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GA SB488
Bill
Status
Introduced
2/27/2012
Primary Sponsor
Barry Loudermilk
Click for details
AI Summary
- Grants reference product (brand-name biologic) license holders and their marketers, sellers, and distributors full immunity from liability under Georgia law for any claims arising from a patient's use of a biosimilar biological product, including interchangeable biosimilars
- Immunity covers a broad range of claims including product liability (failure to warn, design defect, manufacturing defect), breach of warranty (merchantability, fitness, implied or express), and all related legal theories
- Protected losses encompass death, physical/mental/emotional injury or illness, fear of injury or need for medical monitoring, and property damage including business interruption
- Definitions for key terms—biological product, biosimilar, interchangeable, license, and reference product—are tied to Section 351 of the federal Public Health Service Act (42 U.S.C. 262)
- Immunity does not apply when the reference product license holder itself manufactures the biosimilar biological product in question
Legislative Description
Prescription Drugs; reference product license holder; immunity from liability; use of a biosimilar biological product
Last Action
Senate Read and Referred
2/27/2012
Committee Referrals
Judiciary2/27/2012
Full Bill Text
No bill text available