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:
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
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 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
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
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
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
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
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
When we were on a jury last month we were warned not to consult any outside sources. And we didn’t. When we were in high school last century and studied the works of Eliot, Lawrence, Joyce, Waugh, and (another) Eliot, we were instructed not to consider extraneous issues, such as biography or social conditions. Our