preemption

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 Immigration Reform and Control Act (IRCA) states that any information contained in the Form I-9, which is used to verify a person’s eligibility to work in the United States, may only be used for limited federal enforcement. The question the Supreme Court will decide in Kansas v. Garcia is whether the IRCA preempts states from using information contained in the I-9 to prosecute a person under state law (in this case for identity theft).

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.”

Virginia has the largest known uranium deposit in the United States. Since its discovery in the 1980s the Virginia legislature has banned uranium mining. Unsurprisingly the land owner, Virginia Uranium, wants to mine. In Virginia Uranium v. Warren the Supreme Court will decide whether the Atomic Energy Act (AEA) preempts the ban.

The AEA allows states to “regulate activities for purposes other than protection against radiation hazards.” Virginia and Virginia Uranium agree uranium mining isn’t an “activity” per the AEA so states may regulate it for safety reasons. Uranium-ore milling and tailings storage are “activities” under the AEA so states can’t regulate them for safety reasons. Milling is the process of refining ore and tailings storage refers to the remaining (radioactive) material which must be stored.

Most of the Trump administration’s disagreements over protecting undocumented immigrants have been with local governments. But on March 6 the Trump administration filed a complaint against the State of California. The administration claims three California statutes aimed at protecting undocumented immigrants are preempted by federal immigration law. The administration asks the court to issue a preliminary injunction disallowing California from enforcing the statutes.

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