Perhaps the biggest conflict among the circuits in PMA preemption cases involves the extent to which plaintiffs can get away with pleading essentially nothing to support supposed “parallel” violation claims, on the one hand, or on the other must plead a particularized violation of an FDA regulation (usually a “Current Good Manufacturing Practice” or “CGMP”)
As we mentioned, several of your Reed Smith bloggers are making plans to attend ACI’s annual Drug and Medical Device Litigation conference, as they celebrate the 25th anniversary of the event. We’re looking forward to great content and virtual networking opportunities – and maybe even the chance to catch up with some of
This is the third consecutive week a case from Indiana has been in our sights. By and large, we have been impressed with the quality of the Indiana judiciary in both the state and federal courts. One hallmark of exemplary judging is the capacity to revisit rulings and change course when necessary. We clerked for
Today’s topic is something a little different. We don’t usually think of after market modifications to prescription drugs and medical devices. If this were a blog about cars, computers, or almost anything with a motor or engine that can be enhanced for speed – user modifications would be a central theme. In the drug and
Although as of yet the data has not been peer reviewed, or subjected to the necessary administrative and scientific scrutiny, there has been considerable recent good news regarding the efficacy of two COVID-19 vaccines, being developed by Pfizer and Moderna, respectively.
It is now more likely than ever that within a few months the
When we last reviewed the general state of First Amendment jurisprudence, we concluded that on the United States Supreme Court there was “a slim, but solid, First Amendment majority.” Our basis for that conclusion was last term’s decision in Barr v. American Assn. of Political Consultants, Inc., 140 S. Ct. 2335 (2020),
It’s not exactly Groundhog Day, but we are sticking with personal jurisdiction. Today we’re sliding two states over to Missouri. Gateway to the West. Home to Maya Angelou, Mark Twain, Dick Van Dyke, and John Goodman. Birthplace of the waffle cone and home to the largest beer producing plant in the country. Unlike Indiana, Missouri
We’ve all seen lists of so-called hellhole jurisdictions — court systems that treat corporate defendants brutally. What about a list of the places where corporations get a fair shake? Indiana would be on that list. Jurors in the Hoosier State don’t casually toss around multimillion dollar verdicts. Further, both federal and state judges in Indiana
Procedural considerations often decide cases. Sometimes, weighty legal issues are reached through quirky procedural routes. When it comes to whether state tort law provides medical monitoring as a remedy for people who do not have a present compensable injury, that is a legal (and policy) issue. We have written many times that we think foundational
Like many of you, we spend a large portion of our professional life litigating cases consolidated in MDLs. MDLs serve a purpose in this “mass tort” world, but they also breed laziness and complacency among plaintiff lawyers who amass “inventories” of clients they’ve never met and about whose claims they know nothing in the hope