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
Money for Nothing? No Standing This Time in the Third Circuit
We sometimes sit around trading stories about the dumbest lawsuits we have ever seen. Our personal favorite is a class action that the Drug and Device Law Spouse defended years ago seeking damages against a national shipping company because items sent by “Second Day Air” did not always go in an airplane. The packages arrived
California Court Incorrectly Nips And Tucks At Implied Preemption
We understand that we write a lot about federal preemption. You might even be rolling your eyes at yet another post on this most powerful of defenses, but we just can’t help ourselves. Federal regulation runs deep in the drug and medical device world, and the possibility that federal law might preempt state-law claims is
Federal Court Rules That 510(k) Clearance Relates To Safety And Effectiveness
A myth that has regrettably gained some traction lately is that the FDA’s clearance of a medical device under the 510(k) substantial equivalence process is unrelated to safety and efficacy. One notably unfair manifestation of this myth is the entry of orders in limine in a number of recent medical device cases excluding evidence of
Still No Causation, Still No “Parallel Claim”
We have made it no secret that we think the Ninth Circuit wrongly decided Stengel v. Medtronic. That is the case where the Ninth Circuit reversed express preemption of claims involving a pre-market approved medical device by divining a “parallel” state-law duty to report adverse events to the FDA. As we have said here