George Mason University Antonin Scalia Law School

Inventing New Liability? Who Should We Blame When Generic Drugs Harm Patients?

Event Details

  • Date:
  • Venue: Dirksen Senate Office Building, Room 226
  • Division: Civil Justice Academy

Federal law requires generic drug manufacturers to use the identical warning labels as their corresponding innovator or brand-name drugs, and it forbids them from updating or adding to the language authorized by the FDA when approving those products. That means generic manufacturers cannot be sued for deficient warnings when patients using their drugs are injured. But if generic manufacturers are shielded from liability, should the brand drug’s manufacturer be held to account when an injury occurs?

Most state and federal courts to hear such cases have rejected claims of perpetual innovator liability. However, courts in California are letting these cases move forward, and a handful of other states may follow suit. But is it fair to hold a company liable for another company’s products? If not, where can injured patients turn for recourse? Is a legislative fix the way to go?

This Congressional Civil Justice Academy briefing featured:

Leslie A. Brueckner
Senior Attorney, Public Justice

Phil S. Goldberg
Director, Progressive Policy Institute’s Center for Civil Justice
Co-Chair, Shook Hardy & Bacon’s Public Policy Group

Moderator: Gregory Conko
Interim Executive Director, Law & Economics Center