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.
Nos. 94-15688, 94-16405.
United States Court of Appeals,
Ninth Circuit.
Argued and Submitted Nov. 6, 1995.
Decided May 3, 1996.
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.
O'SCANNLAIN, Circuit Judge:
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.I
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
II
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"), amending 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,
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."
Accordingly, the MDA Amendments do not preempt Hawaii law regulating the manufacture, sale, and use of PTFE.
III
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,
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,
Having determined that DuPont's Teflon itself was not inherently dangerous, the court then considered whether DuPont could nonetheless be held liable as the supplier of a raw material used by another company to produce a defective product. Although the district court acknowledged Hawaii's "tradition of expansive construction of strict product liability claims," see id. at 594 (citing In re Hawaii Fed. Asbestos Cases,
Since this question raises an issue of first impression in Hawaii, the district court properly looked to other jurisdictions to predict how the Hawaii Supreme Court would decide the issue. Id. at 594 & n. 9 (citing Takahashi v. Loomis Armored Car Serv.,
Applying the raw material supplier defense, which has been recognized by a number of courts in product liability cases, the district court held: "A manufacturer of a nondefective component part has no duty to analyze the design and assembly of the completed product of an unrelated manufacturer to determine if the component is made dangerous by the integration into the finished product." Kealoha,
[t]he alleged foreseeability of the risk of the finished product is irrelevant to determining the liability of the component part manufacturer because imposing such a duty would force the supplier to retain an expert in every finished product manufacturer's line of business and second-guess the finished product manufacturer whenever any of its employees received any information about any potential problems.
Kealoha,
In reaching this conclusion, the court rejected Kealoha's claim that a longstanding " 'incestuous, mutually beneficial relationship' " existed between Homsy and DuPont such that DuPont should be held responsible for Homsy's implants. Kealoha,
The district court concluded that "[s]ince PTFE is not inherently dangerous and since there was no special relationship between DuPont and Vitek, there is no legal basis for requiring DuPont to warn the ultimate consumers of the Implant." Id.
By endorsing the raw material supplier defense, the district court placed Hawaii law in line with the law of a growing number of states.7 In Childress v. Gresen Manufacturing Co.,
On appeal, Kealoha argues that the district court erred in exonerating DuPont by recognizing the raw material supplier defense. Kealoha contends that Hawaii negligence law can be invoked to hold DuPont liable for its failure to warn Kealoha of the dangers associated with Vitek's use of Teflon in the implants. Citing In re Hawaii Federal Asbestos Cases,
Kealoha argues that DuPont is liable to Kealoha under Hawaii products liability law because (1) the foreseeability of, and DuPont's actual knowledge of, Vitek's use of DuPont's Teflon in a load-bearing implant gave rise to DuPont's duty to warn Kealoha; and (2) DuPont's disclaimers were not adequate warnings. This argument is without merit.
By properly applying the raw material supplier doctrine as a defense to Kealoha's negligence and strict liability claims, the district court correctly concluded that "the alleged foreseeability of the risk of the finished product is irrelevant to determining the liability of [DuPont]." Kealoha,
IV
After granting summary judgment for DuPont under the court's interpretation of Hawaii strict product liability law, the district court in Kealoha declined to consider additional arguments, including DuPont's claim that the bulk supplier/sophisticated purchaser rule relieved DuPont of any liability. Kealoha,
Under the bulk supplier doctrine, " '[b]ulk suppliers of products to manufacturers, who are sophisticated users, have no duty in negligence, strict liability, or breach of warranty to warn ultimate purchasers of the manufacturer's product.' " In re TMJ Implants,
Kealoha argues that DuPont as a bulk supplier had a duty to warn end users such as Kealoha where the end users were foreseeably endangered by the raw material in the final product. DuPont contends that it sold raw materials in bulk to a sophisticated finished product manufacturer, Vitek, that was (1) aware of the alleged risks of using the raw materials in the human body, (2) under an independent duty to warn, and (3) in a better position to warn.8
Section 388 of the Restatement (Second) of Torts sets forth the basis for the bulk supplier/sophisticated purchaser rule:
One who supplies directly or through a third person a chattel for another to use is subject to liability to those whom the supplier should expect to use the chattel with the consent of the other or to be endangered by its probable use, for physical harm caused by the use of the chattel in the manner for which and by a person for whose use it is supplied, if the supplier
(a) knows or has reason to know that the chattel is or is likely to be dangerous for the use for which it is supplied, and
(b) has no reason to believe that those for whose use the chattel is supplied will realize its dangerous condition, and
(c) fails to exercise reasonable care to inform them of its dangerous condition or of the facts which make it likely to be dangerous.
Notes
Restatement (Second) of Torts § 388 (1965).9 When a manufacturer provides a product to an intermediary who will then sell the product to the ultimate user, the Restatement indicates that the following factors should be considered in determining whether a warning to an intermediary from the manufacturer is sufficient:
(1) the dangerous condition of the product; (2) the purpose for which the product is used; (3) the form of any warnings given; (4) the reliability of the third party as a conduit of necessary information about the product; (5) the magnitude of the risk involved; and (6) the burdens imposed on the supplier by requiring that he directly warn all users.
Smith v. Walter C. Best, Inc.,
After considering these factors, the Wolfe court concluded that DuPont was entitled to summary judgment as a matter of law on Kealoha's duty to warn claim. The court emphasized that (1) Homsy and Vitek "had far greater knowledge, expertise and experience with the use of the implant than DuPont"; (2) Vitek was legally obligated to comply with FDA statutes and regulations warning users of the dangers associated with the implants (21 U.S.C.A. §§ 333, 352(f) (West 1972 & Supp.1995)); and (3) DuPont advised Homsy of the dangers of using Teflon in medical applications and Homsy not only signed DuPont's waiver acknowledging the warning, but also wrote to DuPont indicating that "he was intimately familiar with the medical literature on the use of PTFE in implants." Wolfe, slip op. at 12.
The Wolfe court's conclusions are supported by the record and by decisions of other courts that have applied the bulk supplier doctrine to cases brought against DuPont by recipients of the implants. See In re TMJ Implants,
On appeal, Kealoha argues that the bulk supplier doctrine cannot insulate DuPont from liability because Hawaii would not recognize the doctrine. For support, Kealoha asserts the existence of a trend in the modern tort law of California toward the "determination of liability purely according to fault." Kealoha maintains that "[a]rtificial distinctions among the parties are no longer permitted to exonerate a defendant from liability where the defendant's lack of due care was a proximate cause of the plaintiff's injury." However, Kealoha fails to cite a single case in which California expressly renounces the bulk supplier doctrine.
In fact, in Walker v. Stauffer Chemical Corporation,
Therefore, it was not unreasonable for the district court to conclude that the Hawaii Supreme Court would apply the bulk supplier doctrine in favor of DuPont.
V
Kealoha argues that DuPont is liable for defects in the implants because DuPont permitted Vitek to use DuPont's trademark Teflon in marketing the implants. According to Kealoha, Vitek's use of DuPont's trademark was not " 'fair use' of mere 'descriptive information' " because such use created a likelihood of confusion as to the identity of the manufacturer of the implant. Kealoha,
DuPont contends that Vitek was permitted to use DuPont's trademark to indicate that its products contained DuPont raw materials. Prestonettes, Inc. v. Coty,
Finally, the district court correctly concluded that "[e]ven if plaintiffs could show that Vitek improperly used DuPont's trademark, such improper use, standing alone, could not impose liability on DuPont for plaintiffs' injuries." Id. at 596. It is true that the Restatement (Second) of Torts states that a trademark holder can be held vicariously liable when he "puts out as his own product a chattel manufactured by another." Restatement (Second) of Torts § 400. However, courts have only imposed such liability when the trademark holder either voluntarily licensed its trademark or had significant involvement in the design, manufacture, or distribution of the other company's product. Burkert v. Petrol Plus of Naugatuck,
Since Kealoha can offer no evidence that DuPont voluntarily licensed its trademark to Vitek or that DuPont had significant involvement in the design, manufacture, or distribution of Vitek's implant, the district court did not err in rejecting Kealoha's trademark claim.
VI
For the foregoing reasons, we affirm the district court's grants of summary judgment in both cases in favor of DuPont.
AFFIRMED.
TeflonR is a registered trademark of DuPont.
ProplastR is a registered trademark of Vitek.
More than twenty federal courts have granted summary judgment to DuPont on virtually identical claims involving plaintiffs, in states beyond Hawaii, who received the Vitek implants. See, e.g., Jacobs v. DuPont,
By an order filed December 2, 1994, the Ninth Circuit Appellate Commissioner consolidated the Kealoha appeal with an appeal from the district court's grant of summary judgment for DuPont in Wolfe v. Vitek, No. 93-00072, slip op. (D.Haw. July 18, 1994)
Section 360k(a) of the MDA provides:
[No] State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement -
(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and
(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.
21 U.S.C.A. § 360k(a) (West Supp.1994). Pursuant to its power to promulgate regulations under 21 U.S.C.A. § 371(a) (West 1972), the Food and Drug Administration ("FDA") established that the MDA preempts any state law "which is different from, or in addition to, any requirement applicable to such device under any provision of the act." 21 C.F.R. § 808.1(b).
The record supports the district court's conclusion that Teflon is not dangerously defective. We note that other courts of appeals have affirmed the conclusion that Teflon is not inherently dangerous. See, e.g., Jacobs v. DuPont,
See generally In re Silicone Gel Breast Implants,
Vitek qualifies as a sophisticated purchaser because it is undisputed that Dr. Homsy, Vitek's founder and president, received a doctorate in chemical engineering from M.I.T. and served as the Director of the Prosthesis Research Laboratory at the Methodist Hospital in Houston, where he patented the biomaterial Proplast. He has served on the faculty of the Baylor College of Medicine and he has published more than fifty articles on artificial implants
It should be noted that DuPont contends that § 388 does not apply to claims brought by finished product users against suppliers of raw materials. See Veil v. Vitek, Inc.,