FILED

NOT FOR PUBLICATION

APR 2 2021

UNITED STATES COURT OF APPEALS MOLLY C. DWYER, CLERK

U.S. COURT OF APPEALS

FOR THE NINTH CIRCUIT

THE DAN ABRAMS COMPANY LLC, No. 19-56377 Relator, D.C. No. Plaintiff-Appellant, 2:15-cv-01212-JAK-AS

and

MEMORANDUM*

UNITED STATES OF AMERICA, ex rel.;

STATE OF ARKANSAS; STATE OF

CALIFORNIA; STATE OF COLORADO;

STATE OF CONNECTICUT; STATE OF

DELAWARE; DISTRICT OF COLUMBIA;

STATE OF FLORIDA; STATE OF

GEORGIA; STATE OF HAWAII; STATE

OF ILLINOIS; STATE OF INDIANA;

STATE OF IOWA; STATE OF

LOUISIANA; STATE OF

MASSACHUSETTS; STATE OF

MICHIGAN; STATE OF MINNESOTA;

STATE OF MISSOURI; STATE OF

MONTANA; STATE OF NEVADA;

STATE OF NEW HAMPSHIRE; STATE OF

NEW JERSEY; STATE OF NEW MEXICO;

STATE OF NEW YORK; STATE OF

NORTH CAROLINA; STATE OF

OKLAHOMA; STATE OF RHODE

ISLAND; STATE OF TENNESSEE;

STATE OF TEXAS; STATE OF VIRGINIA;

* This disposition is not appropriate for publication and is not precedent except as provided by Ninth Circuit Rule 36-3.

STATE OF WASHINGTON; STATE OF

WISCONSIN,

Plaintiffs,

v.

MEDTRONIC INC.; MEDTRONIC PLC;

MEDTRONIC SOFAMOR DANEK USA,

INC.; WARSAW ORTHOPEDIC, INC.;

MEDTRONIC SOFAMOR DANEK

DEGGENDORF GMBH; MEDTRONIC

PUERTO RICO OPERATIONS CO.;

HUMACAO,

Defendants-Appellees.

Appeal from the United States District Court for the Central District of California John A. Kronstadt, District Judge, Presiding

Argued and Submitted February 10, 2021 Pasadena, California

Before: TALLMAN, CALLAHAN, and LEE, Circuit Judges.

The Dan Abrams Company LLC (Relator) appeals the dismissal of its False

Claims Act (FCA) lawsuit. 31 U.S.C. §§ 3729-3733. Relator alleges that Medtronic

Inc. and various related entities fraudulently obtained Food and Drug Administration

clearance for several devices used in spinal fusion surgeries (Subject Devices),

unlawfully marketed them for an off-label and contraindicated use, and illegally

compensated physicians to use them. According to Relator, these fraudulent and

unlawful practices caused physicians to submit false claims to Medicare. We affirm

2 in part and reverse in part.

The False Claims Act makes liable anyone who “knowingly presents, or

causes to be presented, a false or fraudulent claim for payment or approval,” or

“knowingly makes, uses, or causes to be made or used, a false record or statement

material to a false or fraudulent claim.” 31 U.S.C. § 3729(a)(1)(A), (B). The

essential elements of an FCA claim are “(1) a false statement or fraudulent course

of conduct, (2) made with the [requisite] scienter, (3) that was material, causing (4)

the government to pay out money or forfeit moneys due.” United States ex rel.

Campie v. Gilead Sciences, Inc., 862 F.3d 890, 899 (9th Cir. 2017) (quoting United

States ex rel. Hendow v. Univ. of Phoenix, 461 F.3d 1166, 1174 (9th Cir. 2006)).

1. Off-label/contraindicated-use theory: Relator alleges that Medtronic

marketed the Subject Devices without FDA approval or clearance for use in the

cervical spine—an “off-label” and indeed contraindicated use. Relator thus alleges

that Medtronic engaged in misbranding, mislabeling, and adulterating in violation

of the Food, Drug, and Cosmetics Act (FDCA).

The fundamental problem with this theory is that Relator incorrectly assumes

that the federal government will not reimburse for an off-label use of a medical

device. To the contrary, the federal government has recognized that doctors may

use medical devices for off-label purposes as long as it is medically necessary and

reasonable. See, e.g., Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 350

3 (2001) (“‘[O]ff label’ usage of medical devices . . . is an accepted and necessary

corollary of the FDA’s mission to regulate in this area without directly interfering

with the practice of medicine.”); U.S. Dep’t of Health & Hum. Serv. (HHS),

Medicare Benefit Policy Manual, ch. 14 § 10, available at

https://www.cms.gov/Regulations-and-

Guidance/Guidance/Manuals/Downloads/bp102c14.pdf (noting that Medicare

reimburses for “[d]evices cleared by the FDA through the 510(k) process”—not

cleared uses of a device) (emphasis added).

Thus, the federal government does not distinguish between on-label and off-

label uses in determining whether to pay for medical devices. Rather, to be

reimbursable, a device must (1) have FDA approval/clearance, (2) be “reasonable

and necessary,” Int’l Rehab. Sci. Inc. v. Sebelius, 688 F.3d 994, 997, 1002 (9th Cir.

2012), and (3) meet any other pertinent regulations, HHS, Medicare Benefit Policy

Manual, ch. 14 § 10. Relator’s argument must thus be considered through the prism

of these three requirements.

First, the FDA cleared the Subject Devices through the 510(k) process

(though, as discussed later, Relator claims Medtronic defrauded FDA in the

clearance process).

Second, the Relator has not plausibly alleged that the Subject Devices are not

“reasonable and necessary.” This court has cited Centers for Medicare & Medicaid

4 (CMS) guidance in explaining that “a device is not ‘reasonable and necessary’ —

and thus is not eligible for Medicare coverage—if it is (a) “not ‘safe’ and ‘effective,”

(b) “experimental,” (c) “not appropriate for the individual beneficiary’s needs,” or

(d) “substantially more costly than a medically appropriate and realistically feasible

alternative pattern of care.” Int’l Rehab. Sci., Inc., 688 F.3d at 997 (cleaned up).

CMS guidance makes clear that safety and efficacy determinations are based on

“authoritative evidence” or “general[] accept[ance] in the medical community.” Id.

Relator makes no allegations about published studies demonstrating that

cervical use of vertebral body replacement (VBR) is medically unsafe or ineffective.

Nor does Relator allege that VBR use in the cervical spine is contrary to accepted

standards of medical practice. Instead, Relator points to a few anecdotal examples

of harm caused by the Subject Devices. The problem is that any surgery carries the

potential risk of harm. Merely showing that harm can occur is insufficient. Relator

also argues that the Subject Devices were not reasonable and necessary because

cheaper and equally effective options existed. Yet, as the district court correctly

observed, Relator does not connect any “alleged false statements and the pricing

criterion of Medicare coverage.”

Relator argues that this is not a case of merely off-label use, but

contraindicated use of the Subject Devices. But neither the federal government nor

the judiciary appears to carve out an exception for contraindicated use in discussing

5 off-label uses. Indeed, the FDCA specifically contemplates that devices may be

cleared even if contraindicated uses are expected: if the FDA suspects that a potential

Class II device may be used for contraindicated purposes, the FDA “may require a

statement” on the product’s label disclosing that use. 21 U.S.C. §360c(i)(1)(E)(i).

As long as a doctor finds an off-label use to be medically reasonable and necessary,

then the off-label use is permitted, even if the particular use is contraindicated on the

label.

Third, Relator points to no statute, regulation, or administrative manual that

specifically states that a contraindicated use of a device is categorically not

reasonable and necessary.

Relator cites this court’s Campie decision for the proposition that

“misbranded and adulterated devices are not eligible for Medicare reimbursement.”

But in Campie, one of the relator’s claims was that the drug was “misbranded” or

“adulterated” because the drug company had substituted an unapproved ingredient

for an approved ingredient. 862 F.3d at 902. In contrast here, Relator alleges that

the Subject Devices were misbranded because they were sold for a contraindicated

purpose. But the federal government acknowledges that doctors may use medical

devices for off-label and even contraindicated uses if they believe that such use is

medically necessary and reasonable. So contraindicated use of the Subject Devices

is not material to the government’s decision to pay.

6 We thus affirm the district court’s dismissal of Relator’s claim based on off-

label/contraindicated labels.

2. Fraud-on-the-FDA theory: Relator also alleges that Medtronic

defrauded the FDA into granting the Subject Devices Class II clearance. According

to this theory, since Medicare reimbursement requires FDA clearance, the Subject

Devices would have been ineligible for reimbursement but for Medtronic’s fraud.

Relator appears to divide the Subject Devices into two distinct groups. The

first group of Subject Devices consists of those that allegedly cannot be used for

their labeled intended use and can only be used for their contraindicated use in the

cervical spine. For these “Contraindicated-only Devices,”1 Relator alleges that

Medtronic falsely represented in its clearance application that they were intended for

use in the thoracolumbar spine (the part of the spine below the neck) when in fact

they could not be used there and could only be used in the cervical (neck-area) of the

spine.

The second group of Subject Devices—“Extra-use Devices”2—includes those

that could be used for their stated intended use (i.e., use in the thoracolumbar spine)

but which were contraindicated for use in the cervical spine. Relator alleges that

1 This label was not used by the parties but is included here for the sake of clarity. 2 Again, this is not a term that the parties use and is included here only for the sake of clarity.

7 Medtronic secretly intended to sell these Extra-use Devices for their contraindicated

use.

The district court dismissed Relator’s fraud-on-the-FDA theory for failure to

state a claim, finding that its allegations were offered “solely as a predicate for the

claim that the Subject Devices were intended for off-label use.”

The district court is correct that the materiality element cannot be met for the

Extra-use Devices because the federal government allows reimbursement for off-

label and even contraindicated uses. Put another way, Medtronic’s alleged omission

about its intent to market the devices for a contraindicated use was immaterial to the

FDA’s clearance for Extra-use Devices.

But the Contraindicated-only Devices present a different story. For those

devices, Relator does not allege mere off-label use. Rather, Relator alleges that the

Contraindicated-only Devices were not properly cleared for any use: they cannot be

used for their labeled intended use (and are thus not substantially similar to the

predicate device), and they can only be used for their contraindicated use. Relator

claims that Medtronic knew that cervical VBRs posed different questions of safety

to its previously approved devices, and if Medtronic disclosed that the devices were

intended for use in the cervical spine, then the FDA may have required Class III

approval. These considerations—intended use, similarity to a predicate device, and

different questions about safety—are precisely those that the FDA considers in

8 granting Class II certification. 21 U.S.C. § 360c(i)(1)(A). Put differently,

Medtronic’s alleged fraud went “to the very essence of the bargain.” United Health

Serv., Inc. v. United States ex rel. Escobar, 136 S. Ct. 1989, 2003 n.5 (2016) (cleaned

up).

Medtronic argues that the FCA is not the proper vehicle to bring a fraud-on-

the-FDA claim. In Buckman, the Supreme Court held that the FDCA bars a private

party from asserting state law claims that the device manufacturer defrauded the

FDA during the 510(k)-clearance process concerning a device’s intended use. 531

U.S. at 348. And the First Circuit has extended Buckman’s holding to the FCA

context. United States ex rel. D’Agostino v. ev3, Inc., 845 F.3d 1, 7-9 (1st Cir. 2016).

Medtronic invites us to follow suit. But this court’s decision in Campie forecloses

that path. In Campie, we noted that other jurisdictions had “cautioned against

allowing claims under the False Claims Act to wade into the FDA’s regulatory

regime.” 862 F.3d. at 905 (citing, amongst others, D’Agostino, 845 F.3d at 9). Yet

we nevertheless allowed the relator’s fraud-on-the-FDA theory to go forward. Id. at

905-06.

We thus affirm the district court for claims based on the Extra-use Devices,

but we reverse for claims based on Contraindicated-only Devices.

3. Anti-Kickback Statute (AKS): The AKS prohibits “knowingly and

willfully offer[ing] or pay[ing] any remuneration . . . to any person to induce such

9 person . . . to purchase . . . [any] item for which payment may be made in whole or

in part under a Federal health care program.” 42 U.S.C. § 1320a-7b(b)(2)(B).

Relator first alleges that Medtronic entered into improper rebate agreements

with hospitals to buy the Subject Devices. But the AKS exempts from its scope

discounts offered to providers if properly disclosed to and reflected in charges to the

federal program. 42 U.S.C. § 1320a-7b(b)(3)(A). Similarly, Medicaid allows rebate

agreements so long as the state Medicaid programs are offered the same pricing. 42

U.S.C. § 1396r-8(a)(1). Relator does not explain how Medtronic’s rebate agreement

violated the AKS. Therefore, in relation to the rebate agreements, Relator fails to

state a claim.

Relator next alleges that Medtronic remunerated physicians by paying the

costs, including food, travel, and promotional expenses, in connection with certain

business development events. But as the district court observed, these “general

allegations do not identify any physicians, or categories of them, who actually

received payment in connection with decisions — in which they participated — to

purchase or use of any of the Subject Devices.” We thus affirm the district court’s

dismissal of Relator’s AKS claim.

AFFIRMED IN PART; REVERSED IN PART. Each party shall bear its

own costs.

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