No. 86-1094.United States Court of Appeals, Fifth Circuit.
August 28, 1987.
Page 909
G. Luke Ashley, Thompson Knight, Dallas, Tex., for defendant-appellant.
Dale D. Williams, Rod S. Squires, Williams, Pattillo Squires, Waco, Tex., for plaintiffs-appellees.
Page 910
Appeal from the United States District Court for the Western District of Texas.
Before WISDOM, RUBIN, and GARWOOD, Circuit Judges.
GARWOOD, Circuit Judge:
[1] In this Texas law diversity case, plaintiffs-appellees Clois Osburn and Anita Osburn (Osburns) sued Anchor Laboratories, Inc. (Anchor) and Rachelle Laboratories, Inc. (Rachelle) for personal injuries under negligence and strict products liability theories. The Osburns alleged that due to the defendant drug manufacturers’ failure to warn Mr. Osburn of the dangers to persons administering veterinary chloramphenicol and their failure to give him adequate instructions for its use, Mr. Osburn contracted leukemia. Answering special interrogatories, the jury found the defendants liable under both theories. The district court entered judgment on the verdict in favor of the Osburns. Rachelle appeals, claiming that federal law preempts the Osburns’ tort claims for failure to warn, that the “learned intermediary” doctrine absolved it of any duty to warn Mr. Osburn directly, that the Osburns failed to prove causation, and that newly discovered evidence and an excessive damages award require a new trial, or, alternatively with respect to the excessiveness complaint, a remittitur.[2] Facts and Proceedings Below
[3] When Clois Osburn was diagnosed as having leukemia, he was forty-two years old. For almost the entirety of his adult life, he had worked as a cowboy in the Texas panhandle, often caring for sick cattle and horses. In September 1982, Osburn obtained from Dr. Swain a prescription for veterinary chloramphenicol oral solution, which he immediately began administering daily to the sick calves he was caring for. Over the following eighteen months, he used ten to thirteen cases of chloramphenicol, each containing six sixteen-ounce bottles of the antibiotic. Of this total, two or three cases consisted of chloramphenicol produced by Anchor and the other eight to ten cases were of Mychel-Vet, the brand name for Rachelle’s version of the drug.
Page 911
trial, the Osburns reached a settlement agreement with Anchor and Dr. Swain.[1]
[7] The Osburns tried their case against Rachelle on December 2-6, 1985. Rachelle’s motion for directed verdict at the close of all the evidence was denied. Answering special interrogatories, the jury found that Rachelle had failed to provide adequate warnings to Mr. Osburn regarding the risk of fatal blood disorders from absorption of chloramphenicol, that this failure was a producing (and proximate) cause of Osburn’s leukemia, and, therefore, that Rachelle was liable under both strict products liability and negligence theories. Pursuant to the district court’s instruction that if it found Rachelle liable, then as a matter of law Anchor was also liable, the jury apportioned causation at eighty-five percent attributable to Rachelle and fifteen percent attributable to Anchor. The jury awarded $2,500,000 damages to Clois Osburn and $500,000 damages to Anita Osburn. The district court entered judgment for the Osburns against Rachelle, awarding all damages minus the fifteen percent attributable to Anchor. Rachelle moved for judgment notwithstanding the verdict, and for new trial or, alternatively, a remittitur. The district court denied these motions and this appeal followed.[8] Discussion[9] I. Preemption[10] A. Preemption principles
[11] Preemption doctrine finds its roots in the supremacy clause of the Constitution, which mandates that federal law shall be the “supreme Law of the Land.” U.S. Const. art. VI, cl. 2. The Supreme Court has long interpreted this clause to authorize Congress to enact laws under its enumerated powers that preempt state laws governing the same subject. Gibbons v. Ogden,
22 U.S. (9 Wheat.) 1, 210-11, 6 L.Ed. 23 (1824). State common law as well as state statutes and regulations can be preempted by federal law. See, e.g., Chicago N.W. Transp. Co. v. Kalo Brick Title Co., 450 U.S. 311, 101 S.Ct. 1124, 67 L.Ed.2d 258
(1981).
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state common-law tort claims based upon failure to warn. According to Rachelle, a direct conflict exists between the FDCA and the Osburns’ tort claim under Texas law because it is impossible for Rachelle to comply with both the FDA labeling requirements and the state law duty to warn.[3] Rachelle bases this argument on an FDA regulation, 21 C.F.R. § 201.105, which in the case of veterinary chloramphenicol requires, as part of the manufacturer’s new animal drug application, a label approved by the FDA. Specifically, Rachelle argues that because the FDA regulation required it to use an FDA-approved label in order to escape criminal liability under the FDCA for dispensing a “misbranded” drug, it could not simultaneously comply with Texas tort law obligations that presumably mandated more extensive warnings than those provided in Rachelle’s FDA-approved chloramphenicol label.
[15] We find this argument unpersuasive in the present context. Unlike the FDA regulations for some products, the regulations pertaining to veterinary chloramphenicol did not set forth a particular mandatory label. Instead, the regulations required Rachelle to submit a proposed label of its own choosing, which the FDA would then approve or reject. See 21 C.F.R. Part 514Page 913
conclude that federal law neither made it practically (nor legally) impossible, nor would it have posed an obstacle to accomplishing the objectives of the FDCA, for Rachelle to give warnings that would have satisfied its duty under Texas law. Since Rachelle has not convinced us that the FDA regulations actually conflict with its duty to warn under Texas law, or that Congress intended to exclusively occupy the field presented by the Osburns’ claims, we reject Rachelle’s preemption challenge.
[16] II. Scope of Rachelle’s Duty to WarnPage 914
the drug is properly dispensed for subsequent use by animal owners away from the direct supervision of the prescribing veterinarian.[7] We therefore reject Rachelle’s argument that the learned intermediary doctrine should apply and, consequently, its challenge to the district court’s instructions regarding the scope of Rachelle’s duty to warn.
[20] III. Sufficiency of Causation Evidence[21] A. Standard of reviewPage 915
Dr. Comstock, testified that, in their opinion, chloramphenicol-induced leukemia need not be preceded by aplastic anemia. Both doctors also gave the opinion that, to a reasonable degree of medical certainty, Osburn’s leukemia was caused by his exposure to veterinary chloramphenicol.[9]
[27] Rachelle does not challenge the qualifications of these experts nor the admissibility under the Federal Rules of Evidence of their opinions about causation. Rachelle merely argues that because the notion that chloramphenicol can cause leukemia without first causing aplastic anemia has not been widely accepted in the medical field, the opinions of the Osburns’ experts that Mr. Osburn’s leukemia was caused by exposure to chloramphenicol provide insufficient evidence of causation. [28] This argument misses the point. An expert’s opinion need not be generally accepted in the scientific community before it can be sufficiently reliable and probative to support a jury finding See Wells v. Ortho Pharmaceutical Corp., 788 F.2d 741, 744-45Page 916
leukemia.[11] These are methodologies concededly relied upon generally by physicians in diagnosing etiology of a particular patient’s disease. See, e.g., Wells, 788 F.2d at 744-45; Ferebee, 736 F.2d at 1535-36.
[30] Rachelle of course introduced its own experts, who were of the view that Mr. Osburn’s leukemia was not caused by chloramphenicol, but the testimony of those witnesses was not so overwhelming that the jury had to accept it. Rachelle’s experts relied on essentially the same diagnostic methodologies; they simply drew the opposite conclusion from the available information. The case thus presented a bona fide “battle of the experts” — real, not merely testifying, experts who applied their true expertise — in which a jury must be allowed to make credibility determinations and weigh the conflicting evidence in order to decide the likely truth of a matter not itself initially resolvable by common knowledge or lay reasoning. Ferebee, 736 F.2d at 1535; accord Wells, 788 F.2d at 745.[12] We therefore reject Rachelle’s challenge to the sufficiency of the evidence concerning causation.[13]Page 917
[31] IV. Newly Discovered EvidencePage 918
from date of diagnosis, the jury could not properly have awarded more than $50,000 at the very most for past and future loss of wage earning capacity. According to Rachelle, future loss of earning capacity must be calculated on the basis of actual life expectancy, given the injuries sued for, not on the basis of preinjury work life expectancy. Although this argument has some surface appeal, we find it ultimately unpersuasive.
[38] In support of its argument, Rachelle cites a single Texas case, which held that plaintiffs suing under the Texas “survival statute” could recover for the decedent’s lost earning capacity (and other damages) only through the date of his death. See Norman v. Valley Gin Co., 99 S.W.2d 1065 (Tex.Civ.App. 1936, writ ref’d). According to Rachelle, the Texas rule for survival actions, which allow heirs to recover damages an injured party would have been entitled to recover had he lived, see id. at 1067, should apply equally to Osburn’s claim for loss of future earning capacity. [39] We disagree. The reason that recovery in a survival action is limited to injuries suffered by the decedent only through the date of his death is that as of that date recovery is governed instead by the wrongful death action, which takes over and allows recovery for injuries suffered by the heirs as a result of the decedent’s death. Id. at 1067 (reaching this conclusion on the basis of statutory ancestors to the current Texas wrongful death and survivorship action statutes); Tex.Civ.Prac. Rem. Code Ch. 71 (Vernon 1986); accord 4 F. Harper, F. James O. Gray, The Law of Torts § 24.6 at 474 n. 12, and § 25.16 at 612-14 (2d ed. 1986). In contrast, the “prevailing American rule” is that when the plaintiff is the injured party himself (i.e., when trial occurs before the injured party dies), he can recover lost earning capacity on the basis of work life expectancy at the time of his injury “undiminished by any shortening of that expectancy as a result of the injury.” 4 F. Harper, F. James O. Gray supra, § 24.6, at 475 (emphasis in original); see also id. § 25.8, at 551-52 n. 9; C. McCormick, Handbook on the Law of Damages 303 (1935). [40] No Texas case has expressly articulated this distinction, but it is consistent with Texas case law.[15] Since we see no reason why Texas would deviate from other jurisdictions in this regard, we assume the Texas Supreme Court would follow the majority rule. Consequently, we conclude that the jury was entitled to calculate Osburn’s loss of future earning capacity on the basis of the life expectancy Osburn would have had if he had not contracted leukemia.[16] [41] B. Excessiveness of damagesPage 919
that amount that any reasonable man could feel the claimant is entitled to.'” Caldarera, 705 F.2d at 784 (emphasis in original; citations omitted).
[43] In this case, the jury’s general damage award of $2,500,000 to Mr. Osburn included the following elements: past and future loss of wage earning capacity, past medical expenses, physical pain and suffering, loss of physical capacity other than wage earning capacity, and mental anguish. We find that based on the evidence in this record, $2,500,000 exceeds the amount the jury could properly have awarded. [44] Having determined that the award is excessive, we can either order a new trial on damages or allow plaintiffs the option of avoiding such a new trial by agreeing to a remittitur of the excessive portion of the award. De Centeno v. Gulf Fleet Crews, Inc., 798 F.2d 138, 142 (5th Cir. 1986); Wells v. Dallas Indep. School District, 793 F.2d 679, 683-84 (5th Cir. 1986). This Court follows the maximum recovery rule, according to which remittitur can reduce a damages award only to “the maximum amount the jury could properly have awarded.” Zeno v. Great Atlantic Pacific Tea Co., 803 F.2d 178, 181 (5th Cir. 1986); Caldarera, 705 F.2d at 784. Where the district court used a general verdict interrogatory and instructed on several elements of damages, it is sometimes impossible to determine the reason the verdict was excessive. In that event, an appellate court may elect to grant a new trial without providing the option of remittitur. See Gautreaux v. Insurance Company of North America, 811 F.2d 908Page 920
for loss of past and future wage earning capacity is $350,000.
[48] As the parties concede, the evidence also indicates that at the time of trial Osburn had paid $6,700 in medical expenses. No evidence was submitted regarding probable medical expenses in the future, and the jury was not instructed to consider that element of damages. The jury could therefore properly have awarded a maximum of $6,700 for medical expenses. [49] 2. Pain and suffering, anguish, loss of physical capacityPage 921
excessive as well. We conclude, however, that although it closely approaches the maximum the jury could have properly awarded, it is not excessive.[20] The evidence indicates that Mr. and Mrs. Osburn enjoyed a close, loving relationship and that they remained happy together after almost twenty years of marriage. With regard to Mrs. Osburn’s loss of her husband’s household services, she testified that Mr. Osburn performed many chores for her and the family. Since the Osburns live in a rural environment, the value of those services may be greater than in an urban setting. We therefore sustain the jury’s $500,000 award to Mrs. Osburn.[21]
[56] Conclusion
[57] The district court shall order a new trial on Mr. Osburn’s claims for damages unless Mr. Osburn agrees, within the time specified by the district court following remand, to a remittitur of the award to $1,578,195. We therefore vacate the damage award to Clois Osburn, and in all other respects affirm the judgment below. We remand the cause for further proceedings consistent with this opinion.
“(d) Changes of the following kind proposed in supplemental new animal drug applications should be placed into effect at the earliest possible time:
“(1) The addition to package labeling, promotional labeling, and prescription drug advertising of additional warning, contraindication, side effect, and precaution information.
“. . . .
“(e) The Food and Drug Administration will take no action against a new animal drug or applicant solely because changes of the kinds described in paragraph (d) of this section are placed into effect by the applicant prior to his receipt of a written notice of approval of the supplemental new animal drug application if [certain notice and consistency] conditions are met.”
(1) Fraumeni, Bone Marrow Depression Induced by Chloramphenicol or Phenylbutazone: Leukemia and Other Sequelae,
201 J.A.M.A. 150 (1967). Dr. Fraumeni conducted the only long-term follow-up study of the effects of chloramphenicol. He received information concerning 124 patients listed in the American Medical Association’s Registry of Adverse Drug Reactions and an additional six patients not listed but who had been treated by physicians of listed patients. Of these 130 patients, six cases of leukemia subsequent to chloramphenicol exposure were discovered. After discounting the three reports of leukemia from the six nonlisted patients, Dr. Fraumeni reported a chloramphenicol-induced leukemia ratio of 3/124, compared to the United States age-adjusted annual leukemia mortality ratio of 6/100,000.
(2) Swanson Cook, Blood, Chemicals and Blood Dyscrasias
(1977). Dr. Comstock testified that this treatise represented the most comprehensive review then available of the medical literature dealing with blood disorders associated with drugs or chemicals. He said the treatise listed 19 drugs that had been associated with a total of 271 case reports of leukemia thought to be drug-induced. Of these 271 cases, 160 were associated with benzene exposure, 53 with phenylbutazone, and 34 with chloramphenicol. The remaining 24 cases were associated with 16 other drugs, with no more than four of these cases being linked to any one particular drug. In Dr. Comstock’s view, the treatise indicated that chloramphenicol was among the three drugs sufficiently associated with leukemia to be considered causally related to the disease.
(3) A 1981 case report in the Lancet Medical Journal of a shepherd who suffered from aplastic anemia after administering veterinary chloramphenicol to sheep.
We further note that the present lawsuit of course bars any subsequent wrongful death (or survival) action against Rachelle founded upon Clois Osburn’s death as a result of his referenced exposure to Mychel-Vet. See Prosser and Keeton on Torts § 127, at 955-56 (W. Keeton 5th ed. 1984).
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