Case 3:18-cv AET-LHG Document 1 Filed 10/11/18 Page 1 of 37 PageID: 1 IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF NEW JERSEY. v.

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1 Case 3:18-cv AET-LHG Document 1 Filed 10/11/18 Page 1 of 37 PageID: 1 IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF NEW JERSEY RICHARD GONTESKI, Individually and On ) Behalf of a Class of Similarly Situated Individuals, ) Civil Action No. ) Plaintiff, v. ) ) HUAHAI US, INC., a New Jersey corporation, ) and ZHEJIANG HUAHAI PHARMACEUTICAL ) CO., LTD., a Chinese corporation, ) ) Defendants. ) ) Jury Trial Demanded ) CLASS ACTION COMPLAINT Plaintiff, Richard Gonteski ( Plaintiff ), on behalf of himself and all others similarly situated, by and through his attorneys, alleges as follows upon personal knowledge as to facts pertaining to himself, and upon information and belief based on the investigation of his counsel as to all other matters. NATURE OF THE CASE 1. Plaintiff brings this class action on behalf of himself and all others similarly situated regarding the respective manufacturing, distribution, and sale of valsartan generic prescription medications adulterated with N-nitrosodimethylamine, a carcinogenic substance by Defendants, Huahai US, Inc. ( Huahai ) and Zhejiang Huahai Pharmaceutical Co., Ltd. ( Zhejiang ) (collectively, Defendants ). 2. Valsartan is a prescription medication mainly used for the treatment of high blood pressure and congestive heart failure.

2 Case 3:18-cv AET-LHG Document 1 Filed 10/11/18 Page 2 of 37 PageID: 2 3. Due to manufacturing defects originating in Zhejiang s facility in China, certain generic formulations of Valsartan have become adulterated with an organic chemical known as N-nitrosodimethylamine ( NDMA ). 4. On July 13, 2018, the U.S. Food & Drug Administration ( FDA ) announced a voluntary recall of several brands of Valsartan-containing generic medications, including those manufactured and distributed by Huahai, among others. The recall was due to the presence of NDMA in the recalled products. 5. Generic drugs such as Valsartan are marketed and sold to consumers such as Plaintiff when the brand-name version of the drug comes off patent, and other competitors are able to seek approval for, market, and sell bioequivalent versions of the brand-name drug. These generic equivalents, such as Valsartan, are supposed to be of equal quality and equal safety. 6. Plaintiff and the putative class members were injured by the full purchase price of their valsartan-containing medications and incidental medical expenses. These medications are worthless, as they are contaminated with carcinogenic and harmful NDMA and are not fit for human consumption. 7. Plaintiff and the putative class (defined below) members were advised to cease using their Valsartan-containing medications. 8. Plaintiff brings this action both individually and on behalf of the putative class members for equitable relief and to recover economic damages and restitution for: (1) violation of New Jersey s Consumer Fraud Act; (2) strict products liability; (3) failure to warn; (4) breach of contract; (5) breach of implied warranty of merchantability; (6) unjust enrichment; (7) fraudulent concealment; (8) conversion; (9) negligence; and (10) gross negligence. 2

3 Case 3:18-cv AET-LHG Document 1 Filed 10/11/18 Page 3 of 37 PageID: 3 PARTIES 9. Plaintiff is an individual who is a citizen of New Jersey, domiciled in Riverside, Burlington County, New Jersey. 10. Huahai is a corporation organized and existing under the laws of the State of New Jersey, and it maintains its principal place of business at 2001 Eastpark Boulevard, Cranbury, New Jersey. Huahai is deemed to be a citizen of New Jersey. 11. On information and belief, Huahai conducts substantial business in the State of New Jersey and manufactures, markets and/or distributes Valsartan for use in generic drugs, including the prescription drug, Valsartan, which is the subject of this litigation, by incorporating Valsartan manufactured in China by Zhejiang. According to Huahai s website, it is a whollyowned subsidiary of Zhejiang focusing on the sales and marketing of APIs and Intermediates. Huahai lists Valsartan as one of its products. 12. On information and belief, Zhejiang is a corporation organized and existing under the laws of the People s Republic of China, and it maintains its principal place of business at Xunqiao, Linhai, Zhejiang , China. Zhejiang is deemed to be a citizen of the People s Republic of China. 13. Zhejiang touts on its website that: (a) it is a large scaled modern pharmaceutical group that integrates formulations, APIs (active pharmaceutical ingredients) and intermediates; (b) it has 11 subsidiary entities in the United States, Shanghai, Hangzhou, and Linhai; (c) it occupies an area of 800,000 square meters, and has a staff of 3,400; (d) its formulation workshops are designed in strict compliance with the international cgmp standard (defined below); (e) it is the first pharmaceutical company in China that has passed United States FDA approval; (f) it ensures that production is operated in accordance with good manufacturing 3

4 Case 3:18-cv AET-LHG Document 1 Filed 10/11/18 Page 4 of 37 PageID: 4 practices and that its product quality meets the required specifications; and (g) it is equipped with state-of-the-art devices ensuring high quality raw materials, final products and in process intermediates. JURISDICTION 14. On information and belief, at all times relevant herein Zhejiang exercised a high degree of control over its subsidiary, Huahai, and provided more than just standard administrative services to it. 15. On information and belief, at all times relevant herein Huahai and Zhejiang were agents of each other and/or worked in concert with each other on the development, obtaining of regulatory approval, supplying, manufacturing, marketing, distribution and/or sale of generic drugs, including the prescription drug Valsartan, throughout the United States and including in New Jersey. 16. On information and belief, at all times relevant herein Huahai and Zhejiang each transacted business in New Jersey. 17. On information and belief, at all times relevant herein Huahai and Zhejiang each carried on systematic business activity in New Jersey with a fair measure of permanence and continuity through, in part, efforts to market and sell their products in New Jersey, including the prescription drug, Valsartan. 18. On information and belief, at all times relevant herein Huahai and Zhejiang each delivered their products, including the prescription drug, Valsartan, into the stream of commerce with the expectation that it would be purchased by New Jersey consumers, including Plaintiff and putative class members. 4

5 Case 3:18-cv AET-LHG Document 1 Filed 10/11/18 Page 5 of 37 PageID: On information and belief, at all times relevant herein Huahai and Zhejiang each purposefully directed activities at New Jersey and purposefully availed themselves of the privilege of conducting activities in New Jersey. 20. On information and belief, at all times relevant herein Huahai and Zhejiang each knew, or should have known, that their products, including the prescription drug, Valsartan, would ultimately be sold in New Jersey and throughout the United States. 21. On information and belief, at all times relevant herein Zhejiang, and Huahai each benefitted from New Jersey s system of laws, infrastructure and business climate for the sale of their products, including the prescription drug, Valsartan. 22. Defendants manufacture, marketing, distribution and/or sale of the prescription drug, Valsartan, resulted in millions of dollars in sales of Valsartan to New Jersey consumers, as well as consumers nationwide, including Plaintiff and the putative class members. 23. Huahai and Zhejiang each committed a tortious act when Plaintiff and the putative class members purchased or consumed adulterated Valsartan contaminated with NDMA that had been manufactured, marketed, distributed, and sold by Defendants. 24. The tortious act injured Plaintiff and the putative class members in New Jersey and nationwide. The injuries and losses suffered by the Plaintiff and the putative class members arose out of the forum-related activities of Zhejiang and Huahai. 25. New Jersey has a strong interest in public safety, including the safety of prescription drugs sold by New Jersey entities. New Jersey also has a manifest interest in providing its residents with a convenient forum for redress of their injuries. 26. This Court has subject matter jurisdiction over this class action pursuant to 28 U.S.C. 1332, as amended by the Class Action Fairness Act of 2005, because the matter in 5

6 Case 3:18-cv AET-LHG Document 1 Filed 10/11/18 Page 6 of 37 PageID: 6 controversy exceeds $5 million, exclusive of interest and costs, and it is a class action in which Plaintiff and some members of the putative class are citizens of states different from any Defendant. See 28 U.S.C. 1332(d)(2)(A). 27. This Court has personal jurisdiction over Defendants because they conduct substantial business in New Jersey and Huahai is a citizen of New Jersey and resides within this District. Defendants have sufficient minimum contacts with the State of New Jersey and intentionally avail themselves of the consumers and markets within the State of New Jersey through the promotion and sale of their products, including Valsartan. VENUE 28. Venue is proper in this District pursuant to 28 U.S.C. 1391(b)(2) because a substantial part of the acts giving rise to Plaintiff s claims occurred in this District and because Defendants are subject to personal jurisdiction within this District. BACKGROUND AND DEFENDANTS CONDUCT 29. Valsartan is a generic prescription drug mainly used to treat hypertension, high blood pressure, congestive heart failure and to prevent heart attacks and strokes. It was originally marketed and sold under the brand name, Diovan. 30. Due to manufacturing defects originating from overseas laboratories in China, certain generic formulations have become contaminated with NDMA. 31. At all times during the period alleged herein, Defendants each represented and warranted to consumers that their generic Valsartan products were therapeutically equivalent to and otherwise the same as Diovan, were otherwise fit for their ordinary uses, and were otherwise manufactured and distributed in accordance with applicable laws and regulations. 6

7 Case 3:18-cv AET-LHG Document 1 Filed 10/11/18 Page 7 of 37 PageID: The Drug Price Competition and Patent Term Restoration Act of 1984 more commonly referred to as the Hatch-Waxman Act is codified at 21 U.S.C. 355(j). 33. Brand drug companies submitting a New Drug Application ( NDA ) are required to demonstrate clinical safety and efficacy through well-designed clinical trials. 21 U.S.C. 355, et seq. 34. By contrast, generic drug companies submit an Abbreviated New Drug Application ( ANDA ). Instead of demonstrating clinical safety and efficacy, generic drug companies need only demonstrate bioequivalence to the brand or reference listed drug ( RLD ). Bioequivalence is the absence of significant difference in the pharmacokinetic profiles of two pharmaceutical products. 21 C.F.R (e). 35. The bioequivalence basis for ANDA approval is premised on the generally accepted proposition that equivalence of pharmacokinetic profiles of two drug products is accepted as evidence of therapeutic equivalence. In other words, if (1) the RLD is proven to be safe and effective for the approved indication through well-designed clinical studies accepted by the FDA, and (2) the generic company has shown that its ANDA product is bioequivalent to the RLD, then (3) the generic ANDA product must be safe and effective for the same approved indication as the RLD. 36. Generic drug manufacturers have an ongoing federal duty of sameness in their products. Under 21 U.S.C. 355(j), the generic manufacturer must show the following things as relevant to this case: the active ingredient(s) are the same as the RLD, 355(j)(2)(A)(ii); and, that the generic drug is bioequivalent to the RLD and can be expected to have the same therapeutic effect, id. at (A)(iv). A generic manufacturer (like a brand manufacturer) must also 7

8 Case 3:18-cv AET-LHG Document 1 Filed 10/11/18 Page 8 of 37 PageID: 8 make a full statement of the composition of such drug to the FDA. Id. at (A)(vi); see also 355(b)(1)(C). 37. A generic manufacturer must also submit information to show that the labeling proposed for the new drug is the same as the labeling approved for the [RLD][.] 21 U.S.C. 355(j)(2)(A)(v). 38. Upon granting final approval for a generic drug, the FDA will typically state the generic drug is therapeutically equivalent to the branded drug. The FDA codes generic drugs as A/B rated to the RLD branded drug. Pharmacists, physicians, and patients can fully expect such generic drugs to be therapeutically interchangeable with the RLD, and generic manufacturers expressly warrant as much through the inclusion of the same labeling as the RLD delivered to consumers in each and every prescription of their generic products. 39. Under federal law, pharmaceutical drugs must be manufactured in accordance with current Good Manufacturing Practices ( cgmp(s) ) to assure they meet safety, quality, purity, identity, and strength standards. See 21 U.S.C. 351(a)(2)(B). 40. The FDA s cgmp regulations are found in 21 C.F.R. Parts 210 and 211. These detailed regulations set forth minimum standards regarding: organization and personnel (Subpart B); buildings and facilities (Subpart C); equipment (Subpart D); control of components and drug product containers and closures (Subpart E); production and process controls (Subpart F); packaging and label controls (Subpart G); holding and distribution (Subpart H); laboratory controls (Subpart I); records and reports (Subpart J); and returned and salvaged drug products (Subpart K). The FDA has worldwide jurisdiction to enforce these regulations if a facility is making drugs intended to be distributed in the United States. 8

9 Case 3:18-cv AET-LHG Document 1 Filed 10/11/18 Page 9 of 37 PageID: Any drug not manufactured in accordance with cgmps is deemed adulterated and may not be distributed or sold in the United States. See 21 U.S.C. 331(a), 351(a)(2)(B). 42. Drugs are deemed to be adulterated if the manufacturer fails to comply with cgmps to assure the drugs safety, quality, purity, identity, and strength and/or if they are contaminated. See 21 U.S.C. 351(a)(2)(A), (B). Federal law prohibits a manufacturer from directly or indirectly causing adulterated drugs to be introduced or delivered for introduction into interstate commerce. See id. 331(a). States have enacting laws adopting or mirroring these federal standards. 43. Per federal law, cgmps include the implementation of oversight and controls over the manufacture of drugs to ensure quality, including managing the risk of and establishing the safety of raw materials, materials used in the manufacturing of drugs, and finished drug products. 21 U.S.C. 351(j). Accordingly, it is a cgmp violation for a manufacturer to contract out prescription drug manufacturing without sufficiently ensuring continuing quality of the subcontractor s operations. 44. On May 15-19, 2017, the FDA inspected Zhejiang s Linhai City facilities. That inspection resulted in the FDA s finding that Zhejiang repeatedly re-tested out-of-specification ( OOS ) samples until obtaining a desirable result. This practice allegedly dated back to at least September 2016, per the FDA s letter at the time. 45. This May 2017 inspection also resulted in the FDA s finding that impurities occurring during analytical testing are not consistently documented/quantitated[.] These findings were not made fully available to the public. 46. Further, for OOS sampling results, Zhejiang routinely invalidated these results without conducting any kind of scientific investigation into the reasons behind the OOS sample 9

10 Case 3:18-cv AET-LHG Document 1 Filed 10/11/18 Page 10 of 37 PageID: 10 result. In fact, in one documented instance, the OOS result was attributed to pollution in the environment surrounding the facility. Zhejiang s actions are consistent with systematic data manipulation designed to intentionally conceal and recklessly disregard the presence of harmful impurities such as NDMA. 47. The May 2017 inspection also found that Zhejiang s facilities and equipment [were] not maintained to ensure [the] quality of drug product manufactured at the facility. These issues included the FDA s finding that: equipment that was rusting and rust was being deposited into drug product; equipment was shedding cracking paint into drug product; there was an accumulation of white particulate matter; and black metallic particles were found in API batches. 48. NDMA is not an FDA-approved ingredient for branded Diovan or generic Valsartan. None of Defendants Valsartan products (or any Valsartan product, for that matter) identifies NDMA as an ingredient on the products labels or elsewhere. 49. The FDA maintains a list of Approved Drug Products with Therapeutic Equivalence Evaluations, commonly referred to as the Orange Book. 50. The Orange Book is a public document; Defendants sought and received the inclusion of their products in the Orange Book upon approval of their Valsartan ANDAs. 51. In securing FDA approval to market generic Valsartan in the United States as an Orange Book-listed therapeutic equivalent to Diovan, Defendants were required to demonstrate that their generic Valsartan products were bioequivalent to brand Diovan. 52. Therapeutic equivalence for purposes of generic substitution is a continuing obligation on the part of the manufacturer. For example, according to the FDA s Orange Book, 10

11 Case 3:18-cv AET-LHG Document 1 Filed 10/11/18 Page 11 of 37 PageID: 11 therapeutic equivalence depends, in part, on the manufacturer s continued compliance with cgmps. 53. By introducing their Valsartan products into the United States market under the name Valsartan as a therapeutic equivalent to Diovan and with the FDA-approved label that is the same as that of Diovan, Defendants represented and warranted to end users that their products are, in fact, the same as and are therapeutically interchangeable with Diovan. 54. Each Defendant s Valsartan products were accompanied by an FDA-approved label. 55. By presenting consumers with an FDA-approved Valsartan label, Defendants, as manufacturers, distributors, and sellers of Valsartan, made representations and express or implied warranties to consumers of the sameness of their products to Diovan, and that their products were consistent with the safety, quality, purity, identity, and strength characteristics reflected in the FDA-approved labels and/or were not adulterated. 56. The presence of NDMA in Defendants Valsartan: (1) renders Defendants Valsartan products non-bioequivalent (i.e., not the same) to Diovan and, thus, nontherapeutically interchangeable with Diovan, thus breaching Defendants express warranties of sameness; (2) was the result gross deviations from cgmps, thus rendering Defendants Valsartan products non-therapeutically equivalent to Diovan, breaching Defendants warranties of sameness; and (3) results in Defendants Valsartan containing an ingredient that is not also contained in Diovan, also breaching Defendants warranty of sameness (and warranty that the products contained the ingredients listed on each Defendant s FDA-approved label). 11

12 Case 3:18-cv AET-LHG Document 1 Filed 10/11/18 Page 12 of 37 PageID: Each Defendant willfully, recklessly, and/or negligently failed to ensure their Valsartan products labels and other advertising or marketing statements accurately conveyed information about their products. 58. Due to its status as a probable human carcinogen as listed by both the IARC and the U.S. EPA, NDMA is not an FDA-approved ingredient in Valsartan. The presence of NDMA in Defendants Valsartan means that Defendants have violated implied warranties to Plaintiff and the putative class members. The presence of NDMA in Defendants Valsartan results in Defendants Valsartan products being non-merchantable and not fit for its ordinary purposes (i.e., as a therapeutically interchangeable generic version of Diovan), breaching Defendants implied warranty of merchantability and/or fitness for ordinary purposes. 59. For these and other reasons, Defendants Valsartan is therefore adulterated. See 21 U.S.C Adulterated Valsartan is essentially worthless. No consumer would purchase an adulterated Valsartan product or is even allowed to purchase an adulterated Valsartan product because it was illegally introduced into the United States. This is especially so given that alternative, non-adulterated Valsartan products or competing medications with the same approved indications were available from other manufacturers. 61. Plaintiff s and putative class members causes of action accrued on the date the FDA announced the recall of Defendants generic Valsartan products, which was on or about July 13, Alternatively, any statute of limitation or prescriptive period is equitably tolled on account of fraudulent concealment. Defendants affirmatively concealed from Plaintiff and other putative class members their unlawful conduct. Defendants affirmatively strove to avoid 12

13 Case 3:18-cv AET-LHG Document 1 Filed 10/11/18 Page 13 of 37 PageID: 13 disclosing their knowledge of Zhejiang s cgmp violations with respect to Valsartan, and of the fact that their Valsartan products were adulterated and contaminated with NMDA and were not the same as brand Diovan. 63. For instance, neither Defendant revealed to the public that their Valsartan product contained NDMA or was otherwise adulterated or non-therapeutically equivalent to Diovan until the FDA s recall announcement in July To the contrary, both Defendants continued to represent and warrant that their generic Valsartan products were the same as and therapeutically interchangeable with Diovan. 65. Because of this, Plaintiff and putative class members did not discover, nor could they discover through reasonable and ordinarily diligence, each Defendant s deceptive, fraudulent, and unlawful conduct alleged herein. Defendants false and misleading explanations, or obfuscations, lulled Plaintiff and putative class members into believing that the prices paid for Valsartan were appropriate for what they believed to be non-adulterated drugs despite their exercise of reasonable and ordinary diligence. 66. As a result of Defendants respective affirmative and other acts of concealment, any applicable statute of limitations affecting the rights of Plaintiff and putative class members has been tolled. Plaintiff and putative class members exercised reasonable diligence by, among other things, promptly investigating and bringing the allegations contained herein. Despite these or other efforts, Plaintiff and putative class members were unable to discover, and could not have discovered, the unlawful conduct alleged herein at the time it occurred or at an earlier time so as to enable this Complaint to be filed sooner. 67. Plaintiff seeks to pursue a class action against the Defendants for supplying, manufacturing, distributing, and ultimately selling Valsartan that was adulterated and defective 13

14 Case 3:18-cv AET-LHG Document 1 Filed 10/11/18 Page 14 of 37 PageID: 14 because it contained NDMA, which rendered the Valsartan adulterated, unsafe, and dangerous for consumption by humans ( the Adulterated Valsartan ), to Plaintiff and the putative class members. 68. On information and belief, NDMA is not currently produced in pure form or commercially used in the United States, except for research purposes. On information and belief, NDMA was formerly used in the production of, among other things, liquid rocket fuel. 69. The United States EPA classifies NDMA as a B2 (probable human) carcinogen, based on the induction of tumors in both rodents and non-rodent mammals exposed to NDMA by various routes. 70. According to the EPA, in animal studies of various species including rats and mice, exposure to NDMA has caused tumors primarily of the liver, respiratory tract, kidney and blood vessels. 71. NDMA is listed as a priority toxic pollutant in federal regulations. See 40 CFR The U.S. Department of Health and Human Services states that NDMA is reasonably anticipated to be a human carcinogen (DHHS 2011). 73. The American Conference of Governmental Industrial Hygienists has classified NDMA as a Group A3 confirmed animal carcinogen with unknown relevance to humans (ACGIH 2012). 74. The FDA is an agency within the U.S. Department of Health and Human Services. 75. The FDA protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use. 14

15 Case 3:18-cv AET-LHG Document 1 Filed 10/11/18 Page 15 of 37 PageID: On or about July 13, 2018, the FDA announced a voluntary recall of several brands of drugs containing the Adulterated Valsartan, including those supplied, manufactured, distributed and/or sold by Defendants ( the Recall ). 77. The Adulterated Valsartan is composed of certain specific lots ( the Lots ). The FDA has issued a list of the Lots that are subject to the Recall. 78. Defendants supplied, manufactured, marketed, distributed and/or sold, respectively, the Lots of Adulterated Valsartan that are subject to the Recall. 79. Plaintiff and the putative class members purchased and ingested Adulterated Valsartan from the Lots subject to the Recall that were supplied, manufactured, distributed and/or sold by the Defendants. 80. According to the Recall, the Lots of the Adulterated Valsartan identified on the Recall List contained NDMA. 81. Zhejiang manufactured and/or supplied the Valsartan, and/or the Valsartan active pharmaceutical ingredient used in the manufacture of the Adulterated Valsartan that is subject to the Recall. 82. In addition to the Recall in the United States, prescription drugs containing Adulterated Valsartan have been recalled in approximately 21 other countries. 83. According to the FDA, numerous Adulterated Valsartan-containing prescriptions medications are subject to the Recall, including those identified on Exhibit A hereto. 84. Plaintiff consumed Adulterated Valsartan pursuant to his prescription on a daily basis prior to the Recall. 85. The Adulterated Valsartan purchased and consumed by Plaintiff was included in the Lots subject to the Recall. 15

16 Case 3:18-cv AET-LHG Document 1 Filed 10/11/18 Page 16 of 37 PageID: Plaintiff stopped consuming the Adulterated Valsartan, at least in part, because he learned that it contained NDMA. 87. According to the FDA, on or about July 17, 2018: The companies listed below are recalling all lots of non-expired products that contain the ingredient valsartan supplied to them by Zhejiang Huahai Pharmaceuticals, Linhai, China. Not all valsartan-containing medicines distributed in the United States have valsartan active pharmaceutical ingredient (API) supplied by this specific company. Zhejiang Huahai has stopped distributing its valsartan API and the FDA is working with the affected companies to reduce or eliminate the valsartan API impurity from future products. Recalled Products Medicine Valsartan Valsartan Valsartan Valsartan/Hydrochlorothiazide (HCTZ) Valsartan/Hydrochlorothiazide (HCTZ) Company Major Pharmaceuticals Solco Healthcare Teva Pharmaceuticals Industries Ltd Solco Healthcare Teva Pharmaceuticals Industries Ltd. press release: 88. On or about July 17, 2018, the FDA issued a press release. According to that The U.S. Food and Drug Administration is alerting health care professionals and patients of a voluntary recall of several drug products containing the active ingredient valsartan, used to treat high blood pressure and heart failure. This recall is due to an impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled products. However, not all products containing valsartan are being recalled. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. The presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured. The FDA s review is ongoing and has included investigating the levels of NDMA in the recalled products, assessing the possible effect on patients who have been taking them and what measures can be taken to reduce or eliminate the impurity from future batches produced by the company. The FDA is committed to maintaining our gold standard for safety and efficacy. That includes our efforts to ensure the quality of drugs and the safe manner in which they re manufactured, said FDA Commissioner Scott Gottlieb, M.D. When we identify lapses in the quality of drugs and problems with their 16

17 Case 3:18-cv AET-LHG Document 1 Filed 10/11/18 Page 17 of 37 PageID: 17 know that: manufacturing that have the potential to create risks to patients, we re committed to taking swift action to alert the public and help facilitate the removal of the products from the market. As we seek the removal of certain drug products today, our drug shortages team is also working hard to ensure patients therapeutic needs are met in the United States with an adequate supply of unaffected medications. (Emphasis added.) 89. On or about July 17, 2018, the FDA determined that health professionals should The FDA has determined the recalled valsartan products pose an unnecessary risk to patients. Therefore, FDA recommends patients use valsartan-containing medicines made by other companies or consider other available treatment options for the patient s medical condition. If you have medication samples from these companies, quarantine the products and do not provide them to patients. (Emphasis added.) 90. On or about July 17, 2018 according to Janet Woodcock, M.D., director of the FDA s Center for Drug Evaluation and Research: We have carefully assessed the valsartan-containing medications sold in the United States, and we ve found that the valsartan sold by these specific companies does not meet our safety standards. This is why we ve asked these companies to take immediate action to protect patients. [Emphasis added] 91. On August 21, 2018, Huahai posted information on its Internet website. According to that post, a review of manufacturing and optimization processes in early June 2018 resulted in the discovery of NDMA, an impurity, in its Valsartan. According to Huahai, NDMA is a carcinogen. 92. Huahai has publicly stated that it isolated its storage of Valsartan API on hand, suspended its further release and manufacture, and notified the FDA and other regulatory agencies of its findings. 93. Huahai also notified its customers and instructed them to suspend the further use of its Valsartan API. Huahai then initiated a voluntary recall and provided periodic updates to both regulatory agencies and customers. 17

18 Case 3:18-cv AET-LHG Document 1 Filed 10/11/18 Page 18 of 37 PageID: According to Huahai, it undertook recalls at the consumer level to protect human health. (Emphasis added.) 95. At all times relevant herein Defendants intended to and did convey to Plaintiff and the putative class members that their prescription drug, Valsartan was of the quality necessary to be utilized for its intended purpose. 96. At all times relevant herein, Defendants were negligent in supplying, manufacturing, marketing, distributing and/or selling the Adulterated Valsartan as a prescription drug safe for consumption by Plaintiff and the putative class members because Defendants failed to have adequate quality control procedures in place to determine that Valsartan API was adulterated. 97. As a result of failing to maintain appropriate quality control procedures, Defendants failed to detect NDMA in the Adulterated Valsartan. 98. Defendants made false and misleading representations and, prior to the Recall, failed to disclose to Plaintiff or the putative class members that the Adulterated Valsartan was contaminated with NDMA. 99. The Adulterated Valsartan is worthless Plaintiff and the putative class members suffered economic damages when they paid to purchase Adulterated Valsartan. Plaintiff and the putative class members would not have purchased the worthless Adulterated Valsartan from Defendants if they had known that it was contaminated with NDMA Had Defendants disclosed to Plaintiff and the putative class members that the Adulterated Valsartan was contaminated with NDMA, Plaintiff and the putative class members would not have purchased the Adulterated Valsartan. 18

19 Case 3:18-cv AET-LHG Document 1 Filed 10/11/18 Page 19 of 37 PageID: Plaintiff and the putative class members are subject to increased risk of cancer and disease as a result of their consumption of the Adulterated Valsartan Plaintiff and the putative class members are in need of medical monitoring as a result of their consumption of the Adulterated Valsartan. CLASS ALLEGATIONS 104. Plaintiff and each putative class member purchased and/or ingested Adulterated Valsartan that was subject to the Recall Plaintiff bring Counts One through Ten below, both individually and as a class action, pursuant to Fed. R. Civ. P. 23(a), 23(b)(2) and/or 23(b)(3), on behalf of a class of nationwide consumers who purchased Adulterated Valsartan that is subject to the Recall, as defined below (the Class ): All persons or entities in the United States that purchased Adulterated Valsartan identified in the Lots subject to the Recall. Excluded from the Class are: (1) Defendants, and any entity in which any Defendant has a controlling interest, or which has a controlling interest in any Defendant; (2) Defendants respective legal representatives, assigns and successors; and (3) the judge(s) to whom this action is assigned and any member of the judge s immediate family Plaintiff reserves the right to redefine the Class prior to class certification The rights of each member of the Class (the Class Members ) were violated in a similar fashion based upon the Defendants uniform actions These and other questions of law or fact which are common to the Class Members predominate over any questions affecting only individual members of the Class: a. Typicality: Plaintiff s claims are typical of the claims of the Class Members since Plaintiff and all Class Members purchased and/or consumed the Adulterated Valsartan identified in the Lots. Further, Plaintiff and all Class Members sustained monetary and economic injuries, including ascertainable loss, arising out of 19

20 Case 3:18-cv AET-LHG Document 1 Filed 10/11/18 Page 20 of 37 PageID: 20 Defendants wrongful conduct by, inter alia, purchasing and/or consuming the Adulterated Valsartan identified in the Lots (either out-of-pocket or via co-payments made to their pharmacy or healthcare professionals) and they unknowingly purchased Adulterated Valsartan. Had this material information, i.e., that the prescription Valsartan was adulterated, been disclosed to Plaintiff and the Class Members, they would not have purchased or consumed the Adulterated Valsartan identified in the Lots. Plaintiff is advancing the same claims and legal theories on behalf of himself and all Class Members. b. Adequacy: Plaintiff is an adequate representative of the Class because his interests do not conflict with the interests of the respective Class Members that he seeks to represent. Plaintiff has retained counsel competent and highly experienced in complex class action litigation and they intend to prosecute this action vigorously. The interests of the Class will be fairly and adequately protected by Plaintiff and his counsel. c. Superiority: A class action is superior to all other available means of fair and efficient adjudication of the claims of Plaintiff and Class Members. The injury suffered by each individual Class Member is relatively small in comparison to the burden and expense of individual prosecution of the complex and extensive litigation necessitated by Defendants conduct. It would be virtually impossible for members of the Class to individually and effectively redress the wrongs done to them. Even if the members of the Class could afford such individual litigation, the court system could not. Individualized litigation presents a potential for inconsistent or contradictory judgments. Individualized litigation also increases the delay and expense to all parties, and to the court system, presented by the complex legal and factual issues of the case. By contrast, 20

21 Case 3:18-cv AET-LHG Document 1 Filed 10/11/18 Page 21 of 37 PageID: 21 the class action device presents far fewer management difficulties, and provides the benefits of single adjudication, an economy of scale, and comprehensive supervision by a single court. d. Ascertainability: Class Members are readily ascertainable and can be identified by Defendants records This action has been brought and may be properly maintained as a class action for the following reasons: a. Numerosity: Members of the Class are so numerous that their individual joinder is impracticable. Plaintiff is informed and believes that the proposed Class contains thousands of individuals or entities that purchased Adulterated Valsartan identified in the Lots, either out-of-pocket or via co-payments. The Class is therefore sufficiently numerous to make joinder impracticable, if not impossible. The precise number of Class Members is unknown to Plaintiff at this time. b. Existence and Predominance of Commons Questions of Law and Fact: Common questions of law and fact exist as to all members of the Class. These questions predominate over any questions affecting individual Class Members and these common legal and factual questions include, but are not limited to, the following: i. Whether the Adulterated Valsartan identified in the Lots met the Defendants warranties; ii. Whether the Adulterated Valsartan identified in the Lots was a merchantable good at the time of sale; iii. Whether the Adulterated Valsartan identified in the Lots was fit for its intended purpose; 21

22 Case 3:18-cv AET-LHG Document 1 Filed 10/11/18 Page 22 of 37 PageID: 22 iv. Whether Defendants made fraudulent, false, deceptive, and/or misleading statements in connection with the sale of the Adulterated Valsartan identified in the Lots; v. Whether Defendants omitted material information when they sold the Adulterated Valsartan in the Lots; vi. The date on which Defendants knew or reasonably should have known that the Adulterated Valsartan identified in the Lots was adulterated; vii. viii. Whether Defendants recall notice was timely and/or sufficient; Whether Defendants breached the terms of an express and/or implied warranty; ix. The appropriate nature of class-wide equitable relief; and x. The appropriate measurement of restitution and/or measure of damages to award to Plaintiff and the Class Members. COUNT ONE Violation of New Jersey s Consumer Fraud Act ( NJCFA ) N.J.S.A. 56:8-1 et seq Plaintiff hereby incorporates by reference the allegations contained in all preceding paragraphs of this Complaint as though fully set forth herein Plaintiff brings this claim individually and on behalf of the Class Members Plaintiff and other members of the class are persons within the meaning of N.J.S.A. 56:8-1(d) Defendants conduct alleged herein constitutes a sale within the meaning of N.J.S.A. 56:8-1(e). 22

23 Case 3:18-cv AET-LHG Document 1 Filed 10/11/18 Page 23 of 37 PageID: The NJCFA declares unlawful [t]he act, use or employment by any person of any unconscionable commercial practice, deception, fraud, false pretense, false promise, misrepresentation, or the knowing concealment, suppression, or omission of any material fact with intent that others rely upon such concealment, suppression or omission, in connection with the sale or advertisement of any merchandise or real estate, or with the subsequent performance of such person as aforesaid, whether or not any person has in fact been misled, deceived or damaged thereby[.] N.J.S.A. 56: Defendants have engaged in unfair, unlawful and deceptive acts in trade and commerce which have the capacity and tendency to deceive and, in fact, did deceive Plaintiff and the Class Members, and damaged Plaintiff and Class Members Defendants affirmatively misrepresented (and/or wrongfully concealed and omitted) that the Adulterated Valsartan was therapeutically equivalent to brand Diovan and/or was manufactured in compliance with cgmps and/or was not adulterated. In fact, Defendants Valsartan products were contaminated with NDMA resulting in the Adulterated Valsartan not being therapeutically equivalent to brand Diovan and not manufactured in compliance with cgmps and, in fact, constituting adulterated pharmaceuticals Defendants committed unlawful, deceptive, and unconscionable trade practices by marketing, selling, and otherwise placing into the stream of commerce the Adulterated Valsartan products on the premise they were therapeutically equivalent to brand Diovan and/or manufactured in compliance with cgmps and/or were not adulterated Defendants wrongfully concealed, suppressed, and omitted to disclose that the Adulterated Valsartan was not therapeutically equivalent to brand Diovan and/or not manufactured in compliance with cgmps and/or was, in fact, adulterated. 23

24 Case 3:18-cv AET-LHG Document 1 Filed 10/11/18 Page 24 of 37 PageID: Defendant s misrepresentations and omissions had the capacity to mislead Plaintiff and Class Members into believing that the Adulterated Valsartan (i) was therapeutically equivalent to brand Diovan, (ii) was manufactured in accordance with cgmps, and/or (iii) was not adulterated and was legal to sell in the United States, when the opposite was true Had Defendants not made misrepresentations or not omitted such facts, the Adulterated Valsartan would not have been available to Plaintiff and the Class Members because, among other reasons, it would have been illegal for Defendants to even introduce the Adulterated Valsartan into the United States. Plaintiff and the Class Members suffered ascertainable loss as a result Because of Defendants unlawful, deceptive, unfair, and unconscionable trade practices, Plaintiff and the Class Members have suffered injury and damages an ascertainable loss in an amount to be determined at trial. Pursuant to the NJCFA, this Court has the power to enjoin Defendants conduct The NJCFA prohibits deceptive acts and practices in the sale of products, including the Adulterated Valsartan Plaintiff and the Class Members are consumers, as defined under the NJCFA Defendants conduct as alleged herein occurred in the course of trade or commerce, as defined in the NJCFA Defendants misrepresented the characteristics of the Adulterated Valsartan, the ingredients in the Adulterated Valsartan, the uses or benefits of the drug; that the Adulterated Valsartan was safe for human consumption; that the Adulterated Valsartan did not contain NDMA; and that the Adulterated Valsartan was not adulterated. 24

25 Case 3:18-cv AET-LHG Document 1 Filed 10/11/18 Page 25 of 37 PageID: In fact, the Adulterated Valsartan (a) did not have the characteristics, ingredients, uses or benefits represented, (b) was not safe for human consumption, (c) contained NDMA and (d) was adulterated. This offends public policy, has caused and continues to cause substantial injury to Plaintiff and the Class Members, and constitutes an unfair and deceptive trade practice Upon information and belief, and given the fact that Defendants were responsible for designing, supplying, manufacturing, distributing and/or selling the Adulterated Valsartan to Plaintiff and the Class Members, Defendants knew, or should have known at all relevant times that the Valsartan was adulterated because it contained NDMA and was not safe for human consumption. Nonetheless, Defendants falsely represented that the Adulterated Valsartan purchased by Plaintiff and the Class Members was safe for human consumption, when it was not Defendants false representations were likely to deceive reasonable drug consumers, including Plaintiff and the Class Members Defendants intended for consumers, including Plaintiff and the Class Members, to rely on their representations that the Adulterated Valsartan was safe for human consumption when choosing to purchase the drug. Plaintiff and the Class Members reasonably relied on such representations in making their decision to purchase the Adulterated Valsartan As a direct and proximate result of Defendants deceptive and unfair trade practices, Plaintiff and the Class Members suffered actual damages, including monetary losses for the purchase price of the Adulterated Valsartan which was not safe for human consumption and was worthless, and incidental medical expenses Thus, Plaintiff and the Class Members have been aggrieved by Defendants unfair and deceptive practices, in violation of the NJCFA. 25

26 Case 3:18-cv AET-LHG Document 1 Filed 10/11/18 Page 26 of 37 PageID: Defendants conduct violates the NJCFA and, pursuant to N.J.S.A 56:8-1, et seq Plaintiff and the Class Members are entitled to damages in an amount to be proven at trial, reasonable attorneys fees, injunctive relief prohibiting Defendants unfair and deceptive practices going forward, medical monitoring, and any other penalties or awards that may be appropriate under applicable law. COUNT TWO Strict Product Liability 133. Plaintiff hereby incorporates by reference the allegations contained in all preceding paragraphs of this Complaint as though fully set forth herein Plaintiff brings this claim individually and on behalf of the Class Members At all times relevant to this action, Defendants designed, tested, manufactured, packaged, marketed, distributed, promoted, and/or sold the Adulterated Valsartan, placing the drug into the stream of commerce At all times material, the Adulterated Valsartan was designed, tested, inspected, manufactured, assembled, developed, labeled, sterilized, licensed, marketed, advertised, promoted, sold, packaged, supplied and/or distributed by Defendants in a defective and unreasonably dangerous condition to consumers, including Plaintiff and the Class Members The Adulterated Valsartan was expected to reach, and did reach, users and/or consumers, including Plaintiff and Class Members, without substantial change in the defective and unreasonably dangerous condition in which it was manufactured and sold The Adulterated Valsartan was unreasonably dangerous because it was adulterated and contaminated by NDMA, a carcinogen The Adulterated Valsartan was defective in that it neither bore, nor was packaged with, nor accompanied by, warnings adequate to alert consumers, including Plaintiff and the 26

27 Case 3:18-cv AET-LHG Document 1 Filed 10/11/18 Page 27 of 37 PageID: 27 Class Members, to the risks described herein, including, but not limited to, the risk of serious injury and/or death The Adulterated Valsartan was not accompanied by adequate labeling, instructions for use and/or warnings to fully apprise the medical, pharmaceutical and/or scientific communities, and users and/or consumers of the drug, including Plaintiff and the Class Members, of the potential risks associated with its use, thereby rendering Defendants liable to Plaintiff and the Class Members The Adulterated Valsartan was unsafe for normal or reasonably anticipated use The Adulterated Valsartan was defective in formulation because when the drug left the hands of the Defendants, it was unreasonably dangerous and more dangerous than an ordinary consumer would expect The Adulterated Valsartan was also defective and unreasonably dangerous in that the foreseeable risk of injuries from consuming the Adulterated Valsartan exceeded the benefits associated with the formulation of the Adulterated Valsartan The Adulterated Valsartan is unreasonably dangerous (a) in construction or composition, (b) in design, (c) because an adequate warning about it was not provided, and (d) because the Adulterated Valsartan did not conform to an express warranty about the product The Adulterated Valsartan, as manufactured, distributed, supplied, and/or sold by the Defendants, was also defective due to inadequate testing before exposing Plaintiff and the Class Members to it The Adulterated Valsartan, as manufactured, distributed, supplied and/or sold by Defendants, was defective and after Defendants knew or should have known of the risk of injuries from use and/or ingestion, they failed to provide adequate warnings to the medical 27

28 Case 3:18-cv AET-LHG Document 1 Filed 10/11/18 Page 28 of 37 PageID: 28 community and the consumers, to whom they were directly marketing and advertising; and, further, they continued to affirmatively promote Adulterated Valsartan as safe and effective In light of the potential and actual risk of harm associated with the consumption of the Adulterated Valsartan, a reasonable person who had actual knowledge of this potential and actual risk of harm would have concluded that the Adulterated Valsartan should not have been marketed in that condition Although Defendants knew or should have known of the defective nature of the Adulterated Valsartan, they continued to manufacture, market, distribute and/or sell it so as to maximize sales and profits at the expense of the public health and safety. Defendants, thus, acted with conscious and deliberate disregard of the foreseeable harm caused by the Adulterated Valsartan Plaintiff and the Class Members could not, through the exercise of reasonable care, have discovered the risk of serious injury and/or death associated with and/or caused by their consumption of the Adulterated Valsartan As a direct and proximate result of Defendants conduct, Plaintiff and the Class Members purchased or consumed Adulterated Valsartan, and, as a result, Plaintiff and the putative Class Members suffered harm and loss Information provided by the Defendants to the medical community and to consumers concerning the safety and efficacy of the Adulterated Valsartan, especially the information contained in the advertising and promotional materials, did not accurately reflect the serious and potentially fatal side effects resulting from consumption of the Adulterated Valsartan. 28