wrought by International Shoe.  He seems to think that the consent theory was closer to the original understanding (and he repeats that “the Constitution has no corporate law”).  His conclusion is that until Congress gives corporations the right to operate in other states, “or until it mandates mutual recognition of corporate privileges, these powers are still ‘reserved to the States respectively’ — right where the Constitution left them.”

For the moment we’ll take a pass on whether Sachs’s application of originalism is correct or whether it shows the problems with that approach.  Let’s instead seize on his suggestion that there might be legislative solutions available to the corporate jurisdiction mess (created by Mallory, not International Shoe).  First, state legislatures should not pass corporate registration statutes that impose consent to jurisdiction.  Look at court budgets   Consider whether it is fair or wise to turn one’s state into a litigation hellhole.  Second, Congress could step in and put an end to corporate registration that extracts phony consents to jurisdiction.  But even as we propose these solutions, we feel the futility.  Many important court opinions come down to, ‘Congress, do your job.’  Think about the recent bump-stock decision.  The problem is that Congress hardly ever does its job.  Even the most enlightened legislation rationalizing corporate interstate activities would be buried under demagoguery and trial lawyer campaign contributions.  

And so we continue to litigate, pushing jurisprudential boulders up steep hills.

Sachs’s article is interesting.  It is insightful.  It might even be brilliant.  What it is not is useful.

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We have frequently reported on plaintiffs’ efforts to salvage untimely claims in the Taxotere MDL. See, for example, here, here, and here. As we explained here, the basic problem for many plaintiffs—who claim that the chemotherapy drug Taxotere caused them permanent hair loss—is how the MDL master complaint defines the plaintiffs’ alleged injury. Specifically, because the master complaint characterizes the plaintiffs’ injury as hair loss persisting more than 6 months after the completion of chemotherapy, each plaintiff’s claims accrued 6 months after he or she finished treatment. Yet many plaintiffs finished treatment years before filing suit. As a result, transferor courts addressing cases on remand from the MDL court have repeatedly dismissed Taxotere claims as untimely under different states’ statutes of limitation.

Today’s cases—Sledge v. Sanofi-Aventis U.S., LLC, 2024 WL 2896302 (D. Or. 2024), and Larsen v. Sanofi-Aventis U.S., LLC, 2024 WL 2894131 (D. Or. 2024)—reach a similar result but under Oregon’s statute of repose.

Unlike a statute of limitations, which “governs the time within which an action must be commenced after the cause of action accrues,” a statute of repose “limits the time within which an action may be brought” but “is not related to the accrual of any cause of action.” 54 C.J.S. Limitations of Actions § 6. Thus, “[s]tatutes of ultimate repose establish maximum time limits to commence an action, regardless of when the injury is discovered or any other circumstances that might extend a statute of limitations.” Sledge, 2024 WL 2896302, at *2; Larsen v. Sanofi-Aventis U.S., LLC, 2024 WL 2894131, at *2. Moreover, “unlike statutes of limitation, statutes of repose are generally not subject to equitable tolling.” Id. As a result, “[w]hen the ultimate repose period has expired, the claim is extinguished and no legally cognizable injury exists.” Id. (internal quotation marks omitted).

Thus, a statute of repose might categorically bar product-liability actions brought more than 10 years after the purportedly injurious product was manufactured even if the alleged injury is a latent disease that emerges only decades after use of the product.

Under the Oregon statute of repose in effect through the end of 2009, a product-liability suit had to be initiated within “[t]en years after the date on which the product was first purchased for use or consumption.” Or. Rev. Stat. Ann. § 30.905(2) (2007). Larsen began using Taxotere in November 2007 and filed suit in December 2017; Sledge started in January 2009 and sued in December 2020. The court held that because each plaintiff had “commenced” suit “over ten years after” having “first used” Taxotere, each plaintiff’s “claims fall beyond the time allowed by the [relevant] version of the statute of ultimate repose” and must be dismissed. Sledge, 2024 WL 2896302, at *2; Larsen v. Sanofi-Aventis U.S., LLC, 2024 WL 2894131, at *2.

The Oregon statute of repose was amended effective January 1, 2010. The amended version ties the period of repose, if any, to the law of the state in which the relevant product was manufactured (or imported, if manufactured abroad). It now provides that suit must be filed by the later of “[t]en years after the date on which the product was first purchased for use or consumption” or “[t]he expiration of any statute of ultimate repose for an equivalent civil action in the state in which the product was manufactured.” Or. Rev. Stat. Ann. § 30.905(2) (2009).

Not all states have statutes of repose but—as Larsen and Sledge illustrate—they are powerful defenses where they exist.

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The California Supreme Court issued its widely anticipated opinion on the learned intermediary rule the other day, and the opinion is worth the wait.  Based on the oral argument (which we reported on here), we did not expect the Supreme Court to enact a fundamental change to the learned intermediary doctrine, and the Court delivered.  The Court did not, for example, create any exceptions to the learned intermediary rule, nor did it alter the basic rule that a prescription medical product manufacturer’s duty to warn runs to prescribing physicians, and not directly to patients.  That’s the good news. 

The bad news is that the California Supreme Court’s unanimous opinion lowers the plaintiffs’ burden of proving warnings causation in a way that will only confuse things and lead to outright speculation. 

The issue before the Supreme Court in Himes v. Somatics, LLC, No. S273887, 2024 WL 3059637 (Cal. S. Ct. June 20, 2024) (to be published), was how plaintiffs in prescription medical product, failure-to-warn cases can meet their burden of proving warnings causation under California law.  In a failure-to-warn claim against a prescription medical product manufacturer, is the plaintiff required to show that a stronger warning would have altered the physician’s decision to prescribe the product?  Or can the plaintiff establish causation by showing that the physician would have informed the plaintiff of the stronger warning and that a prudent person in the patient’s position would have declined treatment?  That is, whether said “prudent” person would have ignored his or her physician’s medical advice, given the stronger warning.

We won’t bury the lede.  Here is what the Supreme Court decided:

A plaintiff is not required to show that a stronger warning would have altered the physician’s decision to prescribe the product to establish causation.  Instead, a plaintiff may establish causation by showing that the physician would have communicated the stronger warning to the patient and an objectively prudent person in the patient’s position would have thereafter declined the treatment. 

Himes, slip op. at 2.  Did you get that?  The question of whether inadequate warnings caused an injury still focuses on the warnings’ impact on the prescribing physician—the learned intermediary.  But the analysis does not begin and end there.  Now you need to go multiple steps further and ask whether the physician would have communicated a stronger warning to the patient, what form that communication would have taken, and whether that communication would have changed the patient’s decision to undergo treatment.

The causation inquiry therefore now involves hypothetical upon hypothetical and provides additional opportunities for plaintiffs to raise disputes of fact and for juries to speculate.  This is not a good development. 

To recap, the plaintiff in Himes alleged that the defendant medical device manufacturer did not adequately disclose to physicians that its electroconvulsive therapy device could cause various brain injuries.  Id. at 3.  A federal district court granted summary judgment because the prescribing physician had testified that a stronger warning from the manufacturer would not have altered his decision to prescribe the treatment.  Id. at 4.  The allegedly inadequate warning therefore did not cause the plaintiff’s alleged injury.  The Ninth Circuit approached it differently and found disputed facts on whether the prescribing physician would have passed along a stronger warning to the plaintiff.  Id. at 4-5.  Thus, in an opinion that we reported on here, the Ninth Circuit certified a question to the California Supreme Court asking for guidance on California’s warnings causation standard. 

Again, the California Supreme Court did not re-envision the learned intermediary rule.  Instead, the Court borrowed from the medical malpractice law and informed consent to acknowledge the patient in the decision-making process: 

Although we have long acknowledged that patients have “an abject dependence upon and trust in [their] physician[s] for the information upon which [they] rel[y],” we have also emphasized that “the decision whether or not to undertake treatment is vested in the party most directly affected: the patient.” . . .  Implicit in our informed consent rule is the recognition that patients will sometimes opt out of the medical treatments their physician recommend, as is their right.  If [the defendant] were correct that the physician’s prescribing decision is all that matters, . . . then there would be no need for the informed consent rule.

Id. at 14 (internal citations omitted).  The Court also emphasized, however, that physicians remain critical to the analysis:

That said, our holding does not remove the physician’s expertise from consideration in the causation analysis.  Instead, our holding takes into account the essential role of the physician’s recommendation in the patient’s treatment decision. . . .  The causation analysis must accordingly consider whether an objectively prudent person in the patient’s position would have declined the treatment even where his or her physician would have advised the patient and the treatment would still be in the patient’s best interests, notwithstanding the risks conveyed by a stronger warning. 

Id. at 16 (emphasis added).  The physician is not the sole consideration, but neither is the patient.  Because a patient cannot receive prescription treatment without a prescription, the physician will always serve to inform the patient and filter information that an ordinary patient would not understand, including a stronger warning.  The next block quote is kind of long, but it sums up the Supreme Court’s reasoning extremely well:

For this reason, the causation analysis cannot hinge solely on whether the risk conveyed in a hypothetical warning would have altered the physician’s assessment to such a degree that the physician would no longer recommend the treatment for the patient. But it also cannot turn solely on how the patient alone would have responded to the risk disclosed in the hypothetical stronger warning. This is because the risk of any hypothetical stronger warning would not have been conveyed directly to the patient. Instead, it would have been communicated to the patient by his or her physician who would have utilized his or her medical expertise to assess the risk and to recommend a course of treatment for the patient based on that assessed risk. . . . This is the physician’s function as an intermediary because, as the learned intermediary doctrine recognizes, if the warning were conveyed to the patient directly by the manufacturer, the patient might be inclined to reject even beneficial treatment.

Id. at 23-24.  The learned intermediary’s interaction with the patient is therefore built in: 

The causation analysis should therefore begin by determining what, if anything, the patient’s physician would have communicated to the patient regarding the relative risks and benefits of the prescription drug or medical device in response to a stronger warning, and should then turn to whether an objectively prudent person in the patient’s position would have declined the treatment even where the evidence shows that the physician’s treatment recommendation would have been unchanged by the stronger warning.

Id. at 24.  We appreciate the Supreme Court’s reasoning, but we still think its new causation rule is off the mark.  The traditional formulation of the learned intermediary rule—under which causation turns on whether a stronger warning would have altered the physician’s prescribing decision—is both doctrinally sound and grounded in reality.  By comparison, the Supreme Court’s new rule relies on multiple hypotheticals and invites speculation on numerous levels.  We have always expected plaintiffs to articulate what the manufacturer’s stronger warning should have said.  But now we have to “determine” whether the physician would have passed on any part of the stronger warning, what he or she would have communicated, and whether and how that information would have affected the patient’s conduct. 

Spoiler alert:  Every plaintiff who has already experienced an alleged injury and is suing to collect money will say—always with 20/20 hindsight and often with a semblance of credibility—that he or she would have done something different or even declined treatment altogether.  Plaintiff lawyer minions whose job it is to defeat summary judgment are licking their chops. 

The California Supreme Court was clearly aware of this, so it listed (somewhat defensively) a series of factors relevant to whether an objectively prudent person would have declined physician-recommended treatment.  Those factors include, but are not limited to:

Whether the physician weighed and assessed the risks and benefits of the treatment, and after discussing those risks and benefits with the patient, continued to recommend the treatment; whether the treatment was novel or was instead an established method for addressing the patient’s condition; the availability and utility of alternative treatments and the degree to which they have previously been tried in an effort to address the patient’s condition; the severity of the patient’s condition; and the likelihood that the treatment would have resulted in more than marginal benefit to the patient.  [¶]  In addition, personal characteristics of the patient or circumstances unique to the patient should be taken into account when applying the objectively prudent person in the patient’s position standard.

Id. at 25.  Listing these factors does not fix that the Court’s causation standard inevitably benefits the plaintiffs.  Worse yet, the rule encourages plaintiffs to claim that they would not have followed the medical advice they received, which can only erode the physician-patient relationship that the learned intermediary doctrine was created to preserve.  But at least we know where to start when drafting jury instructions.

There are many good points to emphasize from this opinion.  To start, the learned intermediary doctrine is alive and well in California, and it definitively applies to medical devices, if now subject to a squirrelly and over-engineered causation standard.  The plaintiffs in Himes trotted out the ridiculous argument that the learned intermediary doctrine should not apply at all and that the duty to warn should run to the patient—and only the patient—whenever the manufacturer has not provided sufficient warnings to physicians. 

The Supreme Court rejected this crazy talk as an “incorrect framing” of the issue, and it stated bluntly that “the learned intermediary doctrine is neither a defense nor an exception to a traditional duty rule, and it does not cease to apply where a plaintiff alleges that a manufacturer failed to provide an adequate warning.”  Id. at 10.  This of course is the correct result.  If the learned intermediary rule evaporated whenever plaintiffs alleged inadequate warnings, it would never apply at all, since the plaintiffs in every failure-to-warn case allege that the warnings were inadequate.  We run into this argument fairly often, and having Himes’ persuasive and unanimous rejection of it will help, and not just in California.

Another positive is that the California Supreme Court erected an objective standard under which causation is measured by what an objectively prudent patient would do under the same circumstances.  The plaintiffs urged a subjective standard under which a patient could prove causation with his or own subjective testimony that he or she would have declined treatment in response to a stronger warning no matter what.  But the Supreme Court shot that down with equal bluntness:  “If a subjective test were used, a plaintiff could simply offer self-serving testimony asserting that he or she would have declined the recommended treatment after being informed of the risks.”  Id. at 27.  Of course, an objective standard is not the be-all and end-all that the Supreme Court makes it out to be.  Both subjective standards and objective standards are subject to severe hindsight bias.  The only difference is whose hindsight we’re talking about:  An allegedly injured plaintiff’s hindsight versus a jury’s hindsight in deciding what an objectively prudent person in the (injured) plaintiff’s position would have done upon receipt of medical advice weighing all the risks and benefits.  We are unsatisfied either way, but we will take the objective standard over the alternative.

The Supreme Court also recognized that prescription medical products are different from ordinary consumer products and rejected the plaintiffs’ argument that all products should be considered equal: 

[T]he learned intermediary doctrine recognizes that decision regarding whether to take a prescription drug or medical device are different from decision regarding whether to buy or use a consumer product.  Consumers may reasonably expect consumer products to be safe when used as intended, but “a patient’s expectations regarding the effects of [a prescription] drug [or medical device] are those related to him [or her] by his [or her] physician.”  In addition, whereas consumer products are generally used for personal convenience or pleasure, prescription drugs and medical devices are often necessary to ensure the health of the patient. 

Id. at 28.  Following oral argument, we noted that both sides were swinging for a home run, but that the Supreme Court was looking for a compromise double.  That is basically what they did.  Or maybe they just added extra bases to the playing field, while simultaneously making it easier for base runners to advance.  Whatever you call it, we will see how this plays out in practice.  We will still go through the ritual of asking physicians whether they read the warnings, whether they knew about the risks, and whether additional information about risks would have changed anything.  Our right honorable friends on the other side will still have their clients testify that they never would have used the drug or undergone the procedure “had they known” of the risks that allegedly befell them.  We will seek broader discovery into any other instances whether plaintiffs have ever rejected their physicians’ medical advice.  And we will still move for summary judgment.  More to come. 

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Last July we published a “Here’s Hoping” post that maybe the terrible decision in Atchley v. AstraZeneca UK Ltd., 22 F.4th 204 (D.C. Cir. 2022), allowing drug companies to be sued for purportedly “aiding and abetting” international terrorists (see our takedown of Atchley here), would fall in light of the Supreme Court’s then very recent Twitter, Inc. v. Taamneh, 598 U.S. 471 (2023), decision.  As we argued in Here’s Hoping, the broad version of aiding and abetting in Atchley was “not anywhere near” the tougher standard adopted in Taemneh that requires:  (1) “conscious, voluntary, and culpable participation” in (2) a specific “ act of international terrorism.”  Id. at 493, 495.

We thus opined in Here’s Hoping that Taamneh should result in a “GVR” – Supreme Court lingo for granting certiorari, vacating Atchley in light of Taamneh, and remanding for the District of Columbia Circuit to get it right next time.  But who are we?  We’re nobody in particular, just some blogging defense hacks.

But the Solicitor General of the United States is not nobody.  Sometimes called the “Tenth Justice” for having such a close relationship with the Court, the Solicitor General argues for the federal government in almost every Supreme Court case involving the United States, and even has an office in the in the Supreme Court building.  In Atchley, the Court asked the Solicitor General for the views of the United States.

Last month, the Solicitor General agreed with us about Atchley, filing an amicus curiae (friend of the court) brief supporting the defendants’ request to grant, vacate and remand.

In the view of the United States, the Court should grant the petition for a writ of certiorari, vacate the judgment of the court of appeals, and remand for further consideration in light of Twitter, Inc. v. Taamneh, 598 U.S. 471 (2023).

Brief for the United States as Amicus Curiae, in AstraZeneca UK Ltd. v. Atchley, No. 23-9 (filed May, 2024).

Taamneh satisfied the usual standard for GVR because it occurred “after the decision under review” and “change[d] or clarifie[d] the governing legal principles in a way that could possibly alter” the decision in AtchleyAmicus brief at 11 (citation and quotation marks omitted).

Taamneh emphasized the common law’s recognition of “the need to cabin aiding-and-abetting liability to cases of truly culpable conduct,” and thus to avoid “sweep[ing] in innocent bystanders as well as those who gave only tangential assistance”. . . .   [The statute’s] require[s that] . . . a defendant “consciously and culpably participate[d] in a wrongful act so as to help make it succeed.”

Id. at 12 (quoting Taamneh, other citations and quotation marks omitted).

Contrary to Taamneh, the Atchley plaintiffs alleged only “general” assistance through extorted bribes without a “definable nexus” to the particular acts of terrorism “that injured respondents.”  Id. at 14.

To the extent respondents’ theory would hold petitioners liable for all or a broad swath of . . .  acts of international terrorism during the relevant period, the court of appeals did not address whether respondents’ allegations meet the demanding standard that Taamneh subsequently articulated.

Id. at 15.  Thus, Atchley “made similar errors” to what the Court identified in Taamneh.  Id. at 16.  Atchley’s “focus[] on petitioners’ general awareness” was “incorrect.”  Id. at 16-17.  Therefore:

GVR is thus appropriate to ensure that the court of appeals has not “elided the fundamental question of aiding-and-abetting liability: Did [petitioners] consciously, voluntarily, and culpably participate in or support the relevant wrongdoing?”

Id. at 18 (quoting Taamneh).  Moreover, the District of Columbia Circuit erred in other ways, such as equating the terrorist group that allegedly received the bribes with a different group – which was also essential to plaintiffs’ claims because the statute was only directed at the second group.  Id. at 20.

Thus, we’re even more hopeful than before that Atchley will be vacated and that the anti-terrorism statute involved will not be misdirected against legitimate pharmaceutical companies, rather than actual terrorists and their supporters, simply because a judgment would be easier to collect.


Update: GVR ordered, AstraZeneca UK Ltd., v. Atchley, ___ S. Ct. ___, No. 23-9, 2024 WL 3089470 (U.S. June 24, 2024).

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Standing should not be a political issue.  Ensuring that someone who initiates a lawsuit has enough of a connection to the alleged harm for which they seek redress from a court is a key part of the broader constitutional concept of justiciability.  Because federal courts are courts of limited jurisdiction, they cannot decide just any old dispute.  Imagine how much more clogged federal court civil dockets would be if, in addition to so many dubious product liability claims, there were countless cases pending that fell well outside of the current concept of justiciability.  (Set aside the cost of litigating for this exercise in imagination, as costs do not deter many bogus lawsuits, especially when proceeding pro se is an option.)  Using an implied first person singular unique to this Blog and certain monarchs, imagine if we were litigious, opinionated, and easily offended while otherwise remaining a personal and business resident of the middle Atlantic region.  Should we be allowed to challenge an Alaskan state regulation on the working conditions for salmon fishermen based on our periodic consumption of salmon caught in Alaskan waters?  Should we be allowed to challenge a California state law on animal welfare because it does not comport with our personal religious and ethical precepts?  What about Texas regulation of the cattle industry because of a local environmental impact and/or a suspected detriment to vegans (a group to which we do not belong)?  What about trying to remove a dog food advertisement that appears on billboards in Kansas that depicts our favorite dog breed as not very bright?  Closer to home, what if we wanted to complain about the gaudy color of paint a neighbor chose to repaint their house, which we think might distract drivers into crashing into our car in our driveway or maybe reduce the value of real estate on our block?  There may be other issues with these potential lawsuits, but each one should be dismissed toot sweet for lack of standing, no matter where brought.

For more than a year, we have been following the AHM or Hippo litigation from the Northern District of Texas, through the Fifth Circuit, all the way up to the Supreme Court.  Alliance for Hippocratic Med. v. FDA, 668 F. Supp.3d 507 (N.D. Tex. 2023), stayed in part, 2023 WL 2913725 (5th Cir. Apr. 12, 2023), temporarily stayed, 2023 WL 2942266 (U.S. Apr. 14, 2023), aff’d in part & vacated in part, 78 F.4th 210 (5th Cir. 2023), cert. granted in part and denied in part, 144 S. Ct. 537 (2023).  We documented the many twists and turns along the way here, here, here, here, and here.  Collectively, these posts also give the underlying facts of the case and the details of the prior decisions, which we will not repeat here.  We chose the animalic moniker above primarily because we found the name of the lead plaintiff entity in AHM a bit pretentious if not ironic.  In addition, the humble hippopotamus is actually quite dangerous and is now causing unintended havoc far from its native lands because Pablo Escobar imported some for his Colombian jungle estate.  More substantively, the extremely liberal treatment of established constitutional standards on standing by famously conservative lower courts was a predicate to some really bad and impactful rulings.  The expansion of standing also made us ponder the coming flood of additional litigation should the Supreme Court formally abandon the established standards in an effort to affirm.  The other pachyderm in the room has always been that the underlying issue in Hippo is a limitation on the availability of medication abortion, something that appeals to some people who might otherwise favor federalism and tight standing rules.  Overly simplified, there is a potential conflict—not in the implied preemption sense, although that is clearly an issue in some on-going litigation related to medication abortion (see here, here, here, and here)—between arguably political aims and the larger legal framework.  We saw this conflict when an overlapping panel from the Fifth Circuit applied standard standing principles to decide against the plaintiffs in a case about Sesame Street puppets and vaccination not long after its Hippo decision. We are pleased to report that a unanimous Supreme Court reversed the Fifth Circuit, finding the plaintiffs failed to establish standing for any of their claims.  FDA v. Alliance for Hippocratic Med., — S. Ct. –, 602 U.S. –, 2024 WL 2964140 (Jun. 13, 2024).  In doing so, it reaffirmed the importance of and relatively strict standards for standing.

That is not to say that the Supreme Court’s Hippo decision offers a polemic against federal courts abandoning standing requirements to get to a desired result in a politically charged case.  To the contrary, the reasoning that the district court and Fifth Circuit used to find standing is not discussed, let alone criticized.  In addition, the statement that “[t]he plaintiffs have sincere legal, moral, ideological, and policy objections to elective abortion and to the FDA’s relaxed regulation of mifepristone,” made in the connection with suggesting plaintiffs should raise their concerns in other fora, is one of many in the opinion that seem gratuitous.  Allowing private citizens and ad hoc associations of private citizens to use the Administrative Procedures Act to invalidate, however temporarily, a number of FDA decisions, including approvals of an NDA and ANDA, was unprecedented.  That the plaintiffs were neither users nor prescribers of the drug at issue made the whole Hippo litigation quite threatening to some legal principles previously thought to be untouchable.  The Court’s decision, authored by Justice Kavanaugh, appeared quite conscious in its efforts to link the “bedrock constitutional requirement” of standing to conservative principles.  Early in its analysis, the Court cited to a 1793 letter to President Washington from the Supreme Court (under Chief Justice John Jay, co-author of The Federalist Papers), a 1983 law review article from future Justice Scalia, and a 1993 law review article from future Chief Justice Roberts, each of which emphasized the importance of standing for “Cases and controversies” before Article III courts and, more generally, in the separation of powers.  Id. at *5-6.  (Interestingly, the 1983 article is said to contain a statement from “Justice Scalia” four years before he joined the Court, but the 1993 article is not linked in text to Chief Justice Roberts, who joined the Court twelve years later.)  

After that lead in, the standards for standing, and the cases from which they were derived, were pretty predictable.  The plaintiff must have an injury in fact that is “particularized; the injury must affect the plaintiff in a personal and individual way and not be a generalized grievance.”  Id. at *6 (citation and internal quotation omitted).  “Moreover, the injury must be actual or imminent, not speculative—meaning that the injury must have already occurred or be likely to occur soon.”  Id. (citation omitted).  The injury in fact requirement “screens out plaintiffs who might have only a general legal, moral, ideological, or policy objection to a particular government action.”  Id.  Because the Hippo plaintiffs did not sell, take, or prescribe the medication at issue, their attempt to show an injury in fact that was or likely will be caused by the defendant’s actions—i.e., the FDA’s decisions in connection with exercising its congressional charge to promote public health—relied on a purported cascade of events involving others.  Causation cannot be “too attenuated” and generally cannot “rely on speculation about the unfettered choices made by independent actors not before the courts.”  Id. at *7 (citations omitted).  Instead, “the plaintiff must show a predictable chain of events leading from the government action to the asserted injury—in other words, that the government action has caused or likely will cause injury in fact to the plaintiff.”  Id. at *8.

The plaintiffs did not come close to establishing an injury in fact, causation, and redressability, the third requirement. 

Because the plaintiffs do not prescribe, manufacture, sell, or advertise mifepristone or sponsor a competing drug, the plaintiffs suffer no direct monetary injuries from FDA’s actions relaxing regulation of mifepristone. Nor do they suffer injuries to their property, or to the value of their property, from FDA’s actions. Because the plaintiffs do not use mifepristone, they obviously can suffer no physical injuries from FDA’s actions relaxing regulation of mifepristone.

Id. at *9.  The individual plaintiffs claimed to have suffered “conscience injuries” and both the individual and entity plaintiffs claimed to have suffered economic injuries.  The conscience argument, which was successful below, was that FDA actions increased the risk that the plaintiffs “may be required—against their consciences—to render emergency treatment completing the abortions or providing other abortion-related treatment.”  Although FDA apparently did not contest this as an injury in fact—which the Court said was correct—the full record below made it clear that this was a stretch.  The risk of a specific ER doctor seeing a mifeprestone-related complication requiring surgical intervention was fleetingly small.  Moreover, consistent with the Hippocratic Oath, an ER doctor will surely encounter a wide range of injuries caused by illegal or, from the doctor’s perspective, immoral behavior.  An ER doctor surely would not have standing to challenge a government action that promoted alcohol use and, by extension, the risk of treating a driver injured in a crash that occurred because the driver was affected by alcohol use, albeit had a blood alcohol level below the legal limit.

Even with this concession and the Court’s assumption that the FDA actions that were knocked down by the Fifth Circuit’s ruling had increased the chance that the plaintiffs would encounter women who needed surgical abortions after taking mifepristone, the plaintiffs still could not establish causation.  Federal law allows doctors to refuse to “provide treatment or assistance that would violate the doctors’ religious beliefs or moral convictions,” including abortions.  Id. at *10 (citations omitted).  The plaintiffs could not suffer the harm of which they complained and, indeed, did not identify “any instances where a doctor was required, notwithstanding conscience objections, to perform an abortion or to provide other abortion-related treatment that violated the doctor’s conscience.”  Id.  EMTALA, which is the subject of other litigation, does not override federal conscience law or require individual doctors to do anything.  Id.  Thus, the plaintiffs could not prove causation based on their conscience theory.

The economic theory fared no better.  Again, the doctors had no history of adverse economic consequences or “persuasive evidence or reason to believe that the future will be different.”  Id. at *11.

[T]he law has never permitted doctors to challenge the government’s loosening of general public safety requirements simply because more individuals might then show up at emergency rooms or in doctors’ offices with follow-on injuries. Stated otherwise, there is no Article III doctrine of “doctor standing” that allows doctors to challenge general government safety regulations. Nor will this Court now create such a novel standing doctrine out of whole cloth.

Id.  To us, this also runs against the idea of a conscience injury to the individual plaintiffs, not just that they suffered no injury in fact caused by FDA’s actions.  The same goes for the Court’s conclusion that an expansion on standing “would seemingly not end until virtually every citizen had standing to challenge virtually every government action that they do not like.”  Id. at *12.

Going beyond economic injury theories, it appears that the Court closed the door on standing for doctors to challenge FDA actions in almost all instances:

[I]n the FDA drug-approval context, virtually all drugs come with complications, risks, and side effects. Some drugs increase the risk of heart attack, some may cause cancer, some may cause birth defects, and some heighten the possibility of stroke. Approval of a new drug may therefore yield more visits to doctors to treat complications or side effects. So the plaintiffs’ loose approach to causation would also essentially allow any doctor or healthcare provider to challenge any FDA decision approving a new drug. But doctors have never had standing to challenge FDA’s drug approvals simply on the theory that use of the drugs by others may cause more visits to doctors.


The entity plaintiffs—which appear to have been formed largely to bring such lawsuits—offered the novel argument that pursuing the lawsuit itself, along with citizen petitions, studies, and other voluntary activities, created an economic injury that could create standing.  The entity plaintiffs “cannot manufacture” standing by engaging in such activities in the absence of an actual injury in fact to begin with.  Id. at *13.  Judge Thomas wrote his own concurrence to emphasize his previously stated view that associational standing—the entity plaintiffs suing for alleged injuries to their members—and, indeed, all third party standing should not exist.  That is an issue for another day. 

For now, the Hippo case should be gone—sent to the district court for dismissal—because the plaintiffs never had standing in the first place.  Despite the Court’s strong rejection of indirect and speculative standing to challenge FDA actions, we do not expect such challenges to end.  Indeed, we would not be surprised if the same Hippo plaintiffs rejigger and take another shot at challenging the same FDA actions concerning mifepristone.  Nor would we be surprised to see challenges to FDA decisions on drugs or devices for fertility or contraception based on the same playbook.  If the goal is to deter the marketing of certain medical products by increasing the costs and burdens, then injunctions that will only last until stayed or overturned on appeal can still help further the goal.  One possible solution to this problem would be legislation requiring that challenges to FDA actions be brought in particular courts that have particular experience with these recurring issues and may be inclined to take actions that deter frivolous filings by plaintiffs without standing.  Just a thought.

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Last week we alluded to the utility of bench-bar conferences.  As if to prove that point, we spent Thursday and Friday at a conference on Multidistrict Litigations.  The conference was focused on the sources of, and possible solutions to, “protracted” MDL proceedings.  John Rabiej put the conference together, and that pretty much guarantees that the conference would be productive and constructive.  Rabiej has a track record of helping the judiciary improve rules and procedures. Sometimes he says or does things that please the plaintiff side, and sometimes he manages to hearten the defense side.  That both-sides-ness does not guarantee that Rabiej is always right (that would require a full-on embrace of defense-hack predilections, of course) but it does guarantee that he is that rare thing: an honest broker.  

The conference was attended by many judges and magistrates and special masters who have played roles in important MDLs.  There were also plaintiff attorney luminaries, who occasionally astounded and confounded us with their reasonableness.  And then there was robust attendance by solons and worldly philosophers who expend sweat and gray cells on behalf of corporate defendants.  The conference was governed by the Chatham Rule, which forbids attributing comments to anyone in particular.  Accordingly, we will speak in generalities.  

Naturally, the plaintiff lawyers blamed any protraction of proceedings on defendants.  Plaintiffs want to go fast, including getting trial dates early-on, while defendants want to slow things down to a crawl.  Or so the story goes. And yet it is the defense side that usually wants to expedite discovery of particular plaintiffs, it is the defense side that usually seeks prompt exploration of the preemption defense, and it is the defense side that  frequently moves general causation ahead in the queue.  On that last point, some plaintiff lawyers offered the trenchant observation that early resolution of general causation shortens proceedings only if the defense wins.  True enough. And sometimes that happens.  You needn’t look very hard to find a relatively recent example of an MDL court dramatically reducing its docket by issuing a brave and brilliant Rule 702 decision eviscerating general causation. Granted, the result may have been more a redistribution than reduction of junk cases, as some canny plaintiff lawyers moved cases to state courts with more, er, relaxed views on epidemiology. And granted, general causation should not always go up front.  Defense lawyers need to do something they are not always good at: pick their fights carefully.  

At least one defense lawyer had the temerity to voice some discomfort with the transmogrification of MDLs into vast settlement machines.  Predictably, plaintiff lawyers wondered why settlement shouldn’t happen nanoseconds after the JPML centralizes the litigation.  Sadly, some judges bought into the settlement paradigm.  Why wouldn’t parties want to discuss settlement at the MDL stage? Sigh.  Here we go. Discussion might be fine, except (1) it’s hard to discuss resolving cases when there are real doubts about the merits of a big chunk of the inventory; and (2) some judges seem to make everything else in the MDL subservient to the settlement dynamic.  Some MDL rulings — or, perhaps more commonly, failures to rule on motions — appear designed to incentivize settlements, the law be damned.  Nobody said this last part out loud.  It’s nice to be around judges, but not so nice if they get mad at you. 

Defense hacks would be required to turn in their defense hack cards if they failed to harp on point 1 above, the large percentage of frail cases in the MDL Field of Dreams.  (Terms such as “meritless” and “frivolous” were tossed around, with fine distinctions.  Fair point.  Maybe a case ends up being “meritless,” but it might have been filed legitimately. “Frivolous” from the start is something else entirely.) We sensed some skepticism from some quarters on this point.  Where is the data?  Well, there is data, and there are plenty of cases (see, e.g., Taxotere and Paraquat) in which large percentages of cases turned out to lack evidence of product usage or injury.  

Beyond the threshold skepticism, one judge said that MDLs were not designed to weed out frivolous cases.  Read section 1407 all you want, and you’ll find nothing about dismissing cases on the merits.  That is correct.  But there is also nothing in section 1407 regarding bellwether trials or settlements either.  There seems to be some selectivity as to the proper evolution of the MDL process.  

We were given the last slot on the last panel.  We worried that our grouchy muttering would be drowned out by the sound of exiting rollaboards.  We worried even more that we would manage to be even more annoying than usual, since our topic was Federal Rule of Civil Procedure 11.  It seemed a less than jolly way to end a conference by talking about Rule 11. Rule 11 tends to end conversations, and not in a good way. Hinting at application of Rule 11 offends plaintiff lawyers – it very strongly says they did something very wrong.

In truth, we are rarely tempted to go the Rule 11 route. It raises temperatures and poisons wells. Moreover, many plaintiff lawyers do a good job of vetting their cases.  Then again, that fact highlights the offenders, who pile up junk inventories. Those offenders look all the worse, and the comparative good hygiene of their plaintiff colleagues suggests that some degree of case vetting really is possible. 

The first difficult conversation we defense hacks have regarding Rule 11 is usually with our clients. It does not take long to see that many of the cases filed against our clients are sloppy. We see shotgun pleadings in which the boxes for all defendants are checked. Clearly, some plaintiff firms are essentially slobs when it comes to the intake process.  They operate conveyor belts with zero quality control. The result is that our clients get tagged with massive case filings unconnected to reality.  Those high numbers have a huge impact in terms of case management, expense, and public perception.  Our clients ask us whether Rule 11 applies to MDLs.  The answer is that it does apply in theory, but in reality — well, good luck.  (But see this sterling example in which Rule 11 was applied in a MDL.)

As if to ride in to the rescue comes new Federal Rule of Civil Procedure16.1. If approved, it will go into effect at the end of 2025.  There has been much analysis of Rule 16.1, including on this blog. Reviews have been mixed. Perhaps the new rule could have been more firm on case vetting and less merely hortatory.  But the new rule and comment make clear that Rule 11 applies to MDLs. You might say (as some at the conference said), So what? Rule 11 was always applicable to MDLs. Okay, but sometimes a reminder helps.  After all, recent amendments to Fed. R. Civ. P. 26 and Fed. R. Evid. 702 did not so much rework those rules as remind courts and litigants of how they were always supposed to work, but somehow the thread got lost along the way.  As feckless politicians are wont to say, mistakes were made. 

We hope that Rule 16.1’s reminder about Rule 11 will inspire MDL Courts to remind parties of their Rule 11 obligations.  And then, one fine day, when a plaintiff firm really goes beyond the pale with frivolous, shotgun filings, an MDL court will impose monetary sanctions. We predict that one such sanction will have a beneficent effect in cleaning up the filings, both in that and other MDLs.  

One can dream. 

As Disney said, if you can dream it, you can do it. But that dream will be dashed if courts insist upon neutering Rule 11 in MDLs.  Remember that Rule 11(b) provides that an attorney/party “certifies that to the best of the person’s knowledge, information, and belief, formed after an inquiry reasonable under the circumstances.”  Then Rule11(b)(3) goes on to say that such certification includes 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.”  The word “reasonable” is doing a lot of work in those two places.  We have nothing against a rule of reason, but we fret that some MDL court somewhere will say that what is “reasonable” “under the circumstances” of a MDL is very different from a one-off case.  You won’t be surprised to hear that this blog disagrees.  If plaintiff  lawyers say they cannot conduct adequate prefiling factual investigations because they have thousands of cases, then our response is as simple as it is predictable: then don’t file thousands of cases.

Stay tuned to see how this issue plays out in future MDLs. 

Meanwhile Rabiej continues to fight the good fight.  He will suggest several best practices in MDLs. Those best practices would invite everyone to improve their game. We think the defense side is up to the task. We hope the plaintiff side is as well. 

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We are going to assume that Texans know a few things about horses, carts, barn doors, leading to water, and whatever other horse adages we can come up with.  But when it comes to litigation, the Texas Court of Appeals took a firm line with a plaintiff who was looking to get deposition and document discovery before filing suit.  Platitudes about not wanting to bring a products liability suit without good cause were far from enough to demonstrate entitlement to invasive pre-suit discovery.  In re Acclarent, Inc., 2024 Tex. App. LEXIS 3994 (Tx. Ct. App. Jun. 7, 2024).

Texas Rule of Civil Procedure 202 authorizes pre-suit discovery to investigate potential claims.  But the Texas Supreme Court, interpreting that rule, has held that pre-suit discovery is “an intrusion into otherwise private matters” and therefore “is not to be taken lightly” and pre-suit depositions “are not now and never have been intended for routine use.”  Id. at *5-6.  Because of the clear due process concerns, courts should “strictly limit” pre-suit discovery. 

Against this backdrop, the petitioner (not a plaintiff yet) sought to conduct pre-suit discovery of the manufacturer of a medical device used in her sinus surgery.  Id. at *1-2.  Disregarding that backdrop, the trial court granted the request for both a deposition and document production.  Because there is no right of appeal from such an order, the manufacturer sought mandamus relief arguing that the trial court abused its discretion.  The appellate court agreed. 

Petitioner argued that the deposition was necessary to determine whether a products liability lawsuit should be pursued and the document discovery was needed to determine if the medical device was defective.  Petitioner claimed that she did not want to bring a products liability suit if she did not have to “because they are expensive and time consuming.”  Id. at *3.  Oh, we know.  But money and time do not eclipse burden, privacy, and due process. 

A pre-suit discovery petition has to contain “explanatory facts” demonstrating the need for the discovery and “evidence establishing” those facts.  Id. at *6-7.  Petitioner here included no factual allegations in her petition at all.  Her petition only made conclusory assertions that tracked the language of Rule 202.  Id. at *9.   Which she then tried to supplement at the hearing with “testimony” from her counsel regarding their concerns about removal, preemption, and statute of limitations.  Petitioner also offered up that she had taken discovery of her surgeon and the company responsible for neuromonitoring during the surgery which was “inconclusive” as to the cause of petitioner’s injury.  Regardless of whether counsel’s testimony was “evidence,” it still was not enough to authorize pre-suit discovery. Id. at *11-12.

Perhaps more importantly, petitioner admitted that she already had evidence of an alleged defect related to the artificial intelligence component of the system.  And the manufacturer offered to provide an affidavit identifying the AI suppler and whether the inclusion of the AI component was FDA approved—but petitioner inextricably would only accept that information from a deposition.  Id. at *13.  Given the lack of any alleged factual support combined with the information petitioner alleged to already have, she could not demonstrate that the benefit of taking a pre-suit deposition outweighed the burden to the manufacturer.  Id.  Nor was the court convinced that “burden and cost” of discovery should be discounted because modern electronic discovery is less expensive—that is not per se true.  Id.  Therefore, the appellate court concluded the trial court abused its discretion and ordered it to vacate the prior order and deny the original petition—returning the cart to its proper place behind the horse. 

Since we doubt petitioner would have considered pre-suit discovery a two-way street, this really would have been all burden to one side and all benefit to the other.  To that we say (moving away from horses), you’ve got to put some skin in the game.  Plaintiffs have to be committed enough to file a lawsuit before they get to peak behind the curtain.     

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Beyond the Supreme Court’s rolling out the red carpet to forum shopping plaintiffs, the decision in Mallory v. Norfolk Southern Railway Co., 600 U.S. 122 (2023), was further disturbing to us in that Mallory suggested that a state could deem, through a “consent statute,” grounds for “consent” to general personal jurisdiction that were much less than the “at home” standard previously required for such broad jurisdiction.  Id. at 145-46 (“attach[ing] jurisdictional consequences to what some might dismiss as mere formalities” such as completing a registration form and recognizing jurisdiction from “actions . . . that may seem like technicalities”).  Those other examples, however, all involved limited “special” jurisdiction issues, not the far broader expanse of general personal jurisdiction.

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