We recently discussed how “failure-to-recall” claims essentially don’t exist – outside of a couple of limited fact patterns that plaintiffs asserting such claims in litigation involving FDA-regulated products can almost never allege. Today’s post adds the constitutional defense of preemption to good, old-fashioned state-law failure to state a claim.Continue Reading Bartlett Pairs – “Failure To Recall” As a “Stop-Selling” Variant
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Trying To Make Some Sense Out of OTC Economic Loss Decisions
By Bexis on
Over-the-counter (“OTC”) drugs are protected from civil liability by an express preemption provision that is even stronger than the medical device preemption clause interpreted in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008). That provision is:
…Except as provided in subsection . . . (e) . . ., no State or political subdivision of a State may establish
Reading Tea Leaves: Judge Brown Jackson’s Decisions Relevant To Product Liability
By Eric Alexander on
In the coming weeks, there are sure to be many articles looking at what Judge Brown Jackson has written and what that might suggest about the future jurisprudence of the United States Supreme Court if she is confirmed. We will not predict what will happen in confirmation. We will, however, weigh in on what Judge…
We Report on FDA-Based Failure-To-Report Claims – A Fifty-State Survey
By Bexis on
Not too long ago we discussed the decision in In re Allergan Biocell Textured Breast Implant Products Liability Litigation, 537 F. Supp.3d 679 (D.N.J. 2021) (“TBI”). TBI addressed quite a few topics, one of which was the first nationwide (or close to it) analysis of whether a given jurisdiction permitted, under state…
Prescription Medical Product Causation – Expert Required
By Bexis on
We recently blogged about the final chapter (at the district court level, anyway) of the big defense win in the Mirena MDL. The long-overdue result was entry of summary judgment for the defendant against all claims. As the blog also chronicled, the key Mirena decision had been earlier – and was already appealed and…
(New) Medical Device PMA Preemption Scorecard
By Beck/Herrmann on
After Riegel v. Medtronic, Inc., 128 S. Ct. 999 (2008), was decided, we decided it was time to retire our old device preemption scorecard. The big question, whether PMA device manufacturers are protected by preemption, was resoundingly answered “yes.”
But since then, we’ve said repeatedly that we don’t expect plaintiffs to just fold…