GANZ v. GRIFOLS THERAPEUTICS LLC (2023)

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

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 BACKGROUND 1

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. 1937, 173 L.Ed.2d 868 (2009) (explaining that the Rule 8(a)(2) pleading standard “demands more than an unadorned, the-defendant-unlawfully-harmed-me accusation”). Nor can a complaint rest on “ ‘naked assertion[s]’ devoid of ‘further factual enhancement.’ ” Iqbal, 556 U.S. at 678, 129 S.Ct. 1937 (quoting Twombly, 550 U.S. at 557, 127 S.Ct. 1955 (alteration in original)). The Supreme Court has emphasized that, “[t]o survive a motion to dismiss[,] a complaint must contain sufficient factual matter, accepted as true, to ‘state a claim to relief that is plausible on its face.’ ” Iqbal, 556 U.S. at 678, 129 S.Ct. 1937 (quoting Twombly, 550 U.S. at 570, 127 S.Ct. 1955); see also Am. Dental Assoc. v. Cigna Corp., 605 F.3d 1283, 1288–90 (11th Cir. 2010).

When reviewing a motion to dismiss, a court must accept the plaintiff's allegations as true and evaluate all plausible inferences derived from those facts in favor of the plaintiff. See Iqbal, 556 U.S. at 678, 129 S.Ct. 1937; Chaparro v. Carnival Corp., 693 F.3d 1333, 1337 (11th Cir. 2012). A court is generally limited to the facts contained in the complaint and attached exhibits, including documents referred to in the complaint that are central to the claim. See, e.g., Wilchombe v. TeeVee Toons, Inc., 555 F.3d 949, 959 (11th Cir. 2009). Courts may also take judicial notice of public records and government publications when ruling on a 12(b)(6) motion, including the fact that a prescription drug has been approved by the FDA, along with the contents of its labeling. See, e.g., Coastal Wellness Ctrs., Inc. v. Progressive Am. Ins. Co., 309 F. Supp. 3d 1216, 1220 n.4 (S.D. Fla. 2018); Dye v. Covidien LP, 470 F. Supp. 3d 1329, 1338, 1338 n.2, 1339, 1339 n.4 (S.D. Fla. 2020).

DISCUSSION

I. Personal Jurisdiction

Defendant Shared Services argues that it should be dismissed from this action due to a lack of personal jurisdiction. According to Shared Services, it lacks sufficient contacts with Florida to establish general jurisdiction, and Plaintiff has not justified the exercise of specific jurisdiction under Florida's long-arm statute [ECF No. 15 pp. 24–27]. In support of its position, Shared Services submitted a declaration signed by David Pierce, the Corporate Secretary of Shared Services (the “Pierce Declaration”) [ECF No. 15-2]. Pierce asserts that Shared Services is a Virginia corporation with its principal place of business in Los Angeles, California [ECF No. 15-2 ¶ 2]. Plaintiff concedes these facts [ECF No. 1-2 ¶ 6]. Pierce also states that Shared Services is a holding company that does not design, manufacture, sell, market, or distribute Gamunex in Florida or anywhere else [ECF No. 15-2 ¶¶ 3–4]. Instead, according to the undisputed Pierce Affidavit, Shared Services provides support services to its separately organized subsidiaries [ECF No. 15-2 ¶ 7]. Mr. Pierce avers that Shared Services’ contacts with Florida are limited to eight employees who reside within the State, none of whom perform any work related to Gamunex [ECF No. 15-2 ¶¶ 9–14].

Although Plaintiff frames the Pierce Declaration as supporting a finding of personal jurisdiction, Plaintiff does not counter any of Pierce's statements or provide facts or evidence to rebut those statements [ECF No. 19 pp. 27–30]. Nor does Plaintiff invoke any specific-jurisdiction provision of Florida's long-arm statute, see Fla. Stat. § 48.193(1), focusing on general jurisdiction principles only, see Fla. Stat. § 48.193(2) [ECF No. 20 pp. 13–14].

A. General Jurisdiction

Section 48.193(2) of Florida's long-arm statute authorizes courts to establish general jurisdiction over a defendant “who is engaged in substantial and not isolated activity within the state, whether such activity is wholly interstate, intrastate, or otherwise ․ whether or not the claim arises from that activity.” Fla. Stat. § 48.193(2). “[T]his provision extends to the limits on personal jurisdiction imposed by the Due Process Clause of the Fourteenth Amendment.” Fraser v. Smith, 594 F.3d 842, 846 (11th Cir. 2010). Therefore, to determine if personal jurisdiction exists in this case, the Court “need only determine whether the district court's exercise of jurisdiction over [Shared Services] would exceed constitutional bounds.” Id. A court may assert general jurisdiction over a defendant corporation only where the corporation's contacts with the State “are so constant and pervasive ‘as to render [it] essentially at home in the forum State.’ ” Daimler AG, 571 U.S. at 122, 134 S.Ct. 746 (quoting Goodyear Dunlop Tires Operations, S.A. v. Brown, 564 U.S. 915, 919, 131 S.Ct. 2846, 180 L.Ed.2d 796 (2011)). A corporation is considered at home at its place of incorporation and its principal place of business. Waite v. All Acquisition Corp., 901 F.3d 1307, 1317 (11th Cir. 2018). “Outside of [the corporation's principal place of business and place of incorporation], a defendant's operations will be so substantial and of such a nature as to render the corporation at home in that [s]tate only in an exceptional case.” Id. To determine whether an “exceptional case” exists, courts must consider whether “the corporation's activities in the forum closely approximate the activities that ordinarily characterize a corporation's place of incorporation or principal place of business.” Id. at 1218 (quoting Carmouche v. Tamborlee Mgmt., Inc., 789 F.3d 1201, 1205 (11th Cir. 2015)).

The Complaint in this case is devoid of any non-conclusory jurisdictional allegations fairly supporting a conclusion that Shared Services engages in substantial and not isolated business activity in Florida. Shared Services makes a factual challenge to these conclusory allegations by attaching David Pierce's Declaration to the Motion to Dismiss [ECF No. 15-2]. Specifically, Mr. Pierce notes that Shared Services’ only contacts with Florida consist of eight employees who reside in the State, six of whom work in information technology or employee benefits [ECF No. 15-2 ¶ 13]. Two other employees include the Vice President of the Bio Supplies division, whom Mr. Pierce states has no responsibilities related to Gamunex, and a medical science liaison whom Mr. Pierce asserts has no role in marketing, promoting, or soliciting the sale or use of Gamunex [ECF No. 15-2 ¶ 13]. Plaintiff provides no facts to refute Mr. Pierce's submission, instead conceding that Shared Services is incorporated in Virginia with its principal place of business in California [ECF No. 1-2 p. 6 ¶ 6].

On this record, Shared Services’ minimal connections in Florida do not come close to approximating the continuous and pervasive corporate contacts necessary to establish general jurisdiction, much less to satisfying the “exceptional case” of a corporation's activities in the forum closely resembling the activities of a place of incorporation or place of business. Accordingly, Defendant Shared Services is not deemed at home in Florida, and the Court cannot exercise general jurisdiction over Shared Services.

B. Specific Jurisdiction

As noted, in the Response, Plaintiff does not cite to any specific jurisdiction provision of Florida's long-arm statute [ECF No. 19]. See Fla. Stat. § 48.193(1). Nevertheless, to the extent Plaintiff's general-jurisdiction arguments appear to suggest a basis for the exercise of specific personal jurisdiction, such argument fails. Plaintiff states, for example, that (1) the medical science liaison “may have engaged in the precise conduct Plaintiff alleges was improper” [ECF No. 19 pp. 28–29]; and (2) “it is ambiguous as to whether the Bio Supplies division provided raw materials or ingredients for Gamunex, provided materials for research related to Gamunex, or provided materials related to clinical trials for Gamunex” [ECF No. 19 p. 30]. These speculative arguments are contrary to the unrefuted Pierce Declaration and do not support the exercise specific personal jurisdiction over Shared Services. See City Pension Fund for Firefighters and Police Officers in City of Miami Beach v. Aracruz Cellulose S.A., 41 F. Supp. 3d 1369, 1405 (S.D. Fla. 2011) (determining that “conclusory and speculative allegations fail to support personal jurisdiction”). After Mr. Pierce presented facts in his Declaration contradicting the Complaint's assertion of personal jurisdiction, the burden shifted back to Plaintiff to produce evidence supporting the exercise of jurisdiction under a particular provision of Florida's long-arm statute. Stubbs, 447 F.3d at 1360 (11th Cir. 2006) (citing Meier ex rel. Meier v. Sun Intern. Hotels, Ltd., 288 F.3d 1264, 1269 (11th Cir. 2002)). Plaintiff failed to provide any evidence to the contrary. And more broadly, Florida's long-arm statute must be strictly construed. See Sculptchair, Inc. v. Century Arts, Ltd., 94 F.3d 623, 627 (11th Cir. 1996). In sum, Plaintiff has not supplied a basis from which to exercise specific personal jurisdiction over Shared Services.

C. Jurisdictional Discovery is Unwarranted

As a final attempt, Plaintiff in the Opposition makes a cursory request for leave to conduct jurisdictional discovery to help support the notion that Shared Services is subject to this Court's jurisdiction [ECF No. 19 p. 27]. This is a procedurally improper way to request jurisdictional discovery. See United Techs. Corp. v. Mazer, 556 F.3d 1260, 1280–81 (11th Cir. 2009) (finding no abuse of discretion in court's dismissal on personal-jurisdiction grounds where party opposing personal jurisdiction buried request for jurisdictional discovery in its briefs and never formally moved for jurisdictional discovery).² In any event, the request for jurisdictional discovery is not warranted, where, as here, there is “no genuine dispute on a material fact to warrant jurisdictional discovery.” Snyder v. Royal Caribbean Cruises Ltd., 540 F. Supp. 3d 1175, 1183 (S.D. Fla. 2021) (quoting Peruyero v. Airbus S.A.S., 83 F. Supp. 3d 1283, 1290 (S.D. Fla. 2014) (internal quotations omitted)); see also Yepez v. Regent Seven Seas Cruises, No. 10-23920-CIV, 2011 WL 3439943, at *1 (S.D. Fla. Aug. 5, 2011) (“[T]he failure of a plaintiff to investigate jurisdictional issues prior to filing suit does not give rise to a genuine jurisdictional dispute.”). Plaintiff has not provided any factual support to rebut the Pierce declaration, relying instead on speculative claims about Shared Services’ operations in Florida. And the passing request for jurisdictional discovery does not identify any genuine disputes of fact that would warrant opening jurisdictional discovery [ECF No. 19 pp. 27–30; see ECF No. 27 pp. 4–6].

II. Preemption of Plaintiff's Design Defect and Failure to Warn Claims

The Supremacy Clause of the U.S. Constitution provides that the Constitution and the laws of the United States “shall be the supreme Law of the Land.” U.S. Const. Art. VI, cl. 2. In accordance with the Supremacy Clause, the Supreme Court has recognized three circumstances in which Congress may preempt state law. English v. General Elec. Co., 496 U.S. 72, 78, 110 S.Ct. 2270, 110 L.Ed.2d 65 (1990). “First, Congress can define explicitly the extent to which its enactments pre-empt state law, [Express Preemption].” Id. “Second, in the absence of explicit statutory language, state law is pre-empted where it regulates conduct in a field that Congress intended the Federal Government to operate exclusively, [Field Preemption].” Id. at 79, 110 S.Ct. 2270. “[Third], state law is pre-empted to the extent that it actually conflicts with federal law [Conflict Preemption].” Id. As asserted by Defendants and relevant here, impossibility preemption, a form of conflict preemption, occurs “when it is impossible for a private party to comply with both state and federal requirements.” Merck Sharp & Dohme Corp. v. Albrecht, ––– U.S. ––––, 139 S. Ct. 1668, 1672, 203 L.Ed.2d 822 (2019) (citation and internal quotations omitted). In such cases, a court must find that the record demonstrates an “inevitable collision” between the state and federal schemes; “dissimilarity of the standards” is not enough. Fla. Lime & Avocado Growers, Inc. v. Paul, 373 U.S. 132, 143, 83 S.Ct. 1210, 10 L.Ed.2d 248 (1963).

Grifols argues that Count III (Strict Liability for a Design Defect) and Count IV (Strict Liability for Failure to Warn) are preempted because it would have been impossible for Grifols to comply simultaneously with both its state duties to change the design and label of Gamunex and its federal duties under 21 C.F.R. § 601.12(b)(2)(i), (b)(2)(vi)³ and 601.12(f)(1)⁴ not to make such changes absent FDA approval. Specifically, Grifols argues that, because it cannot, under the applicable FDA regulations, unilaterally make a change to either the design or label of Gamunex, it cannot comply with any duty imposed by Florida law that requires it to do so. Similarly, Grifols argues that, to the extent Count I (Negligence) is based on an alleged design defect or failure to warn theory, that Count is preempted for the same reasons Count III and IV are preempted.

A. Relevant Supreme Court Authority

The Court is guided by the following Supreme Court decisions, each of which addresses preemption in the drug context.

In Wyeth v. Levine, 555 U.S. 555, 129 S.Ct. 1187, 173 L.Ed.2d 51 (2009), a consumer sued the brand-name manufacturer of a drug based on negligence and strict-liability theories under Vermont law. Id. The consumer alleged that the manufacturer failed to provide an adequate warning of the dangers of administering the drug using an IV-push rather than an IV-drip and should have directed doctors to use the IV-drip method only. Id. at 558–61, 129 S.Ct. 1187. The manufacturer asserted that it would have been impossible for him “to comply with the state-law duty to modify [the label] without violating federal law,” meaning that plaintiff's claim was preempted by federal law. Id. at 563, 129 S.Ct. 1187. The Supreme Court disagreed, holding that the failure to warn claim was not preempted because the regulations governing the labeling of drugs permitted a brand-name manufacturer to unilaterally strengthen the warnings on its label without seeking FDA approval. Id. at 573, 129 S.Ct. 1187. “Absent clear evidence that the FDA would not have approved a change” to the label, the Court could not conclude that it was impossible for the manufacturer to comply with both federal and Vermont requirements. Id. at 571, 129 S.Ct. 1187. The Court noted that the manufacturer “offered no such evidence,” and “the mere fact that the FDA approved [the manufacturer's] label [did] not establish that it would have prohibited such a change.” Id. at 572–73, 129 S.Ct. 1187. See also Merck Sharp & Dohme Corp. v. Albrecht, ––– U.S. ––––, 139 S. Ct. 1668, 1675–79, 203 L.Ed.2d 822 (2019) (holding that the “clear evidence” standard articulated in Wyeth is “a matter of law for the judge to decide” by inquiring “whether the relevant federal and state laws ‘irreconcilably conflict’ ”) (citing Rice v. Norman Williams Co., 458 U.S. 654, 659, 102 S.Ct. 3294, 73 L.Ed.2d 1042 (1982)).

A couple of years later, in PLIVA, Inc. v. Mensing, 564 U.S. 604, 131 S.Ct. 2567, 180 L.Ed.2d 580 (2011), the Supreme Court again addressed the issue of preemption in a failure to warn case, this time in the context of a generic drug manufacturer's alleged failure to strengthen its label after initial FDA approval of the brand-name manufacturers’ label. Id. at 608–09, 131 S.Ct. 2567. Consumers in PLIVA, Inc. alleged that generic drug manufacturers failed to provide adequate warnings on their labels about the risks associated with taking those generic drugs. Id. at 610, 131 S.Ct. 2567. The dispute before the Court was “whether, and to what extent, generic manufacturers may change their labels after initial FDA approval.” Id. at 613, 131 S.Ct. 2567 (italics in original). Relying on the FDA's interpretation of its regulations, the Supreme Court determined that the consumers’ labeling-defect claims were preempted by federal law, because the generic manufacturers were required to use the same label as brand-name manufacturers—and hence could not change their label without the brand-name manufacturers first making a change or without first notifying the FDA about the need for a change and obtaining FDA approval. Id. at 615–17, 131 S.Ct. 2567. In light of those restrictions, the Court held, the generic manufacturers could not have unilaterally changed their labels to comply with state law, triggering federal preemption. Id. at 623–24, 131 S.Ct. 2567.

Finally, in Mutual Pharm. Co. v. Bartlett, 570 U.S. 472, 133 S.Ct. 2466, 186 L.Ed.2d 607 (2013), a consumer of a generic drug brought a design defect claim against the generic drug manufacturer alleging the drug was unreasonably dangerous. Id. at 475, 133 S.Ct. 2466. Under the state law at issue, a manufacturer could satisfy its state duty to ensure the drug was reasonably safe either by changing its design or by changing its labeling. Id. at 482, 133 S.Ct. 2466. As the Supreme Court explained, however, the first option was unavailable to the manufacturer, both as a matter of federal law and basic chemistry, id. at 484, 133 S.Ct. 2466, leaving the manufacturer with a change in labeling as the only means to escape state liability, id. at 483–84, 133 S.Ct. 2466. But that labeling change was not possible under the rationale in PLIVA, Inc., 564 U.S. at 617, 131 S.Ct. 2567, the Supreme Court explained, because federal law expressly prohibits manufacturers of generic drugs from making unilateral changes to a drug's label. Mutual Pharm. Co., 570 U.S. at 486–87, 133 S.Ct. 2466. In that circumstance, the Court deemed the state law action preempted because it was impossible for the generic drug manufacturer to comply with both with its state-law duty to strengthen the warnings on the label and the federal-law duty not to alter the label. Id. at 487, 133 S.Ct. 2466. Nor, the Court continued, was it an answer to say that the manufacturer simply could decide not to make the product at all or not to sell it within the state—theories incompatible with pre-emption jurisprudence. Id. at 488, 133 S.Ct. 2466.

With these principles in mind, the Court turns to evaluate whether Counts III and IV of Plaintiff's Complaint are preempted by federal law.

B. Preemption of Count III – Strict Liability – Design Defect

Count III is premised on the allegation that Gamunex contained a design defect that made it unreasonably dangerous at the time it was manufactured and administered to Andrew Ganz [ECF No. 1-2 pp. 11–12 ¶¶ 32–38]. In Defendants’ view, this claim is preempted because Defendants could not have changed the FDA-approved design of Gamunex without first seeking the FDA's approval [ECF No. 15 pp. 15–16]. Defendants rely on two provisions in 21 C.F.R. § 601.12(b)(2) for this proposition, specifically (b)(2)(i) and (b)(2)(vi), both of which regulate how manufacturers can make changes to an approved biologic like Gamunex [ECF No. 15 p. 16]. 21 C.F.R. §§ 601.12(b)(2)(i), (vi).⁵ Defendants also emphasize that courts have held that tort claims based on changes to a prescription drug's FDA-approved design are preempted because the manufacturers “cannot independently and lawfully change a drug formulation that the FDA has approved” [ECF No. 15 p. 16] (quoting In re Zantac (Rantidine) Prods. Liab. Litig., 512 F. Supp. 3d 1278, 1294 (S.D. Fla. 2021)).

In Opposition to Defendants’ Motion, Plaintiff for the first time asserts a pre-approval design defect claim—arguing that Defendants could have come up with a safer design prior to seeking FDA approval [ECF No. 19 p. 15; cf. ECF No. 1-2 p. 11 ¶ 33 (alleging that product was defective in design at the time it was manufactured)]. According to Plaintiff, pre-approval design defect claims for drugs and biologics are not preempted by federal law because nothing stops the manufacturer from designing a safer product before getting FDA approval [ECF No. 19 p. 15]. In support of this argument, Plaintiff cites cases in which courts have rejected preemption in the pre-approval design context [ECF No. 19 p. 15]. See Kaiser v. Johnson & Johnson, 947 F.3d 996 (7th Cir. 2020); Gaetano v. Gilead Scis., Inc., 529 F. Supp. 3d 333, 344 (D.N.J. 2021); Silver v. Bayer Healthcare Pharmaceuticals, Inc., 2:19-CV-3495, 2021 WL 4472857 (D.S.C. Sept. 30, 2021). Defendants, on the other hand, argue that pre-approval design defect claims are preempted to the same extent as post-approval claims, relying on Yates v. Ortho-McNeil-Janssen Pharm., Inc., 808 F.3d 281 (6th Cir. 2015) [ECF No. 20 p. 9].

In light of Plaintiff's failure to plead a pre-approval claim in its Complaint, the Court declines to address that issue at this juncture [ECF No. 1-2 ¶¶ 17–22, 32–38]. See In re Zantac (Rantidine) Prods. Liab. Litig., 512 F. Supp. 3d at 1294 (“The Court declines to determine at this juncture whether a pre-approval design-defect claim is pre-empted. This is because the Plaintiffs have not pled a pre-approval design-defect claim.”). The Court therefore limits its analysis on Count III to whether Plaintiff's claim of a design defect in Gamunex is preempted by federal law, agreeing with Defendants that Plaintiff's current claim is preempted. It would be impossible for Grifols to comply with both its state duty to change the composition of Gamunex and its duty under 21 C.F.R. § 601.12(b)(2) not to make such a change without first obtaining FDA approval. See Mut. Pharm. Co., 570 U.S. at 475, 133 S.Ct. 2466. Therefore, Count III of Plaintiff's Complaint is dismissed. Count I is also dismissed to the extent it alleges a design defect claim.⁶

C. Preemption of Count IV – Strict Liability – Failure to Warn

Count IV of Plaintiff's Complaint is premised on the allegation that Gamunex's label did not sufficiently warn of the dangers and risks associated with its use [ECF No. 1-2 pp. 12–13 ¶¶ 39–45]. Grifols argues that any claim based on a failure to warn theory is preempted, because the only situation in which it could have unilaterally changed the Gamunex label is if it had acquired new information within the meaning of 21 C.F.R. § 601.12(f)(2), but according to Grifols, it did not acquire such information, and Plaintiff has not adequately alleged that it did [ECF No. 15 p. 17].⁷

Plaintiff responds two-fold: first, the Supreme Court's decision in Wyeth v. Levine, 555 U.S. 555, 129 S.Ct. 1187, 173 L.Ed.2d 51 (2009), operates as a complete bar to Grifols's preemption defense [ECF No. 19 p. 17], and second, even if it does not, the Complaint adequately alleges new information such that Grifols would have been authorized under section 601.12(f)(2) to amend the Gamunex label to strengthen its warning.

Upon review of these competing arguments, the Court permits Plaintiff's failure to warn claim to proceed at this stage, reasoning as follows.

First, the Court rejects Plaintiff's argument that Wyeth broadly eliminates any preemption defense for a brand-name manufacturer of drugs like Grifols [ECF No. 19 p. 17]. While the Supreme Court in Wyeth did hold that a failure to warn claim was not preempted against a brand-name drug manufacturer that had acquired new information about risks associated with its drug, see 21 C.F.R. § 601.12(f)(2), the Court did not decide the antecedent question whether a plaintiff needs to plead the existence of newly acquired information to defeat a motion to dismiss on preemption grounds. Rather, the Wyeth Court acknowledged the trial record indicating that the brand-name manufacturer had acquired new information about the risks of its drug as used—thus opening the door to a unilateral label change in accordance with the applicable FDA regulations. 555 U.S. at 569, 129 S.Ct. 1187. As such, Wyeth does not operate as a complete bar to Grifols’ assertion of a preemption defense against Ganz's failure to warn claims. Grifols still may assert a preemption defense against Plaintiff's failure to warn claims if Grifols did not acquire new information that would have allowed Grifols to unilaterally strengthen its label under 21 C.F.R. § 601.12(f)(2).

The Court next turns to evaluate Plaintiff's Complaint to determine if it plausibly alleges that Grifols obtained new information authorizing Grifols to unilaterally change its Gamunex label. Information is considered “newly acquired” for purposes of section 601.12(f)(2)

if it consists of data, analyses, or other information not previously submitted to the agency, which may (but are not limited to) data derived from new clinical studies, reports or adverse events, or new analyses of previously submitted data (e.g., meta-analyses) if the studies, events or analyses reveal risks of a different type or greater severity or frequency than previously included in submissions to FDA.

21 C.F.R. § 601.12(f)(6) (emphasis added).

Here, accepting the allegations in the Complaint as true leads to a plausible inference that Grifols obtained new information about the increased frequency of risks associated with Gamunex. Specifically, Paragraph 16 of the Complaint asserts as follows:

An increase in hypersensitivity reactions in August 2019 led Defendants to initiate recalls of certain lots of Gamunex due to a higher rate of allergic/hypersensitivity type reactions, a number of which were considered medically significant. Serum sickness, which ANDREW GANZ suffered, is one such reaction. Over the course of 2019, 2020, and 2021, Defendants have recalled multiple lots of Gamunex as a result of the increased risk of allergic/hypersensitivity type reactions that could be medically significant.

[ECF No. 1-2 ¶ 16; see ECF No. 19 p. 19]. That allegation—which specifically references Defendants’ recall of lots caused by an increase in hypersensitivity reactions—is sufficient for pleading purposes to indicate that Grifols acquired new information within the meaning of 21 C.F.R. § 601.12(f)(2) and (f)(6).⁸

The Court's Rule 12(b)(6) determination that Grifols obtained new information does not end its preemption inquiry, however. Plaintiff's failure-to-warn claim would nevertheless be preempted if Grifols shows by “clear evidence” that the FDA would not have approved the labeling change after the fact. Wyeth, 555 U.S. at 571, 129 S.Ct. 1187. Grifols has offered no such evidence at this juncture, and in any event, such an argument is more appropriate for summary judgment [ECF No. 20 p. 11 n.7].

For these reasons, the Complaint plausibly alleges that Grifols obtained new information regarding the risks of Gamunex such that it would have been authorized to unilaterally change its label to strengthen its warning. Thus, Grifols has not shown that it would be “impossible for [Grifols] to comply with both the state-law duties underlying [Plaintiff's failure to warn claim] and its federal labeling duties.” Wyeth, 555 U.S. at 568, 129 S.Ct. 1187. Grifols's preemption defense to Count IV fails at this stage, without prejudice to Grifols's continued assertion of such defense as the case proceeds.

III. Rule 12(b)(6) Failure to State a Claim on Which Relief Can Be Granted

Aside from its preemption defense, Grifols seeks dismissal of all counts in the Complaint for failure to state a claim under Rule 12(b)(6) [ECF No. 15 p. 9]. For the reasons stated below, the Court agrees with Grifols in part. Count I fails to the extent it alleges a negligence claim based on a failure to warn theory, a negligent misrepresentation theory, and a design defect theory. Count III fails, as discussed above, on preemption grounds. And Count IV fails for failing to adequately allege a breach of a duty. But Counts II, V, and I (to the extent Count I is based on a manufacturing defect theory or failure to recall theory) may proceed at this point. In reaching this determination, the Court takes judicial notice of Gamunex's FDA-approved label in place at the time Andrew Ganz began his treatment [ECF No. 15-2 pp. 105–43] along with Exhibits A through D of Plaintiff's Response in Opposition to Grifols's Motion [ECF No. 19-1 pp. 4–45].⁹

A. Count I – Negligence

To state a claim for negligence, a plaintiff “must allege four elements: [1] a duty, [2] breach of that duty, [3] causation, and [4] damages.” Virgilio v. Ryland Grp., Inc., 680 F. 3d 1329, 1339 (11th Cir. 2012). In total, Count I alleges twelve different theories of how Grifols allegedly breached its duty to Andrew Ganz [ECF No. 1-2 pp. 9–10 ¶¶ 20(a)–(l)]. The Court does not address Plaintiff's theories found in Paragraphs 20(f), 20(h), 20(i), and 20(l), because the parties agree that the failure to test theories in Paragraphs 20(f) and (i) are classified as design defect claims under Florida law [ECF No. 15 p. 24; ECF No. 19 p. 26], and Paragraphs 20(h) and (i) are standalone design defect claims. For the reasons discussed in Section II (B) above, the theories of liability found in Paragraphs 20(f), (h), (i), and (l) are preempted. The remaining eight negligence theories fall into four categories: (1) a Failure to Warn Theory; (2) a Negligent Misrepresentation Theory; (3) a Failure to Recall Theory; and (4) a Manufacturing Defect Theory.

i. Failure to Warn Theory of Negligence

Four of Ganz's theories of negligence essentially boil down to an allegation that Grifols failed to warn Andrew Ganz and his healthcare providers of the risk of taking Gamunex or failed to instruct Andrew Ganz to cease taking Gamunex [ECF No. 1-2 ¶¶ 20(a), 20(b), 20(c), 20(g)].

Under Florida law, to succeed on a failure to warn claim, Ganz must show “(1) that the product warning was inadequate; (2) that the inadequacy proximately caused [Andrew Ganz's] injury; and (3) that [Andrew Ganz] in fact suffered an injury from using the product.” Eghnayem v. Bos. Sci. Corp., 873 F.3d 1304, 1321 (11th Cir. 2017).

Ganz fails to plead sufficient facts to satisfy the first element of inadequate warnings. The Complaint makes various references to Grifols's failure to warn of risks, but nowhere in the Complaint does Plaintiff actually assert how the label offered was defective or inadequate.¹⁰ Moreover, as the judicially noticed documents indicate, Gamunex's label included multiple warnings specifically discussing the risk of hypersensitivity reactions, including a warning of severe hypersensitivity reactions on the first page of Gamunex's label [ECF No. 15-1 p. 105], and another warning about hypersensitivity reactions on the Contraindications and Warning Sections of the label [ECF No. 15-1 p. 113; see ECF No. 15-1 pp. 105–43 (warning of the risk of hypersensitivity reactions seventeen times)]. Plaintiff fails to allege how these warnings were inadequate to warn of the hypersensitivity risks associated with Gamunex or to lead to a plausible inference that Grifols breached its duty. Accordingly, as pled, Plaintiff fails to state a negligence-based failure to warn claim upon which relief could be granted.¹¹

ii. Negligent Misrepresentation Theory of Negligence

Plaintiff alleges that Grifols “negligently misrepresented affirmatively and by omission that the Gamunex they manufactured, sold, or distributed was safe in its ordinary and foreseeable use, when such representation was untrue” [ECF No. 1-2 ¶ 20(e)].

To state a cause of negligent misrepresentation under Florida law, a Plaintiff must allege “(1) the defendant made a misrepresentation of material fact that he believed to be true but which was in fact false; (2) the defendant was negligent in making the statement because he should have known the representation was false; (3) the defendant intended to induce the plaintiff to rely on the misrepresentation; and (4) injury resulted to the plaintiff acting in justifiable reliance upon the misrepresentation.” Simon v. Celebration Co., 883 So.2d 826, 832 (Fla. Dist. Ct. App. 2004) (citing Johnson v. Davis, 480 So.2d 625 (Fla. 1985)). These allegations are subject to the heightened pleading requirements of Rule 9(b), which requires a party alleging fraud or mistake to “state with particularity the circumstances constituting fraud or mistake,” although “[m]alice, intent, knowledge, and other conditions of a person's mind may be alleged generally.” Fed. R. Civ. P. 9(b); Lamm v. State St. Bank & Tr., 749 F.3d 938, 951 (11th Cir. 2014) (noting that “Rule 9(b)’s heightened pleading standard applies to negligent misrepresentation claims” in a case arising under Florida law); McGee v. JP Morgan Chase Bank, NA, 520 F. App'x 829, 831 (11th Cir. 2013) (determining that “because negligent misrepresentation sounds in fraud, the facts surrounding the claim must be pled with particularity” in accordance with Rule 9(b)). Under Rule 9(b), Plaintiff must allege the “who, what, when, where, and how of the fraud alleged.” Omnipol, A.S. v. Multinational Def. Servs., LLC, 32 F.4th 1298, 1307 (11th Cir. 2022) (citing Mizzaro v. Home Depot, Inc., 544 F.3d 1230, 1237 (11th Cir. 2008)).

Ganz's generalized allegation that Grifols “negligently misrepresented affirmatively and by omission that the Gamunex that they manufactured, sold, or distributed was safe in its ordinary and foreseeable use, when such representation was untrue” [ECF No. 1-2 p. 9 ¶ 20(e)] fails to satisfy the heightened pleading requirement of Rule 9(b). It does not allege what specific affirmations Grifols made regarding the safety of Gamunex—or what information was omitted—let alone who made the statements, when they made the statement, where they made the statement, or how the statement was made. Accordingly, Count I fails to state a claim to the extent it relies upon a negligent misrepresentation theory.

iii. Failure to Recall Theory of Negligence

Grifols also challenges Count I to the extent it advances a failure to recall theory [ECF No. 1-2 ¶ 20(d)]. As Grifols explains, the Complaint lacks “facts suggesting either the additional lots of Gamunex should have been withdrawn from the market, or that Decedent himself received Gamunex from one of those lots” [ECF No. 15 p. 23]. After Plaintiff stated in her Response that Florida law recognizes a failure to recall cause of action [ECF No. 19 p. 26], Defendant asserted for the first time in Reply that Florida does not recognize such a claim [ECF No. 20 p. 8]. While this might be so, see Wright v. Howmedica Osteonics Corp., No. 17-CV-459, 2017 WL 4555901, at *4 (M.D. Fla. Oct. 12, 2017) aff'd, 741 F. App'x 624 (11th Cir. 2018), a party may not wait until a reply brief to raise an argument for the first time. See In re Egidi, 571 F.3d 1156, 1163 (11th Cir. 2009). Therefore, the Court will not address at this juncture Grifols's conclusory argument that Florida law does not recognize a failure to recall theory cause of action.

Returning to Grifols’ original argument that the Complaint lacks facts suggesting that additional lots should have been withdrawn or that Andrew Ganz did not receive Gamunex from one of those lots [ECF No. 15 p. 23], the Court disagrees with Grifols for purposes of Rule 12(b)(6). The Complaint alleges that an increase in hypersensitivity reactions in August 2019 led Grifols to initiate recalls of certain lots of Gamunex [ECF No. 1-2 ¶ 16]. The Complaint also alleges that Andrew Ganz was last treated with Gamunex in August 2019 and was subsequently diagnosed with serum sickness (a form of hypersensitivity) [ECF No. 1-2 ¶¶ 15–16]. Furthermore, this Court takes judicial notice of the fact that Grifols recalled four other lots of Gamunex in the four months following Andrew Ganz's final treatment of Gamunex [ECF No. 19-1 pp. 25–26]. These facts lead to a plausible inference that Andrew Ganz was treated with a contaminated lot that was not recalled at the time of his treatment. Therefore, Plaintiff's negligence claim based on a failure to recall theory survives.

iv. Manufacturing Defect Theory of Negligence

The Complaint asserts that Grifols breached its duty to Andrew Ganz by “failing to adequately control [its] manufacturing process such that each lot left [its] control was uniform and such that there was consistency among lots” [ECF No. 1-2 ¶ 20(j)]. The Complaint also asserts that Grifols “failed to adequately control their manufacturing process to ensure that each lot was actually manufactured to designed specifications” [ECF No. 1-2 ¶ 20(k)]. Grifols argues that these claims fail because Ganz did not identify a specific defect or plead causation. At this stage, the Court disagrees. The Complaint and judicially noticed documents contain enough facts, accepted as true, to plausibly establish a manufacturing defect in the Gamunex lot with which Andrew Ganz was treated. To reiterate, Plaintiff alleges that Grifols recalled certain lots of Gamunex due to a heightened rate of hypersensitivity reactions during the time that Andrew Ganz was treated with Gamunex [ECF No. 1-2 ¶¶ 14, 16]. Plaintiff alleges that Andrew Ganz was diagnosed with serum sickness after being treated with Gamunex, a sickness that allegedly led to his death [ECF No. 1-2 ¶ 15]. And according to an FDA memorandum from the September 2020 Pediatric Advisory Committee Meeting, the FDA is currently working with Grifols “to evaluate manufacturing processes, donor materials, and other factors that may be contributing to the observed [increase in] hypersensitivity reactions” [ECF No. 19-1 pp. 32-33]. These combined facts plausibly support an inference that a manufacturing defect caused Andrew Ganz's death. Count I may proceed insofar as it raises a negligence theory based on a manufacturing defect.

B. Count II – Strict Liability – Manufacturing Defect

Like the negligence manufacturing defect claim found in Count I, Count II also withstands Grifols's Rule 12(b)(6) challenge.

In Florida, to state a strict products liability claim based on a manufacturing defect theory. a plaintiff must plead “(1) a relationship between the defendant and the product; (2) a defect which caused the product to be unreasonably dangerous; (3) causation between the defect and harm suffered by the user.” Dye v. Covidien LP, 470 F. Supp. 3d 1329, 1334 (S.D. Fla. 2020) (quoting Dimieri v. Medicis Pharm. Corp., No. 14-CV-176, 2014 WL 3417364, at *4 (M.D. Fla. July 14, 2014)).

Plaintiff has satisfied the first element in alleging that Andrew Ganz was treated with Gamunex [ECF No. 1-2 ¶¶ 13–15].

As to the second element, Plaintiff alleges that the Gamunex with which Andrew Ganz was treated was in the same or similar condition as when it left Grifols's possession [ECF No. 1-2 ¶ 29]. Plaintiff also alleges that Andrew Ganz was treated with Gamunex in its intended manner [ECF No 1-2 ¶ 13], and that Grifols recalled lots of Gamunex due to a higher rate of hypersensitivity reactions both in the months leading up to Andrew Ganz's treatment and in the months following the conclusion of his treatment [ECF No. 1-2 ¶ 16]. Additionally, this Court takes judicial notice of the fact that the FDA published a safety review of Gamunex noting the FDA's evaluation of Grifols's manufacturing processes to identify the cause of the hypersensitivity reactions [ECF No. 19-1 pp. 32–33]. These facts, viewed in the light most favorable to Plaintiff, lead to a plausible inference that a defect in the Gamunex taken by Andrew Ganz caused the product to be unreasonably dangerous.

Plaintiff also satisfies the third element of causation by alleging (1) that Ganz died because of the serum sickness he developed following his last treatment of Gamunex [ECF No. 1-2 ¶ 15] and (2) that Andrew Ganz's injuries were the result of the manufacturing defect [ECF No. 1-2 ¶ 31].

For pleading purposes, Plaintiff satisfies all three elements of a Strict Liability claim rooted in a Manufacturing Defect. Count II survives.

C. Count IV – Strict Liability – Failure to Warn

In Count IV, Plaintiff raises a strict liability claim based on Grifols's failure to warn of the true risks of Gamunex [ECF No. 1-2 pp. 12–13 ¶ 42]. This claim fails for the same reasons Plaintiff's analogous negligence claim fails. Beyond conclusory allegations, the Complaint fails to plead any facts supporting a plausible inference that Gamunex's label was inadequate or did not warn of the risks of hypersensitivity.

D. Count V – Loss of Consortium

Grifols argues that Vivian Ganz cannot recover for loss of consortium because the estate of her late husband has no valid claims against Grifols [ECF No. 15 p. 24]. As discussed above, Count I survives with respect to its failure to recall and manufacturing defect theories, as does Count II. Accordingly, because the estate of Andrew Ganz has remaining causes of action against Grifols, Vivian Ganz's loss of consortium claim also survives at this stage.

CONCLUSION

For the foregoing reasons, it is hereby ORDERED AND ADJUDGED as follows:

1. Defendants’ Motion to Dismiss [ECF No. 15] is GRANTED IN PART AND DENIED IN PART.

2. All counts as to Defendant Grifols Shared Services North America, Inc. are DISMISSED due to a lack of personal jurisdiction.

3. The Clerk of Court shall TERMINATE Grifols Shared Services North America, Inc. as a defendant in this matter.

4. Count I is DISMISSED WITHOUT PREJUDICE to the extent it alleges negligence based on theories of design defect, failure to warn, or negligent misrepresentation. Count I may proceed only with respect to its failure to recall and manufacturing defecting theories.

5. Count II may proceed.

6. Count III is DISMISSED WITHOUT PREJUDICE.

7. Count IV is DISMISSED WITHOUT PREJUDICE.

8. Count V may proceed.

9. On or before September 8, 2023, Plaintiff shall either (1) move to file an Amended Complaint for the limited purpose of repleading Counts I, III and IV consistent with this Order; or (2) file a notice indicating its intent to proceed on Counts I, II, and V as pled and in accordance with this Order. Should Plaintiff seek to file an Amended Complaint, any such amended pleading must adhere to the rule against shotgun pleadings, including the requirement to separate distinct legal theories into separate causes of action. See Weiland v. Palm Beach Cnty. Sheriff's Off., 792 F.3d 1313, 1321 (11th Cir. 2015).

DONE AND ORDERED in Chambers at Fort Pierce, Florida, this 22nd day of August 2023.

FOOTNOTES

2.   Shared Services previously moved for a protective order staying jurisdictional discovery [ECF No. 21]. Judge Reinhart granted the motion after full briefing [ECF Nos. 23, 25, 26; ECF No. 27 pp. 6–7(“ “Other than conclusory statements that lump both Defendants together and allege that they were engaged in ‘substantial and not isolated activity’ within Florida (ECF No. 1-2 at ¶ 7), the Complaint does not contain any facts linking Shared Services in particular to business activities in Florida.”)]. Plaintiff neither appealed that ruling to this Court nor filed a motion to open jurisdictional discovery.

3.   Section 601.12(b)(2) requires FDA approval for “major changes” to the product, including “changes in the qualitative or quantitative formulation, including inactive ingredients, or in the specifications provided in the approved application,” 21 C.F.R. § 601.12(b)(2)(i), and “[c]hanges which may affect product sterility assurance, such as changes in product or component sterilization method(s), or an addition, deletion, or substitution of steps in an aseptic processing operation,” id. § 601.12(b)(2)(vi).

4.   Section 601.12(f)(1) requires FDA approval before distributing a product with a labeling change except as permitted by paragraphs Section 601.12(f)(2) and (f)(3). 21 C.F.R. § 601.12(f)(1).

5.   These provisions, Defendants point out, are nearly identical to 21 C.F.R. § 314.70(b)(2)(i) and (iv), which regulate how manufacturers can make changes to an approved drug [ECF No. 15 p. 16]. See 21 C.F.R. § 314.70(b)(2)(i), (iv).

6.   Defendants argue in Reply that Florida products liability law does not permit a pre-approval design defect claim [ECF No. 20 p. 10]. Defendants devote one paragraph to this issue, and Plaintiff does not address it all [ECF No. 20 p. 10]. If Plaintiff chooses to bring a pre-approval design defect claim against Grifols in an amended complaint, and if Grifols challenges the claim on pre-emption grounds in a future motion, the parties shall meaningfully brief the matter.

7.   Section 601.12(f)(2) provides in relevant part as follows:Label changes requiring supplemental submission—product with a labeling change that may be distributed before FDA approval.(i) An applicant shall submit, at the time such change is made, a supplement for any change in the package insert, package label, or container label to reflect newly acquired information, except for changes to the package insert required in § 201.57(a) of this chapter (which must be made under paragraph (f)(1) of this section), to accomplish any of the following:(A) To add or strengthen a contraindication, warning, precaution, or adverse reaction for which the evidence of a causal association satisfies the standard for inclusion in the labeling under § 201.57(c) of this chapter;

8.   The parties disagree about whether the Complaint must allege that Grifols obtained new information to defeat Grifols's pre-emption defense [compare ECF No. 19 pp. 18-19 (Plaintiff citing Evans v. Gilead Scis., Inc., 20-cv-00123, 2020 WL 5189995, at *10 (D. Haw. Aug. 31, 2020), and Gaetano v. Gilead Scis., Inc., 529 F. Supp. 3d 333, 349 (D.N.J. 2021)), with ECF No. 20 pp. 11–12 (Defending citing In re Celexa and Lexapro Mktg. and Sales Practices Litig., 779 F.3d 34, 41 (1st Cir. 2015), and Gibbons v. Bristol-Myers Squibb Co., 919 F.3d 699, 708 (2d Cir. 2019))]. In light of the Court's determination that the Complaint adequately alleges that Grifols obtained new information, the Court need not resolve the threshold issue whether Plaintiff is required to make such an allegation at this stage.

9.   Exhibits A and C are FDA memorandums and Exhibit D is an FDA report. Exhibit B is a printout from a Patient Notification System website listing the Gamunex lots that Grifols recalled from August 2018 through August 2021. Grifols does not dispute the validity of any of the exhibits [see ECF No. 20].

10.   [ECF No. 1-2 p. 9 ¶ 20(a) (“Defendants failed to adequately warn ANDREW GANZ and his healthcare providers of the true risk that Defendants’ could cause severe, life-threatening, and potentially fatal reactions.”), ¶ 20(b) (“Defendants failed to disclose post-marketing information about the risk associated with their Gamunex product.”), ¶ 20(c) (“Defendants concealed the true risk of severe, life-threatening, and potentially fatal reactions associated with their Gamunex product.”), ¶ 20(g) (“Defendants failed to warn or advise ANDREW GANZ, his healthcare providers, and others to cease all future exposure to Gamunex.”)].

11.   Grifols argues that Plaintiff's claims for a design defect and failure to warn theory are also barred by the statutory “Government Rules Defense” [ECF No. 15 pp. 19–22]. As provided for in Fla. Stat. § 768.1256, “[i]n a product liability action brought against a manufacturer or seller for harm allegedly caused by a product, there is a rebuttable presumption that the product is not defective or unreasonably dangerous and the manufacturer or seller is not liable if ․ the aspect of the product that allegedly cause the harm: (a) complied with federal or state codes, statutes, rules, regulations, or standards relevant to the event causing the death or injury.” Fla. Stat. § 768.1256(1)(a). Because this Court determines that Plaintiff fails to state a claim based on a failure to warn theory and that her design defect claim is federally preempted, this Court need not address Grifols’ “Government Rules Defense” under Florida law.

AILEEN M. CANNON, UNITED STATES DISTRICT JUDGE