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We’ve written a number of posts on whether, in various jurisdictions across the United States, software and other forms of electronic/magnetic code can be considered to be “products” for purposes of product liability – usually strict liability.  As befits the decentralized product liability litigation landscape in the United States, there is considerable uncertainty, but most decisions, as well as both the Second and Third Restatements of Torts, have determined that incorporeal items composed of electronic bytes are not “products.”…

Continue Reading Software as a Product – The European Union Goes There

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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…

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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…

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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…

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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…

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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

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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…

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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…

Drug & Device Resources

Bexis’ Book

FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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