Not too long ago we researched and posted about how preemption precludes private plaintiffs from second-guessing FDA decisions on the marketing and classification of the products the Agency regulates.  Looking through that post again, we note that quite a few of those decisions (although well less than half) involved commercial disputes of one sort or

To us – and we suspect to most of the exceptional public servants employed by the FDA – Sunday, August 23, 2020 will be a day they would rather forget.  On that day the Agency issued an “emergency use authorization” (“EUA”) for what is known as “convalescent plasma” for the treatment of COVID-19,

One of the advantages that the FDA (and other government agencies) have over other litigants is that it gets to ignore court decisions it doesn’t like, in hopes of trying again later in what the Agency considers a more favorable forum.  Here’s how one court described the same policy by a different agency:

Understood in

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

While the focus of this blog is on product liability cases, we have had occasion to touch upon Lanham Act cases involving litigation between commercial competitors.  One reason is because Lanham Act cases provided significant early precedent for the principle that FDA exclusive enforcement powers prohibit plaintiffs from bringing what amount to private FDCA violation

If there has been one regulatory constant over the years, it has been the FDA’s persistent position that off-label promotion is bad and that companies that engage in it are acting illegally.  Since we first encountered this agency attitude as relatively young lawyers in the 1990s, we’ve thought that this position was unconstitutional under the