Judge Awards Summary Judgment to Roche on Off-Label Injury Claim
December 12, 2007
DALLAS - FDA approval of a drug, even when prescribed for off-label use, precludes state law claims for failure to warn where there is no evidence rebutting the presumption that the drug's warnings were adequate, a judge has ruled. Holland v. Hoffman-La Roche Inc., No. 06-1298 (N.D. Texas).
Awarding summary judgment Nov. 15 to Hoffman-La Roche Inc., Judge Jeff Kaplan of the U.S. District Court for the Northern District of Texas dismissed with prejudice a case brought by a plaintiff who claimed he developed a severe eye infection and sepsis as a result of taking the company's CellCept drug.