Earlier this year we discussed the application of Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), to a variety of private litigation that sought to second-guess the FDA’s drug or medical device classification decisions.  Then we followed up with what we described as a “doozy” of a case along the same lines,

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 of the more peculiar things about Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (U.S. 2019) (“Albrecht”), is the almost off-hand way that the majority (made up mostly of justices that have opposed preemption in closer cases) wandered away from the procedural preemption issues that the Court was

Indulge us for a moment as we recount another airline adventure. Recently, we traveled thousands of miles to an important argument. Our first flight boarded right on time, left the gate right on time, and taxied down the runway . . . partway. Then stopped. Enter the inevitable announcement: “Ladies and gentlemen, we’re very sorry,

Private plaintiffs love to scream “fraud on the FDA”!  Agency fraud is their magic potion for dissolving any FDA action that they don’t like.  Just assert that the FDA was bamboozled and invite some jury somewhere to ignore what the FDA actually did.  Unfortunately for the other side, Buckman Co. v. Plaintiffs Legal Committee,

A year and a half ago we celebrated a rare prescription drug preemption win in the Philadelphia County Court of Common Pleas.  Then the decision was appealed, and we held our breath.  Preemption is never an easy sell in state courts, and Pennsylvania appellate courts are not exactly defendant friendly in prescription medical product liability