James Beck

1 month ago | lexology.com | James Beck

We were promised “radical transparency” by the incoming Secretary of HHS. We recently received something that, while meeting the description of “radical,” doesn’t exactly fit the definition of “transparent.”  Since 1971, that is for over 50 years, HHS has had a policy called the “Richardson waiver” (after Elliot Richardson), whereby it expanded the “notice and comment” concept created by the Administrative Procedure Act, beyond the bare minimum required by the APA itself.

2 months ago | lexology.com | James Beck

We read a brief from the other side recently that claimed that Loper Bright Enterprises v. Raimondo, 603 U.S. 369 (2024), abolished implied preemption altogether. We kid you not. Under the heading, “Implied preemption is an unconstitutional intrusion into the dual sovereignty of the States,” plaintiffs made the following pitch:The Supreme Court elucidated the contours of judicial deference and statutory construction in Loper Bright v. Raimondo, 144 S. Ct. 2244 (2024). A reading of Wyeth[ v.

Sep 11, 2024 | mondaq.com | James Beck

We recently examined one possible beneficial impact of the Supreme Court's recent landmark decision in Loper Bright Enterprises v. Raimondo, 144 S. Ct. 2244 (2024) – that it could bring about critical re-examination of the FDA's questionably supported ban on truthful off-label speech. Well here's another one:Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996).

Aug 29, 2024 | mondaq.com | James Beck

In Cajun French "tracas" means trouble, or so the Internet says. Bexis is updating the learned intermediary rule section of his product liability treatise, and he noticed a little tracas brewing in Louisiana. We're calling it out so that defense counsel litigating in Louisiana are aware of it and (we hope) can do something about it.

Apr 29, 2024 | lexology.com | James Beck

As we’ve discussed, such as here, Fed. R. Civ. P. 702 was amended in late 2023, because the Civil Rules Advisory Committee concluded that too many courts were erroneously admitting expert testimony that proponents had not established was reliable. It does appear that at least some courts are cracking down. Here’s one from an Eighth Circuit court, which is significant since the Eighth Circuit was one of the worst offenders under the prior version of Rule 702.