In re Eli Lilly & Co.

142 F.R.D. 454, 1992 U.S. Dist. LEXIS 7573, 1992 WL 108564
CourtDistrict Court, S.D. Indiana
DecidedMay 22, 1992
DocketMDL No. 907
StatusPublished
Cited by10 cases

This text of 142 F.R.D. 454 (In re Eli Lilly & Co.) is published on Counsel Stack Legal Research, covering District Court, S.D. Indiana primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
In re Eli Lilly & Co., 142 F.R.D. 454, 1992 U.S. Dist. LEXIS 7573, 1992 WL 108564 (S.D. Ind. 1992).

Opinion

ENTRY

DILLIN, District Judge.

This matter comes before the Court on the defendant’s motion for entry of a protective order.1 For the following reasons, the Court grants in part and denies in part the defendant’s motion.

Background

Eli Lilly & Co. (Lilly) is the defendant in a number of products liability suits consolidated in this Court for pretrial purposes by the Judicial Panel on Multidistrict Litigation. In all the cases, the plaintiffs claim that they or their decedents were injured by taking Prozac, a prescription drug manufactured and marketed by Lilly for the treatment of depression.

The plaintiffs seek to discover from Lilly some three or four million documents relating to the drug Prozac. Lilly seeks a protective order to prevent all disclosure of some of the information contained in the documents and to restrict how the plaintiffs may use and with whom they may share certain other information and documents contained within the discoverable material.

The Court held a hearing on February 14, 1992, at which it addressed some of the issues underlying the present motion. The Court, finding that there was no objection to the redaction of patients’ names or to the redaction of information concerning the process by which Prozac is manufactured, ruled that such information would be redacted from the documents before production to the plaintiffs. The Court further [456]*456stated that its ruling concerning the manufacturing process was without prejudice to the plaintiffs’ right to seek manufacturing data later, upon a proper showing, for purposes of establishing a claim of an aberration in the usual manufacturing process, which the plaintiffs have alleged in a few of the individual cases. The Court further approved in principle the plaintiffs’ suggestion that Lilly indicate the nature of each redaction on the documents themselves, such as by means of a stamp. The Court, however, ordered the parties to attempt to resolve between themselves all of these issues, including the labelling of redactions, and to file by March 6, 1992, their motions on any issues remaining unresolved. The parties were unable to agree.

There remain four discovery issues for resolution by the Court. First, Lilly seeks the Court’s permission to redact from the documents the names of, and identifying information regarding, those who have reported patients’ adverse reactions to Prozac. These “reporters” include principally doctors, hospitals and other health-care providers. Second, the parties continue to dispute whether Lilly may redact information concerning the Prozac manufacturing process.

The third matter of dispute concerns the labelling of redacted material. Lilly claims that, pursuant to protective orders entered in other Prozac cases pending in state courts, it has already redacted from approximately 400,000 documents the names of patients and of reporters and information concerning the manufacturing process. Lilly argues that it would be onerous and cause great delay if Lilly were required to go back through each of the 400,000 documents to label each of the redactions.

Finally, the parties have many disputes about the nature of the protective order that the Court should enter to govern material that Lilly deems confidential and does not want publicly disclosed. Lilly has submitted its proposed protective order to the Court. The plaintiffs raise many objections to Lilly’s proposed order and urge the Court to adopt the sample confidentiality order set out in the Manual for Complex Litigation Second (1985), at Section 41.36.

Discussion

Federal Rule of Civil Procedure 26(c), which Lilly invokes for the purpose of obtaining a protective order, provides:

Protective Orders. Upon motion by a party or by the person from whom discovery is sought, and for good cause shown, the court in which the action is pending ... may make any order which justice requires to protect a party or person from annoyance, embarrassment, oppression, or undue burden or expense, including one or more of the following: ... (7) that a trade secret or other confidential research, development, or commercial information not be disclosed or be disclosed only in a designated way....
If the motion for a protective order is denied in whole or in part, the court may, on such terms and conditions as are just, order that any party or person provide or permit discovery____

Fed.R.Civ.P. 26(c). Thus, Rule 26(c) gives the district court broad discretion in fashioning protective orders. See, e.g., Deitch-man v. E.R. Squibb & Sons, 740 F.2d 556, 566 (7th Cir.1984).

Moreover, while Rule 26(c) merely states “good cause” as the standard for ruling on protective orders, “the federal courts have superimposed a somewhat more demanding balancing of interests approach to the Rule.” Farnsworth v. Proctor & Gamble Co., 758 F.2d 1545 (11th Cir.1985) (collecting cases). This standard was described in a Seventh Circuit case as follows:

A motion under Rule 26(c) to limit discovery requires the district judge to compare the hardship to the party against whom discovery is sought, if discovery is allowed, with the hardship to the party seeking discovery if discovery is denied. He must consider the nature of the hardship as well as its magnitude, and thus give more weight to interests that have a distinctively social value than to purely private interests; and he must consider the possibility of reconciling the compet[457]*457ing interests through a carefully crafted protective order.

Marrese v. American Academy of Ortho-paedic Surgeons, 726 F.2d 1150, 1159 (7th Cir.1984), rev’d on other grounds, 470 U.S. 373, 105 S.Ct. 1327, 84 L.Ed.2d 274 (1985).

With these principles in mind, we turn to the arguments of the parties.

I. REPORTERS’ NAMES

Drug manufacturers are required to report adverse reactions to the Food and Drug Administration (FDA) under the regulations governing investigational new drug applications (IND’s) and applications for approval to market new drugs (NDA’s). See, e.g., 21 C.F.R. §§ 312.32, 314.80. Physicians and hospitals, on the other hand, are merely encouraged to make voluntary adverse reaction reports and drug experience reports, either to the FDA or to the drug manufacturers themselves, usually on FDA Form 1639.

Free access — add to your briefcase to read the full text and ask questions with AI

Related

Humboldt Baykeeper v. Union Pacific Railroad
244 F.R.D. 560 (N.D. California, 2007)
Contratto v. Ethicon, Inc.
225 F.R.D. 593 (N.D. California, 2004)
Cook Inc. v. Boston Scientific Corp.
206 F.R.D. 244 (S.D. Indiana, 2001)
Wheeles v. Human Resource Systems, Inc.
179 F.R.D. 635 (S.D. Alabama, 1998)
Arenson v. Whitehall Convalescent & Nursing Home, Inc.
161 F.R.D. 355 (N.D. Illinois, 1995)
Eli Lilly and Co. v. Marshall
850 S.W.2d 155 (Texas Supreme Court, 1993)

Cite This Page — Counsel Stack

Bluebook (online)
142 F.R.D. 454, 1992 U.S. Dist. LEXIS 7573, 1992 WL 108564, Counsel Stack Legal Research, https://law.counselstack.com/opinion/in-re-eli-lilly-co-insd-1992.