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From our very first post back in early 2020 on preclusive power of the PREP Act, 42 U.S.C. §247d-6d, we were impressed by the scope of its combined preemption and immunity language.  There, we quoted the language from the HHS secretary’s emergency declaration:

[A] covered person shall be immune from suit and liability under federal and state law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration to or use by an individual of a covered countermeasure.

Quoting 85 Fed. Reg. 15198, 15199 (HHS March 17, 2020).Continue Reading Deconstructing the PREP Act

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We have been reporting on third party payer/payor (“TPP”) litigation for a long time.  This category covers a range of causes of action and allegations but boils down to boils down to insurance companies or other entities trying to recover amounts they paid for patients to receive medical products because the manufacturers or sellers…

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It seems like a rather basic 1-L contract law proposition, but it bears repeating.  If you want a particular term in your contract, get it in writing.  A recent drug bulk supplier case bears this
out – and some unknown contract lawyer out there is probably feeling some heat because of it. The situation in…

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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