Articles: 1-10 of 1525
Contract Claim Based on Alleged CGMP Violations Held Impliedly Preempted
USA - September 21 2023 As defense attorneys who represent drug and device companies, we generally cheer when a state-law claim is held preempted by the FDCA. We are…
SDNY Dismisses Generic Prednisone Claims
USA - September 20 2023 Kulkarni v. Generics, 2023 U.S.Dist.LEXIS 160730 (S.D.N.Y. Sept. 8, 2023), is an interesting generic preemption (mostly) dismissal involving an “old”…
More Food Labeling Claims Preempted
USA - September 19 2023 We know this is the Drug and Device Law Blog, but the similarities between food labeling preemption and medical device preemption are just too strong…
Thinking About the FDA’s Alternative Summary Reporting Program
USA - September 18 2023 Bexis has been updating the preemption chapter of his treatise on drug/device product liability litigation. He came across several preemption…
Are RICO Claims Assignable? Maybe, Maybe Not
USA - September 15 2023 We often marvel at how plaintiffs’ attorneys find new ways to sue businesses, including under RICO. Take for example the ever-increasing number of…
Fifth Circuit FDA Decision Puzzles
USA - September 14 2023 Sometimes there are decisions that we begin to read with an expectation—perhaps based on a thumbnail from Bexis—that we will have a strong impression…
D.S.C. Dismisses Most Claims Against Blood Temperature Regulator Device
USA - September 13 2023 South Carolina is a lovely state with mostly lovely weather, though this time of year its appearance on the MAP looks like the country's jutted chin…
Plaintiff’s Expert Doesn’t Measure Up
USA - September 12 2023 If a court tells you your only non-preempted claim is one based on a theory that your labeling does not comply with the Federal Food, Drug & Cosmetic…
Another Update on Medical Abortion Litigation
USA - September 11 2023 When we last commented on the Alliance for Hippocratic Medicine v. FDA litigation, back in April, the United States Supreme Court had just stayed…
Delaware Is Definitive On No-Injury Medical Monitoring
USA - September 8 2023 As a defense lawyer, one grows accustomed to clear judicial days on which the state court can foresee forever. See Thing v. La Chusa, 48 Cal. 3d 644…
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