Artiglio v. Corning Inc.

• Decision Date: 09 July 1998
• Docket Number: No. S057133,S057133
• Citation: 18 Cal.4th 604,957 P.2d 1313,76 Cal.Rptr.2d 479
• Court: California Supreme Court
• Parties: , 957 P.2d 1313, 98 Cal. Daily Op. Serv. 5388, 98 Daily Journal D.A.R. 7531 Eda ARTIGLIO et al., Plaintiffs and Appellants, v. CORNING INCORPORATED et al., Defendants and Respondents

Page 479

76 Cal.Rptr.2d 479

18 Cal.4th 604, 957 P.2d 1313, 98 Cal. Daily Op. Serv. 5388,

98 Daily Journal D.A.R. 7531

Eda ARTIGLIO et al., Plaintiffs and Appellants, v. CORNING INCORPORATED et al., Defendants and Respondents.

No. S057133.

Supreme Court of California

July 9, 1998.

Robins, Kaplan, Miller & Ciresi, Alexandra M. Day, Bruce A. Finzen, Minneapolis, Mn., Robinson, Phillips & Calcagnie, Joseph L. Dunn, Laguna Niguel, Thorsnes, Bartolotta, McGuire & Padilla and B. James Pantone, San Diego, for Plaintiffs and Appellants.

McInnis, Fitzgerald, Rees & Sharkey, Luce, Forward, Hamilton & Scripps, Los Angeles, Cary W. Miller, Richard R. Spirra, San Diego, Baker & Hostetler, Peter W. James, Angela C. Agrusa, Los Angeles, Nixon, Hargrave, Devans & Doyle, William D. Eggers, David H. Tennant, Gold River, Mayer Brown & Platt, Herbert L. Zarov, Michele L. Odorizzi, Chicago, IL., Daniel J. Delaney, Morris, Polich & Purdy, Anthony G. Brazil, Steven M. Crane, Los Angeles, Lee A. Miller, Sherman Oaks, Douglas J. Collodel, Los Angeles, Janet M. Richardson, San Francisco, and Gerald P. Schneeweis, San Diego, for Defendants and Respondents.

Daniel J. Popeo, Paul D. Kamenar, Susan W. Liebeler, Malibu, Fred Main, Sacramento, Carrie-Lee Coke, Hugh F. Young, Jr., Reston, VA., Harvey M. Grossman, Los Angeles, Armstrong, Teasdale, Schlafly & Davis, Jordan B. Cherrick, St. Louis, MO., Jeffrey T. McPherson, Thelen, Marrin, Johnson & Bridges, Curtis A. Cole, Fresno, McKenn & Cuneo, Daniel G. Jarcho, Washington, D.C., Larry R. Pilot, Michael H. Hinckle and Stanley W. Landfair, Los Angeles, as Amici Curiae on behalf of Defendants and Respondents.

WERDEGAR, Justice.

In this case we discuss the circumstances under which those who undertake to provide manufacturers of medical products with human toxicology research and fail to exercise reasonable care in performing that undertaking may face potential tort liability pursuant to the "negligent undertaking" theory articulated in Restatement Second of Torts section 324A (section 324A).

As will be seen, California courts, including this court, have long recognized section 324A's negligent undertaking theory, the general viability of which is not at issue. We have limited our review in this matter to whether the trial court erred in granting summary judgment on plaintiffs' section 324A claims, which are based on allegations the defendant corporations negligently discharged an undertaking to provide silicone toxicology research to their subsidiary, a manufacturer, inter alia, of medical devices.

We conclude that, as a matter of law, based on the record before the trial court on summary judgment, when defendant The Dow Chemical Company (Dow Chemical) ¹conducted and reported silicone toxicology research for Dow Corning Corporation (Dow Corning), any risk of physical harm to plaintiffs from negligent performance of that undertaking was unforeseeable. Accordingly, we affirm the judgment of the Court of Appeal upholding the trial court's grant of summary judgment.

Background ²

Dow Corning was incorporated under the laws of Michigan in 1943. Dow Chemical and Corning each contributed to Dow Corning technology and licenses under patents they held in the field of organosilicon compounds and each received 50 percent of Dow Corning's stock. Dow Chemical provided Dow Corning physical facilities in which Dow Corning performed tests on silicone products. In addition, Dow Chemical rendered certain services to Dow Corning.

Scientists working for Dow Chemical (V.K. Rowe, H.C. Spencer and S.L. Bass) published an article in 1948 stating they had conducted toxicological research on various silicones. Rowe, Spencer and Bass stated they had found that, as a group, silicones have a very low order of toxicity. The article also warned that silicone compounds had certain potential hazards. Specifically, the Dow Chemical scientists stated that some types of silicones caused irritation, inflammation, edema and necrosis, that vapors of volatile silicones caused death in a saturated atmosphere, and that exposure to low vapor concentrations slowed growth in guinea pigs and slightly increased the weight of guinea pig livers and kidneys. The Dow Chemical scientists' article also related that high dosages of some silicone compounds caused spleen enlargement and that most tested silicone compounds caused eye irritation.

Dow Chemical and Dow Corning each performed further toxicological tests on silicone. In 1954, Dow Chemical and Dow Corning jointly commissioned a study of the toxicity of a silica dust Dow Corning was producing. This dust proved useful for coating certain types of paper and had potential applications in the pharmaceutical, cosmetic, paint, varnish, ink, rubber, plastic and adhesive industries. Saranac Lake Laboratories of New York performed the study. Published in 1957, the study concluded, generally, that exposing rats to high levels of silica dust severely damaged their breathing apparatus.

In 1956, M.B. Chenoweth of Dow Chemical's biochemistry department participated with Dow Corning scientists in conducting a study on the migration of silicone compounds when introduced into the bodies of mammals. The study found that a silicone compound later used in breast implants migrated throughout dogs when administered orally and throughout a rat when injected intramuscularly. A follow-up report distributed to both Dow Chemical and Dow Corning indicated that, when absorbed through the skin, small amounts of the same silicone compound reached a rabbit's adrenal glands and kidneys. That same year, Dow Corning commissioned Dow Chemical to study whether silicone fluids can be tolerated when injected intravenously and, if so, in what amount. A Dow Corning researcher advised his Dow Chemical counterpart that "[t]he immediate utility of the answer is not too apparent, but the question has been asked repeatedly and we would like to be in a position to reply with some knowledge." Dow Chemical and Dow Corning cooperated with and funded certain silicone toxicology research conducted by the University of Miami in 1957. One project involved feeding rats six different silicone compounds. In a letter to Dow Corning (copied to a Dow Chemical scientist), the University of Miami stated its experimental results were "negative, or in other words, the feeding of the six Dow-Corning silicones resulted in no harmful or deleterious effects with the following exceptions[:] [p] (a) All six compounds depressed the granulocytic elements of the peripheral (tail) blood of the female rats. (The males were not affected.) [p] (b) The livers of rats fed compound 2-4141 were significantly heavier than the livers of the control rats. [p] (c) The livers of rats fed compound 2-4141 demonstrated fatty infiltration or degeneration."

Liver samples from the rats fed compound 2-4141 were submitted for further analysis to Dow Chemical's biochemical research department. These samples showed some changes in fat composition, and Dow Chemical researchers observed "possibly these globules represent silicone rather than fat." As Dow Chemical concedes, its researchers' follow-up observations were not included in the printed report on the University of Miami study that was sent to Dow Corning.

In 1959, Dow Chemical performed an experimental study for Dow Corning that demonstrated silicones may cause eye irritation. The study's author speculated that such irritation was not caused by chemical reaction to the silicone being tested, but by silicone's tendency to reduce the surface tension of the eyeball.

Responding to inquiries from the medical community about medical application of silicones, Dow Corning in 1959 established a Center for Aid to Medical Research. In 1961, T.D. Cronin, a plastic surgeon from Texas, contacted Dow Corning to discuss using silicones for breast implants. Dow Corning eventually employed Cronin and, in 1962, clinical trials on Dow Corning silicone breast implants commenced.

In 1964, Dow Corning formed a medical products division to market breast implants and other medical devices using silicone technology. Plaintiffs "do not dispute that Dow [Chemical] has never made or sold any silicone gel breast implants." ³ Although after beginning to market breast implants Dow Corning apparently continued to receive some silicone toxicology research from Dow Chemical, Dow Corning's medical products division had its own staff of chemists and toxicity experts. Dow Corning's medical products division has worked with more than 35,000 doctors from all over the world and has developed an extensive medical library.

In 1975, Dow Chemical, Corning and Dow Corning entered into trademark agreements. These agreements recited, inter alia, that Dow Chemical and Corning "have controlled [Dow Corning's] operations, including the quality of its goods and services." Dow Chemical granted Dow Corning the right to use its tradename and trademark; in return Dow Chemical retained the right to inspect Dow Corning's manufacturing processes to assure the quality of its products and to approve or disapprove any products manufactured, distributed or sold under the Dow Chemical trademark.

To date, Dow Corning has developed more than 4,500 different silicone products, including the silicone gel breast implants that are the subject of this litigation.

When in 1964 Dow Corning first began marketing breast implants, the Food and Drug Administration (FDA) did not regulate medical devices. In 1991, Dow Corning submitted to the FDA a 25,000-page application for approval of its silicone breast implants. Dow Corning's application referenced hundreds of tests, including toxicological tests Dow Chemical had performed.

The Court of Appeal succinctly related the procedural history of this case. Starting in the early 1990's, many lawsuits were filed against the manufacturers of silicone breast implants, including Dow Corning. Some of these lawsuits also named as de...