Medical device sales representatives are often present in the operating room during surgical procedures, especially with procedures involving orthopedic devices. With those kinds of devices (and others), the hospital typically contacts the sales representative in advance, and he or she is charged with delivering the device in the specified size and providing any specialized instrumentation
Game-Changing Opinion on Venue from Missouri Supreme Court
Bexis is known to say that nothing good ever comes out of Missouri, but the Missouri Supreme Court has proven him wrong. We have long made exceptions to Bexis’ proclamation for Mark Twain, Maya Angelou, and Kansas City barbeque, and we can now add to that list the Missouri Supreme Court’s new opinion in State
First Amendment Pours Cold Water on Sugary Beverage Warning Law
It is easy to articulate the core principle behind the First Amendment right to free speech: The government can’t restrict what you say or make you say what the government wants without a good reason. Ah, but how good a reason and what kind of reason? That is where it gets more complicated. How do
Can’t Tell Who Is in the Class? Class Cert Denied
What do you get when no one has been injured and the most you can say is that maybe someone received medicine made from an active pharmaceutical ingredient that may have contained—but was never actually observed to contain—a harmless contaminant? Add to that that you can’t really tell who might have used the product that
Ninth Circuit Affirms Federal Preemption Over Dietary Supplement Claims
We have taken a daily multivitamin ever since our doctor told us that we were chronically deficient in a particular vitamin, the one you can get from being out in the sun. Given our chosen line of work, we should not be surprised that we don’t get enough sunlight. We should also not be surprised
“Alter Ego” Allegations Aren’t Enough For Personal Jurisdiction
A federal court in Utah ruled the other day that it had no personal jurisdiction over a corporate parent, even though the plaintiffs alleged that the defendant subsidiary was the “alter ego” of its owner. We read the order with great interest for a couple of reasons. First, one of our first assignments out of
FDA Publishes Draft Updated Guidance on Medical Device Cybersecurity
We celebrated National Cybersecurity Awareness Month a few weeks ago by bringing you the FDA’s newly published Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook, with a promise to cover the Agency’s promised update on its Guidance for Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, which was first
Uninjured Class Members Means No Class Certification
What happens when you have a class action where some putative class members suffered an injury while others did not? Can such a proposed class even be certified? The answer depends on whom you ask. The plaintiffs/class representatives will surely point out that whether any individual class member actually suffered a compensable injury is a
FDA Continues Its Press On Medical Device Cybersecurity
Did you know that October is National Cybersecurity Awareness Month? Neither did we, until we started poking around the FDA’s recent press release announcing that it intends to update its guidance on medical device cybersecurity within the next few weeks. We also learned that National Cybersecurity Awareness Month has been observed each October since its
Plaintiffs’ Lead Counsel Off The Hook In Yaz MDL
Multidistrict litigation is not special. By making this pithy observation, we do not mean to denigrate what has become the mother of all procedural mechanisms. What we mean is that multidistrict litigation is, at its core, nothing more than a bunch of venue transfers, bringing multiple cases involving common issues before a single district judge