Judge Solomon Olivier Jr. of the The United States District Court in Cleveland has just ruled that some claims against drug manufacturers are still pre-empted by FDA approval, despite the Supreme Court decision in Wyeth v. Levine.
Longs v Wyeth concerns Redux, one-half of the diet-drug cocktail known as fen-phen. Plaintiff sued for design defect, alleging that Redux was so dangerous a drug that it never should have been approved by the Food and Drug Administration. In February 2008 Judge Olivier dismissed the case on the ground that the FDA had approved Redux. The plaintiff moved for reconsideration of this decision in light of Levine.
Judge Olivier has just upheld his ruling. He distinguished Wyeth v Levine as being concerned with post-FDA-approval events. The claim against Redux was about pre-approval facts, all known to the FDA when it made its ruling that the drug was worthwhile.