Defendant manufacturers of FDA-approved Class III medical devices generally do pretty well with preemption motions, as our PMA Preemption Score Card (now with well over 500 decisions) demonstrates. Conley v. St. Jude Medical, LLC, ___ F. Supp.3d ___, 2020 WL 5087889 (M.D. Pa. Aug. 28, 2020), is one of these, but some aspects of
This post is a little different. Several of my colleagues – Reed Smith attorneys Robert J. Hill, Joseph W. Metro, Kevin M. Madagan, Andrew Y. Lu, Sung W. Park, Janine R. Tougas – wrote a client alert on the four recent executive orders that concerned pharmaceutical pricing. We had
Not long ago, an EPL (evil plaintiff lawyer) relayed to us that, based on reading our posts, another EPL had assumed we had a particular political view. As we laughed at the notion, we pondered the issues of assumption and incomplete information. Much like the old quip about what happens when you assume, many assumptions
People have long been fascinated by robots. Way before the term was coined in a 1920 play or Isaac Asimov popularized it, there were stories about machines that acted like living things. The droids of Star Wars universe are famed for the likeability and pluck. However, there is still the specter that some of those
Today we bring you the DDL blog version of the “duck test.” The “duck test” goes like this – if it walks like a duck, swims like a duck, and quacks like a duck, then it probably is a duck. When you see a duck swimming in a pond, you don’t normally say: “hey, look
t’s cold in New Jersey now. At the time this post hits the blog, it will be about 20 degrees, real feel 15 degrees in most of New Jersey. That’s too cold for this blogger. That’s an extra-large cup of coffee for the ride to work. That’s two-layers of clothing to walk the dog. That’s
Today’s guest post is by Reed Smith‘s Jenn Eppensteiner. In it she discusses a recurring theme on the Blog – claimed product “defects” arising from nothing more than the failure of an implanted medical device. Case after case has recognized that the human body is a hostile environment for implants, surrounded by the
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