Brazil v. Janssen Research & Dev. LLC

• Decision Date: 11 July 2016
• Docket Number: CIVIL ACTION NO. 4:15-CV-0204-HLM
• Parties: Paula BRAZIL Plaintiff, v. JANSSEN RESEARCH & DEVELOPMENT LLC f/k/a Johnson and Johnson Pharmaceutical Research and Development LLC, et al., Defendants.
• Court: U.S. District Court — Northern District of Georgia

196 F.Supp.3d 1351

Paula BRAZIL Plaintiff,

v.JANSSEN RESEARCH & DEVELOPMENT LLC f/k/a Johnson and Johnson Pharmaceutical Research and Development LLC, et al., Defendants.

CIVIL ACTION NO. 4:15-CV-0204-HLM

United States District Court, N.D. Georgia, Rome Division.

Signed July 11, 2016

Adam A. Edwards, Justin G. Day, Mark E. Silvey, Greg Coleman Law PC, Knoxville, TN, for Plaintiff.

Christiana C. Jacxsens, Greenberg Traurig, LLP, Atlanta, GA, for Defendants.

ORDER

HAROLD L. MURPHY, UNITED STATES DISTRICT JUDGE

This case is before the Court on Defendants' Motion to Dismiss [25].

I. Background

A. Plaintiff's Allegations

1. The Parties

Plaintiff is a citizen of the State of Georgia and resides in Dalton, Whitfield County, Georgia. (Am. Compl. (Docket Entry No. 21) ¶ 3.)

Defendant Janssen Research & Development LLC, formerly known as Johnson and Johnson Pharmaceutical Research and Development LLC ("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. (Am. Compl. ¶ 7.) Plaintiff alleges that Janssen R&D "is involved in the research, development, sales, and marketing of pharmaceutical products including Invokana." (Id.) Janssen R&D's sole member is Defendant Janssen Pharmaceuticals, Inc. ("Janssen Pharmaceuticals"). (Id.) Janssen Pharmaceuticals is a Pennsylvania corporation with its principal place of business in Titusville, New Jersey. (Id.¶¶ 7-8.) According to Plaintiff, Janssen Pharmaceuticals "is involved in the research, development, sales, and/or marketing of pharmaceutical products including Invokana," and "at all relevant times,... was in the business of and did, manufacture, advertise, promote, market, sell, and/or distribute Invokana for treatment of type 2 diabetes." (Id.¶ 8.)

Defendant Janssen Ortho LLC ("Janssen Ortho") is a Delaware limited liability company with its principal place of business in Puerto Rico. (Am. Compl. ¶ 9.) Plaintiff claims that "at all relevant times, [Janssen Ortho] was in the business of and did manufacture, advertise, promote, market, sell, and distribute Invokana for use as a drug to treat type 2 diabetes." (Id.) The only member of Janssen Ortho is OMJ PR Holdings, which is incorporated in Ireland and has its principal place of business in Puerto Rico. (Id.) Plaintiff thus states that Janssen Ortho is a citizen of Delaware, Ireland, and Puerto Rico. (Id.)

Defendant Mitsubishi Tanabe Pharma Corporation ("Mitsubishi") is a Japanese corporation with its principal place of business in Osaka, Japan. (Am. Compl. ¶ 10.) According to Plaintiff, Mitsubishi first developed, designed, and tested Invokana and later licensed it to Janssen Pharmaceuticals and its affiliates. (Id.)

Defendants John Does 1-5 are unknown corporations or other legal entities. (Am. Compl. ¶ 11.)

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

. (Am. Compl. ¶ 12.) On May 31, 2012, Janssen R&D submitted a New Drug Application ("NDA") to the United States Food and Drug Administration ("FDA"), seeking approval for the use of canagliflozin, which was later marketed as Invokana. (Id.¶ 13.) The FDA approved Invokana on March 29, 2013 for use in adults with type 2 diabetes to improve glycemic control. (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).’ " (Am. Compl. ¶ 16.) According to Plaintiff, Defendants continue to advertise that Invokana " ‘may help you lose weight’ " even though Defendants also "explicitly stated 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

. (Am. 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 Invokana 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 ketoacidosis

, 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. (Am. Compl. ¶ 18.) According to Plaintiff, this information was not on the warnings section of the Invokana 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 regarding the drug's safety. (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 problems, 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 ketoacidosis

or kidney failure and only states "that a ‘possible side effect’ of Invokana is ‘kidney problems.’ " (Am. Compl. ¶ 20.) Plaintiff claims that Invokana was defective and, as a result, people who consumed it, even for a brief period of time like herself, were at an increased risk for developing serious and sometimes life-threatening complications, including ketoacidosis, (Id.¶ 21.) Plaintiff claims that Defendants withheld knowledge that Invokana can cause serious complications, including diabetic ketoacidosis, from Plaintiff, other consumers, their physicians, the medical community, and the public. (Id.¶ 22.) Plaintiff suggests that other safer alternatives to Invokana were available to treat type 2 diabetes and that consumers who used Invokana were not adequately warned about the risks and benefits associated with Invokana. (Id.¶¶ 23-24.) 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. (Am. Compl. ¶ 27.) In 2014, $19.8 million was spent marketing Invokana to doctors and hospitals, which represents the second highest amount spent for marketing any pharmaceutical drug that year. (Id.¶ 28.) Plaintiff states that Defendants 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. Plaintiff's 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. (Am. 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. Plaintiff's Claims

Count I of Plaintiff's Complaint is a strict liability claim against all Defendants. (Am. Compl. ¶ 33-47.) Plaintiff claims that Janssen R&D and Mitsubishi defectively designed Invokana and that Janssen Pharm and Janssen Ortho failed to properly market, manufacture, distribute, supply, and sell the drug, including failing to warn and placing adequate warning and instructions on Invokana. (Id.¶ 44.) Plaintiff alleges that, as a result of her ingestion of Invokana, she suffered diabetic ketoacidosis

, leading to significant weight loss, nausea, and vomiting, as well as continued injury, emotional distress, and economic loss. (Id. 47.)

In Count II, Plaintiff alleges a design defect claim against Janssen R&D and Mitsubishi. (Am. Compl. ¶¶ 48-56.) Plaintiff claims that Invokana is "defectively designed because it is capable of causing serious medical conditions, such as kidney failure

and ketoacidosis" (id.¶ 51) and because the design "fails to adequately warn that it causes ketoacidosis," has risks that outweigh the benefits of glucose control, and was capable of being made more safe (id.¶ 54).

Count III asserts a failure to warn claim against Janssen Pharmaceuticals and Janssen Ortho. (Am. Compl. ¶¶ 57-73.) Plaintiff states that, according to the FDA's Label and Approval History, only one label was in use during 2013, which the FDA had approved in March 2013. (Id.¶ 61.) According to Plaintiff, the 2013 label mentioned ketoacidosis

three times,...