Case: 17-14607 Date Filed: 12/19/2018 Page: 1 of 7
[DO NOT PUBLISH]
IN THE UNITED STATES COURT OF APPEALS
FOR THE ELEVENTH CIRCUIT ________________________
No. 17-14607 Non-Argument Calendar ________________________
D.C. Docket No. 3:16-cv-00997-MMH-PDB
ROBERT N. MARKLAND, as the Personal Representative of the Estate of Carolyn S. Markland, Deceased,
Plaintiff - Appellant,
versus
INSYS THERAPEUTICS, INC., a Delaware Corporation,
Defendant - Appellee.
________________________
Appeal from the United States District Court for the Middle District of Florida ________________________
(December 19, 2018)
Before MARCUS, WILLIAM PRYOR, and ANDERSON, Circuit Judges.
PER CURIAM:
Plaintiff Robert Markland appeals the district court’s dismissal of his
wrongful death claim against Insys Therapeutics, Inc. In his complaint, Markland Case: 17-14607 Date Filed: 12/19/2018 Page: 2 of 7
alleged that his wife, Carolyn Markland (“Carolyn”), died shortly after receiving a
prescription drug manufactured by Insys, and he brought a single claim of
“negligent marketing” under Florida law. On appeal, Markland argues the district
court erred in finding the claim preempted by the Federal Food, Drug, and
Cosmetic Act (“FDCA”), 21 U.S.C. §§ 301–399h. After careful review, we affirm.
The tragic facts of this case are these.1 Insys Therapeutics is a
pharmaceutical company that manufactures, among other things, a prescription
painkiller called Subsys. Subsys is a spray form of Fentanyl, a powerful opioid
that is a Schedule II controlled substance. See 21 U.S.C. § 812(c), sched. II (b)(6).
The intended use of Subsys is to treat cancer patients with “breakthrough pain,”
i.e., sharp, sudden episodes of pain that occur despite constant treatment with other
pain medications. While this is the sole FDA-approved use of Subsys, Markland
alleges that Insys engaged in a “fraudulent” and “unlawful” marketing scheme to
push doctors to prescribe Subsys “off label” for patients with other kinds of pain.
Carolyn Markland received Subsys, in what the complaint alleges is a prime
example of an off-label use of the drug. At the time, she was receiving treatment
for chronic back pain resulting from a degenerative disc disease. She regularly
took a different opioid, Exalgo, and her pain management physician prescribed
1 Because the district court decided this case on a motion to dismiss, we take the facts alleged in the complaint as true. See Furry v. Miccosukee Tribe of Indians, 685 F.3d 1224, 1226 n.2 (11th Cir. 2012). 2 Case: 17-14607 Date Filed: 12/19/2018 Page: 3 of 7
Subsys for pain on an as-needed basis. One morning after her physician
administered a dose of Subsys, Carolyn suffered respiratory distress and died.
Subsys is known to cause respiratory problems, and the medical examiner
identified the cause of death as drug toxicity. Robert Markland filed this wrongful
death suit as the personal representative of his wife’s estate.
We review de novo the grant of a Rule 12(b)(6) motion to dismiss for failure
to state a claim. Ray v. Spirit Airlines, Inc., 836 F.3d 1340, 1347 (11th Cir. 2016).
We accept the allegations in the complaint as true and view them in the light most
favorable to the plaintiff. Id. Regardless of the district court’s reasoning, “we are
free to affirm the district court’s decision on any ground that is supported by the
record.” United States v. Elmes, 532 F.3d 1138, 1142 (11th Cir. 2008).
As a starting point, we note that the FDCA says that its requirements may
only be enforced by the United States government. 21 U.S.C. § 337(a). In
Buckman Co. v. Plaintiff’s Legal Committee, 531 U.S. 341 (2001), the Supreme
Court explained how this bar on private enforcement of the FDCA interacts with
the background of state tort law. There, patients injured by a medical device sued
a consulting company for allegedly making false representations to the FDA in
order to get approval to market the device. Id. at 343. The plaintiffs’ theory was
that if the defendant had not made those false statements, the devices would not
have been approved and they never would have been injured. The Supreme Court
3 Case: 17-14607 Date Filed: 12/19/2018 Page: 4 of 7
held that these “fraud-on-the-FDA” state tort claims were in conflict with federal
law and were therefore preempted. Id. at 348. The conflict “stem[med] from the
fact that the federal statutory scheme amply empowers the FDA to punish and
deter fraud against” it in pursuit of a “somewhat delicate balance of statutory
objectives.” Id. In other words, Congress made a specific choice to allow only the
government to enforce the FDCA’s requirements, and allowing private litigants to
sue for misrepresentations made to the FDA would conflict with that policy
decision. Id. at 348-51.
After Buckman, this Court noted a distinction between claims that rely on
FDCA violations and claims derived from “traditional state tort law that predated
the federal enactments in question.” Mink v. Smith & Nephew, Inc., 860 F.3d
1319, 1327 (11th Cir. 2017) (quotations and modifications omitted). Traditional
state-law tort claims are not preempted “so long as they don’t seek to privately
enforce a duty owed to the FDA.” Id. The Court’s different treatment of two
claims in that case is instructive: a claim based on the defendant’s failure to file a
required report with the FDA was held to be preempted, but a traditional
manufacturing defect products liability claim was not. Id. at 1330. The key
distinction was that a manufacturing defect claim involves a duty that both
predates the FDCA and is owed to the individual patient, not to the FDA. Id.
4 Case: 17-14607 Date Filed: 12/19/2018 Page: 5 of 7
Here, Markland’s claim is styled as a “negligent marketing” claim, which is
not a recognized tort under Florida law. Markland alleges that after Subsys was
approved to treat pain in cancer patients, Insys “unlawfully and negligently began
an aggressive marketing campaign to get physicians to prescribe Subsys for other
uses including relieving chronic back pain.” More specifically, Markland asserts
that Insys made payments to physicians and other medical professionals who
prescribed the drug, at the same time urging them to write off-label prescriptions.
Among other things, he alleges that Insys paid health care professionals through a
sham “Speakers Bureau,” which rewarded physicians who prescribed Subsys under
the guise of providing compensation for travel and speeches. He adds that Insys
“intentionally violated requirements imposed by the FDA” regarding the proper
use of the drug.
The district court “read the substance of Mr. Markland’s complaint as
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Case: 17-14607 Date Filed: 12/19/2018 Page: 1 of 7
[DO NOT PUBLISH]
IN THE UNITED STATES COURT OF APPEALS
FOR THE ELEVENTH CIRCUIT ________________________
No. 17-14607 Non-Argument Calendar ________________________
D.C. Docket No. 3:16-cv-00997-MMH-PDB
ROBERT N. MARKLAND, as the Personal Representative of the Estate of Carolyn S. Markland, Deceased,
Plaintiff - Appellant,
versus
INSYS THERAPEUTICS, INC., a Delaware Corporation,
Defendant - Appellee.
________________________
Appeal from the United States District Court for the Middle District of Florida ________________________
(December 19, 2018)
Before MARCUS, WILLIAM PRYOR, and ANDERSON, Circuit Judges.
PER CURIAM:
Plaintiff Robert Markland appeals the district court’s dismissal of his
wrongful death claim against Insys Therapeutics, Inc. In his complaint, Markland Case: 17-14607 Date Filed: 12/19/2018 Page: 2 of 7
alleged that his wife, Carolyn Markland (“Carolyn”), died shortly after receiving a
prescription drug manufactured by Insys, and he brought a single claim of
“negligent marketing” under Florida law. On appeal, Markland argues the district
court erred in finding the claim preempted by the Federal Food, Drug, and
Cosmetic Act (“FDCA”), 21 U.S.C. §§ 301–399h. After careful review, we affirm.
The tragic facts of this case are these.1 Insys Therapeutics is a
pharmaceutical company that manufactures, among other things, a prescription
painkiller called Subsys. Subsys is a spray form of Fentanyl, a powerful opioid
that is a Schedule II controlled substance. See 21 U.S.C. § 812(c), sched. II (b)(6).
The intended use of Subsys is to treat cancer patients with “breakthrough pain,”
i.e., sharp, sudden episodes of pain that occur despite constant treatment with other
pain medications. While this is the sole FDA-approved use of Subsys, Markland
alleges that Insys engaged in a “fraudulent” and “unlawful” marketing scheme to
push doctors to prescribe Subsys “off label” for patients with other kinds of pain.
Carolyn Markland received Subsys, in what the complaint alleges is a prime
example of an off-label use of the drug. At the time, she was receiving treatment
for chronic back pain resulting from a degenerative disc disease. She regularly
took a different opioid, Exalgo, and her pain management physician prescribed
1 Because the district court decided this case on a motion to dismiss, we take the facts alleged in the complaint as true. See Furry v. Miccosukee Tribe of Indians, 685 F.3d 1224, 1226 n.2 (11th Cir. 2012). 2 Case: 17-14607 Date Filed: 12/19/2018 Page: 3 of 7
Subsys for pain on an as-needed basis. One morning after her physician
administered a dose of Subsys, Carolyn suffered respiratory distress and died.
Subsys is known to cause respiratory problems, and the medical examiner
identified the cause of death as drug toxicity. Robert Markland filed this wrongful
death suit as the personal representative of his wife’s estate.
We review de novo the grant of a Rule 12(b)(6) motion to dismiss for failure
to state a claim. Ray v. Spirit Airlines, Inc., 836 F.3d 1340, 1347 (11th Cir. 2016).
We accept the allegations in the complaint as true and view them in the light most
favorable to the plaintiff. Id. Regardless of the district court’s reasoning, “we are
free to affirm the district court’s decision on any ground that is supported by the
record.” United States v. Elmes, 532 F.3d 1138, 1142 (11th Cir. 2008).
As a starting point, we note that the FDCA says that its requirements may
only be enforced by the United States government. 21 U.S.C. § 337(a). In
Buckman Co. v. Plaintiff’s Legal Committee, 531 U.S. 341 (2001), the Supreme
Court explained how this bar on private enforcement of the FDCA interacts with
the background of state tort law. There, patients injured by a medical device sued
a consulting company for allegedly making false representations to the FDA in
order to get approval to market the device. Id. at 343. The plaintiffs’ theory was
that if the defendant had not made those false statements, the devices would not
have been approved and they never would have been injured. The Supreme Court
3 Case: 17-14607 Date Filed: 12/19/2018 Page: 4 of 7
held that these “fraud-on-the-FDA” state tort claims were in conflict with federal
law and were therefore preempted. Id. at 348. The conflict “stem[med] from the
fact that the federal statutory scheme amply empowers the FDA to punish and
deter fraud against” it in pursuit of a “somewhat delicate balance of statutory
objectives.” Id. In other words, Congress made a specific choice to allow only the
government to enforce the FDCA’s requirements, and allowing private litigants to
sue for misrepresentations made to the FDA would conflict with that policy
decision. Id. at 348-51.
After Buckman, this Court noted a distinction between claims that rely on
FDCA violations and claims derived from “traditional state tort law that predated
the federal enactments in question.” Mink v. Smith & Nephew, Inc., 860 F.3d
1319, 1327 (11th Cir. 2017) (quotations and modifications omitted). Traditional
state-law tort claims are not preempted “so long as they don’t seek to privately
enforce a duty owed to the FDA.” Id. The Court’s different treatment of two
claims in that case is instructive: a claim based on the defendant’s failure to file a
required report with the FDA was held to be preempted, but a traditional
manufacturing defect products liability claim was not. Id. at 1330. The key
distinction was that a manufacturing defect claim involves a duty that both
predates the FDCA and is owed to the individual patient, not to the FDA. Id.
4 Case: 17-14607 Date Filed: 12/19/2018 Page: 5 of 7
Here, Markland’s claim is styled as a “negligent marketing” claim, which is
not a recognized tort under Florida law. Markland alleges that after Subsys was
approved to treat pain in cancer patients, Insys “unlawfully and negligently began
an aggressive marketing campaign to get physicians to prescribe Subsys for other
uses including relieving chronic back pain.” More specifically, Markland asserts
that Insys made payments to physicians and other medical professionals who
prescribed the drug, at the same time urging them to write off-label prescriptions.
Among other things, he alleges that Insys paid health care professionals through a
sham “Speakers Bureau,” which rewarded physicians who prescribed Subsys under
the guise of providing compensation for travel and speeches. He adds that Insys
“intentionally violated requirements imposed by the FDA” regarding the proper
use of the drug.
The district court “read the substance of Mr. Markland’s complaint as
alleging that Insys violated federal law” and held that his claim was preempted.
We agree. A critical premise of Markland’s complaint is that Insys’s promotion of
off-label uses was improper, a proposition that can only be established by pointing
to federal law. Although the FDCA does not expressly regulate off-label
prescriptions, the FDA has penalized companies for the promotion of off-label uses
under the misbranding provisions of the Act. See, e.g., United States v. Caronia,
703 F.3d 149, 154 (2d Cir. 2012) (“The government has repeatedly prosecuted --
5 Case: 17-14607 Date Filed: 12/19/2018 Page: 6 of 7
and obtained convictions against -- pharmaceutical companies and their
representatives for misbranding based on their off-label promotion.”). At the same
time, however, the FDA also generally permits the off-label prescription of drugs
by physicians. See 21 U.S.C. § 396; cf. Buckman, 531 U.S. at 350 (explaining that
the off-label use 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”).
Notably, Markland has not pointed to any traditional state-law duty owed by
Insys to Carolyn that was breached by the company’s marketing of Subsys for off-
label use. It is only because of the FDCA and FDA enforcement decisions that the
promotion of off-label uses is prohibited. Indeed, the very concept of a drug use
being “off-label” is derived from the FDCA and FDA policymaking decisions.
Markland is correct that under Florida tort law, a negligence claim can be
premised on a duty created by a federal statute or regulation. See Godfrey v.
Precision Airmotive Corp., 46 So. 3d 1020, 1023 (Fla. Dist. Ct. App. 2010). But
preemption is an issue of federal law, and a duty derived from a federal statute is
insufficient to prevent preemption. One cannot say that a claim based on a federal
statutory duty “rel[ies] on traditional state tort law which [predates] the federal
enactments in question[].” Buckman, 531 U.S. at 353. As with the Buckman
6 Case: 17-14607 Date Filed: 12/19/2018 Page: 7 of 7
plaintiffs, Markland seeks to enforce a duty that “exist[s] solely by virtue of the
FDCA.” Id. That kind of claim is preempted.
Because we affirm on the ground that Markland’s claim is preempted, we
need not express any view on the viability of a negligent marketing claim under
Florida law or the application of the learned intermediary doctrine to this case.
AFFIRMED.