In its decision, the appeals Court stated, "...we are not persuaded that it is always impossible to comply with both state law duties and FDA regulations in the process leading up to FDA approval." It added, "...we cannot agree with the district court's conclusion as, not only is there a presumption against preemption, but the case law supports the conclusion that Congress did not intend to preempt state tort law claims when it passed the Food, Drug, and Cosmetics Act (FDCA)."

In a footnote, it commented "...the overwhelming take-away from the Levine majority opinion is that state tort law has historically played a substantial role in the regulation of drug manufacturers and that Congress has never indicated an intent to change this role. Thus, while Levine did leave open the possibility that there may be some state law claims that would conflict with the FDA's regulatory authority and function, the claim at issue in Levine was not one of them. We do not believe that Buchanan's pre-approval negligence claims are, either."

Attorney Anderson, commenting on the interpretation of the Levine ruling in the case, said, "Drug companies are now on notice that they cannot lie to and conceal from the FDA crucial information in the pre-approval process  and then expect to be held harmless once their drugs are responsible for causing pain, suffering and, as in Mrs. Buchanan's case, death."

The Court affirmed the dismissal of the balance of the plaintiff's  claims, and Attorney Anderson said he will  evaluate with appellate counsel Paul Flowers, Esq., and Mrs. Buchanan's family all appropriate legal options.

SOURCE Anderson Law Firm