At last report, a Delaware court had concocted an idiosyncratic standard to enable permit admission of the plaintiffs’ scientific evidence in 75,000 Zantac cases pending in Delaware, one of 44 Daubert states. (All federal courts follow Daubert.) According to the US Supreme Court, this means only evidence which is reliable and relevant may be admitted for a jury’s consideration. But before she was reversed, Judge Vivian Medinilla had her own interpretation.
Daubert suggests five tests to assist judges in making admissibility determinations, but those tests are more the subject of debate than a source of assistance. (By comparison, the earlier Frye standard, now applicable in only six states’ courts, requires the judge to accept the prevailing consensus in the relevant scientific community.) Daubert also imposes on the trial judge the non-delegable role of “gatekeeper.” No longer can judges throw up their hands and dump the proffered evidence into the laps of the jury for them to detangle. Now, judges must make a preliminary determination on the (scientific) sufficiency of the evidence, usually at a pre-trial hearing after reviewing expert evidence and hearing cross-examination. Only then may the jury consider how much weight to afford the expert testimony.
When Cases and Law Give Us Heartburn
Most judges went to law school to avoid learning science; now they can’t avoid it any longer. However, it seemed that Judge Medinilla, who was assigned to the Delaware Zantac multi-county litigation, thought she could.
Ranitidine, trade name-Zantac, was approved by the FDA in 1983 to treat acid reflux, ulcers, and other gastrointestinal upsets. In 2020, the drug, now made by several manufacturers, was voluntarily recalled. The reason for withdrawing the blockbuster billion-dollar drug? In 2019, an “independent” laboratory, Valisure, loosely associated with the plaintiffs’ bar, reported high levels of NDMA, a probable carcinogen, in ranitidine pills. NDMA is ubiquitous; it’s found in trace amounts in food, air, and water, but the laboratory claimed that ranitidine degraded, forming NDMA in excessively high levels. Later tests revealed the pills had been “tortured”, subjected to extraordinary conditions to yield the extreme results, which unsurprisingly, were not reproducible. No matter; the litigation was off and running.
In the first years of litigation, some two hundred thousand “Zantac” cases were filed nationwide, and hundreds of millions of dollars were expended in settlements or verdicts. In December 2022, federal Judge Robin Rosenberg tossed the 50,000 cases pending in her Florida Southern District court, which were seeking damages for five cancers: esophageal, bladder, gastrointestinal, liver, and pancreatic. (The plaintiffs’ lawyers had initially filed cases for ten cancers but withdrew claims for five after determining they didn’t have enough evidence.). In her 341-page opinion, discussed here, Judge Rosenberg reviewed the testimony of the plaintiffs’ ten expert witnesses and concluded that their testimony and the data on which they relied did not meet the Daubert standard. Without expert testimony, the plaintiffs could not prevail, so she dismissed the cases.
That still left over 100,000 cases pending in state courts nationwide. In October 2024, GlaxoSmithKline settled 80,000 of them for $2.2 billion. But 75,000 still cases remained. And guess where those withdrawn Florida claims resurrected? The Delaware court of Judge Vivian Medinilla, which heard 80% of the withdrawn Florida claims along with claims on the five cancers that were brought (and dismissed) in Florida, this time by different plaintiffs.
“Hard Cases Make Bad Law”
Judge Medinilla held her own Daubert hearing, during which she reviewed all of the plaintiffs’ expert evidence. While the Delaware experts differed from those in Florida, the testimony, studies, and evidentiary arguments were similar. Apparently, Judge Rosenberg’s careful analysis and reasoning did not resonate with Judge Medinilla, who crafted her own idiosyncratic “Delaware version” of Daubert, enabling her to send the evidence to the jury to decide whether it was scientific without first making her gatekeeper assessment. In short, at the end of her 104-page opinion, she dumped the entire bundle of scientific evidence on the jury to sort out.
Under normal circumstances, Judge Medinilla’s decision, discussed here, would not be immediately appealable. In Delaware, these decisions initially require the parties to litigate their cases to a final conclusion. There are rare instances in which an interlocutory appeal can be brought before the final verdict, but only with the court's permission. Due to the hassle and expense, permission to bring an interlocutory appeal is rarely sought, let alone granted.
In this case, the defense sought permission to appeal the evidentiary decision, first from Judge Medinilla. She denied it, perhaps hoping the matter would settle during the trial. If so, her absurd decision would go unchallenged and remain (very bad) law in Delaware. The defendants then sought permission from the appellate court; it was granted, their appeal heard, and on July 10th, they received the decision.
The appellate court rejected Judge Medinilla’s decision outright, ruling she “abused her discretion”, meaning her decision “was arbitrary and capricious.”
Their ruling was motivated not only by the immediate resolution of 75,000 cases, but to guarantee that Daubert would never again be undermined by “creative” science-averse judges. While the court’s reach is limited to Delaware, the opinion has broad ramifications as it coheres Delaware law to the federal standards, crystallizing and clarifying Daubert’s premises and principles, holding that the Daubert standard in Delaware is no different from federal standards, and pointedly overruling her insinuation of any presumption of liberality in construing scientific evidence. [1]
The Specifics That Go Beyond the Case
The appellate court also cited errors specific to mass tort case, first rejecting Medinilla’s blanket dismissal of statistical proof, finding:
“Although statistical evidence may not be a prerequisite in every case, it remains an important consideration and its absence should, at a minimum, require the expert to explain why it is not necessary under the particular facts of the case.”
Next, the appeals court assessed the determinative question of all mass tort cases: general causation, i.e., whether a substance is capable of causing a particular injury or condition in the general population. Here, the court rejected Judge Medinilla’s admission of studies documenting the carcinogenic effects of ubiquitous NDMA as determinative, instead focusing on studies of the effects of Zantac specifically (of which there apparently are none ), concluding that the plaintiffs offered no relevant proof of general causation.
“A general causation expert’s opinion must focus on the product at issue and must show that exposures examined in the non-product studies on which the expert relied are reliably linked to the exposures by the product at issue.”
And though the court didn’t directly rule that establishing a threshold dose is required to prove general causation, it implied as much. By defining general causation in terms of the product, rather than its component, the court shifted the focus to how much NDMA Zantac is realistically produced under typical conditions, an indirect way of addressing the dose-causation question.
Plaintiffs’ Bar Revisited
The significance of the Delaware decision cannot be underestimated. As one plaintiff’s website posted some months before the decision,“[The Delaware matter] will likely control the fate of all Zantac cases.”
Flash forward to their posting after the decision.
“While this is a setback, the court did not dismiss the claims. Plaintiffs will now get a chance to develop expert testimony using updated scientific evidence … This ruling delays trials but does not close the door. Plaintiffs remain confident that renewed expert analysis will withstand challenge and bring these cases to juries.”
The plaintiffs’ bar still frames the recent decision favorably because the court didn’t dismiss the case outright (as did Judge Rosenberg) but sent it back to the trial judge for further proceedings. However, Judge Medinillas’ wiggle room is limited, as her ruling must be consistent with the Appellate Court decision, meaning an outright dismissal is more likely at some point.
Back to Judge Rosenberg: Her decision is on appeal before the 11th Circuit. Oral arguments are scheduled for October 6, and we expect to receive a decision shortly thereafter. However, given that the plaintiffs have lost all 8eght of the previous jury verdicts, and the review standard to overrule Judge Rosenberg’s decision is very high – it isn’t likely to be disturbed.
As the songster says: “When will it ever end, when will it ever end?” [2]
[1] The general rulings made by the Appellate Court are noteworthy, including that:
-
There is no presumption favoring evidentiary admissibility.
- The burden of proving admissibility belongs to the proponent.
- Attempts to liberalize admissibility requirements are rejected.
- The “consensus” standard of Frye (the term peppered in plaintiffs’ experts’ reports) is no longer acceptable.
- Preliminary determinations of admissibility “is and always has been” the responsibility of the judicial gatekeeper as the initial fact-finder
[2] Pete Seeger, Where Have All the Flowers Gone?
