Jeffrey R' Pilkington

1
Innovator Liability in Generic Only Cases

• Jeffrey R. Pilkington
• November 14, 2007

2
Traditional Case
3
Generic Only Case
X
4
Plaintiffs Liability Theory in a Generic Only
Case
5
(No Transcript)
6
(No Transcript)
7
(No Transcript)
8
(No Transcript)
9
(No Transcript)
10
Plaintiffs Theories of Liability in a Generic
Only Case
11
(No Transcript)
12
Brand Name Drug
13
(No Transcript)
14
Generic Drug
Brand Name Drug
15
(No Transcript)
16
(No Transcript)
17
(No Transcript)
18
(No Transcript)
19
Reliance Reasonable and Foreseeable
20
Reliance Reasonable and Foreseeable
21
The Same Drug

22
Brand Name Label
Generic Label

23
(No Transcript)
24
(No Transcript)
25
(No Transcript)
26
(No Transcript)
27
(No Transcript)
28
Brand Name Pharmacovigilance
ADEs Annual/Periodic Reports Literature Labeling S
tudies Other
29
Reliance Reasonable and Foreseeable
30
Reliance Reasonable and Foreseeable
31
Generic Substitution Laws
A pharmacist who receives a prescription for a
brand name drug shall, unless requested otherwise
by the purchaser, substitute a less expensive,
generically equivalent drug product . . .
Florida Statutes Annotated 465.025(2)
32
Reliance Reasonable and Foreseeable
33
Who is liable?
34
Foster v. American Home Products Corp., 29 F.3d
165, 171 (3rd Cir. 1994)
35
Rationale Against Innovator Liability
1 No Claim Exists 2 No Duty Exists
36
1 No Claim Exists

• Any case where Plaintiff alleges harm caused by a
  product is a product liability case.
• A product liability case may only be brought
  against the manufacturer of the product.
• The brand name sponsor did not manufacture the
  product.

37
Support for No Claim Existing
38
2 No Duty Exists
Does the manufacturer of a brand-name
prescription drug owe a duty to a consumer
injured by a generic equivalent drug manufactured
by another company, such that the brand-name
manufacturer may be held liable to that consumer
on a negligent misrepresentation or related
theories?
39
Duty?
40
Duty?
41
to impose a duty in the circumstances of this
case would be to stretch the concept of
foreseeability too far. The duty required for the
tort of negligent representation arises when
there is such a relationship that one party has
the right to rely for information upon the other,
and the other giving the information owes a duty
to give it with care . . . . There is no such
relationship . . . as plaintiff was injured by
a product that the brand name manufacturer did
not make.
Foster v. American Home Products Corp., 29 F3d
165, 171 (3rd Cir. 1994)
42
Duty?
43
Duty?
44
Duty?
45
NO DUTY
46
States Finding No Brand Name Liability
47
Generic Drug Liability?
48
While it is true that the ANDA process requires
generic manufacturers to use the same labeling as
the previously approved innovator drug, we cannot
agree that this absolves them of liability for
the misrepresentations made on their own drugs.
Colaccico v. Apotex, Inc., 432 F. Supp. 2d 514,
544 (E.D. Pa. 2006)
49
Generic
Preemption
50
Whats Next?
51
(No Transcript)
52
Brand Name Pharmacovigilance
ADEs Annual/Periodic Reports Literature Labeling S
tudies Other
53
Generic Pharmacovigilance
54
(No Transcript)
55
Innovator Liability in Generic Only Cases

• Jeffrey R. Pilkington
• November 14, 2007