IN RE: Zantac (Ranitidine) Products Liability Litigation

Complaint CAN 4:19-cv-7226

Judicial Panel on Multidistrict Litigation, jpml-0:2019-md-02924

Current View

Full Text

Case MDL No. 2924 Document 1-6 Filed 11/04/19 Page 1 of 42 001213405 6789 6)*+*ÿ-./01.20ÿ34510 367.8419.6ÿ:410;<19ÿ-./01.20ÿ=>6?769@A 3BCBDÿ->3EFGÿH>Iÿ3J+FÿKLÿMLNOP2QPRSTTUP-VI WXYZ[\]^]Zÿ`aÿWb^c]Zde^]ÿfde^YcXgÿhcX]gXi^j\ZiXY[kÿfdiaÿ^\ÿXY qX\^ÿ~ZY^mnÿuuvuxvu€ l[[Zed^mÿ\bnÿoXeZ[\]X\^ÿpjme^ÿqbddXÿoaÿrsj pj]sÿq^gXdmnÿhYXZd\Z q^gXdmnÿtuvvkvvvkvvv ‚X\j]^ÿbÿƒjZ\nÿz„ ÿh^][bdXYÿfd†aÿh]bma wXj[^nÿxynuzzxÿqZ`^][Z\s{h]bmji\ÿ|ZX}ZYZ\s |ZX}ZYZ\s pj]Z[mZi\ZbdnÿqZ`^][Z\s ‡76.90.88 ˆ4/<‰;ÿˆ4;9ÿŠ67./01<1. ]^‹]^[^d\^mÿ}sI4Œ<10ÿŠ1<90ÿ./9<1ÿ WXjgÿŽ^mYjdmÿl]Z[\^ZÿbYmgXdkÿhwÿ uv€vÿ‘ZY[cZ]^ÿWY`makÿu’\cÿ~Ybb]ÿ |b[ÿlde^Y^[kÿwlÿ€vvxÿ “zuv”ÿxv’{zxzzÿ ~X•nÿ“zuv”ÿyxv{’ÿ –gXZYnÿ]}—Z[d^]˜}Xjgc^mYjdmYX—aibgÿ ™šš›œžŸÿš›ÿ¡žÿ›š¢£ž¤ ¥a -<8<9@690 Š4<;1.9¦<1ÿB9¦<7;6§ÿ‡;61§62<50.267/¨ B92* -<8<9@690 +6948.ÿ)+ÿ+<1Q.2</¨ÿB92* -<8<9@690 3;600<§¨ÿB92* -<8<9@690 ‡8.©<1¨ÿB92* -<8<9@690 ª76«4+§.0;E7.9<¨ÿDD3 -60<ÿH.7<@ K -42?<0ÿG<«0 uuvuxvu€ uÿw¬oh|lf‚­ÿXeXZd[\ÿWb^c]Zde^]ÿfde^YcXgÿhcX]gXi^j\ZiXY[kÿfdiakÿwcX\\^gkÿfdiak YX•bƒgZ\c®YZd^kÿ||wkÿhZ¯^]kÿfdiakÿƒXdbZÿ°ƒÿƒ^]`Zi^[kÿfdiaÿ“ÿ~ZYZdeÿ^^ÿtÿvvkÿ]^i^Z‹\ djg}^]ÿv€’u{uzy’vzua”aÿ~ZY^mÿ}spb[^‹cÿpbcdÿWXYZ[\]^]Zaÿ“l\\Xicg^d\[nÿ±ÿuÿwZ`ZYÿwb`^] ƒc^^\kÿ±ÿxÿƒjggbd[”“‘Z[d^]kÿrb}^]\”ÿ“~ZY^mÿbdÿuuuxvu€”ÿ“–d\^]^mnÿuuvuxvu€” uuvuxvu€ xÿwX[^ÿX[[Zed^mÿ\bÿoXeZ[\]X\^ÿpjme^ÿqbddXÿoaÿrsja wbjd[^Yÿb]ÿ‹YXZd\Zÿb]ÿ\c^ÿ]^gb`Zdeÿ‹X]\sÿZ[ÿ]^[‹bd[Z}Y^ÿb]ÿ[^]`Zdeÿ\c^ÿwbg‹YXZd\ÿb] ‚b\Zi^ÿbÿr^gb`XYkÿƒjggbd[ÿXdmÿ\c^ÿX[[Zed^mÿ†jme^²[ÿ[\XdmZdeÿb]m^][ÿXdmÿXYYÿb\c^]ÿd^— 11 ent 1-6 Filed 11/04/19 Page 2 of 42 001213405 6789 6)*+,ÿ./)01,23+ÿ04/2ÿ35,ÿ/44/+627ÿ4*836,+9ÿ:/8ÿ62;/81*36/2<ÿ=6+63ÿ>?@ABACDÿFÿGHIÿJAKABÿJLMH *3ÿ5334NOO)*2.90+)/083+97/=O,);O)*+,/4,26279 P3*2.627ÿ/8.,8+ÿ)*2ÿQ,ÿ./R2S/*.,.ÿ;8/1ÿ35,ÿ)/083T+ÿR,Qÿ4*7,ÿ*3 RRR9)*2.90+)/083+97/=OU0.7,+9ÿV4/2ÿ8,),643<ÿ35,ÿ+011/2+ÿR6SSÿQ,ÿ6++0,.ÿ*2.ÿ8,3082,.,S,)38/26)*SSW9ÿX/02+,Sÿ6+ÿ8,Y068,.ÿ3/ÿ+,2.ÿ)5*1Q,8+ÿ*ÿ)/4Wÿ/;ÿ35,ÿ62636*3627ÿ./)01,23+ 408+0*23ÿ3/ÿZ9[9ÿ\]^_,`_a`9ÿbÿ+)5,.0S627ÿ/8.,8ÿR6SSÿQ,ÿ+,23ÿQWÿc/36),ÿ/;ÿdS,)38/26)ÿ:6S627 _cd:`ÿR63562ÿ3R/ÿQ0+62,++ÿ.*W+9ÿX/2+,23Oe,)S62*36/2ÿ.0,ÿQWÿ^^O^\Ofg^h9ÿ_5*P<ÿXiV[j Pjb::`ÿ_:6S,.ÿ/2ÿ^^O^Ofg^h`ÿ_d23,8,.Nÿ^^Og^Ofg^h` 11 ent 1-6 Filed 11/04/19 Page 3 of 42 0 1 Michael L. Baum, Esq. (SBN: 119511) mbaum@baumhedlundlaw.com 2 Brent Wisner, Esq. (SBN: 276023) rbwisner@baumhedlundlaw.com 3 Bijan Esfandiari, Esq. (SBN: 223216) 4 pesfandiarv@baumhedlundlaw.com Nicole K.H. Maldonado, Esq. (SBN 207715) 5 nmaldonado@baumhedlundlaw.com Adam Foster (SBN: 301507) 6 afoster@baumhedlundlaw.com Pedram Esfandiary, Esq. (SBN: 312569) 7 pesfandiarv@baumhedlundlaw.com 8 BAUM, HEDLUND, ARISTEI & GOLDMAN, P.C. 10940 Wilshire Blvd., 17th Floor 9 Los Angeles, CA 90024 Telephone: (310) 207-3233 10 Facsimile: (310) 820-7444 11 Attorneys for Plaintiff 12 UNITED STATES DISTRICT COURT 13 NORTHERN DISTRICT OF CALIFORNIA 14 15 JOSEPH JOHN BALISTRERI, Case No. 16 Plaintiff, COMPLAINT 17 v. DEMAND FOR JURY TRIAL 18 BOEHRINGER INGELHEIM 19 PHARMACEUTICALS, INC.; 20 SANOFI US SERVICES INC.; 21 CHATTEM, INC.; 22 PFIZER, INC.; and 23 GLAXOSMITHKLINE, LLC, 24 Defendants. 25 26 27 28 1 COMPLAINT Case MDL No. 2924 Document 1-6 Filed 11/04/19 Page 4 of 42 0 1 TABLE OF CONTENTS 2 Page 3 TABLE OF CONTENTS ........................................................................................................................2 4 INTRODUCTION ..................................................................................................................................3 5 PARTIES ................................................................................................................................................3 6 JURISDICTION AND VENUE .............................................................................................................5 7 FACTUAL ALLEGATIONS .................................................................................................................5 8 I. Brief History of Zantac and Ranitidine ...........................................................................5 9 II. Dangers of NDMA ..........................................................................................................7 10 III. How Ranitidine Transforms into NDMA Within the Body..........................................11 11 Figure 1 –Ranitidine Structure & Formation of NDMA ..........................................................11 12 Table 1. Ranitidine Samples Tested by Valisure Laboratory Using GC/MS Protocol ............14 13 Table 2. Valisure Biologically relevant tests for NDMA formation .......................................16 14 Figure 3 –Mechanism for Decomposition of Ranitidine in NDMA .........................................17 15 Figure 4 – Expression levels of DDAH-1 enzyme by Organ ...................................................18 16 IV. Defendants Knew of the NDMA Defect but Failed to Warn or Test ...........................20 17 V. Plaintiff-Specific Allegations........................................................................................22 18 VI. Exemplary / Punitive Damages Allegations .................................................................22 19 TOLLING OF STATUTE OF LIMITATIONS AND ESTOPPEL ..... Error! Bookmark not defined. 20 CAUSES OF ACTION .........................................................................................................................23 21 COUNT I: STRICT LIABILITY – DESIGN DEFECT ..........................................................23 22 COUNT II: STRICT LIABILITY – FAILURE TO WARN ...................................................27 23 COUNT III: NEGLIGENCE ...................................................................................................30 24 COUNT IV: BREACH OF EXPRESS WARRANTIES .........................................................34 25 COUNT V: BREACH OF IMPLIED WARRANTIES ...........................................................37 26 JURY TRIAL DEMAND .....................................................................................................................39 27 PRAYER FOR RELIEF .......................................................................................................................39 28 2 COMPLAINT Case MDL No. 2924 Document 1-6 Filed 11/04/19 Page 5 of 42 0 1 INTRODUCTION 2 1. N-Nitrosodimethylamine ("NDMA") is a potent carcinogen. It used to be a chemical 3 biproduct of making rocket fuel in the early 1900s but, today, its only use is to induce tumors in 4 animals as part of laboratory experiments. Its only function is to cause cancer. It has no business 5 being in a human body. 6 2. Zantac (chemically known as ranitidine), the popular antacid medication used by 7 millions of people every day, leads to the production of staggering amounts of NDMA when it is 8 digested by the human body. The U.S. Food and Drug Administration's ("FDA") allowable daily 9 limit of NDMA is 96 ng (nanograms) and yet, in a single dose of Zantac, researchers are discovering 10 over 3 million ng. 11 3. These recent revelations by independent researchers have caused widespread recalls of 12 Zantac both domestically and internationally, and the FDA is actively investigating the issue, with is 13 preliminary results showing "unacceptable" levels of NDMA. Indeed, the current owner and 14 controller of the Zantac new drug applications ("NDAs") has recalled all Zantac in the United States. 15 4. To be clear, this is not a contamination case—the levels of NDMA that researchers are 16 seeing in Zantac is not the product of some manufacturing error. The high levels of NDMA observed 17 in Zantac is a function of the ranitidine molecule and the way it breaks down in the human digestive 18 system. 19 5. Plaintiff Joseph John Balistreri took Zantac for about 19 years and, as a result, 20 developed bladder cancer. His cancer was caused by NDMA exposure created by the ingestion of 21 Zantac. This lawsuit seeks damages against the Defendants for causing his cancer. 22 PARTIES 23 6. Plaintiff Joseph John Balistreri (hereinafter "Plaintiff"), resides in Alameda County, 24 California and is citizen of California and not of any other state. 25 7. Defendant Boehringer Ingelheim Pharmaceuticals, Inc. ("BI") is a Delaware 26 corporation with its principal place of business located at 900 Ridgebury Road, Ridgefield, 27 Connecticut 06877. BI is a citizen of Connecticut and Delaware, and not of any other state. BI is a 28 subsidiary of the German company Boehringer Ingelheim Corporation. BI owned and controlled the 3 COMPLAINT Case MDL No. 2924 Document 1-6 Filed 11/04/19 Page 6 of 42 0 1 NDA for over-the-counter ("OTC") Zantac between December 2006 and January 2017, and 2 manufactured and distributed the drug in the United States during that period. 3 8. Defendant Sanofi US Services Inc., ("Sanofi") is a Delaware corporation with its 4 principal place of business located at 55 Corporate Drive, Bridgewater, New Jersey 08807, and is a 5 wholly owned subsidiary of Sanofi S.A. Sanofi is a citizen of Delaware and New Jersey and is not a 6 citizen of any other state. Sanofi controlled the NDA for OTC Zantac starting in January 2017 7 through the present and manufactured and distributed the drug in the United States during that period. 8 Sanofi voluntarily recalled all brand name OTC Zantac on October 18, 2019. 9 9. Defendant Chattem, Inc. ("Chattem") is a Tennessee corporation with its principal 10 place of business located at 1715 West 38th Street Chattanooga, Tennessee 37409. Chattem is a 11 citizen of Tennessee and not a citizen of any other state. Chattem is a wholly owned subsidiary of 12 Sanofi S.A., a French multinational corporation. Chattem distributed OTC Zantac for Sanofi 13 throughout the United States until Sanofi's recent voluntary recall. 14 10. Defendant Pfizer, Inc. ("Pfizer") is a Delaware corporation with its principal place of 15 business located at 235 East 42nd Street, New York, New York 10017. Pfizer is a citizen of 16 Delaware and New York and is not a citizen of any other state. In 1993, Glaxo Wellcome, plc 17 formed a joint venture with Warner-Lambert, Inc. to develop and obtain OTC approval for Zantac. 18 That OTC approval was obtained in 1995. In 1997, Warner-Lambert and Glaxo Wellcome ended 19 their joint venture, with Warner-Lambert retaining control over the OTC NDA for Zantac and the 20 Zantac trademark in the U.S. and Glaxo Welcome retaining control over the Zantac trademark 21 internationally. In 2000, Warner-Lambert was acquired by Pfizer, who maintained control over the 22 Zantac OTC NDA until December 2006. 23 11. Defendant GlaxoSmithKline, LLC ("GSK") is a Delaware company with its principal 24 place of business located at 5 Crescent Drive, Philadelphia, Pennsylvania, 19112 and Five Moore 25 Drive, Research Triangle, North Carolina, 27709. GSK is a wholly owned subsidiary of 26 GlaxoSmithKline, plc, which is its sole member. GlaxoSmithKline, plc is a citizen of the United 27 Kingdom, and is not a citizen of any state in the United States. GlaxoSmithKline plc is the 28 successor-in-interest to the companies that initially developed, patented, and commercialized the 4 COMPLAINT Case MDL No. 2924 Document 1-6 Filed 11/04/19 Page 7 of 42 0 1 molecule known as ranitidine. Ranitidine was initially developed by Allen & Hanburys Ltd., which 2 was a subsidiary of Glaxo Labs Ltd. Allen & Hanburys Ltd. was awarded Patent No. 4,128,658 by 3 the U.S. Patent and Trademark Office in December 1978, which covered the ranitidine molecule. In 4 1983, Glaxo Holdings, Ltd. was awarded approval by the U.S.FDA to sell Zantac in the United 5 States. Gl