Statute
FDCA
242 published works
Drug & Device Law
“A Causal Relationship Need Not Have Been Proved”
By Bexis
Here’s a dirty little secret – plaintiffs’ lawyers really love preemption. They love it, but they won’t ever admit it. To them, it’s a doctrine that dares not speak its…
Ad Law Access
GAO Concludes FDA Should Strengthen its Oversight of GRAS Ingredients
By Kelley Drye
This post was written by Sarah Roller On March 5, 2010, the General Accountability Office (GAO) issued a report evaluating the Food and Drug Administration’s (FDA’s) policies concerning food ingredients…
Drug & Device Law
9th Cir – No Negligence Per Se Claim for Off-Label Promotion
By Bexis
In an (unfortunately) not-for-publication opinion, the 9th Circuit affirmed a defense summary judgment in Carson v. Depuy Spine, Inc., No. 08-56698, slip op. (9th Cir. Feb. 16, 2010). There's nothing…
Drug & Device Law
Off-Label Promotion and False Claims
By Bexis
We don't routinely follow qui tam litigation involving our clients. It's not something that we, personally, defend against. It's not our sandbox; qui tam trolls are the responsibility of other…
Drug & Device Law
Generic Preemption – Still Kicking
By Bexis
There's life in generic preemption yet. The court in Gaeta v. Perringo Pharmaceuticals, slip op. (N.D. Cal. Nov. 24, 2009), has denied reconsideration of the preemption summary judgment entered last…
Drug & Device Law
Mensing – Brand Name Wins, Generics Lose
By Bexis
The Eighth Circuit gave brand name drug manufacturers cause to give thanks yesterday, but for generics, is was Black Friday. In Mensing v. Wyeth, Inc., No. 08-3850, slip op. (8th…
Drug & Device Law
Twombly/Iqbal Requires Identifying Allegedly Violated Statute
By Bexis
Although even the academic critics of Twombly/Iqbal have agreed with us that vague "you violated the FDCA" pleadings should not survive a motion to dismiss, apparently there are still lawyers…
Drug & Device Law
Twombly/Iqbal And Product Liability: How Much Progress Is There?
By Bexis
Earlier in the week we got tagged by Amlaw for one of our posts about how boilerplate design and manufacturing defect claims recently got dismissed under Twombly/Iqbal. That’s cool. Amlaw…
Drug & Device Law
Read The Blog, Luke!
By Bexis
C'mon, guys. We publish this blog for a reason. Pay attention. We've explained over and over again that plaintiffs often cannot pursue alleged violations of the Food, Drug, and Cosmetic…
Drug & Device Law
Strike Suit Strikes Out
By Bexis
We're pleased by the dismissal of Myers-Armstrong v. Actavis Totowa LLC, 2009 WL 1082026 (N.D. Cal. April 22, 2009). In M-A, the defendant was basically shut down by the FDA…