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Temporomandibular Joint (TMJ) Implant Recipients v. E.I. Du Pont De Nemours & Co.
97 F.3d 1050
8th Cir.
1996
Check Treatment

*1 that agreement conclude the settlement did

not relieve responsi- defendants criminal In re TEMPOROMANDIBULAR JOINT bility (TMJ) for their actions. in the Nowhere IMPLANTS PRODUCT . agreement S parties did crimes, the mention LIABILITY LITIGATION actions, prosecution, criminal or similar con- (TMJ) TEMPOROMANDIBULAR JOINT Indeed, cepts. only language the in the RECIPIENTS, IMPLANT agreement on which possibly defendants can Appellants, hope rely is the catch-all “any release of statutory all or common law of ac- causes E.I. DU PONT DE general tion.” Yet this AND language NEMOURS is necessar- COMPANY; ily American qualified by Durafilm specific language which Company, Inc., Appellees. precedes it, unless there is evidence of what parties actually by general intended No. 95-1394. language. See United States v. Mexico Feed United States Court of Appeals, & Seed 485 n. 6 Eighth Circuit. Cir.1992). Each of the specifically claims Submitted Oct. 1995. parties claim, released is a civil includ- contract, ing tort, warranty, defamation, con- Oct. Decided tribution, and similar claims. Nothing in the Rehearing Suggestion Rehearing record contrary; is to the defendants did not En Banc Denied Nov. 1996.* allege in their motions before the Dis- trict Court they subjectively believed negotiating non-prosecu- for a

tion agreement. Because the contractual is

language reasonably susceptible of the

meaning proposed defendants, we con-

clude that agreement the settlement is unam-

biguous. See John Morrell &

at 551. The agreement settlement poses no present prosecution.

obstacle

VII.

The judgment of the District Court is re-

versed, and the ease remanded

District Court for reinstatement of the indict-

ment. nary principles contract in that case drafted, was "tem- agreement jointly party neither

pered by implications plea constitutional of a should receive ambiguity. benefit of agreement.” Id. at 351. No such constitutional point case; is moot in this as discussed in the significance present civil action involved opinion, text of this we hold that the settlement here, and we ordinary conclude principles agreement unambiguous. interpretation apply. particular, contract In be- * cause the record reflects that Judge settlement grant McMillian would suggestion. *2 districts,

different such actions transferred to district for coordinated or pretrial consolidated proceedings.”). Temporomandibular Implant Joint Recipi (Recipients) ents appeal judgment from the *3 Court,1 of the District granted which sum mary judgment in favor of defendants E.I. (Du Pont) Du Pont de Company Nemours & (Du and American Company, Durafilm Inc. rafilm). Implants In re TMJ Prods. Liab. (D.Minn.1995). Litig., affirm.

I. Plaintiffs-appellants recipients are the Proplast Interpositional Implant, TMJ a prosthetic device used to temporo- correct (TMJ) joint mandibular disorders. The TMJ upper jaw; connects the and lower it facili- tates jawbone. normal movement of the When jawbone the articulating surface of the that fits diseased, into the TMJ becomes mobility normal by can implant- be restored ing prosthetic device Proplast like the TMJ Interpositional Implant. gravamen The complaint implants failed, abrading surrounding causing bone and pain to Recipients. implants The invented, designed, tested, manufactured, packaged, Vitek, Inc., and sold a now Hahn, Charleston, H. Blair SC, argued, for bankrupt company founded Dr. Charles Appellants. Homsy. Du Pont and Durafilm are the Mansfield, Phoenix, Edward M. AZ, ar- action, named however, defendants in this (Ross gued Schmucki, F. Forsyth, William F. because supplied manufactured and Ryan, Joseph Sullivan, Thomas G. P. Fem B. some of the raw materials were used to Miller, brief), Appellees. on the construct the implants including polytetra- — (PTFE fluoroethylene powder and fiber res- BOWMAN, HEANEY, Before and in) ethylene and fiuorinated propylene film WOLLMAN, Judges. Circuit (FEP film). Du Pont manufactured both of these materials and sold them under the BOWMAN, Judge. Circuit familiar Teflon trademark. Durafilm distrib- appeal film, This arises from uted multidistrict liti- but did manufacture it.2 gation proceeding, PTFE consolidating approxi- resin and FEP film chemically are mately products liability pre- actions for inert with a variety wide of safe industrial purposes trial (1994) § under 28 U.S.C. uses. PTFE is used to every- manufacture (‘When civil involving actions thing one or bearings jet more from aircraft to non- questions common pending fact are stick frying pans. surfaces on FEP film is Magnuson, Judge, Honorable A. merely Paul Chief 2. Durafilm facilitated the distribution of purchasers United States FEP film to District Court for the like Vitek District who desired to buy less FEP willing film Du Pont Minnesota. than directly. sell safety judgment as to the legal medical pipe insula- ranging from applications used implants. Teflon collectors. to solar tion later, agent for Methodist an One 1960s, Homsy invented the week Dr. the late In Dr. Hom- Hospital executed the disclaimer. Proplast while conduct- implant biomaterial that he was explained separate in a letter Hospi- sy at Methodist research ing prosthesis that Du implant studies familiar with Houston, Proplast spongy Texas. tal in disclaimer; he charac- in its designed Pont mentioned gel porous coalesceable highly to the medical Homsy Du Pont’s references terized Dr. attachment. tissue to promote “crueiaUy incomplete.” Letter literature as to manufacture Vitek founded Homsy, Orthopedic Prosthe- A. from Charles devices Proplast prosthetic his distribute Hospital, Laboratory, Methodist sis at Methodist *4 research his he continued while Wilkins, Du Pont Consultant George A. Proplast, Vitek combined make Hospital. To (Mar. 20,1967). study distinguished each He and and solvents with carbons PTFE resin and subse- own and stated that his research eight-step to an subjected this mixture then discovered solu- quent scientific studies had heating, compressing, of process patented earlier Teflon problems with by tions to the formed itself is drying. implant and Homey’s and Dr. letter implants. Based on shape required Proplast into the molding the disclaimer, agreed Pont to Du the executed of it with translucent laminating one side and Hospital’s requests Teflon. fiE the Methodist layer replaced film FEP film. The FEP of the TMJ articulating surface or meniscus the Medical passage In after the underlying protect the designed to was and Food, to the Amendments Device joints load-bearing like from wear in Proplast 94-295, Act, No. Drug, Pub.L. Cosmetic and implant positioned the Surgeons TMJ. the once Vitek Du Pont advised 90 Stat. be anchored Proplast side would the so that grades surgical it again that did market FEP growth while the eventually by tissue sent to pohcy In a statement of Teflon. jaw to shield the lower side abutted film Pont wrote: Du of distribution The chain against wear. began film thus with resin and PTFE resins Teflon® fluorocarbon Du Pont initial suppliers, as the or Durafilm only. Du Pont purposes ... made for industrial are as the finished on Vitek then continued to to as are needed such tests We conduct manufacturer, finally with and ended prod- ordinary of these users protect the users of the as ultimate detailed, long- perform ucts do not but selling implant, while product. Each be made before should term which studies doEars, only a few fifty contained surgical pur- for at least or medical used for are FEP film. PTFE resin and surgical cents’ worth or no medical poses. make sought received or and have not grades Homsy that Dr. learned Du Pont When and Food ruEngs the Federal any from medi- products for use its to Teflon intended any govern- fromor Drug Administration purchas- advised the Du Pont purposes, cal safety or effective- agency as to the mental Hospital by a March agent at Methodist ing purposes. such products for these ness of 13, 1967, Teflon that its letter to use to or proposing evaluate Persons apphcations and for medical not made pur- surgical or products for medical these necessary had not conducted Du Pont medical and rely their own poses suitability must to studies long-term determine representation any judgment without legal Du use. Pont’s for medical of fluorocarbons accept fuE re- They part. must on our published scientific noted several also letter either di- consequences, for aE implants sponsibiEty indicating pure Teflon reports infor- or other Any indirect. data rect or tendency to disinte- badly and had wore good suppEed Pont from Du mation joints. Consequently, load-bearing grate any particular appEcabiEty faith its sign dis- but hospital to required the Du Pont recipi- by the must be determined warnings situation claimer, acknowledging Du Pont’s ent. independent its own agreeing to use Policy Regarding Statement of Medical or contend that while FEP film many have Surgical (May applications, Uses of Plastic Materials 1 safe industrial it designed 1977). defectively specific implants for its use in the implants because caused the to function required Homsy sign Du Pont Dr. to this unreasonably an dangerous manner.3 The statement, policy which also included his Recipients also claim that the defendants agreement Du to use Pont’s materials breached failing duties owed to them compliance regulations with FDA and to con- dangers warn of associated with im- duct clinical tests on humans in accor- plants, insisting that the defendants should Food, Drug, dance with the federal and Cos- conveyed warnings directly physi- metic Act. patients concerning cians and years Based on of clinical studies with implants though the defendants had Proplast implants in animals and humans and designing no direct role in selling experience his extensive in the manufactur- implants. devices, ing marketing prosthetic Dr. granted The District Court sum Homsy Proplast believed was an excel- mary judgment defendants, rejecting Indeed, lent material. FDA two ad- defect claim as well as the failure visory safety committees stated that “the to warn respect claim. With to the *5 [Proplast] effectiveness has been estab- claim, defect the court concluded that long-term through lished clinical trials.” 47 summary judg defendants were entitled to (1982) 2810, (to Fed.Reg. 2818 be codified at undisputed ment because “the evidence dem 878) 1982). pt. (proposed 19, 21 C.F.R. Jan. onstrates that the PTFE FEP film used The FDA authorized the Proplast sale of Implants the Vitek TMJ were not ‘defec implants By 1980s, TMJ the late ” products.’ tive Implants, In re TMJ however, it apparent had become F.Supp. at respect 1024.4 With to the failure FEP film particles abraded into despite the claim, to warn the court held that the defen precautions additional Vitek had taken to dants were summary judgment entitled to ensure that happen. this would not In No- duty because no to warn was owed to the 1989, vember Du Pont informed Vitek and Recipients under material/compo the raw Homsy Dr. longer that it would no fill Vitek’s part supplier nent pro doctrine. The court orders for Teflon because of concerns about premise ceeded on the that the law refuses to by spawned lawsuits disintegrating im- suppliers hold inherently safe and multi- plants. January 1991, In the FDA ordered responsible injuries use raw materials Proplast implants removed from the market resulting dangerous from a condition created fragmentation because of their and irritation a finished manufacturer. Alter to human tissue. natively, that, the court held assuming Recipients The filed against this action duty the defendants owed a to warn the defendants, asserting liability neg- strict Recipients, the defendants discharged had ligence particular, claims. In their case duty their aas matter of law under the bulk grounded on liability: two theories of design supplier/sophisticated purchaser doctrine. defect and Recipients that, failure to warn. The The court suppliers reasoned as bulk appeal, Recipients 3. On products. abandoned all Although defective Id. this "deviation relating claims to PTFE resin and instead focus may appropriate from the norm test” entirely their efforts on FEP film. defect, analyzing manufacturing claims of it is inappropriate case, i.e., to use this test in a 4. The District Court found that PTFE resin and plaintiff where the contends that the FEP film were not defective because defectively designed. entire line is De manufacturing only ‘‘[a] defect exists where an error, spite the trial court’s Du Pont still is enti compared item is substandard when to other summary judgment tled to once the correct test assembly identical units off of the line.” re In applied. may This Court "affirm the district Implants Litig., TMJ Prods. Liab. judgment grounds supported court's 1019, (D.Minn.1995). The court reasoned Lohman, the record.” United States Recipients that because the made no claim that (8th Cir.), -, cert. - U.S. the PTFE and FEP film “were somehow inferior (1996). 116 S.Ct. 135 L.Ed.2d film,” typical to the PTFE and FEP were not parties, originally filed. The actions were the de- purchaser like sophisticated however, appeal have conceded on that “the warn the discharged any fendants part liability law is con- basis under- by making that Vitek sure Recipients jurisdictions.” Recipients’ Br. at stant in all materials in using Teflon risks of stood the i. grant of affirm the sum- implants. We on both the the defendants mary judgment to Liability Claims A. Strict claims on and failure to warn design defect part (Second) material/component the raw the basis of Restatement of Torts The (1965) imposes liability on sell § doctrine.5 402A strict products. “unreasonably dangerous”

ers of “unreasonably A be considered II. (1) manufacturing dangerous” because has the authori A transferee court (3) (2) defect, defect, a failure to terminating dispositive orders ty to enter product’s Ryn in the use. warn § 1407. 28 U.S.C. under cases consolidated Co., 21 v. E.I. Du Pont de Nemours & ders Trump Sec. Donald J. Casino In re See (8th Cir.1994). 835, 842 As noted F.3d Litig., 367-68 Litig. Taj Mahal — above, Recipients that the defen assert (Rule 12(b)(6) order), Cir.1993) (3d cert. de unreasonably dangerous FEP film dants’ nied, 114 S.Ct. 510 U.S. design defect and failure to warn under the (1994). novo the review de L.Ed.2d theories. judgment. summary grant decision design defect We first address the Hood, College, Inc. v. Technical Southern argue the Dis claim. Cir.1996). 1381, 1383 F.3d summary judg granting trict Court erred *6 feder analyzing questions of When they have raised against them because ment apply law, court should the transferee al the film as to FEP was factual issues whether located. See in which it is law of the circuit defectively designed. The insist Disaster, 829 F.2d Air Lines that, many In re Korean safe though FEP film has 122, (D.C.Cir.1987), 1171, 1176 aff'd, 490 U.S. inherently danger not industrial uses and is (1989). 1676, uses, L.Ed.2d 113 104 the film was 109 S.Ct. for all ous or defective law, considering questions “reasonably of state defectively designed for its fore When however, apply the implants. Recipients’ court must Br. the transferee use in the seeable” words, applied they to the claim that FEP would have In other state law that at 12. it they designed defectively, trans not because not been film was cases had individual malfunctioned, incorporat In re Air when See but because for consolidation. ferred Ill., implants implants it the Chicago, 644 F.2d into the caused Near ed Crash Disaster Cir.) dangerous man (7th unreasonably 594, (holding court function in an transferee 610 sup reject argument because ner. We this rules of the apply the “choice-of-law must parts inherently “component pliers safe originally the actions were states where 878, responsible for accidents that result not filed”), 102 S.Ct. are 454 U.S. cert. larger (1981). integrated into a parts are 358, liabili when the Products 70 L.Ed.2d part supplier did course, system component that the are, tort ac state law ty claims Bauermeis design Sperry v. from not or build.” approximately 280 cases tions. With Cir.1993) (dis (8th Inc., 596, action, ter, 4 F.3d consolidated this the nation across application previous court’s daunting cussing a district normally the task would face we law).6 reviewing carefully After the of Missouri law of each state where analyzing the summary judgment the in favor of argue we the are entitled affirm also 5. The defendants grounds. (1) other defendants on summary judgment the Medical because preempt ac- of 1976 state Device Amendments sup- against of bulk medical whether FEP manufacturers no difference tions 6. We believe it makes (2) part” supplier "component plies; to a medical as a bulk as a film is characterized manufacturer, Du Pont De FDA and Vitek had See Bond v. E.I. “raw material." (Colo.Ct.App.1993), Co., adequate warnings. P.2d develop Nemours & need 28, 1994). (Colo. arguments t. denied Feb. because do not consider these not and cer record, cases, we are convinced that component part the undis- may maker be puted facts show as matter of law that the strictly Apperson held liable. v. E.I. du defect was in design the overall of the im- Co., Pont de Nemours & F.3d plants and not film. FEP film is (7th Cir.1994) (“Strict liability may extend to building-block a mere material suitable for component parts inju manufacturers of many Recipients’ argument safe uses. The by design ries caused or manufacturing de nothing boils down to more than the fact that itself.”); component part fects Bond v. proved Vitek decided to use what to be an Co., E.I. Du Pont De Nemours & 868 P.2d unsuitable material to manufacture its im- (“[A] 1119 (Colo.Ct.App.1993) plaintiff plants. The erroneous and unfortunate deci- present jury must evidence from which a design sion to use FEP film in the of the any ‘design’ could find that ‘defect’ inwas Vitek, implant however, was made component part, of the product.”), not the final Du Pont or component Durafilm. part “[A] (Colo. 28, 1994); rt. denied Feb. see ce supplier should not be east the role of also Klem v. E.I. Du Pont De Nemours may insurer for accident that arise after Cir.1994).8 If, 1002-03 on component part supplier’s leaves the hand, the other product finished Quality hands.” Control Crossfield unreasonably dangerous compo because the (8th Cir.1993) Equip. part nent particular was unsuited for the use (discussing a previous applica- district court’s product that the finished manufacturer chose law). Therefore, tion of Missouri as courts in it, to make of then the design defect is held,7 already other TMJ eases the finished rather than in the we hold that the defendants were entitled to design component part. In these summary judgment on the defect cases, it is the finished manufacturer claim. component part and not the supplier that While the law of strictly Sperry, held liable. 4 F.3d at clearly liability extends to finished (affirming summary judgment compo rarely imposes manufacturers like nent part airlock where was “inte liability strict part suppliers grated larger into [spice milling] system merely who parts sell their multi-use to man supplier did not products. ufacturers of Page See W. build”); design or Mfg. Childress v. Gresen al., Keeton et *7 Prosser and Keeton on the (6th Co., 45, Cir.1989) 888 F.2d 49 (affirming (5th 100, § Law Torts at 705 ed. 1984 & summary judgment component sup for valve cases). Supp.1988) (citing inqui The critical plier design where defect inwas the finished ry determining focuses on why the reason log-splitter); see Boy, also Lee v. Butcher component part turned out to be unsuita 375, Cal.App.3d 195, 169 Cal.Rptr. 215 ble for 198- product. use in the finished “If the (1985) (no design 99 component failure defect in was due to a component flaw the motor; part, design then the is itself defect was in defec finished meat grinder); Co., tive and the cause for the assembled Mfg. Moor v. Iowa 320 N.W.2d being 927, (S.D.1982) (no defective.” Id. at 705-06. In such design 928 defect in com See, e.g., 15, (Ariz. 1986); 7. Jacobs v. E.I. du Pont de Apr. Nemours & denied component or if the Co., 1219, (6th Cir.1995); 67 Hoyt F.3d 1241 v. supplier design exercised some control over the Vitek,Inc., 271, 1225, Or.App. 134 894 P.2d 1231 Feeders, product, of the final DeSantis v. Parker (1995). Inc., 357, (7th Cir.1976) (cattle 547 F.2d 361 feeder); Carey by Carey Estate Hy-Temp component parts may A also be held Inc., 666, Mfg., (N.D.Ill.1988) F.Supp. 702 670 strictly parts special liable supplies if the it (furnace Garza, damper); vent Rourke v. 530 ly use, designed particular for a see Fleck v. KDI 794, (Tex.1975) (leased S.W.2d scaffolding Pools, Inc., 107, Sylvan (3d 981 F.2d Cir. supplied case, company). to construction In this 1992) (replacement pool liner in failure to warn undisputed designed it is that FEP film was to be case), 1005, cert. 507 U.S. 113 S.Ct. broad, nonparticularized useful in a range of (1993); Operat L.Ed.2d 267 Maake v. Ross applications and that the defendants did not ex ing Valve 149 Ariz. 717 P.2d any ercise control over (valve of the im (Ariz.Ct.App.1985) designed to limit ma plants. chine cycle on which it was installed to one case), each activation in failure to warn review inherently raw material to insure of an safe roller; in finished design defect was ponent case, undisputed against facts all misuse of his conceivable conveyor). In this expensive.”). law that the defect As an- prohibitively a matter of show as would implants and of the in a panel in the overall of this Court has determined other Recipients film. The design of FEP case, in the would be unreason- previous “[i]t TMJ that the disinte failed to show simply have place impractical and to the burden of able any design implants was due gration of the testing developing all that incor- devices than to FEP film itself rather in the component Du Pont.” porate Teflon as a incorporate decision to erroneous Vitek’s Rynders, Suppliers 21 F.3d at 842. of versa- material to be an unsuitable turned out what valves, sand, chains, gravel, materials like tile implants. into its etc., expected experts in cannot be to become of finished the infinite number our focus Recipients argue that conceivably incorporate multi-use might their of FEP general “on the uses not be should Kealoha, components. or raw materials nature of film rather on the defective but (“[T]here no F.Supp. at 594 would be end reasonably foreseeable use film for its liability every if manufacturer of potential Br. at implants.” Recipients’ Reply in TMJ nuts, could be held liable bolts screws disagree. manufacturers “While 5. We used in a defective when their hardware was dangerous materials will be inherently raw Recipi- that the injury product, product.”). their We thus believe caused held hable differently rejected. manufactur argument ents’ must be courts have treated inherently components when ers safe may allege that FEP While manufacturing assembly, than a rather final unreasonably dangerous or defec- film was itself, ren design defect incorporated implant, in the the Re- tive as Apperson, component dangerous.” ders complaint that FEP film cipients’ real omitted). (citation Indeed, at 1107 material to turned out to be an unsuitable foreseeability risk of the alleged of the “[t]he Thus, implant. the defect was use in the determining product is irrelevant finished than in the design of the rather liability component part manufac of the products. If design of the defendants’ Teflon would imposing such turer because differently, designed FEP film Du Pont had expert supplier to an retain force FEP film. As simply would not have been line of every product manufacturer’s finished recently noted in another the Fifth Circuit second-guess prod business TMJ case: any of its em manufacturer whenever uct any about ployees information received otherwise, designed had Teflon If Du Pont v. E.I. Du problems.” Kealoha potential Similarly, Teflon. it would not been de Nemours & Pont have served if a different would (D.Haw.1994), aff'd, stead, Homsy safely in Dr. erred more its *8 Cir.1996) (“Since applica the district court’s in TMJ im- by choosing Teflon for use is supplier material defense tion of the raw not, in design of Teflon was plants. The record, supported by we the reasonable context, Any lay with fault this defective. in not err that the district court did hold therefore is not Homsy’s selection. Teflon of foreseeabil declining to consider the issue design. unreasonably dangerous inherently Making suppliers of safe ity.”). Klem, 1003; Hoyt accord v. 19 F.3d at pay for component parts raw materials and Inc., Or.App. 894 P.2d product manu mistakes of the finished the (1995) (“In short, designed if Teflon were unfair, it also only be but facturer would properties the differently, it would not have on the impose an intolerable burden would many applica- it useful in so here, that make where, world, the especially as business tions.”); Dupont De Nemours (the Longo v. E.I. FEP material or raw (La.Ct.App.) film) & 632 So.2d only a cents’ worth of accounts for few (“[Bjecause quali- (the peculiar unique of its product the entire finished the cost of Kealoha, ties, question no but appears there implant). Proplast TMJ See designed with (“[T]he have been Teflon could not to a manufacturer F.Supp. at 595 cost so, component part suppli- If it that raw material or consequences. harmful would less Teflon”), duty not have been writ 637 ers have no to warn the ultimate con- (La.1994). allegation companies’ There is no of other finished So.2d sumer itself, film, inherently of components is if raw materials or the Indeed, Recipients dangerous. inherently the concede multiple safe uses and are not many case, that FEP film has safe industrial uses. dangerous. sup- Id. at 706. In that a noted, “Clearly, As the Seventh Circuit Tef plier product a manu- sold a chain to finished uses; many it lon is a raw material with safe subsequently incorporated facturer who the incorpo only dangerous when Vitek became chitterlings cleaning chain into a machine. highly specialized a rated it into medical though the chain itself was not defec- Even device, Implant.” Proplast Apper the TMJ tive, severely injured a worker was when her son, 1106; at v. E.I. F.3d see also Jacobs caught chain-sprocket hand was the mech- du Pont de Nemours & anism of the machine. This Court refused to (6th Cir.1995); Hoyt, at 1232. 894 P.2d liable, supplier finding hold the chain “the circumstances, responsibility In these the primary duty [to warn] was owed design a medical alone safe device Vitek’s machine, designer supplier of the not the because, as the finished manufactur- only component part, one itself non- er, specific it knew the end-use intended to at defective element.” Id. 704. We rea- make of the FEP film and was a far better dangerousness soned stemmed from position safety to evaluate the film’s for that design chitterlings the overall of the machine particular Summary judgment end-use. thus aas and not from the chain properly granted was for the defendants on component part. placed alone as a mere claim. defect particular emphasis on fact that “the chain, alone, standing inherently is not an We next turn to the failure to 703-704, dangerous product,” id. at and that Recipients warn claim. The contend that the supplier designing the chain had no role in summary or granting District Court erred in building product, the finished id. at 705. judgment to the defendants because there is genuine fact as issue material to whether Crossfield, Like the chain in the defen- duty the defendants had a to warn them of multiple dants’ FEP film is safe uses. As dangers posed the FEP film in the already we have noted in our discussion of implants. Whether the defendants owed a claim, Recipients’ design dan- duty question warn the of ger associated with FEP film stemmed from law. See A.O. Smith Harvestore Schaffer Proplast Vitek’s overall of the im- (6th Cir.1996). Prods., Inc., film, itself, plant. FEP in and of is not an material/component part sup Under the raw Moreover, inherently dangerous product. doctrine, inherently plier suppliers of safe Du Pont exercised no control over de- duty raw materials have no to warn end- sign, testing, manufacturing Proplast or users of a finished about implants. Accordingly, as manufac- posed by incorporation of the raw materi perfectly good turer of a material that Vitek product.9 als into that material, put to a use for which the as we know, brought unsuited,

A against failure to warn claim now Du Pont had no suppliers multi-purpose components Recipients. impose to warn the “To precluded by material/compo responsibility the same raw [a nondefee- part supplier analysis component] larger nent that forecloses tive in the context of the *9 example, defectively designed system defect claims. For Cross machine would Co., 704; Quality Equipment simply liability v. 1 Control extend too far.” Id. at field (“[E]xtend- law), Childress, (applying F.3d 701 Missouri we held see also 888 F.2d at 49 1193, Co., (La.Ct. 9. Several courts have reached this conclusion in De & 632 Nemours So.2d 1197 See, denied, (La.1994); e.g., App.), other TMJ cases. v. Kealoha writ 637 So.2d 464 894, Co., Westphal du E.I. Pont de Nemours & 82 F.3d 899- v. E.I. du Pont de Nemours & 192 (9th Cir.1996); Jacobs, 1236-38; (Wis.Ct.App. 67 F.3d at Wis.2d 531 N.W.2d - -, 1995), Klem v. E.I. Du Pont De Nemours & review Wis.2d (5th Cir.1994); (1995). Longo Dupont v. E.I. N.W.2d 571 III. product safe to the duty make a to ing the component a non-defective of manufacturer District articulated The Court charging a com- to be tantamount part would why Durafilm reasons was two additional knowledge with part manufacturer ponent summary judgment prevail on its entitled to completed that of the superior to distributor, First, acting as a motion. Bond, manufacturer.”); at 868 P.2d only product, conduit of a liable mere (“[T]here utility in little social 1120-21 dangers. See American Law Prod known of a manufacturer of placing burden on (Matthew 5.23, Liability § at 43 J. ucts 3d materials parts supplier of raw component 3,1994). Canavan, at pt. If a has ed. injuries caused guarding against defect, duty no on the a latent “there is most component parts or product when the final inspect possibly inherent distributor to were not unreason- materials themselves raw legal on these defects.” Id. at 43-44. Based Crossfield, dangerous.”). As we said ably principles, the District Court concluded expected guar- to suppliers cannot be “Mere argument accept if it “were to Plaintiffs’ safety manufacturers’ ma- of other antee defective, products were such that DuPont’s Similarly, at 704. the de- chinery.” 1 F.3d surely latent.” film, would be considered fendants, FEP suppliers of as mere F.Supp. at safety Implants, In re TMJ guarantee the expected to cannot be analysis. Consequently, agree agree with this therefore medical devices. We Vitek’s duty inspect for and warn Durafilm had no that the defendants with the District Court Recipients. Sum- defects. duty to warn the of such owed no granted properly

mary judgment thus Second, statutory several state schemes failure to warn on the for the defendants from explicitly exempt mere distributors claim. See, liability. e.g., Ann. strict Tenn.Code 29-28-106(b) (Supp.1996) (stating § seller Negligence B. Claims subject liability to strict unless seller is argue also that the defen- The manufacturer); Mo.Rev.Stat. also to warn them of negligently failed dants (1994) (allowing dismissal of seller § 537.762 when used dangerous propensities film’s liability action if manufacturer is fail, how- argument must implants. This defendant). exemptions statutory Such also ever, analysis leads same which because “the independent grant- basis for provide an also had defendants] that [the us to the conclusion summary judgment in some of ing Durafilm theory duty plaintiffs warn under no actions. these consolidated [they] liability us to conclude that strict leads theory negli- duty to warn under had no 1120; Bond, P.2d at accord gence.” IV.

Klem, (holding negligence at 1003 reasons, judgment of foregoing For the “duplicate” each liability claims and strict is affirmed. the District Court Vitek, Inc., other); Veil (D.N.D.1992) (“there significant is no theories”); see also difference between HEANEY, Judge, dissenting. Circuit al., § supra, at 697. Conse- et Keeton majority ex- respectfully I dissent. Recipients frame their quently, whether doctrine pands the negligence or strict argument terms liability suppliers from even those to shield suppliers of liability, is the same: the result going to be product was who knew how their safe, no multi-purpose raw materials have posed use knew that the intended used and of a ultimate consumer to warn the I danger the ultimate consumers. grave may ex- about protection for accept such blanket cannot integrated are when the raw materials ist In this part manufacturers.1 product. into the final trend, however. company decline to follow that recognize majority trine. I that the is in 1. I *10 previous by any expansive is not controlled This case of our sister circuits in its with several Rynders v. E.I. Eighth Both part supplier Circuit decision. application component doc- of the case, majority case, not as the con- permit Recipients’ I would claims to This is tends, incorpo- go jury for a determination of what of an “erroneous decision to to a DuPont knew and whether it had a to out to be an unsuitable rate what turned Rather, Maj. Op., supra for in human prohibit the sale of Teflon use material.” at 1057. fully implants, provide adequate suggests at to that DuPont was least the evidence warnings to Vitek of those known risks. aware of the risk of harm Teflon serious implants. posed when used in human To part Underlying component responsible these known hold DuPont premise doctrine is the that the manufactur- require component part sup- risks would generally in a er of a finished pliers every possible application to research potential dangers position better to detect its recognizes product; of its DuPont’s actual only part than of the the manufacturer knowledge, without further research or Certainly, product manu- product. a finished speculation. Recipients claiming Nor are the responsible dangers facturer is that re- designed FEP film that DuPont should have product design or from the sult from the differently, majority suggests, as the but that component part manner in which a is inte- inappropriate if DuPont the film was knew grated product. into the finished As a corol- implants, in human it should not have for use lary, part gen- manufacturers of a supply film. continued to erally know about such will not required every should not be to research significant utility” There is “social in mak- nondefective, possible application multi- of its ing DuPont for what it accountable knew product. Quality use Con- See Crossfield prevent for its failure to harm to the ultimate (8th Cir.1993) Co., Equip. trol consumers. While Vitek have been in (“ component parts which [M]anufacturers position the better to evaluate film’s safe- standing are not defective alone cannot be use, ty particular position for the DuPont’s taking place hable for accidents after the may it to well have been sufficient for have system part integrated larger has been into a posed harm hu- known Teflon they played building.”). part which no my implants. position man It is that where place But the facts of this case it outside manufacturer knows that parameters general component of the going particular in a its to be used part supplier doctrine. The that, fashion and knows no matter what the presented jury evidence sufficient for a to design, product poses danger to the going find that DuPont knew Vitek was consumer, escape it cannot from ultimate implants. use the Teflon the TMJ There1 liability. Dupont is also evidence that that Tef- knew

lon, load-bearing implants, used human no implants designed,

matter how the can

disintegrate injury re- cause

cipients. DuPont was aware of several stud- demonstrating precise

ies this risk. More-

over, a chemist who worked for DuPont for thirty years

over testified that a known char- Teflon, film, including

acteristic of all severely fragments

that it con- after constant pressure sharp edges.

tact with and from (Tab 61)

(Appellants’ App. (Dep. at 370 of Dr. Fang).)

James DuPont, (8th allegedly unchanged De Nemours & 21 F.3d 835 remained in the TMJ im- Cir.1994) Moreover, summary Hegna plant. Rynders, and our affirmance of the case was tried F.Supp. jury, Hegna, summary De at and in v. E.I. DuPont Nemours & to a (D.Minn.1993) aff'd, warnings judgment premised 27 F.3d 571 Cir. on DuPont's 1994) PTFE resin—the Teflon at 884. Our court has not involved change leaving previously given outright liability exemption that underwent substantial after an film, component parts. DuPont's control—and not the FEP which to all manufacturers of

Case Details

Case Name: Temporomandibular Joint (TMJ) Implant Recipients v. E.I. Du Pont De Nemours & Co.
Court Name: Court of Appeals for the Eighth Circuit
Date Published: Oct 4, 1996
Citation: 97 F.3d 1050
Docket Number: 95-1394
Court Abbreviation: 8th Cir.
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