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Plaintiff brings this action for personal injuries suffered as a proximate result of being prescribed and ingesting INVOKANA/INVOKAMET. 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At all times alleged herein, Defendants shall include any and all named or unnamed parent companies, parent corporations, subsidiaries, affiliates, divisions, franchises, partners, joint venturers, and any organizational units of any kind, their p...) /A 656 0 R /Prev 657 0 R >> endobj 469 0 obj << /Next 658 0 R /Parent 392 0 R /Title <372E20506C61696E7469666620426F6E6E69652048616D6D20696E67657374656420616E642077617320706879736963616C6C79206861726D65642062792074686520446566656E64616E7473902070726F647563742E20208D506C61696E746966668E207768656E207573656420696E207468652073696E67756C61722C2072656665727320746F20706C61696E7469666620426F6E6E69652048616D6D2C2074686520706C61696E74696666207468617420696E67657374656420494E564F4B414E412F494E564F4B414D455420616E642077617320706879736963616C6C79206861726D65642E> /A 659 0 R >> endobj 470 0 obj << /D [398 0 R /XYZ 70 251 0] /S /GoTo >> endobj 471 0 obj << /Next 394 0 R /Parent 12 0 R /Title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rev 661 0 R >> endobj 472 0 obj << /Next 662 0 R /Parent 12 0 R /Title (2. Defendants are the manufacturers of the prescription drug INVOKANA/INVOKAMET, developed and indicated for the treatment of type 2 diabetes. 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The acts, conduct, and omissions of Defendants, as alleged throughout this Complaint were wanton, willful, fraudulent, dishonest and malicious. Defendants committed these acts with a conscious disregard for the rights, health and safety of Plain...) /A 944 0 R >> endobj 913 0 obj << /Next 945 0 R /Parent 4 0 R /Title (COUNT IV) /A 946 0 R /Prev 885 0 R >> endobj 914 0 obj << /D [414 0 R /XYZ 70 389 0] /S /GoTo >> endobj 915 0 obj << /Parent 885 0 R /Title (115. Had Plaintiff received adequate warnings regarding the risks of the subject product, Plaintiff would not have used it.) /A 947 0 R /Prev 948 0 R >> endobj 916 0 obj << /Next 949 0 R /Parent 885 0 R /Title (92. Plaintiff restates the allegations set forth above as if fully rewritten herein.) /A 950 0 R >> endobj 917 0 obj << /D [413 0 R /XYZ 70 113 0] /S /GoTo >> endobj 918 0 obj << /Next 887 0 R /Parent 652 0 R /Title (B. Specific Allegations) /A 951 0 R /Prev 888 0 R /Count 15 /Last 952 0 R /First 953 0 R >> endobj 919 0 obj << /Parent 887 0 R /Title (91. Each Defendant is equitably stopped from asserting any limitations defense by virtue of its fraudulent concealment and other misconduct as described in this Complaint.) /A 954 0 R /Prev 955 0 R >> endobj 920 0 obj << /Next 956 0 R /Parent 887 0 R /Title <38382E20446566656E64616E74732C207468726F7567682074686569722061666669726D6174697665206D6973726570726573656E746174696F6E7320616E64206F6D697373696F6E732C206163746976656C7920636F6E6365616C65642066726F6D20506C61696E7469666620616E6420506C61696E7469666690732070687973696369616E7320616E64206865616C7468636172652070726F76696465727320746865207472756520616E64207369676E69666963616E74207269736B73206173736F636961746564207769746820494E564F4B414E412F494E564F4B414D45542E> /A 957 0 R >> endobj 921 0 obj << /D [402 0 R /XYZ 70 89 0] /S /GoTo >> endobj 922 0 obj << /Parent 888 0 R /Title (72. Consumers, including Bonnie Hamm, have several alternatives safer methods for treating diabetes, including diet and exercise and other antidiabetic agents.) /A 958 0 R /Prev 959 0 R >> endobj 923 0 obj << /Next 960 0 R /Parent 888 0 R /Title (26. This action seeks, among other relief, general and special damages due to Plaintiff Bonnie Hamm suffering severe, life threatening and permanently debilitating side effect[s] of an amputation of the first toe of the right foot through the metatars...) /A 961 0 R >> endobj 924 0 obj << /D [401 0 R /XYZ 70 223 0] /S /GoTo >> endobj 925 0 obj << /Next 892 0 R /Parent 392 0 R /Title (20. J&J, by its employees or agents attended meetings and/or participated in telephone calls regarding the research, and/or development, and/or FDA approval, and/or marketing of INVOKANA/INVOKAMET.) /A 962 0 R /Prev 963 0 R >> endobj 926 0 obj << /Next 964 0 R /Parent 392 0 R /Title (10. Janssen is registered to do business throughout the United States, including New Jersey and Tennessee, where Plaintiff resides and where Plaintiff was treated for her injuries.) /A 965 0 R /Prev 893 0 R >> endobj 927 0 obj << /D [399 0 R /XYZ 70 554 0] /S /GoTo >> endobj 928 0 obj 15 endobj 929 0 obj 3 endobj 930 0 obj 2574 endobj 931 0 obj 216 endobj 932 0 obj << /Type /FontDescriptor /Descent -307 /StemV 72 /FontWeight 400 /CapHeight 662 /FontBBox [-498 -307 1333 1023] /FontStretch /Normal /Flags 98 /XHeight 442 /FontFamily (Times New Roman) /Ascent 1023 /FontName /TimesNewRomanPS-ItalicMT /ItalicAngle -17 >> endobj 933 0 obj << /Type /FontDescriptor /Descent -307 /StemV 136 /FontWeight 700 /CapHeight 662 /FontBBox [-558 -307 2000 1026] /FontStretch /Normal /Flags 34 /XHeight 457 /FontFamily (Times New Roman) /Ascent 1026 /FontName /TimesNewRomanPS-BoldMT /ItalicAngle 0 >> endobj 934 0 obj << /Type /FontDescriptor /Descent -307 /StemV 80 /FontWeight 400 /CapHeight 662 /FontBBox [-568 -307 2000 1007] /FontStretch /Normal /Flags 34 /XHeight 448 /FontFamily (Times New Roman) /Ascent 1007 /FontName /TimesNewRomanPSMT /ItalicAngle 0 >> endobj 935 0 obj << /FontBBox [-203 -303 1050 910] /CapHeight 687 /Type /FontDescriptor /FontFile2 966 0 R /StemV 80 /Descent -210 /Flags 32 /FontName /WCVVZZ+LiberationSans /Ascent 728 /ItalicAngle 0 >> endobj 936 0 obj << /Type /FontDescriptor /Descent -325 /StemV 88 /FontWeight 400 /CapHeight 716 /FontBBox [-665 -325 2000 1006] /FontStretch /Normal /Flags 32 /XHeight 519 /FontFamily (Arial) /Ascent 1006 /FontName /ArialMT /ItalicAngle 0 >> endobj 937 0 obj << /Type /FontDescriptor /Descent -376 /StemV 136 /FontWeight 700 /CapHeight 716 /FontBBox [-628 -376 2000 1018] /FontStretch /Normal /Flags 32 /XHeight 519 /FontFamily (Arial) /Ascent 1018 /FontName /Arial-BoldMT /ItalicAngle 0 >> endobj 938 0 obj << /Type /FontDescriptor /Descent -307 /StemV 124 /FontWeight 700 /CapHeight 662 /FontBBox [-547 -307 1401 1032] /FontStretch /Normal /Flags 98 /XHeight 453 /FontFamily (Times New Roman) /Ascent 1032 /FontName /TimesNewRomanPS-BoldItalicMT /ItalicAngle -17 >> endobj 939 0 obj << /D [434 0 R /XYZ 70 582 0] /S /GoTo >> endobj 940 0 obj << /Next 910 0 R /Parent 4 0 R /Title (FRAUDULENT MISREPRESENTATION) /A 967 0 R /Prev 968 0 R /Count 30 /Last 969 0 R /First 970 0 R >> endobj 941 0 obj << /D [435 0 R /XYZ 70 499 0] /S /GoTo >> endobj 942 0 obj << /Next 911 0 R /Parent 884 0 R /Title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rev 943 0 R >> endobj 943 0 obj << /Next 942 0 R /Parent 884 0 R /Title (205. Prior to the manufacturing, sale, and distribution of INVOKANA/INVOKAMET, Defendants knew that said medication was in a defective condition as previously described herein and knew that those who were prescribed the medication would experience and...) /A 972 0 R /Prev 912 0 R >> endobj 944 0 obj << /D [434 0 R /XYZ 70 535 0] /S /GoTo >> endobj 945 0 obj << /Next 973 0 R /Parent 4 0 R /Title (STRICT PRODUCTS LIABILITY - DESIGN DEFECT) /A 974 0 R /Prev 913 0 R /Count 10 /Last 975 0 R /First 976 0 R >> endobj 946 0 obj << /D [419 0 R /XYZ 70 306 0] /S /GoTo >> endobj 947 0 obj << /D [419 0 R /XYZ 70 361 0] /S /GoTo >> endobj 948 0 obj << /Next 915 0 R /Parent 885 0 R /Title (114. Defendants had a continuing duty to warn Plaintiff of the dangers associated with the subject product.) /A 977 0 R /Prev 978 0 R >> endobj 949 0 obj << /Next 979 0 R /Parent 885 0 R /Title (93. At all times material to this action, Defendants were engaged in the business of designing, developing, manufacturing, testing, packaging, promoting, marketing, distributing, labeling, and/or selling INVOKANA/INVOKAMET.) /A 980 0 R /Prev 916 0 R >> endobj 950 0 obj << /D [414 0 R /XYZ 70 308 0] /S /GoTo >> endobj 951 0 obj << /D [411 0 R /XYZ 70 389 0] /S /GoTo >> endobj 952 0 obj << /Parent 918 0 R /Title <38372E20506C61696E74696666907320696E6A75726965732077657265206120726561736F6E61626C6520666F726573656561626C6520636F6E73657175656E6365206F6620446566656E64616E74739020636F6E6475637420616E6420494E564F4B414E412F494E564F4B414D455490732068617A617264732C20616E642077657265206E6F7420726561736F6E61626C7920666F726573656561626C6520746F20506C61696E74696666206F7220506C61696E7469666690732070687973696369616E732E> /A 981 0 R /Prev 982 0 R >> endobj 953 0 obj << /Next 983 0 R /Parent 918 0 R /Title <37332E20426F6E6E69652048616D6D20686164207365766572616C20616C7465726E617469766520616E64207361666572206D6574686F647320746F20747265617420506C61696E7469666690732064696162657465732C20696E636C7564696E67206469657420616E6420657865726369736520616E64206F74686572206469616265746573206D656469636174696F6E732E2020506C61696E7469666620776173207072657363726962656420494E564F4B414E412F494E564F4B414D455420696E206F722061726F756E64204D617920616E64204A756E65203230313620616E6420757365642069742061732064697265637465642E> /A 984 0 R >> endobj 954 0 obj << /D [414 0 R /XYZ 70 444 0] /S /GoTo >> endobj 955 0 obj << /Next 919 0 R /Parent 887 0 R /Title <39302E20546865206163637275616C20616E642072756E6E696E67206F6620616E79206170706C696361626C652073746174757465206F66206C696D69746174696F6E7320686173206265656E20746F6C6C656420627920726561736F6E206F6620446566656E64616E747390206672617564756C656E7420636F6E6365616C6D656E742E> /A 985 0 R /Prev 956 0 R >> endobj 956 0 obj << /Next 955 0 R /Parent 887 0 R /Title <38392E204173206120726573756C74206F6620446566656E64616E74739020616374696F6E732C20506C61696E7469666620616E6420506C61696E7469666690732070687973696369616E7320616E64206865616C7468636172652070726F766964657273207765726520756E61776172652C20616E6420636F756C64206E6F74206861766520726561736F6E61626C79206B6E6F776E206F722068617665206C6561726E6564207468726F75676820726561736F6E61626C652064696C6967656E63652C207468617420506C61696E7469666620686164206265656E206578706F73656420746F20746865207269736B73206964656E746966692E2E2E> /A 986 0 R /Prev 920 0 R >> endobj 957 0 obj << /D [414 0 R /XYZ 70 720 0] /S /GoTo >> endobj 958 0 obj << /D [411 0 R /XYZ 70 444 0] /S /GoTo >> endobj 959 0 obj << /Next 922 0 R /Parent 888 0 R /Title <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> /A 987 0 R /Prev 988 0 R >> endobj 960 0 obj << /Next 989 0 R /Parent 888 0 R /Title <32372E20494E564F4B414E412028616C736F206B6E6F776E2061732063616E61676C69666C6F7A696E292C20616E6420494E564F4B414D455420286120636F6D62696E6174696F6E206F662063616E61676C69666C6F7A696E20616E64206D6574666F726D696E2920617265206D656D62657273206F6620676C69666C6F7A696E20636C617373206F6620706861726D61636575746963616C7320616C736F206B6E6F776E20617320736F6469756D20676C75636F736520636F2D7472616E73706F72746572203220288D53474C54328E2920696E68696269746F72732E> /A 990 0 R /Prev 923 0 R >> endobj 961 0 obj << /D [403 0 R /XYZ 70 720 0] /S /GoTo >> endobj 962 0 obj << /D [401 0 R /XYZ 70 306 0] /S /GoTo >> endobj 963 0 obj << /Next 925 0 R /Parent 392 0 R /Title <31392E20446566656E64616E74204A4F484E534F4E2026204A4F484E534F4E202868657265696E6166746572208D4A264A8E292C206973206120666963746974696F7573206E616D652061646F7074656420627920446566656E64616E74204A4F484E534F4E2026204A4F484E534F4E20434F4D50414E592C2061204E6577204A657273657920636F72706F726174696F6E2077686963682068617320697473207072696E636970616C20706C616365206F6620627573696E657373206174204F6E65204A6F686E736F6E2026204A6F686E736F6E20506C617A612C204E6577204272756E737769636B2C204D6964646C6573657820436F756E742E2E2E> /A 991 0 R /Prev 992 0 R >> endobj 964 0 obj << /Next 993 0 R /Parent 392 0 R /Title (11. Janssen, by its employees or agents attended meetings and/or participated in telephone calls regarding the research, and/or development, and/or FDA approval, and/or marketing of INVOKANA/INVOKAMET.) /A 994 0 R /Prev 926 0 R >> endobj 965 0 obj << /D [399 0 R /XYZ 70 306 0] /S /GoTo >> endobj 966 0 obj << /Length1 19816 /Length 995 0 R /Filter /FlateDecode >> stream x|y@TGwv74;;t7M5t#-*`UiEDpw01&F',.1.EL2ĉyɘd&f2N&ɛSEf3=]{թSsTF@C8bdn5a1Bdo_iy'!TiILJ/!1OhZrsk&! 1 1#Dq1pI" AΟk\MHhB%sWADȤ6oj[9aǿy ) 0|g"#>X}qsil!o&)gJ0lxStY0̡8snc~lũq8c\r-77B-jJdU[pk5ޚjmo]lnn>h}zzS7Z߷~bC1abB} :4N"ӷI~mҙL& S-5[kX?q -Gn1}Ƅ  ]&d0pj && &&wHݟW ,89;T[Vqʊsۯi:>Mi䧺O嫗t?/qs.z87/.-͗McԯhSxEBˬ6]6~)];JLj~O w7?gk'GY)}DzBRgSrp5RFX:,En9fדCPC`6N{=vvo$g-t#Z< `gDޟG`Bk) &vEzVt;7A,(1t)K&{܅'y9YƎ&%&X-qfc^V+rsHj]o&{ǓҖ1wDFׄY;xMR5ӝ5Eசx&MTSP`1Jo/TW)'H`LTzS׽|aoa}wBoo LK%'Ub̛di;I EhRa JlX/g---,,2R!K]ze^ԥNNn;&mA +\lnjldK7py7RP赱^KE~Kp:3g?GfUKXԍu[L޹gzYLjK޶B0)Vg~5VU/ldKJ/M b˳E5UuJY1AA8Pf3ֳ" oOY/m"NazV?\b`%=%[p5KfTzykqeug⩅-E .ljLY* *nh6y šDwjњ, RX|a8v`JKzl/רD[̭%j.밴y֓UŃ':gGbJ)k<ɸ&j2.9;t#yywvܨZ[l ߛJ[=X1Uf+ugQ hUXs嵰\QCWo P*`|.62?K>A='. !Dy8ګOk#JS;=,q 4svgFhV>N-q!ԠΌ\[l8互ZO|&ijgr紤iˊMIG%{:??^zʆ6\y6l Xc #L=4 @;`'qLxNPb:S ތS<')2NYkǜ0Q̙iVlMÔa^~|y#|/r҄ԓ."7Dnu6Zan5f D[ ]Q, c 1!#*`)=ڥ΄ T&&_4&x"afkkWk@mj;=+@[Yy5RK\!ӿ(\Ι" M83-.{L$l'5jh^df8]Wo9&;*G3yccvƼ9E=4ge1q!us(ސM˱A7nkhihd2ܾNv(Nc"FEFĈĈ@iQMΡ;ts(^ 1 0;aq.0!2&X:RꎵJPrz%JP2(3^* TqUB2$ (ABı(1L- 㙣,q¥rC,G|c ?U&-y_aJyΥ59`ЋUU-?iZqd0m)֌=1~usu֤4nxfȩlc6h+EKU^lCj\ ᡰ :^_Ck;=BL5QrtQ %(F ^1Vs-5hEJc M8;X d7n$rfYLXbQ2a8`}0{֥fIBIINLѡ\MJ É'@eW5YQuuÈM $ ~ͳ3njd,c^ZԲʤF{YYj ZŴ2ü|s]Tzgnw{tMېTcwOdZ:ڪ``(Xx2ӷ;7Vɛ96PZnitZ򸆸8.30nȀ f/=#YɇFUG1: GRu)2S*0&dak|pJ`6jm=PckO$GbiqAl0iЕ!v? 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By virtue of the conscious wrongdoing alleged in this Complaint, Defendants have been unjustly enriched at the expense of Plaintiff, who hereby seeks the disgorgement and restitution of the Defendants' wrongful profits, revenue, and benefits, to ...) /A 998 0 R /Prev 999 0 R >> endobj 970 0 obj << /Next 1000 0 R /Parent 940 0 R /Title (184. Plaintiff incorporates by reference each preceding and succeeding paragraph as though set forth fully at length herein.) /A 1001 0 R >> endobj 971 0 obj << /D [434 0 R /XYZ 70 121 0] /S /GoTo >> endobj 972 0 obj << /D [434 0 R /XYZ 70 341 0] /S /GoTo >> endobj 973 0 obj << /Next 1002 0 R /Parent 4 0 R /Title (COUNT V) /A 1003 0 R /Prev 945 0 R >> endobj 974 0 obj << /D [419 0 R /XYZ 70 292 0] /S /GoTo >> endobj 975 0 obj << /Parent 945 0 R /Title <3132352E204173206120726573756C74206F6620494E564F4B414E412F494E564F4B414D455490732064656665637469766520636F6E646974696F6E2C20506C61696E7469666620737566666572656420746865207065726D616E656E7420696E6A757269657320616E642064616D6167657320616C6C656765642068657265696E2E> /A 1004 0 R /Prev 1005 0 R >> endobj 976 0 obj << /Next 1006 0 R /Parent 945 0 R /Title (116. Plaintiff incorporates by reference each preceding and succeeding paragraph as though set forth fully at length herein) /A 1007 0 R >> endobj 977 0 obj << /D [419 0 R /XYZ 70 416 0] /S /GoTo >> endobj 978 0 obj << /Next 948 0 R /Parent 885 0 R /Title <3131332E20506C61696E746966662C20696E646976696475616C6C792C20616E64207468726F75676820506C61696E746966669073207072657363726962696E672070687973696369616E2C20726561736F6E61626C792072656C6965642075706F6E2074686520736B696C6C2C207375706572696F72206B6E6F776C656467652C20616E64206A7564676D656E74206F6620446566656E64616E74732E> /A 1008 0 R /Prev 1009 0 R >> endobj 979 0 obj << /Next 1010 0 R /Parent 885 0 R /Title (94. At all times material to this action, INVOKANA/INVOKAMET was expected to reach, and did reach, consumers in the State of Tennessee and throughout the United States, including Plaintiff, without substantial change in the condition in which it was s...) /A 1011 0 R /Prev 949 0 R >> endobj 980 0 obj << /D [414 0 R /XYZ 70 280 0] /S /GoTo >> endobj 981 0 obj << /D [413 0 R /XYZ 70 196 0] /S /GoTo >> endobj 982 0 obj << /Next 952 0 R /Parent 918 0 R /Title <38362E204261736564206F6E2074686520446566656E64616E7473902064697265637420746F20636F6E73756D6572206164766572746973696E6720616E6420446566656E64616E747390206D6973726570726573656E746174696F6E7320616E64206F6D697373696F6E732C20506C61696E74696666206D61646520616E20696E646570656E64656E74206465636973696F6E20746F2075736520494E564F4B414E412F494E564F4B414D455420696E207265666572656E636520746F20746865206F766572616C6C2062656E656669747320616E64207269736B7320636F6D6D756E69636174656420627920446566656E64616E74732E> /A 1012 0 R /Prev 1013 0 R >> endobj 983 0 obj << /Next 1014 0 R /Parent 918 0 R /Title (74. In May 2016, Bonnie Hamm was prescribed INVOKANA to be taken once daily to improve glycemic control as an adjunct to diet and exercise.) /A 1015 0 R /Prev 953 0 R >> endobj 984 0 obj << /D [411 0 R /XYZ 70 363 0] /S /GoTo >> endobj 985 0 obj << /D [414 0 R /XYZ 70 499 0] /S /GoTo >> endobj 986 0 obj << /D [414 0 R /XYZ 70 637 0] /S /GoTo >> endobj 987 0 obj << /D [411 0 R /XYZ 70 554 0] /S /GoTo >> endobj 988 0 obj << /Next 959 0 R /Parent 888 0 R /Title <37302E204465737069746520446566656E64616E747390206B6E6F776C65646765206F662074686520696E63726561736564207269736B206F662073657665726520696E6A75727920616D6F6E6720494E564F4B414E412F494E564F4B414D45542075736572732C20446566656E64616E747320646964206E6F7420636F6E6475637420746865206E6563657373617279206164646974696F6E616C207374756469657320746F2070726F7065726C79206576616C75617465207468657365207269736B73207072696F7220746F206D61726B6574696E6720746865206472756720746F207468652067656E6572616C207075626C69632E> /A 1016 0 R /Prev 1017 0 R >> endobj 989 0 obj << /Next 1018 0 R /Parent 888 0 R /Title (28. SGLT2 inhibitors, including INVOKANA/INVOKAMET, inhibit renal glucose reabsorption through the SGL2 receptor in the proximal renal tubules, causing glucose to be excreted through the urinary tract instead of reabsorbed into the blood stream thereb...) /A 1019 0 R /Prev 960 0 R >> endobj 990 0 obj << /D [403 0 R /XYZ 70 610 0] /S /GoTo >> endobj 991 0 obj << /D [401 0 R /XYZ 70 472 0] /S /GoTo >> endobj 992 0 obj << /Next 963 0 R /Parent 392 0 R /Title (18. Janssen R&D, by its employees or agents attended meetings and/or participated in telephone calls regarding the research, and/or development, and/or FDA approval, and/or marketing of INVOKANA/INVOKAMET.) /A 1020 0 R /Prev 1021 0 R >> endobj 993 0 obj << /Next 1022 0 R /Parent 392 0 R /Title <31322E204A616E7373656E206973207468652077686F6C6C79206F776E65642073756273696469617279206F66204A6F686E736F6E2026204A6F686E736F6E20288D4A264A8E292E20204A264A20616E64204A616E7373656E20776F726B656420746F67657468657220746F20616368696576652074686520636F6D6D6F6E20627573696E65737320707572706F7365206F662073656C6C696E6720616E642070726F666974696E672066726F6D20494E564F4B414E412F494E564F4B414D45542E> /A 1023 0 R /Prev 964 0 R >> endobj 994 0 obj << /D [399 0 R /XYZ 70 251 0] /S /GoTo >> endobj 995 0 obj 13074 endobj 996 0 obj << /D [430 0 R /XYZ 70 720 0] /S /GoTo >> endobj 997 0 obj << /Next 968 0 R /Parent 4 0 R /Title (BREACH OF EXPRESS WARRANTY) /A 1024 0 R /Prev 1025 0 R /Count 11 /Last 1026 0 R /First 1027 0 R >> endobj 998 0 obj << /D [434 0 R /XYZ 70 720 0] /S /GoTo >> endobj 999 0 obj << /Next 969 0 R /Parent 940 0 R /Title (202. It would be inequitable for the Defendants to retain this money, because Plaintiff did not, in fact, receive a safe and efficacious drug.) /A 1028 0 R /Prev 1029 0 R >> endobj 1000 0 obj << /Next 1030 0 R /Parent 940 0 R /Title (185. Defendants intentionally and fraudulently misrepresented the safety and efficacy of INVOKANA in the product label. Specifically Defendants intentionally and fraudulently:) /A 1031 0 R /Prev 970 0 R /Count 10 /Last 1032 0 R /First 1033 0 R >> endobj 1001 0 obj << /D [430 0 R /XYZ 70 673 0] /S /GoTo >> endobj 1002 0 obj << /Next 1034 0 R /Parent 4 0 R /Title (STRICT PRODUCTS LIABILITY - FAILURE TO WARN) /A 1035 0 R /Prev 973 0 R /Count 12 /Last 1036 0 R /First 1037 0 R >> endobj 1003 0 obj << /D [421 0 R /XYZ 70 582 0] /S /GoTo >> endobj 1004 0 obj << /D [421 0 R /XYZ 70 637 0] /S /GoTo >> endobj 1005 0 obj << /Next 975 0 R /Parent 945 0 R /Title (124. At the time INVOKANA/INVOKAMET left the control of Defendants, Defendants knew or should have known of the risks associated with ingesting INVOKANA/INVOKAMET.) /A 1038 0 R /Prev 1039 0 R >> endobj 1006 0 obj << /Next 1040 0 R /Parent 945 0 R /Title (117. Defendants had a duty to properly design, manufacture, compound, test, inspect, label, distribute, market, examine, maintain, supply, provide proper warnings, and take such steps as to assure that INVOKANA/INVOKAMET did not cause users to suffer ...) /A 1041 0 R /Prev 976 0 R >> endobj 1007 0 obj << /D [419 0 R /XYZ 70 259 0] /S /GoTo >> endobj 1008 0 obj << /D [419 0 R /XYZ 70 472 0] /S /GoTo >> endobj 1009 0 obj << /Next 978 0 R /Parent 885 0 R /Title (112. The warnings that were given by Defendants failed to properly warn physicians of the increased risks of permanent physical injuries including, but not limited to, diabetic ketoacidosis, kidney failure, myocardial infarction, stroke, amputations, ...) /A 1042 0 R /Prev 1043 0 R >> endobj 1010 0 obj << /Next 1044 0 R /Parent 885 0 R /Title (95. At all times material to this action, INVOKANA/INVOKAMET was designed, developed, manufactured, tested, packaged, promoted, marketed, distributed, labeled, and/or sold by Defendants in a defective and unreasonably dangerous condition at the time i...) /A 1045 0 R /Prev 979 0 R /Count 4 /Last 1046 0 R /First 1047 0 R >> endobj 1011 0 obj << /D [414 0 R /XYZ 70 197 0] /S /GoTo >> endobj 1012 0 obj << /D [413 0 R /XYZ 70 306 0] /S /GoTo >> endobj 1013 0 obj << /Next 982 0 R /Parent 918 0 R /Title (85. Plaintiff relied on claims made by defendants that INVOKANA/INVOKAMET has been clinically shown to improve glycemic control and was generally safe and effective. These claims reached Plaintiff directly, through print and television advertising, a...) /A 1048 0 R /Prev 1049 0 R >> endobj 1014 0 obj << /Next 1050 0 R /Parent 918 0 R /Title (75. In June 2016, Bonnie Hamm was prescribed INVOKAMET to be taken twice daily to improve glycemic control as an adjunct to diet and exercise.) /A 1051 0 R /Prev 983 0 R >> endobj 1015 0 obj << /D [411 0 R /XYZ 70 280 0] /S /GoTo >> endobj 1016 0 obj << /D [411 0 R /XYZ 70 637 0] /S /GoTo >> endobj 1017 0 obj << /Next 988 0 R /Parent 888 0 R /Title <36392E20446566656E64616E7473206661696C656420746F2061646571756174656C79207761726E20636F6E73756D65727320616E642070687973696369616E732061626F757420746865207269736B73206173736F636961746564207769746820494E564F4B414E412F494E564F4B414D455420616E6420746865206D6F6E69746F72696E6720726571756972656420656E737572696E672074686569722070617469656E747390207361666574792E> /A 1052 0 R /Prev 1053 0 R >> endobj 1018 0 obj << /Next 1054 0 R /Parent 888 0 R /Title (29. SGLT2 inhibitors, including INVOKANA/INVOKAMET, are designed to target primarily the SGLT2 receptor, but have varying selectivity for this receptor, and block other sodium-glucose cotransporter receptors, including SGLT1.) /A 1055 0 R /Prev 989 0 R >> endobj 1019 0 obj << /D [403 0 R /XYZ 70 527 0] /S /GoTo >> endobj 1020 0 obj << /D [401 0 R /XYZ 70 554 0] /S /GoTo >> endobj 1021 0 obj << /Next 992 0 R /Parent 392 0 R /Title (17. Janssen R&D is registered to do business throughout the United States, including in New Jersey where the case is filed and Tennessee where Plaintiff resides and where plaintiff Bonnie Hamm was treated for her injuries.) /A 1056 0 R /Prev 1057 0 R >> endobj 1022 0 obj << /Next 1058 0 R /Parent 392 0 R /Title <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> /A 1059 0 R /Prev 993 0 R >> endobj 1023 0 obj << /D [399 0 R /XYZ 70 168 0] /S /GoTo >> endobj 1024 0 obj << /D [428 0 R /XYZ 70 320 0] /S /GoTo >> endobj 1025 0 obj << /Next 997 0 R /Parent 4 0 R /Title (COUNT VIII) /A 1060 0 R /Prev 1061 0 R >> endobj 1026 0 obj << /Parent 997 0 R /Title <3138332E2054686520627265616368206F6620657870726573732077617272616E7469657320627920446566656E64616E747320776173206120666F726573656561626C652C206469726563742C20616E642070726F78696D617465206361757365206F6620506C61696E74696666907320696E6A757269657320616E642064616D6167657320776869636820617265207065726D616E656E742E> /A 1062 0 R /Prev 1063 0 R >> endobj 1027 0 obj << /Next 1064 0 R /Parent 997 0 R /Title (173. Plaintiff incorporates by reference each preceding and succeeding paragraph as though set forth fully at length herein.) /A 1065 0 R >> endobj 1028 0 obj << /D [433 0 R /XYZ 70 154 0] /S /GoTo >> endobj 1029 0 obj << /Next 999 0 R /Parent 940 0 R /Title (201. Plaintiff, however, did not receive a safe and effective drug for which Plaintiff paid.) /A 1066 0 R /Prev 1067 0 R >> endobj 1030 0 obj << /Next 1068 0 R /Parent 940 0 R /Title (186. Defendants knew that their representations were false, yet they willfully, wantonly and recklessly disregarded their obligation to provide truthful representations regarding the safety and risk of INVOKANA/INVOKAMET to Plaintiff, other consumers,...) /A 1069 0 R /Prev 1000 0 R >> endobj 1031 0 obj << /D [430 0 R /XYZ 70 617 0] /S /GoTo >> endobj 1032 0 obj << /Parent 1000 0 R /Title (j. Affirmatively asserted that INVOKANA/INVOKAMET was safe and effective.) /A 1070 0 R /Prev 1071 0 R >> endobj 1033 0 obj << /Next 1072 0 R /Parent 1000 0 R /Title <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> /A 1073 0 R >> endobj 1034 0 obj << /Next 1074 0 R /Parent 4 0 R /Title (COUNT VI) /A 1075 0 R /Prev 1002 0 R >> endobj 1035 0 obj << /D [421 0 R /XYZ 70 568 0] /S /GoTo >> endobj 1036 0 obj << /Parent 1002 0 R /Title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rev 1077 0 R >> endobj 1037 0 obj << /Next 1078 0 R /Parent 1002 0 R /Title (126. Plaintiff incorporates by reference each preceding and succeeding paragraph as though set forth fully at length herein.) /A 1079 0 R >> endobj 1038 0 obj << /D [421 0 R /XYZ 70 720 0] /S /GoTo >> endobj 1039 0 obj << /Next 1005 0 R /Parent 945 0 R /Title (123. The defect in design existed when the product left Defendants' possession.) /A 1080 0 R /Prev 1081 0 R >> endobj 1040 0 obj << /Next 1082 0 R /Parent 945 0 R /Title (118. The aforesaid product was defective and unsafe in design and manufacture such that it was unreasonably dangerous to the user, and was so at the time it was distributed by Defendants and ingested by Bonnie Hamm.) /A 1083 0 R /Prev 1006 0 R >> endobj 1041 0 obj << /D [419 0 R /XYZ 70 203 0] /S /GoTo >> endobj 1042 0 obj << /D [419 0 R /XYZ 70 582 0] /S /GoTo >> endobj 1043 0 obj << /Next 1009 0 R /Parent 885 0 R /Title (111. The warnings that were given by Defendants were not accurate, clear, and/or were ambiguous.) /A 1084 0 R /Prev 1085 0 R >> endobj 1044 0 obj << /Next 1086 0 R /Parent 885 0 R /Title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rev 1010 0 R >> endobj 1045 0 obj << /D [414 0 R /XYZ 70 115 0] /S /GoTo >> endobj 1046 0 obj << /Parent 1010 0 R /Title <642E20546865207375626A6563742070726F647563749073206D616E75666163747572696E6720646566656374732065786973746564206265666F7265206974206C6566742074686520636F6E74726F6C206F6620446566656E64616E74732E> /A 1088 0 R /Prev 1089 0 R >> endobj 1047 0 obj << /Next 1090 0 R /Parent 1010 0 R /Title (a. When placed in the stream of commerce, INVOKANA/INVOKAMET contained manufacturing defects which rendered the subject product unreasonably dangerous;) /A 1091 0 R >> endobj 1048 0 obj << /D [413 0 R /XYZ 70 444 0] /S /GoTo >> endobj 1049 0 obj << /Next 1013 0 R /Parent 918 0 R /Title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rev 1093 0 R >> endobj 1050 0 obj << /Next 1094 0 R /Parent 918 0 R /Title (76. On or about approximately January 23, 2017, as a direct result of her treatment with INVOKANA/INVOKAMET, Bonnie Hamm was hospitalized for a diabetic foot ulcer and osteomyelitis of the first toe of the right foot.) /A 1095 0 R /Prev 1014 0 R >> endobj 1051 0 obj << /D [411 0 R /XYZ 70 225 0] /S /GoTo >> endobj 1052 0 obj << /D [411 0 R /XYZ 70 720 0] /S /GoTo >> endobj 1053 0 obj << /Next 1017 0 R /Parent 888 0 R /Title <36382E204465737069746520446566656E64616E747390206B6E6F776C65646765206F662074686520696E63726561736564207269736B206F662074686573652073657665726520696E6A757269657320616D6F6E6720494E564F4B414E412F494E564F4B414D45542075736572732C20446566656E64616E747320646964206E6F74207761726E2070617469656E74732062757420696E737465616420636F6E74696E75656420746F20646566656E6420494E564F4B414E412F494E564F4B414D45542C206D69736C6561642070687973696369616E7320616E6420746865207075626C69632C20616E64206D696E696D697A6520756E6661762E2E2E> /A 1096 0 R /Prev 1097 0 R >> endobj 1054 0 obj << /Next 1098 0 R /Parent 888 0 R /Title (30. The SGLT2 and SGLT1 receptors are located throughout the body, including in the kidney, intestines, and brain.) /A 1099 0 R /Prev 1018 0 R >> endobj 1055 0 obj << /D [403 0 R /XYZ 70 416 0] /S /GoTo >> endobj 1056 0 obj << /D [401 0 R /XYZ 70 637 0] /S /GoTo >> endobj 1057 0 obj << /Next 1021 0 R /Parent 392 0 R /Title (16. Defendant, JANSSEN RESEARCH & DEVELOPMENT, LLC, is a limited liability company organized under the laws of New Jersey which has its principal place of business at 1125 Trenton-Harbourton Road, Titusville, NJ. Defendant Janssen Research & Developm...) /A 1100 0 R /Prev 1101 0 R >> endobj 1058 0 obj << /Next 1101 0 R /Parent 392 0 R /Title <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> /A 1102 0 R /Prev 1022 0 R >> endobj 1059 0 obj << /D [400 0 R /XYZ 70 720 0] /S /GoTo >> endobj 1060 0 obj << /D [428 0 R /XYZ 70 334 0] /S /GoTo >> endobj 1061 0 obj << /Next 1025 0 R /Parent 4 0 R /Title (BREACH OF IMPLIED WARRANTY) /A 1103 0 R /Prev 1104 0 R /Count 20 /Last 1105 0 R /First 1106 0 R >> endobj 1062 0 obj << /D [429 0 R /XYZ 70 140 0] /S /GoTo >> endobj 1063 0 obj << /Next 1026 0 R /Parent 997 0 R /Title <3138322E20494E564F4B414E412F494E564F4B414D455420646F6573206E6F7420636F6E666F726D20746F2074686520446566656E64616E747390206578707265737320726570726573656E746174696F6E733B207468657265666F72652C20446566656E64616E747320686176652062726561636865642074686520657870726573732077617272616E746965732E> /A 1107 0 R /Prev 1108 0 R >> endobj 1064 0 obj << /Next 1109 0 R /Parent 997 0 R /Title <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> /A 1110 0 R /Prev 1027 0 R >> endobj 1065 0 obj << /D [428 0 R /XYZ 70 286 0] /S /GoTo >> endobj 1066 0 obj << /D [433 0 R /XYZ 70 209 0] /S /GoTo >> endobj 1067 0 obj << /Next 1029 0 R /Parent 940 0 R /Title (200. Plaintiff conferred a benefit on Defendants by purchasing INVOKANA/INVOKAMET.) /A 1111 0 R /Prev 1112 0 R >> endobj 1068 0 obj << /Next 1113 0 R /Parent 940 0 R /Title <3138372E2054686520726570726573656E746174696F6E732077657265206D6164652062792074686520446566656E64616E747320776974682074686520696E74656E74207468617420646F63746F727320616E642070617469656E74732C20696E636C7564696E6720506C61696E746966662C20426F6E6E69652048616D6D2C20616E6420506C61696E7469666690732070687973696369616E732C2072656C792075706F6E207468656D2E> /A 1114 0 R /Prev 1030 0 R >> endobj 1069 0 obj << /D [431 0 R /XYZ 70 416 0] /S /GoTo >> endobj 1070 0 obj << /D [431 0 R /XYZ 70 472 0] /S /GoTo >> endobj 1071 0 obj << /Next 1032 0 R /Parent 1000 0 R /Title (i. On information and belief, failed to disclose that Defendants intentionally withheld safety information from the FDA; and) /A 1115 0 R /Prev 1116 0 R >> endobj 1072 0 obj << /Next 1117 0 R /Parent 1000 0 R /Title <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> /A 1118 0 R /Prev 1033 0 R >> endobj 1073 0 obj << /D [430 0 R /XYZ 70 562 0] /S /GoTo >> endobj 1074 0 obj << /Next 1104 0 R /Parent 4 0 R /Title (NEGLIGENCE) /A 1119 0 R /Prev 1034 0 R /Count 15 /Last 1120 0 R /First 1121 0 R >> endobj 1075 0 obj << /D [423 0 R /XYZ 70 472 0] /S /GoTo >> endobj 1076 0 obj << /D [423 0 R /XYZ 70 582 0] /S /GoTo >> endobj 1077 0 obj << /Next 1036 0 R /Parent 1002 0 R /Title (136. Defendants knew or should have known that the limited warnings disseminated with INVOKANA/INVOKAMET were inadequate, but they failed to communicate adequate information on the dangers and safe use of its product, taking into account the character...) /A 1122 0 R /Prev 1123 0 R >> endobj 1078 0 obj << /Next 1124 0 R /Parent 1002 0 R /Title (127. Defendants designed, developed, researched, tested, licensed, manufactured, packaged, labeled, promoted, marketed, sold, and distributed INVOKANA/INVOKAMET in a defective and unreasonably dangerous condition, including the INVOKANA/INVOKAMET used...) /A 1125 0 R /Prev 1037 0 R >> endobj 1079 0 obj << /D [421 0 R /XYZ 70 535 0] /S /GoTo >> endobj 1080 0 obj << /D [420 0 R /XYZ 70 113 0] /S /GoTo >> endobj 1081 0 obj << /Next 1039 0 R /Parent 945 0 R /Title (122. The design of INVOKANA/INVOKAMET was defective in that the risks associated with using INVOKANA/INVOKAMET outweighed any benefits of the design. Any benefits associated with the use of INVOKANA/INVOKAMET were either relatively minor or nonexiste...) /A 1126 0 R /Prev 1127 0 R >> endobj 1082 0 obj << /Next 1128 0 R /Parent 945 0 R /Title (119. INVOKANA/INVOKAMET was defective at the time of its manufacture, development, production, testing, inspection, endorsement, prescription, sale and distribution in that warnings, instructions and directions accompanying INVOKANA/INVOKAMET failed t...) /A 1129 0 R /Prev 1040 0 R >> endobj 1083 0 obj << /D [420 0 R /XYZ 70 720 0] /S /GoTo >> endobj 1084 0 obj << /D [419 0 R /XYZ 70 637 0] /S /GoTo >> endobj 1085 0 obj << /Next 1043 0 R /Parent 885 0 R /Title (110. Defendants, the manufacturers and/or distributors of the subject prescription product, are held to the level of knowledge of an expert in the field as the Reference Listed Drug Company and the New Drug Application Holder.) /A 1130 0 R /Prev 1131 0 R >> endobj 1086 0 obj << /Next 1132 0 R /Parent 885 0 R /Title (97. As a result of INVOKANA/INVOKAMET's defective condition, Plaintiff suffered the injuries and damages alleged herein.) /A 1133 0 R /Prev 1044 0 R >> endobj 1087 0 obj << /D [415 0 R /XYZ 70 389 0] /S /GoTo >> endobj 1088 0 obj << /D [415 0 R /XYZ 70 444 0] /S /GoTo >> endobj 1089 0 obj << /Next 1046 0 R /Parent 1010 0 R /Title <632E20546865207375626A6563742070726F6475637420776173206E6F74206D61646520696E206163636F7264616E6365207769746820446566656E64616E7473902073706563696669636174696F6E73206F7220706572666F726D616E6365207374616E64617264733B20616E64> /A 1134 0 R /Prev 1090 0 R >> endobj 1090 0 obj << /Next 1089 0 R /Parent 1010 0 R /Title <622E20546865207375626A6563742070726F647563749073206D616E75666163747572696E672064656665637473206F63637572726564207768696C65207468652070726F647563742077617320696E2074686520706F7373657373696F6E20616E6420636F6E74726F6C206F6620446566656E64616E74733B> /A 1135 0 R /Prev 1047 0 R >> endobj 1091 0 obj << /D [415 0 R /XYZ 70 637 0] /S /GoTo >> endobj 1092 0 obj << /D [413 0 R /XYZ 70 637 0] /S /GoTo >> endobj 1093 0 obj << /Next 1049 0 R /Parent 918 0 R /Title <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> /A 1136 0 R /Prev 1137 0 R >> endobj 1094 0 obj << /Next 1138 0 R /Parent 918 0 R /Title (77. On or about approximately January 25, 2017, as direct result of her use of INVOKANA/INVOKAMET, Bonnie Hamm underwent surgery for an amputation of the first toe of her right foot through the metatarsophalangeal joint.) /A 1139 0 R /Prev 1050 0 R >> endobj 1095 0 obj << /D [411 0 R /XYZ 70 170 0] /S /GoTo >> endobj 1096 0 obj << /D [410 0 R /XYZ 70 223 0] /S /GoTo >> endobj 1097 0 obj << /Next 1053 0 R /Parent 888 0 R /Title (67. Despite their knowledge of data indicating that INVOKANA/INVOKAMET use is causally related to the development of diabetic ketoacidosis, kidney failure and amputations, Defendants promoted and marketed INVOKANA/INVOKAMET as safe and effective for p...) /A 1140 0 R /Prev 1141 0 R >> endobj 1098 0 obj << /Next 1142 0 R /Parent 888 0 R /Title (31. The active ingredient in INVOKANA/INVOKAMET, canagliflozin is contained in both INVOKANA and INVOKAMET and has the highest selectivity for the SGLT1 receptor among SGLT2 inhibitors currently marketed in the United States. This makes it unique amo...) /A 1143 0 R /Prev 1054 0 R >> endobj 1099 0 obj << /D [403 0 R /XYZ 70 334 0] /S /GoTo >> endobj 1100 0 obj << /D [400 0 R /XYZ 70 306 0] /S /GoTo >> endobj 1101 0 obj << /Next 1057 0 R /Parent 392 0 R /Title <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> /A 1144 0 R /Prev 1058 0 R >> endobj 1102 0 obj << /D [400 0 R /XYZ 70 610 0] /S /GoTo >> endobj 1103 0 obj << /D [425 0 R /XYZ 70 127 0] /S /GoTo >> endobj 1104 0 obj << /Next 1061 0 R /Parent 4 0 R /Title (COUNT VII) /A 1145 0 R /Prev 1074 0 R >> endobj 1105 0 obj << /Parent 1061 0 R /Title (172. Plaintiff has incurred and will continue to incur medical and related expenses. Plaintiff also has suffered and will continue to suffer diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death...) /A 1146 0 R /Prev 1147 0 R >> endobj 1106 0 obj << /Next 1148 0 R /Parent 1061 0 R /Title (153. Plaintiff restates the allegations set forth above as if fully rewritten herein.) /A 1149 0 R >> endobj 1107 0 obj << /D [429 0 R /XYZ 70 196 0] /S /GoTo >> endobj 1108 0 obj << /Next 1063 0 R /Parent 997 0 R /Title (181. The warranties and representations are false because INVOKANA/INVOKAMET can cause diabetic ketoacidosis, kidney failure, blood infections, kidney infections, diabetic foot ulcers, gangrene, lower limb ischemia and amputations of toes, feet and le...) /A 1150 0 R /Prev 1151 0 R >> endobj 1109 0 obj << /Next 1152 0 R /Parent 997 0 R /Title <3137352E20546865208D5761726E696E677320616E642050726563617574696F6E738E2073656374696F6E206F662074686520494E564F4B414E412F494E564F4B414D4554207072657363726962696E6720696E666F726D6174696F6E20707572706F72747320746F20657870726573736C79206465736372696265207468652072656C6576616E7420616E64206D6174657269616C20736964652D65666665637473207468617420446566656E64616E7473206B6E6577206F722073686F756C642068617665206B6E6F776E2061626F75742E> /A 1153 0 R /Prev 1064 0 R >> endobj 1110 0 obj << /D [428 0 R /XYZ 70 231 0] /S /GoTo >> endobj 1111 0 obj << /D [433 0 R /XYZ 70 265 0] /S /GoTo >> endobj 1112 0 obj << /Next 1067 0 R /Parent 940 0 R /Title (199. Plaintiff incorporates by reference each and every paragraph of this Complaint as if fully copied and set forth at length herein.) /A 1154 0 R /Prev 1155 0 R >> endobj 1113 0 obj << /Next 1156 0 R /Parent 940 0 R /Title <3138382E20446566656E64616E74739020726570726573656E746174696F6E732077657265206D61646520776974682074686520696E74656E74206F662064656672617564696E6720616E6420646563656976696E6720506C61696E746966662C206F7468657220636F6E73756D6572732C20506C61696E7469666690732070687973696369616E732C20616E6420746865206D65646963616C20636F6D6D756E69747920746F20696E6475636520616E6420656E636F7572616765207468652073616C65206F6620494E564F4B414E412F494E564F4B414D45542E> /A 1157 0 R /Prev 1068 0 R >> endobj 1114 0 obj << /D [431 0 R /XYZ 70 306 0] /S /GoTo >> endobj 1115 0 obj << /D [431 0 R /XYZ 70 527 0] /S /GoTo >> endobj 1116 0 obj << /Next 1071 0 R /Parent 1000 0 R /Title (h. Failed to disclose that testing had revealed unreasonably high risk of injury;) /A 1158 0 R /Prev 1159 0 R >> endobj 1117 0 obj << /Next 1160 0 R /Parent 1000 0 R /Title (c. Upon information and belief, each and every advertisement and marketing channel fraudulently omits information about the risks of INVOKANA/INVOKAMET and overstates the benefits;) /A 1161 0 R /Prev 1072 0 R >> endobj 1118 0 obj << /D [430 0 R /XYZ 70 424 0] /S /GoTo >> endobj 1119 0 obj << /D [423 0 R /XYZ 70 458 0] /S /GoTo >> endobj 1120 0 obj << /Parent 1074 0 R /Title (152. Plaintiff has incurred and will continue to incur medical and related expenses. Plaintiff has also suffered and will continue to suffer diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death...) /A 1162 0 R /Prev 1163 0 R >> endobj 1121 0 obj << /Next 1164 0 R /Parent 1074 0 R /Title (138. Plaintiff incorporates by reference each preceding and succeeding paragraph as though set forth fully at length herein.) /A 1165 0 R >> endobj 1122 0 obj << /D [422 0 R /XYZ 70 168 0] /S /GoTo >> endobj 1123 0 obj << /Next 1077 0 R /Parent 1002 0 R /Title (135. Defendants had a duty to properly test, develop, design, manufacture, inspect, package, label, market, promote, sell, distribute, supply, warn, and take other such steps as necessary to ensure that INVOKANA/INVOKAMET did not cause users to suff...) /A 1166 0 R /Prev 1167 0 R >> endobj 1124 0 obj << /Next 1168 0 R /Parent 1002 0 R /Title <3132382E20494E564F4B414E412F494E564F4B414D4554907320696E6164657175617465207761726E696E67732072656E646572656420494E564F4B414E412F494E564F4B414D455420756E726561736F6E61626C792064616E6765726F757320616E64206465666563746976652E> /A 1169 0 R /Prev 1078 0 R >> endobj 1125 0 obj << /D [421 0 R /XYZ 70 479 0] /S /GoTo >> endobj 1126 0 obj << /D [420 0 R /XYZ 70 251 0] /S /GoTo >> endobj 1127 0 obj << /Next 1081 0 R /Parent 945 0 R /Title (121. INVOKANA/INVOKAMET was prescribed to and used by Plaintiff, Bonnie Hamm, as intended by Defendants and in a manner reasonably foreseeable to Defendants.) /A 1170 0 R /Prev 1128 0 R >> endobj 1128 0 obj << /Next 1127 0 R /Parent 945 0 R /Title <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> /A 1171 0 R /Prev 1082 0 R >> endobj 1129 0 obj << /D [420 0 R /XYZ 70 637 0] /S /GoTo >> endobj 1130 0 obj << /D [419 0 R /XYZ 70 720 0] /S /GoTo >> endobj 1131 0 obj << /Next 1085 0 R /Parent 885 0 R /Title (109. Defendants, as manufacturers and/or distributors of the subject prescription product, are held to the level of knowledge of an expert in the field.) /A 1172 0 R /Prev 1173 0 R >> endobj 1132 0 obj << /Next 1174 0 R /Parent 885 0 R /Title (98. Plaintiff restates the allegations set forth above as if fully rewritten herein.) /A 1175 0 R /Prev 1086 0 R >> endobj 1133 0 obj << /D [415 0 R /XYZ 70 196 0] /S /GoTo >> endobj 1134 0 obj << /D [415 0 R /XYZ 70 499 0] /S /GoTo >> endobj 1135 0 obj << /D [415 0 R /XYZ 70 554 0] /S /GoTo >> endobj 1136 0 obj << /D [412 0 R /XYZ 70 140 0] /S /GoTo >> endobj 1137 0 obj << /Next 1093 0 R /Parent 918 0 R /Title <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> /A 1176 0 R /Prev 1177 0 R >> endobj 1138 0 obj << /Next 1178 0 R /Parent 918 0 R /Title (78. Plaintiff was discharged from the hospital on or about approximately January 26, 2017.) /A 1179 0 R /Prev 1094 0 R >> endobj 1139 0 obj << /D [412 0 R /XYZ 70 720 0] /S /GoTo >> endobj 1140 0 obj << /D [410 0 R /XYZ 70 361 0] /S /GoTo >> endobj 1141 0 obj << /Next 1097 0 R /Parent 888 0 R /Title <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> /A 1180 0 R /Prev 1181 0 R >> endobj 1142 0 obj << /Next 1182 0 R /Parent 888 0 R /Title (32. SGLT2 inhibitors, including INVOKANA/INVOKAMET, are currently approved only for improvement of glycemic control in adults with type 2 diabetes.) /A 1183 0 R /Prev 1098 0 R >> endobj 1143 0 obj << /D [403 0 R /XYZ 70 278 0] /S /GoTo >> endobj 1144 0 obj << /D [400 0 R /XYZ 70 472 0] /S /GoTo >> endobj 1145 0 obj << /D [425 0 R /XYZ 70 140 0] /S /GoTo >> endobj 1146 0 obj << /D [428 0 R /XYZ 70 499 0] /S /GoTo >> endobj 1147 0 obj << /Next 1105 0 R /Parent 1061 0 R /Title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rev 1185 0 R >> endobj 1148 0 obj << /Next 1186 0 R /Parent 1061 0 R /Title (154. Defendants manufactured, distributed, advertised, promoted, and sold INVOKANA/INVOKAMET.) /A 1187 0 R /Prev 1106 0 R >> endobj 1149 0 obj << /D [425 0 R /XYZ 70 93 0] /S /GoTo >> endobj 1150 0 obj << /D [429 0 R /XYZ 70 278 0] /S /GoTo >> endobj 1151 0 obj << /Next 1108 0 R /Parent 997 0 R /Title (180. Plaintiff reasonably relied on the skill, judgment, representations, and foregoing express warranties of the Defendants.) /A 1188 0 R /Prev 1189 0 R >> endobj 1152 0 obj << /Next 1190 0 R /Parent 997 0 R /Title (176. In particular the Consumer Medication Guide did not include any language that would suggest INVOKANA/INVOKAMET has been associated with diabetic ketoacidosis, kidney failure, blood infections, kidney infections, diabetic foot ulcers, gangrene, lo...) /A 1191 0 R /Prev 1109 0 R >> endobj 1153 0 obj << /D [429 0 R /XYZ 70 720 0] /S /GoTo >> endobj 1154 0 obj << /D [433 0 R /XYZ 70 320 0] /S /GoTo >> endobj 1155 0 obj << /Next 1112 0 R /Parent 940 0 R /Title (198. The representations by the Defendants were in fact false, in that INVOKANA/INVOKAMET is not safe, fit, and effective for human consumption, using INVOKANA/INVOKAMET is hazardous to health, and INVOKANA/INVOKAMET has a serious propensity to cause ...) /A 1192 0 R /Prev 1193 0 R >> endobj 1156 0 obj << /Next 1194 0 R /Parent 940 0 R /Title (189. Defendants J&J, Janssen, and Janssen R&D, in advertisements through their respective websites, and press releases issued by the respective defendants, stated that the drug INVOKANA/INVOKAMET was generally well tolerated and safe for use, and was ...) /A 1195 0 R /Prev 1113 0 R >> endobj 1157 0 obj << /D [431 0 R /XYZ 70 251 0] /S /GoTo >> endobj 1158 0 obj << /D [431 0 R /XYZ 70 582 0] /S /GoTo >> endobj 1159 0 obj << /Next 1116 0 R /Parent 1000 0 R /Title (g. Failed to disclose that Defendants knew that INVOKANA/INVOKAMET was not adequately tested;) /A 1196 0 R /Prev 1197 0 R >> endobj 1160 0 obj << /Next 1198 0 R /Parent 1000 0 R /Title (d. Failed to disclose that INVOKANA/INVOKAMET was not as safe and effective as other diabetes drugs;) /A 1199 0 R /Prev 1117 0 R >> endobj 1161 0 obj << /D [430 0 R /XYZ 70 259 0] /S /GoTo >> endobj 1162 0 obj << /D [425 0 R /XYZ 70 306 0] /S /GoTo >> endobj 1163 0 obj << /Next 1120 0 R /Parent 1074 0 R /Title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rev 1201 0 R >> endobj 1164 0 obj << /Next 1202 0 R /Parent 1074 0 R /Title (139. At all times relevant times, Defendants had a duty to use reasonable care to properly manufacture, design, formulate, compound, test, produce, process, assemble, inspect, research, distribute, market, label, package, distribute, prepare for use, ...) /A 1203 0 R /Prev 1121 0 R >> endobj 1165 0 obj << /D [423 0 R /XYZ 70 424 0] /S /GoTo >> endobj 1166 0 obj << /D [422 0 R /XYZ 70 278 0] /S /GoTo >> endobj 1167 0 obj << /Next 1123 0 R /Parent 1002 0 R /Title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rev 1205 0 R >> endobj 1168 0 obj << /Next 1206 0 R /Parent 1002 0 R /Title <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> /A 1207 0 R /Prev 1124 0 R >> endobj 1169 0 obj << /D [421 0 R /XYZ 70 314 0] /S /GoTo >> endobj 1170 0 obj << /D [420 0 R /XYZ 70 306 0] /S /GoTo >> endobj 1171 0 obj << /D [420 0 R /XYZ 70 472 0] /S /GoTo >> endobj 1172 0 obj << /D [418 0 R /XYZ 70 196 0] /S /GoTo >> endobj 1173 0 obj << /Next 1131 0 R /Parent 885 0 R /Title (108. Plaintiff could not have discovered any defect in the subject product through the exercise of reasonable care.) /A 1208 0 R /Prev 1209 0 R >> endobj 1174 0 obj << /Next 1210 0 R /Parent 885 0 R /Title (99. INVOKANA/INVOKAMET is defective in its design or formulation in that it is not reasonably fit, suitable, or safe for its intended purpose and/or its foreseeable risks exceed the benefits associated with its design and formulation.) /A 1211 0 R /Prev 1132 0 R >> endobj 1175 0 obj << /D [416 0 R /XYZ 70 720 0] /S /GoTo >> endobj 1176 0 obj << /D [412 0 R /XYZ 70 251 0] /S /GoTo >> endobj 1177 0 obj << /Next 1137 0 R /Parent 918 0 R /Title <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> /A 1212 0 R /Prev 1213 0 R >> endobj 1178 0 obj << /Next 1213 0 R /Parent 918 0 R /Title (79. Plaintiff endured pain and suffering, and will continue to endure pain and suffering as a result of her permanent disability, as well as emotional distress, loss of enjoyment of life, and economic loss, including significant expenses for medical c...) /A 1214 0 R /Prev 1138 0 R >> endobj 1179 0 obj << /D [412 0 R /XYZ 70 637 0] /S /GoTo >> endobj 1180 0 obj << /D [410 0 R /XYZ 70 582 0] /S /GoTo >> endobj 1181 0 obj << /Next 1141 0 R /Parent 888 0 R /Title (65. Defendants were aware that the mechanism of action for INVOKANA/INVOKAMET places extraordinary strain on the kidneys and renal system. They were also aware that INVOKANA/INVOKAMET use causes volume depletion and that, as with thiazide diuretics, ...) /A 1215 0 R /Prev 1216 0 R >> endobj 1182 0 obj << /Next 1217 0 R /Parent 888 0 R /Title (33. At all times herein mentioned, the Defendants were engaged in the business of researching, licensing, designing, formulating, compounding, testing, manufacturing, producing, processing, assembling, inspecting, distributing, marketing, labeling, pr...) /A 1218 0 R /Prev 1142 0 R >> endobj 1183 0 obj << /D [403 0 R /XYZ 70 168 0] /S /GoTo >> endobj 1184 0 obj << /D [428 0 R /XYZ 70 610 0] /S /GoTo >> endobj 1185 0 obj << /Next 1147 0 R /Parent 1061 0 R /Title <3137302E20446566656E64616E74739020627265616368206F6620746865736520696D706C6965642077617272616E746965732063617573656420506C61696E74696666907320696E6A75726965732E> /A 1219 0 R /Prev 1220 0 R >> endobj 1186 0 obj << /Next 1221 0 R /Parent 1061 0 R /Title (155. At all relevant times, Defendants knew of the use for which INVOKANA/INVOKAMET was intended, and impliedly warranted the product to be of merchantable quality and safe and fit for such use.) /A 1222 0 R /Prev 1148 0 R >> endobj 1187 0 obj << /D [426 0 R /XYZ 70 720 0] /S /GoTo >> endobj 1188 0 obj << /D [429 0 R /XYZ 70 334 0] /S /GoTo >> endobj 1189 0 obj << /Next 1151 0 R /Parent 997 0 R /Title (179. Defendants knew or should have known that Plaintiff would rely on their warranties.) /A 1223 0 R /Prev 1224 0 R >> endobj 1190 0 obj << /Next 1224 0 R /Parent 997 0 R /Title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rev 1152 0 R >> endobj 1191 0 obj << /D [429 0 R /XYZ 70 637 0] /S /GoTo >> endobj 1192 0 obj << /D [433 0 R /XYZ 70 499 0] /S /GoTo >> endobj 1193 0 obj << /Next 1155 0 R /Parent 940 0 R /Title (197. These misrepresentations were made directly by the Defendants, by agents of the Defendants, and in written material directed to physicians, medical patients, and the public, with the intention of inducing reliance and the prescription, purchase, ...) /A 1226 0 R /Prev 1227 0 R >> endobj 1194 0 obj << /Next 1228 0 R /Parent 940 0 R /Title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rev 1156 0 R >> endobj 1195 0 obj << /D [431 0 R /XYZ 70 168 0] /S /GoTo >> endobj 1196 0 obj << /D [431 0 R /XYZ 70 637 0] /S /GoTo >> endobj 1197 0 obj << /Next 1159 0 R /Parent 1000 0 R /Title (f. Failed to disclose that the risk of harm associated with INVOKANA/INVOKAMET was greater than the risk of harm associated with other diabetes drugs;) /A 1230 0 R /Prev 1198 0 R >> endobj 1198 0 obj << /Next 1197 0 R /Parent 1000 0 R /Title (e. Failed to disclose that INVOKANA/INVOKAMET does not result in safe and more effective diabetes treatments than other available drugs;) /A 1231 0 R /Prev 1160 0 R >> endobj 1199 0 obj << /D [430 0 R /XYZ 70 176 0] /S /GoTo >> endobj 1200 0 obj << /D [425 0 R /XYZ 70 416 0] /S /GoTo >> endobj 1201 0 obj << /Next 1163 0 R /Parent 1074 0 R /Title <3135302E20446566656E64616E74739020636F6E647563742C206173206465736372696265642061626F76652C20776173207265636B6C6573732E2020446566656E64616E74739020616374696F6E7320616E6420696E616374696F6E207269736B656420746865206C69766573206F6620636F6E73756D65727320616E64207573657273206F662074686569722070726F64756374732C20696E636C7564696E6720506C61696E746966662E> /A 1232 0 R /Prev 1233 0 R >> endobj 1202 0 obj << /Next 1234 0 R /Parent 1074 0 R /Title (140. At all times material hereto, Defendants had actual knowledge, or in the alternative, should have known through the exercise of reasonable and prudent care, of the hazards and dangers of INVOKANA/INVOKAMET to cause or increase the harm of diabeti...) /A 1235 0 R /Prev 1164 0 R >> endobj 1203 0 obj << /D [423 0 R /XYZ 70 369 0] /S /GoTo >> endobj 1204 0 obj << /D [422 0 R /XYZ 70 389 0] /S /GoTo >> endobj 1205 0 obj << /Next 1167 0 R /Parent 1002 0 R /Title (133. Defendants, as manufacturers of pharmaceutical drugs, are held to the level of knowledge of an expert in the field, and further, Defendants knew or should have known that the warnings and other relevant information and data which they distributed...) /A 1236 0 R /Prev 1237 0 R >> endobj 1206 0 obj << /Next 1238 0 R /Parent 1002 0 R /Title (130. Plaintiff was prescribed and used INVOKANA/INVOKAMET for its intended purposes and for purposes that the defendants expected and could foresee.) /A 1239 0 R /Prev 1168 0 R >> endobj 1207 0 obj << /D [421 0 R /XYZ 70 259 0] /S /GoTo >> endobj 1208 0 obj << /D [418 0 R /XYZ 70 251 0] /S /GoTo >> endobj 1209 0 obj << /Next 1173 0 R /Parent 885 0 R /Title (107. Plaintiff was prescribed and used the subject product for its intended purpose.) /A 1240 0 R /Prev 1241 0 R >> endobj 1210 0 obj << /Next 1242 0 R /Parent 885 0 R /Title (100. At all times material to this action, INVOKANA/INVOKAMET was expected to reach, and did reach, consumers in the State of Tennessee and throughout the United States, including Plaintiff, without substantial change in the condition in which it was ...) /A 1243 0 R /Prev 1174 0 R >> endobj 1211 0 obj << /D [416 0 R /XYZ 70 692 0] /S /GoTo >> endobj 1212 0 obj << /D [412 0 R /XYZ 70 416 0] /S /GoTo >> endobj 1213 0 obj << /Next 1177 0 R /Parent 918 0 R /Title <38302E20446566656E64616E7473902077726F6E6766756C20616374732C206F6D697373696F6E7320616E64206672617564756C656E74206D6973726570726573656E746174696F6E732063617573656420426F6E6E69652048616D6D9073207065726D616E656E7420696E6A757269657320616E642064616D616765732E> /A 1244 0 R /Prev 1178 0 R >> endobj 1214 0 obj << /D [412 0 R /XYZ 70 582 0] /S /GoTo >> endobj 1215 0 obj << /D [410 0 R /XYZ 70 720 0] /S /GoTo >> endobj 1216 0 obj << /Next 1181 0 R /Parent 888 0 R /Title (64. INVOKANA/INVOKAMET induced diabetic ketoacidosis may lead to delayed treatment because in many cases INVOKANA/INVOKAMET will keep blood sugar below 250 mg/dl, a threshold often used when diagnosing diabetic ketoacidosis. This may result in increa...) /A 1245 0 R /Prev 1246 0 R >> endobj 1217 0 obj << /Next 1247 0 R /Parent 888 0 R /Title (34. Defendant J&J, the parent company of Janssen, is involved in the marketing and branding of INVOKANA/INVOKAMET, and publishes marketing and warnings regarding the product.) /A 1248 0 R /Prev 1182 0 R >> endobj 1218 0 obj << /D [404 0 R /XYZ 70 720 0] /S /GoTo >> endobj 1219 0 obj << /D [428 0 R /XYZ 70 637 0] /S /GoTo >> endobj 1220 0 obj << /Next 1185 0 R /Parent 1061 0 R /Title <3136392E204E65697468657220506C61696E74696666206E6F7220506C61696E746966669073206865616C746820636172652070726F66657373696F6E616C7320726561736F6E61626C7920636F756C64206861766520646973636F7665726564206F72206B6E6F776E206F6620746865207269736B206F6620736572696F757320696E6A75727920616E64206465617468206173736F636961746564207769746820494E564F4B414E412F494E564F4B414D45542E> /A 1249 0 R /Prev 1250 0 R >> endobj 1221 0 obj << /Next 1251 0 R /Parent 1061 0 R /Title (156. Defendants were aware that consumers, including Plaintiff, would use INVOKANA/INVOKAMET for treatment of type 2 diabetes and for other purposes, including but not limited to weight loss, and reduced blood pressure.) /A 1252 0 R /Prev 1186 0 R >> endobj 1222 0 obj << /D [426 0 R /XYZ 70 665 0] /S /GoTo >> endobj 1223 0 obj << /D [429 0 R /XYZ 70 389 0] /S /GoTo >> endobj 1224 0 obj << /Next 1189 0 R /Parent 997 0 R /Title (178. The product did not conform to representations made by the manufacturer.) /A 1253 0 R /Prev 1190 0 R >> endobj 1225 0 obj << /D [429 0 R /XYZ 70 527 0] /S /GoTo >> endobj 1226 0 obj << /D [433 0 R /XYZ 70 582 0] /S /GoTo >> endobj 1227 0 obj << /Next 1193 0 R /Parent 940 0 R /Title (196. Defendants had a duty to correct these material misstatements because they knew or should have known the statements were false and others would reasonable rely on them and suffer injury.) /A 1254 0 R /Prev 1255 0 R >> endobj 1228 0 obj << /Next 1256 0 R /Parent 940 0 R /Title (191. Plaintiff has incurred and will continue to incur medical and related expenses. Plaintiff has also suffered and will continue to suffer diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death...) /A 1257 0 R /Prev 1194 0 R >> endobj 1229 0 obj << /D [432 0 R /XYZ 70 610 0] /S /GoTo >> endobj 1230 0 obj << /D [431 0 R /XYZ 70 720 0] /S /GoTo >> endobj 1231 0 obj << /D [430 0 R /XYZ 70 121 0] /S /GoTo >> endobj 1232 0 obj << /D [425 0 R /XYZ 70 472 0] /S /GoTo >> endobj 1233 0 obj << /Next 1201 0 R /Parent 1074 0 R /Title <3134392E20446566656E64616E747390206E65676C6967656E636520776173206120666F726573656561626C6520616E642070726F78696D617465206361757365206F6620506C61696E74696666907320696E6A75726965732C206861726D20616E642065636F6E6F6D6963206C6F737320776869636820506C61696E746966662073756666657265642C2061732064657363726962656420616E642070726179656420666F722068657265696E2E> /A 1258 0 R /Prev 1259 0 R >> endobj 1234 0 obj << /Next 1260 0 R /Parent 1074 0 R /Title (141. Defendants had a duty to exercise due care and avoid unreasonable risk of harm to others when developing and selling INVOKANA/INVOKAMET.) /A 1261 0 R /Prev 1202 0 R >> endobj 1235 0 obj << /D [423 0 R /XYZ 70 259 0] /S /GoTo >> endobj 1236 0 obj << /D [422 0 R /XYZ 70 527 0] /S /GoTo >> endobj 1237 0 obj << /Next 1205 0 R /Parent 1002 0 R /Title (132. Plaintiff could not have discovered the unwarned risks of using INVOKANA/INVOKAMET through the exercise of reasonable care.) /A 1262 0 R /Prev 1238 0 R >> endobj 1238 0 obj << /Next 1237 0 R /Parent 1002 0 R /Title (131. Defendants expected and intended INVOKANA/INVOKAMET to reach, and did in fact reach, Bonnie Hamm without any substantial change in the condition of the product from when it was initially manufactured by Defendants.) /A 1263 0 R /Prev 1206 0 R >> endobj 1239 0 obj << /D [422 0 R /XYZ 70 720 0] /S /GoTo >> endobj 1240 0 obj << /D [418 0 R /XYZ 70 278 0] /S /GoTo >> endobj 1241 0 obj << /Next 1209 0 R /Parent 885 0 R /Title (106. The subject product manufactured and supplied by Defendants was defective due to inadequate post-marketing warnings or instructions because, after Defendants knew or should have known of the risk of serious bodily harm from the use of the subject...) /A 1264 0 R /Prev 1265 0 R >> endobj 1242 0 obj << /Next 1266 0 R /Parent 885 0 R /Title (101. At all times material to this action, INVOKANA/INVOKAMET was designed, developed, manufactured, tested, packaged, promoted, marketed, distributed, labeled, and/or sold by Defendants in a defective and unreasonably dangerous condition at the time ...) /A 1267 0 R /Prev 1210 0 R /Count 6 /Last 1268 0 R /First 1269 0 R >> endobj 1243 0 obj << /D [416 0 R /XYZ 70 610 0] /S /GoTo >> endobj 1244 0 obj << /D [412 0 R /XYZ 70 472 0] /S /GoTo >> endobj 1245 0 obj << /D [409 0 R /XYZ 70 196 0] /S /GoTo >> endobj 1246 0 obj << /Next 1216 0 R /Parent 888 0 R /Title (63. Amputations lead to loss of mobility further exacerbating the risks of a sedentary lifestyle, including but not limited to weight gain, cardiovascular risks, pressure ulcers and resulting dangerous infections, as well as the physical and economic ...) /A 1270 0 R /Prev 1271 0 R >> endobj 1247 0 obj << /Next 1272 0 R /Parent 888 0 R /Title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rev 1217 0 R >> endobj 1248 0 obj << /D [404 0 R /XYZ 70 582 0] /S /GoTo >> endobj 1249 0 obj << /D [428 0 R /XYZ 70 720 0] /S /GoTo >> endobj 1250 0 obj << /Next 1220 0 R /Parent 1061 0 R /Title (168. The harm caused by INVOKANA/INVOKAMET far outweighed its alleged benefit, rendering INVOKANA/INVOKAMET more dangerous than an ordinary consumer or health care professional would expect and more dangerous than alternative products.) /A 1274 0 R /Prev 1275 0 R >> endobj 1251 0 obj << /Next 1276 0 R /Parent 1061 0 R /Title (157. INVOKANA/INVOKAMET was neither safe for its intended use nor of merchantable quality, as impliedly warranted by Defendants, in that INVOKANA/INVOKAMET has dangerous propensities when used as intended and can cause serious injuries, including diab...) /A 1277 0 R /Prev 1221 0 R >> endobj 1252 0 obj << /D [426 0 R /XYZ 70 582 0] /S /GoTo >> endobj 1253 0 obj << /D [429 0 R /XYZ 70 416 0] /S /GoTo >> endobj 1254 0 obj << /D [433 0 R /XYZ 70 665 0] /S /GoTo >> endobj 1255 0 obj << /Next 1227 0 R /Parent 940 0 R /Title (195. Defendants failed to exercise that reasonable care and have therefore breached their duty to Plaintiff.) /A 1278 0 R /Prev 1279 0 R >> endobj 1256 0 obj << /Next 1280 0 R /Parent 940 0 R /Title (192. Plaintiff incorporates by reference each preceding and succeeding paragraph as though set forth fully at length herein.) /A 1281 0 R /Prev 1228 0 R >> endobj 1257 0 obj << /D [432 0 R /XYZ 70 527 0] /S /GoTo >> endobj 1258 0 obj << /D [425 0 R /XYZ 70 527 0] /S /GoTo >> endobj 1259 0 obj << /Next 1233 0 R /Parent 1074 0 R /Title <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> /A 1282 0 R /Prev 1283 0 R >> endobj 1260 0 obj << /Next 1284 0 R /Parent 1074 0 R /Title (142. Defendants had a duty to disclose to physicians, healthcare providers, and patients the causal relationship or association of INVOKANA/INVOKAMET to diabetic ketoacidosis, kidney failure, sepsis, and the life threatening complications of those con...) /A 1285 0 R /Prev 1234 0 R >> endobj 1261 0 obj << /D [424 0 R /XYZ 70 720 0] /S /GoTo >> endobj 1262 0 obj << /D [422 0 R /XYZ 70 582 0] /S /GoTo >> endobj 1263 0 obj << /D [422 0 R /XYZ 70 665 0] /S /GoTo >> endobj 1264 0 obj << /D [418 0 R /XYZ 70 472 0] /S /GoTo >> endobj 1265 0 obj << /Next 1241 0 R /Parent 885 0 R /Title (105. INVOKANA/INVOKAMET was defective and unreasonably dangerous when it left the possession of Defendants in that it contained warnings that were insufficient to alert consumers, including Plaintiff, of the dangerous risks and reactions associated wi...) /A 1286 0 R /Prev 1287 0 R >> endobj 1266 0 obj << /Next 1288 0 R /Parent 885 0 R /Title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rev 1242 0 R >> endobj 1267 0 obj << /D [416 0 R /XYZ 70 527 0] /S /GoTo >> endobj 1268 0 obj << /Parent 1242 0 R /Title (f. INVOKANA/INVOKAMET was not accompanied by adequate instructions and/or warnings to fully apprise consumers, including Plaintiff, of the full nature and extent of the risks and side effects associated with its use, thereby rendering Defendants liabl...) /A 1290 0 R /Prev 1291 0 R >> endobj 1269 0 obj << /Next 1292 0 R /Parent 1242 0 R /Title (a. When placed in the stream of commerce, INVOKANA/INVOKAMET contained unreasonably dangerous design defects and was not reasonably safe as intended to be used, subjecting Plaintiff to risks that exceeded the benefits of the subject product, including...) /A 1293 0 R >> endobj 1270 0 obj << /D [409 0 R /XYZ 70 334 0] /S /GoTo >> endobj 1271 0 obj << /Next 1246 0 R /Parent 888 0 R /Title (62. Diabetic ketoacidosis may lead to complications such as cerebral edema, pulmonary edema, cerebrovascular accident, myocardial infarction, nonspecific myocardial injury, severe dehydration, and coma.) /A 1294 0 R /Prev 1295 0 R >> endobj 1272 0 obj << /Next 1296 0 R /Parent 888 0 R /Title <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> /A 1297 0 R /Prev 1247 0 R >> endobj 1273 0 obj << /D [404 0 R /XYZ 70 499 0] /S /GoTo >> endobj 1274 0 obj << /D [427 0 R /XYZ 70 196 0] /S /GoTo >> endobj 1275 0 obj << /Next 1250 0 R /Parent 1061 0 R /Title <3136372E20446566656E64616E7473206272656163686564207468652077617272616E74696573206F66206D65726368616E746162696C69747920616E64206669746E65737320666F722069747320706172746963756C617220707572706F7365206265636175736520494E564F4B414E412F494E564F4B414D45542077617320756E64756C792064616E6765726F757320616E642063617573656420756E64756520696E6A75726965732C20696E636C7564696E6720506C61696E74696666907320696E6A75726965732E> /A 1298 0 R /Prev 1299 0 R >> endobj 1276 0 obj << /Next 1300 0 R /Parent 1061 0 R /Title (158. At all relevant times, Defendants intended that INVOKANA/INVOKAMET be used in the manner used by Plaintiff, and Defendants impliedly warranted it to be of merchantable quality, safe, and fit for such use, despite the fact that INVOKANA/INVOKAMET ...) /A 1301 0 R /Prev 1251 0 R >> endobj 1277 0 obj << /D [426 0 R /XYZ 70 499 0] /S /GoTo >> endobj 1278 0 obj << /D [433 0 R /XYZ 70 720 0] /S /GoTo >> endobj 1279 0 obj << /Next 1255 0 R /Parent 940 0 R /Title (194. Defendants owed a duty to Plaintiff to exercise reasonable care and ensure they did not misrepresent the safety or efficacy of INVOKANA/INVOKAMET.) /A 1302 0 R /Prev 1280 0 R >> endobj 1280 0 obj << /Next 1279 0 R /Parent 940 0 R /Title (193. Defendants made misrepresentations to Plaintiff's physicians, Plaintiff, and the general public from the time INVOKANA/INVOKAMET was first tested until now. The misrepresentation includes but is not limited to the misrepresentation that INVOKANA...) /A 1303 0 R /Prev 1256 0 R >> endobj 1281 0 obj << /D [432 0 R /XYZ 70 320 0] /S /GoTo >> endobj 1282 0 obj << /D [425 0 R /XYZ 70 637 0] /S /GoTo >> endobj 1283 0 obj << /Next 1259 0 R /Parent 1074 0 R /Title (147. At all times herein mentioned, Defendants breached their duty of care by failing to exercise reasonable and ordinary care and negligently and carelessly manufacturing, designing, formulating, distributing, compounding, producing, processing, asse...) /A 1304 0 R /Prev 1305 0 R >> endobj 1284 0 obj << /Next 1306 0 R /Parent 1074 0 R /Title (143. Defendants had a duty to accurately communicate the risks and benefits of INVOKANA/INVOKAMET to physicians, healthcare providers, and patients.) /A 1307 0 R /Prev 1260 0 R >> endobj 1285 0 obj << /D [424 0 R /XYZ 70 665 0] /S /GoTo >> endobj 1286 0 obj << /D [418 0 R /XYZ 70 720 0] /S /GoTo >> endobj 1287 0 obj << /Next 1265 0 R /Parent 885 0 R /Title (104. Plaintiff restates the allegations set forth above as if fully rewritten herein.) /A 1308 0 R /Prev 1288 0 R >> endobj 1288 0 obj << /Next 1287 0 R /Parent 885 0 R /Title (103. As a result of INVOKANA/INVOKAMET's defective condition, Plaintiff suffered the injuries and damages alleged herein.) /A 1309 0 R /Prev 1266 0 R >> endobj 1289 0 obj << /D [417 0 R /XYZ 70 416 0] /S /GoTo >> endobj 1290 0 obj << /D [417 0 R /XYZ 70 527 0] /S /GoTo >> endobj 1291 0 obj << /Next 1268 0 R /Parent 1242 0 R /Title (e. INVOKANA/INVOKAMET caused harmful side effects that outweighed any potential utility; and) /A 1310 0 R /Prev 1311 0 R >> endobj 1292 0 obj << /Next 1312 0 R /Parent 1242 0 R /Title (b. When placed in the stream of commerce, INVOKANA/INVOKAMET was defective in design and formulation, making the use of INVOKANA/INVOKAMET more dangerous than an ordinary consumer would expect, and more dangerous than other risks associated with the o...) /A 1313 0 R /Prev 1269 0 R >> endobj 1293 0 obj << /D [416 0 R /XYZ 70 389 0] /S /GoTo >> endobj 1294 0 obj << /D [409 0 R /XYZ 70 416 0] /S /GoTo >> endobj 1295 0 obj << /Next 1271 0 R /Parent 888 0 R /Title (61. Specifically, Defendants knew or should have known of the risks of diabetic ketoacidosis and kidney failure based on the data available to them or that could have been generated by them, including, but not limited to animal studies, mechanisms of ...) /A 1314 0 R /Prev 1315 0 R /Count 11 /Last 1316 0 R /First 1317 0 R >> endobj 1296 0 obj << /Next 1318 0 R /Parent 888 0 R /Title (37. Through these advertisements, press releases, publications, and web sites, J&J has purposefully directed activities nationally including towards residents of Tennessee and New Jersey.) /A 1319 0 R /Prev 1272 0 R >> endobj 1297 0 obj << /D [404 0 R /XYZ 70 389 0] /S /GoTo >> endobj 1298 0 obj << /D [427 0 R /XYZ 70 278 0] /S /GoTo >> endobj 1299 0 obj << /Next 1275 0 R /Parent 1061 0 R /Title (166. INVOKANA/INVOKAMET was expected to reach and did in fact reach consumers, including Plaintiff, without substantial change in the condition in which it was manufactured and sold by Defendants.) /A 1320 0 R /Prev 1321 0 R >> endobj 1300 0 obj << /Next 1322 0 R /Parent 1061 0 R /Title (159. Defendants were aware that consumers, including Plaintiff, would use INVOKANA/INVOKAMET as marketed by Defendants. As such, Plaintiff was a foreseeable user of INVOKANA/INVOKAMET.) /A 1323 0 R /Prev 1276 0 R >> endobj 1301 0 obj << /D [426 0 R /XYZ 70 361 0] /S /GoTo >> endobj 1302 0 obj << /D [432 0 R /XYZ 70 154 0] /S /GoTo >> endobj 1303 0 obj << /D [432 0 R /XYZ 70 265 0] /S /GoTo >> endobj 1304 0 obj << /D [424 0 R /XYZ 70 168 0] /S /GoTo >> endobj 1305 0 obj << /Next 1283 0 R /Parent 1074 0 R /Title (146. Plaintiff, Bonnie Hamm, did not know the nature and extent of the injuries that could result from INVOKANA/INVOKAMET and were misinformed about the benefits of INVOKANA/INVOKAMET and could not have discovered this information independently.) /A 1324 0 R /Prev 1325 0 R >> endobj 1306 0 obj << /Next 1325 0 R /Parent 1074 0 R /Title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rev 1284 0 R >> endobj 1307 0 obj << /D [424 0 R /XYZ 70 527 0] /S /GoTo >> endobj 1308 0 obj << /D [417 0 R /XYZ 70 140 0] /S /GoTo >> endobj 1309 0 obj << /D [417 0 R /XYZ 70 251 0] /S /GoTo >> endobj 1310 0 obj << /D [417 0 R /XYZ 70 582 0] /S /GoTo >> endobj 1311 0 obj << /Next 1291 0 R /Parent 1242 0 R /Title (d. INVOKANA/INVOKAMET was insufficiently and inadequately tested;) /A 1327 0 R /Prev 1312 0 R >> endobj 1312 0 obj << /Next 1311 0 R /Parent 1242 0 R /Title (c. The design defects of INVOKANA/INVOKAMET existed before it left the control of Defendants;) /A 1328 0 R /Prev 1292 0 R >> endobj 1313 0 obj << /D [416 0 R /XYZ 70 196 0] /S /GoTo >> endobj 1314 0 obj << /D [408 0 R /XYZ 70 610 0] /S /GoTo >> endobj 1315 0 obj << /Next 1295 0 R /Parent 888 0 R /Title (60. Defendants, both individually and in concert with one another, misrepresented that INVOKANA/INVOKAMET is a safe and effective treatment for type 2 diabetes mellitus when in fact the drug causes serious medical problems which require hospitalizatio...) /A 1329 0 R /Prev 1330 0 R >> endobj 1316 0 obj << /Parent 1295 0 R /Title (k. Clinical studies and adverse event reports demonstrating an increased rate of reports of patients developing gangrene, diabetic foot ulcers, lower limb ischemia and running the risk of and/or actually requiring an amputation.) /A 1331 0 R /Prev 1332 0 R >> endobj 1317 0 obj << /Next 1333 0 R /Parent 1295 0 R /Title (a. Canagliflozin selectivity for the SGLT1 receptor;) /A 1334 0 R >> endobj 1318 0 obj << /Next 1335 0 R /Parent 888 0 R /Title <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> /A 1336 0 R /Prev 1296 0 R >> endobj 1319 0 obj << /D [404 0 R /XYZ 70 168 0] /S /GoTo >> endobj 1320 0 obj << /D [427 0 R /XYZ 70 361 0] /S /GoTo >> endobj 1321 0 obj << /Next 1299 0 R /Parent 1061 0 R /Title <3136352E20506C61696E74696666907320757365206F6620494E564F4B414E412F494E564F4B414D455420776173206173207072657363726962656420616E6420696E206120666F726573656561626C65206D616E6E657220617320696E74656E6465642C207265636F6D6D656E6465642C2070726F6D6F7465642C20616E64206D61726B6574656420627920446566656E64616E74732E> /A 1337 0 R /Prev 1338 0 R >> endobj 1322 0 obj << /Next 1339 0 R /Parent 1061 0 R /Title <3136302E2055706F6E20696E666F726D6174696F6E20616E642062656C6965662C20506C61696E7469666620616E642F6F7220506C61696E746966669073206865616C746820636172652070726F66657373696F6E616C73207765726520617420616C6C2072656C6576616E742074696D657320696E2070726976697479207769746820446566656E64616E74732E> /A 1340 0 R /Prev 1300 0 R >> endobj 1323 0 obj << /D [426 0 R /XYZ 70 251 0] /S /GoTo >> endobj 1324 0 obj << /D [424 0 R /XYZ 70 251 0] /S /GoTo >> endobj 1325 0 obj << /Next 1305 0 R /Parent 1074 0 R /Title (145. Defendants knew or should have known that some patients would develop serious injuries that were not adequately warned about, including diabetic ketoacidosis, kidney failure and sepsis, diabetic foot ulcers, gangrene, lower limb ischemia and ampu...) /A 1341 0 R /Prev 1306 0 R >> endobj 1326 0 obj << /D [424 0 R /XYZ 70 472 0] /S /GoTo >> endobj 1327 0 obj << /D [417 0 R /XYZ 70 610 0] /S /GoTo >> endobj 1328 0 obj << /D [417 0 R /XYZ 70 665 0] /S /GoTo >> endobj 1329 0 obj << /D [407 0 R /XYZ 70 140 0] /S /GoTo >> endobj 1330 0 obj << /Next 1315 0 R /Parent 888 0 R /Title (59. At all times herein mentioned, the officers and directors of Defendants participated in, authorized, and directed the production and promotion of the aforementioned product when they knew, or with the exercise of reasonable care should have known,...) /A 1342 0 R /Prev 1343 0 R >> endobj 1331 0 obj << /D [409 0 R /XYZ 70 499 0] /S /GoTo >> endobj 1332 0 obj << /Next 1316 0 R /Parent 1295 0 R /Title (j. Adverse event report analysis demonstrating an increased rate of reports for ketoacidosis in people taking canagliflozin compared to other glucose-lowering medications.) /A 1344 0 R /Prev 1345 0 R >> endobj 1333 0 obj << /Next 1346 0 R /Parent 1295 0 R /Title (b. Animal studies demonstrating increased ketones when given canagliflozin;) /A 1347 0 R /Prev 1317 0 R >> endobj 1334 0 obj << /D [408 0 R /XYZ 70 416 0] /S /GoTo >> endobj 1335 0 obj << /Next 1348 0 R /Parent 888 0 R /Title (39. Defendant J&J also published information touting the strong sales of INVOKANA/INVOKAMET in its corporate reports and in earnings calls.) /A 1349 0 R /Prev 1318 0 R >> endobj 1336 0 obj << /D [405 0 R /XYZ 70 720 0] /S /GoTo >> endobj 1337 0 obj << /D [427 0 R /XYZ 70 416 0] /S /GoTo >> endobj 1338 0 obj << /Next 1321 0 R /Parent 1061 0 R /Title <3136342E20506C61696E7469666620616E6420506C61696E7469666690732070687973696369616E7320726561736F6E61626C792072656C6965642075706F6E20446566656E64616E74739020696D706C6965642077617272616E747920666F7220494E564F4B414E412F494E564F4B414D4554207768656E207072657363726962696E6720616E6420696E67657374696E6720494E564F4B414E412F494E564F4B414D45542E> /A 1350 0 R /Prev 1351 0 R >> endobj 1339 0 obj << /Next 1352 0 R /Parent 1061 0 R /Title <3136312E20494E564F4B414E412F494E564F4B414D4554207761732064616E6765726F757320616E6420646566656374697665207768656E20446566656E64616E747320706C6163656420697420696E746F207468652073747265616D206F6620636F6D6D657263652062656361757365206F66206974732070726F70656E7369747920746F20636175736520506C61696E74696666907320696E6A75726965732E> /A 1353 0 R /Prev 1322 0 R >> endobj 1340 0 obj << /D [426 0 R /XYZ 70 168 0] /S /GoTo >> endobj 1341 0 obj << /D [424 0 R /XYZ 70 361 0] /S /GoTo >> endobj 1342 0 obj << /D [407 0 R /XYZ 70 278 0] /S /GoTo >> endobj 1343 0 obj << /Next 1330 0 R /Parent 888 0 R /Title (58. In May of 2017 the FDA confirmed that INVOKANA and INVOKAMET increase the risk of leg and foot amputations and required a black box warning, as well as announcing further investigation into this safety issue.) /A 1354 0 R /Prev 1355 0 R >> endobj 1344 0 obj << /D [409 0 R /XYZ 70 582 0] /S /GoTo >> endobj 1345 0 obj << /Next 1332 0 R /Parent 1295 0 R /Title (i. Clinical studies, adverse event reports and case reports demonstrating re-challenge responses in increasing Ketones and diabetic ketoacidosis in people taking cangliflozin;) /A 1356 0 R /Prev 1357 0 R >> endobj 1346 0 obj << /Next 1358 0 R /Parent 1295 0 R /Title (c. Studies of SGLT1 inhibitor phlorizin, and its propensity to cause ketoacidosis;) /A 1359 0 R /Prev 1333 0 R >> endobj 1347 0 obj << /D [408 0 R /XYZ 70 389 0] /S /GoTo >> endobj 1348 0 obj << /Next 1360 0 R /Parent 888 0 R /Title (40. Further, J&J employees had responsibility for overseeing promotion strategies for the drug INVOKANA/INVOKAMET.) /A 1361 0 R /Prev 1335 0 R >> endobj 1349 0 obj << /D [405 0 R /XYZ 70 637 0] /S /GoTo >> endobj 1350 0 obj << /D [427 0 R /XYZ 70 499 0] /S /GoTo >> endobj 1351 0 obj << /Next 1338 0 R /Parent 1061 0 R /Title (163. Defendants breached their implied warranty to consumers, including Plaintiff. INVOKANA/INVOKAMET was not of merchantable quality, nor was it safe and fit for its intended use.) /A 1362 0 R /Prev 1352 0 R >> endobj 1352 0 obj << /Next 1351 0 R /Parent 1061 0 R /Title (162. Plaintiff and the medical community reasonably relied upon the judgment and sensibility of Defendants to sell INVOKANA/INVOKAMET only if it was indeed of merchantable quality and safe and fit for its intended use.) /A 1363 0 R /Prev 1339 0 R >> endobj 1353 0 obj << /D [427 0 R /XYZ 70 720 0] /S /GoTo >> endobj 1354 0 obj << /D [407 0 R /XYZ 70 361 0] /S /GoTo >> endobj 1355 0 obj << /Next 1343 0 R /Parent 888 0 R /Title (57. In June 2016, the FDA announced that SGLT2 inhibitors cause severe renal impairment, angioedema, and anaphylaxis.) /A 1364 0 R /Prev 1365 0 R >> endobj 1356 0 obj << /D [409 0 R /XYZ 70 665 0] /S /GoTo >> endobj 1357 0 obj << /Next 1345 0 R /Parent 1295 0 R /Title (h. Clinical studies, adverse event reports, and case reports demonstrating vomiting in people taking canagliflozin;) /A 1366 0 R /Prev 1367 0 R >> endobj 1358 0 obj << /Next 1368 0 R /Parent 1295 0 R /Title (d. Reports involving people with familial glycosuria, an indication of a propensity to develop ketoacidosis;) /A 1369 0 R /Prev 1346 0 R >> endobj 1359 0 obj << /D [408 0 R /XYZ 70 361 0] /S /GoTo >> endobj 1360 0 obj << /Next 1370 0 R /Parent 888 0 R /Title (41. Materials including advertisements, press releases, web site publications, and other communications regarding INVOKANA/INVOKAMET are part of the labeling of the drug, and could be altered without prior FDA approval.) /A 1371 0 R /Prev 1348 0 R >> endobj 1361 0 obj << /D [405 0 R /XYZ 70 582 0] /S /GoTo >> endobj 1362 0 obj << /D [427 0 R /XYZ 70 582 0] /S /GoTo >> endobj 1363 0 obj << /D [427 0 R /XYZ 70 665 0] /S /GoTo >> endobj 1364 0 obj << /D [407 0 R /XYZ 70 416 0] /S /GoTo >> endobj 1365 0 obj << /Next 1355 0 R /Parent 888 0 R /Title (56. In May 2016, the FDA announced that SGLT2 inhibitors have been linked to an increased risk of amputations.) /A 1372 0 R /Prev 1373 0 R >> endobj 1366 0 obj << /D [409 0 R /XYZ 70 720 0] /S /GoTo >> endobj 1367 0 obj << /Next 1357 0 R /Parent 1295 0 R /Title (g. Clinical studies, adverse event reports, and case reports demonstrating dehydration and volume depletion in people taking canagliflozin;) /A 1374 0 R /Prev 1375 0 R >> endobj 1368 0 obj << /Next 1375 0 R /Parent 1295 0 R /Title (e. Clinical studies demonstrating increases in glucagon in people taking canagliflozin;) /A 1376 0 R /Prev 1358 0 R >> endobj 1369 0 obj << /D [408 0 R /XYZ 70 306 0] /S /GoTo >> endobj 1370 0 obj << /Next 1377 0 R /Parent 888 0 R /Title (42. Defendant J&J had the ability and the duty to improve the labeling of INVOKANA/INVOKAMET to warn of the propensity of the drug to cause diabetic ketoacidosis, renal injury, renal failure, severe infections such as urosepsis as well as gangrene lea...) /A 1378 0 R /Prev 1360 0 R >> endobj 1371 0 obj << /D [405 0 R /XYZ 70 527 0] /S /GoTo >> endobj 1372 0 obj << /D [407 0 R /XYZ 70 472 0] /S /GoTo >> endobj 1373 0 obj << /Next 1365 0 R /Parent 888 0 R /Title (55. In December 2015, the FDA announced that SGLT2 inhibitors cause diabetic ketoacidosis, pyelonephritis \(kidney infections\), and urosepsis.) /A 1379 0 R /Prev 1380 0 R >> endobj 1374 0 obj << /D [408 0 R /XYZ 70 140 0] /S /GoTo >> endobj 1375 0 obj << /Next 1367 0 R /Parent 1295 0 R /Title (f. Clinical studies, adverse event reports, and case reports demonstrating increased ketones in people taking canagliflozin;) /A 1381 0 R /Prev 1368 0 R >> endobj 1376 0 obj << /D [408 0 R /XYZ 70 251 0] /S /GoTo >> endobj 1377 0 obj << /Next 1382 0 R /Parent 888 0 R /Title (43. Defendant J&J so substantially dominates and controls the operations of Janssen and Janssen R&D that it could have required them to make changes to the safety label of the drug INVOKANA/INVOKAMET.) /A 1383 0 R /Prev 1370 0 R >> endobj 1378 0 obj << /D [405 0 R /XYZ 70 444 0] /S /GoTo >> endobj 1379 0 obj << /D [407 0 R /XYZ 70 527 0] /S /GoTo >> endobj 1380 0 obj << /Next 1373 0 R /Parent 888 0 R /Title (54. In September 2015, the FDA announced that SGLT2 inhibitors cause premature bone loss and fractures.) /A 1384 0 R /Prev 1385 0 R >> endobj 1381 0 obj << /D [408 0 R /XYZ 70 196 0] /S /GoTo >> endobj 1382 0 obj << /Next 1386 0 R /Parent 888 0 R /Title (44. J&J employees hold key roles in the design, development, regulatory approval, manufacturing, distribution, and marketing of INVOKANA/INVOKAMET and direct these activities on behalf of J&J, Janssen, and Janssen R&D.) /A 1387 0 R /Prev 1377 0 R >> endobj 1383 0 obj << /D [405 0 R /XYZ 70 334 0] /S /GoTo >> endobj 1384 0 obj << /D [407 0 R /XYZ 70 582 0] /S /GoTo >> endobj 1385 0 obj << /Next 1380 0 R /Parent 888 0 R /Title <35332E20494E564F4B414E412F494E564F4B414D4554206973206F6E65206F6620446566656E64616E74739020746F702073656C6C696E672064727567732C207769746820616E6E75616C2073616C657320657863656564696E672024312062696C6C696F6E2E> /A 1388 0 R /Prev 1389 0 R >> endobj 1386 0 obj << /Next 1390 0 R /Parent 888 0 R /Title (45. In fact, J&J so substantially dominates and controls the operations of Janssen and Janssen R&D, that the entities are indistinct for purposes of this litigation such that Janssen and Janssen R&D should be considered agents or departments of J&J, a...) /A 1391 0 R /Prev 1382 0 R >> endobj 1387 0 obj << /D [405 0 R /XYZ 70 251 0] /S /GoTo >> endobj 1388 0 obj << /D [407 0 R /XYZ 70 637 0] /S /GoTo >> endobj 1389 0 obj << /Next 1385 0 R /Parent 888 0 R /Title <35322E20446566656E64616E747390206D61726B6574696E672063616D706169676E2077696C6C66756C6C7920616E6420696E74656E74696F6E616C6C79206D6973726570726573656E74656420746865207269736B73206F6620494E564F4B414E412F494E564F4B414D455420616E64206661696C656420746F207761726E2061626F757420746865207269736B73206F66206469616265746963206B65746F616369646F7369732C206B69646E6579206661696C7572652C207365707369732C20616D7075746174696F6E20616E64206F7468657220696E6A75726965732E> /A 1392 0 R /Prev 1393 0 R >> endobj 1390 0 obj << /Next 1394 0 R /Parent 888 0 R /Title (46. Defendant Janssen, a wholly owned subsidiary of J&J, acquired the marketing right to INVOKANA/INVOKAMET in North America, and marketed, advertised, distributed, and sold INVOKANA/INVOKAMET in Tennessee and New Jersey and the remainder of the Unite...) /A 1395 0 R /Prev 1386 0 R >> endobj 1391 0 obj << /D [405 0 R /XYZ 70 168 0] /S /GoTo >> endobj 1392 0 obj << /D [407 0 R /XYZ 70 720 0] /S /GoTo >> endobj 1393 0 obj << /Next 1389 0 R /Parent 888 0 R /Title (51. Defendants also, through their marketing materials, misrepresented and exaggerated the effectiveness of INVOKANA/INVOKAMET, both as to its ability to lower glucose, and its benefit for non-surrogate measures of health, such as reducing adverse car...) /A 1396 0 R /Prev 1397 0 R >> endobj 1394 0 obj << /Next 1398 0 R /Parent 888 0 R /Title (47. In February, 2014, Janssen R&D submitted an NDA to the FDA for approval to market INVOKANA in the United States.) /A 1399 0 R /Prev 1390 0 R >> endobj 1395 0 obj << /D [406 0 R /XYZ 70 720 0] /S /GoTo >> endobj 1396 0 obj << /D [406 0 R /XYZ 70 196 0] /S /GoTo >> endobj 1397 0 obj << /Next 1393 0 R /Parent 888 0 R /Title (50. In an effort to increase sales and market share, Defendants have aggressively marketed and continue to aggressively market INVOKANA/INVOKAMET to doctors and directly to patients for off-label purposes, including, but not limited to weight loss, re...) /A 1400 0 R /Prev 1401 0 R >> endobj 1398 0 obj << /Next 1401 0 R /Parent 888 0 R /Title (48. In August 2014, the FDA approved INVOKANA as an adjunct to diet and exercise for the improvement of glycemic control in adults with type 2 diabetes.) /A 1402 0 R /Prev 1394 0 R >> endobj 1399 0 obj << /D [406 0 R /XYZ 70 610 0] /S /GoTo >> endobj 1400 0 obj << /D [406 0 R /XYZ 70 306 0] /S /GoTo >> endobj 1401 0 obj << /Next 1397 0 R /Parent 888 0 R /Title (49. As part of its marketing approval of canagliflozin, the FDA required the defendants to conduct five post-marketing studies: a cardiovascular outcomes trial; an enhanced pharmacovigilance program to monitor for malignancies, serious cases of pancre...) /A 1403 0 R /Prev 1398 0 R >> endobj 1402 0 obj << /D [406 0 R /XYZ 70 554 0] /S /GoTo >> endobj 1403 0 obj << /D [406 0 R /XYZ 70 499 0] /S /GoTo >> endobj xref 0 1404 0000000000 65535 f 0000000015 00000 n 0000000531 00000 n 0000000565 00000 n 0000000673 00000 n 0000000748 00000 n 0000005241 00000 n 0000000157 00000 n 0000005363 00000 n 0000005602 00000 n 0000008320 00000 n 0000011664 00000 n 0000011776 00000 n 0000011944 00000 n 0000011965 00000 n 0000012071 00000 n 0000012177 00000 n 0000012283 00000 n 0000012389 00000 n 0000012495 00000 n 0000012601 00000 n 0000012707 00000 n 0000012829 00000 n 0000012884 00000 n 0000012957 00000 n 0000013012 00000 n 0000013067 00000 n 0000013122 00000 n 0000013177 00000 n 0000013233 00000 n 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