Grundberg v. Upjohn Co.

137 F.R.D. 365, 1991 U.S. Dist. LEXIS 17264, 1991 WL 103494
CourtDistrict Court, D. Utah
DecidedJune 12, 1991
DocketNo. 89-C-274 G
StatusPublished
Cited by5 cases

This text of 137 F.R.D. 365 (Grundberg v. Upjohn Co.) is published on Counsel Stack Legal Research, covering District Court, D. Utah primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Grundberg v. Upjohn Co., 137 F.R.D. 365, 1991 U.S. Dist. LEXIS 17264, 1991 WL 103494 (D. Utah 1991).

Opinion

MEMORANDUM AND ORDER ON THE USE OF PROTOCOL 321 REPORT FORMS

RONALD N. BOYCE, United States Magistrate Judge.

The defendants have objected to a subpoena issued by plaintiffs to defendant to produce the underlying raw data of Protocol 321.1 These are the report forms used to record the reaction of persons tested in relation to the use of Halcion in conjunction with clinical study 321 which was conducted prior to the marketing of Halcion by defendant, Upjohn.

The report forms for protocol 321 were filled out by persons used in testing the effect of the ingestion of the drug Halcion and its impact on human subjects. The test was performed at Jackson State Prison in Michigan and the subjects were prisoners. They were exposed to Halcion dosages of .5 mg. and 1 mg. for 42 days. The test was a phase II study preliminary to Federal Drug Administration approval of Halcion. The tests were conducted on a relatively small number of subjects who have the disease the drug was designed to treat. The clinical trial investigator used the report forms for the assessment of the drug. The test was conducted at a facility provided by Upjohn at the Jackson State Prison. The supervising test physician was Dr. H.L. Oster. At this point, Dr. Oster’s connection with Upjohn is not clearly determined. He was apparently not an employee of Upjohn, but what his particular connection to Upjohn was, has not been fully identified. He was using Upjohn’s facility and testing Upjohn’s product. His report and data was used to obtain FDA approval for Halcion.

The defendant contends Dr. Oster’s study was not performed under Upjohn’s control and that Oster was not Upjohn’s agent. The protocol was submitted by Upjohn to the Food and Drug Administration (FDA). The plaintiffs contend that since Upjohn submitted the materials as a clinical basis for FDA approval of Halcion (on or about May 4, 1976) the materials are at least adoptive admissions by Upjohn. Plaintiffs further argue the protocol report forms are otherwise admissible as substantive evidence. The plaintiffs have contended that generally, at the time of the testing, drug manufacturers were not required to send such clinical studies to the FDA, but Upjohn was required to make full reports of “clinical investigations” to show [367]*367the drug safety. The clinical tests encompassed by FDA requirements are those sponsored by the applicant or received or otherwise obtained by the applicant seeking new drug approval. However, the reports were used only when the new drug application was submitted to the FDA for approval. Plaintiffs contend the submission of the reports by Upjohn “manifests an adoption of” the “protocol and the accompanying case report forms ...” The plaintiffs also contend that Dr. Oster was the “resident investigator” for Upjohn from 1957 to 1979.2

Also relevant to the issue of the admissibility of protocol 321 report forms is the ruling of District Judge Greene3 as to the scope of plaintiffs’ claims in light of the Utah Supreme Court’s ruling in Grundberg v. The Upjohn Company, 813 P.2d 89 (Sup. Ct.1991). On May 24, 1991 Judge Greene ruled, in denying a partial motion for summary judgment of Upjohn, “that matters of mismarketing, failure to warn, misrepresentation of FDA and defective design may be presented as matter of evidence under the strict liability cause of action.” (Hearing of May 24, 1991, Minute Entry).

This ruling would allow into evidence any matter relevant to those issues.

The plaintiffs intend to use the protocol 321 case report forms as substantive evidence. They have been subpoenaed by plaintiffs as an exhibit and it is intended they will be offered as substantive evidence at trial. District Judge Greene has determined the magistrate judge should rule on Upjohn’s objections and on any restrictions on the use of the documents. The defendant contends the procedural posture of the case should preclude admission because the documents were not obtained during the discovery period. However, the defendant had the documents, knew of their general content, and has shown no prejudice from the fact that plaintiffs did not make copies during the discovery period.

A more substantial objection is that the defendant has deposed the plaintiffs’ experts and no inquiry was made as to the protocol 321 materials because the reports (as distinct from the 321 summary) was not relied on by any expert. However, Rule 703, F.R.E. expressly allows an expert to rely on material “made known to the expert at ... the hearing.” Thus, an expert can always expand on the basis of an opinion over that on which the expert may have relied at trial. The Notes of the Advisory Committee on 1972 Proposed Rules observes the “second source” of expert testimony is “presentation at trial,” which “reflects existing practice.” A party deposing an expert witness cannot limit the witness to matter in his deposition if new matter supports the expert. The party against whom the new information is offered may bring out the recent additions to the expert opinion as it may bear on credibility. See Weinstein’s Evidence, 11703[01] p. 703-6; United States v. King, 616 F.2d 1034 (8th Cir.1980) (IRS summary witness). However, if an expert is going to rely on evidence introduced at trial, the evidence will need to be admissible. The plaintiffs contend the protocol reports are independently admissible and unable to support plaintiffs’ contentions.

Of course, an expert, under Rule 703, F.R.E. may rely on material made available before trial and then the evidence itself need not be admissible. Ramsey v. Culpepper, 738 F.2d 1092, 1110 (10th Cir. 1984); Graham v. Wyeth Laboratories, 906 F.2d 1399 (10th Cir.1990); Wilson v. Merrell Dow Pharm. Inc., 893 F.2d 1149, 1152-53 (10th Cir.1990).

The defendant, Upjohn, argues that since Ilo Grundberg was never given a 1 mg. dosage of Halcion the reports as to the effects of that dosage are irrelevant. The [368]*368plaintiffs counter that Upjohn’s experts view dosage as irrelevant and that if the drug would produce any unorthodox response, it would occur regardless of dosage. Therefore, the 1 mg. studies are possibly logically relevant. It is admitted that Ilo Grundberg did receive a .5 mg. dosage of Halcion and some of the protocol 321 reports did involve .5 mg. testing. These reports would be relevant to the issues.

A major objection, advanced by Upjohn to the use of the protocol 321 report forms, is the contention they are hearsay. The plaintiffs have advanced several arguments for the admission of the evidence as non-hearsay or as an exception to the hearsay rule.

Admissibility as Regularly Kept Records (Rule 803(6) F.R.E.)

Plaintiffs suggest the protocol report forms are admissible .under Rule 803(6), F.R.E. as regularly kept records. The records are different than the drug experience reports previously ruled inadmissible as business records, (Supplemental Orders Motion # 19), because the reports in question are part of a structured model of a clinical study. The summary of protocol 321 gives some evidence of methodology of the research protocol. The plaintiff contends they are data compilations of events at or near the time of the experience.

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Bluebook (online)
137 F.R.D. 365, 1991 U.S. Dist. LEXIS 17264, 1991 WL 103494, Counsel Stack Legal Research, https://law.counselstack.com/opinion/grundberg-v-upjohn-co-utd-1991.