We have become accustomed to doing things remotely these days. Depositions, court appearances, mediations, conferences, celebrations and family gatherings of all kinds. The variety of activities that we now do by videoconference pales only by comparison to the speed with which we adapted to this new normal. We will refrain from opining on whether we
With apologies to Harry Kalas.
Bexis had a couple of encounters with the “Wayback Machine” (a/k/a/ the “Internet Archive”) recently. If you don’t know what that is, it’s digital library of Internet ephemera – web pages and the like − that have since been taken down, revised, or otherwise have become unavailable in
It is time for our quarterly report on doings in the Nolen IVC case in the Middle District of Tennessee. Last April, we discussed a decision in the Nolen case that was rather bad on failure to warn and rather good on punitive damages. This time, in Nolen v. C.R. Bard, 2021 U.S. Dist.
The Ninth Circuit recently answered a preemption question that we had seen arise intermittently, mostly in food litigation, over the past couple of years. Because the relevant preemption clause closely resembles the language of the Medical Device Amendments, we thought it was worth a look.
In Webb v. Trader Joe’s Co., ___ F.3d ___,
This week my health care colleagues authored an industry trends report highlighting many of the major regulatory issues facing life sciences and health care companies in the coming year. The “Outlook: U.S. Health Care 2021” report includes sections on post-COVID trends and lessons learned, the future of value-based care, the intersection of health care and
Today’s case, BCBSM, Inc. v. Celgene Corp., 2021U.S. Dist. LEXIS 52785 (March 22, 2021), is an antitrust case. The plaintiffs alleged that a pharma company suppressed generic competition. We enjoy reading antitrust cases, always doing so with a healthy skepticism about the merits of the claims. We did, after all, attend the University of
One of the intriguing things about cases decided by a jurisdiction’s highest court is that pronouncements by such courts can often have far-reaching implications. Sometimes they pan out, as the application of the First Amendment to the FDA’s ban on off-label promotion seems to be doing following Sorrell v. IMS Health, Inc., 564 U.S.
A couple of years ago, we chastised a Third Circuit panel in our “Wrong Court” post, pointing out that its decision to declare an Internet marketing platform a “seller” under Pennsylvania law improperly usurped state judicial power under Erie Railroad Co. v. Tompkins, 304 U.S. 64 (1938). That decision, Oberdorf v. Amazon.com,
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
Last year the HHS Office of Inspector General issues a “Special Fraud Alert” (“Alert”) concerning “Speaker Programs” – more usually known as continuing medical education (“CME”). Since we believe that truthful commercial speech is First Amendment protected, seeing “fraud” bandied about like this caused us to take a look. We’re well aware that for years