Learned Intermediary Doctrine: Required By Law?

Law360, New York (July 17, 2007, 12:00 AM EDT) -- For decades, pharmaceutical companies have relied on the widespread acceptance of the learned intermediary doctrine, which protects companies from liability if they provide sufficient warnings to prescribing physicians (the “learned intermediaries”).

This state tort law rule has existed in harmony with FDA’s extensive regulation of physician warnings.

This harmony was substantially disrupted on June 27, 2007, when West Virginia’s Supreme Court of Appeals made it the first state to reject the learned intermediary doctrine.

In State ex. rel. Johnson & Johnson Corp. v. Karl, West Virginia’s...
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