Drug Medication Guide Doesn’t Trump Learned Intermediary In Enbrel Case, Judge Rules

(September 30, 2015, 10:44 AM EDT) -- FORT MYERS, Fla. — The Food and Drug Administration’s requirement that the rheumatoid arthritis drug Enbrel have a medication guide doesn’t preempt Florida’s learned intermediary doctrine, a federal judge ruled Sept. 25 in granting partial summary judgment in an Enbrel injury case (Rebecca A. Small, et al. v. Amgen, Inc., et al., No. 12-476, M.D. Fla.; 2015 U.S. Dist. LEXIS 129195).

(Small opinion available. Document #28-151001-020Z.)

In 2002, Rebecca Small was enrolled in an Enbrel clinical study because she could not afford the drug. She continued...
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