Wilkof v. Carago Pharmaceutical Laboratories, Ltd.

280 F.R.D. 332, 2012 WL 638517
CourtDistrict Court, E.D. Michigan
DecidedFebruary 28, 2012
DocketNo. 09-12830
StatusPublished
Cited by8 cases

This text of 280 F.R.D. 332 (Wilkof v. Carago Pharmaceutical Laboratories, Ltd.) is published on Counsel Stack Legal Research, covering District Court, E.D. Michigan primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Wilkof v. Carago Pharmaceutical Laboratories, Ltd., 280 F.R.D. 332, 2012 WL 638517 (E.D. Mich. 2012).

Opinion

ORDER GRANTING PLAINTIFFS’ MOTION FOR CLASS CERTIFICATION [49] AND FINDING DEFENDANTS’ MOTION FOR LEAVE TO FILE A REVISED EXPERT REPORT MOOT [62]

ARTHUR J. TARNOW, Senior District Judge.

Before the Court is Plaintiffs’ Motion for Class Certification [49]. On December 16, [335]*3352011, the Court heard oral argument on the motion. For the reasons stated below, Plaintiffs’ Motion is GRANTED.

Plaintiffs propose as a class persons who purchased or acquired Caraco Pharmaceutical’s (“Caraco”) marketed securities (in the form of common stock) during the period between May 29, 20081 and June 25, 2009 (the “class period”). Plaintiffs allege that Defendant’s statements and press releases were false, misleading, and/or contained material omissions. Plaintiffs allege that statements by Defendant falsely and misleadingly indicated that Defendant was in compliance or would soon be in compliance with FDA regulations. Plaintiffs allege that Defendants’ false and misleading statements artificially inflated the price of Defendant’s stock, and that the subsequent drop in value of the stock after Defendant’s false representations came to light injured the Plaintiffs. Plaintiffs allege violation of sections 10(b) and 20(a) of the Securities and Exchange Act of 1934, as well as SEC Rule 10b-5.

Procedural Background

Plaintiffs initiated the instant case on July 17, 2009, and filed an Amended Complaint [23] on February 11, 2010. On April 12, 2010, Defendants filed a Motion to Dismiss [28] that was granted in part by this Court on October 21, 2010.2 Plaintiffs filed the instant class certification motion on April 15, 2011.

Factual Background

Plaintiffs filed this federal class action suit on July 17, 2009. Plaintiff seeks to certify as a class purchasers of Defendant Caraco’s securities between May 29, 2008 and June 25, 2009, alleging violations of federal securities laws. According to the Amended Complaint, Defendant Movens served as CEO of Caraco and Defendant Shanghvi was the chairman of Caraco’s Board of Directors. Amended Compl. ¶¶ 27-29 (the “Individual Defendants”). Defendant Sun Pharmaceuticals was the majority and controlling shareholder of Caraco. Id. ¶ 30.

Plaintiffs allege that Caraco was informed by the Food and Drug Administration (“FDA”) after various inspections between 2005 and 2008, about defective and deficient conditions in Caraco’s manufacturing facilities. See Amended Compl. ¶ 6. Failure to comply with the FDA’s current Good Manufacturing Practices can cause delay in the approval of a drug application and, if serious problems continue, can lead to a finding that drugs are “adulterated,” requiring a company to “cease all production and distribution.” Amended Compl. ¶ 5. According to various confidential witnesses who were employed by Caraco, the conditions in the company’s Detroit facility were very poor and included contamination and production of pills that were not the proper size. Amended Compl. ¶7. Despite knowledge of the company’s problems, Defendant Caraco allegedly “minimized both their scope and overall significance” to the public. Amended Compl. ¶¶ 6, 8.

In October 2008, the FDA issued a warning letter to Caraco indicating “that its May 1, 2008 to June 11, 2008 inspection of Caraeo’s manufacturing facilities revealed “‘significant deviations from’ ” cGMP regulations and that a failure to correct the various violations noted could result in legal action. Amended Compl. ¶¶ 70-73. Some of the observations included in the warning letter included the “failure of the Quality Control Unit ... to review and approve all drug product production” to ensure compliance with approved procedures before a batch was distributed, and a “failure to maintain equipment at appropriate intervals to prevent malfunctions or contamination that would alter the safety” and “purity” of the drugs. Amended Compl. ¶ 71. After news of the [336]*336warning letter was released, shares of Cara-co dropped by approximately 22% over three days, closing on November 5, 2008 at $7.91 per share. Amended Compl. ¶ 10. Caraco continued to represent to investors that the company had taken corrective action. Amended Compl. ¶ 74.

On March 31, 2009, Caraco “disclosed that it had commenced a voluntary recall, with the knowledge of the FDA, of certain tablets manufactured by the Company because the tablets might have differed in size and therefore could have more or less of the active ingredient.” Amended Compl. ¶ 14. Following this disclosure, stocks dropped more than 22%, closing at $3.52 per share. Amended Compl. ¶ 125. Although this recall indicated various problems at Caraco, the complete extent of the company’s problems were not shared with the public. Amended Compl. ¶ 15.

On June 15, 2009, Caraco stated in a filing with the SEC that it believed it was “substantially cGMP compliant.” On June 24, 2009, the government filed a complaint for forfeiture of adulterated articles of drugs located in Caraco’s facilities in Farmington Hills and Wixom, Michigan. Amended Compl. ¶¶ 131-133. The complaint alleged that the FDA had found “continuing and significant violation of cGMP.”

Ultimately, “on June 25, 2009, investors learned the true extent of Caraeo’s severe and systemic manufacturing problems. That day, the FDA announced that U.S. Marshals had seized drug products manufactured by Caraco from the Company’s facilities” as a result of “Caraco’s continued failure to meet the FDA’s cGMP requirements.... ” Amended Compl. ¶ 17. The FDA indicated that the aim of the seizure was to prevent the company from continuing to distribute drugs until there was “assurance that the firm complies with good manufacturing requirements.” Amended Compl. ¶ 17-18. On June 25, 2009, shares of Caraco dropped approximately 43%, closing that day at $2.39 per share. Amended Compl. ¶¶ 17-18.

Plaintiffs’ complaint sets forth two claims. First, violation of Section 10(b) of the Exchange Act3 and of Rule 10b-5 4 promulgated thereunder. Plaintiffs allege that Defendants carried out a plan intended to deceive the public, caused Plaintiffs to purchase Caraeo securities at artificially inflated prices, and knowingly and/or recklessly made false statements5 and omitted material facts in order to mislead the public about Caraco’s operations.

Second, Plaintiffs allege violation of section 20(a) of the Exchange Act6 by Defendant Sun Pharmaceuticals and Defendants Movens and Shanghvi. Plaintiffs allege these Defendants had direct and supervisory involvement in Caraco’s operations. Plaintiffs argue that by virtue of Sun Pharmaceuticals’s and the Individual Defendants’ posi[337]*337tions as “controlling persons,” they are liable pursuant to Section 20(a).

Standard of Review

Class Actions are governed by Federal Rule of Civil Procedure 23, which requires that, to obtain class certification, plaintiffs must demonstrated that:

(1) the class is so numerous that joinder of all members is impracticable;
(2) there are questions of law or fact common to the class;
(3) the claims or defenses of the representative parties are typical of the claims or defenses of the class; and

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Bluebook (online)
280 F.R.D. 332, 2012 WL 638517, Counsel Stack Legal Research, https://law.counselstack.com/opinion/wilkof-v-carago-pharmaceutical-laboratories-ltd-mied-2012.