Silverstrand Investments v. AMAG Pharmaceuticals, Inc.

12 F. Supp. 3d 241, 2014 WL 1379792, 2014 U.S. Dist. LEXIS 48231
CourtDistrict Court, D. Massachusetts
DecidedApril 7, 2014
DocketCivil Action No. 10-10470-NMG
StatusPublished
Cited by7 cases

This text of 12 F. Supp. 3d 241 (Silverstrand Investments v. AMAG Pharmaceuticals, Inc.) is published on Counsel Stack Legal Research, covering District Court, D. Massachusetts primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Silverstrand Investments v. AMAG Pharmaceuticals, Inc., 12 F. Supp. 3d 241, 2014 WL 1379792, 2014 U.S. Dist. LEXIS 48231 (D. Mass. 2014).

Opinion

MEMORANDUM & ORDER

GORTON, District Judge.

This complex case concerns the alleged failure of a pharmaceutical company, AMAG Pharmaceuticals, Inc. (“AMAG”), to disclose material defects pertaining to its pharmaceutical drug, Feraheme, prior to a public offering of its stock. Based on that alleged failure to disclose, a group of investment firms (collectively, “plaintiffs”) brought suit under §§ 11, 12 and 15 of the Securities Act of 1933 (“Securities Act”).

During the clinical stages of the drug approval process of the Food and Drug Administration (“FDA”), pharmaceutical companies provide the FDA with detailed reports of patient reactions. Severe Adverse Events (“SAEs”) are one kind of reaction that must be reported to the FDA. They include reactions caused by the drug (“drug-related”), those in which the drugs are a factor (“drug-associated”) and those which may be entirely unrelated to use of the drug. SAEs are generally communicated to the FDA in new drug applications (“NDAs”) but must also be described in various forms submitted to the Securities and Exchange Commission (“SEC”) prior to an offering of stock, including the registration statement, the prospectus and required public filings such as 10-Ks, 10-Qs and 8-Ks.

Plaintiffs purchased AMAG stock as part of a secondary offering conducted on January 21, 2010 (“the Offering”). They allege that between FDA approval of the drug Feraheme in 2009 and the Offering in 2010, AMAG was made aware of 23 SAEs but failed to report them in their offering documents in order to protect Feraheme’s safety profile by deceiving investors, patients and doctors. Shortly after the Offering, an independent analyst uncovered the 23 SAEs and inquired about them publicly. Other analysts became aware of the story and the FDA took notice. Over the next few months, AMAG’s stock decreased 71% from $48.25 per share on January 21, 2010, to $14.05 per share on November 26, 2010. In March, 2010, Plaintiffs filed suit against AMAG, several of its officers and directors and several firms that provided underwriting services in connection with the Offering (collectively, “defendants”).

In August, 2011, this Court allowed defendants’ motion to dismiss all three counts for failure to state claims after applying the standard of Fed.R.Civ.P. 8(a). Plaintiffs appealed to the First Circuit Court of Appeals which, in February, 2013, affirmed, in part, and reversed, in part, remanding the case for further proceedings. The First Circuit determined that under the Rule 8(a) standard the 23 SAEs were actionable omissions, while other alleged omissions were not. On remand, however, the First Circuit left it to this Court to decide whether (1) Rule 8(a) or Rule 9(b) governs the appropriate standard of review and (2) whether defendants meet the statutory definition of “seller” or “solicitor” under § 12(a)(2) of the Securities Act.

Pending before the Court are the renewed motions to dismiss the Second Amended Complaint (“SAC”) by AMAG and its officers and directors (“the AMAG defendants”) and by the firms offering underwriting services (“the underwriter defendants”). For the reasons that follow, the Court will deny the motions to dis[245]*245miss.1

I. Factual Background

Plaintiffs bring this federal securities class action on behalf of themselves and all purchasers of the common stock of AMAG pursuant or traceable to SEC Form S-3/ASR, No. 333-164400, dated January 19, 2010 (“the Registration Statement”) and the Prospectus dated January 21, 2010 (“the Prospectus”) (collectively, “the Offering Documents”) issued in connection with the Offering. The Offering Documents incorporate by reference various other public filings, including several Forms 10-K, 10-Q and 8-K filed with the SEC in 2008 and 2009.

A.The Parties

Plaintiffs Silverstrand Investments (“Sil-verstrand”), Briarwood Investments, Inc. (“Briarwood”) and Safron Capital Corporation (“Safron”) are investment advisor firms that purchased AMAG stock issued in connection with the Offering.

Defendant AMAG is a biopharmaceutical company incorporated in Delaware with its principal place of business in Massachusetts. The individually named defendants are directors and officers of AMAG who signed the Registration Statement, including AMAG’s President and Chief Executive Officer Brian J.G. Pereira (“Pereira”) and AMAG’s Chief Financial Officer David A. Arkowitz (“Arkowitz”). The SAC also names the six AMAG directors who signed the Registration Statement: Joseph V. Vonventre, Michael Narachi, Robert J. Perez, Lesley Russell, Davey S. Scoon and Ron Zwanziger (collectively, “the directors”). Underwriter defendants are various investment banks that provided underwriting services to AMAG for the Offering.

B. The Development of Feraheme

AMAG developed and commercialized Feraheme, an intravenous drug used to treat iron deficiency anemia in adult patients with chronic kidney disease. Also known as ferumoxytol injection, Feraheme is administered by an injection of 510 milligrams in as little as 17 seconds and a complete course of treatment can be accomplished in two to four physician visits. The FDA approved Feraheme for sale in June, 2009. AMAG launched the drug in the United States the following month.

Between 2009 and January 21, 2010 (the date of the Offering), AMAG informed the FDA of 23 SAEs which it did not report in its Offering Documents. At least 16 of the SAEs included hospitalizations and one SAE resulted in the death of a patient.

C. The Offering

On January 21, 2010, AMAG sold 3.6 million shares of its common stock to the public for a price of $48.25 per share, resulting in net proceeds of approximately $174 million. The Offering was a firm commitment secondary offering, meaning AMAG sold the shares to the underwriter defendants who then sold the shares to investors. The underwriter defendants received $7.8 million in fees as a result of the Offering.

1. Post-Offering Developments

Three post-offering developments caused AMAG’s stock price to decline by 24% from $48.25 per share at the Offering on January 21, 2010, to $36.67 per share on February 8, 2010.

[246]*246First, on February 4, 2010, an analyst report, referring to the undisclosed SAEs, stated that several patients had been “hospitalized with anaphylactoid reactions to Feraheme” and that one patient died in an incident “that may or may not be directly related to Feraheme.”

Second, on February 5, 2010, AMAG issued a safety update in a press release, disclosing that it had received reports of 40 serious adverse events (“SAEs”) since the launch of Feraheme and the rate of SAEs was “reported at a rate consistent with that contained in the U.S. package insert.” AMAG noted that the rate was approximately 0.1% “per patient exposure.”

Third, on February 8, 2010, a follow-up analyst report (1) questioned the validity of comparing the 0.1% “per patient exposure” rate (i.e. 40 SAEs per 35,000 exposures) used by AMAG in its safety update with the 0.2% “per patient” rate (i.e. 3 SAEs per 1726 patients) used during clinical trials and (2) noted that AMAG’s competitor Venofer had been associated with only one SAE and one death in the ten years since it was introduced to the market.

2.

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Bluebook (online)
12 F. Supp. 3d 241, 2014 WL 1379792, 2014 U.S. Dist. LEXIS 48231, Counsel Stack Legal Research, https://law.counselstack.com/opinion/silverstrand-investments-v-amag-pharmaceuticals-inc-mad-2014.