We have been consistently critical of the MDL system for encouraging judges presiding over such massive aggregations to manipulate the applicable law to create settlement pressure on defendants.  We’ve seen that with federal preemption, willingness to create novel state-law causes of action, choice of law, and trial consolidation of multiple plaintiffs.  But perhaps none has been more blatant than the exclusion of all mention of FDA medical device clearance on the bogus rationale that, because it is not “rigorous” enough to be preemptive of state-law claims under the obsolete decision in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), it isn’t relevant enough to be admitted at all.

That wasn’t the law anywhere until the Pelvic Mesh MDLs, as we set forth here.  Then Pelvic Mesh cases decided that it would be a great settlement tool to deprive defendants of the jury knowing that their products had, in fact, received FDA’s permission to be marketed, and that FDA saw no reason to require clinical trials before that happened.  E.g., Kaiser v. Johnson & Johnson, 947 F.3d 996, 1018 (7th Cir. 2020); Campbell v. Boston Scientific Corp., 882 F.3d 70, 77 (4th Cir. 2018); Eghnayem v. Boston Scientific Corp., 873 F.3d 1304, 1318-19 (11th Cir. 2017); In re C.R. Bard, Inc., 810 F.3d 913, 922-23 (4th Cir. 2016); Sanchez v. Boston Scientific Corp., 38 F. Supp.3d 727, 744 (S.D.W. Va. 2014); Lewis v. Johnson & Johnson, 991 F. Supp. 2d 748, 755-56 (S.D. W. Va. 2014).  Of course, by the time that appellate courts were able to review this Pelvic Mesh FDA gag rule (years after the fact, another problem with MDLs) hydraulic pressure to affirm existed, since to restore the law to where it belonged would have resulted in throwing out years of MDL activity – and affirm they did.

These cases turned FDA medical device regulation, particularly concerning design defect, into an all-or-nothing game.  Either, the FDA’s decision was preemptive, as with PMA medical devices, or such decisions weren’t admissible at all.  That’s a neat trick, from the plaintiffs’ perspective, because it also had the effect of repealing a dozen states’ pro-defendant compliance presumptions, since when FDA compliance was either preemptive or inadmissible, there was no situation in which such a presumption could ever come into play.  E.g., Adams v. Boston Scientific Corp., 177 F. Supp.3d 959, 963-64 (S.D.W. Va. 2016) (effectively nullifying Texas compliance statute); but see Ocasio v. C.R. Bard, Inc., 2020 WL 3288026, at *5-6 (M.D. Fla. June 18, 2020) (refusing to nullify Florida compliance statute) (discussed here).  These cases also created a “heads plaintiffs win; tails defendants lose” situation with the FDA – so that the FDA did not exist, except when a plaintiff wanted it to exist (when the FDA did something unfavorable to the defense), as we described here.

But particularly outside of the settlement uber alles context of the Pelvic Mesh MDL, there has been a fair amount of push-back against this blatantly pro-plaintiff manipulation of the rules of evidence.  We have discussed several such cases rejecting the Perlvic Mesh FDA gag rule, Keen v. C.R. Bard, Inc., 480 F. Supp.3d 646, 650-51 (E.D. Pa. 2020) (here); In re Cook Medical, Inc., IVC Filters Marketing, Sales Practices & Products Liability Litigation, 2018 WL 6617375, at *1-2 (S.D. Ind. Dec. 18, 2018) (here); In re Bard IVC Filters Products Liability Litigation, 289 F. Supp. 3d 1045, 1047-48 (D. Ariz. 2018) (here); Winebarger v. Boston Scientific Corp., 2015 WL 5567578, at *5-7 (W.D.N.C. Sept. 22, 2015) (here); McCracken v. DePuy Orthopaedics, Inc., 2013 WL 12141334, at *4-5 (N.D. Ohio July 26, 2013) (here).  See also In re Davol, Inc./C.R. Bard, Inc., Polypropylene Hernia Mesh Products Liability Litigation, 2020 WL 6603657, at *7-8 (S.D. Ohio Oct. 20, 2020); Retractable Technologies, Inc. v. Becton, Dickinson & Co., 2013 WL 4101810, at *2 (E.D. Tex. Aug. 12, 2013).

We’re pleased to report that the first state appellate court has agreed with us and refused to follow the same FDA gag rule even in Pelvic Mesh cases.  In Hrymoc v. Ethicon, Inc., ___ A.3d ___, 2021 WL 787039 (N.J. Super. App. Div. Mar. 2, 2021), a unanimous panel of the Appellate Division of New Jersey’s Superior Court recognized that exclusion of FDA device clearance was unduly prejudicial to defendants.  Refusing to bow to the inherent pressure to affirm, Hrymoc reversed two verdicts by juries deprived of FDA clearance information that had hit two different pelvic mesh manufacturers with multi-million dollar awards.  Hrymoc refused to inflate the no-preemption decision in Lohr to into a no-FDA-evidence-at-all gag rule:

[T]he absence of such a regulatory testing requirement does not preempt the ability of state law to impose liability upon manufacturers for selling a defective and unsafe product.  But that does not make a total ban on disclosure to the jury of the FDA’s actual involvement fair or appropriate.

Hrymoc, 2021 WL 787039, at *15 (Lohr citation omitted).  The FDA’s §510(k) process was different now.  “Following amendments to the MDA in 1990, [FDA] special controls could include . . . ‘the promulgation of performance standards as well as postmarket surveillance, patient registries, development and dissemination of guidelines,” and other actions deemed necessary by the FDA.’”  Id. at *7 (quoting FDA, “The 510(k) Program:  Evaluating Substantial Equivalence in Premarket Notifications; Guidance for Industry and Food and Drug Administration Staff,” at 2 (2014)) (for more on the 1990 amendments see our post, here).

Hrymoc found the Pelvic Mesh FDA gag rule unfair to defendants and misleading to juries.  Calling out the Pelvic Mesh MDL judge by name, 2021 WL 787039, at *12, Hrymoc disagreed with those cases, and held the same blanket exclusion of FDA device clearance evidence to be an abuse of discretion under New Jersey law.  A “complete ban on any disclosure of the 510(k) clearance process to the jurors” was reversible error because it “had the clear capacity to lead to possibly unjust results.”  Id. at *17 (footnote omitted).

While it is true that §510(k) clearance “is far less rigorous than the more elaborate and time-consuming process for obtaining the FDA’s premarket approval,” id. at *14, it is hardly a rubber stamp or unconcerned with safety.  As “it has evolved over the years”:

[T]he process for obtaining 510(k) clearance requires an applicant to address a lengthy checklist of filing requirements.  Among other things, the FDA’s review can encompass whether any differences in the submission device from the predicate device affect its safety and effectiveness, detailed information or data concerning adverse health effects, and, in some instances, clinical or scientific data, depending on if the applicant contends its device has the same technological characteristics as the predicate.

Id. (citations and footnote omitted).

That §510(k) clearance is “less rigorous,” does not make it irrelevant.  The FDA’s clearance nonetheless “provide[s] evidence that a device manufacturer obtained regulatory authorization to market the product at issue.”  Id.  That’s all that relevance requires.  “The bar for relevancy under N.J.R.E. 401 only requires a ‘tendency in reason’ for evidence to prove or disprove a fact of consequence to the case.”  Id.

Nor was there a valid argument that the obvious relevance of FDA device clearance was “substantially outweighed” by any “countervailing considerations” under Rule 403 (New Jersey’s evidence rules essentially reflect the federal rules in this area).  2021 WL 787039, at *15.  Many (if not most) jurors know about the FDA and would expect to hear about it in this type of case:

Many jurors in our present society would naturally expect that the FDA would have some involvement in the regulation of a new medical product being implanted in patients, and that the FDA would have had some oversight role concerning bringing a product to market.

Id.  Simply telling jurors “to ignore the possible role of the FDA” was neither a “fair” nor “adequate solution.”  Id.

Nor did “waste of time” or “jury confusion” justify an FDA gag rule.

[T]he judge could impose reasonable limits on the number of witnesses and the amount of trial time expended on the subject.  The judge could also explain to the jury − in a neutral manner − the basic and rather understandable conceptual difference between Class II “substantial equivalency” clearance and the more rigorous Class III premarket approval that evaluates a device’s safety and effectiveness in depth.

Hrymoc, 2021 WL 787039, at *16.  “It is wrong to presume the jury would not have been able to understand and follow a limiting instruction from the judge about the proper use of 510(k) evidence.” Id. at *17.

[W]e believe the revelation of the FDA’s 510(k) clearance of these devices can be conveyed to the jurors effectively and plainly without extensive elaboration.  The subject need not devolve into a “mini-trial” before the jury.  Prudent oversight measures by the court can assure that neither side goes too far in presenting evidence or making arguments to the jury about the 510(k) process.

Id.

We bloggers think the whole “mini trial” argument is ridiculously overblown in §510(k) cases anyway – since plaintiffs’ counsel in other MDLs have no compunction about raising absurdly complex FDA-based liability theories.  The Zantac MDL is but one recent example of the other side’s digging deeply into FDA regulatory workings whenever it suits their purposes.  Their regulatory experts are often walking, talking “mini trials” in their own right.  Thus, we agree that, as to FDA evidence, “[t]he playing field can be leveled without a dramatic alteration of the overall contest.”  Hrymoc, 2021 WL 787039, at *17.

And of course plaintiffs’ counsel at the two trials engaged in their usual hijinks once the FDA gag rule was in effect.  Their “undue tactical advantage,” id. at *17, included arguing that pre-marketing clinical trials were “needed” and “required” – as if these cases involved PMA devices – while the defendants were prohibited from telling the jury that the FDA did not require such costly and time-consuming testing.  Id. at *15.  Moreover, “[t]he inherent unfairness of the situation [was] perhaps most pronounced in connection with the punitive damages aspect of these cases.”  Id. at *16.  Plaintiffs’ counsel “exhorted the jury to impose punitive damages to punish’ defendants so they would ‘do clinical studies.’”  Id. at *15.

Plaintiffs’ trial conduct made it particularly egregious to exclude an FDA document in which “the FDA reviewer who recommended 510(k) clearance for [one] device noted on the clearance form that ‘clinical data’ was not ‘necessary to support the review.’”  Id. at *17.  Hymoc recognized that the defendants had been forced by the FDA gag rule to litigate with one hand tied behind their backs.  “[D]efendants should have been permitted to try to counter [those arguments] by allowing the jurors to at least know about the 510(k) clearance process and the fact that the FDA did not require such clinical studies.”  Id. at *15.

Thus, in future New Jersey trials involving §510(k) cleared medical devices, instead of “complete ban” on FDA evidence, Hrymoc encouraged trial judges to conduct preliminary proceedings under Rule 104 to consider such evidence judiciously.  Id. at *17.  Such hearings would allow:

a more in-depth exploration . . . of exactly what proofs and counterproofs about 510(k) clearance might be appropriately presented, what constraints on counsel might be sensible, and what the precise wording of a limiting instruction might contain.

Id.

There are various and sundry other rulings in Hrymoc that are not as helpful to defendants, see, id. at *18-23, but they are minor and case-specific compared to the court’s resounding rejection of the Pelvic Mesh FDA gag rule.  At least in New Jersey a serious, ongoing injustice has – albeit belatedly − been righted.

Full disclosure:  Reed Smith has been involved in this litigation representing both defendants.  Reed Smith has also been involved in Pelvic Mesh litigation generally.

If hard cases make bad law, big cases make really bad law. No cases are bigger than product liability multidistrict litigations. Some have populations dwarfing the towns where many of you were raised. Perhaps it is the high stakes involved, or perhaps it is the judicial obsession with settling many thousands of cases ASAP, but MDL rulings are as likely to be distortions as applications of the law. Think of the the pelvic mesh rulings preventing juries from learning the basic, important, and undeniable fact that the FDA cleared the products in question. Then again, at least those are rulings you can read and to which you can react. In too many MDLs, the judges, either paralyzed by size of the project, or persuaded that inaction is most likely to prompt settlement (not true, by the way), decide not to decide anything important. If one could look up the job description of an Article III judge, then one would probably not find an entry for “not deciding stuff.” And yet.

But there is a sea change after the MDL courts remand cases. Judges overseeing remand cases manage trial-set cases, not inventories. They actually start deciding motions. Sometimes they get some things right. Cotton v. Ethicon, Inc., 2021 WL 736211 (N.D. Indiana Feb. 25, 2021), is one of those pelvic mesh remand cases. It is a mixed bag. There is a not very interesting denial of summary judgment on the failure to warn claim. The plaintiff did not depose the treating physician, which normally is required for the plaintiff to cobble together warning causation. But the court held that the plaintiff could create a factual dispute via an affidavit from the treating physician. Ho hum.

At the same time, the court granted the defendant’s motion for summary judgment on the negligent misrepresentation and unjust enrichment claims. As a preface to those dismissals, the Cotton court does a nice job of setting forth the merger of product liability claims under the Indiana Product Liability Act, which “codified the entire field of product liability law in Indiana.” The Cotton court’s interpretations of Indiana law might serve you well the next time you are defending a client in the Hoosier State.

First, Indiana law confines negligent misrepresentation to “business transactions.” The Cotton court rejected the plaintiff’s argument for expanding negligent misrepresentation to personal injury cases. But the plaintiffs could not cite a single Indiana product liability case blessing a negligent misrepresentation. The Cotton court seized hold of our beloved Erie conservatism as one reason for that rejection. Quoting a 2014 decision from the same court, the Cotton court made clear that “it is not this Court’s role to expand upon the availability of tort remedies that Indiana has made clear are to be limited in scope.”

Second, the Cotton court held that the plaintiff could not satisfy the elements of unjust enrichment. The plaintiffs were seeking restitution, but they were unable to demonstrate a contractual relationship with the manufacturer. Moreover, the plaintiffs “certainly expected a working product, but likely did not expect any payment following the implantation of the products.” This was simply not a quantum merit case. As with the negligent misrepresentation ruling, the dismissal of the unjust enrichment claim effectively removes this claim from personal injury litigation in Indiana.

The Cotton court was confronted with whether the claims in the case before it would make it to trial. It laid those claims alongside Indiana law to see if they fit the bill. That is a form of case management far more honorable and effective than the stilted gamesmanship one might be unlucky enough to encounter in MDLs.

This time out of Massachusetts.  And in an opinion authored by a female judge.  This isn’t something we would normally take the time to point out, but as we embark on the 39th Women’s History Month, the combination of Massachusetts and a female judge stood out to us.  Afterall, Massachusetts was home to Abigail Adams, one of her husband’s closest advisors.  It was Abigail who implored John Adams in 1776 to “Remember the ladies and be more generous and favorable to them than your ancestors.”  While that may be her most famous quote, it does not end there.  Her letter continued: “If particular care and attention is not paid to the Ladies we are determined to foment a Rebellion, and will not hold ourselves bound by any Laws in which we have no voice, or Representation.”  It would only take another 144 years for women to be granted the right to vote in America.  And, while the first woman was appointed to the bench in 1928, women still only account for 27% of currently presiding federal judges.  So, maybe it is worth pointing out that today’s decision is authored by a Massachusetts woman, following in the footsteps of so many great ladies of that state (Louisa May Alcott, Emily Dickinson, Susan B. Anthony, Clara Barton, Rachel Fuller Brown, Dorthea Dix, Amelia Earhart, Elizabeth Freeman, and Helen Keller – to name a few).

The case is Plourde v. Sorin Group USA, Inc., 2021 WL 736153 (D. Mass. Feb. 5, 2021).  Plaintiffs daughter died following complications from a surgery to remove an aortic bioprosthetic heart valve manufactured by defendants.  Id. at *1.  In 2018, the court granted in part and denied in part defendants’ motion to dismiss.  (2018 WL 1542361).  The only claim that survived the pleadings stage was plaintiff’s failure to report adverse events to the FDA.  In that opinion the court made clear that it had not decided whether Massachusetts law imposed such a duty but would afford plaintiffs an opportunity to demonstrate that it did.  Id.

The valve at issue is a Class III, PMA device that was approved by the FDA in 2007.  Id. at *3.  The Instructions for Use (IFUs) that accompanied the valve, and that were approved by the FDA, provide a warning that patients under the age of 55 “may experience accelerated calcification” of the valve.  Id.  The risk of accelerated calcification in younger patients is “common knowledge” in the medical community due to more active bone turnover and increased cardiac output.  Id. at *5.  Indeed, plaintiffs’ expert testified it was a risk he learned about in medical school in the 1990s and he co-authored, with plaintiff’s implanting surgeon, a study concluding the risk was greater in younger patients.  A study that they published a few months before plaintiffs’ daughter’s procedure.  Id.  The implanting surgeon discussed this risk, and others, with plaintiffs before deciding to proceed with a bioprosthetic valve in part because it would not require daily Coumadin treatment.  Id.

The facts in this case also demonstrated that defendants’ adverse event reporting process had been subject to both FDA and independent audit with no deficiencies found.  Id. at *4.  Despite that, plaintiffs claimed that defendants failed to report all of the events they should have to the FDA.

Plaintiffs argued that the failure to report to the FDA was the basis for their failure to warn, breach of implied warranty, breach of express warranty, and unfair business practices claims.  However, where the basis for the breach of implied warranty claim is a failure to warn, Massachusetts collapses the two causes of action into essentially one.  Id. at *9.

That is where the court’s legal analysis began – failure to warn.  Plaintiffs argued that had defendants reported additional adverse events to the FDA, the FDA would have made the information public which would have provided doctors and patients with more information about the risks.  Id. at *10.  The court did not have to address the attenuated causation problem with plaintiffs’ argument, but we reference it as it has been a sticking point in other cases where failure to report was recognized.  Instead, the court focused on the fact that plaintiffs had “not identified binding or persuasive authority that manufacturers of medical devices have a common law or statutory duty to report advents to the FDA.”  Id.   Further, Massachusetts recognizes the learned intermediary doctrine and plaintiffs could not cite to any law to support a basis to extend the duty to warn physicians to a duty to warn the FDA.  Id.

Therefore, the court held that Massachusetts does not recognize a cause of action for failure to report.  Without a state-law duty, there can be no parallel claim.  Plaintiffs’ failure to warn claim is “different from” federal law and therefore preempted.  Id. at *11-12.

Plaintiff’s breach of express warranty claim failed because (i) the performance of the product must be judged against its warnings and (ii) plaintiffs did not identify any specific false statement made to them or the implanting surgeon.  Id. at *13.  Plaintiffs’ unfair business practices claim failed because it was derivative of plaintiffs’ failure to warn claim.  The statutory claim is only independent if plaintiff “offers separate arguments in support.”  Id. at *14.  Here, the claim was based on the same failure to report, the claim was likewise dismissed.

“If we mean to have heroes, statesmen and philosophers, we should have learned women.”

Abigail Adams

In the third of the three significant decisions issued in the In re Zantac MDL, No. 2924, on New Year’s Eve, preemption prevailed again – this time barring claims asserted against drug retailers and pharmacists, both branded and generic.  In re Zantac (Ranitidine) Products Liability Litigation, ___ F. Supp.3d ___, 2020 WL 7864585 (S.D. Fla. Dec. 31, 2020).  For anyone who hasn’t read our prior “Zantac Chronicles” posts, the relevant facts are these:  the Zantac MDL involves, as a claimed product defect in a drug, the alleged tendency of the active ingredient to break down over time into a substance that “increase[s] the risk of cancer.”  Id. at *2.

This type of substance – nitrosamines − is something anyone who consumes bacon, beer, or cheese has already been exposed to for many years (pills being a lot smaller).  The alleged defect was not discovered until well after the relevant patents had expired and generic versions of the product had entered the market.  Id.  The Zantac plaintiffs sued everyone they could think of, including intermediate sellers, such as pharmacists and retailers.

One of the things we like, as readers, about the Zantac opinions is that the rulings are summarized right up front – so we don’t have to scroll to the end to find the result.  The summary here was short and sweet:

The Court concludes that all of the Plaintiffs’ state-law claims against the [retailer/pharmacy] Defendants are pre-empted by federal law and, as a result, are dismissed.  Without a state-law claim to support it, the Plaintiffs’ sole federal claim is dismissed as well.  The Court will permit the Plaintiffs to re-plead a general negligence claim, subject to certain rulings contained in this Order.

2020 WL 7864585, at *5.

Why?

Once again, we return to what the Supreme Court held in PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013).

The [Mensing] Court stated that the “question for ‘impossibility’ is whether the private party could independently do under federal law what state law requires of it.” “[W]hen a party cannot satisfy its state duties without the Federal Government’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.”

Zantac, 2020 WL 7864585, at *5 (citations to Mensing omitted).  Then, in Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013), the court extended this holding to design defects.  Thus, “the Defendants’ second point − any claim based upon drug design is pre-empted − is also supported by a plain reading of Bartlett.”  Zantac, 2020 WL 7864585, at *5 (block quotation from Bartlett omitted).

The Zantac plaintiffs asserted numerous counts − Failure to Warn (Strict Liability), Design Defect (Strict Liability), Negligence—Failure to Warn, General Negligence, Breach of Express Warranties, Breach of Implied Warranties, Deceptive Acts, and Unjust Enrichment.  Id. at *12-13.  Zantac concluded that “all of the Plaintiffs’ state-law claims against the [retailer/pharmacist] Defendants are based upon [the drug’s] allegedly defective design and inadequate labels/warnings.”  Id. at *13.  Zantac then took the plaintiffs to task:

[C]ourts dismiss design and label-based claims against any defendant that is powerless to alter a design or alter a label.  The Plaintiffs have provided no citation to post-Bartlett authority where a court reached a different conclusion, nor have the Plaintiffs cited to a case where a court held that strict liability is equivalent to absolute liability − a proposition that Bartlett squarely rejected.  Instead, the Plaintiffs rely upon Section 402A of the Restatement of Torts, . . . [b]ut the Supreme Court in Bartlett utilized 402A in reaching its conclusion that strict liability is not equivalent to absolute liability. . . .  In summary, all of the caselaw weighs in favor of a conclusion that the Plaintiffs’ claims are pre-empted. . . .  The Court’s dismissal is with prejudice and without leave to amend.

2020 WL 7864585, at *13-14.  In short, these non-manufacturing defendants were entitled to dismissal because the claims against them were made up from whole cloth, and simply unsupportable post-Mensing/Bartlett.

Zantac then gave special attention to plaintiffs’ “misbranding” and “general negligence” claims, which were the only theories that they seriously attempted to defend.  As for misbranding, first, it amounted to a preempted stop-selling claim.  “[T]he Defendants could not correct the alleged misbranding” by “altering” either the drug’s “composition” or its “label.”  Therefore, even taking plaintiffs’ claim at face value, “[t]he Defendants would have no recourse but to stop selling the drug altogether.”  Id. at *15.  Nor could the misbranding allegations be taken seriously, since, second, they distorted the scope of the FDCA.  “By definition, however, such a claim could only be brought against a manufacturer − not a retailer or a distributor.”  Id.  Third, Zantac again rejected (as it did here) plaintiffs’ reliance on “misbranding” as a get-out-of-preemption-free card:

[A] finding that Plaintiffs can avoid pre-emption by alleging that defects in ranitidine products made the products misbranded under 21 U.S.C. §352 would render the vast body of pre-emption caselaw in the drug context, including binding Supreme Court decisions, meaningless.  If Plaintiffs’ position were accepted, a plaintiff could avoid pre-emption simply by asserting, for example, that a drug’s labeling was “false or misleading in any particular” or that the drug was “dangerous to health when used” as prescribed.  The Court cannot adopt a position that would render pre-emption caselaw meaningless.

Id. (citation omitted).  Fourth, “there is no private right of action to enforce federal misbranding law − a statute that imposes criminal penalties” and “Plaintiffs cannot create a private right of action to enforce federal misbranding rules by disguising it as a state-law strict-liability claim.”  Id. at *16.  Thus, in addition to Mensing and Bartlett, all misbranding clams are also barred by Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001).  Zantac, 2020 WL 7864585, at *16.

Nor could plaintiffs use “general negligence” as a “very broad” dumping ground for otherwise preempted allegations.  Id.  In this count, “Plaintiffs allege[d] that every Defendant in this MDL engaged in every possible action” during “every possible timeframe,” “regardless of the individual Defendant’s role or purpose in this case.”  Id.  Most of this confusing mess was just another preempted attack on the design and labeling of the product.  Id. at *17.  Mixed in, however, were novel allegations about purported duties relating to post-manufacture drug storage and transportation.  Id.  Zantac referred to as a “temperature-based negligence theory.”  Id.  Of course, nothing of the sort was actually pleaded in plaintiffs’ sprawling “shotgun-style pleading,” id. at *16, so as to this one item plaintiffs were granted leave to amend their complaint, but this leave came with a warning that plaintiffs had better “address the Court’s concerns” if they elect to proceed with temperature based negligence.  Those “concerns” were:

  • “Can the Plaintiffs plead in good faith that any Defendant had a policy to store [these] products at temperatures above those approved by the FDA?”
  • “If individual stores negligently stored [the drug] at unsafe, heated temperatures, how is that a global, MDL-based issue?” “[I]ndividualized and fact-specific” storage/transportation issues “have little, if any, bearing on the broader, more global questions in this MDL.”
  • Are “causation questions inherent in a high-temperature allegation” also individualized?  “Investigation where, in a supply chain, overheating occurred appears to the Court to be an individualized, fact-intensive discovery challenge.”
  • “[H]ow are high-temperature allegations to be squared with the Plaintiffs’ theory of the case,” which has been “that the Plaintiffs’ harm was caused at the very moment [the drug] was manufactured?”  “Plaintiffs must explain how that specific theory of liability is compatible with the Plaintiffs’ global theory of liability.”

2020 WL 7864585, at *18-19 (emphasis original).  As we observed in a prior Zantac post, in their desperation to avoid preemption, plaintiffs’ counsel have let their considerable imaginations run wild, and dreamed up non-FDA regulated scenarios with little concern for consistency or existing law.  “Plaintiffs have provided no authority for the proposition that [retailer/pharmacy] Defendants had a duty under state law to hire independent scientists to determine where, in a federally-approved temperature range, a drug should be stored.”  Id. at *19.  There certainly is no federal duty that they do so.  Id. (citing 21 C.F.R. §211.166(a)).  Plainly, the “concerns” discussed at length in Zantac are an attempt to avoid a reprise of Plaintiffs’ previous failed attempt (discussed here) to use the MDL to create novel tort duties that the states themselves have not recognized.

In addition to implied preemption, the Zantac plaintiffs also purported to make claims against the retailer/pharmacy defendants that impinge on matters governed by the Drug Supply Chain Security Act, 21 U.S.C. §§360eee to 360eee-4.  2020 WL 7864585, at *20.  But as discussed in a previous post, this statute contains an express preemption clause that is even more emphatic than the one that supports broad medical device preemption.  See §360eee-4(a) (preempting state law “inconsistent with, more stringent than, or in addition to, any requirements applicable” under the statute).  Plaintiffs attempted to limit the scope of express preemption to “tracing products through the distribution system,” which does not appear to be an issue in the Zantac litigation.  2020 WL 7864585, at *21.  They got spanked again, for “ignor[ing] . . . additional text in the statute” that included “verification, investigation, disposition, notification, or recordkeeping” within this act’s preemptive scope.  Id. (quoting §360eee-4(a)).

The Zantac plaintiffs’ claims that the defendants should not have accepted these drugs because they were defectively designed as a reason “in addition to − not contained in − the Act.”  Id. at *21.  Zantac did not accept the anti-preemption rationale concerning the same statute in In re Valsartan, Losartan, & Irbesartan Products Liability Litigation, 2020 WL 7418006 (D.N.J. Dec. 17, 2020), a decision we lambasted here, because the alleged contamination in Zantac arose “within” the drug supply chain.  Id. at *22.  Ultimately, Zantac did not resolve the issue because, once again this was an unpleaded theory made up by plaintiffs’ counsel “at the Hearing.”  Id.

Finally, the Zantac plaintiffs’ Magnuson-Moss warranty claims were dismissed for the same reasons we detailed in our previous post – they require a valid state-law warranty claim a predicate, and plaintiffs have none.  2020 WL 7864585, at *2.

So once again, almost all of the Zantac plaintiffs’ claims against the moving defendants have been held preempted.  What remains are novel and problematic claims that plaintiffs didn’t actually plead, and as to which the MDL judge expressed significant “concerns.”  Will the Zantac plaintiffs continue to lead with their chins?  Stay tuned.

It’s a good day in suburban Philadelphia.  The sun is shining, the snow is melting, Covid-19 cases are down nationwide, and we just got a text from the Drug and Device Law Rock Climber heralding a weekend visit (with the Irascible Rescue Pomeranian in tow).  We are enjoying a welcome (if cautious) flash of optimism.  And today’s case did nothing to dampen our spirits.

In Lim v. Ethicon, Inc., 2021 WL 612399, __ F. Supp. 3d __, (S.D. Miss. Feb. 12, 2021), the plaintiff alleged that she was injured by the defendant’s pelvic mesh device.  She asserted claims under the Mississippi Product Liability Act for manufacturing defect, failure to warn, and design defect, and the defendant moved for summary judgment on all of the claims.  Now, we move for summary judgment in medical device cases all the time, and we often report on others’ summary judgment motions in these pages.  Over and over again, we see courts go off the rails because they misapply burdens of proof.  Here’s what we mean:  if the plaintiff bears the burden of proof on a substantive claim, and the defendant moves for summary judgment on that claim, the plaintiff is supposed to escape summary judgment only if she can adduce affirmative evidence satisfying her burden of proof on the elements of the claim.  The plaintiff has to prove that she has evidence – the defendant doesn’t have to prove that there is no evidence.  (We talk about this all the time in the warnings causation context – more about that in a minute.)  But, too often, courts upend this, denying summary judgment because the defendant did not “prove the negative.” The Lim court got it right, three times.

Manufacturing Defect

As the court explained, “a manufacturing defect claim under the MPLA requires a showing that a product ‘deviated in a material way from the manufacturer’s or designer’s specifications or from otherwise identical units manufactured to the same manufacturing specifications.’”  Lim, 2021 WL 612399 at *3 (citation to MPLA excluded).  The plaintiff had no such evidence (they never do, in pelvic mesh cases).  Because, as the court emphasized, “the plaintiff bears the burden of proving her manufacturing defect claim at trial,” (burden-of-proof “bingo” #1), the absence of evidence was fatal to the claim.

Design Defect

In Mississippi, a plaintiff cannot prevail on a design defect claim without proving that “an alternative design existed that would not impair the product’s usefulness or desirability [and that] would have to a reasonable probability prevented the harm.”  Id. at *4 (citation omitted).  The plaintiff alleged that her mesh device suffered from defects that included “roping, curling, fraying, particle loss, degradation, contraction and shrinkage, chronic foreign body reaction and decreased pore size.”  Id.  (We mention, parenthetically, that this litany appears in the report of every one of the ubiquitous mesh “experts” we face on a daily basis.)  The court emphasized that, even “accepting this as true for purposes of” the summary judgment motion, the plaintiff could defeat summary judgment only if she could “present an alternative design that would have prevented the harm” the product allegedly caused.  Id.

In the first place, the plaintiff purported to quote the report of one of her experts for the proposition that a safer alternative mesh design existed at the time of the plaintiff’s mesh implant surgery, but, as the court pointed out, the expert didn’t say any of this, in fact, he “[did] not discuss alternative designs . . . anywhere in his report.”  Id.  Never a good idea to make things up, but the court took it a step further, pointing out that, even if the expert actually had said these things, one of plaintiff’s other experts said the opposite, opining that the supposed “alternative” mesh has propensities that produce an “overall result [that] can be worse . . . .”  Id.   Finally, an “alternative” proposed by yet another of plaintiff’s experts did “not involve any implantation of a medical device;” rather, it was a completely different procedure involving tissue harvested from the plaintiff’s own body.  Id. at *5.  Under Mississippi law, like most everywhere else, this does not satisfy the requirement that a plaintiff identify a safer, feasible alternative design for an allegedly-defective product.  (Here and here, you can see a couple of examples of posts on this.) Because the plaintiff had not “put forth evidence” that a “safer alternative design” for her mesh device existed at the time of her implant surgery, the court held that she could not “support her design defect claim,” and it granted summary judgment for the defendant.  (Burden-of-proof “bingo” #2.)

Failure to Warn

Finally, we turn to “warnings causation,” one of our favorite doctrines but also one responsible for countless jurisprudential misadventures.  Causation is an element of a failure-to-warn claim.  Even if a plaintiff can prove that a warning was inadequate, she still must prove that the inadequate warning proximately caused her alleged injuries.  Under Mississippi law, to escape summary judgment on warnings causation, the plaintiff must adduce evidence that an adequate warning would have “altered [the doctor’s] conduct” and would have “caused him not to implant” the product.  Id. at *6.  Again, this is an element of the claim, and the plaintiff has the burden of proving it.

In Lim, the plaintiff “did not claim that any additional warning” by the defendant “would have caused [the doctor] not to implant” the product.  Instead, she “focus[ed] on her mistaken contention” that the defendant owed a duty to warn her directly – “that the learned intermediary doctrine does not apply in cases with medical devices.”  To the contrary, the court emphasized, “it does.”  Id.   So the defendant’s duty to warn ran only to the doctor.  In this case, the doctor testified that he was aware of all of the relevant risks from “his own medical training and research,” that the defendant’s warnings were “not something he would typically consult before implanting the device,” and that he “had not become familiar with the documentation before implanting” the device in the plaintiff.  Id.   Because the doctor did not rely on the defendant’s warnings, the plaintiff could adduce no evidence that any additional warning would have altered the doctor’s prescribing decision (you can see our roundup of similar failure-to-read cases here).  And while the plaintiff also complained that the doctor did not warn her before her surgery, this was not enough for the plaintiff to “overcome her burden on summary judgment.”  (Burden-of-proof “bingo” #3.)

Decisions like Lim bring us great joy because they fall squarely in our personal “wheelhouse” and give us hope for similar results.  We’ll keep you posted on the good and the bad.  In the meantime, stay safe out there.

Today’s case, Knudsen v. Ethicon, Inc., 2021 WL 390825 (M.D. Fla. 2021), involves product-liability claims against a surgical-mesh manufacturer. In a short decision, the court dismissed manufacturing-defect and implied-warranty claims as inadequately pleaded under Michigan law. Although not fully developed, the court’s reasons for dismissing the claims exhibit both insight into manufacturing-defect claims and confusion about implied-warranty claims.

The court’s analysis of the manufacturing-defect claims was spot on, starting with its observation that manufacturing-defect claims are “analyzed very differently” than design-defect claims. Knudsen, 2021 WL 390825, at *1 (internal quotation marks omitted). Under Michigan law (like the law of other states), a manufacturing defect exists when “something goes wrong in the manufacturing process and the product is not in its intended condition.” Prentis v. Yale Mfg. Co., 365 N.W.2d 176, 182 (Mich. 1984) (cited by Knudsen, 2021 WL 390825, at *1). Thus, while a purported design defect will necessarily affect all units of a product, a manufacturing defect generally affects only one unit or a subset of units.

This distinction was alluded to in Bryant v. Medtronic, 623 F.3d 1200 (8th Cir. 2010). In that case, which involved a Class III medical device that had received premarket approval from the FDA, the Eighth Circuit affirmed the dismissal of manufacturing-defect claims as expressly preempted by 21 USC 360k(a) because the plaintiffs had failed to allege a violation of the manufacturing requirements imposed on the device through the premarket approval process. Given the plaintiffs’ contention that the manufacturer was liable to “every person” who had received the defibrillator lead at issue rather than liable only to particular individuals who had received specific units, their manufacturing-defect claims were, the court said, “a frontal assault on the FDA’s decision” to approve the device as designed. 623 F.3d at 1207. In other words, although labeled manufacturing-defect claims, they were in fact thinly veiled design-defect claims.

Because a manufacturing defect exists only when the final product “is not in its intended condition” (Prentis, 365 N.W.2d at 182), “[a] claim for a manufacturing defect ‘necessitates examination of the product itself rather than the manufacturer’s conduct.’” Knudsen, 2021 WL 390825, at *1 (quoting Gregory v. Cincinnati Inc., 538 N.W.2d 325, 329 n.10 (Mich. 1995)). That examination entails comparing the unit in question with other units of the same product to determine whether the unit in question deviates from the others. As the Knudsen court put, “[i]n the case of a ‘manufacturing defect,’ the product may be evaluated against the manufacturer’s own production standards, as manifested by that manufacturer’s other like products.” Id. (quoting Prentis, 365 N.W.2d at 182). The Knudsen plaintiff failed to allege any difference between the surgical mesh that he received and other units of surgical mesh manufactured by the defendant and the court granted the defendant’s motion to dismiss the plaintiff’s manufacturing-defect claim “on that basis.” Id. at *2.

Notably, in dismissing the claim, the court implicitly rejected application of the res ipsa loquitur doctrine to injuries allegedly caused by an implantable medical device. Beloved by plaintiffs facing dismissal because they are unable to identify a defect in a product, the doctrine holds that a defect can be presumed when an injury occurs under certain circumstances. While the precise formulation varies from jurisdiction to jurisdiction, in Michigan as elsewhere a plaintiff wishing to invoke the doctrine must establish, among other things, that the injury is “of a kind which ordinarily does not occur in the absence of someone’s negligence” and was “caused by an … instrumentality within the exclusive control of the defendant.” Woodard v. Custer, 702 N.W.2d 522, 525 (Mich. 2005).

Given these prerequisites, the res ipsa loquitur doctrine is never applicable to injuries allegedly caused by implantable medical devices. Leaving aside the fact that medical devices (particularly those with premarket approval) will sometimes fail to perform as intended even when properly manufactured, implantable medical devices never cause injuries while in the exclusive control of the defendant manufacturer. An implantable medical device cannot cause injury until it is implanted. By that point, the device is outside the manufacturer’s exclusive control. At minimum, the device will have been handled by the implanting surgeon during implantation. And, as in Knudsen (where the mesh had been implanted for a decade), the device often will have been in the patient’s body for years before the alleged injury occurs. The “safety and reliability” of an implantable medical device, however, “cannot be guaranteed indefinitely in the extremely hostile environment of the human body, where myriad other factors external to the device are brought to bear.” Walker v. Medtronic, Inc., 670 F.3d 569, 580 (4th Cir. 2012) (internal quotation marks omitted). Accordingly, the res ipsa loquitur doctrine is inapplicable and, as the Knudsen court held, the mere allegation that an implantable medical device malfunctioned “alone is not enough” to state a manufacturing-defect claim. 2021 WL 390825, at *2.

Less satisfying is the court’s analysis of the plaintiff’s implied-warranty claims, even though the court dismissed those claims too. Indeed, the court’s analysis betrays a serious confusion over the source of implied warranties.

In Knudsen, the defendant manufacturer argued that the plaintiff’s implied-warranty claims failed as a matter of state law because the plaintiff “did not provide notice required by the Michigan Uniform Commercial Code (‘UCC’).” 2021 WL 390825, at *2. The court rejected that argument, tentatively accepting the plaintiff’s counter-argument that “the UCC is inapplicable.” Id. Because the plaintiff received the mesh “from a doctor during an operation,” the court characterized him a purchaser of services from the doctor rather than a purchaser of goods from the manufacturer. The UCC, however, applies only to “transactions in goods.” Id. (quoting Mich. Comp. Laws § 440.2314). Thus, having deemed the plaintiff a purchaser of services rather than goods, the court concluded that UCC—and its notice requirement—did not apply and that the plaintiff’s implied-warranty claims were therefore not subject to dismissal for failure to provide notice.

The court’s reasoning rests on an unacknowledged internal contradiction. “[T]he implied warranties of merchantability and fitness for a particular purpose arise through implication by operation of law.” Heritage Resources, Inc. v. Caterpillar Fin. Servs. Corp., 774 N.W.2d 332, 344 (Mich. Ct. App. 2009) (citing Mich. Comp. Laws §§ 440.2314, 440.2315). In particular, those implied warranties—the warranties invoked by the Knudsen plaintiff—arise by operation of the UCC. Cf. id. Therefore, if the UCC is inapplicable to the plaintiff’s warranty claims, as the Knudsen court held, then there is no legal basis for those claims in the first place. The court did not recognize, let alone address, this contradiction.

Although the harm caused by the court’s error is limited in the particular case by its dismissal of the warranty claims on alternative grounds (namely, plaintiff’s failure to adequately allege a defect), the consequences of the court’s erroneous analysis could prove more significant if adopted in other cases.

The case of Dennis v. Bayer Healthcare Pharmaceuticals Inc., et al., 2020 WL 534307 (W.D. N.C. Feb. 3, 2020), has occupied our in bin for about a year, probably because there are aspects of it that rub us the wrong way. But not all of Dennis is a menace. If you represent a drug distributor, you might find Dennis useful.

The plaintiff in Dennis alleged that she was injured from gadolinium contrast agents used in MRIs. She sued a couple of manufacturers as well as a distributor. Her main claim was that the defendants should have warned that their products could cause retention of toxic gadolinium in patients with normal renal function.

One of the manufacturers had a pretty solid argument that the court could not exercise personal jurisdiction over it. The court essentially punted on this issue, reasoning that “[w]hen a case is at such an early stage in the proceedings, it is hard to expect a plaintiff to have information about a company’s jurisdiction beyond what is alleged by Plaintiff in her Amended Complaint”. We’ve seen that sort of rationale before in various contexts, permitting plaintiffs to file any sort of complaint they want and then see via discovery whether there is any there there. Blessing vague, speculative, or even agnostic complaints strikes us as a soft-headed approach. It is also at odds with the plaintiffs’ burden of proof in establishing personal jurisdiction.

Perhaps the Dennis court had an inkling that its ruling was iffy, because it denied the defendant’s personal jurisdiction without prejudice. The defendant could raise the issue again. When? Later. Meanwhile, the Dennis court invited the plaintiff to do better: “If Plaintiff has more information regarding this Court’s jurisdiction over the Bayer Defendants, she is encouraged to include it if she chooses to further amend her complaint.” That’s nice. Weak and ineffectual, but nice.

The Dennis court also punted on that same manufacturer’s preemption argument. The issue was whether the manufacturer could have, based on newly acquired information, executed a change being effected, and whether the FDA would have rejected such change. Other courts have applied preemption in gadolinium cases involving plaintiffs with normal renal function, but the Dennis court concluded that whether the FDA “would have rejected the label requested is not something that can be decided on the pleadings”. So we get more kicking of the can down the road.

The other manufacturer argued that the plaintiff had inadequately pled injury, causation, foreseeability, fraud, etc. The Dennis court again cut the plaintiff enormous slack in denying the motion to dismiss. And the Dennis court again invited the plaintiff to improve her pleadings: “However, if Plaintiff has more factual allegations to support her claims against Bracco, she is encouraged to include them if she chooses to amend her complaint”.

Hmmmmm. We wish judges would rule our way more often, even if they “encouraged” us to up our game.

Let’s turn to the part of the Dennis opinion where the court issued a more muscular ruling. The distributor relied upon the SCOTUS Pliva v. Mensing case, which held that generic manufacturers could not be liable for state law failure to warn claims because federal law did not allow generic manufacturers to change the warning labels. It was undisputed that distributors, like generic manufacturers, lacked any ability to change the warning labels. Thus, it is unsurprising that numerous courts have ruled that distributors cannot be liable for state law failure to warn claims. The plaintiff cited a Yaz case to the contrary, but it came out before Mensing, so the Yaz case was a worthless has-been (a Yaz-been?). The Dennis court ended up holding that, because federal law would not permit the distributor “to do what state law purports to require of it, Plaintiff’s incompatible state law claims are preempted.” There it is – an actual ruling and an actual dismissal of all the causes of action premised on failure to warn, including negligent misrepresentation and breach of express warranty. That is a bit more and a lot better than a pat on the head and a suggestion to do better. We might even call that ruling encouraging.

The distributor also moved to dismiss the remaining claims against it, but it was hard to determine what they even were, including whether they were any different from the failure to warn claim. The allegations also lumped defendants together and it was hard to tell who was supposed to have done what. Not to put too fine a point on it, the plaintiff’s allegations were a pail of goo. Predictably, the court decided to “allow Plaintiff to file a second amended complaint to address these deficiencies.” The court said that “if Plaintiff chooses to amend her complaint a second time, she should ensure that all her claims are supported by factual allegations.” Yes. Good idea. That same good idea should have held sway for the prior complaints. The Dennis court apparently is reluctant to call a plaintiff out until there are three strikes.

As we mentioned, this Dennis opinion is over a year old. Indeed, the case was already old (pending since September 2018) when the opinion was issued. Thus, the timid nature of the opinion is all the more astonishing and disappointing. But our story does not end there.

Two months after this opinion issued, and one week after an answer was filed, the case was dismissed outright. The stipulation of dismissal has some rather interesting terms:

The undersigned parties further stipulate and agree that, in the event Plaintiff files an action in any jurisdiction against any of the undersigned Defendants or McKesson Corporation (collectively the “Defending Parties”) bringing claims related to gadolinium-based contrast agents, Plaintiff will pay to each Defending Party named in the newly filed case all of that Defending Party’s costs and fees incurred in the defense of the present case, Civil Action No. 3:18-CV-00491 (the “Original Lawsuit”). The undersigned Defending Parties, in turn, agree that they will not otherwise pursue costs and fees associated with the defense of the Original Lawsuit.

All’s well that ends well, right? Perhaps the Dennis court even saw this resolution as a vindication of the kick-the-can strategy. We do not see it that way. The can should have been crushed much earlier.

Wanke v. Invasix, Inc., 2021 WL 325923 (M.D. Tenn. Feb. 1, 2021) is an interesting and somewhat long story, so we’re just going to give it to you straight.

In June 2017, plaintiff underwent a medical procedure on her face in which defendant’s medical device was used.  Her counsel entered into a tolling agreement with defendant in January 2019 and a day before the agreement was to expire, plaintiff filed her lawsuit, which included two other plaintiffs, in federal court in California, the home state of the defendant.  Defendant moved to sever the claims of the unrelated plaintiffs and to transfer them to plaintiff’s home states.  The California court granted that motion and plaintiff’s case was transferred to Tennessee.  Id. at *1-2.

Now for the details that make this case interesting.  In plaintiff’s original and first amended complaints, she alleged that she “knew something had gone terribly wrong” within days of her surgery; that her doctor shared her concern; that she became inconsolable at her doctor’s appointment; and that her doctor told her she would need “multiple additional treatments to address the injuries sustained.”  Id.  So, defendant moved to dismiss the complaint as barred by Tennessee’s one-year statute of limitations.  Plaintiff was given an opportunity to file a second amended complaint.  This time the complaint alleged that she “was told by her treating physician that her procedure had gone normally,” and that another physician told her her healing could take up to one year before they would know if there was any injury.  Id. at *2. Also, the new complaint omitted the prior description of plaintiff’s early post-surgical knowledge and tearful complaints to a doctor who shared her concerns.  Id. at *3.  The court concluded the new allegations raised a factual issue that prevented dismissal on the pleadings, but also expressed its “serous concern that [plaintff’s] actions . . . could amount to bad faith.”  Id.  Afterall, plaintiff wasn’t seeking to add a newly learned fact, but rather to “arguably contradict a factual claim that she made in her two earlier complaints and could not plausibly have been innocently mistaken about.”  Id. (“She has, moreover, offered little by way of a persuasive explanation for why she would seemingly change her story, other than her counsel’s having now realized the dangers posed by her earlier statements.”).

Next, defendant filed a motion for summary judgment pointing to plaintiff’s prior allegations as well as a letter sent from plaintiff’s counsel to defendant’s counsel in October 2018, again pre-tolling agreement, that sets out an account nearly identical to what was in the prior complaints including that plaintiff’s treater voluntarily refunded her the cost of the procedure.  That letter was a settlement demand and also included hundreds of pages of exhibits, including medical records.  Id. at *4.  Plaintiff’s primary opposition to the motion was that the prior pleadings were hearsay and had been superseded and the settlement demand letter was inadmissible for the purpose of establishing a contested issue of liability.  Id.

Before the court got to the statute of limitations ruling, it conducted a thorough choice of law analysis.  The discussion is elongated by the fact that this is a diversity case transferred between district courts.  In such situations, federal law mandates that “the substantive law governing the jurisdiction of the transferor court controls.”  Id. at *7.  Plaintiff argued that meant the Tennessee court had to apply California’s statute of limitations.  What it actually means is that Tennessee had to apply California’s choice of law principles to determine which statute of limitations applies.  Unlike many states that apply a substantive/procedural distinction in deciding statute of limitations issues, California applies a governmental interest test.  But before even getting that far, the court had to decide whether California’s borrowing statute applied.  Under the borrowing statute if a cause of action brought by a non-California resident arises in a foreign state and would be barred by that state’s statute of limitations, California will also bar the claim.  Id. at *8-9.   So that raises the question of where each of plaintiff’s causes of action arose.  To answer that, the court divided plaintiff’s claims into three groups:

  • fraud/warranty claims: which arise in Tennessee because they involve the particular transaction involving the particular device used in plaintiff’s surgery at a particular clinic in Tennessee;
  • product claims: arise in the state of injury, which is Tennessee; and
  • marketing/advertising claims: defendant’s marketing/advertising activities most likely were directed out of California, but because plaintiff’s claims are not about marketing to the general public (marketing in the air claims), that is not enough to answer the question.

Id. at *10.

[Plaintiff]’s causes of action do not arise out of some general grievance that the defendants advertised and marketed inappropriately. That general wrongdoing, if performed in California, would be the basis for a California-based enforcement action by the California state government or a California local government, not for a Tennessee-based private cause of action by an individual. . . . Indeed, if any jurisdiction gave [plaintiff] a cause of action arising merely out of the defendants’ general wrongdoing, that cause of action would be outside this court’s jurisdiction, due to lack of a particularized injury. For [plaintiff]’s cause of action to arise, it had to have some connection to her.

Id. at *11 (citations omitted).  Because plaintiff’s claims must necessarily arise out of particular instances of advertising and marketing that potentially influenced the use of the product in her surgery in Tennessee, the court thought it likely California’s borrowing statute would apply here as well.  But the court also went on to conclude that California would apply Tennessee’s shorter statute of limitations under the governmental interest analysis.  Tennessee’s one-year statute reflects its governmental interest in providing a “hospitable environment for companies to sell their medical products.”  Id.

That brings us finally to the application of the statute to the facts of this case.  Plaintiff’s first objection to the motion was based on Federal Rule of Evidence 408’s restriction on the admissibility of settlement communications.  But plaintiff’s reading of that rule is overly broad because many of the documents she seeks to exclude were not evidence of her offer or statements made during negotiations.  In other words, the inadmissibility of settlement offers does not prevent the use of documents initially provided during a settlement discussion where those documents would be otherwise discoverable.  Id. at *13.

That left plaintiff’s hearsay objection to the statements made in her prior complaints which plaintiff argued were her attorney’s words, not hers.  But that overlooks Federal Rule of Civil Procedure 801(d)(2)(c) which “designates as the equivalent of a statement of a party opponent, any statement that was made by a person whom the party authorized to make a statement on the subject.”  Id.  Plaintiff did not dispute that her attorney was authorized to make those statements about what she knew and when.  Therefore, defendant had admissible evidence to support its factual assertion that plaintiff’s claim is time barred. Id. at *14.

As the court summed it up – this was a case of “unusual” procedural and evidentiary issues, but the underlying facts are “fairly simple.”  Plaintiff knew shortly after her surgery that something was wrong and that triggered her obligation to look further into what that something was.  Therefore, the statute started running in the summer of 2017 and was long expired before the tolling agreement was ever entered.  Id. at *16.

Note:  these “unusual” circumstances were also present in Jones v. Invasix, Inc., 2021 WL 325925 (M.D. Tenn. Feb. 1, 2021) – one of the sister cases of Wanke severed and transferred from California.

Another of the recent significant decisions from the In re Zantac MDL, No. 2924, addressed preemption – mostly but not entirely involving defendants who manufactured generic versions of the drug.  In re Zantac (Ranitidine) Products Liability Litigation, ___ F. Supp.3d ___, 2020 WL 7864213 (S.D. Fla. Dec. 31, 2020).  For those who have not read our prior post, the Zantac MDL involves a claimed product defect in the nature of a design defect (an active ingredient that allegedly breaks down over time into a different chemical that “increase[s] the risk of cancer,” id. at *2).

The type of substance involved – nitrosamines − is something anyone who consumes bacon, beer, or cheese has already been exposed to for many years (pills being a lot smaller).  This purported defect was not discovered until well after the relevant patents had expired and generic versions of the product had entered the market.  Id.  The Zantac plaintiffs sued everyone they could think of, including the generic manufacturers and certain repackagers of the drug.

These defendants responded with preemption motions.  The motion filed by the generics was based on the by-now quite familiar PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013), decisions, which hold that since generic labels and designs must be “the same” as the original branded drug on which their Abbreviated New Drug Applications rest, it is impossible for them to comply with immediate state tort duties without the FDA first having to take action.  Zantac, 2020 WL 7864213 at *7-8 (describing rationale of Mensing and Bartlett).  Zantac also discusses the three types of drug-related “changes”:

  • Major, which “include[s] certain labeling changes, changes in the qualitative or quantitative formulation of the drug product . . . and changes in the synthesis or manufacture of the drug substance that may affect the impurity profile and/or the physical, chemical, or biological properties of the drug substance. A major change requires a supplement submission and [FDA] approval prior to distribution of the product made using the change.
  • Moderate, which is “any change in the drug substance, drug product, production process, quality controls, equipment, or facilities that has a moderate potential to have an adverse effect on the . . . safety or effectiveness of the drug product.. . . . A moderate change generally requires a “supplement submission at least 30 days prior to distribution of the drug product made using the change.”  However, some “moderate changes that may be made upon the FDA’s receipt of the supplement and need not await the passage of 30 days,” such as the label-strengthening “Changes Being Effected supplement.”
  • Minor, which “is a change in the drug substance, drug product, production process, quality controls, equipment, or facilities that has a minimal potential to have an adverse effect on the . . . safety or effectiveness of the drug product.” Minor changes may simply be “described in an annual report,” and do not require FDA pre-approval

Id. at *5-6 (regulatory citations and quotation marks omitted).

The plaintiffs in Zantac, of course, knew that they would be faced with preemption.  So rather than bring types of product liability claims (design, warning, Dear Doctor letter, testing, fraud, misrepresentation, express and implied warranty) that have already have been held preempted, id. at *9, they alleged novel, FDCA-related claims through which they hoped to make an end run around preemption.

For the most part, it didn’t work.  Plaintiffs’ primary effort to dodge preemption was to sprinkle in “misbranding” allegations to their complaints, and claim that – given the very broad language of the FDCA’s misbranding provision, 21 U.S.C. §352 – Mensing, Bartlett, and all forms of impossibility conflict thereby disappeared.  Since “misbranding” under the FDCA exists when a drug’s “labeling is false or misleading in any particular” or when “it is dangerous to health when used in the dosage or manner, or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof,” every common-law tort claim can be recast in this fashion.

First, a version of that argument had been asserted by the FDA in Mensing itself, and was held insufficient to prevent preemption.  2020 WL 7864213 at *11 (discussing Mensing, 564 U.S. at 616-17).  Second, every other court to consider “misbranding” allegations post-Mensing had nonetheless ruled in favor of preemption.  Id. at *12-13.

Third, the Zantac plaintiffs’ “misbranding” argument proved too much.  “No court has adopted Plaintiffs’ theory that impossibility pre-emption can be avoided by showing that a drug is misbranded.”  Id. at *13.  Nor can plaintiffs enforce the misbranding provisions of the FDCA.

It does not follow that, because a drug manufacturer that introduces a misbranded drug into interstate commerce is subject to criminal liability, a civil remedy must also be available.  There is no private cause of action to enforce the federal misbranding statutes.

Id. (citations omitted).  Finally, “misbranding” is not some form of anti-preemption kryptonite:

A finding that Plaintiffs can avoid pre-emption by alleging that defects in . . . products made the products misbranded . . . would render the vast body of pre-emption caselaw in the drug context, including binding Supreme Court decisions, meaningless.  If Plaintiffs’ position were accepted, a plaintiff could avoid pre-emption simply by asserting, for example, that a drug’s labeling was “false or misleading in any particular” or that the drug was “dangerous to health when used” as prescribed.  The Court cannot adopt a position that would render pre-emption caselaw meaningless.

Id. (citations omitted).

Zantac also held that the repackager defendants were entitled to the same relief as the generic manufacturers:

Plaintiffs do not contend that Repackager Defendants could lawfully make product or labeling changes that Generic Manufacturer Defendants could not lawfully make.  The same pre-empted claims against Generic Manufacturer Defendants are likewise pre-empted as against Repackager Defendants.

Id. at *14.

Besides misbranding, the Zantac plaintiffs had a fallback argument based on the expiration dates and testing.  The purported rationale of these allegations was that, since the deterioration that supposedly created the cancer risk was gradual, a shorter expiration date would reduce the claimed risk.  2020 WL 7864213, at *14.  The testing claim was related – if defendants had done more testing, they would have known to shorten the expiration date.  Id. at *14-15.  This argument was completely novel.  “None of the parties have pointed to any case where a claim based on failure to shorten the expiration date for a drug has been presented to a court.”  Id. at *15.

This time the Zantac plaintiffs’ primary problem was that they were making up things as they went along.  The master complaints ran to over 7,000 paragraphs.  Id. at *14 (7,236, to be exact).  But none of them pleaded claims about either expiration dates or testing.  Id. at *16 (“the Master Complaints do not state claims based on expiration dates and testing upon which relief can be granted”).  While that might be correctable by repleading, they have a serious consistency problem – their new argument that the products become more unsafe over time conflict conflicts with their existing allegations “that the products were dangerous upon being manufactured.”  Id.  Oops.  That’s what happens when you change course on the fly.  “Plaintiffs’ incorporation of inconsistent factual allegations into their counts is improper.”  Id.

And there’s more.  “Plaintiffs have not identified in the Master Complaints the state-law duty or duties for each of the 52 jurisdictions that they maintain Defendants did not fulfill when they did not shorten expiration dates for ranitidine products.”  Id.  Most states do not recognize an independent common-law claim for “negligent testing.”  See our duty to test cheat sheet.  Moreover, the only contrary “authority” cited in Zantac, 2020 WL 7864213, at *16 − Atkinson v. Luitpold Pharms., Inc., 448 F. Supp.3d 441, 453-54 (E.D. Pa. 2020) – is a Pennsylvania court misapplying Texas law, as we pointed out here.  If plaintiffs intend to pursue an expiration date claim, they are going to have to plead them separately, and on a state-by-basis.  Id.  Then they will have to defend these novel claims under state law in a new round of motions to dismiss.  Id.  This portion of Zantac closes with one of the finest reiterations of the Mensing independence principle that we’ve yet seen, combined with a warning to plaintiffs:

The question for “impossibility” is whether the private party could independently do under federal law what state law requires of it.”  If a defendant cannot, independently and while remaining in compliance with federal law, do what needs to be done to avoid liability under a state cause of action, the cause of action is pre-empted.  Upon any repleading, Plaintiffs should consider, as to each cause of action, the elements under each state’s law and what state law would require of Defendants to avoid liability.

2020 WL 7864213, at *17.  While we have our doubts about how deterrable MDL plaintiffs are, this time, they cannot say that they weren’t warned.

Another novel plaintiff fallback position was dismissed with prejudice in this Zantac opinion.  They tried to gin up a claim based upon allegations that product labeling lacked proper “storage and transportation” instructions.  Id. at *18-19.  Sorry, but the FDCA’s sameness requirements contains no exemption for these types of instructions:

The Court similarly is not aware of any authority providing that generic drug manufacturers or repackagers can change storage and transportation information on labeling without FDA pre-approval while remaining in compliance with federal law. . . .  Because claims based on labeling defects that a defendant cannot independently change while remaining in compliance with federal law are pre-empted, Plaintiffs’ claims based on allegations that Defendants should have placed different or additional storage and transportation information on their ranitidine products’ labeling are dismissed with prejudice as pre-empted.

Id.  “Testing” claims that would lead to the same result met the same fate.  Id. at *19.  While plaintiffs were allowed to replead storage claims as well, they again face a major problem:

Plaintiffs should be prepared to provide the factual and legal basis for a proposition that, if FDA-approved labeling permits a party to store a drug under certain conditions, a state may nonetheless impose liability for storing the drug under those conditions.

Id.  This sounds like a Rule 11 warning.

Finally, the rest of this Zantac opinion addresses a number of other claims:

  • Failure to Report:  Once again, the plaintiffs failed to plead this claim.  Id. at *20.  One wonders what plaintiffs did in their 7,000+ paragraphs.  Given Eleventh Circuit law, however, this claim looks like a loser.  See Mink v. Smith & Nephew, Inc., 860 F.3d 1319, 1330 (11th Cir. 2017) (“[plaintiff’s] failure to report theory is impliedly preempted . . . [b]ecause this theory of liability is based on a duty to file a report with the FDA, it is very much like the ‘fraud-on-the FDA’ claim the Supreme Court held was impliedly preempted in Buckman”).
  • Manufacturing Defect: TwIqballed.  Plaintiffs “fail[ed] to plead any specific facts such as the identification of how any particular batch of ranitidine products departed from their intended design or of any particular manufacturing processes or procedures that should have been but were not followed.”  Zantac, 2020 WL 7864213, at *21.
  • Magnuson Moss Warranty Act: “[C]laims under the MMWA require a valid state-law warranty claim.”  Id. at *22.  Further, “[t]he MMWA is “inapplicable to any written warranty the making or content of which is otherwise governed by Federal law,” so it “is inapplicable to warranty claims based on language on drug labeling that the FDA governs.”  Id. at *23-24.  Plaintiffs are allowed to replead if they can.  Good luck.
  • Absolute Liability: Absolute liability does not exist.  Dismissed with prejudice.  Id. at *24.

Bottom line?  This Zantac decision is another big win for the moving defendants (here, generic drug manufacturers and repackagers).  While plaintiffs are allowed to replead some of their claims, most of those claims are unprecedented under state law, and thus subject to the Erie conservatism principle already recognized in this MDL.  Plaintiffs’ one traditional product liability claim, manufacturing defect, cannot be squared with the chemical breakdown premise that is at the heart of the MDL.

Those of you following the fortunes of COVID-19-related litigation should check out these two recently decided cases:  Garcia v. Welltower OpCo Group LLC, 2021 WL 492581 (C.D. Cal. Feb. 10, 2021), and Fields v. Brown, 2021 WL 510620 (E.D. Tex. Feb. 11, 2021).

Garcia, the older of the two (by one day), addressed the ability of the PREP Act, 42 U.S.C. §§247d-6d, et seq., to create federal question jurisdiction in nursing home litigation over the alleged rationing of anti-COVID “covered countermeasures” in cases where there is no diversity of citizenship.  Regular readers will remember our post last December about the Department of Health & Human Services (“HHS”) declaration that significantly expanded PREP Act immunity to, inter alia, cases alleging failure to employ such countermeasures.  Garcia involved such allegations.  2021 WL 492581, at *1-2.  Even though there was no diversity of citizenship, the “senior living” defendants removed to federal court on the ground that PREP act immunity created federal question jurisdiction.  Id. at *2.

Plaintiffs in Garcia argued the PREP Act immunity did not apply to “negligence claims unrelated to vaccine administration and use.”  Id. at *4.  They also asserted that “fail[ure] to adhere to infection control protocols . . . do[es] not receive PREP Act immunity.”  Id. at *5.  Both contentions failed.  Contrary precedent preceded, and thus could not have considered, more recent HHS declarations expanding the scope of PREP Act immunity.

[E]ach of these cases precedes more recent guidance from [HHS] which suggests that when a party attempts to comply with federal guidelines – in this case, concerning the COVID-19 pandemic – the PREP Act would provide complete preemption. . . .  [A]s recently as February 2, 2021, a court within this district found that the PREP Act does not provide for complete preemption.  However, it is not clear from that order if [that] court even considered the [more recent] Advisory Opinion. Therefore, the Court declines to defer to that decision.

Id. at *6 (citations omitted).  “That the Advisory Opinions are not binding law or formal rules issued via notice and comment does not render them irrelevant.”  Id.  Decisions imposing a “black and white” distinction between “use or non-use of a covered countermeasure” were erroneous – as pointed out by HHS – because they ignored “the plain language of the PREP Act, which extends immunity to anything ‘relating to’ the administration of a covered countermeasure.”  Id. (citation and quotation marks omitted).  PREP Act immunity can be defeated only where the defendant did nothing at all, not where the adequacy of its COVID response is at issue.  Id. (exception only for “total inaction”).

For all of these reasons, Garcia held that the PREP Act was a “complete preemption” statute that created federal question jurisdiction.

While the Court acknowledges that certain allegations [in the complaint] relate to a failure to abide by local or federal health guidelines, those allegations related to momentary lapses. Taken as true, all [the complaint] discloses are possible unsuccessful attempts at compliance with federal or state guidelines – something which the PREP Act, the Declaration, and the January 8, 2021 Advisory Opinion cover. . . .  Therefore, because [HHS] stated that the PREP Act is a complete preemption statute, the Court finds that an adequate basis for federal question jurisdiction exists.

Id. at *9 (citations omitted).

Thus, should Garcia’s rationale prevail, just about all nursing home litigation involving alleged failure to use countermeasures in a way that could have prevented COVID infections will be heard in federal court – regardless of how many questionable, non-diverse defendants plaintiffs try to add.

Our second case, Fields, involves the application of federal question jurisdiction arising from the defendant “acting under” the authority of a federal officer under 42 U.S.C. §1442.  We suggested the defense counsel give that basis for removal another look last year in this post, which was about the Latiolais v. Huntington Ingalls, Inc., 951 F.3d 286 (5th Cir. 2020), decision – which is the precedent on which Fields turned.  Fields involved allegations about COVID infections in meat packing plants.  2021 WL 510620, at *1.  However, when COVID appeared to be posing a threat to the nation’s food supply, the government invoked the Patriot Act, and declared the defendant’s facilities to be “critical infrastructure.”  Id. at *2.

As defendants note, after this designation, [defendant plant owner] interacted with multiple government agencies, namely by being “in close contact with officials at the U.S. Department of Homeland Security and the U.S. Department of Agriculture regarding continued operations.” [It] also participated in a meeting between [the administration] and other food industry executives “to discuss the stability of the supply chain.”  Part of the collaboration between [owner defendant] and the federal government involved it working directly with the United States Food Safety and Inspection Service (FSIS).

Id. at *3 (record citations omitted).

This critical infrastructure designation meant that the owner defendant was subject to more than just general federal regulation.  Id.

[D]efendants here exhibited an effort to help assist, or carry out, the duties and tasks of the federal superior.  Defendants did so by working directly with the Department of Agriculture and the FSIS to guarantee that there was an adequate food supply.

Id. (citation omitted).  Indeed, Congress “allocated additional funding” to the relevant agency “to ensure that [it] had the resources to adequately supervise” facilities that had received the “critical infrastructure” designation.  Id.

Accordingly, the court now finds that, based on the critical-infrastructure designation, defendants were “acting under” the directions of federal officials when the federal government announced a national emergency.

Id. (footnote omitted).

Then, Fields judged the connection between federal oversight and the plaintiffs’ claims under the new, “more relaxed” standard discussed in Latiolis.  2021 WL 510620, at *4.  That step was relatively easy:

The purported act under color of federal authority is the decision to maintain operations despite the pandemic.  Naturally, the choice of what safety precautions should be taken . . . connects to the broader decision to keep the plant open during the pandemic in the first place.

Id.

Finally, step three – a “colorable” federal defense to the plaintiffs’ claims – was satisfied by defendants raising two forms of preemption:  (1) express preemption under meat inspection statutes, and (2) implied conflict preemption with governmental oversight under the Defense Production Act.  Id. at *4-5.  Defendants did not have to win preemption at this point; they only had to have a “plausible” basis for the defense, which they did.  Id. at *5.

Thus, should Fields’ rationale prevail, all COVID-related litigation over infections allegedly arising from meatpacking and other facilities designated as “critical infrastructure” during the pandemic would likewise be heard in federal court.

Between Garcia and Fields, precedent now exists for the exercise of federal jurisdiction over the vast majority of COVID-related personal injury litigation.