Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-caDC-00-07251/USCOURTS-caDC-00-07251-0/pdf.json

Nature of Suit Code: 365
Nature of Suit: Personal Injury - Product Liability
Cause of Action: 

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United States Court of Appeals

FOR THE DISTRICT OF COLUMBIA CIRCUIT

Argued October 2, 2001 Decided October 26, 2001

No. 00-7241

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

No. 00-7251

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.

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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

__________

1 In light of our disposition, we do not reach the issue of

personal jurisdiction conditionally presented by the defendants in

their cross-appeal. See Appellees' Brief at xii.

2 Scleroderma is a chronic disease that causes sclerosis of the

skin and certain organs; "[t]he skin is taut, firm, and ... feels

tough and leathery." Taber's Cyclopedic Medical Dictionary 1530

(Clayton L. Thomas ed., 15th ed. 1985). One of Meister's expert

witnesses, Dr. Shanklin, testified that scleroderma "is the popular

name given to a process by which this kind of scar tissue is laid

down in the body but not seemingly in direct reaction to something

at that site." Meister described her condition of scleroderma as

consisting of "severe skin tightening, muscle and joint pain, reduced

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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

__________

pulmonary function, esophageal strictures, hair loss, vision impairment, kidney malfunction and chronic fatigue."

3 The Rule 706 National Academy of Sciences Panel, appointed

by Judge Sam C. Pointer, Jr., was instructed to "review and

critique the scientific literature pertaining to the possibility of a

causal association between silicone breast implants and connective

tissue diseases, related signs and symptoms, and immune system

dysfunction." Judge Pointer was the coordinating judge for the

federal breast implant multi-district litigation. The Panel published

a report, dated November 17, 1998, which is entitled Silicone Breast

Implants in Relation to Connective Tissue Diseases and Immunologic Dysfunction.

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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

__________

4 According to Dr. Thomas Fawell, who performed the surgery

implanting Meister's breast implants, gel bleed is a phenomenon

common to all silicone breast implants in which microscopic

amounts of the silicone gel inside the implant seep through the

silicone envelope to the outer surface of the implant.

5 Dr. Borenstein had not received funding to study scleroderma

and had never been affiliated with any organization that devotes

itself to the study of scleroderma.

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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.

__________

6 The district court cited Hopkins v. Dow Corning Corp., 33

F.3d 1116, 1125 (9th Cir. 1994), and the Bendectin cases of Raynor

v. Merrell Pharm., Inc., 104 F.3d 1371 (D.C. Cir. 1997); Richardson

v. Richardson-Merrell, Inc., 857 F.2d 823, 832 (D.C. Cir. 1988), cert.

denied, 493 U.S. 882 (1989).

7 See "Safety of Silicone Breast Implants," Committee on the

Safety of Silicone Breast Implants, Division of Health Promotion

and Disease Prevention, Institute of Medicine, Safety of Silicone

Breast Implants, (Stuart Bondurant, Virginia Ernster & Roger

Herdman eds. 1999) ("IOM Report").

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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

__________

8 Dr. Fawell had used implants containing industrial grade

silicone from General Electric, although appellees dispute whether

the term "industrial" referred to its grade or merely the fact that it

was being supplied to a manufacturer as opposed to a consumer.

See Appellee's Brief at 30 n.31.

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in issue." 509 U.S. at 592. 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 the latter taking the first steps

toward establishing a casual relationship. See, e.g., Richardson v. Richardson-Merrell, Inc., 857 F.2d 823, 830 (D.C. Cir.

1988), cert. denied, 493 U.S. 882 (1989). However, as one of

Meister's medical experts acknowledged at trial, testing the

case reports through epidemiological studies--the methodology that calls for checking controlled population studies to see

if they confirm the hypotheses suggested in individual case

reports--is "an important scientific" approach. Federal Rule

of Evidence 703 provides that "an opinion refuting ... scien-

__________

9 The admissibility of expert testimony and the qualification of

an expert witness are preliminary questions to be determined by

the district court, see Fed. R. Evid. 104(a), and Meister had the

burden of establishing these matters by a "preponderance of proof."

Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579, 592 n.10 (1993)

(citing Bourjaily v. U.S., 483 U.S. 171, 175-176 (1987)).

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tific consensus is inadmissible for lack of an adequate foundation, in the absence of other substantial probative evidence on

which to base [the] opinion." Ealy v. Richardson-Merrell,

Inc., 897 F.2d 1159, 1162 (D.C. Cir. 1990). In the instant

case, the overwhelming evidence from the epidemiological

studies is that there is no causal connection between silicone

breast implants and scleroderma. Meister thus faced the

burden of overcoming the conclusions of the epidemiological

evidence referred to by her own experts and offered by the

defendants that there is insufficient evidence of a casual

relationship between breast implants and scleroderma.10

Meister's first medical expert was Dr. Borenstein, who

began treating Meister in 1987 as a result of color changes in

her hands that indicated to him that she might have a

connective tissue disease or autoimmune disease. He performed a battery of tests that led him to conclude that

Meister was suffering from systemic sclerosis--the disease

complex of which scleroderma is a component--in its diffuse

form. Over the course of the next year, Meister developed

some difficulty with her esophagus, something Dr. Borenstein

thought was probably related to her scleroderma. She also

was experiencing chest pains and difficulty in breathing. In

addition, she was suffering from calcinosis--a condition of

misplaced internal calcium deposits--as a result of her scleroderma. Lung function tests over the next three years revealed abnormal functioning capacity at roughly the fifty-five

percent level. Because lung function below the forty percent

level can be fatal, and because he had read in the literature

that a patient under similar circumstances had improved after

her breast implants were removed, Dr. Borenstein referred

Meister to a plastic surgeon, who was a member of a Federal

Drug Administration committee examining the possible con-

__________

10 To the extent that Meister contends on appeal that a judgment as a matter of law may not be based on evidentiary error, the

contention is waived as she did not raise it in the district court. See

Raynor v. Merrell Pharm., Inc. 104 F.3d 1371, 1373 (D.C. Cir.

1997). In any event, such a contention is meritless as that issue has

been resolved by the Supreme Court. See Weisgram v. Marley,

528 U.S. 440, 457 (2000).

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nection between silicone implants and systemic disease; the

surgeon advised Meister that there was no connection between her scleroderma and silicone implants. After initially

deciding to keep the implants, because her condition was not

improving and because of the lack of any therapy for her

worsening lung condition, Meister had the implants removed

on May 23, 1991.

In response to the question whether he had an opinion to a

reasonable degree of medical certainty as to the cause of

Meister's scleroderma and accompanying symptoms, Dr. Borenstein testified that they were "related to" her silicone gel

breast implants. He arrived at his conclusion, he explained,

based on an extensive review of case reports and the medical

literature, Meister's improved lung function following explantation,11 and his view that she had an "atypical" form of the

disease, that is, "the manifestations don't match up with the

disease she has."12 Although the "trigger" for classical scleroderma is unknown, Dr. Borenstein testified that since the

1960s it has been known that "there are environmental factors that have been associated with the onset and the perpetuation of [systemic sclerosis]." He explained that "at the

time when [he] was investigating," the literature reflected

that "there were patients who had silicone implants who were

described with scleroderma." He referred to various case

reports in several medical journals that suggested some

connection between silica dust and scleroderma in miners, for

example, and between silicone and scleroderma. For example, Dr. Borenstein cited an article by two Japanese physicians on women who received silicone injections directly into

__________

11 Meister's lung function improved, from a fifty-five percent

level to a seventy-seven percent level during the two and a half year

period following Meister's explantation. Explantation refers to the

removal of tissue from the body, the opposite of implantation. See

Taber's Cyclopedic Medical Dictionary 588 (Clayton L. Thomas

ed., 15th ed. 1985).

12 More precisely, Meister has calcifications but does not have

an anticentromere antibody, and that is unusual. There was no

fibrosis and scarring, for example, in her lungs; her force vital

capacity was normal.

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their breasts and subsequently developed systemic sclerosis.

He also reviewed literature linking various environmental

exposures, such as cancer medications but not including

breast implants, to scleroderma. On cross-examination, Dr.

Borenstein acknowledged that there is no proof that silicone

breast implants cause scleroderma, and that he did not personally know what caused classic scleroderma. Although

earlier testifying that Meister's scleroderma was "atypical,"

he revealed that this conclusion was not reflected in his

professional records, and he conceded that each of Meister's

symptoms was within the constellation of symptoms making

up classic scleroderma. Nevertheless, although he produced

no epidemiology associating breast implants to the particular

"atypical" condition he had diagnosed for Meister, Dr. Borenstein believed that her condition was related to her silicone

gel breast implants.

Contrary to Meister's contention, Dr. Borenstein's testimony on causation is not as probative as scientific evidence in

Daubert terms as she would have it. In discussing the case

reports purporting to show a link between scleroderma and

silicone implants, Dr. Borenstein recognized the limits of case

reports to show causation, acknowledging, for example, that

they were not controlled studies. Insofar as he relied on

"differential analysis" to eliminate alternative causes, Dr.

Borenstein's reliance was misplaced. That methodology rests

on the assumption that whatever factors remain after other

alternative causes have been eliminated is at least capable of

causing the disease in question. See Raynor v. Merrell

Pharm., Inc. 104 F.3d 1371, 1376 (D.C. Cir. 1997). Whether

Meister's condition was atypical or not, Dr. Borenstein failed

to show any nexus between her atypical symptoms and her

breast implants; the mere simultaneous existence of the two

clearly is not an appropriate methodology. His reliance on

case reports, temporal methodology, and Meister's atypical

symptoms are not sufficient to show that silicone breast

implants are capable of causing scleroderma, and therefore

his reliance on differential analysis does not meet Daubert

standards. Regarding the literature that he reviewed, Dr.

Borenstein did not testify that any of the studies had actually

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concluded that scleroderma was caused by silicone breast

implants. At most, his testimony revealed that the authors

indicated that their observations support or "suggest" a role

for silicone in the etiology of scleroderma. Additionally, Dr.

Borenstein admitted that the persons with whom he conferred were unable to advise him of a causal nexus between

silicone breast implants and Meister's scleroderma, and that

the published epidemiology did not indicate a causal nexus.

Meister's other expert medical witness, Dr. Shanklin, accepted Dr. Borenstein's diagnosis of scleroderma (while rejecting the view that Meister's scleroderma was atypical) and

testified that in his opinion, with a reasonable degree of

medical probability, Meister's scleroderma "is a consequence

of silicone device implantation in 1977." Dr. Shanklin based

his opinion on an examination of slides of Meister's breast

tissue. As he explained, after implantation silicone particles

begin to come out of the shell of the implant device, causing

cells in the body to respond and "try to fight off the presence

of this foreign material." He went on to testify to the

presence of silica13 in Meister's breast tissue, explaining that

the silica resulted from "a chemical transformation back to

the point of origin" of the silicone that was in Meister's

system. After citing case studies in which miners and stonemasons exposed to silica develop scleroderma in a high frequency of cases, Dr. Shanklin concluded that silicone device

implantation caused Meister's scleroderma.

Dr. Shanklin's testimony is problematic as well. He acknowledged that ongoing research investigating the cause of

scleroderma has merely given rise to ideas about an association between certain environmental factors and scleroderma

and has not yet shown a causal relationship. Instead, jump-

__________

13 Silicone is defined as "[a]n organic compound in which carbon

has been replaced by silicon," which is a nonmetallic element found

in the soil that comprises approximately 25% of the earth's crust.

See Taber's Cyclopedic Medical Dictionary at 1561. Dr. Shanklin

testified that silica is a less complex substance from which silicone is

made.

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ing from an observation of a local tissue reaction to causation

of a systemic disease, Dr. Shanklin identified as the basis for

his causation opinion studies linking silica with scleroderma.

Still, he admitted that, although there are "some associations"

between silica and scleroderma, he was not saying these

environmental factors were causing Meister's scleroderma.

In short, then, the substance of Dr. Shanklin's theory was, to

use his words, first, "[Meister's] tissues were still trying their

best to get rid of this stuff [i.e., silicone] 14 years later;"

second, "after 14 years, it is possible the [immune] system is

beginning to make mistakes;" and third, "Somewhere along

the line she developed clinically diagnosable scleroderma."

Such an approach will not do; "chemical, in vitro, and in vivo

... [s]tudies ... singly or in combination, are not capable of

proving causation in human beings in the face of the overwhelming body of contradictory epidemiological evidence."

Raynor, 104 F.3d at 1374.

The defendants presented such contradictory evidence in

the form of epidemiological studies that found insufficient

evidence of an association between silicone breast implants

and connective tissue disease. In addition to the testimony of

three experts--Dr. Alan Shons, a plastic surgeon who was a

member of the American Medical Association committee that

studied the question raised by the case reports; Dr. Kenneth

Kulig, a toxicologist, who reviewed 50 years of safety data on

silicone; and Dr. Virginia Steen, a rheumatologist who has

treated numerous patients, including those with scleroderma,

for over twenty-five years--the defendants brought to the

district court's attention two recent major epidemiological

studies. In support of their motions to exclude or limit the

testimony of Meister's experts on causation, the defendants

referred to the Rule 706 Panel Report, published November

30, 1998, which reported that there was "[n]o association ...

between breast implants and any of the individual connective

tissue diseases, all definite connective diseases combined, or

the other autoimmune/rheumatic conditions." Although the

district court had expressed concern about whether the Report addressed gel bleed, the Report addressed gel bleed to

the extent that all silicone breast implants bleed and silicone

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breast implants were the object of study in the report.

Additionally, while their post-verdict motions were pending,

the defendants informed the district court of the June 1999

IOM Report, entitled "Safety of Silicone Breast Implants."14

See supra note 7. The IOM Report, commissioned by the

United States Department of Health and Human Services,

concluded that:

The evidence for an atypical disease or a novel syndrome

is insufficient or flawed. It consists of selected case

series, few of which describe a consistent and reproducible syndrome. The controlled epidemiological studies

cited provide stronger, contrary evidence. In view of the

paucity, weakness, and conflicting nature of the evidence,

the committee concludes that there is no rigorous, convincing scientific support for atypical connective tissue or

any new disease in women that is associated with silicone

breast implants. In fact, epidemiological evidence suggests there is no novel syndrome.

The IOM Report was based on "a general review of past and

ongoing research on silicone breast implants." With regard

to connective tissue disease, including scleroderma, the committee reviewed 17 epidemiological studies, nine of which had

been reviewed by Dr. Borenstein, and at least 12 of which

were discussed by defendants' experts. The committee found

"no convincing evidence for atypical connective tissue or

rheumatic disease or a novel constellation of signs and symptoms in women with silicone breast implants."

The district court was thus presented with a classic Daubert case. The scientific method is based on testing to

determine if the questions raised by case studies can be

determined to have a causative relationship. See Daubert,

508 U.S. at 593. The considerable epidemiological evidence

all pointed in one direction. Moreover, the defendants

__________

14 There is no indication in the record that Meister objected to

submission of the IOM Report. Hence, her attempt to object on

appeal to the district court's consideration of the June 1999 IOM

Report is not properly preserved for appeal. See Willoughby v.

Potomac Elec. Power Co., 100 F.3d 999, 1002 (D.C. Cir. 1996).

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brought to the district court's attention a landscape of litigation in other federal districts in which judges were unanimous

in rejecting as lacking in scientific basis and contrary to the

overwhelming medical literature the type of testimony offered

by Drs. Borenstein and Shanklin.15 Affording Meister leeway

to counter this evidence, the district court let the jury hear

her expert evidence. See Richardson v. Richardson-Merrell,

Inc., 857 F.2d 823, 827 n.27 (D.C. Cir. 1988).16 Dr. Borenstein had a causal hypothesis based on treating Meister and

suggestions he found in the medical literature; Dr. Shanklin

had merely a theory. Dr. Borenstein's conclusion is suspect

for two main reasons. "Temporal methodology" may sometimes provide the basis for reliable scientific hypotheses, but

not in the case of scleroderma, which typically waxes and

wanes, or where the focus is on the disappearance of only one

symptom following explantation as proving causation. Even

more crucially, no reasonable scientist would rely on this

methodology in the face of voluminous epidemiological evidence to the contrary. See Raynor, 104 F.3d at 1374. Dr.

__________

15 See, e.g., In re Breast Implant Litig., 11 F. Supp. 2d 1217 (D.

Colo. 1998); Kelley v. American Heyer-Schulte Corp., 957 F. Supp.

873 (W.D. Tex. 1997); Hall v. Baxter Healthcare Corp., 947

F. Supp. 1387, 1414 (D. Or. 1996); In re Breast Implant Cases, 942

F. Supp. 958 (E. & S.D.N.Y. 1996). The defendants also cited cases

from state courts in Texas and California. See Minnesota Mining

and Mfg. Co. v. Atterbury, 978 S.W.2d 183 (Tex. App. 1998);

Johnson v. Baxter Healthcare Corp., No. CV-92-07501 (Tr. Ct.

N.M. Feb. 23, 1998); Dinerman v. McGhan Med. Corp., No. BC

065884 (Super. Ct. Calif. Aug. 12, 1997); Bailey v. Dow Corning

Corp., 1996 WL 937659, at *1, (Tex. D. Ct. Sept. 6, 1996).

16 Contrary to Meister's contention at oral argument that this

court should review the district court's initial rulings, they are

merged when the district court grants judgment. Thus, "[i]t is of

no moment that the district court granted judgment [as a matter of

law] instead of taking the case from the jury earlier by directing a

verdict for [the defendants]. The court has counseled that the

better practice is to let the case go to the jury and, if it finds

liability, to set the verdict aside." Richardson, 857 F.2d at 827 n.27

(citations omitted).

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Shanklin's causation testimony was deficient perhaps most

tellingly insofar as his theory relied on case reports suggesting a connection between silica and scleroderma, even though

he did not purport to find support for such a connection in the

epidemiological studies, thus creating an analytical gap between the data and his opinion that "is simply too great."17

General Electric Co. v. Joiner, 522 U.S. 136, 146 (1997).18

Ultimately, it is Meister's experts' heavy reliance on case

reports that is her undoing. Although case reports may

suffice under some circumstances, the defendants introduced

expert testimony that was supported by a uniform body of

evidence including epidemiological studies failing to establish

a causal link between silicone breast implants and connective

tissue disease. The IOM Report was right on point. Case

reports were presenting hypotheses that needed to be evaluated through the epidemiological method. The National

Academy of Science evaluated the hypotheses being developed in the case studies and concluded that there was insufficient evidence to show a causal relationship between silicone

breast implant and scleroderma. Hence, the district court

could reasonably conclude that reasonable people could not

differ as to the import of the epidemiological evidence.

__________

17 Meister's attempt to rely, for the first time on appeal, on the

testimony of the implanting physician, Dr. Thomas Fawell, is not

properly before the court. See Marymount Hosp., Inc. v. Shalala,

19 F.3d 658, 663 (D.C. Cir. 1994); Roosevelt v. E.I. Du Pont De

Neumours & Co., 958 F.2d 416, 419 n.5 (D.C. Cir. 1992).

18 Meister's reliance on Carmichael v. Samyang, Tire, Inc., 131

F.3d 1433 (11th Cir. 1997), which was overruled sub nom. Kumho

Tire Co, Ltd. v. Carmichael, 526 U.S. 137 (1999), is misplaced. Her

reliance on Toole v. Baxter Healthcare Corp., 235 F.3d 1307 (11th

Cir. 2000), is also misplaced because Dr. Shanklin did not testify on

causation directly but merely described a disease process. Id. at

1312. Her reliance on Jennings v. Baxter Healthcare Corp., 14

P.3d 596 (Or. 2000), is to no avail because in that case the expert

evidence addressed correlations, not causation, and the Oregon

court was not confronted with overwhelming epidemiological evidence contrary to the new theory based on preliminary work that

was at issue. Id. at 601-02, 608.

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Accordingly, we find no abuse of discretion by the district

court in excising Meister's expert medical testimony, see

Raynor, 104 F.3d at 1374, and, in light of the insufficient

remaining evidence to support the jury's verdict, no impermissible usurpation of the jury's function, see Weisgram v.

Marley Co., 528 U.S. 440, 454 n.10 (2000); Richardson, 857

F.2d at 833, in granting judgment as a matter of law, and we

affirm.

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