b'Second Circuit and New York Federal Court Cases to Watch in 2021In addition to the pending Second Circuit appeals inbreast implants (i.e., CE mark), which was set to ex-the Tung v. Bristol-Myers Squibb Company and Liu v.pire on December 16, 2018. Four days later, Frances Intercept Pharmaceuticals, Inc. cases described above,medical product regulator cited the GMEDs decision below are summaries of securities class actions pend- when requesting Allergan to recall its breast implants. ing in the Second Circuit and New York federal courtsOn December 19, 2018, Allergan issued a press release to watch in 2021. announcing that it would no longer sell textured breast implants in Europe. That same day, Allergans stock In re Allergan PLS Securities Litigation,price fell $10.20 per share, or nearly 7%.Case No. 18 Civ. 12089 (CM) (S.D.N.Y.)Investors filed a putative class action complaint against Allergan and its executives, asserting claims under Link Between Product and Cancer Sections 10(b) and 20(a) and Rule 10b-5 of the 1934 Act, alleging that defendants failed to disclose a de-Allergan plc (Allergan) is a pharmaceutical companyfinitive link between the companys breast implants that develops, manufactures, and distributes brand- and ALCL, misrepresented that they complied with ed pharmaceutical and medical-aesthetics products,regulatory obligations, and misrepresented that they including Naturelle 410 and Biocell breast implantsupported further research on the link while working products. From January 30, 2017 to December 19,to undermine such research. Defendants moved to 2018, Allergan made various statements concerningdismiss, and on September 20, 2019, the court denied the quality of its breast implant products, its compli- the motion in part and granted in part. The court found ance with regulatory requirements, and the possiblethat defendants statements concerning the potential association between its breast implants and anaplasticlink between the companys breast implants and ALCL, large cell lymphoma (ALCL). For example, Allergansstatements touting the success of Allergans products, executives issued statements concerning the safety ofand statements related to the companys support of the the companys breast implants, noting that there wasBIA-ALCL research were not actionable. However, the a possible association between breast implants andcourt concluded that plaintiffs sufficiently stated a claim ALCL, but that the medical community has not beenrelated to the companys statements that its breast able to establish causality. Allergan also reported thatimplants were no more likely to be linked to ALCL than it complies with applicable regulations relating to theany other implants, given the results of the studies. reporting of the link between its breast implants andThe court further held that plaintiffs adequately alleged ALCL (BIA-ALCL) to the FDA. The company furtherscienter, reliance and loss causation.stated that it was actively working to help advance the knowledge of this disease, understand the associationOn September 29, 2020, the court issued an unusual of [BIA-ALCL] and textured implants, and educate thedecision denying class certification. The court had pre-community, including by working closely with the FDAviously, in its March 2019 order appointing a lead plain-and global regulatory bodies[,] convening global med- tiff, given plaintiff explicit instruction that there was to ical experts and researchers, and supporting ongoingbe one and only one law firm serving as lead counsel, research. rejecting plaintiffs request to appoint two firms as co-lead counsel, which the court believed would unnec-Between 2015 and 2018, multiple studies found that aessarily inflate fees. Nevertheless, both of the law firms plurality or majority of cases involving a link betweenoriginally selected by plaintiff continued to be involved breast implants and ALCL involved Allergans implants.in the litigation and prosecuted the litigation jointly. For On December 14, 2018, the European regulatory bodyexample, both firms had signed plaintiffs consolidated responsible for certifying medical devices (GMED)complaint and plaintiffs brief opposing the motion to decided not to renew its certification of Allergans 36'