1. Jeffrey R. Pilkington November 14, 2007 Innovator Liability in “Generic Only” Cases

2. BrandName “Traditional” Case Generic

3. BrandName “Generic Only” Case Generic X

4. BrandName Plaintiff’s Liability Theory in a Generic Only CaseGeneric

10. Plaintiff’s Theories of Liability in a Generic Only Case

12. Brand Name Drug

16. Generic

19. Reliance – “Reasonable and Foreseeable”

21. BrandName Generic = The “Same” Drug

22. Brand Name Label Generic Label =

28. Brand Name Pharmacovigilance ADEs Annual/Periodic Reports Literature Labeling Studies Other

29. 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. BrandName Generic Who is liable? BrandName Generic Both?

34. Foster v. American Home Products Corp., 29 F.3d 165, 171 (3 rd Cir. 1994)

35. Rationale Against Innovator Liability #1: No Claim Exists #2: No Duty Exists

36. #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.

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?

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 (3 rd Cir. 1994)

42. Duty?

45. NO DUTY

46. States Finding No Brand Name Liability

47. Generic 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. What’s Next?

52. Brand Name Pharmacovigilance ADEs Annual/Periodic Reports Literature Labeling Studies Other

53. Generic Pharmacovigilance ADEs Annual/Periodic Reports Literature Labeling Studies Other X X X X

55. Jeffrey R. Pilkington November 14, 2007 Innovator Liability in “Generic Only” Cases