The decision in Riera v. Somatics, LLC, 2018 WL 6242154 (C.D. Cal. Sept. 14, 2108), comes from California, a place in which private plaintiffs bring claims against medical device companies for violations of the FDCA all the time, despite the fact that the FDCA prohibits that very kind of thing. We won’t—yet again—get into
As we roll out of bed on the day after Thanksgiving, we are often confronted with contradictory thoughts. For instance, “why did I have that third plate at dinner?” might be followed by “How can I eat some leftovers for breakfast?” Leftovers are as much of an American tradition on this day as watching videos
When it comes to medical device preemption, having Pre-Market Approval (“PMA”) is like being dealt pocket aces in Texas Hold’Em Poker. It’s the strongest starting hand you can have; a 4:1 favorite over any other two card combo. It means you’re starting in the power position. Since the Supreme Court’s decision in Riegel v. Medtronic,
One of our primary goals is to bring you the latest and greatest news in the drug and device litigation world. But sometimes we don’t learn of a case at the time it’s decided. So, then we need to move on to another of our guiding principles – if it’s good for the defense, we
This post is from the non-Reed Smith side of the blog only.
We truly dislike decisions that find that claims of failure to report adverse events to the FDA are non-preempted, parallel violation failure to warn claims. Failure to report claims are not parallel. Federal law does not require warnings to plaintiff or her doctors.
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
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
(Note that this post comes from the Cozen O’Connor side of the blog.)
Good morning. Do you have your coffee? If so, start sipping it. You will need it. Because this morning we’re going to discuss leads for implantable cardiac defibrillators (“ICD”), Riata Leads to be precise. Now, while this may not be the most
Several years ago, in a post entitled “Negligence Per Se Trivia,” we included the following:
In Kentucky, negligence per se has been codified, and claims based on federal (but not state) statutes or regulations (like the FDCA) are prohibited. St. Luke Hospital, Inc. v. Straub, 354 S.W.3d 529, 534 & n.14 (Ky.