Levitt v. Merck Sharp & Dohme Corp. (In re Vioxx Prods. Liab. Litig.)
| Decision Date | 16 September 2016 |
| Docket Number | MDL NO. 1657 SECTION L |
| Parties | IN RE: VIOXX PRODUCTS LIABILITY LITIGATION THIS DOCUMENT RELATES TO: Jo Levitt v. Merck Sharp & Dohme Corp., 06-9757 |
| Court | U.S. District Court — Eastern District of Louisiana |
MAG. JUDGE KNOWLES
Before the Court are Defendant Merck's Motions to Exclude the Expert Opinions of David Madigan, M.D. (R. 65382), Thomas Rosamond, M.D. (R. 65384), Jay Schapira, M.D. (R. 65387), and David Egilman, M.D. (R. 65390). Plaintiff opposes each of the Motions. (R. 65407, 65408, 65410, and 65415). The Court heard oral argument from counsel at a hearing on Wednesday, August 17, 2016. After considering those arguments, the Court has reviewed the parties' submissions and applicable law, and now issues this Order & Reasons.
To put this matter in perspective, a brief review of this multidistrict litigation ("MDL") is appropriate. This litigation involves products liability claims pertaining to the prescription drug Vioxx, known generically as Rofecoxib. Merck, a New Jersey corporation, researched, designed, manufactured, marketed, and distributed Vioxx to relieve pain and inflammation resulting from osteoarthritis, rheumatoid arthritis, menstrual pain, and migraine headaches. On May 20, 1999, the Food and Drug Administration ("FDA") approved Vioxx for sale in the United States. Vioxx remained publicly available until September 30, 2004, when Merck withdrew it from the market after data from a clinical trial known as APPROVe indicated that the use of Vioxx increased the risk of cardiovascular thrombotic events such as myocardial infarction (that is, heart attack) and ischemic stroke. Thereafter, thousands of individual suits and numerous class actions were filed against Merck in state and federal courts throughout the country alleging various products liability, tort, fraud, and warranty claims.
On September 29, 2006, Jo Levitt brought this action against Merck in the United States District Court for the Western District of Missouri. In her complaint, she alleges that she suffered two heart attacks in 2001 as a result of taking Vioxx and seeks compensatory and punitive damages, as well as interest, costs, attorneys' fees and any other available relief. On November 8, 2006, the matter was transferred to this Court for inclusion in the Vioxx MDL.
Following six "bellwether" trials in this proceeding—as well as trials in other proceedings in Alabama, California, Illinois, Florida, New Jersey, and Texas—the negotiating plaintiffs' counsel ("NPC") and Merck's counsel engaged in protracted settlement discussions over the course of a year, conducting hundreds of in-person and telephone meetings. On November 9, 2007, the parties announced a $4.85 billion master settlement agreement ("MSA") that intended to—and actually did—resolve most Vioxx-related claims through a resolution program. In its recitals, the MSA expressly states that its purpose was to "establish a pre-funded, structured private settlement program . . . to resolve . . . claims against Merck involving heart attacks, ischemic strokes and sudden cardiac deaths." This was an "opt-in" program, meaning an interested claimant had to take affirmative steps to enroll in it. Ms. Levitt chose not to enroll, and instead proceeded to litigate her claim. This Court retained jurisdiction for the discovery phase of this case.
On November 14, 2013, this Court ordered that Ms. Levitt designate expert witnesses and provide their reports pursuant to Federal Rule of Civil Procedure 26(a)(2) on or before December 13, 2013. (R. 64688). Ms. Levitt timely designated five expert witnesses.
Of those, Dr. David Madigan proffered opinions relating to statistical issues with Merck's internal studies regarding the potential risks of Vioxx. Ms. Levitt also disclosed Dr. Thomas Rosamond, her cardiologist, and reserved the right to call any and all treating physicians and other providers as fact or expert witnesses regarding the nature and extent of her injuries and resulting damages. Of her treating physicians, Merck only deposed Dr. Arnold Katz, her rheumatologist, who testified he would have prescribed Vioxx even if he were told that Vioxx increased the risks of heart attacks in a certain segment of the population. Notably, Plaintiff was pro se during the original discovery period and never deposed Dr. Katz during that time. Merck deposed Dr. Katz twice. Ms. Levitt also disclosed Dr. Jay Schapira, who addressed specific causation with regard to her two heart attacks, and designated Dr. David Egilman as her expert concerning non-heart attack related injuries.
Defendant Merck filed Motions to Exclude the Expert Opinions of Dr. David Madigan (R. 65382), Dr. Thomas Rosamond (R. 65384), Dr. Jay Schapira (R. 65387), and Dr. David Egilman. (R. 65390). Plaintiff opposes each motion.
Rule 702 of the Federal Rules of Evidence governs the admissibility of expert testimony. Rule 702 is in effect a codification of the United States Supreme Court's opinion in Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579 (1993). In Daubert, the Supreme Court held that trial courts should serve as gatekeepers for expert testimony and should not admit such testimony without first determining that the testimony is both "reliable" and "relevant." Id. at 589.
The trial court is the gatekeeper of scientific evidence. Daubert, 509 U.S. at 596. It has a special obligation to ensure that any and all expert testimony meets these standards. Id. Accordingly, it must make a preliminary assessment of whether the reasoning or methodologyunderlying the testimony is scientifically valid and whether the reasoning or methodology can be properly applied to the facts in issue. Id. at 592-93. In making this assessment, the trial court need not take the expert's word for it. Gen. Elec. Co. v. Joiner, 522 U.S. 136, 147 (1997). Instead, when expert testimony is speculative or lacks scientific validity, trial courts are encouraged to exclude it. Moore v. Ashland Chem., Inc., 151 F.3d 269, 279 (5th Cir. 1998).
In satisfying its "gatekeeper" duty, the Court will look at the qualifications of the experts and the methodology used in reaching their opinions and will not attempt to determine the accuracy of the conclusion reached by the expert. The validity or correctness of the conclusions is a determination to be made by the fact finder after the Daubert analysis.
Scientific testimony is reliable only if "the reasoning or methodology underlying the testimony is scientifically valid," meaning that such testimony is based on recognized methodology and supported by appropriate validation based on what is known. Daubert, 509 U.S. at 592-93. In Daubert, the Supreme Court set forth a non-exclusive list of factors to consider in determining the scientific reliability of expert testimony. Id. at 593-95. These factors are: (1) whether the theory has been tested; (2) whether the theory has been subject to peer review and publication; (3) the known or potential rate of error; (4) whether standards and controls exist and have been maintained with respect to the technique; and (5) the general acceptance of the methodology in the scientific community. Id. Whether some or all of these factors apply in a particular case depends on the facts, the expert's particular expertise, and the subject of his testimony. Kumho Tire Co. v. Carmichael, 526 U.S. 137, 138 (1999).
In addition to the five factors laid out in Daubert, a trial court may consider additional factors to assess the scientific reliability of expert testimony. Black v. Food Lion, Inc., 171 F.3d 308, 312 (5th Cir. 1999). These factors may include: (1) whether the expert's opinion is based onincomplete or inaccurate dosage or duration data; (2) whether the expert has identified the specific mechanism by which the drug supposedly causes the alleged disease; (3) whether the expert has unjustifiably extrapolated from an accepted premise to an unfounded conclusion; (4) whether the expert has adequately accounted for alternative explanations; and (5) whether the expert proposes to testify about matters growing directly out of research he or she has conducted independent of the litigation. See, e.g., id. at 313; Moore v. Ashland Chem., Inc., 151 F.3d 269, 278-79 (5th Cir. 1998); Christophersen v. Allied-Signal Corp, 939 F.2d 1106, 1114 (5th Cir. 1991); Newton v. Roche Labs., Inc., 243 F. Supp. 2d 672, 678 (W.D. Tex. 2002). Scientific testimony is relevant only if the expert's reasoning or methodology can be properly applied to the facts at issue, meaning there is an appropriate fit between the scientific testimony and the specific facts of the case. Daubert, 509 U.S. at 593. Scientific evidence is irrelevant, however, when there is too great an analytical gap between the data and the opinion proffered. Gen. Elec. Co. v. Joiner, 522 U.S. 136, 146 (1997).
The party seeking to introduce the expert testimony bears the burden of demonstrating that the testimony is both relevant and reliable. Moore, 151 F.3d at 275-76. The requirement of reliability does not strictly bind an expert within the proffered field of expertise; an expert may also testify concerning related applications of his or her background. Slatten, LLC v. Royal Caribbean Cruises Ltd., No. 13-673, 2014 WL 5393341, at *2 (E.D. La. Oct. 23, 2014) (citing Wheeler v. John Deere Co., 935 F. 2d 1090, 1100 (10th Cir. 1991). The focus is not on the result or conclusion, but on the methodology. Moore, 151 F.3d at 275-76. The proponent need not prove that the expert's testimony is correct, but must prove by a preponderance of the evidence that the expert's methodology was proper. Id. Here, Merck has filed motions to exclude four different experts in this case. The Court will address each of the motions in turn.
1. Parties' Arguments
Merck argues that the Court should exclude the expert...
To continue reading
Request your trial