Only five days after our recent post highlighting the possible no-private-right-of-action implications of the (to us, anyway) obscure Astra USA, Inc. v. Santa Clara County, California, 563 U.S. 110 (2011), case, the Fourth Circuit applied it along the lines we had speculated could be helpful to defendants.  Bauer v. Elrich, ___ F.4th ___,

Today’s post discusses a recent implied-preemption decision that is relevant beyond the generic-drug context in which it arose.

A bit of background first.

In Buckman Company v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), the Supreme Court held that 21 U.S.C. § 337(a)—which declares that all actions to enforce the FDCA “shall be by

It’s a unique relationship based largely on knowledge and trust.  Doctor’s not only have to rely on their medical knowledge, but they need to apply that to their knowledge of the patient.  Knowledge that often develops overtime through trust.  Patients want and need to be able to trust their doctors.  Sometimes patients share information with

There was a time when we posted frequently about attempts to impose liability for injuries allegedly caused by the use of a generic prescription drug. Much of the attention has been directed to trying to pin liability on the company that developed the drug originally, even when the plaintiff took another company’s generic version. When

Back during the Orthopedic Bone Screw mass tort litigation, one of major avenues of attack on the plaintiffs’ novel claims was to pursue every state-law avenue for rejecting the assertion of negligence per se predicated on supposed violations of the Food, Drug & Cosmetic Act (“FDCA”).  That approach originally led us to 21 U.S.C. §337(a),

We’ve mentioned before that negligence per se requires a claimed violation of a definite enactment – like a 70 mile per hour speed limit – that can substitute for the ordinary negligence “reasonable man” standard.  However, we’ve never really studied it closely.  Because negligence per se seems to be flowing rather than ebbing in prescription

This isn’t the first time, but the Blog has a problem with its reporting on cases decided in the ongoing “Opioid” litigation.  As lawyers, our first obligations are to our clients, and in this instance some of our clients in the opioid litigation don’t want us talking about their cases.  So when that happens, we