Court Opinion

ID: 3149128
Source: CourtListenerOpinion
Date Created: 2015-10-23 20:03:30.036347+00
Date Added: 2024-06-11T11:55:24.123221
License: Public Domain

FILED
                           NOT FOR PUBLICATION                             OCT 23 2015

                                                                       MOLLY C. DWYER, CLERK
                    UNITED STATES COURT OF APPEALS                       U.S. COURT OF APPEALS

                            FOR THE NINTH CIRCUIT

NICOLE WEBER,                                    No. 13-17017

              Plaintiff - Appellant,             D.C. No. 2:12-cv-02388-SRB

 v.
                                                 MEMORANDUM*
ALLERGAN, INC.,

              Defendant - Appellee.

                    Appeal from the United States District Court
                             for the District of Arizona
                     Susan R. Bolton, District Judge, Presiding

                    Argued and Submitted September 18, 2015
                            San Francisco, California

Before: W. FLETCHER, BERZON, and BEA, Circuit Judges.

      Nicole Weber appeals the district court’s dismissal of her second amended

complaint pursuant to Federal Rule of Civil Procedure 12(b)(6).

        *
             This disposition is not appropriate for publication and is not precedent
except as provided by 9th Cir. R. 36-3.
      Weber’s allegations, as they stand, are not sufficient to survive a motion to

dismiss under Rule 12(b)(6), as they are not adequate to “‘nudge [her] claims

across the line from conceivable to plausible.’” Eclectic Props. E., LLC v. Marcus

& Millichap Co., 751 F.3d 990, 997 (9th Cir. 2014) (quoting Bell Atl. Corp. v.

Twombly, 550 U.S. 544, 570 (2007) (internal alteration omitted)); see also Ashcroft

v. Iqbal, 556 U.S. 662, 678 (2009). At oral argument, however, Weber identified

additional facts she can plead that, if added to her complaint, would satisfy the

Twombly/Iqbal standard. Also, Weber has identified, to the extent possible

without discovery, the standards she believes the manufacture of her implants

violated, thereby adequately stating parallel state-law claims under 21 U.S.C. §

360k(a) and 21 C.F.R. § 808.1(d). See 21 C.F.R. § 820.1 et seq.; Bausch v. Stryker

Corp., 630 F.3d 546 (7th Cir. 2010). Accordingly, we conclude that amendment

would not necessarily be futile, and an opportunity to amend should be allowed.

See Foman v. Davis, 371 U.S. 178, 182 (1962).

      Specifically, with the following additions, or similar amendments (if they

are true to the best of Weber’s knowledge, of course), the complaint would meet

the Twombly/Iqbal plausibility requirement:

      1.     At the time of their removal, Weber’s implants had lost approximately

2.8% of their mass and/or volume, whereas Allergan’s Directions for Use and

                                          2
Patient Labeling documents disclose that only 1% of the silicone gel in Allergan’s

implants is expected to bleed from implants manufactured according to FDA-

approved specifications.

      2.     Manganese is a chemical constituent of Allergan’s silicone-gel

implants and/or is present in the implants as a relic of the manufacturing process.

Absent silicone gel bleed beyond that Allergan disclosed to the FDA, manganese at

the levels present in Weber’s body would not be found.

      3.     Weber’s symptoms cannot be entirely explained by her idiosyncratic,

severe generalized reaction to silicone. Rather, the severity of her symptoms

indicates that a bleed occurred that exceeded the extremely low-level gel bleed of

no clinical consequence that Allergan’s implants are known to cause.

      If Weber can and does amend her complaint to add these allegations, or

other allegations at a similar level of specificity and relevance to the plausibility of

her claims, the complaint will contain factual allegations that permit her complaint

to survive a motion to dismiss brought pursuant to Rule 12(b)(6), as interpreted by

Iqbal and Twombly. Accordingly, on remand the district court should entertain a

motion for further leave to amend the complaint.

      REVERSED AND REMANDED.

                                            3
                                                                            FILED
Weber v. Allergan, Inc., No. 13-17017                                       OCT 23 2015

                                                                         MOLLY C. DWYER, CLERK
                                                                          U.S. COURT OF APPEALS

W. Fletcher, J., concurring in the result:

      I would hold that the allegations in the complaint, as they now stand, are

sufficient to meet the particularity and plausibility standards of Federal Rule of

Civil Procedure 8(a). See Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009).