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
In the third of the three significant decisions issued in the In re Zantac MDL, No. 2924, on New Year’s Eve, preemption prevailed again – this time barring claims asserted against drug retailers and pharmacists, both branded and generic. In re Zantac (Ranitidine) Products Liability Litigation, ___ F. Supp.3d ___, 2020 WL 7864585 (S.D.
February is a fine time to cuddle up with a good book or a short case. Take a look at In re Xarelto Products Liability Litigation, 2021 WL 493069 (E.D. La. Feb. 10, 2021). Pro se plaintiffs brought a lawsuit claiming their relative died from a brain hemorrhage caused by Xarelto. Their case was
We are six weeks into 2021 and for most, it stills feels a lot like 2020. We are starting to hear about restrictions being lifted or modified to allow for more . . . well more anything. But that’s happening just as almost the entire country is being overwhelmed by a polar vortex. Ice, snow,
By now our beef with Multidistrict Litigations has become monotonous: plaintiff lawyers assemble enormous inventories of weak cases, then contort the bellwether pool to ensure that only their best cases go to trial. We remember an oral argument in front of an MDL judge in which we employed statistics to show that a representative MDL