CROCKETT v. LUITPOLD PHARMACEUTICALS, INC.

THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA KATHERINE CROCKETT, CIVIL ACTION Plaintiff, v. LUITPOLD PHARMACEUTICALS, INC., NO. 19-276 et al., Defendants.

MEMORANDUM OPINION Defendant Vifor Pharma Management, Ltd. (“Vifor Management”) moves to dismiss the Complaint brought against it by Plaintiff Katherine Crockett on the grounds that this Court lacks personal jurisdiction over Vifor Management.

I. FACTS The facts in this case have already been recounted at length. See Crockett v. Luitpold Pharms., Inc., 2020 WL 433367 (E.D. Pa. Jan. 28, 2020). In brief, this is a product liability action brought by Plaintiff, a Pennsylvania resident, after she took Injectafer, an FDA-approved prescription injection for the treatment of iron deficiency anemia. Injectafer is one of several products available for intravenous iron but is the only such product available in the United States formulated with the unique ferric carboxymaltose (“FCM”) compound. Plaintiff alleges that she developed severe hypophosphatemia after taking Injectafer as prescribed.

Injectafer is manufactured, distributed, and sold in the United States by Defendant American Regent, Inc. (“American Regent”)1 and since 2017 has been marketed in the United States by Defendant Daiichi Sankyo, Inc. (“DSI”).

Plaintiff alleges that Vifor Management—the sole Defendant that has brought a motion premised on lack of personal jurisdiction—is “headquartered in Switzerland.” The rest of her allegations pertain to the Vifor Defendants as a group, claiming they: • “[A]re in the business of researching, developing, designing, licensing, manufacturing, distributing, supplying, selling, marketing, and/or introducing into commerce ferric carboxymaltose, or its European brand bioequivalent, Ferinject.” • “[B]y and through Vifor International, are engaged in a licensing deal with Luitpold that permits Luitpold to design, manufacture, market, supply, promote, label, distribute, and sell Injectafer in the United States.” • “[L]icensed that ferric carboxymaltose design to Luitpold, which in turn designed, manufactured, marketed, supplied, distributed, and sold the bioequivalent Injectafer product to the United States market.” • “[D]irectly participated in the registration and clinical trials, marketing, promotion and marketing sales organization, safety reporting, adverse events arising from clinical trials, and pharmacovigilance obligations for Injectafer, which—either in whole or in substantial part—were conducted or managed in Luitpold’s Norristown, PA location” pursuant to the Vifor International-Luitpold licensing agreement. • “[A]re engaged in the design, manufacture, distribution, marketing, promotion, pharmacovigilance, and/or sale of Injectafer, which—either in whole or in substantial part—were conducted or managed in Luitpold’s Norristown, PA location.”

As discussed below, Vifor Management disputes many of these allegations through a sworn affidavit, the Goulburn Declaration (“Goulburn Decl.”). Plaintiff has not provided an opposing declaration but has attached eleven exhibits to her opposition brief as evidence in support of her argument that there is jurisdiction over Vifor Management in Pennsylvania.

II. LEGAL STANDARD Federal Rule of Civil Procedure 12(b)(2) allows this Court to dismiss a complaint for “lack of personal jurisdiction.” Fed. R. Civ. P. 12(b)(2). To survive a motion to dismiss for lack of personal jurisdiction, “the plaintiff bears the burden of establishing personal jurisdiction.”

O’Connor v. Sandy Lane Hotel, Co., 496 F.3d 312, 316 (3d Cir. 2007). “[W]hen the court does not hold an evidentiary hearing on the motion to dismiss, the plaintiff need only establish a prima facie case of personal jurisdiction and the plaintiff is entitled to have its allegations taken as true and all factual disputes drawn in its favor.” Miller Yacht Sales, Inc. v. Smith, 384 F.3d 93, 97 (3d Cir. 2004); Carteret Sav. Bank, F.A. v. Shushan, 954 F.2d 141, 142 n.1 (3d Cir. 1992).2 If the plaintiff meets her burden, then the burden shifts back to the defendant to present a compelling case that personal jurisdiction is unreasonable. Carteret, 954 F.2d 141-42 (citing Burger King Corp. v. Rudzewicz, 471 U.S. 462, 477 (1985)).

“A Rule 12(b)(2) motion . . . is inherently a matter which requires resolution of factual issues outside the pleadings, i.e. whether in personam jurisdiction actually lies.” Time Share Vacation Club v. Atlantic Resorts, Ltd., 735 F.2d 61, 66 n.9 (3d Cir. 1984). Thus, once the defense has been raised, then the plaintiff must sustain its burden of proof in establishing jurisdictional facts through sworn affidavits or other competent evidence. [A]t no point may a plaintiff rely on the bare pleadings alone in order to withstand a defendant’s Rule 12(b)(2) motion to dismiss for lack of in personam jurisdiction. Once the motion is made, plaintiff must respond with actual proofs, not mere allegations.

Patterson v. FBI, 893 F.2d 595, 603-04 (3d Cir. 1990).

Personal jurisdiction over a non-resident defendant is proper only if permitted by “A district court . . . may require more than a prima facie showing of jurisdiction by holding a quasi-evidentiary hearing. . . .” C. Wright & A. Miller, Federal Practice & Procedure § 1067.6. “[I]f the Court conducts an evidentiary hearing, the plaintiff has the more substantial burden of proving that personal jurisdiction is proper by a preponderance of the evidence.” Steinfeld v. EmPG Intern., LLC, 97 F. Supp.3d 606, 611-12 (E.D. Pa. 2015) (internal quotations and citations omitted). The Court has reviewed the exhibits attached to their briefs by the parties and, having done so, does not find it necessary to hold an evidentiary hearing.

Pennsylvania’s long-arm statute and the United States Constitution. See Pennzoil Prods. Co. v. Colelli & Assocs., Inc., 149 F.3d 197, 200 (3d Cir. 1998). Pennsylvania’s long-arm statute authorizes personal jurisdiction to the extent permitted by the Fourteenth Amendment of the Constitution. See Pa. C.S.A. § 5322(b); Vetrotex Certainteed Corp. v. Consol. Fiber Glass Prods. Co., 75 F.3d 147, 150 (3d Cir. 1996). As a result, the personal jurisdiction inquiry merges into a single due process analysis under the Constitution. O’Connor, 496 F.3d at 316.

III. ANALYSIS Defendant argues that because Vifor Management is a Swiss company with no substantial contacts in Pennsylvania, this Court has neither general nor specific jurisdiction, and the Complaint against it should be dismissed for lack of personal jurisdiction under Rule 12(b)(2).

Plaintiff does not respond to Defendant’s argument that the Court lacks general jurisdiction here. “[I]ssues not briefed are deemed waived. Where a party makes no more than a single mention of the claim, the claim is consequently waived.” United States v. Healy, 2013 WL 1624310, at *1 (M.D. Pa. Apr. 15, 2013) (citing National R.R. Passenger Corp. v. Pa. Pub.

Util. Comm’n, 342 F.3d 242 (3d Cir. 2003)). The issue of general jurisdiction is waived, and the Court turns to specific jurisdiction.

To establish specific jurisdiction, Plaintiff must show that a “defendant’s suit-related conduct . . . create[s] a substantial connection with the forum State.” Walden v. Fiore, 571 U.S. 277, 284 (2014). The Third Circuit has held that the specific jurisdiction inquiry has three parts: (1) the defendant must have “purposefully directed [its] activities at the forum,” (2) the litigation must “arise out of or relate to at least one of those activities,” and (3) “if the first two requirements have been met a court may consider whether the exercise of jurisdiction comports with fair play and substantial justice.” D’Jamoos ex rel. Estate of Weingeroff v. Pilatus Aircraft Ltd., 566 F.3d 94, 102 (3d Cir. 2009). The defendant must have engaged in “a deliberate targeting of the forum.” O’Connor, 496 F.3d at 317. Defendant argues that Plaintiff fails all three requirements.

On the first prong—purposeful availment—Plaintiff argues that Vifor Management designed a product that harmed someone in Pennsylvania—in this instance, the Plaintiff. As a preliminary matter, the Third Circuit has rejected a “stream of commerce” theory as a basis for exercising specific jurisdiction over a foreign defendant. See Shuker v. Smith & Nephew, PLC, 885 F.3d 760, 780 (3d Cir. 2018). An allegation that a foreign party engaged in efforts “‘to exploit a national market’ that ‘necessarily included Pennsylvania’ [is] insufficient.” Id. (quoting D’Jamoos, 566 F.3d at 104). Specific jurisdiction may be asserted over a defendant that places its product into a stream of commerce only where “the defendant’s activities manifest an intention to submit to the power of a sovereign,” that is, “the defendant must purposefully avail[] itself of the privilege of conducting activities within the forum State, thus invoking the benefits and protections of its laws.” J. McIntyre Mach., Ltd. v. Nicastro, 564 U.S. 873, 881-82 (2011) (internal quotations omitted).

Plaintiff relies heavily on the allegation that a different Vifor entity3 entered into a licensing agreement with American Regent, which “sold the bioequivalent Injectafer product to the United States market.” This is far too attenuated to create personal jurisdiction in Pennsylvania. It is notable that Plaintiff’s opposition brief opens by saying “[t]he Vifor Group is a consortium of companies. . . .” An allegation regarding another Vifor entity is not the same as

Specifically, she argues that Vifor Management “purposefully availed” itself of the Pennsylvania forum because it “engag[ed] in tortious misconduct . . . in coordination with the U.S. Defendants within the Commonwealth.” But “a defendant’s relationship with a . . . third party, standing alone, is an insufficient basis for jurisdiction.” See Walden v. Fiore, 571 U.S. 277, 286 (2014).

In Nicastro, the Supreme Court found that the facts showed no “regular course” of sales in New Jersey and noted there was “no ‘something more,’ such as special state-related design, advertising, advice, marketing, or anything else” to warrant specific jurisdiction. 564 U.S. at 889 (Breyer, J., concurring). Plaintiff hangs her hat on the “something more” argument—suggesting “something more” exists here because of Vifor Management’s alleged cooperation with the U.S. Defendants—for example, by alleging the Vifor entities participated in “the registration and

To the extent Plaintiff seeks to impute American Regent and DSI’s Pennsylvania contacts and actions to Vifor Management, she has not cited any case law for doing so—particularly in the context of separate corporate entities. Indeed, this argument is routinely rejected as a basis for personal jurisdiction even in the closer parent-subsidiary context. See Kehm Oil Co. v. Texaco, Inc., 537 F.3d 290, 301 (3d Cir. 2008) (“The mere fact that a subsidiary company does business within a state does not confer jurisdiction over its nonresident parent.” (quoting Escude Cruz v. Ortho Pharm. Corp., 619 F.2d 902, 905 (1st Cir. 1980)); see also Arch v. Am. Tobacco Co., 984 F. Supp. 830, 838 (E.D. Pa. 1997) (refusing to impute an in-state entity’s contacts to a foreign parent company under the alter ego theory because there was no evidence of parent’s “undue domination and control”). Plaintiff conceded at oral argument that she is not pursuing an alter ego theory.

In Vaughan v. Olympus Am., Inc., 208 A.3d 66, 74 (Pa. Super. 2019), the court attributed an in-state subsidiary’s conduct to its foreign parent because the subsidiary admitted it was the parent’s agent for “FDA-related conduct in Pennsylvania.” Here, there is no allegation or evidence that the U.S. Defendants were Vifor Management’s agents in Pennsylvania.

In short, Plaintiff has failed to meet her burden of establishing specific jurisdiction. See Patterson, 893 F.2d at 603-04 (noting that “once the [jurisdictional] defense has been raised, then the plaintiff must sustain [her] burden of proof in establishing jurisdictional facts through sworn affidavits or other competent evidence”). At most, Plaintiff’s exhibits show that Vifor entities worked cooperatively with the U.S. Defendants to achieve growth in the American market. The exhibits make references, for example, to “Vifor Pharma’s U.S. partner American Regent, Inc.” and the “continued close collaboration between Vifor Pharma and its U.S. partner Luitpold Pharmaceuticals, Inc.” Even accepting Plaintiff’s allegations as true and viewing all factual disputes in her favor, see Miller Yacht, 384 F.3d at 97, this submitted proof is a far cry from supporting the allegation that Vifor Management purposefully directed its activities at Pennsylvania. For the same reasons, Plaintiff has failed to satisfy the second prong, requiring that the litigation “arise out of or relate to” the defendant’s activities in Pennsylvania.

Even if Plaintiff could establish the requisite minimum contacts with Pennsylvania, she must also demonstrate that exercising jurisdiction over Vifor Management would not offend “traditional notions of fair play and substantial justice.” See Int’l Shoe Co. v. State of Wash., 326 U.S. 310, 316 (1945); see also Asahi Metal Indus. Co. v. Superior Court, 480 U.S. 102 (1987).

In evaluating the reasonableness of exercising jurisdiction, courts consider (1) the burden on the defendant, (2) the interests of the forum state, (3) the plaintiff’s interest in obtaining relief, and (4) interstate policy interests. Asahi, 480 U.S. at 113.

Vifor Management argues that the burden on it is substantial and thus outweighs the other factors. The Supreme Court has recognized the “unique burdens” on foreign defendants being forced to litigate in the United States and stated this “should have significant weight in assessing the reasonableness of stretching the long arm of personal jurisdiction over national borders.”

Asahi, 480 U.S. at 114. Vifor Management is a Swiss company that has no employees, offices, facilities, or any physical presence in Pennsylvania. Vifor Management argues that Swiss blocking statutes and foreign data protection laws would make it costly and burdensome to litigate in this forum. Plaintiff responds that “Vifor is a pharmaceutical colossus” with “United States affiliates, subsidiaries, and partners” and one employee who lives in New Jersey. While this may be so, it does not negate the fact that Vifor Management’s employees and operations are overwhelmingly in Switzerland.

Under these facts, specific jurisdiction does not exist over Vifor Management in Pennsylvania. Plaintiff’s request for jurisdictional discovery is denied.6 Defendant’s motion to dismiss shall be granted with prejudice.7 An appropriate order follows.

June 11, 2020 BY THE COURT:

/s/ Wendy Beetlestone WENDY BEETLESTONE, J.

Based on the parties’ submissions and arguments, Plaintiff has failed to show that Vifor Management purposefully availed itself of the Pennsylvania forum.