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Markland v. Insys Therapeutics, Inc.

United States District Court, M.D. Florida, Jacksonville Division

September 15, 2017

ROBERT N. MARKLAND, as the Personal Representative of the Estate of Carolyn S. Markland, Deceased, Plaintiff,
v.
INSYS THERAPEUTICS, INC., Defendant.

          ORDER

          MARCIA MORALESH 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]

         I. STANDARD OF REVIEW

         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 (2009); Swierkiewicz v. Sorema N.A., 534 U.S. 506, 508, n 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 Telecomm., 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 (2007) (per curiam) (quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (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. “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 (citing Twombly, 550 U.S. at 556).

         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 (citations omitted); see also BellSouth Telecomm., 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. 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 (quoting Twombly, 550 U.S. at 570).

         II. BACKGROUND AND ARGUMENTS OF THE PARTIES

         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.

         III. DISCUSSION

         a. Standing

         Insys contends that Mr. Markland lacks standing to bring this action because he was not the Personal Representative of his wife's estate at the time he initiated this lawsuit. In his Response, Mr. Markland acknowledges that he was not the Personal Representative of his wife's estate at the time he filed this wrongful death action, but asserts that because he has since been reappointed as such, he does have standing. In making these arguments, both parties rely on publicly available records from the Circuit Court for Duval County, Florida Probate Division. See Motion, Exhibits 1-8; Response, Exhibits 3-4.

         A motion to dismiss based on lack of standing is considered a challenge to the court's subject matter jurisdiction pursuant to Rule 12(b)(1), Federal Rule of Civil Procedure (Rule(s)). Townsend v. U.S. Dep't of Agric., Case No. 2:05-cv-439-FtM-99DNF, 2007 WL 177857, at *1-2 (M.D. Fla. Jan. 19, 2007) (citing Morrison v. Amway Corp., 323 F.3d 920, 924 n.5 (11th Cir. 2003)). Attacks based on a lack of subject matter jurisdiction come in two forms: facial attacks and factual attacks. Lawrence v. Dunbar, 919 F.2d 1525, 1528-29 (11th Cir. 1990) (internal quotations and alternations omitted); see also Jones v. Waffle House, Inc., Case No. 6:15-cv-1637-Orl-37DAB, 2016 WL 3231298, at *3 (M.D. Fla. June 13, 2016). “Facial attacks on the complaint require the court merely to look and see if the plaintiff has sufficiently alleged a basis of subject matter jurisdiction, and the allegations in his complaint are taken as true for the purposes of the motion.” Lawrence, 919 F.2d at 1529. “Factual attacks, on the other hand, challenge the existence of subject matter jurisdiction in fact, irrespective of the pleadings, and matters outside the pleadings, such as testimony and affidavits, are considered.” Id. Additionally, a court may consider judicially noticed documents. United States ex rel. Osheroff v. Humana Inc., 776 F.3d 805, 811 (11th Cir. 2015); see also Cair Florida, Inc. v. Teotwawki Inv., LLC, Case No. 15-cv-61541-BLOOM/Valle, 2015 WL 11198249, at *2 (S.D. Fla. Nov. 24, 2015); Gibbs v. U.S., 865 F.Supp.2d 1127, 1135 (M.D. Fla. 2012) (court may consider extrinsic evidence in resolving a factual attack to subject matter jurisdiction). Therefore, in resolving the issue of standing, the Court will take judicial notice of the publicly filed probate records relied upon by both parties. See Fed.R.Evid. 201(b) (“The court may judicially notice a fact that is not subject to reasonable dispute because it: is generally known within the trial court's territorial jurisdiction; or can be accurately and readily determined from sources whose accuracy cannot reasonably be questioned.”).

         Florida law establishes that a wrongful death action “shall be brought by the decedent's personal representative.” Fla. Stat. § 768.20 (2015). As such, an individual who is not the decedent's personal representative lacks standing to maintain a wrongful death action. Zaccone v. Ford Motor Co., Case No. 2:15-cv-287-FtM-38CM, 2016 WL 705964, at *1 (M.D. Fla. Feb. 23, 2016); see also Reshard v. Britt, 839 F.2d 1499, 1501 (11th Cir. 1988) (personal representative is the only person who can bring a wrongful death action in Florida on behalf of a decedent's estate) (Tjoflat, J., dissenting on other grounds). However, where the administrator or personal representative of an estate is appointed after the instigation of a wrongful death action, Florida courts have ruled that the appointment relates back to the initiation of the wrongful death proceeding. See Griffin v. Workman, 73 So.2d 844, 846-847 (Fla. 1954); Univ. of Miami v. Wilson, 948 So.2d 774, 777-778 (Fla. Dist. Ct. App. 2006); Bermudez v. Florida Power & Light Co., 433 So.2d 565, 566 (Fla. Dist. Ct. App. 1983). See also Fla. Stat. § 733.601 (“The powers of the personal representative relate back in time to give acts by the person appointed, occurring before appointment and beneficial to the estate, the same effects as those occurring after appointment.”).

         With the foregoing in mind, the Court determines that Mr. Markland has standing to bring this action. Carolyn Markland named her husband as the Personal Representative of her estate in her Last Will and Testament. See Motion, Exhibit 3 at 3, Last Will and Testament of Carolyn S. Markland. Upon her death, Mr. Markland was appointed as the Personal Representative, and proceeded to administer his wife's estate. Id., Exhibit 4 at 2-3, Order Admitting Will to Probate and Appointing Personal Representative; id., Exhibit 1, Petition for Administration; id., Exhibit 2, Oath of Personal Representative, and Designation and Acceptance of Resident Agent. In February and March of 2016, Mr. Markland sought leave of the probate court to close the administration of his wife's estate, or in the alternative, to convert the estate to summary administration, and for discharge from his role as Personal Representative. Id., Exhibit 5, Petition to Close Administration and for Discharge of Personal Representative; id., Exhibit 6, Amended Petition to Close Administration, for Discharge of Personal Representative, and Alternatively for Conversion to Summary Administration. The probate court granted his request and closed Carolyn Markland's estate in April of 2016. Id., Exhibit 8, Order Converting to Summary Administration, Discharge of Personal Representative, and Closing Estate.

         On August 4, 2016, Mr. Markland filed this wrongful death action against Insys. Given that Carolyn Markland's estate was closed and Mr. Markland was no longer the Personal Representative for the estate, he lacked standing at that time. See Zaccone, 2016 WL 705964, at *1 (an individual who is not the decedent's personal representative lacks standing to bring a wrongful death action). However, in September of 2016, the probate court reappointed Mr. Markland as the Personal Representative for the estate. See Reply, Exhibit 3, Order Appointment Personal Representative; id., Exhibit 4, Letters of Administration. Pursuant to Florida law, the probate court's September 2016 reappointment of Mr. Markland as Personal Representative of Carolyn Markland's estate relates back to Mr. Markland's initial filing of the wrongful death action. See Fla. Stat. § 733.601 (“The powers of the personal representative relate back in time to give acts by the person appointed, occurring before appointment and beneficial to the estate, the same effects as those occurring after appointment.”); see also Griffin, 73 So.2d at 846-847; Univ. of Miami, 948 So.2d at 777-778; Bermudez, 433 So.2d at 566. Therefore, Mr. Markland has standing to pursue this action, and the Court rejects Insys' argument that this matter should be dismissed for lack of standing.

         b. Failure to state a claim upon which ...


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