Petition for Writ of Certiorari — Amber Brooks, et al., Petitioners v. Mentor Worldwide LLC

Supreme Court briefJun 25, 2021

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No. _________

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In The

Supreme Court of the United States

---------------------------------♦--------------------------------AMBER BROOKS AND JAMIE GALE,

Petitioners,

MENTOR WORLDWIDE LLC,

Respondent.

---------------------------------♦--------------------------------On Petition For A Writ Of Certiorari

To The United States Court Of Appeals

For The Tenth Circuit

---------------------------------♦--------------------------------PETITION FOR WRIT OF CERTIORARI

---------------------------------♦--------------------------------ANDY DOGALI

DOGALI LAW GROUP, P.A.

19321 US Hwy. 19 North, Suite 307

Clearwater, FL 33764

adogali@dogalilaw.com

(813) 289-0700

Counsel for Petitioners

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COCKLE LEGAL BRIEFS (800) 225-6964

WWW.COCKLELEGALBRIEFS.COM

QUESTION PRESENTED

The question presented is whether preemption

under 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 public reporting of adverse

events, and claims alleging defective manufacture of

medical devices.

PARTIES TO THE PROCEEDING

The parties in the court below, petitioners here,

are Jamie Gale and Amber Brooks, on behalf of themselves. The respondent here is Mentor Worldwide LLC,

on behalf of itself.

STATEMENT OF RELATED CASES

The following proceedings are directly related to

this petition:

•

Brooks v. Mentor Worldwide LLC, 19-cv02088, United States District Court for the

District of Kansas. Judgment entered September 24, 2019.

•

Brooks v. Mentor Worldwide LLC, 19-3240,

United States Court of Appeals for the Tenth

Circuit. Judgment entered January 26, 2021.

iii

TABLE OF CONTENTS

Page

QUESTION PRESENTED....................................

PARTIES TO THE PROCEEDING........................

STATEMENT OF RELATED CASES ..................

TABLE OF CONTENTS ........................................

iii

TABLE OF AUTHORITIES ...................................

PETITION FOR A WRIT OF CERTIORARI .........

OPINION BELOW .................................................

JURISDICTION .....................................................

STATUTORY PROVISIONS ..................................

STATEMENT..........................................................

Introduction ...............................................

Factual Background ..................................

a. FDA Approval of Silicone Gel-Filled

Breast Implants ...................................

b. Adverse Event Reporting ....................

Breast Implant Illness ........................

d. Facts Specific to Amber Brooks and

Jamie Gale ........................................... 11

Facts and Allegations Specific to Mentor ........................................................ 12

This Court’s Pronouncements Regarding MDA Preemption ........................... 16

Proceedings Below ..................................... 18

TABLE OF CONTENTS – Continued

Page

REASONS FOR GRANTING THE PETITION .....

Lower Courts, including the Court Below,

Uniformly Acknowledge Difficulty in Applying the Buckman and Riegel “Parallel

Claim” Analysis, Leading to Inconsistent

Rulings Among the Circuits ...................... 20

Lower Courts, Including the Court Below,

are Inappropriately Dismissing Negligent

Manufacture Claims on Preemption Grounds,

Because Preemption is an Affirmative Defense ........................................................... 25

Buckman Does Not Apply to a Manufacturer’s Post-Sale Submissions of False or

Inaccurate Adverse Event Reports; the

Order Below Manifests a Split Among the

Circuits ...................................................... 33

a. Buckman Does Not Apply to Manufacturers’ Post-Sale Conduct .................... 33

b. Buckman Does Not Apply to Reports

Submitted to the FDA for Reliance by

Others .................................................. 36

The Case Presents an Issue of National

Importance ................................................. 37

CONCLUSION ...........................................................40

TABLE OF CONTENTS – Continued

Page

APPENDIX

United States Court of Appeals for the Tenth

Circuit, Opinion, Filed Jan. 26, 2021............... App. 1

United States District Court for the District of

Kansas, Memorandum and Order, Filed Sep.

23, 2019 .......................................................... App. 19

Relevant Statutory and Regulatory Provisions ... App. 38

TABLE OF AUTHORITIES

Page

CASES

ABB Turbo Sys. AG v. Turbousa, Inc., 774 F.3d

979 (Fed. Cir. 2014) ........................................... 28, 29

Allo v. Allergan USA, Inc., 2020 WL 814855

(E.D. La. 2020) .........................................................32

Anguiano v. E.I. DuPont de Nemours & Co., 808

F. Supp. 719 (D. Ariz. 1992), affirmed, 44 F.3d

806 (9th Cir. 1995) ...................................................22

Ashcroft v. Iqbal, 556 U.S. 662 (2009) ............ 20, 26, 31

Babayev v. Medtronic, Inc., 228 F. Supp. 3d 192

(E.D.N.Y. 2017) .................................................. 23, 24

Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir.

2010) ............................................................ 23, 26, 27

Bedoya v. Am. Eagle Express Inc., 914 F.3d 812

(3d Cir. 2019), cert. denied, 140 S. Ct. 102

(2019) .......................................................................28

Bell Atlantic Corp. v. Twombly, 550 U.S. 544

(2007) ........................................................... 20, 26, 31

Benson v. Fannie May Confections Brands, Inc.,

944 F.3d 639 (7th Cir. 2019) ....................................27

Billetts v. Mentor Worldwide LLC, 847 F. App’x

377 (9th Cir. 2021) ...................................................31

Brooks v. Mentor Worldwide LLC, 985 F.3d 1272

(10th Cir. 2021)............................................ 19, 21, 26

Brown v. Earthboard Sports USA, Inc., 481 F.3d

901 (6th Cir. 2007) ...................................................28

Bruesewitz v. Wyeth LLC, 562 U.S. 223 (2011) ...........28

vii

TABLE OF AUTHORITIES – Continued

Page

Buckman v. Plaintiffs’ Legal Committee, 531

U.S. 341 (2001) ................................................ passim

Caiola v. Citibank, N.A., 295 F.3d 312 (2d Cir.

2002) .................................................................. 22, 36

Caplinger v. Medtronic, Inc., 784 F.3d 1335 (10th

Cir. 2015) ........................................................... 21, 23

Carrelo v. Advanced Neuromodulation Sys., Inc.,

777 F. Supp. 2d 303 (D. P.R. 2011) ..........................25

Chester Cty. Employees’ Ret. Fund v. KCG Holdings, Inc., 2019 WL 2564093 (Del. Ch. 2019) ..... 22, 36

Cupek v. Medtronic, Inc., 405 F.3d 421 (6th Cir.

2005) ........................................................................37

Deswal v. U.S. Nat. Ass’n, 603 F. App’x 22 (2d Cir.

2015) ........................................................................29

Doe v. GTE Corp., 347 F.3d 655 (7th Cir. 2003) .........28

Dominick v. Dixie Nat. Life Ins. Co., 809 F.2d

1559 (11th Cir. 1987) ......................................... 23, 36

D’Addario v. Johnson & Johnson, 2021 WL

1214896 (D.N.J. 2021) .............................................32

Ebrahimi v. Mentor Worldwide LLC, 804 F.

App’x 871, 2020 WL 2510760 (9th Cir. 2020) .........32

Fernandez v. Clean House, LLC, 883 F.3d 1296

(10th Cir. 2018)........................................................29

Fifth Third Bank ex rel. Tr. Officer v. CSX Corp.,

415 F.3d 741 (7th Cir. 2005) .............................. 27, 28

Fisher v. Halliburton, 667 F.3d 602 (5th Cir.

2012) ........................................................................28

viii

TABLE OF AUTHORITIES – Continued

Page

Flo & Eddie, Inc. v. Pandora Media, LLC, 789 F.

App’x 569 (9th Cir. 2019) ........................................28

Flying Food Grp., Inc. v. N.L.R.B., 471 F.3d 178

(D.C. Cir. 2006) ........................................................29

Fulgenzi v. PLIVA, Inc., 711 F.3d 578 (6th Cir.

2013) ........................................................................23

Funk v. Stryker Corp., 631 F.3d 777 (5th Cir.

2011) ........................................................................23

Garcia v. Does, 779 F.3d 84 (2d Cir. 2015)..................30

Gomez v. Toledo, 446 U.S. 635 (1980) .........................28

Hale v. Emporia State Univ., 2018 WL 1609552

(D. Kan. 2018)..........................................................34

Hughes v. Boston Scientific Corp., 631 F.3d 762

(5th Cir. 2011)..........................................................23

Ignacuinos v. Boehringer Ingelheim Pharm. Inc.,

2020 WL 5659071 (D. Conn. 2020) .........................32

In re Medtronic, Inc., Sprint Fidelis Leads Products Liab. Litig., 623 F.3d 1200 (8th Cir. 2010) ......23

In re Volkswagen “Clean Diesel” Marketing,

Sales Practices, and Prods. Liability Lit., 959

F.3d 1201 (9th Cir. 2020) .........................................34

Jankowski v. Zydus Pharm. USA, Inc., 2021 WL

2190913 (D.N.J. May 28, 2021) ...............................32

Kallal v. CIBA Vision Corp., 779 F.3d 443 (7th

Cir. 2015) .................................................................23

Kemp v. Medtronic, Inc., 231 F.3d 216 (6th Cir.

2000) ........................................................................35

TABLE OF AUTHORITIES – Continued

Page

L. Jacob v. Mentor Worldwide LLC, 2019 WL

6766574 (M.D. Fla. 2019) ........................................32

La Grasta v. First Union Sec., Inc., 358 F.3d 840

(11th Cir. 2004)........................................................29

Lau v. Opera Limited, 2021 WL 964642 (S.D.N.Y.

2021) .................................................................. 22, 36

Lesti v. Wells Fargo Bank, N.A., 960 F. Supp. 2d

1311 (M.D. Fla. 2013) ..............................................30

Marion v. Smith & Nephew, Inc., 2015 WL

7756063 (D. Utah 2015) ..........................................26

Martin v. Medtronic, Inc., 254 F.3d 573 (5th Cir.

2001) ........................................................................21

Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) ..... 16, 17, 24

Mories v. Boston Scientific Corp., 494 F. Supp. 3d

461 (S.D. Ohio 2020) ................................... 34, 31, 35

Muhammad v. Norfolk S. Ry. Co., 925 F.3d 192

(4th Cir. 2019)..........................................................28

N. Am. Elite Ins. Co. v. SW Transp. Servs., Ltd.,

2014 WL 12452456 (S.D. Fla. 2014) .......................30

New Milford Sav. Bank v. Zandy, 2001 WL

79830 (Conn. Super. Ct. 2001) .......................... 22, 36

Nunn v. Mentor Worldwide LLC, 847 F. App’x

373 (9th Cir. 2021) ...................................................32

Oakes v. United States, 400 F.3d 92 (1st Cir.

2005) ........................................................................29

Omar ex rel. Cannon v. Lindsey, 334 F.3d 1246

(11th Cir. 2003).................................................. 29, 30

TABLE OF AUTHORITIES – Continued

Page

Osterhaus v. Toth, 249 P.3d 888 (Kan. 2011) .............34

Owens v. Nationwide Prop. & Cas. Ins. Co., 2014

WL 4258084 (N.D. Ala. 2014)............................ 23, 36

Pence v. United States, 316 U.S. 332 (1942) ......... 24, 33

Riegel v. Medtronic, Inc., 552 U.S. 312

(2008) ........................................................ 3, 4, 17, 24, 25

Schouest v. Medtronic, Inc., 13 F. Supp. 3d 692

(S.D. Tex. 2014) ........................................................24

Scott v. Kuhlmann, 746 F.2d 1377 (9th Cir.

1984) ..................................................................... 29

Sewell v. Mentor Worldwide LLC, 847 F. App’x

380 (9th Cir. 2021) ...................................................32

Shelp v. Allergan, Inc., 2018 WL 6694287 (W.D.

Wash. 2018) .............................................................32

Sickle v. Torres Advanced Enter. Sols., LLC, 884

F.3d 338 (D.C. Cir. 2018) .........................................28

Silkwood v. Kerr–McGee Corp., 464 U.S. 238

(1984) .......................................................................27

Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir.

2013) ...................................................... 21, 22, 36, 37

Stransky v. Cummins Engine Co., Inc., 51 F.3d

1329 (7th Cir. 1995) ........................................... 22, 36

Thimjon Farms P’ship v. First Int’l Bank & Tr.,

837 N.W.2d 327 (N.D. 2013) .............................. 22, 36

Trahan v. Interactive Intel. Grp., Inc., 308

F. Supp. 3d 977 (S.D. Ind. 2018) ....................... 22, 36

TABLE OF AUTHORITIES – Continued

Page

Tregenza v. Great Am. Commc’ns Co., 12 F.3d

717 (7th Cir. 1993) ...................................................29

United States v. Singh, 2020 WL 5500232 (S.D.

Cal. 2020)........................................................... 22, 36

Vieira v. Mentor Worldwide LLC, 845 F. App’x

503 (9th Cir. 2021) ...................................................32

Webb v. Mentor Worldwide LLC, 453 F. Supp. 3d

550 (N.D.N.Y. 2020) .................................................32

Weber v. Allergan, Inc., 940 F.3d 1106 (9th Cir.

2019), cert. denied, 140 S. Ct. 2555 (2020) .............24

White v. Medtronic, Inc., 808 F. App’x 290 (6th

Cir. 2020), cert. denied, 141 S. Ct. 239 (2020) .........24

Williams v. Mentor Worldwide LLC, 2019 WL

4750843 (N.D. Ohio 2019) .......................................32

Xechem, Inc. v. Bristol-Myers Squibb Co., 372

F.3d 899 (7th Cir. 2004) ...........................................29

STATUTES

21 U.S.C. § 360c(a)(1)(A) ...............................................4

21 U.S.C. § 360c(a)(1)(B) ...............................................4

21 U.S.C. § 360c(a)(1)(C)(ii) ..........................................4

21 U.S.C. § 360e(d)(2)....................................................5

21 U.S.C. § 360i ....................................................... 7, 33

21 U.S.C. § 360k ............................................................2

xii

TABLE OF AUTHORITIES – Continued

Page

21 U.S.C. § 360k(a) ................................................ 17, 26

28 U.S.C. § 1254(1) ........................................................1

RULES AND REGULATIONS

Fed. R. Civ. P. 12(b)(6) ......................................... passim

21 C.F.R. § 803.1(a) .....................................................32

21 C.F.R. § 803.9(a) .....................................................32

21 C.F.R. § 803.50 .........................................................7

21 C.F.R. § 812.150(b) ...................................................6

21 C.F.R. § 820.198(a) ...................................................7

OTHER AUTHORITIES

2020 National Plastic Surgery Statistics Report,

Cosmetic Surgical Procedures, American

Society of Plastic Surgeons, https://www.

plasticsurgery.org/documents/News/Statistics/

2020/plastic-surgery-statistics-report-2020.pdf

(last visited June 19, 2021) .....................................38

Corinne E. Wee, M.D., et al., Understanding

Breast Implant Illness, Before and After Explantation, A Patient-Reported Outcomes Study, 85

Annals of Plastic Surgery, Sup. 1, S82, S84

(July 2020) https://www.ncbi.nlm.nih.gov/pmc/

articles/PMC7294749/pdf/spa-85-s82.pdf (last

visited June 19, 2021) ......................................... 9, 10

xiii

TABLE OF AUTHORITIES – Continued

Page

D. Chang, Note, Internalizing the External Costs

of Medical Device Preemption, 65 Hastings

L.J. 283 (2013) .........................................................25

Diana Zuckerman, Ph.D., Breast Implant Illnesses:

What’s the Evidence? National Center for

Health Research, https://www.center4research.org/

wp-content/uploads/2020/09/Breast-ImplantIllnesses-Whats-the-Evidence.pdf (last visited

June 19, 2021) ...........................................................9

FDA, Breast Implants, https://www.fda.gov/

medical-devices/implants-and-prosthetics/

breast-implants (last visited June 19, 2021)............7

FDA, The FDA Requests Allergan Voluntarily

Recall Natrelle BIOCELL Textured Breast

Implants and Tissue Expanders from the

Market to Protect Patients: FDA Safety Communication (June 1, 2020), https://www.fda.gov/

medical-devices/safety-communications/fdarequests-allergan-voluntarily-recall-natrellebiocell-textured-breast-implants-and-tissue

(last visited June 22, 2021) .....................................10

FDA, MedWatch: The FDA Safety Information and

Adverse Event Reporting Program, https://www.

fda.gov/safety/medwatch-fda-safety-informationand-adverse-event-reporting-program (last visited June 19, 2021) ....................................................7

xiv

TABLE OF AUTHORITIES – Continued

Page

FDA, Medical Device Reports for Systemic

Symptoms in Women with Breast Implants

(Aug. 20, 2020) (“Medical Device Reports for

Systemic Symptoms”), https://www.fda.gov/

medical-devices/breast-implants/medicaldevice-reports-systemic-symptoms-womenbreast-implants (last visited June 19, 2021) .............9

M. Helveston, Preemption Without Borders: The

Modern Conflation of Tort and Contract Liabilities, 48 Ga. L. Rev. 1085 (2014) .........................25

M. Herrmann, D. Alden, B. Harrison, The Meaning of the Parallel Requirements Exception

Under Lohr and Riegel, 65 N.Y.U. Ann. Surv.

Am. L. 545 (2010) ....................................................25

Mark W. Clements, M.D., et al., How to Diagnose

and Treat Breast Implant-Associated Anaplastic Large Cell Lymphoma, Plast. Reconst.

Surgery Journal 141(4), 568e (2018) ......................10

Press Release, FDA, FDA Updates Analysis of

Medical Device Reports of Breast Implant

Illness and Breast Implant-Associated Lymphoma (Aug. 20, 2020), https://www.fda.gov/

news-events/press-announcements/fda-updatesanalysis-medical-device-reports-breast-implantillness-and-breast-implant-associated (last visited June 22, 2021) ........................................ 8, 11, 39

PETITION FOR A WRIT OF CERTIORARI

Petitioners respectfully petition for a writ of certiorari to review the judgment of the United States

Court of Appeals for the Tenth Circuit.

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OPINION BELOW

The decision of the Tenth Circuit Court of Appeals

affirming the District Court of Kansas ruling is reported at 985 F.3d 1272 (10th Cir. 2021), App. 1. The

memorandum and order of the United States District

Court of Kansas is not officially reported but is otherwise available at 2019 WL 4628264 (D. Kan. 2019),

App. 19.

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JURISDICTION

The judgment of the Court of Appeals was entered

on January 26, 2021. The jurisdiction of this Court is

invoked pursuant to 28 U.S.C. § 1254(1).

This Petition is timely under this Court’s Order of

March 19, 2020, issued in relation to the COVID-19

pandemic, extending the time for filing the Petition to

150 days from the date of the judgment below.

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STATUTORY PROVISIONS

21 U.S.C. § 360k

§ 360k. State and local requirements respecting devices

(a)

General rule

Except as provided in subsection (b), no State or

political subdivision of a State may establish or continue in effect with respect to a device intended for

human use any requirement –

(1) which is different from, or in addition to,

any requirement applicable under this chapter to the device, and

(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the

device under this chapter.

(b)

Exempt requirements

Upon application of a State or a political subdivision thereof, the Secretary may, by regulation promulgated after notice and opportunity for an oral hearing,

exempt from subsection (a), under such conditions as

may be prescribed in such regulation, a requirement of

such State or political subdivision applicable to a device intended for human use if –

(1) the requirement is more stringent than

a requirement under this chapter which

would be applicable to the device if an exemption were not in effect under this subsection;

(2)

the requirement –

(A) is required by compelling local conditions, and

(B) compliance with the requirement

would not cause the device to be in violation of any applicable requirement under

this chapter.

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STATEMENT

1. Introduction

Through its rulings in Buckman Co. v. Plaintiffs’

Legal Committee, 531 U.S. 341 (2001) and Riegel v.

Medtronic, Inc., 552 U.S. 312 (2008), this Court established that state law claims arising from requirements

that are “parallel” under state and federal law are neither expressly nor impliedly preempted.

The court below misapplied Buckman and Riegel

in finding that claims alleging failure to warn through

inaccurate public reporting of adverse events are

preempted. The Tenth Circuit’s misapplication of this

Court’s precedent reflects a conflict between circuits

and an acknowledged state of confusion across the federal judiciary.

The court below further misapplied Buckman and

Riegel in declaring defective manufacture claims to be

preempted, and by granting, without leave to amend,

a 12(b)(6) motion based upon preemption, an affirmative defense. The Tenth Circuit’s ruling manifests a

nationwide wave of federal court rulings extending

Buckman and Riegel far beyond the Court’s intention,

establishing what now appears to be overbroad immunity from suit for medical device manufacturers

who defectively manufacture their products, an immunity never intended by Congress.

2. Factual Background

a. FDA Approval of Silicone Gel-Filled

Breast Implants

Silicone gel-filled breast implants first entered the

American market in 1963. For more than a decade, the

devices were largely subject to regulation by the states.

In 1976, Congress passed the Medical Device

Amendments (“MDA”) to the Federal Food, Drug, and

Cosmetic Act (“FDCA”). The MDA divides medical devices into three classes, based upon patient risk and

need for regulatory scrutiny. Class I devices require

the least, and most general, oversight. 21 U.S.C.

§ 360c(a)(1)(A). Class II devices are reviewed according

to more stringent “special controls,” such as performance standards. Id. § 360c(a)(1)(B). Finally, Class III

devices receive the most oversight and require rigorous

premarket review and approval. Id. § 360c(a)(1)(C)(ii).

Initially, breast implants were categorized as

Class II devices, reviewed only through the premarket

notification process. In 1988, due to growing safety concerns, the FDA re-classified breast implants as Class

III devices.

Class III devices support or sustain human life,

are of substantial importance in preventing impairment of human health, or present a potential, unreasonable risk of illness or injury. Because the FDA

deems general and special controls alone to be insufficient to assure the safety and effectiveness of Class

III devices, the FDA subjects breast implants to the

more rigorous premarket approval (“PMA”) process.

Through the PMA process, the FDA conducts a scientific and regulatory evaluation of the safety and

effectiveness of Class III medical devices. When a manufacturer submits a PMA application, the application

is to be denied where the manufacturer fails to give

“reasonable assurance” of the products’ safety and effectiveness. 21 U.S.C. § 360e(d)(2).

In 1991, the FDA finalized its regulations implementing the PMA process for silicone gel-filled breast

implants. Later that year, the FDA determined that

the PMA application data submitted by manufacturers, including Mentor Worldwide LLC (“Mentor”) for

its MemoryGel Silicone Gel Breast Implants, was insufficient to support approval.

In January 1992, the FDA announced a voluntary

moratorium on silicone gel-filled breast implants, requesting that manufacturers stop supplying them and

surgeons stop implanting them, while the FDA reviewed new safety and effectiveness information that

had been submitted.

On April 16, 1992, the FDA made the moratorium mandatory, when it announced it would allow

implantation of silicone gel-filled breast implants only

after mastectomy or correction of congenital deformities (reconstruction), or replacement of ruptured silicone gel-filled implants due to medical or surgical

reasons (revision). Even for these applications, the

FDA would consider silicone gel-filled implants to be

investigational devices, requiring women who received

them to be monitored through adjunct clinical studies.

After the April 1992 moratorium, silicone gel-filled

breast implants, including Mentor’s MemoryGel Silicone Gel products, were no longer openly marketed in

the United States.

In December 2003, Mentor submitted a PMA for

its MemoryGel Silicone Gel Breast Implants. In 2006,

the FDA approved Mentor’s PMA, ending the 14-year

moratorium against marketing silicone gel-filled

breast implants for augmentation. Mentor’s approval

was conditioned on the performance by Mentor of six

specific post-approval studies.

b. Adverse Event Reporting

Separate from the requirements of the Mentorspecific post-approval studies that were imposed upon

Mentor by the FDA, Mentor was required to meet the

reporting requirements imposed upon all manufacturers by 21 C.F.R. § 812.150(b), including the duty

to report unanticipated adverse device effects (with

evaluation) to the FDA, all Institutional Review

Boards, and investigators within 10 working days after

notification by the investigator.

Mentor is further required to maintain and submit

information required by 21 U.S.C. § 360i, including

adverse reaction reports, 21 C.F.R. § 803.50, and to

establish internal procedures for reviewing complaints

and event reports, 21 C.F.R. § 820.198(a). 21 C.F.R.

§ 803.50 requires a manufacturer to report information no later than 30 days after it is received, from

any source, if that information suggests that the device

may have contributed to a serious injury or has malfunctioned in a manner likely to contribute to a serious

injury if it were to recur.

In addition to requiring manufacturers to submit

adverse event reports, the FDA also encourages patients and physicians to submit them, as part of

“MedWatch, the FDA’s medical product safety reporting program for health professionals, patients and

consumers.”1

Information and reports submitted to the FDA

have long been made available to the public through

a searchable internet database called MAUDE (Manufacturer and User Facility Device Experience),

which is updated monthly. The general public, including physicians and patients, is encouraged to

FDA, MedWatch: The FDA Safety Information and Adverse

Event Reporting Program, https://www.fda.gov/safety/medwatchfda-safety-information-and-adverse-event-reporting-program (last

visited June 19, 2021); See also FDA, Breast Implants, https://www.

fda.gov/medical-devices/implants-and-prosthetics/breast-implants

(last visited June 19, 2021) (through which FDA “Encourage[s] patients to report adverse events associated with breast implants

through the FDA’s Medwatch.”).

access information available through the MAUDE database to obtain safety data on medical devices.

On August 20, 2020, the FDA released its own

study across its history of adverse event reports. The

FDA tabulated the adverse event reports it had received that contained reference to BII symptoms. The

agency reported that it received only 1,080 such reports during the 11 years encompassed by the period

of January 2008 to October 2018. The FDA received

more than twice as many such reports, a total of 2,497

reports, during the next 11 months.2 The inference is

inescapable: manufacturers were systematically under-reporting breast implant illness symptoms, for

more than a decade.

c. Breast Implant Illness

Breast implant illness (“BII”) is a term generally

applied to a collection of systemic signs and symptoms

which patients often report after receiving breast implants. The FDA identifies the most common symptoms reported by patients with breast implants as

fatigue, “brain fog,” joint pain, anxiety, hair loss, depression, rash, autoimmune diseases, inflammation,

See Press Release, FDA, FDA Updates Analysis of Medical

Device Reports of Breast Implant Illness and Breast ImplantAssociated Lymphoma (Aug. 20, 2020), https://www.fda.gov/newsevents/press-announcements/fda-updates-analysis-medical-devicereports-breast-implant-illness-and-breast-implant-associated (last

visited June 22, 2021).

and weight fluctuation.3 These ten symptoms are only

a few of 89 systemic symptoms that the FDA recognizes as included in BII.4 Many medical providers classify the indicators as connective tissue or autoimmune

symptoms, but women are often not diagnosed with a

specific disorder.

Commonly diagnosed conditions that arise after

implant rupture include fibromyalgia, Hashimoto’s

thyroiditis, mixed connective tissue disease, and pulmonary fibrosis, among others.5

Recent research suggests that BII is an autoimmune or inflammatory response to silicone. Histological analysis of tissue surrounding implants reveals

infiltration of inflammatory cells into tissue surrounding the implants.6 Silicone reactions occur irrespective

See id., Food and Drug Administration, Medical Device Reports for Systemic Symptoms in Women with Breast Implants

(Aug. 20, 2020) (“Medical Device Reports for Systemic Symptoms”),

https://www.fda.gov/medical-devices/breast-implants/medicaldevice-reports-systemic-symptoms-women-breast-implants (last

visited June 19, 2021) (identifying most common systemic signs

and symptoms from MDR database review).

See Medical Device Reports of Systemic Symptoms, supra.

See Diana Zuckerman, Ph.D., Breast Implant Illnesses:

What’s the Evidence? National Center for Health Research, p. 10,

12, https://www.center4research.org/wp-content/uploads/2020/09/

Breast-Implant-Illnesses-Whats-the-Evidence.pdf (last visited

June 19, 2021).

See Corinne E. Wee, M.D., et al., Understanding Breast Implant Illness, Before and After Explantation, A Patient-Reported

Outcomes Study, 85 Annals of Plastic Surgery, Sup. 1, S82, S84

of whether the recipient’s implants remained intact or

ruptured.7 Some patients who present common symptomatic BII frequently experience significant immediate and sustained improvement on explant surgery.8

Unfortunately, not all patients enjoy substantial relief.

After years of denial by manufacturers, the FDA

has acknowledged that breast implants increase the

risk of an especially serious autoimmune disease

known as breast implant-associated anaplastic large

cell lymphoma (“BIA-ALCL”) BIA-ALCL is a cancer of

the immune system with symptoms that include fluid

collection, capsular mass, skin rash, and lymphadenopathy.9

The FDA currently does not limit the risk of developing BIA-ALCL to any particular product model or

manufacturer, though textured breast implants are

(July 2020) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7294749/

pdf/spa-85-s82.pdf (last visited June 19, 2021).

See id. at S85 (explaining than an analysis of intact implants illustrates mild cell reactions with minimal chronic inflammatory infiltrate, while tissue surrounding ruptured implants

will exhibit a more severe reaction, i.e., foreign body giant cell reaction, in response to free silicone).

See id. at S83, S85.

See FDA, The FDA Requests Allergan Voluntarily Recall

Natrelle BIOCELL Textured Breast Implants and Tissue Expanders from the Market to Protect Patients: FDA Safety Communication, (June 1, 2020) https://www.fda.gov/medical-devices/

safety-communications/fda-requests-allergan-voluntarily-recallnatrelle-biocell-textured-breast-implants-and-tissue (last visited

June 22, 2021); Mark W. Clements, M.D., et al., How to Diagnose

and Treat Breast Implant-Associated Anaplastic Large Cell Lymphoma, Plast. Reconst. Surgery Journal 141(4), 568e (2018).

six times more likely than smooth implants to lead to

BIA-ALCL. The FDA’s most recent update confirms

733 total unique cases and 36 deaths associated with

BIA-ALCL.10

d. Facts Specific to Amber Brooks and

Jamie Gale

Amber Brooks underwent surgery and received

Mentor MemoryGel Silicone Breast Implants in March

2016. Though Ms. Brooks is a resident of Missouri, she

chose a surgeon a short distance away across the river

in Kansas. After the surgery was completed, she was

released from the hospital and returned home. Soon

thereafter, Ms. Brooks developed an array of ailments

and painful symptoms that are consistent with breast

implant illness. Less than one year after the devices

were implanted, they were surgically explanted, and it

was discovered that silicone was present in Ms. Brooks’

system. After removal of the implants, some of Ms.

Brooks’ symptoms and conditions improved or disappeared. Some of the conditions remain and may be

permanent. The remaining pertinent events occurred

in Missouri.

Jamie Gale was implanted with Mentor MemoryGel Silicone Gel Breast Implants in September 2009.

See Press Release, FDA, FDA Updates Analysis of Medical

Device Reports of Breast Implant Illness and Breast ImplantAssociated Lymphoma (Aug. 20, 2020), https://www.fda.gov/

news-events/press-announcements/fda-updates-analysis-medicaldevice-reports-breast-implant-illness-and-breast-implant-associated

(last visited June 22, 2021).

Thereafter, she suffered for many years from a variety

of symptoms consistent with breast implant illness. In

2017, an MRI showed extracapsular silicone around

both implants. Soon thereafter, the implants were removed. After the surgery, it was observed that silicone

had escaped from both implants and their capsules.

Immediately after removal, many of Ms. Gale’s symptoms greatly improved or disappeared. Some of the

conditions remain and may be permanent. Jamie Gale

is a resident of the state of Kansas, where all pertinent

events occurred.

e. Facts and Allegations Specific to

Mentor

Amber Brooks and Jamie Gale’s Complaint contains considerable allegations relating to Mentor’s

checkered manufacturing past. The allegations include

testimony from Mentor’s management-level employees

in the late 1990s about deliberately false reporting of

rupture rates, systemic inadequacies in Mentor’s manufacturing processes, concealment of data relating to

rupture rates and defective manufacture, omitted finished device testing, and omitted materials sterilization testing. Comp. [D.1] ¶¶ 48-50.

The Complaint further alleges that in 2005 and

2006, additional witnesses reported that Mentor was

still fraudulently reporting its test results and device

failure rates and that Mentor has destroyed or is concealing evidence relating to such witnesses. Id. ¶¶ 51,

90. These witnesses include multiple Mentor ‘whistle

blowers,’ one of whose comments was published by a

non-profit consumer rights advocacy group.

Ms. Brooks and Ms. Gale allege that detailed information relating to a manufacturer’s experiences

rests solely with the manufacturer. Id. ¶ 87. That is, in

the absence of accurate reporting, no plaintiff can

possess, at the time she files her complaint, detailed

information about inadequacies in a manufacturer’s

reporting, or about its inaccurate manufacturing processes and experiences. Only Mentor can accurately report its own knowledge relating to rates of rupture,

causes of ruptures, and linkage between any claimed

symptoms or injuries and its breast implant products.

Id. Similarly, only Mentor can maintain accurate records of its own processes, records that, absent court

permitted discovery, will never be available to patients

who fear or discover that dangerous devices have been

surgically implanted into their breasts. Id. ¶¶ 116,

131, 194.

Petitioners specifically alleged in their Complaint

that Mentor failed to accurately “report newly acquired

information [and] true information about: instances of

silicone toxicity; instances of adverse events; instances

of adverse events requiring removal; instances of constellations of adverse symptoms; instances of chronic/

persistent autoimmune-like complaints and inflammatory issues; rupture rates; and more.” Id. ¶ 108. They

allege that if Mentor had accurately reported its experience and knowledge relating to ruptures, Ms. Brooks

and Ms. Gale would have been on notice of a rupture

rate for Mentor MemoryGel Breast Implants that is

significantly higher than the rates publicly disclosed

by Mentor and touted in Mentor’s product insert. Id.

¶ 88.

Petitioners further specifically allege that if Mentor

had accurately reported its experience and knowledge

of patient symptoms, Ms. Brooks and Ms. Gale would

have been on notice of risks attendant to Mentor’s

MemoryGel Breast Implants that are significantly

greater than the risks publicly reported by Mentor and

touted in Mentor’s product insert. Id. ¶ 89.

Both Petitioners allege that if Mentor had accurately reported adverse events that were known to it,

“additional information would have been available to

the public, including Plaintiffs’ treating physicians,

[and] [i]f Plaintiffs had been adequately warned of the

serious risks and adverse events by Defendant Mentor,

they would not have agreed to implantation of Mentor

MemoryGel Silicone Gel Breast Implants.” Id. ¶¶ 114115. Likewise, if post-implant adverse events had been

accurately reported, risk data and patient experiences

would have been available to the medical community

at a significantly earlier date than was otherwise the

case, and “Plaintiffs would have been able to undergo

the explantation surgery at an earlier date and would

have been less severely damaged and injured.” Id.

¶¶ 182-183.

The Complaint alleged that under applicable state

law, once a manufacturer is called upon to report information relating to the safety of its products, it must do

so accurately. Id. ¶¶ 98-100, 112, 161-163; 183. This

duty to accurately report safety experience is parallel

with, and no broader or stricter than, the same duty

that is imposed upon Mentor by FDCA. Mentor expected that patients and their physicians, in deciding

whether to incorporate Mentor’s devices into the patients’ bodies, would rely upon the accuracy of Mentor’s

adverse event reports. Mentor knew the FDA routinely

publishes such information on its public websites for

precisely such reliance by physicians and patients. Id.

¶¶ 101-103, 107, 167-169.

The Complaint also alleged that Mentor defectively manufactured the implants, by failing to follow

the product specifications approved by the FDA, using

unapproved materials and components, using materials and components that were not commercially reasonable, failing to follow standard manufacturing

processes, failing to follow FDA-approved manufacturing processes, failing to use reasonable care in inspecting and testing, and in quality control and quality

assurance. Id. ¶¶ 120, 123. The devices’ “rupture, leakage, and bleeding of silicone . . . , due to porous or weak

containment in the Implant shell, is inconsistent with

[FDA regulations].” Id. ¶¶ 196. As with failure to warn,

the Plaintiffs expressly alleged that the duties and

standards imposed by Kansas law upon Mentor in its

manufacturing processes, and its reporting of same,

are no different than, and are thus parallel with, the

duties imposed upon Mentor by federal law. Id. ¶¶ 119,

121, 132.

As further evidence of defective manufacture,

Amber Brooks’ Complaint specifically alleged that one

of her devices ruptured less than one year after it was

implanted into her breast. Id. ¶¶ 14-15.

f. This Court’s Pronouncements Regarding MDA Preemption

On three prior occasions, this Court has considered preemption under Section 360k of the MDA. In

1996, the Court ruled that the MDA does not expressly

preempt state law requirements that parallel federal

requirements. See Medtronic, Inc. v. Lohr, 518 U.S.

470, 494-497 (1996). Lohr established that the MDA

preemption analysis is appropriate when a duty imposed under state law relates to a particular device

that is also the subject of a duty imposed under federal

law. In that event, a common law claim arising from

breach of a duty imposed by state law which parallels

a duty imposed by federal law is not preempted by

MDA. Id. at 492-494, 499-501. Because Congress intended to preempt state law only where it creates a

broader duty that is specific to a particular device, the

FDA’s labeling and manufacturing regulations, which

apply generally on an industry-wide basis, do not trigger preemption as they do not include device-specific

requirements. Id. at 501.

In 2001, the Court decided Buckman v. Plaintiffs’

Legal Committee, 531 U.S. 341 (2001). In Buckman, the

Court held that the MDA preempts claims that effectively allege “fraud on the FDA.” That is, where a manufacturer lies to the FDA, inducing the FDA to approve

the public sale of a device, a plaintiff cannot contort the

claim into a common law tort. The so called “fraud on

the FDA” is impliedly preempted. The Court explained

that this unusual fraud-based claim stems from the

breach of a duty that exists solely under federal law –

a duty to be truthful in making statements to the FDA

which are intended to induce FDA reliance during the

product approval process. See Buckman, 531 U.S. at

352-353. Because manufacturers might lie to the FDA

to induce the FDA to approve a product for public sale,

“the federal statutory scheme amply empowers the

FDA to punish and deter fraud against the Administration.” Id. at 348.

In 2008, the Court issued its decision in Riegel v.

Medtronic, Inc., 552 U.S. 312 (2008). In Riegel, the

Court held that the PMA through which some medical

devices secure marketing permission from the FDA

establishes device-specific requirements that, under

§ 360k(a), expressly preempt different or additional

state-law requirements, but not, the Court reiterated,

state-law claims that parallel federal requirements.

Section 360k(a), the Court stated, “does not prevent a

State from providing a damages remedy for claims

premised on a violation of FDA regulations.” Riegel,

552 U.S. at 330. The Court also restated Lohr’s conclusion that federal labeling requirements that apply

“across the board to almost all medical devices” generally do not preempt state requirements. Id. at 322.

3. Proceedings Below

Amber Brooks and Jamie Gale filed their Complaint in the United States District Court for the District of Kansas on February 14, 2019. The Complaint

alleged claims under Kansas law, including actions

sounding in negligence, in relation to Mentor’s failure

to warn (Count 1, part A) and defective manufacture of

the devices (Count 1, part B), and strict products liability, in relation to Mentor’s failure to warn (Count 2)

and defective manufacture (Count 3). [D.1].

On April 15, 2019, Mentor moved to dismiss the

Complaint, on preemption grounds. [D.11].

On September 23, 2019, the District of Kansas issued its order granting Mentor’s motion. [D.40]. The

court separately addressed the Plaintiffs’ failure to

warn claims and defective manufacture claims, each of

which was pleaded under theories of negligence, strict

products liability, and negligence per se.11

On the failure to warn claims, the district court

considered the claims as asserting a duty to warn three

distinct bodies: patients, physicians and the FDA. The

court determined that:

•

State law will not support a claim against

a manufacturer for failing to warn a patient;

This Petition does not challenge the district court’s dismissal of the claims predicated upon a theory of negligence per se.

•

Any state law claim based upon a “duty to

report negative test results to the FDA” is

impliedly preempted; and

•

Any state law claim that a manufacturer

breaches a duty to warn physicians by

failing to report information to the FDA

is impliedly preempted.

In dismissing the Complaint, the district court denied leave for Plaintiffs to amend, finding the Plaintiffs

had failed to comply with a local rule relating to

amendments.12

On October 23, 2019, Petitioners filed their Notice

of Appeal to the United States Court of Appeals for the

Tenth Circuit. [D.42]. After briefing and oral argument,

the Tenth Circuit issued its opinion on January 26,

2021. See Brooks v. Mentor Worldwide LLC, 985 F.3d

1272 (10th Cir. 2021), App. 1. The Tenth Circuit affirmed the district court, finding the failure to warn

claims to be preempted. Id. at 1280-1281. The appellate court followed the district court’s approach to analyzing the failure to warn claims, dividing them into

A District of Kansas Local Rule requires a plaintiff to file,

along with its opposition to a motion to dismiss, a motion expressly seeking leave to amend and attaching a draft of the

amended complaint that would be filed if the existing complaint

is dismissed. Separate from the fact that the local rule requires

clairvoyance, in so far as it requires a plaintiff to predict the nature and scope of a future order of dismissal, Petitioners argued

that the rule should not apply in the context of a motion to dismiss

that is based upon an affirmative defense, like preemption, since

the defense bears the burden of presenting prima facie support

for an affirmative defense in the first instance.

three distinct categories based upon whether the recipient of the “warning” was to be patients, physicians, or

the FDA, and issuing similar rulings as to each. Id. at

1280.

The Tenth Circuit took a different approach toward the defective manufacture claims, affirming the

district court’s result, but for a different reason: The

Tenth Circuit ruled that Ms. Brooks and Ms. Gale’s

Complaint failed to meet the Iqbal/Twombly specificity

standard for stating a plausible claim. The court otherwise left the district court’s preemption ruling in place.

Id. at 1281-1282.

-----------------------------------------------------------------------

REASONS FOR GRANTING THE PETITION

1. Lower Courts, including the Court Below, Uniformly Acknowledge Difficulty

in Applying the Buckman and Riegel

“Parallel Claim” Analysis, Leading to Inconsistent Rulings Among the Circuits

The opinion of the court below begins with the

court’s observation that the concept of federal preemption of state law claims in relation to medical devices

first appeared when Congress enacted the MDA in

1976. That introduction of federal law “has left, by both

express and implied preemption, only a narrow gap

within which a plaintiff can plead a tort claim arising

from the failure of a medical device. Successful pleading requires navigating a legal quagmire that has consumed unwary legal professionals for more than forty

years. Today we again wade into that quagmire.”

Brooks v. Mentor Worldwide LLC, 985 F.3d 1272, 1276

(10th Cir. 2021), App. 1.

“Lower courts have struggled ever since [Lohr]

when it comes to trying to decide whether particular

state claims do or don’t ‘parallel’ putative federal counterparts.” Caplinger v. Medtronic, Inc., 784 F.3d 1335,

1338 (10th Cir. 2015). Applying Congress’ and the

Court’s “competing instructions [is] ‘no easy task.’ ” Id.

at 1340, quoting Martin v. Medtronic, Inc., 254 F.3d

573, 578-579 (5th Cir. 2001) (noting difficulty in “extracting the final meaning” of the Supreme Court’s

preemption decisions). “The Supreme Court has issued

a number of opinions that embody ‘divergent views’

about the proper role of the MDA’s preemption provision, a fact that has yielded considerable ‘uncertainty’

among the lower courts seeking to apply the statute to

cases like this one.” Id. at 1337.

The conflict among circuits is precisely manifested

by the present case. To the extent the Tenth Circuit

barred Petitioners from bringing a claim for failing to

report adverse events occurring after approval of the

product or its implantation into Petitioners’ breasts,

the decision cannot be reconciled with the Ninth Circuit’s decision in Stengel v. Medtronic Inc., 704 F.3d

1224, 1233 (9th Cir. 2013).

The conflict is most apparent in relation to adverse events that are reported inaccurately, versus reports that are not submitted at all. Stengel found that

Arizona law imposes upon manufacturers a parallel

duty to warn of adverse post-sale events, and such duty

can apply where the manufacturer’s disclosures are

submitted to or through a third party. Stengel v. Medtronic Inc., 704 F.3d 1224, 1233 (9th Cir. 2013) (“Under

Arizona law, a warning to a third party satisfies a manufacturer’s duty if, given the nature of the warning and

the relationship of the third party, there is “reasonable

assurance that the information will reach those whose

safety depends on their having it”), quoting Anguiano

v. E.I. DuPont de Nemours & Co., 808 F. Supp. 719, 723

(D. Ariz. 1992), affirmed, 44 F.3d 806 (9th Cir. 1995).

Even in the absence of Kansas decisions addressing

this precise issue, there is no reason to believe Kansas

law does not recognize the same duty, especially in relation to the submission of adverse event reports that

are inaccurate, in contrast to those a manufacturer

simply fails to submit. The common law consistently

recognizes, across the states, that even where no duty

to report is created by law or contract, once a party undertakes to make a disclosure, it must do so accurately,

and inaccurate or dishonest disclosures are actionable

at common law. See, for example, Caiola v. Citibank,

N.A., 295 F.3d 312, 331 (2d Cir. 2002); Lau v. Opera

Limited, 2021 WL 964642, *6 (S.D.N.Y. 2021); Trahan

v. Interactive Intel. Grp., Inc., 308 F. Supp. 3d 977, 991

(S.D. Ind. 2018), citing Stransky v. Cummins Engine

Co., Inc., 51 F.3d 1329, 1331 (7th Cir. 1995); Thimjon

Farms P’ship v. First Int’l Bank & Tr., 837 N.W.2d 327,

339 (N.D. 2013); New Milford Sav. Bank v. Zandy, 2001

WL 79830, *2 (Conn. Super. Ct. 2001); United States v.

Singh, 2020 WL 5500232, *6 (S.D. Cal. 2020); Chester

Cty. Employees’ Ret. Fund v. KCG Holdings, Inc., 2019

WL 2564093, *11 (Del. Ch. 2019); Owens v. Nationwide

Prop. & Cas. Ins. Co., 2014 WL 4258084, *6 (N.D. Ala.

2014) (where insurer had no duty to disclose, “once it

undertook to speak, it was required to make a full and

fair disclosure”), quoting Dominick v. Dixie Nat. Life

Ins. Co., 809 F.2d 1559, 1570 (11th Cir. 1987). Here,

Petitioners allege not only that Mentor failed to submit

required post-approval reports and data, but that it

also submitted false and inaccurate post-approval and

post-sale reports and data.

The district court in Babayev v. Medtronic, Inc.,

228 F. Supp. 3d 192, 212 (E.D.N.Y. 2017), in the absence of Second Circuit authority, surveyed the “parallel claim” decisions and found in 2017 that “[a]t least

six Circuit Courts of Appeals have attempted to clarify

this issue, but have promulgated standards which are

at least somewhat – and sometimes very – different

from one another.” Babayev, 228 F. Supp. 3d at 212. The

Babayev court’s survey found preemption to be more

broadly applied in the Sixth and Eighth Circuits, based

upon “an expansive view of Buckman.” Id. at 213, citing In re Medtronic, Inc., Sprint Fidelis Leads Products

Liab. Litig., 623 F.3d 1200, 1204 (8th Cir. 2010) (the

“contours of the parallel claim exception” are “as-yet ill

defined”) and Fulgenzi v. PLIVA, Inc., 711 F.3d 578, 586

(6th Cir. 2013).

In contrast, the Fifth, Seventh and Eleventh Circuits have more narrowly limited preemption under

Buckman to fraud-on-the-FDA claims. Babayev, 228

F. Supp. 3d at 213, citing, e.g., Funk v. Stryker Corp.,

631 F.3d 777, 779 (5th Cir. 2011), Bausch v. Stryker

Corp., 630 F.3d 546, 552 (7th Cir. 2010), Kallal v. CIBA

Vision Corp., 779 F.3d 443, 447 (7th Cir. 2015) (a state

tort claim is “parallel” if it is a “remedy for claims

premised on a violation of FDA regulations”) and

Hughes v. Boston Scientific Corp., 631 F.3d 762, 774-776

(5th Cir. 2011) (claims for failure to warn, premised on

violation of FDA regulations, are not preempted).

Citing Caplinger, the Tenth Circuit was said to

have “adopted an entirely different approach.” Babayev, 228 F. Supp. 3d at 214. Presumably, with its decision issued in the instant case, the Tenth Circuit has

joined the Sixth and Eighth Circuits in adopting an

analysis which adds to the “quagmire” for practitioners

attempting to draft a pleading that might survive Rule

12 scrutiny.

Most recently, the Sixth Circuit noted while addressing this question that “[s]ince Riegel, courts have

struggled to determine which claims fit into the ‘narrow exception’ to MDA preemption left open by Riegel

and Lohr.” White v. Medtronic, Inc., 808 F. App’x 290,

294 (6th Cir. 2020), cert. denied, 141 S. Ct. 239, 208

(2020), quoting Weber v. Allergan, Inc., 940 F.3d 1106,

1114 (9th Cir. 2019).

The Ninth Circuit, in Weber, supra, noted the existence of an “intercircuit disagreement” regarding

the breadth of the “parallel claim” exception to

preemption. Weber, 940 F.3d at 1114, cert. denied, 140

S. Ct. 2555 (2020); see also, gen., Schouest v. Medtronic,

Inc., 13 F. Supp. 3d 692, 700 (S.D. Tex. 2014) (“Courts

have struggled with applying the Supreme Court’s

preemption rulings to cases involving the Infuse device”); Carrelo v. Advanced Neuromodulation Sys., Inc.,

777 F. Supp. 2d 303, 310 (D. P.R. 2011) (noting “the present struggle . . . to determine whether state-law

claims are preempted by the MDA”); M. Helveston,

Preemption Without Borders: The Modern Conflation of

Tort and Contract Liabilities, 48 Ga. L. Rev. 1085, 1124

(2014); M. Herrmann, D. Alden, B. Harrison, The Meaning of the Parallel Requirements Exception Under Lohr

and Riegel, 65 N.Y.U. Ann. Surv. Am. L. 545, 546 (2010)

(“This parallel requirements exception is far from

clear”); D. Chang, Note, Internalizing the External

Costs of Medical Device Preemption, 65 Hastings L.J.

283, 295 (2013) (the Court’s decisions have not “provide[d] much guidance as to what constitutes a parallel

claim”).

The Court should bring clarity to this area of the

law.

2. Lower Courts, Including the Court Below,

are Inappropriately Dismissing Negligent

Manufacture Claims on Preemption

Grounds, Because Preemption is an Affirmative Defense

The Court should grant the Petition because dismissal of Petitioners’ complaint by the court below was

premature, and the premature dismissal is indicative

of an unfortunate nationwide trend.

As noted supra, the court below observed that the

present uncertainty regarding the state of preemption

law not only creates a “struggle” for the courts; it also

creates a “quagmire” for plaintiffs attempting to draft

a complaint that states a viable action. See Brooks, 985

F.3d at 1276, App. 1. As it turns out, the ruling of the

court below leave Ms. Brooks and Ms. Gale as unfortunate victims of this “quagmire.” The Tenth Circuit dismissed the Plaintiffs’ negligent manufacture claims

due to the Plaintiffs’ failure to plead specific facts that,

in the Tenth Circuit’s view, were required to meet the

“plausibility” pleading standard established by this

Court’s decisions in Ashcroft v. Iqbal, 556 U.S. 662

(2009) and Bell Atlantic Corp. v. Twombly, 550 U.S. 544

(2007).

The Seventh Circuit has noted that, even in a jurisdiction in which “federal law does not preempt parallel claims under state law based on a medical device

manufacturer’s violation of federal law,” it is “difficult

. . . to plead such a claim sufficiently to survive a motion to dismiss” under Rule 12(b)(6). Bausch, 630 F.3d

at 558. The court held that district courts applying the

Iqbal/Twombly plausibility standard “must keep in

mind that much of the product-specific information

about manufacturing needed to investigate such a

claim fully is kept confidential by federal law. Formal

discovery is necessary before a plaintiff can fairly be

expected to provide a detailed statement of the specific

bases for her claim.” Bausch, at 558. Upon such a ruling, the Bausch court reversed a district court’s order

dismissing, without leave to amend, a complaint alleging defective manufacture of a medical device. Id.;

accord Marion v. Smith & Nephew, Inc., 2015 WL

7756063, *2 (D. Utah 2015) (“Given the disparate outcomes and uncertainty among the federal courts on

this issue, the court understands the Marions’ initial

uncertainty with respect to the required pleading

standard. While ‘the difficulty of crafting a complaint

sufficient to satisfy all [the] demands’ of § 360k(a) is

not a proper legal basis for allowing a plaintiff to proceed to discovery, the court does find it sufficient to

warrant leave to amend.”).

The Seventh Circuit’s decision in Bausch soundly

acknowledges a practical reality that exists for plaintiffs who suffer with defectively manufactured devices

implanted into their bodies. But the decision and line

of reasoning are not simply sound as a practical matter. Bausch is sound as a matter of law, while many

contrary decisions, including the ruling of the court below, are unsound as a matter of law, because the federal

courts should not be routinely dismissing complaints

that allege defective manufacture, or claims alleging

other “parallel claims” for that matter, because a Rule

12(b)(6) motion is an inappropriate vehicle for addressing claims of preemption. This principle was recognized in the Seventh Circuit’s recent application of

Bausch.

In Benson v. Fannie May Confections Brands, Inc.,

944 F.3d 639 (7th Cir. 2019), the court reversed a district court’s dismissal on preemption grounds, noting

that preemption is “an affirmative defense upon which

the defendants bear the burden of proof,” and “[a]ffirmative defenses do not justify dismissal under Rule

12(b)(6).” Id. at 645, quoting Fifth Third Bank ex rel.

Tr. Officer v. CSX Corp., 415 F.3d 741, 745 (7th Cir.

2005), Doe v. GTE Corp., 347 F.3d 655, 657 (7th Cir.

2003).

Unable to ignore the important distinctions between Rule 12(b)(6) motions and other types of motion

practice, the court concluded that “[t]he district court

thus erred by penalizing Benson for failing to anticipate an affirmative defense in her complaint and dismissing the action based on FDCA preemption.” Id. at

645.

It is quite clear that “preemption is an affirmative

defense.” Bruesewitz v. Wyeth LLC, 562 U.S. 223, 251

n.2 (2011) (Sotomayor, J., dissenting), citing Silkwood

v. Kerr-McGee Corp., 464 U.S. 238, 255 (1984); Brown v.

Earthboard Sports USA, Inc., 481 F.3d 901, 912 (6th

Cir. 2007) (“ ‘federal preemption is an affirmative defense upon which the defendants bear the burden of

proof ’ ”), quoting Fifth Third Bank, 415 F.3d at 745;

accord Flo & Eddie, Inc. v. Pandora Media, LLC, 789 F.

App’x 569, 572 (9th Cir. 2019); Muhammad v. Norfolk

S. Ry. Co., 925 F.3d 192, 196 (4th Cir. 2019); Bedoya v.

Am. Eagle Express Inc., 914 F.3d 812, 817 (3d Cir.

2019), cert. denied, 140 S. Ct. 102 (2019); Sickle v.

Torres Advanced Enter. Sols., LLC, 884 F.3d 338, 345

(D.C. Cir. 2018); Fisher v. Halliburton, 667 F.3d 602,

609 (5th Cir. 2012) (“Federal preemption is an affirmative defense that a defendant must plead and prove.”).

A plaintiff is not required to anticipate and negate

an affirmative defense in his complaint. See Gomez v.

Toledo, 446 U.S. 635, 640 (1980); ABB Turbo Sys. AG v.

Turbousa, Inc., 774 F.3d 979, 985 (Fed. Cir. 2014); Flying Food Grp., Inc. v. N.L.R.B., 471 F.3d 178, 183 (D.C.

Cir. 2006); Oakes v. United States, 400 F.3d 92, 98 (1st

Cir. 2005); La Grasta v. First Union Sec., Inc., 358 F.3d

840, 845 (11th Cir. 2004); Tregenza v. Great Am.

Commc’ns Co., 12 F.3d 717, 718 (7th Cir. 1993). For this

reason, it is generally inappropriate to grant a Rule

12(b)(6) motion to dismiss based upon an affirmative

defense. Fed. R. Civ. P. 12(b)(6); see Deswal v. U.S. Nat.

Ass’n, 603 F. App’x 22, 23-24 (2d Cir. 2015); Omar ex

rel. Cannon v. Lindsey, 334 F.3d 1246, 1252 (11th Cir.

2003); Scott v. Kuhlmann, 746 F.2d 1377, 1378 (9th Cir.

1984).

The general rule is subject to an exception where

it is unequivocally established from the face of the

pleading that the claim is barred as a matter of law.

See ABB Turbo Sys. AG, 774 F.3d at 985 (dismissal

based upon an affirmative defense “ordinarily is improper unless it is ‘apparent from the face of the complaint that the claim is time-barred’ ”), quoting La

Grasta, 400 F.3d at 845-846, quoting Tregenza, 12 F.3d

at 718.

Dismissal based upon an affirmative defense is

proper “only when the complaint itself admits all the

elements of the affirmative defense by alleging the factual basis for those elements,” as when the “ ‘plaintiff

pleads itself out of court [b]y admit[ting] all [of ] the

ingredients of an impenetrable defense.’ ” Fernandez v.

Clean House, LLC, 883 F.3d 1296, 1299 (10th Cir.

2018), quoting Xechem, Inc. v. Bristol-Myers Squibb

Co., 372 F.3d 899, 901 (7th Cir. 2004)

In application, “[a]lthough a motion to dismiss

based upon an affirmative defense may be granted if ‘it

is apparent from the face of the complaint’ that dismissal is warranted, a motion to dismiss should not be

granted ‘where resolution depends either on facts not

yet in evidence or on construing factual ambiguities in

the complaint in defendants’ favor.’ ” N. Am. Elite Ins.

Co. v. SW Transp. Servs., Ltd., 2014 WL 12452456, *4

(S.D. Fla. 2014), quoting Lesti v. Wells Fargo Bank,

N.A., 960 F. Supp. 2d 1311, 1317 (M.D. Fla. 2013), citing Omar, 334 F.3d at 1252.

With these principles firmly established, the

courts should be loath, and not eager, to grant Rule 12

motions based upon preemption. See Garcia v. Does,

779 F.3d 84, 96-97 (2d Cir. 2015) (“It is certainly true

that motions to dismiss a plaintiff ’s complaint under

Rule 12(b)(6) on the basis of an affirmative defense will

generally face a difficult road”).

Since the burden of proof is on the defendant in

relation to preemption, it is indeed penalizing, as the

Seventh Circuit has noted, to dismiss a complaint for

a lack of detailed factual allegations relating to issues

that cannot be known to a plaintiff in the absence of

discovery. The punitive nature of the ruling is compounded when the complaint is the initial filing, as is

the case here, and is dismissed without leave to

amend.13

In the court below, this argument was most clearly expressed during oral argument. See https://www.ca10.uscourts.gov/

oralarguments/19/19-3240.mp3 at 35:00.

The court below should not have dismissed, particularly without leave to amend, Petitioners’ defective

manufacture claim. Petitioners cannot possess, without discovery, the kind of information that the Tenth

Circuit apparently deemed necessary under Iqbal and

Twombly. Even with no discovery, the dismissed complaint included extensive allegations regarding Mentor’s historically horrid manufacturing processes,

along with anticipated witness and whistleblower testimony. The court below should have taken the approach espoused in Mories v. Boston Scientific Corp.,

494 F. Supp. 3d 461 (S.D. Ohio 2020). The Mories court

recognized the inappropriateness of granting a Rule

12(b)(6) motion based upon preemption, ruling that

“[i]f, following the completion of discovery, Plaintiff

cannot sustain a claim under state requirements that

parallel federal requirements, Defendant would be free

to file a motion for summary judgment.” Mories, 494

F. Supp. 3d at 471.

Troublingly, and deserving of this Court’s attention in deciding whether to grant this Petition, is the

fact that the federal courts are now reading this

Court’s decisions as support for preemption-based dismissals of manufacturing claims on a widespread basis. This trend creates a patent unfairness, in so far as

manufacturing claims are among those that most

clearly call for some level of discovery prior to preemption-based dismissal. Even so, it appears only this

Court can advise whether immunity against liability

for defective manufacturing is the intended scope of

the Court’s rulings. See Billetts v. Mentor Worldwide

LLC, 847 F. App’x 377 (9th Cir. 2021) (affirming dismissal of manufacturing defect claim on basis of

preemption); Vieira v. Mentor Worldwide LLC, 845 Fed.

Appx 503 (9th Cir. Feb. 5, 2021) (affirming dismissal of

manufacturing defect claim on basis of preemption);

Sewell v. Mentor Worldwide LLC, 847 F. App’x 380

(9th Cir. Feb. 5, 2021) (affirming dismissal of manufacturing defect claim on basis of preemption); Nunn v.

Mentor Worldwide LLC, 847 F. App’x 373 (9th Cir.

Feb. 5, 2021) (affirming dismissal of manufacturing

defect claim on basis of preemption); Ebrahimi v.

Mentor Worldwide LLC, 804 F. App’x. 871, 2020 WL

2510760 (9th Cir. May. 15, 2020) (affirming dismissal

of manufacturing defect claim on basis of preemption);

Jankowski v. Zydus Pharm. USA, Inc., 2021 WL

2190913 (D.N.J. 2021) (dismissal based on preemption of manufacturing defect claim); D’Addario v.

Johnson & Johnson, 2021 WL 1214896 (D.N.J. 2021)

(dismissing manufacturing defect claim on basis of

preemption); Ignacuinos v. Boehringer Ingelheim Pharm.

Inc., 2020 WL 5659071 (D. Conn. 2020) (dismissing design and manufacturing defect claims as preempted);

Webb v. Mentor Worldwide LLC, 453 F. Supp. 3d 550

(N.D.N.Y. 2020) (dismissing defective manufacture

claim on basis of preemption); Allo v. Allergan USA,

Inc., 2020 WL 814855 (E.D. La. 2020) (dismissing product defect claim on basis of preemption); L. Jacob v.

Mentor Worldwide LLC, 2019 WL 6766574 (M.D. Fla.

2019) (dismissing product defect claims on basis of

preemption); Williams v. Mentor Worldwide LLC, 2019

WL 4750843 (N.D. Ohio 2019) (dismissing design defect, product defect and manufacturing defect claims);

Shelp v. Allergan, Inc., 2018 WL 6694287 (W.D. Wash.

Dec. 20, 2018) (dismissing design defect claims).

3. Buckman Does Not Apply to a Manufacturer’s Post-Sale Submissions of False or

Inaccurate Adverse Event Reports; the

Order Below Manifests a Split Among

the Circuits

a. Buckman Does Not Apply to Manufacturers’ Post-Sale Conduct

In this case, Petitioners claim that Mentor submitted false adverse event data to the FDA. In this context, “to the FDA” relates to reports that are submitted

with the express expectation that the FDA will make

the reports available for public review and analysis,

through public websites that are specifically intended

for physician and patient reliance. 21 U.S.C. § 360i,

21 C.F.R. §§ 803.1(a), 803.9(a). The database through

which adverse event reports are made available to the

public could easily be maintained by any federal

agency, or by an outside contractor – it does not contain

work product that is uniquely attributable to the FDA.

Rather, the FDA uses its websites simply to make the

reported information publicly available. The FDA’s

MAUDE and MedWatch programs are more akin to a

public library than public regulation.

Petitioners do not claim that any “fraud on the

FDA” occurred here, as no reliance by FDA is directly

at issue. Reliance has long been an element of any

fraud-based claim. See, e.g., Pence v. United States, 316

U.S. 332, 338 (1942); Osterhaus v. Toth, 249 P.3d 888,

896 (Kan. 2011); Hale v. Emporia State Univ., 2018 WL

1609552, *3 (D. Kan. 2018) (noting that elements of

Kansas common law fraud claim are the same as those

listed in Pence v. United States, 316 U.S. at 338). Reliance by FDA is at the core of Buckman, as the Court

stressed that its analysis was limited to untruthful

statements made by a manufacturer to induce the

agency’s reliance in approving the product for public

sale. See Buckman, 531 U.S. at 348. Buckman emphasizes its application to statements made to induce FDA

reliance in the approval process. See id. at 348-351.

Buckman simply does not apply to post-sale conduct.

Cf. In re Volkswagen “Clean Diesel” Marketing, Sales

Practices, and Prods. Liability Lit., 959 F.3d 1201,

1225-1226 (9th Cir. 2020) (reversing dismissal upon

finding no basis for Clean Water Act preemption of

claims arising from post-sale conduct). Nor does Buckman apply to submission of information to FDA that is

intended not for FDA pre-approval reliance but instead for patient and physician post-approval reliance.

Petitioners are not the first medical device patients to argue for allowance of their claims arising

from post-sale or post-implantation conduct. One court

recently reached precisely this conclusion, that claims

asserting a breach of duty arising after FDA approval

simply do not trigger a federal preemption analysis. In

Mories v. Boston Scientific Corp., 494 F. Supp. 3d 461,

473 (S.D. Ohio 2020), the court properly extended inferences in favor of the plaintiff ’s pleading, as is appropriate in connection with a Rule 12(b)(6) motion. Upon

doing so, the court noted a distinction between preapproval, Buckman-barred activity, and post-approval

activity, observing that “[t]he difference between the

preempted and non-preempted failure-to-warn claim

is temporal – i.e., before or after the FDA approved the

warnings and literature associated with the [product].”

Mories, 494 F. Supp. 3d at 473. Based upon this logical

temporal distinction, the court denied the motion to

dismiss the plaintiff ’s failure to warn claim to the extent the complaint alleged “a breach of Defendant’s

duty under state law to warn of potential defects, based

on information Defendant obtained after the FDA’s approval of the medical device. In other words, if Plaintiff

is alleging that Defendant failed-to-warn of design or

manufacture defects after the FDA approved of the

warnings and literature, then she is not asking for a

court to disagree with any federal determination at

Mories at 473 (emphasis in original), citing Kemp v.

Medtronic, Inc., 231 F.3d 216 (6th Cir. 2000).

The Tenth Circuit, like the District of Kansas,

over-simplified the analysis by separating the parties

into separate categories of persons – FDA, patients,

physicians – toward which a false representation

might be made. However, the Tenth Circuit gave no

credence to the potential that Mentor can disseminate

false information indirectly, through the FDA, to the

medical and patient community.

As outlined supra, even if state law does not expressly impose a duty to accurately report information

to or through the FDA, the court below ignored the fact

that even where no duty to report is created by law or

contract, once a party undertakes to make a disclosure,

it assumes a duty to do so accurately, and inaccurate

or dishonest disclosures are actionable at common law.

See Caiola v. Citibank, N.A., 295 F.3d 312, 331 (2d Cir.

2002); Lau v. Opera Limited, 2021 WL 964642, *6

(S.D.N.Y. 2021); Trahan v. Interactive Intel. Grp., Inc.,

308 F. Supp. 3d 977, 991 (S.D. Ind. 2018), citing Stransky v. Cummins Engine Co., Inc., 51 F.3d 1329, 1331

(7th Cir. 1995); Thimjon Farms P’ship v. First Int’l

Bank & Tr., 837 N.W.2d 327, 339 (N.D. 2013); New Milford Sav. Bank v. Zandy, 2001 WL 79830, *2 (Conn. Super. Ct. 2001); United States v. Singh, 2020 WL

5500232, *6 (S.D. Cal. 2020); Chester Cty. Employees’

Ret. Fund v. KCG Holdings, Inc., 2019 WL 2564093,

*11 (Del. Ch. 2019); Owens v. Nationwide Prop. & Cas.

Ins. Co., 2014 WL 4258084, *6 (N.D. Ala. 2014) (where

insurer had no duty to disclose, “once it undertook to

speak, it was required to make a full and fair disclosure”), quoting Dominick v. Dixie Nat. Life Ins. Co., 809

F.2d 1559, 1570 (11th Cir. 1987).

b. Buckman Does Not Apply to Reports

Submitted to the FDA for Reliance

by Others

As recognized in Stengel v. Medtronic Inc., 704 F.3d

1224 (9th Cir. 2013), a common law duty to accurately

report adverse events and data “through” the FDA will

support a parallel claim. Stengel, 704 F.3d at 1233

(state common law claim to accurately report events

and data to a third party is not preempted, where manufacturer is reasonably assured the information will

reach physicians and patients). Just as Petitioners

alleged in the instant case, Mentor’s reports were submitted to the FDA not for reliance by the FDA, but for

the reliance of others. For exactly this reason, the court

in Stengel recognized that where post-approval submissions to the FDA are intended to be relied upon by

others, the FDA is a “third party” to the communication. Id.

Mentor’s duty to submit adverse event reports for

public reliance is distinguishable from Mentor’s duty

to submit test results for FDA reliance in approving

Mentor’s PMA application. Such results are calculated

principally for consumption by the FDA, and are provided to the FDA in response to a requirement that is

“particular” to Mentor’s breast implant device. Consequently, Petitioners’ claim is not similar to Cupek v.

Medtronic, Inc., 405 F.3d 421 (6th Cir. 2005), in which

the Sixth Circuit preempted claims that a device manufacturer was negligent per se and negligent in failing

to provide post-sale test data and thus in “failing to

comply with the FDA’s conditions of [premarket] approval.” 405 F.3d at 423. Petitioners here do not rely

upon Mentor’s failure to comply with the FDA’s conditions of approval, abject as such failure may have

been.

4. The Case Presents an Issue of National

Importance

The unfettered defense of preemption is an issue

of national importance for the health and safety of the

community. Between 2007 and 2020, American plastic

surgeons placed more than 4,000,000 breast implant

devices inside Americans’ bodies.14 About 60% of the

total, or at least 2.4 million implants, were filled with

silicone gel.15 Meanwhile, the FDA has given heightened focus to the nationwide growth of the adverse effects of silicone implants, noting the need to further

investigate the widespread common symptoms of BII.

The FDA has only recently recognized a connection between breast implants and a rare cancer known as

BIA-ALCL, an illness which has killed dozens of persons to date.

Perhaps due to the negative impression of legacy

cases, the federal judiciary is struggling to consistently

analyze MDA preemption cases, routinely issuing irreconcilable rulings. In addition, the federal courts seem

to be routinely dismissing state law claims, particularly

claims alleging negligent manufacture claims, on Rule

12 motions, even though preemption is an affirmative

defense, one about which manufacturers possess all

relevant evaluative data, which the claimants cannot

access without some level of discovery.

By taking steps to curtail this trend, the Court can

realign the judiciary with the need to provide relief to

See 2020 National Plastic Surgery Statistics Report, Cosmetic Surgical Procedures, American Society of Plastic Surgeons,

https://www.plasticsurgery.org/documents/News/Statistics/2020/

plastic-surgery-statistics-report-2020.pdf (last visited June 19,

2021), and corresponding annual reports for each prior year,

2007-2010, 2012-2018 (each last visited June 19, 2021).

Id. (2011, 2019 data not available).

thousands of Americans who are living in pain and

fear due to the presence of the dangerous products

that have been implanted in their bodies. Broad

preemption, particularly of claims based upon defective manufacture and inaccurate post-sale reports and

warnings, is deterring individuals from pursuing relief

from the effects of the foreign objects which now reside

inside them.

During more than a decade from 2008 to late 2018,

FDA focused little on BII. During that time, manufacturers rarely reported adverse events relating to BII

symptoms. As soon as the FDA began to give due attention to widespread complaints of BII, the frequency

of manufacturers’ reports of adverse events relating to

BII symptoms increased 2700%. Thousands of patients

whose claims accrued during the period of under-reporting appear now to have little recourse. With each

year of continued deterrence, thousands of potential

claims are barred by the various state product liability

statutes of limitation.16 The judicial process will give

these women a chance to investigate their own claims

and discovery, in parallel with the FDA, the information the manufacturers have known all along.

See Press Release, FDA, FDA Updates Analysis of Medical

Device Reports of Breast Implant Illness and Breast ImplantAssociated Lymphoma (Aug. 20, 2020), https://www.fda.gov/

news-events/press-announcements/fda-updates-analysis-medicaldevice-reports-breast-implant-illness-and-breast-implant-associated

(last visited June 22, 2021). From 2008 to October 2018 manufacturers submitted, on average, 8 adverse event reports per month

in relation to reported BII symptoms and experiences. Beginning

in November 2018, the average jumped to 227 per month.

Judicial divisions on the basic questions of the

MDA’s preemptive scope produce widespread uncertainty and unfairness. Potential claimants should not

feel frozen out of relief, nor should medical device

manufacturers feel the comfort of overbroad immunity

against liability, based purely upon geography. Such

legal uncertainty would be undesirable in relation to

any particular body of federal law, but is especially untenable in relation to MDA preemption. The purpose of

the MDA was to render consistent conflicting regulations and requirements, thereby promoting the availability of safe and effective medical devices. Instead of

the intended consistency, Americans have confusion.

Only this Court can render order from the present

chaos.

-----------------------------------------------------------------------

CONCLUSION

The petition for a writ of certiorari should be

granted.

Respectfully submitted,

ANDY DOGALI

DOGALI LAW GROUP, P.A.

19321 US Hwy. 19 North, Suite 307

Clearwater, FL 33764

adogali@dogalilaw.com

(813) 289-0700

Counsel for Petitioners

This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.