Meister v. Med. Engineering Corp.

• Decision Date: 26 October 2001
• Docket Number: No. 00-7241,No. 00-7251,00-7241,00-7251
• Citation: 267 F.3d 1123
• Parties: (D.C. Cir. 2001) Brenda G. Meister, Appellant/Cross-Appellee v. Medical Engineering Corporation, a Wisconsin Corporation, and Bristol-Myers Squibb Company, a Delaware Corporation, Appellees/Cross-Appellants Consolidated with
• Court: U.S. Court of Appeals — District of Columbia Circuit

Page 1123

267 F.3d 1123 (D.C. Cir. 2001)

Brenda G. Meister, Appellant/Cross-Appellee v. Medical Engineering Corporation, a Wisconsin Corporation, and Bristol-Myers Squibb Company, a Delaware Corporation, Appellees/Cross-Appellants

No. 00-7241 Consolidated with No. 00-7251

United States Court of Appeals FOR THE DISTRICT OF COLUMBIA CIRCUIT

Argued October 2, 2001

Decided October 26, 2001

Appeals from the United States District Court for the District of Columbia (No. 92cv02660) Stephen L. Snyder argued the cause for appellant/crossappellee. With him on the briefs was Sheldon N. Jacobs. Robert J. Weltchek entered an appearance.

James T. Conlon, pro hac vice, argued the cause for appellees/cross-appellants. With him on the briefs was Kimberly S. Penner. Dino S. Sangiamo and James L. Shea entered appearances.

Before: Edwards, Rogers and Tatel, Circuit Judges.

Opinion for the Court filed by Circuit Judge Rogers.

Rogers, Circuit Judge:

Brenda Meister opted out of the omnibus settlement in the silicone breast implant products liability litigation and pursued her claims in federal court in the District of Columbia. She now appeals the grant of judgment as a matter of law, or a new trial, on the ground that the district court overlooked a substantial portion of her scientific evidence and otherwise mischaracterized that evidence, thereby impermissibly usurping the role of the jury. We hold that the district court properly applied Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579 (1993), in concluding that Meister failed to show causation and did not usurp the role of jury in granting judgment as a matter of law. Accordingly, we affirm.¹

I.

Nearly ten years after her breast implants in 1977, Meister developed symptoms that Dr. Brian Arling, and later Dr. David Borenstein, diagnosed as late diffuse scleroderma.² In 1992, she filed a products liability lawsuit, alleging that she developed scleroderma as a result of exposure to silicone breast implants manufactured by Medical Engineering Corporation ("MEC"). Meister sought punitive damages from MEC and Bristol-Myers Squibb Company, which became the sole shareholder of MEC in 1982. In her complaint she pled strict liability in tort, negligence, breach of warranties, and misrepresentation, deceit or concealment. Following a remand from the consolidated breast implant litigation proceedings in the Northern District of Alabama, the district court here denied the defendants' motion to dismiss the complaint for lack of personal jurisdiction pursuant to Federal Rule Civil Procedure 12(b)(2).

The defendants thereafter moved to exclude or limit the testimony of Meister's expert witnesses on causation, pursuant to Daubert and Federal Rules of Evidence 702 and 703. The district court denied the motion after argument, ruling that Meister's witnesses should be allowed to testify. The defendants urged reconsideration of their motion a month later, in December of 1998, citing a recently published report of the Rule 706 National Academy of Sciences Panel that had found no association between breast implants and any of the individual connective tissue diseases or other autoimmune/rheumatic conditions.³ Again, following argument, the district court denied the defendants' motion, noting that the studies did not address the specific issues presented by Meister's complaint, such as gel bleed.⁴

At trial, Meister presented two medical experts. The first was Dr. Borenstein, her treating physician and a specialist in rheumatology and internal medicine. He had published several peer-reviewed articles and medical textbook chapters on scleroderma and had also written a paper on silicone-related disorders. However, he disclaimed expertise in scleroderma and stated that he "didn't know too much about breast implants" before treating Meister.⁵ Meister's other expert was Dr. Douglas Shanklin, a pathologist tenured as a Professor at the University of Tennessee who had authored several hundred peer-reviewed medical articles, made numerous presentations to the medical community regarding the effects of silicone, and testified in several other breast implant cases. However, he had no particular training or expertise in rheumatic diseases or immunology and until 1996 had never treated a scleroderma patient. Nor had he published on scleroderma.

After Meister had finished presenting her evidence, the defendants moved for judgment as a matter of law, pursuant to Federal Rule of Civil Procedure 50(a), on the ground that Meister's case was barren of any reliable scientific evidence on causation. The district court reiterated its concern that the Panel Report had not addressed gel bleed, stated that it had yet to read the entire report, and determined that it was not comfortable granting the motion "at this time." Upon renewal of defendants' Rule 50(a) motion at the close of all the evidence, the district court denied the motion, observing that one of Meister's proposed expert witnesses "has a theory that may or may not be viable, but he has testified in other cases that have no more evidence than we have here." The jury returned a verdict for Meister, awarding her $10 million in damages.

The defendants moved for judgment as a matter of law, pursuant to Federal Rule of Civil Procedure 50(b), or alternatively for a new trial, pursuant to Federal Rule of Civil Procedure 59(b), and to alter or amend the judgment, pursuant to Federal Rule of Civil Procedure 59(e). The district court granted the motion for judgment as a matter or law, or a new trial. The district court ruled that, standing alone, the testimony of Meister's experts failed to carry her burden. The court found that the reliance of one of her experts "on the case reports is demonstratively unacceptable as a valid basis for his opinion [on causation]," and that the "ipse dixit" testimony of Meister's only other expert did not fill the void. Further, the court found, "any credence that might be attributed to their testimony falls in the face of what courts have referred to as a 'solid body of epidemiological data.' "⁶ The district court referred to a June 1999 report of the Institute of Medicine, commissioned by the National Academy of Sciences, that concluded, after a general review of the known research on silicone breast implants, that there was insufficient evidence to support any association of the silicone breast implants with defined connective tissue disease, with any atypical connective tissue disease, or any new disease in women that is associated with implants.⁷ Given this record, the district court concluded that there was "no valid basis" for the jury's verdict.

II.

On appeal, Meister contends that in granting judgment as a matter of law, or a new trial, the district court impermissibly usurped the role of the jury by overlooking a substantial portion of her scientific evidence, mischaracterizing it, and ignoring the fact that her counsel poked numerous holes in the defendants' "supposed 'fortress' of epidemiological and other scientific evidence." Specifically, Meister maintains, first, that there is real doubt as to the validity of any epidemiological study because no study has ever indicated whether any of the subjects had implants containing industrial use silicone as was contained in Meister's implants.⁸ Second, she maintains, in urging the probativeness of her causation evidence, that her expert rheumatologist was also her primary treating physician for approximately ten years, unlike the experts in most toxic tort cases who make their living from forensic testimony and lack the benefit of experience "in the trenches." Further, Meister stresses that her treating physician used a traditional method of "differential diagnosis" hypothesis to determine the cause of her scleroderma. Moreover, she maintains, the district court, pursuant to Daubert, repeatedly denied defendants' motions to preclude her scientific evidence, each time confirming that her scientific evidence was reliable, relevant, and entitled to be heard by the jury. Finally, Meister maintains that the district court erred in relying on the June 1999 Report of the Institute of Medicine because it was not in existence at the time of trial. For these reasons, Meister contends this court should find no difficulty in reinstating the verdict. It is not to be so.

Under Daubert, the district court is required to address two questions, first whether the expert's testimony is based on "scientific knowledge," and second, whether the testimony "will assist the trier of fact to understand or determine a fact in issue." 509 U.S. at 592. 113 S.Ct. 2786 The first inquiry forces the court to focus on "principles and methodology, not on the conclusions that they generate," id. at 595, and thus demands a grounding in the methods and procedures of science, rather than subjective belief or unsupported speculation. Id. at 590; Ambrosini v. Labarraque, 101 F.3d 129, 133 (D.C. Cir. 1996). While rejecting a requirement of scientific certainty, the Supreme Court instructed that "in order to qualify as 'scientific knowledge,' an inference or assertion must be derived by the scientific method. Proposed testimony must be supported by appropriate validation--i.e., 'good grounds,' based on what is known." Daubert, 509 U.S. at 590. The Court identified four factors for courts to consider in evaluating scientific validity, focusing on whether the theory or technique had been tested, whether it had been subjected to peer review and publication, the method's known or potential error rate, and the method's general acceptance in the scientific community. Id. at 593-94. Meister fails to demonstrate that her expert medical evidence passes muster under any of these factors, and thus fails to show error by the district court in applying Daubert.⁹

Both case reports and epidemiological studies may be used in the study of silicone breast implants, the former identifying a temporal relationship, and...