HUG, Senior Circuit Judge:
Plaintiff Inter-Local Pension Fund GCC/IBT ("Plaintiff") brought a securities fraud action
The complaint focuses on alleged statements by Rigel and other individuals concerning the results of a clinical drug trial and alleged statements about partnership prospects for Rigel. Named defendants include Rigel, James M. Gower, Ryan D. Maynard, Donald G. Payan, Raul R. Rodriguez, Elliott B. Grossbard, Jean Deleage, Bradford S. Goodwin, Gary A. Lyons, Walter H. Moos, Hollings C. Renton, Peter S. Ringrose and Stephen A. Sherwin ("Defendants").
Plaintiff timely appealed the district court's August 24, 2010 order granting defendants' motion to dismiss the complaint.
Rigel is a clinical-stage drug development company that discovers and develops novel, small-molecule drugs for the treatment of inflammatory and autoimmune diseases, certain cancers, and other diseases. One of those drugs is R788, which Rigel is developing to treat and stop the progression of rheumatoid arthritis.
Rigel conducted a Phase IIa clinical trial to evaluate the safety and preliminary clinical efficacy of R788 in patients who were suffering from active rheumatoid arthritis despite therapy with methotrexate. The clinical trial was a multi-center, randomized, double-blind, placebo-controlled, ascending dose study involving 189 patients in the United States and Mexico. Rigel placed patients into one of three cohorts receiving either 50, 100, or 150 mgs of
Rigel measured efficacy for each participant based on the American College of Rheumatology ("ACR") criteria, which denote at least a twenty percent improvement (ACR20), at least a fifty percent improvement (ACR50), or at least a seventy percent improvement (ACR70). For scientific and ethical reasons, people conducting clinical trials generally select their trial methodology, including primary efficacy endpoints and statistical methodology, before the clinical trial begins. Rigel's chosen primary efficacy endpoint for the trial was the percentage of patients who were ACR20 responders by the end of the 12-week trial. ACR50 and ACR70 were secondary endpoints.
The complaint alleges that, on December 13, 2007, Rigel issued a press release concerning its Phase 2 clinical study for R788.
The press release included the following chart, entitled "Efficacy Results":
Treatment Assigned Number ACR20 ACR50 ACR70 DAS28-CRP 2.6 po bid (N) % (N) % (N) % (N) % (N) Placebo 47 38% (18) 19% (9) 4% (2) 17% (8) 50 mg 46 32% (15) 17% (8) 2% (1) 20% (9) 100 mg 49 65% (32) 49% (24) 33% (16) 35% (17) (p=.008) (p=.002) (p<.001) (p=.005) 150 mg 47 72% (34) 57% (27) 40% (19) 47% (22) (p<.001) (p<.001) (p<.001) (p<.001)
The press release also included information concerning side effects, stating:
In addition, the press release also provided:
Placebo 50mg 100mg 150mg po BID po BID po BID po BID N = 47 N = 46 N = 49 N = 47 Completed Study at Reduced Dose (N) 1 0 5 13 Dropouts (N): 11 6 6 8 Withdrew Consent 6 3 2 1 Adverse Event 2 1 3 6 Other 3 2 1 1 Neutropenia (N) Requiring dose 0 0 5 10 reduction ALT>3XULN(N) 2 0 0 3 Diarrhea (N) (severity moderate 0 3 2 10 or greater) Upper GI side effects (N) (gastritis, 2 1 2 12 nausea, dyspepsia) (severity moderate or greater) Hypertension (N) (severity moderate 0 0 2 0 or greater)
The complaint alleged that, on the same day that Rigel issued its press release, it also held a conference call with, among others, Gower and Dr. Grossbard. During the conference call, Dr. Grossbard referenced the handout and discussed some of the results. When discussing efficacy and the statistical significance of the results, Dr. Grossbard stated:
Dr. Grossbard then went on to discuss the reported safety results. As part of that discussion, he allegedly stated:
During the conference call, Dr. Grossbard stated that he would be writing a paper with Dr. Michael Weinblatt, Professor of Medicine at Harvard Medical School, and that the paper would be "the next significant statement about the results of this study."
On July 8, 2008, Rodriguez allegedly presented efficacy and safety graphs at the Collins Stewart 4th Annual Growth Conference. Among other things, Rodriguez allegedly stated that, during the clinical trial, there was "[a] bit of hypertension here and there."
The complaint alleges that Defendants subsequently reported additional information about the clinical trial when Drs. Weinblatt and Grossbard gave a presentation to physicians at the ACR Annual Scientific Meeting on October 27, 2008 and when a scholarly article was published in the November 2008 issue of the medical journal "Arthritis and Rheumatism." This information was more academic and detailed.
During the October 27, 2008 presentation, Rigel allegedly provided dose response information, broken down based on whether the patient received R788 in Mexico or in the United States. The following chart was presented:
Placebo 50MG 100MG 150MG # of U.S. Patients 25 46 21 5 ACR20 6 (24%) 15 (33%) 11 (52%) 2 (40%) ACR50 1 (4%) 8 (17%) 6 (29%) 2 (40%) ACR70 0 (0%) 1 (2%) 3 (14%) 2 (40%) Placebo 50MG 100MG 150MG # of Mexico Patients 22 0 28 42 ACR20 12 (55%) 0 (0%) 21 (75%) 32 (76%) ACR50 8 (36%) 0 (0%) 18 (64%) 25 (60%) ACR70 2 (9%) 0 (0%) 13 (46%) 17 (40%)
On the day that this data was presented, Dr. Grossbard allegedly stated:
Dr. Grossbard explained, "you get the same difference but different points of departure." The journal article contained a similar discussion, stating that there were "higher clinical responses being observed in patients enrolled from Mexico in both the placebo group and the R788 groups. Even with this difference in response rates between the 2 countries, the difference between active drug and placebo remained >20%."
The journal article repeated some of the same earlier information regarding efficacy, including the same p-values. In addition, the journal article discussed statistical analysis used for the study.
The complaint alleges that Defendants made misleading comments about Rigel's prospects for obtaining a partner for development of R788. On October 27, 2008, Gower allegedly stated that Rigel was "[s]till on track for what we've been saying all along, which is putting the partnership in place as early as the early part of next year." He indicated that the end of the first quarter of the following year would be "ideal," but that "it's certainly not in our control that it would be." In addition, he acknowledged that he could not know that potential partners would not "freak out" about the credit crisis occurring at the time and also recognized that partnership deals can take a long time to put in place. On November 3, 2008, Gower allegedly stated: "We expect to establish a collaboration partnership to further these ends, and that in fact is going quite well."
The decisions of a district court on motions to dismiss are reviewed de novo. Zucco Partners, LLC v. Digimarc Corp., 552 F.3d 981, 989 (9th Cir.2009). We must accept as true all well-pleaded allegations in the complaint. S. Ferry LP, No. 2 v. Killinger, 542 F.3d 776, 782 (9th Cir.2008). "If support exists in the record, the dismissal may be affirmed on any proper ground, even if the district court did not reach the issue or relied on different grounds or reasoning." Steckman v. Hart Brewing, Inc., 143 F.3d 1293, 1295 (9th Cir.1998).
Rule 8(a) of the Federal Rules of Civil Procedure requires only "a short and plain statement of the claim showing that the pleader is entitled to relief." Fed.R.Civ.P. 8(a)(2). Rule 12(b)(6) authorizes courts to dismiss a complaint for "failure to state a claim upon which relief can be granted." Fed.R.Civ.P. 12(b)(6). To avoid dismissal, the complaint must provide "more than labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do." Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007). Factual allegations must be enough to raise a right to relief above the speculative level on the assumption that all the allegations in the complaint are true. Id. Our review of challenges
In addition to the pleading requirements of Rule 8, there are more demanding pleading requirements for certain causes of action, especially securities fraud. We discuss those specific requirements in the relevant sections below.
The district court dismissed the section 10(b) and Rule 10b-5 claim on the grounds that the complaint failed to sufficiently allege a false or misleading statement or omission and failed to sufficiently allege scienter. We conclude that this was not error.
Section 10(b) of the Securities Exchange Act of 1934 makes it unlawful for any person to:
15 U.S.C. § 78j(b). One of those rules promulgated under the Act is Securities and Exchange Commission Rule 10b-5, which makes it unlawful to, among other things, "make any untrue statement of a material fact or to omit to state a material fact necessary in order to make the statements made, in the light of the circumstances under which they were made, not misleading." 17 C.F.R. § 240.10b-5(b).
To sufficiently plead a primary violation of Rule 10b-5 based on misstatements, a plaintiff must adequately allege the following: 1) a material misrepresentation or omission by the defendant; 2) scienter; 3) a connection between the misrepresentation or omission and the purchase or sale of a security; 4) reliance upon the misrepresentation or omission; 5) economic loss; and 6) loss causation. Stoneridge Inv. Partners, LLC v. Scientific-Atlanta, Inc., 552 U.S. 148, 157, 128 S.Ct. 761, 169 L.Ed.2d 627 (2008). In the case before us, the district court held that Plaintiff had failed to sufficiently plead that there was a misrepresentation or omission and also had failed to sufficiently plead scienter.
At the pleading stage, a complaint alleging claims under section 10(b) and Rule 10b-5 must not only meet the requirements of Rule 8, but must satisfy the heightened pleading requirements of both Federal Rule of Civil Procedure 9(b) and the Private Securities Litigation Reform Act ("PSLRA"). Zucco, 552 F.3d at 990. Rule 9(b) provides: "In alleging fraud or mistake, a party must state with particularity the circumstances constituting fraud or mistake." Fed.R.Civ.P. 9(b). Thus, Rule 9(b) requires particularized allegations of the circumstances constituting fraud, including identifying the statements at issue and setting forth what is false or misleading 10670 about the statement and why the statements were false or misleading at the time they were made. In re GlenFed, Inc. Sec. Litig., 42 F.3d 1541, 1547-49 (9th Cir.1994).
The PSLRA imposes additional specific pleading requirements, including requiring plaintiffs to state with particularity both the facts constituting the alleged violation and the facts evidencing scienter. See Tellabs, Inc. v. Makor Issues & Rights, Ltd.,
Under the PSLRA, to properly allege falsity, a securities fraud complaint must now "specify each statement alleged to have been misleading, the reason or reasons why the statement is misleading, and, if an allegation regarding the statement or omission is made on information and belief,... state with particularity all facts on which that belief is formed." 15 U.S.C. § 78u-4(b)(1); see also Matrixx Initiatives, Inc. v. Siracusano, ___ U.S. ___, 131 S.Ct. 1309, 1318 n. 4, 179 L.Ed.2d 398 (2011); Zucco, 552 F.3d at 990-91.
To adequately plead scienter under the PSLRA, the complaint must "state with particularity facts giving rise to a strong inference that the defendant acted with the required state of mind." 15 U.S.C. § 78u-4(b)(2)(A); see also Tellabs, 551 U.S. at 314, 127 S.Ct. 2499.
Plaintiff's allegations regarding falsity fall into three general categories: 1) statements related to efficacy; 2) statements related to safety; and 3) statements about Rigel's future partnership prospects.
Plaintiff contends that the district court's analysis of the alleged statements relating to efficacy was erroneous because Plaintiff adequately pled falsity with respect to reported study results and adequately pled falsity with respect to country effect.
The district court held that Plaintiff had failed to adequately plead a false statement regarding efficacy because disagreements over statistical methodology and study design are insufficient to allege a materially false statement. Plaintiff argues that it met the pleading requirements by alleging "false" study results, including allegations of "statistically `false p-values'"
In order to allege falsity, a plaintiff must set forth facts explaining why the difference between two statements "is not merely the difference between two permissible judgments, but rather the result of a falsehood." In re GlenFed, Inc. Securities Litigation, 42 F.3d 1541, 1549 (9th Cir.1994) (en banc).
It is apparent from the complaint that Plaintiff's allegations of "falsity" were based on its contention that Defendants should have used a particular statistical methodology, which it described in the complaint. Plaintiff did not allege that Defendants inaccurately reported the results of their own statistical analysis. Plaintiff also did not allege that Defendants had chosen or changed their statistical methodology after seeing the unblinded raw data from the clinical trial. Instead, Plaintiff challenged Defendants' reported statistical results by alleging that Defendants should have used Plaintiff's chosen statistical methodology, including calculating separate p-values for the United States and Mexico and combining those results using "Fisher's method," and using "Tukey's Studentized Range test." Plaintiff alleged that using its proposed statistical methodology would result in different p-values for the 100 mg and 150 mg doses at ACR 20 and that these newly calculated p-values were not statistically significant.
Although Plaintiff argues that it is simply challenging the truth of the reported results, not the study design, there are multiple problems with this argument. First, regardless of whether the statistical methodologies used to calculate p-values are considered part of the study design, Plaintiff is alleging that Defendants should have used different statistical methodologies, not that Defendants misrepresented the results they obtained from the methodologies they employed.
Second, to accept Plaintiff's argument that it is not challenging the study design, we would have to draw a line between using a particular method of statistical analysis that was part of a study's protocol and adopted prior to unblinding the data and disclosing results that were calculated using that statistical analysis. Drawing such a distinction would suggest that a company should announce statistical results that are obtained using a statistical methodology that is adopted after the study data is made available to the researchers and that is different from the methodology used as part of the clinical trial. Such a post-hoc adoption of a statistical method could raise concerns regarding reliability, biased scientific methods, or even fraud. See United States v. Harkonen, No. C 08-00164, 2010 WL 2985257, at *4, 7-10 (N.D.Cal. July 27, 2010).
Neither the Supreme Court nor this court has addressed the question of whether statements concerning statistical results of a clinical trial may be considered false or misleading under Rule 10b-5 because the statistical methodology that produced those results was not the best or most acceptable methodology. However, the district courts that have addressed this issue support our conclusion that merely alleging that defendants should have used different statistical methodology in their drug trials is not sufficient to allege falsity. For example, in Padnes v. Scios Nova Inc., No. C 95-1693, 1996 WL 539711 (N.D.Cal. Sept. 18, 1996), the plaintiffs alleged that the defendants made false public statements relating to the results of a Phase II drug study. The defendants had made public statements that the results of
The court held that the fact that the plaintiffs disagreed with the researchers about the import of the data did not make the defendants' summaries of the study false or misleading. Id. In addition, the court concluded that the securities laws do not require that companies report information only from optimal studies, even assuming that scientists could agree on what is optimal, and that companies reporting information from imperfect studies are not required to disclose alternative methods for interpreting the data. Id. The court therefore held that the plaintiffs did not plead facts sufficient to explain why the defendants' summaries of the study were false or misleading. Id.; see also In re Adolor Corp. Sec. Litig., 616 F.Supp.2d 551, 568 n. 15 (E.D.Pa.2009) (where plaintiffs' statistician identified what he believed were problems with a defendant's statistical analysis of a clinical trial, plaintiff merely alleged a disagreement about how to conduct and analyze the study, not a false or misleading statement); DeMarco v. DepoTech Corp., 149 F.Supp.2d 1212, 1225 (S.D.Cal.2001) ("Although Plaintiffs may have established a legitimate difference in opinion as to the proper statistical analysis, they have hardly stated a securities fraud claim.").
We find this reasoning persuasive. Because Plaintiff does not allege that Defendants misrepresented their own statistical methodology, analysis, and conclusions, but instead criticizes only the statistical methodology employed by Defendants, Plaintiff did not adequately plead falsity with respect to statistic results.
Plaintiff argues that the complaint adequately alleges falsity by alleging that Defendants' initial presentation of results based on combined data
We reject this argument. In fact, according to Plaintiff, the press release regarding the results of the study stated that the "efficacy results for the 100mg and 150mg dose groups were fairly comparable."
Accordingly, we affirm the district court's ruling that Plaintiff did not sufficiently plead falsity with respect to the allegations relating to efficacy.
Plaintiff contends that the district court erred when it ruled that Plaintiff failed to adequately plead falsity with respect to Defendants' initial statements about certain safety-related results from the clinical trial.
The December 13, 2007 press release clearly identified its table of results for certain side effects as "key safety results," not "all safety results" or even just "safety results." Defendants never claimed that these were all of the safety results or that these results included every occurrence of every possible side effect.
Moreover, for each category of side effect the press release did address, the press release made clear what the criteria were for including patients in the category. For example, for hypertension, the press release stated that it was including hypertension of moderate severity or greater. The press release did not state that it was including all incidents in which a patient experienced an increase in blood pressure during the course of the trial. With regard to liver function, the press release did not state that it was including all patients in which there was any increase in liver enzymes regardless of the degree or impact of the increase. Rather, the press release stated that it was noting cases in
Plaintiff does not allege that Defendants omitted information that fell into these categories. Rather, Plaintiff alleges that Defendants should have initially reported other information concerning side effects instead of waiting to report that information in the journal article. However, the subsequent release of more extensive information, such as a few cases of mild hypertension or some cases of neutropenias that did not require dose reductions, was not inconsistent
Plaintiff contends that the district court erred when it held that Plaintiff had not sufficiently alleged that Defendants' statements regarding partnership prospects were false or misleading. The complaint alleges that, on October 27, 2008, Gower falsely stated: "[S]till on track for what we've been saying all along, which is putting the partnership in place as early as the early part of next year. I doubt it will be this year." The complaint also alleges that, on November 3, 2008, Gower falsely stated: "We remain committed to doing everything possible to develop and commercialize R788 in RA. We expect to establish a collaboration partnership to further these ends, and that in fact is going quite well."
The complaint further alleges that, because potential partners had access to the clinical trial data, and because Defendants "knew" the results were not really statistically significant, Rigel was not on track for
Accordingly, we hold that Plaintiff has failed to meet the pleading requirements for falsity under Rule 8, Rule 9(b), and the PSLRA.
Plaintiff contends that the district court erred when it concluded that Plaintiff had not sufficiently pled scienter. Scienter is "a mental state embracing intent to deceive, manipulate, or defraud." See Tellabs, Inc. v. Makor Issues & Rights, Ltd., 551 U.S. 308, 319, 127 S.Ct. 2499, 168 L.Ed.2d 179 (2007) (internal quotation marks omitted).
To adequately plead scienter under the PSLRA, the complaint must "state with particularity facts giving rise to a strong inference that the defendant acted with the required state of mind." 15 U.S.C. § 78u-4(b)(2); see also Zucco Partners, LLC v. Digimarc Corp., 552 F.3d 981, 991 (9th Cir.2009). To qualify as a "strong inference,"
Plaintiff argues that it met the requirements for pleading scienter by alleging that Defendants knew of the detailed study results when they made the allegedly fraudulent statements and by alleging that Defendants had financial motives for making fraudulent statements. These arguments are unconvincing, and we hold that the district court did not err when it determined that Plaintiff had not sufficiently pled scienter.
Plaintiff argues that Defendants knew that their statements regarding statistical significance and efficacy were false because they had access to the clinical trial results and therefore knew there was a substantial country interaction and knew what the blood pressure data was. Even assuming, arguendo, that Plaintiff adequately pled that all of the defendants had knowledge of the detailed clinical results at the time the allegedly false statements were made, such an allegation does not support a strong inference of scienter.
Although Plaintiff notes that it alleged that Dr. Grossbard knew there was a country effect, Plaintiff points us to no allegations that Dr. Grossbard or any of the other defendants believed that they made false or misleading statements relating to a country effect or that Defendants believed that they were misrepresenting the statistical significance of their results. Moreover, to the extent Plaintiff has provided us with any indication about Dr. Grossbard's views regarding country effects, the inference is that, after looking at the results, Dr. Grossbard was not concerned about comparative patient responses in the United States and Mexico for at least two reasons: 1) he believed the differences between the active and placebo patients were similar for both countries, but simply had different starting and ending points; and 2) he was aware of other rheumatoid arthritis drugs that had been approved by the FDA and similarly had included a significant number of Latin American patients in their clinical trials and had shown higher response rates in Latin American patients than in American and European patients during their drug trials.
Plaintiff next contends that it adequately pled scienter by alleging that the earlier reports by Defendants failed to disclose some blood pressure information. Plaintiff acknowledges that Rodriguez stated that there was a "bit of hypertension here and there," but asserts that he concealed the fact that five patients experienced hypertension, not two as was initially reported. The complaint does not specifically allege that Rodriguez himself stated that there was any particular number of patients who
In addition, as the district court noted, if Defendants were intent on misleading investors about the safety of R788, it does not make sense that the safety information they would choose to disclose in their initial, allegedly fraudulent, reports, would be the most severe adverse events.
Plaintiff contends that its allegations regarding motive bolster its scienter pleadings. In support of this argument Plaintiff argues that it alleged a motive to commit fraud when it alleged that, at the time the allegedly fraudulent statements were made, Defendants were seeking a partner and were planning to raise capital in a stock offering. In addition, Plaintiff points to its allegations that individual defendants knew that they would receive higher salaries, bonuses, and stock options and that the value of their stock options would increase substantially if Rigel reported positive results from the clinical trial.
However, allegations of routine corporate objectives such as the desire to obtain good financing and expand are not, without more, sufficient to allege scienter; to hold otherwise would support a finding of scienter for any company that seeks to enhance its business prospects. Lipton v. Pathogenesis Corp., 284 F.3d 1027, 1038 (9th Cir.2002). In addition, it is common for executive compensation, including stock options and bonuses, to be based partly on the executive's success in achieving key corporate goals. Thus, especially given the holistic approach to assessing scienter adopted in Tellabs and the requirement that we take into account plausible opposing inferences, we will not conclude that there is fraudulent intent merely because a defendant's compensation was based in part on such successes. See Rubke v. Capitol Bancorp Ltd., 551 F.3d 1156, 1166 (9th Cir.2009) (holding that allegations of motive and opportunity were not enough to create a strong inference of scienter).
In addition, the individual defendants' conduct concerning their stock is inconsistent with Plaintiff's theory that financial motive establishes scienter here. The complaint alleges that individual defendants knew that the value of their stock options would increase if Rigel reported positive results from the clinical trial. However, because none of the defendants sold stock during the period between the allegedly fraudulent statements and the subsequent public disclosure of the detailed data, which is the period during which they would have benefitted from any
Moreover, if the individual defendants were acting based on their belief that they had a financial motive to conceal the "true" results of the clinical trial, they would not have voluntarily publicly disclosed all the data and the statistical methodology. They also would not have decided that the people to receive that detailed information should be the people most likely to identify any problems with the study — the doctors and scientists who were at the scientific meeting and who were publishing and reading the journal article.
Overall, the inference of scienter here is weak, and certainly not as strong as the inference that Defendants had a non-fraudulent intent. Thus, the district court did not err when it determined that Plaintiff did not sufficiently plead scienter.
Plaintiff contends that the district court erred when it dismissed the section 11 claim.
The particularity requirements of Rule 9(b) apply to claims brought under section 11 when such claims are grounded in fraud. Stac Elecs., 89 F.3d at 1404-05. Plaintiff argues that its section 11 claim is not grounded in fraud, pointing out that it disclaimed in its complaint any allegation of fraud in connection with the section 11 cause of action, and contending that it did not incorporate any of the section 10(b) conduct allegations in its section 11 claim.
We have held that a plaintiff's nominal efforts to disclaim allegations of fraud with respect to its section 11 claims are unconvincing where the gravamen of the complaint is fraud and no effort is made to show any other basis for the claims. Stac Elecs., 89 F.3d at 1405 n. 2. "To ascertain whether a complaint `sounds in fraud,' we must normally determine, after a close examination of the language and structure of the complaint, whether the complaint `allege[s] a unified course of fraudulent conduct' and `rel[ies] entirely on that course of conduct as the basis of a claim.'" Rubke v. Capitol Bancorp Ltd, 551 F.3d 1156,
Here, although the section 11 claim does not adopt all of the allegations contained in the rest of the complaint, it does not allege different misrepresentations. Instead, it merely relies on the same alleged misrepresentations from the December 13, 2007 press release that are central to Plaintiff's section 10(b) fraud claim. Accordingly, Plaintiff's section 11 claim is grounded in fraud and Plaintiff must meet Rule 9(b)'s pleading requirements. This does not mean, as Plaintiff contends, that it may not plead alternative theories of liability; it merely means that, with both the section 10(b) and the section 11 claims, Plaintiff must meet the pleading requirements of Rule 9(b). For the same reasons discussed above regarding the section 10(b) claim, we hold that, for the section 11 claim, Plaintiff has failed to meet Rule 9(b)'s pleading requirements with respect to pleading a false or misleading statement.
Section 20(a) and section 15 both require underlying primary violations of the securities laws. 15 U.S.C. §§ 77o, 78t(a). Because Plaintiff here has failed to adequately plead a violation of the federal securities laws, it follows that Plaintiff also has failed to adequately plead violations of section 20(a) and section 15.
For the foregoing reasons, the district court's order granting the motion to dismiss is
In addition, to the extent Plaintiff suggests that parties conducting clinical trials necessarily are required to release all the detailed data or break that data down by categories that may plausibly be of interest to some investors, Plaintiff is incorrect. Section 10(b) and Rule 10b-5 do not categorically prohibit statements that are incomplete or that report cumulative figures instead of detailed breakdowns of the underlying data or subcategories of data. Brody v. Transitional Hosps. Corp., 280 F.3d 997, 1006, 1006 n. 8 (9th Cir.2002); see also In re Adolor Corp. Securities Litigation, 616 F.Supp.2d at 569 (holding that company was not required to provide data or analysis on subgroups of patients in clinical trial even if sub-group information was material and the company had made public statements about top-line results).
Plaintiff contends that, after the Supreme Court's decision in Matrixx Initiatives, Inc. v. Siracusano, ___ U.S. ___, 131 S.Ct. 1309, 179 L.Ed.2d 398 (2011), once a company chooses to disclose any safety information, it must disclose all material information regarding safety. This contention misconstrues the Supreme Court's opinion in Matrixx. Matrixx established that section 10(b)(5) and Rule 10b-5 do not create an affirmative duty to disclose any and all material information; section 10(b) and Rule 10b-5 prohibit only misleading and untrue statements, not statements that are incomplete. Matrixx, 131 S.Ct. at 1321-22. The Matrixx Court made it clear that not all adverse events would be material and, more importantly, that not all material adverse events would have to be disclosed. See id. "Even with respect to information that a reasonable investor might consider material, companies can control what they have to disclose under these provisions by controlling what they say to the market." Id. at 1322. Thus, as long as the omissions do not make the actual statements misleading, a company is not required to disclose every safety-related result from a clinical trial, even if the company discloses some safety-related results and even if investors would consider the omitted information significant.
In their brief, Defendants argue that it would be appropriate for us to take judicial notice of a number of other documents in order to address misrepresentations made by Plaintiff with respect to other issues such as clinical trial results and analyst reports. Although we understand Defendants' frustrations, we decline to take judicial notice of any documents. The record is sufficient for us to address any issues that are relevant to our analysis.