Senator Harkin and Representative Waxman File Brief on Preemption in Bartlett Supreme Court Decision

Senator Tom Harkin and Representative Henry A. Waxman have filed a brief of amici curiae in support of Karen L. Bartlett over the Supreme Court of the United State’s decision in the case of Mutual Pharmaceutical Company, Inc. v. Karen L. Bartlett. The brief concerns pharmaceutical regulation and federal preemption under the Food, Drug, and Cosmetic Act (FDCA) and the Hatch-Waxman Amendments, of which Representative Waxman was co-sponsor during its creation in 1984. Under preemption, federal law overrides state law. In regard to issues of defective drugs or product liability, preemption would mean that plaintiffs can’t file claims in state court if a federal agency such as the U.S. Food and Drug Administration (FDA) has already approved the product in question.

The brief argues that the text and the purpose of the FDCA and the Hatch-Waxman Amendments require preemption when injured patients bring state law design defect claims against prescription drug manufacturers. The amici claim that these federal laws have long coexisted with state regulations concerning defective drugs and product liability claims. Since the Food and Drug Administration (FDA) allows over-the-counter (OTC), brand name, and generic drugs to be marketed on a risk-benefit analysis, state law design claims do not interfere with the FDCA and are not in need of preemption.

Additionally, in the 30 years since the creation of the Hatch-Waxman Amendments, it has been seen that state law design defect claims pose no threats to the reduction of anticompetitive barriers in marketing generic drugs.

The brief argues that the decision to preempt cases should remain within Congress’ authority, rather than the Supreme Court. Through multiple amendments to the FDCA, Congress has continued to support the claim that the act does not preempt state law concerning prescription drugs. Additionally, Congress explicitly provided that an express preemption provision created in 1997 would not affect state product liability law. Amici argue that since there are no differences between OTC and prescription drugs requiring different rules, this should apply in both cases and the idea of FDA regulation broadly preempting claims is not supported in 75 years of court history.

The amici also argues that Congress has not viewed tort liability as a barrier to introducing generic drugs, which is the goal of the Hatch-Waxman Amendments. In the time since their creation, the growth and price drop of generic drugs has continued without impediment by cases brought against pharmaceutical manufacturers.

Congress has been well aware of its authority to preempt, the amici argue, but has not taken action with OTC drugs, even with multiple cases brought before them. The brief states that “preemption would cut off patients from even the possibility of holding a prescription drug manufacturer accountable for harm caused by a defective product. Preemption, where accepted, leaves no room for factual distinctions between individual cases, sweeping away traditional common-law approaches to assessing liability.”

In summary, the senator and representative argue that there is no evidence that impediments to federal law have been created by the coexistence of state law design defect claims and FDA drug approval since the creation of the FDCA and Hatch-Waxman Amendments. As such, the decision concerning compensation for those injured by drugs should be left to the states and the Supreme Court should not alter this tradition.

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