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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 ...

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