Federal law regulates medical devices differently from pharmaceuticals, and branded drugs differently from generic drugs. Whether a particular state-law tort claim is preempted often depends on whether the claim involves a medical device, a branded drug, or a generic drug. Often but not always. As today’s case illustrates, there is one implied-preemption principle that applies
Medical Device
Conclusory Allegations Don’t Cut It In External Pacemaker Case
As we age, we sometimes forget how things used to be. It is not just age-related deterioration of the synapses in our hippocampi. (We do question why hippocampi and hippopotamuses are the preferred plural forms these days and why more anatomic structures are not named for things like seahorses.) There is also a recency effect. …
Banned on the Run
FDA Discretion Limited By D.C. Circuit
When we think about litigation involving the FDA, our first thought is about preemption of claims brought by product liability plaintiffs. Our second is probably the relatively recent line of cases where these plaintiffs would like no mention of FDA’s existence, let alone its requirements and actions, during the trial on their claims. However, there…
If It Walks and Talks Like a Duck . . .
This post is from the non-Reed Smith side of the blog.
Shouldn’t you call it a duck? Apparently not in New Jersey. Primarily because New Jersey is still governed by one of our Bottom Ten decisions of 2012 — Cornett v. Johnson & Johnson, 48 A.3d 1041 (N.J. 2012). Today’s ducky decision was handed…
N.D. Alabama Delivers One-Two Punch – Part Two
Last week we posted about the Daubert decision in Lowery v. Sanofi-Aventis LLC, that tossed out both plaintiff’s medical causation expert and FDA expert. As promised, that was just the first blow. The knockout came in its companion decision granting summary judgement not just on medical causation but also on the grounds of preemption.…
Vermont Learned Intermediary Law Prediction And Quirky Application In Pelvic Mesh Remand Case
In addition to having Green Mountains, maple syrup, lake houses, an ice cream company run by summer camp buddies, a mitten wearing Senator, and a history of low COVID rates, Vermont has a history of being a legal outlier. Some of its positions might be considered progressive or regressive. The legislation discussed here is a…
Eighth Circuit Affirms Refusal To Create A Contraceptive Exception To Nebraska’s Learned Intermediary Doctrine
Given the events of the last eleven months or so, we give ourselves and other legal commentators a preemptive pass for the following situation: you read a case, you think about how you would describe it, and you see that you have described similar cases in a similar way more than once. This could be…
Shameless Plug — CLE Webinar on the best and worst drug/medical device decisions of 2020
As 2020 ended, our loyal readers joined us in reviewing our worst decisions of the past year – true superspreaders of litigation against our clients – and our best decisions of the past year, which we termed “tort pandemic countermeasures.”
As we do each year, we’re pleased to announce that four of your bloggers…
Another PMA Preemption Win
Albert Einstein supposedly said, “Insanity is doing the same thing over and over again and expecting different results.” He may not have, but the point is well taken. We often think the same thing – particularly about plaintiffs that sue manufacturers of FDA premarket-approved (“PMA”) medical devices with vague, boilerplate complaints. Haven’t they heard about…