Warning, Fraud Claims Survive Preemption Analysis in Calif. Ultherapy Case

SACRAMENTO, Calif. — Claims accusing the manufacturers of a skin tightening device of failing to report adverse events to the Food and Drug Administration are not preempted because they are based upon violations of state requirements that parallel federal regulations, a California federal judge has ruled.

In a Feb. 21 order, Judge Dale Drozd of the U.S. District Court for the Eastern District of California further ruled claims alleging defendants misrepresented the safety of using the Ulthera System on the entire face in their marketing and training materials are not impliedly preempted because they do not arise solely by virtue …