We’ve explained at length why Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), is an anachronism with respect to preemption, given the complete overhaul that Congress gave to §510(k). Still, strange things happen when preemption meets product liability, and there seems to be a conspiracy of silence among judges with respect to current FDA
It was a Merry Christmas and a Happy New Year for Tucker Ellis’ Dustin Rawlin and his breast implant defense team – and they were considerate enough to share it with us.
Wait a minute, you might be saying, breast implant litigation? Isn’t that passé? I n a sense, we’d agree with you. This
We’ve always hated the Ninth Circuit’s decision in Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir. 2013) (applying Arizona law), holding that allegations of failure to provide adverse event reports (“AERs”) to the FDA created a viable, and unpreempted, state law claim. Now our #2 worst case of 2013 is effectively gone. Kaput.
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
This post is from the non-Reed Smith side of the blog.
You’re likely all familiar with the phrase, “don’t look a gift horse in the mouth.” Checking out a gift horse’s teeth is like looking for the price tag of the gift to see how much it’s worth. The expression is meant to convey that
This post is from the non-Reed Smith side of the blog.
What happens when a case involving a medical device that received Pre-Market Approval from the FDA survives, or at least some part of it survives, a motion to dismiss based on preemption? In recent years, as the law has developed and become increasingly favorable
First, we’ve endured MDL courts messing around with Utah law and ignoring the usual congruence in the treatment of prescription drugs and prescription medical devices under Restatement (Second) of Torts §402A, comment k (1965). We covered that kerfuffle here, here, here, and here. More recently, the Fifth Circuit in In re
This one comes from Alabama and it’s pretty straightforward – plaintiff’s claims are preempted and therefore dismissed with a little wiggle room left for an attempted amended complaint. But as we know, for Pre-Market Approved (PMA) devices, there is only a “narrow gap” between express and implied preemption through which a claim must fit to
This is not new. PMA devices should have broad preemption against product liability claims. Not just from the express preemption provisions of the MDA, but from attempts to get around express preemption by basing claims on violations of the FDCA and running smack into implied preemption under Buckman. We have talked about the
This post is from the non-Reed Smith side of the blog.
We’ve posted on two other occasions about the Shuker v. Smith & Nephew case as the Eastern District of Pennsylvania systematically dismantled the case on the grounds of preemption and pleading deficiencies. You can find those posts here and here. Unfortunately, the recent