Temporomandibular Joint (TMJ) Implant Recipients v. E.I. Du Pont De Nemours & Co. ( 1996 )

___________
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 judgment of the District Court,1 which granted summary judgment in
favor of defendants E.I. Du Pont de Nemours & Company (Du Pont) and
American Durafilm Company, Inc. (Durafilm). In re TMJ Implants Prods.
Liab. Litig., 872 F. Supp. 1019 (D. Minn. 1995). We affirm.
I.
Plaintiffs-appellants are the recipients of the Proplast TMJ
Interpositional Implant, a prosthetic device used to correct
temporomandibular joint (TMJ) disorders. The TMJ connects the upper and
lower jaw; it facilitates normal movement of the jawbone. When the
articulating surface of the jawbone that fits into the TMJ becomes
diseased, normal mobility can be restored by implanting a prosthetic device
like the Proplast TMJ Interpositional Implant. The gravamen of the
complaint is that the implants failed, abrading the surrounding bone and
causing pain to the Recipients. The implants were invented, designed,
tested, manufactured, packaged, and sold by Vitek, Inc., a now bankrupt
company founded by Dr. Charles Homsy. Du Pont and Durafilm are the named
defendants in this action, however, because they manufactured and supplied
some of the raw materials that were used to construct the implants--
including polytetrafluoroethylene powder and fiber (PTFE resin) and
fluorinated ethylene propylene film (FEP film). Du Pont manufactured both
of these materials and sold them under the familiar Teflon trademark.
Durafilm distributed FEP film, but did not manufacture it.2 PTFE resin and
FEP film are chemically inert with a wide variety of safe industrial uses.
PTFE is used to manufacture everything from bearings in jet aircraft to
non-stick
1
The Honorable Paul A. Magnuson, Chief Judge, United States
District Court for the District of Minnesota.
2
Durafilm merely facilitated the distribution of FEP film to
purchasers like Vitek who desired to buy less FEP film than Du Pont
was willing to sell directly.
-2-
surfaces on frying pans. FEP film is used in applications ranging from
pipe insulation to solar collectors.
In the late 1960s, Dr. Homsy invented the implant biomaterial
Proplast while conducting prosthesis research at Methodist Hospital in
Houston, Texas. Proplast is a spongy and highly porous coalesceable gel
designed to promote tissue attachment. Dr. Homsy founded Vitek in 1969 to
manufacture and distribute his Proplast prosthetic devices while he
continued his research at Methodist Hospital. To make Proplast, Vitek
combined PTFE resin with carbons and solvents and then subjected this
mixture to an eight-step patented process of heating, compressing, and
drying. The implant itself is formed by molding the Proplast into the
required shape and laminating one side of it with translucent FEP film.
The FEP film layer replaced the meniscus or articulating surface of the TMJ
and was designed to protect the underlying Proplast from wear in load-
bearing joints like the TMJ. Surgeons positioned the implant so that the
Proplast side would be anchored eventually by tissue growth while the FEP
film side abutted the lower jaw to shield against wear. The chain of
distribution for PTFE resin and FEP film thus began with Du Pont or
Durafilm as the initial suppliers, then continued on to Vitek as the
finished product manufacturer, and finally ended with the Recipients as the
ultimate users of the finished product. Each implant, while selling for
at least fifty dollars, contained only a few cents' worth of PTFE resin and
FEP film.
When Du Pont learned that Dr. Homsy intended to use its Teflon
products for medical purposes, Du Pont advised the purchasing agent at
Methodist Hospital by a March 13, 1967, letter that its Teflon products
were not made for medical applications and that Du Pont had not conducted
the necessary long-term studies to determine the suitability of
fluorocarbons for medical use. Du Pont's letter also noted several
published scientific reports indicating that pure Teflon implants wore
badly and had a tendency to disintegrate
-3-
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
-4-
indirect. Any data or other information from Du Pont is
supplied in good faith but its applicability in any particular
situation must be determined by the recipient.
Statement of Policy Regarding Medical or Surgical Uses of Plastic Materials
1 (May 13, 1977).
Du Pont required Dr. Homsy to sign this policy statement, which also
included his agreement to use Du Pont's materials in compliance with FDA
regulations and to conduct any clinical tests on humans in accordance with
the federal Food, Drug, and Cosmetic Act.
Based on years of clinical studies with Proplast implants in animals
and humans and his extensive experience in the manufacturing and marketing
of prosthetic devices, Dr. Homsy believed that Proplast was an excellent
implant material. Indeed, two FDA advisory committees stated that "the
safety and effectiveness of [Proplast] has been established through long-
term clinical trials." 47 Fed. Reg. 2810, 2818 (1982) (to be codified at
21 C.F.R. pt. 878) (proposed Jan. 19, 1982). The FDA authorized the sale
of Proplast TMJ implants in 1983. By the late 1980s, however, it had
become apparent that the FEP film abraded into particles despite the
additional precautions Vitek had taken to ensure that this would not
happen. In November 1989, Du Pont informed Vitek and Dr. Homsy that it
would no longer fill Vitek's orders for Teflon because of concerns about
lawsuits spawned by the disintegrating implants. In January 1991, the FDA
ordered Proplast implants removed from the market because of their
fragmentation and irritation to human tissue.
The Recipients filed this action against the defendants, asserting
strict liability and negligence claims. In particular, their case is
grounded on two theories of liability: design defect and failure to warn.
The Recipients contend that while FEP film may have many safe industrial
applications, it was designed
-5-
defectively for its specific use in the implants because it caused the
implants to function in an unreasonably dangerous manner.3 The Recipients
also claim that the defendants breached duties owed to them by failing to
warn of dangers associated with the implants, insisting that the defendants
should have conveyed warnings directly to physicians and patients
concerning the dangers of the implants even though the defendants had no
direct role in designing or selling the implants.
The District Court granted summary judgment to the defendants,
rejecting the design defect claim as well as the failure to warn claim.
With respect to the design defect claim, the court concluded that the
defendants were entitled to summary judgment because "the undisputed
evidence demonstrates that the PTFE and FEP film used in the Vitek TMJ
Implants were not `defective products.'" In re TMJ Implants, 872 F. Supp.
4
at 1024. With respect to the failure to warn claim, the court held that
the defendants were entitled to summary judgment because no duty to warn
was owed to the Recipients under the raw material/component part supplier
doctrine. The court proceeded on the premise that the law refuses
3
On appeal, the Recipients have abandoned all claims relating
to PTFE resin and instead focus their efforts entirely on FEP film.
4
The District Court found that PTFE resin and FEP film were
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-
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
5
The defendants also argue that they are entitled to summary
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.
-7-
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 "choice-
of-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
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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,7 we hold
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
6
We believe it makes no difference whether FEP film is
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).
7
See, e.g., Jacobs v. E.I. du Pont de Nemours & Co., 67 F.3d
1219, 1241 (6th Cir. 1995); Hoyt v. Vitek, Inc., 894 P.2d 1225,
1231 (Or. Ct. App. 1995).
-9-
(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).8 If, on the other hand, the finished product was unreasonably
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
8
A supplier of component parts may also be held strictly
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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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
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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
9
Several courts have reached this conclusion in other TMJ
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).
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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 non-
defective 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.
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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
1
I recognize that the majority is in
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.
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).)
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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.
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