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,
Buckman
Situation Normal, All Federal-Questioned Up

Things have been weird. What was normal is not now. What has been common recently is not normal. The phrase “the new normal” has been so over-used that hearing it induces a sour look on our face. Somewhere in our brain—like our face, the bloggers have a single, first-person plural brain for stylistic purposes—there is…
Texas Law Yields A Better Result On A Motion To Dismiss

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…
Viewing Buckman as a Logical Contradiction Decision

As we mentioned in our recent Preemption Teaser post, last month’s concurrence in denial of certiorari in Lipschultz v. Charter Advanced Services (MN), LLC, ___ S. Ct. ___, 2019 WL 5300908 (U.S. Oct. 21, 2019), provides an indication that, at least to some extent, Justice Thomas might have found a kindred spirit of sorts…
“Fully Informing” the FDA

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…
Excellent Infuse Preemption Decision out of Eastern District of Michigan
Most Claims Dismissed with Prejudice in N.D. Cal. Amiodarone Case

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,…
Eleventh Circuit Holds Off-Label Marketing Claim Preempted under Buckman, Even When Disguised as “Negligent Marketing” Claim
On Prevention of Federal Fraud on the FDA Claims That Avoid Buckman

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,…
Pennsylvania Preemption Win Now Final

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…