Who is an Expert? Daubert et al. v. Merrell Dow Pharmaceuticals, Inc.

Facts District Appeals Issue Rule 702 Reasoning Ruling Summary Notes

 
Facts:

Jason Daubert and Eric Schuller were born with serious birth defects. These infants and their guardians ad litem sued Merrell Dow Pharmaceuticals, Inc., to recover money for limb reduction birth defects allegedly caused by the antinausea drug Bendectin[1], which their mothers took while pregnant.[8]

 
District Court Case History:

In the case of Dubert et. al v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 113 S.Ct. 2786 125 L.Ed.2d 469, the United States District Court for the Southern District of California, granted Merrell Dow Pharmaceuticals' motion for summary judgment, and Daubert appealed.

Merrell submitted an affidavit from Dr. Steven H. Lamm, physician and epidemiologist. He was a well-credentialed expert on the risks from exposure to various chemical substances. Dr. Lamm stated that he had reviewed all the literature on Bendectin and human birth defects, which included more than 30 published studies involving over 130,000 patients, and that no study had found Bendectin to be a human teratogen. On the basis of this review, Dr. Lamm concluded that maternal use of Bendectin during the first trimester of pregnancy had not been shown to be a risk factor for human birth defects.[8]

Daubert did not contest Dr. Lamm's testimony concerning Bendectin. They responded to Merrell with testimony from eight experts with impressive credentials. These experts concluded that Bendectin could cause birth defects, but their conclusions were based on in vitro and in vivo studies that found a link between Bendectin and malformations, pharmacological studies of the chemical structure of Bendectin that seemed to show similarities between the structure of the drug and others known to cause birth defects, and the reanalysis of previously published epidemiological studies.[8]

Quoting United States v. Kilgus, 571 F. 2d 508, 510 (CA9 1978),[4] the District Court stated that scientific evidence was admissible only if the principle upon which it is based is "sufficiently established to have general acceptance in the field to which it belongs."[8]

The court concluded that Daubert's evidence did not meet that standard. Given the substantial amount of epidemiological data concerning Bendectin, the court held, that the opinions provided by Daubert's experts were not based on sufficient epidemiological evidence to establish causation.[8]

The animal cell studies, live animal studies, and chemical structure analyses on which Daubert's experts had relied could not provide a reasonably disputable jury issue regarding causation. Daubert's experts' epidemiological analyses, based on recalculations of data in previously published studies that had found no causal link between the drug and birth defects, were ruled to be inadmissible because they had not been published or subjected to peer review. [8]

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Court of Appeals Case History:

The United States Court of Appeals for the Ninth Circuit, 951 F.2d 1128, affirmed. The plaintiffs filed petition for a writ of certiorari, which was granted.[8]

Citing Frye v. United States, 54 App. D.C. 46, 47, 293 F. 1013, 1014 (1923), the court stated that expert opinion based on a scientific technique is inadmissible unless the technique is "generally accepted" as reliable in the relevant scientific community.[10]

Quoting United States v. Solomon,[5] 753 F. 2d 1522, 1526 (CA9 1985), the court said that expert opinion based on a methodology that diverges "significantly from the procedures accepted by recognized authorities in the field...cannot be shown to be generally accepted as a reliable technique."[8] (The U.S. Supreme Court opinion, below, would find "general acceptance" wasn't particularly relevant.)

The court emphasized that other Courts of Appeals considering the risks of Bendectin had refused to admit reanalyses of epidemiological studies that had been neither published nor subjected to peer review. Referring again to Frye, the court said those courts had found unpublished reanalyses "particularly problematic in light of the massive weight of the original published studies supporting [respondent's] position, all of which had undergone full scrutiny from the scientific community."[8]

Contending that reanalysis is generally accepted by the scientific community only when it is subjected to verification and scrutiny by others in the field, the Court of Appeals rejected Daubert's experts' reanalyses as "unpublished, not subjected to the normal peer review process and generated solely for use in litigation."[8]

The court concluded that the expert testimony provided by Daubert's witnesses was insufficient to demonstrate that Bendectin caused their injuries and that Daubert did not prove its case.

The case then went to the U.S. Supreme Court.

 
Issue:

The issue before the U.S. Supreme Court was whether or not the testimony given by Daubert's experts was admissible in court.[8]

 
Rule 702 Testimony by Expert Witnesses:

Rule 702, part of Article VII of the Federal Rules of Evidence, helps courts determine the admissability, relevance, and reliability of expert testimony. The rule states that an expert's opinion is admissible if:

Rule 702 was amended in response to the U.S. Supreme Court's decision in this case, Daubert v. Merrell Dow Pharmaceuticals, Inc., which outlined some of the factors for the courts to consider when determining the expert testimony admissibility. Although the specific Daubert factors are not codified in Rule 702, was changed enough to allow consideration of any of the factors listed in Daubert and cases that followed it.[8]

 
Reasoning:

The U.S. Supreme Court noted that there was no law requiring "general acceptance" as an absolute prerequisite to admissibility, and noted that a rigid "general acceptance" requirement would be at odds with the "liberal thrust" of the Federal Rules and their "general approach of relaxing the traditional barriers to 'opinion' testimony." Rules assign to trial judge the task of ensuring that expert's testimony both rests on reliable foundation and is relevant to task at hand.[8]

The court continued: "Given the Rules' permissive backdrop and their inclusion of a specific rule on expert testimony that does not mention "general acceptance," the assertion that the Rules somehow assimilated Frye is unconvincing. Frye made 'general acceptance' the exclusive test for admitting expert scientific testimony. That austere standard, absent from and incompatible with the Federal Rules of Evidence, should not be applied in federal trials."[8]

The Court held that one of its functions was "gatekeeper," and that Rule 702 granted wide judicial discretion in determining admissibility. Most importantly, the breadth of Rule 702, along with the case law that follows, establishes that exclusion of expert testimony is the exception rather than the rule.[8]

 
Ruling:

The U.S. Supreme Court vacated, and remanded, the case.[8]

 
Summary:

This case started in United States District Court for the Southern District of California, where the court determined that the evidence was inadmissable because it was not "sufficiently established to have general acceptance in the field to which it belongs."[8]

The United States Court of Appeals for the Ninth Circuit agreed with the District Court, and added that some of the evidence presented by Daubert's experts, specifically reanalyses of epidemiological studies, were not admissable because they had not been published nor subjected to peer review.[8]

The U.S. Supreme Court ruled that there was no law that required "general acceptance," remanding the case to the lower courts.[8]

Rule 702, modified as a result of Daubert, now provides courts with a set of criteria they can apply to determine admissability of expert testimony, with one noted caveat: the Court emphasized that the inquiry under Rule 702 is "a flexible one,"[8] which leaves the decisions to admit particular expert testimony in the hands of judges.

The purpose of the appellate courts is to review the procedures and the decisions in trial courts to make sure that the proceedings were fair and that the proper law was applied correctly.

Appellate courts do not retry cases or hear new evidence, nor do they hear witness tesimony, and there is no jury. They review the procedures and the decisions in the trial court to make sure that the proceedings were fair and that the proper law was applied correctly.[14]

 
Notes:

Courts sometimes provide minimal analyses or explanations, and other courts write lengthy decisions, citing years of precedents, affirming and dissenting opinions, statutes, and rules. Judicial opionions can be, at times, difficult to read, and hard to follow.

Sometimes court decisions affirm previous decisions, using the same or different legal bases and forming different opinions. Sometimes they reject previous decisions, establishing precedent, based on judicial efficiency, societal needs, new statutes and laws, and to "right a wrong."

Sources:

[1] Bendectine.com. Bendectine. https://www.bendectin.com/en/#:~:text=Following%20this%20article
%2C%20the%20FDA,defects.%22%2010%20A%20series%20of

[2] CaseBriefs. Daubert v. Merrell Dow Pharmaceuticals, Inc. https://www.casebriefs.com/blog/law/torts/torts-keyed-to-prosser/causation-in-fact/daubert-v-merrell-dow-pharmaceuticals-inc-4/

[3] CaseLaw. Daubert v. Merrell Dow Pharmaceuticals, Inc., United States Court of Appeals, Ninth Circuit. https://caselaw.findlaw.com/us-9th-circuit/1430422.html

[4] CaseText.com. United States v. Kilgus. https://casetext.com/case/united-states-v-kilgus

[5] CaseText.com. United States v. Solomon. https://casetext.com/case/united-states-v-solomon-7

[6] Expert Institute. Rule 702 - Testimony By Expert Witnesses. https://www.expertinstitute.com/resources/insights/the-ultimate-guide-to-the-federal-rules-of-evidence-and-expert-witnesses
/#:~:text=Rule%20702%20%E2%80%93%20Testimony%20By%20
Expert%20Witnesses&text=It%20states%20that%20an%20
expert's,on%20sufficient%20facts%20or%20data

[7] Justia. Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993). https://supreme.justia.com/cases/federal/us/509/579/

[8] Legal Information Institute. Daubert v. Merrell Dow Pharmaceuticals, Inc., (92-102), 509 U.S. 579 (1993). https://www.law.cornell.edu/supct/html/92-102.ZO.html

[9] Legal Information Institute. Federal Rules of Evidence. https://www.law.cornell.edu/rules/fre

[10] LexisNexis. Law School Case Brief for Frye v. United States - 293 F. 1013 (D.C. Cir. 1923). https://www.lexisnexis.com/community/casebrief/p/casebrief-frye-v-united-states

[11] LexisNexis. Law School Case Brief for Daubert v. Merrell Dow Pharmaceuticals, Inc., (92-102), 509 U.S. 579 (1993). https://www.lexisnexis.com/community/casebrief/p/casebrief-daubert-v-merrell-dow-pharms

[12] Mintz, M. (February 11, 1980). Drug for 'Morning Sickness' Is Suspected in Birth Defects. Washington Post. https://www.washingtonpost.com/archive/politics/1980/02/11/drug-for-morning-sickness-is-suspected-in-birth-defects/19db732c-319e-4f65-bef2-1a24e9c96333/

[13] National Academies Press. (2009). Strengthening Forensic Science in the United States: A Path Forward. http://nap.edu/12589

[14] United States Courts. About the U.S. Courts of Appeals. https://www.uscourts.gov/about-federal-courts/court-role-and-structure/about-us-courts-appeals#:~:
text=Appellate%20courts%20review%20the%20procedures,proper%20law%20was%20applied%20correctly.

[15] Wikipedia. Daubert v. Merrell Dow Pharmaceuticals, Inc. https://en.wikipedia.org/wiki/Daubert_v._Merrell_Dow_Pharmaceuticals,_Inc.


Denise Meeks, dmeeks@email.arizona.edu