Apicella v. McNeil Laboratories, Inc.

66 F.R.D. 78, 19 Fed. R. Serv. 2d 1360, 1975 U.S. Dist. LEXIS 13677
CourtDistrict Court, E.D. New York
DecidedFebruary 24, 1975
DocketNo. 74 C 635
StatusPublished
Cited by61 cases

This text of 66 F.R.D. 78 (Apicella v. McNeil Laboratories, Inc.) is published on Counsel Stack Legal Research, covering District Court, E.D. New York primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Apicella v. McNeil Laboratories, Inc., 66 F.R.D. 78, 19 Fed. R. Serv. 2d 1360, 1975 U.S. Dist. LEXIS 13677 (E.D.N.Y. 1975).

Opinion

MEMORANDUM and ORDER

WEINSTEIN, District Judge.

The discovery issue now presented is another example of the tension between the needs of news reporters in protecting confidential sources and of the public in providing effective justice. For the reasons indicated below, under the special circumstances now presented, we find the cost of requiring disclosure overbalances the speculative losses to a just determination of the facts in this litigation.

I. FACTS

Plaintiffs Vincent and Josephine Apicella are suing McNeil Laboratories, manufacturer of the drug Innovar. On August 2, 1972, Mr. Apicella was operated on. As part of the anesthesia procedure, Innovar was administered. The plaintiffs contend that severe and permanent disabilities were caused by the drug because McNeil failed adequately to investigate, test and provide a warning of hazards known to it.

Defendant McNeil seeks to depose the chief executive officer of The Medical Letter on Drugs and Therapeutics, a bi-monthly publication widely circulated among members of the medical profession. Published by a non-profit corporation, this newsletter reports on the properties, effectiveness, and adverse effects of various drugs. In its issue of May 10, 1974, The Medical Letter published an article entitled “Dangers ■of Innovar.” After stating that one consultant had witnessed at least three deaths from cardiovascular collapse following use of this medication, the article concluded that the drug “should be withdrawn from the market.” Dr. Mark Abramowicz, appearing for The Medical Letter at the deposition, refused to identify the physician who had prepared the preliminary draft of the article and the consultants who had responded to that draft, particularly the one who had provided the evidence relating to the deaths caused by Innovar.

Since the safety of Innovar will be at issue at trial, plaintiffs argue that specific knowledge of adverse reactions to the drug would support their claim. Defendant McNeil believes that unless it is able thoroughly to evaluate the material used in preparation- of the article, it will be hampered in its defense.

Defendant moves for an order under Rule 37 of the Federal Rules of Civil ¡Procedure to compel The Medical Letter to disclose the name of the person who wrote the preliminary draft, and the names of the consultants to whom the draft was sent, and to produce related correspondence and documents. Plaintiffs have joined in this motion.

It is not clear that sources of information, other than The Medical Letter, about death and disability associated with use of the drug will be unavailable to the parties. Hearings on Innovar held before a subcommittee of the Committee on Government Operations of the House of Representatives in August 1973 and March 1974 suggest that McNeil Laboratories and the Food and Drug Administration (FDA) were aware of the potential dangers of Innovar and of [81]*81a number of adverse reactions, including death, following administration of the drug. See Hearings on the Safety of a New Combination Drug, Innovar, Before a Subcommittee of The House Comm, on Gov’t Operations, 93d Cong., 1st & 2d Sess. at 1, 5, 11 (1973-74).

According to the testimony at the hearing, a representative of McNeil had told a public advisory committee at FDA that 218 individuals had died after receiving Innovar. Id. at 11. A written report concerning a FDA investigation in St. Louis stated that during the premarketing stage and the five years since FDA approval of Innovar for marketing, 65 reports of adverse reactions considered either serious or unusual had been received. Dr. John Adriani, Professor of Surgery at Tulane University School of Medicine and Director of the Department of Anesthesiology at Charity Hospital in New Orleans, Louisiana, reported that the American Medical Association’s (AMA) 1971 edition of Drug Evaluations, prepared by the AMA’s Council on Drugs, of which he was chairman, found that the fixed ratio combination drug was “irrational” and “not recommended.” Id. at 19.

News clippings reprinted in the Hearing Report indicate that there are at least ten other lawsuits involving alleged adverse reactions to Innovar. Id. at 2-3. In response to these reports, Dr. J. Richard Crout, Director of the FDA’s Bureau of Drugs, stated that his office had been able to match eight eases submitted by McNeil with descriptions from the St. Louis, Missouri, news article.

Pertinent records of the FDA may be subject to the provisions of the Freedom of Information Act, 5 U.S.C. § 552, and to the regulations pertaining to official records and information of the Department of Health, Education and Welfare and the FDA. 45 CFR § 5 and 21 CFR § 4.1. See also Pub.L. 93-502, 88 Stat. 1561, amending 5 U.S.C. § 552 (1974). The court has communicated with the FDA and has received some information, now part of the public court file, which may be helpful to the parties. Thus far the court has been denied access to other information which the FDA considers exempt from disclosure pursuant to 18 U.S.C. § 1905, 21 U.S.C. § 331 (j) and 5 U.S.C. § 552(b) (4) covering “trade secrets and commercial or financial information obtained from a person and privileged or confidential.” If the parties’ request for the information is also denied, they may file a complaint in the appropriate district court to review the agency’s refusal to produce the records. 5 U.S.C. § 552(a) (3) and (4).

Defendant may already have in its files much, or all, of the information it seeks in this discovery motion. Plaintiffs could obtain it for their use by unobjectional discovery devices.

II. BALANCING APPROACH IN DISCOVERY

The Apicellas and McNeil Laboratories maintain that Garland v. Torre, 259 F.2d 545 (2d Cir.), cert. denied, 358 U.S. 910, 79 S.Ct. 237, 3 L.Ed.2d 231 (1958), requires denial of The Medical Letter’s motion for a protective order. That case involved a libel action by actress Judy Garland against Marie Torre, a columnist who had allegedly written defamatory statements about Miss Garland which Miss Torre attributed to a CBS executive. The court compelled disclosure of the name of the executive because the identity of the newswoman’s source was essential to the libel action —it “went to the heart of the plaintiff’s claim.” 259 F.2d at 550. In a libel case, unlike other civil actions, the reporter or publication is a party to the suit. Moreover, the identity of the source may be crucial to the claim or defense. See also Carey v. Hume, 160 U.S.App.D.C. 365, 492 F.2d 631, cert. pet. dismissed, 417 U.S. 938, 94 S.Ct. 2654, 41 L.Ed.2d 661 (1974); Adams v. Assoc. Press, 46 F.R.D. 439 (S.D.Tex. 1969).

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Bluebook (online)
66 F.R.D. 78, 19 Fed. R. Serv. 2d 1360, 1975 U.S. Dist. LEXIS 13677, Counsel Stack Legal Research, https://law.counselstack.com/opinion/apicella-v-mcneil-laboratories-inc-nyed-1975.