Food and Drug Administration

Merck v. Albrecht is a simple issue contained in a long story.

In 2009 in Wyeth v. Levine the Supreme Court held that federal law preempts state law failure to warn claims that a drug manufacturer failed to change a drug label if there is “clear evidence” the Food and Drug Administration (FDA) would not have approved the label change. In Merck v. Albrecht a unanimous Supreme Court held that a judge rather than a jury determines if the FDA would have approved the change.

The federal Food, Drug, and Cosmetic Act (FDCA) provides no federal remedy for unsafe and ineffective drugs but state law may in the form of a failure to warn claim. The FDA allows manufacturers to change warnings on drug labels when newer drug safety information becomes available. The Supreme Court has held if the FDA would not have approved a drug label change, which a state failure to warn law would have required, the FDCA preempts the state law claim.

The Supreme Court has long resolved whether and when state law claims against drug manufacturers are preempted by federal law. The Third Circuit ruling in Merck Sharp & Dohme Corp. v. Albrecht is very favorable to state-law claims and likely will be modified, if not reversed, by the Supreme Court.

The Food and Drug Administration’s (FDA) approval of a drug warning label does not necessarily insulate drug manufacturers from state-law failure-to-warn claims. In Wyeth v. Levine (2009), the Supreme Court held that state failure-to-warn claims are preempted when there is “clear evidence” the FDA would not have approved the warning a plaintiff claims was necessary. In Merck Sharp & Dohme Corp. v. Albrecht, Merck claims there was such “undisputed” evidence in this case but the Third Circuit improperly allowed the case go to a jury for “conjecture as to why the FDA rejected the proposed warning.”