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No. 93-3947
CAROL APPERSON, SANDRA BOTT, DANELLA POLING, et al.,
Plaintiffs-Appellants,
v.
E.I. DU PONT DE NEMOURS & COMPANY,
Defendant-Appellee.
No. 93-3950
JANET STYCK,
Plaintiff-Appellant,
v.
E.I. DU PONT DE NEMOURS & COMPANY,
Defendant-Appellee.
Appeals from the United States District Court for the
Central District of Illinois, Danville Division.
Nos. 92 C 2214 and 91 C 2038--Harold A. Baker, Judge.
ARGUED MAY 18, 1994--DECIDED NOVEMBER 18, 1994
Before SPROUSE,* CUDAHY, and KANNE, Circuit Judges.
CUDAHY, Circuit Judge. The plaintiffs in these
diver-
sity cases brought products liability actions against E.I.
du Pont de Nemours and Company (DuPont) claiming they
were injured by medical prostheses manufactured with
DuPont materials. The district court granted summary
judgment in favor of DuPont, and the plaintiffs' suits were
consolidated on appeal.
I.
After experiencing problems with their temporomandibu-
lar joints (TMJ) (the joint connecting the upper and lower
jaw), the plaintiffs received a medical prosthesis known as
the Proplast TMJ Interpositional Implant. After implanta-
tion, the Proplast TMJ Implants failed, abrading the sur-
rounding bone and triggering immune system reactions.
The plaintiffs were required to undergo further surgery
to remove the implants and, in some cases, to reconstruct
the facial bones.
The Proplast TMJ Implant was designed, manufactured
and sold by Vitek, Inc., a now-bankrupt company founded
by Dr. Charles Homsy, a former DuPont scientist. In the
late 1960s, Homsy developed and patented the biomaterial
"Proplast," a spongy implant material designed to encour-
age tissue ingrowth. Proplast is made by combining car-
bon and soluble ingredients with polytetrafluorethylene
(PTFE, better known by its tradename Teflon), a safe and
inert plastic sold in resin, powder or fiber form. Although
the physical and mechanical properties of Teflon change
during the multi-stage Proplast manufacturing process, its
chemical composition remains the same. The Proplast TMJ
Implant is a pre-formed Proplast device, and received FDA
approval for sale in 1983.
DuPont supplied Vitek with the Teflon for the Proplast
TMJ Implants. DuPont knew that Vitek intended to use
the Teflon to manufacture Proplast TMJ Implants, and at
one point considered entering into a joint marketing agree-
ment with Vitek. DuPont also knew that Teflon implants
had met with mixed success. In particular, published studies
in the 1960s had shown that Teflon tended to abrade when
used in hip implants.
When Vitek first sought to purchase Teflon from DuPont,
DuPont informed Vitek of these studies of hip implants.
DuPont also advised Vitek that its Teflon was industrial
grade and had not been manufactured for medical appli-
cations, and that DuPont had not studied its suitability
for medical use. DuPont conditioned the sale of Teflon on
Vitek's acknowledgement of DuPont's disclaimers and agree-
ment to use its own medical judgment as to the safety of
Teflon in the TMJ Implant. Upon passage of the Medical
Device Amendments of 1976 to the Federal Food, Drug
and Cosmetic Act, 21 U.S.C. sec. 301 et seq., DuPont again
wrote to Vitek, reiterating that Teflon was not manufac-
tured for medical purposes and Vitek would be required
to exercise its own judgment and comply with all FDA
regulations.
The plaintiffs contend that DuPont knew that Teflon was
not appropriate for use in the Proplast TMJ Implant. The
plaintiffs alleged three theories of liability: that DuPont
was strictly liable for selling an unreasonably dangerous
product; that DuPont was strictly liable for failing to warn
both Vitek and the plaintiffs that Teflon was unsuitable
for use as a TMJ Implant; and that DuPont was negligent
in supplying Teflon to Vitek and failing to warn plaintiffs
when it knew that it was unsafe in human implants. DuPont
responded that it owed no duty to the plaintiffs for injury
caused by a specialized end-use of its product; that the
Teflon in Proplast was substantially altered; that DuPont
satisfied any duties since Vitek was a sophisticated pur-
chaser; and that any state claims were preempted by fed-
eral drug laws.
The district court granted summary judgment to DuPont,
finding that it owed no duty of care to the plaintiffs since
"it is simply not responsible for a product that it did not
create." We, of course, review the grant of summary judg-
ment de novo.
II.
Whether DuPont owed a duty to the plaintiffs is a ques-
tion of law. Kirk v. Michael Reese Hospital and Medical
Ctr., 513 N.E.2d 387, 396 (Ill. 1987), cert. denied, 485 U.S.
905 (1988). Illinois follows the Restatement (2d) of Torts
/8 402A (1965), and imposes strict liability on sellers of un-
reasonably dangerous products where the dangerous condi-
tion existed when it left the manufacturer's control. Lamkin
v. Towner, 563 N.E.2d 449, 457 (Ill. 1990); Suvada v. White
Motor Co., 210 N.E.2d 182 (Ill. 1965), overruled on other
grounds, Dixon v. Chicago, 601 N.E.2d 704, 711 (1992).
A product may be considered "unreasonably dangerous"
due to either a design or manufacturing defect, or the
manufacturer's failure to warn of a non-obvious risk. Lam-
kin, 563 N.E.2d at 457. The plaintiffs allege that DuPont's
Teflon was unreasonably dangerous under both theories,
and that DuPont should have refused to sell Teflon to
Vitek.
A.
A design defect will render a product unreasonably
dangerous when the product is "dangerous to an extent
beyond that which would be contemplated by the ordi-
nary consumer who purchases it, with the ordinary knowl-
edge common to the community as to its characteristics."
Lamkin, 563 N.E.2d at 457; Dunham v. Vaughan & Bush-
nell Mfg. Co., 247 N.E.2d 401 (Ill. 1969); see also Todd
v. Societe BIC, 21 F.3d 1402 (7th Cir. 1994) (en banc);
Todd v. Societe BIC, 9 F.3d 1216 (7th Cir. 1993) (en
banc), cert. denied, 115 S. Ct. 359 (1994) (extensive discus-
sions of design defects under Illinois law). Strict liability
may extend to manufacturers of component parts for in-
juries caused by design or manufacturing defects in the
component part itself. Suvada, 210 N.E.2d at 188; Thomas
v. Kaiser Agric. Chemicals, 407 N.E.2d 32 (Ill. 1980). It
will also extend to a manufacturer of an inherently dan-
gerous raw material. Hammond v. North American As-
bestos Corp., 454 N.E.2d 210, 215-16 (Ill. 1983) (raw as-
bestos inherently dangerous). The plaintiffs contend that
Teflon was unreasonably dangerous when used in TMJ
Implants, since the "ordinary" consumer would not expect
Teflon to disintegrate and cause injury.
But the plaintiffs do not contend that Teflon is an inher-
ently dangerous product with no safe applications. Clear-
ly, Teflon is a raw material with many safe uses; it only
became dangerous when Vitek incorporated it into a high-
ly specialized medical device, the Proplast TMJ Implant./1
The drafters of the Restatement took no position on whether
sec. 402A applies in this context, but did offer some commen-
tary:
If, for example, raw coffee beans are sold to a buyer
who roasts and packs them for sale to the ultimate
consumer, it cannot be supposed that the seller will
be relieved of all liability when the raw beans are
contaminated with arsenic, or some other poison. . . .
On the other hand, the manufacturer of pigiron, which
is capable of a wide variety of uses, is not so likely
to be held to strict liability when it turns out to be
unsuitable for the child's tricycle into which it is final-
ly made by a remote buyer. The question is essen-
tially one of whether the responsibility for discovery
and prevention of the dangerous defect is shifted to
the intermediate party who is to make the changes.
Restatement (2d), /8 402A, comment p.
Illinois courts have largely followed the logic of the
Re-
statement. While manufacturers of inherently dangerous
raw materials will be held liable for injury caused by their
product, Hammond, 454 N.E.2d at 215-16, courts have
treated differently manufacturers of inherently safe com-
ponents when the final assembly, rather than a manufac-
turing or design defect in the component itself, renders
the component dangerous. "[S]uch a manufacturer will not
be held liable if the injury resulted from a dangerous con-
dition created by the party who created the final product.
'The obligation that generates the duty to avoid injury
to another which is reasonably foreseeable does not . . .
extend to the anticipation of how manufactured components
not in and of themselves dangerous or defective can be-
come potentially dangerous dependent upon the nature of
their integration into a unit designed, assembled, installed,
and sold by another.' " Woods v. Graham Engineering
Corp., 539 N.E.2d 316, 319 (Ill. App. 1989) (quoting Curry
v. Louis Allis Co., 427 N.E.2d 254 (Ill. App. 1981)); Loos
v. American Energy Savers, Inc., 522 N.E.2d 841, 845
(Ill. App. 1988) ("A component part manufacturer is not
obligated to anticipate how a nondangerous part may be-
come unreasonably dangerous as used in the final assem-
bly."). See also Kokoyachuk v. Aeroquip Corp., 526 N.E.2d
607, 610 (Ill. App. 1988).
The rule is particularly applicable when an inherently
safe raw material is used in the manufacture of a highly
specialized finished product. Illinois adopted the doctrine
of strict products liability to ensure that the loss caused
by unsafe products is borne by those who created the
harm, who derive economic benefits from them, and, im-
portantly, "who are in a position to eliminate the unsafe
character of the product and prevent the loss." Hebel v.
Sherman Equip., 442 N.E.2d 199, 205 (Ill. 1982). A rule
placing liability for a defective product on the manufac-
turer of a specialized end-product, rather than the supplier
of safe raw materials follows from these policies. The man-
ufacturer of a finished product knows the precise use it
intends to make of the raw material or component part,
and is in a far better position than the manufacturer of raw
materials to determine whether it is safe for that purpose.
We believe that, in this case, the Illinois courts would
not place that burden on DuPont. Teflon was a safe, raw
material. DuPont informed Vitek that Teflon was not man-
ufactured and had not been tested for use in medical de-
vices. Although the plaintiffs allege that DuPont was inti-
mately aware of Vitek's plans for developing and marketing
a Proplast TMJ Implant, they have not alleged that DuPont
had any control over the design or composition of the Pro-
plast TMJ Implants, or that there was a manufacturing
defect in the Teflon. "[T]here is a marked difference be-
tween knowing the identity of the equipment into which
a component part will be integrated and anticipating any
hazardous operation by that equipment that might be fa-
cilitated by the addition of the component part." Childress
v. Gresen Mfg. Co., 888 F.2d 45, 49 (6th Cir. 1989). Clearly
Vitek--an FDA-regulated manufacturer of medical devices--
was in a better position than DuPont to determine whether
an inert raw material could be safely implanted in the
human body, it seems clear that Illinois would not hold
DuPont liable for the eventual failure of Teflon in the Pro-
plast TMJ Implant. Cf. Rynders v. E.I. du Pont and de
Nemours & Co., 21 F.3d 835, 842 (8th Cir. 1994) (no liabil-
ity applying sec. 402A).
B.
A product that is not inherently dangerous may be con-
sidered defective if the manufacturer fails to warn of its
non-obvious dangers. A manufacturer need warn only of
dangers of which it knows or should know. Woodill v.
Parke Davis & Co., 402 N.E.2d 194 (Ill. 1980). The plain-
tiffs alleged that DuPont breached its duty by failing to
warn Vitek, physicians and the plaintiffs that Teflon was
unsuitable for use in the Proplast TMJ Implant. Clearly,
DuPont told Vitek everything that it knew: in addition
to the warnings that DuPont had not tested Teflon for
medical use, DuPont pointed Vitek to the studies showing
that Teflon had failed when used in hip implants. The
plaintiffs rely in great part on their expert's affidavit
stating (unsurprisingly) that the hip and jaw implants
could be expected to perform similarly, and thus DuPont
should have discerned from the studies on hip implants
that Teflon was unsuitable for TMJ Implants.
We find that DuPont's warnings to Vitek were sufficient
as a matter of law. DuPont warned Vitek of everything
that it knew; the plaintiffs have put forth no evidence
from which a jury could find that DuPont should have
known anything more. Indeed, when DuPont told Vitek
about the studies on hip implants, Dr. Homsy replied that
he was familiar with those studies, had been in contact
with their author, but believed for numerous reasons that
a Proplast TMJ Implant would function better than the
pure Teflon hip implant. Moreover, a duty to warn arises
only when there is unequal knowledge with respect to the
risk of harm, Smith v. American Motors Sales Corp., 576
N.E.2d 146, 151 (Ill. App. 1991); Collins v. Hyster Co.,
529 N.E.2d 303, 307 (Ill. App. 1988); and while DuPont
had superior knowledge of any of Teflon's hidden dangers,
Vitek clearly had superior knowledge of its suitability for
use in joint implants.
DuPont's duty to warn did not, however, require it to
warn physicians and the plaintiffs. Were Teflon an inher-
ently dangerous raw material, DuPont would have a duty
to warn the plaintiffs, as well as Vitek, of its hazards.
Hammond, 454 N.E.2d at 215-16. But, as a supplier of
raw materials, DuPont cannot warn plaintiffs of dangers
created by the faulty design of a finished product manu-
facturer. "The alleged foreseeability of the risk of the
finished product is irrelevant to determining the liabil-
ity of the component part manufacturer because impos-
ing such a duty forces the supplier to retain an expert
in every finished product manufacturer's line of business."
Kealoha v. E.I. du Pont de Nemours & Co., 844 F. Supp.
590, 594 (D. Haw. 1994). Federal law generally places the
burden of gaining FDA approval for medical devices and
warning labels on the manufacturer of the medical device,
not the manufacturer of the component parts. 21 C.F.R.
secs. 807.20(a), 807.65, 807.81(a); Rynders, 21 F.3d at 842./2
We believe that after DuPont has warned Vitek of any
dangers, and so long as there are no inherent dangers,
Illinois would shift the burden of subsequent warnings to
Vitek.
C.
The plaintiffs also brought causes of action in negligence,
alleging that DuPont was negligent in selling Teflon to
Vitek, and negligent in failing to warn Vitek and the
plaintiffs of Teflon's unsuitability. But the elements of
negligence and of strict liability do not differ in any sense
relevant here. For the same reasons that DuPont is not
strictly liable for the plaintiff's injuries, it was not neg-
ligent in either selling the product or failing to warn the
plaintiffs of the risk of failure in a Proplast TMJ Implant.
The district court's grant of summary judgment is there-
fore AFFIRMED.
FOOTNOTES
*
The Hon. James M. Sprouse, Circuit Judge for the United
States Court of Appeals for the Fourth Circuit, is sitting
by designation.
/1
There is a factual dispute about whether Teflon was
changed significantly in the Proplast manufacturing pro-
cess. If the Teflon underwent significant changes that were
not foreseeable to DuPont, DuPont would not be held liable
to the plaintiffs. Thomas v. Kaiser, 407 N.E.2d at 37
(manufacturer of component part liable only when
assembler makes no substantial change in the part);
Woods v. Graham Engineering Corp., 539 N.E.2d 316,
318-19 (Ill. App. 1989). We do not need to consider
whether the Teflon was significantly altered, since we find
that DuPont had no duty to the plaintiffs even if the
Teflon remained the same.
/2
DuPont argues in support of its judgment below that
the Medical Device Amendments of 1976, 21 U.S.C. sec. 360
et seq., preempt state actions against manufacturers of
bulk medical supplies. 21 U.S.C. sec. 360(k)(a). See LaMon-
tagne v. E.I. du Pont de Nemours & Co., 834 F. Supp.
576, 580-86 (D. Conn. 1993) (thorough discussion of
preemption claim). We do not need to reach that issue
here since we affirm on other grounds.
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WHERE WOULD WE BE TODAY....
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TMJD_SAFE_HAVEN_4_LIFE_ISSUES · TMJ SUPPORT GROUP
This TMJD Support Group is intended to be a Safe Haven and provide a place where people with TMJ pain can come and offer and receive support from people who know what they are going through. This is not a medical group and we do not have medical degrees or medical backgrounds. However, with the variety of members in here, there is bound to be someone who has been there and done that and can answer your questions.
This group is in memory of Debbie Ward whom suffered from TMJD & died of unknown causes.
There are many types of members with TMJD. Some have been treated medically, some treated with various splint therapies and physical therapies as well as some with surgical treatments ranging from Arthroscopy to full jaw joint replacements. Everyone with any degree of TMJD or has a family member that deals with it is welcome to join and offer and receive support that we all so badly need to get through each day with the pain we have to live with.
It is YOUR place to cry, scream or vent on the pain you are dealing with and how it is affecting your life and the lives of your loved ones. The group is MODERATED to avoid the unsolicited advertisements and spam. We are all in pain and do not need to have to deal with that too.
TMJ SURGERY FAMILY!.
A Great Place to Share Information! This site is for sharing and is not a substitute for the advise of your physician/oral surgeon. Please consult with your health care professional.
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