Regina Warshaw and John D. Kaufman, on Behalf of Themselves and All Others Similarly Situated v. Xoma Corporation Steven C. Mendell

74 F.3d 955, 96 Cal. Daily Op. Serv. 525, 34 Fed. R. Serv. 3d 502, 96 Daily Journal DAR 847, 1996 U.S. App. LEXIS 1215, 1996 WL 26911
CourtCourt of Appeals for the Ninth Circuit
DecidedJanuary 25, 1996
Docket94-16271, 94-16297
StatusPublished
Cited by414 cases

This text of 74 F.3d 955 (Regina Warshaw and John D. Kaufman, on Behalf of Themselves and All Others Similarly Situated v. Xoma Corporation Steven C. Mendell) is published on Counsel Stack Legal Research, covering Court of Appeals for the Ninth Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

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Regina Warshaw and John D. Kaufman, on Behalf of Themselves and All Others Similarly Situated v. Xoma Corporation Steven C. Mendell, 74 F.3d 955, 96 Cal. Daily Op. Serv. 525, 34 Fed. R. Serv. 3d 502, 96 Daily Journal DAR 847, 1996 U.S. App. LEXIS 1215, 1996 WL 26911 (9th Cir. 1996).

Opinion

*957 PREGERSON, Circuit Judge:

This is a class action brought under Section 10(b) of the Securities and Exchange Act of 1934, 15 U.S.C. § 788(b), and Rule 10b-5 promulgated by the Securities and Exchange Commission, 17 C.F.R. § 240.10b-5. The district court allowed plaintiffs to amend their complaint three times and then dismissed the third amended complaint (the Complaint) under Fed.R.Civ.Pro. 12(b)(6) for failure to state a claim upon which relief can be granted.

We review a district court’s 12(b)(6) dismissal of a federal securities claim de novo. Holden v. Hagopian, 978 F.2d 1115, 1118 (9th Cir.1992). Our review is limited to the contents of the complaint. Argabright v. United States, 35 F.3d 472, 474 (9th Cir.1994). We take as true all allegations of material fact stated in the complaint and construe them in the light most favorable to the nonmoving party. National Wildlife Federation v. Espy, 45 F.3d 1337, 1340 (9th Cir.1995).

We have jurisdiction under 28 U.S.C. § 1291. We reverse and remand.

BACKGROUND

For the purposes of reviewing this 12(b)(6) dismissal, we relate the facts in this case as stated in the Complaint.

Xoma Corporation is a biotech company that develops and produces protein therapeutic pharmaceuticals based on DNA technology. Complaint ¶¶ 6, 14. Steven Mendell is Xoma’s chief executive officer. Complaint ¶7. Before 1992, the United States Food and Drug Administration (FDA) had never approved any Xoma-developed drugs. As a result, Xoma had never made a profit on its research. Complaint ¶ 15. Xoma’s financial success depended on FDA approval of the drug “E5.” Complaint ¶¶ 16-17, 25-26. According to Xoma, E5 is “an anti-endotoxin monoclonal antibody designed to treat gram-negative sepsis, an acute illness that is a major cause of death and serious disease in hospitalized patients.” Appellee’s Brief at 6; see Complaint ¶ 6. Prompt FDA approval of E5 in 1992 would have allowed Xoma to capture the lucrative sepsis-treatment market. Complaint ¶¶ 24-25.

Plaintiffs represent a class of persons who purchased Xoma common stock between March 2, 1992 and June 3, 1992. Complaint ¶ 5. During this period, plaintiffs assert that Xoma made repeated assurances that FDA approval of E5 was “imminent.” Complaint ¶ 2. The Complaint asserts that Xoma intentionally made these reassuring public statements even after serious doubts were raised about E5’s effectiveness and the chances for prompt FDA approval. Complaint ¶¶ 34-35. Xoma’s reassurances about E5, according to the Complaint, catalyzed a rapid rise in Xoma share prices as stock analysts and the press reacted positively to Xoma’s confidence that E5 would be approved. Complaint ¶¶ 39-42. An abbreviated chronology of the events as stated in the Complaint is as follows.

On March 2, 1992, a securities analyst for Oppenheimer and Co., Inc., Jeffrey Casdin, reported that there was “no hope for any approval of E5.” Complaint ¶34. Casdin based his report on his examinations of data from two “Phase III” clinical studies of E5 that had been presented to the FDA advisory committee on September 4,1991. He reported a disturbing possibility that “E5 actually increases mortality in a large percentage of gram-negative sepsis patients.” Complaint ¶ 34. Casdin also expressed doubts on whether “the FDA would allow a meta-analysis combining this [second Phase III] study with the previous Phase III study to overcome a glaring safety issue.” Complaint ¶ 34.

On the same day, Xoma responded to Cas-din’s criticisms over Dow Jones News Wire. Dr. Patrick Scannon, then President of Xoma and Vice Chairman for scientific and medical affairs, attacked Casdin’s report as “scientifically wrong” and “irresponsible.” Complaint ¶35. He allayed shareholders fears about FDA approval, stating “everything is going fine.” Complaint ¶ 35.

On April 14, 1992, Xoma issued a press release that announced that the FDA had rejected the first Phase III study of E5. Complaint ¶37. This announcement triggered a downward slide in Xoma stock price. *958 Complaint ¶37. On the same day, CEO Mendell and Dr. Scannon issued a series of statements to reassure the market. Mendell stated that the market’s “concerns are unfounded; we think the market misunderstood the earlier announcement and overreacted to it.” Complaint ¶37. Scannon announced that the negative news

does not in any way imply a delay or setback in the agency’s review of E5. In fact, we are encouraged by the progress FDA is making in its review.... When the two trials are combined, we believe the safety and effectiveness of E5 is clearly demonstrated.

Complaint ¶37. Mendell also told Reuters news service that the FDA’s notification “shows positive forward progress.” Complaint ¶ 37. On May 5, 1992, Mendell made similar optimistic statements regarding the safety of E5 and the “positive forward progress” of the FDA review. Complaint ¶ 40; see generally Complaint ¶¶ 37-43.

The market responded favorably to Xoma’s assurances that E5 was safe, effective and that FDA approval of the drug was “imminent.” Complaint ¶43. Based on these statements and information from Xoma, other securities analysts began to give favorable evaluations of Xoma stock. Complaint ¶¶ 43-43C. These endorsements resulted in an upward movement in Xoma stock price. Xoma stock rose to a high of 23 points on May 22, 1992. Complaint ¶ 39B. Part of this rise in the value of Xoma stock was attributable to the analysts’ reports that E5 would be approved by the FDA Complaint ¶¶ 4SB-13C.

On June 4,1992, the FDA denied approval of E5 because it found the Phase III clinical studies to be inconclusive. Mendell issued a statement reported over Dow Jones News Wire that the FDA had advised Xoma that “based on their review, they felt there wasn’t sufficient efficacy.” Complaint ¶ 45. On this news, Xoma stock plummeted and lost twenty-four percent of its value. It was the most actively traded NASDAQ stock for that day. Complaint ¶47. On June 11, Xoma announced that the FDA required additional information and analyses; this process would delay approval for months if not years. Complaint ¶ 48. Delayed approval greatly diminished Xoma’s chances of capturing the sepsis-treatment market. Xoma was trading at 6 points per share when the Complaint was filed. Complaint ¶ 48.

The Complaint alleges in Count I that Xoma and CEO Mendell knew during this course of events that there was no chance for timely FDA approval of E5. Complaint ¶¶ 51-54. The Complaint asserts that Xoma’s statements and failure to inform the public of shortcomings in its E5 analyses, when taken in context, were part of an intentional and fraudulent omission of material information. Complaint ¶¶ 52-54.

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74 F.3d 955, 96 Cal. Daily Op. Serv. 525, 34 Fed. R. Serv. 3d 502, 96 Daily Journal DAR 847, 1996 U.S. App. LEXIS 1215, 1996 WL 26911, Counsel Stack Legal Research, https://law.counselstack.com/opinion/regina-warshaw-and-john-d-kaufman-on-behalf-of-themselves-and-all-others-ca9-1996.