throbber
Case 3:19-cv-06601-BRM-TJB Document 82 Filed 03/29/21 Page 1 of 42 PageID: 1473
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`NOT FOR PUBLICATION
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`UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
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`IN RE AMARIN CORPORATION PLC
`SECURITIES LITIGATION
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`Case No. 3:19-cv-06601 (BRM) (TJB)
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`OPINION
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`MARTINOTTI, DISTRICT JUDGE
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`Before the Court are three motions: (1) a Motion to Dismiss filed by Amarin Corporation,
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`PLC (“Amarin”), Craig B. Granowitz, Steven Ketchum, John F. Thero, and Joseph S. Zakrzewski
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`(collectively, “Defendants”), seeking to dismiss Gaetano Cecchini, as Trustee of the Gaetano
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`Cecchini Living Trust, and Dan Kotecki’s (collectively, “Plaintiffs”) Amended Class Action
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`Complaint (“Amended Complaint”) (ECF No. 51); (2) Plaintiffs’ Motion to Strike exhibits
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`attached to Defendants’ Motion to Dismiss (ECF No. 52); and (3) Plaintiffs’ Motion to Strike
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`exhibits attached to Defendants’ reply (ECF No. 63). Plaintiffs’ Amended Complaint alleges
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`violations of Section 10(b) of the Exchange Act and Rule 10b-5 against Amarin, John F. Thero,
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`Steven Ketchum, and Craig Granowitz (individuals collectively, the “Officer Defendants”) and a
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`violation of Section 20(a) of the Exchange Act against John F. Thero, Steven Ketchum, Craig
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`Granowitz, and Joseph S. Zakrzewski (collectively, the “Individual Defendants”). (See ECF No.
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`43 ¶¶ 194–208.) Plaintiffs filed an opposition to Defendants’ Motion to Dismiss (ECF No. 53),
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`and Defendants filed a reply to Plaintiffs’ opposition. (ECF No. 58.) Further, Defendants filed
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`oppositions to Plaintiffs’ Motions to Strike (ECF Nos. 56, 64), and Plaintiffs filed replies to
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`Defendants’ oppositions (ECF Nos. 57, 65). Pursuant to Federal Rule of Procedure 78(a), the Court
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`heard Oral Argument on September 9, 2020. (ECF No. 81.) For the reasons set forth below and
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`1
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`

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`for good cause shown, Plaintiffs’ Motions to Stay are DENIED and Defendants’ Motion to
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`Dismiss is GRANTED without prejudice.
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`I.
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`BACKGROUND
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`A.
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`Factual Background1
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`Amarin is a pharmaceutical company that has, since 2008, focused exclusively on testing
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`and marketing Vascepa, a drug intended to treat heart disease. (ECF No. 43 ¶ 1.) The company is
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`traded on the NASDAQ Global Market under the ticker “AMRN.” (Id.) Amarin undertook three
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`trials to demonstrate the drug’s efficacy. (Id. ¶ 2.) The first two trials—the MARINE and
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`ANCHOR trials—were conducted to demonstrate how Vascepa could lower patients’ triglyceride
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`levels. (Id.) The third and longest trial—the REDUCE-IT trial—was conducted to show Vascepa
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`could reduce patients’ major adverse cardiac events. (Id.)
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`The REDUCE-IT trial concluded in the summer of 2018 and while it appeared to show
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`positive results, the trial featured two issues that may have impacted data: (1) the placebo used did
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`not appear to be acting as an inert placebo and (2) the trial data could not explain how the drug
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`was actually reducing negative cardiac events. (Id. ¶ 3.) Amarin decided to publish the REDUCE-
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`IT trial’s apparently positive results while keeping both issues with the trial a secret. (Id. ¶ 5.) At
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`a conference call following the trial, Defendants stated the trial’s results exceeded expectations
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`and were “the single most, significant advance in preventive cardiovascular drug therapy since the
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`advent of statin therapy” while also priding it was “an overall robust study result.” (Id. ¶ 5.) As a
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`result of this announcement, Amarin’s share price rose 433% over the course of two days. (Id.)
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`1 For the purposes of this Motion to Dismiss, the Court accepts the factual allegations in the
`Amended Complaint as true and draws all inferences in the light most favorable to Plaintiffs. See
`Phillips v. Cty. of Allegheny, 515 F.3d 224, 228 (3d Cir. 2008).
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`2
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`

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`Following this price spike, “Amarin’s top officers seized on the opportunity to sell an
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`unprecedented number of shares.” (Id. ¶ 6.) But when the issues with the REDUCE-IT trial were
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`disclosed at an American Heart Association (“AHA”) conference on November 10, 2018, where
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`top health experts noted the placebo “may have helped overstate Vascepa’s true effect,” share
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`prices dropped 27% over the course of a few days. (Id. ¶ 7.) Plaintiffs and other Class members
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`seek to recover the damages they suffered as a result of “Defendants’ fraudulent acts and
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`omissions.” (Id. ¶ 8.)
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`The Court has jurisdiction over this action pursuant to Section 27 of the Exchange Act, 15
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`U.S.C. § 78aa and 28 U.S.C. § 1331. (Id. ¶ 9.) Lead Plaintiff Gaetano Cecchini, as Trustee of the
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`Gaetano Cecchini Living Trust, purchased Amarin American Depository Shares (“ADS”) during
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`the Class Period, and was damaged as a result. (Id. ¶ 13.) Defendant Amarin is a biotechnology
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`company with its headquarters in Dublin, Ireland and its U.S. office at 1430 Route 206,
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`Bedminster, New Jersey 07921. (Id. ¶ 14.)
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`Plaintiffs allege the Individual Defendants, “as senior executive officers and directors of
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`Amarin, were privy to confidential and proprietary information concerning Amarin, its operations,
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`product, finances, financial condition, and present and future business prospects.” (Id. ¶ 20.)
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`According to Plaintiffs, “[b]ecause of their possession of such information, the Officer Defendants
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`knew or recklessly disregarded that the adverse facts contradicting their misrepresentation and
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`relating to their omissions had not been disclosed to, and were being concealed from, the investing
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`public.”2 (Id.)
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`2 Plaintiffs spend several pages describing heart disease in general, Vascepa’s function, the
`MARNIE trial, the ANCHOR trial, and the REDUCE-IT trial (ECF No. 43 ¶¶ 25–46.) Plaintiffs
`detail other information in its Amended Complaint as well, including: FDA rejection of expanded
`approval of Vascepa based on the ANCHOR trial (id. ¶¶ 47–63); a previous securities class action
`based on Amarin shares (id. ¶¶ 64–68); and the conclusion of the REDUCE-IT trial (id. ¶¶ 69–71.)
`3
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`On September 24, 2018, “the Class Period began when Amarin announced the results of
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`the REDUCE-IT trial.” (Id. ¶ 71.) Defendants reported the REDUCE-IT trial showed using
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`Vascepa, when compared to a placebo, resulted in a 25% reduced risk of major adverse
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`cardiovascular events. (Id.) They noted the trial showed “that pure EPA Vascepa at 4 grams/day
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`can provide additional cardiovascular risk reduction benefit on top of LDL-C control with standard
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`care statin therapy in studied patients.” (Id.) During a conference call that same day, Amarin
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`officers further touted the “truly remarkable” results of the REDUCE-IT study, emphasizing the
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`risk reduction the drug offered, which was “supported by robust demonstrations of efficacy across
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`multiple secondary endpoints.” (Id. ¶ 72.) Defendants stated the results “represent[ed] a greater
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`reduction than demonstration on top of statin therapy for any other drug” and “positions Vascepa
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`to be first to market in addressing a large unmet medical need.” (Id.) During the conference,
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`Defendants “indicated that they had reviewed the entire data set, but explained that they were
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`withholding the remaining results for the forthcoming AHA Conference presentation.” (Id. ¶ 73.)
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`Plaintiffs allege the statements made by Defendants were misleading when made in the
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`context of the FDA’s prior concerns with the mineral oil placebo in the ANCHOR trial, the FDA’s
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`rejection of the ANCHOR supplemental new drug application (“sNDA”), the FDA’s direction to
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`Amarin to monitor the placebo arm in the REDUCE-IT trial, the allegations in the Sklar Action
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`regarding the use of mineral oil as a placebo, Regulation 21 C.F.R. 201.302(G)(a) (2018), and
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`recent failed cardiovascular studies of omega-3 products. (Id. ¶ 83.) Plaintiffs allege these
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`statements were misleading because Defendants omitted several facts from these communications.
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`(Id.)
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`These omissions include not disclosing that the mineral oil used as a placebo “may have
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`interfered with patients’ cholesterol-lowering statins” which impacted the relative risk reduction
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`4
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`of Vascepa. (Id.) Plaintiffs allege omissions were made about the mineral oil that affected various
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`aspects of the patient’s studied metrics—that is, the mineral oil raised various metrics across
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`groups in the REDUCE-IT trial, making Vascepa seem more effective in comparison to the
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`placebo arm of the study. (Id.) According to Plaintiffs, even though Defendants were aware of the
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`issues with the REDUCE-IT trial, they “decided to conceal [that] information from the market to
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`drive up Amarin’s share price and keep it inflated.” (Id. ¶ 84.)
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`Plaintiffs allege “publicizing only the efficacy results that claimed a 25% reduction of
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`major adverse cardiovascular events on top of statin therapy was false and misleading.” (Id. ¶ 139.)
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`Relatedly, Plaintiffs assert as of September 24, 2018, when Defendants announced the REDUCE-
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`IT trials’ results, they “had already analyzed the full REDUCE-IT trial data and thus knew that
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`publicizing the results without important caveats would likely mislead investors.” (Id. ¶ 140.)
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`Further, “Amarin and the Officer Defendants’ public statements confirm that the Company had
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`the full data when Amarin announced the results on September 24, 2018.” (Id. ¶ 143.) Plaintiffs
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`point to statements where Amarin’s CEO and CSO, who both had access to the full data set before
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`it was released to the public, said they were not going to disclose additional details or “talk too
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`much about the results of the REDUCE-IT study because” they were saving those further details
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`for presentation at the AHA Conference. (Id. ¶¶ 144–48.) According to Plaintiffs, Defendants,
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`knowing the full results of the REDUCE-IT trial, mislead investors by choosing not to “provide
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`the necessary qualifications” before the full results were released at the AHA Conference. (Id. ¶
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`151.) Even if Defendants had not reviewed the full dataset “about which they spoke during the
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`Class Period, they were deliberately reckless in making statements about such data when they
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`could have easily reviewed it in the database to which they had access.” (Id. ¶ 152.)
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`5
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`Plaintiffs allege the fact that Defendants first chose to disclose the issues with the
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`REDUCE-IT trial at the AHA Conference “confirms that Defendants were aware they were
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`important.” (Id. ¶ 154.) Plaintiffs refer to articles from the New England Journal of Medicine and
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`Forbes which summarize the concerns of various cardiologists once the full results of the
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`REDUCE-IT trial became available. (Id. ¶¶ 157–60.) Plaintiffs also assert that Defendants’ use of
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`mineral oil—an allegedly biologically active oil—as a placebo, was nothing new since the FDA,
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`as early as 2013, had previously scrutinized Defendants for using the oil as a placebo. (Id. ¶¶ 161–
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`65.) Lastly, Plaintiffs note Defendants filed a 10-Q where they represented the report did not
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`contain any untrue statements of material fact, even though, according to Plaintiffs, “Thero’s
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`possession of the full analyzed REDUCE-IT trial data set, and appreciation of the aberrations in
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`the placebo arm of the data . . . suggests that Thero was either reckless in making his Sarbanes-
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`Oxley certification” or had actual knowledge the filing contained untrue statements of material
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`fact. (Id. ¶¶ 166–67.)
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`B. Procedural Background
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`On February 22, 2019, Plaintiffs filed a Complaint against Amarin, John F. Thero, and
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`Steven Ketchum. (ECF No. 1.) On July 22, 2019, Plaintiffs filed an Amended Class Action
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`Complaint (“Amended Complaint”). (ECF No. 43.) The Amended Complaint alleges violations of
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`Section 10(b) of the Exchange Act and Rule 10b-5 against Defendants (Count One) and a violation
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`of Section 20(a) of the Exchange Act against the Individual Defendants (Count Two). (See id. ¶¶
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`194–208.)
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`On October 4, 2019, Defendants filed a Motion to Dismiss Plaintiffs’ Amended Complaint.
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`(ECF No. 51.) On November 26, 2019, Plaintiffs filed a Motion to Strike certain exhibits contained
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`within Defendants’ Motion to Dismiss. (ECF No. 52.) On November 26, 2019, Plaintiffs filed an
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`6
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`opposition to Defendants’ Motion to Dismiss. (ECF No. 53.) On December 23, 2019, Defendants
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`filed an opposition to Plaintiffs’ Motion to Strike. (ECF No. 56.) On January 3, 2020, Plaintiffs
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`replied. (ECF No. 57.) On January 10, 2020, Defendants filed a reply to Plaintiffs’ opposition.
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`(ECF No. 58.) On January 23, 2020, Plaintiffs filed a Motion to Strike exhibits and related
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`arguments in Defendants’ reply. (ECF No. 63.) On February 4, 2020, Defendants filed an
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`opposition to Plaintiffs’ Motion to Strike. (ECF No. 64.) On February 11, 2020, Plaintiffs filed a
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`reply. (ECF No. 65.)
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`II.
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`LEGAL STANDARD
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`In deciding a motion to dismiss pursuant to Federal Rule of Civil Procedure 12(b)(6), a
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`district court is “required to accept as true all factual allegations in the complaint and draw all
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`inferences in the facts alleged in the light most favorable to the [plaintiff].” Phillips v. Cty. of
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`Allegheny, 515 F.3d 224, 228 (3d Cir. 2008). “[A] complaint attacked by a Rule 12(b)(6) motion
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`to dismiss does not need detailed factual allegations.” Bell Atlantic Corp. v. Twombly, 550 U.S.
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`544, 555 (2007) (citations omitted). However, the plaintiff’s “obligation to provide the ‘grounds’
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`of his ‘entitle[ment] to relief’ requires more than labels and conclusions, and a formulaic recitation
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`of the elements of a cause of action.” Id. (citing Papasan v. Allain, 478 U.S. 265, 286 (1986)). A
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`court is “not bound to accept as true a legal conclusion couched as a factual allegation.” Papasan,
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`478 U.S. at 286. Instead, assuming the factual allegations in the complaint are true, those “[f]actual
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`allegations must be enough to raise a right to relief above the speculative level.” Twombly, 550
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`U.S. at 555.
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`“To survive a motion to dismiss, a complaint must contain sufficient factual matter,
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`accepted as true, to ‘state a claim for relief that is plausible on its face.’” Ashcroft v. Iqbal, 556
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`U.S. 662, 678 (2009) (citing Twombly, 550 U.S. at 570). “A claim has facial plausibility when the
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`7
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`pleaded factual content allows the court to draw the reasonable inference that the defendant is
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`liable for misconduct alleged.” Id. This “plausibility standard” requires the complaint allege “more
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`than a sheer possibility that a defendant has acted unlawfully,” but it “is not akin to a probability
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`requirement.” Id. (quoting Twombly, 550 U.S. at 556). “Detailed factual allegations” are not
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`required, but “more than an unadorned, the defendant-harmed-me accusation” must be pled; it
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`must include “factual enhancements” and not just conclusory statements or a recitation of the
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`elements of a cause of action. Id. (citing Twombly, 550 U.S. at 555, 557).
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`“Determining whether a complaint states a plausible claim for relief [is] . . . a context-
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`specific task that requires the reviewing court to draw on its judicial experience and common
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`sense.” Iqbal, 556 U.S. at 679. “[W]here the well-pleaded facts do not permit the court to infer
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`more than the mere possibility of misconduct, the complaint has alleged—but it has not
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`‘show[n]’—‘that the pleader is entitled to relief.’” Id. at 679 (quoting Fed. R. Civ. P. 8(a)(2)).
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`However, courts are “not compelled to accept ‘unsupported conclusions and unwarranted
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`inferences,’” Baraka v. McGreevey, 481 F.3d 187, 195 (3d Cir. 2007) (quoting Schuylkill Energy
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`Res. Inc. v. Pa. Power & Light Co., 113 F.3d 405, 417 (3d Cir. 1997)), nor “a legal conclusion
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`couched as a factual allegation.” Papasan, 478 U.S. at 286.
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`While, as a general rule, the court may not consider anything beyond the four corners of
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`the complaint on a motion to dismiss pursuant to Rule 12(b)(6), the Third Circuit has held that “a
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`court may consider certain narrowly defined types of material without converting the motion to
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`dismiss [to one for summary judgment pursuant to Rule 56].” In re Rockefeller Ctr. Props. Sec.
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`Litig., 184 F.3d 280, 287 (3d Cir. 1999). Specifically, courts may consider any “document integral
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`to or explicitly relied upon in the complaint.” In re Burlington Coat Factory Sec. Litig., 114 F.3d
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`1410, 1426 (3d Cir. 1997 (quoting Shaw v. Digital Equip. Corp., 82 F.3d 1194, 1220 (1st Cir.
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`8
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`1996)).
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`III. DECISION
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`Before deciding the Motion to Dismiss, the Court must determine which exhibits are proper
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`to consider at this stage.
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`A. Plaintiffs’ Motions to Strike
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`i. Plaintiffs’ First Motion to Strike
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`Plaintiffs filed two motions to strike exhibits Defendants attached to their Motion to
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`Dismiss and Reply pursuant to Fed. R. Civ. P. 12(f)(2). The first Motion to Strike asks the Court
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`to strike twenty-two exhibits, Exhibits B through W, that Defendants submitted with their Motion
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`to Dismiss and the portions of Defendants’ briefs that discuss them. (ECF No. 52-1 at 2–3.) The
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`challenged exhibits are:
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`• Exhibit B: Excerpts from Amarin Form 10-Q for the period ending September 30,
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`2013 (filed Nov. 7, 2013);
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`• Exhibit C: Excerpts from Amarin’s Form 10-K for the period ending December 31,
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`2018 (filed Feb. 27, 2019);
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`• Exhibit D: Excerpts from FDA Briefing Document Endocrinologic and Metabolic
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`Drugs Advisory Committee Meeting (Oct. 16, 2013);
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`• Exhibit E: Excerpts of the transcript from the FDA’s Endocrinologic and Metabolic
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`Drugs Advisory Committee Hearing of Wednesday, October 16, 2013 (the
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`“AdCom”);
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`• Exhibit F: Stipulation and Order of Settlement, Amarin Pharma, Inc, et al. v. United
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`States Food & Drug Administration, et al., 15-cv-3588 (PAE), ECF No. 84
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`(S.D.N.Y. Mar. 8, 2016);
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`9
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`• Exhibit G: Transcript of Amarin Conference Call at American Heart Association
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`Scientific Conference, November 10, 2018 (from Bloomberg);
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`• Exhibit H: Amarin press release titled “REDUCE-IT Cardiovascular Outcomes
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`Study of Vascepa (icosapent ethyl) Capsules Met Primary Endpoint,” dated
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`September 24, 2018;
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`• Exhibit I: Transcript of Vascepa REDUCE-IT Study Result Call (Sept. 24, 2018)
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`(from Bloomberg);
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`• Exhibit J: Excerpts from Amarin Form 10-Q for the period ending September 30,
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`2018 (filed Nov. 1, 2018);
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`• Exhibit K: Deepak L. Bhatt, M.D., M.P.H., et al., Cardiovascular Risk Reduction
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`with Icosapent Ethyl for Hypertriglyceridemia, 380 N. Engl. J. Med. 11 (2018);
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`• Exhibit L: Amarin Corp., How does Vascepa Work? Potential Mechanism of Action
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`for Vascepa, July 15, 2019;
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`• Exhibit M: Matthew Herper, Amarin’s Fish-Oil-Derived Drug Shows Great
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`Promise—With Big Caveats, Forbes Healthcare (Nov. 10, 2018) (the “Forbes
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`Article”);
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`• Exhibit N: Deepak L. Bhatt, M.D., M.P.H., et al., Cardiovascular Risk Reduction
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`with Icosapent Ethyl for Hypertriglceridemia, 380 N. Engl. J. Med. 11 (Jan 3,
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`2019);
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`• Exhibit O: Amarin press releases titled “Amarin Provides Preliminary 2018 Results
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`and 2019 Outlook,” dated January 4, 2019 (referenced AC at 1); “New Updates for
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`the American Diabetes Association’s 2019 Standards of Medical Care in Diabetes
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`Incorporate Findings from the REDUCE-IT Cardiovascular Outcomes Study,”
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`10
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`dated March 28, 2019; and “New 2019 Updates to the European Society of
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`Cardiology’s and European Atherosclerosis Society’s Guidelines for
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`the
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`Management of Dyslipidaemias Incorporate Findings from the REDUCE-IT
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`Cardiovascular Outcomes Study,” dated September 3, 2019;
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`• Exhibit P: Deepak L. Bhatt, M.D., M.P.H., et al., Effects of Icosapent Ethyl on Total
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`Ischemic Events, 73 J. Am. C. Cardiology 2791 (2019);
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`• Exhibit Q: John M. Mandrola, M.D., Pure Fish Oil Lowers CVS Risk Even If We
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`Don’t Understand How, Medscape (Nov. 11, 2018);
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`• Exhibit R: Taylor Carmichael, How Fishy Is This Fish Oil Pill?, The Motley Fool
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`(Oct. 2, 2019) (the “Motley Fool Article”);
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`• Exhibit S: DoctoRx, Amarin’s REDUCE-IT Trial: Something Fishy?, Seeking
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`Alpha (“Seeking Alpha Article”);
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`• Exhibit T: Excerpts from Amarin’s Form 10-K for the period ending December 31,
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`2015 (filed Feb. 25, 2016);
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`• Exhibit U: Form 4s filed by John F. Thero, Joseph T. Kennedy, Michael W. Kalb,
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`Joseph S. Zakrzewski, David Stack, Kristine Peterson, Jan van Heek, Lars G.
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`Ekman, and Patrick J. O’Sullivan;
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`• Exhibit V: Historical Stock chart of AMRN for period of September 15, 2018 to
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`November 15, 2018; and
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`• Exhibit W: Excerpts from Amarin’s Schedule 14A Proxy Statement, dated April
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`25, 2019
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`(ECF No. 51-1 at 2–4.) Defendants also attached two additional exhibits to their reply in further
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`support of their motion to dismiss:
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`11
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`• Exhibit X: FDA News Release: FDA approves use of drug to reduce risk of
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`cardiovascular events in certain adult patient groups, dated December 13, 2019; and
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`• Exhibit Y: Transcript of Amarin Q3 2018 Earnings Call (Nov. 1, 2018) (from
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`Bloomberg)
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`(ECF No. 59 at 2.) In their reply, Defendants clarify “Amarin has no objection if this Court chooses
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`to disregard Exhibits C-I, K-L, and N-S.” (ECF No. 58 at 15.) Therefore, the Court’s analysis of
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`both motions will be limited to the Amended Complaint, Amarin’s public filings (Exs. B, J, T, and
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`Y), the Forbes blog (Ex. M), documents showing stock sales (Exs. U, V, and W), and the FDA’s
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`press release granting expanded approval (Ex. X).
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`Plaintiffs contend the Court should not consider “evidence outside the amended complaint
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`unless (1) the document is incorporated by reference, or (2) the adjudicative fact at issue is subject
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`to judicial notice.” (Id. at 2 (citing Institutional Inv’rs Grp. V. Avaya, Inc., 564 F.3d 242, 260 n.31
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`(3d Cir. 2009).) Plaintiffs argue “Defendants make no effort whatsoever to explain which Exhibits
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`they allege are incorporated by reference and which of these Exhibits are properly subject to
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`judicial notice to establish a specific adjudicative fact.” (Id.) Alternatively, Plaintiffs asks the Court
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`to “convert the Defendants’ motion into a motion for summary judgment pursuant to Rule 12(d)
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`and provide Plaintiffs with an opportunity to respond after conducting discovery.” (Id. at 3.)
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`Defendants argue Plaintiffs’ first Motion to Strike is procedurally improper. (ECF No. 56
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`at 3–4.) In response, Plaintiffs argue its Motion to Strike is procedurally proper “under Rule 12(d),
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`FRE 201, and the Court’s inherent authority” but does not argue its Motion to Strike is proper
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`under Rule 12(f). (ECF No. 57 at 15.)
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`Federal Rule of Civil Procedure 12(f) provides: “[t]he court may strike from a pleading an
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`insufficient defense or any redundant, immaterial, impertinent, or scandalous matter.” Fed. R. Civ.
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`12
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`P. 12(f) (emphasis added). Plaintiffs move to strike exhibits attached to Defendants’ Motion to
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`Dismiss. (See ECF No. 52.) The Federal Rules of Civil Procedure include a list of permitted
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`“pleadings,” which does not include motions, briefs supporting motions, or attached exhibits, and
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`addresses motions under a separate subsection. See Fed. R. Civ. P. 7. Plaintiffs’ motion to strike
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`does not attack a pleading, rather it attacks exhibits attached to Defendants’ motion to dismiss,
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`which is procedurally improper. See, e.g., Gresko v. Pemberton Township Board of Education,
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`Civ. A. No. 19-00638, 2020 WL 6042317, at *3 (D.N.J. Oct. 13, 2020); Litgo New Jersey, Inc. v.
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`Martin, Civ. A. No. 06-2891, 2012 WL 32200, at *11 (D.N.J. Jan. 5, 2012), aff’d sub nom. Litgo
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`New Jersey Inc. v. Comm’r New Jersey Dep’t of Env’t Prot., 725 F.3d 369 (3d Cir. 2013)
`
`(“[M]otions to strike are generally directed at pleadings, see Fed. R. Civ. P. 12(f), not at motions,
`
`briefs, or other filings . . . .”); Faulman v. Sec. Mut. Fin. Life Ins. Co., 2006 WL 2482926, at *3
`
`(D.N.J. Aug. 28, 2006). Therefore, Plaintiffs’ first Motion to Strike is denied under Fed. R. Civ.
`
`P. 12(f).
`
`Next, the Court will address Plaintiffs’ argument that “the Court should convert
`
`Defendants’ motion into a motion for summary judgment pursuant to Rule 12(d).” (ECF No. 52-1
`
`at 3.) Plaintiffs argue Defendants’ incorporation by reference demand “should be rejected for a
`
`failure to explain how Plaintiffs’ claims are ‘based on’ each of the 22 Exhibits.” (ECF No. 52-1 at
`
`8 (citing Schmidt v. Skolas, 770 F.3d 241, 249 (3d Cir. 2014)).) Plaintiffs argue “nine of
`
`Defendants’ Exhibits—F, L, N, O, P, Q, R, T, and U—were never cited in the [Amended
`
`Complaint].” (Id. at 9.)
`
`Defendants argue their motion “identifies every factual assertion for which a document is
`
`cited, the specific document, and in most instances the specific page number of the specific
`
`document, in which the respective fact is contained.” (ECF No. 56.) Defendants also argue
`
`
`
`13
`
`

`

`Case 3:19-cv-06601-BRM-TJB Document 82 Filed 03/29/21 Page 14 of 42 PageID: 1486
`
`Exhibits B, C, J, T, U, and W, SEC filings, are documents that the Court can consider in deciding
`
`the motion. (ECF No. 56 at 17–22.) The Court will only consider arguments for Exhibits B, J, T,
`
`U, and W.
`
`In their reply, Plaintiffs argue several of Defendants’ exhibits should be stricken because
`
`they were improperly submitted. (ECF No. 57 at 5–14.) These include Exhibit C (Amarin’s 2018
`
`Form 10-k); Exhibits D and E (the FDA Documents); Exhibit F (the Amarin/FDA Dispute);
`
`Exhibits G and I (Conference Call Transcripts); Exhibits B, H, J, and T (Amarin SEC filings and
`
`Press Release); Exhibits K and N (the NEJM Article); Exhibits L, M, N, O, P, Q, R and S (Amarin
`
`Publications and Articles Stating Reactions to REDUCE-IT Results); Exhibits U and W (Forms 4
`
`and Schedule 14A); and Exhibit V (the Stock Price Chart). (See id.) The Court will only consider
`
`Plaintiffs’ arguments regarding Exhibits B, J, T, M, U, V, and W for the first Motion to Strike.
`
`When considering a motion to dismiss pursuant to Fed. R. Civ. P. 12(b)(6), district courts
`
`“generally consider only the allegations contained in the complaint, exhibits attached to the
`
`complaint and matters of public record.” Schmidt, 770 F.3d at 249 (citing Pension Benefit Guar.
`
`Corp. v. White Consol. Indus., Inc., 998 F.2d 1192, 1196 (3d Cir. 1993)). An exception to this
`
`general rule is “that a document integral to or explicitly relied upon in the complaint may be
`
`considered without converting the motion to dismiss into one for summary judgment.” Id. (internal
`
`quotation marks omitted) (citing In re Burlington Coat Factory Sec. Litig., 114 F.3d at 1426).
`
`“[W]hat is critical is whether the claims in the complaint are ‘based’ on an extrinsic document and
`
`not merely whether the extrinsic document was explicitly cited.” In re Burlington Coat Factory
`
`Sec. Litig., 114 F.3d at 1426 (3d Cir. 1997) (citing Shaw, 82 F.3d at 1220).
`
`It is also “axiomatic that the complaint may not be amended by the briefs in opposition to
`
`a motion to dismiss.” Olson v. Ako, 724 F. App’x 160, 166 (3d Cir. 2018) (citation omitted); Bolden
`
`
`
`14
`
`

`

`Case 3:19-cv-06601-BRM-TJB Document 82 Filed 03/29/21 Page 15 of 42 PageID: 1487
`
`v. Nat’l Fin. Servs. LLC, Civ. A. No. 04-5527, 2005 WL 8175134, at *6 (D.N.J. May 23, 2005)
`
`(noting that a plaintiff “cannot rely on new facts not alleged in their Complaint to defeat a motion
`
`to dismiss”). However, Federal Rule of Evidence 201(b) allows a court “to take judicial notice of
`
`facts that are not subject to reasonable dispute in that they are either: (1) generally known within
`
`the territorial jurisdiction of the trial court; or (2) capable of accurate and ready determination by
`
`resort to sources whose accuracy cannot reasonably be questioned.” In re Synchronoss Sec. Litig.,
`
`705 F. Supp. 2d 367, 390 (D.N.J. 2010) (quoting In re NAHC, Inc. Sec. Litig., 306 F.3d 1314, 1331
`
`(3d Cir. 2002)) (alterations omitted). “Conversely, judicial notice is improper if a legitimate
`
`question exists as to the underlying source of the information.” Id.
`
`Taking notice of matters of public record does not convert a motion to dismiss into a motion
`
`for summary judgment so long as the facts are noticed in accordance with the Federal Rules of
`
`Evidence. Intri-Plex Techs., Inc. v. Crest Grp., Inc., 499 F.3d 1048, 1052 (9th Cir. 2007).
`
`However, it “is improper for a court to take judicial notice of the veracity and validity of a public
`
`document’s contents when the parties dispute the meaning and truth of the contents.” See, e.g., Lee
`
`v. City of L.A., 250 F.3d 668, 690 (9th Cir. 2001) (reversing a district court’s grant of a motion to
`
`dismiss where the court not only took judicial notice of undisputed matters of public record but
`
`also took judicial notice of “disputed facts stated in public records” and relied on the validity of
`
`those facts in deciding the motion to dismiss).
`
`
`
`
`
`
`
`
`
`
`
`1. Amarin’s Public Filings (Exs. B, J, and T)
`
`Plaintiffs assert the reasons for introducing Exhibits B, J, and T—to show Defendants had
`
`disclosed the fact that (1) the placebo might not be inert and (2) the mechanism of action for EPA
`
`had not been identified—is irrelevant “because the [Amended Complaint] alleges that Defendants
`
`failed to disclose the specific Adverse REDUCE-IT Data, generated in 2018, which data itself
`
`
`
`15
`
`

`

`Case 3:19-cv-06601-BRM-TJB Document 82 Filed 03/29/21 Page 16 of 42 PageID: 1488
`
`called into question the relative risk reduction seen in the REDUCE-IT trial.” (ECF No. 57 at 9.)
`
`Plaintiffs also argue “Exs. B and T were not [incorporated by reference] because Ex. T was never
`
`cited in the [Amended Complaint], Ex. B simply provided background facts, and neither formed
`
`the basis of the claims.” (Id.)
`
`Defendants argue the Court may take judicial notice of Exhibit B, which provides excerpts
`
`from Amarin’s Form 10-Q for the quarter ending September 30, 2018 (filed with the SEC on
`
`November 7, 2013), because “the portion of Exhibit B that is quoted in the MTD Brief is also
`
`quoted in the Complaint.” (ECF No. 56 at 17 (citing Am. Compl. ¶ 62).) Further, Defendants argue
`
`Exhibit B, as an SEC filing, is the kind of document that courts routinely judicially notice. (Id. at
`
`18.) Defendants similarly assert “the Complaint plainly relies on Exhibit J, Exhibit J is integral to
`
`the Complaint, and Exhibit J is subject to judicial notice.” (Id. at 19.) Defendants also make similar
`
`arguments for the judicial notice of Exhibit T. (Id. at 20.)
`
`
`
`The Third Circuit permits a district court to judicially notice SEC filings and public
`
`disclosures. In re NAHC, Inc. Sec. Litig., 306 F.3d at 1331 (affirming district court’s decision to
`
`judicially notice documents “comprising Company SEC filings and press releases” relied upon in
`
`the Complaint, “documents filed with the SEC, but not relied upon in the Complaint,” and “stock
`
`price data compiled by the Dow Jones news service”); Ieradi v. Mylan Lab’ys, Inc., 230 F.3d 594,
`
`600 n.3 (3d Cir. 2000) (taking judicial notice of “the opening and closing stock prices on the New
`
`York Stock Exchange for Mylan . . . reported by Quotron Chart Service”); In re Intelligroup Sec.
`
`Litig., 527 F. Supp. 2d 262, 273 (D.N.J. 2007) (taking judicial notice of an SEC Investigation
`
`Notice “duly filed with by Intelligroup with the SEC” among several other documents); Howard
`
`v. Arconic Inc., 395 F. Supp. 3d 516, 530 n.1 (W.D. Pa. 2019) (noting SEC filings “are documents
`
`of which the Court may take judicial notice”). However, when judicially noticing documents filed
`
`
`
`16
`
`

`

`Case 3:19-cv-06601-BRM-TJB Document 82 Filed 03/29/21 Page 1

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