Expert Testimony: Experts Must Address Negative Epidemiology to Survive Summary Judgment in Products Liability Cases Involving Silicone Breast Implants-Norris V. Baxter Healthcare Corp.1

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Expert Testimony: Experts Must Address Negative Epidemiology to Survive Summary Judgment in Products Liability Cases Involving Silicone Breast Implants-Norris v. Baxter Healthcare Corp.1-The United States Court of Appeals for the Tenth Circuit held that a breast implant recipient alleging systemic autoimmune disease and local injury from implants must counter the manufacturer's epidemiological evidence to satisfy the general causation requirement. The Tenth Circuit upheld the lower court's summary judgment on the grounds that the recipient's expert testimony was insufficiently reliable as to the causation of the systemic injury and, thus, was inadmissible.3 Furthermore, the Tenth Circuit affirmed the lower court's declaration that the statute of limitations for the claim of local injury started when the recipient had the implants replaced and became aware of the scarring of her breasts.4

In 1970, Dee Norris underwent bilateral breast augmentation surgery, during which she received her first set of silicone and saline filled breast implants manufactured by a division of Dow Corning Corporation.5 In 1974, due to problems with her left implant, Norris had the implant removed and replaced, this time receiving a silicone and saline implant manufactured by Heyer-Schulte.6 In 1978, when her right implant ruptured, Norris had both implants replaced by another set of implants manufactured by Dow Corning.7 In 1987, she began to suffer a variety of ailments, including pain in her right shoulder, foot, and other joints, for which she sought medical help.8 After a diagnosis of silicone-induced lupus, Norris underwent surgery on October 23, 1989, to have both implants removed.9 Subsequently, a second doctor changed Norris's diagnosis to silicone-associated connective tissue disease, which allegedly resulted from silicone leaking from Norris's breast implants.10

Norris brought suit in Colorado state court against several defendants, including Baxter Healthcare, the corporate successor to Heyer-Schulte.11 Norris brought claims of negligence, strict liability, breach of implied warranty, and breach of express warranty, alleging that her breast implants caused systemic autoimmune disease and local injuries.12 Norris also alleged that the defendants knew that there was evidence linking silicone breast implants to various diseases.13 After the claims were transferred and consolidated, Dow Corning filed for bankruptcy, and Norris's claims against Baxter regarding the 1974 left implant were remanded back to the United States District Court for the District of Colorado.14 The district court granted summary judgment to Baxter on Norris's systemic and local injury claims, finding that Norris failed to establish a triable issue of fact regarding whether silicone breast implants are capable of causing systemic injuries.15 Furthermore, the district court held that the claims for breach of warranty, negligence, and products liability were barred, as the statutes of limitations for those claims had expired.16

On appeal, the Tenth Circuit affirmed the grant of summary judgment, emphasizing the district court's finding that epidemiological evidence is the best evidence of general causation in a toxic tort case.17 The court went on to say that although epidemiological evidence may not be required, "where epidemiology is available, it cannot be ignored."18 Thus, because Baxter presented a body of epidemiological evidence showing a lack of connection between silicone implants and immune system diseases, Norris was required to at least address such studies "with evidence based on medically reliable and scientifically valid methodology."19

Norris had presented the testimony of two rheumatologists, both of whom completely ignored or discounted the epidemiological studies that found no medically reliable connection between silicone implants and systemic disease.20 Instead, both experts relied solely on differential diagnosis and case studies to support their belief that silicone gel breast implants can cause systemic disease. …