Valsartan, Again. (Deep Sigh) | Drug & Device Law

We have spilled a good deal of ink on the Valsartan MDL.  The back-end of the blog says 18 posts (and counting) already reference Valsartan.  Why so many?  Because they usually are so bad.  Today’s post is more of the same.  Hence the deep sigh.

Today’s Valsartan opinion, In re Valsartan, Losartan, & Irbesartan Products Liability Litigation, 2024 U.S. Dist. LEXIS 32726; 2024 WL 776757 (D.N.J. Feb. 26, 2024), relates to the class certification decision that we named last year’s #1 worst case, In re Valsartan, Losartan, & Irbesartan Products Liability Litigation, 2023 U.S. Dist. LEXIS 21112, 2023 WL 1818922 (D.N.J. Feb. 8, 2023).  For ease of reference, let’s call that February 8, 2023 opinion “Valsartan Class Cert.” and this new February 26, 2024 opinion “Valsartan Denial of Decertification.”

Taking a walk down unhappy memory lane, readers may recall that the Valsartan Class Cert. opinion certified not one, not two, not three, but four—count ‘em, four!—classes:  one for economic loss, one for third party payors (“TPPs”), and two for medical monitoring.  Bexis bemoaned that

These class certifications combined 428 different pharmaceutical products, produced and marketed by 28 separate defendants, with claims governed by the laws of 52 separate jurisdictions.  There’s no way on earth that common issues could predominate over individual ones, or that this morass could possibly be tried to a jury.

The Valsartan court views such concerns as overblown, “but a lamentation in the wind, predicting doom and destruction because the jurors won’t be able to comprehend the multidinous pages of jury instructions on each state’s laws.”

As Bexis also noted, the whole point of the class certification order seemed results-oriented:

We know, as do most of our readers, that this decision is not intended as a legal opinion.  It’s not published.  It’s simply a club with which to bludgeon the defendants into settling what are factually unprovable and legally untenable claims.

The certifying judge said almost as much himself, finding the morass of classes and sub-classes to be the “superior litigation mechanism” because it “concentrates litigation efforts for both parties into fewer trials as well as promoting Class Action settlement.”

(An aside:  Those excerpts come from this passage, one of many like it in Valsartan Class Cert.: 

Managing a TPPEcoLoss class with 18 subclasses is likely less onerous than managing the 93 subclasses of the ConEcoLoss class. Weighing this burden against its own experience with the MDL, the Court observes that certification of a large TPPEcoLoss class and a proper division of it into subclasses based on state law variation in legal standards is the better mechanism for efficient adjudication than individual law suits by TPPEcoLoss plaintiffs. Class certification with appropriately defined subclasses promotes fewer inconsistent verdicts and concentrates litigation efforts for both parties into fewer trials as well as promoting Class Action settlement, thereby decreasing unnecessary cost and effort overall for both parties.

So why would a lengthy and ground-breaking opinion like Valsartan Class Cert. go unpublished?  You tell us.)

Anyway, after the district court’s class certification order, a number of defendants sought interlocutory appellate review from the Third Circuit pursuant to Federal Rule of Civil Procedure 23(f) (for example, see here). 

Rule 23(f) in theory allows federal appellate courts to “permit an appeal from an order granting or denying class-action certification.”  In practice, Rule 23(f)’s potential is rarely realized, and it went unrealized here as well.  The Third Circuit denied the petitions for review without explanation (“The petitions for permission to appeal are DENIED. All pending motions are DISMISSED”), even though the Third Circuit supposedly is among the more liberal in its standard for granting Rule 23(f) interlocutory review of class certification decisions.  See, e.g., Laudato v. EQT Corp., 23 F.4th 256, 260 (3d Cir. 2022).

With the Third Circuit summarily declining to involve itself by interlocutory appeal, district court activity kicked into high gear, with assorted Rule 702 expert exclusion motions, motions for summary judgment on both sides, motions in limine, and numerous other matters filed or decided over the past year. 

Relevant here to the Valsartan Denial of Decertification opinion, this activity included a motion by certain defendants to decertify the TPP Trial Subclasses (and more specifically, “the claims of Plaintiff MSP Recovery Claims, Series LLC, as class representative of TPP Breach of Express Warranty Subclass B, TPP Breach of Implied Warranty Subclass D, TPP Fraud Subclass C, and TPP State Consumer Protection Laws Subclass A.”)

Amongst the arguments raised by the defendants seeking decertification of these particular subclasses were arguments based on developments occurring after the Valsartan Class Cert. order.  One was that the damages model proposed by plaintiff MSP Recovery’s expert, Dr. Rena Conti, did not match the class the court had certified.  Another was that post-certification developments regarding plaintiff MSP Recovery—including reports that it is facing federal civil and criminal investigations by the SEC, IRS, FBI, and US Attorney—destroyed any adequacy it may have had to act as a class representative.    

The district court wasted no time rejecting all of the defense decertification arguments.  The defense class decertification motion was filed on February 13, 2024, and the court issued the Valsartan Denial of Decertification opinion on February 26, 2024 without even waiting for an opposition, as far as we can tell from the docket.

What most caught our attention about the Valsartan Denial of Decertification, however, was what the district court did with the Third Circuit’s summary denial of the petitions for interlocutory Rule 23(f) review.  The Valsartan Denial of Decertification opinion says that the Third Circuit’s non-merits denials of review in fact reflected an “affirmation” of its class certification order that “rendered this Court’s [Valsartan Class Cert. opinion] ‘the law of the case’ for all certified classes and subclasses,” and accordingly, its Valsartan Class Cert. order thus was beyond reconsideration absent extraordinary circumstances.   

That’s simply not an accurate statement of the law of the case doctrine. 

The law of the case doctrine has two parts to it:  One part is the mandate rule, meaning that when a higher court actually has decided a merits issue, the district court’s duty on remand is to follow the appellate court’s direction on that issue.  That is, for one thing, precisely what did not happen in the Carson panel decision we criticized earlier this week. The second part is that a court generally will follow its own legal decisions made at an earlier stage of the case, absent a change in law or facts, or something that would make rote application of law of the case unjust.  The Valsartan Denial of Decertification opinion mixes elements of both, and gets them wrong.

First, there is no mandate rule-type issue at play, because the Third Circuit did not decide any legal issue (explicitly or by necessary implication) when it passed on interlocutory review of the initial class certification decision.  All the Third Circuit did with its order stating that “[t]he petitions for permission to appeal are DENIED” is punt on the merits of the class certification issues, probably hoping that it will never have to address them after judgment either.  It certainly did not “affirm” the district court’s class certification order.  Without a merits decision by the Third Circuit, it is black letter law that there was no appellate mandate to tie the district judge’s hands:

The law of the case doctrine applies to an issue or issues that have actually been decided explicitly or by necessary implication. The doctrine does not apply to statements made by the court in passing, or stated as possible alternatives.  Nor does it apply to an opinion that does not embody the holding of the court.

18 Moore’s Federal Practice – Civil § 134.20 (2024) (emphasis added). See, e.g., In re City of Philadelphia Litig., 158 F.3d 711, 718 (3d Cir. 1998) (“The law of the case doctrine, however, acts to preclude review of only those legal issues that the court in a prior appeal actually decided, either expressly or by implication; it does not apply to dicta.”).

If the Valsartan Denial of Decertification meant to reference the second aspect of law of the case—the district court just wanted to follow one of its own legal decisions made at an earlier stage of the case—it would not have referenced the Third Circuit’s denial of the Rule 23(f) petition, and it should have recognized that while no judge is required to endlessly revisit his or her own prior legal decisions, the law of the case doctrine is far more flexible when a judge is revisiting his or her own prior decision versus when a judge is asked to revisit a prior judge’s rulings.  That goes double for class certification decisions, since Rule 23(c)(1)(C) specifically provides that “[a]n order that grants or denies class certification may be altered or amended before final judgment.”

In same-judge circumstances, “the traditional formulations of the doctrine must be conceived as rules of thumb and not as straightjackets on the informed discretion and sound practical judgment of the judge.”  Id. § 134.21.  “The law of the case doctrine does not limit a federal court’s power; rather, it directs its exercise of discretion.”  Pub. Interest Research Grp. v. Magnesium Elektron, 123 F.3d 111, 116 (3d Cir. 1997).  In other words, the Valsartan court was not forbidden from reconsidering its class certification order, and indeed there were good grounds to do so and reach a different conclusion.