Daubert v. Merrell-Dow - Case Notes

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Author - John Shepherd - Summer/Fall 1998

Background Bendectin was prescribed for women experiencing "morning sickness" (nausea associated with early pregnancy) starting in 1956 and was taken during more than 30 million pregnancies by 1983.   In 1975 David Mekdeci was born with birth defects that the mother attributed to her use of the drug and the parents sued Merrell-Dow, Bendectin's manufacturer.  They were awarded $20,000 in damages in 1980.  Settlements in successful suits increased, culminating in a 1987 federal court jury award of $95 million to eight-year-old Sekou Ealy, who was born with deformed hands and arms allegedly as a result of his mother's taking Bendectin.  In 1985,  a suit by 1100 women against Merrell-Dow caused a judge to arrange a preliminary trial in which the jury was to decide first whether a) Bendectin could be shown to cause birth defects and b) whether they could be held liable.  The jury found Bendectin did not cause birth defects.  Merrell-Dow continued to settle some of these cases out of court.  By 1983, Merrell-Dow had suffered $120 million in legal fees and settlements and took the drug off the market.

In 1984, the parents of Jason Daubert and Eric Schuller filed against Merrell- Dow, seeking compensation for their children, who were born with short, rudimentary arms, a "limb reduction" birth defect.  In a California district court Merrell-Dow argued that many published medical studies had established Bendectin's safety and asked for a "summary judgement" that would dismiss the Daubert's suit.  The judge discounted the unpublished evidence by Daubert's hired experts and dismissed the case.  The Dauberts appealed to the Ninth Circuit Court of Appeals, which supported the lower courts reliance on published epidemiological studies and upheld the decision of the lower court.  In both of these cases, expert witnesses for the defendants presented evidence from published studies that found no link between Bendectin and limb reduction birth defects.  The plaintiffs' experts argued for the plausibility of Bendectin causing the birth defects by pointing out flaws in the published studies.  The methodology the plaintiffs experts used to analyze the data in the published studies was an issue of contention, especially in the Appeals Court. 

Both of these Courts applied the Frye Rule.   Frye v US was a 1923 Supreme Court case in which a murder suspect wanted to introduce evidence from a blood pressure-lie dectector test.  The lower court ruled the evidence inadmissible because this was not an accepted procedure in the scientific community: evidence "must be generally accepted {in the appropriate scientific community} to render expert testimony admissible."

After being reject in the Ninth Circuit Court of Appeals, the Daubert case was taken to the US Supreme Court, which agreed to hear the case in 1992 because it raised significant questions about the nature and admissibility of expert scientific testimony in courts.  A large number of "friends of the court" (amici curiae), including a number of Nobel laureates, filed briefs with the court to try to influence the outcome.  Excerpts from some of those form part of the case materials.

The Supreme Court was NOT being asked to decide whether Bendectin causes birth defects.  The Petitioners are arguing that the lower courts made a mistake in legal procedure by ignoring, or discounting, the evidence presented by the Dauberts' experts, and relying instead on the published studies cited by the respondents' experts.  The Respondents argue that the lower courts were correct in weighing the evidence presented by the experts on both sides.  Friends of the Petitioners generally argue that the Frye Rule and an insistence on publication and peer review are inappropriate because they exclude valid scientific testimony.  Friends of the Respondents argue that the lower courts appropriately relied on consensus in the scientific community.   There is also a less interesting discussion about whether federal legislation (the Federal Rules of Evidence, FRE) replaced the Frye Rule as the current legal standard, but I ommitted most references to that in the excerpts.

Teaching Notes

Assignment for first class day:

• Read these excerpts from the US District Court of the Southern District of California Decision.
• Read these excerpts from the decision of the US Ninth Circuit Court of Appeals
• Find out what treatments are currently recommended for morning sickness.
• Come to class prepared to discuss the following issues (a quiz is possible):
  • How did the judge in the California District Court reach his decision in the Daubert's case?
  • How did the judge in the Court of Appeals reach his decision in the Daubert's case?
  • Under what conditions should a manufacturer have to pay damages to a consumer?
  • What evidence should be required of a plaintiff in order to collect damages?

Discussion for first class day:

• Ice-breaker: What is morning sickness and how is it treated?
• Under what conditions should a manufacturer have to pay damages to a consumer?
• What evidence should be required of a plaintiff in order to collect damages?
• California Decision/Ninth Circuit Decision:
  • As best you can tell from the excerpts, what specific evidence was presented by the plaintiffs and defendants to support their cases?  For each kind of evidence, identify a plausible design for the study.
    • Plaintiffs: 8 expert scientists reported the results of unpublished 1) in vitro studies, 2) in vivo studies, 3) chemical structural analyses, 4) re-analysis of epidemiological studies. 
    • Defendants: 4 expert scientists who reviewed the published literature of over 30 studies that used a total of 130,000 patients.
  • As best you can tell from the excerpts, what specific criteria did the judges use to evaluate this evidence?  Are these criteria reasonable and justified?

Assignment for Second Class Day:

After the Dauberts lost their case in the Ninth Circuit, they appealed their case to the US Supreme Court.  With jury awards approaching $100 million, the stakes were high.  The Supreme court agreed to hear the case because it raised significant questions about how to determine which scientific evidence should be admitted to court, and which experts should be allowed to testify.  For class next time, you will be asked to review a portion of the arguments that were made before the Supreme court.

Everyone needs top read  Frye v United States, the 1923 US Supreme Court Decision that was the basis of the Frye rule, which allowed admissibility of "generally accepted" scientific evidence for 70 years. 

In class on Monday, you will be assigned to one of the following groups. {If you are absent on Monday, and don't want a second zero for Wed, I can tell what you need to do in a reply email.}  Read the legal briefs relevant to your group and come prepared to discuss them with others who have read the same material.

1. Petitioners (the Dauberts)
   • Petitioners' Brief before US Supreme Court asking for the 9th Circuit ruling to be overturned.
   • Petitioner's Reply to Merrell-Dow Brief.
2. Friends of the Court in support of the petitioners
   • Daryl Chubin, et al
   • Ronald Bayer, et al
3. Respondents (Merrell-Dow)
   • Respondents' Brief before US Supreme Court asking for the 9th Circuit ruling to be upheld.
4. Friends of the Court in support of the respondents
   • Nicolaas Bloembergen, et al
   • AAAS/NAS
   • NEJM/JAMA/AIM

The following may be useful to any of the groups:

• Carnegie Commission on Science, Technology and Gvoernment, filed this brief in support of neither party
• Federal Rules of Evidence 702 & 703 describe the admissibility of expert testimony as legislated by congress. Other FRE information is available at the Cornell University Legal Information Institute.

Second Class Meeting: Discussion of the Frye Rule with any benefits and shortcomings.   Also a discussion of the process of peer review.  They are then told that they will have to represent those legal arguments in an open forum. They should also be prepared to counter the arguments made by people from the other groups.  The groups are given the rest of the class to talk about the briefs that they read and prepare for the forum.   It will take them some time to sort out the various legal perspectives.

Assignment for Third Class Meeting:

In class on Friday we will have an open forum in which we discuss the arguments for and against granting Petitioner's request for certiorari (review of the lower court decisions).   First the Petitioners and Respondents will make brief (5+ minute) presentations of their arguments.  Then we will open the discussion to all viewpoints.  I will act as moderator as necessary to get everyone wanting to speak into the discussion.   It is your job to get the views you represent into the dialogue, but you should also respond to the arguments put forth by others.  You have been given the material actually presented to the court by a variety of prestigious attorneys, Nobel laureate scientists, and professional associations.  You should keep your focus on the ideas and avoid personal commentaries and digressions.  I will ask you for your personal views a little later; at this point your job is to represent the views you've been assigned.

Keep in mind the focus of the case before the court.   The Supreme Court is NOT being asked to decide whether Bendectin causes birth defects.  The petitioners are arguing that the lower courts made a mistake in legal procedure by ignoring, or discounting, the evidence presented by the Dauberts' experts, and relying instead on the published studies cited by the respondents' experts.  The respondents argue that the lower courts were correct in weighing the evidence presented by the experts on both sides.  Friends of the Petitioners generally argue that the Frye Rule and an insistence on publication and peer review are inappropriate because they exclude valid scientific testimony.  Friends of the Respondents argue that the lower courts appropriately relied on consensus in the scientific community.

Third Class Meeting: Forum/debate of the issues raised in the briefs the students have read.

Assignment for Fourth Class Meeting: For Monday, read the following.  As always, come prepared to discuss the issues raised by the readings and ready for a short quiz at the start of class.

• Supreme Court Daubert Decision This is the full text of the decision, so you will get a feeling for how intensely I edited the earlier decisions you read.  Extract the main arguments as you read and skip over the legalese as necessary to get the main points.
• Science in the Courtroom.  This contains some background on the case that will be familiar to you, and a summary of the Supreme court decisionthat may help you read the decision itself.  Toward the end of the article, it assesses the consequences of the decision and has a short review of "the real tragedy of Bendectin."

Fourth Class Meeting: At the start of the class, students are asked to write a page defending the position either that the Supreme Court made a wise decision or an unwise decision. They should carefully justify the position they adopt.