stipulated order effectuating agreement regarding … · 2020. 7. 14. · united states district...
TRANSCRIPT
UNITED STATES DISTRICT COURT DISTRICT OF NEW JERSEY
IN RE: VALSARTAN, LOSARTAN, AND IRBESARTAN PRODUCTS LIABILITY LITIGATION Civil No. 19-2875 (RBK/JS)
This Document Relates to:
All Actions
STIPULATED ORDER EFFECTUATING AGREEMENT
REGARDING ESI SEARCH TERMS PERTAINING TO THE MYLAN DEFENDANTS
THIS MATTER HAVING COME before the Court on Defendants’ Motion to Modify
the ESI Search Terms (Dkt. 445); and
THIS COURT HAVING CONSIDERED the parties’ submissions in support of and in
opposition to said Motion, as well as the argument and representations of counsel made during the
telephonic status conference on June 17, 2020,
IT IS HEREBY ORDERED, this the _____ day of June 2020, as follows:
1) Based on affirmations from counsel that an agreement has been reached to resolve
the parties’ current dispute concerning ESI search terms, the Defendants’ Motion to Modify the
ESI Search Terms is DENIED AS MOOT only with respect to Mylan Pharmaceuticals Inc. and
Mylan Laboratories Ltd. (collectively, “Mylan”).
2) For purposes of effectuating and memorializing the agreement reached between
Plaintiffs and Mylan, the Court STATES FURTHER:
a. Mylan will run the revised set of ESI search terms attached hereto as
Exhibit A with respect to Mylan’s nineteen (19) finished-dose custodians;
Case 1:19-md-02875-RBK-JS Document 485 Filed 06/23/20 Page 1 of 2 PageID: 7725
b. Mylan will run the revised set of ESI search terms attached hereto as
Exhibit B with respect to all remaining custodians identified in Exhibit D of the
Court’s December 23, 2020 Order (Dkt. 328); and
c. The parties will confer in accordance with the ESI Protocol (Dkt. 125), as
well as their representations and the Court’s instructions made during the June 17,
2020 status conference, to resolve issues, if any, that might arise during the
processing, review, and production of Mylan’s ESI.
SO ORDERED.
JOEL SCHNEIDER United States Magistrate Judge
Case 1:19-md-02875-RBK-JS Document 485 Filed 06/23/20 Page 2 of 2 PageID: 7726
EXHIBIT A
Case 1:19-md-02875-RBK-JS Document 485-1 Filed 06/23/20 Page 1 of 20 PageID: 7727
Standalone Page 1
*ghost*
*NDEA*
*NDMA*
nitra* AND (<DRUG NAME> OR <Manufacturing
Modifiers>)
*nitrite*
*nitrosa*
*nitroso*
*NMBA*
*trosomine*
C2H6N2O or "(CH3)2NN=O" or "CH32NN=O" or
"(CH3)2NC(O)H" or CH32NCOH or C3H7NO or
"(CH3CH2)2NH" or CH3CH22NH or C4H11N or
"(CH3)2NH" or CH32NH or C2H7N or "(C2H5)2NNO" or
C2H52NNO or C4H10N2O
deviat* /5 cancer* or deviat* /5 toxic or or deviat* /5
hazard* or deviat* /5 fatal
gene* /3 mutat*
solvent /5 cancer* or solvent /5 toxic or or solvent /5
hazard* or solvent /5 fatal
solvent* /5 contamin*
(test* /5 canc*) AND <Drug Name>
tetrazol*
Valisure*
Case 1:19-md-02875-RBK-JS Document 485-1 Filed 06/23/20 Page 2 of 20 PageID: 7728
Standalone Page 2
<term> (no modifiers)^
^Except as indicated
Case 1:19-md-02875-RBK-JS Document 485-1 Filed 06/23/20 Page 3 of 20 PageID: 7729
Authors or Inspectors Page 3
Last Name First Name Facility
Agrawal Atul Nashik
Ford Susanna Nashik
Pitts Simone Nashik
Arroyo Rafael Nashik
Mueller Eric Nashik
Motemed Massoud Nashik
Melendez Jose Nashik
Shah Dipesh Nashik
Hicks Kellia Nashik
Warnick William Aurangabad
Verdel Helen Aurangabad
Cruz Concepcion Aurangabad
Dong Eric Aurangabad
Nguyen, Truong Aurangabad
Podaralla, Satheesh Aurangabad
Bretz Paula Morgantown
Warnick William Morgantown
Bizjak Ernest Morgantown
Ghoshal Rabin Morgantown
Chapman Jonathan Morgantown
Higgins Brooke Morgantown
Oladimeji, Toyin Morgantown
Xu Qin Morgantown
Agrawal Atul Morgantown
Motemed Massoud Morgantown
Upadhyay Pratik Morgantown
Wakijira Chaltu Morgantown
Rebecca Dombrowski Morgantown
Espinal Nancy Morgantown
Patel Sneha Morgantown
Patkar Kshitij Morgantown
Ileana Barreto‐Pettit Morgantown
Mason James Morgantown
Min Ko Morgantown
Ray Marcus Morgantown
Roy Melissa Morgantown
Steig Alison Morgantown
Arasu Tamil Morgantown
Arista Thomas Morgantown
Marcsisin Sean Morgantown
Mistler John Morgantown
Ulysse Guerlain Morgantown
Staub‐Zamperini Katelyn Morgantown
Case 1:19-md-02875-RBK-JS Document 485-1 Filed 06/23/20 Page 4 of 20 PageID: 7730
Authors or Inspectors Page 4
Inspection Date
5.27.11
8.30.12
8.30.12
3.25.15
3.25.15
9.14.16
4.12.18
1.18.19
1.18.19; 2.3.20
3.9.12
5.16.14
5.26.17
5.26.17
4.26.19
4.26.19
2.19.10; 7.28.11; 2.2.12; 3.21.14
12.9.10; 2.2.12
2.2.12
2.2.12
3.21.14; 4.24.15
3.21.14
4.24.15
4.24.15
11.18.16; 4.12.18
11.18.16
11.18.16
11.18.16
8.25.17; 4.12.18
8.25.17
8.25.17
8.25.17
4.12.18
4.12.18
4.12.18
4.12.18
4.12.18
4.12.18
7.25.19
7.25.19
7.25.19
7.25.19
7.25.19
8.15.19
Case 1:19-md-02875-RBK-JS Document 485-1 Filed 06/23/20 Page 5 of 20 PageID: 7731
Regulatory Page 5
"changes being effected"
"prior approval supplement"
adulterat*
alert* /5 safe*
CAPA or corrective pre/3 "preventive action"
Citizen* pre/3 Petition
(Establishment pre/3 Inspection)
import* /3 (ban or alert or restrict*)
Inspect* /500 <DRUG NAME>
Investig* /500 <DRUG NAME>
(official pre/3 action* /4 indicat* )
(observation or observations) /500 <DRUG
NAME> or <FACILITY NAME> (excluding
(OOS or "out of spec*" or "out‐of‐spec*") /500
<DRUG NAME> or <FACILITY NAME> (excluding
"Morgantown")
(OOT or "out‐of‐trend" or "out of trend") /500
<DRUG NAME>
PADER*
VAI or (voluntary pre/3 action* /4 indicat*)
violat* /500 <drug name> or <facility name>
warn* /500 <drug name > or <facility name>
OAI or "official action indicated"
"voluntary action indicated"
(Form483) or (Form /3 483) or (483 /3 letter) or
(483 /3 warn*) or (704 pre/3 b)
EIR or "establishment inspection report"
Case 1:19-md-02875-RBK-JS Document 485-1 Filed 06/23/20 Page 6 of 20 PageID: 7732
Regulatory Page 6
Except where indicated in red, <Term> AND (<Drug Name> OR <facility name>
Case 1:19-md-02875-RBK-JS Document 485-1 Filed 06/23/20 Page 7 of 20 PageID: 7733
cGMP Page 7
((bottle pre/2 lies) or Eban) /200 ("inspect*" OR "FDA" OR "Food /300 Drug
Administration" OR FDA OR USFDA OR "US‐FDA" OR "Agency" OR "recall" OR <medical
conditions> OR <drug name> OR test OR chromatog* OR peak)
(bury OR burie* OR conceal*) /200 ("inspect*" OR "FDA" OR "Food /300 Drug
Administration" OR FDA OR USFDA OR "US‐FDA" OR "recall" OR <drug name> OR test
OR chromatog* OR peak OR EMPOWER)
(cGMP* or (current pre/5 manufacturing) or GMP*) /200 <DRUG NAME>
("cover up*" or coverup* or "cover‐up*") /200 ("inspect*" OR "FDA" OR "Food /300
Drug Administration" OR FDA OR USFDA OR "US‐FDA" OR "recall" OR EMPOWER OR
<drug name> OR test OR chromatog* OR peak)
suppress* /200 ("inspect*" OR "FDA" OR "Food /300 Drug Administration" OR FDA OR USFDA OR "US-FDA" OR "recall" OR EMPOWER OR <drug name> OR test OR chromatog* OR peak)malfunct* /200 (<drug name> OR "test" OR "chromatog*" or "Empower")(crash* or disaster*) /200 (<drug name> OR "test" OR "chromatog*" or "Empower")
(data /4 integrity or data /4 reliabl*) /200 (<drug name> OR "test" OR "chromatog*" or
"Empower")
(destroy* NOT "immediately destroy all electronic") /200 (<drug name> OR "test" OR
"chromatog*" or "Empower")^
delet* /200 (<drug name> OR "test" OR "chromatog*" or "Empower")
trash* /200 (<drug name> OR "test" OR "chromatog*" or "Empower")
shred* /200 (<drug name> OR "test" OR "chromatog*" or "Empower")
(hide* OR suppress*) /200 "inspect*" OR "FDA" OR "Food /300 Drug Administration" OR
FDA OR USFDA OR "US‐FDA" OR "recall" OR <drug name> OR test OR chromatog* OR
peak OR EMPOWER)
whistleblow* /200 "inspect*" OR "FDA" OR "Food /300 Drug Administration" OR FDA OR
USFDA OR "US‐FDA" OR "recall" OR <drug name> OR test OR chromatog* OR peak OR
EMPOWER)
^Will not exclude responsive documents
Case 1:19-md-02875-RBK-JS Document 485-1 Filed 06/23/20 Page 8 of 20 PageID: 7734
QA‐Testing Page 8
"anion‐exchange" or anionexchange or "anion exchange"
"ion‐exchange" or ionexchange or "ion exchange"
*PCRC*
aberran* AND <DRUG NAME>
abnorm*
bioequiv*
CAPA or (corrective /3 action) or (preventative /5 action)
Chromato* /500 (<DRUG NAME> OR (unk* /3 peak*) or (unk* /3
spike*) OR (unk* /3 impurit*) or (unk* /3 contamin*))
contami* /500 (<DRUG NAME> OR <Manufacturing Modifiers>)
detect* /500 (<DRUG NAME> OR <Manufacturing Modifiers>)
EI‐MS or EL‐MS or "electron ionization"
elude*
fail* /500 <DRUG NAME>
GC or "GC‐FID" or GCMS or "GC‐MS"
("HS" or headspace)
HPLC‐UV
incomplet* /5 data*
LCMS
method /5 qualification
noise*
obscure*
(peak* or impurit* or degradant*) AND (<DRUG NAME> OR (unk* /3
spike) or (unk* /3 contamin*))
problem* /200 <drug name>
puri* /200 <drug name>
recall* /200 <drug name>
repe* /4 error*
risk* /200 <drug name>
signal* AND (<DRUG NAME> OR (unk* /3 spike) or (unk* /3 contamin*))(spectro* OR mass spec*) AND <drug name>
spike* /200 <drug name>
toxic* /200 <drug name>
validat* /200 <drug name>
Case 1:19-md-02875-RBK-JS Document 485-1 Filed 06/23/20 Page 9 of 20 PageID: 7735
QA‐Testing Page 9
Except where indicated in red, <Term> AND (<Drug Name> OR <manufacturing modifiers>)
Case 1:19-md-02875-RBK-JS Document 485-1 Filed 06/23/20 Page 10 of 20 PageID: 7736
Manufacturing Page 10
(empower or chromatograph*) /200 assay* AND
<DRUG NAME>
assessment* AND <DRUG NAME>
batch /3 records AND <DRUG NAME>
biocompat*AND <DRUG NAME>
(certificat* OR" COA") /300 <drug name>
critical /4 change AND <DRUG NAME> deviat* /300 (<drug names> OR <manufacturing
modifiers>)
discrepanc* /300 (<drug names> OR
<manufacturing modifiers>)
(error* NOT "received this email in error ") /200
(<drug names> OR <manufacturing modifiers>)^
esterficat* AND <DRUG NAME>
material* /3 loss* AND <DRUG NAME>
reclaim* AND <DRUG NAME>
repack* or "re‐pack*" AND <DRUG NAME>
resal* AND <DRUG NAME>
resell* AND <DRUG NAME>
moiety or moieties AND <DRUG NAME>
ring* AND (<drug names> OR <manufacturing
modifiers>)
^Will not exclude responsive documents
Case 1:19-md-02875-RBK-JS Document 485-1 Filed 06/23/20 Page 11 of 20 PageID: 7737
Medical Conditions Page 11
bladder*
cancer* or precancer* or pre‐cancer*
colon*
death or deaths or dead or deadly or fatal
esophag*
gastro*
intestin*
kidn* or renal*
laten*
leukemia*
liver*
lymphoma*
mutagen*
myeloma*
NHL or non‐hodgkin*
toxicolog*
onset*
oncolog*
ovar*
pancrea*
prostate*
stomach*
("adverse event*" or AER)
Case 1:19-md-02875-RBK-JS Document 485-1 Filed 06/23/20 Page 12 of 20 PageID: 7738
Medical Conditions Page 12
<Term> /200 (<Drug Name>
Case 1:19-md-02875-RBK-JS Document 485-1 Filed 06/23/20 Page 13 of 20 PageID: 7739
Entities Page 13
ABDC or Amerisource* or "American Health
Packaging" or AHP
ANDA AND NOT ((abbreviated w/3 application) OR FDA)Aurobindo
Hetero
Lantech*
Prinston
Teva
Torrent
Zhejian*
Camber
ZHP
Case 1:19-md-02875-RBK-JS Document 485-1 Filed 06/23/20 Page 14 of 20 PageID: 7740
Entities Page 14
<Term> /300 (<Drug Name>
Case 1:19-md-02875-RBK-JS Document 485-1 Filed 06/23/20 Page 15 of 20 PageID: 7741
Drug Name Modifiers Page 15
*Valsartan*
Diovan* <drug names modifiers>
Exforg*
sartan or sartans
Case 1:19-md-02875-RBK-JS Document 485-1 Filed 06/23/20 Page 16 of 20 PageID: 7742
Regulatory Modifiers Page 16
CDER or "Center for Drug Evaluation and
Research"<regulatory modifiers>
"Food and Drug Administration" or FDA or USFDA
or "US‐FDA" or "College Park"
"GDUFA"
Case 1:19-md-02875-RBK-JS Document 485-1 Filed 06/23/20 Page 17 of 20 PageID: 7743
Manufacturing Modifiers Page 17
recall*spike* <manufacturing modifiers> ((unknown or unk) /3 peak) or ((unknown or unk)
/3 spike) or ((unknown or unk) /3 impurit*) or
((unknown) or unk /3 contamin*) or ((unknown or
unk) /3 degradant*)
Case 1:19-md-02875-RBK-JS Document 485-1 Filed 06/23/20 Page 18 of 20 PageID: 7744
Medical Conditions Modifiers Page 18
"adverse event*" or AER*
bladder*
cancer* or precancer* or pre‐cancer* <medical conditions modifiers>
colon*
death* or dead or fatal
esophag*
gastro*intestin*
kidn* or renal*
laten*
leukemia*
liver*
lymphoma*
MedWatch* or "Safety Information and
Adverse Event Reporting"muta*
myeloma*
NHL or non‐hodgkin*
toxicolog*
onset*
oncolog*ovar*
PADER*
pancrea*
prostate*
stomach*
Case 1:19-md-02875-RBK-JS Document 485-1 Filed 06/23/20 Page 19 of 20 PageID: 7745
Facility Names Modifiers Page 19
3003937580 or Unit 3
3002785310 or Unit 8
3008316970 or Aurangabad
<facility names modifiers>
3005587313 or Nashik
1110315 or Morgantown or Chestnut Ridge
Case 1:19-md-02875-RBK-JS Document 485-1 Filed 06/23/20 Page 20 of 20 PageID: 7746
EXHIBIT B
Case 1:19-md-02875-RBK-JS Document 485-2 Filed 06/23/20 Page 1 of 28 PageID: 7747
Standalone Page 1
(*90483* OR *90866* OR *78020*)
OAI or "official action indicated"
"voluntary action indicated"
*diethylamine or "*diethyl amine"
*dimethylamine or "*dimethyl amine"
*dimethylformamide
*dimethylmethanamide
*ghost*
*NDEA*
*NDMA*
*nitra*
*nitrite*
*nitrosa*
*nitroso*
*NMBA*
*trosomine*
(Form483) or (Form /3 483) or (483 /3 letter) or
(483 /3 warn*) or (704 pre/3 b)
C2H6N2O or "(CH3)2NN=O" or "CH32NN=O" or
"(CH3)2NC(O)H" or CH32NCOH or C3H7NO or
"(CH3CH2)2NH" or CH3CH22NH or C4H11N or
"(CH3)2NH" or CH32NH or C2H7N or
"(C2H5)2NNO" or C2H52NNO or C4H10N2O
carcin*
deviat* /5 cancer* or deviat* /5 toxic or or
deviat* /5 hazard* or deviat* /5 fatal
FDA /10 warning
gene* /3 mutat*
solvent /5 cancer* or solvent /5 toxic or or
solvent /5 hazard* or solvent /5 fatal
solvent* /5 contamin*
(test* /5 canc*) AND (<Drug Name> OR
(<Solvents> AND NOT <other drug names>))
tetrazol*
Valisure*
Case 1:19-md-02875-RBK-JS Document 485-2 Filed 06/23/20 Page 2 of 28 PageID: 7748
Standalone Page 2
<term> (no modifiers)^
^Except if run against custodians in management
over more than one facility, in which case to be
run as indicated in agreed to procedure.
Case 1:19-md-02875-RBK-JS Document 485-2 Filed 06/23/20 Page 3 of 28 PageID: 7749
Authors or Inspectors Page 3
Last Name First Name Facility Inspection Date
Philopoulos Constantin Unit 8 8.2.12
Bonita Chester Unit 8 4.17.12
George Jogy Unit 8 8.10.17
Bernard Tonia Unit 8 4.13.18
Akhtar Saleem Unit 8 12.10.18
Brown Darren Unit 8 12.10.18
Patel Nayan Unit 8 12.10.18
Martinez Miguel Unit 8 6.5.19
Srivastava, Rajiv Unit 8 6.5.19
Matthews Sony Unit 3 2.3.14
Case 1:19-md-02875-RBK-JS Document 485-2 Filed 06/23/20 Page 4 of 28 PageID: 7750
Regulatory Page 4
("adverse event*" or AER) and (<drug name> or
<solvents> or <facility names>)
"changes being effected"
"prior approval supplement"
adulterat*
(alert or alerts) w/500 (drug name or (solvents
and NOT other drug names) or facility names or
regulatory modifiers)
CAPA or corrective pre/3 "preventive action"
CFR or eCFR or "code of federal regulations" or
USC or "United States Code" or "Title 21"
Citizen* pre/3 Petition
(Establishment pre/3 Inspection)
import* /3 (ban or alert or restrict*)
inadequat*
inspect* /200 (drug name or (solvents and NOT
other drug names) or facility names or regulatory
modifiers)
investigat* /200 (drug name or (solvents and
NOT other drug names) or facility names or
regulatory modifiers)
major /3 change
(master /3 file) and (<drug name> or <solvents>)
minor /3 change
moderate /3 change
Monthly /3 update
(official pre/3 action* /4 indicat* )
(observation or observations) /500 (drug name or
(solvents and NOT other drug names) or facility
names or regulatory modifiers)
Case 1:19-md-02875-RBK-JS Document 485-2 Filed 06/23/20 Page 5 of 28 PageID: 7751
Regulatory Page 5
(OOS or "out of spec*" or "out‐of‐spec*") /500
(drug name or (solvents and NOT other drug
names) or facility names or regulatory modifiers)
OOT or "out‐of‐trend" or "out of trend"
PADER* and (<drug name> or <solvents> or
<facility names>)
VAI or (voluntary pre/3 action* /4 indicat*)
violat*
warn*
EIR or "establishment inspection report"
genotoxic*
Case 1:19-md-02875-RBK-JS Document 485-2 Filed 06/23/20 Page 6 of 28 PageID: 7752
Regulatory Page 6
Except where indicated in red, <Term> AND (<Drug Name> OR (<Solvents> AND NOT <other drug names>) OR <regulatory modifiers> OR <facility names>)
Case 1:19-md-02875-RBK-JS Document 485-2 Filed 06/23/20 Page 7 of 28 PageID: 7753
cGMP Page 7
((bottle pre/2 lies) or Eban) /200 ("inspect*" OR "FDA" OR "Food /300 Drug
Administration" OR FDA OR USFDA OR "US‐FDA" OR "Agency" OR "recall" OR <medical
conditions> OR <drug name> OR <solvents> OR test OR chromatog* OR peak)
(bury OR burie* OR conceal*) /200 ("inspect*" OR "FDA" OR "Food /300 Drug
Administration" OR FDA OR USFDA OR "US‐FDA" OR "Agency" OR "recall" OR <medical
conditions> OR <drug name> OR <solvents> OR test OR chromatog* OR peak)
(cGMP* or (current pre/5 manufacturing) or GMP*) /200 (<drug name> OR <solvents>
OR inspect* OR violat*
("cover up*" or coverup* or "cover‐up*") /200 ("inspect*" OR "FDA" OR "Food /300
Drug Administration" OR FDA OR USFDA OR "US‐FDA" OR "Agency" OR "recall" OR
<medical condictions> OR <drug name> OR <solvents> OR test OR chromatog* OR peak)
(crash* or disaster*) /200 (<drug name> OR <solvents> OR "backup /3 data" OR "test")
(data /4 integrity or data /4 reliabl*) /200 (<drug name> OR <solvents> OR "backup /3
data" OR "test" or chromatog*)
(destroy* NOT "immediately destroy all electronic") /200 (<drug name> OR <solvents>
OR facilities names OR test OR chromatog* OR backup /3 data)^
delet* /200 (<drug name> OR <solvents> OR facilities names OR test OR chromatog* OR
backup /3 data)
trash* /200 (<drug name> OR <solvents> OR facilities names OR test OR chromatog* OR
backup /3 data)
shred* /200 (<drug name> OR <solvents> OR facilities names OR test OR chromatog* OR
backup /3 data)
(hide* OR suppress*) /200 ("inspect*" OR "FDA" OR "Food /300 Drug Administration"
OR FDA OR USFDA OR "US‐FDA" OR "Agency" OR "recall" OR <medical conditions> OR
<drug name> OR <solvents> OR test OR chromatog* OR peak)
whistleblow* /200 ("inspect*" OR "FDA" OR "Food /300 Drug Administration" OR FDA
OR USFDA OR "US‐FDA" OR "Agency" OR "recall" OR <medical conditions> OR <drug
name> OR <solvents> OR test OR chromatog* OR peak)
^Will not exclude responsive documents
Case 1:19-md-02875-RBK-JS Document 485-2 Filed 06/23/20 Page 8 of 28 PageID: 7754
QA‐Testing Page 8
"anion‐exchange" or anionexchange or "anion exchange"
"ion‐exchange" or ionexchange or "ion exchange"
*PCRC*
aberran*
abnorm*
ALS
bioequiv*
CAPA or corrective pre/5 action
Chromato* /500 (drug name OR (solvents AND NOT other drug names) OR manufacturing modifiers) contami*
degradant*
detect* /200 (drug name OR (solvents AND NOT other drug names) OR
manufacturing modifiers)
EI‐MS or EL‐MS or "electron ionization"
elude*
fail* /500 (drug name OR (solvents AND NOT other drug names))
fatal*
GC or "GC‐FID" or GCMS or "GC‐MS"
hazard*
headspace
heat
HPLC‐UV
HS
incomplet* /5 data*
LCMS
mass spectro*
method /5 qualification
noise*
noti* w/5 pharm*
obscure*
peak*
press /4 release
preventative /5 action
problem* /200 (drug name OR (solvents AND NOT other drug names)
OR manufacturing modifiers)
Case 1:19-md-02875-RBK-JS Document 485-2 Filed 06/23/20 Page 9 of 28 PageID: 7755
QA‐Testing Page 9
puri* /200 (drug name OR (solvents AND NOT other drug names) OR
manufacturing modifiers)
recall*
repe* /4 error*
residu* ‐ residu* /200 (drug name OR (solvents AND NOT other drug
names) OR manufacturing modifiers)
retrospec*
risk* /200 (drug name OR (solvents AND NOT other drug names) OR
manufacturing modifiers)
signal*
spectro*
spike*
toxic*
unknown* or unk or unks
validat* /200 (drug name OR (solvents AND NOT other drug names) OR
manufacturing modifiers)
genotoxic*
Case 1:19-md-02875-RBK-JS Document 485-2 Filed 06/23/20 Page 10 of 28 PageID: 7756
QA‐Testing Page 10
Except where indicated in red, <Term> AND (<Drug Name> OR (<Solvents> AND NOT <other drug names>) OR <manufacturing modifiers>)
Case 1:19-md-02875-RBK-JS Document 485-2 Filed 06/23/20 Page 11 of 28 PageID: 7757
Manufacturing Page 11
"PROCESS I" or "PROCESS II"
assay*
assessment* /200 (drug name OR (solvents AND
NOT other drug names) OR manufacturing
modifiers)
batch /5 records
biocompat*
byproduct*
CAPA or corrective pre/3 "preventive action"
certificat*
change* /3 control*
change* /5 process*
COA or certificat* pre/3 analys*
concentra*
condensa*
conversion*
critical /4 change
crude*
deviat*
diastereo*
discrepanc*
(error* NOT "received this email in error ") /200 (drug name OR (solvents AND NOT other drug names) OR manufacturing modifiers)^esterficat*
expir*
*formaldehyde*
malfunct*
material* /3 loss*
moiety or moieties
process /5 change
quench*
reagent*
reclaim*
recover* /200 (drug name OR (solvents AND NOT
other drug names) OR manufacturing modifiers)
recycl* /200 (drug name OR (solvents AND NOT other drug names) OR manufacturing modifiers) repack* or "re‐pack*"
resal*
resell*
Case 1:19-md-02875-RBK-JS Document 485-2 Filed 06/23/20 Page 12 of 28 PageID: 7758
Manufacturing Page 12
reuse*
ring*
solvent /200 (drug name OR (solvents AND NOT other drug names) OR manufacturing modifiers)suppress*
TEA or Triethyl*
TIN or Tributyl*
yield* /200 (drug name OR (solvents AND NOT
other drug names) OR manufacturing modifiers)
^Will not exclude responsive documents
Case 1:19-md-02875-RBK-JS Document 485-2 Filed 06/23/20 Page 13 of 28 PageID: 7759
Manufacturing Page 13
Except where indicated in red, <Term> AND (<Drug Name> OR (<Solvents> AND NOT <other drug names>))
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Medical Conditions Page 14
bladder*
cancer* or precancer* or pre‐cancer*
colon*
(death or deaths or dead or deadly or fatal) w/200 (drug name OR (solvents AND NOT other drug names) OR medical term modifiers)esophag*
gastro*
intestin*
kidn* or renal*
laten*
leukemia*
liver*
lymphoma*
muta*
myeloma*
NHL or non‐hodgkin*
toxicolog*
onset*
oncolog*
ovar*
pancrea*
prostate*
stomach*
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Medical Conditions Page 15
Except where indicated in red, <Term> AND (<Drug Name> OR (<Solvents> AND NOT <other drug names>))
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Economic Terms Page 16
AWP or "average wholesale price" or WAC or
"wholesale acquisition cost"
best /3 pric* <Term> AND (<Drug Name> OR (<Solvents> AND NOT <other drug names>))^
bulk /3 suppl*
impairment
IRR ^To be run against economic
custodian(s) only manufactur* /3 cost*
marginal /5 cost*
market* /5 share*
net /5 profit*
net /5 valu*
NPA
NPV
rate /10 return
rebate*
sourc* w/5 agree* or sourc* w/5 anal* or sourc*
w/5 contract* or sourc* w/5 forecast* or sourc*
w/5 plan* or sourc* w/5 strat*
suppl* w/5 agree* or suppl* w/5 anal* or suppl*
w/5 contract* or suppl* w/5 forecast* or suppl*
w/5 plan* or suppl* w/5 strat*
SWOT or (strength pre/7 threat*)
writ* pre/5 off
(ABDC or Amerisource* or "American Health
Packaging" or AHP) AND (pric* or cost or market*
or AWP or WAC or profit or margin* or stock or
share or indemn* or indemn* or loss)
(AG) AND (pric* or cost or market* or AWP or
WAC or profit or margin* or stock or share or
gross or gross or loss)
(amerisource* ) AND (pric* or cost or market* or
AWP or WAC or profit or margin* or stock or
share or indemn* or indemn* or loss)
(ANDA) AND (pric* or cost or market* or AWP or
WAC or profit or margin* or stock or share or
indemn* or indemn* or loss)
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Economic Terms Page 17
(ASB) AND (pric* or cost or market* or AWP or
WAC or profit or margin* or stock or share or
indemn* or indemn* or loss)
(Authorized /4 generic) AND (pric* or cost or
market* or AWP or WAC or profit or margin* or
stock or share)
(average or avg) AND (pric* or cost* or margin*
or profit* or revenue*)
(avg ) AND (pric* or cost* or margin* or profit* or
revenue*)
(boehringer ingelheim) AND (pric* or cost or
market* or AWP or WAC or profit or margin* or
stock or share or indemn* or indemn* or loss)
(cardinal) AND (pric* or cost or market* or AWP
or WAC or profit or margin* or stock or share or
indemn* or indemn* or loss)
(contract ) AND (distrib* or PBM)
(cost* ) AND (analy* or forecast* or plan* or
strat*)
(CVS*) AND (pric* or cost or market* or AWP or
WAC or profit or margin* or stock or share or
indemn* or indemn* or loss)
(Epic) AND (pric* or cost or market* or AWP or
WAC or profit or margin* or stock or share or
indemn* or indemn* or loss)
(ESI) AND (pric* or cost or market* or AWP or
WAC or profit or margin* or stock or share or
indemn* or indemn* or loss)
(Express*) AND (pric* or cost or market* or AWP
or WAC or profit or margin* or stock or share or
indemn* or indemn* or loss)
(IMS) AND (pric* or cost or market* or AWP or
WAC or profit or margin* or stock or share or
loss)
(IQVIA) AND (pric* or cost or market* or AWP or
WAC or profit or margin* or stock or share or
loss)
(Kroger) AND (pric* or cost or market* or AWP or
WAC or profit or margin* or stock or share or
indemn* or loss)
(mckesson) AND (pric* or cost or market* or AWP
or WAC or profit or margin* or stock or share or
indemn* or loss)
(operat* w/5 margin*) AND (margin* or profit*)
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Economic Terms Page 18
(Optum*) AND (pric* or cost or market* or AWP
or WAC or profit or margin* or stock or share or
indemn* or loss)
(pric*) AND (decreas* or increas* or list* or strat*
or expect* or project*)
(recall) AND (loss or impairm* or write* or
reimburs* or indemn* or charg* or replace*)
(Redoak) AND (pric* or cost or market* or AWP or
WAC or profit or margin* or stock or share or
indemn* or loss)
(retail) AND (pric* or cost or market* or AWP or
WAC or profit or margin* or stock or share or
loss)
(Rite*) AND (pric*)
(sales ) /5 (expect* or project*)
(var* ) /5 (cost*)
(variable ) /5 (cost*)
(Walgreen* or WBDA) AND (pric* or cost or
market* or AWP or WAC or profit or margin* or
stock or share or indemn* or indemn* or loss)
(Walmart) AND (pric* or cost or market* or AWP
or WAC or profit or margin* or stock or share or
indemn* or indemn* or loss)
Case 1:19-md-02875-RBK-JS Document 485-2 Filed 06/23/20 Page 19 of 28 PageID: 7765
Entities Page 19
Alembic
ABDC or Amerisource* or "American Health
Packaging" or AHP
Amerigen
ANDA AND NOT ((abbreviated w/3 application)
OR FDA)
Auro* or APL or APUSA
boehringer ingelheim
Bristol
Camber
Cobalt
Forest
Hetero
Huahai
Indoco
Ivax
Jubilant
Lantech*
Macleod*
Novartis
Par
Prinston
Qualanex
Ranbaxy
Sandoz
Syncore
Synthon
Teva
Torrent
Unichem
Watson
Zhejian*
ZHP
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Entities Page 20
<Term> AND (<Drug Name> OR (<Solvents> AND NOT <other drug names>))
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Drug Name Modifiers Page 21
*Valsartan*
Diovan*
Exforg* <drug names modifiers>
sartan or sartans
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Solvents Modifiers Page 22
*azide*
*formaldehyde*
*‐N3* <solvents modifiers>*xylene*
aqueous*
chloramin*
HNO2hydrochlor*
N‐3*
NaNO*
tolue*
Tributyl* or TIN
Triethyl* or TEAzinc /3 chloride
Amlodipine
HCT or HCTZ
ZnCI*
Case 1:19-md-02875-RBK-JS Document 485-2 Filed 06/23/20 Page 23 of 28 PageID: 7769
Regulatory Modifiers Page 23
"Abbreviated New Drug Application" or ANDA
CDC or "Centers for Disease Control"
CDER or "Center for Drug Evaluation and
Research"<regulatory modifiers>
DEA or "Drug Enforcement Administration" or
"Drug Enforcement Agency"
"Environmental Protection Agency" or EPA or
USEPA or "US‐EPA" or "1200 Pennsylvania
Avenue"
"Food and Drug Administration" or FDA or USFDA
or "US‐FDA" or "College Park"
NIH or "National Institutes of Health"
Case 1:19-md-02875-RBK-JS Document 485-2 Filed 06/23/20 Page 24 of 28 PageID: 7770
Medical Conditions Modifiers Page 24
"adverse event*" or AER*
bladder*
cancer* or precancer* or pre‐cancer* <medical conditions modifiers>
colon*
death* or dead or fatal
esophag*
gastro*intestin*
kidn* or renal*
laten*
leukemia*
liver*
lymphoma*
MedWatch* or "Safety Information and
Adverse Event Reporting"muta*
myeloma*
NHL or non‐hodgkin*
toxicolog*
onset*
oncolog*ovar*
PADER*
pancrea*
prostate*
stomach*
Case 1:19-md-02875-RBK-JS Document 485-2 Filed 06/23/20 Page 25 of 28 PageID: 7771
Facility Name Modifiers Page 25
3003937580 or Unit 3
3002785310 or Unit 8
3008316970 or Aurangabad
<facility names modifiers>
3005587313 or Nashik
1110315 or Morgantown or Chestnut Ridge
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Economic Modifiers Page 26
analys*
AWP
cost* <economic modifiers>decreas*
distrib*
expect*
gross
impairm*
increas*
indem*
list*
loss*
margin*
market*
net
PBM
plan
pric*
profit*
project*
recall*
revenue*
share*
stock*
strat*
WAC
write*
Case 1:19-md-02875-RBK-JS Document 485-2 Filed 06/23/20 Page 27 of 28 PageID: 7773
Manufacturing Modifiers Page 27
backup /3 data
impurit* and degradant*
recall* <manufacturing modifiers>
residu*
solvent*
spike*
test*
unknown /3 peak or unknown /3 spike or
unknown /3 impurit* or unknown /3 contamin*
acid*
Complain*
Case 1:19-md-02875-RBK-JS Document 485-2 Filed 06/23/20 Page 28 of 28 PageID: 7774