For several years now, the Valsartan MDL has been something of a poster child for the problems with modern serial product liability litigation.  It started with questionable data coming out of a questionable lab, leading to publicity and regulatory actions that outpaced reliable evidence of increased risk from an alleged carcinogenic contamination.  It snowballed from there, which we have chronicled here.  Along the way, there has been an obvious contrast with the many good rulings coming out the Zantac MDL, which is also a litigation based on questionable data coming out of a questionable lab, which led to publicity and regulatory actions that outpaced reliable evidence of increased risk from an alleged carcinogenic contamination.  The law in the Eleventh Circuit, where the Zantac MDL’s court is, is not so much more defense friendly than the law in the Third Circuit, where the Valsartan MDL’s court is, to explain the differences in results between the two MDLs formed about a year apart.  As far as we can tell with some gross overgeneralization, the facts and science are not that different either.  We are loathe to talk about specific judges, but we cannot ignore the possibility that the explanation is that the judge assigned to the Valsartan MDL for its first five years and a few months was simply overly inclined to the plaintiffs’ positions.  In May 2024, the original Valsartan MDL judge retired and the MDL was reassigned to the Chief Judge of the United States District Court for the District of New Jersey.  We now have our first major substantive ruling under the new regime, and things seem to be different now.

The signal that there is a new sheriff in town, without overtly dumping on the prior sheriff, is quite clear in In re Valsartan, Losartan, and Irbesartan Prods. Liab. Litig., MDL No. 19-2875 (RMB/SAK), 2025 U.S. Dist. LEXIS 66185 (D.N.J. Apr. 7, 2025) (“Valsartan ‘25”).  It was obvious that plaintiffs pushed the narrative that the prior judge’s rulings precluded the new judge from ruling on the motion before her.  We will not belabor the rejection of those arguments and the skill evident in avoiding saying that any prior decision was wrong.  The ruling in Valsartan ‘25 related to the admissibility under Rule 702 of plaintiffs’ economist expert’s opinions offered in support of the express warranty claims asserted in a third party payor (“TPP”) bellwether trial.  If that seems pretty specific, it is.  But it is also a lesson in how granular the fit requirement can be, derived as it is from Rule 702(a)’s insistence that expert opinion “help the trier of fact to understand the evidence or to determine a fact in issue.”  The claims, defenses, and applicable law determine what facts are truly at issue in a case.  Rule 702 veterans will be familiar with fit being used to attack causation opinions based on, for instance, exposure to a substance at much higher levels and/or for a much longer time than is alleged in the case.  It is easy to understand that an opinion that ingestion of one pill of a drug with alleged contamination of an alleged carcinogen at the level of one part per billion can cause cancer in a human cannot be based solely on data that long-term ingestion of thousands of times as much of the alleged carcinogen was associated with increased rates of cancer in certain laboratory animals.  Of course, we did not pick that example out of thin air.  The premise of the Valsartan and Zantac litigations, at least from our perspective, has been that allegations of contamination—without proof of any particular plaintiff taking pills that had any contamination, let alone risky levels of contamination—were sufficient to create liability.  Contaminated drugs did not meet specifications and were defectively manufactured.  They should not have been sold.  For generics, they failed the duty of sameness.  They were all adulterated and misbranded.  And the drugs were inherently worthless, and nobody should have ever had to pay for them.  So goes the “logic” of these claims going back to the citizen’s petitions filed by that questionable lab with unquestioned ties to the plaintiff lawyers.  As Valsartan ‘25 said of one of plaintiffs’ specific arguments in support of their expert’s opinion, “But this is both too simplistic and too doctrinaire.”  2025 U.S. Dist. LEXIS 66185, *52.

The opinion at issue was that the drugs of the defendants in this TPP bellwether trial had no value based on the assumption that they were all contaminated, and thus adulterated and illegal to sell, the entire time they were on the market.  The piggyback opinion was that the plaintiffs were entitled to huge damages for having paid for “worthless” drugs, even if the drugs actually worked really well at treating hypertension and related conditions.  Because the TPP plaintiffs claimed only economic injuries from paying for drugs, their theory did not turn on whether patients ever suffered any harm.  To us, if liability is predicated on state law, then we are talking about the stop selling theory held preempted in Bartlett and we do not even need to get to the admissibility of this particular economist to support it.  Well, the prior judge had rejected a range of preemption arguments, so we can set that concern aside for now.  Of more pressing concern was that the prior judge had accepted essentially the same opinion from the same expert, Dr. Conti, in connection with the denial of a motion to decertify a TPP class.  The new judge found enough leeway in the prior ruling to decide the admissibility of Dr. Conti’s worthlessness opinion on its merits.  Id. at 37-41.  To get there, the court first had to identify what Dr. Conti was being offered to support, and then determine if her proposed opinions would be helpful to the jury in resolving the issues implicated by the TPP plaintiffs’ triable claims.  Prior motions practice allowed the TPP plaintiffs enough wiggle room to offer pretty fuzzy claims that were designed to skirt preemption.

The TPP plaintiffs offered an express warranty theory, which can often be based on voluntary representations beyond FDA-required labeling.  However, these plaintiffs were suing over “the labeling-based representations by the Defendants that they were selling FDA approved, Orange Book A/B rated, USP compliant valsartan that was manufactured in a manner that was compliant with cGMPs and was not adulterated.“  Id. at *10.  For us, that is clearly preempted claim and not an express warranty at all.  Perhaps because its hands were somewhat tied by the prior rulings, the Valsartan ‘25 decision did not directly address state law on express warranty beyond how damages are measured.  Id. at *18 n.10.  To obtain the full refund they sought, the TPP plaintiffs had three damages theories available.  Only one, that the products were inherently valueless because of contamination, was available, because plaintiffs did not allege the drugs failed to perform their intended function of lowering blood pressure and because the drugs had been used, negating the contention that they were unusable.  Id. at *18-25.  This theory dictates the scope of proof at trial and the issues that Dr. Conti’s opinions had to fit:

This entire litigation is about the alleged contamination of lifesaving VCDs with cancer-causing nitrosamines. To try this case without evidence of cancer causation is to ignore the elephant in the room. Causation must be front and center. As a result, not only will the Court permit the parties to present evidence regarding the nitrosamines in question and cancer causation, but it will require it.

Id. at *24-25.  This may seem like an obvious requirement, but it was clear that the plaintiffs envisioned not having it.

As might be expected from an economist, Dr. Conti did not evaluate any science related to contamination and its attendant risk.  Instead, she assumed the drugs at issue were always contaminated and that contamination rendered them adulterated.  Of course, adulteration is an FDCA concept and predicating a purported state law claim on a violation of the FDCA not found by FDA should be a big no-no.  It is also clear that this part of Dr. Conti’s proposed testimony was a legal conclusion, not an opinion based on scientific or technical expertise.  A legal conclusion that supported a preempted claim, which Dr. Conti reinforced by offering that the drugs should not have been sold because they were “adulterated,“ one of her foundational assumptions.  Rather than looking at preemption and that Dr. Conti was being offered as a mouthpiece for legal conclusions, Valsartan ‘25 addressed whether Dr. Conti’s opinions would be helpful to the jury and were based on a reliable methodology.

As to the former,

Conti readily opined there was no legitimate supplier for the adulterated VCDs and therefore the VCDs had no economic value from the day the VCDs were first sold. Conti’s conclusion rests solely on the fact that it was “impermissible” to have sold the VCDs. Because it was impermissible – in hindsight – the value of the VCDs is zero and the Plaintiffs should receive a full refund. These are neither the facts of the case nor an adequate statement of the law as to damages in a breach of express warranty case.

Id. at *43-44 (emphasis in original and internal citation omitted).  Put another way, “Economic supply curves say nothing about whether any defect in the VCDs is ‘fundamental’” and proof of a defect “requires an analysis of causation and risks versus benefits.  But Conti’s methodology and testimony do not even account for the nature, impact, or extent of the adulteration.”  Id. at *47-48.  As to the latter,

The Court finds that Conti’s testimony is unreliable in light of its inconsistencies and the stark lack of scientific or economic basis for her methodology. Conti’s opinion is largely argument and advocacy based on her own ipse dixit, rather than a reliable application of economic principles and methods to the facts of the case. Perhaps this has all come about because of Plaintiffs’ failure to appreciate the critical distinction between alleging an injury in fact for standing, sustaining an injury as an element of the claim to establish liability, and then proving the injury to calculate damages.

Id. at *54-55.  By Rule 702 standards—and Valsartan ’25 noted the 2023 revision, see id. at *26 & n.15, *39-41 for an excellent discussion of those amendments—Dr. Conti’s core opinion did not come close to being admissible.

We know that we have not done a very good job of setting aside preemption as we promised a few paragraphs ago.  We are hopeful that the new direction of the Valsartan MDL signaled in Valsartan ‘25 will result in a serious reexamination of the basic question of whether plaintiffs’ state law claims are preempted.  If that is a bridge too far, then other holes in plaintiffs’ case—at least while it is based on the mere assumption of dangerous contamination—should present real obstacles for the Valsartan MDL plaintiffs.