No one will deny that the law should in some way effectively use expert knowledge wherever it will aid in settling disputes. The only question is as to how it can do so best.
Learned Hand 1901
How to best use or challenge expert and scientific testimony is a question that continually confronts even the most seasoned defense attorneys. Since the Supreme Court’s landmark decision in Daubert v. Merrell Dow Pharmaceuticals, which resoundingly affirmed the role of trial court judges as “gate-keepers” of scientific evidence, there have been hundreds of cases attempting to refine the doctrine. 509 U.S. 579, 592 (1993). Even the Federal Rules of Evidence were redrawn to capture the Daubert test, and some states have gone so far as to codify Daubert as part of their court rules.[1] Despite the wealth of case law and various interpretations of Daubert, the core question of how best to use scientific evidence and when Daubert challenges are most effective is still elusive.
What is certain in today’s product liability and mass tort cases, however, is that expert testimony is a fact of life. The reason is simple: Experts provide vital testimony regarding causation, the mechanisms of harm, and other essential proofs. Advances in science, and the standardization of scientific methodology and learning, have propelled scientific testimony to the forefront of causation. Moreover, experts are typically given wide latitude compared to fact witnesses and therefore can have a profound effect on persuading juries and influencing verdicts. Cases increasingly turn on the testimony of experts. If improperly admitted, expert testimony poses grave risks to the integrity of the trial process. Daubert, 509 U.S. at 595. Courts have taken notice of these changes and are increasingly taking control of the use of scientific and expert testimony in the courtroom.
Yet far too often defendants wait until they are in the litigation “red zone” -- close to the trial date -- to raise critical scientific issues with the court. Today, attorneys and judges can employ a variety of tools and strategies to try to bring science and expert testimony to the very earliest stages of litigation. The push to resolve critical scientific issues at the outset of product liability and mass tort litigation appears in a variety of formats, from class certification motions to education days and mini science trials. All are attempts to resolve scientific causation issues early -- saving clients, counsel and the courts both time and resources. A recent case in the District of New Jersey provides a noteworthy example of how courts can address the admissibility of expert causation testimony early in the litigation, thereby providing defendants with an early forum to seek relief from questionable claims and dubious science.
In the In re Human Tissue Products Liability Litigation (“Human Tissue Litigation”), tissue and bone processing defendants -- with the encouragement of the district court -- filed a “science first” motion aiming to dismiss plaintiffs’ claims by establishing a lack of general causation. See In re Human Tissue Products Liab. Litig., 582 F. Supp. 2d 644 (D.N.J. 2008). The motion was filed before the completion of discovery, before the exchange of expert reports, and long before the typical Daubert challenges are made. Under management by the Hon. William J. Martini, the court embraced this “science first” plan, and in a notable Daubert opinion, ultimately granted defendants summary judgment for lack of general causation. Id.
This article will explore some of the tools litigators can use to promote science to the forefront of their cases and resolve issues of general causation early -- a concept in full keeping with the gate-keeping function annunciated in Daubert. Furthermore, it will examine the example set in the Human Tissue Litigation for raising Daubert issues at the start of the litigation process. Finally, it will offer practical guidance on issues that practitioners should consider when filing a science first motion. Bringing scientific and expert knowledge to the forefront of the litigation not only saves time and resolves critical issues early, it can be economically beneficial to all parties involved.
In today’s complex products liability actions, expert testimony often goes to the heart of causation. Thus, securing credible scientific testimony and challenging your opponent’s experts is critical to success. Depending on the nature of the case and the scientific evidence supporting the proposed harm, it is often important to differentiate between general and specific causation -- especially when considering raising an early Daubert challenge. General causation refers to whether a particular product is capable of causing a particular injury or condition in the general population. See Perry v. Novartis Pharms. Corp., 564 F. Supp. 2d 452, 463 (E.D. Pa. 2008); Mary Sue Henifin, et al., Reference Guide on Medical Testimony, in Reference Manual on Scientific Evidence 439, 444 (Fed. Jud. Ctr. 2d ed. 2000). Specific causation, on the other hand, focuses on the individual plaintiff’s background and exposure. In the ordinary single-plaintiff cases, these issues are almost always considered in tandem; however, in many mass tort cases it is important to take note of the differences between general and specific causation, because general causation can be an unsettled area that is ripe for an early Daubert challenge. That being said, in some cases, as in connection with some asbestos claims, for example, general causation will have already been established and there will be no need to re-litigate these issues.
Daubert’s focus on judicial gate-keeping not only plays into the notion of bifurcating general and specific causation, but when combined with modern MDL and mass tort procedures there is also a strong presumption that issues of general causation should be resolved as early in the litigation as possible. Indeed, Daubert clearly establishes that trial judges must evaluate proffered testimony “at the outset” of the litigation. This makes sense not only on a practical level but also on a far more basic level, as general causation asks the question of whether the drug or product in question is even capable of causing the alleged harm. Likewise, the Reference Manual on Scientific Evidence encourages courts to discuss these issues “at an early Rule 16 conference” with an eye towards an early summary judgment motion and targeted discovery so as to avoid unnecessary pretrial activity.
The most common tool utilized by both practitioners and the courts to fulfill their Daubert responsibilities has been and continues to be the use of summary judgment motions. Typically, either plaintiff or defense counsel raises the issue of the adequacy of the proposed evidence surrounding both general and specific causation in a summary judgment motion. These motions often coincide with special Daubert hearings, for which each judge and jurisdiction may have a unique format. While these motions can be effective, they are ordinarily filed late in the litigation and typically deal with both general and specific causation issues, which can limit their overall scope.
For example, in In re Rezulin Litigation, the defendant, in classic fashion, moved for summary judgment dismissing the plaintiff’s complaint on the grounds that the plaintiff could not provide any evidence sufficient to raise a genuine issue of material fact as to whether the medicine was capable of causing the injury that resulted in the plaintiff’s injury. At the same time, the defendant also moved to exclude the plaintiff’s expert witnesses on Daubert grounds. The defendant’s motion papers, however, did not frame the issue in terms of general and specific causation. Instead a broader argument was made: the plaintiff could not “establish the essential element of causation.” Ruggiero v. Warner-Lambert Co., 424 F.3d 249, 251 n.1 (2d Cir. 2005). The court granted summary judgment to the defendant on the ground that the plaintiff submitted no admissible evidence to show, as a matter of general causation, that Rezulin caused the injury claimed, and ruled as inadmissible the testimony of the plaintiff’s experts under the standards set out in Fed. R. Evid. 702 and Daubert.
Similarly, in the Seroquel Litigation, a very similar pattern was followed. After a prolonged discovery process, the defendant moved for summary judgment in the first two trial-ready cases based on the plaintiffs’ failure to establish either general or specific medical causation. On the same day the defendant moved for summary judgment, it also moved to exclude the specific-causation testimony of the plaintiffs’ case-specific causation witnesses. In response to the motions, the court held a detailed Daubert hearing where the plaintiffs’ expert was subject to direct and cross-examination. The court ultimately granted summary judgment but only on specific causation grounds. Haller v. Astrazeneca Pharmaceuticals LP, 598 F. Supp. 2d 1271 (M.D. Fla. 2009). The court left open the door for a challenge regarding general causation as to all similar plaintiffs.
While these cases both reflect a positive result for the defendants involved, if the court had focused on scientific issues sooner, the defense may have had a similar result, more expeditiously. Further, a more hands-on and scientific focus may have streamlined discovery. Daubert motions may still be the most common method of raising issues regarding the viability of scientific testimony, but a number of courts have increasingly begun to utilize a broader array of procedures to fulfill their Daubert responsibilities as early as possible. These tools and their timing vary greatly depending on the nature of the challenge and the science supporting the method of harm. Properly applied, Daubert hearings allow courts to conduct a more detailed preliminary review of scientific claims than most practitioners typically push for.
One recent development that can be beneficial in focusing the early attention of the court on general causation is the so-called education or science day. Science days are proceedings that are held outside the normal motion schedule and are designed to inform the court on relevant science issues at hand. Typically, these science days are not as formal as a Daubert hearing and do not involve cross-examination. Both parties typically present briefs and/or then present their experts at a hearing. Recently, education days were held in both the Bextra Litigation and in the Atypical Anti-Psychotics Mass Tort Litigation in New Jersey. While this format helps to focus the court on the factual issues early and informs the court on causation issues at the start of the litigation, the fact that they generally take place off-the-record makes any favorable testimony of lesser value. Additionally, some courts have moved beyond passive education days and have posed their own questions to the parties regarding the science at issue. This type of pro-active questioning was also employed in the Human Tissue Litigation, as this article will discuss further below.
Some courts have even used impartial panels or special masters to advise the judge of the science at issue. For example, in the Swine Flu Litigation -- a pre-Daubert case -- the judge appointed a panel of nonparty experts to advise the court. See In re Swine Flu Immunization Products Liability Litigation, 495 F. Supp. 1185 (W.D. Okla. 1980). Court appointed experts have also been used in a number of asbestos cases and in the silicone breast implant litigation. For the most part, these impartial panels have proven inefficient, as it often takes times to find impartial experts who are qualified on the topics at issue, thus defeating the very purpose of raising these issues early in the litigation.
While science days and impartial panels are gaining in popularity, an increasing number of defendants may choose to be even more assertive in raising Daubert challenges in light of defendants’ success in introducing a “science first” motion in the Human Tissue Litigation. Late last year, Judge Martini issued a noteworthy Daubert summary judgment decision in the Human Tissue MDL granting the science first motion. In re Human Tissue Products Liab. Litig., 582 F. Supp. 2d at 644. The decision, which granted summary judgment for defendants on two key general causation issues and excluded all of plaintiffs’ key expert witnesses, was the result of one of the best examples of how to push core scientific issues to the forefront of the litigation processes. The Human Tissues Litigation arose from a macabre set of facts involving an alleged criminal enterprise to remove human tissue and bones from corpses without following necessary regulations, screening for diseases, or securing families’ consent. While a separate trial took place regarding the criminal enterprise, the MDL litigation centered on plaintiffs who were the recipients of illegally harvested tissue and who had allegedly suffered some harm from processed tissue product.
Specifically, plaintiffs claimed that they either contracted a blood related disease, or live in fear of contracting a disease, from the transplantation of illegally harvested tissues. Most of the cases were first filed in early 2006, and on June 21, 2006, the Judicial Panel on Multidistrict Litigation consolidated these cases as In re Human Tissue Products Liability Litigation, MDL No. 1763, and assigned the litigation to the District Court of New Jersey for pretrial proceedings. Pursuant to its duty as the MDL transferee court, at the very outset of the litigation the court was active in case management and sought to identify common issues of fact and law. After numerous pretrial orders and conferences, defendants initially filed a motion to dismiss all of plaintiffs’ claims because the sterilized tissue was incapable of transmitting disease. (MDL No. 1763 Docket No. 133). Defendants’ science first motion was filed on October 20, 2006, less than five months after the MDL had been established.
Defendants’ argument was at its core a simple one: Dead cells are incapable of transmitting disease and therefore plaintiffs could not establish general causation. In support of the motion to dismiss, defendants relied on the opinions of five eminent experts who all concluded that the transmission of disease from sterilized harvested bone tissue and bone paste is impossible. Likewise, the experts opined that the incubation period for the diseases plaintiffs feared they would contract had passed, making medical monitoring unnecessary, and that the time span between the initial recovery of the tissues and the implantation was, even without sterilization, sufficient to kill any disease.
These facts, defendants argued, made it scientifically impossible for plaintiffs to prove general causation. The motions were fully briefed by February 13, 2007, and oral arguments were held on March 28, 2007. At the oral arguments, the court indicated its inclination to convert the motion to dismiss into a summary judgment motion on the issue of causation. Additionally, the court invited the parties to propose key scientific questions to be addressed by further briefing and with the benefit of limited discovery. These questions went to the very heart of general causation:
(1) Assume bone tissue from a cadaver that has been infected with hepatitis B, hepatitis C, HIV, syphilis, cancer (all types), and prions, and has not undergone any processing, is stored at a temperature of [blank] for [blank] days, can the bone tissue still transmit one of these viruses/diseases to a donee?
(2) What is the incubation period for hepatitis B, hepatitis C, HIV, syphilis, cancer (all types), and prions?
In response to these questions, the parties supplemented their initial science first motion submissions with additional briefing and worked with the court to identify common issues of law and fact. In support of this new round of briefing, the parties conducted limited discovery, including expert reports and depositions. The focus of this new round of briefing involved the period of time contaminated tissues could continue to transmit disease. Both sides agreed that un-sterilized bone tissue stored at room temperature could in theory transmit disease; the only question was, for how long.
Plaintiffs’ experts opined that disease could be transferred beyond thirty days, while defendants, through their experts, argued that disease transmission was impossible after thirty days or more of exposure. Additionally, defendants also argued that the incubation period for all claimed diseases did not exceed six months. In response to the new round of submissions, the court conducted a day of oral arguments on both parties’ motions for summary judgment as well as their respective motions to exclude the proposed testimony of various experts. Additionally, the court undertook a comprehensive review of the scientific literature, including epidemiology, animal, and in vitro studies regarding the transmission of disease.
In coming to its decision, the court recognized that courts are “charged with the role of gate-keeper and can only allow presently reliable evidence.” In re Human Tissue Products Liab. Litig., 582 F. Supp. 2d at 690. While recognizing that science is still evolving, the court quoted Judge Richard Posner: “The courtroom is not the place for scientific guesswork, even of the inspired sort. Law lags science; it does not lead it.” Id. (quoting Rosen v. Ciba-Geigy Corp., 78 F.3d 316, 319 (7th Cir.1996)). By addressing the causation questions posed by the court, extensive party discovery was ultimately unnecessary. The parties’ efforts to raise these core scientific issues early had framed the causation issues presented to the court and the thus allowed the court to rule on the limited -- but targeted -- record.
In reaching its ultimate decision, the court found that plaintiffs failed to provide any reliable evidence to support their claims of general causation with respect to the transmission of disease through unprocessed human bone tissue that has been stored at room temperature for thirty days. Id. at 690-91. Likewise, the court also found that plaintiffs failed to put forth any reliable evidence to support their claims that those plaintiffs who tested negative for disease after six months from exposure to potentially harmful tissue were still capable of developing those diseases. Id. In so ruling, the court also found that plaintiffs’ expert opinions regarding the capacity of tissues stored for over thirty days did not satisfy Daubert or a Fed. R. Evid. 702 inquiry.
While the Human Tissue defendants’ pursuit of a science first motion provides a useful roadmap for future defendants, nothing in the Federal Rules of Evidence expressly requires a court to determine preliminary questions surrounding the admissibility of expert testimony or general causation. Judges have wide discretion to either permit these types of motions or pursue a more traditional approach when examining general causation issues. Thus it is important to know if a judge will be receptive to a science-first line of attack. Litigators should also be cognitive of the type of claims they are defending against. Science first motions may prove successful in cases where scientific support is clearly lacking, and thus product-specific or company-wide discovery is unnecessary. In cases with a more developed scientific backing, however, the motions risk falling on deaf ears. In any event, bringing these issues to the attention of the court as early as possible -- in whatever format -- can produce such benefits as reducing discovery costs, educating the court, and learning valuable information about your adversary’s causation theories. As science and the use of expert testimony continue to evolve, the answer to Learned Hand’s question of how best to use scientific evidence may become a direct one: Use it as early as you can.
David J. Cooner is a partner in the Firm of McCarter & English, LLP, and a member of the Firm’s Products Liability Group. His practice is concentrated in civil litigation, with particular emphasis on the defense of claims against medical product manufacturers, pharmaceutical and chemical companies and healthcare organizations. Among other things, he handles depositions, motions, hearings and trial proceedings involving scientific issues and evidence, and he has written and lectured on products liability law and issues of interest to product manufacturers, including Daubert and similar state law authority pertaining to scientific evidence. He can be reached at dcooner@mccarter.com.
Zane Riester specializes in products liability litigation with a focus on pharmaceutical and medical device defense. Mr. Riester has extensive experience in the defense and coordination of mass torts/class actions in both state and federal court. Mr. Riester received his Juris Doctorate from Fordham University School of Law, where he served as the Managing Editor of the Fordham Moot Court Board and the captain of Fordham’s constitutional law moot court team that won the 2002 William B. Spong, Jr. National Invitational Moot Court Tournament. Before attending law school, Zane graduated from Union College where he was awarded a Thomas J. Watson Fellowship. He can be reached at zriester@mccarter.com.
