Kealoha v. E.I. du Pont de Nemours and Co., Inc.
| Citation | 82 F.3d 894 |
| Decision Date | 03 May 1996 |
| Docket Number | 94-16405,Nos. 94-15688,s. 94-15688 |
| Parties | , Prod.Liab.Rep. (CCH) P 14,589, 96 Cal. Daily Op. Serv. 3123, 96 Daily Journal D.A.R. 5152 Elysa KEALOHA, Individually and as Next Friend to Gabe Kealoha; Esther Cabalse; Moses Cabalse; Jonnie Cook; David Frederickson; Barbara Hook; Raymond Hook; and Jack Hook, Plaintiffs-Appellants, v. E.I. DU PONT DE NEMOURS AND COMPANY, INC.; Dow Corning Corporation, Defendants-Appellees. Cynthia WOLFE, Individually and as Next Friend to Sarah Straub, Individually and as Next Friend to Matthew Wolfe; Kent Wolfe, Plaintiffs-Appellants, v. VITEK, INC., Defendant, E.I. du Pont de Nemours and Company, Inc., Defendant-Appellee. |
| Court | United States Courts of Appeals. United States Court of Appeals (9th Circuit) |
Alan R. Brayton, Brayton, Gisvold & Harley, Novato, California, for the plaintiffs-appellants.
Edward M. Mansfield, Lewis and Roca, Phoenix, Arizona, for the defendants-appellees.
Appeal from the United States District Court for the District of Hawaii; Harold M. Fong, Chief Judge, Presiding. Nos. CV-92-00282-HMF, CV-93-00072-HMF.
Before: HUG, Chief Judge; THOMPSON, and O'SCANNLAIN, Circuit Judges.
We must decide whether, under Hawaii law, a manufacturer has a duty to warn of danger posed by a material that is later used in a medical implant device.
Elysa Kealoha and the eight other appellants (collectively "Kealoha") appeal the district court's grant of summary judgment in favor of E.I. du Pont de Nemours & Company ("DuPont") in this products liability action arising under diversity jurisdiction. Kealoha sued DuPont as the manufacturer of a raw material (Teflon) 1 used by Vitek, Inc. to produce Proplast, 2 which Vitek in turn used to create jaw implants.
Between 1983 and 1987, oral surgeons used a medical device known as the Vitek Proplast Interpositional TMJ Implant (the "implant") to correct problems in each appellant's temporomandibular joint ("TMJ"). The implant recipients suffered debilitating tissue reactions when the implants fragmented.
The implants were made by Vitek, which also manufactured the Proplast used to produce the implants. Vitek combined polytetrafluoroethylene ("PTFE"; also known as "Teflon"), purchased from DuPont, with other material, such as carbon fibers, to make Proplast. In addition, Vitek used fluorinated ethylene propylene ("FEP") film, which DuPont manufactured and sold under the Teflon trademark to intermediaries who, in turn, sold the material to Vitek. PTFE and FEP are chemically inert materials with numerous industrial applications. Kealoha sued DuPont, alleging that DuPont had a duty to warn them of the danger of deteriorating PTFE in the implants.
The implant was designed and manufactured by Dr. Charles Homsy, who founded the now-bankrupt Vitek in 1969. Homsy worked for DuPont from 1959 to 1966, but he did not work on the medical applications of any DuPont products while he was a DuPont employee. He left DuPont to develop human implants made from Teflon and eventually patented an implant material called Proplast, which was made of a processed form of PTFE. The process of turning PTFE into Proplast included mixing PTFE with carbon fibers and other material; filtering, compressing, and rolling the mixture into a cake; and heating, drying, leaching and redrying the cake. After this process, PTFE constituted approximately ninety percent of Proplast. Vitek fused the FEP film to the Proplast after sanding, heating, and compressing the film.
Vitek purchased the PTFE from DuPont. Because Vitek planned to use PTFE for medical purposes, DuPont required Homsy to sign a letter stating that Vitek assumed full responsibility for any consequences resulting from its use of PTFE. In the letter, DuPont informed Vitek that DuPont had not conducted tests on Teflon's suitability for medical uses and that some studies had concluded that PTFE implants deteriorated dangerously. DuPont referred Vitek to two studies from the 1960s-conducted by Dr. John Charnley and Dr. John Leidholt, respectively-which indicated that pure PTFE was not an acceptable material for hip implants in dogs. Dr. Charnley observed that pure PTFE deteriorated rapidly in the implants. Dr. Leidholt noted that PTFE flaked into particles causing inflammation in the dogs' hips. Homsy signed the waiver and acknowledged the existence of these studies.
In 1983, the FDA granted Vitek permission to market the Proplast TMJ Implant. In making this decision, the FDA considered the studies from the 1960s involving pure PTFE in dog hip implants as well as more recent studies supporting the use of Proplast (of which PTFE was an ingredient) in human implants. Finally, in March 1983, Vitek introduced the implants made of Proplast.
In 1984, a DuPont researcher attended an oral surgeons' conference and completed a memo on the lectures and papers delivered. He noted that at least two speakers warned that Proplast implants, though not the Vitek Proplast TMJ Implant in particular, were problematic because they fragmented and deteriorated.
In January 1991, the FDA removed Proplast implants from the market because of concern over damage attributed to the implants. Hundreds of suits have been filed in both state and federal courts. 3
Kealoha alleged causes of action based on negligence, strict liability, breach of warranty, and misrepresentation. DuPont moved for summary judgment on all counts on the issue of duty, claiming that as a raw material supplier, DuPont owed no duty to Kealoha who was an ultimate consumer of another company's medical device. DuPont contended that it (1) owed no duty, under strict product liability, to assure the safety of Vitek's specialized use of its raw material; and (2) owed no duty because it sold the PTFE to a sophisticated purchaser.
Kealoha argued that DuPont did owe a duty to warn because (1) as a raw material supplier, DuPont was required to warn Vitek and the ultimate consumer of the dangerous applications of its product; (2) Vitek was not a sophisticated purchaser; and (3) DuPont is strictly liable as a trademark licensor of Teflon.
DuPont moved for summary judgment, which was granted. The district court denied Kealoha's motion for reconsideration, and Kealoha timely filed a notice of appeal. 4
As a threshold matter, we address DuPont's argument that Kealoha's state-law claims are preempted by federal law.
DuPont argues that since the Medical Device Amendments of 1976 ("MDA"), 21 U.S.C. §§ 301-392, and their implementing regulations preempt state statutes and common law regulating medical devices, Kealoha's state-law claims for negligence and strict liability are preempted. 5 This argument is without merit.
Three months after the parties filed their briefs, this court expressly held that the MDA Amendments do not preempt a state law action against DuPont for the manufacture of PTFE. Anguiano v. DuPont, 44 F.3d 806, 809-10 (9th Cir.1995); accord LaMontagne v. DuPont, 41 F.3d 846, 853-55 (2d Cir.1994).
As this court concluded in Anguiano:
There is no federal preemption here because the FDA has issued only identification and classification regulations relating to PTFE vitreous carbon material, 21 C.F.R. § 872.3680, mandibular implant facial prosthesis, 21 C.F.R. § 874.3695, and PTFE with carbon fibers composite implant material, 21 C.F.R. § 878.3500. As identification provisions, these regulations do not "relate to the safety or effectiveness of the device," 21 U.S.C. § 360k(a), and so are not specific requirements which preempt state law. "An 'identification provision' in the federal regulations does not act as a specific requirement which would preempt state common law."
44 F.3d at 809-10 (footnote and citations omitted); see also id. at 810 (citations omitted) (as a Class II device, PTFE vitreous carbon material "must carry some specific regulation beyond the identification regulation for preemption to apply").
Accordingly, the MDA Amendments do not preempt Hawaii law regulating the manufacture, sale, and use of PTFE.
Kealoha contends that the district court erred in granting summary judgment for DuPont because there is a genuine issue of material fact as to whether DuPont had a duty to warn Kealoha of dangers posed by the use of Teflon in Vitek's production of the implant devices.
Whether DuPont owed a duty to warn Kealoha is a question of law. Cuba v. Fernandez, 71 Haw. 627, 801 P.2d 1208, 1211 (1990). Under Hawaii strict product liability law, a defendant is only liable if a plaintiff can show "that the seller is engaged in the business of selling the product, that the product contains a defect dangerous to the user or consumer, and that the defect is the cause of the injury." Johnson v. Raybestos-Manhattan, Inc., 69 Haw. 287, 740 P.2d 548, 549 (1987) () (citing Ontai v. Straub Clinic and Hosp., 66 Haw. 237, 659 P.2d 734, 739 (1983)); see In re Hawaii Fed. Asbestos Cases, 960 F.2d 806, 815 (9th Cir.1992). "A product is dangerously defective if it does not meet the reasonable expectations of the ordinary consumer or user as to its safety." Johnson, 740 P.2d at 549 (citing Ontai, 659 P.2d at 739). In a strict product liability case for injuries caused by an inherently unsafe product, "the issue of whether the seller knew or reasonably should have known of the dangers inherent in his or her product is irrelevant to the issue of liability." Id.
Since "it is undisputed that Teflon is safe for multiple industrial uses and there is no evidence that Teflon is an inherently dangerous or unsafe raw material," the district court held that "DuPont cannot be held liable for the use of its safe raw material in a defective end product." Kealoha v. DuPont, 844 F.Supp. 590, 595 (D.Haw.1994). 6
Having determined that DuPont's Teflon itself was not inherently dangerous, the court then considered whether DuPont could nonetheless be held...
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