Petition for a Writ of Certiorari Filed
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No. _________ ================================================================================================================ In The Supreme Court of the United States --------------------------------- ♦ --------------------------------- BRITTANY BILLETS, et al., Petitioners, v. MENTOR WORLDWIDE LLC, Respondent. --------------------------------- ♦ --------------------------------- On Petition For A Writ Of Certiorari To The United States Court Of Appeals For The Ninth Circuit --------------------------------- ♦ --------------------------------- PETITION FOR WRIT OF CERTIORARI --------------------------------- ♦ --------------------------------- ANDY DOGALI DOGALI LAW GROUP, P.A. 19321 US Hwy. 19 North, Suite 307 Clearwater, FL 33764 [email protected] (813) 289-0700 Counsel for Petitioners ================================================================================================================ COCKLE LEGAL BRIEFS (800) 225-6964 WWW.COCKLELEGALBRIEFS.COM i QUESTION PRESENTED The question presented is whether preemption un- der the Medical Device Amendments to the Food, Drug, and Cosmetic Act supports Rule 12(b)(6) dismissal of state common law claims alleging failure to warn by virtue of inaccurate post-approval, post-sale public re- porting of adverse events, and claims alleging defective manufacture of medical devices. ii PARTIES TO THE PROCEEDING Petitioners here include appellants in four appeals in the court below, pursuant to this Court’s Rule 12.4. The court below issued identical orders on the same date in all four appeals, and Petitioners’ allegations and positions here are materially identical. Not all appellants in the proceedings below are parties to this Petition. The Petitioners before this Court include: Brittany Billetts, et al. v. Mentor Worldwide LLC, et al., 9th Circuit, 19-56398; Dist. of Cent. California 19-cv-01026 (including petitioners Brittany Billetts, Vivian Aguiar, Cornelia Ditto, and Leah Johnson); Nicole Vieira, et al. v. Mentor Worldwide LLC, et al., 9th Circuit 19-56394; Dist. of Cent. California 19-cv-04939 (including peti- tioners Nicole Vieira and Emilia Barozzi); Kate Nunn, et al. v. Mentor Worldwide LLC, et al., 9th Circuit 19-56391, Dist. of Cent. California 19-cv-01484 (including peti- tioners Kathryn Nunn, Aluvia Solano, and April Zimmerman); Mary Sewell, et al. v. Mentor Worldwide LLC, et al., 9th Circuit 19-56393; Dist. of Cent. California 19-cv-01126 (including peti- tioners Mary Sewell, Yulia Rose, Aurora Victoria Corona Cattuzzo, Michael An- thony Cattuzzo, Barbara Johncke, An- ders Johncke, Marianne Curry, Joseph Zacharzuk Jr., Deborah Michelle Destasio, iii PARTIES TO THE PROCEEDING – Continued Joseph Destasio, Stacey Holden, Mark Clark Holden, Kristina Ruiz, and Steven Ruiz) Each of the four appeals included multiple appel- lees, but only one is implicated by this Petition, Re- spondent Mentor Worldwide LLC. STATEMENT OF RELATED CASES The following proceedings are directly related to this petition: • United States District Court for the Cen- tral District of California Judgments: ◦ Billetts v. Mentor Worldwide LLC, ED CV 19-01026-AB (PLAx). Judg- ment entered October 29, 2019. ◦ Vieira v. Mentor Worldwide LLC, CV 19-04939-AB (PLAx). Judgment en- tered October 29, 2019. ◦ Jacob v. Mentor Worldwide LLC, CV- 19-01484-AB (PLAx). Judgment en- tered October 29, 2019. ◦ Sewell v. Mentor Worldwide LLC, SA CV 19-01126-AB (PLAx). Judgment entered October 29, 2019. iv STATEMENT OF RELATED CASES – Continued • United States Court of Appeals for the Ninth Circuit Judgments: ◦ Billetts v. Mentor Worldwide LLC, 19- 56398. Judgment entered February 5, 2021. ◦ Vieira v. Mentor Worldwide LLC, 19- 56394. Judgment entered February 5, 2021. ◦ Nunn v. Mentor Worldwide LLC, 19- 56391. Judgment entered February 5, 2021. ◦ Sewell v. Mentor Worldwide LLC, 19- 56393. Judgment entered February 5, 2021. • A substantially similar Petition for Writ of Certiorari was filed before this Court on June 25, 2021 in Brooks v. Mentor Worldwide LLC, 985 F.3d 1272 (10th Cir. 2021). v TABLE OF CONTENTS Page QUESTION PRESENTED .................................... i PARTIES TO THE PROCEEDING ....................... ii STATEMENT OF RELATED CASES ................... iii TABLE OF CONTENTS ........................................ v TABLE OF AUTHORITIES ................................... viii PETITION FOR A WRIT OF CERTIORARI ......... 1 OPINIONS BELOW ............................................... 1 JURISDICTION ..................................................... 2 STATUTORY PROVISIONS .................................. 2 STATEMENT.......................................................... 4 1. Introduction ............................................... 4 2. Factual Background .................................. 5 a. FDA Approval of Silicone Gel-Filled Breast Implants ................................... 5 b. Adverse Event Reporting .................... 7 c. Breast Implant Illness ........................ 9 d. Facts Specific to Petitioners ................ 12 e. Facts and Allegations Specific to Men- tor ........................................................ 13 f. This Court’s Pronouncements Regard- ing MDA Preemption ........................... 17 3. Proceedings Below ..................................... 19 vi TABLE OF CONTENTS – Continued Page REASONS FOR GRANTING THE PETITION ... 20 1. Lower Courts Widely Acknowledge Diffi- culty in Applying the Buckman and Reigel “Parallel Claim” Analysis, Leading to In- consistent Rulings Among the Circuits; the Courts are Erroneously Applying an Ever-Narrowing “Narrow Gap” ................. 20 2. Buckman Does Not Apply to Manufactur- ers’ Post-Sale Submissions of False or In- accurate Adverse Event Reports ............... 23 a. Buckman Does Not Apply to Reports Submitted to the FDA for Reliance by Others .................................................. 24 b. Buckman Dos Not Apply to Manufac- turers’ Post-Sale Conduct .................... 26 3. Lower Courts, Including the Court Below, are Inappropriately Dismissing Claims of Defective Manufacture on Preemption Grounds, Because Preemption is an Af- firmative Defense; a Split Among the Cir- cuits Exists ................................................ 29 4. The Case Presents an Issue of National Importance ................................................. 38 CONCLUSION ..................................................... 41 vii TABLE OF CONTENTS – Continued Page APPENDIX United States Court of Appeals for the Ninth Circuit, Memorandum, Billetts, et al. v. Mentor Worldwide LLC, Filed Feb. 5, 2021 ................. App. 1 United States District Court, Central District of California, Order Granting Motion to Dismiss, Filed Aug. 27, 2019 ........................................... App. 6 United States Court of Appeals for the Ninth Circuit, Memorandum, Nunn, et al. v. Mentor Worldwide LLC, Filed Feb. 5, 2021 ............... App. 29 United States District Court, Central District of California, Order Granting Motion to Dismiss, Filed Aug. 1, 2019 ........................................... App. 34 United States Court of Appeals for the Ninth Circuit, Memorandum, Sewell, et al. v. Mentor Worldwide LLC, Filed Feb. 5, 2021 ............... App. 60 United States District Court, Central District of California, Order Granting Motion to Dismiss, Filed Aug. 27, 2019 ......................................... App. 65 United States Court of Appeals for the Ninth Circuit, Memorandum, Vieira v. Mentor World- wide LLC, Filed Feb. 5, 2021 ......................... App. 92 United States District Court, Central District of California, Order Granting Motion to Dismiss, Filed Aug. 1, 2019 ........................................... App. 97 Relevant Statutory and Regulatory Provisions .... App. 121 viii TABLE OF AUTHORITIES Page CASES ABB Turbo Sys. AG v. Turbousa, Inc., 774 F.3d 979 (Fed. Cir. 2014) ........................................... 33, 34 Allo v. Allergan USA, Inc., 2020 WL 814855 (E.D. La. 2020) ..................................................... 37 Anguiano v. E.I. DuPont de Nemours & Co., 808 F. Supp. 719 (D. Ariz. 1992), affirmed, 44 F.3d 806 (9th Cir. 1995) ................................................... 26 Ashcroft v. Iqbal, 556 U.S. 662 (2009) ............ 30, 31, 36 Babayev v. Medtronic, Inc., 228 F. Supp. 3d 192 (E.D.N.Y. 2017) ........................................................ 28 Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010) ............................................................ 28, 31, 32 Bedoya v. Am. Eagle Express Inc., 914 F.3d 812 (3d Cir. 2019), cert. denied, 140 S. Ct. 102 (2019) ....................................................................... 33 Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007) ........................................................... 30, 31, 36 Benson v. Fannie May Confections Brands, Inc., 944 F.3d 639 (7th Cir. 2019) .................................... 32 Billetts v. Mentor Worldwide LLC, 2019 WL 4038218 (C.D. Cal. Aug. 27, 2019) ...................... 1, 30 Billetts v. Mentor Worldwide LLC, 847 F. App’x 377 (9th Cir. Feb. 5, 2021) ................. 1, 20, 25, 26, 30 Brooks v. Mentor Worldwide LLC, 985 F.3d 1272 (10th Cir. 2021) ................................................ passim ix TABLE OF AUTHORITIES – Continued Page Brown v. Earthboard Sports USA, Inc., 481 F.3d 901 (6th Cir. 2007) ................................................... 33 Bruesewitz v. Wyeth LLC, 562 U.S. 223 (2011) ........... 33 Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341