___________ No. 95-1394

___________ In re: Temporomandibular Joint * (TMJ) Implants Products * Liability Litigation *

__________________________ * * Temporomandibular Joint (TMJ) * Implant Recipients, * Appeal from the United States
* District Court for the Appellants, * District of Minnesota.
* v. * * E.I. Du Pont De Nemours and * Company; American Durafilm * Company, Inc., * * Appellees. *

___________ Submitted: October 19, 1995 Filed: October 4, 1996

___________ Before BOWMAN, HEANEY, and WOLLMAN, Circuit Judges.

___________ BOWMAN, Circuit Judge.

This appeal arises from a multidistrict litigation proceeding , conso lidating approximately 280 products liability actions for pretria l purposes under 28 U.S .C. § 1407 (1994) ("When civil actions involving one or more common questi ons of fact are pending in different districts, such actions may be transferred to any district for c oordinated or consolidated pretrial proceedings."). Temporomandibular Joint Implant Recipient s (Recipients) appeal from

### The Honorable Paul A. Magnuson, Chief Judge, United State s 1 

### District Court for the District of Minnesota. Durafilm merely facilitated the distribution of FEP film to 2 

### purchasers like Vitek who desired to buy less FEP film than Du Pont was willing to sell directly.
-2- the judgment of the District Court, which granted summary judgment i n 1 favor of defendants E.I. Du Pont de Nemours & Company (Du Pont) an d American Durafilm Company, Inc. (Durafilm). In re TMJ Implants Prods

. Liab. Litig. , 872 F. Supp. 1019 (D. Minn. 1995). We affirm.

I.

Plain tiffs-appellants are the recipients of the Proplast TM J Interpositional Implant, a prosthetic device used to correc t temporomandibular joint (TMJ) disorders. The TMJ connects the upper and lower jaw ; it facilitates normal movement of the jawbone. When th e articula ting surface of the jawbone that fits into the TMJ become s diseased, normal mobility can be restored by implanting a prosthetic devic e like the Proplast TMJ Interpositional Implant. The gravamen of th e complaint is that the implants failed, abrading the surrounding bone and causing pain to the Recipients. The implants were invented, designed , tes ted, manufactured, packaged, and sold by Vitek, Inc., a now bankrup t 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) an d fluorinated ethylene propylene film (FEP film). Du Pont manufactured both of thes e materials and sold them under the familiar Teflon trademark

. Durafilm distributed FEP film, but did not manufacture it. PT FE resin and 2 FEP film are chemically inert with a wide variet y of safe industrial uses. PTFE is used to manufacture everything from bearings in jet aircraft t o non-stick

### -3-

surfaces on frying pans. FEP film is used in applications ranging fro m pipe insulation to solar collectors.

In the late 1960s, Dr. Homsy invented the implant biomateria l Prop last while conducting prosthesis research at Methodist Hospital i n Houston, Texas. Proplast is a spongy and highly porous coalesceable gel designed to promote tissue attachment. Dr. Homs y founded Vitek in 1969 to manuf acture and distribute his Proplast prosthetic devices while h e continued his research at Methodist Hospital. To make Proplast, Vite k combine d PTFE resin with carbons and solvents and then subjected thi s mixtur e to an eight-step patented process of heating, compressing, an d drying. The implant itself is formed by molding the Proplast into th e required shape and laminating one side of it with translucent FEP film

. The FEP film layer replaced the meniscus or articulating surface of the TM J and w as designed to protect the underlying Proplast from wear in load

bearing joints like t he TMJ. Surgeons positioned the implant so that the Proplast side would b e anchored eventually by tissue growth while the FEP film side abutted the lower jaw to shield against wear. The chain o f distribut ion for PTFE resin and FEP film thus began with Du Pont o r Dura filmas the initial suppliers, then continued on to Vitek as th e finished product manufacturer, and finally ended with the Recipients as th e ultimate users of the finished product. Each implant, while selling for at least fifty dollars, contained only a few cents' worth of PTFE resin an d FEP film.

When Du Pont learned that Dr. Homsy intended to use its Teflo n products for medical purposes, Du Pont advised the purchasing agent a t Methodist Hospital by a March 13, 1967, letter that its Teflon product s were not made for med ical applications and that Du Pont had not conducted the necessary long-term studies to determine the suitability o f fluorocarbons for medical use. Du Pont's letter also noted severa l publ ished scientific reports indicating that pure Teflon implants wor e badly and had a tendency to disintegrate

### -4-

in load-bearing joints. Consequently, Du Pont required the hospital t o sign a disclaimer, acknowledging Du Pont's warnings and agreeing to use it s
own independent medical and legal judgment as to the safety of Teflon in the implants.

One week later, an agent for Methodist Hospital executed th e disclaimer. Dr. Homsy explained in a separate l etter that he was familiar with the i mplant studies that Du Pont mentioned in its disclaimer; h e characterized Du Pont's references to the medica l literature as "crucially inc omplete." Letter from Charles A. Homsy, Orthopedic Prosthesi s Laboratory, Methodist Hospital, to George A. Wilkins, Du Pont Consultant 1 (Mar. 20, 1967). He distinguished each study and stated that his ow n research and subsequent scientific studies had d iscovered solutions to the problems with earlier Teflon implants. Based on Dr. Homsy's letter and th e 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, an d Cosmetic Act, Pub. L. No. 94-295, 90 Stat. 539, Du Pont advi sed Vitek once again that it did not market surgical grades o f Teflon. In a policy statement sent to Vitek, Du Pont wrote:

Du Pont Teflon® fluorocarbon resins . . . are made fo r industrial purposes only . We conduct such tests as are needed to p rotect the ordinary users of these products but do no t perfor mthe detailed, long-term studies which should be mad e before they are used for medical or surgical purpos es. We make no medical or surgical grades and have not sought or received any rulings from the Federal Food and Drug Administration o r from any governmental ag ency as to the safety or effectiveness of these products for such purposes.

Pe rsons proposing to evaluate or to use these product s for medical or surgical purposes must rely on their own medical and legal judgment without any representation on our part

. Theymust accept full responsibility for all consequences , either direct or

### -5- indirect

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

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

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

Based on years of clinical studies w ith Proplast implants in animals and humans and his extensive experience in the m anufacturing and marketing of prosthetic devices, Dr. Homsy believed that Proplast was an excellent imp lant material. Indeed, two FDA advisory committees stated that "th e safety and effectiven ess of [Proplast] has been established through longterm clinical trials. " 47 Fed. Reg. 2810, 2818 (1982) (to be codified at 21 C.F.R. pt. 878) (p roposed Jan. 19, 1982). The FDA authorized the sale of Propla st TMJ implants in 1983. By the late 1980s, however, it ha d beco me apparent that the FEP film abraded into particles despite th e addi tional precautions Vitek had taken to ensure that this would no t happen. In November 1989, Du Pont informed Vitek and Dr. Homsy that i t would no longer fill Vitek's orders for Teflon because of concerns about lawsuits spawned by the disintegrating implants. In January 1991, the FDA ordere d Proplast implants removed from the market because of thei r fragmentation and irritation to human tissue.

Th e Recipients filed this action against the defendants, assertin g strict liability and negligence claims. In particular, their case i s grounded on two theories of liability: design d efect and failure to warn. The Recipients contend that while FEP film may have many safe industrial applications, it was designed

### On appeal, the Recipients have abandoned all claims relating 3 

### to PTFE resin and instead focus their efforts entirely on FE P film.
The D istrict Court found that PTFE resin and FEP film wer e 4 

### not defective products because "[a] manufacturing defect exist s only where an item is substand ard when compared to other identical units off of the assembly line." In re TMJ Implants Prods. Liab. Liti g. , 872 F. Supp. 1019, 1024 (D. Minn. 1995). The cour t reasoned that because the Recipients made no claim that the PTF E and F EP film "were somehow inferior to the typical PTFE and FE P film," they were not defective products. Id. Although thi s "devia tion from the norm test" may be appropriate for analyzin g claims of manufacturing defect, it is inappropriate to use thi s test in a design defect case, i.e. , where the plaintiff contend s that the entire product line i s defectively designed. Despite the trial court's error, Du Pont s till is entitled to summary judgment once the c orrect test is applied. This Court may "affirm th e district court's judgment on a ny grounds supported by the record." United States v. Lohman , 74 F.3d 863, 866 (8th Cir.), cert. denied , 116 S. Ct. 2549 (1996).
-6- defec tivelyfor its specific use in the implants because it caused th e implants to function in an unreasonab ly dangerous manner. The Recipients 3 also claim that the d efendants breached duties owed to them by failing to

warn of dangers associated with the implants, insisting that the defendant s sho uld have conveyed warnings directly to physicians and patient s concerning the dangers of the implants even though the defendants had no direct role in designing or selling the implants.

The Di strict Court granted summary judgment to the defendants , rejecting the design defect claim as well as the failure to warn claim

. With respe ct to the design defect claim, the court concluded that th e de fendants were entitled to summary judgment because "the undispute d evidence demonstrates that the PTFE and FEP film used in the Vitek TM J Implants were not `defective products.'" In re TMJ Implants , 872 F. Supp. at 1024. With respect to the failure to warn claim, the court held that

4 the defendants were entitled to summary judgment because no duty to warn was owed to the Recip ients under the raw material/component part supplier doctrine. The court proceeded on the premise that the law refuses

### The defendants also argue that they are entitled to summary 5 

### judgment because (1) the Medic al Device Amendments of 1976 preempt state actions against manufacturers of bulk medical supplies; and (2) as a bulk supplier to a me dical products manufacturer, the FDA and Vitek had the duty to develop adequate warnings. We need not and do not consider these arguments because we affirm the summary judgment in favor of the defendants on other grounds.
-7- to hol d suppliers of inherently safe and multi-use raw material s responsible for injuries resulting from a dangerous condition created by a finished product manufacturer. Alternatively, the court held that, even

assu ming that the defendants owed a duty to warn the Recipients, th e defendants had discharged their duty as a matter of law under the bul k supplier/sophisticated purchaser doctrine. The court reasoned that, a s bulk s uppliers to a sophisticated purchaser like Vitek, the defendant s disc harged any duty to warn the Recipients by making sure that Vite k understood the risks of using Teflon materials i n the implants. We affirm the grant of summary judgment to the defendants on both the design defect and failure to warn claims on the basis of the r aw material/component part supplier doctrine. 5

II.

Atransferee court has the authority to enter dispositive order s terminating cases consolidated under 28 U.S.C. § 1407. See In re Donald J. Trump Casino Sec. Litig.--Taj Mahal Litig. , 7 F.3d 357, 367-68 (3d Cir. 1993) (Rule 12(b)(6) order), cert. denied , 510 U.S. 1178 (1994). We revie w de novo the decision to grant summary judgment. Southern Technica l College, Inc. v. Hood , 89 F.3d 1381, 1383 (8th Cir. 1996).

When analyzing questions of federal law, the transferee court should apply the law of the circuit in which it is loca ted. See In re Korean Air Lines Disaster , 829 F .2d 1171, 1176 (D.C. Cir. 1987), aff'd , 490 U.S. 122 (1989). When conside ring questions of state law, however, the transferee court must apply the state law that

### -8-

would have applied to the individual cases had they not been transferred for consolidation. See In re Air Crash Disaster Near Chicago, Ill. , 644 F.2d 594, 610 (7th Cir.) (holding transferee cou rt must apply the "choiceof-law rules of the states where the actions were originally filed"), cert
. denied , 454 U.S. 878 (1981). Products liability claims are, of course , state law tort actions. With approximately 280 cases from across th e nat ion consolidated in this action, we would normally face the dauntin g task of analyzing the law of each state where the actions were originally filed. The parties, however, have conceded on appeal that "the basis of component part liability law is constant in all jurisdictions. " Recipients' Br. at i.

A. Strict Liability Claims

The Restatement (Second) of Torts § 402A (1965) imposes stric t liability on sellers of "unreasonably dangerous" products. A product may be cons idered "unreasonably dangerous" because of (1) a manufacturin g defec t, (2) a design defect, or (3) a failure to warn of dangers in th e product's use. Rynders v. E.I. Du Pont, de Nemours & Co. , 21 F.3d 835, 84 2 (8 th Cir. 1994). As noted above, the Recipients assert that th e defendants' FEP film is unreasonably dangerous u nder the design defect and failure to warn theories.

We first address the design defect c laim. The Recipients argue that the District Court erred in granting summary jud gment against them because they have raised factual issues as to whether FEP film was defectivel y designed. The Recipi ents insist that, even though FEP film has many safe industrial uses and is not inherently dangerous or defective for all uses, the film was defectiv ely designed for its "reasonably foreseeable" use in the implants. Recipients' Br. at 12. In other words, they claim that FEP filmwas designed defectively, not because it malfunctioned, but because when incorporated int o the implants it caused the implants to function in an unreasonably dangerous manner. We

### We believe it makes no difference whether FEP film i s 6 

### characterized as a "component part" or a "raw material." See Bond v. E .I. Du Pont De Nemours & Co. , 868 P.2d 1114, 1118 (Colo. Ct

. App. 1993), cert. denied (Colo. Feb. 28, 1994).
See , e.g. , Jacobs v. E.I. du Pont de Nemours & Co. , 67 F.3d 7 

### 1219, 1241 (6th Cir. 1995); Hoyt v. Vitek, Inc. , 894 P.2d 1225 , 1231 (Or. Ct. App. 1995).
-9- reject this argument because suppliers of inhere ntly safe "component parts

are not responsible for accidents that result when the parts are integrate d into a la rger system that the component part supplier did not design o r build." Sperry v. Bauermeister, Inc. , 4 F.3d 596, 598 (8th Cir. 1993 ) (discus sing a district court's previous application of Missouri law). 6 After carefully reviewing the record, we are con vinced that the undisputed facts show as a matter of law that the defect wa s in the overall design of the implants and not in the FEP film. FEP film is a mere building-block material suitable for many safe uses. The Recip ients' argument boils down to nothing more than the fact that Vitek decided to use what proved to be

an unsuitable material to manufacture its implants. The erroneous an d unfortunate decision to use FEP film in the desi gn of the implant was made by Vitek, however, not by Du Pont or Durafilm. "[A] component par t supplier should not be cast in the role of insurer for any accident that may ar ise after that component part leaves the supplier's hands. " Crossfield v. Quality Control Equip. Co. , 1 F.3d 701, 705 (8th Cir. 1993) (discus sing a district court's previous application of Missouri law)

. Therefore, as courts in other TMJ implant cases already have hel d, we hold 7 that the defendants were entitled to summary jud gment on the design defect claim.

While the law of design defect clear ly extends liability to finished produc t manufacturers like Vitek, it rarely imposes strict liability o n compon ent part suppliers who merely sell their multi-use parts t o manufacturers of finished products. See W. Page Keeton et al., Prosser an d Keeton on the Law of Torts § 100, at 705

### A supplier of component parts may also be held strictl y 8 

### liable if the parts it supplies were specially designed for a particular use, see Fleck v. K DI Sylvan Pools, Inc. , 981 F.2d 107, 118 (3d Cir. 1992) (replacement pool liner in failure to war n case), cert. denied , 507 U.S. 1005 (1993); Maake v. Ross Operating Valve Co. , 717 P.2d 923, 926 ( Ariz. Ct. App. 1985) (valve designed to lim it machine on which it was installed to one cycle for eac h activation in failure to warn case), review denied (Ariz. Apr. 15, 1986); or if the component supplier exercised some control o ver the design of the final product, D eSantis v. Parker Feeders, Inc. , 547 F.2d 357, 361 (7th Cir. 1976) (cattle feeder); Estate of Carey by Carey v. Hy-Temp Mfg., Inc. , 702 F. Supp. 666, 670 (N.D. Ill . 1988) (furnace vent damper); Rourke v. Garza , 530 S.W.2d 794, 801 (Tex. 1975) (leased scaffolding supplied to construction company). I n this case, it is undisputed that FEP film was designed to be useful in a broad, nonparticularized range of applications and that th e defendants did not exercise any control over the design of th e implants.
-10- (5th ed. 1984 & Supp. 1988) (citing cases). The critical inquiry focuses

on deter mining the reason why the component part turned out to b e unsuitable for use inthe finished product. "If the failure was due to a flaw in the component part, then the component part is itself defective an d the cause for the ass embled product being defective." Id. at 705-06. In such cases, the component part maker may be held strictly liable. Apperso n
v. E. I. du Pont de Nemours & Co. , 41 F.3d 1103, 1106 (7th Cir. 1994 ) ("Stri ct liability may extend to manufacturers of component parts fo r injuries caused by design or manufacturing defects in the component part itself.") ; Bond v. E.I. Du Pont De Nemours & Co. , 868 P.2d 1114, 111 9 (Colo. Ct. App. 1993) ("[A] plaintiff must present evidence from which a jurycould find that any `defect' was in the `design' of the componen t part, not the final product."), cert. denied (Colo. Feb. 28, 1994); se e also Klem v. E.I. Du Pont De Nemours Co. , 19 F.3d 997, 1002-03 (5th Cir. 1994). If, on the other hand, the finished product was unreasonabl y

8 dangerous because the component part was unsuited for the particular use that the finished product manufacturer chose to make of it, then the defec t is in the design of t he finished product rather than in the design of the component part. In these cases, it is the finished product

### -11-

manufacturer and not the component part supplier that may be held strictly liable. Sperry , 4 F.3d at 598 (affirming summary judgment for component airlock supplier wher e part was "integrated into a larger [spice milling] system t hat the component part supplier did not design or build") ; Childress v. Gresen Mfg. Co. , 888 F.2d 45, 49 (6th Cir. 1989) (affirming summaryjudgment for component valve supplier where design defect was in the finished log-splitter); see also Lee v. Butcher Boy , 215 Cal. Rptr

. 195, 198-99 (Cal. Ct. App. 1985) (no design defect in component motor ; design de fect was in finished meat grinder); Moor v. Iowa Mfg. Co. , 32 0 N.W.2d 927, 928 (S.D. 1982) (no design defect in component roller; design defect was in finished conveyor). In this case, the undisputed facts show

as a matter of law that the defect was in the overall design of th e implants and not in the design of FEP film. The Recipients simply have fai led to show that the disintegration of the implants was due to an y design def ect in the FEP film itself rather than to Vitek's erroneou s decision to incorpora te what turned out to be an unsuitable material into its implants.

The Recipients argue that our focus should not be "on the genera l

uses of FEP film but rather on the defective nature of FEP film for it s reasonably foreseeabl e use in TMJ implants." Recipients' Reply Br. at 5. We disagree. "While manufacturers of inherently dangerous raw materials will be held liable for injury caused by their product, courts have treate d diff erentlymanufacturers of inherently safe components when the fina l

ass embly, rather than a manufacturing or design defect in the componen t itse lf, renders the component dangerous." Apperson , 41 F.3d at 110 7 (citation omitted). Indeed, "[t]he alleged foreseeability of the risk of the finished product is irrelevant to determining the liability of th e component part manufacturer because imposing such a duty would force the supplier to retain an expert in every finished p roduct manufacturer's line of business and second-guess the finished product manufacturer whenever an y of its employees received any information about any potential

### -12-

problems." Kealoha v. E.I. Du Pont de Nemours & Co. , 844 F. Supp. 590, 59 4 (D. Haw. 1994), aff'd , 82 F.3d 894, 901 (9th Cir. 1996) ("Since th e distri ct court's application of the raw material supplier defense i s reasonable and supported by the record, we hold that the district court di d not err in declining to consider the issue of foreseeability."). Making suppliers of inherently safe raw materials and c omponent parts pay for the mistakes of the finished product manufacturer would not only be unfair, bu t it al so would impose an intolerable burden on the business world , espec iallywhere, as here, the raw material or component part (the FE P film) acco unts for only a few cents' worth of the cost of the entir e finished product (the Proplast TMJ implant). Se e Kealoha , 844 F. Supp. at 595 ("[T]he cost to a manufacturer of an inherently safe raw material to insure against all conceivable misuse of his product would be prohibitivel y expensive."). As another panel of this Court ha s determined in a previous TMJ case, "[i]t wouldbe unreasonable and impractical to place the burden of testi ng and developing all devices that incorporate Teflon as a component on Du Pont." Rynders , 21 F.3d at 842. Suppliers of versatile materials like chains, valves, sand, gravel, etc., cannot be expected to become experts in the infinite number of finished products that migh t
co nceivablyincorporate their multi-use raw materials or components

. Kealoha , 844 F. Supp. at 594 ("[T]here would be no end to potentia l liabilityif every manufacturer of nuts, bolts and screws could be hel d liable wh en their hardware was used in a defective product."). We thu s believe that the Recipients' argument must be rejected.

While the Recipients may allege that FEP film was unreasonabl y dangerous or defective as incorporated in the implant, the Recipients' rea l complaint is that FEP film turned out to be an unsuitable material to use in the implant. Thus , the defect was in the design of the implant rather than in the design of the defendants' Teflon products. If Du Pont ha d designed FEP film

### -13-

differently, it simply would not have been FEP f ilm. As the Fifth Circuit recently noted in another TMJ case:

If Du P ont had designed Teflon otherwise, it would not hav e bee n Teflon. Similarly, if a different product would hav e served more safely in its stead, Dr. Homsy erred by choosin g Teflon for use in TMJ im plants. The design of Teflon was not, in this context, defective. Any fault lay with Homsy' s selection. Teflon therefore is not unreasonably dangerous in design.

Klem , 19 F.3d at 1003; accord Hoyt v. Vitek, Inc. , 894 P.2d 1225, 1231 (Or

. Ct. App. 1995) ("In short, if Teflon were designed differently, it would not have the properties that make it useful in so many applications.") ; Longo v. E.I. Dupont De Nemours & Co. , 632 So. 2d 1193, 1197 (La. Ct. App. ) ("[B]ecause of its unique and peculiar qualities, there appears to be no question but that Teflon could not have been designed with less harmfu l consequences. If so, it would not have been Teflon."), writ denied , 637 So. 2d 464 (La. 1994). There is no allegation that FEP film, in and o f itself, is inherently dangerous. Indeed, the Recipients concede that FEP fil mhas many safe industrial uses. As the Seventh Circuit noted , "Clearly, Teflon is a raw material with many safe uses; it only becam e danger ous when Vitek incorporated it into a highly specialized medica l device, t he Proplast TMJ Implant." Apperson , 41 F.3d at 1106; see als o Jac obs v. E.I. du Pont de Nemours & Co. , 67 F.3d 1219, 1241 (6th Cir

. 1995); Hoyt , 894 P.2d at 1232. In these circums tances, the responsibility to design a safe medi cal device is Vitek's alone because, as the finished product manufacturer, it knew the specific end-use it intended to make of the FEP film and was in a far better position to evaluate the film's safet y for that particular end-use. Summary judgment thus was properly granted for the defendants on the design defect claim.

We nex t turn to the failure to warn claim. The Recipients conten d that the District Court erred in granting summary judgment

### Seve ral courts have reached this conclusion in other TM J 9 

### implant cases. See , e.g. , Kealoha v. E.I. du Pont de Nemours & Co. , 82 F.3d 894, 899-901 (9th Cir. 1996); Jacobs , 67 F.3d a t 1236- 38; Klem v. E.I. Du Pont De Nemours & Co. , 19 F.3d 997, 1003 (5th Cir. 1994); Longo v. E.I. Dupont De Nemours & Co. , 632 So. 2 d 1193, 1197 (L a. Ct. App.), writ denied , 637 So. 2d 464 (La. 1994) ; Westph al v. E.I. du Pont de Nemours & Co. , 531 N.W.2d 386, 39 1 (Wis. Ct. App.), review denied , 537 N.W.2d 571 (Wis. 1995).
-14- to the defendants bec ause there is a genuine issue of material fact as to whether the defendants had a duty to warn them o f the dangers posed by the FEP film in the impla nts. Whether the defendants owed a duty to warn the Recipient s is a question of law. See Schaffer v. A.O. Smith Harvestor e Prods., Inc. , 74 F.3d 722, 729 (6th Cir. 1996). Under the ra w material/component part supplier doctrine, suppliers of inherently safe ra w mate rials have no duty to warn end-users of a finished product abou t dangers posed by the incorporation of the raw materials into tha t product. 9

Afailure to warn claim brought against suppliers of multi-purpos e components is precluded by the same raw material/component part supplier analysis that forecloses design defect claims. For example, in Crossfield

v. Quality Control Equipment Co. , 1 F.3d 701 (applying Missouri law), we held that raw material or component part suppliers have no duty to warn th e ultima te consumer of other companies' finished products if the ra w materials or components have multiple safe uses and are not inherentl y danger ous. Id. at 706. In that case, a supplier sold a chain to a finished product manufacturer who subsequently i ncorporated the chain into

a chi tterlings cleaning machine. Even though the chain itself was no t defective, a worker was severely injured when her hand was caught in the chain-sprocket mechanism of the machine. This Court refused to hold the chain supplier liable, finding "the primary duty [to warn] was owed by the designer of the machine, not the supplier of only one component part, in itself a non-defective element." Id. at 704. We reasoned that th e dangerousness stemmedfrom the overall design of the chitterlings machine as a finished

### -15-

product and not from the chain alone as a mere component part. We placed particular emphasis on the fact that "the chain, standing alone, is not an inherently dangerous product," id. at 703-704, a nd that the chain supplier had no role in designing or building the finished product, id. at 705.

Like th e chain in Crossfield , the defendants' FEP film is safe fo r mul tiple uses. As we already have noted in our discussion of th e Recipi ents' design defect claim, any danger associated with FEP fil m stemmed from Vitek's overall design of the Propl ast implant. FEP film, in and of itself, is not an inherently dangerous product. Moreover, Du Pont exercised no control over the design, testing, or manufacturing of Proplas t
or th e implants. Accordingly, as the manufacturer of a perfectly goo d material that Vitek put to a use for which the material, as we now know,

was unsui ted, Du Pont had no duty to warn the Recipients. "To impos e responsibility on the supplier of [a nondefective component] in the contex t of the larger defectively designed machine system would simply exten d liability t oo far." Id. at 704; see also Childress , 888 F.2d at 4 9 ("[E]xtending the duty to make a product safe to the manufacturer of a non

defective component p art would be tantamount to charging a component part manufac turer with knowledge that is superior to that of the complete d produc t manufacturer."); Bond , 868 P.2d at 1120-21 ("[T]here is littl e social utility in pla cing the burden on a manufacturer of component parts

or supplier of raw materials of guarding against injuries caused by th e final product when the component parts or raw materials themselves were no t
unreas onablydangerous."). As we said in Crossfield , "Mere supplier s cannot be expected to guarantee the safety of other manufacturers ' machinery." 1 F.3d a t 704. Similarly, the defendants, as mere suppliers of FEP film, cannot be expected to guarantee the safety of Vitek's medical devices. We therefore agree with the District Court that the defendants owed no duty to warn the Recipients. Summary judgment thus was properly granted for the defendants on the failure to warn claim.

### -16-

B. Negligence Claims

The Recip ients also argue that the defendants negligently failed to warn them of FEP film 's dangerous propensities when used in the implants. This argument must fail, however, because "the same analysis which leads us to the conclusion that [the defendants] had no duty to warn plaintiffs under a theory of strict liability leads us to c onclude that [they] had no duty to warn under a theory of negligence." Bond , 868 P.2d at 1120; accor d Klem , 1 9 F.3d at 1003 (holding negligence and strict liability claim s "duplicate" each other); Veil v. Vitek, Inc. , 803 F. Supp. 229, 234 (D.N.D

. 1992) ("there is no significant difference between the theories"); see als o Keeton et al., supra , § 99, at 697. Consequently, whether the Recipients frame their argument in terms of negligence or strict liability, the resul t is the same: supplie rs of safe, multi-purpose raw materials have no duty to warn the ultimate consumer of a finished prod uct about dangers that may exist when the raw materials are integrated into the final product.

III.

Th e District Court articulated two additional reasons why Durafil m
was enti tled to prevail on its summary judgment motion. First, a distributor, acting as a mere conduit of a product, is only liable fo r known d angers. See American Law of Products Liability 3d § 5.23, at 4 3 (Matthew J. Canavan, ed. pt. 3, 1994). If a product has at most a latent defe ct, "there is no duty on the distributor to inspect for possibl y inherent defects." Id. at 43-44. Based on these legal principles, th e Dist rict Court concluded that even if it "were to accept Plaintiffs ' argument that DuPont's products were defective, such defect would surely be considered latent." In re TMJ Implants , 872 F. Supp. at 1034. We agre e with this analysis. Consequently, Durafilm had no duty to inspect for and warn of such defects.

### I recognize that the majority is in 1 

### our sister circuits in its expansive application of the component
Thi s t decision. Both , 21 F.3d 835 8th Cir. 1994) and our summary affirmance of Hegna v. E.I DuPont De Nemours & Co. , 825 F. Supp. 880 (D. Minn. 1993) f'd , 27 d 571 (8th Cir. 1994) involved PTFE resin--the Teflon produc that underwent substantial cha nge after leaving DuPont's control-- the TMJ implan Moreover, in Rynders 1 F.3d at 84, and in , summary judgment was premised on D uPont's gs to Vitek, 825 F. Supp. at 884. Our court has no previo usly l manufacturers of component parts. Second, several state statutory schemes explicitly exempt mer distributors from strict liability. , e.g. 106(b) (Supp. 1996) (stating seller not subject to strict liability unless

is also the manufacturer); Mo. Rev. Stat. § 537.762 (1994) (allowin dismissal of seller in products liability defendant). Such statutory exemptions also for gr d actions.

Fo r s affirmed.

I respectfully dissent. The majority expands the component par supplier doctrine to shield from liability knew how their product was going to be used and knew d grave er to the ultimate consumers. I cannot accept such blanke t In this case, I would permit the Recipients' claim s to go to a jury for a determination of what DuPont

### -18-

whe ther it had a duty to prohibit the sale of Teflon for use in huma n implants, or at least to provide adequate warnin gs to Vitek of those known risks.

Underlyin g the component part supplier doctrine is the premise that the manufacturer of a finished product is generally in a better position to detect its potential dangers than the manufacturer of only a part of th e produc t. Certainly, a finished product manufacturer is responsible fo r dangers that result f rom the product design or from the manner in which a component part is integrated into the finished product. As a corollary,

manu facturers of a component part generally will not know about suc h dangers and should no t be required to research every possible application of its nondefective, multi-use product. See Cro ssfield v. Quality Control Equip. Co. , 1 F.3d 701, 705 (8th Cir. 1993) ("[M ]anufacturers of component parts which are not defective standing alone cannot be liable for accident s taking place after the part has been integrated into a larger system which they played no part in building.").

But the f acts of this case place it outside the parameters of th e general component part supplier doctrine. The Recipients have presented evidence sufficient for a jury to find that DuPo nt knew Vitek was going to

use the Teflon in the TMJ implants. There is also evidence that Dupon t knew that Teflon, used in load-bearing human implants, no matter how the implan ts were designed , can disintegrate and cause injury to implan t recipients. DuPont was aware of several studies demonstrating this precis e risk. Moreover, a chemist who worked for DuPont for over thirty year s testified that a known characteristic of all Teflon, including FEP film, is that it severely fragments after constant contact with and pressure fro m sharp edges. (Appellants' App. at 370 (Tab 61) (Dep. of Dr. James Fang).)

### -19- This is not a case, as the majority contends, of an "erroneou s decision to incorporate what turned out to be an unsuitable material. " Maj. Op., supra at 11. Rather, the evidence suggests that DuPont was full y
aware of the serious risk of harm Teflon posed when used in human implants

. To hold DuPont responsible for these known risks would not requir e compon ent part suppliers to research every possible application of it s product ; it recognizes DuPont's actual knowledge, without any furthe r
researc h or speculation. Nor are the Recipients claiming that DuPon t should have designed FEP film differently, as the majority suggests, but that if DuPont knew t he film was inappropriate for use in human implants, it should not have continued to supply the film.

Th ere is significant "social utility" in making DuPont accountabl e for what i t knew and for its failure to prevent harm to the ultimat e
consumers. While Vitek may have been in the better position to evaluate the film's safety for the particular use, DuPont's position may well have been sufficient for it to have known of the harm Teflon posed in the human implants. It is my position that where the component part manufacture r knows th at its product is going to be used in a particular fashion an d knows that, no matter what the design, the product poses a danger to the ultimate consumer, it cannot escape from liability.

A true copy.

Attest:

CLERK, U. S. COURT OF APPEALS, EIGHTH CIRCUIT.