Florida courts are handling a lot of lawsuits. Lots and lots of lawsuits, and for a convergence of reasons. Backlogs from pandemic-related closures and delays. The highest per capita rate of federal court personal injury cases in the country by some measures. Claims over last year’s Category 4 Hurricane Ian. Recent tort law changes
Warning Adequacy
FDA Finalizes Guidance on Prescription Drug REMS

The FDA recently published its Final Guidance on REMS programs for prescription drugs, which we thought might interest our readers. The document is formally called “Format and Content of a REMS Document: Guidance for Industry” and you can download and review the Final Guidance here. You might be thinking two things at this moment: …
Quasi-Guest Post – Feel the Brr: Cryotherapy Manufacturer Wins in Florida

What follows is another “guest post” by our sixth (actually seventh)-man poster, Dean Balaes. It features litigation that the good guys won the old-fashioned way – with warnings that were adequate as a matter of law. Take it away Dean.
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Legal professionals know all too well that building a healthy and active lifestyle…
Texas Presumption of Adequacy Precludes Prempro Claims

Happy San Jacinto Day. On April 21, 1836, Texans won the battle of San Jacinto, the last battle of the Texas revolution, in which Texas secured its independence from Mexico. In the past 185 years, Texans have never ceased showing an independent streak.
That is true for Texas product liability law. It is uncommonly sensible.…
Delaware Court Weighs In On Texas Law And Dismissal Ensues

Delaware is having something of a moment in the sun. Although the state’s license plates have long announced it as “The First State,” that refers to being the first to ratify the U.S. Constitution. It is the second smallest in size and sixth smallest in population of the current fifty states. The casual peruser of…
Adequate Warnings Need Not Specify Defects, Mechanisms, or Sequelae

Consider this an addendum to the “Adequate Warnings Should be Enough” post that Bexis wrote back in February. What makes a warning “adequate”? Insistence on truth and completeness is of little help. One does not have to be one of history’s all-time villains to ask what is truth, and it is just as legitimate to…
More Great News from the Taxotere MDL

Yesterday afternoon, only a few minutes after we saw the storm warning and cut short our walk with the Drug and Device Law Little Rescue Dogs, a brief but violent thunderstorm crashed through our neighborhood in the western suburbs of Philadelphia. (We note, parenthetically, that the adjective “violent” describes our weather with unprecedented and escalating…
Adequate Warnings Should Be Enough

It seems so obvious as not to require a citation – but this is the Drug and Device Law Blog, so we’ll provide some anyway.
Furnishing an adequate warning satisfies a product manufacturer’s duty to warn.
Thus, in a prescription medical product case, “if the manufacturer provides complete, accurate, and appropriate warnings about the product…
Brand & Generic Defendants Win in Amiodarone Litigation

You’ll find plenty of decisions from the amiodarone litigation discussed on the blog. Not surprisingly, because it is a generic drug, they almost exclusively focus on Mensing preemption – or we should say on plaintiffs’ attempts to bypass Mensing. But there are cases involving exposure to the branded product as well. And earlier this…
Adequate Warnings plus No Warnings Causation Equals Summary Judgment for Defendants in Risperdal Gynecomastia Case

We love the unexpected. We loved standing up after what we thought was the finale of the fireworks show last night only to be left breathless by a stunning and unexpected encore. We loved walking in to a “quiet family dinner” for our recent advanced birthday to find the room filled with dear relatives and…