Shands Jacksonville Med. Ctr. v. Azar

SHANDS JACKSONVILLE MEDICAL CENTER, INC.,a Florida non-profit corporation d/b/a UF Health Jacksonville Plaintiff, v. ALEX AZAR, in his official capacity as Secretary of the United States Departmentof Health & Human Services and NADIA CARO, Defendants.

Case No. 3:19-cv-579-J-32MCR

UNITED STATES DISTRICT COURT MIDDLE DISTRICT OF FLORIDA JACKSONVILLE DIVISION

June 10, 2020

ORDER

This case presents questions concerning federalism and the relationship between federal and state courts. Plaintiff Shands Jacksonville Medical Center, Inc. contends that the Patient Safety and Quality Improvement Act ("Federal Act"), 42 U.S.C. §§ 299b-21-299b-26—which allows certain healthcare organizations to document and share particular information without redress—preempts Article X, § 25(a) of the Florida Constitution, commonly referred to as Amendment 7—which provides Florida patients the "right to have access to any records made or received in the course of business by a health care facility or provider relating to any adverse medical incident." In 2017, the Florida Supreme Court disagreed with Shands's position, holding that the Federal Act did not preempt Amendment 7. Charles v. S. Baptist Hosp., 209 So. 3d 1199, 1216 (Fla.), cert. denied, 138 S. Ct. 129, 130 (2017). Defendants Alex Azar, in his official capacity as Secretary of the United States Department of Health & Human Services ("HHS") and Nadia Caro, a former Shands patient, argue that this Court lacks subject matter jurisdiction to address the preemption issue. The Court agrees; thus, this case must be dismissed for lack of jurisdiction.

This case is before the Court on HHS's Motion to Dismiss, (Doc. 25), and Caro's Motion to Dismiss, (Doc. 33), to which Shands responded in opposition, (Docs. 28, 40). HHS's motion argues, inter alia, that Shands lacks standing. (Doc. 25). Caro's motion contends, inter alia, that the Court lacks subject matter jurisdiction. (Doc. 33). On May 8, 2020, the Court held a hearing on the motions, the record of which is incorporated herein.

I. BACKGROUND

A. Facts

Caro has requested adverse medical incident documents relating to her care at Shands. (Docs. 18 ¶¶ 9-10; 49 at 3). Shands has information that Caro believes is responsive, but Shands contends is privileged under the Federal Act. (Doc. 18 ¶ 11). Shands alleges that if it complies with Caro's request—which Florida state courts will likely compel it to do—it will violate the Federal Actand be subjected to mandatory penalties imposed by HHS. Id. ¶¶ 45-47, 53. Thus, Shands filed this federal action seeking a declaration that: (1) certain patient safety work product ("PSWP") Caro requested is protected under the Federal Act and not subject to disclosure; (2) the Federal Act preempts Amendment 7, insofar as Amendment 7 requires disclosure of information protected by the Federal Act; and (3) Caro's assertion of her Amendment 7 rights, as interpreted by the Florida Supreme Court, violates Shands's equal protection rights. Id. ¶ 50. Further, Shands seeks to enjoin Caro from "pursuing her request for the privileged information" or in the alternative enjoining HHS from imposing a penalty against Shands for violating the Federal Act if required to disclose the information by a Florida state court. Id. ¶¶ 55-56.

B. Amendment 7 and the Federal Act

Amendment 7 provides patients the "right to have access to any records made or received in the course of business by a health care facility or provider relating to any adverse medical incident." Art. X, § 25(a), Fla. Const. Shands alleges that "[t]he Florida Supreme Court's construction [of Amendment 7] has left health care facilities and providers essentially no discretion or defenses in providing documents in response to broad Amendment 7 requests." (Doc. 18 ¶ 15).

The Federal Act, enacted in 2005, was implemented to "facilitate an environment in which health care providers are able to discuss errors openlyand learn from them" by making privileged "information reported to patient safety organizations for the purposes of quality improvement and patient safety." H.R. Rep. No. 109-197, at 9 (2005). Additionally, the Federal Act authorizes HHS to impose sanctions against organizations that violate the Federal Act's privilege provisions. 42 U.S.C. § 299b-22(f) (2018). However, the Florida Supreme Court determined that "Congress did not intend to preempt state laws or Amendment 7 through the passage of the Federal Act." Charles, 209 So. 3d at 1216. Thus, Shands alleges it is stuck between a rock and a hard place—if ordered to comply with Caro's request it will either be subject to monetary sanctions by HHS if it complies, or contempt of state court if it does not.

II. JURISDICTION

A. Shands's Standing to Sue HHS

HHS seeks dismissal asserting that Shands lacks standing because any action HHS might take against Shands in the future is not imminent. (Doc. 25 at 9-10). Shands contends that fines by HHS are "certainly impending" and therefore it has standing. (Doc. 28 at 10-12).

To satisfy the "'irreducible constitutional minimum' of standing," the "plaintiff must have (1) suffered an injury in fact, (2) that is fairly traceable to the challenged conduct of the defendant, and (3) that is likely to be redressed by a favorable judicial decision." Spokeo, Inc. v. Robins, 136 S. Ct. 1540, 1547(2016) (quoting Lujan v. Defs. of Wildlife, 504 U.S. 555, 560 (1992)). "To establish injury in fact, a plaintiff must show that [it] suffered 'an invasion of a legally protected interest' that is 'concrete and particularized' and 'actual or imminent, not conjectural or hypothetical.'" Id. at 1548 (quoting Lujan, 504 U.S. at 560). "An allegation of future injury may suffice if the threatened injury is 'certainly impending,' or there is a 'substantial risk that the harm will occur.'" Susan B. Anthony List v. Driehaus, 573 U.S. 149, 158 (2014) (quoting Clapper v. Amnesty Int'l USA, 568 U.S. 398, 409 (2013)).

"When an individual is subject to the threatened enforcement of a law, an actual arrest, prosecution, or other enforcement action is not a prerequisite to challenging the law." Wollschlaeger v. Governor, Fla., 848 F.3d 1293, 1304 (11th Cir. 2017) (en banc) (alteration adopted) (quoting Driehaus, 573 U.S. at 160). "[A] plaintiff satisfies the injury-in-fact requirement where he alleges 'an intention to engage in a course of conduct arguably affected with a constitutional interest, but proscribed by a statute, and there exists a credible threat of prosecution thereunder.'" Driehaus, 573 U.S. at 160 (quoting Babbitt v. Farm Workers, 442 U.S. 289, 298 (1979)). The credible threat of prosecution must be objectively reasonable. See Wollschlaeger, 848 F.3d at 1304; ACLU v. The Fla. Bar, 999 F.2d 1486, 1492 n.13 (11th Cir. 1993).

In Driehaus, the plaintiffs challenged an Ohio law prohibiting false statements during a political campaign. 573 U.S. at 151-52. In determiningwhether the pre-enforcement challenge was justiciable, the Supreme Court analyzed three factors in concluding that the plaintiffs had alleged a credible threat of enforcement. Id. at 161-64. First, the Court looked at whether the plaintiffs alleged "an intention to engage in a course of conduct arguably affected with a constitutional interest." Id. at 161 (quoting Babbitt, 442 U.S. at 298). In Driehaus, the plaintiffs asserted First Amendment rights to engage in speech they contended was prohibited by the challenged statutes. Id. (speech criticizing congressional representatives' votes for the Affordable Care Act as supporting abortion); see also Wollschlaeger, 848 F.3d at 1304 (speech by physicians asking patients about firearm ownership). Second, the Court analyzed whether the plaintiffs' "intended future conduct [was] 'arguably . . . proscribed by [the] statute' they wish[ed] to challenge." Driehaus, 573 U.S. at 162 (quoting Babbitt, 442 U.S. at 298). Third, the Court considered whether "the threat of future enforcement of the [challenged] statute [was] substantial." Id. at 164. Specifically, the Court found significant that the statute at issue had a history of past enforcement, complaints asserting a violation of the statute could be lodged by anyone, and enforcement proceedings were "not a rare occurrence." Id.

Even granting, arguendo, that Shands meets the first Driehaus requirement, Shands cannot satisfy the second or third requirements. Shands asserts it does not intend to disclose PSWP unless ordered by a court to do so,Caro has revised her document request to no longer require Shands to produce PSWP, and HHS asserts that Caro's Amended Amendment 7 Request (Doc. 49 at 3) likely does not seek PSWP. Thus, HHS and Caro seem to agree that producing documents in compliance with Caro's narrowed request is not proscribed by the Federal Act. Cf. Driehaus, 573 U.S. at 162. Further, future enforcement of the Federal Act is unlikely. HHS has sole authority to impose sanctions for violating the Federal Act and, per its counsel at the hearing, it has never done so in the fifteen years since the Federal Act's passage. Despite arguing that the penalty provisions are mandatory, Shands admitted at the hearing that other hospitals have produced PSWP without being penalized by HHS.¹ Thus, even if the string of contingent, necessary prerequisites occur—Caro requests privileged documents, the state court orders Shands to produce them, and Shands produces them—it is unlikely that HHS will impose sanctions against Shands. See Driehaus, 573 U.S. at 164; cf. Wollschlaeger, 848 F.3d at 1304 (finding credible threat of prosecution where plaintiffs averred to engage in conduct proscribed by statute, Florida had vigorously defended thechallenged act, and the enforcement agency had been inconsistent in its position).

Shands's alleged injury is not "'certainly impending,' [nor is] there . . . a 'substantial risk that the harm will occur.'" Driehaus, 573 U.S. at 158 (quoting Clapper, 568 U.S. at 409). Accordingly, Shands lacks standing to...