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1 in the United States District Court for the District Of Case 1:19-cv-09348-RBK-JS Document 1 Filed 04/05/19 Page 1 of 48 PageID: 1 IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF NEW JERSEY CAMDEN VICINAGE PAULETTE SILBERMAN, Individually and on behalf of all others similarly situated, Civil Action No.:______________ Plaintiff, Jury Trial Demanded v. Complaint-Class Action ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD.; HUAHAI US INC.; PRINSTON PHARMACEUTICAL INC. d/b/a SOLCO HEALTHCARE LLC; SOLCO HEALTHCARE U.S., LLC; TEVA PHARMACEUTICAL INDUSTRIES LTD.; ACTAVIS LLC; TEVA PHARMACEUTICALS USA, INC.; CARDINAL HEALTH, INC.; THE HARVARD DRUG GROUP, L.L.C.; MAJOR PHARMACEUTICALS, INC.; ARROW PHARM (MALTA) LTD.; ACTAVIS PHARMA, INC.; TORRENT PRIVATE LIMITED; TORRENT PHARMACEUTICALS, LTD.; TORRENT PHARMA, INC.; AUROBINDO PHARMA, LIMITED; AUROBINDO PHARMA USA, INC.; AUROLIFE PHARMA LLC; AND JOHN DOES 1-100, Defendants. 1. Plaintiff Paulette Silberman (“Plaintiff”), individually and on behalf of all others similarly situated, brings this action against Zhejiang Huahai Pharmaceuticals Co., Ltd. (“ZHP”), Huahai US Inc. (“Huahai US”), Prinston Pharmaceutical Inc. d/b/a Solco Healthcare LLC (“Prinston"), Solco Healthcare U.S., LLC (“Solco”), Teva Pharmaceutical Industries Ltd. (“Teva”), Actavis LLC (“Actavis”), Teva Pharmaceuticals USA, Inc. (“Teva USA”), Cardinal Health, Inc. (“Cardinal”), The Harvard Drug Group, L.L.C. (“Harvard”), Major Pharmaceuticals, Inc. (“Major”), Arrow Pharm (Malta) Ltd. (“Arrow”), Actavis Pharma, Inc. (“Actavis Pharma”), 1 Case 1:19-cv-09348-RBK-JS Document 1 Filed 04/05/19 Page 2 of 48 PageID: 2 Torrent Private Limited (“Torrent Private”), Torrent Pharmaceuticals, Ltd. (“Torrent Pharmaceuticals”), Torrent Pharma, Inc. (“Torrent Pharma”) (ZHP, Huahai US, Prinston, Solco, Teva, Actavis, Teva USA, Cardinal, Harvard, Major, Arrow, Actavis Pharma, Torrent Private, Torrent Pharmaceuticals, and Torrent Pharma, collectively, “ZHP Defendants”), Aurobindo Pharma, Limited (“Aurobindo”), Aurobindo Pharma USA, Inc. (“Aurobindo USA”), Aurolife Pharma LLC (“Aurolife”) (Aurobindo, Aurobindo USA, and Aurolife, collectively, “Aurobindo Defendants”), and John Does 1-100 (“John Does”) (ZHP Defendants, Aurobindo Defendants, and John Does, collectively, “Defendants”). Plaintiff’s allegations are based upon personal knowledge, the investigation of counsel, and information and belief. I. INTRODUCTION 2. Plaintiff brings this action on behalf of herself and other Valsartan consumers who consumed Defendants’ generic Valsartan that was contaminated with an IARC- and EPA-listed probable human carcinogen known as N-nitrosodimethylamine (“NDMA”), and/or an IARC- and EPA-listed probable human carcinogen known as N-nitrosodiethylamine (“NDEA”), and who suffered cellular damage, genetic harm, developed cancer, and/or are at an increased risk of developing cancer as a result, but have not yet been diagnosed with cancer. Plaintiff seeks injunctive and monetary relief, including creation of a fund to finance independent medical monitoring services, including but not limited to notification to all people exposed to this contamination, examinations, testing, preventative screening, and care and treatment of cancer resulting, at least in part, from the exposure to the NDMA or NDEA contamination. 3. At all times during the period alleged herein, Defendants represented and warranted to consumers that their generic Valsartan products were therapeutically equivalent to and otherwise the same as the brand name medication, DIOVAN® (“Diovan”), were otherwise fit for 2 Case 1:19-cv-09348-RBK-JS Document 1 Filed 04/05/19 Page 3 of 48 PageID: 3 their ordinary uses, and were otherwise manufactured and distributed in accordance with applicable laws and regulations. 4. However, for years, ZHP wrongfully manufactured ZHP Defendants’ Valsartan products in a manner that they were contaminated with NDMA and NDEA as a result of ZHP’s failure to manufacture the Valsartan Active Pharmaceutical Ingredient (“API”) in a safe manner. On information and belief, ZHP changed its manufacturing process and/or introduced chemicals into the manufacturing process, without due care or tests, leading to the creation of NMDA and NDEA, which contaminated the Valsartan. ZHP Defendants negligently and willfully ignored warning signs regarding the operating standards at the ZHP manufacturing facilities in Linhai City, Zhejiang Province, China, and continued to allow ZHP to manufacture their Valsartan products for sale to consumers in the United States even after ZHP Defendants knew or should have known that their Valsartan products manufactured by ZHP contained or likely contained NDMA, NDEA, and/or other impurities. 5. ZHP and Huahai US1 sold ZHP’s contaminated Valsartan API to at least four distribution chains: one containing Prinston and Solco; the second comprising Teva and Actavis; the third composed of Teva, Teva USA, Cardinal, Harvard, Major, Arrow, and Actavis Pharma; and the fourth consisting of Torrent Private, Torrent Pharmaceuticals, and Torrent Pharma. 6. Additionally, Aurobindo wrongfully manufactured Aurobindo Defendants’ Valsartan products in a manner that they were contaminated with NDEA as a result of Aurobindo’s failure to manufacture the Valsartan API in a safe manner. Aurobindo Defendants negligently and willfully ignored warning signs regarding the operating standards at the Aurobindo manufacturing 1 “Huahai US Inc. is a subsidiary of Zhejiang Huahai Pharmaceutical Ltd., Co., focusing on the sales and marketing of APIs and Intermediates.” Huahai US, HOMEPAGE, https://www.huahaius.com/index.html (last visited Apr. 5, 2019). 3 Case 1:19-cv-09348-RBK-JS Document 1 Filed 04/05/19 Page 4 of 48 PageID: 4 facilities in India, and continued to allow Aurobindo to manufacture their Valsartan products for sale to consumers in the United States even after Aurobindo Defendants knew or should have known that their Valsartan products manufactured by Aurobindo contained or likely contained NDEA and/or other impurities. 7. Aurobindo sold its contaminated Valsartan API to at least two distribution chains: the first containing Aurobindo USA, and the second comprising Aurobindo USA and Aurolife. 8. These contaminated, adulterated Valsartan drugs were introduced into the American market potentially as far back as November 2011 by Defendants. Plaintiff and other Class Members were exposed to highly dangerous and potentially fatal carcinogenic substances because they consumed Defendants’ contaminated Valsartan. Defendants’ conduct constitutes negligence, breach of express warranty, breach of implied warranty, defective manufacture, failure to warn, and other violations of state law. II. PARTIES 9. Plaintiff is a New Jersey resident. During the class period, she consumed one or more of Defendants’ Valsartan products. Defendants expressly and impliedly warranted to Plaintiff that their respective generic Valsartan products were the same as the brand name medication Diovan. Had the truth about the contaminants within Defendants’ products been made known, Plaintiff Silberman would not have consumed Defendants’ Valsartan products. At all relevant times, there were adequate alternative medications and therapies available to Plaintiff. A. ZHP Defendants 10. ZHP is based on investigation, information, and belief, a corporation in China, located at Xunqiao, Linhai City, Zhejiang Province, 317024. ZHP also has a United States headquarters located at 2009 Eastpark Boulevard, Cranbury, New Jersey 08512. At all times relevant to this case, ZHP has been a manufacturer of the contaminated Valsartan API at issue in 4 Case 1:19-cv-09348-RBK-JS Document 1 Filed 04/05/19 Page 5 of 48 PageID: 5 this Complaint, and has been involved in and/or responsible in whole or in part, for the distribution, sales, and marketing of the contaminated Valsartan in finished form both directly and through its subsidiaries, affiliates, and other purchasers. 11. Huahai US is a New Jersey corporation, with its principal place of business located at 2002 Eastpark Boulevard, Cranbury, New Jersey 08512. Huahai US is a wholly-owned subsidiary of ZHP. At all times material to this case, Huahai US has been engaged in the manufacture, sale, and distribution of contaminated Valsartan in the United States, including in the State of New Jersey. 12. Prinston is a Delaware corporation with its principal place of business located at 2002 Eastpark Boulevard, Cranbury, New Jersey 08512. Prinston is a majority-owned subsidiary of ZHP. At all times material to this case, Prinston has been engaged in the manufacturing, sale, and distribution of contaminated Valsartan in the United States, including in the State of New Jersey. 13. Solco is a Delaware limited liability company with its principal place of business located at 2002 Eastpark Boulevard, Cranbury, New Jersey 08512. Solco is a wholly-owned subsidiary of Prinston and ZHP. At all times material to this case, Solco has been engaged in the manufacturing, sale, and distribution of contaminated Valsartan in the United States, including in the State of New Jersey. 14. Teva is a foreign company incorporated in Peta Tikvah, Israel, and headquartered at 5 Basel Street, Petach Tikva, Israel, 49131. Teva on its own and/or through its subsidiaries regularly conducts business throughout the United States of America and its territories and possessions. At all times material to this case, Teva has been engaged in the manufacturing, sale, 5 Case 1:19-cv-09348-RBK-JS Document 1 Filed 04/05/19 Page 6 of 48 PageID: 6 and distribution of contaminated Valsartan
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