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Just a few months ago we blogged about cloned discovery pointing out that in a world of already asymmetrical discovery burdens on defendants, allowing plaintiffs to magnify that discrepancy by forcing defendants to reproduce discovery from prior cases is an abusive process.  We stand by that position and are happy to add to the list of cases denying cloned discovery requests.  But it also got us thinking about cloning.  Not real-life therapeutic cloning that is amazing science and medicine, but the cloning you see in movies.  The stuff of science fiction.    We were hard pressed to come up with an example where the cloning didn’t go horribly wrong.  There are comedies like Multiplicity (where Michael Keaton’s clones get “weirder” with each version) and The Santa Clause 2 (where Tim Allen’s Santa clones threaten to ruin Christmas).  There are dramas aimed to explore the moral and ethical implications of cloning such as The 6th Day, or Godsend where Greg Kinnear and Rebecca Romijn are offered a chance to clone their deceased son.  Some movies address the “why” of clones such as The Island where humans are cloned for their organs or Star Wars:  Episode II – Attack of the Clones where clones are needed to quickly build an army (this one doesn’t exactly support our premise that cloning doesn’t work, but had to include it — clones is in the title).  And last but certainly not least, Jurassic Park clearly demonstrated the downside to cloning dinosaurs.

Following on that theme of no good can come of cloning, we bring you Matosich v. Wright Med. Group, 2020 U.S. Dist. 81001 (D. Mon. May 7, 2020) in which the judge agreed with us.  Plaintiff brought a suit alleging he suffered injuries from his hip implant when it broke.  Id. at *1.  Nearing the end of discovery, plaintiff filed a motion to compel asking the court to force defendant to produce, among other things, cloned or “piggyback” discovery.  The specific request at issue asked defendant to produce ten categories of documents from any prior case filed against the defendant related to the fracture of a device similar to that implanted in plaintiff.  Id. at *7-8.  The categories included complaints, answers, defense and plaintiff expert reports, and depositions/videos of plaintiffs, plaintiffs’ experts, defendant’s experts, and company witnesses.  Id.  The fact that plaintiff was seeking all of this near the end of the discovery period just further emphasizes the problem with allowing cloned discovery.  Plaintiff apparently sat back and did very little discovery of his own opting instead to just gather all the work that was done in other cases.  To borrow from chaos theorist Ian Malcolm (Jeff Goldblum):  “the problem with the [cloning] that you’re using here — it didn’t require any discipline to attain it. You read what others had done and you took the next step. You didn’t earn the knowledge for yourselves, so you don’t take any responsibility for it.”  Unlike the “blood sucking lawyer” who was taking John Hammond’s side and eventually became t-rex dinner, we agree with Malcolm.  Defendants shouldn’t have to do plaintiffs’ work for them by just throwing open the doors to everything that came before.  Discovery should be tailored to the facts and needs of the case and that requires some intellectual rigor on the part of plaintiff’s counsel to get there.

In Matosich, defendant estimated that plaintiff’s request for cloned discovery implicated its files in approximately 300 other cases.  Id. at *10.  That’s 300 different cases involving 300 plaintiffs whose personal information would have to be redacted to preserve confidentiality and privacy if it had to be produced.  Redactions are time consuming and labor intensive.  And, are a waste of time where “[m]ost of the information sought is not reasonably likely to aid in resolution of this case on its merits.”  Id.  Defendant had already produced its “complaint files” documenting each fracture of which the company was notified.  Id. at *9.  So, the court was

unclear what benefit will arise from litigation documents developed in cases involving other patients, distinguishable law, and potentially different medical devices. Given the volume of other cases in play—which [defendant] estimates at over 300—the Court agrees that any potential benefit is outweighed by the economic and time burdens that [defendant] would surely incur if it were required to produce all responsive complaints, answers, reports, and depositions.

Id. at *10.

Rather than allow the overwhelmingly broad discovery plaintiff sought, the court directed defendant to produce two things.  First, a list of other lawsuits involving a fracture of the same component at issue in this case.  If plaintiff wants any materials in any case, they can pull them themselves.  Second, the reports and depositions of any expert defendant intended to rely on in the current case (with redactions of private health information).   The court concluded these much narrower categories were potentially aimed at discovering impeachment evidence and therefore discoverable.

And, although it has nothing to do with our subject, we’re ending with this blogger’s favorite clip from Jurassic Park.  Enjoy.

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“Remembrance of things past is not necessarily the remembrance of things as they were.” – Proust

The lesson of today’s case, Racies v. Quincy Biosciences, LLC, 2020 WL 2113852 (N.D. Cal. May 4, 2020), is worth remembering. Litigation can turn on recollections, and they can be fragile. (That is undoubtedly why documents end up being so important.) Such fragility can have implications not only in the eyes of the jury, but in the eyes of the judge. For example, poor memory can be a barrier to class certification.

But getting to that point can take a while.

In Racies, the plaintiff filed a consumer class action under under California’s Unfair Competition Law, Cal. Bus. & Prof. Code §§ 17200 et seq. (“UCL”), and Consumers Legal Remedies Act, Cal. Civ. Code §§ 1750 et seq. (“CLRA”) against the manufacturer of a brain health supplement. The plaintiff alleged that the manufacturer falsely boasted that the supplement improved memory and supported brain function and clearer thinking. (Please hold your emails suggesting that we could use a gallon of this stuff.)

The court preliminarily certified a class of all California consumers who purchased the brain supplement. The case went to trial and the result was a hung jury. Both parties then filed motions for judgment as a matter of law. The defendant moved to decertify the class. The court denied the motions for judgment as a matter of law, but granted the defendant’s motion to decertify the class.

Why? It’s been said that one of the keys to happiness is a bad memory. In Racies, the plaintiff’s bad memory certainly delivered much happiness to the defendant.

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‘If you tell the truth, you don’t have to remember anything.” – Mark Twain.

If ever a case demonstrated the fragility of memory, Racies is it. During trial, the plaintiff testified that he purchased the brain supplement because he was “dealing with some memory recall issues” and wanted to purchase a product to help him “with those issues, focus, memory, recall.” The plaintiff testified that he believed the product could help him because of “what it says on the box. It says it targets enhancing memory and improving brain functioning. It — yeah, so it looked like it was targeted right for what I was feeling I needed help with at that time.” In response to a question as to what “specifically” about the product appealed to him, the plaintiff stated:
“That it addresses memory problems. It improves memory, focus, recall. It — it seemed like a — a relatively natural supplement. I remember the jellyfish reference, said clinical studies done on it, I think a blind placebo. I believe I got the impression in a relatively short amount of time I would — I would experience improvement in my memory.”

It obviously did not work.

Amazingly, the plaintiff did not introduce at trial any actual bottle of the product or any actual advertisement. Instead, the plaintiff brought in a drugstore receipt. That led to some fun cross-examination. The defense lawyer asked the plaintiff, “isn’t it the case [that the bottle of the supplement] you purchased did not say ‘Improves Memory’ on the front, but instead, said ‘Brain Cell Protection’? Isn’t that correct?”

Here is the plaintiff’s answer: “I – I couldn’t honestly tell you at this point.”

The label containing the claim of “Brain Cell Protection” makes various representations, but does not say “Improves Memory.” This concatenation of facts is what we folks in the business would call a problem for the not-remembering party.

How to get around this problem? You might think that the gap could be filled via admissions/testimony/documents from the defendant. That out was apparently not available in the Racies case. In fact, the President of the defendant was asked when the company first started selling the product with the “Brain Cell Protection” label or when it stopped using that particular label.

Can you guess what the President’s answer was? Sure you can. He “did not remember.”

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“Right now, I’m having amnesia and de ja vu at the same time. I think I’ve forgotten this before.” – Steven Wright.

The representative plaintiff’s vague and contradictory testimony about whether he ever saw the alleged false statements or whether the health claim at issue was even made to him undermined any basis for class certification. The court, of course, needed to explain why it certified the class pretrial and then decertified after trial. The explanation was not difficult. Pretrial, the plaintiff needed to demonstrate typicality and commonality to secure class certification. But the plaintiff’s pretrial promise of typicality “was not borne out by the evidence at trial.” During class certification, the plaintiff had argued that every package of the brain supplement claimed to improve memory. That turned out not to be true. It appears that there were different labels available on the shelves, and the plaintiff’s “equivocal” testimony underscored that the plaintiff “may not have been exposed to the same representations as the rest of the class.” Farewell, typicality.

Predominance, or absence thereof, was also now in play. The plaintiff’s candid admission that he could not honesty say whether he was exposed to the alleged misrepresentations demonstrated that it could not be presumed that the same material representations were relied upon by all members of the class. Therefore, proof of reliance could not be shown on a common basis, and common questions of fact did not predominate.

It is almost as if the plaintiff during trial did not remember the promises he made during class certification. Once the muddled record came in, the court had no choice but to decertify the class. Kudos to the defendant for continuing the fight against class certification even after the court’s adverse ruling and after trial began. All defense hacks should remember that.

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We’re calling this a “quasi” guest post because the author, Reed Smith‘s Dean Balaes, is actually trying out to join our blogging team.  This is his inaugural post, of what we hope will be many more.  This particular post addresses the causation aspects of a case, Gayle v. Pfizer, Inc., ___ F. Supp.3d ___, 2020 WL 1685313 (S.D.N.Y. April 7, 2020), that we mentioned in yesterday’s preemption post.  As we hope you’ll see shortly, the causation issues in Gayle are also interesting, and favorable to the right side of the “v.”  Without further ado, take it away Dean.

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As is often the case in pharmaceutical product liability actions, another group of plaintiffs’ claims suffered a fatal deficiency:  establishing a causal association between the drug at issue and the alleged injury.  Gayle v. Pfizer, Inc., ___ F. Supp.3d ___, No. 19-CV-3451, 2020 WL 1685313 (S.D.N.Y. April 7, 2020), illustrates this debilitating deficiency when the other side alleged that Lipitor causes Type 2 diabetes by relying on anecdotal adverse event reports.  This blog will provide specific attention and commentary regarding causation fallacies as observed in Gayle, but note that one should also review Gayle for its favorable preemption ruling.

The other side tried to Febreze the air around this malodorous causation reality by relying on 6000 adverse event reports related to an earlier “changes being effected” (“CBE”) labeling change between the defendant manufacturer and the FDA.  The idea was to suggest that the mere existence of adverse event reports related to a drug (without evidence showing a causal association between the drug and the alleged injury) means that the manufacturer knew that the drug categorically caused the disease.  Thus, the Gayle plaintiffs nitpicked the drug’s label change – claiming it only warned about two conditions related to Type 2 diabetes, but should have warned that it causes Type 2 diabetes.

Opposing counsel’s legal gymnastics to hurtle over the fallacy in causation did not work.  According to the FDA, adverse reactions listed in the label are limited to “only those adverse events for which there is some basis to believe there is a causal relationship between the drug and the occurrence of the adverse event.”  21 C.F.R. § 201.57(c)(7).  After initial FDA-approval, a manufacturer can change labels through the CBE regulation to promote the safe use of the drug product only on the basis of “newly acquired information.”  21 C.F.R. § 314.70(c)(6)(iii).  As the blog’s readers know from scores of preemption posts, the FDA narrowly defines “newly acquired information” as:

[D]ata, analyses, or other information not previously submitted to the [FDA], which may include (but is not limited to) data derived from new clinical studies, reports of adverse events, or new analyses of previously submitted data (e.g., meta analyses) if the studies, events, or analyses reveal risks of a different type or greater severity or frequency than previously included in submissions to the FDA. 

21 C.F.R. § 314.3(b) (cited at 2020 WL 1685313, at *3) (emphasis added).  FDA imposes this limit for a reason.  “Over-disclosure dilutes warnings of more significant adverse reactions both by likelihood and severity of the reaction and can unjustifiably deter patients from a helpful drug or therapy.”  Id. at *3.

On a motion to dismiss, there is no weighing of evidence yet to prove causation, so Gayle highlights a well- (or at least over-) used plaintiffs’ strategy just to plead some purported evidence – here adverse event reports – and allege that such reports mean that the defendant knew that Lipitor causes Type 2 diabetes.  It is like Senator Hendrickson in the 1954 comic book hearings alleging that reading comic books causes juvenile delinquency.  With no actual evidence proving causality, plaintiffs rely on anecdotal, one-sided, and unverified hearsay (see the blog’s cheat sheet here) such as adverse event reports.  Throw mud against the wall and hope something sticks − either plaintiffs do not have a firm grasp of logical causation, or (more likely) they are hoping judges do not, when all they plead is that there are adverse event reports making the same allegations.

Thus, these plaintiffs erroneously alleged that the 6,000 adverse event reports constituted “newly acquired information.”  Gayle, 2020 WL 1685313, at * 5.  TwIqbal prevailed again, as plaintiffs’ claims were dismissed with prejudice and either barred by the state’s statute of limitations or preempted by federal law (see the blog’s preemption cheat sheet here).  Whether it was one, or 6000, the pleading of adverse event reports were simply vague causation assertions that did not amount to a plausible claim.  See Id. at *5.  As the blog has already discussed, an entire MDL raising the same purported injury against the same drug was dismissed a few years ago for – guess what – failure to establish causation.  Indeed, one would not be at all surprised if the purported 6000 adverse event reports include thousands of plaintiffs from that previous MDL whose claims have already been conclusively adjudicated non-causal.

The fundamentally flawed presumption in the plaintiffs’ causation reasoning is simple:  a phenomenon cannot be proven to occur on the basis of anecdotal adverse event reports.  It is like the child who believes that the song of birds makes the morning happen or the Monte Carlo Fallacy, which makes gamblers believe that a winning streak increases the chances of future winnings.  Alas for plaintiffs, coincidence is not causation.  These plaintiffs’ reliance on adverse event reports did not constitute “newly acquired information” because the reports merely described instances “where patients taking [the drug] were diagnosed with type 2 diabetes, but do not reach any conclusions regarding a causal association.”  Id. at * 6.  Thus, “under a plain reading of the regulations, adverse event reports, without any analysis indicating causality, cannot constitute ‘newly acquired information.’”  Id.

Gayle is worth the read because it is yet one more case (and this is yet one more post) reminding plaintiffs that the mere presence of anecdotal adverse event reports does not necessitate a causal connection based on coincidental relationships. Thankfully, Gayle also shows that judges do understand the fallacies of logical causation.

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We’ve noticed quite a few prescription drug preemption decisions lately involving “newly acquired information.”  That’s because the Supreme Court doubled down in Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (U.S. 2019), on the boundary of impossibility preemption being set by a defendant’s ability to utilize the FDA’s “changes being effected” regulation, 21 C.F.R. §314.70(c)(6)(iii)(A), to make certain label changes unilaterally. 139 S. Ct. at 1673.  If a defendant can’t make a CBE change, then it has to get FDA pre-approval for that change, so a state-law claim for not based on not changing the label is preempted under the Mensing independence principle.  You can find all these cases on our post-Levine prescription drug preemption cheat sheet.

While we question the wisdom of having something as important as preemption turn on the complexities of an FDA regulation not intended for that purpose, Albrecht is what it is.  Thus, we’ve been parsing the CBE regulation closely, looking at the prerequisites for its application.  Chief among them is a requirement that a manufacturer possess “newly acquired information” concerning a “clinically significant adverse reaction.”  See 21 C.F.R. §201.57(c)(6)(i) (defining “newly acquired information” for purposes of CBE regulation as concerning an adverse reaction that is either “potentially fatal,” “serious even if infrequent,” or can “be prevented or mitigated through appropriate use of the drug”).  These definitions give our side quite a bit to work with.

Albrecht was decided a little less than a year ago.  Post-Albrecht precedent can’t tell us definitively what “newly acquired information” is, but we can identify with some confidence four things that are not enough.

First, because the information in question must be “new,” when “the undisputed evidence shows that the FDA was aware of the nature of the data it received from” the manufacturer, that data isn’t “new,” even when it is later regurgitated in another article.  Dolin v. GlaxoSmithKline LLC, 901 F.3d 803, 815 (7th Cir. 2018) (blogged about here).  In CBE-land, plagiarism cannot preclude preemption.  “[A]ny claim that a drug label should be changed based solely on information previously submitted to the FDA is preempted because the CBE regulation cannot be used to make a label change based on such information.”  In re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices & Product Liability Litigation, 185 F. Supp.3d 761, 769 (D.S.C. 2016).  “New” information must “reveal[] risks of a different type or greater severity or frequency than previously included in submissions to the FDA.”  Gibbons v. Bristol-Myers Squibb Co., 919 F.3d 699, 708 (2d Cir. 2019) (quoting 21 C.F.R. §314.3(b)) (blogged about here).

Thus, the plaintiffs in Ridings v. Maurice, ___ F. Supp.3d ___, 2020 WL 1264178 (W.D. Mo. March 16, 2020) (blogged about here), could not avoid preemption where “[b]y and large, nearly all of the ‘newly acquired information’” they relied upon “still relies upon . . . and reflects information – for all intents and purposes – that was provided to the FDA at the time of the initial approval of [the drug] for the American market.”  Id. at *15.  Information that was in essence “previously submitted to the [FDA]” or that “contained the same figures as [defendant’s pre-approval] analysis, which [was] submitted to the FDA” doesn’t become shiny and new again simply because somebody discusses it again later on.  Roberto v. Boehringer Ingelheim Pharmaceuticals, Inc., 2019 WL 5068452, *18 (Conn. Super. Sept. 11, 2019) (blogged about here).  Accord Adkins v. Boehringer Ingelheim Pharmaceuticals, Inc., 2020 WL 1890681, at *10 (Conn. Super. March 13, 2020) (reaching same conclusion as Roberto) (blogged about here).

Second, data cannot be “new” when that data did not exist until after a particular plaintiff’s use of the drug was over. “[N]ewly acquired information must have been available to [defendant] after the FDA approved the relevant label on . . ., but before Plaintiff last used [the product].”  Mahnke v. Bayer Corp., 2020 WL 2048622, at *3 (C.D. Cal. March 10, 2020).  “The Court will disregard the many articles cited in the Amended Complaint that were published after [plaintiff’s] last [use of the product].  These studies can have no bearing on her failure-to-warn claim.”  Sabol v. Bayer Healthcare Pharmaceuticals, Inc., ___ F. Supp.3d ___, 2020 WL 705170, at *12 n.13 (S.D.N.Y. Feb. 12, 2020) (blogged about here).

[T[he complaint does not cite any newly acquired information that arose after the FDA’s approval of [the product’s] revised label . . . and before Plaintiff was administered [the product. . . .  Without factual allegations that [defendant] had new information in this time period such that it could have or should have amended the label pursuant to the CBE regulation, the complaint is barred as preempted.

Goodell v. Bayer Healthcare Pharmaceuticals, Inc., 2019 WL 4771136, at *4 (D. Mass. Sept. 30, 2019) (blogged about here).

In Ridings, the plaintiff used the drug at issue between early 2012 and mid-2013.  2020 WL 1264178, at *5, 11.  “[S]tudies published after a plaintiff’s injury [are not] relevant to constitute newly acquired information.”  Id. (quoting Roberto, 2019 WL 5068452, at *14).  “Based on [that] reasoning,” Ridings determined that post-use materials could not “constitute even prima facie ‘newly acquired information’” and did not consider that material further.  Id. at *16.  Accord McGrath v. Bayer HealthCare Pharmaceuticals, Inc., 393 F. Supp.3d 161, 170 (E.D.N.Y. 2019) (“this study . . . was published after Plaintiff’s exposure to [the product] and thus cannot support a failure-to-warn claim based on what [defendant] knew or should have known”).

Third, “[c]linically significant” risks must be “‘potentially fatal’ or ‘serious,’ [or have] a ‘significant impact on therapeutic decision-making.’”  Klein v. Bayer Healthcare Pharmaceuticals, Inc., 2019 WL 3945652, at *5 (D. Nev. Aug. 21, 2019) (quoting 71 Fed. Reg. 3922, 3946 (FDA Jan. 24, 2006)) (blogged about here).  Thus, post-Albrecht case law also rejects inconclusive studies as “newly acquired information.”

[S]tudies concluding that it “remains unknown” whether a drug is linked to a particular adverse reaction or risk or that “further studies are required to address possible clinical consequences” do not constitute reasonable or well-grounded scientific evidence of “clinically significant adverse effects” under the CBE regulation.

Ridings, 2020 WL 1264178, at *15.

McGrath likewise held that “[r]eports and studies that . . . do not reach any conclusions regarding the adverse effects or risks” of a product cannot be “newly acquired information” that could support a going ahead with a CBE warning change.  393 F. Supp.3d at 169 (emphasis original).  “[I]t helps precious little to mount scientific minutiae on top of technical jargon if that information ultimately does not plead a plausible causal association between [the product] and adverse effects.”  Id.  See Sabol, 2020 WL 705170, at *13 (“a tentative, at best, suggestion of a causal relationship” cannot “support[] the inference” of “a clinically significant adverse reaction that would require a manufacturer to change its label”); Adkins, 2020 WL 1704646, at *13 (article’s “rather tentative statement . . . and its conclusion that its proposal . . . ‘lends itself to further clinical trials’ do not establish newly acquired information”).In sum, the “new information” at issue must make out a “a reasonable, if not compelling, causal association” so that the risk at issue “become[s] apparent” as specified by Albrecht.  McGrath, 393 F. Supp.3d at 170-71 (quoting Albrecht, 138 S. Ct. at 1677) (emphasis original).

Fourth, unanalyzed adverse event reports are sufficiently low on the hierarchy of scientific evidence that they “do[] not necessarily reflect a conclusion . . . that the drug caused or contributed to an adverse effect.”  Gayle v. Pfizer Inc., ___ F. Supp.3d ___, 2020 WL 1685313, at *5 (S.D.N.Y. April 7, 2020) (quoting 21 C.F.R. §314.80(l)).

[A]dverse event reports do not constitute “newly acquired information.”  In order to qualify as “newly acquired information,” the information must demonstrate “reasonable evidence of a causal association with a drug.”  But “[t]he fact that a user of a drug has suffered an adverse event, standing alone, does not mean that the drug caused that event.”  The reports describe instances where patients taking [the drug] were diagnosed with [a condition] but do not reach any conclusions regarding a causal association.  Under a plain reading of the regulations, adverse event reports, without any analysis indicating causality, cannot constitute “newly acquired information.”

Id. (quoting Matrixx Initiatives, Inc. v. Siracusano, 563 U.S. 27, 44 (2011), other citations omitted).  Raw AERs “miss[] the mark,” where plaintiffs “offer no analysis” and “merely proffer the adverse event reports by themselves.”  Id.  Voluntarily collected AERs are such weak evidence that “sheer numbers of case reports . . . reveal little about how frequently the events occur in the broader patient population.”  Utts v. Bristol-Myers Squibb Co., 251 F. Supp.3d 644, 664 (S.D.N.Y. 2017) (blogged about here), aff’d, 919 F.3d 699 (2d Cir. 2019).  Even “[r]eports and studies that discuss” adverse events are not “newly acquired information.”  McGrath, 393 F. Supp.3d at 169.

We’ve said it before, and we’ll say it again – many (probably most) allegations of causation that we get from the other side are based on pseudoscientific garbage.  With Albrecht mandating that courts, not juries, decide preemption questions, plaintiffs are no longer entitled to the benefit of the doubt, because courts now have to decide “material” factual disputes in the preemption context.  A judge who “simply ask[s] himself or herself whether the relevant federal and state laws irreconcilably conflict,” 139 S. Ct. at 1679, is much more likely to see the garbage for what it is, and to do the right thing.

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The Third Circuit issued a gem of an opinion on class certification last month, and we like it because it puts a laser focus on what a plaintiff has to prove to get a class certified and the district court’s duty to examine and resolve disputes at the class certification stage.  In In re Lamictal Direct Purchaser Antitrust Litigation, No. 19-1655, 2020 WL 1933260 (3d. Cir. Apr. 22, 2020), the Third Circuit reaffirmed the very sound rule that a plaintiff bears the burden of proving the requirements of Rule 23 by a preponderance of the evidence and that the court must resolve all disputes—legal or factual—relevant to class certification, even if they overlap with the merits.

It’s an antitrust case, which is not our usual cup of tea, but it involves prescription drugs and, again, is very useful on class certification.  In Lamictal, the innovator manufacturer of an anti-epilepsy drug had a dispute with a generic manufacturer who attempted to enter the market before the innovator’s patent expired.  Id. at *1-*2.  To make a long story short, the parties compromised:  They settled with an agreement that allowed the generic manufacturer to start selling its product later than it wanted, but before it would have been allowed had the innovator won in litigation.  Id. at *2.  In addition the innovator manufacturer agreed that it would not launch its own authorized generic product to compete.  Id.

Hence, the antitrust dispute.  Companies that purchased the products filed a class action alleging that the lack of competition caused them to pay too much.  Id.  As the theory goes, had the innovator not “paid” the generic manufacturer to wait and had the innovator not agreed to refrain from launching its own authorized generic, the purchasers would have paid less for the medicine.  Id.

It’s a nice theory, but the truth is considerably more complex.  The price that purchasers actually paid depended on multiple factors, and the purchasers actually paid dramatically different prices when taking into account such variables as discounts and charge-backs.  Particularly relevant was the innovator’s strategy to compete directly against the generic manufacturer by contracting directly with certain pharmacies to offer significant discounts.  Still further, the generic manufacturer learned about the innovator’s “contracting strategy” before it was implemented and preemptively lowered its own drug prices to compete.  Id. at *3.  These market pressures yielded differences in price from purchaser to purchaser, and some purchasers never paid more for the products then they would have but for the manufacturers’ settlement agreement.  Id. at *6.

You can start to see the class certification arguments forming.  The plaintiffs moved to certify a class and predictably relied on expert opinion that brushed over the complexity of drug pricing and instead relied on “an average hypothetical price” based on economic literature and sales data.  Id. at *5 (emphasis in original).  By using an average, the expert purported to conclude that the entire class suffered a competitive injury.  Id.  The manufacturers countered with an expert of their own, who opined that it was not possible, absent individualized inquiry, to determine whether any particular purchaser actually paid a higher price than it would have paid absent the settlement.  Id. at *6.  According to the defendants’ expert, the purchasers’ expert wrongly relied on averages and general information, instead of pricing information specific to the product.  Id.

The district court certified the class, but in doing so, it made no attempt to analyze whether it was appropriate to use averages.  That was error.  The Third Circuit laid out the standard in a clear and useful way:

To determine whether the putative class has satisfied predominance (indeed, all applicable Rule 23 requirements), the District Court must conduct a “rigorous analysis” of the evidence and arguments presented. . . .  That involves three key aspects. First, the court must “find[ ]” that the requirements of Rule 23 are met and any “[f]actual determinations supporting Rule 23 findings must be made by a preponderance of the evidence.”  . . . Second, “the court must resolve all factual or legal disputes relevant to class certification, even if they overlap with the merits.” . . .  Third, the court must consider “all relevant evidence and arguments,” including “expert testimony, whether offered by a party seeking class certification or by a party opposing it.” . . .

Id. at *4 (citations omitted).  If after undertaking this “rigorous analysis” the court is convinced, by a preponderance of the evidence, that the plaintiff’s claims are capable of common proof, then the plaintiff has met its burden of proving predominance.  Id.

In setting forth this rule, the Third Circuit followed its own precedent in In re Hydrogen Peroxide Antitrust Litigation, 552 F.3d 305 (3d Cir. 2009), on which we blogged way back in the day here.  At the same time, the Third Circuit rejected the purchasers’ citation to a Fair Labor Standards Act case, Tyson Foods v. Bouaphakeo, 136 S. Ct. 1036 (2016), where the Supreme Court suggested that the predominance standard is satisfied “unless no reasonable juror could believe the common proof at trial.”  According to the Third Circuit, that lower standard has no application outside of FLSA cases.  Id. at *4-*5.  As the Third Circuit held, “Our non-FLSA case certification decisions that post-date Tyson Foods have reiterated that district courts are required, per Hydrogen Peroxide, to resolve factual determinations by a preponderance of the evidence at the class certification stage.”

From here, the Third Circuit reversed the class certification order on two bases.  First, the district court abused its discretion when it failed to apply a “rigorous analysis” that examined the expert opinions, scrutinized the underlying evidence, and resolved the factual disputes.  Id. at *6.  Second, the district court confused injury with damages.  While damages do not always need to be “susceptible to measurement across the entire class for purposes of Rule 23(b)(3),” that is not true when determining whether injury is capable of common proof on a classwide basis.  Id. at *7.

The Third Circuit remanded for further proceedings, which may or may not include another motion for class certification.  Either way, the Third Circuit has clarified the applicable rules in a clear and helpful way.

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When a lawsuit settles, both sides get something. When one of our cases settles, one of the things we get is a raft of mixed emotions. Undeniably, there is a sense of relief. Three weeks of 20 hour days suddenly open up. We can go home. (That sounds a little funny now that we are homebound courtesy of the Coronavirus pandemic.) But equally undeniable is an immense letdown. There is more glory from victory than from compromise. People come up to congratulate you on the settlement, and you wonder why. But at least there is closure.

Or is there? Can a settling party undergo a change of heart? When we prosecuted cases, one or two criminal defendants withdrew their guilty pleas. They usually offered no real reason, but the courts usually let them try their luck with the jury. (That luck ended up being bad for them.) We have heard of cases where criminal defendants withdrew their guilty pleas because the prosecutor had withheld exculpatory evidence. That’s a Brady violation, that’s the ultimate prosecutorial no-no, and that should not happen. In our career as a civil lawyer, we once dealt with a plaintiff who tried to renege on a settlement. That led to our motion to enforce settlement, which led to the single most comical court hearing we ever attended, which led to an angry judge scolding the plaintiff and granting our motion.

We never heard of a civil plaintiff who settled a case, but then filed a follow-up action premised on an alleged discovery violation. It is bad enough when plaintiffs make a case about the conduct of discovery in that case. It is even worse for plaintiffs to make a case about the conduct of discovery in a prior case. Inasmuch as plaintiffs always think defendants are stiffing them in discovery, such a theory would take a big chunk out of any closure that a settlement is supposed to provide.

That’s why we read Turubchuk v. Southern Illinois Asphalt Co., 2020 WL 2059931 (7th Cir. April 29, 2020), with interest. It is not a drug or device case, but if the plaintiff in Turubchuk had been permitted to get away with filing a post-settlement lawsuit, we and our clients would have something new to worry about. Those mixed emotions we get from settling a case would be even more mixed, and more – ahem – unsettled.

Turubchuk involved a very serious one car accident. One passenger died, and everyone else was hurt. The plaintiffs sued two construction companies that had repaved the road. The claim was that the construction companies created an unsafe condition, failed to erect appropriate barricades, and failed to warn of the dangers caused by the repaving. The plaintiffs settled with the construction companies for a million dollars. The plaintiffs signed a release, which included a standard non-reliance clause, in which the plaintiffs agreed that they were not relying on any statements by, among others, the parties’ attorneys.

End of story, right?

Nope.

The plaintiffs filed a second lawsuit against the construction companies four years later. Why? According to plaintiffs, they settled the first lawsuit for a million dollars only because the construction companies disclosed a million dollars of insurance when, in reality, considerably more insurance was available. The plaintiffs contended that the inaccurate disclosure regarding the amount of insurance amounted to a discovery violation. There were some factual disputes about what had actually happened. For example, the defendants asserted that the plaintiffs made a million dollar demand (which was accepted) before the amount of insurance was discussed. Be that as it may, the issue in Turubchuk was whether the plaintiffs could file a claim against the construction companies for negligent misrepresentation based on the failure in the original, settled case to comply with Federal Rule of Civil Procedure 26, which sets forth discovery obligations.

The district court permitted this second lawsuit to proceed. Over seven years, the district court made many rulings, mostly against the defendants. Some of those rulings strike us as rather remarkable. Even putting aside the fundamental ruling that a new lawsuit could be filed because of an alleged discovery violation in an earlier, settled lawsuit, the district court issued rulings that were about as pro-plaintiff and anti-defendant as one could conceive. For example, the district judge did not give effect to the clear release, prevented a defense expert (a retired judge) from testifying about liability issues and the settlement value of the earlier case, permitted the plaintiffs to bring in the plaintiff lawyer in the earlier case to furnish “expert” testimony about the value of the earlier case, permitted that prior plaintiff lawyer to speculate as to the other side’s motives, while excluding evidence that that same plaintiff lawyer/expert had resigned his law license in lieu of disbarment for alleged acts of fraud. Whew! This is the sort of thing that makes defense hacks pessimistic about litigating in Illinois. Whether you’re in federal or state court in Illinois, the lower courts can be frightening places for corporate defendants. Sometimes you just have to hold on until you can get to the appellate courts, which are usually better. (Then again, the Bausch abomination did come out of the Seventh Circuit.).

That is what happened in Turubchuk. After pretty much everything went the plaintiffs’ way in the trial court and the jury awarded over eight million dollars, the defendants appealed to the Seventh Circuit. The issue was whether “a negligent misrepresentation claim under Illinois law can be predicated on an incomplete initial discovery disclosure under Rule 26.” That is a purely legal issue that the Seventh Circuit review de novo. The Seventh Circuit decided that such a claim should not proceed and that the district court got it wrong.

Negligence misrepresentation is an action in – duh – negligence. One of the first things we learned in law school is that a negligence cause of action requires a duty of care. What allegedly created the duty in Turubchuk requiring the defendants to make a complete disclosure of insurance? According to the plaintiffs and the district court, it was Federal Rule of Civil Procedure 26. That is – here comes another duh – a procedural rule. It is also federal. The Seventh Circuit could not find a single case in which a duty under state negligence law was premised on a Federal Rule of Civil Procedure.

That is hardly surprising. The Federal Rules of Civil Procedure were created pursuant to the Rules Enabling Act, which provided that the Federal Rules “Shall not abridge, enlarge, or modify any substantive right.” 28 U.S.C. Section 2072(b). The plaintiffs and the district court (in denying the defendants’ post-trial motions) rationalized the result below by saying that the plaintiffs’ case proceeded on a negligent misrepresentation claim, not a violation of Rule 26. But the plaintiffs grounded the misrepresentation in an alleged violation of Rule 26, and the district court instructed the jury that the violation of Rule 26 constituted a negligent misrepresentation. Astonishingly, the district court ruled that the only liability issue to be decided by the jury was whether the defense lawyer intended to induce the plaintiffs to settle when he sent the incomplete insurance disclosures.

There was so much wrong with the negligent misrepresentation claim. In the case below, “any duty was rooted in an incorrect source.” Contrary to the Rules Enabling Act, Rule 26 was being used to “enlarge” the plaintiffs’ substantive rights. There is no case “in which an Illinois negligent misrepresentation claim was used to attack an earlier federal judgment.” Even the Ninth Circuit held that alleged violation of discovery rules did not create a private right of action.

Here is how the Seventh Circuit summarized its rulings in Turubchuk. “Plaintiffs incorrectly based their negligent misrepresentation claim on Federal Rule of Civil Procedure 26. The district court also incorrectly found as a matter of law that all but one of that claim’s elements had been met. The evidentiary decisions reached on that element were an abuse of discretion, and viewing the trial evidence in a light most he verdict, the jury’s verdict must be reversed.”

With all of that, one (okay, we) would think that the Seventh Circuit would have granted the defendants’ request that judgment be entered as a matter of law in their favor. That is not what happened. Instead, the Seventh Circuit remanded to the district court for further proceedings consistent with the opinion.

Pity.

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Not long ago, in our “Post-Albrecht Preemption Pummels Pradaxa Plaintiffs” post we discussed several recent favorable preemption decisions in product liability litigation involving that drug:  Ridings v. Maurice, ___ F. Supp.3d ___, 2020 WL 1264178 (Mag. W.D. Mo. March 16, 2020), Adkins v. Boehringer Ingelheim Pharmaceuticals, Inc., 2020 WL 1704646 (Conn. Super. March 13, 2020), Ridings v. Maurice, 2019 WL 8223599 (W.D. Mo. Oct. 20, 2019), and Roberto v. Boehringer Ingelheim Pharmaceuticals, Inc., 2019 WL 5068452 (Conn. Super. Sept. 11, 2019).

Those were all favorable cases, but they were all by trial-level courts, and thus subject to the vagaries of the appellate process.  How about a similar decision from the other end of the appellate process?  Thus, we present Boone v. Boehringer Ingelheim Pharmaceuticals, Inc., ___ A.3d ___, slip op., 2020 WL 2121063 (Conn. May 4, 2020).

Boone was an appeal from a trial that produced a defense verdict.  The opinion addresses several rather case/product-specific issues before it gets to the preemption topic that is near and dear to our blogging hearts.  Thus, we’ll pass over pages *2-11 of the Connecticut Supreme Court’s opinion (which resolve disputes over spoliation and rebuttal evidence).

Boone unanimously affirmed the trial court’s grant of a preemption summary judgment motion against “a design defect claim related to the defendants’ failure to develop and market a reversal agent.”  2020 WL 2121063, at *12.  This claim ran afoul of what we call the “Mensing independence principle” – “The relevant inquiry, [Mensing] held, was whether the defendants ‘‘could independently do under federal law what state law requires. . . .”  Id. at *14 (quoting PLIVA, Inc. v. Mensing, 564 U.S. 604, 620 (2011)) (emphasis supplied by Boone).

The preempted claim, which really isn’t a “design defect” since it doesn’t involve any aspect of the actual product’s design, see id. at *12 n.32, was that the defendant should not have sold the drug at all until it had also developed and obtained FDA approval for a different drug.  As the Boone court recognized, id. at *14, this claim was also preempted under Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013).  Moreover, footnote 32 is itself interesting, since usually courts steer away from deciding constitutional issues when they can avoid them.  But in Boone, “[b]ecause we conclude that the trial court properly granted the defendants’ motion for summary judgment on federal preemption grounds,” the court did not address whether a claim was stated under Connecticut state law.  Preemption was evidently an easy call in Boone.

Boone recognized that, despite a purported presumption against preemption, the logic of Mensing and Bartlett “compels” preemption.  Plaintiff was using state law to hold one drug’s FDA approval hostage to the agency also approving a second drug.  That theory self-evidently depended on the FDA acting to approve the second drug – which required preemption.  “[I]t is enough to hold that when a party cannot satisfy its state duties without the [f]ederal [g]overnment’s special permission and assistance, which is dependent on the exercise of judgment by a federal agency, that party cannot independently satisfy those state duties for [preemption] purposes.’’  Boone, 2020 WL 2121063, at *14 n.34 (quoting Mensing, 564 U.S. at 623-24) (emphasis added by Boone).

In order to cure the design defect alleged by the plaintiff, the defendants would have had to bring [the second drug] to market before the [alleged injury occurred].  Because there is no dispute that [the second drug] was not approved by the FDA until [later], the defendants could not have satisfied their alleged state law duty to the decedent without marketing an unapproved drug in violation of federal law.

Id. at *15.

Plaintiff unsuccessfully argued “that the test for preemption set forth in Mensing and Bartlett is inapplicable to present case because those cases do not involve brand-name drugs.”  Id.  No dice.  While the “different levels of control” that branded and generic manufacturers exercised over their labels “informed the [supreme] court’s analysis . . ., the nature of the underlying test remained consistent:  whether the defendant ‘‘could independently do under federal law what state law requires.”  Id. (once again quoting and emphasizing Mensing independence principle).  Boone agreed with the holding in Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., 808 F.3d 281 (6th Cir. 2015), that, ‘‘contrary to [the plaintiff’s] contention that the impossibility preemption in Mensing and Bartlett is limited to generic drugs, we view Levine, Mensing, and Bartlett as together stating the same test for impossibility preemption.’  Boone, 2020 WL 2121063, at *15 (quoting Yates, 808 F.3d at 296-97).

Along the way, Boone rejected the plaintiff’s argument (which readers will recognize from our previous Pradaxa preemption pummels plaintiffs post) that Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (U.S. 2019), somehow confined the preemption inquiry in branded drug cases to the so-called “clear evidence” test.  Boone made clear that “clear evidence” was only a piece of the implied preemption puzzle:

The plaintiff in the present case asserts that a recent United States Supreme Court case explaining that particular standard, [Albrecht], stands for the broad proposition that impossibility preemption ‘‘only applies when a defendant can affirmatively show that it attempted to get the FDA to allow the safer alternative proposed by the plaintiff and the FDA affirmatively and officially rejected it.’’ (Footnote omitted.)  We disagree. The clear evidence standard in [Levine] applies only when a defendant seeks to prove that compliance with a state law obligation remains impossible notwithstanding its ability to act unilaterally under federal law.

2020 WL 2121063, at *13 n.33 (emphasis original).  The clear evidence test applies when drug manufacturers “could have satisfied their state law obligation to provide a label with an adequate warning by unilaterally making label amendments.”  Id. (citing FDA CBE regulation).  Because the plaintiff’s preempted theory was not something that could be addressed by a CBE label change, “Albrecht is inapposite.”  Id.

The plaintiff’s last-ditch, state-of-the-art argument against preemption in Boone also failed.  Whether or not it was “technologically feasible” to seek FDA approval of the second drug, doing so still required the FDA to act to grant approval.  That pesky Mensing independence principle sank the plaintiff once again.

Although such practical considerations may sometimes limit the options available to a manufacturer; that fact is inapposite to the question of whether marketing [the second drug] would have required the FDA’s ‘‘special permission and assistance.”  For similar reasons, we are also unpersuaded that the FDA’s subsequent approval of [the second drug] is dispositive.  The possibility that the FDA would have looked favorably on an earlier application does nothing to alter the fact that, at the time of the decedent’s death, the defendants were prevented from unilaterally marketing [the second drug] under federal law.

Boone, 2020 WL 2121063, at *15 (quoting Mensing, other citations omitted).  Boone agreed with earlier decisions (including Maurice) that had held similar claims preempted.  Id. at *15 n.38 (reaching “same conclusion” as Ridings v. Maurice, 2019 WL 4888910, at *6 (W.D. Mo. Aug. 12, 2019), and Chambers v. Boehringer Ingelheim Pharmaceuticals, Inc., 2018 WL 849081, at *13 (M.D. Ga. Jan. 2, 2018), and giving the “but see” to In re Xarelto (Rivaroxaban) Products Liability Litigation, 2017 WL 1395312, at *3 (E.D. La. April 13, 2017)).  We agree that the Xarelto decision is wrongly decided.

Unless the plaintiff wants to appeal Boone to the United States Supreme Court – go ahead make our day, after Bartlett we can imagine what the Court would do with this theory – this is the end of the appellate line.  Further, given the Connecticut Supreme Court’s reasoning in Boone, we’re cautiously optimistic that it will uphold the later Connecticut state decisions in Roberto and Adkins, which are wending their way through the appellate process.  While the arguments aren’t all identical, at least two of those plaintiffs’ major contentions (generics are different and Albrecht) bit the dust in Boone.

Finally, we are gratified to see implied impossibility preemption applied to “you should have made a different/additional drug” claims.  The same preemption rationale that Boone adopted should also be fatal to the claims we discussed here, that the drug that reduced AIDS from a death sentence to a treatable chronic condition was “defective” because the defendant didn’t make a “better” drug sooner.  Any defect claim predicated on the possible FDA approval of a different drug necessarily depends on action by the FDA, and is thus preempted under the Mensing independence principle.

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Today’s case is about the clash between these two basic rules.  Before we get to the rules, we look at how we get there.  A standard defense discovery request in any personal injury litigation is:  how much are your medical bills?  This is routinely followed by:  do you have any medical liens, and if so, how much?  Both are designed to help fill in the damages picture.  Not that medical expenses are a precise indication of damages, but they provide some context as to case value.  Not to mention, bills can sometimes reflect treatment that defendants were not aware of.  This is also a good reason to get insurance records, but we digress.  What if plaintiff objects and raises the collateral source rule?  Then you find yourself at the intersection of reasonable value and collateral source.

That was where the court found itself in Shaw v. Shandong Yongsheng Rubber Co. Ltd., 2020 WL 1974762 (D. Colo. Apr. 24, 2020).  This is not a prescription drug or medical device case, but the issue could certainly arise in one of our cases, so we thought it was worth a mention.  Plaintiff brought a products liability suit for injuries she sustained in a car accident.  In response to defendant’s discovery requests – similar to those noted above — plaintiff produced her medical records and medical bills but redacted information she contended was non-discoverable under the collateral source doctrine.

Applying Colorado law, the collateral source rule bars evidence at trial of payments made by an independent entity or person that compensates plaintiff for his/her injuries.  Id. at *1-2.  Most commonly, that applies to insurance companies that pay or reimburse plaintiff’s medical expenses.  The policy reason behind the evidentiary bar is “because such evidence could lead the fact-finder to improperly reduce the plaintiff’s damages award.”  Id. at *1.  But, Colorado has a “competing” reasonable value rule which provides “that amounts paid for medical services is some evidence of the reasonable value of those expenses.”  Id.

What shouldn’t be overlooked is that those rules are talking about evidence at trial and the question before the court was an issue of discovery.  That detail was not missed by the judge.  But before even reaching that issue, the court had to address the question of whether medical lien companies were collateral sources.  A medical lien company purchases medical debt at a discount from healthcare providers and then seeks recovery from the patients owing the debt.  They are debt collectors.  But they are not collateral sources.  A collateral source compensates the plaintiff.  The medical lien companies are setup to receive compensation from plaintiffs, not the other way around.  Id. at *2-3.  Because medical lien companies are not subject to the collateral source rule, that rule can’t be use to block discovery of medical liens against plaintiff.  “For discovery purposes, amounts paid by medical lien companies are relevant to Plaintiff’s claimed damages, and this discovery is proportional to the needs of the case.”  Id. at *3.

Plaintiff had also redacted amounts paid by Medicare and Medicaid – which would be considered collateral sources.  But, the collateral source rule is “one of admissibility, not discoverability.”  Id.  That combined with Rule 26’s provision that discoverable evidence need not be admissible means that amounts paid for medical services are discoverable as “some evidence of the reasonable value of those medical expenses.”  Id.  So, at the discovery stage the reasonable value rule gets the right of way over the collateral source rule.  Whether that holds true at trial is a question left for the trial judge, and is the subject of a different blogpost of ours about phantom damages.

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The “fraud on the FDA” claim that the Supreme Court held preempted in Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), was actually the most extreme form of a private plaintiff second-guessing the result of an FDA process classifying a regulated product.  Plaintiffs claimed that, because of purported “fraud” in the §510(k) process, the FDA incorrectly cleared the orthopedic bone screw spinal fixation device at issue as a Class III medical device.  Id. at 344.  We describe the claim as “most extreme” because plaintiffs in Buckman didn’t claim that the device should have received some other classification, but that it shouldn’t have been approved for marketing and labeling for any classification at all.  Id. (“but for” the supposed fraud, “the FDA would not have approved the devices”).

The Supreme Court rejected that claim – held it preempted – for a number of reasons, chief of which is that how the FDA decides to classify the products it regulates was none of the plaintiffs’ business as Congress gave sole FDCA enforcement power to the government:

The FDCA leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance with the medical device provisions: “[A]ll such proceedings for the enforcement, or to restrain violations, of this chapter shall be by and in the name of the United States.”  21 U.S.C. §337(a).

The FDA . . . has at its disposal a variety of enforcement options that allow it to make a measured response to suspected fraud upon the Administration.

This flexibility is a critical component of the statutory and regulatory framework under which the FDA pursues difficult (and often competing) objectives. . . .  For example, with respect to Class III devices, the FDA simultaneously maintains the exhaustive PMA and the more limited §510(k) processes. . . .

Buckman, 531 U.S. at 349 & n.4.  It was solely FDA’s function to decide whether to require pre-market approval, as opposed to §510(k) clearance, as the method to market for that product and to determine what the resultant classification would be.

The extreme form of second-guessing of FDA classification decisions exemplified by the preempted claims in Buckman – that the product should have been rejected altogether – has largely fallen by the wayside after Buckman.  The Supreme Court’s decision in Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013), finding “stop-selling” claims (another theory challenging the presence of an FDA regulated product on the market) should have nailed that coffin shut.  Occasional False Claims Act suits (which, being brought under a federal statute aren’t subject to “preemption”), of the sort we blogged about here still happen, but not many state-law claims see the light of day.  See United States ex rel Dan Abrams Co. LLC v. Medtronic, Inc., 2017 WL 4023092, at *7 (C.D. Cal. Sept. 11, 2017) (“claims of fraud are disfavored if made by third parties who seek to second guess a decision by the FDA to certify a device”).  Cf. Loreto v. Procter & Gamble Co., 515 F. Appx. 576, 579 (6th Cir. 2013) (warning claim based on product being “illegal” under FDCA preempted under Buckman) (applying New Jersey law).

But that doesn’t mean plaintiffs ever stopped trying to overturn FDA classification decisions in other, less blatant, ways.  One, which as we’ve discussed before hasn’t made much headway, is to attack the sufficiency of the information on which the FDA’s decision is based.  But that’s not all.  Plaintiffs fairly regularly claim that they know better than the FDA how regulated products should be classified under the Agency’s regulations.

We’ve been thinking about this aspect of Buckman ever since last year, when we blogged about the preemption-based dismissals in the related cases Borchenko v. L‘Oreal USA, Inc., 389 F. Supp.3d 769 (C.D. Cal. 2019), and Borchenko v. L‘Oreal USA, Inc., 2019 WL 3315289 (C.D. Cal. July 18, 2019).  We’ve discussed this type of case quite a few times, but our posts were about individual cases.  We’ve never researched this issue comprehensively before, and we’ve been meaning to.

In the two Borchenko cases, preemption barred plaintiffs from claiming that products the FDA had regulated as “cosmetics” should instead have been subject to regulation as “drugs.”  Classifications were for the FDA to decide, even if California state law provided a way for plaintiffs to enforce some FDCA aspects under the guise of its consumer protection statutes:

The fact that Plaintiff’s claim is technically brought under the UCL and the Sherman Law does not override the fact that Plaintiff explicitly requests relief which lies squarely within the province of the FDA.  There can be no state law cause of action if a plaintiff’s true goal is to privately enforce alleged violations of the FDCA.

389 F. Supp.3d at 773 (citations omitted).

So, we’ve decided to collect what else is out there.

Even before Buckman, this type of claim had been frowned on.  “A federal court may not “determine preemptively how a federal administrative agency will interpret and enforce its own regulations.”  Sandoz Pharmaceuticals Corp. v. Richardson-Vicks, Inc., 902 F.2d 222, 231 (3d Cir. 1990).  See PDK Labs, Inc. v. Friedlander, 103 F.3d 1105, 1113 (2d Cir. 1997) (affirming dismissal; plaintiff’s “dogged insistence that [defendant’s] products are sold without proper FDA approval suggests . . . that [his] true goal is to privately enforce alleged violations of the FDCA”); Braintree Laboratories, Inc. v. Nephro-Tech, Inc., 1997 WL 94237, at *7 (D. Kan. Feb. 26, 1997) (“it is not for this court to interpret and apply the statutory definition of ‘dietary supplement’”).

We soon encountered the odd case of Amarin Pharma, Inc. v. International Trade Commission, 923 F.3d 959 (Fed. Cir. 2019), which we blogged about here, where the plaintiff tried to use the Lanham Act (another federal statute not subject to preemption) to claim that a product the FDA was regulating as a “dietary supplement” should instead be considered an “unapproved new drug.”  Id. at 967.  Relying on PhotoMedex, Inc. v. Irwin, 601 F.3d 919 (9th Cir. 2010), the federal circuit held that a plaintiff cannot challenge an in-force FDA classification:

As in PhotoMedex . . . affirmative FDA approval is not required in the dietary supplement context.  Instead, manufacturers self-police. . . .  [T]he FDA has not provided guidance as to whether the products at issue in this case should be considered “new drugs” that require approval.  Given this lack of guidance, we . . . therefore hold that a complainant fails to state a cognizable claim under [the Lanham Act] where that claim is based on proving violations of the FDCA and where the FDA has not taken the position that the articles at issue do, indeed, violate the FDCA.  Such claims are precluded by the FDCA.

Id. at 968 (citations omitted).

PhotoMedex involved another competitor’s claim that the defendant’s product required a separate device clearance that the defendant had not sought and the FDA had not required.  The court held that private litigants cannot challenge the FDA’s decisions (even when implicit) how to classify a product.

[Plaintiff] is not permitted to circumvent the FDA’s exclusive enforcement authority by seeking to prove that Defendants violated the FDCA, when the FDA did not reach that conclusion.  In a context where the statute and regulations place responsibility in the first instance on the manufacturer to determine whether its device is covered by a previous FDA clearance and permit marketing of the product without an affirmative statement of clearance by the FDA, it is impossible for [plaintiff] to prove that [defendant’s] device had not been cleared by the FDA when the FDA itself did not take that position.

Id. at 928.  For other similar Lanham Act claims, see Hi-Tech Pharmaceuticals, Inc. v. Hodges Consulting, Inc., 230 F. Supp.3d 1323, 1331 (N.D. Ga. 2016) (“the Court declines to determine whether the supplement at issue is a drug or whether its sale violated the FDCA”); Intra-Lock International, Inc. v. Choukroun, 2015 WL 11422285, at *7 (S.D. Fla. May 4, 2015) (“the mere fact that Defendants may be erroneously selling the Competing Device as a Class I device when it is more appropriately considered a Class II device, is a violation of the FDCA, not a violation of the Lanham Act”); JHP Pharmaceuticals, LLC v. Hospira, Inc., 52 F. Supp. 3d 992, 1004 (C.D. Cal. 2014) (“determination of whether a drug is ‘new,’ and whether it can be lawfully marketed under the FDCA, involves complex issues of history, public safety, and administrative priorities that Congress has delegated exclusively to the FDA”); Catheter Connections, Inc. v. Ivera Medical Corp., 2014 WL 3536573, at *5-6 (D. Utah July 17, 2014) (Lanham Act claim that defendant “is engaging in false advertising when it represents (or implies) that [its product] does not need FDA clearance independent of the 510(k) clearance letter the FDA [already] issued . . . is precluded by the FDCA”) (blogged about here); Healthpoint, Ltd. v. Stratus Pharmaceuticals, Inc., 273 F. Supp.2d 769, 787 (W.D. Tex. 2001) (“It is for the FDA to exercise its discretion to determine whether [the products] are on the market lawfully, whether it be because they are grandfathered or are exempt from the FDA pre-clearance process.”).

Note:  Much earlier in the Blog’s history, we wrote a post similar to this one on how to challenge Lanham Act claims that alleged un-preempted claims of fraud on the FDA.

While we were writing this article, we learned of Somers v. Beiersdorf, Inc., 2020 WL 1890575 (S.D. Cal. April 15, 2020) (blogged about here), in which the plaintiff’s allegations that a “cosmetic” lotion was really an illegally marketed “drug” were dismissed as preempted.  “Recognizing that the distinction between drugs and cosmetics is a difficult one, Congress gave the FDA the sole authority to police violations of the FDCA.”  Id. at *2 (citing §337(a)).

[Plaintiff] alleges, for example, that “Defendant engaged in illegal conduct . . . that resulted in its [product] being deemed a drug under FDA regulations, but did so without obtaining required FDA approval through the FDA NDA [New Drug Approval] process.”  There is no reasonable way to construe this allegation except as an attempt to privately enforce the FDCA, enforcement that has been committed by law to the FDA.

Id. at *3.  The Plaintiff’s argument based on California’s “Sherman Act” – a state FDCA analog – was rejected as “largely circular,”  Id. at *4.  “[A] drug can only be unlawful under the California statute if it violates the FDCA, and determining whether the California statute has been violated requires first determining whether the article is a drug under the FDCA.”  Id.

The plaintiff in Obermeier v. Northwestern Memorial Hospital, 134 N.E.3d 316, 335 (Ill. App. 2019), which we blogged about here, claimed that the defendant was liable under an informed consent theory because it “bore the direct responsibility for registering the [device] with the FDA and for ensuring that it was properly cleared or approved . . ., but that it did not do so.”  Id. at 335.  The defendant contended that an additional FDA registration was not required, id., but that didn’t matter since preemption precluded the plaintiff from challenging at all how the device was properly characterized under the FDCA:

Plaintiff’s theory, therefore, is that [defendant] failed to proceed through the proper regulatory pathway, ensuring that the [device] was properly cleared by the FDA.  This claim, however, is precluded by the Food, Drug, and Cosmetic Act (FDCA), which provides that such alleged violations are the exclusive domain of the FDA.

Id. (citations omitted).  See Midlothian Laboratories, L.L.C. v. Pamlab, L.L.C., 509 F. Supp.2d 1065, 1086 (M.D. Ala. 2007) (same result on claim challenging whether the product was actually generic; “any false-equivalency claim based on the fact that [defendant’s] product does not appear in [a list of generic products] is preempted by the FDA’s exclusive authority to approve products pursuant to the FDCA”), vacated in part other grounds, 509 F. Supp.2d 1095 (M.D. Ala. 2007).

Ostensibly state-law “mislabeling” claims were preempted under Buckman and “the FDA[’s] regulatory authority over the enforcement of the FDCA” in Elkind v. Revlon Consumer Products Corp., 2015 WL 2344134, at *9 (E.D.N.Y. May 14, 2015), which we blogged about here.  Plaintiff had “dispute[d] whether the [products] are subject to the FDCA’s regulation as cosmetics or over-the-counter drugs.”  Id. at *7.  However, certain other claims, “hing[ing] on the perceived intended use” of the product, survived dismissal when the court “assumed” they were “drugs.”  Id.

Similar claims – disputing whether the products at issue were cosmetics or drugs − were held preempted in Reid v. GMC Skin Care USA, Inc., 2016 WL 403497, at *9 (N.D.N.Y. Jan. 15, 2016).  Following this aspect of Elkind, the court held preempted plaintiff’s purported state-law claims challenging product classification:

Plaintiffs . . . assert that they are bringing their claims − not under the FDCA − but under [state] law.  The complaint, however, belies Plaintiffs’ assertion . . . alleg[ing] that: “The . . . Products are Misbranded Because their Labels Violate FDCA Regulations for Over-the-Counter Drugs” . . . “The . . . Products are Unapproved New Drugs;” and “Placing an unapproved new drug into the stream of commerce is an independent wrongful act. . . .” Therefore, to the extent the complaint alleges violations of the FDCA, because there is no federal private right of action to enforce the FDCA, those allegations are dismissed.

Id. at *10 (citing Buckman and Elkind, other citations omitted).

The plaintiff’s challenge to the defendant’s device classification in Kapps v. Biosense Webster, Inc., 813 F. Supp. 2d 1128 (D. Minn. 2011) (blogged about here), was rather complex – involving a §510(k) clearance for reprocessing of 68 devices and a defendant’s use of a “line extension” internally to extend that clearance to “sufficiently similar” devices.  Id. at 1138.  The preemption ruling in Kapps, however, was simple – under Buckman a private plaintiff cannot challenge how an FDA-regulated product is classified:

[E]ven if [plaintiff’s] failure-to-warn claim were viable under [state] law, it would be foreclosed by Buckman.  [Plaintiff’s] argument (as the Court understands it) is that, regardless of whether the [device] was defective . . ., [defendant] should have warned . . . that the catheter was not really FDA-approved. . . .  To allow [plaintiff] to recover on a failure-to-warn claim if the catheter was not in fact defective or unreasonably dangerous would amount to creating a cause of action for a violation of the FDCA. Such a cause of action is preempted under Buckman.

Kapps, 813 F. Supp.2d at 1153.

Similarly, in In re Alloderm® Litigation, 2015 WL 13780242 (N.J. Super. Law Div. Aug. 14, 2015), the plaintiffs asserted a claim, ostensibly under state law, that an article the FDA had classified as a “human tissue” should have been classified as a medical device.  Id. at *2.  The court excluded all evidence of this allegation because “the FDA has not classified [the product] . . . as a medical device, and has never required [defendant] to comply with the FDCA medical device regulations for such use.”  Id. at *4.  Because the FDA had not made such a classification, state law could not usurp the FDA’s authority.  “It is not for a jury to second-guess the actions or inactions of the FDA in rendering complex decisions about product classification.”  Id. (citations omitted).

Buckman has also barred plaintiffs from suing over whether a defendant’s alteration to a product was a “major change” that required a supplemental application to the FDA.

Obtaining supplemental premarket approval for a change in the [product’s] specifications might change those requirements, but failing to obtain that approval would not cause previously established requirements to simply evaporate. . . .  The only violation of federal regulations that [plaintiff] alleges is the failure to comply with procedures governing supplemental premarket approval of a device.

Vincent v. Medtronic, Inc., 221 F. Supp.3d 1005, 1010-11 (N.D. Ill. 2016) (citation omitted) (blogged about here).  Thus, “claims based solely on [defendant’s] noncompliance with the FDA’s supplemental premarket approval procedures . . .  are impliedly preempted.”  Id. at 1011.

Somewhat similarly, in a case from the same judicial district as Vincent, the plaintiff in Aquino v. C.R. Bard, Inc., 413 F. Supp.3d 770, 784 (N.D. Ill. 2019), filed a complaint claiming that a raw materials change required a supplemental FDA filing when the FDA itself said it didn’t.  Id. at 783-84.  In the face of an implied preemption, however, plaintiff hastily abandoned that claim.  Id. at 784 (although plaintiff’s complaint “spends considerable space on [those] allegations,” plaintiff now “argues . . . that her claims sound in negligence and strict liability”).  Even when preemption becomes “inapposite,” id., it still has deterrent effect.

A spate of litigation raising failure-to-supplement claims (in the wake of a particular FDA enforcement action to this effect) got nowhere.  Courts refused to allow private plaintiffs to argue that product changes for which the FDA had not required a supplemental clearance in fact required such a supplement.

[A] claim . . . for [defendant’s] failure to file or obtain a PMA Supplement . . . is impliedly preempted.  [The] failure to file a PMA Supplement is a violation of an administrative obligation, required . . . in FDCA regulations.  A state law claim seeking a remedy for this violation is a disguised claim to privately enforce the federal law, prohibited under 21 U.S.C. § 337(a).  Any derivative claim that the [device] was adulterated as a result of the failure to obtain a PMA Supplement is likewise preempted for the same reasons.

Sadler v. Advanced Bionics, Inc., 929 F. Supp.2d 670, 685 n.20 (W.D. Ky. 2013) (blogged about here).

Plaintiffs’ negligence claims based on [defendant’s] failure to obtain supplemental PMA approval . . . are impliedly preempted.  PMA approval is an administrative requirement created by the FDA, not a substantive safety requirement of state law.  Claims premised on PMA approval are disguised fraud-on-the-FDA claims which are impliedly preempted.

Stout v. Advanced Bionics, LLC, 2013 WL 12133966, at *5 (W.D. Pa. Sept. 19, 2013) (citations omitted).  Accord Littlebear v. Advanced Bionics, LLC, 896 F. Supp.2d 1085, 1092 (N.D. Okla. 2012) (“the FDCA do not provide a private right of action. And no pre-existing state law duty existed requiring such supplemental approval”) (blogged about here, sort of); Purchase v. Advanced Bionics, LLC, 896 F. Supp.2d 694, 696 (W.D. Tenn. 2011) (“claims premised on PMA approval are disguised fraud-on-the-FDA claims”) (blogged about here).  Cf. Otero v. Zeltiq Aesthetics, Inc., 2018 WL 3012942, at *3 (C.D. Cal. June 11, 2018) (Buckman preempted claim that it was tortious for a “cleared” §510(k) medical device manufacturer to call its product “approved”; “Plaintiffs’ theory ignores the significance of the FDA’s decision to classify [the product] as a Class II medical device.”).

Finally, the doctrine of primary jurisdiction has also been invoked in this situation.  Postponing a commercial express warranty claim that sought “to determine whether [the product] should be classified a drug” or as one of three types of dietary supplements, the court held that such a determination should be made by the FDA.  “Classification of a product is within the primary jurisdiction of the FDA.”  Imagenetix, Inc. v. Frutarom USA, Inc., 2013 WL 6419674, at *4 (S.D. Cal. Dec. 9, 2013).  “[W]hether [the product] should be classified a drug, dietary supplement, ODI or NDI[ is] an issue that should be left to the expertise of the relevant agency, the FDA.”  Id.

There, one more thing we’ve been meaning to do is now done.

Photo of Rachel B. Weil

In these strangest of times, we find ourselves seeking comfort in the familiar. Many times each day, we dial the numbers of faraway loved ones, just to hear their voices (the twenty-something Drug and Device Law Rock Climber has threatened to block our number). We gravitate toward favorite foods of our childhood (we just resorted to Amazon to replenish our peanut butter supply). And we have watched our favorite Downton Abbey episode six times (“Of course I’ll marry you, you old booby. I thought you’d never ask.”).

So we were drawn to today’s case, Cofresi v. Medtronic, Inc., et al., — F. Supp. 3d –, 2020 WL 1887862 (W.D. Tex. Mar. 30, 2020), because it deals with issues we brief over and over again in our representation of medical device manufacturers. In Cofresi, the plaintiff underwent left inguinal hernia repair with one of the defendants’ mesh products. About a month later, he was diagnosed with a right inguinal hernia and with an infection at the site of the left hernia repair. He underwent a second surgery, during which surgeons repaired the new hernia with a different defendant’s mesh product and addressed the issues they attributed to the first surgery. The plaintiff alleged that he developed additional symptoms and that he was scheduled for another mesh revision surgery. He sued the manufacturers of both hernia mesh products, asserting the usual litany of product liability claims sounding in negligence and strict liability. The defendants filed separate 12(b)(6) motions, both of which are addressed in the court’s decision, arguing that the plaintiff had not alleged sufficient facts to satisfy federal pleading (Twiqbal) standards. The court explained that it needed to analyze the claims only against a strict liability standard, because “a manufacturer logically cannot be held liable for failing to exercise ordinary care when producing a product that is not defective.” Cofresi, 2020 WL 1887862 at *3. (We like that) The decision includes separate analyses of the defendants’ separate motions, but the key points and holdings are the same, and we will consider them together.

Design Defect

Both defendants argued that the plaintiff had failed to plead the elements of his design defect claim. To prevail on a design defect claim under Texas law, a plaintiff must prove that a safer, feasible alternative design existed at the time of his alleged injury. The plaintiff alleged that the “alternative design” was a product made from organic tissue, not the synthetic mesh that composed both defendants’ products. The court held that mesh made from organic tissue was not an “alternative” to the defendants’ synthetic mesh products – it was an entirely different product. And, under Texas law, an entirely different product does not satisfy a plaintiff’s burden to prove that a safer, feasible alternative design exists.   As the court explained, “[T]hat Plaintiff now believes that [organic tissue mesh] would have been a better choice does not mean that it is an ‘alternative’ under the law.” Id. at *4.   The court held that the plaintiff had failed to state a claim for design defect sounding either in negligence or in strict liability.  That’s quite familiar to us and our readers.

Manufacturing Defect

In Texas, “[a] manufacturing defect exists when a product deviates, in its construction or quality” from the manufacturer’s own specifications, “in a manner that renders it unreasonably dangerous.”   Id. (citation omitted).   The court held, “Nowhere in the [Complaint] does Plaintiff allege that a particular mishap occurred in the manufacturing process that rendered the [defendants’ products] unreasonably dangerous” or that the products deviated from the manufacturers specifications in a manner that rendered the products unreasonably dangerous. Id.  As such, the plaintiff had not adequately pled a manufacturing defect against either defendant.  That’s familiar, too.

Warnings Causation

Regular readers of this blog may recall that warnings causation is one of our pet issues. In Texas, like most everywhere else, a plaintiff cannot prevail on a failure-to-warn claim unless he can prove both that a warning was inadequate and that the inadequate warning was the proximate cause of his injuries; in other words, that a different or stronger warning would have altered the prescribing physician’s decision to prescribe the product. In this case, the court held that the plaintiff had not pled either element of the claim – he had not included specific allegations identifying how the products’ warnings were inadequate or what additional information the warnings should have included, and he had not adequately pled that his surgeon would have altered his prescribing decision if the warnings had been different.  That’s a well-trodden TwIqbal path.

Other claims

The plaintiff asserted gross negligence and punitive damages claims against both defendants. The court held that, although it was a “close call,” the plaintiff had not adequately pled that the defendants “acted with an extreme degree of risk or [were] consciously indifferent to the safety of others” by creating their products. The court also held that “merely listing claims for defective construction/composition and breach of express warranties” [was] not enough to meet the pleading standard. Id. at *7.  This result, we wish was more common.

Bottom line: the court held that the plaintiff had not adequately pled any of his claims against either defendant, and it granted both defendants’ motions. But here’s something else that is familiar: plaintiffs get too many bites of the apple when they had every opportunity to do it right the first time. All of the plaintiff’s claims were dismissed without prejudice, and he was given 21 days to re-plead his claims. We’ll keep you posted on that. Meanwhile, a bowl of Cap’n Crunch is calling our name. Stay safe out there.

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FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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