Klem v. E.I. DuPont De Nemours Co.

• Court: Court of Appeals for the Fifth Circuit
• Decided: April 18, 1994
• Docket: 93-04626
• Status: Published

Opinion

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,

E.I. DUPONT DE NEMOURS & CO., ET AL., Defendants,

E.I. DUPONT DE NEMOURS & CO.,

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.