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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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We hope our loyal readers have recovered from indulging (or perhaps overindulging) on candy during Halloween and are now looking forward to the Thanksgiving holiday. As you reflect on what you’re thankful for this year, consider adding discounted registration to ACI’s Drug and Medical Device Litigation Conference, coming up on December 3-4, to your list. As we mentioned, the good people at ACI asked the blog to be a media sponsor once again – and are offering a special registration discount for the conference for the blog’s readers. If you use the code D10-999-DDLB25 when you register, you’ll save 10 percent off your conference registration.

A number of your bloggers will be present, and we look forward to insightful presentations from the consistently outstanding faculty of in-house counsel, top defense firms, and seasoned jurists.

If you want to register, you can do so here. We look forward to seeing you in New York!

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We posted earlier this year about the failure to warn causation decision from the California Supreme Court in Himes v. Somatics, 549 P.3d 916 (Cal. 2024), and the potential parade of horribles that might ensue.  Here comes the grand marshal of the parade.

Continue Reading California District Court Punts on Learned Intermediary Causation Post-Himes
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When it comes to MDLs that concern a bunch of cases about a drug or device, they typically have a name like “In re [name of product(s)] Product Liability Litigation” or “In re [name of product(s) Marketing and Sales Practices Litigation.”  In theory, the first group of MDLs involves, shockingly, product liability claims because the plaintiffs allege a physical injury, and the second group of MDLs involves non-product liability claims because the plaintiffs allege only economic injuries.  In reality, the lines are not so clean.  Many non-product liability claims, such as consumer protection and express warranty, are thrown into complaints by plaintiffs claiming injury.  In addition, some plaintiffs assert product liability claims without present injury, including in the context of medical monitoring and fear of future injury theories.  However, in almost every jurisdiction, you need some past or present physical injury to support a product liability claim.  Less universal, but no less logical, is the requirement that warnings claims be based on an inadequate disclosure of the risk of harm that the plaintiff claims to have suffered.

A number of recent litigations have been predicated on purported issues with drugs that do not always translate to an actual physical injury to the plaintiff.  Litigation based on alleged contamination–ranitidine comes to mind–where most plaintiffs allege that they would not have used the drug and been exposed to a hypothetical health risk (that did not manifest in an injury in them) if the defendants had done something different along the way.  There is a less common variant that we see in In re Oral Phenylephrine Marketing and Sales Practice Litigation, MDL No. 3089, — F. Supp. 3d –, 2024 WL 4606818 (E.D.N.Y. Oct. 29, 2024) (“OP”).  That MDL is predicated on the idea that phenylephrine is not effective as a decongestant when included in a bunch of OTC medications made by a bunch of companies.  There is, as far as we can tell, no allegation of a risk of injury from the use of the medications, realized in particular plaintiffs or otherwise.  In OP, the court considered the non-product liability claims asserted in a class complaint under New York law and federal civil RICO as a “test case.”  Without any physical injuries or risks, not asserting product liability claims makes sense.  It also meant that the state law claims were expressly preempted.

Phenylephrine has been approved as a safe and effective OTC decongestant since 1985, and has had a monograph specifying its labeling since 1994.  In 2023, an FDA advisory committee “found that scientific data did not support the use of [phenylephrine] as a decongestant.”  Id. at *1.  (We quote this language because advisory committees only give advice to FDA.)  FDA has not changed the regulatory status of these drugs and all but one of the OP defendants still sell them.  The OP plaintiffs contend that they would have not bought the OTC drugs with phenylephrine or would have paid less for them if they had been labeled with a disclosure that phenylephrine did not work.  We have heard many plaintiffs argue that an FDA-regulated medical product should have been labeled to say something like “this does not work” for its approved indication or “do not use this” for its approved indication, but we have never seen any products with such labeling out in the real world.  One reason is that such labeling would be tantamount to a rejection of FDA’s decision to allow the product to be used legally for a particular purpose.  That could run into a number of preemption theories, but OTC drugs have express preemption of state law requirements that are “different from or in addition, to, or that is otherwise not identical with” the federal requirements under the FDCA.  Id. at *3 (quoting 21 U.S.C. § 379r).  That express preemption provision has a giant exception for product liability claims, but, like we said above, this litigation without any risk or physical injuries had no product liability claims, at least in the test class complaint.  

Plaintiffs’ New York state law claims, regardless of how titled, related to the content of the labeling for the OTC drugs, which complied with the monograph governing labeling for OTC decongestants instead of saying what plaintiffs wanted them to say.  The monograph permitted the indication for these drugs to pick from a range of specified language related to efficacy for temporary relief of congestion.  Id. at *4.  The general regulation on indications for monograph drugs required the use of language from the monograph or “alternative truthful and nonmisleading statements describing only those indications for use that have been established in an applicable monograph.”  21 C.F.R. § 330.1(c)(1).  “Nothing in the PE monograph or the general monograph suggests manufacturers have a freestanding duty to update their indications in response to new scientific information.”  2024 WL 4606818, *4.  You certainly cannot truthfully describe the approved indications by having labeling that says the “exact opposite” of the monograph language—i.e., that the drug is not effective for the indication.  Id.  Imposing a duty to contradict the monograph would clearly be expressly preempted, as the Second Circuit previously held in a cosmetics case discussed here. Plaintiffs tried to muddy the water by referring to FDA requirements about updating a label via CBE or ceasing sale of a misbranded drug that is “dangerous to health when used in the dosage or manner, or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof.”  21 U.S.C. § 352(j).  These provisions trigger no duties based on doubts about the drug’s efficacy for an approved indication, though.

Calling the labeling claims “false advertising,” “false concealment,” and “express warranty” did not change that they turn on having labeling consistent with the monograph language on the approved indication.  “Because each duty would have required defendants to update the labels of their [phenylephrine] products or stop selling the products altogether, the claims are preempted.”  2024 WL 4606818, *7.  The rejection of a stop selling argument based on express preemption is noteworthy, given that Bartlett arose in the conflict preemption content.

In terms of the preemption of state law claims, there is no particular reason why the ruling on New York law would not apply to other states’ laws.  Plaintiffs’ express warranty claim was rejected in part because New York treats economic express warranty claims as contract claims.  Id.  Some states may treat express warranty claims that involve personal injury as product liability claims, which would be subject to the savings clause in the express preemption provision for OTC drugs.  However, these plaintiffs appear not to have any injuries to shoehorn their claims into a product liability bucket.  Even if they escaped express preemption, product liability claims as directly contrary to an approved monograph as these would likely be impliedly preempted.

The last part of OP was to address standing for the civil RICO claims.  Plaintiffs were all indirect purchasers of the drugs, so, following the rule long-established in antitrust cases, they had no standing.  Findings that indirect purchasers lack standing to bring civil RICO claims is apparently the majority position.  Id. at *8 n.6.  Thus, we need not dwell on it, except to say that the standing argument should apply to other cases against manufacturers in the OP MDL.  If state law claims are preempted and there is no standing to assert a federal claim that would not be subject to preemption, then there should not be much if anything left in the OP MDL.  Not that we expect the plaintiff lawyers to give up in pursuing this MDL that involves no risk and no physical injury.  Have we already mentioned that?

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[This post is from the non-Reed Smith side of the blog.]

Today we report on Dickson v. Dexcom, Inc, 2024 WL 4291511 (W.D. La. 2024), an important medical-device preemption case that started with a doctrinal bang but ended on a factual whimper.

Committed to nationally uniform standards based on good science, we believe that the FDA rather than lay juries should determine how medical devices are designed and labeled. Fortunately, our policy preference is enshrined in law: 21 U.S.C. § 360k(a) prohibits states (and juries applying state tort law) from imposing safety or efficacy requirements on medical devices that are “different from, or in addition to,” those imposed by the FDA. Unfortunately, many courts—led astray by Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996)—have unduly limited § 360k(a)’s preemptive scope, holding that it applies only to Class III medical devices that have received premarket approval (or an investigational-device exemption) from the FDA.

Dissatisfied with the judicially imposed limitation on § 360k(a)’s scope, we were pleased when Dickson v. Dexcom, Inc, 2024 WL 2846055 (W.D. La. 2024), correctly held that § 360k(a) preempts claims challenging the safety and effectiveness of a Class II device whose sale was authorized by the FDA through the de novo classification process. As we reported at the time, the decision was very good insofar as it squarely recognized that § 360k(a)’s preemptive shield covers such devices.

Still, we were troubled by the court having granted the plaintiff leave to replead her failure-to-warn claim. Without explicitly saying so, the court held that the claim could survive preemption if the plaintiff alleged facts that, if true, would have allowed the defendant manufacturer to unilaterally the revise device’s labeling under the FDA’s changes-being-effected (CBE) regulation codified at 21 C.F.R. § 814.39(d). Specifically, the court concluded that the claim might not be preempted if the plaintiff adequately alleged the existence of “newly acquired information,” which is a necessary precondition for changes under that provision. 2024 WL 3417392, at *8.

As we explained at the time, the hypothesized loophole to express preemption—which the court derived from inapposite pharmaceutical cases addressing implied preemption—is foreclosed as a matter of law. The only labels that may be revised under the CBE regulation are those for Class III medical devices that have received premarket approval; the regulation does not allow a manufacturer to revise the labeling of a device that received de novo classification. But even “assum[ing] for the sake of argument that there might have been some way for” the defendant to have invoked the CBE regulation (Dickson, 2024 WL 3417392, at *8), it would not save the plaintiff’s failure-to-warn claim from express preemption because the regulation does not require a manufacturer to unilaterally revise device labeling based on newly acquired information and any state-law requirement that it do so would be “different from, or in addition to,” the federal requirements and therefore barred by 21 U.S.C. § 360k(a).

When recounting Dickson, we expressed the hope that the court would correct its error if the plaintiff chose to amend her complaint to include purportedly sufficient allegations of “newly acquired information.”

Alas, that did not happen.

Ruling on the defendant’s motion to dismiss the plaintiff’s amended complaint, the court dismissed her failure-to-warn claim as preempted but on factual rather than legal grounds, concluding that “[e]ven if plaintiff could show a mechanism like the CBE regulation requiring [the manufacturer] to independently reevaluate and amend its label, she has twice failed to show sufficient ‘newly acquired information’ to trigger any relevant change to the existing warnings.” Dickson, 2024 WL 4291511, at *4. In reaching that conclusion, the court correctly recognized that adverse-event reports by themselves do not constitute such information. We welcome that. But we sure wish that the court had also recognized that § 360k(a) categorically bars claims based on a manufacturer’s purported ability to revise a device’s labeling under the CBE regulation.

So, at the end of the day, the Dickson duology represents a significant step forward and a minor step back. Let us hope that future courts apply § 360k(a) to claims implicating devices that received de novo classification but do so with the understanding that the CBE regulation cannot save otherwise preempted failure-to-warn claims.

In the meantime, thanks to friend-of-the-blog P.J. Cosgrove of UB Greensfelder LLP for bringing Dickson to our attention.

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