jeffrey r. pilkington november 14, 2007 innovator liability in “generic only” cases
TRANSCRIPT
Jeffrey R. Pilkington
November 14, 2007
Innovator Liability in “Generic Only” Cases
BrandName
“Traditional” Case
Generic
BrandName
“Generic Only” Case
GenericX
BrandName
Plaintiff’s Liability Theory in a Generic Only Case
Generic
Plaintiff’s Theories of Liability in a Generic Only
Case
Brand
Name
Drug
Brand
Name
Drug
Generic
Reliance – “Reasonable and Foreseeable”
Reliance – “Reasonable and Foreseeable”
BrandName
Generic=
The “Same” Drug
Brand Name Label
Generic Label
=
Brand Name Pharmacovigilance
ADEs
Annual/Periodic Reports
Literature
Labeling
Studies
Other
Reliance – “Reasonable and Foreseeable”
Reliance – “Reasonable and Foreseeable”
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)
Reliance – “Reasonable and Foreseeable”
BrandName
Generic
Who is liable?
BrandName
Generic
Both?
Foster v. American Home Products Corp.,
29 F.3d 165, 171 (3rd Cir. 1994)
Rationale Against Innovator Liability
#1: No Claim Exists
#2: No Duty Exists
#1: No Claim Exists
1. Any case where Plaintiff alleges harm caused by a product is a “product liability case.”
2. A “product liability case” may only be brought against the manufacturer of the product.
3. The brand name sponsor did not manufacture the product.
Support for No Claim Existing
#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?
Duty?
Duty?
“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)
Duty?
Duty?
Duty?
NO DUTY
States Finding No Brand Name Liability
Generic
Generic Drug Liability?
“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)
Generic
Preemption
What’s Next?
Brand Name Pharmacovigilance
ADEs
Annual/Periodic Reports
Literature
Labeling
Studies
Other
Generic Pharmacovigilance
ADEs
Annual/Periodic Reports
Literature
Labeling
Studies
Other
XXXX
Jeffrey R. Pilkington
November 14, 2007
Innovator Liability in “Generic Only” Cases