Daubert v. Merrell Dow Pharmaceuticals, Inc.

• Decision Date: 14 December 1989
• Docket Number: Civ. No. 84-2013-G(IEG),84-2929-G(IEG).
• Parties: William DAUBERT and Joyce Daubert, individually and as Guardians ad Litem for Jason Daubert, a minor, Plaintiffs, v. MERRELL DOW PHARMACEUTICALS, INC., et al., Defendants. Michael SCHULLER, Anita De Young, and Anita De Young as Guardian ad Litem for Eric Schuller, Plaintiffs, v. MERRELL DOW PHARMACEUTICALS, INC., et al., Defendants.
• Court: U.S. District Court — Southern District of California

727 F. Supp. 570

William DAUBERT and Joyce Daubert, individually and as Guardians ad Litem for Jason Daubert, a minor, Plaintiffs, v. MERRELL DOW PHARMACEUTICALS, INC., et al., Defendants.

Michael SCHULLER, Anita De Young, and Anita De Young as Guardian ad Litem for Eric Schuller, Plaintiffs, v. MERRELL DOW PHARMACEUTICALS, INC., et al., Defendants.

Civ. Nos. 84-2013-G(IEG), 84-2929-G(IEG).

United States District Court, S.D. California.

November 1, 1989.

As Modified December 14, 1989.

Mary Gillick, San Diego, Cal., Barry Nace of Paulson, Nace, Norwind & Sellinger, Washington, D.C., for plaintiffs.

George Berry, Robert Dickson and Pamela Yates, Santa Monica, Cal., for defendants.

MEMORANDUM DECISION AND ORDER

GILLIAM, District Judge.

The defendant's motion for summary judgment was scheduled for hearing on October 6, 1989, in Courtroom 7 before the Honorable Earl B. Gilliam. Plaintiffs were represented by Mary Gillick and Barry Nace. George Berry, Robert Dickson and Pamela Yates appeared on behalf of defendant. Having considered the points and authorities and oral argument of counsel, the court issues this memorandum decision and order granting defendant's motion for summary judgment.

FACTS

This case involves personal injuries sustained by plaintiffs. Infant plaintiffs and their guardians ad litem seek damages from defendant for injuries (limb reduction birth defects) allegedly sustained as a result of the mothers' ingestion of Bendectin during pregnancy. Bendectin is a prescription pharmaceutical product previously manufactured by Merrell Dow, indicated solely for the treatment of nausea and vomiting during pregnancy. Defendant has moved for summary judgment, arguing that plaintiffs have failed to sustain their burden of establishing a genuine issue of material fact regarding causation.

DISCUSSION

Summary judgment is proper "after adequate time for discovery and upon motion, against a party who fails to make a showing sufficient to establish the existence of an element essential to that party's case, and on which that party will bear the burden of proof at trial...." Celotex Corp. v. Catrett, 477 U.S. 317, 322, 106 S.Ct. 2548, 2552, 91 L.Ed.2d 265 (1986). "The standard for granting summary judgment mirrors the standard for a directed verdict under Federal Rule of Civil Procedure 50(a)...." Id. at 323, 106 S.Ct. at 2552 (citing Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 250, 106 S.Ct. 2505, 2511, 91 L.Ed.2d 202 (1986)).

In this case the defendant has moved for summary judgment. Plaintiffs, who have the burden of proof by a preponderance of the evidence, oppose the motion. The court must therefore determine "whether a fairminded jury could return a verdict for the plaintiff based on the evidence presented." Anderson v. Liberty Lobby, Inc., 477 U.S. at 251-252, 106 S.Ct. at 2511-2512. The court must view the evidence in a light most favorable to plaintiff, however, "the evidence is insufficient if the strongest inference to be drawn in the plaintiff's favor is that defendant's negligence could possibly have been the cause of the accident." Bieghler v. Kleppe, 633 F.2d 531, 533 (9th Cir.1980) (emphasis in original) (citing Neely v. St. Paul Fire & Marine Insurance Co., 584 F.2d 341, 345 (9th Cir.1978)). The plaintiff must show that defendant's negligence "was more probably than not the proximate cause of the accident" to defeat summary judgment and take the issue to a jury. Bieghler at 533. The court should exclude inadmissible evidence objected to by either party prior to ruling upon the motion. See, Hollingsworth Solderless Terminal Co. v. Turley, 622 F.2d 1324, 1335 (9th Cir.1980).

Federal Rule of Evidence (FRE) 703, restricts the admissibility of scientific evidence. "A necessary predicate to the admission of scientific evidence is that the principle upon which it is based `must be sufficiently established to have general acceptance in the field to which it belongs.'" United States v. Kilgus, 571 F.2d 508, 510 (9th Cir.1978). Therefore, expert opinion not based on facts or data "of a type reasonably relied upon by experts in the particular field" is not helpful, but instead is confusing or misleading and should therefore be excluded. See, Fed.R.Evid. 403. See also Barrel of Fun, Inc. v. State Farm Fire and Casualty Co., 739 F.2d 1028, 1033 (5th Cir.1984) (excluding expert's opinion based on polygraph test). "Whether an expert's opinion has an adequate basis, and whether without it an evidentiary burden has been met, are matters of law for the court to decide." Richardson v. Richardson-Merrell, 857 F.2d 823, 829 (D.C.Cir.1988), cert. denied, ___ U.S. ___, 110 S.Ct. 218, 107 L.Ed.2d 171 (1989).

There are two schools of thought governing expert testimony in these Bendectin cases, and one seems to be prevailing in the federal courts. Unfortunately for the plaintiffs, the prevailing school of thought warrants summary judgment in this case.

The prevailing school is best exemplified by Brock v. Merrell Dow Pharmaceuticals, 874 F.2d 307 (5th Cir.1989), modified, 884 F.2d 166 (5th Cir.1989), rehr'g denied, en banc, 884 F.2d 167 (5th Cir.1989) where the court held the following:

We find, in this case, the Brocks' failure to present statistically significant epidemiological proof that Bendectin causes limb reduction defects to be fatal to their case.

Id. at 313. The court also noted:

Hopefully, our decision will have the effect of encouraging district judges faced with medical and epidemiological proof in subsequent toxic tort cases to be especially vigilant in scrutinizing the basis, reasoning, and statistical significance of studies presented by both sides. However, we do not wish this case to stand as a bar to future Bendectin cases in the event that new and statistically significant studies emerge which would give a jury a firmer basis on which to determine the issue of causation.

Id. at 315. Several other cases are in accord with this reasoning. See, Richardson v. Richardson-Merrell, supra; Lynch v. Merrell-National Laboratories, 830 F.2d 1190 (1st Cir.1987); Hull v. Merrell Dow Pharmaceuticals, Inc., 700 F.Supp. 28 (S.D.Fla.1988); In re Richardson-Merrell, Inc. "Bendectin" Products Liability Litigation, 624 F.Supp. 1212 (S.D.Ohio 1985), aff'd, 857 F.2d 290 (6th Cir.1988), cert. denied ___ U.S. ___, 109 S.Ct. 788, 102 L.Ed.2d 779 (1989); Thompson v. Merrell Dow Pharmaceuticals, Inc., 229 N.J.Super. 230, 551 A.2d 177 (1988).

In medical cases like this one, courts must "critically evaluate the reasoning process by which the experts connect data to their conclusions in order for courts to consistently and rationally resolve the disputes before them." Brock, 874 F.2d at 310. Absent a scientific understanding of the cause of the birth defects at issue in Bendectin cases, causation may be shown only through reliance upon epidemiological evidence. See, Richardson v. Richardson-Merrell; Lynch v. Merrell-National Laboratories. See also In re Agent Orange Product Liability Lit., 611 F.Supp. 1223 (E.D.N.Y.1985), aff'd, 818 F.2d 187 (2nd Cir.1987) (stating that epidemiological studies were "the only useful studies having any bearing on causation" in Agent Orange cases).

In Richardson, Dr. Done, the plaintiff's expert, relied upon 1) chemical structure activity analysis, 2) in vitro (test tube) studies, 3) in vivo (animal teratology) studies, and 4) reanalysis of epidemiology studies. He used the results of these four types of studies to conclude that within a reasonable degree of certainty, Bendectin causes birth defects. The court concluded that Dr. Done's testimony lacked an adequate scientific basis:

These three types of studies — chemical, in vitro, and in vivo — cannot furnish a sufficient foundation for a conclusion that Bendectin caused the birth defects at issue in this case. Studies of this kind singly or in combination are not capable of proving causation in human beings in the face of the overwhelming body of contradictory epidemiological evidence.

Richardson, 857 F.2d at 830. The court also rejected the reanalysis of the epidemiological studies:

Dr. Done further admitted that no one who had published work on Bendectin had concluded that there was a statistically significant association between Bendectin and limb reduction defects.... Only by recalculating the data was Dr. Done able to obtain what he deems a statistically significant result. Moreover, the studies rejected by Dr. Done had been published in peer-reviewed scientific journals, while Dr. Done has neither published his recalculations nor offered them for review.

Id. at 831 (emphasis added).

The plaintiffs rely on Oxendine v. Merrell Dow Pharmaceuticals, Inc., 506 A.2d 1100 (D.C.App.1986) and other cases which basically give more deference to the expert's opinion. Oxendine is the leading Bendectin case in this regard, and the appellate court found that Dr. Done had a sufficient foundation for his testimony when he relied upon chemical analyses, animal studies, in vitro studies and recalculations of epidemiological studies:

Dr. Alan Done, appellant's sole causation witness, had testified that no conclusion about Bendectin's effect on humans could be drawn from any of the four types of scientific data upon which he principally relied when each type was considered separately from the others. The trial court focused on this fact and concluded that if each type of data, viewed in isolation, was not sufficient to prove that Bendectin caused birth defects, then all of them taken together could not prove it either. In so doing, the trial court erred by granting defendant's motion for J.N.O.V..

Oxendine, 506 A.2d at 1104. The Oxendine court viewed the recalculations of epidemiological studies and the varying conclusions as involving a "classic battle of the experts." Id. at 1110. The court refused to find that plaintiffs had provided insufficient evidence to support the jury verdict solely because they had not provided a single...