Hoyt v. Vitek, Inc.

• Citation: 134 Or.App. 271,894 P.2d 1225
• Parties: , Prod.Liab.Rep. (CCH) P 14,244 Judy HOYT, Plaintiff, v. VITEK, INC., a Texas Corporation; Novamed, Inc., a Texas Corporation; Charles A. Homsy and John N. Kent, and E.I. du Pont de Nemours and Company, a Delaware Corporation, Defendants. Lisa Kay MORSS and Kenneth Morss, Appellants, v. VITEK, INC., a Texas Corporation; Charles A. Homsy, and Holladay Park Medical Center, an Oregon Corporation, Defendants, E.I. du Pont de Nemours & Co., a Delaware Corporation, Respondent. A8807-03720, A8901-00022; CA A80213 (Control), CA A81272.
• Decision Date: 10 May 1995
• Court: Court of Appeals of Oregon

Page 1225

894 P.2d 1225

134 Or.App. 271, Prod.Liab.Rep. (CCH) P 14,244

Judy HOYT, Plaintiff, v. VITEK, INC., a Texas Corporation; Novamed, Inc., a Texas

Corporation; Charles A. Homsy and John N. Kent,

and E.I. du Pont de Nemours and Company,

a Delaware Corporation, Defendants.

Lisa Kay MORSS and Kenneth Morss, Appellants, v. VITEK, INC., a Texas Corporation; Charles A. Homsy, and Holladay Park Medical Center, an Oregon

Corporation, Defendants,

E.I. du Pont de Nemours & Co., a Delaware Corporation, Respondent.

A8807-03720, A8901-00022; CA A80213 (Control), CA A81272.

Court of Appeals of Oregon.

Argued and Submitted Nov. 23, 1994.

Decided May 10, 1995.

Henry Kantor, Portland, argued the cause for appellants Morss. With him on the briefs were Michael S. Morey and Kantor and Sacks.

Edward M. Mansfield, Phoenix, AZ, and John R. Faust, Jr., Portland, argued the cause for respondent E.I. du Pont de Nemours & Co. With them on the briefs were Barry Fish, Bret A. Maidman and Lewis and Roca, Phoenix, AZ, and Wayne Williamson, Mildred J. Carmack and Schwabe, Williamson & Wyatt, Portland.

Before RIGGS, P.J., ^* and De MUNIZ and LEESON, JJ.

LEESON, Judge.

Plaintiff ¹ brought this product liability action against E.I. du Pont de Nemours and Company (du Pont) for damages allegedly caused by the use of Teflon, which was manufactured and sold by du Pont, in a temporomandibular joint implant designed, manufactured and marketed by Vitek, Inc. (Vitek). ² The trial court granted du Pont's motion for summary judgment on plaintiff's strict liability claim that Teflon is unreasonably dangerous because it was defectively designed and her claims of strict liability and negligence for failure to warn the medical community of risks associated with the use of Teflon in prosthetic implants in load-bearing human joints.

Plaintiff assigns error to the trial court's granting of that motion. We view the evidence and all reasonable inferences in the light most favorable to plaintiff, Seeborg v. General Motors Corporation, 284 Or. 695, 699, 588 P.2d 1100 (1978), and, because du Pont is entitled to judgment as a matter of law, we affirm.

Most of the facts in this case are not disputed. After experiencing problems with her temporomandibular joints (TMJ)--the joint that connects the jaw bone to the skull--plaintiff underwent surgery in March 1986 to have implanted a prosthetic replacement known as the Proplast/Teflon TMJ Interpositional Implant or as the Proplast TMJ Implant. The implanted device gradually fragmented and released particles of Teflon, ³ which caused a giant cell foreign body reaction, resulting in the formation of granulomatous tissue and erosion of the surrounding bone. Plaintiff underwent additional surgeries to remove the fractured implants and to reconstruct her jaw.

The TMJ implant that failed was designed, manufactured and sold by Vitek, a company founded by Dr. Charles Homsy in 1969. Homsy, a chemical engineer with a doctoral degree, was employed from 1959 to 1966 by du Pont, where he worked extensively with Teflon and related products. Homsy was interested in the biomedical uses of Teflon but was unable to interest du Pont in pursuing medical applications, because of du Pont's concerns about profitability and potential products liability. He subsequently accepted a position as director of the Prosthesis Research Laboratory at the Methodist Hospital in Houston, Texas, where he pursued the development of biocompatible Teflon applications.

Du Pont was aware that Homsy was investigating the possible use of Teflon in human joint implants while at Methodist Hospital. When Homsy ordered 60 pounds of PTFE resin in 1967, du Pont wrote to Methodist Hospital's purchasing agent and Homsy, stating:

"Du Pont 'Teflon' is not made for medical use. While we carry out such tests as are needed to protect the ordinary users of our products, we do not perform the detailed long-time studies which should be made before those products are employed for purposes such as in medicine and surgery. Accordingly, we are reluctant to encourage the use of 'Teflon' for surgical purposes."

Du Pont's letter pointed out various studies that identified severe foreign body reactions to synthetic medical implants, especially results reported by Dr. Charnley in 1963 in a letter published in a British medical journal. Charnley had written:

"Surgeons, and especially orthopedic surgeons, should be warned that tissue reactions are likely to follow implantation of polytetrafluoroethylene (P.T.F.E., 'Teflon', 'Fluon') if this material is subjected to abrasion, and that these reactions may not be manifest for two years." The Lancet 1379 (December 28, 1963).

Du Pont required Methodist Hospital to accept the following precondition to sale:

"Since we have no knowledge of the suitability of 'Teflon' for your medical use, and since the contemplated use is one that you propose and has not been recommended by us, it must be understood that you are relying upon your own medical judgment as to its safety and effectiveness. Therefore, we will provide you with * * * 'Teflon' * * * only on the understanding that you assume full responsibility for any consequences which may result directly or indirectly from its use." (Emphasis supplied.)

Homsy responded by letter that he understood du Pont's need to "require disclaimers from medical users," but disputed the cautionary studies cited by du Pont. According to Homsy, those studies were based on an "incomplete understanding of polymer application" and had "produced a literature which unfairly indicts TFE polymer." He ascribed Charnley's research results to the use of pure PTFE for hip protheses. Homsy expressed his intention to engage Charnley in discussion and eventually "to place the medical application of this remarkable material on an unambiguous basis."

Du Pont was aware of other studies that questioned the safety of Teflon implants, such as a 1965 study by Leidholt and Gorman that concluded that Teflon hip joints were unsafe when implanted in dogs. However, du Pont was also aware that such studies were not directly applicable to the evaluation of TMJ implants, because the hip joint bears significantly more weight and because those studies concluded that the lack of success with pure Teflon did not foreclose the possibility of better results from Teflon modified by impregnation with other substances.

Homsy's research into modified Teflon materials led to the invention of Proplast, a porous spongy biomaterial that encourages human tissue ingrowth. Proplast is made by mixing PTFE fiber and resin with either carbon or aluminum oxide and salt and subjecting the mixture to a multi-step manufacturing process of filtering, compressing, rolling, drying, high temperature sintering, leaching and redrying. Although the PTFE remains unchanged chemically, Proplast has very different physical characteristics than pure PTFE. Short of chemical analysis, the two substances appear quite different. Homsy patented both Proplast and the manufacturing process. In 1969, he formed Vitek to manufacture and market Proplast implants.

Extensive studies of Proplast by Vitek researchers demonstrated its apparent reliability. Those studies included a five-year evaluation of implants performed at 12 hospitals, involving about 900 patients. In 1974, Vitek began selling Proplast implant materials commercially in various forms, including blocks, coatings on metal implants and sheets. One form of sheeting, developed by Dr. Kent, a consultant to Vitek and chair of the Oral and Maxillofacial Surgery Department at Louisiana State University, was a lamination of Proplast and FEP film formed by fusing the two substances. Kent's clinical studies and Vitek's load-bearing tests suggested the suitability of the laminated material for TMJ implants.

In May 1977, after passage of the Medical Device Amendments of 1976 (MDA) to the Food, Drug and Cosmetics Act, 21 U.S.C. § 301 et seq., du Pont again wrote to Vitek to reiterate its concerns about medical uses of Teflon. As Vitek's president, Homsy agreed to comply with all federal Food and Drug Administration (FDA) regulations and signed du Pont's disclaimer as a precondition to purchase:

"Du Pont Teflon TM fluorocarbon resins * * * are made for industrial purposes only. We conduct such tests as are needed to protect the ordinary users of these products but do not perform the detailed, long-term studies which should be made before they are used for medical or surgical purposes. We make no medical or surgical grades and have not sought or received any rulings from the Federal Food and Drug Administration or from any governmental agency as to the safety or effectiveness of these products for such purposes.

"Persons proposing to evaluate or to use these products for medical or surgical purposes must rely on their own medical and legal judgment without any representation on our part. They must accept full responsibility for all consequences, either direct or indirect."

Under the statutory scheme of the MDA, the FDA classified Proplast implant material (identified as PTFE with carbon fibers composite implant material) under "Class II." 21 CFR § 878.3500. That classification permits a device to be marketed under the "general controls" applicable to all devices--including registration, labeling, good manufacturing practices and compliance with misbranding provisions--until the FDA establishes specific performance standards for that device. See 21 U.S.C. § 360c, 360d. The FDA noted that it was accepting the recommendations of two panels of experts who believed that "the safety and effectiveness of the material has been established through long-term clinical trials," after reviewing clinical data presented by Homsy and Kent. 47 Fed.Reg. 2818 (1982).

The type of Proplast TMJ implant at issue in this case was developed in 1982. It was composed of the same laminated Proplast/FEP sheeting already available, but...