Court Opinion

ID: 185509
Source: CourtListenerOpinion
Date Created: 2011-02-05 02:32:54+00
Date Added: 2024-06-11T17:26:16.390542
License: Public Domain

267 F.3d 1123 (D.C. Cir. 2001)
Brenda G. Meister, Appellant/Cross-Appelleev.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, 2001Decided 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:

1
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.

2
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).

3
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

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.

5
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.

6
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.

7
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.

8
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. 2786The 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

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 ... scientific 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

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 connection 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.

11
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 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.

12
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 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.

13
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.

14
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 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.

15
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 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:

16
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.

17
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."

18
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 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. 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

19
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.

20
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.

Notes:

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  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.

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.

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").

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.

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)).

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).

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.

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.

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).

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).

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.