In pharmaceutical litigation, understanding the science involved in the efficacy or safety of a drug or device is essential to obtaining favorable outcomes. But the medical literature is notoriously opaque and difficult to parse. Judges have crammed dockets and often do not spend much time in the scientific world, and the trial setting is not an ideal forum for explaining complex science to juries. An attorney’s hard work in unpacking the scientific literature, and digging into the data on which it is based, can make all the difference. Even more importantly, an attorney’s ability to translate technical data and medical jargon into language accessible to those responsible for litigation of a case, and ultimately to lay decision makers like judges and juries, is more than an essential skill. It is a science in itself—the science of storytelling.
Here we explore the component steps for preparing to tell a successful scientific story in pharmaceutical product liability litigation. Take, for instance, a litigation in which a large number of plaintiffs allege that a drug has produced a disease temporally related to ingestion of the drug. A successful defense depends directly on the assimilation of what is likely to be an avalanche of data and medical literature, much of which may be conflicting—alongside important strategic calculations about when, where, why, how and to whom the information is optimally presented. These decisions are paramount at two key junctures: the pretrial or “Daubert” stage[1] (to the judge) and at trial (sometimes, again, to the judge, and ultimately to the jury).
CONSIDERATIONS WHEN PRESENTING TO THE COURT
Courts use the Daubert “gatekeeping” process to decide whether expert opinions are unreliable and therefore inadmissible; astute science counsel use this process to expose scientific flaws in their opponents’ cases. The highly structured Daubert proceedings require the judge to adjudicate science, particularly when the court holds a pretrial evidentiary hearing. The judge will have the opportunity to review the parties’ briefing, read the expert testimony, and even study scientific articles, textbooks, and other sources of science. In some instances, she may even consult her own experts.[2] At such an evidentiary hearing, the judge metaphorically takes off her robe and becomes a student of science. Rather than parsing procedural rules or regulatory statutes or common law doctrine—the day-to-day fodder of a judge—she must immerse herself in a highly-specialized terrain. An attorney who understands the science and can function as an engaged and interesting educator is best-equipped to convey the salient data in a way that both informs the judge’s decision and helps her to write an opinion that captures the sophistication of the science.
CONSIDERATIONS WHEN PRESENTING TO THE JURY
When science is presented at trial, the strategy changes. Juries do not read written briefs setting forth logical arguments based upon scientific data; nor do they have the time or even the opportunity to study the original source documents themselves. Juries are instead asked to absorb science through courtroom testimony elicited on direct and cross-examinations of expert witnesses. The task of building a persuasive scientific story is further complicated by several realities: that expert testimony is dependent on expert availability (making it more difficult for trial counsel to build their story); that expert testimony cannot be unduly repetitive (depriving jurors of rehearing important points); and that testimony is often interrupted by objections and lengthy sidebar arguments (breaking juror concentration).
Most lay people understand instinctively that announcements of scientific breakthroughs may be premature, and even wrong. When physicists claimed to have performed nuclear fusion in a bottle, or when researchers linked daily coffee drinking to elevated rates of pancreatic cancer, suspicions abounded in the public consciousness. The news report that binging on chocolate is good for us generated as much skepticism as it did satisfaction. But in the fast-moving world of pharmaceutical litigation, there can be a temptation (particularly among lay decision makers) to defer, without close inspection of the empirical data, to conclusions conveyed by others.
A juror’s temptation to rely on the conclusions of witnesses cloaked with the imprimatur of “expert” is a well-recognized phenomenon. Litigation experts have the power to persuade not because they are necessarily right, but because they have pedigrees, experience, and authority. Daubert erected the gatekeeper apparatus to help judges keep the junkiest of expert opinions out of earshot of the jury, but even adherence to the Daubert standard does not preclude admission of opinions relying upon shaky science, science that has been misinterpreted, or no science at all.
BREAKING DOWN AN EXPERT’S OPINIONS
Let’s consider the plaintiffs’ expert who presents the opinion that your drug caused a rare disease in a multi-plaintiff litigation. Assume this expert has issued a Rule 26 report explaining the rarity of the condition, how it is diagnosed, and detailing the “lines of evidence” supporting this opinion. One line of evidence consists of case reports where authors have investigated but “ruled out” other causes, leaving your drug as the “culprit.” Another line consists of laboratory studies performed in animal models which report features of the disease and suggesting a biologically plausible mechanism of injury. A third line of evidence consists of human population studies using various methodological designs and reporting associations of different strengths and statistical significance.
Decision makers may be tempted to evaluate these sources collectively: i.e., they may, even unconsciously, determine that the aggregation of different types of scientific data presents a compelling, maybe even foolproof, scientific story. But by digging into the empiricism that underlies the reports or studies, science counsel can convey to those decision makers that the data are not as robust as they seem to be. This, in turn, can establish the groundwork for telling successful stories at both the Daubert stage and trial. Let’s examine an approach that science counsel, when faced with such a daunting task, might use to capture and convey the scientific information.
The process consists of four components: First, all the relevant data must be collected and organized into the hierarchy of scientific evidence, a process which lays the foundation for critical analysis. Second, a narrative must be developed that enables laypeople to understand complicated data, forcing them beyond facile anecdotal conclusions. Third, knowledge of the science must be used to elicit important concessions about the weaknesses of their competing stories from opposing experts at deposition. Fourth, science counsel must work as a conduit between the experts and trial counsel in the team effort of marshaling the key information and presenting it at trial in a comprehensible and persuasive way.
To begin, the relevant data must be collected, classified, and ranked in accordance with the hierarchy of scientific evidence. This process culminates in the development of a figurative pyramid depicting the highest-value, most robust scientific data at the top, with layers of less robust (but still essential) data through the middle, with the least robust data at the bottom.
This hierarchy becomes a valuable tool, indeed the most valuable tool, in the development of the scientific narrative for the litigation. It helps science counsel identify the data (and categories of experts) that your adversaries are likely to use, evaluate how to structure a Daubert strategy, and craft the approach for that strategy from the outset of the case. It also provides a foundation for assessing whether scientific studies should be undertaken to help answer vital questions necessary to defend the litigation.
In developing the narrative, science counsel is forced to take a deep dive into the empiricism of the dataset as a whole. This critical analysis is often undertaken with the crucial input of retained expert witnesses who can identify lurking problems in study design, identify data points that do not make sense, and question the validity of reported results. By fully understanding the strengths and weaknesses of the studies, science counsel can separate opinion from data and then can begin the arduous process of constructing a scientific narrative for the litigation founded on a bedrock of knowledge.
DEVELOPING A NARRATIVE TO DEBUNK JUNK SCIENCE
One of the frustrating features of mass tort litigation is its failure to quickly end claims predicated on the allegation of disorders and syndromes on the margins of medical acceptance. Alleged “syndromes” are often so poorly defined that plaintiffs with barely cognizable medical problems are squeezed into the “big litigation tent” erected by their lawyers. Sometimes a disease which is rarely diagnosed in the United States is alleged, forcing plaintiffs to claim that the diagnosis has been “overlooked” by the U.S. medical profession because accepted criteria used to diagnose it are inappropriately restrictive. Whatever tactic is pursued, the scientific narrative must always address threshold issues of scientifically reliable disease definitions and diagnostic criteria.
The most commonly contested scientific issue in pharmaceutical product liability cases is general causation—i.e., the requirement that the plaintiff establish that the drug or device is, in fact, capable of causing the harm alleged. Science counsel’s narrative will address the plaintiff’s general causation theory not only by challenging key studies, but also by explaining deficiencies in whole classes of evidence. For example, returning to our hypothetical, even if a rare disease has a low background rate in the population, case reports can be challenged because they rarely provide all the information needed to evaluate the authors’ conclusions about causation. Such reports also fail to rule out the occurrence of disease in any one person due to random chance. Laboratory experiments performed in animals are fraught with vulnerabilities which make extrapolation of data to humans quite hazardous. Indeed, when the concentration of drug administered to an animal is converted from the milligram per kilogram measurement used in the experiment to the dose in an “average” person of 70 kg, the end result is usually equivalent to a massive overdose that far exceeds the recommended dose. Finally, human population studies need to be critically evaluated for biases and confounding factors, lack of statistical significance, and improper control groups. Defects in study design can make results of even controlled epidemiological studies unreliable.
When the analysis is complete, the narrative pulls together all the data demonstrating that your drug has a remarkable safety record and does not cause the alleged injury, based upon reliable scientific evidence in accordance with the hierarchy of scientific evidence. The narrative also addresses the scientific data propounded by plaintiff experts and systematically evaluates each category of data, each individual study, and any speculative mechanisms of biological plausibility. The narrative then serves as the blueprint for cross-examining plaintiff experts during their depositions for the purpose of obtaining critical admissions or even concessions for use in Daubert challenges and at trial.
Obtaining this type of useful testimony at expert depositions is not accidental. It requires the formulation of a methodical game plan that combines many strategies built upon intensive preparation. These include review of the expert’s published scientific work, identification of the expert’s scientific methods and procedures (e.g., the use of the 95% confidence interval), recognition and exploitation of all the relevant data the expert has ignored in his expert report, and a keen understanding of how that expert approaches the dataset as a whole. Science counsel with this heightened state of preparation is then able to actively listen to the expert’s testimony, waiting for clues to exploit. Allowing an opposing expert who values the sound of his own voice to talk endlessly at a deposition can be productive, but only when that expert is prone to providing useful admissions in his monologues. Knowing when to politely interrupt and compel an answer to a specific question requires patience, experience, and a keen sense of when to press the point.
STORYTELLING AT TRIAL
We now can address the trial of the case. Though jury trial in civil cases is often considered a dying phenomenon,[3] it is in front of the jury that the role of science counsel in constructing a cohesive and compelling scientific story becomes even more important. Together with the trial lawyers charged with actually presenting the defense to lay decision makers, science counsel must develop a trial plan. In that process, science counsel serves as an important intermediary between the scientific experts and the trial lawyers. Together as a team, attorneys and expert witnesses are then able to use the special skill sets of each to determine how best to present complicated scientific data.
Trial lawyers are adept at seeing the overarching structure of a case and figuring out how to use evidence within that landscape to paint a detailed picture of their client’s story. Scientific evidence presents a special challenge, however; trial lawyers must both employ that evidence strategically and translate it successfully to lay decision makers. Science counsel plays an essential role in that process. At this point in the litigation, science counsel has been immersed in the medical data and literature, and has become adroit at identifying the most salient (in terms of both relevance and reliability) data. And because science counsel has also gained a fluency in the lingua franca of the scientific world, he is able to serve as a conduit between the medical experts and trial counsel, translating the jargon to make it more accessible without losing its important nuances. Science counsel also forms important relationships with the scientific experts, usually medical doctors, establishing trust and assimilating the experts into the trial team.
The art of storytelling has long been a key component
to effective trial preparation. Successfully using scientific evidence,
particularly expert testimony, in that preparation is especially challenging.
But complicated scientific data can be captured into a coherent story that fits
into an overarching narrative. The collaborative process among science counsel,
expert witnesses, and trial lawyers is one that is both art and science. And it
is essential for success.
[1] Or the Frye stage, in those jurisdictions still using the Frye standard to assess the admissibility of expert opinion testimony.
[2] Under the Federal Rules of Evidence, a federal court may empanel its own experts, as occurred in the silicon gel breast implant litigation.
[3] See Laura G. Dooley, National Juries for National Cases: Preserving Citizen Participation in Large-Scale Litigation, New York University Law Review.
Finis
