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FDCA
242 published works
Mass Tort Litigation Blog
Warner Lambert – Opinion Below Affirmed Without Opinion
By joetort
The no decision decision: BNA reports that an equally divided court affirmed the ruling of the Second Circuit, which had held that the FDCA does not preempt product liability claims…
Drug & Device Law
Much Is Given, Much Is Expected
By Bexis
Yeah, it was a hell of a party … but we’re sober now. One of us even got almost hilariously misquoted in the press, when the reporter got the effect…
Drug & Device Law
In California, A Four-Letter Word Beginning With “F”
By Bexis
Fish. Well, not exactly. In reading and actually thinking about yesterday's Farm Raised Salmon decision (now published at 42 Cal. 4th 1077; 175 P.3d 1170) from the California Supreme Court,…
Mass Tort Litigation Blog
Another Development in the Preemption Wars
By joetort
The Supreme Court granted cert in Warner-Lambert v. Kent, No. 06-1498. The question presented is whether the Food, Drug and Cosmetic Act preempt product liability claims under Michigan law against…
Drug & Device Law
Vaccine Preemption – A Murder At The Bates Motel?
By Bexis
How many times have we heard that, in deciding preemption issues the “purpose” or “intent” of congress is the “ultimate touchstone” that the courts must respect? Lots. We can start…
Drug & Device Law
Striking Back at Strike Suits
By Bexis
OK class, for today’s lesson, assume you are a major, sophisticated drug company. That means you have to have at least one (actually, a bunch) FDA-approved drug that’s safe and…
Drug & Device Law
Agency Deference Prevents “Evisceration” of the FDCA Regulatory Scheme
By Bexis
We’re going to discuss preemption “inside baseball” again. If that’s not your thing, then click on the “back” button. If that’s what you’re really hot to hear about, then keep…
Drug & Device Law
Finger Lickin’ Good
By Bexis
Courts have said over and over again that there's no private right of action under the Food, Drug and Cosmetic Act. There's a footnote four pages long to that effect…
Drug & Device Law
How Able Is Grable To Support Removal?
By Bexis
We were reading recent cases (yeah, we do other things, too) and part of the discussion of removal in In re Aredia & Zometa Products Liability Litigation, 2007 WL 649266…
White Collar Crime Prof Blog
Charges Against Four Related to Collapse of Generic Drugmaker
By Ellen Podgor
Able Laboratories, Inc., which made generic drugs, collapsed in 2005 due to improper manufacturing procedures at its New Jersey facility, and now a former vice president and three former chemists…