In re U.S. Bioscience Securities Litigation

150 F.R.D. 80, 1993 U.S. Dist. LEXIS 6591, 1993 WL 325673
CourtDistrict Court, E.D. Pennsylvania
DecidedMay 20, 1993
DocketCiv. A. No. 92-678
StatusPublished
Cited by2 cases

This text of 150 F.R.D. 80 (In re U.S. Bioscience Securities Litigation) is published on Counsel Stack Legal Research, covering District Court, E.D. Pennsylvania primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
In re U.S. Bioscience Securities Litigation, 150 F.R.D. 80, 1993 U.S. Dist. LEXIS 6591, 1993 WL 325673 (E.D. Pa. 1993).

Opinion

MEMORANDUM

DALZELL, District Judge.

This class action involves alleged securities laws violations in connection with securities of U.S. Bioscience, Inc. (“Bioscienee”), a cor[81]*81poration whose common stock is traded on the American Stock Exchange. On November 10, 1992, we certified a class of all individuals who purchased Bioscience common stock or call options, or sold put options, from April 12, 1991 through January 31, 1992.

In essence, these twenty-six consolidated actions allege in their Revised Consolidated Complaint that representatives of Bioscience made false and misleading statements about the prospects for the approval of its chemotherapy and radiation therapy protective agent, Ethyol, and, most importantly, Ethyol’s prospects for approval by the United States Food and Drug Administration (“FDA”). Far from granting early approval to Ethyol, as had been hoped, an Advisory Committee of the FDA late on January 31, 1992, rejected the drug for prompt human use because, according to the complaint, “The clinical trials required by the FDA failed to demonstrate statistically significant evidence of the efficacy of Ethyol” (Complaint ¶ 6).

On the next day of trading on the American Stock Exchange, Bioscience fell $16 per share, resulting in a loss of market capitalization of over $320 million in a matter of hours.

Procedural Background

In the course of discovery, plaintiffs have sought to obtain certain information from three individuals who work at the FDA, Kathleen Downs and Drs. Gerald H. Sokol and Stanley Lin. Pursuant to the FDA’s regulation, 21 C.F.R. § 20,1, plaintiffs’ counsel requested of Dr. David Kessler, the FDA’s Commissioner, “to compel through subpoena oral testimony of’ Dr. Sokol and Ms. Downs. In addition, on the same day Dr. Kessler received subpoenas that were not yet served on these two individuals.

On March 12, 1993, the FDA refused this request. On or about April 6, 1993, plaintiffs’ counsel served the subpoenas on the three1 individuals, calling upon them to appear for depositions on April 22, April 26, and April 28, and to produce and permit inspection of the deponents’ “file(s) relating to U.S. Bioscience’s application for approval of Ethyol in the period 1990 through June 1992”.

In response, the United States of America, on behalf of these three FDA employees, on April 21 filed a motion to quash the subpoenas. Plaintiffs responded to that opposition on May 17, and for the reasons that follow we will only grant in part the Government’s motion to quash.

Legal Analysis

The Government has argued, in its memorandum in support of its motion to quash, that the “FDA’s long-standing policy, codified in the agency’s regulations at 21 C.F.R. § 20.1, is to refuse to make agency employees available to testify in litigation to which the government is not a party.” Memorandum in support of motion to quash subpoena at 2. The Government adds that “An exception to this policy is made only if the testimony is in the public interest and promotes the statutory mission of the FDA” Id.

The FDA regulation in question was adopted pursuant to the so-called federal Housekeeping Statute, 5 U.S.C. § 301, which provides, in relevant part, that:

The head of an Executive department ... may prescribe regulations for the ... conduct of its employees ... and the custody, use, and preservation of its records, papers and property.

The FDA’s regulation is set forth, in relevant part, in the margin 2. The critical lan[82]*82guage of the regulation is that the Commissioner will permit the testimony of an FDA employee if “such testimony will be in the public interest and will promote the objectives of the [FDA] act and the agency”. 21 C.F.R. § 20.1(c). Unsurprisingly, such “housekeeping” regulations as 21 C.F.R. § 20.1 have received judicial approval. See, e.g., United States ex rel. Touhy v. Ragen, 340 U.S. 462, 468, 71 S.Ct. 416, 419, 95 L.Ed. 417 (1951).

Plaintiffs’ counsel do not quibble with the legitimacy, as a general proposition, of the FDA’s regulation. They take sharp issue, however, with the Commissioner’s appraisal of the “public interest” involved here. While we agree with the FDA that, as a general proposition, its'employees should be protected “concerning testimony in private lawsuits”, we believe the FDA’s March 12, 1993 proforma response to plaintiffs’ request caricatures the nature of the instant litigation by referring to it as merely “private lawsuits.”

The Supreme Court takes a more positive view of the “public interest” served by litigation like this one:

Moreover, we repeatedly have emphasized that implied private actions provide “a most effective weapon in the enforcement” of the securities laws and are “a necessary supplement to [Securities and Exchange] Commission action.”

Bateman Eichler, Hill, Richards, Inc. v. Berner, 472 U.S. 299, 310, 105 S.Ct. 2622, 2629, 86 L.Ed.2d 215 (1985), quoting J.I. Case Co. v. Borak, 377 U.S. 426, 432, 84 S.Ct. 1555, 1560, 12 L.Ed.2d 423 (1964).

While it is certainly true that these actions involve claims by shareholders of U.S. Bioscience, all private citizens, for large losses they have incurred, it is also true that the interests they seek to vindicate are those that Congress has regarded as very much in the federal public interest. See, e.g., Bateman Eichler, supra. Put another way, the “public interest” does not exist in a vacuum, isolated at the FDA’s offices in Rockville, Maryland. The “public interest” also includes the Congressionally-mandated assurance of the integrity of the public securities markets that are so crucial to the nation’s economic well-being. That issue is most assuredly involved here.

Further, the heart of plaintiffs’ claims here is that Bioscience representatives misrepresented what was said to them by FDA employees. The FDA certainly has an interest in preventing misrepresentations about its approval process, and in assuring the truthfulness of representations, to the public by public companies, about the efficacy of drugs for which FDA approval has been sought.

It also seems to us critical, in vindicating the public interests that collide here, that the three FDA employees are the only independent sources for discovery and evidence on this crucial issue. The Bioscience representatives who were part of communications with these three FDA employees have told, or will tell, their story in depositions and at trial.

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150 F.R.D. 80, 1993 U.S. Dist. LEXIS 6591, 1993 WL 325673, Counsel Stack Legal Research, https://law.counselstack.com/opinion/in-re-us-bioscience-securities-litigation-paed-1993.