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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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In our two prior posts, Loper Bright Likely Lays Lohr Low, and Could Loper Bright Finally Do in FDA’s Rickety Off-Label Speech Ban?, we focused on ways that Supreme Court’s holding in Loper Bright Enterprises v. Raimondo, 144 S. Ct. 2244 (2024), that courts were not to defer to administrative agency views in evaluating such agencies’ interpretations of their organic statutes, could be used by our clients in a positive fashion in the defense of prescription medical product liability.

Today we’re addressing the flip side.  How do we defend against the other side’s attempts to use Loper Bright for nefarious purposes?

Understanding the limitations of Loper Bright is a good start.

Continue Reading Limits to Loper Bright
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To anyone who needs a few more CLE hours before the end of the 2024, we wanted to let you know that videotaped sessions from last week’s Reed Smith Annual Life Sciences Litigation CLE Week are now available on demand. Here are descriptions of the topics and the registration link.

340B Program: Update on Current Developments | Presented by Joe Metro and David Bender | This session updates attendees on the current status of the 340B drug discount program, including ongoing litigation over manufacturer contract pharmacy limits, potential implications of Loper Bright, developments with the administrative dispute resolution process, state legislative initiatives, and potential emerging mechanisms to identify ineligible and duplicate 340B discounts, including under the Inflation Reduction Act’s price regulation programs. Click to register and view on demand.

How the toughened up, amended Fed. R. Evid. 702 has been faring | Presented by Blogger Jim Beck (Bexis) and Sarah Johansen | The new and improved Fed. R. Evid. 702 has been in place since last December. During this session, we examine how the toughened up rule was created, the favorable Committee Notes and other committee materials, and precedent about rules amendments. Then we discuss how the amendments have fared in court, not only favorable decisions that exist in almost every circuit, but also the unfortunate persistence of propositions that the Committee Notes s declared “incorrect.” Finally, we discuss state rules adopting similar amendments. Click to register and view on demand.

New Rule 16.1 on MDLs | Presented by Blogger Steven Boranian and Christian Olivos | Proposed Federal Rule of Civil Procedure 16.1, which sets forth procedures for handling Multi-District Litigations (MDLs), is likely to go into effect in December 2025. This presentation explains what persistent MDL issues prompted the creation of Rule 16.1, and what Rule 16.1 does and does not do. It also suggests potential best practices for dealing with Rule 16.1, particularly with a view toward improving the efficiencies of MDLs and facilitating early vetting of cases. Click to register and view on demand.

PFAS Litigation in the MedTech Industry: Key Cases and Emerging Trends | Presented by Matt Jacobson, Allie Hussey, and Alexis Rochlin | PFAS are a broad class of substances found in numerous consumer, commercial, and industrial products, including medical devices, pharmaceuticals, and their packaging. In recent years, litigation over allegations of PFAS being potentially hazardous to human and environmental health has exploded. This presentation includes an overview of the history of PFAS litigation and how it sheds light on potential PFAS litigation against medical device and pharmaceutical companies. This presentation also offers practical pointers on how MedTech companies can mitigate risk associated with potential PFAS litigation. Click to register and view on demand.

Product Liability in Europe: Understanding and Planning for the EU’s Recent Complainant-Friendly Shift | Presented by Blogger Lisa Baird and Wim Vandenberghe | Imminent legal reforms will radically change the liability risks for drug and device manufacturers and suppliers in Europe. This session focuses on the recently adopted EU Product Liability Directive, which is dramatically complainant-friendly, both expanding the scope of permissible claims and range of damages, as well as imposing pro-claimant presumptions. Synergy between the new Product Liability Directive and the EU’s new class action regime is also examined. This session assists life sciences leaders understand these developments – and specifically the resultant compliance challenges and litigation risks posed to their companies – and identifies practical steps companies can begin now, to lower their risks and improve compliance. We also compare these European product liability changes to the existing U.S. litigation and product liability landscape. Click here to register and view on demand.

The New Frontier: AI in Product Liability Law | Presented by Mildred Segura and Christian Castile | This presentation is devoted to the rapidly growing AI movement as it impacts life science companies, calling out key legal developments and related business considerations. Click here to register and view on demand.

CLE Information: For On-Demand Viewers

In order to receive CLE credit, you will need to notify Learning & Development CLE Attendance once you have viewed the program on-demand.

**Please note – CLE credit for on-demand viewing is only available in California, Connecticut, Illinois, New Jersey, New York, Pennsylvania, Texas, and West Virginia. Credit availability expires two years from the date of the live program.

CLE Questions? Contact Learning & Development CLE Attendance.

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The district court’s order applying Michigan law and dismissing one plaintiff’s complaint in the Tapezza MDL may be the last of a dying breed.  The court faithfully enforced Michigan’s statute providing a presumption of non-defectiveness for FDA approved drugs and dismissed the plaintiffs’ case.  But alas, Michigan repealed that law effective February 13, 2024, thus discarding a defense that over the years has successfully done away with hundreds of product liability claims against drug manufacturers.  See Mich. Comp. Laws Ann. § 600.2946 (repealed).  Of course, in the high-regulation-low-litigation model that we favor in our drug and medical device space, we quite like laws like Michigan’s woebegone presumption.  But if the recent Tapezza order is the last gasp of reason, so be it.

The recent dismissal order in In re Tapezza, No. 1:23-cv-03568, 2024 WL 4590744 (N.D. Ill. Oct. 28, 2024), involved one in a long line of Michigan residents trying to escape Michigan law—a member of the “Michigan diaspora,” as Bexis sometimes says.  Here, the plaintiff lived in Michigan, was treated with the product in Michigan, and experienced an alleged injury in Michigan.  She sued, however, in Illinois and sought application of Illinois law—which does not have a presumption of non-defectiveness for FDA-approved drugs comparable to Michigan’s. 

Applying Illinois choice-of-law rules, the district court rejected the plaintiff’s arguments and applied Michigan law.  First, the court found a dispositive conflict between Michigan and Illinois law because Michigan law “in effect at the time of [the plaintiff’s] alleged injury and the filing of her complaint bars ‘a product liability action” against a manufacturer of an FDA-approved drug.”  Id. at *2.  This is really important because it confirms that the repeal of section 600.2946 is not retroactive.  This is the correct outcome, as we explained here.  Claims that accrued before February 13, 2024, are still subject to the law, which is good.

From there, it was relatively straightforward for the court to rule that Michigan law applied and that the complaint should be dismissed.  Under Illinois choice-of-law rules, there is a “strong presumption that the law of the place of injury . . . governs the substantive issues.”  Id. (quoting Townsend v. Sears, Roebuck & Co., 227 Ill. 2d 147, 155 (2007) (emphasis in original).  Michigan law therefore carried substantial weight from the start, as would be the case under most states’ choice-of-law rules. 

Moreover, a weighing of the relevant factors failed to dislodge Michigan law.  Some of the alleged wrongful conduct occurred in Illinois, which is where the defendant was headquartered and manufactured the drug.  But other conduct occurred in Michigan, including the diagnosis of the plaintiff’s condition and administration of the drug.  Id. at *3.  The same goes for the domicile of the parties—the defendant was incorporated in Delaware and headquartered in Illinois, but the plaintiff was domiciled in Michigan.  These factors were neutral.  Finally, the relationship between the parties was formed in Michigan, where the plaintiff was treated with the defendant’s product. 

The plaintiff argued that Illinois’ interest in regulating its corporate citizens exceeded Michigan’s interest in enforcing a now-repealed “exercise in corporation protectionism.”  The district court, however, rejected that argument and reasoned that one of the policy concerns behind section 600.2946 was to increase access to affordable prescription drugs for Michigan residents, not mere “corporate protectionism.”  The court further reasoned that a consumer-versus-corporation paradigm was simply not useful and that laws limiting liability are deserving of equal dignity:

In any case, “pro-consumer” and “pro-business” labels do not further the analysis.  “[T]ort rules which limit liability are entitled to the same consideration when determining choice-of-law issues as rules that impose liability.”  The fact that Michigan law is less favorable to [the plaintiff] is not an appropriate policy consideration.

Id. at *4 (quoting Townsend).  If the Michigan legislature had intended to abandon its interest in enforcing section 600.2946, it would have repealed the law retroactively, which it probably could not have legally done even if it wanted to.  Id.  And, even if Illinois’ interest in regulating its corporate citizens outweighed Michigan’s interest in enforcing a repealed statute, that still does not overcome the strong presumption that Michigan law should apply.

Our “last of a dying breed” lamentation at the beginning was a little overdramatic.  Call it blogger’s license.  The reality is that the repeal went into effect less than one year ago, and there are probably many pending cases to which Michigan’s presumption of non-defectiveness still applies.  Defendants should not be bashful in pressing it as a defense in those cases. 

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A long time ago, in a mass tort far, far away, the plaintiffs’ lawyers were not content with collecting plaintiffs from within the US.  They also brought a putative product liability class action in federal court in the U.S. on behalf of European plaintiffs.  As a result, your bloggers learned a little bit (a very little bit) about product liability law and collective/representative actions in Europe. 

Our main take-away from the then-applicable E.U. Product Liability Directive was that it seemed like something academics would dream up in their ivory towers, far removed from the reality of litigating product liability actions in the United States.  A great deal of debate went into issues that the E.U. drafters seemed to believe would have case-determinative effect, whereas in our experience litigation is never so easily resolved. 

For example, the “state of the art” defense (or “defence”, we should say) was so hotly debated that the 1985 E.U. Product Liability Directive made it optional:  Member States could elect to enact that provision or skip it, depending on whether they thought a manufacturer should be able to avoid liability by declaring the risk was unknown at the time the product was made.  It seemed to us the debate was premised on the assumption that a manufacturer could say “But I didn’t know!” and the lawsuit would be over.  Perhaps things do work that way in the courts of the Member States of the E.U. But in the U.S., when a manufacturer says “But I didn’t know!”, the plaintiffs (and the court) respond “that’s nice”, and then the parties just continue on for years with discovery into what was known or could have been known decades earlier. Eventually, various experts materialize and declare that signals should have been seen and tests should have been run long ago, and then the whole thing–including what was the state of the art at a certain time–goes to the jury anyway.

Now, after 40 years under the prior regime, the E.U. is re-booting its Product Liability Directive, due to concerns that the 1985 version made it too difficult for claimants to bring claims. We, of course, do not share the view that the long-standing E.U. Product Liability Directive needs to be loosened to make product liability litigation in Europe more common. 

The new Product Liability Directive has been fully adopted by the EU, but it has not yet been published in the Official Journal.  From the date it enters into force (20 days after publication), each E.U. Member State will have two years to “transpose” it their national law (effectively, enact it in the national language and their legal system).  The new Product Liability Directive will apply to products sold in the E.U. as of the end of 2026. 

The Directive is meant to be almost fully “harmonized”, meaning each nation is expected to enact a law that adheres to its provisions–except with respect to the state of the art defense, which apparently is still so hotly debated that it remains optional, in each Member State’s discretion. 

Key substantive features in the new Product Liability Directive are:

  • It is a strict/no-fault liability scheme.  The question is whether the product is defective and caused harm, not whether the defendant was at fault.
  • Defectiveness:  The test for a product defect is that the product “does not provide the safety that a person is entitled to expect or that is required” under EU or national law, and the Directive cross-references other E.U. safety directives and rules.  All we can say is, while this is pretty vague, at least it isn’t a consumer expectations test (we think).
  • The definition of “product” now includes intangible goods, such as software, an approach more liberal than generally is allowed in the U.S, as we discussed in this post.
  • The Directive applies to goods and related services.
  • Potential defendants are any “economic operators”, a term which includes manufacturers, component part manufacturers, providers of related services, authorized representatives, distributors, and fulfilment service providers (which seems to include online sales platforms).
  • Allowable damages include:  Death, personal injury, medically recognized damage to psychological health, certain damage to or destruction of property, and destruction or corruption of data used for professional purposes.

Key procedural features of the new Product Liability Directive are:

  • A 3 year statute of limitations (expiry of claim); this limitations period runs from the date the claimant knew or reasonably should have been aware of the damage, the defectiveness, and the identity of the relevant economic operator.
  • Latent personal injury claims may be brought within 25 years (the long-stop limitations period).
  • Individual and collective actions are allowed (whereas in the U.S., personal injury claims are deemed inherently too individualized to allow for class treatment).
  • Disclosure requirements:  In place of U.S.-style discovery, the Directive allows national courts to require both claimants and/or defendants to disclose “necessary and proportionate” “facts and evidence” which are “sufficient to support the plausibility of the claim”.  Member states are allowed to—but not required—to protect trade secrets and confidential information. 
  • There is a minimum damage requirement (500 euros) but the prior maximum damage threshold (70 million euros) has been abolished.

The new Product Liability Directive also provides three “rebuttable presumptions” and these provisions, in our view, are perhaps the worst part of the new Directive.  The new presumptions are:

  • A rebuttable presumption of defectiveness, which will arise where there is non-compliance with disclosure requirements or mandatory legislative and safety requirements, and “obvious malfunction”;
  • A rebuttable presumption of causation, which will arise where it is established that the product is defective and the damage caused is of a “kind typically consistent” with the defect; and
  • A rebuttable presumption of both defectiveness and causation, which will arise where the claimant faces “excessive difficulties, in particular, due to technical or scientific complexity” with the product, and the claimant can demonstrate that it is likely that the product is defective or that there is a causal link.  One example given?  Medical devices. 

Our response:  Ugh. 

Instead of recognizing that a plaintiff’s difficulty in proving up product defect or causation usually results because they have no valid claim—because there is insufficient proof that the product actually has anything wrong with it or causes harm—the E.U. has decided that difficulty proving up defect and causation means the standards should be lower.  

In fact, if a claimant can say “the product is beyond my technical understanding” and get a presumption of defectiveness or causation, doesn’t that flip the burden of proof entirely on its head?   Does no one involved with the new E.U. directive follow what has happened in the U.S. with out of control mass torts, or with regard to pharmaceuticals and medical devices driven from the market only to have the precipitating scientific studies withdrawn and their conclusions debunked? 

In addition to the Product Liability Directive revisions, and probably making matters worse:  The E.U. also adopted the Representative Actions Directive, which already took effect on June 25, 2023.  “Directive (EU) 2020/1828 of the European Parliament and of the Council of 25 November 2020 on representative actions for the protection of the collective interests of consumers and repealing Directive 2009/22/EC,” Official Journal of the European Commission (November 25, 2020). The E.U. Representative Actions Directive is designed to make consumer class actions easier to bring—something we also do not think was necessary. 

The Representative Actions Directive provides minimum standards to be adopted by Member States to supplement to any national procedures that already may exist (some Member States had no previous representative action mechanism). 

There are notable differences from U.S. class actions, however.  First, the claims have to arise from one of 66 specific E.U. Directives and Regulations, which limits the subject matter and in theory should constrain the creativity of the plaintiffs’ bar to conjure up imagined harms.  Second, only “qualified representative entities” (or “QREs”, such as public agencies or consumer groups) may bring representative actions on behalf of EU consumers.  Third, the E.U. Representative Actions Directive specifically permits single-nation/domestic and cross-border representative actions, something that doesn’t exist in the U.S., if for no other reason than differences between U.S. tort law and that of other nations.

Taken together, these are quite substantial changes that portend an increase in litigation in the E.U. We understand that litigation funders already are opening branches in cities like London and Amsterdam, so undoubtedly we all will be talking more about Europe in the years to come. 

If this has piqued your interest, Reed Smith is holding a CLE on this topic this morning at 9:30 Eastern time; the link to register and join is here.

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Just about three months ago, we blogged about Rule 25 dismissals in the Bair Hugger MDL, and today we bring you more of the same from Taxotere.  Federal Rule of Civil Procedure 25 provides that “[i]f a party dies . . . the court may order substitution of the proper party.”  Rule 25 goes on to set a time limit for accomplishing the substitution: 

A motion for substitution may be made by any party or by the decedent’s successor or representative. If the motion is not made within 90 days after service of a statement noting the death, the action by or against the decedent must be dismissed.

FRCP 25(a)(1).  The “statement noting the death” is typically referred to as a “suggestion of death.”  It is not a complicated filing.  Usually just a single page notifying the court that a party has died, the date of death, and advising of Rule 25’s requirements.  We say “party,” but in the drug and device litigation world, we are really talking about plaintiffs.  Plaintiffs often who are older or who were receiving medical treatments for pre-existing illnesses.  Given the simplicity of the process, it seems like it should be an easy thing for plaintiffs’ counsel to do.  A client passes, you file a suggestion of death, you talk to their family, if they want to continue with the action, you get a representative of the estate appointed, and finally you move to substitute.  But in mass tort litigation, that first step—being aware that your client has died—can be a major hurdle for plaintiffs’ counsel. 

In our Bair Hugger post we asked:  “How do plaintiff lawyers misplace their clients?”  The reality is, it happens all the time because of the difficulty they have keeping track of hundreds of clients.  Mind you, on the defense side we are busy keeping track of every plaintiff represented by every lawyer running into the thousands.  Yet somehow, we seem to be more aware of when a plaintiff dies than their own counsel. 

Which brings us back to Rule 25’s 90-day deadline.  Since filing a suggestion of death starts the clock running on the time to move to substitute a proper party, the suggestions or notices are often filed by defendants.  But sometimes even clearing that first hurdle for plaintiffs is not enough.  That is what happened in In re Taxotere Docetaxel Products Liability Litigation, 2024 U.S. Dist. LEXIS 200763 (E.D. La. Nov. 5, 2024).

Defendant filed and served suggestions of death for twenty plaintiffs who had passed away several years earlier.  Plaintiffs took no action in response, not even a request for more time to make a proper party substitution.  So, several months later, defendant moved to dismiss.  Seven plaintiffs opposed the motion and one requested more time. 

The seven oppositions were based on an alleged deficiency in defendant’s suggestions of death.  Rule 25(a)(3) provides that a suggestion of death “must be served on the parties as provided in Rule 5 and on non-parties as provided in Rule 4.”  While the rule itself does not specify which non-parties need to be served, most circuits to have considered the issue have ruled that a valid Rule 25 suggestion of death must be served on the personal representative of the estate, “even where it is difficult to determine who the personal representative is.”  Id. at *8.  That means when a defendant is filing a suggestion of death, it is best to serve the decedent’s heirs or those with a “significant financial interest” in the outcome of the case. 

Defendant in In re Taxotere did just that.  It served the relevant non-parties with the suggestion of death via certified mail which is a form of service permitted under Louisiana’s long-arm statute.  Id. at *10.  Plaintiffs argued that was not personal service as required by Rule 4.  But Rule 4 allows service by various means, one of which is by “following state law for serving a summons in an action brought in courts of general jurisdiction in the state where the district court is located or where service is made.”  Rule 4(e)(1). 

Plaintiffs tried to read into Rule 25 a requirement of personal service on non-parties that simply does not exist.  As the court noted, plaintiff’s proposed strict reading of the rules, “seems unnecessary, particularly in light of the . . . difficulties with locating the proper parties to substitute in as plaintiff.”  Id. at *12.  Rule 25 merely requires service “as provided in Rule 4.”  Since Rule 4 allows service in accordance with state law and defendant followed state law in serving the non-parties via mail, that service was valid and began the 90 days for plaintiffs to substitute a proper party. 

Because plaintiffs did not demonstrate excusable neglect that would warrant allowing more time for the substitutions, and given how long some of the plaintiffs had already been deceased, the court dismissed nineteen of the twenty plaintiffs.  The final plaintiff actually filed a motion to substitute that mooted the motion to dismiss.

This order and that entered by the Bair Hugger court are prime examples of plaintiffs’ counsel failing in MDLs to do even the absolute minimum to keep cases active.  Is it surprising?  Not to us.  We know most MDL inventories are full of garbage that needs to be cleared out.  So, we appreciate when district courts use the rules to do a little spring cleaning, even in November. 

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Lord knows, there are a lot of meritless MDLs.  Bexis’ and Michelle’s Bone Screw litigation, prompted by a televised CYA freak-out by then-FDA Commissioner David Kessler over an off-label use that had become the medical standard of care, was one, and it gave us Buckman.  Several MDLs against modern anticoagulants, such as Xarelto, are another example, since all of those second-generation drugs were safer than the older forms of blood thinners they superseded.  Currently, the Taxotere MDL – based on the dubious proposition that the plaintiffs cared more about hair loss than most effectively treating their breast cancer – and Zostavax – where not a single plaintiff can prove causation – come to mind.  Our colleagues defending other MDLS can also be excused for believing that their own litigation should be added to this list.

But for sheer factual baselessness, it would be hard to top the still-ongoing Avandia MDL, which somehow has managed to persist since 2007.  The Avandia litigation is infamously based on a purported increased risk that, over a decade ago, the FDA scientifically determined did not exist.  Briefly, a study erroneously found an increased risk of cardiovascular events with Avandia that led to both a boxed warning and additional studies.  The additional studies debunked that supposed increased risk and the FDA removed the boxed warning:

Continue Reading Avandia Litigation – Is This Finally the End?

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FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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