___________

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,

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 Honorable Paul A. Magnuson, Chief Judge, United States

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.

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the judgment of the District Court, which granted summary judgment in

1

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. PTFE resin and 2

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
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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 loadbearing 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
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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® 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
-5-

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

to PTFE resin and instead focus their efforts entirely on FEP film.

 The District Court found that PTFE resin and FEP film were

4

not defective products because "[a] manufacturing defect exists

only where an item is substandard when compared to other identical

units off of the assembly line." In re TMJ Implants Prods. Liab.

Litig., 872 F. Supp. 1019, 1024 (D. Minn. 1995). The court

reasoned that because the Recipients made no claim that the PTFE

and FEP film "were somehow inferior to the typical PTFE and FEP

film," they were not defective products. Id. Although this

"deviation from the norm test" may be appropriate for analyzing

claims of manufacturing defect, it is inappropriate to use this

test in a design defect case, i.e., where the plaintiff contends

that the entire product line is defectively designed. Despite the

trial court's error, Du Pont still is entitled to summary judgment

once the correct test is applied. This Court may "affirm the

district court's judgment on any grounds supported by the record."

United States v. Lohman, 74 F.3d 863, 866 (8th Cir.), cert. denied,

116 S. Ct. 2549 (1996).

-6-

defectively for its specific use in the implants because it caused the

implants to function in an unreasonably dangerous manner. The Recipients 3

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. 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 Recipients 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 Medical Device Amendments of 1976 preempt

state actions against manufacturers of bulk medical supplies; and

(2) as a bulk supplier to a medical 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.

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to hold suppliers of inherently safe and multi-use raw materials

responsible for injuries resulting from a dangerous condition created by

a finished product manufacturer. Alternatively, the court held that, even

assuming that the defendants owed a duty to warn the Recipients, the

defendants had discharged their duty as a matter of law under the bulk

supplier/sophisticated purchaser doctrine. The court reasoned that, as

bulk suppliers to a sophisticated purchaser like Vitek, the defendants

discharged any duty to warn the Recipients by making sure that Vitek

understood the risks of using Teflon materials in 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 raw material/component part

supplier doctrine.5

II.

A transferee court has the authority to enter dispositive orders

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 review

de novo the decision to grant summary judgment. Southern Technical

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 located. See In re Korean Air

Lines Disaster, 829 F.2d 1171, 1176 (D.C. Cir. 1987), aff'd, 490 U.S. 122

(1989). When considering 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 court 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 the

nation consolidated in this action, we would normally face the daunting

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 strict

liability on sellers of "unreasonably dangerous" products. A product may

be considered "unreasonably dangerous" because of (1) a manufacturing

defect, (2) a design defect, or (3) a failure to warn of dangers in the

product's use. Rynders v. E.I. Du Pont, de Nemours & Co., 21 F.3d 835, 842

(8th Cir. 1994). As noted above, the Recipients assert that the

defendants' FEP film is unreasonably dangerous under the design defect and

failure to warn theories. 

We first address the design defect claim. The Recipients argue that

the District Court erred in granting summary judgment against them because

they have raised factual issues as to whether FEP film was defectively

designed. The Recipients insist that, even though FEP film has many safe

industrial uses and is not inherently dangerous or defective for all uses,

the film was defectively designed for its "reasonably foreseeable" use in

the implants. Recipients' Br. at 12. In other words, they claim that FEP

film was designed defectively, not because it malfunctioned, but because

when incorporated into the implants it caused the implants to function in

an unreasonably dangerous manner. We
 We believe it makes no difference whether FEP film is

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 inherently safe "component parts

are not responsible for accidents that result when the parts are integrated

into a larger system that the component part supplier did not design or

build." Sperry v. Bauermeister, Inc., 4 F.3d 596, 598 (8th Cir. 1993)

(discussing a district court's previous application of Missouri law).6

After carefully reviewing the record, we are convinced that the undisputed

facts show as a matter of law that the defect was 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 Recipients' 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 and

unfortunate decision to use FEP film in the design of the implant was made

by Vitek, however, not by Du Pont or Durafilm. "[A] component part

supplier should not be cast in the role of insurer for any accident that

may arise after that component part leaves the supplier's hands."

Crossfield v. Quality Control Equip. Co., 1 F.3d 701, 705 (8th Cir. 1993)

(discussing a district court's previous application of Missouri law).

Therefore, as courts in other TMJ implant cases already have held, we hold 7

that the defendants were entitled to summary judgment on the design defect

claim. 

 

While the law of design defect clearly extends liability to finished

product manufacturers like Vitek, it rarely imposes strict liability on

component part suppliers who merely sell their multi-use parts to

manufacturers of finished products. See W. Page Keeton et al., Prosser and

Keeton on the Law of Torts § 100, at 705
 A supplier of component parts may also be held strictly

8

liable if the parts it supplies were specially designed for a

particular use, see Fleck v. KDI Sylvan Pools, Inc., 981 F.2d 107,

118 (3d Cir. 1992) (replacement pool liner in failure to warn

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 limit machine on which it was installed to one cycle for each

activation in failure to warn case), review denied (Ariz. Apr. 15,

1986); or if the component supplier exercised some control over the

design of the final product, DeSantis 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). In

this case, it is undisputed that FEP film was designed to be useful

in a broad, nonparticularized range of applications and that the

defendants did not exercise any control over the design of the

implants.

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(5th ed. 1984 & Supp. 1988) (citing cases). The critical inquiry focuses

on determining the reason why the component part turned out to be

unsuitable for use in the finished product. "If the failure was due to a

flaw in the component part, then the component part is itself defective and

the cause for the assembled product being defective." Id. at 705-06. In

such cases, the component part maker may be held strictly liable. Apperson

v. E. I. du Pont de Nemours & Co., 41 F.3d 1103, 1106 (7th Cir. 1994)

("Strict liability may extend to manufacturers of component parts for

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, 1119

(Colo. Ct. App. 1993) ("[A] plaintiff must present evidence from which a

jury could find that any `defect' was in the `design' of the component

part, not the final product."), cert. denied (Colo. Feb. 28, 1994); see

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 unreasonably

8

dangerous because the component part was unsuited for the particular use

that the finished product manufacturer chose to make of it, then the defect

is in the design of the finished product rather than in the design of the

component part. In these cases, it is the finished product
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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 where part was "integrated into a larger [spice milling]

system that the component part supplier did not design or build");

Childress v. Gresen Mfg. Co., 888 F.2d 45, 49 (6th Cir. 1989) (affirming

summary judgment 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 defect was in finished meat grinder); Moor v. Iowa Mfg. Co., 320

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 the

implants and not in the design of FEP film. The Recipients simply have

failed to show that the disintegration of the implants was due to any

design defect in the FEP film itself rather than to Vitek's erroneous

decision to incorporate what turned out to be an unsuitable material into

its implants.

 

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

uses of FEP film but rather on the defective nature of FEP film for its

reasonably foreseeable 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 treated

differently manufacturers of inherently safe components when the final

assembly, rather than a manufacturing or design defect in the component

itself, renders the component dangerous." Apperson, 41 F.3d at 1107

(citation omitted). Indeed, "[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
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problems." Kealoha v. E.I. Du Pont de Nemours & Co., 844 F. Supp. 590, 594

(D. Haw. 1994), aff'd, 82 F.3d 894, 901 (9th Cir. 1996) ("Since the

district court's application of the raw material supplier defense is

reasonable and supported by the record, we hold that the district court did

not err in declining to consider the issue of foreseeability."). Making

suppliers of inherently safe raw materials and component parts pay for the

mistakes of the finished product manufacturer would not only be unfair, but

it also would impose an intolerable burden on the business world,

especially where, as here, the raw material or component part (the FEP

film) accounts for only a few cents' worth of the cost of the entire

finished product (the Proplast TMJ implant). See 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 prohibitively

expensive."). As another panel of this Court has determined in a previous

TMJ case, "[i]t would be unreasonable and impractical to place the burden

of testing 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 might

conceivably incorporate their multi-use raw materials or components.

Kealoha, 844 F. Supp. at 594 ("[T]here would be no end to potential

liability if every manufacturer of nuts, bolts and screws could be held

liable when their hardware was used in a defective product."). We thus

believe that the Recipients' argument must be rejected.

 

While the Recipients may allege that FEP film was unreasonably

dangerous or defective as incorporated in the implant, the Recipients' real

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 had

designed FEP film
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differently, it simply would not have been FEP film. As the Fifth Circuit

recently noted in another TMJ case: 

If Du Pont had designed Teflon otherwise, it would not have

been Teflon. Similarly, if a different product would have

served more safely in its stead, Dr. Homsy erred by choosing

Teflon for use in TMJ implants. 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 harmful

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 of

itself, is inherently dangerous. Indeed, the Recipients concede that FEP

film has many safe industrial uses. As the Seventh Circuit noted,

"Clearly, Teflon is a raw material with many safe uses; it only became

dangerous when Vitek incorporated it into a highly specialized medical

device, the Proplast TMJ Implant." Apperson, 41 F.3d at 1106; see also

Jacobs v. E.I. du Pont de Nemours & Co., 67 F.3d 1219, 1241 (6th Cir.

1995); Hoyt, 894 P.2d at 1232. In these circumstances, the responsibility

to design a safe medical 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 safety

for that particular end-use. Summary judgment thus was properly granted

for the defendants on the design defect claim.

We next turn to the failure to warn claim. The Recipients contend

that the District Court erred in granting summary judgment
 Several courts have reached this conclusion in other TMJ

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 at 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. 2d 1193,

1197 (La. Ct. App.), writ denied, 637 So. 2d 464 (La. 1994);

Westphal v. E.I. du Pont de Nemours & Co., 531 N.W.2d 386, 391

(Wis. Ct. App.), review denied, 537 N.W.2d 571 (Wis. 1995).

-14-

to the defendants because there is a genuine issue of material fact as to

whether the defendants had a duty to warn them of the dangers posed by the

FEP film in the implants. Whether the defendants owed a duty to warn the

Recipients is a question of law. See Schaffer v. A.O. Smith Harvestore

Prods., Inc., 74 F.3d 722, 729 (6th Cir. 1996). Under the raw

material/component part supplier doctrine, suppliers of inherently safe raw

materials have no duty to warn end-users of a finished product about

dangers posed by the incorporation of the raw materials into that product.9

A failure to warn claim brought against suppliers of multi-purpose

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 the

ultimate consumer of other companies' finished products if the raw

materials or components have multiple safe uses and are not inherently

dangerous. Id. at 706. In that case, a supplier sold a chain to a

finished product manufacturer who subsequently incorporated the chain into

a chitterlings cleaning machine. Even though the chain itself was not

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 the

dangerousness stemmed from 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, and that the chain supplier

had no role in designing or building the finished product, id. at 705. 

Like the chain in Crossfield, the defendants' FEP film is safe for

multiple uses. As we already have noted in our discussion of the

Recipients' design defect claim, any danger associated with FEP film

stemmed from Vitek's overall design of the Proplast 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 Proplast

or the implants. Accordingly, as the manufacturer of a perfectly good

material that Vitek put to a use for which the material, as we now know,

was unsuited, Du Pont had no duty to warn the Recipients. "To impose

responsibility on the supplier of [a nondefective component] in the context

of the larger defectively designed machine system would simply extend

liability too far." Id. at 704; see also Childress, 888 F.2d at 49

("[E]xtending the duty to make a product safe to the manufacturer of a nondefective component part would be tantamount to charging a component part

manufacturer with knowledge that is superior to that of the completed

product manufacturer."); Bond, 868 P.2d at 1120-21 ("[T]here is little

social utility in placing the burden on a manufacturer of component parts

or supplier of raw materials of guarding against injuries caused by the

final product when the component parts or raw materials themselves were not

unreasonably dangerous."). As we said in Crossfield, "Mere suppliers

cannot be expected to guarantee the safety of other manufacturers'

machinery." 1 F.3d at 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.
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B. Negligence Claims

The Recipients 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 conclude that [they] had no

duty to warn under a theory of negligence." Bond, 868 P.2d at 1120; accord

Klem, 19 F.3d at 1003 (holding negligence and strict liability claims

"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 also

Keeton et al., supra, § 99, at 697. Consequently, whether the Recipients

frame their argument in terms of negligence or strict liability, the result

is the same: suppliers of safe, multi-purpose raw materials have no duty

to warn the ultimate consumer of a finished product about dangers that may

exist when the raw materials are integrated into the final product.

III. 

The District Court articulated two additional reasons why Durafilm

was entitled to prevail on its summary judgment motion. First, a

distributor, acting as a mere conduit of a product, is only liable for

known dangers. See American Law of Products Liability 3d § 5.23, at 43

(Matthew J. Canavan, ed. pt. 3, 1994). If a product has at most a latent

defect, "there is no duty on the distributor to inspect for possibly

inherent defects." Id. at 43-44. Based on these legal principles, the

District 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 agree

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

This 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 change after leaving DuPont's control--

the TMJ

implan Moreover, in Rynders 1

F.3d at 84, and in , summary judgment was premised on DuPont's

gs to Vitek, 825 F. Supp. at 884. Our court has no

previously 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.

For 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 blanket

 In this case, I would permit

the Recipients' claims to go to a jury for a determination of what DuPont
-18-

whether it had a duty to prohibit the sale of Teflon for use in human

implants, or at least to provide adequate warnings to Vitek of those known

risks. 

Underlying 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 the

product. Certainly, a finished product manufacturer is responsible for

dangers that result from the product design or from the manner in which a

component part is integrated into the finished product. As a corollary,

manufacturers of a component part generally will not know about such

dangers and should not be required to research every possible application

of its nondefective, multi-use product. See Crossfield 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 accidents

taking place after the part has been integrated into a larger system which

they played no part in building."). 

But the facts of this case place it outside the parameters of the

general component part supplier doctrine. The Recipients have presented

evidence sufficient for a jury to find that DuPont knew Vitek was going to

use the Teflon in the TMJ implants. There is also evidence that Dupont

knew that Teflon, used in load-bearing human implants, no matter how the

implants were designed, can disintegrate and cause injury to implant

recipients. DuPont was aware of several studies demonstrating this precise

risk. Moreover, a chemist who worked for DuPont for over thirty years

testified that a known characteristic of all Teflon, including FEP film,

is that it severely fragments after constant contact with and pressure from

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 "erroneous

decision to incorporate what turned out to be an unsuitable material."

Maj. Op., supra at 11. Rather, the evidence suggests that DuPont was fully

aware of the serious risk of harm Teflon posed when used in human implants.

To hold DuPont responsible for these known risks would not require

component part suppliers to research every possible application of its

product; it recognizes DuPont's actual knowledge, without any further

research or speculation. Nor are the Recipients claiming that DuPont

should have designed FEP film differently, as the majority suggests, but

that if DuPont knew the film was inappropriate for use in human implants,

it should not have continued to supply the film.

There is significant "social utility" in making DuPont accountable

for what it knew and for its failure to prevent harm to the ultimate

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 manufacturer

knows that its product is going to be used in a particular fashion and

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.