In Re GeoPharma, Inc. Securities Litigation

399 F. Supp. 2d 432, 2005 WL 2431518
CourtDistrict Court, S.D. New York
DecidedSeptember 30, 2005
Docket04 Civ.9463 SAS
StatusPublished
Cited by23 cases

This text of 399 F. Supp. 2d 432 (In Re GeoPharma, Inc. Securities Litigation) 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
In Re GeoPharma, Inc. Securities Litigation, 399 F. Supp. 2d 432, 2005 WL 2431518 (S.D.N.Y. 2005).

Opinion

OPINION AND ORDER

SCHEINDLIN, District Judge.

I. INTRODUCTION

Plaintiffs bring this putative class action on behalf of certain purchasers of common stock in GeoPharma, Inc. (“GeoPharma”), a publicly-traded pharmaceutical company. The gravamen of plaintiffs’ allegations is that defendants issued a deliberately misleading press release that caused investors to believe that the Food and Drug Administration (“FDA”) had granted GeoPharma approval for a new drug, when in fact the FDA had merely approved a (much less potentially lucrative) medical device. Plaintiffs allege violations of sections 10(b) and 20(a) of the Securities Exchange Act of 1934, and Rule 10b-5 promulgated thereunder by the Securities and Exchange Commission (“SEC”). 1 Defendants now move to dismiss the Complaint pursuant to Federal Rule of Civil Procedure 12(b)(6). 2 For the following reasons, defendants’ motion is granted.

II. THE COMPLAINT

A. The Parties

Plaintiffs are a group of investors who purchased GeoPharriia common stock during the putative class period. 3 Plaintiffs are suing on behalf of a putative class defined as “all persons or entities who purchased the common stock of GeoPharma on December 1, 2004 and/or December *436 2, 2004, inclusive (the ‘Class Period’), and who were damaged thereby.” 4

GeoPharma manufactures, packages and distributes dietary supplements, over-the-counter drugs, pharmaceuticals and health/beauty care products for companies. 5 Belcher Pharmaceuticals, a unit of GeoPharma, develops and manufactures generic and over-the-counter drugs. 6

Plaintiffs also name three individual defendants, all of whom are officers and directors of GeoPharma. Kotha S. Sekharam is President, 7 Mihir K. Taneja is the Chief Executive Officer and Secretary, 8 and Jugal Taneja is the Chairman of the Board of Directors. 9 All three individual defendants held their current positions during the putative class period. 10

B. The Alleged Scheme

1. Development of Mucotrol

Beginning in early 2004, GeoPharma made several announcements regarding its development of a new product, eventually designated as Mucotrol, intended to treat a condition called mucositis. 11 Mucositis is an inflammation of the mucosa in the mouth, caused by chemotherapy and radiation. 12 According to a GeoPharma press release excerpted in the Complaint, “mucositis affects approximately 15-40% of patients receiving standard-dose chemotherapy and 76-100% of patients receiving higher doses of chemotherapy in bone marrow transplant ... [mjucositis complications may lead to (a) delay in the chemotherapy schedule (b) reduction from the desired dose (c) complications such as pain, dehydration, malnutrition and infection.” 13

On June 29, 2004, GeoPharma filed its annual report with the SEC. According to a GeoPharma Form 10-K filed at that time:

[Fjormulation work and stability studies are currently underway on three other drug products one of which is a product that treats mucositis ... [w]e have developed a formulation using all natural ingredients. Preliminary results indicated promising results in the regeneration of mucosal lining. We have filed a patent on this formulation. Preliminary double blind placebo controlled clinical studies are underway in a prestigious hospital abroad. 14

Defendants again referred to a mucositis drug in a July 13, 2004 press release (entitled “GeoPharma Reports Success in Clinical Studies on Oral Mucositis Drug for Cancer Patients.”) 15 The release reported that GeoPharma had completed a double blind clinical study to evaluate the efficacy of “a patent-pending drug for mucositis in cancer patients.” 16 This press release also stated that “the market potential is estimated to be at $300 million to $500 million.” 17 In the same release, defendant Sekharam was referred to as the drug’s *437 inventor, and was quoted as asserting that this drug was expected to have no side effects. 18

However, while GeoPharma had characterized this new mucositis treatment as a drug, by September 2004 it apparently realized that it was actually a medical device. On September 1, 2004, GeoPharma filed an application with the FDA seeking 510(k) approval 19 to market a medical device by the name of Mucotrol Concentrated Oral gel wafer (“Mucotrol”). 20 Nowhere on the application was Mucotrol referred to as a drug. 21

The FDA granted marketing approval for Mucotrol in a letter dated November 24, 2004. 22 This letter stated that, as required by the 510(k) approval process, the FDA determined that the device is substantially equivalent to other products already in the market. 23 Defendants did not disclose the receipt of this letter until December 2, 2004. 24

Plaintiffs assert that GeoPharma’s sudden shift from development of a drug to a medical device carries great significance. A device has a more limited market than a drug, because a device can only be used for relief once mucositis develops, while a drug can be administered to cancer patients to reduce their chances of developing mucositis in the first place. 25 Similarly, a drug, but not a medical device, shortens hospital stays, a factor important to insurance companies. 26 Finally, while there was no available drug for treatment of mucositis, there were already several medical devices in the market. 27 For these reasons, plaintiffs estimate the potential market for a medical device treating mucositis at $1.2 million, as opposed to $150 million for a drug treatment. 28

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Bluebook (online)
399 F. Supp. 2d 432, 2005 WL 2431518, Counsel Stack Legal Research, https://law.counselstack.com/opinion/in-re-geopharma-inc-securities-litigation-nysd-2005.