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We have decried several times plaintiffs’ tendency in prescription medical product litigation, particularly mass torts, to try to sue into submission their opponents in scientific debates.  This often takes the form of lawsuits alleging that journal articles, continuing medical education, and other forms of scientific discussion are actionable “misrepresentations.” We said some time ago:

[W]e’re sick and tired of plaintiffs alleging “you ghostwrote this” or “the article misrepresented the data.”  We’re pleased to find a decision [referring to Bracco Diagnostics, Inc. v. Amersham Health, Inc., 627 F. Supp.2d 384, 456-57 (D.N.J. 2009)] saying that the publication of scientific articles, per se, is protected by the right of free speech and can’t be the basis for a lawsuit.  We don’t think courtrooms should be places where one side of a scientific debate seeks to sue the other side into silence.

Well, it’s not just the tort plaintiffs who want to litigate scientific opponents into submission, and it’s not just our clients being targets of such efforts.  That’s why we’re pleased with the ruling in Informed Consent Action v. Becerra, 2022 WL 992814 (S.D.N.Y. March 31, 2022) (“ICA”), in which the plaintiffs were a couple of antivax groups, and the target of their scientific suppression was none other than Centers for Disease Control itself.

It seems that the CDC – in accord with essentially all gold-standard scientific studies ever conducted – includes on its website the following statement:

Vaccines do not cause autism

Some people have had concerns that ASD [autism spectrum disorder] might be linked to the vaccines children receive, but studies have shown that there is no link between receiving vaccines and developing ASD.  The National Academy of Medicine, formerly known as Institute of Medicine, reviewed the safety of 8 vaccines to children and adults. The review found that with rare exceptions, these vaccines are very safe.

A CDC study published in 2013 added to the research showing that vaccines do not cause ASD.  The study focused on the number of antigens given during the first two years of life. . . .  The results showed that the total amount of antigen from vaccines received was the same between children with ASD and those that did not have ASD.

CDC, Vaccine Safety – Autism (links brought into text).  This position has been the considered judgment of “federal health authorities” for “the past four decades.”  ICA, 2022 WL 992814, at *2.

The plaintiff antivax organizations sued the federal government (the CDC is part of the Health & Human Services department run by Secretary Becerra, the nominal defendant) demanding that this statement be “forthwith” removed, allegedly because not every approved vaccine had been specifically studied for autism.  Id.  The government initially tried to accommodate the antivaxxers.  But after the antivaxxers loudly proclaimed that accommodation meant more than was justified, the government ultimately said “pound sand,” and returned to its original position:

On August 27, 2020, Plaintiffs state that the CDC “finally removed” the “Vaccines Do Not Cause Autism” claim from its website and, after ICAN “widely publicized” the removal of the statement, the CDC restored the statement to its website.

Id. at *3.  The scientific community responded vigorously to the misleading antivax media blitz, with the plaintiff antivax groups claiming that they were “removed from various social media platforms” as a result.  Id. at *5 n.4.  Good riddance.

Plaintiffs argued that they had standing to attack the CDC’s view of vaccine science because the online statement would somehow chill scientific research.  Id. (“until the CDC removes the statement, ‘the necessary scientific inquiries will never receive the funding or the attention they deserve’”) (quoting complaint).  The court agreed with the CDC, finding this statement to be even more unfounded than we’ve come to expect from antivaxxers.  The CDC’s statement reflecting forty years of science was unlikely to cause anybody to do, or not to do, anything:

Defendant’s argument in chief is that the Complaint is too speculative, surmising that removal of the CDC Statement would somehow coerce independent researchers, none of whom are parties to this lawsuit, to begin studying and publishing research on the vaccine-autism connection for babies.  The Court agrees.  Plaintiffs’ causation theory is purely speculative and conjectural.

Id. at *6.

Given that research concerning vaccines and autism has been a dry hole for over 40 years, plaintiffs offered no basis for believing that the CDC’s statement – as opposed to the discredit blanketing this area due to pseudoscientific charlatans (underwritten by some p-side lawyers) with whom antivaxxers have allied.  “Plaintiffs have not proffered facts to demonstrate that the alleged lack of research is not just explained by the fact that there is scientific consensus that vaccines do not cause autism.”  Id.  Plaintiffs’ purported “harm” from the statement was nothing but an unsupported house of cards that, upon examination, promptly collapsed:

Plaintiffs’ alleged injury would only be remedied if HHS removed the CDC Statement and if researchers refrained from citing or referencing the CDC Statement and if researchers began to study the vaccine-autism link for babies and if the researchers published their research findings so that eventually Plaintiffs could investigate their findings and disseminate them.

Id. at *7 (emphasis original).  Plaintiffs did “not proffer[] facts” that the CDC’s accurate assessment of current science had anything to do with the scientific community’s reluctance to follow the antivax road to perdition.

Thus, ICA refused to allow plaintiffs suit seeking to silence the defendant’s public statements about vaccine science to proceed.  “Because none of Plaintiffs’ standing theories satisfy the Article III case-or-controversy requirement, this Court must dismiss this case for lack of subject matter jurisdiction.”  Id. at *8.

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Over the past seven months, we reported (here, here, here, here, here, and here) on cases in which relatives of individuals sick with COVID-19 sued to force hospitals to administer ivermectin to their loved ones. Apart from one that issued a quickly lifted emergency injunction and another that was reversed on appeal, each court to hear such a suit ruled against the plaintiff.

Asserting constitutional, statutory, regulatory, and contractual claims, the plaintiffs advanced various theories as to why their relatives had a right to receive—and the hospitals had a duty to administer—ivermectin, an anti-parasitic drug used to treat horses more often than humans. Each theory was rejected.

There were several recurring themes in the decisions refusing to compel administration of ivermectin.

One was that “judges are not doctors” and that “[j]ust as [judges] cannot legislate from the bench, [they] cannot practice medicine from the bench.” Texas Health Huguley, Inc. v. Jones, 637 S.W.3d 202, 207 (Tex. App. 2021).

Another was that “[t]reating COVID-19 with ivermectin is undisputedly contrary to generally accepted health care standards” and that “[p]reeminent institutions representing numerous facets of the national medical establishment, including the FDA, CDC, AMA, World Health Organization, and Infectious Disease Society of America, have criticized the use of ivermectin as a treatment for COVID-19.” DeMarco v. Christiana Care Health Servs., Inc., 263 A.3d 423, 435 (Del. Ch. 2021).

Finding that “the weight of [scientific] authority shows that [ivermectin] is not an effective treatment” for COVID-19,” courts repeatedly denied the injunctive relief sought because the plaintiffs could not establish that “its administration is necessary to avoid irreparable harm.” DeMarco, 263 A.3d at 438; accord, e.g., Smith v. West Chester Hosp., LLC, 2021 WL 4129083, at *4 (Ohio Com. Pl. 2021).

Now, as reported in the New York Times, a newly published study in the New England Journal of Medicine reinforces the previous scientific consensus. The paper, which analyzes the results of a large-scale clinical trial, concludes that “[t]reatment with ivermectin did not result in a lower incidence of medical admission to a hospital due to progression of Covid-19.” Although not surprising, the results of the clinical trial are nonetheless notable because they directly refute several earlier meta-analyses that, contrary to most, had suggested a benefit from ivermectin.

As the new study notes, the meta-analyses suggesting a benefit from ivermectin were deeply flawed. They were based on “a reported trial of ivermectin treatment for Covid-19 [that] was suspected of malfeasance and … withdrawn from publication” and “other trials [that] have been weakened by concerns about quality.” When a consortium of researchers performed a meta-analysis that excluded the dubious data, it “concluded that ivermectin did not offer a treatment benefit.” And even if the meta-analyses suggesting a benefit from ivermectin had been derived from trustworthy data, they studied fewer patients combined than the new large-scale clinical trial, which enrolled over 3,500 patients.

In short, as the FDA, every major medical organization, and even a manufacturer of ivermectin has concluded, there is no basis to think that ivermectin is an effective treatment for COVID-19. Judges might not be doctors, but in the case of ivermectin the courts have gotten it right.

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The pelvic mesh remand hits just keep coming. We like Shostrom v. Ethicon, Inc., 2022 U.S. Dist. LEXIS 55748 (D. Colorado March 28, 2022), because it hammers some ubiquitous plaintiff mesh experts and because it finds a way to depart from an awful MDL ruling. The fact that the opinion comes at the expense of a plaintiff lawyer who is annoyingly talented makes it even better.

The defendant filed a motion in limine to limit the plaintiffs’ medical causation experts on issues reserved by the MDL court. The remand court began its opinion with a reference to the court’s gatekeeper role in admitting or excluding expert testimony, so we immediately suspected we were in for a good ride. The first expert up for discussion was the plaintiff’s expert urogynecologist/surgeon. The plaintiff proffered this expert’s opinions on both general and specific medical causation. This expert is one many of us have seen before, either in depositions or courtrooms. He is a skillful story-teller, has a good memory of the medical records, and can weave together a “differential diagnosis” at the drop of a hat. He is smart, articulate, and adept at heading off traps. We like the guy personally and can see why he often scores well with juries. But many of his opinions are, to our highly biased eyes, bunk. They distort reality and make a mockery of most states’ design defect and failure to warn laws. The issue is whether a trial court has the moxy to draw lines and limit this clever expert’s testimony.

The Shostrom court had that moxy, drew the right lines, and limited the urogynecologist’s testimony. Let’s go through the rulings.

First, the plaintiff expert was not permitted to opine on non-mesh surgical procedures as alternative designs. We have seen this ruling many times before (see here and here). A Burch procedure, for example, is not an alternative product.

Second, the court curtailed the expert’s criticisms of how the mesh was cut. Mesh can be cut by either a machine in a standard fashion or be cut by a laser. Whichever way the mesh at issue in a case was cut, you can bet that the plaintiffs will say it should have been cut the other way. This very expert has gone on record damning both ways of cutting the mesh. But since when has two-facedness been a problem for plaintiff experts? It was a problem here because Colorado law requires that the plaintiff show that the urged alternative would have prevented the plaintiff’s injury. That’s a bit of a problem for this expert, because he would never-ever want to go on record that any particular mesh-cut would avoid or reduce the risk of injury. Such testimony would come back to bite him in another case. That dilemma for the expert made the decision easy for the Shostrom court: “Because none of her experts will opine that her injuries would have been avoided or that the mesh would have been safer if cut differently, testimony on this point appears irrelevant. Moreover, it would be confusing to a jury.”

Third, because Colorado law requires an alternative product to be “practicable and available,” the plaintiff urogynecology expert was not allowed to testify that “lighter weight” mesh is an alternative since the FDA has never approved/cleared any lighter weight product. The plaintiff correctly pointed out that the mesh MDL court had already denied this same motion by the same defendant aimed at the same plaintiff expert. How, given that unfortunate precedent, did the defendant prevail on this point? When the MDL judge ruled on this issue, he was not deciding any particular state’s law. In “the interests of justice,” the Shostrom court construed the defendant’s motion as seeking reconsideration of the court’s earlier order adopting “the relevant MDL orders.” The Shostrom court then refused to follow this aspect of the MDL rulings on this expert because it conflicted with Colorado law. It was undisputed that no mesh products recommended by the plaintiff expert had been marketed in the United States.

We do not want you to think that all of the Shostrom court’s opinion picked on only one plaintiff expert. The Shostrom court made similar rulings regarding an ob-gyn plaintiff expert, who was proffered on general medical causation. This expert also was precluded from bloviating about alternative surgical procedures or the virtues of lighter mesh. Even worse for the plaintiff, the court held that this expert was unqualified to testify on product design and design controls.

It turns out that the plaintiff in Shostrom wanted to bring an “army of experts” to trial. This might be a response to the dismal results that mesh plaintiffs have recently met with in trials. The Shostrom court continued to perform its gatekeeping role well, ruling that opinions about the defendant’s surgeon training were “irrelevant, speculative and misleading” because the plaintiff offered no expert opinion that her surgeon provided substandard care. (Mesh plaintiffs almost never blame their doctors. They want all fault assigned to the mesh manufacturer.). The Shostrom court also held that expert opinions on the defendant’s state of mind were excluded – as per MDL rulings. This was one of the expert rulings that the MDL court consistently got right. The Shostrom court also ruled that another plaintiff expert could not comment on the defendant’s “failure to conduct certain testing because he is not qualified to opine on what testing a manufacturer should do, and the ‘factual underpinnings’ of a lack of testing would be nothing more than a summary of corporate documents from an expert witness, which the MDL court rejected.” Yay, MDL court.

Finally, the Shostrom court made an additional observation about the plaintiff’s “army of experts.” The court firmly stated that it would foreclose duplicative testimony. Exercising its authority under Fed. R. Evid. 611 to control the introduction of testimony and avoid cumulative material, the Shostrom court held that the plaintiff must choose only one expert on each of the topics.

Given our undisguised rooting for the defense side, we hope and expect at the end of the Shostrom case to quote the ancient knight in Indiana Jones and the Last Crusade and say that the plaintiff lawyers “chose poorly.”

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A post-sale duty to warn is almost oxymoronic.  If you think about a typical warnings case, the focus is on whether the manufacturer/seller had notice of a potential risk before the product left its control (or prescribed to the plaintiff), and if so, whether that risk was adequately conveyed to the plaintiff.  The question we routinely ask in drug and device warnings cases is whether additional or different information would have made a difference to the prescribing physician in choosing a course of treatment.  So, when a manufacturer acquires information after a medical device has been implanted, for instance, causation for a post-sale duty to warn seems tenuous at best.  And that single, flimsy strand should snap completely in a case where the device is already explanted.

Those were the facts in Hix v. Zimmer Biomet Holdings, Inc., 2022 U.S. Dist. LEXIS 56749 (D. Nev. Mar. 29, 2022).  The case was filed originally in 2014 in the Biomet M2a Magnum Hip Implants Products Liability MDL pending in the Northern District of Indiana.  After the MDL pre-trial proceedings, it was transferred in 2018 to the District of Nevada.  Id. at *2-3.

Plaintiff had a total hip replacement in 2010 and a little over two years later had a revision surgery during which the original metal-on-metal artificial hip device was explanted and a metal-on-polyethylene device was implanted.  Id. at *3-4.  The original device, the one at issue in the suit, was manufactured by Biomet.  Three years after it was explanted and one year after plaintiff filed his lawsuit, Zimmer Holdings, Inc. acquired Biomet and changed its name to Zimmer Biomet Holdings, Inc.  Id. at *4.  In 2020 plaintiff filed an amended complaint adding Zimmer Biomet Holdings as a Defendant.

Since it was not disputed that the new parent holding company, Zimmer Biomet, did not design, manufacture, label, or sell the device implanted in plaintiff in 2010, plaintiff had to come up with both a basis for personal jurisdiction against the new parent company and a theory of liability.  Id. at *9.  As to personal jurisdiction, the specific jurisdiction the court exercised over the subsidiary was not enough to confer specific jurisdiction over the parent because “corporate entities are presumed separate.”  Id. at *8.  Thus, plaintiff’s two-pronged argument was that the new parent company assumed Biomet’s debts or the new company was the result of a merger.  Plaintiff had proof of neither.  The discussion is case specific to the terms of the deal between the two companies, but the bottom line was that plaintiff could “not raise an inference that the subsidiaries lack a separate and distinct corporate form, or that Zimmer Biomet Holdings is merely an alter ego for any of its subsidiaries.”  Id. at *12.

Plaintiff’s second argument was that the new parent company was liable for a post June 2015 failure to warn claim.  It had to be post June 2015 because the company did not exist before then.  Nevada has not ruled on whether it would recognize a claim for post-sale duty to warn.  But, in this case the court presumed that such a duty existed for defects that the manufacturer learns about after the manufacture and sale of the device.  Id. at *13.  The court also had to assume that such a duty would extend to the manufacturer’s parent company.  But even under this make-believe version of Nevada law, the court knew where to draw the line:

Such a duty, however, does not and cannot extend to a person who is no longer the consumer of the medical device at issue.

Id. at *14.  So simple, so obvious.  A post-sale duty to warn, where it exists, cannot be the basis for a cause of action where plaintiff has stopped using the product.  In this case, that was at the time of explant.  However, it should apply equally to drug cases where plaintiff had stopped using the medication.  If the product is no longer in use, any additional warning would have made no difference to plaintiff’s treatment or outcome.  While this makes logical sense for products liability cases generally, it makes even more sense in drug and device cases where there is rarely a direct relationship between the manufacturer and the patient.  Even factoring in the learned intermediary does not solve the problem.  Patients switch doctors because they move, because they change health insurance, or just because they want to try someone new.  To whom is the post-sale duty to warn owed – the original prescribing or implanting physician?  Much like Hix who was an ex-consumer of the product, the link to an ex-patient is weak.

Without personal jurisdiction or a cognizable legal theory, the claims against the new parent company were dismissed on summary judgment.

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The long-planned New York trip is in the books, and it was a smashing success.   The Drug and Device Law Dowager Countess (almost 88) was ecstatic throughout, and all of the puzzle pieces meshed seamlessly.  We can report that The Music Man is a serviceable revival of a silly, illogical musical (most of our classic favorites fit this description – see Camelot).  But the secret ingredient that turned a minor smile into a wonderful evening was Hugh Jackman.  Candidly, we were not optimistic.  We have spent way too much money on shows featuring splashy headliners who ultimately disappointed.   But Jackman, only a passable singer, explodes with charisma and is a darn good dancer.  We couldn’t take our eyes off of him.   And we loved this best of all:  after the curtain call (at the end of a two-show day), Jackman remained onstage for a good twenty minutes auctioning signed show memorabilia (the gloves he and Sutton Foster were wearing) and raising thousands of dollars to benefit Broadway Cares – Equity Fights Aids.  The guy is the real deal (this has been confirmed by a friend who knows him), and the show was a “win” the second he stepped onstage.

Today’s case also had a “secret ingredient” – the ten-year statute of repose applied to cases governed by Tennessee’s Products Liability Act.– that ensured a defense win.  In Jones v. Smith & Nephew, 2020 Tenn. App. LEXIS 94 (Tenn. Ct. App. Mar. 14, 2022), the plaintiff/appellant was implanted with the defendant’s hip implant system in January 2009.  She alleged that metal-on-metal device released toxic cobalt and chromium ions into her hip joint, eventually causing her to develop metal ion disease. She alleged that this was discovered during November 11, 2019, surgery to replace the hip implant.  She filed suit 364 days later (Tennessee has a one-year statute of limitations for product liability cases), on November 10, 2020.  On November 20, 2020, she filed an amended complaint, adding an assertion that she had “a good faith cause to believe that [the case fit] within the meaning of an exception to Tennessee’s [ten-year] statute of repose” because the injuries she suffered “often take considerably longer to manifest themselves, in a fashion similar to injuries from exposure to asbestos.”  Jones, 2020 Tenn. App. LEXIS 94 at *3.  The defendant moved to dismiss with prejudice, arguing that the suit was barred by the statute of repose, the trial court granted the motion, and the plaintiff appealed.

She presented two issues for appeal: 1) whether the trial court erred in failing to determine that the “latent nature” of her disease took her claims outside of the statute of repose, and 2) whether the trial court erred in failing to exempt the claims from the statute of repose based on the defendant/appellee’s “fraudulent concealment” of the device’s “defective nature.”  Id. at *55.

Under the TPLA’s statute of repose, as the Court of Appeals explained, a product liability action is barred if it is not “brought within ten (10) years from the date on which the product was purchased for use or consumption . . . .”  Id. at *7.  The statute “is an absolute time limit within which actions must be brought, regardless of whether a plaintiff’s cause of action has accrued.”  Id. at *6.  In other words, a statute of repose is not a statute of limitations, triggered by the accrual of a cause of action – there are no “discovery rule” qualifiers built in to the pure “elapsed time” analysis applied to the statute of repose.

Tennessee law provides only two exceptions that allow lawsuits to survive the repose period:  minors must file suits within one year of attaining majority, and the ten-year repose period does not apply to suits involving asbestos or silicone gel breast implants.  Obviously, neither exception applied to the appellant’s hip implant, and the appellant did not argue otherwise.  “Instead, she ask[ed] the Court to create two new exceptions.”  Id. at *8 (emphasis in original).  She argued that other states make exceptions to statutes of repose for latent disease and for fraudulent concealment, and that Tennessee should do the same.

The court declined, stating, “We are not a legislative body, and Appellant’s request is not within our purview.  Our role is to apply the law as the legislature has written it.  Id. at *9.  The court explained that, under hornbook principles of statutory construction, it was required to interpret statutory terms “under their natural and ordinary meaning in the context in which they appear and in light of the statute’s general purpose,” without “forced interpretation.” Id. (citations omitted).  And the language of the statute of repose, as the court emphasized, is perfectly clear, providing that “any action against a manufacturer or seller or a product for injury to person . . . caused by its defective or unreasonably dangerous condition” is subject to the ten-year bright line rule.  Id. (emphasis in original).   Moreover, the General Assembly included express exceptions to the ten-year cutoff, twice amending the statute to do so.  Under “a well-established canon of statutory construction,” the “mention of one subject in a statute means the exclusion of other subjects that are not mentioned.”  Id. at *11-12 (citations omitted).  The court concluded, “The Court cannot expand/rewrite the statute to create a general latent disease exception or a fraudulent concealment exception to the TPLA’s statute of repose. Under the current version of the TPLA, . . . Appellant’s lawsuit falls outside the statute of repose and any exceptions thereto.”  Id. at *12.   Judgment affirmed.

Simple, basic, unambiguous stuff.   But the bigger principle is worth emphasizing:  the law is what it is.  Sometimes, that means that people who think they deserve their “day in court” are denied it.  Innovator liability is another example.  And only when courts resist pressure to turn jurisprudence into an insurance policy does the rule of law prevail.   Stay safe out there.

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Counsel defending depositions have a decision to make – whether, after opponent’s the direct examination of the witness is complete, whether to “cross-examine” a witness aligned with our own client.  Usually, the answer will be “no,” because such questioning usually offers no advantages and could well undermine the witness (who may lose focus under friendly questioning) or provide clues as to the client’s trial strategy.  In Berroteran v. Superior Court, ___ P.3d ___, 2022 WL 664719 (Cal. March 7, 2022), the California Supreme Court unanimously held that these practical concerns defeated the “similar interest and motive” element required under Cal. Evid. C. §1291(a)(2) (the California equivalent of F.R. Evid. 804(b)(1)(B), although §1291 predates the Federal Rules) for an “unavailable” witness’ former testimony to be admissible at trial as substantive evidence.  Thus, in California, the testimony of corporate witnesses is no longer freely admissible, neither in the case where it was taken – nor, more importantly, in in future cases against the same party.  Since this ruling will have its greatest impact in mass tort litigation where the same defendant gets sued repeatedly about the same alleged product “defects,” we thought Berroteran was worth discussing.

The short answer is, if the deposing party wants a trial deposition, that party should take one, rather than try to repurpose a discovery deposition after the fact.

As might be expected, Berroteran was a mass tort case, only involving cars rather than prescription medical products.  The discovery depositions of a number of the defendant manufacturers’ non-California corporate witnesses occurred in a federal MDL, which (like many MDLs) later settled.  2022 WL 664719, at *1.  The plaintiff, who had declined to participate in that settlement, subsequently filed a substantively identical suit in California state court.  Id.  For trial – taking the easy/cheaper way − he designated testimony from nine of these “unavailable” (because they were not subject to California subpoena) witnesses.  Id.  The trial court excluded them all, because plaintiff did not establish the aforesaid “similar interest and motive” element, but the intermediate appellate court, on mandamus, reversed.  The defendant, of course, had not cross-examined any of its own witnesses.  Id. at *3.  The intermediate court held that a manufacturer defendant in a mass tort “has an interest and motive to examine its own witnesses during their depositions” because of its “interest and motive “to disprove” the [underlying] allegations . . . concerning the [product].  Id. at *1 (emphasis original with the California Supreme Court).  It imposed on the manufacturer “the burden to show that it lacked a similar interest and motive.”  Id.

Thus the intermediate court accepted, essentially, that as long as the defendant continued to defend itself against the “underlying” product liability claims (that is, doesn’t concede defeat), then that position on liability ipso facto satisfied the “interest and motive” prerequisite to use of prior deposition testimony.  That was contrary to the legislative commentary that accompanied §1921:

The determination of similarity of interest and motive in cross-examination should be based on practical considerations and not merely on the similarity of the party’s position in the two cases. . . .  [T]estimony contained in a deposition that was taken, but not offered in evidence at the trial, in a different action should be excluded if the judge determines that the deposition was taken for discovery purposes and that the party did not subject the witness to a thorough cross-examination.

Id. at *8 (quoting Comment − Assembly Committee on Judiciary) (emphasis omitted).

Fortunately, the California Supreme Court rejected this dumbed down approach to “interest and motive” that would have opened the door to use of almost any discovery deposition at any trial in a mass tort.  Rather than authorizing broad use of discovery depositions in mass tort cases, Berroteran held that California’s evidentiary statute “articulates a general rule (not a categorical bar) against admission at trial of prior testimony from a typical discovery deposition.”  2022 WL 664719, at *12.  Only prior trial testimony – not prior discovery depositions – is presumptively admissible.  Id.  The lower court’s contrary ruling flew in the face of the legislatively-approved comment that more than “merely . . . the similarity of the party’s position in the two cases” is necessary.  Id.  Discovery depositions were different than testimony taken for purposes of a trial:

Although depositions are sometimes conducted to preserve the testimony of a witness for trial, many are commonly conducted for the purpose of discovery.  The goal of discovery depositions is ordinarily twofold:  to obtain information from the witness and to provide a foundation for the witness’s impeachment, if necessary, at trial. . . .  A discovery deposition, in other words, is normally intended as a precursor to trial testimony − not as a substitute for such testimony.

Id. at *13 (citations omitted).

Given this difference between the ordinary reasons for seeking deposition, as opposed to trial, testimony, “the “‘interest and motive’ of the party opponent in cross-examination at a discovery deposition is generally not, as required by section 1291(a)(2), similar to that prevailing at trial.”  Id.  Discovery depositions have “no fact-finding audience.”  “[P]ersuasion is ordinarily a secondary consideration,” with the primary goal of a discovery deposition being to “get a ‘fix’ on” an adverse witness’ “expected” testimony.  Id.

In this context, cross-examination of the witness risks unintentionally educating and aiding the deposing party because questioning necessarily reveals information and commits the witness to particular testimony.  The interest and motive of an opposing party at a discovery deposition is therefore often against cross-examination of the witness.

Berroteran, 2022 WL 664719, at *13 (emphasis original).  Further, “[e]ffective cross-examination at a discovery deposition may be hindered by the absence” of “advance planning and a complete evidentiary record.”  Id.  For all of these reasons, “leading treatises are consistent in discouraging opposing parties from conducting cross-examination at a discovery deposition, at least when the witness being deposed is aligned in interest with the opposing party.  Id. at *14 (emphasis original).  “There was and remains overwhelming support for the proposition that defending counsel at a civil discovery deposition typically have strategic reasons to avoid questioning an aligned witness.”  Id. at *16

Thus, if a party wants to preserve testimony for trial, it should notice a trial deposition, with everything that entails, not a mere discovery deposition.

[D]epositions may preserve testimony when there is reason to believe the deponent will not later be called at trial − whether due to ill health or because of statutory provisions that allow for the use of deposition testimony at trial. . . .  [C]ross-examination may be appropriate when a deposition serves “to preserve the testimony of a deponent who either will not or may not be available at trial.”

Id. at *14 (citations and quotation marks omitted) (emphasis original).  Thus, to gain admission of a mere discovery deposition as trial evidence, the proponent “bears the burden of rebutting the general rule by submitting appropriate information justifying the admission of designated deposition testimony.”  Id.

Berroteran made a couple of other interesting observations.  First, cases involving admission of prior testimony in the criminal context are distinguishable because they “concern testimony arising in earlier adjudicative hearings” where a criminal defendant “often has an interest and motive to examine the witness in order to avoid being bound over for trial.”  Id. at *16 (emphasis original).  Second, “videotaping, in itself, does not affect the decision whether to examine an aligned witness at deposition.”  Id.  Third, §1291 places the burden of proving each if its prerequisites on the proponent of the prior deposition testimony – nothing is “presumed”:

[T]he appellate court implicitly presumed that because of the similarity of the suits and [the manufacturer’s] position in each, [that defendant] had an interest and motive to cross-examine each aligned witness during each deposition.  In so reasoning, the court appears to have discounted, if not ignored, the comment’s admonition that “mere[] … similarity of the party’s position in the two cases” is not dispositive, and instead must yield to other “practical considerations.”

Id. at 18 (citation to previously quoted legislative comment omitted) (emphasis original).  If a mass tort plaintiff does not want “to incur the expense of deposing each out-of-state witness in order to obtain and introduce that same testimony,” then the plaintiff should utilize other, available discovery tools, rather than rely on inadmissible hearsay.  Id. at *18.

Much of the discussion in Berroteran seems equally applicable to the analogous provisions of Federal Rule 804, even though California’s statute predated the Federal Rules of Evidence by about a decade.  While rejecting the intermediate appellate court’s argument that federal decisions applying Rule 804 were more liberal in admitting prior deposition testimony, 2022 WL 664719, at *15, the unanimous opinion directly dealt with federal Rule 804 cases only in footnotes:

We note that federal courts have denied motions to introduce deposition testimony at trials in subsequent cases even when the issues in the two cases were similar − suggesting that, consistent with our own understanding, similarity of the issues is not dispositive under the federal rule.

Id. at *15 n.22 (citations omitted).  See Id. at *15 n.23 (certain federal cases cited below did not “mean[] to suggest that a party’s reasons for limiting cross-examination in a deposition are categorically irrelevant to the similarity of interest inquiry”).

Finally, the court in Berroteran laid out a detailed process for evaluating claims that deposition testimony should be admissible, notwithstanding §1291(a)(2).  2022 WL 664719, at *19-21.  We won’t go into that in detail, but it should be required reading for counsel defending corporate witness depositions in mass tort cases.  Bottom line – to avoid having a discovery deposition become admissible, don’t do anything that makes it look like a trial deposition:

Conduct such as compelling out-of-state witnesses to appear for a videotaped deposition, and references made at the ensuing deposition to “testimony for the jury,” particularly by the party opposing admission, may contribute to a showing that testimony preservation was among the purposes of a deposition.  Relatedly, if the party opposing admission actually undertook an apparently searching examination of the deponent, the court may determine that such conduct suggests an interest and motive with respect to cross-examination similar to that which the party would have at trial in the present case.

Id. at *20 (emphasis original).  “Presumably, counsel for a party would not agree to a deposition’s use in any future different albeit related case unless counsel was satisfied that there had been, at that deposition, a right and opportunity to examine the declarant with an interest and motive similar to that which the party would have at trial in a future related case.”  Id. at 19 n.30 (emphasis original).

In sum, we find Berroteran remarkable in the degree of realism with which it viewed the motivations, strategies, and tactics of parties defending depositions.

And, geez, we also find the decision remarkable for the amount of emphasis the court used – another thing different about California.

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This post is from the non-Dechert side of the blog.

Our latest Zantac litigation decision is not from the Florida MDL, but rather a standalone case in Maryland − Mayor & City Council of Baltimore v. GlaxoSmithKline, LLC, 2022 WL 537004 (Md. Cir. Jan. 28, 2022).  It’s a split decision, and depending on which side of the split a defendant to that suit is on, the decision is either excellent or atrocious.

The Baltimore litigation is also rather strange, and apparently unprecedented in Maryland.  The underlying liability allegations are little different than what has been asserted in the Zantac MDL, which we described here:

Zantac is a drug that has been around, in branded or generic form, since 1983.  After more than 30 years, it was discovered that the active ingredient could break down into an alleged carcinogen – nitrosamines, the same type of substance anyone who consumes bacon, beer, or cheese has already been exposed to for many years (pills being a lot smaller).

The weirdness is from the identity of the plaintiff – the City of Baltimore.  What the heck is a municipality suing for?  It can’t get, or even be at a risk of, cancer.  The City’s supposed damages got all of one sentence in the Baltimore opinion:

The City asserts that “[t]housands of Baltimore residents” purchased prescription and OTC Zantac/ranitidine and it funded payment for substantial portions of the drugs through healthcare insurance programs.

2022 WL 53700, at *3.  That’s it?  If that’s the case, then the City could sue for similar damages over essentially any purported defect in a prescription drug – or virtually any other product that might change hands in the context of a municipal social welfare program.

This kind of extra-legislative attempt to impose tort taxes to pay for public services is not a good idea.  It violates the separation of powers.  The Supreme Court rejected a similar attempt by the United States seeking recovery of hospitalization costs for a soldier allegedly tortiously injured in an auto wreck in United States v. Standard Oil of California, 332 U.S. 301 (1947).  The Court accurately perceived the issue as “not. . .simply a question of creating a new liability in the nature of a tort,” but rather one of “fiscal policy” and what branch of government properly sets such policy. Id. at 314.

Thus, the Standard Oil court rejected the government’s “tort law analogy” as a basis for “establishing . . . fiscal and regulatory policies.”  Id.  The task of funding government services belongs to the legislature, not the courts:

[This] is a proper subject for Congressional action, not for any creative power of ours.  Congress, not this Court or the other federal courts, is the custodian of the national purse . . . [and] the exclusive arbiter of federal fiscal affairs.  And these comprehend, as we have said, securing the treasury or the government against financial losses however inflicted, including requiring reimbursement for injuries creating them, as well as filling the treasury itself.

Id. at 314-15.

The simple truth is that “the government constantly sustains losses [from] tortious or even criminal conduct,” and only the legislature should decide whether to authorize recovery.  Id. at 315.  The “exercise of judicial power to establish the new liability. . .would be intruding within a field properly within Congress’ control and as to a matter concerning which it has seen fit to take no action.”  Id. at 316.  Unless the legislature “acts to establish the liability, this Court and others should withhold creative touch.” Id. at 317.  We discussed these concerns – which have since crystallized into what is called either the “municipal cost recovery rule” or the “free public services doctrine” – more detail back in one of the Blog’s early(2007) posts.

So to us, the fundamental issue in Baltimore – nowhere discussed in that opinion – is whether a governmental entity can recover its expenditures via tort litigation rather than taxation.  We think that the answer in Maryland is “no,” see Crews v. Hollenbach, 751 A.2d 481, 489 (Md. 2000) (“taxpayers should not be subjected to. . .one charge in the form of state tax and the second in paying damages in [a government] civil suit”), but that question was never raised in Baltimore, let alone decided.

What Baltimore did decide is preemption.  Generic manufacturers of Zantac justifiably view this ruling as a huge win, since the claims against them were justifiably dismissed in toto.

[T]he City’s claims against the Generic Manufacturer Defendants are subject to impossibility preemption. . . .  The generic manufacturers must establish that the generic label is the same as the brand name label to fulfill its duty of sameness.  In other words, the generic manufacturers are not allowed to change the FDA-approved label.  The Generic Manufacturer Defendants here were prohibited by federal law from changing the design or labeling of [their products]. . . .

To the extent that the City’s allegations can be read to allege design defect claims against the Generic Manufacturer Defendants, such claims also are impliedly preempted.  This is because the City alleged that ranitidine was inherently dangerous even when taken as directed and when appropriately stored. . . .  Assuming the truth of the City’s allegations, the Generic Manufacturer Defendants . . . would have been required to stop selling [their products].

Baltimore, 2022 WL 537004, at *4 (citations to Mensing omitted).

The City could not escape preemption by slapping novel labels (“negligent product containers,” “negligent storage and transportation,” etc.) on its claims.  For the same reasons we discussed here, all of the City’s purported “subduties” were merely variations on the theme of preempted warning or design-based claims.  Id. at *5.  Nor was a mere trial court free to invent new causes of action.  “[I]t is not this Court’s role to adopt novel causes of action.  No such causes of action exist under Maryland law and the prerogative to adopt new causes of action is left to the discretion of the General Assembly or the Court of Appeals.”  Id. (citation omitted).

For the same reasons, Baltimore also dismissed all of the retailer defendants.

The Store Brand Retailer Defendants are removed from any FDA requirements as they are not involved in the approval or labeling process at all.  The allegations rendered by the City would require the Store Brand Retailer Defendants to have stopped selling ranitidine all together.

Id. at *6 (finding preemption under Bartlett as well as Mensing).

So that’s the good part of the split decision.

But from the perspective of the branded manufacturers, the Baltimore decision was a superficial mess.  As we’ve discussed, over-the-counter drugs are protected by an express preemption clause, 21 U.S.C. §379r, with a “product liability” exception that has universally been limited to claims for personal injury.  Citing nothing beyond the Maryland cases that adopted Restatement §402A, Baltimore becomes the sole exception to this rule, tersely stating, “There is no requirement that a plaintiff allege a physical injury.”  2022 WL 537004, at *7.  This is probably the most critical holding in this half of the decision, but if you blink you might miss it.  However, even §402A – by itself – defeats this proposition:

Special Liability of Seller of Product for Physical Harm to User or consumer

‘(1) One who sells any product in a defective condition unreasonably dangerous to the user or consumer or to his property is subject to liability for physical harm thereby caused to the ultimate user or consumer, or to his property. . . .

Restatement (Second) of Torts §402A (1965), as quoted in Phipps v. General Motors Corp., 363 A.2d 955, 957 (Md. 1976) (emphasis added).  “Physical harm” is right there in the title; it’s not even necessary to read the comments.  This utterly unsupported holding in Baltimore is simply wrong.

Baltimore dodges preemption a second way, by holding that a “consumer protection” claim is purportedly “parallel” to “misbranding” under the FDCA.  2022 WL 537004, at *7.  That aspect of the decision is also full of holes.

First, the City, as a municipality, cannot consume any drug.  It did no more than pay some of the costs of drugs bought by individuals – it’s essentially a third-party payer.  Again citing nothing, Baltimore holds that a municipal corporation has standing as a “consumer.”  Id. at *9.  While we haven’t researched it thoroughly, this holding appears to be contrary to Maryland law.  E.g, Morris v. Osmose Wood Preserving, 667 A.2d 624, 636 (Md. 1995) (“the deceptive practice must occur in the sale or offer for sale to consumers,” not “entirely during the marketing of the [product]”); Penn-Plax, Inc. v. L. Schultz, Inc., 988 F. Supp. 906, 909 (D. Md. 1997) (“only a consumer may be a proper plaintiff” under the act).  We came across no case allowing a municipality, or even some other third-party payer, such as an insurer, to bring suit under the Maryland consumer protection statute.

Second, the City’s consumer protection claim is justified as “parallel” to vague, never-described “misbranding” allegations:

The City argues that these factual allegations demonstrate that OTC Zantac’s label was misbranded pursuant to 21 U.S.C. §331(a). . . .  It claims that the Brand Manufacturer Defendants should have changed [the drug’s] labeling and by failing to do so failed to comply with parallel duties under Maryland and federal law.  Assuming the truth of the allegations in the FAC, the City has adequately plead a parallel state law claim for relief.

Baltimore, 2022 WL 537004, at *7.  While Baltimore purports to be following Zantac MDL decisions, id., in fact it did just the opposite.  The MDL expressly rejected the plaintiffs’ attempt to bring broad “misbranding” claims as a preemption dodge:

[A] finding that Plaintiffs can avoid pre-emption by alleging that defects in ranitidine 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.

In re Zantac (Ranitidine) Products Liability Litigation, 510 F. Supp.3d 1234, 1253 (S.D. Fla. 2020) (citations omitted).

Baltimore also held that another preemption dodge – a “pre-approval design defect” – survives preemption.  We disagree, for all the reasons stated here, which we won’t repeat.  However, once again the utterly unprecedented nature of this claim under Maryland law goes unsaid in Baltimore.  Maryland decisions have only recognized strict liability claims for “design defect” (or any other kind of defect) when the product was defective at sale, not at any other time.  E.g., Ford Motor Co. v. General Accident Insurance Co., 779 A.2d 362, 370 (Md. 2001) (“irrespective of the theory of recovery . . . a prerequisite to recover against a manufacturer for a defective product is that the plaintiff must show the product was defective at the time it left the manufacturer’s control”) (quoting Giant Food, Inc. v. Washington Coca-Cola Bottling Co., 332 A.2d 1, 10 (Md. 1975)).

The next novel claim that Baltimore allowed was “common law public nuisance.”  In two superficial paragraphs, Baltimore allows the City to claim that federally approved and legally sold prescription drugs can be a state-law nuisance.  2022 WL 537004, at *9.  Baltimore cites two Maryland nuisance cases, both of which deal solely with improper land use − where nuisance law belongs − not products.  Tadjer v. Montgomery County, 479 A.2d 1321 (Md. 1984) (abatement action against owner of landfill for methane explosion); Adams v. Commissioners of Town of Trappe, 102 A.2d 830, 833 (Md. 1954) (the defendant built an underground storage tank after being denied a permit).  Once again, the opinion sweeps under the rug the real public policy implications of this gross overstretch of the law of nuisance, as discussed in State ex rel. Hunter v. Johnson & Johnson, 499 P.3d 719, 724-31 (Okla. 2021); In re Paraquat Products Liability Litigation, 2022 WL 451898, at *9-10 (S.D. Ill. Feb. 14, 2022); and Restatement (Third) of Torts:  Liability for Economic Harm §8 comment g (2020).  Somewhere between pages *5 and *9 of the Baltimore opinion, the caution that “it is not this Court’s role to adopt novel causes of action” fell by the wayside.

Finally, Baltimore does away with Maryland’s economic loss doctrine.  Ironically, the opinion cites Morris v. Osmose – only not the part discussed above that requires the consumer protection plaintiff actually to be a consumer – for the proposition that there is “a public safety exception to the economic loss doctrine.”  2022 WL 537004, at *10.  Once again, the pieces of the puzzle don’t fit together.  The City is not suing over “a serious risk of death or personal injury,” since it could not itself use this product, and thus be exposed to such a risk.  Morris allowed a plaintiff to recover costs of repair and replacement of a dangerously defective product that was removed “before a tragedy result[ed].”  667 A.2d at 632.  The City in Baltimore did nothing of the sort.  It did not repair anything, replace anything, or make any expenditure that in any way reduced the claimed risk.  Returning to the beginning of this post, all the City sought is recoupment of “funded payment[s] . . . through healthcare insurance programs.”  2022 WL 53700, at *3.  Taking this “public safety exception” on its face, none of the damages this municipal plaintiff is seeking falls within that exception.

Thus, the two sides of the Baltimore opinion remind us of the classic “The Strange Case of Doctor Jekyll and Mister Hyde.”  The first part is rational, restrained, and full in accord with governing precedent.  The second part is wild and uncontrolled – repeatedly making unprecedented leaps so that this bizarre and improper plaintiff can pursue novel claims with no basis in existing Maryland law.

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The Orthopedic Bone Screw litigation would never have occurred – and Bexis might never have found his way to prescription medical product liability litigation – if not for the Kessler-era FDA’s ill-considered salami slicing of the “intended use” of that product.  In that instance, the FDA had limited its cleared “intended use” to disc spaces in the lowest part of the spine, while essentially identical, equally safe placement in adjacent disc spaces was off-label (and also the medical standard of care).  That was what the Bone Screw plaintiffs attempted to convert into a tort, with spectacular lack of success.

Given what a salami-sliced intended use put our clients through in Bone Screw, we’re still alert to similar attempts, even in areas outside of product liability.  Thus, we were pleased that the Medicare recipient in Dobson v. Secretary of HHS, 2022 WL 424813 (11th Cir. Feb. 11, 2022), prevailed against similarly crabbed thinking.  The claimant in Dobson had a severe spinal cord injury that caused “severe nausea and vomiting multiple times each day.”  Id. at *2.  Only one drug worked – but it was an off-label use:

But [the drug] is not FDA-approved for use in this way, so Medicare Part D would not reimburse [claimant] for the drug unless his use qualified as an approved off-label use, known as a “medically accepted indication.”  This case requires us to determine whether the statutory definition of “medically accepted indication” covers [this] off-label use

Id. at *1

Medicare covers quite a few off-label uses, because the relevant term – “medically accepted indication” – includes all drug uses, whether or not FDA-approved, that are “supported by one or more citations included or approved for inclusion in any of the [certain medical] compendia.”  42 U.S.C. §1396r-8(k)(6).  For a much longer, and heavily footnoted description, this issue, see James Beck, “Off-Label Use in the Twenty-First Century:  Most Myths & Misconceptions Mitigated, 54 UIC J. Marshall L. Rev. 1, 32-34 (2021).  In Dobson, one of those compendia, the Drugdex Information System (we can’t link directly to it because it’s proprietary), included two on-label and six off-label uses for the drug.  2022 WL 424813, at *3.  One of those off-label uses was for “[i]ntractable nausea and vomiting related to metastatic cancer of the gastrointestinal mucosa.”  Id.  But because this claimant’s intractable nausea and vomiting arose from a spinal cord injury, not the particular cancer mentioned in Drugdex, the government denied coverage.  Id. at *4.

The drug in question was a palliative – it did nothing to treat the underlying condition that caused vomiting, be it spinal cord damage or cancer.  Thus, from a medical perspective, what caused the vomiting really didn’t matter much.  But it mattered to the folks that administered Medicare.  It presented a question of law of first impression:  how “to construe the term ‘supported by’ in the governing statute.”  Dobson, 2022 WL 424813, at *6.  Dobson contains a lot of administrative law mumbo-jumbo, but the bottom line of the decision is clear:  don’t salami slice the support for the off-label use.

The Medicare statute did not define “supported by,” so Dobson resorted to common dictionary definitions.  Id. at *7.  The dictionary definition precluded the government’s attempt to limit coverage solely to those victims of intractable nausea and vomiting who had the aforementioned “metastatic cancer of the gastrointestinal mucosa.”  Rather:

Using these definitions to construe the phrase “supported by” . . . requires the conclusion that the compendium citation must tend to show or help prove the efficacy and safety of the prescribed off-label use.  Nothing about the common meaning of “support” means that a compendium citation must hyperspecifically identify a prescribed off-label use to tend to show or help prove its efficacy and safety.

Id. (emphasis added).  “Hyperspecifically identify” is what we call salami slicing for short.  All the medical article in Drugdex had to do was check three general boxes, which it did in Dobson.

[The court] conclude[s] that the citation supports [claimant’s] use:  nausea and vomiting − check; disease-related − check (Central Cord Syndrome and Eagle Syndrome); treatment refractory − check (the usual drugs used to treat nausea and vomiting did not work . . .).

2022 WL 424813, at *8.  Nor was there anything in the article in question that “contraindicate[d]” the off-label use at issue.  Id.  Thus, the claimant’s “understanding of the citation to support refractory, disease-related nausea and vomiting is consistent with the notion indicated in the overview” of the article.  Id.  “Nothing about that process [of drug action] is described in a way peculiar to cases of diffuse gastrointestinal mucosa metastases (as opposed to being applicable to nausea and vomiting caused by disease in general).”  Id.

Further, this relatively broad construction of “supported by” was consistent with the purpose of the statute.

Congress’s decision to amend Medicare Part D to reimburse for previously uncovered off-label uses of outpatient drugs that are supported by a citation in the compendia obviously represented an enlargement of Medicare drug coverage. . . .  We think that suggests the same or very similar concerns motivated the 2008 amendment to Part D − namely, that Medicare participants receive coverage for off-label uses but that those off-label uses be objectively demonstrated to be efficacious and safe, as demonstrated by their inclusion in one of the drug compendia.  Plus, the statutory definition of “medically accepted indication” logically indicates as much.

Dobson, 2022 WL 424813, at *10.  Thus, Dobson “conclude[d]” that all of the considerations relevant to statutory construction “require[d] the conclusion that ‘supported by one or more citations included or approved for inclusion’ in [a compendium] means that the [compendium] citation relied upon must tend to show or help prove the efficacy and safety of the prescribed off-label use.”  Id.

Why do we care, and why should our drug clients care?  Here’s a big reason – the False Claims Act.  Almost all the cases in Bexis’ law review article on Medicare and off-label use are FCA cases.  The “supported by” language that Dobson construed broadly also determines what off-label uses are and are not covered by Medicare, and thus what FCA plaintiffs can sue over when they allege that this or that off-label use was improperly paid for by the government.  Dobson’s rejection of salami slicing likewise is strong precedent for rejecting FCA plaintiffs’ attempts to nitpick the reimbursabilty of off-label uses on a much broader scale.  For that reason, it’s a pity that Dobson – a thorough treatment (eleven Westlaw pages) of a question of first impression – is not precedential.

Note:  in case our readers did not realize it, Thompson/West has discontinued the Federal Appendix reporter as of January 1, 2022.

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Enborg v. Ethicon, Inc., 2022 U.S. Dist. LEXIS 51601 (E.D. Cal. March 21, 2022), is the pelvic mesh case of the week, and it involves a variety of plaintiff challenges to the defendant’s experts. That fact in itself is interesting. Usually it is the defense side that challenges expert opinions. Maybe the plaintiff side is smarting from the recent trend of defense verdicts in mesh cases. Desperate times call for desperate measures.

Several of the rulings in Enborg are common to numerous mesh decisions out there, but there is a favorable decision about Rule 30(b)(6) deposition testimony not being a judicial admission that we have not seen addressed before in any detail. Even in pelvic mesh world, there really can be new things under the sun. There is also a more detailed and nuanced discussion of challenges to a defense regulatory expert, particularly regarding testimony about testing, than is normally the case in mesh decisions.

The Enborg court ruled against the defendant on some issues, due to adverse (and awful) MDL decisions, but the defendant won more of these issues than is normally the case. Once again, remand courts facing actual trials tend to render better rulings than MDL courts that treat the litigation as a settlement mill. Finally, because warning claims were out of the case, a number of opinions were excluded as irrelevant.

Let’s get to the key rulings.

The plaintiffs tried to foreclose a defense materials expert from testifying that the mesh does not degrade in vivo. The court held that the defense expert identified the relevant data and appropriate methodology, so his opinions passed muster. But the plaintiff contended that those expert opinions should stay out of the case because a defense 30(b)(6) witness had testified that degradation can occur. The Enborg court rejected the plaintiff’s position, holding that the testimony by the 30(b)(6) representative was an evidentiary admission, not a judicial admission. The jury could hear both the 30(b)(6) and expert testimony and sort any possible conflict out for themselves. Moreover, the Enborg court reasoned that the expert’s opinion that the mesh was not suffering from any quantifiable degradation while in vivo was not necessarily in irreconcilable conflict with the 30(b)(6) testimony that surface degradation can occur. Consequently, the court denied the plaintiffs’ motion to exclude the expert testimony.

The defense also proffered a urogynecologist who would testify that the mesh implant did not cause the alleged injuries. The plaintiffs endeavored to shut down such testimony because the expert had last implanted the mesh device in question 15 years ago and most of his experience was with other devices. The court held that the expert had plenty of experience (200 implants) with the device and such experience, along with his education could support general causation opinions. Nevertheless, the court held that the urogynecologist’s “limited — and dated — clinical experience” with the device meant that he could not opine about specific issues of biocompatibility, degradation, pain, and erosion.

Another defense expert was an ob-gyn who had been retired since 2015. The plaintiffs argued that this expert had been out of the game too long and should not be permitted to testify about the device’s safety and efficacy, as well as the issue of degradation. The court held that the expert’s clinical experience and literature review made his opinions sufficiently reliable and sufficiently helpful for the jury.

The defense also sought to bring in an expert who would explain the 510(k) clearance process to the jury. As we have mentioned many times before, the problem is that the pelvic mesh MDL court made a hash out of the FDA 510(k) clearance issue, ruling that such clearance had nothing to do with safety and that any mention of it would confuse the jury. As the defendant argued in Enborg, the MDL court’s reliance on the SCOTUS Lohr opinion was misplaced. The Lohr case looked at unclassified, pre-1976 comparators that had undergone no safety review, whereas the post-1976, class II comparators used in securing 510(k) clearance for pelvic mesh had undergone safety screening. The defendant implored the Enborg court to “exercise its inherent authority to disagree with the MDL court.” Obviously, that is a tough ask. We have seen some mesh remand courts push back against the MDL 510(k) ruling after those courts see how the unfairness plays out in trial. The Enborg court was not prepared at this point to push back, but made its exclusion of 510(k) evidence “subject to the caveat that Plaintiffs do not seek to show that [the defendant] failed to comply with regulations pertaining to premarket review.” That is some consolation. Further, the Enborg court reserved ruling on whether the defense expert could opine that the particular mesh in question went through “a review process that is different from — and meaningfully more rigorous than — mere 510(k) clearance.”

There is fundamental unfairness if a plaintiff expert criticizes the extent of premarket mesh testing while the defense expert is muzzled from pointing out that the premarket mesh testing fully complied with 510(k) requirements. The plaintiff in Enborg seemed to be exploiting precisely that unfairness. The trick is for the plaintiff regulatory expert to say that the limited premarket testing fell short of industry, rather than regulatory, standards. To our eyes, the plaintiff expert was a wolf (regulatory) expert in a sheep (industry) expert disguise. Thus, the Enborg court was right to be suspicious, as it viewed the plaintiffs’ position “as something less than a full-throated renunciation of regulatory evidence as to the adequacy of premarket testing.” The Enborg court said that it will revisit this issue depending on where the plaintiff expert’s testimony goes. Will the plaintiff open the regulatory door? Heck, in our view, the moment the plaintiff expert discusses her qualifications she will blow the door off its hinges.

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FDA’s exclusive enforcement powers prohibit plaintiffs from bringing what amount to private FDCA violation claims in the guise of private civil litigation.  21 U.S.C. §337(a).  That is the foundation on which prescription drug and device preemption is built. However, preemption is about the interplay between federal and state law requirements and where the latter must cede to the former.  When two federal statutes are at issue, the question is one of preclusion rather than preemption.  It’s a little bit po-tay-to versus po-tah-to, but the Supreme Court made sure to draw the distinction in POM Wonderful v. Coca-Cola Co., 134 S.Ct. 2228 (2014), and since we do not want to suggest that POM Wonderful had any effect on preemption, we restate the distinction here.

The other thing that distinguishes the case we are going to address today is it is not a products liability case, but rather a Lanham Act case – essentially marketing litigation between competitors.  That is what POM Wonderful was about as well, but in the food context rather than drugs and devices, and it found the FDCA was not preclusive.  Since POM Wonderful is not a SCOTUS decision we would rave about, we keep an eye on cases that examine the interplay between the FDCA and the Lanham Act just to make sure nothing creeps over to the products liability area we are focused on.  So far, so good.  While case specific holdings on the issue vary, the general principle is that if a Lanham Act claim challenges an FDA policy choice, meaning the court has to interpret or enforce FDA regulations, it is barred.  If it doesn’t, it’s not.  That does not stray too far from “no private enforcement” to keep us at night.

The most recent case to examine the intersection between the Lanham Act and the FDCA is Ciccio v. SmileDirectClub, LLC, 2022 U.S. Dist. LEXIS 49562 (M.D. Tenn. Mar. 21, 2022).  We gather from the opinion that the court has entertained numerous pleadings motions and discovery disputes that it did not rehash in this most recent decision, nor did it want to “belabor the details” of the case again.  But we think we got the gist.  Defendant sells plastic aligners for orthodontic use.  Orthodontists brought a Lanham Act claim against defendant alleging their misleading marketing deceived consumers into purchasing the aligners as an alternative to traditional orthodontic treatment which they allege the devices were not.  Id. at *3-4.  While plaintiffs’ claims survived earlier motions to dismiss, defendants brought this new motion to address the narrow issue of whether claims based on the allegation that defendant “improperly marketed itself as in compliance with federal regulations governing dental devices” were adequately pleaded.  Plaintiffs’ claim boils down to an allegation that defendant’s marketing misled consumers to believe the aligners were FDA approved when they were in fact not.

As a representation about FDA-approval status was not squarely addressed in POM Wonderful, defendants argued the claims in Ciccio “more seriously intrude on FDA’s prerogatives under the FDCA” such as to make the case more akin to Buckman than POM Wonderful.  Nothing would make us happier than a Lanham Act dismissal based on Buckman, but Ciccio is not that case.  Courts to have looked at the issue have gone both ways.  Ciccio at *19-20.  Here the court was persuaded that plaintiffs’ claims were not that defendant had “violated the FDCA or [ ] any general duty to disclose” whether a product is FDA-approved, but rather that their marketing was “misleading in a way that could have been, but was not, rectified by such a disclosure.”  Id. at *21.  If you can remedy the problem by disclosing, doesn’t that create a duty to disclose?  While that does make us wonder, we’ll leave that alone for now because we have an amendment to our Buckman statement above – Nothing would make us happier than a Lanham Act dismissal based on Buckman, but Ciccio is not that case – yet:

It may be that, once the facts of SmileDirect’s dealings with the FDA are established and in the record, the plaintiffs will be unable to state any theory of the case under the [Tennessee Consumer Protection Act] TCPA that would avoid Buckman-type preemption because any such claim would improperly call on this court to intrude on the FDA’s decisionmaking.

Id. at *29-30.  Yes, we know the court here was talking about plaintiff’s state law claim which is a matter of preemption as opposed to preclusion.  But the analysis should equally apply to the Lanham Act and preclusion. If the facts, in this case or another, ask the court to “improperly intrude” on FDA decision-making, such claims are preempted and/or precluded.  We retain our ability to rest easy that POM Wonderful and its progeny have left untouched the foundation of drug and device products liability preemption.

 

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