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Sometimes bench-bar conferences are actually useful.  Last week we wrote a post about a district court’s application of the New York statute of limitations to shut down a product liability lawsuit.  The key holding was that the statute of limitations began to run as soon as the plaintiff experienced relevant symptoms.  There was no need to wait for a medical diagnosis or, even worse, a plaintiff lawyer ‘diagnosis.’  Shortly after our post was unleashed upon the general populace, a fellow defense hack bumped into one of our fellow bloggers at a conference and mentioned that they had recently won on a similar issue – except their victory was before the Second Circuit.  How’s that for one-upmanship? The case is Rouviere v. Howmedica Osteonics Corp., et al., 2024 U.S. App. LEXIS 8201, 2024 WL 1478577 (2d Cir. April 5, 2024).  It is a summary order, meaning it has no precedential effect.  But it can still be cited and discussed, and that’s what we are doing today. (Rouviere has been a long and storied litigation. We have recited parts of that story here (Zoom depositions during Covid), here (turncoat experts), and here (reflections on Rambo litigation).

The plaintiff, proceeding pro se on appeal, had filed a lawsuit against two medical device companies in 2018. She claimed that she suffered complications from her hip replacement in 2012 after parts made by the defendants allegedly impinged upon one another and eventually caused a wide variety of issues, including metallosis.  The court helpfully explained what metallosis is, but we won’t.  From the name alone, you can assume that metallosis is not something you’d want. 

The causes of action sounded in product liability and breach of warranty.  The defendants prevailed on their motion for summary judgment on various grounds, including statutes of limitations.  The Second Circuit reviewed the decision granting summary judgment de novo. The Second Circuit also observed that pro se pleadings are “liberally construed” to raise the strongest arguments they suggest.  That observation might signal a bad result for the defense, but it doesn’t here. It turns out that the strongest arguments even possibly raised by the plaintiff were not strong enough. 

The appellate court affirmed the district court’s summary judgement in favor of the defense on statute of limitations grounds. The record revealed no genuine issue of material fact that the relevant symptoms began before May 2015. That timing turned out to be fatal for the plaintiff’s claims.  

The parties agreed that a four-year statute of limitations applied to the warranty claims, pursuant to N.Y. U.C.C section 2-725. A breach of warranty claim accrues “when tender of delivery is made” — regardless of “the aggrieved party’s lack of knowledge of the breach.”  There is no provision in the UCC for an extension of the limitations period based on tardy discovery of the alleged breach.  Accordingly, the plaintiff’s claims for breach of warranty were time-barred because they accrued, at the latest, on the date of her surgery (that is the latest date when the medical device could have been “tendered”) in 2012. Now for a little pseudo math: (2018-2012 > 4) = dismissal. 

The analysis for the product liability claim was slightly different, but equally dispositive. First, the limitations period for product liability is only three years, as opposed to the four years for warranty claims. Second, for purposes of the appeal, the Second Circuit assumed, without deciding, that the product liability claim was governed by the New York statute applying to toxic torts.  If you read our post last week, you know that such an assumption does the plaintiff a big favor because the statute of limitations for toxic torts postpones accrual until the plaintiff “discovers the primary condition on which the claim is based”. In last week’s case, the court held that the toxic tort did not apply because there was no latency issue, so the plaintiff was stuck with a statute of limitations that cut no slack for late discovery. 

By contrast, the Second Circuit in Rouviere  did cut such slack for the plaintiff, or at least concluded that such slack would do the plaintiff no good.  Why?  There is a huge difference between  the plaintiff’s recognition that she is suffering from a certain condition (which is what triggers accrual) vs. when “the connection between the symptoms and the injured’s exposure to a toxic substance is recognized” (which is the position every enterprising plaintiff lawyer will urge). Importantly, the Second Circuit rejected the plaintiff position and held that accrual does not depend “on the medical sophistication of the individual plaintiff [or] the diagnostic acuity of his or her chosen physician.”  Good reasoning and good turn of phrase.  

Third, even assuming application of the more plaintiff-friendly statute of limitations provision that bends time to await discovery of the injury, the plaintiff’s product liability claim in Rouviere was time-barred because there was no genuine dispute of material fact that she discovered the “manifestations or symptoms” of her injury from the hip replacement procedure more than three years before she filed suit in 2018. The plaintiff did not dispute that she experienced the relevant symptoms from 2012 to 2014. (The court does not tell us directly, but we are pretty sure that the defense lawyers did a nice job in discovery to nail this fact down.) The plaintiff connected those symptoms to her hip replacement in her amended complaint. Oops.  (We teach a litigation strategy class at the University of Pennsylvania Law School. In the second session of the class, we spend some time discussing the tension between telling a really good story in your complaint and pleading yourself into dismissal.) Even if, as the plaintiff argued on appeal, she did not subjectively identify the impingement of the hip replacement products as the cause of her symptoms before her revision surgery in 2016, that medical ignorance would not prevent her claim from accruing. 

Usually the last resort of a tort plaintiff trying to stave off the statute of limitations is a demand for equitable estoppel or tolling based on some alleged misconduct by the plaintiff. Rouviere follows this pattern. The plaintiff pointed to the defendants’ alleged concealment of the defectiveness of their products (that would be an exception swallowing up the statute of limitations entirely) and their alleged misrepresentations to the FDA about the safety of their products (you probably thought of Buckman before you read these words, right?). 

The Second Circuit rejected these bases for equitable estoppel/tolling.  First, the plaintiff was simply replaying her product liability failure to warn claims (which, again, is why we suggested that it would be an exception that would make the statute of limitations disappear in virtually every product liability case). Second, the plaintiff failed to explain what “subsequent and specific action” the defendants took, beyond their initial alleged omissions and representations about the safety of their products, to prevent the plaintiff from timely suing. None of the allegedly fraudulent actions involved the plaintiff. She did not show that either plaintiff misrepresented the appropriate statute of limitations or sought to prevent her lawsuit after she began to experience symptoms from her hip replacement procedure.  Further, the plaintiff did not show that she did not file her case within the statute of limitations because she reasonably relied on the defendants’ alleged misrepresentations to the FDA. 

We are grateful to Paul Asfendis (Gibbons P.C.) for alerting us to the Rouviere decision, and we congratulate Paul and his partner, Kim Catullo, for attaining such a fine result.  As always, we welcome news and suggestions from our readers. 

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No one can argue with that title because Bruno v. Bluetriton Brands, Inc., was most definitely dismissed completely on preemption grounds.  2024 U.S.Dist. LEXIS 98451 (C.D. Cal. May 6, 2024).  In so ruling, the court handed class action plaintiffs a significant defeat on of their latest litigation endeavors:  “microplastics” in water.  It’s not a drug or device case, but it is squarely an FDA preemption case, and that’s good enough to warrant a mention here.

Plaintiffs brought the putative class action alleging that defendant’s label– “100% Mountain Spring Water”—was misleading because during the manufacturing process and/or from the degradation of the plastic bottle, the product also contains microplastics.  Plaintiffs allege ingesting microplastics can cause various health issues.  Id. at *2.    

The FDA has specific regulations governing what products can be sold as “spring water.”  And they focus on where the water comes from and how it is collected.  Plaintiffs were not challenging that defendant’s product was in fact “spring water.”  Their dispute, according to plaintiffs, was with calling it 100% water because the presence of microplastics makes that an untrue statement.  Plaintiffs thought this distinction would put them outside of FDA regulations.  The court disagreed.

First, this is not a case where plaintiffs are alleging that defendant has failed to comply with the FDCA.  Not only are plaintiffs not challenging that defendant’s product is indeed spring water, there is no regulation prohibiting microplastics in spring water.  Plaintiffs cannot, therefore, assert they are pursuing a parallel claim.  Id. at *7. 

Second, challenging the “100%” on defendant’s label is essentially a request that either it be removed or that defendant be required to “more accurately disclose the composition” of its product.  Id.  Either would impose obligations on defendant beyond those imposed by the FDA.  Plaintiffs’ claims would therefore run afoul of the FDCA’s provision that “no state may directly or indirectly establish . . . any requirement for a food which is the subject of a standard of identity established” by the FDCA.  Id. at *5 (quoting 21 U.S.C. §343-1(a)(5)).        

Explicitly expressing skepticism that plaintiffs can replead their case to avoid preemption, the court is giving plaintiffs one more chance to amend.  The court also advised plaintiffs to look at the alternative grounds for dismissal raised by defendants in their motion.  Although not ruled on, the court suggested plaintiff consider any other deficiencies because plaintiffs’ Second Amended Complaint will be 100% their last.  Id. at *9.

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We recently discussed how “failure-to-recall” claims essentially don’t exist – outside of a couple of limited fact patterns that plaintiffs asserting such claims in litigation involving FDA-regulated products can almost never allege.  Today’s post adds the constitutional defense of preemption to good, old-fashioned state-law failure to state a claim.

Continue Reading Bartlett Pairs – “Failure To Recall” As a “Stop-Selling” Variant
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We like decisions applying Fed. R. Evid. 702 that recognize the recent amendment’s impact on judicial gatekeeping. A status update on post-amendment decisions is here, and there’s a lot to like.  We don’t like post-amendment decisions that barely recognize the amendments to Rule 702 and instead parrot pre-amendment case law. As key proponents of the recent rule amendments continue to emphasize, “Don’t Say Daubert.”  Hunt v. Covidien, 2024 WL 2724144 (D. Mass. May 28, 2024) says a lot about Daubert and pre-amendment case law, but very little about the recent rule amendments. Nonetheless, the decision excludes entirely the opinions of an expert regularly disclosed by plaintiffs on FDA regulatory issues—Dr. Laura Plunkett. 

Continue Reading Mixed Bag Rule 702 Ruling from D. Mass.
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The title is ridiculous, but unfortunately true.

Muldoon v. DePuy Orthopaedics, Inc., is a suit over “hip-replacement surgery conducted in 2007.”  2024 WL 1892907, at *1 (N.D. Cal. April 30, 2024) (“Muldoon II”).  Suit was not filed, however, until 2015 – undoubtedly Muldoon is another example of the flotsam and jetsam dredged up by MDL lawyer solicitation.

Continue Reading 15 Years After the Fact, This MDL Remand Case Is Still at the Pleading Stage
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(The Butler Snow members of the DDL blog had nothing to do with today’s post.)

Intricate issues of New York law have been in the news lately — but that has been about criminal law.  By contrast, New York’s application of the statute of limitations in civil tort cases did not surface on CNN, Fox, or MSNBC last week.  For that matter, this blog would not ordinarily discuss a court’s interpretation of the statute of limitations.  Such interpretations are usually pedestrian and fact-driven.  

But today’s decision, In re Ethicon Physiomesh Flexible Composite Hernia Mesh Products Liability Litigation, 2924 U.S. Dist. LEXIS 93722 (N.D. Ga. April 9, 2024), in which the court granted summary judgment on statute of limitations grounds, hits some important, generally applicable issues. 

The plaintiff claimed that she had been injured by hernia mesh that had been implanted in her. New York law applied because she was a citizen of New York, was implanted with the mesh in New York, sustained her alleged injuries in New York, and underwent a revision surgery in New York.  Her complaint included causes of action for negligence, breach of express and implied warranties, and strict products liability. 

Under New York law, the statute of limitations for personal injury torts is three years from the date of injury. Thus, the “statute of limitations issue turns upon when determination of Plaintiff’s injury occurred such that claim accrual began. Plaintiff argues that the ‘when’ is a matter to be decided by a jury.”  Wrong. The court decided the issue, and decided it against the plaintiff. 

First, the court held that New York law starts the statute of limitations running from the date symptoms first occur. There is no need to wait for any definitive medical diagnosis: the “three year limitations period runs from the date when plaintiffs first noticed symptoms, rather than when a physician first diagnosed those symptoms.” Symptoms = injury.  

Second, there is no discovery rule in New York, except for toxic tort cases. As is typical, the plaintiff argued for a discovery exception.  Often, plaintiffs end up arguing that such discovery does not happen until a helpful plaintiff lawyer tells plaintiffs they have a case.  Maybe an action does not accrue until a plaintiff’s lawyer hits the send button for electronic filing of the complaint.  Yes, plaintiff arguments are often that ridiculous.  But the court in this case was not having any of that.  

Still, there was that pesky New York statutory discovery exception  for actions “to recover damages for personal injury or injury to property caused by the latent effects of exposure to any substance or combination of substances.”  But medical device cases are not toxic torts, and medical device injuries are not latent.  In this case, the plaintiff felt pain from the mesh way, way back.  She was on inquiry notice.  

The plaintiff “erroneously” focused on “discovery of the hernia defect that resulted in the revision surgery” as the necessary trigger.  Wrong, again. “Simply put, under New York law, the diagnosis of Plaintiff’s hernia recurrence is not the trigger for commencing the three year statute of limitations. As harsh as it may seem, this rule is unaltered even when there are multiple potential causes for symptoms and even in the case of misdiagnosis.”

Third, the plaintiff’s warranty claims were also barred, since the four year New York warranty statute of limitations runs from the delivery of the product.  The plaintiff endeavored to toll or enlarge this statute of limitations by extending the warranties to future performance. But the future performance exception is narrow.  There must be evidence of an explicit extension of warranty of future performance.  Mere promotion of a medical device does not expressly warrant its future performance.  In any event, the plaintiff “failed to produce evidence of her reliance.”

Finally, there can be no express warranty of future performance in an implied warranty case.  An “implied warranty, by definition, cannot contain an explicit guarantee.”  

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A little over two years ago, we wrote a post called What’s In a Name? discussing an attempt by two plaintiffs to hold Pfizer liable for fraud and misrepresentation based on an allegation that it was misleading to call the drug Chantix by its name if it was contaminated.  That case, as we noted in our post, was dismissed.  But, in the meantime, additional lawsuits were being filed around the country and eventually became an MDL in the Southern District of New York – In re: Chantix (Varenicline) Marketing, Sales Practices and Products Liability Litigation.  So today we turn from star-crossed lovers to the sorcery and revenge of The Tempest.  While Shakespeare’s characters were attempting to justify murder, here “what’s past is prologue” means another preemption victory (except for some manufacturing defect claims). 

The MDL decision, available at 2024 WL 2784234 (S.D.N.Y. May 28, 2024), is lengthy and thorough.  And notes from the outset that the Harris decision (our What’s in a Name case), “looms in the background” because the key allegations in the MDL are virtually identical to those in Harris.  Leading the court to a seemingly inevitable conclusion that plaintiffs are not permitted to “relitigate Harris’s rejection of Plaintiff’s alleged misstatements in connection with Defendant’s use of the Chantix brand name.”  Id. at *6.  Leaving plaintiffs with only “a narrow set” of manufacturing defect claims based on Current Good Manufacturing Practices (“CGMP”) violations that were not dealt with in Harris.

A couple of facts we want to set out to help fill in the picture.  The contaminants at issue are nitrosamines.  In 2021, Pfizer voluntarily recalled Chantix because it may contain nitrosamine levels above the FDA’s acceptable intake limit.  The FDA also advised patients and doctors that “there is no immediate risk to patients taking this medication” and that patients should continue taking the Chantix they had.    

Plaintiffs allege three categories of misstatements.  The first of which the court calls the Sameness Misstatement – our rose-by-any-other-name misstatement.  To get around Harris, however, the MDL plaintiffs make a “sweeping” argument that the presence of contaminants in Chantix “rendered Chantix so different that it should be considered to be a new and unapproved drug with additional active ingredients” making it not the therapeutic equivalent of Chantix.  Id.  In attempting to dodge Harris, plaintiffs ran headfirst into preemption.  Plaintiff’s entire argument relies exclusively on the FDA’s standard for therapeutic equivalence.  Decisions about therapeutic equivalence are made by the FDA, not the courts.  Nowhere does plaintiff allege any independent state law duty that defendant is in violation of.   Making this nothing more than “an impermissible attempt to privately enforce provisions of the FDCA.”  Id. at *15.

Further bolstering the court’s decision to dismiss claims based on the Sameness Misstatement is that plaintiffs are essentially asking the court to apply the FDA’s own regulations to reach a conclusion that “the FDA itself has declined to make . . . and even advised patients to continue taking the medication notwithstanding the issue.” *16.  That would go against Buckman.  The court also distinguishes the decision reached in the Valsartan MDL (which we scathingly review here) as one involving generic drugs.  Since we think Valsartan got it wrong, we won’t pick apart the analysis other than to say we think it may be a distinction without a difference.  Id. at *17.   

Finally, even if a claim based on bioequivalence was not preempted, plaintiff’s argument is that the bioequivalence requires the drugs to be absolutely identical.  Not so.  The FDA standard only requires “the absence of a significant difference” regarding the active ingredient.  All Chantix on the market had the same dose of active ingredient and plaintiffs do not allege otherwise.

Plaintiff’s second misrepresentation is what the court calls the Active Ingredient Misstatement.  Plaintiffs allege that nitrosamines were an active ingredient in Chantix that should have been disclosed on the drug’s labeling.  Id. at *7.  However, manufacturers have limited ability to unilaterally change a drug’s label.  So, a labeling claim is preempted unless plaintiffs plead a “labeling deficiency that [Defendant] could have corrected using the [Changes Being Effected (“BE”)] regulation.  Id. at *18.   The CBE regulation only allows a manufacturer to add or strengthen a warning where there is “sufficient evidence of a causal association” based on “newly acquired information.”  But the Chantix plaintiffs “do not identify any studies, data, or other information evidencing the specific causal association between the nitrosamine contaminants in Chantix and a clinically significant adverse reaction from taking Chantix.”  Id. at *19.  In fact, the FDA reached the opposite conclusion, finding no immediate or significant health risk.   

Even if the contamination could be such a risk, it was not known prior to the recall.  In response to FDA guidance on nitrosamines, defendant opted to recall Chantix rather than pursue a labeling change. And the court was unwilling to allow issues with other drugs to serve as newly acquired information on which a CBE could be based.  Because plaintiffs did not sufficiently plead facts that support that defendant would have been able unilaterally to change its label to add nitrosamines, all claims based on the Active Ingredient Misstatement were preempted.     

That leaves only plaintiffs’ cGMP Misstatement—that defendant, by selling Chantix as FDA-approved, represented and warranted that the drug had been manufactured in accordance with CGMPs.  Id. at *7.  Defendant’s motion to dismiss claims based on the cGMP Misstatement was denied based on the court’s conclusion that manufacturing defect claims are non-preempted parallel claims.  And if you are now wondering when this case turned into a PMA medical device case, so are we.  Plaintiff alleges defendant failed to adhere to two cGMPs requiring a “quality control unit” and “written procedures.”  Id. at *21.  Neither regulation specifies particular actions, but the court lets that slide.  Stressing that the case is at the pleadings stage, the court found plaintiffs plausibly alleged cGMP violations staving off dismissal but commenting that discovery might shed light that would lead to a different conclusion down the road.  Id.   

The decision deals with some other issues as well, such as:  plaintiffs have standing except as to injunctive relief (id. at *11-12); fraud was dismissed for failure to plead scienter (id. at *22-23); issues related to privity and notice requirements for plaintiffs’ remaining warranty claim (limited to manufacturing defects) are premature and require additional briefing (id. at *24-27); Magnuson Moss claims dismissed as inapplicable (id. at *28); consumer fraud survives for now (id. at *29-31); and unjust enrichment claims under certain states’ laws are dismissed as duplicative (id. at *31-34). 

But the core of plaintiffs’ claims has been struck as preempted.  And to that we say O just but severe law!

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It’s been a little less than a year since the Supreme Court’s rolling out the red carpet to forum-shopping plaintiffs in Mallory v. Norfolk Southern Railway Co., 600 U.S. 122 (2023).  Mallory was, in places 5-4, and elsewhere 4-1-4, and everywhere extremely fact specific – to the point of including a defendant-specific image of its Pennsylvania contacts that, as far as we can tell, wasn’t even in the record, but rather was found on the Internet.  600 U.S. at 142-43.  The result – beyond the Dormant Commerce Clause flag waving in Justice Alito’s concurrence (discussed here) – was to punch this plaintiff’s one-time ticket against the Norfolk Southern Railway.  “To decide this case, we need not speculate whether any other statutory scheme and set of facts would suffice to establish consent to suit.”  Id. at 136.

Continue Reading Mallory in the States – A Year After the Deluge
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We brought you yesterday an example of a district court using Rule 23(d) to order a curative action vis-à-vis a putative class, but not in a good way.  In that case, a medical device manufacturer initiated a recall of certain lots and published recall information for patients, in coordination with the FDA.  Some enterprising plaintiffs’ attorney then filed a class action and succeeded in convincing the district judge to order the defendants to disclose in their recall communications that there was a pending case—one that is extremely unlikely to ever result in a certified class.  The defendant’s recall communications therefore turned into court-ordered plaintiff lawyer advertising.  Sheesh. 

Today we bring you a counter story, the yin to yesterday’s yang, an example of a district court using Rule 23(d) not to interfere with justice, but to promote it.  In Braswell v. Bow Plumbing Group, Inc., No. 2:21-cv-25, 2024 WL 2401782 (M.D. Ala. May 23, 2024), the product was not a medical device, but the facts are comparable to yesterday’s case because they too involved plaintiff’s lawyers trying to interfere with communications to putative class members. 

In Braswell, the plaintiffs sued over allegedly defective plastic plumbing and later agreed to a class settlement.  The district court approved the parties’ proposed settlement and directed notice to the settlement class.  Days later, attorneys representing several of the individual plaintiffs sent their clients emails that “contain[ed] misleading or inaccurate statements regarding the proposed class action settlement and associated proceedings in this case.”  Id. at *1.  These attorneys were essentially encouraging their clients to pursue individual claims and opt out of the settlement, but were doing do in a misleading way.  The court therefore entered an order finding that the emails “materially interfered” with class notice and the court’s efforts to “fairly, accurately, and reasonably inform[ ] the settlement class members of the proposed settlement terms.”  Id.  The court further found that counsel’s misinformation risked coercing class member to opt out of the settlement.  Id.

What did counsel do in response to this admonition?  They doubled down and emailed their clients again and falsely portrayed class counsel and the court as “delaying” their individual claims.  Worse yet, counsel emailed their clients yet again and suggested that they should not communicate with class counsel, despite a court order expressly allowing such communications.  Id.  The court-appointed settlement administrator ultimately received 322 opt-out requests, almost all from individuals represented by the email-happy, court-admonished attorneys.  Hundreds of the opt-out requests were dated before the settlement administrator even sent out class notice.  Id. at *2. 

You can see what was going on here.  Counsel did not like the terms of the settlement and were trying to use their individual clients to leverage a better deal.  They crossed the line, however, by sending serial emails that the court found to be misleading and inaccurate and by discouraging class members from communicating with class counsel.  As the district court saw it,

Based on these communications, as well as the date that many of the requests for exclusion were signed (i.e., before the Court’s curative notice or before the Court-approved notice of the settlement was even issued), the Court is highly concerned that a significant percentage of these requests for exclusion were caused, in whole or in part, by the inaccurate or incomplete information disseminated by [these] Attorneys . . . . 

Id. at *2.  This court certainly did not beat around the bush, and to correct the potential damage, the court basically ordered a do over. 

Invoking Rule 23(d)—which we conveniently laid out for you verbatim here—the court struck 319 opt-out requests and directed that each of those class members should receive additional curative notice of the proposed settlement terms.  Those class members would also receive a new opportunity to opt out, but this time with complete and accurate information about the settlement terms.  Id. at *3. 

We have to say, we like this solution.  If class members opt out, so be it.  But they need to make informed decisions.  That is the way the court saw it, too:

The Court finds that striking these opt-outs will protect the integrity of the class while imposing little to no prejudice on the affected class members because if those class members did, in fact, make a free and unfettered decision in choosing to [opt out], then they will do so again during the re-opened opt-out period.

Further, this Court has a responsibility to give class members “the best notice that is practicable under the circumstances.” FED. R. CIV. P. 23(c)(2)(b). It is essential that class members’ decisions to participate or to withdraw be made on the basis of independent analysis of their own self interest, and the vehicle for accomplishing this is the class notice. 

Id. at *3 (internal quotations and citations omitted).  Yes, this is a plastic pipe case, but after reading about the court’s misuse (in our opinion) of Rule 23(d) in yesterday’s medical device case, we thought it important to bring you this other side of the coin. 

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When we tell people what we do, we often get a response, from lawyers and non-lawyers alike, to the effect of, “so you do class actions.”  The somewhat canned response is that “serial product liability litigations” or “mass torts” rarely involve certified classes other than settlement classes because individual factors in personal injury cases almost always predominate.  If the glazed eyes do not deter us, then we might talk about how class actions for medical monitoring were hot for a while but largely fizzled out when the clear majority of states required cognizable clinical injuries before medical monitoring could be sought.  On this Blog, we write about a number of issues in purported class actions, such as economic classes that complain about issues like slack fill for their snacks and the font size of “organic” or “all natural” on their gas station supplements.  Many such purported class actions are pursued to be settled for the benefit of class action plaintiff lawyers without any meaningful impact on the consumers who allegedly were harmed by the amount of air in the bag or the details of product labeling they never read.  We are curmudgeonly skeptical of such classes, but we are right that the vast majority of product liability injury classes should not and do not get far.

We ran across an issue we had not seen before in a product liability class action case that involves a class II medical device that had a lot-specific recall.  Federal Rule of Civil Procedure 23(d)(1) authorizes the court dealing with a class or purported class to issue orders that:

(A) determine the course of proceedings or prescribe measures to prevent undue repetition or complication in presenting evidence or argument;

(B) require—to protect class members and fairly conduct the action—giving appropriate notice to some or all class members of:

(i) any step in the action;

(ii) the proposed extent of the judgment; or

(iii) the members’ opportunity to signify whether they consider the representation fair and adequate, to intervene and present claims or defenses, or to otherwise come into the action;

(C) impose conditions on the representative parties or on intervenors;

(D) require that the pleadings be amended to eliminate allegations about representation of absent persons and that the action proceed accordingly; or

(E) deal with similar procedural matters.

As a practical matter, 23(d)(1)(B) most often comes up either after a class has been certified or when there is going to be a fairness hearing before a decision on class certification.  That is how it is discussed in the advisory committee notes from the amendment of this rule in 1966.  In F.G. v. CooperSurgical, Inc., No. 24-cv-01261-JST, 2024 U.S. Dist. LEXIS 90329 (N.D. Cal. May 20, 2024), within three months of the initiation of the recall, the plaintiffs had already brought a proposed class action based on various theories and filed a motion for protective order related to communications about the recall.  As far as we can tell, that motion was filed before defendants had even been served with a summons and ages before class certification will be decided.

A little more detail, some from the decision itself and some from clicking through links on FDA’s website that started with the address of the recall notice in a footnote in the decision—in other words, potential judicial notice material available to the court if it chose to look.  Defendants’ “culture media” is a class II medical device cleared for the “culture of human embryos from zygote to blastocyst, embryo transfer,” and defendants initiated a recall of three lots after receiving complaints of “performance issues.”  In connection with the recall, FDA was informed, hence why there was information on the website about the recall.  The facts are lacking in the decision, but the submission to FDA for a class 2 recall like this is supposed to include plenty of information about the plan for communications concerning the recall.  Without recapping all the regulations and guidance in this area, some of which we discussed here, we note two things about FDA’s position on recall communications:

Where appropriate, that the direct account should in turn notify its customers who received the product about the recall.

* * *

The recall communication should not contain irrelevant qualifications, promotional materials, or any other statement that may detract from the message. Where necessary, follow-up communications should be sent to those who fail to respond to the initial recall communication. A recalling firm is encouraged to discuss the recall letter with its [FDA Office of Regulatory Affairs Division Recall Coordinator] prior to issuing the notification.

Keep these in mind as we return to the motion for protective order in F.G.

The plaintiffs’ motion for protective order complained that, since the day the suit was filed (including before it was properly served), the defendants had continued to conduct their recall communications—which had been coordinated with FDA—without mentioning the existence of the proposed class action that is very unlikely to ever get certified.  These communications have been relayed to certain patients “through third-party clinics” and have included an offer of compensation in connection with the use of recalled medium.  Because these patients could be part of a class one day, however unlikely, the plaintiffs asserted that the communications were unfair and that Rule 23(d)(1) authorized the court to require defendants to do various things that would benefit the plaintiffs and their lawyers.  Mind you, there has been plenty of litigation involving recalled drugs or devices where the plaintiffs complained that the recall communications were not sent directly to or relayed to patients.  Here, the fundamental complaint was that the clinics that would know which patients used the recalled medium relayed the recall communications to them, as FDA encourages.  (FDA can require the manufacturer to ask the clinics to pass over information, but it cannot require that the clinics that it does not regulate do anything.)  F.G. did not consider anything about FDA regulation, let alone that a protective order might compel the manufacturer to act contrary to any FDA requirements.

Instead, the decision treated the recall communications like any other communication with a potential class member, such as an alleged aggrievedly franchisee or shareholder as in the cases the court discussed.  The first step in the court’s analysis was to determine if Rule 23(d)(1) applied before class certification that would probably never happen.  Acknowledging the unlikelihood with a quote from the famous Amchem decision, the court nonetheless moved on with the conclusion that “it is well-established that a Rule 23(d) protective order can precede class certification.”  2024 U.S. Dist. LEXIS 90329, *9-10.  The accompanying case citation had a parenthetical quotation that would seem to caution against messing with a recall communication:  “Pre-certification communications to potential class members by both parties are generally permitted, and also considered to constitute constitutionally protected speech.”  The next step in the court’s analysis was to determine whether the defendants’ recall communications had been sufficiently misleading or coercive so as to require some correction.  Per the Supreme Court’s decision in Gulf Oil Co. v. Bernard, 452 U.S. 89, 101 (1981), there should be a high bar for issuing a protective order in this context:  “[A]n order limiting communications between parties and potential class members should be based on a clear record and specific findings that reflect a weighing of the need for a limitation and the potential interference with the rights of the parties.”  Not mentioning the existence of the nascent proposed class action was determined to be misleading and, in the context of offering compensation, created “a potential for unknowing waivers from a lack of information.”  2024 U.S. Dist. LEXIS 90329, *13 (citation omitted).  Without apparent consideration of the details of the communications, defendants’ rights, or FDA’s role, the court concluded that “[c]aselaw is clear that omitting mention of a pending class action—even an uncertified one—can be misleading.”  Id.  The cases cited in support of this conclusion were a handful of district court decisions that seemed, on our quick look at least, to involve very different fact patterns.  No appellate decisions were cited in support of a protective order being issued.

The first of those district court decisions cases did cite some circuit court cases that, at a minimum, raised cautions about requiring pre-certification communications to potential class members alert them to the existence of a lawsuit.  In Jackson v. Motel 6 Multipurpose, Inc., 130 F.3d 999, 1004 (11th Cir. 1997), the court stated:

While we cannot say that orders authorizing communication with potential class members may never precede class certification, district courts must strive to avoid authorizing injurious class communications that might later prove unnecessary. . . . In such circumstances, the danger of abuse that always attends class communications [is that] plaintiffs might use widespread publication of their claims, disguised as class communications, to coerce defendants into settlement[.]

Williams v. U.S. Dist. Court, 658 F.2d 430, 432-33 (6th Cir. 1981), contained a discussion of the potential issues with pre-certification communications, including those identified in the non-partisan Manual for Complex Litigation.  The Manual noted that “Attorney solicitation of clients, funds, and fee agreements are among the most prevalent perceived evils of the class action procedure.”  We see no real consideration of these issues in F.G. in granting a protective order or even in shaping the order for what the defendants would have to do to cure the perceived failures of the prior recall communications.

We could walk through the eight “remedies” authored by the court and question how they meet the standards in Gulf Oil, but we will not.  Instead, we will return to the advisory committee notes from when Rule 23(d) was adopted.  As we said, the gist of them that pre-certification orders related to notice would focus on fairness hearings and the class certification process, not on helping plaintiff lawyers solicit clients or encouraging courts to second-guess recall communications that had been run by FDA.  The notes also provided that, “In appropriate cases the court should notify interested government agencies of the pendency of the action or of particular steps therein.”  Maybe, before weighing in on communications on a recalled medical device that were relayed to relevant patients by the clinics that treated them—something FDA encourages—the court should have notified FDA.  We wonder what FDA might have said had it been given a chance.  One obvious concern might have been to not violate the privacy of patients who sought in vitro fertilization by giving their names to plaintiff lawyers without their consent.  After all, even the named plaintiffs and wannabe class reps in F.G. asked to proceed anonymously.