Statute
FDCA
242 published works
Drug & Device Law
A Day Shopping At Walmart and Mensing Preemption
Are any of you Walmart shoppers? Would you admit it? This DDL blogger does. Walmart sells everything, and at prices too good to pass up: HDTVs, electronics, car stuff, refurbished…
Drug & Device Law
Wisconsin Preemption Ruling Makes Our Cheese Curdle
A federal judge in Wisconsin issued an order a few weeks ago that covers two topics on which we often write—negligence per se and implied preemption. The two concepts are…
Drug & Device Law
First Amendment Follow-Up
By Bexis
The other day, we posted about, inter alia, the Department of Justice’s proposed jury instruction, in the Vascular Solutions case in Texas conceding the legality of truthful off-label promotion. In…
Drug & Device Law
California Supreme Court – Presumption Against Preemption Still Around
By Bexis
Last month, in Quesada v. Herb Thyme Farms, Inc., 361 P.3d 868 (Cal. 2015), the California Supreme Court did to “organic” foods what it had done to most other foods…
Marler Blog
Putting Prosecuting Food Producers in Perspective
By Bill Marler
So, when to prosecute and when to not? What are the criteria, if any, that the Justice Department now uses to decide to prosecute? For those that are prosecuted, does…
Mass Tort Defense
Stay in Amarin Extended
By Sean Wajert
The court recently extended its stay of the proceedings in Amarin Pharma Inc.'s suit against the FDA challenging threatened agency action concerning t
Drug & Device Law
In Case of Good Judge, Break Glass – Implied Impossibility Preemption in Cases Involving §510(k) Cleared Medical Devices
By Bexis
We have alluded on a couple of occasions to the likelihood that the recent generic drug implied impossibility preemption decisions in PLIVA v. Mensing, 131 S. Ct. 2567 (2011), and…
Drug & Device Law
Guest Post – The Sweet Smell of Preemption Overcomes Plaintiffs’ Stinky Consumer Fraud Claims
By Bexis
What follows is a guest post from Reed Smith’s Andrew Stillufsen, an associate in our Princeton office. He discusses a new FDCA preemption case involving a cosmetic, rather than a…
Marler Blog
Food “Crimes” – When to Prosecute and When to Not?
By Bill Marler
Is it time for prosecutors to set forth clear guidelines for who is prosecuted and who is not? A few weeks ago I was quoted in an article entitled “Will…
Drug & Device Law
Evening The Score On Off-Label Use Information
By Bexis
Two stories in 360 yesterday – the timing was pure coincidence – have us thinking again about the FDA’s muddled and increasingly untenable position on truthful off-label “promotion” – broadly defined as any…