Crockett v. Luitpold Pharm., Inc.

KATHERINE CROCKETT, Plaintiff, v. LUITPOLD PHARMACEUTICALS, INC., et al., Defendants.

CIVIL ACTION NO. 19-276

UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA

June 11, 2020

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").

In addition to American Regent and DSI, the Third Amended Complaint names as Defendants Vifor Management and several other Vifor entities—Vifor Pharma, Ltd., Vifor Pharma Participations, Ltd., Vifor (International) AG, and Relypsa, Inc. (together, "Vifor Defendants"). The Vifor Defendants develop, manufacture, and sell FCM in Europe as Ferinject.

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 byPennsylvania'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 AircraftLtd., 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 asan allegation about Vifor Management. Moreover, regardless of which Vifor entity is being discussed, the allegation speaks to selling in "the United States," not in Pennsylvania specifically, and a third-party licensing agreement does not show intent to distribute in Pennsylvania. See Yohn v. Waco Equip. Co., 2003 WL 22844220, at *3 (E.D. Pa. Nov. 26, 2003) (third-party defendant's distribution agreement suggested it was aware its products would be sold in the United States but did not reflect an intent to distribute in Pennsylvania). "Mere knowledge or awareness" that a product may end up in Pennsylvania is not sufficient for personal jurisdiction. See Renner v. Lanard Toys, 33 F.3d 277, 282 (3d Cir. 1994).⁴

Plaintiff next turns to Vifor Management's "coordination" with the U.S. Defend...