In Re Allergan PLC Securities Litigation

District Court, S.D. New York·Decided September 8, 2021·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 GRANTING PLAINTIFF’S MOTION FOR CLASS CERTIFICATION

McMahon, C.J.:

This is the second motion for class certification in this putative class action, in which plaintiffs accuse Allergan PLC and associated individual defendants (collectively “Allergan”) of securities fraud for allegedly failing to disclose information about a potential link between the company’s textured silicone-gel breast implants and a rare form of cancer. The Court previously denied a motion for certification filed by the former lead plaintiff, Boston Retirement System, on the ground that the lead plaintiff would be unable to adequately represent the interests of the class. See In re Allergan PLC Secs. Litig., No. 18-cv-12089 (CM)(GWG), 2020 WL 5796763, at *9 (S.D.N.Y. Sept. 29, 2020) (“Allergan II”). However, I observed in that opinion that, “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.” Id. at *1. This observation remains true; and as the inadequacy issues do not exist for the replacement lead plaintiff, the motion to certify the class is GRANTED. I. Background The newly appointed lead plaintiff, DeKalb County Pension Fund, seeks to certify a class action pursuant to Federal Rule of Civil Procedure 23(b)(3) consisting of: All individuals and entities that purchased or otherwise acquired Allergan preferred stock or common stock between January 30, 2017 and December 19, 2018, inclusive (the “Class Period”), and who were damaged thereby. Excluded from the Class are the Defendants; the officers, directors, and affiliates of Allergan, at all relevant times; Allergan’s employee retirement or benefit plan(s) and their participants or beneficiaries to the extent they purchased or acquired Allergan common stock through any such plan(s); any entity in which Defendants have or had controlling interest; immediate family members of any excluded person; and the legal representatives, heirs, successors, or assigns of any excluded person or entity.

Unless otherwise noted, the following allegations in support of class certification are adopted from the Consolidated Amended Complaint (“CAC”), originally filed by the former lead plaintiff, which DeKalb has now adopted. (Dkt. No. 58). The allegations are accepted as true for purposes of this motion. See Waggoner v. Barclays PLC, 875 F.3d 79, 86 n.5 (2d Cir. 2017). The Court assumes the parties’ familiarity with the facts and recounts only the facts relevant to this decision. A more extensive discussion about the background of this case is available in the Court’s opinion and order addressing Allergan’s motion to dismiss. See In re Allergan PLC Secs. Litig., No. 18-cv-12089 (CM)(GWG), 2019 WL 4686445 (S.D.N.Y. Sept. 20, 2019) (“Allergan I”). A. Allergan’s Textured Breast Implants & ALCL Allergan is a global pharmaceutical and medical products company that manufactures and sells, among other things, textured breast implants for use in breast-augmentation and breast- reconstruction procedures. During the class period, Allergan employed approximately 17,000 people and had two classes of publicly traded equity securities – common stock and preferred stock. Two of Allergan’s breast implant product lines – the “Natrelle 410” and “Biocell” – are the subject of this lawsuit. (CAC ¶¶ 2, 7). Anaplastic large cell lymphoma (“ALCL”) is a rare form of non-Hodgkin lymphoma. In 1997, doctors first began associating the disease with women who have had breast implants, particularly in the scar tissue surrounding the implant. (CAC ¶¶ 3, 11). Since then, DeKalb claims that there has been a parade of medical studies and regulatory alerts examining Breast-Implant

Associated ALCL (“BIA-ALCL”), including several linking the disease specifically to breast implants with a textured outer shell, such as those offered by Allergan. (CAC ¶¶ 63–117). For example, in 2011, the Food and Drug Administration (“FDA”) issued a report detailing the agency’s belief that “there is a possible association between breast implants and ALCL,” and that “ALCL has been found more frequently in association with breast implants having a textured outer shell rather than a smooth outer shell.” (CAC ¶ 66). Beginning in 2015, scientists began linking BIA-ALCL to Allergan products. In a report published in March 2015, doctors identified 173 cases of BIA-ALCL, 97 of which (or 56%) affected women who had Allergan’s Biocell textured implants – by far the largest percentage associated with one manufacturer. (CAC ¶ 75). Studies describing the apparent link between

textured breast implants and BIA-ALCL continued, with some indicating that Allergan’s implants were more closely associated with the incidence of BIA-ALCL than any other manufacturer. For example: • In April 2017, two doctors from the MD Anderson Cancer Center published an article reviewing the data on BIA-ALCL from three sources: (1) MD Anderson’s ALCL tracking data; (2) The University of Southern California’s ALCL tracking data; and (3) the FDA’s Manufacturer and User Facility Device Experience – which is a database that houses medical device incident reports submitted to the FDA. Out of the MD Anderson data, 76 cases (or 41.8%) of BIA-ALCL were associated with Allergan implants. Out of the USC data, 97 cases (or 56%) were associated with Allergan implants. And out of the FDA data, 184 cases (or 80.3%) were associated with Allergan implants. (CAC ¶ 91).1

1 Of course, the results of this study did not necessarily indicate that Allergan’s implants were more dangerous than other types of implants. The higher percentage of cases associated with Allergan could have occurred because Allergan’s textured implants were the most common type of textured implant on the market. However, Allergan’s • In October 2017, another team of researchers analyzed all cases of BIA-ALCL in Australia and New Zealand from 2007 to 2016 and found that Allergan’s Biocell textured implants accounted for 58.7% of the implants used (75 total) in patients who had developed the disease. The risk of developing BIA-ALCL was 14.11 times higher for Biocell as compared to a leading competitor’s textured implants. (CAC ¶¶ 100–101).

• On January 4, 2018, a group of Dutch researchers found that, between 1990 to 2016, there were twenty-three known cases of BIA-ALCL in the Netherlands, twenty-two of which involved Allergan implants. (CAC ¶ 103).

The CAC discusses other such reports as well; this is simply a sampling. B. Allergan’s Allegedly Misleading Statements and Omissions DeKalb argues that Allergan was well aware of the studies that showed a higher incidence of BIA-ALCL in patients with Allergan’s textured breast implants, but nonetheless decided to downplay the strength of the link between its products and cancer. (CAC ¶ 78). This took the form of both misstatements and omissions of information concerning the relative risk of developing BIA-ALCL associated with Allergan’s textured implants as compared to the implants of other manufacturers, as well as a possible recall based on that link. DeKalb alleges that at least four statements made during the class period beginning January 30, 2017, downplayed the risk of recall and gave investors a false impression that Allergan’s implants were no more linked with ALCL than the implants of other manufacturers.

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In Re Allergan PLC Securities Litigation, (S.D.N.Y. 2021).

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