Beyond Preemption of Generic Drug Claims

Abstract

Recent research indicates that the current cost of generic medications in the United States is the highest in history. Many patients are no longer able to afford life saving medications that were once affordable only five years ago. Concurrent to the rising prices of generic drugs, pharmaceutical companies have lauded preemption as a necessary and viable solution to combat the increasing prices. Two recent Supreme Court decisions, PLIVA, Inc. v. Mensing and Mutual Pharmaceutical Co. v. Bartlett, have agreed with this logic, and have attempted to pervert the Hatch-Waxman Act, and its corresponding ANDA approval process to shield generic drug manufacturers from liability. Not only has this immunity done nothing to combat the price of drugs, but it has also decreased incentives for generic manufacturers from engaging in thorough pre-market testing and studies, putting consumers of generic drugs at an increased risk of injury.

Mensing and Bartlett have impressed upon the courts a strong directive to preempt any product liability claims made against a generic manufacturer. However, by shielding generic drug manufacturers from liability, Mensing and Bartlett have placed consumers, especially low income consumers, at an increased risk of injury. Additionally, Mensing and Bartlett may ultimately hurt, rather than help the generic drug industry. While there has been an effort to introduce regulatory action that minimizes the impact of the decisions, the FDA seems largely powerless for the time being to implement any regulatory changes. Plaintiff attorneys have also met limited success in attempting to circumvent, reframe or distinguish the holdings in Mensing and Bartlett. However, as long as regulatory change is stagnant, expect plaintiff attorneys to continue to try and poke holes in holdings in Mensing and Bartlett with limited success in narrow circumstances.

Keywords: Mensing, Bartlett, generic drug, brand new drug, preemption