Guidry v. Janssen Pharm., Inc.

• Decision Date: 29 August 2016
• Docket Number: CIVIL ACTION NO. 15-4591
• Citation: 206 F.Supp.3d 1187
• Parties: Gloria GUIDRY v. JANSSEN PHARMACEUTICALS, INC., et al.
• Court: U.S. District Court — Eastern District of Louisiana

206 F.Supp.3d 1187

Gloria GUIDRY

v.JANSSEN PHARMACEUTICALS, INC., et al.

CIVIL ACTION NO. 15-4591

United States District Court, E.D. Louisiana.

Signed August 29, 2016

Richard J. Arsenault, Jennifer Mae Hoekstra, Neblett, Beard & Arsenault, Alexandria, LA, Mekel Smith Alvarez, Morris Bart, III, Morris Bart, LLC, New Orleans, LA, for Gloria Guidry.

James B. Irwin, V, Kelly Juneau Rookard, Irwin Fritchie Urquhart & Moore, LLC, New Orleans, LA, John Q. Lewis, Jones Day, Cleveland, OH, Mollie F. Benedict, Tucker Ellis LLP, Los Angeles, CA, for Janssen Pharmaceuticals, Inc., et al.

SECTION "F"

ORDER AND REASONS

MARTIN L. C. FELDMAN, UNITED STATES DISTRICT JUDGE

Before the Court are two motions to dismiss the plaintiff's amended complaint. The first motion is by two defendants the Court refers to as the Mitsubishi Defendants. The group includes Mitsubishi Tanabe Pharma Corporation (Mitsubishi Japan) and Mitsubishi Tanabe Pharma Development America, Inc. (Mitsubishi America). The second motion is by a group of defendants the Court refers to as the Janssen Defendants. This group includes: Janssen Pharmaceuticals, Inc.; Janssen Ortho, LLC; Janssen Research & Development, LLC; Johnson & Johnson Services, Inc.; and Johnson & Johnson. For the following reasons, the Mitsubishi Defendants' motion is GRANTED; the Janssen Defendants' motion is GRANTED IN PART and DENIED IN PART.

Background

This case is here for Round Two.

Gloria Guidry brings this products liability lawsuit after suffering acute kidney injury and acute kidney failure allegedly caused by taking Invokana, a prescription drug manufactured, licensed, and distributed by the defendants.

After Guidry filed her initial complaint, the defendants moved for dismissal under Federal Rule of Civil Procedure 12(b)(6). In its Order and Reasons dated February 17, 2016, the Court granted the defendants' motion and dismissed the plaintiff's complaint. The Court, however, allowed the plaintiff to amend her complaint and refile it within fourteen days. The plaintiff complied with the Court's Order. Now the defendants seek dismissal of her amended complaint.

Gloria Guidry's doctor prescribed Invokana to treat her Type II diabetes. She took Invokana from approximately March 11, 2014 until she was hospitalized for acute kidney injury and acute kidney failure on September 21, 2014. She remained hospitalized for a week. Guidry charges that the prescription drug caused her kidney failure.

Invokana is the first diabetes treatment to be approved in a new class of drugs known as sodium-glucose co-transporter 2 (SGLT2) inhibitors. Invokana is designed to help diabetics reduce excess blood sugar. It works by blocking reabsorption of glucose in the kidneys, and, instead, it increases glucose excretion through urination. Other diabetes drugs help the body reabsorb or metabolize blood sugar; Invokana is designed to help the body reduce blood sugar through urination.

According to the plaintiff, Invokana overworks the kidneys by forcing them to filter the excess blood sugar. Because Invokana blocks the kidneys from reabsorbing the sugar, the kidneys push the excess blood sugar through the urinary tract instead. The plaintiff urges that this excess sugar builds up in the tubes connecting the kidneys to the bladder, forcing the kidneys to work harder than normal to function properly. The plaintiff maintains that this added stress causes kidney injury or failure.

The plaintiff contends that the defendants were aware of these adverse effects before Invokana was ever approved by the Food and Drug Administration. She points out that medical documents submitted with Invokana's New Drug Application disclosed a three-fold increase (1.7% compared to 0.6%) in acute renal (kidney) failure for patients taking a higher dose of Invokana compared to those taking a placebo. This was true even in patients with normal kidney function.

The plaintiff also submits that the defendants marketed and promoted Invokana for off-label purposes such as weight loss. She contends (somewhat vaguely) that she "became aware" of these promotional materials and formed the belief that Invokana was safe to treat her diabetes.¹ The plaintiff claims that the defendants' advertisements overstated Invokana's ability to reduce blood sugar levels and failed to disclose the risks of severe kidney injury. She maintains that Invokana's risks substantially outweigh its benefits. Invokana reduces hemoglobin levels (i.e., blood sugar levels) by 0.62% for the 100 mg dosage and by 0.77% for the 300 mg dosage, both of which the plaintiff describes as a "very weak reduction."

The plaintiff claims that the defendants concealed their knowledge of the dangerous side effects of the medication and provided inadequate warnings to doctors and consumers. Had she known of the risks, the plaintiff maintains, she would not have taken Invokana. She also urges that the defendants failed to adequately complete testing of Invokana before filing for a New Drug Application with the FDA. She concludes that the defendants' negligent actions and omissions were a proximate cause of her acute kidney failure, a condition that has left her with permanent injuries.²

The plaintiff makes claims under the Louisiana Products Liability Act. She asserts five Invokana defects: 1) in composition or construction; 2) in design; 3) for failing to provide adequate warnings; 4) for breach of an express warranty; and 5) because it is either useless or so inconvenient that a knowing buyer would not have purchased it.

The Mitsubishi Defendants move to dismiss on three grounds. First, they challenge this Court's personal jurisdiction, invoking Federal Rule of Civil Procedure 12(b)(2). Second, they assert insufficient service of process under Rule 12(b)(5). Finally, they submit that the plaintiff has failed to plead facts sufficient to satisfy Rule 12(b)(6). They urge that the plaintiff's claims are preempted by federal law.

The Janssen Defendants also move to dismiss under Rule 12(b)(6). They contend that the plaintiff has failed to allege sufficient facts to satisfy federal pleading standards, and the plaintiff's state law claims are preempted by federal law. The Court addresses each motion separately.

I. The Mitsubishi Defendants

The Mitsubishi Defendants move to dismiss the plaintiff's complaint for lack of personal jurisdiction, insufficient service of process, and failure to state a claim. The Mitsubishi Defendants also incorporate by reference the arguments made by the Janssen Defendants. The Court first addresses the existence of its personal jurisdiction over the Mitsubishi Defendants. Finding it lacking, the Court does not consider Mitsubishi's remaining grounds for dismissal.

A.

"Federal courts ordinarily follow state law in determining the bounds of their jurisdiction over persons." Daimler AG v. Bauman , –––U.S. ––––, 134 S.Ct. 746, 753, 187 L.Ed.2d 624 (2014). However, "[t]he Due Process Clause of the Fourteenth Amendment sets the outer boundaries of a state tribunal's authority to proceed against a defendant." Goodyear Dunlop Tires Operations, S.A. v. Brown , 564 U.S. 915, 923, 131 S.Ct. 2846, 180 L.Ed.2d 796 (2011). Louisiana's long-arm statute confers personal jurisdiction over out-of-state defendants who conduct a wide range of activities within the State. See La. R.S. § 13:3201. But because the State's authority to proceed against an out-of-state defendant is confined by the Fourteenth Amendment, the Court first addresses whether it may exercise personal jurisdiction over the defendants in a manner consistent with due process.

The "canonical opinion" governing personal jurisdiction remains International Shoe Co. v. Washington , 326 U.S. 310, 66 S.Ct. 154, 90 L.Ed. 95 (1945). See Daimler , 134 S.Ct. at 754. There, the Supreme Court held that "a State may authorize its courts to exercise personal jurisdiction over an out-of-state defendant if the defendant has ‘certain minimum contacts with [the State] such that the maintenance of the suit does not offend traditional notions of fair play and substantial justice.’ " Goodyear , 564 U.S. 915, 923, 131 S.Ct. 2846 (2011) (quoting International Shoe , 326 U.S. at 316, 66 S.Ct. 154 ). Within the International Shoe framework, two categories of personal jurisdiction exist: specific jurisdiction and general jurisdiction. See id. Specific jurisdiction exists when a suit arises out of or relates to the defendant's contacts with the forum state. Daimler, 134 S.Ct. at 754 ; Helicopteros Nacionales de Colombia, S.A. v. Hall , 466 U.S. 408, 414, 104 S.Ct. 1868, 80 L.Ed.2d 404 (1984). On the other hand, a court has general jurisdiction over a foreign corporation "to hear any and all claims against them when their affiliations with the State are so continuous and systematic as to render them essentially at home in the forum State." Daimler , 134 S.Ct. at 754 (quoting Goodyear , 564 U.S. at 919, 131 S.Ct. 2846 ).

The plaintiff here does not contend that the Court has general jurisdiction over the Mitsubishi Defendants. She relies exclusively on specific jurisdiction.

The Fifth Circuit instructs, "Specific jurisdiction ‘focuses on the relationship among the defendant, the forum, and the litigation.’ " Monkton Ins. Services, Ltd. v. Ritter , 768 F.3d 429, 432–33 (5th Cir.2014) (quoting Walden v. Fiore , ––– U.S. ––––, 134 S.Ct. 1115, 1121, 188 L.Ed.2d 12 (2014) ). " ‘For a State to exercise jurisdiction with due process, the defendant's suit-related conduct must create a substantial connection with the forum State.’ " Id. (quoting Walden , 134 S.Ct. at 1121 ). This Circuit applies a three-step analysis for the specific jurisdiction inquiry:

(1) whether the defendant has minimum contacts with the forum state, i.e., whether it purposely directed its activities toward the forum state or purposefully availed itself of the privileges of conducting activities there; (2) whether the plaintiff's cause of action arises out of or results from the defendant's forum-related

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