R.J. REYNOLDS TOBACCO COMPANY et al v. UNITED STATES FOOD AND DRUG ADMINISTRATION et al

Filing 10

MOTION for Summary Judgment by COMMONWEALTH BRANDS INCORPORATED, LIGGETT GROUP LLC, LORILLARD TOBACCO COMPANY, R.J. REYNOLDS TOBACCO COMPANY, SANTA FE NATURAL TOBACCO COMPANY, INC. (Attachments: # 1 Appendix A)(Francisco, Noel). Added MOTION for Permanent Injunction on 8/22/2011 (znmw, ).

Appendix A

Summary of FDA "Unexplained" Differences
Canada
U.S.
Unexplained* Unexplained* Difference
Year
1994-95
(0.142)
0.109
(0.251)
1996-97
0.344
0.428
(0.084)
1998
(0.053)
1.463
(1.516)
1999
(0.261)
(0.655)
0.394
2000
0.060
(0.699)
0.759
2001
(0.226)
(2.388)
2.162
2002
0.121
(0.847)
0.968
2003
(0.635)
0.626
(1.261)
NA
0.004
NA
2004
2005
(0.814)
(0.542)
(0.272)
2006
(0.882)
(0.350)
(0.532)
2007
(1.762)
0.593
(2.355)
2008
(0.539)
(0.391)
(0.148)
2009
0.323
(0.707)
1.030
Pre-2001 Average
(0.010)
0.129
(0.140)1
Post-2000 Average
(0.552)2
(0.445)2
(0.051)1
"Unexplained"
0.541
0.574
(0.089)
1

Unexplained difference between U.S. and Canada is greater before
introduction of graphic warnings in Canada than after.
2
Unexplained difference in U.S. after 2000 (without graphic
warnings) is greater than in Canada after 2000 (with graphic
warnings).
* Data taken from FDA Final Rule, Tables 43-44.