## F I L E D United States Court of Appeals Tenth Circuit 

### FEB 8 2005 

### PATRICK FISHER Clerk PUBLISH
UNITED STATES COURT OF APPEALS

TENTH CIRCUIT

DEE NORRIS, Plaintiff - Appellant,

v. BAXTER HEALTHCARE CORPORATION, Defendant - Appellee. No. 03-1471

APPEAL FROM THE UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF COLORADO

(D.C. No. 91-S-1021)

Derek Regensburger (Stephen H. Cook on the brief) o f The Law Firm of Stephen H. Cook, P.C., Boulder, Colorado, for Plaintiff-App ellant. Mary A. Wells (Suanne M. Dell of Wells, Anderson & Race, LLC, Denver, Colorado; Debra E. Pole and Roger K. Smith of Sidle y, Austin, Brown & Wood, LLP, Los Angeles, California, with her on the brief ), Wells, Anderson & Race, LLC, Denver, Colorado, for Defendant-Appellee.

Before SEYMOUR , McKAY, and MURPHY , Circuit Judges.

McKAY , Circuit Judge.-2-

This case involves Plaintiff’s claims of systemic d isease allegedly caused by a silicone gel breast implant Plaintiff received in 1974. The implant at issue was manufactured by Defendant’s predecessor. In 19 70, Plaintiff underwent bilateral breast augmentation surgery and received her first set of silicone gel and saline filled breast implants manufactured by a div ision of Dow Corning Corporation. Four years later, due to problems with her left implant, Plaintiff had the left implant removed and replaced with another silicone gel and saline filled breast implant manufactured by Defendant’s predeces sor corporation. This implant is the sole focus of this appeal. In 1978, because of a rupture of her right implant, Plaintiff had both implants replaced with another set of implants manufactured by Dow Corning. Plaintiff points to n o specific evidence in the record that the left implant which was manufacturedby Defendant had leaked prior to the time of removal. Beginning in 1987, Plaintiff began to suffer from avariety of ailments including pain in her right shoulder and foot and p ain and swelling in her right knee, hip, and other joints. On October 23, 1989, Plaintiff had both implants removed because her doctor believed that she had si licone-induced lupus. The diagnosis was subsequently changed by Dr. Vasey, on e of Plaintiff’s proffered experts, to silicone-associated connective tissue d isease–autoimmune disease-3-

caused by silicone which leaked from breast implant s. This disease allegedly caused Plaintiff to suffer tenderness in the muscle s of her mid and low back in addition to joint swelling in her upper extremities

. In 1991, Plaintiff filed suit in Colorado state cou rt against several Defendants, including Defendant Baxter as the corpo rate successor to HeyerSchulte, seeking compensatory and punitive damages based on claims of negligence, strict liability, breach of implied war ranties, and breach of express warranties/misrepresentation. Plaintiff alleged tw o types of injuries as a result of her silicone breast implants: (1) systemic autoimm une disease and (2) local injuries such as pain suffered as a result of scarr ing and leakage. Plaintiff further alleged that Defendants knew that there was evidenc e linking silicone breast implants to various serious diseases. The action w as removed to federal court and transferred to the Northern District of Alabama forconsolidated proceedings. Dow Corning, the manufacturer of all but one of Pla intiff’s breast implants, filed for bankruptcy. Plaintiff’s claims against Baxter regarding the 1974 left implant were remanded back to the United States District Co urt for the District of Colorado. After remand, Baxter moved for summary judgment on Plaintiff’s systemic injury claims. Baxter argued that there was no epi demiological evidence showing an association between silicone breast implants andautoimmune disorders;1 We need not specifically discuss Plaintiff’s other contentions of error

because they all fall within the umbrella of whethe r she raised a genuine issue of material fact that silicone breast implants caused her alleged systemic injuries. See Aplt. Br. at 2. Therefore, all of Plaintiff’s cla ims are within the scope of this opinion. -4- therefore, Plaintiff could not meet her burden of p roof with respect to general causation. Baxter further argued that the statute of limitations barred Plaintiff’s local injury claims. In her opposition to Baxter’s motion for summary judgment, Plaintiff primarily relied on the expert testimony of two physicians, Dr. Vasey and Dr. Espinoza. The district court granted Baxter’s motion for summary judgment on Plaintiff’s systemic and local injury claims. The issue on appeal is whether the district court e rred in granting Baxter summary judgment on (1) Plaintiff’s claim of system ic autoimmune disease because she failed to meet her burden of establishi ng a triable issue of fact that silicone breast implants are capable of causing sys temic injuries 1 and (2) Plaintiff’s claims for breach of warranty, negligen ce, and products liability on the basis that the applicable statute of limitations ha d expired. We review de novo a district court’s grant of summary judgment, appl ying the same legal standard employed by the district co urt, to determine whether there is a genuine issue as to any material fact and whet her a party is entitled to judgment as a matter of law. Gossett v. Oklahoma e x rel. Bd. of Regents for Langston Univ. , 245 F.3d 1172, 1175 (10th Cir. 2001). Plaintiff’ s main assertion-5-

on appeal is that the district court erred in findi ng that she failed to meet her burden of establishing a triable issue of fact thather 1974 silicone breast implant was a factor in the development of her alleged syst emic injuries. To support her theory of causation, Plaintiff presented expert tes timony from two doctors. That evidence was excluded by the district court. Before specifically addressing Plaintiff’s proffer of expert testimony relating to her alleged silicone-associated connect ive tissue disease, it is necessary to highlight the hurdle Plaintiff must ov ercome. We cannot consider whether Plaintiff’s silicone breast implants causedher specific autoimmune disease until Plaintiff presents reliable evidence that silicone breast implants are capable of causing disease in people in general. The district court correctly noted that, in silicon e breast implant litigation, plaintiffs must show both general and specific caus ation. See Raynor v. Merrell Pharm., Inc. , 104 F.3d 1371, 1376 (D.C. Cir. 1997) (causation i n toxic tort cases is discussed in terms of general causation and spec ific causation); Kelley v. American Heyer-Schulte Corp. , 957 F. Supp. 873, 875 (W.D. Tex. 1997); see also Jones v. United States , 933 F. Supp. 894, 900-01 (N.D. Cal. 1996), aff’d, 127 F.3d 1154 (9th Cir. 1997); Hall v. Baxter Healthcar e Corp. , 947 F. Supp. 1387, 1412-13 (D. Or. 1996). General causation is whethe r a substance is capable of causing a particular injury or condition in the gen eral population and specific2 There are at least seventeen, if not more, signific ant published, peerreviewed epidemiological studies that were consider ed by the district court. In re Breast Implant Litig. , 11 F. Supp. 2d 1217, 1227 (D. Colo. 1998); Aplt. App., Vol. III, at 821 (district court’s oral order incorporating the studies and articles (continued...) -6- causation is whether a substance caused a particular individual’s injury. Plaintiff must first demonstrate general causation because wi thout general causation, there can be no specific causation. In other words, if s ilicone breast implants are incapable of causing systemic injuries in anyone, i t follows a fortiorithat silicone breast implants could not have caused systemic inju ries in Plaintiff. Addressing the question of general causation, the d istrict court first discussed the necessity of epidemiological evidence . It did not hold that epidemiology is the only admissible evidence on cau sation. However, the district court did conclude that it needed epidemiological e vidence in order for Plaintiff to overcome Defendant’s motion for summary judgmentin this case. This decision was grounded largely on the fact that manyepidemiological studies and other data were available regarding the alleged ass ociation between silicone breast implants and immune system diseases. Defend ant had already proffered a significant body of epidemiology in support of its contention that silicone breast implants do not cause disease in anyone. The volum e of epidemiological evidence is reflected in the record and in other co urt cases dealing with the same subject matter. 22 (...continued)

discussed in In re Breast Implant Litig. , 11 F. Supp. at 1231-32). -7- One such examination of the alleged link was conduc ted in 1996 when Judge Pointer, United States District Court, Northe rn District of Alabama, appointed a Rule 706 National Science Panel to lookat available scientific literature to determine whether breast implants mig ht cause connective tissue disease. In November 1998, the Panel issued its re port, finding that “[t]he most likely conclusion from these several analyses is th at there is no meaningful or consistent association between breast implants or s ilicone gel-filled implants and any of the conditions studied.” Aplt. App., Vol. I I, at 417. The Panel’s immunologist, Dr. Diamond, testified that there is “no reproducible[,] reliable data” supporting the theory that silicone gel breas t implants cause any immune system dysfunction. Id. at 438. The Panel’s epidemiologist, Dr. Hulka, st ated that she “did not find a reliable or consistent ass ociation between breast implants and any of the conditions that we studied.” Id. at 457. Dr. Tugwell, the Panel’s rheumatologist, stated that “there is no proven ass ociation between those diseases and silicone breast implants.” Id. at 447. In 1997, Congress instructed the United States Department of Health and Human Services to contract with the Institute of Me dicine of the National Academy of Sciences to conduct a “comprehensive eva luation of the evidence for-8-

the association of silicone breast implants . . . w ith human health conditions . . . .” Id. at 427. In July 1999, the report concluded that t here was “no elevated relative risk or odds ratio for an association of implants w ith disease.” Id. at 430. The report further stated that there was not “even sugg estive evidence” that silicone breast implants caused systemic disease. Id. at 432. We agree with the district court that epidemiology is the best evidence of general causation in a toxic tort case. See In re Breast Implant Litig. , 11 F. Supp. 2d 1217, 1224 (D. Colo. 1998); Linda A. Bailey, et al., “Reference Guide on Epidemiology,” Reference Manual on Scientific Evide nce at 126 (1994); see also Wilson v. Merrell Dow Pharm., Inc. , 893 F.2d 1149, 1154 (10th Cir. 1990); Renaud v. Martin Marietta Corp. , 749 F. Supp. 1545, 1554 (D. Colo. 1990), aff’d, 972 F.2d 304, 307 (10th Cir. 1992). While the pres ence of epidemiology does not necessarily end the inquiry, where epidemiology is available, it cannot be ignored. As the best evidence of general causation, it must be addressed. Plaintiff disputes the necessity of epidemiological evidence citing Glastetter v. Novartis Pharm. Corp ., 252 F.3d 986 (8th Cir. 2001); Kennedy v. Collagen Corp. , 161 F.3d 1226 (9th Cir. 1998); and Benedi v. McNe il-P.P.C.,
Inc. , 66 F.3d 1378 (4th Cir. 1995). See Aplt. Br. at 15-16. Plaintiff asserts that in all of these cases, epidemiological studies were unnecessary to prove general causation. These cases are inapposite. First, non e involve breast implants.-9-

Second, and more importantly, in all three cases, u nlike the case at hand, there was no body of epidemiological evidence demonstrati ng the absence of a causal relationship. In cases where there is no epidemiol ogy challenging causation available, epidemiological evidence would not neces sarily be required. This is not a case where there is no epidemiology. It is a case where the body of epidemiology largely finds no association b etween silicone breast implants and immune system diseases. We are not ho lding that epidemiological studies are always necessary in a toxic tort case. We are simply holding that where there is a large body of contrary epidemiolog ical evidence, it is necessary to at least address it with evidence that is based on medically reliable and scientifically valid methodology. In light of the significant body of epidemiological evidence proffered by Defendant, and in attempting to reach the epidemiol ogical evidence proffered by Plaintiff, the district court necessarily focused o n two expert witnesses, Dr. Vasey and Dr. Espinoza, to establish a link. Both doctor s asserted a belief that silicone breast implants can cause immune system diseases. Additionally, the doctors evaluated Appellant and concluded that her specific systemic injuries were a result of her silicone breast implants. After cond ucting a Daubert v. Merrell Dow2 The district court did not specifically state in it s oral order that it was

conducting a Dauberthearing. The district court did say, as part of i ts order, that “under Daubert , in Tenth Circuit law, the court must make the det ermination initially if there is a significant showing of caus ation based on some evidence.” Aplt. App., Vol. III, at 827. Additionally, in det ermining whether there was a genuine issue of material fact to overcome Baxter’s summary judgment motion, it was necessary for the district court to assess the admissibility of Plaintiff’s experts under Daubert . The court stated that “Dr. Vasey’s opinions, bas ed on his report, appear to be based on matters which do not satisfy the scientific requirements.” The court further stated that “Dr. Espinoza suffers from the same problem.” Id. at 835-36. -10- Pharm., Inc. , 509 U.S. 579 (1993), inquiry 2 , the district court excluded both experts because they were unreliable. We review de novo whether the district court applied the proper stan dard in determining whether to admit or exclude expert test imony. Dodge v. Cotter Corp. , 328 F.3d 1212, 1223 (10th Cir. 2003) (citation om itted). That is, whether the district court properly performed its role as “ gatekeeper” pursuant to Federal Rule of Evidence 702 and Daubert . Id. ; Bitler v. A.O. Smith Corp. , 391 F.3d 1114, 1119 (10th Cir. 2004). We then review the manner in which the district court “exercises its Daubert‘gatekeeping’ role in making decisions whether to admit or exclude testimony” for an abuse of discret ion. Bitler , 391 F.3d at 1119;

see also Dodge , 328 F.3d at 1223. “[W]e will not disturb the dis trict court’s ruling unless it is arbitrary, capricious, whimsica l or manifestly unreasonable or when we are convinced that the district court made a clear error of judgment or exceeded the bounds of permissible choice in the ci rcumstances.” Dodge , 328-11-

F.3d at 1223 (citation and internal quotations omitted). In evaluating the district court’s gatekeeping role , we are not necessarily concerned with its “exact conclusions reached to ex clude or admit expert testimony.” Bitler , 391 F.3d at 1119. The district court must make s ome reliability determination on the record; however, “ we recognize the wide latitude a district court has in exercising its discretion t o admit or exclude expert testimony.” Id. (citation omitted). The district court “has wide discretion both in deciding how to assess an expert’s reliability and in making a determination of that reliability.” Id. at 1120 (citation omitted). Mindful of this deferential standard of review, we begin our discussion of the district court’s exclusion of Plaintiff’s expert testimony with Rule 702. See id. Rule 702 states that [i]f scientific, technical, or other specialized kn owledge will assist the trier of fact to understand the evidence or to determine a fact in issue, a witness qualified as an expert by knowledg e, skill, experience, training, or education, may testify the reto in the form of an opinion or otherwise . . . . Rule 702 requires the district court to “ensure that any and all scientific testimony or evidence is not only relevant, but reliable.” I d. (quoting Daubert , 509 U.S. at 589). This obligation involves a two-part inquiry. Id. “[A] district court must [first] determine if the expert’s proffered testimo ny . . . has ‘a reliable basis in the knowledge and experience of his [or her] discipline .’” Id. (quoting Daubert , 5092 The second inquiry is related to the first. Under the relevance prong of the

Daubertanalysis, the court must ensure that the proposed expert testimony logically advances a material aspect of the case. Daubert v. Merrell Dow Pharm., Inc. , 43 F.3d 1311, 1315 (9th Cir. 1995) (on remand). The evidence must have a valid scientific connection to the disputed facts i n the case. Daubert , 509 U.S. at 591.

3 Additionally, even if an expert’s opinion or eviden ce is relevant and admissible, if “insufficient to allow a reasonable juror to conclude that the position more likely than not is true,” it may be t he basis for a grant of summary judgment. Daubert , 509 U.S. at 596. -12- U.S. at 592). In making this determination, the di strict court must decide “whether the reasoning or methodology underlying th e testimony is scientifically valid . . . .” Id. (quoting Daubert , 509 U.S. at 592-93). Second, the district court must further inquire into whether proposed testimony is sufficiently “relevant to the task at hand.” 2 Daubert , 509 U.S. at 597. Because Plaintiff’s proffered e xpert testimony fails the first requirement, we need not specifically address the second. 3 In determining whether the expert’s reasoning or me thodology is valid, the Supreme Court has suggested that a court consid er: (1) whether a theory has been or can be tested or falsified, (2) whether the theory or technique has been subject to peer review and pu blication, (3) whether there are known or potential rates of errorwith regard to specific techniques, and (4) whether the theory or approach has “general acceptance.” Daubert , 509 U.S. at 593-94. The Court has made clear, however, that this list is neither defi nitive nor exhaustive.

. . . . Accordingly, a trial court’s focus generally shouldnot be upon the precise conclusions reached by the expert, but on the methodology employed in reaching those conclusions. Daubert , 509 U.S. at 595. Bitler , 391 F.3d at 1120-21.-13-

The district court noted that Dr. Vasey and Dr. Esp inoza have impressive credentials in the field of rheumatology. However, as a basis for their conclusions regarding the connection between silico ne breast implants and autoimmune diseases, Plaintiff’s experts completelyignored or discounted without explanation the many epidemiological studie s which found no medically reliable link between silicone breast implants and systemic disease. Therefore, the district court concluded that the methodology u sed by Plaintiff’s experts was not medically or scientifically valid. See Daubert , 509 U.S. at 592-93. Because of this, the district court determined that Plainti ff’s experts’ opinions were not reliably grounded in the knowledge and experience o f their discipline. In Dr. Vasey’s “opinion[,] silicone gel breast impl ants cause both local and systemic inflammatory conditions.” Aplt. App., Vol . II, at 305. As a basis for this opinion, Dr. Vasey primarily relied on his own“case series with sequential observations in many patients.” Id. at 306. He further stated that his “opinion is based on the unique and atypical findings in women with silicone gel breast implants . . . [and on] sequential observations inc luding the beneficial effect of breast implant removal.” Id. Dr. Vasey did not rely on any epidemiological studi es or other controlled studies for his opinion that silicone gel breast implants can cause systemic disease. Additionally, Dr. Vasey completely ignore d the many epidemiological-14-

studies that do not find a link between silicone ge l breast implants and any systemic disease. He conclusively, and without sup port, stated that epidemiological studies relied on by the industry “ are not definitive.” Id. at 307. In order to escape the volume of contrary opinions, Dr. Vasey indicated that the comprehensive syndrome he described, “atypical fibromyalgia chronic fatigue syndrome[,] has escaped study.” Id. at 306. However, he asserted that Plaintiff has “silicone associated connective tissue disease. ” Id. It is unclear from Dr. Vasey’s opinion how Plaintiff’s disease fits into the category of disease that has allegedly escaped study. Additionally, he never di scusses why the voluminous other studies on silicone gel breast implants are c ompletely irrelevant to Plaintiff’s stated condition. Like Dr. Vasey, Dr. Espinoza relied not on epidemio logy but on clinical case studies and differential diagnosis. Basing hi s conclusion on his “prior clinical experience in dealing with this unusual as sociation,” Dr. Espinoza stated that “[i]t is my personal opinion that some individ uals exposed to silicone breast implants developed systemic illness that mimic idio pathic autoimmune disorders . . . .” Aplt. App., Vol. III, at 667-68 . He further said that “[i]t is my feeling that [Plaintiff’s] arthritis is related to her underlying silicone breast implants.” Id. at 667. While stating that his “opinion is based on a reasonable degree of medical probability,” Dr. Espinoza agreed that the body of the evidence-15-

says that there is no association between silicone breast implants and connective tissue diseases. Aplt. Id. at 667-69. He was unable to articulate why his vi ew did not comport with the “body of the evidence,” other than to say that “no study has been designed to specifically address atypical conn ective tissue disease . . . .” Id. Plaintiff’s experts relied solely on differential d iagnosis and case studies to support their belief that silicone gel breast impla nts can cause systemic disease. Their reliance on differential diagnosis without supporting epidemiological evidence is misplaced and demonstrates the unreliab le nature of the testimony. Observations cannot define a disease. The foundati onal evidence that the doctors rely upon do not reach conclusions based on accepte d scientific methodology. “[D]ifferential diagnosis assumes that general causation has been proven . . . .”
See Hall , 947 F. Supp. at 1413 (emphasis in original). It is [] important to recognize that a fundamental assumption underlying [differential diagnosis] is that the fin al, suspected “cause” remaining after this process of elimination must actually be capable of causing the injury. That is, the expert must “rule in” the suspected cause as well as “rule out” other possibl e causes. And, of course, expert opinion on this issue of “general causation” must be derived from a scientifically valid methodology. Id. (emphasis in original) (quoting Cavallo v. Star Enterprise , 892 F. Supp. 756, 771 (E.D. Va.1995), aff’d on this ground, rev’d on other grounds, 100 F.3d 1150 (4th Cir. 1996). Case reports suffer from a similar failing. Case reports that state that some women with breast implants developed dise ase do not provide an-16-

adequate scientific basis from which to conclude th at breast implants in fact cause disease. A correlation does not equal causation. We are unable to find a single case in which differ ential diagnosis that is flatly contrary to all of the available epidemiological evidence is both admissible and sufficient to defeat a defendant’s motion for s ummary judgment. Plaintiff’s experts’ differential diagnoses and case studies ar e scientifically unreliable because they assume what science has largely shown does not exist–a causal connection between silicone breast implants and dis ease. The district court did not abuse its discretion in exercising its Daubert gatekeeping role. “Although it is not always a str aightforward exercise to disaggregate method and conclusion, when the conclu sion simply does not follow from the data, a district court is free to determin e that an impermissible analytical gap exists between premises and conclusion.” Bitle r , 391 F.3d at 1121 (citing General Elec. Co. v. Joiner , 522 U.S. 136, 146 (1997); Dodge , 328 F.3d at 1222;

see also Bragdon v. Abbott , 524 U.S. 624, 653 (1998) (“Scientific evidence an d expert testimony must have a traceable, analytical basis and objective fact before it may be considered on summary judgment.”) (citing Joiner , 522 U.S. 136, 144- 46 (1997)). Although “[t]rained experts commonly e xtrapolate from existing data,” neither Daubertnor the Federal Rules of Evidence “require[] a dis trict court to admit opinion evidence which is connected to existing data only by the4 We note that the district court was not the first c ourt to hold that Dr.

Vasey’s and Dr. Espinoza’s opinions did not meet th e Dauberttest for expert testimony. See Bushore v. Dow Corning-Wright Corp. , No. 92-344-CIV-T-26C, 1999 WL 1116920, at *7 (M.D. Fla. Nov. 15, 1999) (c iting Kelley , 957 F. Supp. at 882). -17- ipse dixitof the expert.” Joiner , 522 U.S. at 146. “A court may conclude that there is simply too great an analytical gap between the data and the opinion proffered.” Id. The district court determined that Plaintiff’s expe rts did not offer valid testimony to support either general or specific cau sation. 4 As to the question of general causation, both experts ignored or discount ed without explanation the contrary epidemiological studies. According to Pla intiff and her experts, the vast majority of epidemiological evidence which shows no strong consistent association between silicone breast implants and di sease is not “useful” with regard to whether silicone breast implants cause sy stemic disease. Aplt. Br. at 19. Overcoming this large body of epidemiology requires more than simply stating that the studies are wrong. Mere criticism of epid emiology cannot establish causation. Conde v. Velsicol Chem. Corp. , 24 F.3d 809, 814 (6th Cir. 1994) (explaining that published critiques of studies “un derscore the need for further studies” but do not establish causation). Plaintiff’s and her experts’ efforts to discredit the epidemiology are not peer-reviewed, are not developed independent of lit igation, and are not generally5 We need not address the question of whether epidemi ological studies

showing a relative risk between 1.0 and 2.0 for dev eloping symptoms of connective tissue disease from silicone breast impl ants are admissible evidence. The district court did not need to reach this issue because it excluded the expert opinions of Doctors Vasey and Espinoza. The distri ct court excluded the experts’ opinions not based on the epidemiological studies b ut based on their failure to address or discuss the prevailing contrary views out there. -18- accepted by the relevant scientific community. The se are all important Daubert considerations. 509 U.S. at 593. Plaintiff and he r experts have to base their positions on reliable studies and methodology. In failing to properly address the previous and contrary views, Plaintiff’s experts ma de their opinions and testimony unreliable as to the issue of general causation. 5 In addition, Plaintiff’s experts were unreliable as to the issue of specific causation. Plaintiff’s experts both based their op inions on examinations of Plaintiff, clinical experience, and case studies. In concluding that Plaintiff’s systemic injuries were a result of her silicone bre ast implants, Plaintiff’s experts attempted to demonstrate specific causation withoutfirst demonstrating general causation. Both of Plaintiff’s experts agree that, at best, silicone-associated connective tissue disease is an untested hypothesis . At worst, the link has been tested and found to be untenable. Therefore, there is no scientific basis for any expert testimony as to its specific presence in Pla intiff. Plaintiff attempted to use Dr. Vasey and Dr. Espino za to get to epidemiological evidence which would allegedly supp ort her position. However,6Non-epidemiological studies, “singly or in combinat ion[,]” are “not

capable of proving causation in human beings in the face of [an] overwhelming body of contradictory epidemiological evidence.” R aynor , 104 F.3d at 1374; see also Elkins v. Richardson-Merrell, Inc. , 8 F.3d 1068, 1073 (6th Cir. 1993); Daubert , 509 U.S. at 592. -19- the district court properly excluded these two expe rts that were trying to get the court to the epidemiological evidence. We cannot a llow the jury to speculate based on an expert’s opinion which relies only on c linical experience in the absence of showing a consistent, statistically sign ificant association between breast implants and systemic disease. 6 This is not a case where the experts’ opinions were based on “objective, verifiable evide nce and scientific methodology of the kind traditionally used by rheum atologists.” Kennedy v. Collagen Corp. , 161 F.3d 1226, 1230 (9th Cir. 1998). Plaintiff’s experts’ conclusions about systemic disease have not gained acceptance in the relevant scientific community. Additionally, neither of the proffered experts demonstrated that their scientific methods were reliable to over come the volume of contrary medical opinion regarding the alleged link between silicone breast implants and autoimmune disease. Plaintiff provided no explanat ion why Dr. Vasey’s and Dr. Espinoza’s opinions are reliable notwithstanding th e epidemiological studies finding no significant risk of autoimmune disease r esulting from silicone breast implants. Plaintiff next argues that the district court erred by granting summary7 Prior to 1986, the statute of limitations for produ cts liability claims based

upon strict liability and/or negligence in Colorado was three years after the claim for relief arose. In 1986, the statute was amendedto a two-year statute of limitations. See C.R.S. § 13-80-106(1). -20- judgment to Defendant on Plaintiff’s local injury c laims because they were time barred. Colorado has adopted the discovery rule to determin e when a product liability action accrues. See Persichini v. Brad Ragan, Inc. , 735 P.2d 168, 173 n.6 (Colo. 1987). Pursuant to the discovery rule, a pl aintiff must bring her product liability and misrepresentation claims within three years 7of when she is aware or should be aware, in the exercise of reasonable dili gence, of all of the elements of the cause of action. C.R.S. § 13-80-108(1); Millerv. Armstrong World Industries, Inc. , 817 P.2d 111, 113-14 (Colo. 1991). Once a plaint iff has suspicion of wrongdoing, she is under a duty to att empt to find the facts. Trinity Broad. of Denver, Inc. v. City of Westminster , 848 P.2d 916, 926-27 (Colo. 1993). Uncertainty as to the full extent of the da mage does not stop the accrual of a cause of action. Taylor v. Goldsmith , 870 P.2d 1264, 1266 (Colo. App. 1994);

see also Jones v. Cox , 828 P.2d 218, 224 (Colo. 1992); Dove v. Delgado , 808 P.2d 1270, 1273 (Colo. 1991). Therefore, pursuant to Colorado law, the statute of limitations began to run when the fact of injury was known or should have be en known. Plaintiff testified that, as early as 1978, she felt that something was not “normal” in her right breast8 Plaintiff unsuccessfully attempts to use her allege d systemic injuries to

argue that her claims based on her local injuries w ere not barred by the statute of limitations. See Aplt. Br. at 41-42.

9 We do not even begin to discuss how Plaintiff has b een unable to dissect the alleged local injuries from Defendant’s implantfrom all of the alleged local injuries caused by the Dow Corning implants. Even if Plaintiff were not barred by the statute of limitations, the record reflects that Plaintiff had continuous local injuries from her repeated explantation and implant ation surgeries which were unrelated to Defendant’s implant. Aplt. App., Vol. I, at 137-38. -21- (not the left which is the subject of this litigati on). Aplt. App., Vol. I, at 180. Plaintiff also admits that her doctor told her thathe believed that her implants were causing the problem and informed her that bothof her implants needed to be removed. Id. at 182-83. Plaintiff had both implants (including the one at issue) removed on May 26, 1978, and replaced with implants manufactured by Dow Corning. Id. at 134-35, 137. She admitted that there was scarr ing of the breasts at the time of this surgery. Id. at 137. Based on these facts, Plaintiff had an obligation, beginning in 1978, to investigate the p roblems with her breast implants. 8 Plaintiff did not file suit until 1991, thirteen years later–ten years past the expiration of the statute of limitations for pr oduct liability and misrepresentation. 9 The district court did not err in granting summary judgment to Baxter on Plaintiff’s product liability and misr epresentation claims. The district court also did not err in granting sum mary judgment to Baxter on Plaintiff’s breach of warranty claims. A plaint iff is obligated to bring her10 The statute of limitations for breach of warranty c laims in Colorado in

1974 was four years. See 1965 Colo. Sess. Laws, ch. 330, § 155-2-725(1), at 1344. -22- breach of warranty claims within four years 10of the date of delivery or sale of the product unless the warranty explicitly extends to f uture performance of the product. C.R.S. § 4-2-725; Wieser v. Firestone Tir e & Rubber Co. , 596 F. Supp. 1473, 1475 (D. Colo. 1984); Persichini , 735 P.2d at 176. Plaintiff received Defendant’s implant in 1974. Plaintiff has submitt ed no argument or evidence that Defendant provided her with a warranty explici tly based on the future performance of her implant. The statute of limitat ions for her breach of warranty claim expired in 1978.
AFFIRMED.