Claims Against Pain Pump Manufacturer are Preempted, Court Affirms

ATLANTA - State law claims brought against the manufacturer of a pain pump are federally preempted because the plaintiffs failed to establish a connection between the alleged injury and defendants' alleged violation of Food and Drug Administration regulations, a federal appeals court has affirmed. Wolicki-Gables v. Arrow International Inc., et al., No. 09-14342 (11th Cir.).

On March 8, the 11th Circuit U.S. Court of Appeals further ruled that plaintiffs are not entitled to a presumption that the pump was not designed in accordance with FDA regulations because they failed to demonstrate that a defect in device "most probably" caused the …