An amendment to the FDCA, called the “Verifying Accurate Leading-edge IVCT Development Act” – or VALID Act (cute) for short – has been wending its way through Congress. It appears intended to codify FDA regulatory authority over in vitro chemical tests, and is not the kind of thing we would ordinarily concern ourselves with on
Today’s somewhat unusual guest post is by Reed Smith‘s Matt Loughran. It concern’s the Supreme Court’s 6-3 decision to permit the government to continue enforcement of its requirement that healthcare workers (at least those in facilities that accept Medicare/Medicaid, which is most of them) be vaccinated to avoid infecting themselves and their patients
Last week the Third Circuit became the first federal appellate court to decide the question of whether federal courts have jurisdiction over COVID-related tort litigation. It concluded they did not. Maglioli v. Alliance HC Holdings LLC, — F.4th –, 2021 WL 4890189 (3d. Cir. Oct. 20, 2021). A decision directly at odds with
Back in May, we discussed the latest amendments proposed by the Advisory Committee on Civil Rules to Fed. R. Evid. 702. These amendments, while not changing the substance of Rule 702’s standards for admission of expert testimony – helpfulness, factual basis, reliability – are intended to reinforce other aspects of the Rule. These
A month ago we thought our country had turned the corner on Covid-19. Not so. The plague continues. Bad show, America. We’re sick of Covid, sick of reading about Covid, sick of the controversies, sick of the deprivations, and, most of all, sick of all the disease and death. We won’t say we’re sick of
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
We’ve heard politicians advocate importing “cheaper” prescription medical products from Canada for years. We’ve always thought the idea was ludicrous. As we said, a little more than two years ago:
Think about it. California alone has a greater population than Canada. Any large-scale importation of cheaper Canadian drugs to the United States would almost immediately
We’ve already commented about the broad scope of tort immunity conferred by the March, 2020 Notice of Declaration under the Public Readiness & Emergency Preparedness Act (“PREP Act”), 42 U.S.C. §247d-6d. That original immunity covered all aspects of government-related or sponsored production and use of anti-COVID countermeasures. It was, as one of our colleagues put
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