Off-Label Promotion By Generic Drug Makers Is Preempted, Judge Rules

(July 26, 2016, 11:27 AM EDT) -- NEW BERN, N.C. — A North Carolina federal judge on July 20 ruled that a plaintiff’s claim of off-label promotion by generic drug makers is preempted by federal law because the manufacturers have no control over the drug’s label (Sara G. Purdue, et al. v. Wyeth Pharmaceuticals Inc., et al., No. 15-208, E.D. N.C.; 2016 U.S. Dist. LEXIS 94636).

(Opinion available. Document #28-160728-008Z.)

In 2006, Marjorie S. Newton was diagnosed with non-life-threatening atrial fibrillation. Her doctor prescribed a course of 200 milligrams a day of amiodarone,...
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