The federal government and the Fourth Circuit have ruled that a charitable patient assistant program conceived to increase access to cancer drugs for needy patients violated the federal Anti-Kickback Statute. In an opinion long on canons of statutory interpretation and short on compassion for sick and dying patients, the Fourth Circuit upheld an HHS advisory
pharmaceuticals
Recent Second Circuit Implied-Preemption Decision Confirms That A ‘Major Change’ Is A Big Deal In Pharmaceutical Litigation

We’ll get to the recent Second Circuit decision, Ignacuinos v. Boehringer Ingelheim Pharms., Inc., — F.4th —-, 2021 WL 3438355 (2d Cir. 2021), in due course, but first some background.
One of our top ten decisions in 2018 was Gustavsen v. Alcon Labs., Inc., 903 F.3d 1 (1st Cir. 2018), an important implied-preemption…
CARES Act Dooms Claim Targeting the Marketing of “Infant” Acetaminophen

Today’s post is a report on Jazmine Harris v. Topco Associates, LLC, ___ F. Supp.3d ___, 2021 WL 1885981 (N.D. Ill. May 11, 2021), which dismissed on preemption grounds a putative class action that challenged as fraudulent the marketing of acetaminophen for infants. The decision, whose result departs from earlier decisions in the area,…
A Defense-Friendly Take on Albrecht

This blog has discussed Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (2019), and its progeny on multiple occasions. We provided a quick take when Albrecht was issued; discussed the decision’s possible ramifications here and here; expressed consternation at certain parts of the decision; reported here and here on how…