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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.

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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 BatesCarson 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.

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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. 

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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.

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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. 

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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. 

  1. 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.

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In our recent post on the Onglyza affirmance, we mentioned that the Sixth Circuit rejected the plaintiffs’ attempt at a do-over after the expert they chose to ride into battle with was unhorsed by Rule 702.  The MDL plaintiffs flunked both “good cause” grounds for modifying the existing expert scheduling orders.  First, plaintiffs were not “diligent” as they could “not explain why they have failed to identify other, reliable, general causation experts − despite years of expert discovery.”  In re Onglyza (Saxagliptin) & Kombiglyze (Saxagliptin & Metformin) Products Liability Litigation, ___ F.4th ___, 2024 WL 577372, at *7 (6th Cir. Feb. 13, 2024).  Second, restarting expert discovery “would delay the MDL’s resolution for years − just consider that plaintiffs requested three months to simply identify an expert.”  Id. at *8.  The attempted do-over would thus have prejudiced the defendants by “impos[ing] significant costs on defendants . . . and years of delay.  Id.

That’s hardly the first time that plaintiffs, having hired presumably the best experts their money could buy, have gone whining back to courts for do-overs after their first choices were excluded.  Searching the Blog’s posts for “do-over,” we most recently speculated that plaintiffs would pull the same stunt after their experts were found wanting in the Acetaminophen MDL.  Sure enough, that’s precisely what happened. Claiming they were not bound by the MDL-wide Rule 702 order, In re Acetaminophen ASD-ADHD Products Liability Litigation, ___ F. Supp. 3d ___, 2023 WL 8711617 (S.D.N.Y. Dec. 18, 2023), some late-arrival plaintiffs in that litigation sought a do-over, which is now being litigated.  Also, similarly to their federal counterparts, The Onglyza state-court plaintiffs sought their own do-over and lost. Onglyza Product Cases, 307 Cal. Rptr.3d 480, 495 (Cal. App. 2023) (denying do-over not an abuse of discretion; “allowing plaintiffs to designate a new expert would prejudice defendants”).

On the other hand, we also discussed the notorious expert do-over in the Zoloft MDL.  After the plaintiffs’ causation expert was hoist with her own petard in the initial Rule 702 decision, In re Zoloft (Sertraline Hydrochloride) Products Liability Litigation, 26 F. Supp.2d 449 (E.D. Pa. 2014), the MDL court let plaintiffs try againIn re Zoloft Products Liability Litigation, 2015 WL 115486 (E.D. Pa. Jan. 7, 2015).  The new expert was ultimately excluded as well.  In re Zoloft (Sertraline Hydrochloride) Products Liability Litigation, 2015 WL 7776911 (E.D. Pa. Dec. 2, 2015).  However, that do-over took a year and cost the defendant who knows how much money, headaches and heartburn.

In the middle was In re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices. & Products Liability Litigation, which we discussed here, where:

Over Defendant’s strenuous objections, the Court reopened discovery to allow Plaintiffs’ experts to serve supplemental reports. . . .  However, the Court agreed not to allow Plaintiffs “an entire Daubert do over.”  The Court limited the experts to data and studies cited in the experts’ prior reports or cited to the Court in the parties’ supplemental briefing.

174 F. Supp.3d 911, 932 (D.S.C. 2016) (citation omitted).  Nonetheless, plaintiffs filed a supplemental report that amounted to a “complete do over,” thereby failing to comply with the court’s order.  Id. at 933.  That report was excluded.  Id. at 933-34.

So we decided to take a broader look, seeking support for the proposition that plaintiffs, having taken presumably their best shot, are not entitled to expert do-overs.  We start with the Supreme Court.  Given the saliency of Rule 702:

[i]t is implausible to suggest . . . that parties will initially present less than their best expert evidence in the expectation of a second chance should their first try fail. . . .  [A]lthough [plaintiff] was on notice every step of the way that [defendant] was challenging his experts, he made no attempt to add or substitute other evidence.

Weisgram v. Marley Co., 528 U.S. 440, 455-56 (2000).  Plaintiffs will not be heard to argue that they “could have shored up their cases by other means had they known their expert testimony would be found inadmissible.”  Id.

A plaintiff seeking to replace an excluded expert likewise drew back a nub in Winters v. Fru-Con Inc., 498 F.3d 734 (7th Cir. 2007).  Rule 702 “does not include a dress rehearsal or practice run for the parties.”  Id. at 743 (citation and quotation marks omitted).

[Plaintiff] had ample time to develop his case and conduct his testing . . . during the discovery period.  His inability to produce admissible expert testimony is due to his own actions, namely the failure of his proposed experts to test their alternatives.  The district court was not required to give [plaintiff] a “do over” and therefore we find that the district court did not abuse its discretion.

Id. Right on.

On analogous facts, Nelson v. Tennessee Gas Pipeline Co., 243 F.3d 244 (6th Cir. 2001), recognized that “fairness does not require that a plaintiff, whose expert witness testimony has been found inadmissible . . ., be afforded a second chance to marshal other expert opinions and shore up his case before the court may consider a defendant’s motion for summary judgment.”  Id. at 249-50.  Nelson thus made it “ clear that [an expert’s] purported unavailability does not give [plaintiff] the right to a ‘do-over’ as to the district court’s unfavorable Daubert ruling.”  Allied Erecting & Dismantling Co. v. United States Steel Corp., 2023 WL 5322213, at *6 (6th Cir. Aug. 18, 2023).  Likewise, Lippe v. Bairnco Corp., 99 F. Appx. 274 (2d Cir. 2004), held that “plaintiffs had a full and fair opportunity to develop and defend their choice of experts.  That they failed in that endeavor does not entitle them to begin anew.”  Id. at 280.  A Vaccine Act case similarly held that “parties are expected to put their best case forward in the first instance.”  Piscopo v. Secretary of HHS, 66 Fed. Cl. 49, 55 (2005).

In Rimbert v. Eli Lilly & Co., 2009 WL 10672150 (D.N.M. Nov. 16, 2009), which the blog discussed here, the plaintiff in a pharmaceutical product liability case, after having his chosen expert excluded, blithely claimed that “he can easily designate a new expert,” but did “not provide[] the Court with any indication of who this witness might be or what the basis for the witness’s testimony would be.”  Id. at *3.  Because “the Court has nothing more to go on than Plaintiff’s assurances that his new expert would succeed where his initial choice failed,” id., there was no good cause for allowing the plaintiff a second bite at the apple:

That Plaintiff initially chose an expert whose methodology the Court deemed unreliable does not constitute “good cause” to modify the scheduling order.  This is especially true in this instance where the case is ripe for dismissal and where Plaintiff had adequate notice early on of the flaws in [the expert’s] report, flaws that the Court ultimately found precluded her testimony, and Plaintiff made no attempt to fix these flaws or to offer a substitute expert until it was too late.

Id. (citations omitted).  The plaintiff in Rimbert had more than enough “notice and opportunity” to “shore up” the flaws in the report “or to name a new expert” before the court ruled, but did not.  Id. at *4.  Since “[h]e did not do so, [plaintiff] cannot, at this stage, seek a ‘do-over.’”  Id. (footnote omitted).

[A] core principle . . . guides determination of this matter − the Rules of Civil Procedure simply do not automatically afford a party a second chance to find a new expert after its initial expert’s testimony has been found inadmissible.

Id. at *4 n.4.

Last month’s decision in Martins v. Sherwin-Williams Co., 2024 WL 641383 (E.D.N.Y. Jan. 10, 2024), was also music to our ears.  The expert whose testimony the Martins plaintiffs purchased turned out to be a bozo.  Id. at *1 (“plaintiff’s counsel picked the wrong expert”; his opinion “met none of the Daubert criteria”).  Could plaintiff get a do-over?  Martins responded with a resounding “no.” 

Plaintiff was not diligent in obtaining reliable expert discovery before that deadline.  Plaintiff is charged with notice that each of his expert witnesses . . . would have to meet the well-established standards. . . .  [P]laintiff cannot shift the blame to [his expert search firm] or [the excluded “expert”].  They are not lawyers.  Plaintiff’s counsel had to make the call under Rule 702 . . . as to whether the proffered expert was qualified and could give an admissible opinion.

The Federal Rules of Civil Procedure do not guarantee plaintiff a do-over just because his expert witness was disqualified.  That would not be fair to defendants.

Id. at *1-2.

In holding that the rules “do not alow plaintiff a second bite at the apple,” Martins relied on several earlier decisions:  Lippe v. Bairnco Corp., 249 F. Supp. 2d 357, 386 (S.D.N.Y. March 14, 2003), recognized that replacing an excluded expert “is not the way the Federal Rules of Civil Procedure work.  Plaintiffs do not get a ‘do-over.’”

[I]t is more than just delay and additional work and expense.  Rather, it would be fundamentally unfair to require defendants to go through the process again, to delay the final resolution of this very difficult and burdensome case, solely because plaintiffs made some ill-advised tactical choices and refused to adjust when it was apparent that they should.  When a party loses . . ., it does not get to do it again.

Id.  Accord Exist, Inc. v. Tokyo Marine American Insurance Co., 2023 WL 7117369, at *3-4 (S.D.N.Y. Oct. 5, 2023) (no good cause without “concrete information suggesting that [a second expert] would be successful”; no new report submitted); Bermudez v. City of New York, 2018 WL 6727537, at *7 (E.D.N.Y. Dec. 21, 2018) (no “good cause as to why [plaintiff] should be permitted a second chance to fulfill his obligations under” the rules);

In Bank of America, N.A. v. Jericho Baptist Church Ministries, Inc., 2020 WL 128455, at *1 (D. Md. Jan. 10, 2020), aff’d, 2022 WL 11112695 (4th Cir. Oct. 19, 2022), a party − the defendant, this time − “chose to designate [the excluded expert] as its sole standard-of-care expert and vigorously persisted in” supporting that expert only.  Once excluded, “the Court will not allow [defendant] a ‘do-over.’”).  Similarly, Brown v. China Integrated Energy, Inc., 2014 WL 12577131, at *3-4 (C.D. Cal. Nov. 21, 2014), held that “[p]laintiffs are not entitled to a ‘do-over’ after their expert witness is disqualified”) (collecting cases).  See also Syneron Medical Ltd. v. Invasix, Inc., 2018 WL 4696969, at *1 n.1 (Mag. C.D. Cal. Aug. 27, 2018) (an expert “do-over would be unjust to [defendant], unless [plaintiff] agrees to reimburse [it] for the considerable fees and costs that it will be incurred in connection with such a do-over”), adopted, 2018 WL 11351325 (C.D. Cal. Sept. 28, 2018); In re M/V MSC Flaminia, 2017 WL 3208598, at *5 (S.D.N.Y. July 28, 2017) (“the disclosure obligations . . . do not provide for a “do over” . . ., what is done is done”);

No do-overs was also the theme in a couple of bankruptcy cases. In re HHE Choices Health Plan, LLC, 2019 WL 6112679, at *8 (Bankr. S.D.N.Y. Nov. 15, 2019), held that

Giving parties a ‘do-over’ if and when their [expert] reports are found to be unreliable would just encourage parties and experts to cut corners and to submit sub-standard work in the first go-round.  It would also force innocent adversaries to incur additional and unnecessary expense and inconvenience.

Id. at *8.  The same result occurred in In re H & M Oil & Gas, LLC, 511 B.R. 408 (Bankr. N.D. Tex. 2014), where the trustee requested that shoddy expert preparation “not be held against” him.  Id. at 421.  That amounted to a request for a “do-over” and was denied:

[C]ounsel is asking for a “do-over” of the Daubert Hearing − i.e., by (1) attempting to supplement the evidentiary record after the close of evidence . . .; and (2) suggesting that the Defendants can cross-examine [the expert] about this at trial.  Not surprisingly, the Defendants object to any “do-over.”  There will be no “do-over” here.  The Daubert Motions were timely filed by the Defendants[, and] . . . [t]he case law is clear that the proponent of the expert evidence − here the Trustee − had the burden of proof.

Id.

There’s probably even more out there.  All we did was search for Rule 702 and “do-over” and follow wherever the cases we found led us.  But we’re confident that the basic legal proposition is sound – parties are expected to take their best shot with experts the first time around, and when they lose, they don’t get do-overs.

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

Today we discuss two discovery orders from a case in the Northern District of California, Lin v. Solta Medical, Inc.  In this case, Plaintiff, a California resident, alleged that she was burned by a skin treatment she received in Taiwan with the Thermage CPT device manufactured by Defendant.  Plaintiff sought expansive discovery from Defendant while at the same time trying to restrict discovery plainly relevant to her own claims for her damages.  The court didn’t buy it.

Continue Reading Solid Discovery Orders in the Northern District of California
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We are medical device and pharmaceutical lawyers, so preemption is our thing.  It may not make for scintillating cocktail conversation, but we find the intersection between Constitutional law (the Supremacy Clause and the federal/state balance of power) and public policy issues (health and safety, and regulation versus litigation as the best way to promote same) to be a pretty interesting topic. 

Not to mention, it is a powerful defense for our clients in product liability matters because it can foreclose liability and plaintiffs’ use of tort lawsuits (invariably creatures of state law origin) to impose requirements on medical devices or pharmaceuticals that the federal FDA did not.

What could be better than preemption?  How about “immunity”?  Or is it that the same thing by a different name?

And that brings us to the Public Readiness and Emergency Preparedness Act (or “PREP Act”), 42 U.S.C. §§ 247d-6d, 247d-6e.  The PREP Act has captured our attention before, but recently, in Baghikian v. Providence Health & Services, No. CV 23-9082-JFW(JPRX), __ F.Supp.3d __, 2024 U.S. Dist. LEXIS 22420, 2024 WL 487769 (C.D. Cal. Feb. 6, 2024), the Central District of California looked at the PREP Act in the usual context in which we deal with preemption:  A tort lawsuit (involving product liability and related state law tort claims) against a medical product manufacturer (here, the manufacturers of the COVID 19 antiviral medications remdesivir and tocilizumab).

A Primer on the PREP Act.  Through the PREP Act, Congress hoped to facilitate the quick deployment of crucial medical resources during public health emergencies, in part by freeing “covered person[s]” from the threat of civil litigation and liability.  In relevant part, it provides that:

“a covered person shall be immune from suit and liability under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration to or the use by an individual of a covered countermeasure.”

42 U.S.C. § 247d-6d(a)(1) (emphasis added). 

The only exception to this broad grant of immunity is a quite particular “exclusive Federal cause of action against a covered person for death or serious physical injury proximately caused by willful misconduct,” although that remedy is only available (1) in the United States District Court for the District of Columbia; (2) requires pleading with particularity, a complaint supported by a verification under oath, a doctor’s affidavit, and certified medical records; (3) requires conduct more dangerous than negligence or recklessness; (4) can be pursued only after the plaintiff first pursues an administrative claim; and (5) must be proven by clear and convincing evidence.  42 U.S.C. §§ 247d-6d & 247d-6e.

Other key PREP Act provisions:

  • “Covered person[s]” include manufacturers and distributors of “covered countermeasures.”  42 U.S.C. § 247d-6d(i)(2)(B)(i)–(ii). 
  • “Covered countermeasures” include “qualified pandemic or epidemic product[s]” so designated by a declaration of the Secretary of Health and Human Services. 42 U.S.C. § 247d-6d(i)(7). 
  • “All claims” in the PREP Act’s immunity clause means all claims with “a causal relationship” to the covered countermeasure’s “design, development, clinical testing or investigation, manufacture, labeling, distribution, formulation, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing, or use.” 42 U.S.C. § 247d-6d(a)(2)(B).
  • Reminiscent of the Vaccine Injury Compensation Act, 42 USC §300aa-22(b-c), the PREP Act also created an alternative no-fault system for individuals to seek recovery if they believe they have been injured by a covered countermeasure.  See 42 U.S.C. § 247d-6e(a) (creating the “Covered Countermeasure Process Fund”).

The Baghikian Opinion.  Not all that long after the PREP Act passed, the COVID-19 pandemic started, quickly confirming the importance of freeing government and industry to work together to deploy every type of desperately needed medical resource.  The government issued the necessary “public health emergency” declaration in March 2020, and the PREP Act kicked in.

The Baghikian defendants’ antiviral medications were and are an important part of the battle against COVID-19.  One defendant developed and manufactures remdesivir, covered by an Emergency Use Authorization issued by the FDA in May 2020 and full approval in October 2020.  The other defendant manufactures a rheumatoid arthritis medicine, tocilizumab, but contracted with the federal government to conduct clinical trials regarding its use in treating COVID-19 leading to an Emergency Use Authorization in June 2021 and full approval for COVID-19 use in December 2022.

The plaintiffs alleged that the decedent had been hospitalized for COVID-19 and treated with the defendants’ antivirals without adequate informed consent, and passed away after three weeks.  They did not, however, contest that defendants were “covered person[s]” or that the antiviral medications were “covered countermeasures.” 

Instead, the plaintiffs argued that an allegedly insufficient informed consent about the treatments vitiated the PREP Act’s immunity provision—a contention the Baghikian court quickly rejected as unfounded in the statute’s language and unsupported by any caselaw.

The plaintiffs also took a shot at arguing for application of the “willful misconduct” exception to PREP Act immunity.  But even setting aside the procedural problems (like the requirement that such claims be pursued only in the District of Columbia), the plaintiffs’ assertions of strict liability or, at most, recklessness, fell short of the “willful misconduct” needed under the PREP Act.

As the first case directly addressing the PREP Act in a product liability case against manufacturers, Baghikian is significant, and its rejection of liability was clearly the right result.  Baghikian already has been followed in Fust v. Gilead Sciences, Inc., No. 2:23-cv-2853 WBS DB, 2024 U.S. Dist. LEXIS 30894 (E.D. Cal. Feb. 21, 2024)).

One final item of note about the PREP Act:

Defendants should not get carried away trying to remove PREP Act claims to federal court, potentially hurting themselves on the main issue (immunity) over a skirmish about jurisdiction.  In Saldana v. Glenhaven Healthcare LLC, 27 F.4th 679, 686 (9th Cir. 2022), the Ninth Circuit held that the PREP Act does not result in “complete” preemption.  Complete preemption is not a defense to liability and is not the same as field preemption;  it is a jurisdictional doctrine.  Complete preemption allows removal of a case to federal court, based on the understanding that any attempt to state a claim on the relevant subject is deemed to be based on federal law instead.  See Retail Prop. Tr. v. United Bhd. of Carpenters & Joiners of Am., 768 F.3d 938, 941 (9th Cir. 2014).  Complete preemption gets you into federal court, but not dismissed from the case, and Saldana says it doesn’t apply to PREP Act claims in any event.

That said, Baghikian does highlight one potential, albeit unusual, path to federal court: the federal officer removal statute, 28 U.S.C. § 1442(a)(1), available because the claims were based on actions the tocilizumab manufacturer took at the direction of a federal officer.   

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Back in 1997, a Chicago Tribune columnist wrote a hypothetical commencement speech that garnered a lot of attention. Like most commencement speeches, it offered uplifting advice to the bright young minds about to enter the working world. Unlike most, it directed the graduates to wear sunscreen.  That suggestion (often wrongly attributed to Kurt Vonnegut) became A Thing.  Baz Luhrmann that same year put out a song called “Everybody’s Free to Wear Sunscreen.”

It seems that many plaintiff lawyers today harbor a different view.  There’s a not-so-mini-industry of suing manufacturers for selling sunscreen allegedly contaminated with benzene. In Cascio v. Johnson & Johnson, et al., 2024 WL 693489 (N.D. Ga. Feb. 20, 2024), the plaintiff, who said she applied an astonishing amount of sunscreen — several times per day, though a little less if it was raining — claimed that benzene-tainted sunscreen caused her to suffer from acute lymphoblastic leukemia, “a disease that is rarely seen in adults without benzene exposure.”  All lots of the sunscreen product (one of the more expensive brands on the drugstore shelves) had been recalled “in response to a citizen petition to the FDA by Valisure, LLC.”  The complaint included causes of action for product liability, negligence, misrepresentation, breach of warranty, and loss of consortium.  

The defendants moved to dismiss the complaint. They argued that the plaintiff failed to allege product identification, causation, and misrepresentation.  The claims for loss of consortium and punitive damages, being purely derivative, would also go away. 

And so they did. The Cascio court agreed that the plaintiffs failed to allege causation and, therefore, dismissed all the claims. 

We’re not going to ask you to stop us if you’ve heard this before, because we know you have.This is yet another claim based on the Valisure lab’s product testing results. Valisure reported that it found benzene in certain batches of sunscreen. 

Valisure did not test the particular tube of sunscreen actually used by the named plaintiff. Rather, Valisure tested 14 batches of sunscreen and found excessive benzene in 10 of them.  One of those batches was referenced in the complaint, but it does not appear to be a batch relevant to the particular sunscreen used by the plaintiff.  It was easy enough for the court to discount the positive results from products the plaintiff did not use.  Thus, the question is whether the one positive result in the batch referenced by the plaintiff legitimately supports an inference that the sunscreen used by the plaintiff contained benzene.  The court held that such an inference was not sufficiently supported, because Valisure admitted that there was “significant variability from batch to batch, even within a single brand.” 

Given that Valisure’s limited batch testing could not establish causation, the plaintiff was left to argue that the mere fact of a product recall should establish a defect in the sunscreen used by the plaintiff.  The Cascio court rejected that argument because the fact of a product recall, by itself, does not establish a product defect. Recalls can be over inclusive. (The Cascio court cites a couple of good cases supporting this point). Moreover, the recall applied to only certain batches, and there was no allegation that the plaintiff’s sunscreen came from any of those batches.  (Again, the Cascio court collected several nice cases on this point, including other favorable Valisure-based decisions.)

The plaintiff cited three cases that seemed to go the other way, insofar as they denied motions to dismiss similar allegations. But those cases contained no reasoning to justify a departure from the majority of cases supporting dismissal — the cases that framed what we and the Cascio court deem the better rule.  

That last point gladdens our flinty defense hearts. We practice in far too many jurisdictions where courts deal with righteous motions to dismiss via what amounts to postcard denials. There is no reasoning. There is not even a pretense of justification.  Now maybe that, er, reticence can be justified by overwhelming caseloads.  Or maybe it is sheer lassitude. Or fear of reversal.  Or reflexive pro-plaintiff-ness. There are some plaintiff lawyers who argue with a straight face that motions to dismiss violate the constitutional right to a jury trial, and there are some courts silly enough to agree.  Whatever the reason for these substance-less summary denials, they are pernicious.  Cass Sunstein, the most cited law professor in America (and our Con Law teacher way back when) has a draft article online about what it means to be a classical liberal. He’s talking about “liberal” as in John Stuart Mill, not, say, AOC.  Part of being a liberal in this sense means respecting the rule of law. More specifically, it means, among many other things, “reason giving in the public domain.”  Not giving reasons is a step toward authoritarianism.  One would think that the sine qua non of judging is making decisions and supplying reasons for such decisions.  Some judges do neither.  Some grudgingly do the first, but not the second.  Not to put too fine a point in it, this practice stinks. 

We are hardly unbiased on this point. Summary denials are a disappointment to defendants.   They wreak havoc in a particular case and offer no guidance to aid future conduct.  But at least, following the Cascio precedent, summary denials should count for nothing in other cases going forward. If there are no reasons, there should be no precedential force.  

But back to the matter at hand.  The result in Cascio is sound, it does have ample precedential force, and we are always happy to see Valisure testing get precisely the respect it deserves – darned little.  We offer a tip of our cyber cap to prevailing defense counsel, Robyn Maguire and Nadine Kohane at Barnes & Thornburg.