Lauris et al v. Novartis Ag et al

COMPLAINT against NOVARTIS AG, a Global Healthcare Company; NOVARTIS PHARMACEUTICALS CORPORATION, a Delaware Corporation by KRISTI LAURIS, Individually and as Successor In Interest to the ESTATE OF DAINIS LAURIS; KRISTI LAURIS as Guardian ad Litem for L.L.; and TAYLOR LAURIS. Attorney Weakley, James D. added. (Filing fee $ 400, receipt number 0972-6380040)

Eastern District of California, caed-1:2016-cv-00393

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Case 1:16-cv-00393-LJO-SAB Document 1 Filed 03/22/16 Page 1 of 12 1 James D. Weakley, Esq. Bar No. 082853 2 WEAKLEY & ARENDT, LLP 1630 East Shaw Avenue, Suite 176 3 Fresno, California 93710 Telephone: (559) 221-5256 4 Facsimile: (559) 221-5262 Jim@walaw-fresno.com 5 Attorneys for Plaintiffs, Kristi Lauris, Individually and as Successor In Interest to the Estate of 6 Dainis Lauris; Kristi Lauris as Guardian ad Litem for L.L.; and Taylor Lauris 7 8 IN THE UNITED STATES DISTRICT COURT 9 FOR THE EASTERN DISTRICT OF CALIFORNIA 10 11 Kristi Lauris, Individually and as Successor) CASE NO. 12 In Interest to the Estate of Dainis Lauris;) Kristi Lauris as Guardian ad Litem for L.L.;) 13 and Taylor Lauris,) COMPLAINT FOR WRONGFUL DEATH) AND PERSONAL INJURIES 14 Plaintiffs,)) 15 v.) JURY TRIAL DEMANDED) 16 Novartis AG, a Global Healthcare) Company; Novartis Pharmaceuticals) 17 Corporation, a Delaware Corporation,)) 18 Defendants.) __________________________________) 19 20 INTRODUCTION 21 1. This is an action brought by Plaintiffs against Defendants Novartis AG and Novartis 22 Pharmaceuticals Corporation (collectively "Novartis") to recover for injuries resulting from 23 Novartis’s intentional failure to warn of dangerous and known risks associated with Tasigna—a 24 Novartis-manufactured prescription medication for treatment of chronic myeloid leukemia (CML). 25 Specifically, Novartis failed to warn of risks that Tasigna caused severe, accelerated, and 26 irreversible forms of atherosclerosis-related conditions—i.e., the narrowing and hardening of 27 arteries delivering blood to the arms, legs, heart, and brain. Despite warning doctors and patients 28 in Canada of the risks of atherosclerosis, Novartis intentionally failed to warn United States ____________________________ Plaintiffs’ Complaint for Wrongful Death and Personal Injuries Case 1:16-cv-00393-LJO-SAB Document 1 Filed 03/22/16 Page 2 of 12 1 doctors and patients of these risks. 2 2. Decedent Dainis Lauris, a California resident, was prescribed and took Tasigna for 3 over a year. Upon taking Tasigna, Dainis Lauris developed severe, accelerated, and irreversible 4 atherosclerosis-related conditions, which caused, among other things, 100-percent narrowing of his 5 femoral arteries, 40-to 60-percent narrowing of his coronary arteries, and 70-percent narrowing of 6 his cerebral arteries. At no time while he was prescribed and took Tasigna did Novartis properly 7 warn Dainis Lauris or his prescribing doctors about the atherosclerosis-related risks Novartis knew 8 were associated with Tasigna. As a proximate result of Dainis Lauris’s atherosclerosis-related 9 conditions and Novartis’s intentional failure to warn of them, Dainis Lauris died. 10 JURISDICTION AND VENUE 11 3. This Court has diversity subject matter jurisdiction under 28 U.S.C. § 1332 because 12 Plaintiffs and Novartis are citizens of different states, and the amount in controversy exceeds 13 $75,000. 14 4. Venue is appropriate in this Court under 28 U.S.C. § 1391(a) & (b) because a 15 substantial part of the events and omissions giving rise to this action occurred in this district, and 16 because Novartis resides in this district. 17 5. This Court has personal jurisdiction over Novartis, as Novartis marketed 18 Tasigna in California and sold Tasigna to Dainis Lauris in California. 19 THE PARTIES 20 A. The Plaintiffs 21 6. Dainis Lauris and Kristi Lauris were legally married on May 24, 1995, and 22 were husband and wife prior to and as of the date of Dainis Lauris’s death on March 31, 2014. 23 Together they have two children – Plaintiffs Taylor Lauris and L.L. 24 7. Plaintiffs Kristi Lauris, L.L., and Taylor Lauris are the sole heirs of 25 decedent Dainis Lauris for the purposes of bringing this wrongful death lawsuit. They reside in 26 Fresno County, California. 27 8. Kristi Lauris is the sole legal guardian of Plaintiff L.L. 28 9. Plaintiff Kristi Lauris is the Successor in Interest to the Estate of Dainis Lauris. ____________________________ Plaintiffs’ Complaint for Wrongful Death and Personal Injuries 2 Case 1:16-cv-00393-LJO-SAB Document 1 Filed 03/22/16 Page 3 of 12 1 Prior to or coincident with the commencement of this action, Plaintiff Kristi Lauris filed a 2 declaration as successor in interest of decedent Dainis Lauris, pursuant to California Code of Civil 3 Procedure § 377.32. Said declaration accompanies and is served with this Complaint. In such 4 capacity, plaintiff Kristi Lauris brings this claim for a Survival Cause of Action for Decedent 5 pursuant to Code of Civil Procedure § 377.30, et seq. 6 B. The Defendants 7 10. Defendant Novartis AG is a global healthcare company based in Switzerland. 8 Novartis AG is in the business of, among other things, manufacturing, marketing, distributing, 9 promoting, testing, labeling, and selling Tasigna. Novartis AG sells Tasigna to patients in the 10 United States through its wholly-owned subsidiary, Novartis Pharmaceuticals Corporation. 11 11. Defendant Novartis Pharmaceuticals Corporation is a Delaware Corporation with its 12 principal place of business in East Hanover, New Jersey. Novartis Pharmaceuticals Corporation is 13 in the business of, among other things, manufacturing, marketing, distributing, promoting, testing, 14 labeling, and selling Tasigna. 15 12. Defendants, and each of them, were the agents, servants, representatives and 16 employees of the remaining defendants, and each of them, and were at all times herein acting 17 within the purpose and scope of said agency, service, representative and employment. 18 IV. GENERAL ALLEGATIONS 19 C. Novartis’s Aggressive and Illegal Marketing of Tasigna 20 13. Tasigna is a prescription medication used to treat adults who have CML. CML is a 21 cancer which starts in certain blood-forming cells of the bone marrow, where a genetic change 22 occurs in an immature version of certain cells that make red blood cells, platelets, and most types 23 of white blood cells. Tasigna is part of a group of treatments known as tyrosine-kinase inhibitors 24 (TKIs), which target a protein—BCR-ABL—which is unique to CML cells. 25 14. The first TKI drug—Gleevec—was introduced in 2001, and, like Tasigna, is 26 produced and sold by Novartis. At an annual cost that has more than tripled since it was 27 introduced and is now over $100,000 per patient, Gleevec earned Novartis billions of dollars per 28 year while it maintained patent exclusivity. For example, in 2012, Gleevec sales generated ____________________________ Plaintiffs’ Complaint for Wrongful Death and Personal Injuries 3 Case 1:16-cv-00393-LJO-SAB Document 1 Filed 03/22/16 Page 4 of 12 1 approximately $4.7 billion for Novartis. 2 15. Novartis’s patent on Gleevec expired on July 4, 2015, and there are currently 3 several generic forms of Gleevec on the market, which cost as little as $500 per year. 4 16. In the years leading up to the expiration of Novartis’s patent on Gleevec, 5 Novartis developed Tasigna as a replacement for Gleevec, and began an aggressive campaign to 6 attempt to convince doctors to prescribe, and patients to take, Tasigna over Gleevec. Beginning as 7 early as 2010, Novartis’s strategy was, in the words of one senior Novartis executive, to have 8 Tasigna "cannibalize" Gleevec as Gleevec’s patent approached expiration. This, the executive 9 said, would "create a fairly large amount of the Gleevec business that will be indirectly protected 10 because it [would be] switched already to Tasigna." 11 17. In furtherance of its strategy to have Tasigna cannibalize Gleevec, Novartis engaged 12 in aggressive, and, at times, unethical and illegal marketing of Tasigna. One illegal and unethical 13 practice was Novartis’s disseminating widely-shared social media content that (1) promoted the 14 efficacy of Tasigna while failing to disclose any safety information, including known risks of 15 potentially fatal adverse reactions, (2) misrepresented that Tasigna was approved as a first-line 16 therapy for CML (like Gleevec), when, at the time, it had only been approved as a second-line 17 therapy for CML, and (3) described Tasigna as a "next generation" treatment for CML, which, in 18 the words of the Food & Drug Administration, "misleadingly suggests superiority over other" TKI 19 drugs (including Gleevec), "when this advantage has not been demonstrated by substantial 20 evidence or substantial clinical experience." These practices caused the FDA to issue Novartis a 21 cease and desist letter on July 29, 2010, finding that Novartis had misbranded Tasigna in violation 22 of FDA regulations, and demanding that Novartis immediately cease the misleading and illegal 23 advertising. 24 18. Another unethical practice involved Novartis, beginning in at least 2007, paying 25 illegal kickbacks disguised as rebates and discount payments to specialty pharmacies in exchange 26 for those pharmacies recommending to patients, doctors, and other healthcare managers the 27 ordering and refilling of Tasigna, among other drugs. Novartis took steps to steer patients to these 28 specialty pharmacies, who then encouraged patients and their doctors to switch to or stay on ____________________________ Plaintiffs’ Complaint for Wrongful Death and Personal Injuries 4 Case 1:16-cv-00393-LJO-SAB Document 1 Filed 03/22/16 Page 5 of 12 1 Tasigna through several aggressive intervention programs designed by Novartis. These kickbacks 2 paid to specialty pharmacies in exchange for their promotion of Tasigna were done in violation of 3 the Federal Healthcare Program Anti-kickback Statute, 42 U.S.C. § 1320a-7b(b). 4 19. Another unethical practice involved Novartis’s Japanese operations, where Novartis 5 staff hid reports of adverse reactions in clinical studies of patients taking Tasigna. Novartis staff 6 shredded or deleted thousands of reports of side effects associated with Tasigna, and in multiple 7 instances, Novartis’s sales staff helped doctors rate the severity of side effects. This egregious 8 conduct resulted in the Japanese government ordering an unprecedented 15-day suspension of 9 Novartis’s Japanese operations. 10 D. Novartis Failed to Warn Americans of Known Risks that Tasigna Causes 11 Atherosclerosis 12 20. Tasigna causes several dangerous adverse conditions, including severe, accelerated, 13 and irreversible atherosclerosis-related conditions. These atherosclerosis-related conditions 14 include peripheral arterial occlusive disease (hardening and narrowing of arteries supplying blood 15 to the legs and arms), coronary atherosclerosis (hardening and narrowing of the arteries supplying 16 blood to the heart), and cerebral atherosclerosis (hardening and narrowing of the arteries supplying 17 blood to the brain). These conditions are life-threatening and lead to amputations, heart-attacks, 18 strokes, and death. 19 21. Since at least 2011, Novartis was aware that Tasigna caused severe, accelerated, and 20 irreversible atherosclerosis-related conditions. This knowledge came from several sources, 21 including (1) multiple medical studies and reports linking Tasigna to accelerated and severe 22 atherosclerosis; (2) multiple instances of patients developing atherosclerosis-related conditions 23 reported during clinical trials and post-marketing experience with the use of Tasigna; and (3) 24 information gathered in a Novartis global safety database reporting hundreds of cases of patients 25 developing accelerated and severe atherosclerosis conditions after taking Tasigna. 26 22. The clear and alarming link between Tasigna and atherosclerosis prompted a 27 Canadian health agency—Health Canada—to investigate the risks. As a result, in April 2013, 28 Novartis issued an advisory to Canadian health care professionals and the Canadian public, which ____________________________ Plaintiffs’ Complaint for Wrongful Death and Personal Injuries 5 Case 1:16-cv-00393-LJO-SAB Document 1 Filed 03/22/16 Page