Brazil v. Janssen Research & Development LLC (249 F. Supp. 3d 1321, 2016)

ORDER

HAROLD L. MURPHY, UNITED STATES DISTRICT JUDGE

This case is before the Court on Defendants’ Motion to Dismiss [10],

I. Background

A. Plaintiffs Allegations

1. The Parties

Plaintiff is a citizen of the State of Georgia and resides in Dalton, Whitfield County, Georgia. (Compl. (Docket Entry No. 1) ¶ 3.)

Defendant Janssen Research & Development LLC, formerly known as Johnson and Johnson Pharmaceutical Research and Development LLC (“Defendant Janssen R & D”), is a limited liability company organized under the laws of New Jersey with its principal place of business in New Brunswick, New Jersey. (Compl. ¶ 7.) Plaintiff alleges that Defendant-Janssen R & D “is-involved in the research,-development, sales, and marketing of pharmaceutical products- including Invokana.” (Id.) Defendant Janssen R & D’s sole member is Defendant Janssen Pharmaceuticals, Inc. (“Defendant Janssen Pharmaceuticals”). (Id.) Defendant Janssen Pharmaceuticals is a Pennsylvania corporation with its principal place of business in Ti-tusville, New Jersey. (Id. ¶¶ 7, 9.) According to Plaintiff, Defendant Janssen Pharmaceuticals “is involved in the. research, development, sales, and/or marketing of pharmaceutical products including Invoka-na,” and “at all relevant times,... was in the business of and did design, research, manufacture, test, advertise, promote, market, sell, and/or distribute the drug Invokana for treatment of type 2 diabetes.” (Id ¶ 9.)

Defendant Johnson & Johnson Company (“Defendant J & J”) is a New Jersey corporation with its principal place of business in New Brunswick, New Jersey. (Compl. ¶8.) Plaintiff alleges that.; at all relevant times, “Defendant J & J was engaged in the business of designing, developing, manufacturing, testing, packaging, promoting, marketing, distributing, labeling, and/or selling Invokana.” (Id.)

-Defendant Janssen Ortho LLC (“Defendant Janssen Ortho”) is a Delaware limited liability company with its principal place of business -in Puerto Rico. (Compl. ¶ 10.) Plaintiff claims that “at all relevant timés, Defendant, Janssen Ortho,-was in the business of and did design, research, manufacture, test, advertise, promote, market, sell, and distribute the drug Invokana for use as a drug to treat type 2 diabetes.” (Id.) The only member of Defendant Janssen Ortho is OMJ PR Holdings, which is incorporated in Ireland and has its principal place of business in Puerto Rico. (Id.) Defendant Mitsubishi Tanabe Pharma Corporation (“Defendant Mitsubishi”) is a Japanese corporation with its principal place of business in Osaka, Japan. (Id. ¶ 11.) According to Plaintiff, Defendant Mitsubishi first developed Invokana and later licensed it to Janssen Pharmaceuticals. (Id.) Defendants John Does 1-5 are unknown-corporations or other legal entities, (Id. ¶ 12.)

2. Development of Invokana

According to Plaintiff, “Defendants” manufactured, marketed, advertised, distributed, promoted, labeled, tested, and sold Invokana as a drug to treat type 2 diabetes. (Compl. ¶ 13.) The United States Food and Drug Administration (“FDA”) approved Invokana on March 29, 2013 for use to improve glycemic control in adults with type 2 diabetes. (Id ¶ 14.) Invokana was the first of a new class of antidiabetic drugs known as sodium glucose co-transporter 2 (“SGLT2”) inhibitors, which work by blocking the reabsorbtion of glucose by the kidney, increasing glucose excretion, and lowering blood glucose levels for diabetics who have elevated blood glucose levels. (Id. ¶ 15.) Plaintiff states that Defendants’ marketing materials represent Invokana as a once-a-day pill “that is ‘proven to lower blood sugar (A1C).’ ” (Id. ¶ 16.) According to Plaintiff, Defendants advertise that Invokana “‘may help you lose weight’ ” even though they also “explicitly state that Invokana is not a weight-loss drug.” (Id.)

According to Plaintiff, on May 15, 2015, the FDA warned that treatment with SGLT2 inhibitors, including Invokana, could lead to serious complications, including diabetic ketoacidosis. (Compl. ¶ 17.) Diabetic ketoacidosis is a condition where high levels of acid accumulate in the blood and occurs when the body does not have enough insulin to manage glucose levels. (Id.) As a result, the body begins burning fatty acids, creating a waste product called ketones, which trigger the symptoms of ketoacidosis, including nausea, vomiting, abdominal pain, confusion, fatigue, and sleeplessness. (Id.) Plaintiff alleges that other complications associated with Invo-kana include heart attack, kidney failure, kidney impairment, kidney stones, urinary tract infections, and abnormal weight loss. (Id.)

Plaintiff states that the FDA has identified twenty cases reported as diabetic ke-toacidosis, ketoacidosis, or ketosis in patients treated with SGLT2 inhibitors from March 2013 to June 6, 2014, and all of those patients required emergency room visits or hospitalization. (Compl. ¶ 18.) According to Plaintiff, this information was not on the warnings section of the Invoka-na warning label. (Id.) Plaintiff claims that this lack of warning resulted in patients using Invokana and doctors prescribing Invokana without sufficient information to make an informed decision. (Id.) According to Plaintiff, the Institute for Safe Medication Practices’ (the “ISMP”) May 6, 2015 edition of Quarter Watch warns about a number of adverse reactions that have been reported about Invokana. (Id. ¶ 19.) According to the ISMP, 450 serious adverse event reports were filed in the first year after Invokana was related, and many of those were related to kidney failure, including fifty-four reports of kidney failure or impairment, fifty-four cases of severe dehydration or fluid imbalance, eleven cases of kidney stones, and fifty-two cases of abnormal weight loss. (Id.)

Plaintiff alleges that Defendants’ warning information for Invokana does not address the increased risk of diabetic ketoa-cidosis or kidney failure and only states that a possible side effect of Invokana is “ ‘kidney problems.’ ” (Compl. ¶ 20.) Plaintiff claims that Invokana was defective and, as a result, people who consumed it, even for a brief period of time, were at an increased risk for developing serious complications, including ketoacidosis. (Id. 21.) Plaintiff claims that Defendants withheld knowledge that Invokana can cause serious complications, including diabetic ketoacido-sis, from Plaintiff, other consumers, their physicians, and the public at large. (Id. ¶22.) Plaintiff suggests that other safer alternatives to Invokana were available to treat type 2 diabetes. (Id. ¶23.) Plaintiff alleges that Invokana is unreasonably dangerous and defective as formulated. (Id. ¶ 25.) Plaintiff claims that Defendants knew or should have known that Invokana was associated with serious complications and could cause diabetic ketoacidosis. (Id. ¶ 26.)

According to Plaintiff, Defendants continue to promote Invokana as a safe and effective treatment for people with type 2 diabetes, despite knowing about the risks associated with it. (Compl. ¶ 27.) In 2014, $19.8 million was spent marketing Invoka-na to doctors and hospitals, which represents the second highest amount spent for marketing any pharmaceutical drug that year. (Id. ¶ 28.) Plaintiff states that Defendant J & J reported 2014 domestic sales of Invokana in the amount of $569 million and as of June 2015 domestic sales had reach a total amount of $266 million. (Id. ¶29.)

3. Plaintiffs Use of Invokana

Plaintiff suffers from type 2 diabetes, and began using Invokana, as prescribed by her physician, to treat her diabetes on October 21, 2013. (Compl. ¶¶ 4, 31.) After using Invokana, Plaintiff began losing weight and suffered nausea and vomiting. (Id. ¶¶ 5, 32.) On or around November, 3, 2013, Plaintiff was admitted to Hamilton Medical Center to treat her nausea and vomiting and was diagnosed with diabetic ketoacidosis. (Id. ¶¶ 5, 32.) Plaintiff claims that, had Defendants properly disclosed the risks associated with Invokana, she would not have used it because safer alternatives were available. (Id. ¶ 32.)

4. Plaintiffs Claims

Count I of Plaintiffs Complaint is a strict liability claim. (Compl. ¶¶ 33-48.) In Count II, Plaintiff alleges a design defect claim. (Jd. ¶¶ 49-54.) Count III makes a failure to warn claim. (Id. ¶¶ 55-62.) Count IV alleges that Defendants were negligent. (Id. ¶¶ 63-68.) In Count V, Plaintiff claims that Defendants breached an express warranty. (Id. ¶¶ 69-73.) In Count VI, Plaintiff claims that Defendants breached an implied warranty. (Id. ¶¶ 74-79.) Count VII is a claim for fraud. (Id. ¶¶ 80-87.) Count VIII is a fraudulent misrepresentation claim. (Id. ¶¶ 88-96.) In Count IX, Plaintiff brings a fraudulent concealment claim. (Id. ¶¶ 97-105.) Count X is a negligent misrepresentation claim. (Id. ¶¶ 106-11.) In Count XI, Plaintiff alleges that Defendants violated the Georgia Fair Business Practices Act of 1975, O.C.G.A. § 10-1-390, et seq. (Id. ¶¶ 112-23.) Finally, in Count XII, Plaintiff requests an award of punitive damages. (Id. ¶¶ 124-29.)

B. Procedural Background

Plaintiff filed this case on October 29, 2015. (Docket Entry No. 1.) On January 7, 2016, Defendants Janssen Ortho, Janssen Pharmaceuticals, Janssen R & D, and J & J (collectively “Defendants”), filed their Motion to Dismiss. (Docket Entry No. 10.) The briefing process for that Motion is now complete, and the Court finds that the matter is ripe for resolution.

II. Discussion

A. Personal Jurisdiction over Defendant Johnson and Johnson

1. Standard Governing a 12(b)(2) Motion to Dismiss

“A plaintiff seeking the exercise of personal jurisdiction over a nonresident defendant bears the initial burden of alleging in the complaint sufficient facts to make out a prima facie case of jurisdiction.” Diamond Crystal Brands, Inc. v. Food Movers Int'l, Inc., 593 F.3d 1249, 1257 (11th Cir.2010) (quoting United Techs. v. Mazer, 556 F.3d 1260, 1274 (11th Cir.2009)), “Where.. .the Defendant challenges jurisdiction by submitting affidavit evidence in support of its position The burden traditionally shifts back to the plaintiff to produce evidence supporting jurisdiction.’ ” Id. (quoting Meier ex rel. Meier v. Sun Int’l Hotels, Ltd., 288 F.3d 1264, 1269 (11th Cir.2002)). The Court “accept[s] the allegations stated in the complaint as true for purposes of resolving the jurisdictional issue” to the extent such factual allegations are not contradicted by the defendant’s affidavits. Posner v. Essex Ins. Co., 178 F.3d 1209, 1215 (11th Cir.1999). “Where the Plaintiffs 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.

Determining whether a federal court sitting in diversity can exercise jurisdiction over a non-resident defendant is a two-step inquiry. Diamond, 593 F.3d at 1257. “[T]he exercise of jurisdiction must (1) be appropriate under the state long-arm statute and (2) not violate the Due Process Clause of the Fourteenth Amendment to the United States Constitution.” Id. at 1257-58 (internal quotation marks omitted) (quoting United Techs., 556 F.3d at 1274).

2. Personal Jurisdiction under the Georgia Long-Arm Statute

The Court first must determine whether the Georgia long-ai*m statute Would allow the Court to exercise jurisdiction over Defendants. <