preemption

The Supreme Court held 6-3 in Virginia Uranium v. Warren that Virginia’s statute prohibiting uranium mining isn’t preempted by the federal Atomic Energy Act (AEA).

The State and Local Legal Center (SLLC) filed an amicus brief arguing for this result. The SLLC brief encouraged the Court to not inquire into the intent of the Virginia legislature in deciding whether the statute was preempted. Justice Gorsuch, writing for himself and Justices Thomas and Kavanaugh, went to such great length discussing “the perils of inquiring into legislative motive,” that Justices Ginsburg, joined by Justices Sotomayor and Kagan, only joined his plurality opinion as to its result (not its reasoning).

Atlantic Richfield Co. v. Christian is a complicated case raising three legal issues which the Supreme Court has agreed to decide. To summarize the case in one sentence, the owners of a Superfund site object to having to take remedial action not required by the Environment Protection Agency (EPA) to benefit landowners located within the bounds of the site.   

The Anaconda Smelter, now owned by ARCO, processed copper ore from Butte for nearly one hundred years before shutting down in 1980. That same year Congress enacted the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) or Superfund law. The purpose of this law is to “foster the cleanup of sites contaminated by hazardous waste, and to protect human health and the environment.”

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.”

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