The “fraud on the FDA” claim that the Supreme Court held preempted in Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), was actually the most extreme form of a private plaintiff second-guessing the result of an FDA process classifying a regulated product.  Plaintiffs claimed that, because of purported “fraud” in the §510(k)

Truly unique cases are, well, unique. Most cases involve variations or combinations of cases we have seen before. Sometimes you get different results between two decisions on basically the same case with a single fact different. In February, we posted on an Eastern District of Pennsylvania decision on a motion to dismiss in a case

One slushy morning this week, we found ourselves searching for our favorite black duck boots.   We found one and put in on, then, after much rummaging in the dark recesses of our closet, found a second.   At this point, we were on the edge of missing our train, so we put on the second shoe

Plaintiffs in (mostly) prescription drug cases have tried, with decreasing success, to limit the scope of implied impossibility preemption under the Mensing/Bartlett line of supreme court precedent to generic drugs.  It’s not a particularly satisfying rationale, but the simple claim that “those were generic drug cases” did at least convince some courts that