Prescription Drugs

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.”

In 2016, five states enacted legislation designed to mitigate a controversial health insurance procedure known as step therapy, which requires patients to try less expensive, often generic medications before being approved for costlier treatments. With the growing availability of generics step therapy, alongside prior authorization and benefit tiers, has emerged as a popular cost savings tool for private insurers, as well as Medicaid and Medicare programs.

Insurance companies and...

On July 5, 2016, Hawaii became the third state to require all public and private health insurance providers to cover 12 months’ worth of contraceptives at one time. Other states introduced similar legislation in 2016. Research has shown that this change could have enormous effects.

Kaiser Family Foundation has posted an excellent web panel discussion on drug pricing. Representatives from Pfizer, a large international pharmaceutical company; Express Scripts, and Aetna, a major health insurance carrier, talk with Larry Levitt, a Kaiser senior vice president.

Zubik v. Burwell, involving religious nonprofit objections to providing notice objecting to the Affordable Care Act’s (ACA) birth control mandate, does not directly affect state and local government. But it is one piece of a litigation puzzle over this law; most of the puzzle pieces do affect state and local government. In a three-page unauthored opinion the Court did not rule on the merits of the case leaving the lower courts to “resolve any outstanding issues.”

The ACA regulations requires employers offering health insurance to cover certain contraceptives unless employers object on religious grounds. Religious nonprofits claim that submitting a form to their insurer or the federal government saying they object to providing contraception coverage on religious grounds violates the Religious Freedom Restoration Act.  

The U.S. Food and Drug Administration announced yesterday it will require “black box” warnings on all immediate-release opioid pain medications. The target of the warning is prescribers.