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
We praised Brooks v. Mentor Worldwide, LLC, 2019 WL 4628264 (D. Kan. Sept. 23, 2019), when it was first decided, as “checking all the boxes.” Last week the Tenth Circuit affirmed, and believe us, it rechecked all those boxes.
In Brooks v. Mentor Worldwide LLC, ___ F.3d ___, 2021 WL 245246
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
Our days of the week are mostly named based on Norse mythology, but our months are firmly Roman. May is named after the deity Maia, whose Roman version was honored for her role in the growth of plants. Her cousin Juno, the queen of the Roman gods, gave us the name for June. In their
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
As we roll out of bed on the day after Thanksgiving, we are often confronted with contradictory thoughts. For instance, “why did I have that third plate at dinner?” might be followed by “How can I eat some leftovers for breakfast?” Leftovers are as much of an American tradition on this day as watching videos
Way back in law school we learned that a plaintiff suing for negligence must satisfy four elements: (1) duty, (2) breach, (3) causation, and (4) injury. Every one of these elements can be a battleground. Even what seems like the simplest inquiry – whether the plaintiff was injured – can be controversial. We have