# Opposition — Haste v. American Home Products Corp. > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40385005_1702%3A2 ## Record - **Collection:** Supreme Court brief - **Document type:** Opposition - **Published:** January 1, 1978 - **Citation:** 439 U.S. 955 ## Text eee eae en “we ar Core ? id Supreme VOUTL, U 2 107f IN THE SUPREME COURT OF THE uNrreD SrATES October Term, 1978 \EL R@DAK, JR., CLE No. 78-429 WILLIAM and MAXINE HASTE, Petitioners Ve AMERICAN HOME PRODUCTS CORPORATION, Respondent. ON PETITION FOR A WRIT OF CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR THE TENTH CIRCUIT BRIEF FOR THE RESPONDENTS IN OPPOSITION GLENN PARKER HIRST & APPLEGATE 200 BOYD BUILDING CHEYENNE, WYOMING 82001 COUNSEL FOR RESPONDENT BYRON HIRST, JAMES L. APPLEGATE, and THOMAS N. LONG 200 Boyd Building Cheyenne, Wyoming 82001 and LEWIS PERKISS 685 3rd Avenue New York, New York 10017 OF COUNSEL f FILED INDEX Opinion Below .... .- Statement of the Case . Summary of Argument . . Argument . . « »« »« « « 1. The Tenth Circuit Did Not Make A Finding Of Fact Unproven In The Record... 4 2. The Tenth Circuit Decision Is Not In Conflict With Decisions Of Other Circuits Or 21 U.S.C. §353(b)(2). 3. There Is No Conflict Among The Tenth Circuit » did Decision And The Decisions Of Other Circuits And State Courts In Evaluating The Duty To Warn Where Advertising Is Involved. CONGLUBAOGR «4 1 6 ss * Appendix . « « « « « e Reply Brief of Appellant and Cross-Appellee ... (1) s 83 - 29 -App. -App. 1 1 AUTHORITIES CITED CASES: Beauharnais v. Illinois, 343 U.S. 250, 96 L.Ed. 919, 72 S. Ct. 725, (1951), reh. den. 343 U.S. 988, 96 L.Ed. 1375, 72 S. Ct. 1070 (1952) e o . . . ° e . e ° 6 California v. Taylor, 353 U.S. 553, o07 (1957). ° ° ° ° . ° ° ° | Colorado Serum Co. v. Arp, 504 P.24 801 (Wyo. 1972) . . ++ + + 13 Davis v. Wyeth Labortories, Inc., 399 F.2d 121, 130 (9th Cir. 1968) .« « «© «© «eo © w © © © co © «61617, 18,19, 20,22 Desper v. Starved Rock Ferry Co., 342 U.S. 187, 96 L.Ed. 205, 72 S. Ct. 216 (1951), reh. den. 342 U.S. 934, 96 L.Ed. 695, 72 S. Ct. S76 (i9SS)< + we he ee eh First National Bank v. Ford, 216 P. 691, 30 Wyo. 110 (1933) . 15 Gravis v. Parke-Davis & Co., 502 S.W.2d 863 (Tex. App. 1973) . 21,22, Haste v. American Home Products Corp., 577 F.2d 1122, 1124, 1125 (10th Cir. 1978). . * e e ° ° e ° 1,10, 11,14 22,28 Heirs of Fruge v. Blood Services, 365 F.Supp. 1344, 1350 (W.D.La. SUTel* 6 4 4° O93 Se sO a a Oe (ii) Helvering v. Fuller, 310 U.S. 69, 84 L.Ed. 1082, 60 S. Ct. 784 (1939) e eo ° . 7 . e . . . eo . . 6 Helvering v. Tex-Penn Oil Co., 300 U.S. 481, 81 L.Ed. 755, 57 S. ce. 569 (1936) . . ° e ° . . . 6 Incollingo v. Ewing, 444 Pa. 263, aus Meee Gee CAPTAls + s « 4 « «© 36,26 Kay v. United States, 303 U.S. 1, 82 L.Ed. 607, 58 S. Ct. 568 (1937) ° . ° . . ° . ° ° ° ° ° ° 6 Lanasa Fruit S.S. & Importing Co. v. Universal Ins. Co., 302 U.S. 556, 82 L.Ed. 422, 58 S. Ct. 371 Bes ys ee ee ey ee ee Lawn v. U.S., 355 U.S. 339, 362-363 (1957) ° ° . ° . . . . e 5 Love v. Wolf, 249 Cal. App. 2d 822, 58 Cal. Rptr. 42 (3rd Dist. Cl. App. 1967) « «= 2 es «+ 26,35 Love v. Wolf, 266 Cal. App. 2d 378, 38 Cal. Rptr. 183 (3rd D.C. MPs £906). «© «6 oe © tt el ee st hl el| 6S 2 Maxted v. Pacific Car & Foundry Co., 527 P.2d 832 (Wyo. 1974). . 13 Michel v. Louisiana, 350 U.S. 91, 100 L.Ed. 83, 76 S. Ct. 158 (1955), reh. den. 350 U.S. 955, 100 L.Ed. 831, 76-S. Ct. 340 6) Be ee ae ae ee ee (iii) Reyes v. Wyeth Laboratories, Inc. 498 F.2d 1264 (5th Cir. 1974). . 17,18 20,22 Ruhlin v. New York Life Ins. Co., 304 U.S. 202, 58 S. Ct. 860, ge OE eS | re be Singer v. Sterling Drug, Inc., 461 F.2d 288 (7th Cir. 1972) .. 16 Sonzinsky v. United States, ° 300 U.S. 506, 81 L.Ed. 772, 57 Se Ct. 554 (1936) . ~. «© «© «© «© « «© 6 Sterling Drug, Inc. v. Cornish, 370 F.2d 82, 85 (8th Cir. 1966). 20 Sterling Drug v. Yarrow, 408 F.2d 976 (Gth Cir. 1969). « « « © « «© 24,27 Stevens v. Parke Davis & Co., 107 Cal. Rptr. 45, 507 P.2d 653 (1973) . . . . . . . . . . . . . 24,27 Youakim v. Miller, 96 S. Ct. 1399 (1976) . . . . . . . . . . . . . 5 MISCELLANEOUS: 21 U.S.C. §352(n) . 8 6 6 6 ae a. Saweme Memeekt@ls « « 2:8 « « 2 2l Fe § 353 >. .* . . . . >. >. 2 Be Weteee Baoeeemitay « « « « « « 12,34 32 Am. Jur. 2d Federal Practice 6 Proceagure S297. <2 « «© «© ee 8 4 C.J.S. Appeal and Error §228 . uw Dixon, Drug Product Liability §9.02[2] . . . . . . . . . . 20 (iv) IN THE SUPREME COURT OF THE UNITED STATES October Term, 1978 No. 78-429 WILLIAM and MAXINE HASTE, Petitioners Ve . AMERICAN HOME PRODUCTS CORPORATION, Respondent. BRIEF IN OPPOSITION TO PETITION FOR A WRIT OF CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR THE TENTH CIRCUIT OPINION BELOW The Court of Appeals' Opinion has now been published and is7~ reported, Haste v. American Home Products Corp., 577 F.2d 1122 (10th Cir. 1978). STATEMENT OF THE CASE Petitioners' statement of the case is Slanted, argumentative and omits important circumstances established by the evidence, necessitating a statement by Respondent, which can probably be best done by quoting from Respondent's Appeal ale and Reply Brief, which were not challenged in the Court of Appeals: "In 1970 Mr. and Mrs. William Haste, Meeteetse, Wyoming, ranchers, running some 250 head of Santa Ger- trudis type cattle, had a problem when some of their cows became af- flicted with what their veterinarian, Dr. Humphreys, diagnosed as anaplas- mosis. They talked to him about vaccinating with Anaplaz, a vaccine dispensed by Defendant, if they had more trouble in the future. He advised of the possibility of Neonatal Isoerythrolysis in calves from the use of the vaccine and they did nothing about vaccinating at that time. In May of 1971 Hastes had Dr. Humphreys vaccinate two of their bulls with Anaplaz. Later that year they bought 45 head of Angus cows from an area infested with anaplasmosis and after they had lost 28 cows from that disease, they secured Anaplaz vaccine from Dr. Roberts, another of their ‘regular veterinarians', who also explained to them the possibility of the side effects of NI in calves of the vaccinated cows. They vaccinated cows themselves, after reading the warning and directions on and in the containers, each package bearing on the outside a prominent caution sign reading "Caution; See Enclosed Leaflet Concerning Possible Risk In Vaccinating Breeding Females.' (Ex. L, R. Vol. VII, Ex. App. p. 122). The Hastes also read the cautionary ae Statement on the inside of the package. "Thereafter they lost no cows from anaplasmosis, but after two booster shots of vaccine, the last of which was secured in 1973 from another of their ‘regular veterinarians', Dr. Lester, a number (39) of their calves died of a disease which was diagnosed as NI. . "Plaintiffs had a marginal opera- tion of crossbreed cattle (Santa Gertrudis), which were particularly susceptible to anaplasmosis." "Anaplaz, a vaccine against anaplasmosis could be procured only from veterinarians all of whom had been advised by American Home that the vaccine might cause NI in calves of vaccinated animals. .. ." "The vaccine which Plaintiffs purchased had a prominent red warning on the outside and also had a clear understandable warning on the inside that detailed the risk to one using the product. The Hastes admitted that they read and understood such warning.” SUMMARY OF ARGUMENT l. Petitioners' "finding of fact unproven" argument was not raised below and is specious. The Tenth Circuit adopted the Trial Court's supported finding that Anaplaz, procurable only -3- through veterinarians, should be governed by the “prescription drug" doctrine. 2. The Tenth Circuit decision by extending the "prescription drug" doc- trine to Anaplaz, because it is dispensed in a manner similar to the sale of pre- scriptions, is not in conflict with deci- Sions of other circuits or with federal Statutes regarding "prescription drugs." No circuit has held that the "prescrip- tion drug" doctrine applies only to those products defined in 21 U.S.C. §353. 3. There is no conflict among the decisions of the circuit courts regarding the effect of advertising on the duty to warn. Also this argument was not raised by Petitioners below. No circuit has imposed a duty to warn the public on a drug manufacturer when all physicians have been adequately warned. 1. THE TENTH CIRCUIT DID NOT MAKE A FINDING OF FACT UNPROVEN IN THE RECORD. Petitioners criticize the Court of Appeals for "making a finding of fact unproven in the record", saying “at the trial no substantial evidence of any sort -4- waS presented to prove that Anaplaz was considered a prescription drug." Such a criticism is unwarranted and provides no basis for a consideration of the matter by this Court for. several reasons: (a) Respondent on page 10 of its brief to the Court of Appeals. said, "Judge Winner in his opinion has agreed with Defendant that Anaplaz is to _ be considered a prescription drug." (R. Vol. IV, p. 1352, App. p.32) Petitioners did not challenge this as being unsuppor- ted by the evidence, in either’ their briefs or oral argument to the Court of Appeals. (Their original Brief relates only to damages. For their Reply Brief see Appendix pages 1-35). They cannot raise the question now. It is well established that this Court will refuse to consider claims not made below. 32 Am. Jur. 2d Federal Practice & Procedure §297; 4 C.J.S. Appeal and Error §228; Youakim v. Miller, 96 S. Ct. 1399 (1976); California v. Taylor, 353 U.S. 553, 557 (1957); Lawn v. -5- U.S., 355 U.S. 339, 362-363 (1957); Michel v. Louisiana, 350 U.S. 91, 100 L.Ed. 83, 76 S. Ct. 158 (1955), reh. den. 350 U.S. 955, 100 L.Ed. 831, 76 S. Ct. 340 (1956); Beauharnais v. Illinois, 343 U.S. 250, 96 L.Ed. 919, 72 S.Ct. 725 (1951), reh. den. 343 U.S. 988, 96 L.Ed. 1375, 72 S. Ct. 1070 (1952); Desper v. Starved Rock Ferry Co., 342 U.S. 187, 96 L.Ed. 205, 72 S. Ct. 216 (1951), reh. den. 342 U.S. 934, 96 L.Ed. 695, 72 S. Ct. 374 (1952); Helvering v. Fuller, 310 U.S. 69, 84 L.Ed. 1082, 60 S. Ct. 784 (1939); Kay v. United States, 303 U.S. l, 82 L.Ed. 607, 58 S. Ct. 568 (1937); Lanasa Fruit S. S. & Importing Co. v. Universal Ins. Co., 302 U.S. 556, 82 L.Ed. 422, 58 S. Ct. 371 (1937); Sonzinsky v. United States, 300 U.S. 506, 81 L.Ed. 772, 57S. Ct. 554 (1936); Helvering v. Tex-Penn Oil Co., 300 U.S. 481, 81 L.Ed. 755, 57 S. Ct. 569 (1936). (b) The statement of Judge Winner "Moreover, for the purposes of resolution of this case, I accept Defendants' arguments that Anaplaz and its sale should be treated as -6- the sale of a prescription drug, albeit the record is. short a few elements of proof of a true prescription drug." [Emphasis sup- plied] (Petitioner's App. p.42) is, in reality a finding of fact, based on evidence that Anaplaz is sold under circumstances which are sufficient to invoke the "prescription drug" doctrines. The Tenth Circuit did no more than repeat this finding. Petitioners have failed to consult the record when they say, "At the trial no_- substantial evidence of any sort was presented to prove that Anaplaz was considered a_ prescription drug." Dr. Roberts when asked by Judge Winner, "Did you write a prescription for it?" answered, "No. It is not required to write a prescription for it." (R. Vol. X, p.- 40), and at another point said, "I don't feel that I have to write a pre- scripton to sell this product" (R. Vol. X, p. 41). However, at another time he conceded that the Hastes could not pur- chase the vaccine themselves from Fort -7- Dodge, as he said, "because this is sold to veterinarians only." (R. Vol. X, DP. 45). Dr. Lester, another of the Hastes' "regular veterinarians", when asked, "Dr., what kind of a drug is Anaplaz, what kind of a vaccine is Anaplaz according to your knowledge or informa- tion?" answered “It is a prescription drug." [Emphasis supplied] (R. Vol. X, p. 105) Dr. Searl, a veterinarian employed by Defendant, when asked about the restric- tions with respect to Anaplaz answered, "Anaplaz is a veterinary prescription biological product." When counsel queried, ". . . at least that is what you think it is", Dr. Searl responded, "That's what I know it is, and it is sold only to licensed veterinarians and to no one else, including M.D.'sS. And as with a prescription biological, there are requirements and obligations when he gets it as to what he does with it." (R. Vol. XIII, pp. 182, 183). The Anaplaz carton and package insert clearly stated: @8-= "Warning: Restricted by the U.S. Department of Agriculture to use by or on the order of a licensed veterinarian." (Ex. L, R. Vol. VII; Ex. 24, R. Vol. VI) As indicated on the package and insert, the Department of Agriculture restricts the use of Anaplaz to veterinarians in much the same way that the Food and Drug Administration restricts use of human prescription drugs to physicians. In both cases it is clear that the purpose of the restrictions is to prevent the public at large from having direct access to those medical products which are too complex for lay use and for which the layman does not have the training or knowledge to know when, where and how to use or not use the product. Thus, there was before the trial Court substantial evidence that Anaplaz waS a prescription type drug sold only on the order of a veterinarian, and the Statement of Judge Winner, when fairly interpreted, was a fully supported finding of fact that ". . . Anaplaz and its sale should be treated as the sale of -9- a prescription drug." (Petitioners' App. p.42) (c) If the sentences of the Circuit Court opinion are not isolated in the analysis, they fairly reflect the trial Court's finding: "The trial Judge acknowledged that the drug was a ‘prescription drug.' The Anaplaz vaccine was only available from veterinarians, and Plaintiffs obtained the dosages here concerned from their veterinar- ians. In this aspect of the case, it makes no difference whether the drug was compounded by the defendant or by a pharmacist. Since it is a prescription drug, the doctrines applicable thereto must be applied, and the trial Court was in error in not doing so." Haste v. American Home Products Corp., 577 F.2d 1122, 1124, (10th Cir. 1978). "The records shows the typical ‘prescription drug' sequence of events: The Hastes had livestock exposed to anaplasmosis from new stock they had brought into the herd; they became interested in Anaplaz from the ads in the live- stock magazines; they consulted their ‘regular' veterinarians (two of them) before making a decision as to what to do; they received typical medical advice; they balanced the risks; they decided to have the alGie Anaplaz ordered by Dr. Roberts (a veterinarian was the only source); they received it from him; they read and understood the leaflets, and used it. Their veterinarians were knowledgeable on the problem, and were well advised by defendant as to the risks. In this chain or se- quence of events, the defendant discharged its duty to plaintiffs by the warnings to the veterinarians." Haste v. American Home Products COfG., St! sae Lh88, 4445 [itn Cir. 2078). It is submitted that the West head- note 2 well summarizes the Court of Appeals holding: "Products Liability. Where cattle vaccine in question was only available from veterinarians, and cattle breeders obtained dosages for their herd from their veterinarians, vaccine was "prescription drug," regardless of whether it was compounded by manufacturer or by pharmacist, and prescription drug doctrines were applicable in prod- ucts liability action arising out of use of vaccine." Haste v. American Home Products Corp., 577 F.2d 1122 (lOth Cir. 1978) Petitioner's did not raise the point before the Court of Appeals, so that the sufficiency of the evidence to support Judge Winner's acceptance could there -ll- have been determined. They cannot now avoid the fact that both the trial Court and the Court of Appeals have held that the vaccine, because it could be procured Only through doctors, should be governed by the doctrines applicable to prescription drugs. 2. THE TENTH CIRCUIT DECISION IS NOT IN CONFLICT WITH DECISIONS OF OTHER CIRCUITS OR 21 U.S.C. §353(b) (2). It should be noted initially that Petitioners base their second and third grounds for review upon a purported con- flict of opinions among the Circuit Courts of Appeal. However, all cases mentioned by Petitioners were brought as diversity actions involving application of the law of California, Illinois, Montana, Pennsylvania, South Dakota or Texas. In this action, the Tenth Circuit acknowledged that Wyoming law is control- ling and that the matter must_ be =} 2e ——— considered in light of such Wyoming decisions as Maxted v. Pacific Car & Foundry Co., 527 P.2d 832 (Wyo. 1974) and Colorado Serum Co. v. Arp, 504 P.2d 801 (Wyo. 1972). Petitioners have not cited a conflict between the Tenth Circuit Opinion and other reported cases involving Wyoming law. The decision of the Tenth Circuit is Supportable as a matter of Wyoming state law, as Respondent herein contends, and thus any "conflict" (which Respondent denies in the argument below) may be the result of differing state laws and does not warrant the extraordinary relief sought by Petitioners, Ruhlin v. New York Life Ins. Co., 304 U.S. 202, 58 S. Ct. 860, 82 L.Ed. 1290 (1938). Furthermore, Petitioners do not_~ raise important questions of federal law nor any issues of constitutional dimension. Petitioners have cited no conflict between the Tenth Circuit Opinion and any decisions of this Court. Petitioners merely seek review to obtain a reversal of the Tenth Circuit Opinion for their own private benefit. -]13- The Court of Appeals actually adopted the finding of Judge Winner that, "Anaplaz and its sale should be treated as the sale of a prescription drug" (Petitioners' App. p. 42) [Emphasis supplied] and stated as its reason the fact that "The Anaplaz vaccine was only available from veterinarians, and Plaintiffs obtained the dosages here concerned from their veterinarians." Haste v. American Home Products Corp., 577 F.2d 1122, 1124 (10th Cir. 1978). Neither Court, by fair analysis, said that Anaplaz was a prescription drug within the meaning of 21 U.S.C. §353(b), nor could they have properly done. so, Since that statute specifically limits the "prescription by physician" to "the drug intended for use by man .. ." [Emphasis supplied]. Certainly Congress adopting 21 U.S.C. §353(b6)(2) did not intend it to apply to animals. A fair reading of Judge Winner's Opinion and that of the Court of Appeals indicates that neither meant to say that Anaplaz was in fact a prescription drug -14- but rather that it bore the characteris- tics of a prescription drug, which cir- cumstance justified its being treated as One, Since it could be procured only from a doctor, familiar with diseases, their prevention or cure, and familiar with the circumstances of his patients who may have need of the drug. It must also be be cne in mind that Dr. Roberts was not the only veterinarian who testified concerning Anaplaz as a prescription drug and that Dr. Lester Said unequivocally, "It is a prescription drug." Also, aS waS pointed out at page 6 of Respondent's Court of Appeals Reply Brief, which was unchallenged by Petitioners, Dr. Searl testified that the "Dear Doctor" warning letters were sent to all veterina- rians (R. XIII, p. 180). There is a pre- Sumption that they were received, First National Bank v. Ford, 216 P. 691, 30 Wyo. 110 (1933), and the District Court adopted this presumption (Petitioners' App. p. 42). That presumption is unrebutted here. =} 5= Further, Dr. Humphreys discussed the "Dear Doctor" letters in his testimony (R. Vol. X, p. 23) and indicated that he had seen these as_ well as like publications containing warnings. The District Court found that these letters to veterinarians ", . « recognized the risk of N.I.,.. ." (Petitioners' App. p. 36). In this light, discussion of the cases cited by Petitioners in this sec- tion is relevant and desirable. Singer _v. Sterling Drug, Inc., 461 F.2d 288 (7th Cir. 1972) was a case where the drug manufacturer failed to give notice of the danger to the doctor, who gave an oral prescription to pharmacists, ana where there was no evidence of a warning to the user, except that she stay out of the sun. Here there was positive evidence that the veterinarians were warned, that they relayed the warnings to the Hastes and additionally the Hastes read the written warnings on and in the vaccine packaging. Davis v. Wyeth Laboratories, Inc., 399 F.2d 121 (9th Cir. CA 1968) dealt with a human vaccine for polio, dispensed -l16- in mass clinics where individual consul- tations between patient and doctor were non-existent. The Court held that under such a situation there was no sufficient warning to a customer who had no contact with a physician who had received the warning. However, that Opinion contained a statement at page 131 which is signifi- cant in the present case: "When drugs are sold over the counter to all comers’ warnings normally can be given by proper labeling." The Hastes admitted the reading of the warnings on the outside of the Anaplaz package as well as that contained in the inserts. (R. Vol. XI, pp. 50, 51) In Reyes v. Wyeth Laboratories Inc., 498 F.zd 1264 (5th Cir. 1974), a case which also dealt with oral polio vaccine, the Court affirmed a judgment for the Plaintiff citing Davis v. Wyeth Labora- tories of the 9th Cir., supra, holding that where the laboratory marketed unavoidably unsafe trivalent oral polio vaccine and failed to provide parents of infants with either warning of risk or -l17- individualized medical judgment it was liable for failing to warn. Both of the Wyeth cases are consistent with the hold- ing of the Court of Appeals in Hastes. Petitioners' conclude that, on the Strength of the Davis case, "if the drug is not dispensed by filling and refilling a prescription, warning must be given to the consumer directly by the most reasonable means available to adequately inform the user of the risks." The Court of Appeals decision, as already pointed out, noted the Hastes read and understood the written warnings which the vaccine package contained, and as to that from the veterinarians stated succinctly: "The trial Judge considered and evaluated the warnings’ given Plaintiffs by the veterinarians, and found them minimal. However, the record shows that the veterinarians were well aware of the risks. They had adequate advice as to the risks from Defendant. These were- the ‘warnings’ which are significant for prescription drugs, and thus- con- trolling here. There were no fact questions as to these warnings." -18- Certainly the Haste decision followed, rather than departed from the holding in Davis v. Wyeth. The line of cases which reflect the "prescription drug" doctrine do not focus on whether the product is in fact a "pre- scription drug" within the meaning of the federal statutes and regulations, nor on whether the sale of the drug is adminis- tered strictly through doctor's prescrip- tion and subsequent purchase from a phar- macist. The key factor cited by the courts is the contact between the consu- mer and a licensed practitioner who has received warnings from the manufacturer and who is’ familiar with the circum- Stances of his patients. The one-to-one contact permits the licensed practitioner to give sound advice to the consumer regarding a decision within his field of practice. "Ordinarily in the case of prescrip- tion drugs warning to the prescrib- ing physician is sufficient. In such cases the choice involved is essentially a medical one involving an assessment of medical risks in ~19— light of the physician's knowledge of his patient's needs and susceptibilities." Davis v. Wyeth Laboratories, Inc., 399 F.2d 121, t ir. ). "In such a case the purchaser's doctor is a learned intermediary between the purchaser and the manu- facturer. If the doctor is properly warned of the possibility of a side- effect in some patients, and is advised of the symptoms normally accompanying the side-effect, there is an excellent chance that injury to the patient can be avoided." Sterling Drug, Inc. v. Cornish, 370 F.2d 82, 85 (8th Cir. 1966) "The universal view is that a warn- ing in a prescription drug should be made to the prescribing practition- er, because he is in the theoretical position of being able to evaluate and balance the dangers of the drug against the utility from the drug." Dixon, Drug Product Liability, §9.02([2]. Certainly non-prescription drugs can be dispensed under circumstances in which a “learned intermediary" is involved, and can therefore fall into the category of "prescription drugs" for the purpose of determining to whom the manufacturer's warning should be directed. This has =~2@= been recognized in existing case law, and therefore the Tenth Circuit opinion is not in conflict with other opinions by extending the “prescription drug" doc- trine to products which are not prescrip- tion drugs under federal Statutory definitions. For example, in Heirs of Fruge v. Blood Services, 365 F.Supp. 1344 (W.D.La. 1973), the court noted at page 1350 that blood products are ". . . analogous to ‘prescription only' drugs . - -" and proceeded to apply the general rule that, in Situations where a product can be obtained only through a physician, only the physician need be warned. Similarly, in Gravis v. Parke-Davis §& Co., 502 S.W.2d 863 (Tex. App. 1973), the court noted that the product’ involved therein, an anesthetic, wasS available Only upon order of a physician, and went on to hold: "The laws and regulations prevent prescription type drugs from being purchased by individuals without the advice, guidance and consent of li- censed physicians and pharmacists. These professionals are in the best position to evaluate the warnings put out by the drug- industry." -2li- (Emphasis supplied) Gravis v. Parke-Davis & Co., 502 S.W.2d 863, 870 (Tex. App. 1973). It is equally clear that when the "“"lear- ned intermediary" is not involved in a sale of a drug to consumers, the mere fact that the product involved is a pre- scription drug within the meaning of federal statutes will not permit’ the product's manufacturer to invoke the protection of the "prescription drug" doctrine. In Davis, supra. and Reyes, supra., the Sabin Type III oral polio vaccine was indeed a prescription drug within the meaning of the federal statutes, but nevertheless a warning to the physician was insufficient where the physician did not fill the role of "learned intermediary." The Tenth Circuit Opinion likewise focused on the presence of the ". . . typical ‘prescription drug' sequence of events . . .", Haste v. American Home Products Corp., 577 F.2d 1122, 1125 (10th Cir. 1978). The Tenth Circuit Opinion is therefore in harmony with the other cases -22- which form the basis of the "prescription drug" doctrine, and there exists no con- flict among the circuits which would warrant the issuance of ae writ of certiorari. 3. THERE IS NO CONFLICT AMONG THE TENTH CIRCUIT DECISION AND THE DECISIONS OF OTHER CIRCUITS AND STATE COURTS IN EVALUATING THE DUTY TO WARN WHERE ADVER- TISING IS INVOLVED. Petitioner erroneously claims there is a conflict among the circuits’ and State courts concerning the effect of advertising on the duty to warn. Petitioner also cites a conflict between the Tenth Circuit decision and federal law. It should again be noted that the federal laws regarding advertising of prescription drugs, 21 U.S.C. §352(n) and 21 C.F.R. §202.1(e), are not applicable to Anaplaz because it is not a prescrip- tion drug within the meaning of 21 U.S.C. §353. Thus no actual conflict or erron- eous ruling of law exists in this regard which would call for review by this Court. Furthermore, Petitioners' -23- argument regarding federal statutory advertising requirements was not raised in the Court below, being nowhere found in the Petitioners' Tenth Circuit Reply Brief attached hereto at Appendix pp. 1-35, and should not be considered by this Court. The cases cited by Petitioners for the proposition that a seller's over- promotion of a drug mitigates the warn- ings otherwise given to practitioners are not on point and are not in conflict with the opinion of the Tenth Circuit Court of Appeals. In all four cases (Love _ v. Wolf, 249 Cal. App. 2d 822, 58 Cal. Rptr. 42 (Ct. App. 1967); Incollingo v. Ewing, 444 Pa. 263, 283 A.2d 206 (1971); Stevens v. Parke Davis & Co., 107 Cal. Rptr. 45, 507 P.2d 653 (1973); and Sterling Drug v. Yarrow, 408 F.2d 978 (8th Cir. 1969)) the Courts were dealing with situations involving over-promotion of a prescription drug to a physician. The cases did not involve advertising directed to the public. The trial court in this action did not find that American Home _ had directed its advertising to the -24- veterinarians, but rather found that it had directed its advertising toward cattlemen, Petitioners' Appendix pp. 35, 42. In Love v. Wolf, 249 Cal. App. 2d 822, 58 Cal. Rptr. 42 (Ct. App. 1967) the Court noted at 58 Cal. Rptr. 49, 249 Cal. App. 2d 832, 833, that the doctor's state of mind is an important factor, particularly as it is affected by the drug manufacturer. The Court found that the warnings to the doctor were inadequate and that the drug manufacturer was aware of the inadequacy. The Court concluded that over-promotion of the drug to the doctor was one factor in the inadequacy of the warnings. In this case, the District Court did not find that American Home gave inadequate warnings to the veterinarians, nor did it find that there was any over-promotion of the drug to the veterinarians, nor did it find that American Home was aware of any inadequacy in the warnings given. to veterinarians. It should further be noted that in an earlier case involving the same parties and facts, Love v. Wolf, -25- 266 Cal. App. 2d 378, 38 Cal. Rptr. 183, Ct. App. 1964), the Court had held that the drug manufacturer only had a duty to warn the doctor: "Parke-Davis has no contact with the ultimate consumer of this drug, the patient. The duty, therefore, whatever its extent may be, must be a duty to warn the doctor’ who prescribes the drug. This would be the only effective means by which warning could help the patient." Love v. Wolf, 38 Cal. Rptr. 183, —-——_- 192, 266 Cal. App. 2d 378 (Ct. App. 1964). In Incollingo v. Ewing, 444 Pa. 263, 283 A.2d 206 (1971), again there was Over-promotion of the drug to the doctor, but there was no advertising to’ the public. The court held that ". . . the warning required is not to the general public or to the patient, but to the pre- scribing doctor." The Court went on to find that the warnings given doctors were inadequate in light of the manufacturer's knowledge and were further nullified by the representations of "detail men" which amounted to over-promotion of the drug. Again, distinquishing the present case _ from Incollingo are the absence of a finding that advertising was directed to the physician, and the absence of a finding that warnings actually given to the veterinarians were inadequate. In Stevens v. Parke-Davis & Co., 107 Cal. Rptr. 45, 507 P.2d 653 (1973) the Court found that warnings to doctors were inadequate because they had been "watered down" by over-promotion of the drug to the doctors. Again, no duty to warn the public was involved, but rather a finding that a duty to warn the doctors had not been fulfilled. In the present case, the District Court did not find that American Home had failed to adequately warn the veterinarians. In Sterling Drug v. Yarrow, 408 F.2d 978 (8th Cir. 1969) the Court repeated the standard "prescription drug” doctrine that a warning need only be given to doctors. However, again the drug manu- facturer's "detail men" failed to point out the side effects of the drug, and the Court found that such failure amounted to a failure to give adequate warning to the -27- doctors of the possible side effects. Again, no advertising was directed to the public and no duty to warn the public was established. The District Court held here that there is a duty to warn the consumer directly when advertising is aimed at the consumer: "I think that the direct sales effort (even though the product was channeled through veterinarians) imposed on Defendant a duty to warn the ultimate consumer’ before he spent his money on the purchase." (Petitioners' App. 43, 44.) The Tenth Circuit held that it was error to ignore the warnings given to veteri- narians and to impose such a duty: "The Trial Court was in error in holding that the contents of the advertisements of Anaplaz in the various livestock publications are controlling on the warnina issue, and thus override the practical considerations which arise from the requirement that the consumer purchase the vaccine only from veterinarians, and override the established "prescription drug' doctrines." Haste v. American Home Products Corp., 577 F.2d 1122, 1125 (1lOth Cir. 1978). -28< American Home in its Appeal Brief stated that the duty imposed by the District Court iS unsupported in the law. In the Tenth Circuit, Petitioner was unable to point out any law in support of such a duty. The cases now cited by Petitioner can only stand for the proposition that advertising directed to physicians must be considered in determining the adequacy of warnings given to the physician, and they cannot be considered as support for the proposition that there is an absolute duty to warn consumers in advertising directed to the consumer when adequate warnings have been given to physicians. Here all of the advertising directed to the consumers advised them to first consult their veterinarian; the veteri- narians were warned by American Home and these warnings were also relayed to the Petitioners when they consulted with their “regular veterinarians" regarding vaccinating with Anaplaz. CONCLUSION The Tenth Circuit Court of Appeals did not make a "finding of fact unproven in the record," nor is its decision in =-29< conflict with the decisions of other cir- cuits or with federal law. The Petition- ers have raised spurious arguments in order to obtain review by this Court of their private grievance which involves no questions of federal or constitutional import. The Petition for a Writ of Certiorari should be denied. Respectfully Submitted, SLENN PARKER HIRST & APPLEGATE 200 Boyd Building Cheyenne, Wyoming 82001 BYRON HIRST, JAMES L. APPLEGATE, and THOMAS N. LONG 200 Boyd Building Cheyenne, Wyoming 82001 and LEWIS PERKISS 685 3rd Avenue New York, New York 10017 OF COUNSEL b October 1978 «3@0 UNITED STATES COURT OF APPEALS TENTH CIRCUIT Nos. 76-2015 and 76-2016 WILLIAM HASTE and MAXINE HASTE, Plaintiff-Appellant and Cross-Appellee, VS. AMERICAN HOME PRODUCTS CORPORATION, Defendant-Appellee and Cross-Appellant. ) ) ) ) ) ) ) ) ) ) ) ) ) REPLY BRIEF OF APPELLANT AND CROSS-APPELLEE BADER & DUFTY Pamela N. Hultin 600 Boston Building 828 - 17th Street Denver, Colorado 80202 ATTORNEY FOR PLAINTIFF- APPELLANTS August 10, 1977 App. p. l TABLE OF CONTENTS Brief (App.) Page Page ISSUES PRESENTED .. . « « «© «© « ef (5) STATEMENT OF THE CASE ....e. 2 (6) ARGUMENT . . «© © © © ew ew ee ow oe eG (8) I. Computation of cows was in CCfOE« « 2 + s+ ss + we « 2 6 (8) II. Upgrading program damages. .5 (9) Itz. Oxhibite 91 and 92. « « » of (12) IV. Increased Feed Costs ... .8 (13) 7, Gaesatiowh s » + a i « « o » wf (13) VI. Waerning®S . . «© «6 » «© © «© « ohh (18) VII. Contributory Negligence and Assumption of the Risk. . .16 (25) VIII. Limitation of Implied Warranty. «© « « s «6 « « « «40 (32) IX. Unusual Susceptibility ... (33) CONCLUSION ° ° . ° ° ° . . ° ° . 022 (34) App. p.2 TABLE OF CASES CITED Brief(App.) Page Page Elder v. Crawley Book Machine Co, 441 F.20 771 (3rd Cir. 1971). . .18 (27) Ferraro vs. Ford Motor Co., 423 Pa. 324, 223 A.2d 746 (1966) .18 (29) Love vs. Wolf, 226 Cal. App. 2d 378, 38 Cal.Rptr.15 .(24) Ralston’ vs. Illinois Power Co., 299 @U.W. 24 497 (Ill. 1973) « « « 19 (36) Stevens vs. Parke Davis and Co., 507 P.2d 653 (Calif. 1973) « « « 83 €23) Vernon vs. Lake Motors, 466 P.26 362 (Utah. i971) « « « « @ (31) OTHER AUTHORITIES STATUTES Wyoming Statutes Section 34-2-316 ° ° ° *- 2°© ° 20 (32) PUBLICATIONS United States Department of Agriculture release dated December 29, 1969 .14 (21) Restatement of Torts 2d Section 496A, Comment d.. .18 (28) Section 496C, Comment e .. .18 (28) Section 496D, Comment c.. .18 (28) Section 496E, Comment a... .18 (29) App. p. 3 UNITED STATES COURT OF APPEALS TENTH CIRCUIT Nos. 76-2015 and 76-2016 WILLIAM HASTE and MAXINE HASTE, Plaintiff-Appellant and Cross-Appellee, AMERICAN HOME PRODUCTS CORPORATION, De fendant-Appellee ) ) ) ) ) ) vs. ) ) ) ) ) ) and Cross-Appellant.) REPLY BRIEF OF APPELLANT AND CROSS-APPELLEE This reply brief is submitted in rebuttal on the issues presented in the Opening brief of Appellee and Cross- Appellant. Appellant and Cross-Appellee responds first to the Appellee and Cross- Appellant's rebuttal regarding the issues of Damages and then to the issues regard- ing Cross-Appellant's challenge of the finding of liability in the trial ,court. Parties will be referred to by name or aS designated Plaintiff oor Defendant in the trial court. App. p.4 All citations to the Appendix prepared in this case shall be in this form [App. p. 366, L.2]. Citation to the Prepared Exhibits will be in this form [Ex. p.616]. Citation to the Record shall be [Rec.Vol. XX p.3010, Le 2). Citation to exhibits not in the Prepared Exhibits shall be in this form [Rec.Vol. VII, Ex.198]. ISSUES PRESENTED I. The trial Court erred in its computations regarding the number. and value of cows sold. Ir. The trial Court erred in failing to award damages for loss to the upgrading program. III. The trial court erred in failing to admit Exhibits 91 and 92. IV. The trial court erred in failing to award for increased _ feed costs. V. The Record discloses sub- stantial evidence of causation; VI. Any warnings were insubstan- tial, inadequate and eroded by publicity promoting the product. VIII. Actual and implied warran- ties were given by Defendant in App. p. 5 promotional literature. STATEMENT OF THE CASE The Hastes would incorporate the Statement of the case presented in the opening brief as if fully set out here- in. The statement of the case as presented in the Defendant's brief is objectionable in that it represents "facts" as "proven" where obvious) and continuing conflict existed in the exhibits and testimony. A reading of the entire record, particularly the tran- Script of trial testimony, discloses that the plaintiffs and the veterinarians called by Defendant gave continually conflicting testimony regarding the conversations between them and the particulars of those conversations. The record discloses that none of the veterinarians called by the Defendant testified to having received any of the "Dear Doctor" letters apparen- tly sent by the Defendant. Furthermore, the testing of Anaplaz performed by Outside experts has continually shown that Anaplaz causes Neonatal Isoerythro - lysis (N.I.). Plaintiffs did not seek to App. p. 6 © RELI NEE DD show that Anaplaz is the only cause, but that it was the cause in this case. Defendant states in its Statement of the Case that: "To this date, it is the opinion of veterinarians’ and scientists who have participated in the investigations that there is not enough scientific proof to establish a cause and effect relationship between Anaplaz and N.I." (Brief of Appellee and Cross-Appellant P.7). This totally mistates the status of the present scientific investigation and ignores the evidence presented at this trial from scientists such as Dr. Stormont and Dr. Young, the veterinarians called by the Defendant, and the United States Government as well as the Defen- dant itself who saw fit to include a warning in the insert indicating that there are indications that N.I. may result. Certainly at the time of trial in this matter substantial testing had been performed as testified to by Dr. Stormont and indicated by the articles of Dr. Stormont and Dr. Young. Plaintiffs invite the Court to read the record of the liability trial, specifically the App. p. 7 testimony of Dr. Stormont, for evidence presented on the relationship of Anaplaz to N.I. It is evident that the Defendant is hiding its corporate head in the sand to ignore and discount the overwhelming evidence that Anaplaz has a direct rela- tionship to the occurrence of N.I. ARGUMENT I. Computation of cows was in error. Plaintiffs make no argument that Defendant's exhibit U indicates that 40 cattle were not worth more than slaughter value. However, the evidence discloses that the plaintiffs gave value to the cows and estimated a life for them as indicated in their tax returns. Dr. Charlesworth indicates that these cows had no practical value as breeders. He never saw these cows or the results of their breeding. His opinion is’ based upon generalities of his experience and not supported by any actual evidence that the particular cattle had no value as breeders to the Hastes, There is no evidence that these cows would fail to produce viable, saleable calves. App. p. 8 Furthermore, the Plaintiffs testified that due to the N.I. propensi- ties of their brood cows they were forced to sell at slaughter prices. Mr. Haste testified that he actually received $300.00 on an average for each cow sold for slaughter. [Mr. Haste's testimony, App. p.94, L.1l-ll]j. The Defendant's Exhibit U indicates that the slaughter value according to Dr. Searl and 0Dr. Charlesworth would be $353.00. The forced sale at the time the Hastes had to sell breeding cows in Wyoming, where no other Santa Gertrudis herds’ existed, caused at least a minimum loss. of $2,120.00. {I. Upgrading program damages. Defendant states, as did the trial Court memorandum on the issue of damages, that the request for damages for losses sustained by the up-grading pro- gram was actually a request for multiple damages since before and after value of the cows was given. Yet neither Judge Winner nor the Defendant indicates how this award would be duplicitous of the other award if the before and after value of the cows is subtracted from the App. p. 9 loss to the upgrading program. Mr. Elrod testified that the Hastes entered into the upgrading program in February of 1972. This program had value to the Hastes in that, at its con- clusion the Hastes would have not only a herd of cattle, but the reputation, good- will and certification as breeders of purebred Santa Gertrudis cattle. The loss of the individual cattie at the time of the injury and the loss of breeding capacity cannot compensate fully for the loss of future profit from the termina- tion of the involvement in this program. This is not simply a speculative improvement of the breed but a program determined by other breeders designed to provide standards of quality and a rating procedure. All testimony -indicated that cattle given a higher’ classification (except bulls until they were registered pure-bred) were of increasingly greater value. The program was scientifically controlled by inbreeding to achieve ultimate perfection within tthe Santa Gertrudis' breed. There was ample evidence that the Hastes were following the program and actively App. p. 10 Wa a Ae ge See 6 attempting to increase the value of the herd. This loss was not easily calcu- lable. However, the case law is clear that simply because the damages. are difficult of ascertainment the fact finder is not relieved of the ~