We had been waiting for the Utah Supreme Court’s decision in Burningham v. Wright Medical for some time. As we pointed out in a blogpost when Burningham was first certified by the district court (Utah is one of the few courts allowing district court certification), over a year ago, “[p]ractically no court has . .
This post is from the non-Reed Smith side of the blog.
It’s not a long decision – but there’s still a lot to it. Maybe that’s because there wasn’t a lot to plaintiff’s complaint. Regardless, Sharp v. St. Jude Medical, S.C., Inc., 2019 WL 3821895 (N.D.GA Aug. 14, 2019) makes some key defense rulings.
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