In Re Allergan PLC Securities Litigation

District Court, S.D. New York·Decided September 29, 2020·No. 1:18-cv-12089·Unknown

Opinion

UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF NEW YORK

IN RE ALLERGAN PLC SECURITIES No. 18 Civ. 12089 (CM)(GWG) LITIGATION

DECISION AND ORDER DENYING PLAINTIFF’S MOTION FOR CLASS CERTIFICATION and GRANTING IN PART AND DENYING IN PART THE PARTIES’ RESPECTIVE MOTIONS FOR PERMISSION TO FILE UNDER SEAL

McMahon, C.J.:

On April 19, 2019, Lead Plaintiff Boston Retirement System (hereinafter referred to as “BRS” or “Plaintiff”) filed the Consolidated Amended Class Action Complaint (“CAC”) against Defendant Allergan PLC (“Allergan” or the “Company”) and certain of its executives (the “Executive Defendants”), alleging that Defendants had made materially false and misleading statements and omitted to make necessary disclosures about an alleged link between breast implant-associated anaplastic large cell lymphoma (“BIA-ALCL” or “ALCL”) and the variety of silicone-gel breast implants manufactured by the Company. (CAC, Apr. 19, 2019, Dkt. No. 58.) Plaintiff now seeks to certify a class of all individuals and entities that purchased or otherwise acquired Allergan preferred stock between January 30, 2017 and December 19, 2018—the period during which Defendants’ alleged misstatements and omissions caused the price of Allergan stock to artificially inflate. There is absolutely no question that this action should proceed as a class action. It is a garden-variety securities fraud suit, a type of action particularly well suited to class treatment. What has become clear, however, is that BRS is not the plaintiff who should be controlling the representation of the class. Because BRS is an inadequate representative of the

class, its motion for class certification is DENIED. The parties also move to seal certain exhibits to their briefs in support of and in opposition to Plaintiff’s motion for class certification. That motion is GRANTED IN PART and DENIED IN PART, for the reasons stated in Section II, below. This opinion shall be filed without redaction. While this opinion refers to matters that the parties wish to remain sealed, to that extent the court is denying the motion to file under seal, so the information that one or both parties would like to keep confidential is not, in the opinion of this court, confidential or proprietary. Relevant Factual Background The allegations of the CAC are accepted as true for purposes of the instant motion. See Waggoner v. Barclays PLC, 875 F.3d 79, 86 n.5 (2d Cir. 2017), cert. denied, 138 S. Ct. 1702,

(2018) (citing Shelter Realty Corp. v. Allied Maintenance Corp., 574 F.2d 656. 661 n.15 (2d Cir. 1978)). The Court presumes the parties’ familiarity with the facts of this case, which this Court recited in detail in its earlier Decision and Order Granting in Part and Denying in Part Defendants’ Motion to Dismiss (Op. Granting in Part and Denying in Part Mot. to Dismiss, Sept. 20, 2019, Dkt. No. 81 (“MTD Order”).) The following provides a summary of facts that the parties have deemed pertinent to class certification. a. Allergan’s Breast Implants & ALCL Allergan is a global pharmaceutical and medical products company that develops, manufactures, and sells, among other things, breast implants. Allergan’s Natrelle BIOCELL line of breast implants is the subject of this lawsuit. (CAC ¶ 2, 7.) BIA-ALCL – a rare form of non-Hodgkin’s lymphoma that typically occurs in the scar

tissue surrounding the breast implant – was first reported in 1997. (CAC ¶¶ 3, 7, 64, 92, 111.) Since, a parade of medical studies and regulatory alerts have outlined the progression of BIA- ALCL-related knowledge, including several linking ALCL specifically to breast implants with a textured outer shell. (CAC ¶¶ 63-117.) Plaintiff alleges that Defendants misrepresented the relative strength of the link between reported cases of BIA-ALCL and Allergan’s textured silicone-gel filled breast implants as compared to other manufacturers. (See generally CAC.) b. Incidence Reports Beginning in 2015, scientists began to report that a disproportionately high number of cases of ALCL were linked to Allergan’s textured breast implants. That March, a team of

doctors published a study that identified 173 cases of BIA-ALCL. 97 of those cases (56%) named women who had Allergan’s Biocell textured implants. (CAC ¶ 75.) The studies and media reports that followed during the class period took varying forms. Many indicated that Allergan’s implants were more closely associated with the incidence of BIA-ALCL than other breast implants on the market. For example: • In April 2017, two doctors from the M.D. Anderson Cancer Center in Houston published an article that found that, of the total number of BIA-ALCL cases reported to the University of Southern California’s ALCL Tracking Reporting system, 56% of them involved Allergan/Inamed/McGhan implants, while of the total number of BIA-ALCL cases reported to the FDA MAUDE database, 80.3% involved Allergan/Inamed/McGhan implants. (CAC ¶ 91.) • In October 2017, another team of researchers who analyzed all cases of BIA- ALCL in Australia and New Zealand from 2007 to 2016 found that Allergan’s Biocell salt textured implants accounted for 58.7% of the implants used, which meant that the risk of developing BIA-ALCL when one used Biocell implants was 14.11 times greater than when a leading competitor’s textured implants were used. (CAC ¶¶ 100–01.) • On January 4, 2018, another team of researchers from the Netherlands found that, between 1990 to 2016, there were twenty-three known cases of BIA-ALCL— twenty-two of which involved Allergan/Inamed/McGhan implants. (CAC ¶ 103.) c. Allegedly Misleading Statements and Omissions Plaintiff alleges that Allergan was well-aware of the studies that found a higher incidence of BIA-ALCL in patients with Allergan’s textured breast implants. (CAC ¶ 78.) Nonetheless, Plaintiff alleges, Defendants continued to downplay the strength of the link between its product and the illness. This took the form of both misstatements and omissions of information concerning the relative risk of developing BIA-ALCL after receiving Allergan textured implants as compared to other manufacturers’ implants. For example, on January 30, 2017 ABC News published an article reporting the cancellation of an Allergan post-approval study of textured breast implants. The article included a statement from Defendant Mark Marmur that “BIA-ALCL has been reported in patients in patients with textured breast implants from all manufacturers.” (CAC ¶ 84 (emphasis added).) Plaintiff alleges that Allergan and its representatives made other similar remarks to the public during 2017 and 2018. (CAC ¶¶ 126, 159.) Allergan continued to reaffirm the safety of its breast implants in its 2016 and 2017 annual reports filed on February 24, 2017, and February 26, 2018, respectively. The reports repeat the same stock phrase regarding incidences of BIA-ALCL: that “a breast implant manufacturer that is not affiliated with the Company” was subject to “negative reports from regulatory authorities in Europe.” (CAC ¶¶ 134, 152 (emphasis added).) Plaintiff alleges that these and other similar statements and omissions made during the class period (1) gave the impression that Allergan’s textured breast implants were no more closely associated with ALCL than implants made by other manufacturers, and (2) concealed the risk that Allergan’s products could be recalled because of a possible link to BIA-ALCL, thereby

causing Allergan’s stock price to drop. (See MTD Order at 53-54.) d. Materialization of the Risk On December 14, 2018, “GMED,” the European regulatory body responsible for certifying the manufacture of medical devices in Europe, opted not to re-certify Allergan’s breast implant portfolio, which was set to expire, and requested additional data from the manufacturer.

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