• Embed Doc
  • Readcast
  • Collections
  • 2
    CommentGo Back
Download
 
1 of 999 DOCUMENTS
Esther R. Kociemba and William J. Kociemba, Plaintiffs, v. G. D.Searle& Co.,DefendantCivil No. 3-85-1599UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MINNESOTA,THIRD DIVISION683 F. Supp. 1582; 1988 U.S. Dist. LEXIS 14042February 12, 1988, DecidedFebruary 12, 1988, FiledCASE SUMMARY:PROCEDURAL POSTURE:
In an action alleging negligent testing of Cu-7, defendant company brought a motion inlimine to exclude a Food and Drug Administration (FDA) Task Force Report critical of the company's laboratory andanimal testing procedures. The company claimed the report was not relevant, constituted inadmissible characterevidence and inadmissible hearsay, and its prejudicial effect on the factfinder would substantially outweigh its probativevalue.
OVERVIEW:
During legislative hearings regarding the clinical testing practices in the pharmaceutical industry,serious allegations regarding the company's testing procedures surfaced. An FDA task force investigated the company'sanimal testing and procedures in 25 different animal studies over a seven year period. The only Cu-7 related studyincluded in the
investigation
was a 52-week copper toxicity study of laboratory rats. The FDA's report raised seriousquestions regarding the reliability and the scientific integrity of the company's studies on the products investigated. Thecourt granted the motion to exclude the report in plaintiffs' case-in-chief. The court was not persuaded that the reportwas relevant to the issues of the case. Under Fed. R. Evid. 403, the court conducted the balancing test and concludedthat the report's minimal probative value was clearly outweighed by its prejudicial impact. The report questioned thecompany's honesty and commitment to the protection of public health and recommended a criminal
investigation.
Thecourt concluded that exclusion in plaintiff's case-in-chief was the only way to ensure a fair trial.
OUTCOME:
The court granted the company's motion to exclude the report from plaintiffs' case-in-chief. The courtwithheld judgment until trial on whether it could be used for impeachment or rebuttal purposes.
CORE TERMS:
task force, animal, laboratory, copper, rebuttal, toxicity, probative value, case-in-chief, inadmissible,investigated, prejudicial, testing procedures, character evidence, impeachment purposes, grand jury proceedings,subcommittee, impeachment, recommended, factfinder, admissible, outweighed, questioned, deposition, probable,testing, hearsay, impeach, rebut, safe
LexisNexis(R) Headnotes
 Evidence > Relevance > Relevant Evidence
[HN1] Relevant evidence is generally admissible at trial. Fed. R. Evid. 402. "Relevant evidence" is evidence having anytendency to make the existence of any fact that is of consequence to the determination of the action more or lessprobable than it would be without the evidence. Fed. R. Evid. 401.Page 1
 
 Evidence > Relevance > Confusion, Prejudice & Waste of Time
[HN2] Even if evidence is arguably relevant to some part of a plaintiff's case, Fed. R. Evid. 403 dictates that suchevidence may be excluded if its probative value is substantially outweighed by the danger of unfair prejudice, confusionof the issues, or misleading the jury, or by considerations of undue delay, waste of time, or needless presentation of cumulative evidence. Fed. R. Evid. 403, by its very words, requires the court to conduct a balancing test to determine if otherwise admissible evidence should be excluded at trial.
COUNSEL: [**1]
Michael V. Ciresi, Roger P. Brosnahan, David L. Suggs, Roberta Walburn of Robins, Zelle, Larson& Kaplan, Minneapolis, Minnesota, represent Plaintiffs.Michael Berens, Madge S. Thorsen, Paula D. Osborn of Oppenheimer, Wolff & Donnelly, Minneapolis, Minnesota, andPaul Strain of Venable, Baetjer & Howard, Baltimore, Maryland, represent Defendant.
JUDGES:
Robert G. Renner, United States District Judge.
OPINION BY:
RENNER
OPINION[*1582]
MEMORANDUM AND ORDERROBERT G. RENNER, UNITED STATES DISTRICT JUDGEBefore the Court is defendant's motion in limine to exclude a 1976 Food and Drug Administration ("FDA") Task ForceReport ("report") critical of defendant's laboratory and animal testing procedures. On October 23, 1987, the Court, aftera hearing on the matter, took it under advisement.Defendant seeks to exclude the report because 1) it is irrelevant to any material issue in this case; 2) it constitutesinadmissible character evidence; 3) its prejudicial effect on the factfinder would substantially outweigh its probativevalue; and 4) it is inadmissible hearsay.
[*1583]
After careful review, the Court grants defendant's motion to exclude the report from plaintiffs' case-in-chief.The court withholds judgment at this time as to whether it may be used for impeachment and/or rebuttal purposes.FACTS
[**2]
In 1975, a Senate subcommittee held hearings regarding the clinical testing practices in the pharmaceuticalindustry. Serious allegations regarding
Searle's
testing procedures surfaced at those hearings. As a result, the FDAinvestigated
Searle's
laboratory animal testing and data reporting procedures.FDA investigators and scientists conducted a three month on-site
investigation
at various
Searle
laboratories locatedthroughout the country. A steering committee comprised of FDA bureau chiefs and FDA Commissioner, Dr. AlexanderSchmidt, oversaw the
investigation.
In the Fall of 1976, the task force investigated 25 different animal studies conducted by
Searle
between 1968 and 1975.These studies were representative of all of 
Searle's
animal studies during that period. However, the only Cu-7 relatedstudy included in the task force
investigation
was a 1971-1972 copper toxicity study of laboratory rats.On March 24, 1976, the FDA issued an 84-page report highly critical of 
Searle.
The report concluded, in part, that the
investigation
raises serious questions regarding the reliability and the scientific integrity of the studies submitted in support of the productsinvestigated.
Page 2683 F. Supp. 1582, *; 1988 U.S. Dist. LEXIS 14042, **
 
Searle [**3] Investigation
Task Force Report of Preclinical (Animal) Studies of G.D.
Searle
Company, Skokie,Illinois, p.8.The report further recommended that the Justice Department initiate grand jury proceedings against
Searle
to "identifymore particularly the nature of the violations and to identify all those responsible for such violations."
Id 
. at p. 10.FDA Commissioner Schmidt accepted the findings of the task force and presented the report to the Senatesubcommittee on April 8, 1976.In response to the report, the United States Attorney for the Northern District of Illinois initiated a grand jury
investigation
of 
Searle.
Fifteen months later, the grand jury proceedings were terminated. No charges have ever beenbrought against
Searle
or any of its employees as a result of the report.ANALYSIS[HN1] Relevant evidence is generally admissible at trial. Fed. R. Evid. 402. "Relevant evidence" is evidence
having any tendency to make the existence of any fact that is of consequence to the determination of the action more or lessprobable than it would be without the evidence.
Fed. R. Evid. 401.Plaintiffs contend that the FDA report is relevant for several reasons. First, they assert
[**4]
that the report's findingsregarding the 52-week copper toxicity study, coupled with other evidence of 
Searle's
misconduct in Cu-7 relatedstudies, is relevant evidence that
Searle
negligently tested the Cu-7. Second, plaintiffs assert that the report's mention of the copper toxicity study is relevant as to Dr. Fives-Taylor's anticipated expert testimony showing a link between bodilyuse of copper and an increased risk of infection.These relevancy arguments are not persuasive. The FDA
investigation
was undertaken to investigate
Searle's
generalresearch practices and methodology in laboratory studies. It was never intended to be a study of the safety andeffectiveness of the Cu-7. Although the report is highly critical of 
Searle's
general conduct between 1968 and 1975,such conduct is not relevant to the issues of this case unless plaintiffs can show that any part of the report makesdefendant's liability more probable than not. The examples cited by plaintiffs simply do not make such a showing.Furthermore, [HN2] even if the report is arguably relevant to some part of plaintiffs'
[*1584]
case, Fed. R. Evid. 403dictates that such evidence may be excluded
if its probative value is substantially
[**5]
outweighed by the danger of unfair prejudice, confusion of the issues, or misleading the jury, or by considerations of undue delay, waste of time, or needless presentation of cumulative evidence.
Fed. R. Evid. 403.Fed. R. Evid. 403, by its very words, requires the Court to conduct a balancing test to determine if otherwise admissibleevidence should be excluded at trial. Here, the task force report's relevance is questionable at best. The reportdocuments a general
investigation
of 
Searle's
research practices. It focuses on only one of the many Cu-7 animalstudies
Searle
conducted. Indeed, the Cu-7 is mentioned only six times in the entire 84-page report. In addition, theFDA decided, subsequent to the report, that Cu-7 research was not compromised by
Searle's
conduct in the 52-week copper toxicity study.
Searle
was not required to repeat the questioned study.The report's minimal probative value is clearly outweighed by its prejudicial impact. It, in no uncertain terms,questioned
Searle's
integrity, honesty, and commitment to the protection of the public health. Further, it recommendeda criminal
investigation
of 
Searle's
activities. Such language will surely prejudice the factfinder
[**6]
in a way thatno cautionary instruction could prevent. Exclusion under Fed. R. Evid. 403 is the only way to ensure a fair trial basedPage 3683 F. Supp. 1582, *1583; 1988 U.S. Dist. LEXIS 14042, **
2
of 00

Leave a Comment

You must be to leave a comment.
Submit
Characters: ...

When is enough enough? They know exactly how to get around the law. Dr. Betty Martini, D.Hum, Founder Mission Possible International 9270 River Club Parkway Duluth, Georgia 30097 770 242-2599 www.mpwhi.com, www.dorway.com, www.wnho.net Aspartame Toxicity Center, www.holisticmed.com/aspartame

When lots of information gets out on what aspartame triggers such as seizures, the aspartame industry does its own studies to show consumers aspartame doesn't cause these problems. Here is how they fix the studies: http://www.holisticmed.com/aspartame/... They are scholars on it. Then when independent researchers do studies on aspartame which give the real results they immediately get someone to rebut it. In the case of the damning Ramazzini studies showing aspartame to be a multipotential carcinogen it had to be reviewed by the European Food Safety Authority. They used the flimsiest excuse saying the rats had respiratory disease, knowing full well that respiratory disease is the dying process. Dr. Herman Koter, Director of Science, of EFSA before he resigned confessed that they were pressured by industry to highjack science. The NutraSweet Company will do anything to stop a hearing because they know all this information is going to come out. In a report published by UPI in 1987, Dr. Woodrow Monte said he was convinced in 1983, when the FDA okayed use of NutraSweet in carbonated beverages, that the sweetener would break down into poisonous quantities of methyl alcohol in diet sodas left in the Southwest sun. Monte, director of the Food Science and Nutrition Laboratories at Arizona State, and two consumer groups petitioned the Arizona Department of Health Services to ban the sweetener. Monte said his rat studies had shown that chronic ingestion of methyl alcohol causes brain damage similar to that in humans suffering from multiple sclerosis - including seizures, amnesia, optic neuritis, numbness and dizziness. In the desert heat, Monte said, methanol degrades faster into toxic methyl alcohol. He said his petition signaled a threat to the company because it could have opened the door for regulatory actions in other states. In April of l985, about the same time Monte and his associates finally were to be granted a hearing before the state agency on their petition, they learned that the Arizona legislature had used a rare maneuver to change the law, without public notice, to bar state regulation of FDA approved food additives. The measure passed under the misleading title of a TOXIC WASTE BILL!! Stephen Fox, Mission Possible New Mexico tried to get aspartame banned through the Environmental Improvement Board in New Mexico who twice granted a hearing. It was never held. After a meeting with aspartame attorneys it was prevented. Today even regulatory agencies put aspartame industry loyalty before the law. The law states a Citizens Petition must be answered in 180 days. It's been over 7 years and the FDA has ignored it along with an amendment on an imminent health hazard which should be answered in a week or ten days. When is enough enough? They know exactly how to get around the law. Dr. Betty Martini, D.Hum, Founder Mission Possible International 9270 River Club Parkway Duluth, Georgia 30097 770 242-2599 www.mpwhi.com, www.dorway.com, www.wnho.net Aspartame Toxicity Center, www.holisticmed.com/aspartame

You must be to leave a comment.
Submit
Characters: ...