Opinion ID: 442774
Heading Depth: 1
Heading Rank: 3

Heading: The Role of the Jury in New Drug Cases.

Text: 30 Immediately prior to submission of this case to the jury, the FDA moved for a directed verdict on the grounds that, in light of the statutory structure and all the evidence adduced by both sides, there was no issue of fact left for the jury to decide. Alcon suggests that to accept this position would be tantamount to usurping the jury's historic, constitutional role. 11 Alcon's argument cannot be accepted as a general proposition. Although the jury's role in determining disputed facts cannot be denied in a new drug case such as this, neither should a jury be asked to decide issues that are of a legal, not factual nature.
31 When injunctive relief and seizure of drugs are sought together in an FDA new drug action, it is apparent that the drug manufacturer has a right to have certain issues decided by a jury. An action for an injunction under 21 U.S.C. Sec. 332(a) is, of course, purely equitable in nature, and a jury trial on the injunction alone would not be required under the Seventh Amendment. United States v. Ellis Research Laboratories, Inc., 300 F.2d 550, 554 (7th Cir.), cert. denied, 370 U.S. 918, 82 S.Ct. 1558, 8 L.Ed.2d 499 (1962); see United States v. Louisiana, 339 U.S. 699, 706, 70 S.Ct. 914, 917, 94 L.Ed. 216 (1950). But in this case the FDA also brought four actions for seizure and forfeiture against quantities of WANS under 21 U.S.C. Sec. 334. Section 334(b) expressly provides for a trial by jury of any issue of fact. Moreover, it is well settled that seizure actions, at least on land, are actions at law guaranteed a jury trial under the Seventh Amendment. C.J. Hendry Co. v. Moore, 318 U.S. 133, 153, 63 S.Ct. 499, 510, 87 L.Ed. 663 (1943). The government did not object to consolidation of the injunction and seizure actions. In any case, the Supreme Court has held that where factual issues are common between legal and equitable claims, the right to a jury trial cannot be withheld. Dairy Queen, Inc. v. Wood, 369 U.S. 469, 479, 82 S.Ct. 894, 900, 8 L.Ed.2d 44 (1962). Analysis of the instant actions reveals that both might depend ultimately upon determination of the same factual issues: whether WANS was in 1962 and is today generally recognized among qualified experts as safe and (if the grandfather clause does not apply) effective. 12 Thus Alcon had the right to go before a jury on genuinely disputed factual questions. 13 32
33 Although the right to a jury trial in a case may be clear, that right is never all-encompassing. It is, of course, a fundamental of the jury trial ... that the jury acts, not at large, but under the supervision of a judge. United States v. Taylor, 464 F.2d 240, 242 (2d Cir.1972) (citation omitted). Under the Federal Rules of Civil Procedure, a district court judge has both the right and the duty to determine prior to submitting a case to a jury whether there exist material issues of fact that are genuinely disputed. See Fed.R.Civ.P. 56(c). A factual dispute is material if it 'affects the outcome of the litigation,' and genuine if manifested by 'substantial' evidence 'going beyond the allegations [of the party opposing judgment.]'  Pignons S.A. de Mecanique v. Polaroid Corp., 657 F.2d 482, 486 (1st Cir.1981). Thus upon proper pre-trial motion a trial judge must carefully sift the evidence submitted by all parties to determine whether disputes are factual (as opposed to legal) and genuine, and then further review and interpret relevant statutes, to see if any genuine factual dispute is material to the merits of the case. 34 Even after evidence has been presented to the jury, a judge must carefully review all the evidence before submitting the case for the jury's consideration, and determine whether each party has adduced evidence sufficient to warrant a verdict in its favor. If the court finds that such is not the case, it may grant a directed verdict without asking the jury for findings. See Fed.R.Civ.P. 50(a); Brady v. Southern Railway Co., 320 U.S. 476, 479-80, 64 S.Ct. 232, 234-35, 88 L.Ed. 239 (1943). Finally, even after a jury has rendered a verdict, if the trial court decides after careful reconsideration that the evidence was insufficient to submit the case to the jury after all, it has the power to grant a judgment non obstante veredicto and reverse the jury's verdict. Fed.R.Civ.P. 50(b). The exercise of the judicial prerogative to terminate a case must be painstaking. Nevertheless, whether there exist factual questions sufficiently disputed to warrant a verdict for either side is an issue of law, not fact, and its determination is quintessentially the function of the trial judge, not the jury. 35 Because of the constitutional status of the right to trial by jury, exercise of the judicial power to terminate a case is also subject to a stringent standard of review. Thus a directed verdict can be ordered only when, 36 viewing the evidence in the light most favorable to [the party opposing the motion, the court] find[s] that, without weighing the credibility of the witnesses or otherwise considering the weight of the evidence, there is only one verdict reasonable men could reach. 37 Trinidad v. Pan American World Airways, Inc., 575 F.2d 983, 984 (1st Cir.1978), quoting Harrington v. United States, 504 F.2d 1306, 1311 (1st Cir.1974). The standard for reviewing a judgment n.o.v. is similar if not identical: The motion is properly granted only when, as a matter of law, no conclusion but one can be drawn. Rios v. Empresas Lineas Maritimas Argentinas, 575 F.2d 986, 990 (1st Cir.1978); accord, Robinson v. Watts Detective Agency, 685 F.2d 729, 733 (1st Cir.1982), cert. denied, 459 U.S. 1105, 103 S.Ct. 728, 74 L.Ed.2d 953 and 459 U.S. 1204, 103 S.Ct. 1191, 75 L.Ed.2d 436 (1983). Nevertheless it should be clear that, while special deference is due the verdict of a civil jury, nothing in the Seventh Amendment removes the appellate court's duty to correct errors of law. Ballwanz v. Isthmian Lines, Inc., 319 F.2d 457, 460 (4th Cir.1963), cert. denied, 376 U.S. 970, 84 S.Ct. 1136, 12 L.Ed.2d 84 (1964). Thus, in a new drug case as in any other, the trial court as well as this court has an obligation to render judgment as a matter of law when it is clear from the evidence that such is required. 38