Statute
FDCA
242 published works
The Appellate Strategist
The Gap Between Express and Implied Preemption Narrows In The Ninth Circuit
The Ninth Circuit Court of Appeals recently shrank universe of state law claims pertaining to Class III medical devices that remain untouched by Riegel express preemption or Buckman implied preemption. In…
Drug & Device Law
Bartlett – Take It Up
By Bexis
The First Circuit decided Bartlett v. v. Mutual Pharmaceutical Co., No. 10-2277, slip op. (1st Cir. May 2, 2012) today - suggesting that it is the worst court of appeals…
Drug & Device Law
If At First You Don’t Succeed….
By Bexis
Sometimes good ideas don’t prevail the first time – or even the first few times – they make their appearance. With that in mind we bring to your attention Windle…
Drug & Device Law
Pain Pump Plaintiff’s Promotion-Based Punitives Precluded
By Bexis
It’s déjà vu all over again. Taking a rather tattered page from the Bone Screw plaintiffs’ spectacularly unsuccessful playbook of a decade ago, at least some plaintiffs in the every-man-for-himself…
Ad Law Access
Fourth Circuit Clarifies Scope of Federal Preemption for Requirements Governing Medical Devices
By Kelley Drye
The United States Court of Appeals for the Fourth Circuit recently affirmed a West Virginia federal district court's holding that a plaintiff's common law tort claim was preempted by the…
Drug & Device Law
More Breaking News – Generic Preemption
By Bexis
Today's decision in Guarino v. Wyeth, No. 8:10-cv-2885-T-30TGW, slip op. (M.D. Fla. Nov. 11, 2011), contains the following interesting holdings: (1) Mensing, being an implied preemption case, contains no exception…
Drug & Device Law
You Heard It Here First
By Bexis
Yesterday's Wall Street Journal has an interesting article about the FDA's off-label promotion ban being "in some jeopardy" after the Supreme Court's Sorrell decision, and pointing to the Caronia case,…
Drug & Device Law
Four More Reasons To Love TwIqbal
By Bexis
Bexis was away on vacation last week. When he returned, he found four more reasons why we (on the defense side) should love TwIqbal. These four opinions have been duly…
Drug & Device Law
We Don’t Recall
By Bexis
We’ve been around the preemption block a few times – we know what happens when the mainstay claim in prescription medical product liability litigation, that being inadequate warnings, gets preempted. We first…
Ad Law Access
Sens. Hatch and Harkin Send Letter to FDA in Anticipation of NDI Guidance
By Kelley Drye
Senators Hatch and Harkin, the principle architects of the Dietary Supplements Health and Education Act (DSHEA) (amending the Federal Food Drug and Cosmetic Act (FDCA)), submitted a letter yesterday to…