In re Prempro Products Liab. Litig.
| Decision Date | 30 August 2010 |
| Docket Number | Civil Nos. 06-3120 (ADM/JJG),Civil Nos. 06-3123 (ADM/JJG),MDL No. 4:03-CV-1507-WRW,Civil Nos. 06-3112 (ADM/JJG) |
| Citation | 738 F.Supp.2d 887 |
| Parties | In re PREMPRO PRODUCTS LIABILITY LITIGATION. Natalie Beylin, et al., Plaintiffs, v. Wyeth, et al., Defendants. Jeanne Yobs, et al., Plaintiffs, v. Wyeth, et al., Defendants. Pamela Dawn Thorne, et al., Plaintiffs, v. Wyeth, et al., Defendants. |
| Court | U.S. District Court — Eastern District of Arkansas |
W. Stewart Calwell and Alex McLaughlin, The Calwell Practice, PLLC, Charleston, WV; and Robert A. Schwartz, Law Office of Robert A. Schwartz, Houston, TX, on behalf of plaintiffs.
Loren H. Brown, DLA Piper LLP, New York, NY; and F. Lane Heard, III, Williams & Connolly LLP, Washington, DC, on behalf of Wyeth Inc. and associated defendants (the defendants).
JOINT MEMORANDUM ORDER
The primary question in this litigation is whether the plaintiffs developed breast cancer from hormone replacement therapy (HRT) medications. Most plaintiffs received Prempro, a combined hormone replacement therapy (CHRT) consisting of estrogen and progesterone. The parties have already litigated the admissibility of expert testimony on whether CHRT causes breast cancer.
Some plaintiffs received Premarin, which generally is described as an estrogen-only form of hormone replacement therapy (EHRT). We have yet to consider the admissibility of expert testimony on whether EHRT causes breast cancer, and trials involving this issue are anticipated in both the multidistrict litigation in Arkansas and in the satellite litigation in Minnesota. The plaintiffs accordingly seek admission of expert testimony on this issue, and the defendants move to exclude this testimony.
The admissibility of expert testimony is governed by Rule 702, which provides:
If scientific, technical, or other specialized knowledge will assist the trier of fact to understand the evidence or determine a fact in issue, a witness qualified as an expert by knowledge, skill, experience, or education, may testify thereto in the form of an opinion or otherwise, if (1) the testimony is based on sufficient facts or data, (2) the testimony is the product of reliable principles and methods, and (3) the witness has applied the principles and methods reliably to the facts of the case.
When considering scientific evidence, this rule requires us to perform as gatekeepers, separating legitimate scientific inquiry from subjective speculation. Presley v. Lakewood Eng'g & Mfg. Co., 553 F.3d 638, 643 (8th Cir.2009) (quoting Glastetter v. Novartis Pharm. Corp., 252 F.3d 986, 989 (8th Cir.2001)).
To perform this gatekeeping function, we examine whether expert testimony is reliable and whether it is relevant. See, e.g., Barrett v. Rhodia, Inc., 606 F.3d 975, 980 (8th Cir.2010) (quoting Marmo v. Tyson Fresh Meats, Inc., 457 F.3d 748, 757 (8th Cir.2006)); In re Prempro Products Liability Litig., 586 F.3d 547, 565 (8th Cir.2009) (quoting Unrein v. Timesavers, Inc., 394 F.3d 1008, 1011 (8th Cir.2005)). Although the admissibility of expert testimony is favored unless fundamentally flawed, the testimony should be excluded where these standards are not met. See, e.g., Polski v. Quigley Corp., 538 F.3d 836, 839-841 (8th Cir.2008). The objective is to ensure that scientific evidence will assist the jury in resolving disputed fact issues. Miller v. Baker Implement Co., 439 F.3d 407, 412 (8th Cir.2006).
To determine reliability, we focus on an expert's methodology, considering whether the expert was using scientifically valid reasoning to assess the facts. In re Prempro Products Liability Litig., 586 F.3d at 565; Synergetics, Inc. v. Hurst, 477 F.3d 949, 955 (8th Cir.2007) (quotation omitted). As the U.S. Supreme Court explained inDaubert v. Merrell Dow Pharmaceuticals, Inc., many factors inform this analysis, including but not limited to (1) whether the methodology is tested; (2) whether it is subject to peer review or publication; (3) whether it has a known rate of error; and (4) whether the theory is generally accepted by the scientific community. 509 U.S. 579, 593-94, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993).
To determine relevancy, we consider whether an expert's opinion can be applied to facts at issue. See, e.g., Barrett, 606 F.3d at 980. This is sometimes described as whether expert testimony "fits" with the issues. Daubert, 509 U.S. at 591, 113 S.Ct. 2786; see generally Federal Judicial Center, Reference Manual on Scientific Evidence 12 (2d ed.2000) (hereinafter Reference Manual ). Even where an expert opinion is reliable, if it cannot be applied to the specific facts of the case, the opinion should be excluded. Concord Boat Corp. v. Brunswick Corp., 207 F.3d 1039, 1056 (8th Cir.2000).
The proponent of expert testimony has the burden to show both reliability and relevancy. Barrett, 606 F.3d at 980 (quoting Marmo, 457 F.3d at 757). When deciding whether this burden is met, we are accorded substantial flexibility. See, e.g., In re Prempro Products Liability Litigation, 586 F.3d at 565; Marmo, 457 F.3d at 757.
Here, the plaintiffs have designated two experts to opine about general causation. This means the experts considered only the broad question of whether EHRT can cause breast cancer in the general population; they have not considered specific causation, meaning whether EHRT caused breast cancer in any particular plaintiff. Dr. Jasenka Demirovic, an epidemiologist, evaluated the statistical relationship between use of EHRT and the risk of breast cancer, and Dr. Marcelo Aldaz, a cell biologist, assessed the biological plausibility of EHRT causing breast cancer. After considering the Daubert standard, we conclude that their proposed testimony is not sufficiently reliable and relevant, and must be excluded.
Although the defendants have challenged the underlying qualifications of Dr. Demirovic, we have concluded that other concerns have greater weight. These concerns are informed by a decade-long clinical study conducted by the Women's Health Initiative (the WHI), a subdivision of the U.S. Department of Health and Human Services. (Exhs. 1, 2.) 1
In one branch of this study, the WHI tracked women receiving CHRT; the other tracked women receiving EHRT, specifically Premarin. Both branches were controlled and blind studies, meaning that neither treating physicians nor the participants were informed about which participants received EHRT. (Exhs. 1, 2.)
When the recipients of CHRT started displaying increased risk of breast cancer, the WHI terminated that branch of the study in 2002. (Exh. 1 at 1647-48.) The EHRT branch, however, continued until 2004. After that branch terminated, WHI scientists found there was no increased risk of breast cancer from Premarin.2 (Exh. 2 at 3243-44.)
The only countervailing evidence to the WHI studies is from observational studies. Unlike clinical studies, which are blinded and controlled, observational studies select patients from existing populations, based on whether or not they have or will be receiving treatment. Because this procedure lacks controls, observational studies are more susceptible to bias and other confounding factors, and so are less reliable than clinical studies, which are often referred to as the "gold standard." See Reference Manual 338-39. Neither Dr. Demirovic nor the parties contest these general principles. (See Exh. 3 at 76-77, 304-05.)
As the sole clinical study to examine the relationship between EHRT and breast cancer, the WHI study has substantially influenced scientific thinking on this question. Prior to the WHI study, several observational studies suggested a link between EHRT and increased risk of breast cancer. (See, e.g., Exh. 4.) When the WHI study showed contrary results, those observational studies were called into serious doubt.
Several major authorities, such as the National Cancer Institute, the American Cancer Society, and the National Institutes of Health, have since cited the WHI study for the proposition that Premarin does not increase the risk of breast cancer. We believe these authorities represent the generally accepted scientific view of the issue. (Exhs. 5, 6, 7.)
Dr. Demirovic contends that the WHI study has numerous deficiencies, and that when other observational studies are considered, there is reason to conclude that EHRT increases the risk of breast cancer. Because some of these observational studies were published after the WHI study, they arguably could rebut the WHI findings. We, accordingly, examine whether Dr. Demirovic can, consistent with reliable scientific methodology, disregard a generally accepted clinical study and instead rely on contrary observational studies.
The defendants assert that, in her efforts to distinguish the WHI study, Dr. Demirovic has misconstrued other observational studies. According to Dr. Demirovic, the WHI study failed to account for various confounding factors. (Exh. 8 at 20-21.)
The record does not include all the observational studies that Dr. Demirovic cited in her report. Nor is there any practical means to review the relevant literature and determine whether Dr. Demirovic reliably has presented the range of scientific opinion in this area. To the contrary, the record suggests there may be dozens of germane studies, and so Dr. Demirovic necessarily had to select some studies to form the basis for her opinion.
Dr. Demirovic selected studies that purportedly explain why the WHI study was deficient. Brinton (2008) and Rosenberg (2006), for example, found increased risk of breast cancer in certain lean women who received EHRT for more than ten years. But when reviewing these studies, Dr. Demirovic focused on those subgroups with the greatest risk, while discounting subgroups where EHRT had no statistically significant effect. (Exh. 8 at 14-15, 17-18.)
This concern can be illustrated by Rosenberg. The Rosenberg study found no statistically...
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