41 F.3d 846 (2nd Cir. 1994), 1907-1909, LaMontagne v. E.I. Du Pont De Nemours & Co., Inc.
|Docket Nº:||1907-1909, Docket 93-9165, 93-9169 and 93-9171.|
|Citation:||41 F.3d 846|
|Party Name:||Annamarie LAMONTAGNE, Doreen A. Festa and Susan B. Pregler, Plaintiffs-Appellants, v. E.I. DU PONT DE NEMOURS & COMPANY, INC., Defendant-Appellee.|
|Case Date:||December 05, 1994|
|Court:||United States Courts of Appeals, Court of Appeals for the Second Circuit|
Argued June 29, 1994.
[Copyrighted Material Omitted]
David A. Reif, New Haven, CT (Elizabeth L. McMahon, Susman, Duffy & Segaloff, P.C., on the brief), for plaintiffs-appellants.
Edward M. Mansfield, Phoenix, AZ (Barry Fish, Bret A. Maidman, Lewis & Roca, Phoenix AZ, Ross F. Schmucki, Wilmington, DE, Harry M. Stokes, Wiggin & Dana, New Haven, CT, on the brief), for defendant-appellee.
Before: KEARSE and ALTIMARI, Circuit Judges, and SEYBERT, District Judge [*].
KEARSE, Circuit Judge:
Plaintiffs Annamarie LaMontagne, Doreen A. Festa, and Susan B. Pregler appeal from a judgment of the United States District Court for the District of Connecticut, Jose A. Cabranes, then-District Judge [**], dismissing their claims seeking damages against defendant E.I. Du Pont De Nemours & Co. ("Du Pont") under the Connecticut Product Liability Act, Conn.Gen.Stat.Ann. Secs. 52-572m et seq. (West 1991) ("CPLA"), on theories of negligence, failure to warn, and breach of implied warranty in connection with plaintiffs' receipt of artificial medical prostheses made by Vitek, Inc. ("Vitek"), using a Du Pont plastic known as "Teflon." The district court granted Du Pont's motion for summary judgment, dismissing plaintiffs' claims principally on the grounds (a) that Du Pont neither knew nor should have known that the device was unreasonably dangerous, and (b) that Du Pont adequately disclaimed any warranty as to the merchantability of Teflon for use in medical implants. On appeal, plaintiffs contend that their failure-to-warn and negligence theories should not have been rejected because there were genuine issues to be tried as to Du Pont's knowledge. Du Pont contends that the district court's rulings in its favor were correct and that the court could properly have granted it summary judgment on other grounds as well, including preemption of the CPLA by the Medical Device Amendments of 1976 to the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. Sec. 301 et seq. (1988 & Supp. V 1993) ("MDA"). For the reasons below, we conclude that the district court correctly ruled as a matter of law that plaintiffs failed to show a duty on the part of Du Pont.
Many of the facts and events are not substantially in dispute. In the late 1960s, the founder of Vitek, a company unrelated to Du Pont except as a customer, developed a material known as "Proplast," one component of which was a form of Teflon. In the 1980s, Vitek fashioned a Proplast implant for the temporomandibular joint ("TMJ") of the human jaw, which connects the upper and lower parts of the jaw. After receiving approval to do so from the United States Food and Drug Administration ("FDA") in 1983, Vitek began to market its Proplast TMJ implant.
In 1985 or 1986, each plaintiff received a Proplast TMJ implant. They subsequently developed health problems that they attribute to those implants. Vitek, after being served with numerous product liability suits related to the Proplast TMJ implants, filed for bankruptcy protection. Plaintiffs brought their lawsuits against Du Pont in state court, alleging principally that Du Pont had been negligent in selling Teflon to Vitek, had failed to issue adequate warnings of the risks associated with the use of Teflon in the Proplast TMJ implants, and had breached implied warranties of merchantability and fitness for a particular use. The state-court suits were removed to federal court, with jurisdiction premised on diversity of citizenship, and were consolidated into the present action.
Following a period of discovery, Du Pont moved for summary judgment, contending principally that plaintiffs' claims were preempted by the MDA. Alternatively Du Pont argued, inter alia, that it had no legal responsibility because (a) Vitek, in creating Proplast, substantially altered Du Pont's Teflon, thereby severing any chain of liability leading to Du Pont, (b) Du Pont, as a bulk supplier of raw material, had no duty to assure the safety of the Proplast TMJ implants or to warn of danger from the use of those implants, and (c) Du Pont neither knew nor reasonably should have known of the hazards in the use of the implants. The record, with permissible inferences drawn in favor of plaintiffs, reveals the following history of the development of Proplast.
Du Pont and Teflon; Vitek and Proplast
For more than 50 years, chemical companies have manufactured plastic materials incorporating polytetrafluoro-ethylene ("PTFE"), which has uses in numerous products ranging from frying pans, to submarine piston rings, to artificial human veins. Du Pont sells its PTFE under the trademark Teflon.
From 1959 to 1966, Dr. Charles Homsy was employed by Du Pont as an engineer and had extensive experience with Teflon and related products. During his tenure, Homsy spent "personal time" investigating the possibility of using certain plastic resins related to Teflon for medical applications and eventually suggested that the Du Pont Plastics Department explore biomedical uses for Teflon. (Homsy Memorandum dated January 3, 1966 re "Orthopedic Prostheses of Polymeric Materials, Especially 'Teflon' Fluorocarbon Resin[:] A Preliminary Venture Proposal.") The Plastics Department promptly rejected Homsy's proposal, concluding that the likely profit was small and was in any event insufficient to justify the risk of major medical liability:
The conclusion we have come to and the conclusion I must now come to is that the Plastics Department has no interest in embarking on a venture to fulfill this need. For one thing, I am sure it could be demonstrated that it would not be a profitable venture for Du Pont. Above all, however, ... we have not been given much encouragement from the Legal Department as to how we would face the consequences of the liability involved in operating in this area. For this reason alone I am not willing to pursue the matter any further.
(O.G. Youngquist Memorandum dated January 7, 1966, re Orthopedic Prostheses of Polymeric Materials.)
Unable to interest Du Pont in pursuing medical applications, Homsy resigned from the company and became Director of the Prosthesis Research Laboratory at The Methodist Hospital ("Hospital") in Houston, Texas, with a view toward investigating the development of plastic materials for use in human implants. As part of his investigations,
Homsy purchased Teflon from Du Pont.
Du Pont was aware that Homsy's purchases of Teflon were linked to his investigations into the possible use of Teflon as a component of human implants. In 1967, having been advised that Homsy would be ordering a total of 60 pounds of Teflon resins, Du Pont wrote to the Hospital's purchasing agent, sending a copy to Homsy, stating in part as follows:
Since the proposed use of these industrial materials is in the medical field, it is necessary for us to write you as follows.
I should point out that 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 these 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 letter dated March 13, 1967 ("Du Pont 1967 Letter"), at 1.) After discussing several studies suggesting that the use of Teflon for medical implants might be hazardous, including a study by British researcher Sir John Charnley published in 1963 in the United Kingdom's leading medical journal, Lancet, the Du Pont 1967 Letter concluded as follows:
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 material that you are ordering and such "Teflon" as you order in the future only on the understanding that you assume full responsibility for any consequences which may result directly or indirectly from its use.
Accordingly, if you are in agreement with the conditions outlined above, will you indicate your acceptance of these conditions by having an authorized representative of your hospital sign and return to us the enclosed copy of this letter.
(Du Pont 1967 Letter at 2.) A Hospital representative signed and returned the letter as requested.
Homsy had previously been aware of the studies discussed in the Du Pont 1967 Letter, and he responded that though he understood Du Pont's need "to require disclaimers from medical users," he believed the existing literature resulted from an "incomplete understanding of polymer applications." (Homsy letter to Du Pont dated March 20, 1967, at 2.) He stated in part that
Charnley's report of tissue reaction from abraded particles of TFE, in the absence of comparative data, should rationally be ascribed to the mechanical form of the material and not to specificity of reaction to TFE polymer (Lancet v. 11, p. 1379-1963). Charnley's use of [pure] TFE for hip prostheses would naturally dispose to abrasive wear of the polymer. He will be here in April for a symposium on the "Painful Hip"; at that time I hope to inquire further on his work.
Research evaluations as to the safety of using Teflon in implants were mixed and undefinitive. At least one study of which Du Pont was aware, in addition to the Charnley study, concluded that artificial hip joints made of Teflon were unsafe when implanted in dogs. Leidholt &...
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