January 27, 2016

Mastery in the MDL: Maximizing the MDL
Daubert Process

Appeared in Law360 on January 29, 2016. Originally appeared in Kaye Scholer's Product Liability Report.

—by Andrew Solow, Alan Rothman and Ari Fontecchio

Imagine having the ability to defeat dozens, if not hundreds or even thousands of cases, with a single motion. From a defendant’s perspective, finding the tool to accomplish that goal would be a dream come true. The process of multidistrict litigation (MDL), whereby federal cases from around the country are centralized in a single federal district court for coordinated pretrial proceedings, provides such an opportunity.

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One of the most important features of product liability litigation is the role of the expert. Products cases often rise and fall upon whether a court will accept the methodology and testimony of an expert, particularly one who espouses an opinion as to whether the product at issue could cause, and in fact caused, the alleged injury. Under well-enshrined case law, the trial court plays an essential “gatekeeping” role in determining whether expert testimony is admissible in a particular case, commonly referred to in the federal system as “Daubert.”[i]

This article explores the interplay (or intersection) between the worlds of MDLs and Daubert in product liability litigation. In particular, this article addresses:

  • The import of Daubert to the MDL process
  • The timing of Daubert motions in an MDL proceeding
  • The use of “Science Days”Favorable MDL Daubert rulings
  • Overcoming an adverse Daubert ruling
  • Federal-state coordination of the expert process

I. The MDL Process

Before exploring the vital role of expert testimony and Daubert motions, a brief primer on MDLs is in order. 28 U.S.C. § 1407 provides for the coordination of cases into a single MDL proceeding for purposes of pretrial motions and discovery. Under Section 1407, “[w]hen civil actions involving one or more common questions of fact are pending in different districts, such actions may be transferred to any district for coordinated or consolidated pretrial proceedings.” The Judicial Panel on Multidistrict Litigation (JPML), a panel of seven district court and Circuit Court judges appointed by the Chief Justice of the United States Supreme Court, makes the decision as to whether to create an MDL and before which district court judge the MDL will proceed. That MDL judge has full discretion to decide which issues to address and how long to keep the cases before sending them back to the respective transferor courts for trial. Under the US Supreme Court’s Lexecon precedent, the MDL judge generally cannot try cases that did not originate in the MDL district, unless the parties agree.[ii]

II. The Import of Daubert to the MDL Process

Essential to the MDL process is the goal of consistency, particularly with respect to expert and Daubert issues. As the JPML has repeatedly held in several recent decisions: “Centralization will eliminate duplicative discovery, avoid inconsistent pretrial rulings (including with respect to discovery, privilege and Daubert motion practice), and conserve the resources of the parties, their counsel and the judiciary.”[iii] In the context of an MDL, Daubert rulings can have a magnified impact, largely avoiding the litigation of a string of non-meritorious actions[iv] because they can apply to large swaths of cases.

Issues ripe for Daubert consideration include general and specific causation. A ruling on general causation (whether the product at issue could cause plaintiff’s injury in any case) could determine whether any of the cases in the MDL go forward. Similarly, a ruling on specific causation (whether the product caused a particular injury to a particular plaintiff), could impact whether the cases of similarly situated plaintiffs advance.

Because of their applicability to such a wide range of cases in the MDL, successful Daubert motions can have a significant impact on the trajectory of the MDL, including by teeing up dispositive summary judgment motions based on a favorable Daubert ruling, narrowing key issues for trial and reducing case values for settlement purposes. Even where the MDL judge defers ruling on a dispositive summary judgment motion following a favorable Daubert ruling, Daubert motions can still affect the disposition of the individual cases on remand because the MDL judge can couple the Daubert ruling with a Suggestion of Remand to the JPML to remand the cases to transferor courts. This enables transferor courts to be knowledgeable of favorable rulings and avoid re-litigation of the same complicated issues.

III. Timing

In light of the importance of Daubert motions, timing is everything. Daubert motions can come earlier or later in the MDL process. The Human Tissue MDL proceeding serves as a good example of where an early Daubert ruling created efficiency down the line. In that case, there were five months between the creation of the MDL and the first science-based motion, which was before the completion of fact discovery in any of the cases. Based on its rejection of plaintiffs’ experts, the court found a lack of general causation.

Sequenced discovery is one means of moving toward an early ruling on general causation. For example, in the Viagra litigation, Judge Magnuson ordered that the “first phase of discovery for all cases shall be focused on the sole issue of general causation—whether Viagra® is capable of causing” the alleged optical injuries.[v] Because Judge Magnuson granted defendant’s motions to exclude plaintiffs’ general causation experts at the end of the limited discovery period, defendant was spared unnecessary time and expense.

The Daubert case itself—in which plaintiffs’ cases lingered for far longer than the science warranted—demonstrates why early expert determinations can be crucial to testing the strength of plaintiffs’ cases. There, based on scientific studies that were later discredited, plaintiffs dragged out litigation until defendant’s legal costs (that is, the fees for litigating the case; not for damages) became so prohibitive that the company chose to pull its drug from the shelves rather than continue the litigation. In its summary judgment decision, the Supreme Court recognized the importance of addressing scientific issues early in the MDL process by noting the importance of the “gatekeeping role for the judge.”[vi] As a practical matter, most MDL judges defer Daubert rulings until some cases have been worked up for trial. But whether Daubert issues are addressed sooner or later in the MDL process, the MDL judge’s “gatekeeping” role is critical.

IV. Science Days

MDL judges have developed a number of ways to achieve their gatekeeping role even short of an early Daubert motion. For example, when an MDL involves complicated scientific issues, courts often permit the use of tutorials called “Science Days” to explain the science involved. The ABA’s Civil Trial Practice Standards suggest that once the court agrees to permit a Science Day and the parties agree on the content, the court should establish the structure of the presentations.[vii] The court could ask for pre-recorded or live presentations by one or more experts, and the court could permit the parties to conduct cross-examination. Generally, those Science Days are presented in a neutral fashion, with courts encouraging the parties to avoid overt advocacy in their presentation of the relevant science.

V. Examples of Successful MDL Daubert Motions

Recent examples of successful MDL Daubert motions illustrate the MDL judge’s gatekeeping role.

In the Zoloft birth defects litigation, the MDL issued three Daubert opinions over the course of 18 months, excluding all of plaintiffs’ experts from opining that Zoloft causes various types of birth defects in humans. In June 2014, Judge Cynthia Rufe initially excluded plaintiffs’ expert epidemiologist, stating that the epidemiologist “takes a position in this litigation which is contrary to the opinion she has expressed to her peers in the past, relies upon research which her peers do not recognize as supportive of her litigation opinion, and uses principles and methods which are not recognized by the relevant scientific community and are not subject to scientific verification.”[viii] That opinion was followed by an opinion prohibiting plaintiffs’ biological mechanism experts from using their reliance on animal and in vitro studies to opine that “Zoloft, when used by pregnant women at conventional doses, causes an increased risk of congenital malformations in human babies.”[ix] Following those decisions, the MDL court allowed plaintiffs a do-over by granting their motion for leave to submit a new expert report. Most recently, the court struck that new expert’s testimony, concluding that a biostatistician “failed to consistently apply the scientific methods he articulates, has deviated from or downplayed certain well-established principles of his field, and has inconsistently applied methods and standards to the data so as to support his a priori opinion.”[x]

In the Denture Cream litigation, the MDL court rejected plaintiffs’ attempt to introduce new evidence in an effort to come back from a previous exclusion of their general causation experts. The court found that plaintiffs’ new evidence—a new study, expert analysis, epidemiological evidence, evidence of a dose-repose relationship and case reports—failed to satisfy Daubert because the evidence was riddled with methodological flaws. In light of the “factually inaccurate data and unsupported assumptions,” the court found that plaintiffs’ experts’ theory “generally lacks the sound scientific basis and intellectual rigor required by Daubert.”[xi]

In a series of Daubert decisions in the Boston Scientific Pelvic Mesh litigation, the MDL court found that plaintiffs’ many experts committed a number of Daubert violations, including summarizing corporate documents instead of providing expert analysis, using unreliable methods, failing to provide a rationale for rejecting contrary evidence, providing common sense analysis for which an expert’s opinion was unnecessary, and failing to rule out alternative causes.[xii]

In the Prempro hormone therapy proceeding, the MDL court excluded plaintiffs’ experts’ testimony that an estrogen-only form of hormone replacement therapy caused breast cancer. Interestingly, that decision was issued jointly by the MDL judge and another federal judge who had a number of hormone therapy cases that could not be transferred to the MDL proceeding because those cases had been removed to federal court under the Class Action Fairness Act’s “mass action” provision.[xiii] That provision precluded MDL transfer absent the consent of a majority of the plaintiffs. In their Daubert decision, the judges rejected the testimony because the experts discounted data that undermined their opinions, relied on statistically insignificant data and did not understand the differences among the various drugs involved in the case. The judges found that the experts’ opinions were not sufficiently reliable to undercut a decade-long study from the Department of Health and Human Services demonstrating that estrogen-only hormone replacement did not increase the risk of breast cancer.[xiv] This decision moved a large swath of cases closer to settlement or dismissal.

Similarly, in the Viagra proceeding, the MDL judge granted defendant’s motions to exclude plaintiffs’ general and specific causation experts. Effectively ending the MDL, the judge held, “[b]ecause Plaintiffs have failed to produce admissible expert testimony that Viagra caused their NAION [non-arteritic anterior ischemic optic neuropathy], [defendant’s] motion for summary judgment must be granted.”[xv]

VI. Strategies to Fight the Unsuccessful Daubert Ruling

Of course, not every Daubert motion is successful, so defendants have developed various methods of appealing an adverse decision. Upon receiving an unfavorable Daubert ruling, defendants can ask the MDL court’s permission to take interlocutory appeal to the MDL district’s Circuit Court of Appeals under 28 U.S.C. § 1292. If the district court and the Circuit Court both permit it, the interlocutory appeal can proceed. Defendants also can appeal upon the conclusion of an MDL trial (often referred to as a “bellwether trial”) that was subject to the adverse Daubert ruling. The US Supreme Court recently held that a party need not wait for the conclusion of the entire MDL proceeding before appealing a final decision in an individual case within the MDL.[xvi]

Another option is for defendants to appeal after remand to the transferor courts, but the “law of the case” doctrine can limit this strategy. The Manual on Complex Litigation (§ 20.133) provides that “[a]lthough the transferor judge has the power to vacate or modify rulings made by the transferee judge, subject to comity and ‘law of the case’ considerations, doing so in the absence of a significant change of circumstances would frustrate the purposes of centralized pretrial proceedings.”

In practice, the “law of the case” doctrine can take the form of an elevated “clear error” standard of review by the transferor court.[xvii] Alternatively, as some courts have held, the review could entail the same standard applicable to a motion for reconsideration.[xviii] Although there is a high hurdle in overturning a decision of the MDL court, the law does not foreclose such a challenge after remand and presenting those arguments to the transferor court.

VII. Federal-State Coordination

MDLs often involve similar cases pending in state court arising from use of the same product. To boost efficiency, federal and state courts have the option of cooperating. The courts can hold a joint Science Day, pursue joint expert discovery or have coordinated Daubert hearings.[xix] Similarly, federal courts could invite state court judges to sit in on federal Daubert hearings. Although a federal court’s proceedings cannot bind state court judges, such coordination could educate state court judges on key issues in the case, develop relationships between federal and state court judges, and avoid end-runs in state courts around rulings of MDL judges.

Thus, the Daubert process is an essential element of litigating any product liability action. But its power is particularly pronounced in the context of an MDL proceeding. Understanding its impact and how to use the process to best position your company will place you one step ahead in both mastering and maximizing the MDL Daubert process.

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[i] Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579 (1993).

[ii] Lexecon Inc. v. Milberg Weiss Bershad Hynes & Lerach, 523 U.S. 26 (1998).

[iii] In re: Bard IVC Filters Products Liab. Litig., 2015 WL 4885543, at *1 (J.P.M.L. Aug. 17, 2015) (emphasis added).

[iv] In re Human Tissue Products Liab. Litig., 582 F. Supp. 2d 644 (D.N.J. 2008).

[v] In re Viagra Products Liability Litigation, MDL No. 1724, slip op. at 1-2 (D. Minn. June 30, 2006).

[vi] Daubert, 509 U.S. at 597.

[vii] BA – Civil Trial Practice Standards, Section 7.

[viii] In re Zoloft (Sertraline Hydrochloride) Products Liability Litigation, 26 F. Supp. 3d 449, at 465 (E.D. Pa. June 27, 2014).

[ix] Id. at 481 (E.D. Pa. June 27, 2014).

[x] In Re: Zoloft (Sertraline Hydrochloride) Products Liability Litigation, 2:12-md-02342-CMR, Doc. 1519, Dec. 2, 2015).

[xi] In re Denture Cream Prods. Liab. Litig., No. 09-2051, 2015 U.S. Dist. LEXIS 9653, at *142 (S.D. Fla. Jan. 28, 2015).

[xii] E.g., Sanchez v. Boston Sci. Corp., No. 12-5762, 2014 U.S. Dist. LEXIS 137189 (S.D. W. Va. Sept. 29, 2014).

[xiii] 28 U.S.C. § 1332(d)(11)(C)(i) (“[a]ny action(s) removed to Federal court pursuant to this subsection shall not thereafter be transferred to any other court pursuant to section 1407, or the rules promulgated thereunder, unless a majority of the plaintiffs in the action request transfer pursuant to section 1407”).

[xiv] In re Prempro Products Liab. Litig., 738 F. Supp. 2d 887, 893 (E.D. Ark. 2010).

[xv] In re Viagra Products Liab. Litig., 658 F. Supp. 2d 950, 968 (D. Minn. 2009).

[xvi] Gelboim v. Bank of America Corp., 135 S. Ct. 897 (2015).

[xvii] Motorola Mobility, Inc. v. AU Optronics Corp., No. 09 C 6610, 2014 WL 258154, at *5 (N.D. Ill. Jan. 23, 2014) (citations omitted) (“the ‘clear error’ standard of review to the MDL court’s denial of summary judgment, while being mindful of the fact that ‘[i]t would vitiate most of the purposes of consolidating litigation if, after remand, parties could simply re-visit the transferee court’s pre-trial rulings’”).

[xviii] Hill v. Ford Motor Co., 2013 WL 5360015 (N.D. Ga. Sept. 25, 2013) (court should apply reconsideration standard rather than “law of case” doctrine, although as a practical matter they are the same standard).

[xix] See, e.g., In re Bausch & Lomb Contact Lens Solution Prods. Liab. Litig., MDL No. 1785, Pretrial Order No. 16 (D.S.C. June 6, 2008) (joint order of MDL and New York State Coordinated Proceeding courts regarding expert discovery schedule; setting joint Daubert/Frye hearing).

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