Another Weird Alabama Decision

By Bexis on March 18, 2024

Alabama has always had some rather unusual jurisprudence. In product liability, the Yellowhammer State doesn’t have negligence or strict liability, but rather a hybrid called the Alabama Extended Manufacturers Liability Doctrine (“AEMLD”). See Casrell v. Altec Industries, Inc., 335 So.2d 128, 132-33 (Ala. 1976). More recently, the Alabama Supreme Court twice adopted the extreme pro-plaintiff innovator liability theory in Wyeth, Inc. v. Weeks, 2013 WL 135753 (Ala. Jan. 11, 2013), withdrawn and superseded, Wyeth, Inc. v. Weeks, 159 So.3d 649 (Ala. 2014). On that occasion, the Alabama legislature overruled the court. See Ala. C. §6-5-530. More recently than that, the same court authorized plaintiffs to perjure themselves and claim that they would have ignored their doctors’ recommendations in order to claim causation in learned intermediary cases. Blackburn v. Shire U.S., Inc., ___ So.3d ___, 2022 WL 4588887, at *11-12 (Ala. Sept. 30, 2022). Most recently, and most notoriously, the Alabama Supreme Court declared frozen embryos to be people – at least for the purposes of tort law. LePage v. Center for Reproductive Medicine, P.C., ___ So.3d ___, 2024 WL 656591, at *4 (Ala. Feb. 16, 2024). Who knows? By 2030, Alabama might attempt to count blastocysts as “people” for purposes of the census – although not for tort purposes, since the legislature appears to have stepped in again.

We read another bizarre – if not nearly as notorious – Alabama law decision recently. Ahmed v. Johnson & Johnson Healthcare Systems, Inc., 2024 WL 693078 (S.D. Ala. Feb. 20, 2024), reconsideration & certification denied, 2024 WL 947447 (S.D. Ala. March 5, 2024). What’s bizarre about it? It allowed a plaintiff in a medical device product liability case (hip implant) get to the jury without any medical expert testimony on causation. Id. at *16 (entitled “Summary Judgment is not Required on All of Plaintiff’s Claims Even Though She Offers No Expert Evidence Regarding Medical Causation”).

Getting it Right on PMA Preemption

By Eric Hudson on March 15, 2024

We all know that getting it right isn’t as easy as it sounds. Straightforward application of established law ought to be simple. If only it were so. Today’s decision gets it right, and we’re happy to report on Wilhite v. Medtronic, Inc., 2024 WL 968867 (N.D. Ala., Mar. 6, 2024).

Wilhite involved allegations that a Class III defibrillator malfunctioned and resulted in the plaintiff’s death. The defendant recalled the defibrillator in 2021 due to possible battery depletion. Plaintiff had the device implanted prior to the recall, and she died about two months after the recall. The amended complaint alleged that a physician determined that the cause of death was due to a problem with the defibrillator—either its generator stopped working or the device stopped emitting shocks.

After an initial round of removal, motion to dismiss, and an amendment, plaintiff brought claims under Alabama’s Extended Manufacturer’s Liability Doctrine (AEMLD) and asserted claims for negligence, negligence per se, wantonness, and breach of implied warranty. Plaintiff also included a general claim that the defendant made misrepresentations about the reliability and longevity of the defibrillator. Before addressing the specific counts of the amended complaint, the Court provided an overview of the PMA preemption analysis. The Court noted the rigorous process for PMA approval, emphasizing that the FDA spends an average of 1,200 hours reviewing an application for PMA. Describing the role of the FDA, the Court recognized that the FDA may “approve devices that present great risks if they nonetheless offer great benefits in light of available alternatives.” Id. at *3 (citing Riegel v. Medtronic, Inc., 552 U.S. 312, 318 (2008)). The Court also walked through the express and implied preemption provisions of the Medical Device Amendments of 1976 (MDA), and recognized the possibility of a parallel state law claim.

The Court then turned to the plaintiff’s claims under the AEMLD and for negligence, negligence per se, wantonness and breach of warranty. The Court read all these claims as asserting that the defibrillator was not reasonably safe either as approved by the FDA or because the design and manufacture of the defibrillator deviated from FDA requirements. For the claims that the device was not reasonably safe as approved, the Court got it exactly right and recognized that those claims were expressly preempted by the MDA.

The Court also got it right on the plaintiff’s claim that the design and manufacture of the defibrillator deviated from the FDA’s approval requirements. Although the Court noted that such a claim might be capable of escaping express preemption, it is well settled in the Eleventh Circuit that for a claim to survive preemption, a complaint must allege specific facts establishing the deviation from FDA requirements. The plaintiff’s amended complaint fell short of this standard, alleging only that the defendant had a continuing duty to comply with the FDA requirements and that a violation of those requirements gave rise to a violation of state law duties.

The Court characterized these allegations as nothing more than an “oblique suggestion” of a violation of an FDA requirement, and the “ultimate failing” of the amended complaint was “the absence of factual allegations accompanying the oblique suggestion.” Id. at *5. The amended complaint did not contain any factual allegations identifying a specific deviation from a federal requirement that caused sudden battery depletion. Absent those allegations, the claims in the amended complaint sought to impose requirements different from, or in addition to, the FDA’s requirements and were expressly preempted.

The Court also held that the plaintiff’s failure to warn claims were preempted. Plaintiff alleged that the defendant failed to report certain adverse events to the FDA, but the Court could find no independent duty under Alabama law requiring a manufacturer to report adverse events to the FDA. Absent such an identified state law duty, plaintiff’s claims sought to enforce a duty owed only to the FDA, and those claims were impliedly preempted by the MDA. The same analysis applied to the plaintiff’s claim that the defendant should have recalled the device sooner. There was not an independent duty under Alabama law to recall the device, so that claim was also preempted. The Court got it right again, and its straightforward application of established law is refreshing.

Turning to the last count of the amended complaint, the Court dismissed the plaintiff’s false representation claims under the good, old fashioned Rule 9(b) fraud analysis. The amended complaint did not include the substance of any false representations made by the defendant regarding the reliability or longevity of the defibrillator. Instead, the amended complaint included only generalizations and legal conclusions. Absent specific factual allegations of the actual misrepresentation, any claim sounding in fraud failed, and the Court did not need to determine whether those claims would have been impliedly preempted if sufficiently pleaded.

Finally, the Court held that the dismissal of the plaintiff’s claims was with prejudice. The Court recognized that a plaintiff must be given at least one chance to amend. The prior amendment was filed “as a matter of course” and could not be considered a prior opportunity to amend. But in the Eleventh Circuit a district court is not required to afford a plaintiff leave to amend sua sponte where the plaintiff is represented by counsel. Since the plaintiff was represented by counsel and did not request leave to amend in response to the motion to dismiss, the Court was within its authority to dismiss the amended complaint with prejudice. Id. at *7, n.6. Getting it right indeed.

Valsartan, Again. (Deep Sigh)

By Lisa Baird on March 14, 2024

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.

MDL Mischief

By Stephen McConnell on March 13, 2024

In the last couple of years we have gone to plenty of Multidistrict Litigation (MDL) court conferences. We’ve also gone to plenty of bench-bar conferences about MDLs. From the defense point of view, the key issues are early vetting of cases, even-handed discovery, and avoidance of bellwether trials where the deck is stacked in favor of the plaintiffs. In addition, in both types of conferences, issues will arise about relationships among the plaintiff lawyers. Who will be on the Plaintiff Steering Committee (PSC) or Plaintiff Leadership Committee (PLC)? To what extent do the members of the PSC or PLC owe fiduciary duties to non-clients? What percent of recoveries go to the common benefit fund?

We mostly daydream during these discussions. It’s not our fight.

But sometimes our voyeurism gets the better of us. Sometimes the plaintiff lawyer issues get more contentious than anything involving plaintiff-defendant dynamics. And sometimes the gamesmanship among the plaintiff lawyers can resemble a train wreck. It can be hard to avert one’s eyes from the carnage. The biggest victims are often the people that the plaintiff lawyers claim to be helping — the actual plaintiffs.

The recent case of Drake v. DePuy Orthopaedics, Inc., 2024 U.S. Dist. LEXIS 39715 (N.D. Ohio Feb. 6, 2024), is an example of some of the ugliness going on behind the scenes in an MDL. Despite the styling of the case caption, the beef here was between the plaintiff and his former lawyer about how much money the latter could extract from the former. The former lawyer claimed to be entitled to an enormous chunk of the plaintiff’s recovery. Therefore, the battle here was between the plaintiff and the lawyer “claimant.”

The litigation began the way these things often do – with a lawyer advertisement. The plaintiff was a Minnesota resident who had hip replacement systems implanted in both hips. Then he learned of the manufacturer’s 2010 recall of the hip systems. He learned that because he saw an advertisement from a law firm in Texas. The plaintiff responded to that attorney ad, but did not immediately sign up with that lawyer. Over the next year and a half the claimant’s firm bombarded the plaintiff with 57 follow-up calls or emails, an average of 3.56 times per month, eventually wearing him down so that he finally signed an attorney representation agreement (ARA) Big mistake. The ARA contained a 40% contingency fee provision. It contained something else that you’ll learn about in a few moments. Talk about stacked deck.

From what we gather from the court opinion, nothing much happened thereafter for a good long while with the plaintiff’s case. Did we mention that this was an MDL?

Eleven months later, the plaintiff decided to hire new counsel, closer to where the plaintiff lived. The original lawyer (the claimant) then filed a short-form complaint in 2012 in the MDL on “behalf” of the plaintiff. How thoughtful. The plaintiff terminated the ARA, and his new counsel filed a complaint in Minnesota. That new complaint was removed and transferred to the MDL to join the plaintiff’s 2012 complaint. What a mess. The 2012 action filed by the original attorney (the claimant) was ultimately dismissed, subject to the disputed “right” of that attorney/claimant to take a 40% contingent fee from any recovery.

The plaintiff opted into the settlement agreement negotiated between the PLC and the defendants, and secured a settlement of $561,750. Not bad. But then the original counsel/claimant invoked a one-sided arbitration agreement giving the attorney the right to choose the arbitrator (this fact is from the prior Sixth Circuit opinion) and conduct the arbitration in the attorney’s home state. The arbitrator found for the claimant, and in addition to the contingent fee (cut to a still, er, robust 35%) awarded attorney fees and costs – the result being that the arbitrator awarded the original, claimant attorney $353,214.97. All told, that means the original, claimant attorney took 62.88% of the underlying settlement for doing nothing more than belatedly filing a form complaint after being told he was on the outs with his client.

The plaintiff filed a motion to vacate the arbitrator’s award and the claimant attorney filed a motion to confirm it. The MDL court deemed that recovery by the claimant attorney to be “unconscionable” and struck the arbitrator’s award. But unfortunately for the plaintiff, the Sixth Circuit (2-1) reversed the MDL judge’s vacation of the arbitration award (such awards being extremely difficult to overturn), and the claimant lawyer is going to get the money. (Imagine the stink if a corporate defendant attempted to enforce such a brutal, one-sided contract.)

The plaintiff argued to the MDL court on remand that the Sixth Circuit’s ruling was “narrow” and left the MDL court room to overturn the arbitration on other grounds The MDL court “regrettably” concluded that the Sixth Circuit left no such room. The MDL court was forced to confirm the arbitrator’s award. It ordered the “Clerk of the Court to close this case.” It is a rotten result. It is also further evidence that MDLs are vast sadness machines.

Plaintiffs’ Parent Trap Foiled in E.D.N.Y MDL

By Michelle Yeary on March 12, 2024

Depending on your age, today’s title may evoke images of Hayley Mills or Lindsay Lohan. We won’t ask you which. It can be your secret. But in an industry where remakes are rarely worth the price of admission, the Parent Trap is a rare exception, and we won’t fault you for liking both. Today’s parent trap is slightly different, and not just because it does not involve an adorable teen playing twins to trick their parents into getting back together. No, our parent trap is about plaintiffs from 18 different states thinking they could sue both the manufacturer and its parent company and one MDL court who saw through the ruse.

Plaintiffs in the Exactech MDL allege that they were injured by defective hip, knee, and ankle implants manufactured by a Florida-based medical device company. In re: Exactech Polyethylene Orthopedic Products Liability Litigation, 2024 U.S. Dist. LEXIS 40439, *87 (E.D.N.Y Mar. 7, 2024). However, they did not just sue the manufacturer, but also its ultimate parent corporation as well as several of its subsidiaries in the ownership chain. Id. at *90. The group of parent companies moved to dismiss for failure to sufficiently plead facts that support corporate veil-piercing to hold a corporate parent liable for the conduct of a subsidiary. Id. at *93. Plaintiffs’ opening gambit was to try to convince the court that the motion was premature because the choice of law questions were “fact-intensive” and required discovery. But that theory didn’t really hold water.

As with many MDLs, the court ordered the filing of a Master Complaint and individual short form complaints. The court also allowed direct filing into the MDL, provided that plaintiffs identify on their short form complaint the district where the case would have been properly filed. Apparently not all plaintiffs complied with that last step, meaning defendants had to make assumptions about original courts in addressing choice of law issues. But determining where plaintiffs would have filed their complaints is not up to defendants or the court and it does not require discovery. It simply requires plaintiffs to cure their deficient pleadings. Id. at *96-97. For purposes of deciding the current motion, the court looked to just those cases with properly filed short form complaints and put off those that were deficient. That resulted in 18 states’ laws being at issue—which turned out not to be all that complicated.

That is because the majority of states follow the “internal affairs” doctrine which means you apply the law of the state of incorporation to questions like shareholder liability. What follows next is an analysis of all 18 states’ laws, with a conclusion that even those states that take a flexible approach to the internal affairs doctrine (New York, South Carolina, and Tennessee) would apply the law of Florida, the state of incorporation, in this instance because Florida has stronger interests than any other state. Id. at *100-108. So choice of law turned out to be less “fact-intensive” and burdensome than plaintiffs made out.

Under Florida law, to pierce the corporate veil, plaintiffs must show that the parent “dominated and controlled the corporation;” “the corporate form was used fraudulently or for an improper purpose;” and “the fraudulent or improper use” caused injury to the plaintiff. Id. at *108-109. As to domination, complete ownership is not enough. Control over policy and business practices is also required. Here, the parent company filled three of nine seats on the manufacturer’s board—a minority position which did not demonstrate the requisite complete control. Id. at *110-11. Nor did plaintiffs allege any type of coercion or pressure by the minority board members or any disregard for corporate formalities. The court also took note of the fact the manufacturer’s policies regarding selling its orthopedic implants did not change once it became a subsidiary of the parent. A change in policy “may provide support for an inference that the daily operations of the two corporations are not kept separate.” Id.at *111. But that did not happen here.

Nor did plaintiff allege any improper use of defendant’s corporate form. Corporations exist for the very reason of protecting assets and limiting liability. So, the fact that a corporation’s tort liabilities may exceed its assets does not rise to deliberate improper use of the corporate form without more. Id. at *112-13. Such as knowingly accruing debt while continuing to disperse payments to shareholders. That type of siphoning of funds leaving a subsidiary unable to repay its liabilities would be enough. But again, that did not happen here.

Without adequately pleading both requisite control by the parent and abuse of that control, plaintiffs failed to pierce the corporate veil and therefore, the court dismissed the parent companies. It’s not a rom-com happy ending, but we give it two thumbs up or 80% on the Tomatometer. Again, you pick your generation.

Rounding Up the Eleventh Circuit Zombie

By Bexis on March 11, 2024

In Puerto Rico v. Franklin-California Tax-Free Trust, 579 U.S. 115 (2016) (initially discussed here), the Supreme Court drove a stake through the heart of the misbegotten “presumption against preemption” in express preemption cases.

[B]ecause the statute contains an express pre-emption clause, we do not invoke any presumption against pre-emption but instead focus on the plain wording of the clause, which necessarily contains the best evidence of Congress’ pre-emptive intent.

Id. at 125 (citations and quotation marks omitted). As we also discussed, this abolition has been recognized as generally applicable by every Court of Appeals in the country, save the Third Circuit.

We have applauded this development, but we have also warned against “zombie” presumption against preemption decisions – courts that do the same thing sub rosa, by quoting and following language from pre-PR v. Franklin cases while simply omitting the dirty word “presumption.” That post criticized Mata v. Allupick, Inc., 2022 WL 1541294, at *2 (N.D. Ala. May 16, 2022), for the foible of relying on quotes from earlier presumption-based cases, but with the P-word excised.

Mata was from the Eleventh Circuit, and two months after that decision, the en banc Eleventh Circuit joined the abolitionist movement recognizing that the presumption against preemption was no more. See Carson v. Monsanto Co., 72 F.4th 1261 (11th Cir. 2023) (“Carson I”). Carson I recognized that PR v. Franklin, “abrogated” earlier Supreme Court decisions that had applied a presumption in express preemption cases:

Express preemption turns primarily on “the language of the pre-emption statute and the statutory framework surrounding it.” Medtronic, Inc. v. Lohr, 518 U.S. 470, 486 (1996) (citation and internal quotation marks omitted), abrogated in part on other grounds by Puerto Rico v. Franklin Cal. Tax-Free Tr., 579 U.S. 115 (2016). Where Congress has enacted an express-preemption provision, we identify the state law that it preempts according to ordinary principles of statutory interpretation, and no presumption against preemption applies. See Franklin Cal. Tax-Free Tr., 579 U.S. at 125.

72 F.4th at 1267. Carson I accordingly overturned a panel decision that had interposed a “force of law” requirement to avoid the statute’s express preemption clause. Id. at 1267-68. That requirement was “inapposite”; only applying to implied preemption. Id. at 1267. Agency force of law is not needed to activate the Supremacy Clause where Congress did so in the relevant statute. Thus, it “does not extend to express-preemption cases, where, as we have explained, the meaning of the express-preemption provision—not conflicting federal and state legal obligations—triggers preemption.” Id. at 1268.

Rather than decide the preemption issue itself, however, Carson I remanded the matter to the anti-preemption appellate panel that had decided that issue erroneously the first time around.

That turned out to be a big mistake.

On remand, the original Carson 3-judge panel again rejected preemption. In so doing, Carson v. Monsanto Co., 92 F.4th 980 (11th Cir. 2024) (“Carson II”), let loose the biggest zombie presumption against preemption decision that we have yet seen. The Carson litigation isn’t about prescription medical products, but rather about a herbicide – Roundup. Regardless, defense counsel in the Carson litigation, and we hope the en banc court, needs to round up and extinguish this zombie before it runs amok in the Eleventh Circuit.

Here’s how Carson II created the zombie.

The Roundup litigation involves the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”), which has an express preemption clause almost verbatim identical to the FDCA provision (21 U.S.C. §360k(a)) protecting medical devices − albeit limited to labeling. Section 136v(b) mandates that states may “not impose or continue in effect any requirements for labeling or packaging in addition to or different from those required under this subchapter” (emphasis added). Except for being in reverse order – “in addition to or different from” versus “different from or in addition to” − both statutes share the same basic preemption language. Carson II gave lip service to the abolition of the presumption against preemption, 92 F.4th at 989, but that was all. Rather than apply the express terms of the statute, it turned to one of those pre-PR v. Franklin cases, that, with respect to the erstwhile “presumption,” has been (in Carson I‘s terms) “abrogated.” Bates v. Dow Agrosciences LLC, 544 U.S. 431 (2005). See Carson II, 92 F.4th at 990 (“To determine whether FIFRA preempts state requirements that go beyond mere duplication of FIFRA’s requirements, we turn to Bates”).

After PR v. Franklin, as applied to FIFRA in Carson I, the panel should not have simply have “turned to” Bates, because Bates was practically marinated in the now-abolished “presumption against preemption.” “[W]e have long presumed that Congress does not cavalierly pre-empt state-law causes of action.” 544 U.S. at 449 (quoting what Carson I recognized as the “abrogated” Lohr presumption against preemption discussion). Thus, from among “plausible alternative reading[s]” of FIFRA’s preemption clause, Bates found “a duty to accept the reading that disfavors pre-emption.” Id. Thus, Bates followed a −

basic presumption against pre-emption. If Congress had intended to deprive injured parties of a long available form of compensation, it surely would have expressed that intent more clearly.

Id. at 449. But this “intended to deprive” proposition involved implied preemption − Silkwood v. Kerr-McGee Corp., 464 U.S. 238, 251 (1984), that the Supreme Court (two years after Silkwood) ruled was inapplicable to express preemption cases – since express preemption clauses have precisely that function. See Riegel v. Medtronic, Inc., 552 U.S. 312, 326 (2008) (rejecting dissent’s reliance on Silkwood; precluding “judicial recourse . . . is exactly what a pre-emption clause . . . does by its terms”). An express preemption clause precludes Silkwood’s airy speculation about unstated congressional intent. “The operation of a law enacted by Congress need not be seconded by a committee report on pain of judicial nullification.” Riegel, 552 U.S. at 326 (citation omitted).

Having explained why Bates is no longer good law in disfavoring preemption where (as here) Congress has enacted an express preemption provision, we return to Carson II. In Carson II, the plaintiff’s principal claim was that the defendant “should have included a warning about [the product’s] potentially carcinogenic effects on its label,” 92 F.4th at 991, even though the relevant federal regulator (the EPA) did not require any such warning. If that allegation had been asserted against a PMA medical device claim, under the essentially identical wording of the FDCA’s preemption clause, it would be preempted, since a common-law claim demanding an unapproved warning would be both “different” and “in addition” to the federally required warning. E.g., Riegel, 552 U.S. at 329 (“a state common-law requirement for additional warnings” is “surely” preempted).

By citing Bates, as supposedly “preserv[ing] a broad role for state regulation,” 92 F.4th at 991, Carson II turned the plaintiff’s demand for a warning found nowhere on the approved label into a “parallel claim.” By calling it “misbranding,” Carson II transformed essentially anything a plaintiff might allege about a warning’s claimed inadequacy into a purportedly “parallel” FIFRA violation. Id. at 991-92. In the FDCA context, we’ve decried similar abuse of broad misbranding language, for the same basic reason (sub rosa disinterment of the presumption against preemption), in OTC drug litigation.

How did Carson II accomplish this?

Any state-law labeling requirement, no matter how entirely different from what the EPA approved, survives because FIFRA “effectively imposes a strict-liability standard.” Id. at 991. State common-law, by contrast, is “narrower” because it imposes only a “knows or reasonably should have known” standard. Id. at 992. Carson II then put the rabbit in the hat using Bates. “Different” as used in the FIFRA preemption clause doesn’t really mean what it says – that is, barring claims that are actually “different” − because anything “narrower” escapes preemption under Bates. Or, quoting directly from Carson II:

[T]he Supreme Court has explained that “state law need not explicitly incorporate FIFRA’s standards as an element of a cause of action in order to survive pre-emption.” Rather, so long as the state-law duty parallels or is “fully consistent” with FIFRA, FIFRA does not preempt it. . . . If anything, Georgia common law about failure-to-warn claims imposes less of a duty on pesticide manufacturers than FIFRA. . . . Because Carson’s state failure-to-warn claim is “fully consistent with” or even narrower than federal requirements, FIFRA does not expressly preempt that claim. After all, as the Supreme Court has reasoned, “[w]hile such a narrower requirement might be ‘different from’ ” FIFRA’s requirements “in a literal sense,” that would be “a strange reason for finding pre-emption of a state rule insofar as it duplicates” FIFRA. So FIFRA does not expressly preempt “narrower” state requirements.

92 F.4th at 992 (all quotations are to Bates).

So, relying on the (unnamed) presumption as applied in Bates, “different” and “addition” only mean not “narrower,” rather than the actual words Congress used.

Got that? Because of the presumption against preemption-based rationale in Bates, any state common-law warning claim – no matter how disparate – is automatically not preempted because state common law claims are inherently “narrower” than FIFRA’s requirements, and anything “narrower” cannot be preempted due to Bates’ refusal to read FIFRA’s preemption language “in addition to or different from” literally due to a now-abolished presumption against preemption. That’s pretzel logic if we’ve ever seen it.

Thus a zombie presumption against preemption now stalks the Eleventh Circuit. To finish the job of emasculating FIFRA preemption, Carson II next returned to Bates to re-import through a side door the very same “force-of-law” inquiry the Carson I had rejected.

To establish whether a particular Agency action amounts to a “requirement” under FIFRA, we must determine whether that Agency action carries the force of law. If it is not “a rule of law that must be obeyed,” then as the Supreme Court has directed, it is not a “requirement.” Bates, 544 U.S. at 445, 125 S.Ct. 1788. So though we need not perform a threshold force-of-law analysis before defining the scope of FIFRA’s preemption, we must do that analysis to determine whether an Agency action qualifies as a “requirement.”

92 F.4th at 993.

We’ve read a lot of judicial opinions in our time, but we can’t recall any remand decision that so thoroughly ignores the decision that remanded it as Carson II did to Carson I. At every turn Carson II reflected the walking dead − the influence of the presumption against preemption in Bates from beyond its PR v. Franklin grave.

Adding insult to EPA on top of the injury it inflicted on the plain language of FIFRA’s preemption clause, Carson II went on to oust EPA product approvals from preemption entirely. The EPA’s approvals were supposedly not “requirements” because “Agency approvals provide only ‘prima facie evidence,’ not conclusive proof, that a pesticide is not misbranded” since “the Agency can later retract its approval.” Id. at 993 (quoting 7 U.S.C. §136a(f)(2)). “Since the Agency’s determination is neither conclusive nor irrevocable, it would make little sense to deem it a “requirement” on equal footing with FIFRA’s prohibition on misbranding.” Id. (citation omitted).

Thus, by using Bates to impose a presumption against preemption sub silentio, Carson II: (1) construed any common-law warning claim, no matter how divergent from the product’s actual approved warnings, as not “in addition to or different from” that warning; and (2) deprived the EPA’s product approval of any preemptive force at all, because it wasn’t a “requirement.”

Is the Carson II zombie likely to eat the brains of FDCA preemption clauses, too?

We don’t think so − ironically because to distinguish Riegel, Carson II had to violate another of the Supreme Court’s holdings from Riegel itself. Again, we’ll explain.

Emphasizing the nearly identical express preemption clauses that govern both medical devices and FIFRA, the defendant in Carson II relied heavily on Riegel’s recognition of broad preemption of product liability claims under the relevant FDCA preemption clause in §360k(a). 92 F.4th at 993-94. In reaching its preemption friendly result, Riegel flatly rejected a plaintiff-side argument that claimed the meaning of the word “requirement” could vary by statute. Instead, Riegel declared that “Congress is entitled to know what meaning this Court will assign to terms regularly used in its enactments.” 552 U.S. at 324. Any state “damages” award “is designed to be[] a potent method of governing conduct and controlling policy.” Id. (citation and quotation marks omitted).

To avoid these Riegel-based arguments about what constitutes a “requirement,” Carson II contradicted these two key aspects of Riegel. First, contrary to Riegel’s opposite holding, Carson II denied that state-law litigation imposes mandatory “requirements” through damage awards – rather, the pressure of tort liability may merely “lead” either the regulated defendant or the agency itself to “decide that revised labels are required in light of the litigation.” 92 F.4th at 995 (quoting, of course, Bates). Second, and equally contrary to Riegel, Carson II held that what constitutes a preemptive “requirement” varied depending on the “context” of the two “different” statutes, with the FDCA being more “rigorous,” and thus more preemptive, than the essentially identical preemption language in FIFRA:

[W]hile the preemption provisions are similar, we must read them in context. The statutes’ distinct approval processes confirm this significant difference. Premarket approval under the [Medical Device] Amendments represents a “rigorous” conclusion that a device is safe and effective. . . . By contrast, the [EPA’s] approval of a pesticide’s registration serves as only “prima facie evidence” that the pesticide complies with FIFRA’s requirements. . . . What’s more, the [MDA] preemption provision expressly contemplates device-specific application, as it preempts requirements “with respect to a device.” FIFRA, on the other hand, contains no such limitation − it imposes only “general standards.” And different federal statutes and regulations may lead to different preemption results. Given the differences between FIFRA and the [FDCA’s] statutory schemes, Riegel does not control here.

Carson II, 92 F.4th 995 (citations and quotation marks omitted).

This aspect of Carson II reminds us of the Vietnam-era quotation, “We had to destroy the village in order to save it.” To save Riegel-based preemption of medical device claims from the zombie it created, Carson II found it necessary to destroy the rationale of Riegel itself – by once again relying on the pre-Riegel and pre-PR v. Franklin decision in Bates to resurrect propositions about the meaning of “requirement” that Riegel flatly rejected.

There’s more we could criticize about Carson II – particularly its rejection of implied preemption on the “Mouse Trap game” possibility that the relevant government agency could always change its mind, 92 F.4th at 998-99, which the Supreme Court rejected in PLIVA, Inc. v. Mensing, 564 U.S. 604, 619 (2011) – but we’ll stop here. Carson II is a paradigmatic zombie presumption against preemption case, since it is 100% dependent on the presumption-based torturing of the relevant preemption language that initially occurred in Bates. Carson II also illustrated why PR v. Franklin was right to abolish that presumption, because the FIFRA preemption clause as construed in Carson II no longer meant anything close to its plain statutory language. A state-law cause of action demanding a warning that was never approved (and indeed had been rejected) by the relevant agency at the time of the claimed product use simply cannot be anything other than “in addition to or different from” the agency’s “requirements.”

Not surprisingly, the defendant has again sought en banc review. One can only hope that the en banc Eleventh Circuit has the fortitude to reverse this Orwellian statutory result yet again, and thereby to finish off, once and for all, the zombie presumption against preemption, before it eats any more judicial brains.

Enough Is Enough In Taxotere Remand Case

By Steven Boranian on March 8, 2024

The unwieldy and sometimes unfair nature of multidistrict litigation has become a recurring theme on the DDL Blog. We have long commented on the “if you build it, they will come” dynamic that leads to hundreds or thousands of cases gathered, filed, and then parked in an MDL—all hoping to do as little work as possible while waiting for a global settlement. The masses of cases being filed in and transferred to MDLs has created a now-familiar pattern: MDLs often start by facilitating and allowing the amassing of even more cases, arguably under means that are outside the Federal Rules of Civil Procedure. Take for example “direct filing” procedures, under which plaintiffs can file directly in an MDL transferee district without regard to venue rules or personal jurisdiction. Or how about “master complaints” that provide an umbrella for thousands of plaintiffs to file their claims (sometimes by merely checking boxes), without any genuine opportunity to test the basis for any plaintiff’s claim. Some MDLs have even allowed plaintiffs to lodge their claims without actually filing them, thus avoiding filing fees in thousands of cases and potentially allowing those claimants to wait and see. We could go on (and Bexis has, here).

At some point though, judges say enough is enough and start drilling down on the plaintiffs’ cases and become less forgiving. Our defense-side bias leads us to believe that the point of all this is to pressure defendants into mass settlements, but we don’t want to judge too harshly. Whatever the reason, the rules kick in at some point and the plaintiffs no longer get a break.

That’s good, but our beef is that it takes far too long. We wrote a few weeks ago about a good Lone Pine order entered in the Taxotere MDL—but only after four years of urging by the defendants. Another recent post reported on a case where the judge denied the plaintiff’s motion to amend her complaint. That was good and fair too—but the plaintiff made her motion six years after filing her complaint.

The most recent example is another Taxotere case, one remanded from the MDL along with hundreds of other cases. The plaintiff in Sherratt v. Sanofi US Servs. Inc., No. #:23-cv-00580, 2024 U.S. Dist. LEXIS 33866 (D. Nev. Feb. 28, 2024), wanted to take punitive damages discovery after discovery had long been closed. We understand why. Having failed under the most basic strategy—lay low and do as little as possible while waiting for a group settlement—this remanded plaintiff could no longer hide in the weeds. So what better way is there to coerce the defendant into paying more in an individual settlement than reopening discovery into “punitive damages.”

The district court on remand said no. The MDL judge had allowed the MDL plaintiffs to conduct extensive general merits discovery against the defendant for the benefit of all MDL plaintiffs. That included discovery into issues affecting punitive damages, without regard to whether the applicable law in a given plaintiff’s case would actually permit the introduction of such evidence at trial. Id. at *2-*3. The plaintiff in Sherratt was present for all of this, but somehow they claimed that it was not enough.

The remand judge shut that down pretty quickly, first because the MDL plaintiffs already took a boatload of discovery:

According to [Defendant], the general merits discovery against it remained open for 16 months in the MDL and included: “(1) the production of more than 576,100 documents (or 6,320,000 pages) from 43 separate custodians, (2) depositions of 28 current and former . . . employees (including . . . 30(b)(6) witnesses), and (3) responses to more than 160 written discovery requests.” . . . [T]he discovery effort focused on what [Defendant] knew or should have known about the alleged injury in this litigation “across different functional areas within the company, including pharmacovigilance, medical, safety, regulatory, labeling, marketing and sales, among others.”

Id. at *3-*4. This description is useful and compelling, and most every defendant in an MDL is able to roll out similarly impressive numbers. The linchpin, however, was that general discovery closed more than five years ago:

[G]eneral merits discovery against [Defendant] (which included punitive damages discovery) closed on December 15, 2018. Any remaining discovery was to be “case specific,” which was described as the collection of records and depositions of the plaintiffs and plaintiff’s health care providers, spouses, friends, family, and case-specific expert discovery.

Id. at *4. The plaintiff could not show (and did not even really attempt to show) that extraordinary circumstances existed that would justify reopening general discovery, including punitive damages discovery. Id. at *5-*6.

You could see this as one case where a plaintiff failed to meet his or her burden to receive some special dispensation, but we prefer to see this as part of a larger narrative. There are rules, and rules apply—just not as soon or as consistently as they should. The plaintiff here was not allowed to take further discovery against the Defendant; one of the plaintiffs mentioned above was not allowed to amend her complaint; and a whole bunch of plaintiffs in the Taxotere MDL now have to comply with a Lone Pine order and actually demonstrate that they have even arguably viable claims.

So again, the rules apply, but why did it take so long? This is our frustration with MDLs. We appreciate judges who promote efficiency and employ some creativity in managing large caseloads. But we continue to believe that MDL judges can accomplish all that while predictably applying the regular rules of the road along the way (and we can think of numerous examples where MDL judges have done just that). There is no reason to wait.

California Federal Court Holds Onto Purported Class To Dismiss It Under The PREP Act

By Eric Alexander on March 7, 2024

Much like the placement of a comma, differences in capitalization can affect meaning quite a bit. Take PrEP and PREP. The former refers to the use of certain antiviral medications for pre-exposure prophylaxis to HIV, which has been hailed as a paradigm shift in treating HIV. We recall that FDA was so impressed with the first published studies supporting PrEP that it asked the manufacturer of the study drugs—a three-in-one pill—to apply for the novel indication. One of those drug substances, tenofovir, has for the last few years been the subject of a truly bizarre theory of liability that the manufacturer should have switched from the original chemical, tenofovir disoproxil fumarate, to an allegedly better version it developed, tenofovir alafenamide, sooner than it did. While many courts have rejected these claims, including based on preemption, recently both a California state appellate court and a California federal court have endorsed the novel “duty to innovate” in these cases. In addition to being fundamentally inconsistent with product liability principles and public policy, the application to a drug that has been key in addressing a decades-long pandemic is distasteful, to put it mildly.

PREP, at least on these pages, generally refers to the sweeping immunity for COVID-19 counter-measures pursuant to the Public Readiness and Emergency Preparedness Act of 2005. The manufacturer of tenofovir and the original PrEP drugs also manufactures remdesivir, which has been one of the main antivirals to treat COVID-19. In Fust v. Gilead Sciences, Inc., No. 2:23-cv-2853 WBS DB, 2024 WL 732965 (E.D. Cal. Feb. 22, 2024), two plaintiffs filed a purported nationwide class action in California state court that asserted a number of consumer protection claims on behalf of people allegedly injured by the use of remdesivir, including the survivors of people allegedly killed by the use of remdesivir. Of note, California has expansive consumer protection laws, especially as applied by its state courts, and these plaintiffs elected not to pursue them instead of product liability claims, except for negligent misrepresentation, which could fit in either bucket. The defendant removed and moved to dismiss primarily under the PREP Act; meanwhile, plaintiffs moved to remand.

First up was the motion to remand. The removal was based on CAFA, the Class Action Fairness Act, which was intended to provide subject matter jurisdiction in federal court for pretty much this exact situation—a class that would cross state lines and involve substantial remedies even when brought in the state where the defendant is based. The plaintiffs made some borderline frivolous arguments in support of remand, so we will address only the least frivolous one. Plaintiffs argued that its proposed nationwide class was not worth the $5 million minimum under CAFA even though it sought compensatory and punitive damages and relief that included a corrective ad campaign and disgorgement of the profits from the sale of the drug. The Fust court did not have to look past the corrective ad campaign cost, because multiple cases estimated the cost of equivalent or cheaper campaigns at well above $5 million. Id. at *1.

That meant that the federal court also got to decide if PREP Act immunity wiped out all of plaintiffs’ claims. (To us, they would also have been preempted had the case proceeded.) The PREP Act immunity analysis has three parts, the first two of which were basically walkovers here. A drug approved to treat COVID-19—remdesivir received an emergency use authorization in March 2020 and an approval for its SNDA in April 2022—was clearly a covered countermeasure and its manufacturer was clearly a covered person. Id. at *5. All that was left was whether the claims in the suit related to “loss caused by, arising out of, relating to, or resulting from the administration of” the drug. More specifically, claims for loss allegedly caused by the “manufacture, labeling, distribution . . . packaging, marketing, promotion, [and] sale” of the drug would trigger immunity. Not surprisingly, the consumer protection, false advertising, and misrepresentation claims about the alleged over-statement of the benefits and under-statement of the risks of a prescription drug walked right into immunity. The court perused the complaint and concluded “[e]very major noun and verb comprising plaintiffs’ allegations regarding act, injury, and causation manifestly implication the broad protections” of the PREP Act. Id. at *6. This was consistent with other decisions we have discussed and common sense.

Speaking of common sense, we would be remiss if we did not note that indication for remdesivir was limited to patients hospitalized for COVID-19. The proposed class was similarly limited. So, had it stuck around long enough, every member in the class would had to have been hospitalized due to the effects of a virus that caused a pandemic and received the antiviral that was the first—and, for a long time, only—to receive FDA authorization to treat their life-threatening condition. The relief requested by that class would have included that the manufacturer disgorge the profits from the sale of the drug to everyone, including those whose lives were saved by its use. As a convicted felon turned boxing promoter used to say, “Only in America.” Well, except for the PREP Act and its application in cases like Fust. Even in California.

Judicial Nominee Jeopardy

By Stephen McConnell on March 6, 2024

Last week we read a couple of online articles, including in the ABA Journal, about the unique questioning style of United States Senator John Kennedy (R- Louisiana) when it comes to federal judicial nominees.

By now, we all know how judicial nominees do the usual dance of saying as little as possible. Understandably, they decline to predict how they would decide specific issues. But, too often, they wave away anything with an aroma of substance, to the point where they end up saying precisely nothing. It becomes an empty exercise.

Senator Kennedy will fence with nominees on matters of judicial philosophy. But he does something else; he asks specific questions. They are concrete. There are right and wrong answers.

For example, Senator Kennedy has asked nominees:

What does Article I of the Constitution cover? How about Article II?
Contrast a stay order with an injunction
Explain what multidistrict litigation is.
What is collateral estoppel?

Nominees either know the answers or they do not. It is shocking how many nominees flub the answers. (This is not quite the same thing as the nominee who had to admit he had never tried a case before a jury. We get it. It’s getting harder and harder to get civil jury trial experience. Still, wouldn’t it be better if your trial judge had some sense of how these things really work?)

We are not expecting perfection. We have to admit that we could not immediately recall what Article V of the Constitution addressed (amendment).

You’ve almost certainly seen Senator Kennedy on the news or the weekend talking head shows. He is not close to being camera shy. He has something of a cornpone act. At times, he sounds a bit like Foghorn Leghorn. But he is definitely not stupid. Far from it. He got a magna and a Phi Beta Kappa key at Vanderbilt, was on the University of Virginia Law Review and earned Order of the Coif, and then earned a degree from Oxford. He was also an adjunct law professor at LSU.

By the way, we are not suggesting that academic achievements necessarily confer virtue. In fact, there are a couple of U.S Senators with sparkling credentials – Ivy League colleges and law schools, Supreme Court clerkships – who seem utterly steeped in mendacity. But that’s a different topic. Let’s chat about it the next time we see each other at DRI or ACI.

Naturally there are critics of Senator Kennedy’s pop quizzes. Some say the questions are unfair. (We should point out that Senator Kennedy is an equal opportunity interrogator. He tortures Biden nominees currently, but he also sunk at least one Trump nominee whose answers were weak.) A representative from the Alliance for Justice suggested that Senator Kennedy seems not to know that judges have access to law libraries. Apparently, all a judge needs to know is how to look stuff up to get the right answer.

That’s complete balderdash. First, we agree with Senator Kennedy that “these are the kind of questions that I would expect my students to know the answer to.” We’d be terrified to litigate a case in front of a judge who was clueless about collateral estoppel. Moreover, not all of legal practice is open book. Sometimes immediate decisions need to be made. “Objection, your Honor, Rule 602.” “Huh?” Actually, what would come out of the judge’s mouth would be something equally useless, like “I’ll allow it.”

The real beauty of the Kennedy Quiz is that it tolerates no BS. That’s why we like to see similar questioning by moderators at candidate debates. Get the politicians away from their stale scripts and dumb catchphrases. Test actual knowledge. We remember Senator Fred Thompson scratching his head a while before he managed to recall the name of Canada’s Prime Minister. But at least he got it. We’d like to ask candidates to state the amount of the national debt, list the countries bordering Ukraine, describe what product categories are the U.S’s biggest exports, explain price elasticity, etc. (In addition, we really want to know the candidate’s position on the Spring-ahead and Fall-back time changes. The first one who proposes to ditch that idiocy will get our vote.)

(We cannot resist this brief diversion. The way we pick judges is … suboptimal. We’re not even talking about jurisdictions where judges are elected. Politics is a lousy means of quality control. Long ago, when we were in law school, one of our law professors constantly referred to the German legal system as “the mind of God revealed to man.” In Germany, people go to a school to learn how to be judges. Maybe that’s superior. Maybe not. But they’d probably do a better job of fielding Senator Kennedy’s questions.)

Senator Kennedy’s questioning style is not merely an academic issue for us. We try to do something similar when we take expert depositions. Sure, we have to ask the experts about their opinions — bases, methodologies, etc. Somewhere along the way, we know we’ll run into a blizzard of nonsense and evasion. But we always insert into our depo outline a litany of purely factual questions. We call it the Jeopardy section of the deposition. For example, if the expert opines that our client’s product has a defective design, we will ask specific questions about the design process. Did you review the entire design file? Who was in charge? What materials did they consider? What testing was done? If the expert is trashing regulatory compliance, let’s see if that expert knows which people at the company and FDA were involved. Or if an expert is rendering a specific medical causation opinion, we will get mighty specific.

Mind you, we do not ask these questions with a gotcha tone. Rather, we ask them in a perfunctory manner, as if we fully expect the expert to know. If the expert does know, we casually move on and ask the next question. If the expert does not know, we pause, as if momentarily arrested by disappointment. Try this approach sometime. If nothing else, the experts will lose some of their haughtiness. Remind them who’s the boss. Maybe it’s you. Maybe it’s the facts. But it’s certainly not the expert slinging half-cooked hash.

Back to Senator Kennedy and his judicial nominee quiz. What questions would we ask? Here are a few:

What was the holding of Marbury v. Madison?

How many times has the Constitution been amended?

What is the incorporation doctrine?

What does the eleventh amendment provide?

What is the difference between subject matter and personal jurisdiction?

What are the requirements for federal diversity jurisdiction?

What is the difference between general and specific personal jurisdiction?

What was the holding of the SCOTUS BMS decision?

What does Article VI of the Constitution address?

How does conflict preemption work?

What is Chevron deference?

How should the court approach a Rule 702 issue as to whether an expert’s testimony is admissible?

What is the significance of the Youngstown Steel case?

What is the Rooker-Feldman doctrine?

Who was the first Chief Justice?

Okay, those last two might seem a little squirrelly. Maybe they fall into the category of making the nominee uneasy and reminding the nominee who’s the boss. (Be grateful we did not ask about the rule in Shelley’s Case.)

What questions would you want to ask judicial nominees? The next time we run into you, we might quiz you on that.

Yes, Plaintiffs, Medical Records are Necessary!

By Michelle Yeary on March 5, 2024

Plaintiffs in mass tort drug and device litigation do not like to focus on the individual cases. They like to amass the individual cases. They like to file the individual cases. But as we see all too often those filings tend to be indiscriminate and without the benefit of proper early vetting. That is what leads to situations like the Taxotere MDL we discussed last week – eight years of litigation and thousands of cases without basic proof of injury. Which means the burden of finding the evidence, or lack thereof, on case specific causation and injury usually falls to the defendants. Defendants who spend hundreds of thousands of dollars to obtain copies of plaintiff’s medical records. Medical records, which most courts eventually recognize plaintiffs should have as part of their Rule 11 due diligence. So, we couldn’t ignore a ruling granting defendants’ motion to recover the costs of doing that case-specific leg work that plaintiffs ignore. In re Zofran (Ondansetron) Products Liability Litigation, 2024 WL 841413 (D. Mass. Feb. 28, 2024).

So much good news has come from the Zofran MDL that today’s case is just the latest chapter. As we have previously discussed, the defendant won the MDL on preemption grounds, and had that win affirmed on appeal. As the prevailing party, the defendant earned the right to recover taxable costs as permitted by Federal Rule of Civil Procedure 54(d) and 28 U.S.C. § 1920. Section 1920 enumerates the specific allowable costs. The court examined each in turn.

Filing fees for removing 40 cases to federal court. These were denied as “not necessarily incurred in the defense of the cases.” Id. at *2.

Process server fees for 27 subpoenas. Defendant used a private process server but was only allowed to recover the equivalent of the marshal’s fee which is capped at $65 per subpoena. Id.

Deposition transcript fees. Defendant sought to recover the costs associated with 56 depositions. Plaintiff argued the costs were not recoverable because the depositions had not been used at trial and/or were depositions of defendant’s own employees. The court agreed with the latter point and disallowed costs for depositions of current employees. Id. at *3. However, as to the former point, the court found that it had discretion to permit recovery where depositions are relied on by the prevailing party in a dispositive motion. Therefore, the court allowed recovery for seven of the depositions relied on by defendant in its motion for summary judgment. The court did not agree that this extended to depositions of experts challenged by plaintiff on Daubert motions. Id.

Witness fees. The court allowed the recovery of the statutory attendance fee of $40 for 20 of defendant’s employees who were deposed. Id. at *4.

Fees for Exemplification and Copies aka Medical Records.

Defendant sought recovery of over $400,000 in costs associated with obtaining plaintiff’s medical records. Those are the costs charged by the recorders providers themselves and did not include the fees to the vendor retained by defendant to scan, upload, and process the records. Plaintiff argued that the costs should be disallowed because defendant “failed to explain their purpose or necessity to the judgment obtained.” Id.

The “critical” question for the court was whether the medical records were “necessary” for use in the litigation. Plaintiff argued that question should be answered in the negative because no medical records were used at trial or in the preemption ruling that terminated the litigation. While that may mean they were not “used in the strictest sense of the term,” the court took a different view of necessity:

The fees at issue here, however, stand on a different footing from ordinary photocopying costs. This proceeding involved hundreds of personal-injury lawsuits, each of which alleged that children were being born with serious birth defects. The fees in question were imposed by health-care providers and other third parties as a condition of obtaining the relevant medical records. It would have been folly, if not actual legal malpractice, for [defense] counsel to have neglected to obtain and review those medical records. Nor would it have been possible, as a practical matter, to pick and choose among them in advance. It was therefore reasonable under the circumstances for [defendant] to seek copies of those records.

Under the circumstances presented here, the Court concludes that the costs are properly taxable. Defense counsel was effectively required to obtain their medical records, and had little, if any, discretion in selecting among them or narrowing the scope of the requests. No aspect of those costs was driven solely by the convenience of counsel, as opposed to the practical necessities of defending hundreds of personal-injury cases.

Id. at *4-5 (emphasis added). Amen! Defendants are obligated to get medical records in personal injury cases and not to do so would be malpractice. As we discussed last week and so often when we talk about things like Lone Pine orders, those medical records are crucial documents that plaintiffs themselves should obtain even before filing suit. Having not undertaken that proper vetting task at the outset, it seems entirely reasonable to charge them in the end for defendant taking on that burden.

Docket Fees. Plaintiff only wanted to allow recovery of a single docketing fee of $20, but the court agreed with defendant that the docket fees were recoverable per case.

Finally, plaintiff argued the court should exercise its discretion to disallow all fee recovery because the corporate defendant was in a better position to absorb the costs than the individual families who filed suit. Even assuming it had such discretion (doubtful), the court declined to exercise it. District Court guidance provides that the court “can give no consideration to whether the lawsuit addressed important social issues, whether it was brought in good faith, or whether the relative financial status of the parties.” Id. at *5. Nor did the court need individualized hearings for each plaintiff. Each plaintiff will bear the costs of his/her own medical records and the remaining costs will be divided pro rata—working out to a little over $1000 per plaintiff. Hardly an unreasonable amount for a complete defense victory.

Drug & Device Law