Markland v. Insys Therapeutics, Inc.

Decision Date15 September 2017
Docket NumberCase No. 3:16–cv–997–J–34PDB
Citation270 F.Supp.3d 1318
Parties Robert N. MARKLAND, as the Personal Representative of the Estate of Carolyn S. Markland, Deceased, Plaintiff, v. INSYS THERAPEUTICS, INC., Defendant.
CourtU.S. District Court — Middle District of Florida

Bryan Scott Gowdy, Meredith Ross, Creed & Gowdy, P.A., Charles Wayne Alford, Charles Wayne Alford, Jr., Alford Law Group, PA, Jacksonville, FL, for Plaintiff.

Adam P. Schwartz, David J. Walz, Mariko K. Shitama Outman, Carlton Fields Jorden Burt, PA, Tampa, FL, for Defendant.


MARCIA MORALES HOWARD, United States District Judge

THIS CAUSE is before the Court on Defendant Insys Therapeutics, Inc.'s (Insys) Amended Motion to Dismiss (Doc. 15; Motion), filed on September 2, 2016. In the Motion, Insys requests that this Court dismiss plaintiff Robert N. Markland's complaint for Damages and Demand for a Jury Trial (Doc. 2; Complaint). Mr. Markland, who files this action as the Personal Representative of the Estate of Carolyn S. Markland, opposes the Motion. See Plaintiff's Response to Defendant's Motion to Dismiss (Doc. 23; Response), filed September 29, 2016. With leave of Court (Doc. 28), Insys filed a Reply in Support of its Amended Motion to Dismiss. See Defendant Insys Therapeutics, Inc.'s Reply in Support of its Amended Motion to Dismiss (Doc. 30; Reply), filed October 25, 2016. Accordingly, this matter is ripe for review.1


In ruling on a motion to dismiss, the Court must accept the factual allegations set forth in the complaint as true. See Ashcroft v. Iqbal, 556 U.S. 662, 678, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009) ; Swierkiewicz v. Sorema N.A., 534 U.S. 506, 508, n 1, 122 S.Ct. 992, 152 L.Ed.2d 1 (2002) ; see also Lotierzo v. Woman's World Med. Ctr., Inc., 278 F.3d 1180, 1182 (11th Cir. 2002). In addition, all reasonable inferences should be drawn in favor of the plaintiff. See Omar ex rel. Cannon v. Lindsey, 334 F.3d 1246, 1247 (11th Cir. 2003) (per curiam). Nonetheless, the plaintiff must still meet some minimal pleading requirements. Jackson v. BellSouth Telecomms., 372 F.3d 1250, 1262–63 (11th Cir. 2004) (citations omitted). Indeed, while "[s]pecific facts are not necessary," the complaint should " ‘give the defendant fair notice of what the ...claim is and the grounds upon which it rests.’ " Erickson v. Pardus, 551 U.S. 89, 93, 127 S.Ct. 2197, 167 L.Ed.2d 1081 (2007) (per curiam) (quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007) ). Further, the plaintiff must allege "enough facts to state a claim to relief that is plausible on its face." Twombly, 550 U.S. at 570, 127 S.Ct. 1955. "A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged." Iqbal, 556 U.S. at 678, 129 S.Ct. 1937 (citing Twombly, 550 U.S. at 556, 127 S.Ct. 1955 ).

A "plaintiff's obligation to provide the grounds of his entitlement to relief requires more than labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do." Twombly, 550 U.S. at 555, 127 S.Ct. 1955 (citations omitted); see also BellSouth Telecomms., 372 F.3d at 1262 (explaining that "conclusory allegations, unwarranted deductions of facts or legal conclusions masquerading as facts will not prevent dismissal") (citations and quotations omitted). Indeed, "the tenet that a court must accept as true all of the allegations contained in a complaint is inapplicable to legal conclusions," which simply "are not entitled to [an] assumption of truth." See Iqbal, 556 U.S. at 679, 129 S.Ct. 1937. Thus, in ruling on a motion to dismiss, the Court must determine whether the complaint contains "sufficient factual matter, accepted as true, to ‘state a claim to relief that is plausible on its face.’ " Id. at 678, 129 S.Ct. 1937 (quoting Twombly, 550 U.S. at 570, 127 S.Ct. 1955 ).


This wrongful death action arises from the prescribed use of the drug known as Subsys, a sublingual spray formation of Fetanyl, and the untimely death of Carolyn S. Markland, a resident of Jacksonville, FL. Complaint at ¶¶ 5, 13.

Carolyn Markland, the deceased wife of Mr. Markland, suffered from degenerative disc disease

which caused her chronic back pain. Complaint at ¶ 35. Her pain management physician, Dr. Orlando G. Florente, M.D., of Jacksonville, FL, prescribed her a dose of Subsys at his office on July 2, 2014. Id. at ¶ 34. She subsequently suffered from respiratory distress early the following morning and died. Id. at ¶ 36. Reports from the Duval County Medical Examiner noted "drug toxicity" as her cause of death. Id. at ¶. 5.

Subsys is a drug developed and produced by Insys, a Delaware Corporation with its principal place of business in Arizona. Id. at ¶¶ 6, 9.2 On January 4, 2012, the Food and Drug Administration (FDA) specifically approved Subsys for treatment of breakthrough pain in cancer

patients. Id. at ¶¶ 6–7. One significant risk associated with the drug, and as noted in the FDA mandated Medical Guide accompanying Subsys, was that the drug could cause respiratory depression and death. Id. at ¶¶ 21, 23–24.3 Tragically, this appears to have been true for Carolyn Markland.

Despite the fact that the FDA approved Subsys solely for treatment of breakthrough pain in cancer

patients, id. at ¶¶ 6–7, Insys engaged in an "aggressive marketing campaign to get physicians to prescribe Subsys for other uses including relieving chronic back pain."Id. at ¶¶ 26, 28–30. In doing so, Mr. Markland alleges that Insys "negligently convinced physicians,...pain management physicians, and doctors specializing in internal medicine that the physicians should and could write prescriptions for Subsys Fetanyl as an off-label use. This was unlawful conduct by Insys and was in violation of federal law." Id. at ¶ 28(d). Mr. Markland describes Insys' marketing scheme as one that "did not consider the safety and wellbeing of patients who were prescribed this extremely dangerous drug and was undertaken only to increase the earnings of Insys. This scheme placed company profits ahead of patients' safety." Id. at ¶ 31. At bottom, Mr. Markland alleges that Insys was "negligent in aggressively promoting the off-label use or prescribing of" Subsys, id. at ¶ 28(e), which resulted in his wife's death.

Based on this conduct, Mr. Markland asserts a single claim of negligent marketing against Insys. Id. at ¶¶ 32–38. Mr. Markland also asserts that as a direct and proximate cause of Insys' negligent marketing, he lost the support, services, comfort, society, companionship, protection, and attention of his deceased wife, along with bearing his own mental pain and suffering. Id. at ¶ 37. Additionally, Mr. Markland asserts that as a direct and proximate cause of Insys' negligent marketing, he individually, and as representative of his deceased wife's estate, incurred funeral expenses resulting from Carolyn Markland's death, along with losing her earnings and net accumulations that she otherwise would have acquired over her natural life span. Id. at ¶ 38.

In the Motion, Insys raises several arguments in support of its request for dismissal of this case. First, Insys asserts that Mr. Markland lacks standing to bring this action on behalf of his wife's estate because his status as Personal Representative ceased when he closed Carolyn Markland's estate in April of 2016. See Motion at 6. Insys argues that when Mr. Markland initiated this action after closing the estate, he could not claim the status of Personal Representative, and therefore lacks standing. Id. at 8. Second, Insys argues that even if Mr. Markland has standing to bring this suit, the tort of negligent marketing is not a recognized cause of action in Florida. Id. at 8. Third, Insys proffers that Mr. Markland's claims are more accurately characterized as violations of the Food, Drug and Cosmetic Act (FDCA), 21 U.S.C. § 301, et seq. Id. at 11. In this regard, Insys contends that a private right of action is barred under the statute. Id. at 14–15. Fourth, and allied with the preceding position, Insys argues that Mr. Markland's action is impliedly preempted by the FDCA. Id. at 15–16. Fifth, Insys contends that in the event the Court nonetheless finds that Mr. Markland is able to assert a claim of negligent marketing, the claim is foreclosed by the learned intermediary doctrine. In support of this contention, Insys asserts that any duty it possessed in terms of ensuring that it delivered a safe product to the market, was discharged because it provided clear and unambiguous warnings regarding dangers associated with Subsys to Carolyn Markland's prescribing physician. Id. at 18–19. Finally, Insys argues that Mr. Markland is judicially estopped from bringing his action. Id. at 26.

In his Response, Mr. Markland notes that he has standing to bring his action because he was reappointed Personal Representative of his wife's estate. See Response at 7–8. Further, Mr. Markland contends that his action is recognized under Florida law, because whether framed as "negligent marketing" or simply as "negligence," id. at 8–9, 11, every drug manufacturer has a duty to ensure that its "products will be reasonably safe for consumers in the marketplace." Id. at 8. He asserts that he is not seeking to bring a private right of action under the FDCA, id. at 11–12, but rather, is seeking to use Insys' alleged violation of federal law as evidence to support his negligence claim. Id. Mr. Markland also proffers that his action is not impliedly preempted by the FDCA, id. at 14, nor should the learned intermediary doctrine be applied in this case due to Insys' aggressive over promotion of Subsys. Id. at 20–22. Finally, Mr. Markland asserts that judicial estoppel is not appropriate. Id. at 24–25.

a. Standing

Insys contends that Mr. Markland lacks standing to...

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    ...Cal. 2013) ("Any negligence claim based solely on illegal off-label promotion is impliedly preempted"); Markland v. Insys Therapeutics, Inc. , 270 F.Supp.3d 1318, 1330 (M.D. Fla. 2017) ("Because the existence of off-label promotion is a critical element in his case, [the plaintiff's] claim ......
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    • Emory University School of Law Emory Law Journal No. 72-3, 2023
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