In case our title was too subtle, we think that a stack of purported inferences should neither state a claim for strict liability with a prescription medical device nor sidestep express preemption in the case of a Class III device. We have long been dubious of the idea of a true parallel claim as articulated
We recently attended the ACI Drug & Medical Device Seminar in New York, where we always enjoy catching up with old friends, making new acquaintances, and hearing what’s new in our drug and device sandbox. This year we spoke on the extensive and active litigation that is currently going on over the 340B drug pricing
It’s the most wonderful time of year, or at least Sirius channel 79 keeps telling us that. Too much food, too much drink, too much family, and not quite enough presents. Or, at least, not enough of the right presents. Or, maybe, lots of those veritable mixed bags. You know – a six pack of
Today’s guest post is from Dechert’s Chris McKeon who updates us on a rare application of the political question doctrine. As always, our guest posters deserve 100% of the praise (and any of blame) for their posts. Not that we expect the latter.
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In our earlier post, we explored whether the political question
We reported two years ago on a Third Circuit opinion holding that the federal government did not have the authority to require drug manufacturers to deliver 340B-discounted drugs to an unlimited number of pharmacies. The D.C. Circuit came to the same conclusion a year later. See Sanofi Aventis U.S. LLC v. HHS, 58 F.4th
It feels like 20 years ago when we were doing almost monthly fen-phen diet drug trials in the Philadelphia Court of Common Pleas. The old timey-air-conditioning units in City Hall, along with subways rumbling underfoot, occasionally drowned out the testimony of plaintiff experts taking both scientific studies and internal company documents out of context. That
We start with some disclaimers. Not the usual disclaimers about which of the Blog authors’ respective firms deny responsibility for the post. We disclaim that we care much about the availability of cigarettes and vaping products, except insofar as litigation over them says something about litigation over medical products and the general interplay between state
We have always been flummoxed by California’s Sherman Law. That is the California statute that purports to incorporate by reference the Food, Drug, and Cosmetic Act, supposedly making violations of that federal also offensive to state law. Why does this matter? Because there is no private right of under the FDCA, and 21 U.S.C. §
There is a documentary out on the actor Charlie Sheen and it reminded us that, long before the current denizen of the White House crowed about “winning,” that was a staple of many bizarre rants by Sheen.
We’re not ranting, whether bizarrely or sanely, but it is nice to post about yet another defense win
Not too long ago, we tried to extrapolate from a doctoral thesis on quantum dots to lessons for litigation. That “[q]uantum dots are between one-billionth of a meter and one-hundred-millionth of a meter in size” emphasized that “appreciating the scope and scale of what is being discussed can be critical.” In the spate of litigation