Temporomandibular Joint (TMJ) Implants Products Liability Litigation, In re

• Citation: 97 F.3d 1050
• Decision Date: 29 November 1996
• Docket Number: No. 95-1394,95-1394
• Parties: Prod.Liab.Rep. (CCH) P 14,749 In re TEMPOROMANDIBULAR JOINT (TMJ) IMPLANTS PRODUCTS LIABILITY LITIGATION. TEMPOROMANDIBULAR JOINT (TMJ) IMPLANT RECIPIENTS, Appellants, v. E.I. DU PONT DE NEMOURS AND COMPANY; American Durafilm Company, Inc., Appellees.
• Court: United States Courts of Appeals. United States Court of Appeals (8th Circuit)

Page 1050

97 F.3d 1050

Prod.Liab.Rep. (CCH) P 14,749

In re TEMPOROMANDIBULAR JOINT (TMJ) IMPLANTS PRODUCTS

LIABILITY LITIGATION.

TEMPOROMANDIBULAR JOINT (TMJ) IMPLANT RECIPIENTS, Appellants, v. E.I. DU PONT DE NEMOURS AND COMPANY; American Durafilm

Company, Inc., Appellees.

No. 95-1394.

United States Court of Appeals,

Eighth Circuit.

Submitted Oct. 19, 1995.

Decided Oct. 4, 1996.

Rehearing and Suggestion for Rehearing En Banc Denied Nov.

29, 1996. ^*

H. Blair Hahn, Charleston, SC, argued, for Appellants.

Edward M. Mansfield, Phoenix, AZ, argued (Ross F. Schmucki, William F. Forsyth, Thomas G. Ryan, Joseph P. Sullivan, Fern B. Miller, on the brief), for Appellees.

Before BOWMAN, HEANEY, and WOLLMAN, Circuit Judges.

BOWMAN, Circuit Judge.

This appeal arises from a multidistrict litigation proceeding, consolidating approximately 280 products liability actions for pretrial purposes under 28 U.S.C. § 1407 (1994) ("When civil actions involving one or more common questions of fact are pending in different districts, such actions may be transferred to any district for coordinated or consolidated pretrial proceedings."). Temporomandibular Joint Implant Recipients (Recipients) appeal from the judgment of the District Court, ¹ which granted summary judgment in favor of defendants E.I. Du Pont de Nemours & Company (Du Pont) and American Durafilm Company, Inc. (Durafilm). In re TMJ Implants Prods. Liab. Litig., 872 F.Supp. 1019 (D.Minn.1995). We affirm.

I.

Plaintiffs-appellants are the recipients of the Proplast TMJ Interpositional Implant, a prosthetic device used to correct temporomandibular joint (TMJ) disorders. The TMJ connects the upper and lower jaw; it facilitates normal movement of the jawbone. When the articulating surface of the jawbone that fits into the TMJ becomes diseased, normal mobility can be restored by implanting a prosthetic device like the Proplast TMJ Interpositional Implant. The gravamen of the complaint is that the implants failed, abrading the surrounding bone and causing pain to the Recipients. The implants were invented, designed, tested, manufactured, packaged, and sold by Vitek, Inc., a now bankrupt company founded by Dr. Charles Homsy. Du Pont and Durafilm are the named defendants in this action, however, because they manufactured and supplied some of the raw materials that were used to construct the implants--including polytetrafluoroethylene powder and fiber (PTFE resin) and fluorinated ethylene propylene film (FEP film). Du Pont manufactured both of these materials and sold them under the familiar Teflon trademark. Durafilm distributed FEP film, but did not manufacture it. ² PTFE resin and FEP film are chemically inert with a wide variety of safe industrial uses. PTFE is used to manufacture everything from bearings in jet aircraft to non-stick surfaces on frying pans. FEP film is used in applications ranging from pipe insulation to solar collectors.

In the late 1960s, Dr. Homsy invented the implant biomaterial Proplast while conducting prosthesis research at Methodist Hospital in Houston, Texas. Proplast is a spongy and highly porous coalesceable gel designed to promote tissue attachment. Dr. Homsy founded Vitek in 1969 to manufacture and distribute his Proplast prosthetic devices while he continued his research at Methodist Hospital. To make Proplast, Vitek combined PTFE resin with carbons and solvents and then subjected this mixture to an eight-step patented process of heating, compressing, and drying. The implant itself is formed by molding the Proplast into the required shape and laminating one side of it with translucent FEP film. The FEP film layer replaced the meniscus or articulating surface of the TMJ and was designed to protect the underlying Proplast from wear in load-bearing joints like the TMJ. Surgeons positioned the implant so that the Proplast side would be anchored eventually by tissue growth while the FEP film side abutted the lower jaw to shield against wear. The chain of distribution for PTFE resin and FEP film thus began with Du Pont or Durafilm as the initial suppliers, then continued on to Vitek as the finished product manufacturer, and finally ended with the Recipients as the ultimate users of the finished product. Each implant, while selling for at least fifty dollars, contained only a few cents' worth of PTFE resin and FEP film.

When Du Pont learned that Dr. Homsy intended to use its Teflon products for medical purposes, Du Pont advised the purchasing agent at Methodist Hospital by a March 13, 1967, letter that its Teflon products were not made for medical applications and that Du Pont had not conducted the necessary long-term studies to determine the suitability of fluorocarbons for medical use. Du Pont's letter also noted several published scientific reports indicating that pure Teflon implants wore badly and had a tendency to disintegrate in load-bearing joints. Consequently, Du Pont required the hospital to sign a disclaimer, acknowledging Du Pont's warnings and agreeing to use its own independent medical and legal judgment as to the safety of Teflon in the implants.

One week later, an agent for Methodist Hospital executed the disclaimer. Dr. Homsy explained in a separate letter that he was familiar with the implant studies that Du Pont mentioned in its disclaimer; he characterized Du Pont's references to the medical literature as "crucially incomplete." Letter from Charles A. Homsy, Orthopedic Prosthesis Laboratory, Methodist Hospital, to George A. Wilkins, Du Pont Consultant 1 (Mar. 20, 1967). He distinguished each study and stated that his own research and subsequent scientific studies had discovered solutions to the problems with earlier Teflon implants. Based on Dr. Homsy's letter and the executed disclaimer, Du Pont agreed to fill Methodist Hospital's requests for Teflon.

In 1977, after the passage of the Medical Device Amendments of 1976 to the Food, Drug, and Cosmetic Act, Pub.L. No. 94-295, 90 Stat. 539, Du Pont advised Vitek once again that it did not market surgical grades of Teflon. In a policy statement sent to Vitek, Du Pont wrote:

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. Any data or other information from Du Pont is supplied in good faith but its applicability in any particular situation must be determined by the recipient.

Statement of Policy Regarding Medical or Surgical Uses of Plastic Materials 1 (May 13, 1977).

Du Pont required Dr. Homsy to sign this policy statement, which also included his agreement to use Du Pont's materials in compliance with FDA regulations and to conduct any clinical tests on humans in accordance with the federal Food, Drug, and Cosmetic Act.

Based on years of clinical studies with Proplast implants in animals and humans and his extensive experience in the manufacturing and marketing of prosthetic devices, Dr. Homsy believed that Proplast was an excellent implant material. Indeed, two FDA advisory committees stated that "the safety and effectiveness of [Proplast] has been established through long-term clinical trials." 47 Fed.Reg. 2810, 2818 (1982) (to be codified at 21 C.F.R. pt. 878) (proposed Jan. 19, 1982). The FDA authorized the sale of Proplast TMJ implants in 1983. By the late 1980s, however, it had become apparent that the FEP film abraded into particles despite the additional precautions Vitek had taken to ensure that this would not happen. In November 1989, Du Pont informed Vitek and Dr. Homsy that it would no longer fill Vitek's orders for Teflon because of concerns about lawsuits spawned by the disintegrating implants. In January 1991, the FDA ordered Proplast implants removed from the market because of their fragmentation and irritation to human tissue.

The Recipients filed this action against the defendants, asserting strict liability and negligence claims. In particular, their case is grounded on two theories of liability: design defect and failure to warn. The Recipients contend that while FEP film may have many safe industrial applications, it was designed defectively for its specific use in the implants because it caused the implants to function in an unreasonably dangerous manner. ³ The Recipients also claim that the defendants breached duties owed to them by failing to warn of dangers associated with the implants, insisting that the defendants should have conveyed warnings directly to physicians and patients concerning the dangers of the implants even though the defendants had no direct role in designing or selling the implants.

The District Court granted summary judgment to the defendants, rejecting the design defect claim as well as the failure to warn claim. With respect to the design defect claim, the court concluded that the defendants were entitled to summary judgment because "the undisputed evidence demonstrates that the PTFE and FEP film used in the Vitek TMJ Implants were not 'defective products.' " In re TMJ Implants, 872 F.Supp. at 1024. ⁴ With respect to the failure to warn claim, the court held that the defendants were entitled to summary judgment because no duty to warn was owed to the Recipients under the raw material/component part supplier doctrine. The court proceeded on the premise that the law refuses to hold suppliers of...