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