國立高雄第一科技大學 科技法律研究所 課程：醫療與法律 項目：案例討論 16 藥物治療不同用法之爭議

1. 國立高雄第一科技大學科技法律研究所課程：醫療與法律項目：案例討論16藥物治療不同用法之爭議國立高雄第一科技大學科技法律研究所課程：醫療與法律項目：案例討論16藥物治療不同用法之爭議 指導老師: 周天 所長 報告人：碩專班二年級 林杏麟

2. United States Court of Appeals, Sixth Circuit.（被告勝訴) United States Court of Appeals 1974 United States District Court and Court of Appeals (原告敗訴) Court of Appeals 1971 United States District Court Medical Malpractice, product liability D P Marguerite Wallace McCLURE, Executrix of C. C. McClure Ayerst Laboratories Boyce E. CHUMBLER 案號：Chumbler v. McClure, C.A.Tenn. 1974

3. 事實 • 時：April, 1971 • 地：Nashville, Tennessee • 人： • Defendant Dr. C. C. McClure：a neurosurgeon. • Defendant Ayerst Laboratories：produced and marketed commercially as Premarin . • Plaintiff Chumbler's：Dr. McClure diagnosed illness as cerebral vascular insufficiency and prescribed a female hormone known as Estrogen(Premarin).

4. Side effects • Enlargement of the breasts and a loss of libido. • Plaintiff also sought damages for impotence and menopausal symptoms, that issue need not be reached.

5. 爭點 • Whether district Court acted properly in directing verdicts for the defendants on whether Dr. McClure violated the accepted medical standards in his community in his treatment of Chumbler. • Whether defendant Ayerst acted negligently in the production or sale of Premarin. • District Court erred in excluding all testimony on the issue of plaintiff's informed consent to his drug treatments.

6. 判決 • In view of the proper exclusion of certain evidence under the Tennessee dead man's statute, evidence failed to make a case for the jury against either the laboratory or the estate of the deceased physician. • Affirmed.

7. 判決理由 • A diversity case • The trial judge is bound by state law as to the sufficiency of evidence. • To look to all the evidence, to take as true the evidence for the plaintiff, to discard all countervailing evidence, to take the strongest legitimate view of the evidence for the plaintiff, to allow all reasonable inferences from it in his favor; and if then there is any dispute as to any material determinative evidence, or any doubt as to the conclusion to be drawn from the whole evidence, the motion for a directed verdict must be denied.

8. We find that the trial court did not err in directing a verdict for defendant Ayerst Laboratories. • Plaintiff failed to prove participation of Ayerst in any alleged experiments by Dr. McClure, any overpromotion, or a lack of warning concerning side effects of Premarin.

9. From the evidence adduced at trial, we find that taking the strongest legitimate view of the evidence for the plaintiff and resolving all inferences in his favor, reasonable minds could only have found in favor of defendant Ayerst Laboratories. • We find that the District Court acted properly in directing a verdict for defendant Ayerst.

10. Since Dr. McClure was deceased, the plaintiff was confronted with the Tennessee Dead Man's Statute.

11. Dead man statute • A statute designed to prevent perjury in a civil case by prohibiting a witness who is an interested party from testifying about communications or transactions with a decedent unless there is a waiver. • This prohibition applies only against a witness who has an interest in the outcome of the case and applies only where that witness is testifying for his own interests and against the interests of the decedent. Furthermore, the restriction only exists in civil cases, never in criminal cases. • The restriction can be waived. A waiver can occur if the decedent's testimony is brought before the jury in the form of a deposition.

12. Plaintiff asserted that proof of his informed consent is an affirmative defense and, consequently, that the burden lies upon the defendant. The trial court properly found that the burden rested on the plaintiff.

13. The harshness of this statute may be as severe as plaintiff argues in effectively making it impossible to obtain a judgment against any deceased doctor. • While not deciding this issue, this Court must point out that relief lies not with the courts but with the Legislature of the State of Tennessee.

14. Deviation from accepted medical practices and community standards is a prerequisite for maintenance of a medical malpractice suit. • The record in this case is devoid of evidence of such deviation.

15. Accompanying testimony as to the medical acceptability of this practice and of the drug itself leave no other possible outcome other than plaintiff's failure to present even a prima facie case of malpractice. • Under Tennessee law on directed verdicts, we find that the trial court acted properly in directing a verdict for the doctor's estate at the close of all the evidence.

16. Accordingly, for this and reasons mentioned before, the actions of the trial court, both as to defendant Estate of Dr. C. C. McClure, Jr. and defendant Ayerst Laboratories, Inc. are hereby affirmed.

17. Thanks for your attentions.