This week, the United States Supreme Court issued a ruling in Wyeth v. Levine sending shockwaves through the already precarious minefield of consumer products regulation. It is hard to anticipate just how much Wyeth will impact the preemptive effect of CPSC regulations under the CPSIA and other Acts, but it could be significant.
On Wednesday, March 4, the Supreme Court held that even if a drug company complies with all FDA regulations and receives FDA approval, the company is not insulated from state consumer liability lawsuits. Concluding that Congress did not intend to bar state failure-to-warn suits, the court denied companies safe harbor under the FDA warning regulations.
The preemptive reach of the Consumer Product Safety Act as amended by the CPSIA is currently unclear. For instance, the CPSIA explicitly allows states to regulate consumer products if the state requirements are identical to federal requirements. It also specifies that the CPSC may not expand the preemptive effect of the statutes it enforces through rulemaking. In addition, the CPSIA provides that it does not preempt or affect state warning requirements that were in effect on August 31, 2003 (e.g.,California’s Prop 65). When read together, the preemption provisions of the Consumer Product Safety Act (as amended by the CPSIA) could be construed narrowly, and, under Wyeth, courts may not be willing find preemption in such murky waters.
We continue to track the evolution and application of several state consumer product safety laws with care and will provide regular updates. If you are a business subject to CPSC regulation, it is very important to remain up-to-date on state consumer product regulations, as well. Note that states across the country are at various stages in adoption of laws which require warning labels or other chemical content limits in children’s products. We will continue to keep readers apprised of the influence Wyeth has on future delineation of the preemptive effect of federal consumer product safety laws and regulations.