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
We Report on FDA-Based Failure-To-Report Claims – A Fifty-State Survey (Part 1)
Not too long ago we discussed the decision in In re Allergan Biocell Textured Breast Implant Products Liability Litigation, 2021 WL 1050910 (D.N.J. March 19, 2021) (“TBI”). TBI addressed quite a few topics, one of which was the first nationwide (or close to it) analysis of whether a given jurisdiction permitted, under
Civil Rules Committee Proposes to Toughen Rule 702
For almost as long as we’ve been blogging, we’ve complained about some courts’ flaccid and lackadaisical Daubert gatekeeping. It’s not just trial courts, but courts of appeals as well. Now it appears that the Advisory Committee on Civil Rules of the Federal Judicial Conference shares our frustrations. The Committee recently approved a couple of
Possibly Off-the-Wall Ideas Triggered by Recent Cases
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.
Bexis Writes Another Law Review Article On Off-Label Use
Back in 1998, Bexis published the first major law review article about off-label use of drugs and medical devices and tort liability, James Beck & Elizabeth Azari, “FDA, Off-Label Use, & Informed Consent: Debunking Myths & Misconceptions,” 53 Food & Drug L.J. 71 (1998). This article came to be cited twice by the United States
Revisionist Drug History Litigation Hits East Coast
We lived through the AIDS epidemic – which is more than we can say for some of our friends. We were in law school when people started dying. Throughout our careers as junior lawyers AIDS was a death sentence. We attended memorials. We walked in AIDS walks. We’ve seen the AIDS quilts. Ask Dr. Anthony
If at First You Don’t Succeed – Incretin Edition
When last we tuned into the In re Incretin-Based Therapies (“Incretin”) multi-district litigation, the Ninth Circuit had just undone a preemption-based dismissal – but only on procedural grounds. As we discussed, here, the Ninth Circuit avoided the merits, but ruled that the MDL court had erred in “rel[ying] on Buckman [Co.
Something Interesting We Didn’t Know
Sometimes we get an opinion back from a court, and the reasoning leaves us scratching our heads and wondering, “Where did that come from?” In the opinion, the court has decided the case on something that neither party ever argued. We blogged about a case like that once, here. In that case at least,
Ford Personal Jurisdiction Case Decided – In-State Plaintiffs Win; Forum Shoppers Lose
We’ve blogged about the United States Supreme Court’s pending personal jurisdiction cases before. Well, they pend no longer. Yesterday the Court unanimously (with a couple of concurrences) ruled that resident plaintiffs injured by products originally manufactured and sold elsewhere could sue a nationwide company like Ford – that “purposefully avail[ed] itself of the privilege
Wrong Court Redux – Novel Valsartan Predictions Defy Erie & Third Circuit Precedent
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,