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Merrell Dow Pharmaceuticals, Inc. v. Oxendine


November 9, 1994


Appeal from the Superior Court of the District of Columbia. (Hon. Richard A. Levie, Motions Judge)

Before Steadman, Schwelb and Sullivan, Associate Judges. Opinion for the court by Associate Judge Steadman. Concurring opinion by Associate Judge Schwelb.

The opinion of the court was delivered by: Steadman

STEADMAN, Associate Judge: The fourth appeal in this extended litigation raises two issues: first, whether the trial court properly ruled that neither the Federal Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C. §§ 301-393 (1988 & Supp. V 1994), nor approval of Bendectin by the Food and Drug Administration ("FDA") preempts state *fn1 tort law; and second, whether the trial court properly refused to reconsider the jury verdict in the light of post-trial developments. We hold that the trial court correctly decided the preemption issue and correctly determined that Merrell Dow must meet a rigorous standard in order to reopen the issue of causation, but erred in flatly refusing to consider any of the proffered post-trial developments. Accordingly, we are reluctantly compelled to, remand for further limited consideration.


In this product liability case, plaintiff-appellee Mary Oxendine alleges that her mother's ingestion during pregnancy of Bendectin, a prescription drug manufactured by defendant-appellant Merrell Dow Pharmaceuticals, Inc. ("Merrell Dow"), caused her birth defects. In May of 1983, a jury awarded Oxendine $750,000 in compensatory damages. The trial court granted Merrell Dow's motion for judgment notwithstanding the verdict and, alternatively a new trial, and Oxendine appealed. This court reversed and remanded with instructions to reinstate the jury verdict and conduct further proceedings on punitive damages. Oxendine v. Merrell Dow Pharmaceuticals, Inc., 506 A.2d 1100 (D.C. 1986) (Oxendine I). On remand, the trial court granted Merrell Dow's motion, filed under Rule 60(b), vacating the jury verdict and granting a new trial based on perceived failings in Oxendine's expert witness. Oxendine again appealed and this court reversed and remanded with instructions to reinstate the jury verdict. Oxendine v. Merrell Dow Pharmaceuticals, Inc., 563 A.2d 330 (D.C. 1989) (Oxendine II), cert. denied, 493 U.S. 1074, 107 L. Ed. 2d 1028, 110 S. Ct. 1121 (1990). The trial court entered final judgment in favor of Oxendine on compensatory damages, but postponed the trial on punitive damages. Merrell Dow appealed and this court dismissed the appeal for want of a final judgment with instructions to vacate the judgment entered under Rule 54(b). Merrell Dow Pharmaceuticals, Inc. v. Oxendine, 593 A.2d 1023 (D.C. 1991) (Oxendine III).

While Oxendine III was pending on appeal, Merrell Dow moved the trial court for permission to brief the issues of punitive damages and federal preemption of state tort law. The trial court ordered the parties to brief the issues of preemption and punitive damages and granted Merrell Dow permission to file a Rule 60(b) motion challenging the validity of the jury verdict in light of post-trial information. The briefs were filed and on September 6, 1991, Merrell Dow moved for relief from the verdict or, in the alternative, a new trial based on post-1983 developments. Oxendine filed a praecipe seeking dismissal of her punitive damages claim and a motion for entry of final judgment on compensatory damages. Merrell Dow's response opposed final judgment until all other pending issues were resolved, including preemption and the September motion. On June 9, 1992, the trial court granted Oxendine's motion for entry of judgment, but did not order the punitive damages claim dismissed or rule on Merrell Dow's outstanding motions. On June 18, 1992, judgment was docketed in favor of Oxendine on compensatory damages. Merrell Dow filed a motion to clarify and amend the judgment or, alternatively, to reconsider and stay execution of judgment. On September 3, 1992, the court dismissed Oxendine's punitive damages claim, ruled against Merrell Dow on the issues of preemption and reconsideration in light of post-trial developments, and ordered entry of final judgment in Oxendine's favor. On September 4, 1992, judgment was again entered in favor of Oxendine. Merrell Dow appeals the trial court's rulings that the FDCA does not preempt state tort law and that the verdict would not be reconsidered in light of post-1983 developments.


Merrell Dow first argues that the trial court incorrectly ruled that the tort claim in this case was not preempted by the FDCA. *fn2 Preemption arises from the Supremacy Clause, which provides:

This Constitution, and the Laws of the United States which shall be made in Pursuance thereof . . . shall be the supreme Law of the Land; and the Judges in every State shall be bound thereby, any Thing in the Constitution or Laws of any State to the Contrary notwithstanding.

U.S. CONST. art. VI, cl. 2. Preemption of state law may occur in three ways. First, a federal law may expressly preempt state law. Michigan Canners & Freezers Ass'n, Inc. v. Agricultural Marketing & Bargaining Bd., 467 U.S. 461, 469, 81 L. Ed. 2d 399, 104 S. Ct. 2518 (1984). Second, Congress may "so thoroughly occupy a legislative field 'as to make reasonable the inference that Congress left no room for the States to supplement it.'" Cipollone v. Liggett Group, Inc., U.S. , 112 S. Ct. 2608, 2617 (1992) (quoting Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230, 91 L. Ed. 1447, 67 S. Ct. 1146 (1947)). Third, preemption results if a state law directly conflicts with a federal law in one of two ways: compliance with both federal and state law is impossible; or state law obstructs the federal purpose. *fn3 Michigan Canners, supra, 467 U.S. at 469. Where the state laws at issue affect health and safety issues, there is a presumption against implied preemption by congressional enactments. Hillsborough County, Florida v. Automated Medical Laboratories, Inc., 471 U.S. 707, 715, 85 L. Ed. 2d 714, 105 S. Ct. 2371 (1985). Finally, preemption is less likely if the federal law leaves a plaintiff without any available legal means of redress. Silkwood v. Kerr-McGee Corp., 464 U.S. 238, 251, 78 L. Ed. 2d 443, 104 S. Ct. 615 (1984); Abbot v. American Cyanamid Co., 844 F.2d 1108, 1112 (4th Cir.), cert. denied, 488 U.S. 908, 102 L. Ed. 2d 248, 109 S. Ct. 260 (1988).

The essential failing of Merrell Dow's claim of preemption is Merrell Dow's insistence that Congress intended the FDCA to be more than a minimum standard of drug safety and that the FDA likewise intended its approval of Bendectin to be a standard which the jury could not override by effectively forcing the drug off the domestic market. From this basis, Merrell Dow argues that state action here did not simply supplement but rather completely overrode FDA standards, with the practical effect of creating an obstacle or direct conflict with the FDA's approval of Bendectin.

Merrell Dow's argument, however, is negated by the numerous cases which have specifically ruled that the FDA prescription drug regulations and safety determinations are intended to be minimum standards which "do not conflict with state law which sets higher standards for due care and safety in the manufacture of drugs." Allen v. G.D. Searle & Co., 708 F. Supp. 1142, 1152 (D. Or. 1989); see, e.g., Brochu v. Ortho Pharmaceutical Corp., 642 F.2d 652, 658 (1st Cir. 1981); Salmon v. Parke, Davis & Co., 520 F.2d 1359, 1362 (4th Cir. 1975); Kociemba v. G.D. Searle & Co., 680 F. Supp. 1293, 1299 (D. Minn. 1988); Spychala v. G.D. Searle & Co., 705 F. Supp. 1024, 1030 (D.N.J. 1988); Stromsodt v. Parke-Davis & Co., 257 F. Supp. 991, 997 (D.N.D. 1966), aff'd, 411 F.2d 1390 (8th Cir. 1969). *fn4

In Silkwood, (supra) , the Supreme Court determined that the Atomic Energy Act of 1954 did not preempt all state tort action against manufacturers of plutonium products for personal injuries. The Court said:

No doubt there is tension between the Conclusion that safety regulation is the exclusive concern of the federal law and the Conclusion that a State may nevertheless award damages based on its own law of liability. . . . Congress intended to stand by both concepts and to tolerate whatever tension there was between them. We can do no less. It may be that the award of damages based on the state law of negligence or strict liability is regulatory in the sense that a nuclear plant will be threatened with damages liability if it does not conform to state standards, but that regulatory consequence was something that Congress was quite willing to accept.

Silkwood, supra, 464 U.S. at 256. The Supreme Court's reasoning in Silkwood has been found "equally compelling in the context of the FDCA." Kociemba, supra, 680 F. Supp. at 1299. In ruling that the FDCA did not preempt state tort law actions against manufacturers of prescription drugs, the court in Kociemba found that "if Congress wants to take the extraordinary step of giving drug manufacturers immunity from personal tort actions, it would expressly state such intentions whether by statute or legislative history," Kociemba, supra, 680 F. Supp. at 1299-1300 (citing Silkwood, supra, 464 U.S. at 251), as Congress did for medical devices. *fn5 Spychala, supra, 705 F. Supp. at 1029. One court further noted that "state tort law may have some regulatory effect on federal laws and regulations, however, such effect does not conflict in such a manner that compliance with both federal and state law is impossible." Kociemba, supra, 680 F. Supp. at 1300. We agree with this reasoning and find that federal law does not preempt the local tort law claims here.

Merrell Dow also argues that because the FDA found Bendectin to be safe and the jury found it to be unsafe, the FDA and jury findings are irreconcilable and resolution of the conflict requires federal preemption. However, an FDA finding that a drug is "safe and effective" is a term of art, not a legal Conclusion for state tort law purposes. Kociemba v. G.D. Searle & Co., 707 F. Supp. 1517, 1525-26 (D. Minn. 1989). FDA approval is not determinative of preemption, but is instead one factor for the jury to consider in reaching a verdict. Tobin v. Astra Pharmaceutical Products, Inc., 993 F.2d 528, 537-38 (6th Cir.), cert. denied, U.S. , 114 S. Ct. 304 (1993). Courts have overwhelmingly found no general preemption of all state tort claims. Hurley v. Lederle Lab. Div. of Am. Cyanamid Co., 863 F.2d 1173, 1176 (5th Cir. 1988) (and see cases cited therein). *fn6 Hence, the FDA action with respect to Bendectin was not intended to resolve the issue of safety for all purposes, and its finding of safety does not irreconcilably conflict with the jury's finding of liability with respect to Merrell Dow. *fn7


Merrell Dow also contends that the trial Judge erred in flatly refusing to consider post-1983 evidence regarding Bendectin's safety. *fn8 The trial court determined that the new circumstances upon which Merrell Dow relied did not meet what it deemed the Rule 60(b)(2) standard of "pertaining to facts in existence at the time of the trial, and not to facts that have occurred subsequently." 6A JAMES W. MOORE ET AL., MOORE'S FEDERAL PRACTICE P 59.08[3], at 59-101 (2d ed. 1994). See 11 CHARLES A. WRIGHT & ARTHUR R. MILLER, FEDERAL PRACTICE AND PROCEDURE §§ 2808, 2859 (1973); National Anti-Hunger Coalition v. Executive Committee of the President's Private Sector Survey on Cost Control, 229 U.S. App. D.C. 143, 147 n.3, 711 F.2d 1071, 1075 n.3 (1983). The trial court reasoned that the real developments were the studies published after May 1983 rather than the data upon which the studies were based. It did not matter that the data existed at the time of trial because the Conclusions of the new studies were developed after trial. Hence, Merrell Dow's new evidence pertained to facts that occurred subsequently and the court denied Merrell Dow's motion. *fn9

Although we entirely agree with the trial court's general approach of exercising great caution in considering new evidence as here, we think the trial court went just a step too far in this analysis of the nature of the proffered newly discovered evidence in the context of an issue of scientific fact. The basic scientific fact at issue in this litigation is whether Bendectin possesses teratogenic qualities; that is, whether it can be a cause of birth defects. At least some of the proffered evidence, although in the form of studies published, or even conducted, after the time of trial, were not independent subsequent facts as such but rather further investigation into and evidence relating to the on-going and yet at bottom timeless scientific question of Bendectin's teratogenic qualities.

This state of affairs is inherent in scientific inquiry. The very nature of science incorporates a view of even generally accepted explanations of phenomena as tentative truths, not settled certainties. Daubert v. Merrell Dow Pharmaceuticals, Inc., U.S. , 113 S. Ct. 2786, 2795 (1993). *fn10 Scientific inquiry contemplates continuing investigation, development, testing and reevaluation even of what has been regarded and accepted as scientific reality. See Margaret A. Berger, Procedural Paradigms for Applying the Daubert Test, 78 MINN. L. REV. 1345, 1382-86 (1994) (discussing pressures caused by developing scientific knowledge in mass tort litigation). See generally THOMAS S. KUHN, THE STRUCTURE OF SCIENTIFIC REVOLUTIONS (2d ed. 1970). Thus, scientific evidence arises in a somewhat different context than normal "newly discovered evidence."

The question, then, is how courts should deal with subsequent scientific inquiry and developments which cast doubt upon the correctness of a jury's Conclusion with respect to a scientific fact. While the trial court erred in its refusal to consider the proffered evidence at all, we think it rightly adopted a tightly limited receptiveness to Merrell Dow's motion in the circumstances here, reflecting an essential difference between science and the law. The requirements and realities of the courtroom are not those of the laboratory. See Ferebee v. Chevron Chemical Co., 237 U.S. App. D.C. 164, 736 F.2d 1529, 170-71, 736 F.2d 1529, 1535-36 (allowing recovery without scientific certainty), cert. denied, 469 U.S. 1062 (1984). Although science is a constantly evolving process, the law depends upon a high level of certainty once an outcome has been determined. A trial can be no more than a resolution of an immediate dispute on the basis of present knowledge; its outcome must turn upon the teachings of science as understood at the time of trial as best can be discerned through the presentations of the parties. Where scientific facts are at issue, it is not unexpected, given the nature of the process, that the passage of time will bring forth further scientific data and inquiry relating to the ultimate scientific fact at issue. To reopen the trial's determination of scientific truth, however, runs squarely into the fundamental principle of certainty. *fn11

We recently had occasion to examine and reassert this principle in Clement v. District of Columbia Dep't of Human Servs., 629 A.2d 1215 (D.C. 1993) (trial court without basis in law to reopen case after final judgment in circumstances presented). "A fundamental principle of litigation that has been stressed in a variety of contexts is the importance of finality." Id. at 1218. Consistent with this approach, courts have generally held that part of the criteria for the grant of a motion on the basis of newly-discovered evidence *fn12 is that the evidence "is material and controlling and clearly would have produced a different result if presented before the original judgment," Brown v. Petrolite Corp., 965 F.2d 38, 50 (5th Cir. 1992) (Rule 60(b)(2) test), or at least is material and would probably produce a new result at a new trial. Jones v. Aero/Chem Corp., 921 F.2d 875, 878 (9th Cir. 1990) (applying Rule 60(b)(2) test of whether new evidence is "likely to change the Disposition of the case" to Rule 59 motion); Rosebud Sioux Tribe v. A & P Steel Inc., 733 F.2d 509, 515 (8th Cir.) (Rule 60(b)(2) test of whether new evidence "probably would produce a new verdict"), cert. denied, 469 U.S. 1072, 83 L. Ed. 2d 506, 105 S. Ct. 565 (1984); Philip v. Mayer, Rothkopf Indus., Inc., 635 F.2d 1056, 1063 (2d Cir. 1980) (affirming denial of Rule 59 motion in part because evidence could not change result); United States v. Walus, 616 F.2d 283, 287-88 (7th Cir. 1980) (Rule 60(b)(2) test of whether new evidence "would probably produce a new result"); 6A MOORE ET AL., (supra) note 12, at P 59.08[3]. In this jurisdiction in particular, as set forth in the seminal case on the point, Merrell Dow must demonstrate that the newly discovered evidence "would probably produce a different verdict if a new trial were granted." Imhoff v. Walker, 51 A.2d 309, 312 (D.C. 1947). See also Forgotson v. Shea, 491 A.2d 523, 528 (D.C. 1985) (evidence "would likely produce a different result at a new trial"); Mahallati v. Williams, 479 A.2d 300, 305 (D.C. 1984) (affirming denial of motion where new testimony "would probably not have produced a different result at a new trial"); Frost v. Hays, 146 A.2d 907, 909 (D.C. 1958) (requiring that evidence "would likely produce a different result at a new trial"); Bradley v. Prince, 105 A.2d 253, 254-55 (D.C. 1954) (requiring that evidence "would probably produce a different verdict if a new trial were granted"). *fn13 This strict standard seems a particularly sound requirement in the context of a factual dispute turning on scientific evidence, as here. It is far too little for the movant simply to proffer new developments which might tip the preponderance of evidence the other way. Rather, later scientific inquiry must establish that in probability the scientific fact on which the verdict relies is wrong. *fn14 Given the nature of the scientific process and its continuing development of data and on-going examination of scientific truth, decisions in trials turning on scientific factual determinations would be at constant risk if a lesser standard were used. The ends of the litigation process would be subverted if, as Merrell Dow seems to suggest, a jury's determination of a scientific fact after a full trial, twice affirmed by an appellate court, could be the subject of potentially endless re-examination except in the most unusual of circumstances. *fn15

A trial court decision on whether to grant or deny a motion for relief is reviewed for abuse of discretion. Gause v. C.T. Management, Inc., 637 A.2d 434, 437 n.3 (D.C. 1994) (abuse of discretion standard for Rule 60(b)); Fleming v. District of Columbia, 633 A.2d 846, 849 (D.C. 1993) (same); Foretich v. CBS, Inc., 619 A.2d 48, 63-64 (D.C. 1993) (applying abuse of discretion standard to Rule 59(e) motion); State Farm Mut. Auto. Ins. Co. v. Brown, 593 A.2d 184, 185 (D.C. 1991) (abuse of discretion standard for Rule 60(b) motion); 6A MOORE ET AL., (supra) note 12, at P 59.08[3] (abuse of discretion standard for Rule 59). Accordingly, since for the reasons stated the trial court erred in refusing to consider at all the proffered new evidence, we remand the case to the trial court for further proceedings. Not only is that court in a better position than we to evaluate in detail the proffered evidence, it is that court that is empowered to make the discretionary decision in ruling on the motion, subject only to review for abuse. See Stridiron v. Stridiron, 698 F.2d 204, 208 (3d Cir. 1983) (remanding for a hearing where trial court's consideration of new evidence was incomplete). *fn16 The order from which Merrell Dow appeals is vacated and the case remanded for further proceedings in accordance with this opinion.

So ordered.

SCHWELB, Associate Judge, Concurring: I join without reservation Judge Steadman's lucid opinion for the court. I write separately, however, to address some of the practical implications of the positions taken by Merrell Dow in this appeal.


In a case like this one in particular, I think it appropriate to stress that the decisions which we are asked to make are not solutions to algebraic problems. Rather, they affect real people. Mary Virginia Oxendine was born on January 25, 1971 with a shortened right forearm and with only three fingers on her right hand. In her complaint, filed on February 1, 1982, she alleged that her mother used Bendectin during her pregnancy, and that Bendectin caused Ms. Oxendine's birth defects. Following a protracted trial in May 1983, the jury credited her allegations and awarded her substantial damages. In Oxendine I and again in Oxendine II, *fn1 this court sustained the judgment.

Ms. Oxendine will soon be twenty-four years old. This suit was filed almost thirteen years ago. More than eleven years have elapsed since the trial. Now, four appeals later, Ms. Oxendine has yet to receive a penny from Merrell Dow. Although our decision in this case probably brings us somewhat closer to the day on which Ms. Oxendine will actually receive some compensation, we cannot say with assurance, even today, that the end of the long journey is imminent.

Justice delayed is Justice denied. Ms. Oxendine's childhood is over. Timely receipt of the money might perhaps have made it easier for her to deal with the consequences of her handicap during her teen-age years. Unfortunately, that opportunity has been lost forever.

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