Norris v. Baxter Healthcare Corp.

• Decision Date: 08 February 2005
• Docket Number: No. 03-1471.,03-1471.
• Citation: 397 F.3d 878
• Parties: Dee NORRIS, Plaintiff-Appellant, v. BAXTER HEALTHCARE CORPORATION, Defendant-Appellee.
• Court: U.S. Court of Appeals — Tenth Circuit

397 F.3d 878

Dee NORRIS, Plaintiff-Appellant, v. BAXTER HEALTHCARE CORPORATION, Defendant-Appellee.

No. 03-1471.

United States Court of Appeals, Tenth Circuit.

February 8, 2005.

Derek Regensburger (Stephen H. Cook on the brief) of The Law Firm of Stephen H. Cook, P.C., Boulder, CO, for Plaintiff-Appellant.

Mary A. Wells (Suanne M. Dell of Wells, Anderson & Race, LLC, Denver, CO; Debra E. Pole and Roger K. Smith of Sidley, Austin, Brown & Wood, LLP, Los Angeles, CA, with her on the brief), Wells, Anderson & Race, LLC, Denver, CO, for Defendant-Appellee.

Before SEYMOUR, McKAY, and MURPHY, Circuit Judges.

McKAY, Circuit Judge.

This case involves Plaintiff's claims of systemic disease allegedly caused by a silicone gel breast implant Plaintiff received in 1974. The implant at issue was manufactured by Defendant's predecessor. In 1970, Plaintiff underwent bilateral breast augmentation surgery and received her first set of silicone gel and saline filled breast implants manufactured by a division 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 predecessor 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 no specific evidence in the record that the left implant which was manufactured by Defendant had leaked prior to the time of removal.

Beginning in 1987, Plaintiff began to suffer from a variety of ailments including pain in her right shoulder and foot and pain 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 silicone-induced lupus. The diagnosis was subsequently changed by Dr. Vasey, one of Plaintiff's proffered experts, to silicone-associated connective tissue disease — autoimmune disease caused by silicone which leaked from breast implants. This disease allegedly caused Plaintiff to suffer tenderness in the muscles of her mid and low back in addition to joint swelling in her upper extremities.

In 1991, Plaintiff filed suit in Colorado state court against several Defendants, including Defendant Baxter as the corporate successor to Heyer-Schulte, seeking compensatory and punitive damages based on claims of negligence, strict liability, breach of implied warranties, and breach of express warranties/misrepresentation. Plaintiff alleged two types of injuries as a result of her silicone breast implants: (1) systemic autoimmune disease and (2) local injuries such as pain suffered as a result of scarring and leakage. Plaintiff further alleged that Defendants knew that there was evidence linking silicone breast implants to various serious diseases. The action was removed to federal court and transferred to the Northern District of Alabama for consolidated proceedings. Dow Corning, the manufacturer of all but one of Plaintiff's breast implants, filed for bankruptcy. Plaintiff's claims against Baxter regarding the 1974 left implant were remanded back to the United States District Court for the District of Colorado.

After remand, Baxter moved for summary judgment on Plaintiff's systemic injury claims. Baxter argued that there was no epidemiological evidence showing an association between silicone breast implants and autoimmune disorders; therefore, Plaintiff could not meet her burden of proof 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 erred in granting Baxter summary judgment on (1) Plaintiff's claim of systemic autoimmune disease because she failed to meet her burden of establishing a triable issue of fact that silicone breast implants are capable of causing systemic injuries¹ and (2) Plaintiff's claims for breach of warranty, negligence, and products liability on the basis that the applicable statute of limitations had expired.

We review de novo a district court's grant of summary judgment, applying the same legal standard employed by the district court, to determine whether there is a genuine issue as to any material fact and whether a party is entitled to judgment as a matter of law. Gossett v. Oklahoma ex rel. Bd. of Regents for Langston Univ., 245 F.3d 1172, 1175 (10th Cir.2001). Plaintiff's main assertion on appeal is that the district court erred in finding that she failed to meet her burden of establishing a triable issue of fact that her 1974 silicone breast implant was a factor in the development of her alleged systemic injuries. To support her theory of causation, Plaintiff presented expert testimony 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 connective tissue disease, it is necessary to highlight the hurdle Plaintiff must overcome. We cannot consider whether Plaintiff's silicone breast implants caused her 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 silicone breast implant litigation, plaintiffs must show both general and specific causation. See Raynor v. Merrell Pharm., Inc., 104 F.3d 1371, 1376 (D.C.Cir.1997) (causation in toxic tort cases is discussed in terms of general causation and specific 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 Healthcare Corp., 947 F.Supp. 1387, 1412-13 (D.Or.1996). General causation is whether a substance is capable of causing a particular injury or condition in the general population and specific causation is whether a substance caused a particular individual's injury. Plaintiff must first demonstrate general causation because without general causation, there can be no specific causation. In other words, if silicone breast implants are incapable of causing systemic injuries in anyone, it follows a fortiori that silicone breast implants could not have caused systemic injuries in Plaintiff.

Addressing the question of general causation, the district court first discussed the necessity of epidemiological evidence. It did not hold that epidemiology is the only admissible evidence on causation. However, the district court did conclude that it needed epidemiological evidence in order for Plaintiff to overcome Defendant's motion for summary judgment in this case. This decision was grounded largely on the fact that many epidemiological studies and other data were available regarding the alleged association between silicone breast implants and immune system diseases. Defendant had already proffered a significant body of epidemiology in support of its contention that silicone breast implants do not cause disease in anyone. The volume of epidemiological evidence is reflected in the record and in other court cases dealing with the same subject matter.²

One such examination of the alleged link was conducted in 1996 when Judge Pointer, United States District Court, Northern District of Alabama, appointed a Rule 706 National Science Panel to look at available scientific literature to determine whether breast implants might cause connective tissue disease. In November 1998, the Panel issued its report, finding that "[t]he most likely conclusion from these several analyses is that there is no meaningful or consistent association between breast implants or silicone gel-filled implants and any of the conditions studied." Aplt.App., Vol. II, at 417. The Panel's immunologist, Dr. Diamond, testified that there is "no reproducible[,] reliable data" supporting the theory that silicone gel breast implants cause any immune system dysfunction. Id. at 438. The Panel's epidemiologist, Dr. Hulka, stated that she "did not find a reliable or consistent association 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 association 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 Medicine of the National Academy of Sciences to conduct a "comprehensive evaluation of the evidence for the association of silicone breast implants ... with human health conditions...." Id. at 427. In July 1999, the report concluded that there was "no elevated relative risk or odds ratio for an association of implants with disease." Id. at 430. The report further stated that there was not "even suggestive 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 Evidence 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 presence of epidemiology does not necessarily end the inquiry, where epidemiology is available, it cannot be...