Not quite two months ago, the Dept. of HHS published a notice of proposed rulemaking that would make a significant change in the National Vaccine Injury Compensation program. See 85 Fed. Reg. 43,791 (HHS July 20, 2020). If this becomes a final rule, it could affect the prevalence of civil litigation involving vaccines.
HHS seeks
We haven’t had a word to say on the Blog about the biggest health story in the world. That was because, until now, there wasn’t a product liability angle to it. That’s now changed. On March 17, 2020, the U.S. Department of Health and Human Services (“HHS”) published in the Federal Register a “notice of
Not too long ago we criticized a proposed “restatement” from the American Law Institute that sought to absolve plaintiffs who acted intentionally from having their conduct (such as stealing drugs, deliberately taking someone else’s prescription), count as comparative fault in the lawsuits such plaintiffs frequently file against our clients. That particular proposal has been withdrawn
As we’ve gleefully chronicled, recently the tide has been running distinctly in our favor on defendants being permitted to remove cases to federal court before plaintiffs – every one of them a non-resident litigation tourist – can serve a so-called “forum defendant” – that is, a completely diverse defendant that is also a resident
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
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
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
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
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
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