Tansy v. Dacomed Corp.

рetition for certio- did not file ri.3 Mosier peti- response to the Association’s

rari nor a has, party No on certio-

tion for certiorari.

rari, these requested that this Court review As such the resolution of those

other issues. subject by Appeals is not

issues Court Ford, P.2d Ford v.

to our review. (Okia.1988).4 regard on to the decision With setoff benefits, compensation

workers’ Court opinion part and re-

Appeals’ is vacated by opinion of

placed this one. Otherwise the Appeals stands as the settled Court judgment of the trial

law of the case. The reversed,

court is and the case is remanded entry judgment

to the District Court for writing.

consistent with this

HODGES, C.J., LAVENDER, V.C.J., and WATT, JJ.,

SIMMS, OPALA, KAUGER and

concur. WILSON, J., part, concurs in

ALMA part.

dissents

HARGRAVE, J., disqualified. TANSY, Appellant,

Robert CORPORATION, Appellee.

DACOMED

No. 80662.

Supreme Court of Oklahoma. 20, 1994.

Dec. Leonard, Hough any petition recognize for cer- 4. We 3. Those issues not raised in (Okla.1993) tiorari, opinion, changed previous rule re- upon express we no garding petitions to make it un- applicable certiorari so as include: whether the limit is 2007, (2) "winning” party necessary to file a certio- for the in the 1987 to Section amendment fully petition have a review where the Court of exhausted remedies rari whether the claimant Here, by Appeals unaddressed. through Guaranty has left issues available Texas’ Association limit, Appeals raised settling statutory addressed all the issues than the Court of for less $30,000.00 reducing parties appeal, paid by Mosier's the American whether the thirds, against thus we are not con- award two Standard should have been set off Hough’s applicability. Guaranty the Oklahoma Association. fronted jury turer. The reached a defendant’s ver- plaintiff appeals, raising dict and the three issues for our resolution: whether the properly instructed on the law of products” as that rule unsafe appears in Comment k of the Restatement of Torts, whether evidence of a doctor’s acts were admissible under O.S. 2404(B), whether a witness was properly qualified testify expert. as an We affirm. Tansy impotent

Robert became due to an prescription adverse reaction to medication neurological for a disorder. He went to a Barnes, urologist, trying Dr. and after sever- alternatives, penile implant. al decided on a Tansy Dr. Barnes discussed with the differ- implants Eventually Tansy ent available. and Dr. Barnes on the decided OmniPhase рrosthesis appeal. because of its cosmetic implant on The OmniPhase was based new technology manufactured and and was dis- tributed the defendant Dacomed. The implant literature on the OmniPhase stated relatively that it a low failure rate as had market, compared to others was unique design and use of metal its cables. Tansy experienced difficulty no with the implant period of time. But less than for years implantation two after the of the de- vice, developed he a knot on the side of his Barnes, penis. Upon returning Dr. it appeared contained in the that the cables broken, prosthetic had and immediate device necessary prevent further removal was Tansy surgery to bodily damage. underwent prosthesis. remove in the The evidence showed that the cables fatigue. Apparently the device failed due to against another when metal cables rub one period the device is activated. Over McClure, City, ap- L. Oklahoma for Kevin time the cables break. Dacomed was aware pellant. plain- possibility fatigue. The of the of cable Rhodes, Hierony- Eldridge, Richard M. expert design that was tiffs testified Gable, Tulsa, mus, Jones, ap- Tucker & defective, safer and could have been made pellee. by avoiding metal using larger cables and rubbing on metal when it was activated. SUMMERS, Justice: However, leading engineer for Dacomed options that these other had been pende implant Plaintiffs failed and had to stated tested, was the best brought and that the one chosen surgically removed. He knowledge. current against option manufac- available under products suit public. that If the Omni- are menace such The evidence also showed way important step for- nevertheless find their into implant was an Phase public implant technology, as it was the market is to the interest penile ward injury “impart rigidity place responsibility fоr whatever unique capability upon ... flaecidity It also had a much occur the manufacturer on demand.” pro- type the inflatable manufacturer is best situated to [T]he lower failure rate than protection. vide such implant. Kirkland, 1362, quoting 521 P.2d at Escola v. given instructions on the Bottling Cocar-Cola Cal.2d theory manufacturer’s

plaintiffs in a instructed, P.2d 436 The manufacturer is liability. also over the It was position of control over the manufacture and objection plaintiff, as follows: of the Further, testing product. manu- you penile prosthesis man- If find that the likely party capa- facturer is the most to be Corporation by Dacomed ufactured handling ble of the financial burden caused unsafe, pre- in a unavoidably that it was product. a defective incapa- scription medical device which was being at the time of manufacture of ble speaks k 402A to of Section safe, totally unreasonably made it is not products described as unsafe.” dangerous proper if it was marketed with It seeks to strike a balance between manu- use, adequate directions for or included responsibility encourage- facturer and the warnings potential dangers or contrain- of development of research and of new ment dications. in products. certain instances it is the public products interest to allow to mar- a in of Da- The returned verdict favor unsafe, keted which are because the benefits comed. product justify its risks. Comment k Tansy appealed Appeals and the Court of reads as follows: verdict, jury’s holding upheld the Unavoidably products. k. unsafe There appropriate. granted instruction was We which, products present are some “unavoidably unsafe certiorari to address the knowledge, quite incap- state of human are jury- product” question, and ‍‌​‌​‌​​‌‌‌‌​‌‌​​‌‌​‌‌​​​‌​‌​‌​​‌​​‌‌‌​‌‌‌‌​​​​​‌‍now affirm the being able of made safe for their intended ver diet. ordinary especially and use. These are drugs. common in of An the field out- COMMENT K AND ITS APPLICABIL- standing example is the vaccine for the ITY TO MEDICAL DEVICES rabies, Pasteur treatment of which not un- of Section 402A the Restatement commonly very leads to serious and dam- (Second) of Torts sets forth the elements of aging consequences injected. when products liability. a manufacturer When invariably Since the disease itself leads product in sells a a defective condition death, marketing a dreadful both the unreasonably dangerous, makes it and the fully justified, the use of the vaccine are physical harm to causes the user notwithstanding high de- the unavoidable product, manufacturer can be held gree they risk which involve. Such responsible damage if the for the caused product, properly prepared, accompa- product reaches the user without substantial by proper warning, nied directions and change. prod adopted We manufacturers’ defective, unreasonably nor is it dan- liаbility ucts v. Motors Kirkland General many gerous. The same is true of other (Okla.1974), Corporation, as a 521 P.2d 1353 like, many drugs, vaccines and the of which legitimate cause of action in Oklahoma. very legally for this reason cannot be sold purpose prod- behind manufacturers’ except physicians, pre- or under the liability protect ucts is to the ultimate con- scription physician. of a It is also true in from sumer the burden of loss caused many experimental particular of new or product: defective which, drugs lack of as to because of time public discourage opportunity It is to interest for sufficient medical ex- marketing products having perience, can be no assurance of defects there

885 1990) 328, 593 A.2d 318 ingre- aff 'd 125 N.J. purity safety, perhaps even (blood patient causing transfused into AIDS dients, experience as there is but such k); drug was covered under Comment marketing use of the justified the Perfetti McGhan, (Ct.App. 662 P.2d 646 99 N.M. medically recognizablе notwithstanding a 1983) (Comment applied k to a im again breast products, The seller of such risk. Searle, F.Supp. plant); Allen v. G.D. 708 they proper- are qualification Moore, (D.Ore.1989), marketed, McKee v. proper ly prepared and (Okla.1982) Robins, v. AH. and Terhune given, the situation calls warning is where (1978) (Comment it, 577 P.2d 975 to strict for Wash.2d is not to be held IUD); Sherwood, applied Phelps k to an consequences attending their unfortunate (7th Cir.1987) 836 F.2d 296 and Brooks v. use, merely because he has undertaken (4th Cir.1984) Medtronic 750 F.2d 1227 apparently useful supply public with an (pacemaker catheter covered un and heart product, attended with and desirable k). But see Hawkinson v. risk. der Comment apparently reasonable known but (D.Colo. F.Supp. AH. Robins liability law seeks to products While 1984) (Daikon Shield); v. AH. Rob Coursen unreasonably danger protect public from (9th. 1985) (Daikon ins, protect products, seeks ous Shield). 70 A.L.R.4th 16 for a See public’s facet of the interest —that another Court, complete rеview of these cases. This having available new whose benefits Moore, (Okla.1982), 648 P.2d 21 McKee v. justify great enough as to associated are IUD, applied implanted k to an who protects It certain manufacturers risks. “unavoidably un holding that it be an develop products at the time of new k, and thus product safe” under Comment incapable being made manufacture are not “defective.” Id. at 23. safe, totally products shields certain and Horowitz, supra, v. and Harwell classifying them as unsafe” Hufft Inc., Systems, supra, pen- v. American Med. rather than as “defective.” Hill v. Searle pro- implants held to be within the ile were (8th Cir.1989). Laboratories, 884 F.2d 1064 k. The court held tection of Comment policy development favors the Hufft Public salutary type of devices “serve the that these drugs marketing of new beneficial and de normalcy purposes restoring degree lives, they pain can save reduce vices because organic dys- to the lives of those who suffer quality v. imрrove of life. Hufft impaired quality of functions and an life.” Horowitz, 8, Cal.Rptr.2d 4 Cal.App.4th 5 877 Cal.Rptr.2d at 383. Id. 5 (4 Dist.1992). liability might prove “Strict a dis-incentive to manufacturers to devel k an affirmative serves as op drugs because of and market beneficial incapable product is defense when the large monetary judgments’ ‘fear of adverse present technology, being made safe under insurance, expense of strict and the product for the warrants but the social need ‘place that could the cost of medication costs Hill, 1068; production. 884 F.2d at Lar its beyond it the reach of those who need Inc., 1, Systems, 74 Haw. sen v. Pacesetter ” Hufft, Cal.Rptr.2d quoting at 381 most.’ 5 (1992) (pacemaker did not fall 837 P.2d 1273 Court, 1049, Superior 44 245 Brown v. Cal.3d capable of k because it was under Comment (1988). 412, Cal.Rptr. 751 P.2d 470 manufac being made safer at the time of its ture). ‍‌​‌​‌​​‌‌‌‌​‌‌​​‌‌​‌‌​​​‌​‌​‌​​‌​​‌‌‌​‌‌‌‌​​​​​‌‍as the design must be as safe “[T]he

Most courts which have considered the permits.” testing and research question applies have found that Comment k best available Laboratories, 112 devices, Idaho especially those which are Toner v. Lederle to medical (1987) 328, 297, cert. denied 485 body. v. 732 P.2d 306 implanted the human See Hufft 1122, Horowitz, 942, 8, 99 L.Ed.2d 282 Cal.App.4th Cal.Rptr.2d 4 377 108 S.Ct. 5 U.S. (4th must be at the time of manu- Dist.Ct.App.1992) Harwell v. Amer. There “no feasible alterna Systems, F.Supp. 803 1287 fácture and distribution Med. (M.D.Tenn.1992) accomplished design prosthesis pro tive which on balance (penile k); subject purpose a lesser product’s Snyder v. tected under Comment Mekh (A.D. 281, at 306. The manufactur jian, N.J.Super. risk.” Id. 732 P.2d 244 582 A.2d 307 886 Following guidance knowledge of our product are held

ers of the jurisdictions, experts in fields. Id. case law as well as that of other experience of their 307; apply k Wyeth v. Laborato we hold that Comment can to medi P.2d at White 732 748, devices, ries, Inc., 390, im particularly N.E.2d cal those which are 40 533 Ohio St.3d (1988); planted. provide The Comment does not v. Lederle Laborato 753 Feldman (1984) 374, ries, 429, protection for all medical 479 A.2d 386-87 blanket devices. 97 N.J. — -, 3027, aрplies only 112 as an affirmative de S.Ct. Rather cert. denied U.S. (1992).1 following eases in fense those which the 120 L.Ed.2d 898 (1) product properly met:

criteria are is adequate manufactured and contains warn only defense is available- when risks, ings, justify its benefits properly manufactured and product Id.; product was at the time of manufacture warnings. adequate McPheron contains incapable being Laboratories, Inc., 31, and distribution made 888 F.2d 33 v. Searle Co., (5th safe. Allen v. Searle 708 Cir.1989); more See G.D. Sys Harwell v. Amer. Med. (D.Ore.1989); F.Supp. 1149 Goursen v. tems, Inc., & supra; Allen G.D. Searle Co., (D.Ore.1989). AH. Co., Robins 1338 F.Supp. 1149 Cir.1985). generally ques These issues are apply when The Comment defense does determination, jury’s tions for the and must faulty defective due to manu case-by-case be determined on a basis. See facturing inadequate warnings. Grund Coursen, 1338; Kociemba, (Utah 764 F.2d at berg Upjohn 1300; White, 1991). F.Supp. at 533 N.E.2d at 752. defense, Because it is an affirmative the de risk-utility courts have held that a Several proof. fendant bears the burden Id. 680 analysis emрloyed before Com- must also be F.Supp. at 1338. recovery ment k will bar under 383; Here, Tansy liability. Hufft, Cal.Rptr.2d question at does not See Searle, F.Supp. proper product. Kociemba v. manufacture of the As for G.D. (D.Minn.1988); warning requirement, Lederle Laborato- we note that Toner v. first ries,. 328, adopted 112 Idaho 732 P.2d 297 The Oklahoma has the learned interme McKee, outweigh diary must its doctrine. P.2d at 24. This product benefits of the 648 Toner, 306; permits at Kearl v. a manufacturer risks. 732 P.2d doctrine to warn the Laboratories, 812, consumer, Cal.App.3d physician, 172 rather than the ultimate Lederle (Div. 1985). weigh- problems product. 4 Cal.Rptr. 218 453 “This associated with the Here, ing process party questions the value of the neither the doctrine’s should consider benefit, risk, application present In the seriousness of the and the circumstances. Toner, 306, stead, Tansy urges at that likelihood of both.” 732 P.2d the doctor was not citing given Blood Bank v. information to Belle Memorial sufficient evaluate the Bonfils Hansen, (Colo.1983). product. Tansy that Dr. 665 P.2d 118 Comment claims Barnes was implicitly, by language, requires given regarding k this incorrect information the ex its analysis; speaks pected prosthesis. risk-benefit the Comment lifetime of the OmniPhase product’s utility justifying repre- Dr. a its risks.2 Barnes testified that Dacomed require sey, College, complete listing State 1. For a of the states that Calabrese v. Trenton 162 145, design, (1978), there be no see 70 N.J.Super. safer alternative 392 A.-2d600 New Mexi co, Bodelson, 243, A.L.R.4A at 37. Davila v. 103 704 P.2d N.M. Texas, (App.1985), Paper 1119 Borel v. Fibreboard jurisdictions employ 2. The a risk- other (5th Cir.1973) Corp., Products 493 F.2d 1076 cert. analysis applying benefit before Comment k are denied, 869, 127, 419 U.S. 95 S.Ct. 42 L.Ed.2d Arizona, Hunter, Gaston v. 121 Ariz. 588 P.2d Utah, (1973), ‍‌​‌​‌​​‌‌‌‌​‌‌​​‌‌​‌‌​​​‌​‌​‌​​‌​​‌‌‌​‌‌‌‌​​​​​‌‍107 Patten v. LederleLaborato Colorado, (App.1978), 326 Pharmaceutical Ortho ries, (D.C.Utah 1987). F.Supp. 676 233 The 5th Illinois, Heath, (Colo.1986), Corp.v. 722 P.2d 410 Circuit, Pruitt, in Helene Curtis Ind. v. (7th F.2d 651 Beetler Sales Affiliates denied, Cir.1967), cert. 391 U.S. Cir.1970), Kansas, Cyanamid Johnson v. Amer. (1967), applied S.Ct. 20 L.Ed.2d 652 Okla (1986), 239 Kan. Michi and determined that Oklahoma Laboratories, homa law would gan, 73, Mich.App. Dunn v. Lederle (1982), Missouri, analysis applying utilize a risk-benefit before 328 N.W.2d 576 Racer Utterman, (Mo.1981), k. 629 S.W.2d 387 New Jer Comment IUD, functioning properly was for its intend- would last for told him the device sentative However, purpose preventing pregnancy, but that 10,000 the brochure ed activations. no claims as to effects. He claims it by Dacomed made it caused unwanted side distributed protect- stated that expected only lifetime and also these side effects which were prosthesis could movements of ed k. certain Comment reliability. The documentation also affect its First, disagree. in McKee the facts We re- complications could showed that various that the had not functioned as showed IUD Al- surgical of the device. quire the removal Thus, prevent pregnancy. intended to conflicting, there though was the evidence support Tansy’s asser- McKee lends no for to support the defendant’s as- was evidence to protected tion that “side еffects” are while warnings given. adequate were sertion that Furthermore, “defects” are not. the eases jury fact for the to question It then a was apply k are clear that Comment is meant find that the first criteria determine. We unavoidably product when a unsafe be- met. application k’s Comment fact, cause of a defect. courts hold product’s question next is whether The applies “re-classify” product k Comment justify its risks. The OmniPhase benefits unsafe.” from “defective” im- step penile prosthesis was a forward Hill, expressly As it 884 F.2d at 1068. market technology. Implants on the plant states, apply all conse- Comment k can as had failure rates before the OmniPhase quences caused the use of the device. high The studies on the OmniPhase as 40%. example k illustrates The used Comment implant a failure rate of between revealed could con- point. this The Rabies vaccine Furthermore, the cosmetic and 6%. 3.7% its life-threaten- sidered dеfective because of required that implants appearance of other However, ing it is the intent of side effects. clothing tight binding be avoided. re-classify as implant permitted a man to wear OmniPhase unavoidably public unsafe so As stated the trousers of his choice. necessary a valued and have access to such degree Hufft, implants help restore a these vaccine. suffer normalcy to the lives of those who jury dysfunction. agree that a sexual We given regard As for the instruction reasonably that the benefits could conclude k, only remaining question justified the prosthesis of the OmniPhase adequate to is whether the instruction was implantation. risks associated with its will not inform the of the law. We judgment where the instructions criteria, reverse Tansy argues that As for the last fairly presented the as a whole when viewed been made safer. the OmniPhase could have pleadings applicable law as raised larger could that a cable Dr. Barnes testified Inc., Ray 845 Dutsch v. Sea Boats fatigue. evidence. avoid the cable have been used to (Okla.1992); v. Kamo Elec. Co P.2d 187 Root However, engineer Dacomed testified (Okla.1985). Here op P.2d 1083 tried, its results that a cable was but thicker defendant’s k was the basis of the Comment unsatisfactory it decreased the because were held that theory we have of defense. Since appear flaccid. The ability penis of the particular applicable k to this Comment no alter- engineer also testified that suitable device, correct to the trial court was medical rubbing on existed to avoid the “metal native it. given explaining an instruction problem, materials were metal” as no other jury question strength. A was of sufficient did not Tansy urges that the instruction this, ap- the final criteria presented thus jury legal defi- adequately explain to the plicable. The instruc- nition of unsafe.” unavoidably product that a was Tansy urgеs k does tion stated that Comment “prescription a medical de- unsafe if it was operate protect products which are incapable at the time of man- “defective”, vice which was only protection offers when but Al- being totally safe-” ufacture of made of the causes “side effects.” the use Moore, agree instruction could supra, though we that the urges that in McKee v. He detail, in more it was product, an have been worded applied k because apprise applicable showing some reason other than action in sufficient to regarding conformity In the future instructions with character is admissible. law. include the conditions to should interpreted While this Court has not Sec- out in applicability as we have set its 2404(B), tion other courts have found that opinion. permits testimony this section of other acts knowledge to show in civil cases. McCor- THE THE OF DOCTOR’S EVIDENCE (4th Ed.1992). Evidence, § mick on For IMPLANTATION PREVIOUS O’Brien, example, in United States v. (9th Cir.1979), F.2d 1067 evidenсe was admit- error, assignment In his next 404(B) ted under of the Federal Section Tansy in asserts that the trial court erred Rules of Evidence.4 The evidence showed evidence, objection, permitting regard over acceptance continued the defendant of ing prior in which Dr. incident Barnes is state and federal funds to which he was not alleged improperly implanted to have government entitled. The introduced this Tansy complains OmniPhase. the ad prosecution making in a evidence false of 12 mission of this evidence was violation Security statements to the Social Administra- 2404(B). 2404(B) O.S.1991 Section reads: tion to rebut the defendant’s claims of inad- crimes, wrongs, B. Evidence of other mistake, and that it vertent asserted showed prove admissible to charac- acts is not knowledge the defendant’s that he was mak- person in order to action in ter of show appeal false statements. On the Ninth however, conformity may, therewith. It upheld Circuit the trial court’s decision to purposes, admissible for other such as holding admit the evidence. In so court motive, intent, proof opportunity, prepa- stated before evidence can be admitted ration, plan, knowledge, identity or ab- 404(B), weight under Rule the “court must sence of mistake or accident. probative against potential prej- value 1070; udice.” Id. at see also United States urges that this evidence was admis- Dacomed Pavers, Inc., Bi-Co F.2d 730 Cir. falling sible within one of the as enumerated 1984). 2404(B), exceptions namely of Section that of knowledge. Dacomed claims that the evi- Gutierrez-Rodriguez Cartagena, knowledge Dr. dence showed Barnes’ of how (1st Cir.1989), F.2d 553 the First Circuit implanted to determine whether it had been question asked to resolve the of whether correctly, knowledge of how to conceal prior complaints against police evidence an error. during officer were admissible a trial rights which the officer was for civil sued evidence, in sec- Character as mentioned part violations. The court on a two relied “generalized description tion involves a test to make its decision: was the evi disposition respect general of one’s to a dence of bad acts introduced for a honesty, temperance trait such as or careful- legitimate purpose, sup should it be Whinery, ness....” Oklahoma Evidence: pressed prejudice? because of substantial Evidence, Commentary on the Law of The court held that 15.03, the evidence was admis § quoting Henry, Frase v. 444 F.2d Cir.1971). (10th sible not to show the tendencies of the defen The restrictions dant, supervisors but to show that his had admissibility apply on its in criminal and civil knowledge poor performance § of his record. cases. Title 12 O.S.1991 2103.3 Under 2404(B), also In re Air Section character evidence is See Crash dealt Bali Cir.1982) (9th through application specialized with of a cert. denied 493 U.S. (1989) (evi relevancy inquiry. Only Id. at 311. that 110 S.Ct. 107 L.Ed.2d 258 pilot’s prior poor flight evidence of other acts which is relevant for dence of a record was 404(B) part substantially 3. Section 2103 states in relevant “this Code 4. Federal Rules similar to apply proceed- 2404(B). shall ings, in both criminal and civil our Oklahoma Rule supervision conducted or under the aof court ...” diagnosis proved of a broken show that the airline had notice cable admissible to inabilities).5 pilot’s correct. that the evi- In this case Dacomed asserts Gutierrez-Rodriguez, Under we first look introduced to show the doctor’s dence was the admission of whether this evidence device, knowledge of how to insert the how to legitimate purpose was for a and showed correctly implant- it was determine whether something propensity. other than In our any professional disguise how to er- ed and very question. this is a difficult case close theories was that the ror. One of Daeomed’s We conclude Dacomed had reasоn to seek the OmniPhase was due to an failure of admission of the that evidence show Dr. implantation by In the incorrect Dr. Barnes. procedures Barnes was familiar with the re- implantation requested, prior Dacomed had quired by Dacomed for removal of the Omni- taken, x-rays Dr. Barnes had of the prior Phase. The incident shows that Dr. prosthesis Dacomed’s wit- before removal. problem Barnes had been faced with a required x-rays that such ness testified the OmniPhase the incident with Tan- before warranty removal or the would not be before sy, x-rays and had been to take instructed x-rays Those in the other case had honored. implanted. the device while it remained pieces pros- revealed that one of the knowledge require- Doctor’s of Dacomed’s down, implanted upside thesis had been theory ments are thus relevant to this the device to fail. had caused Dacomed. case, Tansy’s Dr. Barnes failed to take part The second of the test ais x-rays requested before removal as Da- balancing very test similar to that under x-rays comed. These would have shown Section 2403.6 We must determine whether correctly implanted. the device was whether probative outweighs value of the evidence Dacomed’s introduction of the incident prejudicial effect. that Our concern is argued to be that Dr. was relevant show improperly evidence could have been inter procedure requir- Barnes knew Dacomed’s preted by propensity to show a device, x-rays ing before removal of the part implant of the doctor to these im if improperly knew that the device had been properly, up and to cover such mistake. As implanted, x-rays failure to take would have court, however, reviewing we will not eliminated evidence of such mistake. Dr. ruling overturn the trial court’s under Sec x-rays did Barnes claimed he not take tion 2403 unless there is a сlear abuse of Tansy, after his examination of he because Harvey, discretion. See Gabus v. 678 P.2d thought it was obvious that the cable had (Okla.1984); broken, Mfg. Jones v. Stemco nec- and that immediate removal was Co., essary. no The evidence was He stated he saw need for relevant; taking x-ray. prejudice time or cost in an there was also a risk of the additional removed, implant regard jury. was Dr. Barnes’ with But do not find When we separate opinion concurring part retaliatory practices); 5. The show Crowston v. Good- (N.D. dissenting part urges year that this case does not Tire and Rubber 521 N.W.2d 401 1994) require (testimony involve “character evidence” so as to in a admissible 2404(B). application apply- liabilüy provi- §of For other cases case under the evidence character provision plaintiff likely code in civil evidence sions to show that most did not ours, analogous knowledge warnings by reading cases under circumstances have them); (Ariz.1994) Penn, e.g. Hodge, See. (trial Lee v. 882 P.2d 408 Eaves v. 587 F.2d 453 Cir. 1978) (evidence court did not abuse its discretion in refus- was admissible under character ing evidence which showed that a automobile provision evidence to show intent to defraud in a repair shop knowledge, acted with intent and a dealing fiduciary duty). civil case with breach of causing damage motive in extra to vehicles in costs); repair Co. v. order to raise Boettcher & 6. 12 O.S.1991 Munson, (evidence (Colo.1993) 854 P.2d 199 was 404(b) may case to Relevant evidence be excluded if its admissible under Rule in a civil plan recommending probative substantially outweighed by value is show the and intent of un- danger prejudice, suitable investments in order to defraud the in- the issues, of unfair confusion of the Edwards, vestors); misleading delay, Jay England Toyo- jury, Inc. v. New the undue need- Distrib., Inc., (1st Cir.1983) evidence, presentation ta less of cumulative or F.2d 814 (evidence 404(B) surprise. was admissible under Rule to unfair and harmful allowing ny entirely up jury. jury in was The the testim the an abuse of discretion qualifications рosi- evidence that of her was no other aware and her ony.7 There by incor They give Dr. Barnes was tion within could her implantation Dacomed. this clearly rect, jury testimony weight they observed that the whatever determined the a cable broke. appropriate. Again, failed because we find no device abuse allowing testify. discretion in her to EXPERT THE WITNESS error, assignment final his As CONCLUSION permit error to Tansy that was claims Regulatory Affairs of Director of Clinical opinion Appeals of the Court testify expert as an “medical” Dacomed vacated, although reach we the same conclu- Wilen, Mary “engineering” witness. judgment sion reached there. The for De- Director, practical licensed nurse. She is a in fendant rendered the District Court based years, and was a nurse several worked as jury on the verdict is affirmed. carry employed as a research nurse to later Dacomed, At her duties out clinical studies. HARGRAVE, LAVENDER, V.C.J., and setting up clinical studies and select include OPALA, WATT, JJ., ALMA WILSON and to be in those studies. She was doctors concur. study in clinical conducted on involved prosthesis, and has extensive the OmniPhase HODGES, C.J., KAUGER, J., concur conducting in clinical research. experience in result. any person who handled was also the She by during doctors or af problems presented SIMMS, J., part, concurs in dissents in implantation of the device. ter the part. testified that on an occasion At trial Wilen Tansy’s, implanted SIMMS, Justice, Barnes concurring part, Dr. had incorrectly. device In her dissenting an OmniPhase in part: explained testimony, she how the device portion respectfully I dissent to that of the testified as to the implanted. She should be majority opinion dealing with evidence by ordinary procedures followed Dacomed implantations by being previous the doctor complaint. Lastly, there is a she testi- when I as character evidence. fear the admissible clinical studies were con- fied as to how the majority may misleading opinion as Dr. ducted, showed a 3.77% and that studies Barnes’s character is not an issue this OmniPhase. fail rate with the propensity to case. Neither is his err while by were with- The statements made Wilen implanting prosthetic devices. The witness’s knowledge expertise. She in her base of testimony judged has to be the standard engineering testify proper as to the did not § set out in 2401. I of relevance section simply designing prosthesis. She was, testimony questioned believe that the at opinions to facts and that were with- testified best, barely Tansy relevant. has not shown knowledge Director of in her realm of as the admission, any prejudice resulting from its Clinical Affairs. however, and for that sole reason the trial regarding ruling ma- court’s should be affirmed. The The trial court’s decision appears expert jority’s question treatment of this qualifications of an will not be clear certain to cause confusion later decisions unless there is a abusе reversed Gabus, involving evidentiary rulings, as it unneces- 678 P.2d at 257. The discretion. jury sarily present- discusses issues which are not gave an instruction which trial court ed facts of this case. weight give expert testimo- stated that the propensity, parties request, but can be used to show knowl- did not nor show 7. We note that the intent, motive, opportunity, plan, prepara- give, ‍‌​‌​‌​​‌‌‌‌​‌‌​​‌‌​‌‌​​​‌​‌​‌​​‌​​‌‌‌​‌‌‌‌​​​​​‌‍limiting edge, instruction the trial court did instances, identity regard or absence of mistake or accident. In some tion to this evidence. 2404(B). parties limiting given explain to See 12 O.S.1991 Because instruction is issue, it. we do not address considered to did not raise that the evidence not be is, may § provides that evi- certain amount of discretion be and Title O.S.1991 respects, in some instances and vested in person’s character is not admissi- dence of a trial tribunals”. Id. P.2d at 582. In except in when a criminal defen- ble evidence Kum, of other evidence acts was admitted issue; in puts his character as evidence dant cautionary by under a admonition the trial case, by by in a criminal or the an accused judge jury. to the prosecution aggressiveness or to show either example, For in Hackbarb v. peacefulness a of a on Cincinnati of victim crime the Inc, Clark, Bengals “Booby” and Charles question aggressor. the of who was Sections (10th Cir.1979) the Tenth Cir- attacking 2607 and 2608 deal with the credi- addressing by cuit in other violent acts foot- bility through of a witness character evi- players, ball observed at Id. at P. “The impeach- dence. Section 2609 addresses the namely aspect, proof other the of character by a evidence of of ment of witness conviction by production acts, plaintiff prior of crime. The last three mentioned sections of only would be admissible if his character was in the evidence code are referred plaintiff an issue in the case. Unless the 2404(A)(3). majority acknowledges, § As the aggressor shown to have been an unlawful in case, distinguished there is no civil as from incident, his'prior the immediate acts could case, dealing in prior criminal Oklahoma not be relevant. The indications from the party activities of a or a witness under the picture of the action here are that he threw a rubric of “character evidence”. * * * body lapse block and after the of evidentiary standpoint, time, From an what we period short the was struck blow question in deal with this case is the of while Haekbart was down on his knee watch- Therefore, ing the action. this evidence admissibility person of other acts of a as appear questionable would to be if not irrele- imputing knowledge. type This of evidence added) (Emphasis vant.” 2404(B) § is admissible under of the evidence clearly code. B states that Section this evi- majority opinion misinterprets character, prove dence is not admissible dissenting part writing. say in do not We establish, alia, may but be admitted to inter inapрlicable ques- the evidence code is of, of, knowledge simply or tioned evidence in this case. absence mistake acci- We point § separate out that 2404 addresses two dent. types of evidence. A deals with Subsection acts, Admissibility prior by as addressed evidence, admissibility the of character while Code, our is Evidence neither new nor novel subject B Subsection addresses of evi- jurisprudence. to Oklahoma In Kurn v. Ra separate dence of “other acts”. These are dencic, 126, 141 193 Okla. P.2d 680 types and distinct of evidence. The cases recognized general that it this Court is the majority in 3 of cited footnote proof charged against of “an act rule opinion support do conclusion person may proved by showing not be a like evidence of “other acts” is admissible as evi- previous act to have been committed Hodge, supra, dence of “character”. Lee v. (Citations Omitted) However, рerson.” same case, admissibility the Arizona addresses the point the court went on to out that there are damage of other acts of of evidence cus- many proof instances where of acts or similar being repaired tomers cars while in defen- permitted because misconduct such evi Munson, shop. dant’s Boettcher & Co. bearing phase dence on have some supra, dealt with other acts committed concluding the case. In that such evidence bearing defendant’s course of business as on bearing" knowledge, had a issue of an investor. the intent to defraud This was provisions -court stated: “Thus each class of cases our discussed under 2404(B). Edwards, Jay Eng- § inquiry Inc. v. New question when the into collateral Distrib., Inc., Toyota supra, pres- land also presented sought matters is and it question acts of a defendant ents rule, opposing establish a considerations retaliatory practices per our to show weighed pro must bе and the value of the 2404(B). posed phase evidence on the issue or of issue weighed against objec Rubber, must be the normal Goodyear Tire & Crowston supra, permitted per- tions that A court evidence of a arise connection therewith. 892 (Sec- k,1 holding Restatement on a that Comment would bear

sonality disorder ond) 402A,2 applies to medical of Torts warning, but the ability to read a plaintiffs devices, including penile prostheses,3 which evi- character specifically excluded court k, body. implanted in the are Also, case of in the Tenth Circuit dence. unavoidably appli- Penn, which deals supra, evidence of other al- Eaves unsafe ances, against an affirmative defense affords properly admit- improper acts were legedly liability manufac- products claims where the motive, opportunity or intent. proving ted as (1) medical de- demonstrates that turer urge, majority implies, that do not as the We contains properly is manufactured and vice are never admissible evidence of other acts justify its adequate warnings, its benefits civil action. production and and at the time of its risks character is not at issue. Dr. Barnes’s distribution, incapable of safer the device was distinguish majority’s failure to between The manufacture.4 might bear on of other acts which evidence knowledge and “character evi- the issue of today’s judgment and in I concur in While ill advised. dence” is opinion, separately I the court’s write likely embod- explain that the elements to be Justice, ALA, concurring. OP (Third) of Torts5 would ied Restatement modify jurispru- today judgment significantly court affirms on defendant-manufacturer, dence. jury verdict for the 5. 4. See Allen v. G.D. Searle & 3. See Harwell v. Amer. Med.

2. Section 1. The Aaron D. Robins 2. The American Law Institute taken the Henderson, Professor, F.Supp. ment states in (Third) See the ultimate user or sonable risk.” with an warning, dangerous.... human use.... made uct, erty....” liability not to be held to strict or consumer or tо his consequences attending their again some erly prepared condition cause he “(1) "k. (Second) Products is pertinent portions attended with a known but One Unavoidably accompanied by proper directions and of Torts: with the given, 1287, safe for pertinent part: knowledge, 402A, apparently process is Twerski, Professor, who has undertaken to Such unreasonably dangerous n. 1 (Emphasis physical of where Liability, § qualification sells Restatement defective, Torts, (Emphasis which, (D.Or.1989); The seller of such Products their intended unsafe product, properly prepared, marketed, (M.D.Tenn.1992). are any product useful consumer, Cornell drafting harm are: added.) of Comment liability quite incapable in the situation property nor is it products. There are Liability. added.) and desirable Systems, (Second) thereby Council Draft No. supply Co., Law (ALI) Coursen v. A.H. Restatement the present use, merely for unfortunate Brooklyn apparently (9th Cir.1985). they in a defective and сalls for unreasonably proper School, to his to the user has under- k, subject caused to James A. products, are ordinary of F.Supp. state of Restate- public Torts, warn- prop- prop- prod- being it, Law rea- 803 be- is Help Products Restating scription Revision Section 402A the Restatement Aaron Should Thomas, The terms (Third), Makers Jr., 402A— pertinent part: ber of Comment k Corn.L.Rev. U.L.Rev. analysis project. cal Harvey 1257 have been The most recent version here), See, Torts, 64 debate and discussion CounsJ. School, 1993; for Harm Medical Devices "§ Aaron vice is one medical for harm to utes a defective defect. A devices, (a) 2, e.g., Roland F. Settle Troubled 8. 27 U.Rich.L.Rev. Council Draft No. D. Design Defect, 72 Council Draft No. 1 in A manufacturer of a Adopt of 1994. L. have been selected as Restatement of the Third Restatement: Products and the Liability Several drafts Twerski, Proposed Liability released: a Drugs the Restatement §of D. Kaplan, (1994); Tenn.L.Rev. device whо sells or otherwise distrib- 1512 Caused see Teresa Moran jurisprudence Twerski, (1993); The Henderson-Twerski prescription drug Each distribution has persons caused and Medical of Seller or Other Distributor A (1992); Council Draft No. 402A, see also James A. Tort Scott W. product Banks, Waters: by Prescription among the commentators. preliminary 857 James 1357, Will A New Restatement of the third Restatement 2, Reform: Restatement (and the one discussed OrL.Rev. (Second) Proposed Peter Nash (Third)'s (1993). legally Margaret prescription drug or New Reflections, Revision Section A. 1369-1377 (Second), Sayler, subject September 1993. reporters for the released Devices, ^[61] drugs and medi- Henderson, Jr., Prescription Schwartz, or medical Why sold or other- draft in For a modification Restatement 411 Henderson, (Second) Drugs 2, Steven M. O’Connor, of Torts, Proposed spawned Swisher, Septem- Virginia state in Section (1993); 42 Am. cogent April Def. Pre- de- for 77 any patients.9 the device for class of This I wording represents pre a modifiсation of the RE- THE PROPOSED 8 OF SECTION risk-utility analysis in vious alluded to Com (THIRD) OF TORTS: STATEMENT developed largely by jurisp kment extant LIABILITY MODIFIES PRODUCTS § risk-utility approach The is rudence.10 K JURISPRUDENCE COMMENT considerably rigorous more than that of its BASIC EL- RETAINING ITS WHILE Yesteryear’s “unavoidably predecessor. un EMENTS safe” device must now have so little merit 8(a), general which embodies a Section compared its attendant that no benefits liability for manufacturers of statement of provider pre reasonable health care would prescribed drugs or medical de- defective any patient scribe it to class.11 The drafters vices,6 subject explicitly medical de- would justify change regu in deference to the § rule of 402A. It vices to the black letter by giv lated market for medical devices § replace category 402A of “unrea- would ing proper weight pro to the intercession of sonably dangerous” products with a new ru- judgment by fessional learned intermediari reasonably safe.”7 Accord- bric called “not es.12 8(c) (d), may § a medical device to (a) reasonably 8(d) “due to de- draft, § of Under the current medi- safe defective ” (b) sign inadequate of instruc- or “because reasonably cal device is not because safe of warnings.”8 tions or warnings inadequate instructions or when warnings or reasonable instructions are not reasonably A medical device is not safe given prescribing other health to and/or design the foresee because when defect may providers position care who be in a to posed by sufficiently able risk of harm posed by reduce the risks of harm the defec- great prospective in relation to its benefits product.13 tive This sentence articulates the provider, that no reasonable health care risks/benefits, prescribe intermediary rule” that de- knowing those would so-called “learned wise distributed care tion therapeutic its foreseeable relation to fits so that no reasonable health care foreseeable who are in a directly warnings; or or ably or medical device are drug er, ably (b) garding harm in tients. garding ably (2) of sale or distribution: of (c) (d) prescribing inadequate warnings drugA reasonable instructions For reasonable instructions drugA knowing drug drug provider’s prescription. (a), product n safe safe safe or drug purposes foreseeable risks foreseeable risks of harm medical device accordance with the instructions or or medical device are not or medical device are not due because due to defective n not reason- or medical device is or medical device is not reason- risks of harm or medical device is not reason- benefits, when of such foreseeable risks patient position and other health care to defective instructions or n only pursuant ! when the manufacturer inadequate instructions defective would ! n sufficiently reduce the risks of posed by design of harm therapeutic bene- design or or any under Subsec- n ! warnings. prescribe if warnings warnings class to a health at the time or because when posed by posed providers provided provided great n ^[5] provid- drug pa- re- re- 6. For the terms of 7. For the terms of 9. See 8. See 10. Id. See 12. 11. 13. See Comment Pharmaceutical note 5. supra ber see note 5. ment L.Ed.2d 252 Products 5. See Tobin, supra knew or had reason to know that no health scribed in Subsection added.) care 4, 1994). (Third), supra § § Reporter's § 8(c) 8(c), Cir.1993), Liability provider 8(d)(1), note 5. — Restatement U.S. Prods., Inc., (d)(1), b, Restatement Note, (Council § would be in the § note cert denied sub Restatement 8(a), -, 8(b)(2), Restatement Restatement (Third), Draft No. 114 S.Ct. citing (d)(1).” Restatement (Third), (Third) F.2d g, § Tobin v. Astra supra nom, (Third), supra position (Third), 2, Septem- supra (Emphasis 8, Restate Duphar note 5. (Third), Torts: 536- note see de- duty regime spawned by affirmative-defense Com a manufacturer’s fines ment k and relieve the manufacturer of its warn.14 present burden show the device falls (§ 8) would now acknowl- new text liability. exception an within exception to the “learned intermedi- edge an device be “not ary A medical rule”. Ill inadequate in- reasonably safe” because provid- warnings where none is structions CONCLUSION (although patient-user directly to the ed Currently changes debated 402A— knew or had reason to know manufacturer reflected Council Draft No. Restate- provider avail- care would be that no health (Third) Liability, ment of Torts: Products warnings expect- the vicarious able to receive § generally track the current trends 8— rule”).15 intermediary “learned ed products jurisprudence. unsafe” change reflects the trend of mod- The draft likely is more than The next Restatement jurisprudence which has weakened ern producers’ embrace standards of different impregnable once all- shield otherwise liability for defective medical devices. The intermediary “learned rule”.16 exclusive § presently proposed 8 draft retains all basic elements, tighten k

Comment but would analysis as well create an as risk/benefit II intermediary exception to the “learned rule”. THE 8 WOULD ABROGATE SECTION Taking path lit case from several law DEFENSE CON- AFFIRMATIVE jurisdictions, the drafters would cast on the K AND OF COMMENT plaintiff proving CEPT that a the entire burden of reasonably THE PLAINTIFF THE PLACE ON is “not safe.” This medical device present-day PROVING THE DEVICE Comment k’s allo- ONUS OF would discard regime cation-of-proof that now casts the REASONABLY SAFE NOT probandi on manufacturers.19 onus jurispru Mainstream complete accord While not with some dence, ‍‌​‌​‌​​‌‌‌‌​‌‌​​‌‌​‌‌​​​‌​‌​‌​​‌​​‌‌‌​‌‌‌‌​​​​​‌‍just today’s pronouncement, gener as evolving jurisprudential trends and with the ally interprets Comment to create a manu underpinnings likely to influence intellectual facturer’s Section 8 affirmative defense.17 Restatement, today’s opinion is en- the next dramatically depart concept. from this would tirely with the mainstream of consistent proof in its It would transfer the burden present-day k case law. I hence Comment entirety plaintiff-user of the device. cоncur. approach taken in those Its text mirrors jurisdictions high require threshold liability may test be deemed estab before summary judgment stage

lished at the short, § 8 would reallocate the

case.18 536-537; 15, Moore, Okl., 21, (1982). Reyes, supra F.2d at note 498 F.2d 14. McKeev. 648 P.2d Givens, 1277; 15, supra note 556 F.2d at 1345. at 8(d)(2), pertinent provisions § 15. For the Re- Report- supra see note 5. The (Third), statement Laboratories, 1064, 17. v. Searle 884 F.2d Hill Note, (direct warning pa- e er’s Comment (8th Cir.1989); Systems, Larsen v. Pacesetter tients), many explains that of the cases in this 1, 1273, 74 Haw. 1285-1286 category deal with vaccines administered en clinics, public citing masse at health Givens v. Lederle, (5th Cir.1977) (applying 556 F.2d 1341 Labs., law); Note, f, 8, Reyes Wyeth Florida Reporter's § 18. See Comment Restate (5th law); Cir.1974) (applying Texas Davis citing supra note Williams v. (Third), ment Labs., (9th Cir.1968) Wyeth (ap- F.2d 121 Ciba-Geigy Corp., F.Supp. 577-579 law). plying Idaho For a criticism of the inclu- (W.D.La.1988), aff'd, 864 F.2d 789 Cir. Note, Reporter's sion of these cases in the see 1988). Kaplan, supra 5. note Note, f, 8, Reporter’s 19. Restatement Note, Reporter's g, § 16. Restatement (Third), supra note 5. Tobin, 5; supra supra note note (Third),

Case Details

Case Name: Tansy v. Dacomed Corp.

Court Name: Supreme Court of Oklahoma

Date Published: Dec 20, 1994

Citation: 890 P.2d 881

Docket Number: 80662

Court Abbreviation: Okla.