Westwood v. Cohen

838 F. Supp. 126, 1993 U.S. Dist. LEXIS 16453, 1993 WL 487498
CourtDistrict Court, S.D. New York
DecidedNovember 17, 1993
Docket92 Civ. 4406(VLB)
StatusPublished
Cited by8 cases

This text of 838 F. Supp. 126 (Westwood v. Cohen) is published on Counsel Stack Legal Research, covering District Court, S.D. New York primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Westwood v. Cohen, 838 F. Supp. 126, 1993 U.S. Dist. LEXIS 16453, 1993 WL 487498 (S.D.N.Y. 1993).

Opinion

MEMORANDUM DECISION

VINCENT L. BRODERICK, District Judge.

I

This is a securities fraud class action filed against Barr Laboratories, Inc. (“Barr”) and officers of Barr (collectively, the “defen- ■ dants”) based on alleged deficiencies in disclosures to the public related to testing procedures concerning certain generic pharmaceutical products. , The plaintiff claims that a decline of Barr’s stock price was artificially delayed between October 24, 1991 and February 4, 1993', the class, period.

The case is brought under § 10(b) of the Securities Exchange Act of 1934 (“Exchange Act”), 15 U.S.C. § 78j(b); Rule 10-b-5 promulgated under it, 17 CFR § 240.10-b-5; and Section 20 of the Exchange Act, 15 U.S.C. § 78t. By order, dated February 10, 1993, I granted the plaintiff leave to file an amended complaint under Fed.R.Civ.P. 15(a), see Jacobson v. Cohen, 146 F.R.D. 95 (S.D.N.Y.1993), which I now accept as “the complaint”. 1

The defendants have moved to dismiss the complaint as supplemental under Fed. R.Civ.P. 15(d), or in the alternative for failure to state a claim upon which relief can be granted pursuant to Fed.R.Civ.P. 12(b)(6) and for failure to allege fraud with particularity as required by Fed.R.Civ.P. 9(b).

I deny the motion to dismiss the complaint without accepting as actionable some of the legal conclusions or categorizations contained within it. See Peckham Materials Corp v. Raima, 821 F.Supp. 123 (S.D.N.Y.1993).

A complaint that survives dismissal at this stage of the litigation still faces additional hurdles, inasmuch as many of it allegations would be insufficient if standing alone. As the United States Supreme Court stated in Scheuer v. Rhodes, 416 U.S. 232, 236, 94 S.Ct. 1683, 1686, 40 L.Ed.2d 90 (1974):

When a federal court reviews the sufficiency of a complaint, before the reception of any evidence ..., its task is necessarily a limited one. The issue is not whether the claimant will ultimately prevail but whether the claimant is entitled to offer evidence in support of the claims. Indeed it may appear on the face of the pleadings that a recovery is very remote and unlikely but that is not the test.

II

The complaint alleges that Barr and its officers misled securities buyers and holders as to the seriousness of misconduct uncovered by the Food and Drug Administration concerning testing and consequent labelling of various generic pharmaceutical products.

Generic products serve an important function in the economy by providing consumers with means of purchasing goods without be *129 ing required to pay for expensive promotion of brand names which carry higher prestige and recognition. At the' same time, generic manufacturers and distributors, 2 like any other vendors, at times engage in misleading behavior including erroneously indicating that their products are equivalent to promoted brands when this is not necessarily the case.

Thé function of generics in disciplining the market and avoiding price escalation detrimental to the public, 3 is balanced by thé fact that almost by definition generic products are copies of other wares and not innovative. 4 In the case of the pharmaceutical industry, complaints about high consumer prices for some promoted brands led to state laws requiring pharmacists to substitute generics unless otherwise directed by prescribing physicians, and to regulatory support for greater availability of generic pharmaceuticals. 5

In 1984, Congress recognized the importance of both pioneer/promoted brand and generic pharmaceuticals in the Drug Price Competition and Patent Restoration Act, Pub Law 98-417, 98 Stat 1585. See generally Wheaton, Generic Competition and Pharmaceutical Innovation: The Drugr Price Competition and Patent Term Restoration Act of 1981, 34 Cath U L Rev 433 (1986). This statute, known' as the Waxman-Hateh Act after its bipartisan sponsors, permits pioneering pharmaceutical patentees to obtain restoration of patent life lost during regulatory evaluation of new preparations. The Act also exempts generic producers from the need to repeat expensive human and other testing of pharmaceuticals where they are shown to be effectively the same as previously approved pioneer brands. In the latter respect, the Act codified and extended Burroughs Wellcome Co. v. Schweiker, 649 F.2d 221 (4th Cir.1981), which had held that generic producers could rely on published scientific literature to support new drug applications without repeating tests described in such literature.

Where differences in inactive • ingredients which serve to dilute or carry active medicinal ingredients in a preparation differ from those in a previously tested product, reliable evidence in some .form of safety and efficacy is required. United States v. Generix Drug Corp., 460 U.S. 453, 103 S.Ct. 1298, 75 L.Ed.2d 198 (1983). This is recognized as important by the generic industry; without such a requirement, the need for governmental approval could- not be cited as evidence of the safety and efficacy of the generic products.

The Waxman-Hatch Act was abused by some generic manufacturers who claimed that a preparation was proven identical to a previously approved pioneer brand when this was not the case and failed to.take other required precautions. This short-circuited the requirement for testing or scientific literature support for the safety and efficacy of the actual 'preparation sold. Such charges and accusations of corruption involving some generic industry members and staff of the Food and Drug Administration surfaced in a congressional investigation in the late 1980’s *130 and . received substantial public notice through widespread press coverage.

Ill

The essence of the present complaint is that Barr and its defendant officers disseminated false and misleading information about a Food and Drug Administration (“FDA”) investigation, fraudulently concealed inadequate testing procedures concerning pharmaceuticals, and omitted material information from Securities Exchange Commission (“SEC”) filings, news reports and public statements.

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838 F. Supp. 126, 1993 U.S. Dist. LEXIS 16453, 1993 WL 487498, Counsel Stack Legal Research, https://law.counselstack.com/opinion/westwood-v-cohen-nysd-1993.