For a few years, it seemed like we were blogging about the Weeks case every few months. Beyond providing an opportunity for temporal quippery, Weeks caught our attention because it was one of the holdout cases against the tide of cases rejecting Conte, the crappy California case that invented innovator liability. After the
Legislation
Missouri Amends Venue Provisions To Prevent Forum Shopping
We’ve posted before about Missouri’s wretched venue rules that had allowed litigation tourists to flock to the plaintiffs’ favored St. Louis City venue in mass tort (and other) actions by joining dozens of non-residents with a single resident plaintiff. In particular, earlier this year we hailed a Missouri Supreme Court decision, State ex rel. Johnson …
More Confirming Than Surprising − CMS DTC Drug Pricing Diktat Fails in Court
We’ll get right to the point. In Merck & Co. v. United States Department of HHS, ___ F. Supp.3d ___, 2019 WL 2931591 (D.D.C. July 8, 2019), the court held that the direct-to-consumer pricing regulation proposed by the Centers for Medicare & Medicaid Services (“CMS”) – on which we’ve commented here, and here…
Further Thoughts on the Proposed DTC Advertising Drug Pricing Rule
To the surprise of almost nobody, the Centers for Medicare & Medicaid Services finalized their proposed direct-to-consumer advertising regulation the other day. That’s the one that would require a statement of the promoted drug’s “list price” in all DTC advertising. We’ve already discussed why we thought the regulation was on shaky ground in terms of…
The CMS DTC Drug Pricing Rule – FDA v. Brown & Williamson All Over Again?
We saw recently that Centers for Medicare & Medicaid Services (“CMS”) has sent its proposed “Regulation To Require Drug Pricing Transparency” to the Office of Management & Budget (“OMB”). We’d heard about this proposed regulation, of course, but we hadn’t gotten around to reading it. We finally took the time.
Many readers probably…
Biomaterials Access for the 21st Century
We’ve blogged several times about the Biomaterials Access Assurance Act of 1998, 21 U.S.C. §§1601-06. In a nutshell, the BAAA provides suppliers of “raw materials and component parts” used in the manufacture of medical devices with a “Get Out of Litigation Free” card in most situations. It allows manufacturers of “biomaterials” – defined as “a…
Yo, Canada! Oy, Vermont!
The federal right-to-try (“RTT”) adventure, which we chronicled here, and here, concluded not long ago with the final passage of S. 204, signed into law on May 30. The final bill is not materially different from the house draft we analyzed earlier. The final bill cleaned up some of the previous hastily-drafted…
Federal Right To Try Legislation – Is It Any Better? – 2018 Edition
A little more than six months ago, we reviewed then-pending federal right-to-try legislation. Since then it’s become a shiny object, capable of distracting those governing the country from more important matters. One version, H.R. 5247, just passed the House of Representatives. Another version, S. 204, which we reviewed in our prior post, passed…
More Legislation To Watch
Like a lot of large firms, Reed Smith has a number of blogs. We don’t mention them much because, DDL has product liability pretty well covered, and the others mostly don’t overlap a lot with what we do. But occasionally….
The other day, Reed Smith’s Health Industry Washington Watch blog described a couple of pieces…
Items of Interest on the Federal Civil Rules Committee Agenda
The federal Advisory Committee on Rules of Civil Procedure released its latest Civil Rules Agenda Book on November 7, 2017. A copy of it is available here. A couple of items on the agenda should be of interest to blog readers.
The first topic has to do with proposed changes Fed. R. Civ. P.…