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This is from the non-Dechert and non-Reed Smith side of the Blog.

We are not bankruptcy lawyers.  So, even though we are discussing a Supreme Court decision on the powers of a bankruptcy court, we are not purporting to be experts in that area.  The decision, of course, is Harrington v. Purdue Pharma L.P., 603 U.S. –, 2024 WL 3187799 (June 27, 2024), and it relates to a bankruptcy pursued in relation to actual and potential liabilities from a range of opioid litigation.  We have discussed opioid litigation quite a bit, within the bounds of frequent disclaimers.  While public discourse about the most recent opioid epidemic in the United States has generally addressed the human cost of opioid abuse and its persistence despite a variety of governmental actions and policy initiatives, our focus has been on the use of public nuisance as the basis for many governmental suits that threatened huge liability for a range of defendants to essentially reimburse governmental entities for expenditures allegedly tied to the epidemic.  After a number of trial courts, including MDL No. 2804, greatly expanded the scope of public nuisance compared to how it had been applied for centuries, the clear trend has been for appellate courts to reverse.  Simply put, a county utilizes tax revenues to provide governmental services, including social services, operating a morgue and coroner’s office, offering emergency medical services, and sometimes offering drug rehabilitation services.  It is not entitled to get reimbursement for its expenditures from a person or entity it claims necessitated them, any more than it would be entitled to the costs of repairing a guard rail or repainting the road after a traffic accident.  Of course, causation is also extremely tricky in part because a large number of criminal actors—from cartels to dealers to those who divert prescription drugs to those who illegally purchase a street drug or a prescription drug without an actual prescription—play a role in the epidemic.  Without arguing for or against the role of any prescription drug manufacturer, any distributor, or any retailer in the epidemic, it is hard to pretend that responsibility for the epidemic writ large, or any small slice of it, is simple.  (We could probably say the same about the crack epidemic or other periods of significant problems in the U.S. with a particular street or diverted drug, none of which led to an attempt by struggling governmental entities to use public nuisance as a means to get at deep pockets.)

This is part of what struck us about the Harrington decision.  The majority opinion used the term “victim” nineteen times in referring to opioid litigation plaintiffs, potential creditors of Purdue, and those who would receive compensation according to the bankruptcy plan that it overturned.  The 184 uses of “victim” in the much longer dissent covered these categories as well as those whose claims might be addressed in the bankruptcy of any entity subject to a mass tort.  By contrast, there was no mention in either opinion of public nuisance, in pari delicto, or any non-bankruptcy decision in connection with opioid litigation.  The majority opinion, in particular, seemed not particularly well-versed in the details of opioid litigation, suggesting that the liability for Purdue and its owners, officers, and directors related to product liability suits by individuals who abused opioids or were affected by the abuse of family members.  Direct product liability actions like that, including a wave against Purdue in the early 2000s related to Oxycontin, have generally been unsuccessful.  As one court put it in granting summary judgment against plaintiffs (previously purportedly on behalf of a class) asserting product liability claims related to Oxycontin, “[t]his Court, however, will not accept the plaintiffs’ ‘victimization’ mentality.”  Foister v. Purdue Pharma, LP, 295 F. Supp. 2d 693, 695 (E.D. Ky. 2003).  The criminal acts of the plaintiffs and their decedents, along with “the warnings and instructions provided by the defendants and by other third party intermediaries” severed any proximate cause for the purported injuries.  They still usually do.  (See here, here, here, here, and more generally here.)

This is why the expanded version of public nuisance was so popular to opioid plaintiffs.  Faced with huge potential liability to governmental entities, the Purdue bankruptcy estate offered to provide compensation for certain individuals who would never have been able to recover directly.  Litigants often settle to avoid the cost and uncertainty of trial.  Litigants who become claimants when the defendant seeks bankruptcy protection may get less than they would have had they won a trial, but they avoid the cost and uncertainty of pursuing a case to a successful trial verdict and possible appeal.  As the Harrington dissent put it,

Bankruptcy seeks to solve a collective-action problem and prevent a race to the courthouse by individual creditors who, if successful, could obtain all of a company’s assets, leaving nothing for all the other creditors. The bankruptcy system works to preserve a bankrupt company’s limited assets and to then fairly and equitably distribute those assets among the creditors—and in mass-tort bankruptcies, among the victims.

2024 WL 318779, *12.  As non-bankruptcy lawyers who defend drug and medical device companies in mass torts and write about developments in the field, this description certainly squares with the practice we have observed.

The primary issue in Harrington was that the bankrupt company that sought protection, Purdue, also sought protection for its primary owners, directors, and officers, collectively “the Sackler Family.”  While there may be some circumstances in this case that set it apart from the usual mass tort bankruptcy discussed by the dissent, the focus on owners, directors, and officers of a business entities as being distinct from the bankrupt company that sought protection seems strange to us.  Absent proof that the corporate veil should be pierced, a lawsuit against a company does not open the door to the assets of its owners.  Also, in product liability and, we suspect, actual public nuisance, it is rare that officers and directors of large corporations have personal liability.  Under Supreme Court authority on personal jurisdiction, which generally respects corporate form (e.g., not inferring a subsidiary’s jurisdictional contacts to its parent), an individual who, for example, lives and works in New York is unlikely to be amenable to suit in Oklahoma, Kentucky, or West Virginia simply because of the contacts of a New York-based company of which she is a partial owner, officer, and/or director.  As both opinions discuss, any claims against the Sackler Family would likely be subject to indemnity from Purdue, so such claims could be seen for bankruptcy purposes as claims against Purdue.  In this way, the majority opinion seems off.

Others will write and have written about the proper interpretation of a bankruptcy court’s authority under 11 U.S.C. § 1123, which the 5-4 majority in Harrington held did not support extinguishing claims against the Sackler Family.  The issue for us is what this decision means for the use of bankruptcy in the mass tort context.  As the dissent noted,

For decades, bankruptcy courts and courts of appeals have determined that non-debtor releases can be appropriate and essential in mass-tort cases like this one. Non-debtor releases have enabled substantial and equitable relief to victims in cases ranging from asbestos, Dalkon Shield, and Dow Corning silicone breast implants to the Catholic Church and the Boy Scouts. As leading scholars on bankruptcy explain, “the bankruptcy community has recognized the resolution of mass tort claims as a widely accepted core function of bankruptcy courts for decades”—and they emphasize that a “key feature in every mass tort bankruptcy” has been the non-debtor release.

Id. at *13 (citation omitted).  Is that all gone after Harrington?  Maybe not. 

After all, there was “nearly universal” support for the plan that discharged the Sackler Family, including “virtually all of the opioid victims and creditors” and “all 50 state Attorneys General . . . a rare consensus.”  Id. at *12.  (DOJ also resolved all of its criminal and civil investigations as to Purdue and civil investigations as to the Sackler Family subject to the bankruptcy court’s approval.)  If the frequent use of the word “victim” were insufficient to show what justices in both camps felt about the underlying litigation, then check out the references to the Sackler Family being responsible for a wide range of harms without specifying legal theories, courts, or other details.  Both opinions also declared that Congress was the appropriate forum for the change in law for which the corresponding adverse opinion allegedly advocated.  (We note that the majority implicitly advocated for an expansion of state tort law, something best left to state legislatures.)  The Court clearly did not view this as a typical mass tort that might lead to a request for bankruptcy protection for a defendant.  In addition, the majority opinion described more than a decade of the systematic transfer of assets from Purdue to the Sackler Family in connection with predicted liabilities from litigation.  We hazard that allegations of fraudulent transfers out of a company that is going bankrupt due to product liability or mass tort litigation are exceedingly rare at a level close to what was alleged here.

Focusing back on the “typical” mass tort that could result in a defendant seeking bankruptcy protection, nothing in Harrington limits the ability of the logical corporate defendant—for example, the entity that designs, manufactures, and sells a prescription medical product—from utilizing chapter 11 for protection for itself.  The change relates to entities or individuals that would not be the petitioner/debtor, but could conceivably have liability in the litigation.  That would include individual or corporate owners—but not random minority shareholders of a public company—directors, and officers.  Except in rare instances where the parent company has no assets except for the debtor company, we do not see many of these individuals or entities choosing to be additional debtors.  Instead, it may be advisable to get rulings that the individuals and entities do not have any liability to the various plaintiffs.  Given the “case or controversy” requirement, such rulings would likely require being added to lawsuits in courts of competent jurisdiction, permitting enough discovery to determine the issues (e.g., following corporate formalities and proper accounting practices to avoid piercing the corporate veil), and getting favorable rulings affirmed on appeal.  If bankruptcy courts cannot do what they have been doing for quite some time in terms of bankruptcies driven by mass tort liability, then there would need to plenty of extra work to get to the same place and avoid second rounds of litigation against targets not covered by the debtor’s plan.

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This post is not from the Reed Smith, Dechert, or Holland & Knight side of the blog.

We’re pretty sure no one teaches about MDL census registries in law school. They’re a relatively new creation, and we previously blogged about them here. Essentially, registries create a mechanism where plaintiffs’ counsel can park potential claims without paying a filing fee while records are collected to determine if the claimant can establish Rule 11 basics like product use and injury.  Records are typically collected by a vendor—for which the MDL defendants pay half the costs. The benefit defendants receive is a commitment that, if the claim is ultimately filed, it has to be filed in the MDL or other federal court.

Continue Reading More from the Zantac MDL – Census Registries and Enforcement of Forum Selection Certifications
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 Lokkart v. Aziyo Biologics, Inc., 2024 U.S. Dist. LEXIS 111265 (C.D. Cal.  May 29, 2024), is yet another case arising from the unfortunate contamination of a batch of tissue allograft with a disease. We have written about similar cases before. These cases have consistently produced favorable precedent concerning state human tissue shield statutes (in this instance, in California). 

In Lokkart, the plaintiff alleged that she was infected with tuberculosis from a human tissue allograft that was implanted in her foot during bunion correction surgery. The plaintiff alleged that she suffered serious and continuing injuries from that infection. She and her husband filed a complaint against the defendants. The complaint included causes of action for strict products liability, negligence, and breach of the implied warranty of merchantability. 

The defendants moved for partial summary judgment. The central legal issue was whether California’s human tissue shield statute (Cal. Health & Safety Code section 1635.3) barred the strict liability and warranty claims.  

The court dismissed the strict  liability and warranty actions because the state’s blood shield statute facially applied. The statute characterizes the processing, storage, distribution, etc. of tissue for the purpose of transplantation to be a service that is not subject to the sales and warranty provisions of the state’s Commercial Code. California courts have held that the explicit exclusion of warranty liability was also an implicit exclusion of strict liability. 

Against what appears to be controlling precedent, the plaintiffs argued that whether the product implanted in this case met the definition of “tissue” under the statute was open to question and required a factual analysis that could not be resolved at the pleading stage. But the problem for the plaintiffs is that their own pleading – the complaint – repeatedly referred to the product at issue as being a human cellular and tissue based product harvested from cadavers.  That description matches the language in the California shield statute.  

The plaintiffs’ attempt to “sidestep their own allegations” was premised on the theory that the implanted product had been so heavily manipulated, altered, and processed such that it no longer met the statutory definition of human cells.  The court disagreed. That human tissue is processed into a product before being used does not make it any less human tissue.  The terms of the statute do not admit of such an exception, since the statute actually includes “processing.”  Moreover, there is no inherent contradiction between something being both “tissue” and “manufactured.”  Plenty of other courts held that human tissue allografts fall under the California human tissue shield statute, “even when they have been processed and altered.”

Further, the product packaging, which was quoted and incorporated by reference in the complaint, recited that the product was regulated as a “Human Cellular and Tissue Based Product” (HCT/P) under 21 C.F.R. section 1271. The only fair reading of the federal regulations is that the defendants’ product was human tissue.  Under those regulations, an HCT/P must be “minimally manipulated,” which is defined as “processing that does not alter the relevant biological characteristics of the cells or tissues.”  Given that standard, the court rejected the plaintiffs’ hypothetical argument that the allograft product no longer  qualified as a “group of [human] cells.”  

Accordingly, the court dismissed the plaintiffs’ claims for strict liability and breach of warranty.  Presumably, all that is left is a claim for negligence. 

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How is the Georgia General Assembly like Dr. Seuss’s kind-hearted Horton the Elephant?  They both meant what they said and said what they meant.  Horton was talking about an elephant’s faithfulness (being 100%).  The Georgia General Assembly was talking about requiring that product liability claims be initiated within ten years from “the first sale for use or consumption” of the product allegedly causing injury.  Unlike Dr. Seuss who delivers Horton’s heroic tale in anapestic tetrameter, the court in L’Oreal USA, Inc. v. Burroughs, 2024 GA App. LEXIS 250, *14 (GA Ct. App. Jun. 21, 2014), limited its poetic meter to that one line.  And so, will this post.

Burroughs isn’t a drug or device case.  But as is often the case with prescription drugs, plaintiff alleged that she purchased and used certain cosmetic products over many years.  Her first purchase was in 1995 and her last was in 2014.  Plaintiff alleges she suffered an injury in 2018 caused by her prior use of those products and she filed suit against the manufacturers in 2022.  Id. at *22.

In response to defendants’ motion to dismiss her claim as barred by Georgia’s 10-year statute of repose, plaintiff argued that each purchase and use of the products “constituted a new exposure to a new product.”    Id. at *5.  An argument the trial court accepted, ruling that the “last sale” triggered the statute of repose.  Id.  Fortunately, the Court of Appeals disagreed.

Nowhere does the Georgia statute of repose mention application or use of a product.  Its sole triggering event is “first sale for use or consumption.”  To interpret the statute as plaintiff urges would make the word “first” “mere surplusage.”  Id. at *14-15.  Had the General Assembly wanted to allow “any” sale to be the trigger, rather that the “first” sale, it would have said so. 

In focusing on the “last” sale, the trial court misapplied an earlier decision by the Court of Appeals in which that court held that the “last sale” of a finished product to a consumer, rather than inter-manufacturer sales of component parts, was the relevant sale. *9. 

Plaintiff next tried to argue that her claims should survive dismissal because the question was really one of causation.  She should be given the opportunity to prove that it was a product purchased within the repose period that caused the injury.  Id. at *13.  Not only did the court disagree, but it pointed out that plaintiff’s complaint made no allegations that would support this new theory.  Plaintiff did not allege that the products changed over time nor that it was the products she used within ten years of filing her claim that caused her injury.  Id. at *15.  If plaintiff wanted to make a run at bypassing the statute of repose, she needed to introduce supporting allegations into the “framework of her complaint.”  Id.

The trial court also made a passing reference to the statute of repose possibly triggering from plaintiff’s date of injury.  But the appellate court simply pointed out that statutes of repose are not statutes of limitations, and the former are not triggered by the injury. *9.              

By no means did we undertake a complete survey of all products liability statutes of repose, but a quick search did reveal that several use the same “first sale” language as Georgia’s.  So, we hope that other courts would likewise hold that successive uses of the same product by the same person for which injury is claim do not restart the repose period.  While that is the message relevant to prescription drug litigation, we can’t help but end our post with Horton’s more profound and globally noteworthy lesson – A person’s a person, no matter how small.

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We could care less about almost everything in Driver v. Naranjo, 2024 WL 2869367 (S.D. Cal. June 6, 2024), which dismissed an overly litigious pro se prisoner’s product liability and other claims involving his purportedly forced use of a prescription drug.

But Driver’s first footnote raises an interesting question of judicial notice – whether notice can extend to the “characteristics” of prescription medical products. Driver held that “[t]he Court may take judicial notice of medical facts regarding prescription drugs, their active ingredients and effects.”  2024 WL 2869367, at *1 n.1.  The opinion cited two cases for that proposition, United States v. Howard, 381 F.3d 873, 880 & n.7 (9th Cir. 2004) (taking judicial notice of certain effects of a drug listed in the product warnings reprinted in the Physician’s Desk Reference (“PDR”)); and Lolli v. County of Orange, 351 F.3d 410, 419 (9th Cir. 2003) (“Well-known medical facts are the types of matters of which judicial notice may be taken.”) (citation omitted).

Continue Reading Are Prescription Medical Product Characteristics Subject to Judicial Notice?
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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.