Ganz v. Grifols Therapeutics LLC

688 F.Supp.3d 1209

Vivian GANZ, individually and on behalf of the Estate of Andrew Ganz, Plaintiff, v. GRIFOLS THERAPEUTICS LLC and Grifols Shared Services North America, Inc., Defendants.

CASE NO. 21-82072-CIV-CANNON/Reinhart

United States District Court, S.D. Florida, West Palm Beach Division

Signed August 22, 2023

Katherine Ann Kiziah, Searcy Denney Scarola Barnhart and Shipley, P.A., West Palm Beach, FL, Steven D. Davis, TorHoerman Law LLC, Edwardsville, IL, for Plaintiff.

Matthew Seth Podolnick, Stearns Weaver Miller Weissler Alhadeff & Sitterson, PA, Fort Lauderdale, FL, Gabriel I. Schonfeld, Pro Hac Vice, Sidley Austin

LLP, Washington, DC, Michelle A. Ramirez, Pro Hac Vice, Sidley Austin LLP, Chicago, IL, Eric S. Roth, Stearns Weaver Miller Weissler Alhadeff & Sitterson, P.A., Miami, FL, for Defendants.

ORDER GRANTING IN PART AND DENYING IN PART DEFENDANTS' MOTION TO DISMISS

AILEEN M. CANNON, UNITED STATES DISTRICT JUDGE

THIS CAUSE comes before the Court upon Defendants' Motion to Dismiss Plaintiff's Complaint (the "Motion") [ECF No. 15]. The Motion seeks dismissal for lack of personal jurisdiction over Defendant Shared Services North America, Inc. under Rule 12(b)(2) as well as dismissal of the Complaint in its entirety for failure to state a claim upon which relief can be granted under Rule 12(b)(6). The Court has reviewed the Complaint [ECF No. 1-2], the Motion [ECF No. 15], Plaintiff's Response in Opposition [ECF No. 19], Defendants' Reply [ECF No. 20], and the full record. For the reasons set forth below, Defendants' Motion [ECF No. 15] is GRANTED IN PART AND DENIED IN PART. Plaintiff is granted one final opportunity to file an Amended Complaint in accordance with this Order as set forth below.

FACTUAL BACKGROUND¹

Plaintiff Vivian Ganz is a citizen of the State of Florida [ECF No. 1-2 ¶ 2]. She is bringing a lawsuit in her individual capacity and also on behalf of the estate of her deceased husband, Andrew Ganz, who was a citizen of Florida until his death on October 8, 2019 [ECF No. 1-2 p. 5 ¶¶ 2, 4].

Defendant Grifols Therapeutics LLC ("Grifols") is a Delaware company with its principal place of business in Research Triangle Park, North Carolina [ECF No. 1-2 p. 6 ¶ 6]. Defendant Grifols Shared Services North America, Inc. ("Shared Services") is a Virginia corporation with its principal place of business in Los Angeles, California [ECF No. 1-2 p. 6 ¶ 6]. Shared Services is a holding company [ECF No. 15-2 ¶ 3] and is the sole member of Grifols [ECF No. 1-2 p. 6 ¶ 6].

Grifols manufactures a prescription drug approved by the Federal Drug Administration ("FDA") called Gamunex [ECF No. 1-2 p. 7 ¶ 8]. Gamunex is an immune globulin injection ("IGIV") that is used to treat autoimmune diseases such as primary humoral immunodeficiency, idiopathic thrombocytopenic purpura, and chronic inflammatory demyelinating polyneuropathy [ECF No. 1-2 p. 7 ¶ 8; see ECF No. 15-1 p. 5 (FDA-approved labeling for Gamunex-C)]. Andrew Ganz suffered from an autoimmune disease and was treated with Gamunex for the first time on February 18, 2019 [ECF No. 1-2 p. 7 ¶¶ 12, 14]. His doctors continued to treat him with Gamunex through August 6, 2019 [ECF No. 1-2 p. 7 ¶ 14]. On August 15, 2019, Andrew Ganz was diagnosed with serum sickness [ECF No. 1-2 p. 8 ¶ 15], which is a form of a hypersensitivity reaction that can be caused by Gamunex [ECF No. 1-2 p. 8 ¶ 16]. On October 8, 2019, Andrew Ganz died from serum sickness [ECF No. 1-2 p. 8 ¶ 15].

Around the time of Andrew Ganz's final treatment of Gamunex, Grifols voluntarily recalled certain lots of Gamunex due to an increase in hypersensitivity reactions in those lots [ECF No. 1-2 p. 8 ¶ 16]. Based on the same increased frequency of hypersensitivity reactions, Grifols subsequently recalled additional lots of Gamunex over the course of 2019, 2020, and 2021 [ECF No. 1-2 p. 8 ¶ 16].

Gamunex's FDA-approved label that was in place throughout Andrew Ganz's treatment referenced the risk of hypersensitivity reactions seventeen times [ECF No. 15-1 pp. 105-43 (FDA-approved label for Gamunex in effect from June 2018 through January 2020)]. The first page of the label warned that certain patients were at a greater risk of developing a severe hypersensitivity reaction [ECF No. 15-1 p. 105]. It instructed that epinephrine should be available to immediately treat any acute severe hypersensitivity reaction [ECF No. 15-1 p. 105]. The risk of severe hypersensitivity is also listed first under the "Warning and Precautions" subheading of the Gamunex label [ECF No. 15-1 p. 113]. In conducting a review of the safety of Gamunex following Grifols' voluntary withdrawal of certain lots, the FDA concluded in September 2020 that the risk of hypersensitivity was adequately described in Gamunex's labeling [ECF No. 19-1 p. 33 (FDA Addendum Memorandum)].

PROCEDURAL HISTORY

Based on the facts above, Plaintiff filed suit in the Fifteenth Judicial Circuit in and for Palm Beach County, Florida, on October 8, 2021 [ECF No. 1-2 (Case No. 021-CA-011452)]. Defendants subsequently removed the action to this Court, asserting diversity jurisdiction under 28 U.S.C. § 1332(a)(1) [ECF No. 1 p. 2]. Plaintiff brings the following claims against Defendants:

• Count I - Negligence;

• Count II - Strict Liability - Manufacturing Defect;

• Count III - Strict Liability - Design Defect;

• Count IV - Strict Liability - Failure to Warn; and

• Count V - Loss of Consortium

[ECF No. 1-2 ¶¶ 17-48].

On December 6, 2021, both Defendants filed the instant Motion pursuant to Rule 12(b)(6), arguing that Plaintiff fails to state a claim upon which relief can be granted [ECF No. 15]. In support of the 12(b)(6) motion, Defendants argue that (1) Plaintiff's claims based on design defect and failure to warn theories (Counts III and IV) are preempted by federal law [ECF No. 15 pp. 15-19]; (2) those same counts are barred by the "Government Rules Defense" in Fla. Stat. § 768.1256 [ECF No. 15 pp. 15-22]; and (3) Plaintiff has failed to sufficiently plead facts to state any plausible claim for relief [ECF No. 15 pp. 22-24]. Defendant Shared Services also moves to dismiss the Complaint in its entirety for lack of personal jurisdiction under Rule 12(b)(2) [ECF No. 15 pp. 24-27]. The Motion is ripe for adjudication.

LEGAL STANDARD

Rule 12(b)(2) Standard

"Because federal courts ordinarily follow state law in determining the bounds of their jurisdiction over persons, a federal court sitting in Florida must conduct a two-step inquiry to determine whether it has personal jurisdiction over [a] non-resident defendant." Atmos Nation LLC v. Alibaba Grp. Holding Ltd., No. 15-CV-62104, 2016 WL 1028332, at *2 (S.D. Fla. Mar. 15, 2016) (citing Daimler AG v. Bauman, 571 U.S. 117, 134 S. Ct. 746, 753, 187 L.Ed.2d 624 (2014)). Specifically, a federal court sitting in Florida must consider (1) whether personal jurisdiction exists over the non-resident defendant under Florida's long-arm statute, and (2) whether that exercise of jurisdiction would violate the Due Process Clause of the Fourteenth Amendment to the U.S. Constitution. Louis Vuitton Malletier, S.A. v. Mosseri, 736 F.3d 1339, 1350 (11th Cir. 2013) (citing Mutual Serv. Ins. Co. v. Frit Indus., Inc., 358 F.3d 1312, 1319 (11th Cir. 2004)). If personal jurisdiction is improper under either Florida's long-arm statute or the U.S. Constitution, then the court lacks jurisdiction over the non-resident defendant.

In all cases, "[a] plaintiff seeking the exercise of personal jurisdiction over a non-resident defendant bears the initial burden of alleging in the complaint sufficient facts to make out a prima facie case of jurisdiction." United Techs. Corp. v. Mazer, 556 F.3d 1260, 1274 (11th Cir. 2009) (citing Posner v. Essex Ins. Co., 178 F.3d 1209, 1214 (11th Cir. 1999)). "A prima facie case is established if the plaintiff presents enough evidence to withstand a motion for directed verdict." Madara v. Hall, 916 F.2d 1510, 1514 (11th Cir. 1990) (citing Morris v. SSE, Inc., 843 F.2d 489, 492 (11th Cir. 1988)). If the defendant submits affidavits contrary to the allegations in the complaint, "the burden shifts back to the plaintiff to produce evidence supporting personal jurisdiction, unless the defendant's affidavits contain only conclusory assertions that the defendant is not subject to jurisdiction." Stubbs v. Wyndham Nassau Resort & Crystal Palace Casino, 447 F.3d 1357, 1360 (11th Cir. 2006) (citing Meier ex rel. Meier v. Sun Intern. Hotels, Ltd., 288 F.3d 1264, 1269 (11th Cir. 2002)). "Where the plaintiff's complaint and supporting evidence conflict with the defendant's affidavits, the court must construe all reasonable inferences in favor of the plaintiff." Meier, 288 F.3d at 1269 (citing Madara v. Hall, 916 F.2d 1510, 1514 (11th Cir. 1990)). Regardless of how the district court proceeds—whether it considers the motion to dismiss under a prima facie standard based on the complaint and any affidavits (as it does here), or whether it conducts an evidentiary hearing to weigh evidence and determine the credibility of witnesses—"the plaintiff must eventually, by the close of the evidence, establish personal jurisdiction by a preponderance of the evidence." AcryliCon USA, LLC v. Silikal GmbH, 985 F.3d 1350, 1364 (11th Cir. 2021).

Rule 12(b)(6) Standard

A pleading in a civil action must contain "a short and plain statement of the claim showing that the pleader is entitled to relief." Fed. R. Civ. P. 8(a)(2). To satisfy Rule 8, a complaint must provide the defendant fair notice of what the plaintiff's claim is and the grounds upon which it rests. Swierkiewicz v. Sorema N.A., 534 U.S. 506, 512, 122 S.Ct. 992, 152 L.Ed.2d 1 (2002). While a complaint "does not need detailed factual allegations," it must provide "more than labels and conclusions" or "a formulaic recitation of the elements of a cause of action." Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007); see Ashcroft v. Iqbal, 556 U.S. 662, 678, 129 S.Ct....