In the drug and device product liability world, we love our acronyms and our short-hand phrases. The MDAs to the FDCA. Class III. PMA. 510(k).
Today’s acronym is CGMP, which sometimes you will see written as “cGMP”. The GMP stands for Good Manufacturing Practices, and the “C” (or “c”) has, since a 1996 Final Rule
This post is from the non-Reed Smith side of the blog.
This blog has repeatedly lamented the tendency of MDL courts to flout federal pleading standards when assessing the sufficiency of master complaints. All too often MDL courts disregard Rule 8(a), which—as authoritatively interpreted by the Supreme Court in Twombly and Iqbal—requires plaintiffs to
Today we report on a recent decision dismissing manufacturing-defect, warranty, and failure-to-warn claims arising from an allegedly defective breast implant. Although the decision, D’Addario v. Johnson & Johnson, 2021 WL 1214896 (D.N.J. 2021), does not stray far from the beaten path, it covers ground worth revisiting. The decision is a useful (if cursory) reminder