Photo of Bexis

In 1919, J. Edgar Hoover described Communism as a “conspiracy so vast” that it was impossible for the populace to comprehend it.  The Palmer Raids and the first Red Scare soon followed.

That phrase echoed in our minds when we first read In re Valsartan, Losartan, & Irbesartan Products Liability Litigation, 2023 WL 1818922 (D.N.J. Feb. 8, 2023).  The Valsartan opinion was similarly mind-boggling in its scope.  It certified not one, not two − but four class actions:  one for economic loss, one for third-party payors (“TPPs”), and two for medical monitoring (“remedy” and “independent claim”).  Id. at *3.  Compare that to the state of class action precedent in product liability litigation not too long ago when we made this statement in 2007:

As far as we know, there has not been a single contested class action in product liability, personal injury litigation that’s been affirmed anywhere in the federal system in the decade since the Supreme Court put the kibosh on such things with its Ortiz and AmChem decisions.  That’s not limited to just pharmaceuticals, that’s every kind of product that’s made.

Four in a single MDL order?  These class certifications glommed together no less than 111 consumer and TPP subclasses.  Valsartan, 2023 WL 1818922, at *24.  These class certifications combined 428 different pharmaceutical products, produced and marketed by 28 separate defendants, with claims governed by the laws of 52 separate jurisdictions.  There’s no way on earth that common issues could predominate over individual ones, or that this morass could possibly be tried to a jury.

That boggled our minds and was one reason we titled this post “An Abuse of Discretion So Vast.”  The other is that, unlike the largely fictitious communist plots, the Valsartan opinion really is huge and hard to get our hands around.  The opinion spans almost 300 (292, to be exact) Lexis star pages and weighs in at over 40,000 words.  Two of your intrepid bloggers took shots at writing blogposts about Valsartan shortly after it was decided – but found the opinion simply too complicated, verbose, and depressingly wrong for us to wrap our hands, or our brains, around.

However, since Valsartan is certain to wind up on our 2023 bottom ten drug/device decisions, we’re taking another, more superficial, shot at describing it.  We know, as do most of our readers, that this decision is not intended as a legal opinion.  It’s not published.  It’s simply a club with which to bludgeon the defendants into settling what are factually unprovable and legally untenable claims.  See Valsartan, 2023 WL 1818922, at *24 (justifying unprecedented class certifications as “promoting Class Action settlement”).  Cf. In re National Prescription Opiate Litigation, 976 F.3d 664, 670 (6th Cir. 2020) (abuse of discretion to certify settlement negotiation class; certification was “designed to fundamentally alter the nature of the MDL-to foster settlement through a novel means of class action”).

How untenable?  Well, the factual allegations here are essentially the same as those in the Zantac MDL – that these 428 different drugs “were contaminated with . . . nitrosamines, N-nitrosodimethylamine (‘NDMA’) and N-N-nitrosodiethylamine (‘NDEA’),” which plaintiffs claim can, at the minuscule dosages involved, cause various cancers.  Valsartan, 2023 WL 1818922, at *1.  That’s garbage, as the Zantac MDL has already determined applying the standards of Fed. R. Civ. P. 702.  See Our post here, discussing In re Zantac (Ranitidine) Products Liability Litigation, 644 F. Supp.3d 1075 (S.D. Fla. 2022), a decision that sliced diced, and pureed almost identical nitrosamine/cancer causation allegations raised about a different class of prescription drug.

Indeed, the FDA stated, in connection with the same drug recalls that the Valsartan plaintiffs use to define their classes, 2023 WL 1818922, at *20-21:

[These] medicines . . . remain on the market and have been determined not to contain any nitrosamine impurities.  We continue to encourage patients talk to a health care professional if they have questions about their medicine, as the risks of stopping taking [these drugs] for treating high blood pressure and heart failure greatly outweighs the potential risk of exposure to trace amounts of nitrosamines.

FDA, “Statement on the agency’s ongoing efforts to resolve safety issue with ARB medications” (Aug. 18, 2019) (emphasis added).  Even Valsartan had to admit that the “scientific community itself cannot tease out a single, individual cause of cancer from a lifetime of nitrosamine exposure from various sources.”  2023 WL 1818922, at *36.  “Nor can [science] determine the cause of an inflection point making one’s likelihood of developing cancer more and more probable.”  Id.

Valsartan thus admits that no individual plaintiff can establish causation. Were these individual cases, that means they would have been dismissed. A procedural rule, such as Rule 23 governing class actions, should not, and legally cannot, change that result.

But rather than grappling with these scientific issues, and concluding, as did the Zantac MDL court, that causation cannot be proven under the evidentiary standards used in mass tort cases, Valsartan instead glossed over both general and individual causation issues with 50,000-foot generalizations.  That’s simply not permissible.  E.g., Barnes v. American Tobacco Co., 161 F.3d 127, 145 (3d Cir. 1998) (non-certification of medical monitoring class affirmed because “plaintiffs cannot prove causation by merely showing that smoking cigarettes causes cancer and other diseases” but must prove that defendants’ conduct “caused each individual plaintiff to have a significantly increased risk of contracting” disease).

Since we know medical monitoring the best – we recently prepared, and have kept up to date, a 50-state survey of monitoring decisions both pro and con (recently, mostly con) – we’ll critique the massive Valsartan opinion mostly on that issue.  Valsartan barely addressed the dramatic variance in medical monitoring precedent over the 52 relevant American jurisdictions.  Instead, it accepted plaintiff’s contention that a single case − Redland Soccer Club, Inc. v. Dep’t of the Army, 696 A.2d 137, 145-46 (Pa. 1997), “reliably sets forth the legal framework for deciding if medical monitoring stands as an independent cause of action.”  Valsartan, 2023 WL 1818922, at *35.

That’s complete malarkey – or hooey, balderdash, poppycock, tripe, crock, or whatever descriptive term you prefer.

For one thing, Redland Soccer nowhere recognizes medical monitoring as an “independent” cause of action, even under Pennsylvania law.  Rather, Redland treated medical monitoring as an equitable remedy – not an “independent” anything.

[T]he Redland Plaintiffs filed their complaint [under a Pennsylvania statute] and . . . requested equitable relief . . . in the form of a medical monitoring trust fund, which they claim is a cognizable response cost. . . .  Although [the statute] does not explicitly use the words “medical monitoring trust fund”, we believe that the [statute’s] terms . . . encompass such a remedy.

696 A.2d at 142.  Far from being a separate cause of action, medical monitoring in Redland Soccer was simply a remedy for “negligence” − negligence being an essential element for recovery of medical monitoring in Pennsylvania.  Id. at 145 (any claimed risk must be “caused by the defendant’s negligence”).

Nor can Redland Soccer’s Pennsylvania criteria for medical monitoring be extrapolated to the rest of the country.  First, Valsartan grossly overstates the American jurisdictions that allow medical monitoring – including, for example, the three states whose high courts have most recently flatly rejected no-injury medical monitoring – Delaware, New Hampshire, and Illinois.  2023 WL 1818922, at *25, 34 n.48.  Compare, Our 50-State Survey, citing, inter alia, Baker v. Croda, Inc., ___ A.3d ___, 2023 WL 5517797 (Del. Aug. 24, 2023), Brown v. Saint-Gobain Performance Plastics Corp., 300 A.3d 949 (N.H. 2023), and Berry v. City of Chicago, 181 N.E.3d 679 (Ill. 2020).  Of the 28 states that Valsartan includes in its medical monitoring “class definition,” 2023 WL 1818922, at *25, our evaluation indicates that Alaska, Arizona, Delaware, Hawaii, Idaho, Illinois, Iowa, Maine, Massachusetts, Minnesota, Montana, New Hampshire, New Mexico, New York, North Dakota, Oregon, Rhode Island, South Dakota, and Wyoming all should not be there.  At best, some of these states’ law is unclear, but under controlling Third Circuit precedent, detailed here, lack of definitive state-law precedent is not a basis for a federal court such as Valsartan to predict expansions of state law.  To the contrary, “federal courts may not engage in judicial activism.  Federalism concerns require that we permit state courts to decide whether and to what extent they will expand state common law. . . .  Our role is to apply the current law of the jurisdiction, and leave it undisturbed.”  Leo v. Kerr-McGee Chemical Corp., 37 F.3d 96, 101 (3d Cir. 1994) (one of many Third Circuit decisions for this proposition).

Second, Redland Soccer is not even typical of states that permit no-injury medical monitoring claims.  As discussed fully in our 50-state survey:

  • Pennsylvania is one of six jurisdictions (the others being California, Florida, Nevada, Utah, and the District of Columbia) that expressly limit recovery to negligence actions.
  • Not a single state, including Pennsylvania, allows recovery of medical monitoring for “breach of warranty or fraud or violation of consumer protection statutes,” and Valsartan doesn’t cite any precedent for its contrary conclusion.  2023 WL 1818922, at *36.
  • Pennsylvania is one of four states (the others being Florida, Utah, and West Virginia) that expressly list a plaintiff’s exposure exceeding background levels as a prerequisite to recovery.
  • Unlike Pennsylvania, three states retain a diminished present injury element for medical monitoring, requiring at minimum “subcellular” changes (Massachusetts and Minnesota), or “physical manifestation of or clinically demonstrable presence of toxins” (New York).
  • Unlike Pennsylvania, the District of Columbia and two other states that allow no-injury medical monitoring, (Missouri and New Jersey) have precedent precluding no-injury medical monitoring in prescription medical product actions.
  • Unlike Pennsylvania, three states (California, Maryland, and West Virginia) retain the traditional “reasonably certain” limit on recovery of future damages in medical monitoring cases.
  • Unlike Pennsylvania, three states impose other limits on no-injury medical monitoring:  Maryland requires quantification of the increased risk.  Utah requires a plaintiff-specific benefit.  Vermont statutorily limits liability to owners of “large facilities.”

Thus, the medical monitoring “claims” in Valsartan fully justify the Third Circuit’s “skeptic[ism] that the necessity for individuals’ medical monitoring regimes can be proven on a class basis.”  Gates v. Rohm & Haas Co., 655 F.3d 255, 268 (3d Cir. 2011).

So Pennsylvania law isn’t close to being the nationwide “framework” for no-injury medical monitoring that Valsartan claimed it was.  2023 WL 1818922, at *35.  Moreover, Valsartan ultimately didn’t really follow Redland Soccer anyway.  Instead, we found this nugget:

[A]lthough the precise increase in cancer risk due to ingestion of [nitrosamines], and therefore the overall increase in cancer risk, is unknowable, every class member shares a common legal question that need not be resolved at this stage, viz. the possibility of an increased cancer risk as well as an increased fear that class members have such a higher risk.

Id. at *37 (emphasis added).  The standard Valsartan actually employed − a mere “possibility of an increased cancer risk” − dumbed down even Redland Soccer’s “significantly increased risk” standard.  Cf. 696 A.2d at 145.  See also Gates, 655 F.3d at 267 (under Redland Soccer, the claimed exposure must “create a significant risk of contracting a serious latent disease for all class members”).  Further, Redland Soccer rejected “fear” altogether as a purported basis for a medical monitoring claim.

We held that damages for increased risk and fear of cancer were too speculative to be recoverable where cancer was not present. Because the plaintiffs in Simmons had not developed cancer, we did not permit them to recover for their increased risk and fear of cancer.

696 A.2d at 145 (discussing Simmons v. Pacor, Inc., 674 A.2d 232 (Pa. 1996)).

Medical-monitoring class actions much less convoluted than Valsartan have usually “founder[ed] for lack of cohesion” when brought under Rule 23(b)(2), and for failure of factual predominance if brought under Rule 23(b)(3).  Gates, 655 F.3d at 264, 270 (affirming denial of certification for medical-monitoring class under both sections of Rule 23); see Barnes, 161 F.3d at 143 (same, solely under Rule 23(b)(2), for medical-monitoring class).  As the American Law Institute pointed out when it addressed medical monitoring class actions:

The question of liability, however, will turn on particular facts of each individual’s claimed exposure − for instance, the magnitude of their respective exposures (relative to the level that would warrant medical monitoring). . . .  This individual inquiry will control the outcome of the proceedings, regardless of whether applicable substantive law requires physical injury beyond exposure alone, or, alternatively, recognizes an entitlement to medical monitoring in the absence of physical injury.  Because the liability inquiry turns on the individual circumstances of exposure for the particular persons involved, aggregate treatment is unwarranted. . . .  Even when medical-monitoring claims are allowed, there is no basis for aggregating claims that ultimately rely on individual considerations to prove liability.

ALI, Principles of the Law of Aggregate Litigation §2.04, comment b (2010).

Thus, our limited examination of Valsartan concerning medical monitoring − the class certification issue that we know the best − demonstrates that the decision:  (1) fragrantly violated jurisprudential limits on expansive predictions of state law; (2) included states that outright reject no-injury medical monitoring; (3) papered over dramatic state-by-state differences even among states permitting no-injury medical monitoring; and (4) ultimately ignored even the one case (Redland Soccer) it purported to rely on, in favor of a minimal “possibility” of “increased risk”/”fear” standard that is not the law of any jurisdiction in the United States.

We fully expect, that if we picked through the other purported “state law” aspects of the sprawling Valsartan opinion with the same thoroughness − economic loss claims, third-party payor liability, consumer protection, unjust enrichment, etc. – we’d find similarly novel theories, ignored state-law differences, avoidance of inconvenient legal elements, and lowering of standards of proof that we found with that decision’s medical monitoring analysis.

We did look for the never-been-adopted-anywhere “express warranty” claim based on the mere listing of certain drugs in the “Orange Book” that we previously criticized as unprecedented, and thus totally contrary to the role of federal courts in diversity cases.  Sure enough, we found it front-and center in the “predominance” discussion of the economic loss class.  Valsartan, 2023 WL 1818922, at *23 (“these central issues revolve around defendants’ conduct of asserting that the [drugs] were the chemical equivalent of the patented reference listed drug [RFL] in the Orange Book”).  Thus, a theory of liability that has not been adopted by any state appears to be the linchpin of the economic loss class certification in Valsartan.

Valsartan is one of the most nakedly result-oriented mass tort decisions that we have ever read, and that’s saying something.  We hope that the Valsartan defendants continue to resist the “hydraulic pressure on defendants to settle” that class certification creates − and here was intended to create.  In re National Football League Players Concussion Injury Litigation, 775 F.3d 570, 586 (3d Cir. 2014).  If they can, we see virtually no likelihood that this “abuse of discretion so vast” can survive eventual appellate review.