Klem v. E.I. DuPont De Nemours Co. ( 1994 )

IN THE UNITED STATES COURT OF APPEALS
FOR THE FIFTH CIRCUIT
Nos. 93-4414 and 93-4626
BARBARA M. KLEM and CALVIN R. KLEM,
Plaintiffs-Appellants,
versus
E.I. DUPONT DE NEMOURS CO.,
Defendant-Appellee.
* * * * * * * * * * * * * * *
MARCIA Y. COPELAND, ET AL.,
Plaintiffs-Appellants,
versus
E.I. DUPONT DE NEMOURS & CO., ET AL.,
Defendants,
E.I. DUPONT DE NEMOURS & CO.,
Defendant-Appellee.
Appeals from the United States District Court
for the Western District of Louisiana
(April 18, 1994)
Before HIGGINBOTHAM, and DUHÉ, Circuit Judges, and LITTLE,*
District Judge.
HIGGINBOTHAM, Circuit Judge:
E.I. DuPont De Nemours & Co. produces a substance called
Teflon. Another company, Vitek, purchased and altered DuPont's
*
District Judge of the Western District of Louisiana,
sitting by designation.
Teflon to create a new, patented material, Proplast, which Vitek
used to make medical implants. DuPont warned Vitek of failed
experiments in the past using Teflon in implants and required Vitek
to take full responsibility for the results of its efforts. Vitek
accepted this responsibility. DuPont had no financial interest in
Vitek.
Plaintiffs sued DuPont, complaining that they received Vitek
implants and suffered injuries from failures of Proplast.
These suits were filed in the state court of Louisiana.
DuPont removed them to the Western District of Louisiana. Federal
jurisdiction rests on diversity of citizenship and Louisiana law
controls. The district court granted summary judgment for DuPont.
Plaintiffs appeal. Applying Louisiana law as it developed prior to
the Louisiana Products Liability Act, we hold that DuPont did not
manufacture an unreasonably dangerous product and that DuPont
fulfilled any duty it may have had to warn of its dangers. DuPont
is not liable for any injuries plaintiffs suffered from Vitek's
implants.
I.
DuPont produces various plastic materials under the trademark
name Teflon, among them polytetrafluoroethylene.1 Teflon is used
in hundreds of products, including nonstick frying pans and support
pads on which buildings and bridges sit. Teflon also serves as an
1
Plaintiffs appeal from a grant of summary judgment, so we
summarize the facts in the light most favorable to them. See
Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 255 (1986).
2
ingredient, sometimes the primary ingredient, in various medical
implant devices.
The success of such implant devices has been mixed. Reports
have long indicated that Teflon may not be a suitable component for
medical implants. Sir John Charnley, an English surgeon who
employed Teflon to replace worn cartilage in the hip joints of
dogs, found that the substance abraded or disintegrated causing
serious harm. He published his conclusions in December 1963. Dr.
John Leidholt, an orthopedic surgeon in Denver, Colorado, undertook
similar experiments with similar results. A representative of
DuPont corresponded with Dr. Leidholt about the doctor's findings
as early as 1966.
An employee of DuPont, Dr. Charles Homsy, wished to develop
implant technology using Teflon as an ingredient. Dr. Homsy asked,
but DuPont declined to participate. Dr. Homsy left DuPont in 1966
to teach at Baylor College of Medicine and Methodist Hospital in
conjunction with its Prosthesis Research Laboratory.
The following year Dr. Homsy sought to purchase Teflon from
DuPont, but DuPont responded that it did not prepare Teflon for
medical purposes. DuPont also insisted that Dr. Homsy exercise
independent judgment regarding any medical uses he might make of
Teflon insisting that Homsy assume full responsibility for the
consequences of such uses. Dr. Homsy responded by explaining his
familiarity with the relevant body of scientific knowledge about
the use of Teflon in implants and signed a letter accepting
3
DuPont's policy. Only then did DuPont sell Teflon to Methodist
Hospital and Dr. Homsy.
By the following year, 1968, Dr. Homsy had developed Proplast,
a material employing Teflon but altering its physical composition.
Dr. Homsy designed his process for making Proplast attempting to
avoid problems of past implants made of Teflon. He obtained a
patent on Proplast and in 1969 founded Vitek for its manufacture.
Vitek undertook extensive testing to evaluate Proplast as a
material for making medical implant devices. These efforts and the
work of another scientist2 indicated that Proplast, and substances
derived from Teflon in general, might prove useful in replacing the
meniscus in the temporomandibular joint (TMJ), a joint in the jaw
in front of the ear. Proplast TMJ implants made by Vitek became
available in 1974.
After passage of the 1976 Medical Device Amendments to the
Food, Drug, and Cosmetic Act of 1938, DuPont contacted Vitek in
1977 iterating that Vitek must render independent judgment as to
the suitability of Teflon as an ingredient in medical devices.
DuPont required assent to this policy and compliance with FDA
statutes and regulations as a condition of its sales of Teflon to
Vitek. Vitek and Dr. Homsy assented and obtained FDA
classification of Proplast. Vitek then obtained FDA permission to
sell its TMJ implant devices.
2
British researcher Dr. H. P. Cook reached this conclusion
in 1972.
4
In the late 1970s, oral surgeons began using Proplast in TMJ
replacements. Responding to this trend, Vitek began to market a
pre-formed TMJ implant in 1983. Persons receiving TMJ implants
made of Vitek's Proplast that contained DuPont's Teflon are now
suing alleging that Proplast abraded in use, causing serious
injury. II. Strict Liability
We must apply Louisiana law governing products liability as
set out in Halphen v. Johns-Manville Sales Corp.3 The Louisiana
legislature overruled an aspect of Halphen in the Louisiana
Products Liability Act.4 The Act did not take effect, however,
until September 1, 1988, and the Louisiana Supreme Court has held
that the Act does not apply retroactively.5 The events relevant to
this dispute occurred before 1988. We look to the case law that
developed before the Act became effective.
A manufacturer is liable to a consumer under Louisiana law if
(1) a condition of its product caused a harm to the consumer; (2)
the condition made the product unreasonably dangerous to normal
use; and (3) the condition existed at the time the product left the
manufacturer's control.6 There are several categories of
unreasonably dangerous products. A product is unreasonably
3
484 So.2d 110 (La. 1986).
4
Gilboy v. American Tobacco Co., 582 So.2d 1263, 1264 (La.
1991).
5
Id.6
Antley v. Yamaha Motor Corp., 539 So.2d 696, 699-700 (La.
App. 3d Cir. 1989) (citing Halphen v. Johns-Manville Sales Corp.,
484 So.2d 110 (La. 1986)).
5
dangerous: (1) if the danger involved in its use outweighs its
utility, it is said to be per se unreasonably dangerous; (2) in
construction or composition, if it contains an unintended
abnormality or condition that renders it more dangerous than it was
designed to be; (3) for lack of warning, if the manufacturer failed
adequately to warn of the dangers that attend its use; or (4) by
design, if safer alternative products were available or the product
could have been designed in a less dangerous manner.7 Plaintiffs
must place Teflon within one of these categories.
A. Unreasonably Dangerous Per se
A product is unreasonably dangerous per se if it does more
harm than good in society. Plaintiffs argue that, in making this
evaluation, we should strike the balance of the harms and benefits
only through their eyes. We have read Louisiana law as rejecting
this approach.8 Louisiana law requires the weighing of costs and
benefits to all consumers of a product, not just to the plaintiffs.
Plaintiffs argue in the alternative that although their suit
is against DuPont, we should gauge the net utility of TMJ implants,
not of the ingredient of the implants that DuPont produced. The
7
Halphen, 484 So.2d at 114-15. These categories overlap.
A product, for example, that is unreasonably dangerous per se--
that is, its danger outweighs its utility--also qualifies as
unreasonably dangerous by design. Id. The four approaches
listed, although they are at times referred to by different
labels under Louisiana law, exhaust the various definitions of
unreasonable dangerousness under Halphen.
8
See Valenti v. Surgiteck-Flash Medical Eng'g Corp., 875
F.2d 466, 467 (5th Cir. 1989) (rejecting analysis of whether
dangers to plaintiff posed by product outweighed utility to
plaintiff).
6
ambit of inquiry into whether a product is dangerous per se
includes all and not a subclass of users.9 Louisiana law not only
refuses to disaggregate different users of a product, it also
declines to disaggregate different uses of an ingredient in a
product.10 We are constrained by Louisiana law not to limit
analysis to costs and benefits of Proplast in TMJ implants. We ask
instead whether Teflon does more harm than good in society.
Plaintiffs understandably do not contend that harm suffered by
users of TMJ implants renders Teflon on the whole a harmful
substance. Given the many productive uses of Teflon, the
conclusion that it is not unreasonably dangerous per se is
inevitable.11
B. Unreasonably Dangerous
In Construction or Composition
A product is unreasonably dangerous in construction or
composition if it contains an unintended abnormality or condition
that renders it more dangerous than it was designed to be.
Plaintiffs do not here allege that DuPont manufactured and sold
Teflon for Vitek's implants that varied from the substance DuPont
intended to produce.
9
See Sharkey v. Sterling Drug, Inc., 600 So.2d 701, 707
(La. App. 1 Cir.), writ denied, 605 So.2d 1100 (La. 1992)
(refusing to limit analysis of utility of aspirin to children
users).
10
See Longo v. E.I. DuPont De Nemours & Co., No. 93-CA-
0756, 1994 La. App. LEXIS 300 at *10 (La. App. 4th Cir. Feb. 18,
1994) (applying law prior to Louisiana Products Liability Act).
11
See id. This method of analysis supports the same
result if one addresses the harms and benefits of a particular
form of Teflon, polytetrafluoroethylene.
7
C. Failure to Warn
Louisiana law requires a manufacturer not only to keep abreast
of scientific developments but also to perform its own tests to
determine that its products are safe.12 The Louisiana Supreme Court
in Halphen cited our opinion in Borel v. Fibreboard Paper Products
Corp.13 In Borel we held:
The manufacturer's status as an expert means that at a
minimum he must keep abreast of scientific knowledge,
discoveries, and advances and is presumed to know what is
imparted thereby. But even more importantly, a
manufacturer has a duty to test and inspect his product.
The extent of research and experiment must be
commensurate with the dangers involved. A product must
not be made available to the public without disclosure of
those dangers that the application of reasonable
foresight would reveal. Nor may a manufacturer rely
unquestioningly on others to sound the hue and cry
concerning danger in its product. Rather, each
manufacturer must bear the burden of showing that its own
conduct was proportionate to the scope of its duty.14
As lofty as this language is, the Louisiana courts have never held
that the manufacturer of a component part of a finished product has
a duty to the ultimate consumer to test the suitability of the
component for its use in the finished product.
We reach now the most difficult question in this case:
Where does the responsibility lie to assess and warn a
consumer of the appropriateness of use of a component or ingredient
in a product? DuPont made an effort to act responsibly. DuPont
12
Halphen, 484 So.2d at 115.
13
493 F.2d 1076 (5th Cir. 1973), cert. denied, 419 U.S.
869 (1974).
14
Id. at 1090 (footnotes and citations omitted).
8
informed Vitek, as DuPont does other potential customers, that
DuPont does not produce a medical grade Teflon and has not
adequately tested the substance for use in medical devices. DuPont
required Vitek to assume responsibility for testing Proplast, the
product Vitek developed from Teflon. Vitek also sought and
received both a patent and FDA approval for Proplast.
Further, DuPont was not involved in the development of
Proplast. Vitek and DuPont were independent companies. DuPont
made no gains from the sale of Vitek's products other than the
price of the Teflon DuPont sold Vitek. This amount was a tiny
percentage of the value of each implant and an even tinier
percentage of DuPont's total sales of Teflon. DuPont exercised no
control over the design, composition, testing, or manufacture of
Proplast or the TMJ implants. Our review of Louisiana law suggests
that DuPont fulfilled any obligation it had to warn of the dangers
of Teflon.
A Louisiana court in Reeves v. Great Atlantic & Pacific Tea
Co.15 held: "The mere supplier of a component part of a finished
product is not liable for damages in tort, absent a showing that
the injury was caused by a defect contained in the component part,
rather than a defect contained in the finished product."16
Expanding on this notion, a Louisiana court in Champion v. Panel
15
370 So.2d 202, 209 (La. App. 3d Cir.), writ denied, 371
So.2d 835 (La. 1979).
16
Reeves, 370 So.2d at 209.
9
Era Mfg. Co.17 addressed the problem of liability that arises when
a product proves to be harmful in its application as a component of
another product. In Champion, insulation material used in chicken
houses caused the houses to erode prematurely. A jury found the
manufacturer of the chicken houses liable for the damage that
resulted but, in a third party action, refused to find the
manufacturers of components in the insulation material liable to
the manufacturer of the chicken houses.18 In affirming the jury
verdict on appeal, the court noted that a finished product
manufacturer has the obligation to ascertain whether a component is
appropriate for its intended use.19
A Louisiana court in Longo v. DuPont recently adopted a
similar approach in assessing the relationship between DuPont,
Vitek, and recipients of Vitek's implants. The court reasoned:
Teflon was a component part of Proplast and therefore
DuPont owed no duty to warn [implant recipients]. Vitek
became the manufacturer. While DuPont may have sold
Teflon to Vitek knowing the possibility existed that
products manufactured with Teflon as a component part
would be used in medical and surgical applications, it
had no control over the design, composition, testing, or
manufacture of Vitek products.20
The court concluded that DuPont had no duty to warn the recipients
of Vitek's implants.21
17
410 So.2d 1230 (La. App. 3d Cir.), writ denied, 414
So.2d 389 (La. 1982).
18
Id. at 1234, 1241.
19
Id. at 1241-42.
20
Longo, 1994 La. App. LEXIS 300 at *13.
21
Id.10
DuPont informed Vitek of danger in using Teflon in implants.
But Vitek went its own way with its own expertise and its own
testing. Vitek altered Teflon, creating a distinct potential
product, Proplast, in an effort to cure the problems scientists
confronted in the past when using Teflon in implants. As we
earlier noted, Vitek also secured FDA approval for the use of
Proplast. Under these circumstances and in light of Longo, we
conclude that DuPont fulfilled any obligation it had to warn of the
dangers of using Teflon in medical implants.
D. Unreasonably Dangerous by Design
A product is unreasonably dangerous by design if it could have
been safer had it been designed differently or if a different
product could have served the same purpose and posed less danger.22
DuPont did not, however, design Teflon for use in medical implants.
To the contrary, DuPont made clear to Dr. Homsy that such use could
be dangerous. Further, DuPont insisted that if Dr. Homsy persisted
in using Teflon in implant devices, he had to do so with his own
research and at his own risk. Dr. Homsy chose to adapt Teflon for
use in implants because he believed the substance held particular
promise. If DuPont 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
22
Halphen, 484 So.2d at 115.
11
context, defective. Any fault lay with Homsy's selection. Teflon
therefore is not unreasonably dangerous in design.23
III. Negligence, Negligence Per Se, Redhibition,
False Representation, and Other Causes of Action
Plaintiffs contend, in the alternative, that DuPont had a duty
to warn, or not to mislead by implication, and that the breach of
that duty sounded in negligence, redhibition, and other areas of
the law. These arguments essentially duplicate plaintiffs' failure
to warn claim under Halphen, and the result is the same. The label
placed on DuPont's activities does not change DuPont's
responsibilities or its fulfillment of them.24 Nor does the fact
that DuPont let it be known that its product, Teflon, was an
ingredient in Vitek's medical implants.25 We conclude that DuPont
met any duty it may have had when it informed Vitek that it did not
make a medical grade Teflon and that it had not tested the
23
See Longo, 1994 La. App. LEXIS 300 at *11-12.
24
The court in Longo, for example, limited DuPont's duty
to warn in strict liability by looking to the obligation of the
manufacturer of a component in redhibition. See Longo, 1994 La.
App. Lexis 300 at *12-13 (relying on Austin's of Monroe, Inc. v.
Brown, 474 So.2d 1383 (La. App. 2d Cir. 1985) ("The manufacturer
of a non-defective, even though substantial, component of a thing
assembled and created by another should not be liable to the
buyer of that thing for redhibitory vices in the assembled and
created thing. In this sense, the assembler or creator of the
thing from component parts effectively becomes the manufacturer
of the thing.")).
25
Chappuis v. Sears Roebuck & Co., 358 So.2d 926 (La.
1978), on which plaintiffs rely, does not hold the contrary.
Chappuis addressed the liability of the manufacturer of a
defective product and of a subsequent party that sold the product
under its own name. Id. at 930. DuPont did not sell Vitek's
product at all, much less under its own name.
12
substance adequately for medical use. As a matter of Louisiana
law, at least as it existed prior to the Louisiana Products
Liability Act, DuPont had no further obligation to warn.
AFFIRMED.
13