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Before we dive into today’s case, Avrin v. Mentor Worldwide LLC, 2024 WL 115672 (C.D. Cal. March 15, 2024), we offer two preliminary observations:

1. We love to hear from our readers.  Sometimes we get emails commenting on a post.  Often, those comments arrive in the form of gushing reviews. That’s nice.  Less often, people gripe about a post, telling us that we got something wrong, or elided over some complexity, or descended into rank punditry.  Guess what? That’s nice, too.  If lawyers suffer hurt feelings from criticism, they are in the wrong business.  Sometimes clients express gratitude for providing a user-friendly resource for spelunking into difficult legal issues.  That’s nice.  Last week a prospective client during a pitch meeting showered the blog with praise.  That’s not only nice, but gives us hope that the prospective client will soon become an existing client. And sometimes colleagues send us cases that are interesting and blog-worthy.  That’s not only nice, it’s a huge help. Our gratitude is enormous, and not quite fully captured by our usual tip of the cyber cap at the end of a case discussion (and which you will see at the bottom of this post). 

2. Express preemption for medical devices applies to manufacturing defect claims.  We’d like to think that is a self-evident proposition.  But we encounter many plaintiff lawyers and, sadly, some courts, that think that while express preemption might put the kibosh on design defect and warning claims, manufacturing defect claims somehow escape preemption.  We are working on several cases where our preemption notion eliminated every product liability claim … save for manufacturing defect.  We also have cases where manufacturing defect was the only claim, as if the plaintiff thought that such leanness or restraint would avoid a preemption headache.  To be sure, the manufacturing defect claims are occasionally design defect claims in disguise.  Moreover, most manufacturing defect claims never get to the finish line, because there is simply no evidence of any deviation from design specs.  Rather, the manufacturing defect claim presumes that an alleged malfunction itself proves the manufacturing defect.  Wrong. But wouldn’t it be splendid if we could head off all those debates by embracing our old friend, preemption?

That’s what the court did in Avrin.  The plaintiff alleged that she developed Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) from implantation of the defendant’s textured breast implants.  (The name of the injury is not great from the perspective of a defendant contesting medical causation.) The plaintiff alleged that the process of producing the defendant’s textured shell produces adulterated implants with excessive silicone debris fragments and particles that remained on the implants in violation of the FDA’s quality system regulation and current good manufacturing practice (CGMP) requirements. 

It’s not hard to see how the plaintiff was trying to evade 21 USC section 360k(a), which bars any claim that would impose any health safety oriented  requirement on a Pre-Market Approved (PMA) medical device (which the class III breast implants are) that is “different from, or in addition to, any requirement” developed by the FDA. The plaintiff’s proposed evasion follows the “parallel claim” route, in which the plaintiff asserts that the medical device violates both federal and state law.  A parallel claim must navigate the “narrow gap” between merely enforcing federal law or contradicting it, neither of which is permissible. 

The plaintiff’s manufacturing defect claim attacks the process by which the defendant manufactures the implants at issue. As such, the claim would require the defendant “to have manufactured, designed, or marketed the [implants] in a manner different from, or in addition to, the FDA’s PMA of the [implants].”  The plaintiff argued that she was not asking to impose any requirement different from or in addition to the federal regulations; rather, her claims paralleled federal requirements that products be manufactured in conformance with CGMP and not be “adulterated.”  

This maneuver is nothing new. It seems to be part of the current plaintiff lawyer playbook. Sometimes they get away with it. Sometimes they don’t. 

Avrin is in the latter, happier, sane category. The Avrin court reasoned that “saying the implants were ‘adulterated’ does not invoke a magic word that automatically saves plaintiffs’ claims from preemption.”  If the plaintiff succeeded in her lawsuit, she would force the manufacturer to stop using the precise manufacturing process approved by the FDA.  Moreover, because her claim was that the process caused not only her breast implants to be “adulterated,” but many or all of the relevant implants to be adulterated, the lawsuit would “encourage, and in fact require, lay judges and juries to second-guess the balancing of benefits and risks of a specific device to their intended patient population — the central role of FDA — sometimes on behalf of a single individual or group of individuals.”  

It’s good to know that “magic words” such as manufacturing defect, adulteration, or CGMP do not make medical device preemption disappear.  Chalk Avrin up as one for the good guys, and be ready to cite it the next time your client gets hit with the manufacturing defect/adulteration evasion. 

The plaintiff also alleged failure to warn. There was a choice of law question as to whether California or Colorado law applied.  California might have recognized a claim for failure to warn based on failure to report adverse events (boo/hiss), while Colorado law would not. The plaintiff was a resident of Colorado, Colorado had the greater interest in having its law applied to its citizens, so Colorado applied, and, therefore, the failure to warn claim was a goner.  

We are grateful to Dustin Rawlin for sending this case our way, and we congratulate him, Monee Hanna, Rachel Byrnes, and the entire Nelson Mullins team for earning such an excellent result.

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So plaintiffs learned in the In re: Gardasil Products Liability Litigation, MDL 3036, 2024 WL 1197919 (W.D.N.C. Mar. 20, 2024).  Try as they did in 550-paragraph and 120-page complaints to muddle their claims, the court cleared away the muck and found what was left was almost all preempted by the Vaccine Act.

While pending motions to dismiss were stayed when the MDL first was created, the court gave defendants permission to file two bellwether Rule 12 motions.  Defendants chose a case under New York law and one under North Carolina law.  Defendants moved to dismiss all design defect and manufacturing defect claims and certain failure to warn and fraud claims.  To put defendants’ preemption claims in context, the court provides a thorough summary of the Vaccine Act.  Most importantly pointing out that the Vaccine Act creates a “no-fault compensation system funded by vaccine manufacturers.”  Individuals who allege injury as a result of a vaccine can file a petition for compensation in Federal Claims court.  The quid pro quo for this compensation system, “is the provision of significant tort-liability protections for vaccine manufacturers.”  Id. at *6.  Those protections include preemption of design defect claims and of direct-to-consumer failure to warn claims.  Id. 

The preemption of design defect claims is so clear cut that plaintiffs did not argue against it.  Rather, they argued that they were not making such claims.  Even going so far as to tell the court at oral argument that they “scrubbed the word “design” from the complaints in response to [defendants’] earlier successful motions to dismiss.”  Id. at *7.  But a global search and replace for the word design wasn’t persuasive for the court.  “[T]he Court must look at the true nature of the allegations, not just how Plaintiffs have self-described their claims.”  Id.  That analysis led the court to find several design defect claims that plaintiffs tried to hide under negligence or manufacturing defect causes of action:

  • Claims that the ingredients in the vaccine are dangerous is a design defect claim.  Because the FDA approved those ingredients, an attack on them is an attack on the design of the product.  Id.
  • Claims that the vaccine was not properly developed or inadequately tested challenge the design of the product.  Inadequate testing is a “not an independent wrong.”  Rather, because the vaccine was approved based on that testing, it is an “attack on the design of the approved vaccine.”  Id. at *8.
  • Allegations that a product is not safe and effective “is effectively an allegation that the entire design of the vaccine is defective.”  Id.

Similarly, in their manufacturing cause of action, plaintiffs alleged, upon information and belief, that the defendants failed to comply with manufacturing specifications and protocols required by the FDA.  Id. at *10.  While that is the technical definition of a manufacturing defect, what plaintiffs allege in support is that the “vaccine recipe itself, not any specific instances of improper manufacturing, is the problem.”  Id.

A claim that all the doses of a vaccine are inherently and unreasonably dangerous when manufactured as intended is not a “manufacturing defect” claim. Rather, it is an allegation of a “design defect,” which is barred by the Vaccine Act.  Id. (emphasis in original).

Therefore, plaintiffs “upon information and belief” manufacturing allegations are contradicted by their own allegations that the dangerous ingredient is in every vaccine on the market.

On failure to warn, the Vaccine Act only allows claims for failure to warn medical providers.  Claims premised on failing to warn plaintiffs, their parents, or the general public, direct-to-consumer claims, are expressly barred.  Id. at *8-9.  The wording of the Act says there is no liability in a civil action “solely due to the manufacturer’s failure to provide direct warnings to the injured party.”  Id. at *9.  Having lost on this issue in every other federal court, this time plaintiffs tried to argue that “solely” meant a direct-to-consumer failure to warn claim could proceed here because plaintiffs were also alleging a failure to warn medical providers.  The court “decline[d] the invitation to reach such an absurd result.”  Id. Plaintiffs’ interpretation would “nullify the prohibition” on direct warning claims.  So, only failure to warn the learned intermediary survives.

The last claim at issue was for fraud.  To the extent plaintiffs’ fraud claims were premised on an alleged failure to warn, they suffer the same fate as plaintiffs’ failure to warn claims—no fraud directed to plaintiff.  Id. at *11.  Plaintiffs tried to argue that the statutory prohibition did not include intentional tort claims, but once again the court found plaintiffs’ interpretation “would significantly undermine, if not fully eliminate” the quid pro quo established by the Act.

With respect to fraud on medical providers, plaintiffs’ complaints fail to meet the heightened pleadings standard of Rule 9.  Plaintiffs conceded they had not pleaded the time, place, or content of any allegedly fraudulent statements made to plaintiffs’ medical providers, but tried to blame that lapse on doctors not liking to talk to plaintiffs’ lawyers.  Neither we nor the court thought much of that excuse. The court found the failure to plead these essential elements “dooms their claims.”  Id. at *12.  That left only plaintiffs’ fraudulent concealment claims which the court determined was to be held to a more lenient pleadings standard.  Further as the discovery on this claim would overlap with the permitted failure to warn medical providers claim, the court sort of a took a no harm, no foul approach leaving for summary judgment the differences of proof needed for the two claims.

The court also denied any leave to amend as pointless given the advance stage of the case.  So, these claims are gone and what remains is a significantly pared down case.

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It is a whole lot harder to file documents under seal than it used to be.  We recall an MDL in the early 2000s where the parties filed everything under seal over the course of multiple years—litigating for the viewing pleasure of our “friends and family,” as the district judge often chided us.  Times have changed.  In our home state of California, filing under seal is now such a hassle that it adds substantial time and expense to any filing of truly confidential documents.  But we jump through the hoops anyway for the benefit of our clients, if not for the sake our hard-working paralegals and assistants. 

You might think, what about protective orders?  If we enter into a stipulated protective order, we can file “Confidential” documents under seal, correct?  Well, the answer is not always, and it depends primarily on how confidential the information is, but also on other factors, including what the court does with the information, whether it is relevant to the case, and who requested the sealing.     

Take for example In re Birmingham Hip Resurfacing Hip Implant Products Liability Litigation, No. 1:17-md-2775, 2024 WL 1050925 (D. Md. Mar. 11, 2024).  In that case the plaintiffs took advantage of a protective order to receive enormous volumes of confidential information from the defendant—information that they might otherwise not have received and all of it marked “Confidential” under the protective order.  The plaintiffs did not object to any of the confidentiality designations when they were made, and the plaintiffs themselves filed multiple “Confidential” documents under seal.  Significantly, the plaintiffs often filed entire documents under seal, even when they were relying solely on certain portions.  Id. at *1.

Now, “as the MDL nears its conclusion” (the court’s description, not ours), the plaintiffs want to unseal certain documents over the defendant’s objection.  You can see what is going on here.  The plaintiffs took advantage of a stipulated protective order to obtain “countless documents” (again, the court’s description, not ours) from the defendant, and they relied on that same protective order to load up the public record with entire documents designated “Confidential,” even when they did not need to. 

Then, when all was said and nearly done, the plaintiffs turned around and requested that many of these documents unsealed and placed in the public record.  The consequences are significant.  Having relied on the protective order in producing proprietary and other sensitive information, the defendant was at risk of having its Confidential documents released into the public record, where anyone and everyone can view them at their pleasure. 

Note here that the plaintiffs were not acting in their own interest.  They and their lawyers already had access to the documents.  We are talking here about public access.  We favor and embrace litigation within the public’s view, but we can’t help but question the plaintiffs’ strategy when they freely and affirmatively participated in loading up the court file with “Confidential” documents, often gratuitously, then pulled a veritable switcheroo before getting out of dodge.  We can only suppose they wanted to make those documents available to their own friends and family (and their press agents) for purposes unknown, but presumably not to tout the defendant’s good deeds. 

The district court largely shot them down, noting that the plaintiffs could not so blithely reverse course on agreed confidentiality:

The documents at issue have already been sealed either at the Plaintiffs’ request or without their opposition. . . .  Although the presumption is in favor of public access to documents, courts in this circuit have repeatedly recognized that it is inappropriate for a party to weaponize the public right of access to undermine a protective order to which it agreed.

Id. at *3 (emphasis added).  Those are pretty strong words, and “weaponize” is (again) the court’s description, not ours.  The court further emphasized that protective orders are “essential to the efficient functioning of the discovery process” in complex cases and that defendants are entitled to rely on them.  Id.  Thus, while the First Amendment right of access to judicial records is vital and important, it is not unlimited; and it must be balanced against the confidentiality granted by protective orders upon which parties in litigation rely. 

What follows is an exacting, document-by-document analysis of the materials at issue—governmental documents, analysis of foreign registries, internal audits and analyses, employee information, strategy documents, and training materials.  All but a few of the documents were exhibits to dispositive motion papers or were exhibits at trial.  The court made clear that, having already sealed the documents, in would consider “limited unsealing . . . focusing on instances where the balance of interests in sealing has significantly changed since the seal was imposed.”  Id. at *5.  In this regard, the key “change” was that the court cited portions of certain exhibits in its rulings, and “the public interest in access is naturally heightened for sections of a sealed documents that the court cited.”  Id. 

Why is this important?  Recall that many documents were unnecessarily filed under seal in their complete form, containing “extensive information not relevant to the proposition for which they were submitted.”  Id.  The result is that the court was judicious in ordering information unsealed.  The parties agreed that certain documents could be unsealed, and the court made it so.  Where the plaintiffs themselves filed documents under seal, the court took the plaintiffs’ request to unseal those same documents with a large grain of salt.  Sensitive business information and trade secrets stayed under seal; and even when unsealing documents, the court ordered sensitive information to be redacted.  The court, however, rejected redaction as a solution where it would create unnecessary work for the parties with little benefit to the public.  Under those circumstances, documents remained sealed.  E.g., id. *7. 

Some documents contained proprietary information acquired from third parties under separate confidentiality agreements.  The court noted multiple times that it was not bound by these third-party agreements.  “Nevertheless, the fact that documents contain a third party’s proprietary information weighs in favor of sealing.”  Id.  In the end, the court clearly valued most highly whether the information the plaintiffs wanted in the public record was “relevant.”  If the court did not rely on the information in making its rulings, the information remained under seal.  The court was clearly irritated with the overabundance of irrelevant “Confidential” information in the record, and its order keeping those documents under seal reflects the court’s conclusion that the public has little interest in access to judicial records that never should have been filed in the first place.  By the way, we check the docket from our early 2000s MDL where we filed everything under seal.  Those documents are still sealed. 

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On March 18, 2024, the Supreme Court heard argument in a matter, National Rifle Association of America v. Vullo, No. 22-842, that from its caption would seem to have nothing to do with our sandbox.

But it might.

One of the issues before the Supreme Court in NRA is whether administrative action, labeled only as “guidance” (in NRA, certain letters issued by the head of the New York State banking agency) were sufficiently coercive – despite not being presented as anything “final” – that they could unconstitutionally restrict speech in violation of the First Amendment.  Appellant NRA, represented by the American Civil Liberties Union (among others), contends that the defendant “issued formal guidance letters” that “promised enforcement leniency” and  “urged” the banks it regulated to cease doing business with the NRA for political reasons.  Petitioner’s Br., at 1.  Even though this “guidance” neither had nor claimed to have force of law, it had the desired effect – causing regulated entities to do what the government wanted for “fear of losing our license to do business.”  Id. at 8 (citation and quotation marks omitted).

To us, the analogy is obvious. The FDA also relies heavily on “guidance” that it likewise considers non-“final,” and has similarly done so in ways that impinge on First Amendment-protected speech.

Continue Reading Could the Supreme Court Blindside the FDA on the First Amendment?
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Today’s guest post is by Amy McVeigh and Jessica Farmer, who are partners at Holland & Knight. They comment on the demise of another purported class action against a manufacturer of hydrogen peroxide, which is an FDA-regulated over-the-counter (“OTC”) drug. As always our guest posters deserve 100% of the credit (and any blame) for for their work.

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Today’s post dives into the fizz of legal battles over the adequacy of labeling of over-the-counter (“OTC”) hydrogen peroxide.  You might think hydrogen peroxide is just a humble brown bottle in your medicine cabinet, revered for its old-timey wound-cleaning prowess and its uncanny ability to bleach your hair in moments of teenage rebellion.  But what’s really behind that label on your bottle of H2O2? And is it misleading to say that it can be used to “treat” minor cuts and abrasions?

The Western District of Michigan said “No” to the latter question in the latest OTC preemption decision involving a hydrogen peroxide product, Bridges v. Meijer, Inc.,2024 WL 1007883, at *3 (W.D. Mich. Feb. 20, 2024), report and recommendation adopted sub nom. Lashan Bridges, Plaintiff, v. Meijer, Inc., Defendant, No. 1:22-CV-1112, 2024 WL 1141865 (W.D. Mich. Mar. 15, 2024).  Frequent readers may recall a prior post focusing on a similar decision out of the Northern District of Illinois, Novotney v. Walgreen Co., — F. Supp. 3d —, 2023 WL 4698149 (N.D. Ill. July 20, 2023).  This latest casebuilds on Novotney and also gets it right.

Hydrogen peroxide has long been sold over-the-counter as a first aid antiseptic.  Like other OTC products, the FDA regulates hydrogen peroxide products through a monograph process.  A “monograph” is a detailed regulation describing the conditions under which a class of drugs can be marketed without a prescription.  See 21 C.F.R. § 330.1; Nat. Res. Def. Council, Inc. v. U.S. Food & Drug Admin., 710 F.3d 71, 75 (2d Cir. 2013) (describing monograph process).  It is like a “recipe” for that particular product which, among other things, sets out labeling requirements.  NRDC, 710 F.3d at 75.

In Bridges, the plaintiff asserted a number of state-law claims claiming that Meijer’s private-label hydrogen peroxide solution was “misbranded” because it was promoted “For Treatment of Minor Cuts and Abrasions.”  Like other recent hydrogen peroxide cases, plaintiff argued that the word “treatment” on the label was misleading because the word “treat” means to “heal” or “cure” and hydrogen peroxide could not, actually, heal or cure cuts or abrasions.  She alleged that she paid a premium for the product—of at least $1.29—based on her understanding of the word “treat” and sought to certify economic loss classes of Illinois, Michigan, Ohio, Indiana, Kentucky, and Wisconsin residents.

Of course, Blog devotees and preemption enthusiasts know that with respect to OTC products, Congress prohibited the states from establishing “any requirement … that is different from or in addition to, or that is otherwise not identical with, a requirement” imposed under federal law.  21. U.S.C. § 379r(a)(2).  Plaintiff argued that her state law claims were not preempted by this provision because the FDA never endorsed the labeling of hydrogen peroxide for “treatment” purposes and because “hydrogen peroxide does not treat minor cuts and abrasions because no evidence supports a connection between the number of bacteria and reduction in healing time of a clean wound.”  But as Defendants pointed out, the FDA itself used the word “treat” more than 50 times in the monograph, and used it to mean “give medical care to” or “apply topically.”  See Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for First Aid Antiseptic Drug Products, 56 Fed. Reg. 33651; 33655, 1991 WL 303853 (Jul. 22, 1991).

Ultimately, relying heavily on Novotney’s reasoning, the Court held that the product’s labeling complied with FDA standards, citing Novotney’s conclusion that “by claiming that some other terminology is necessary to ensure that the label is not misleading, plaintiff impermissibly claims that state law imposes requirements that are different from, additional to, or otherwise not identical with, the requirements of the FDCA. 2024 WL 1007883 at *3 (citing Novotney v. Walgreen Co., No. 22 C 3439, 2023 WL 4698149, — F. Supp. 3d — (N.D. Ill. July 23, 2023)).  The Court therefore dismissed all of plaintiff’s state law claims as expressly preempted under 379(r).

Having dispensed with the state law claims, the Court next turned to the lone claim brought under federal law:  violation of the Magnusson-Moss Warranty Act (“MMWA”).  To state an MMWA claim, however, a plaintiff needs a viable, underlying state law breach of warranty claim.  The Court rightly held—like others before it—that when the underlying breach of warranty claims under state law are preempted, the MMWA claim must also be dismissed, stating “plaintiff’s MMWA claim fails because she has no state law warranty claim with respect to the Product or its label as a “treatment;” any such state law claim is preempted by federal law.”  2024 WL 1007883 at *3; see also In re Zantac (Ranitidine) Prod. Liab. Litig., 510 F. Supp. 3d 1141, 1172, (S.D. Fla. 2020).

In sum, it is not misleading to say that hydrogen peroxide can be used for treatment of minor cuts and abrasions.  But the eternal question remains for another day: “who is responsible for my hair turning orange?”

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McMillian v. Sanofi-Aventis U.S. LLC, 2024 U.S. Dist. LEXIS 44783 (March 13, 2024), is another example where a court shot down a belated, post-remand attempt by a Taxotere plaintiff to change the allegations of her complaint. You might think that we will mimic some of our earlier posts about remand courts fixing a mess created by a Multidistrict Litigation (MDL) court.  Not so. In this instance, both the MDL and remand courts clamped down on MDL plaintiff mischief. What sort of mischief?  Filing slapdash short-form complaints, parking frail cases for years, then waking up, realizing the case is rickety, and insisting on a last-minute (or past deadline) makeover of the case.

First, some general background.  Thousands of plaintiffs alleged that Taxotere, a chemotherapy drug, caused them to suffer permanent hair loss. The cases were collected in a MDL in the Eastern District of Louisiana.  

Next, our camera focuses on the individual plaintiff, McMillian, who filed her complaint in the MDL in September 2017, using the standard Amended Short Form Complaint (SFC) then in effect in the MDL.  The SFC incorporated by reference the Amended Master Long Form Complaint and Jury Demand that had been filed in the MDL.

If you are confused or annoyed by this MDL terpsichore, join the club. (The American College of Embittered Defense Hacks?)

The plaintiff’s SFC listed ten counts of liability.  Eight were from the master complaint, and two came from California law.  The defendants filed their master answer (wait a minute – isn’t all this “master” lingo now forbidden?).  Then the MDL plaintiffs filed a Second Amended Master (d’oh!) Complaint, which was identical to the prior master complaint, except for adding two more plaintiffs.  

So far, this is all scene-setting.  Now we get to what the screenwriters call the inciting event.

In October, the MDL plaintiffs sought leave to amend the master complaint again, this time seeking “to no longer define their injury as manifesting six months after chemotherapy” as the prior master complaint alleged.  

We would have denied this request because it deployed a split infinitive.  

The MDL court denied it for a better, substantive reason: “the parties and the Court had been operating under Plaintiffs’ original definition of their alleged injury for years.”  The MDL court conducted an analysis under Fed. R. Civ. P. 15(a)(2) and concluded that the amendment would be “inappropriate at this time” because the amendment “would negate a significant amount of the work that has been done in this MDL. Defendants would undoubtedly want to revise certain expert reports and conduct supplemental depositions, and certain rulings from the Court would be mooted.”

Nicely done.  Did the plaintiffs take this setback with grace and stoicism?  They did not. There followed an “influx” of motions by individual plaintiffs to amend their short form complaints.  The MDL court denied these motions, reasoning that the amendments would prejudice the defendants, who would “need to conduct additional discovery and prepare a different statute of limitations defense.”  The MDL court also issued a Pretrial Order making clear what sorts of amendments were permissible and what sorts were not.  The Pretrial Order also set a deadline for filing such amendments.  The deadline passed, and the plaintiff in McMillian did not file an amendment in the MDL court.

More than two years after the amendment deadline passed, the MDL court remanded Wave 2 cases, including the McMillian case.  The remand order stated that the time for any pleading amendments had long since passed.  

Nonetheless, the McMillian plaintiff sought an amendment in the remand court.  The new complaint included two claims for failure to warn: negligence and strict liability.  But the real problem was that the amendment was totally at variance with the MDL master complaint.  Of course, the “six-month” definition of injury in the MDL complaint that resulted in many statute of limitations dismissals is one of the things the plaintiff sought to change. 

Many Taxotere plaintiffs have tried similar gamesmanship, none have succeeded, and neither did this plaintiff. (We have written before about Taxotere plaintiffs’ attempts to amend the definition of injury so as to escape the statute of limitations.)  The McMillian court observed that the plaintiff had “not pointed to a single case in which a Taxotere plaintiff has been granted leave to amend a complaint in a similar matter after remand from the MDL.”  The plaintiff did direct the court to certain similar motions filed by other plaintiffs, but “neglected to mention in her statement that that one of those motions had already been denied.”  Oops.  And by the time of the McMillian court’s decision, the other, similar motions to amend had also been denied.  Double oops.  Or maybe triple oops. 

The McMillian court believed that what the plaintiff was trying to do was “less a motion to amend the complaint than it is a Motion for the Court to reconsider prior rulings in the MDL.”  Remand courts are not completely without power to revisit MDL rulings, but that is the exception rather than the rule.  Willy-nilly deviations from MDL rulings would offend comity and law of the case considerations, and “would frustrate the purposes of centralized pretrial proceedings.”  More specifically he point here, the McMillian court observed that the MDL court’s rejection of similar amendments “to remove the six-month injury definition, and that Ms. McMillian did not avail herself of the MDL court’s process for amending to allege plaintiff-specific facts (see PTO 105) weighs heavily against the granting of the plaintiff’s present motion.”  

Just like the MDL court, the remand court in McMillian applied Rule 15 regarding amendments (and also Rule 16 as to whether there was “good cause” to amend scheduling orders), and decided that a post-remand amendment “would prejudice defendants, …  undo years of litigation and discovery efforts, necessitate the reopening of discovery, and create further delay.”  

The McMillian court was also displeased with what it perceived as the plaintiff’s “lack of candor” in characterizing the MDL court as putting a “proverbial pin” on the possibility of amendment.  No, the MDL court had “expressly denied, multiple times, attempts by plaintiffs to amend allegations in precisely the way plaintiff seeks here.”  The plaintiff in McMillian was attempting an “end-run around the the MDL court’s rulings.”

The McMillian court did something that we pretty much never saw the Philadelphia Eagles defense do last season: tackled the end-run for a loss.  

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Sometimes there’s a little something for everyone.  Today’s case has personal jurisdiction, corporate veil piercing, PMA preemption, statute of limitations, and learned intermediary.  Not every decision on these issues goes the way we think it should, and perhaps the thorns outnumber the roses, but it caught our attention nonetheless.

The case is Franks v. Coopersurgical, Inc., 2024 WL 1109055 (D.R.I. Mar. 14, 2024).  It involves allegations against the manufacturer and distributor of surgical clips used in tubal ligation surgery—Class III Pre-Market Approved (“PMA”) medical devices.  Plaintiff had surgery in 2014 in which the clips were used.  Shortly thereafter she began experiencing several adverse symptoms, including pain.  In 2021, a CT scan revealed the clips had migrated.  Id. at *1-2.  Plaintiff’s primary allegation is that the clips have a migration rate higher than what was reported to the FDA. 

The first issue the court tackled were personal jurisdiction challenges.  The manufacturer argued that it did not purposefully avail itself of the privilege of conducting business in Rhode Island because it manufactured a global product that it delivered to distributors who were responsible for marketing and selling the clips in the United States.  And while the court agreed that placing a product into the stream of commerce is not enough to be “purposeful availment,” the manufacturer here did more.  The court found all of the following persuasive:  over 3000 clips had been sold in Rhode Island, the manufacturer was responsible for ensuring FDA compliance; the manufacturer was obligated to provide marketing materials and samples to the distributor and retained the right to “have its hand in” how the device was marketed in the United States; and the manufacturer was responsible for tracking distribution within the United States.  Id. at *5.  All of that added up to “something more” making the court’s exercise of jurisdiction “voluntary and foreseeable.”  Id. at *6.

Two affiliated companies, however, were dismissed for lack of personal jurisdiction.  First, at least one of the companies did not become involved with the product until well after plaintiff’s surgery.  Therefore, plaintiff’s claims could not possible “arise out of or relate to” that defendant’s contacts with Rhode Island.  Id. at *7.   So, plaintiff tried to argue that the affiliates were “alter egos” of the manufacturer and distributor.  However, a “blurred” line of separation between two companies or crossover by means of shared officers and employees is not enough to pierce the corporate veil.  Plaintiff was missing any “indicia of fraud, wrongdoing, domination, misuse, or subversion of corporate formalities.  Id. at *9. 

The court then turned to the motion to dismiss plaintiff’s claims as preempted under the Riegel two-part test.  Since the clips are PMA, the first prong is met—PMA devices have specific FDA requirements.  So, the court moved onto to prong two which it summed up as “whether the plaintiff’s allegations, if true, would impose liability on a manufacturer defendant even though it complied with the FDA requirements.”  Id. at *13.  The court answered that question affirmatively for plaintiff’s design defect and manufacturing defect claims.  Plaintiff did not allege that the design of the clips deviated from the FDA approved design.  Nor did plaintiff allege that the clips were manufactured in a way not approved by the FDA.  So, both claims were expressly preempted.  Id. at *13-14.

On failure to warn, this case simply compounds an error made by In re Allergan Biocell Textured Breast Implant Products Liability Litigation, 537 F. Supp.3d 679 (D.N.J. 2021) (“TBI”).  TBI was the first nationwide (or close to it) analysis of whether a given jurisdiction permitted, under state law, a “warning”-based cause of action against a manufacturer of an FDA-regulated prescription drug or medical device for allegedly failing to report adverse events to the FDA.  See id. at 729-34.  TBI  listed Rhode Island as a state that allowed FDCA-based failure-to-report claims, id. at 731, based on a pre-Riegel decision, Hodges v. Brannon, 707 A.2d 1225, 1228 (R.I. 1998).  Hodges doesn’t stand for that at all, since the case had nothing to do with failure to report.  Hodges was about the evidentiary use of actual adverse event reports for “notice” – not failure to report.  Moreover, the defense prevailed in Hodges:

The plaintiffs next argue that the trial justice erred in restricting the jury’s use of the evidence it introduced concerning certain government reports filed by [defendant] that detailed patients’ negative experiences after taking [the drug].  [Defendant] had submitted these reports to the FDA, but the trial justice limited their evidentiary use to the duty-to-warn and notice issues. . . .  We do not believe that the trial justice abused her discretion in so ruling.  The trial justice was entitled to conclude that the various patients mentioned in these reports were not necessarily similarly situated to each other or to [the decedent].

Id. at 1228 (emphasis added).  Hodges simply doesn’t stand for the proposition for which TBI cited it.  However, without any independent analysis, Franks follows it.  2024 WL 1109055, at *14-15.  Having made up a new state-law duty, the court found no express or implied preemption of plaintiff’s failure to warn/failure to report claims – both strict liability and negligence.  Id. at *15-16. 

The court also disagreed with defendants’ argument that plaintiff’s claims should be time barred because she alleges that she began experiencing symptoms soon after her surgery in 2014 and therefore, she should have discovered her injury before the statute of limitations ran in 2017.  Plaintiff countered that she and her doctors took many steps to try to identify the source of her symptoms, but that defendants’ failure to report the higher migration rates prevented them from exploring that as a cause.  The court agreed with plaintiff.  Id. at *17.

The last issue to be decided was whether plaintiff’s claims were barred by the learned intermediary doctrine.  The good news here is that the court predicted that even though the Rhode Island Supreme Court has not decided the issues, because Rhode Island’s product liability law is based on the Second and Third Restatement of Torts, the state would adopt the learned intermediary rule.  Id.  However, relying again on her allegation of a failure to report to the FDA, plaintiff argued that her physician was not adequately warned about the migration rate.  At the pleadings stage, that was enough for her claim to survive.  Id.

So, Franks has a couple of blooms, but you’ll get a little bloodied plucking them out. 

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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”).

Continue Reading Another Weird Alabama Decision
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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. 

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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. 

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