The Trasylol (aprotinin) Story Illustrates Why FDA Preemption is Bad Public...
The crux of the argument that FDA approval of a drug should preempt state lawsuits over that drug is that it should be experts at the FDA who decide whether a drug is safe and what warnings that drug’s...
View ArticleThe Digitek Recall Shows Us Once Again That the FDA Can’t Protect Us
A Brief History of Digitek In 1779, the English doctor William Withering discovered that the Foxglove plant could be used to treat congestive heart failure, and in 1785 he published An Account of the...
View ArticleBlack Box Warning for Amputation Finally Ordered
It came a little late for Diana Levine, but at least it finally came. TRENTON, N.J. — Makers of injected promethazine, a sedative also used to treat nausea and vomiting, are being required to put the...
View ArticleAnother Wyeth Preemption Case Goes to the Supreme Court
Bruesewitz v. Wyeth looks like it will be the Wyeth v. Levine of vaccine lawsuits: Erwin Chemerinsky, a liberal scholar, and Kenneth Starr, a conservative, may appear to be the Oscar and Felix of...
View ArticleSolicitor General Files Brief in Pliva v. Mensing, Rejects Preemption
A little late, but better than never. Especially since the Solicitor General agrees that failure to warn lawsuits against generic manufacturers are not preempted by the FDCA: The court of appeals...
View ArticleWill consumers once again be able to sue generic drug manufacturers?
Longtime readers of this (or any drug-related blog) know that the U.S. Supreme Court ruled that manufacturers of generic drugs cannot be sued for failure-to-warn claims. The ruling created a legal...
View ArticleGeneric Drug Companies Held to a Lesser Standard: It’s a Hard-Knock Life with...
Generic brands. Knock-offs. It’s probably safe to assume that all of us have used one at some point or another. Many of us use them on a regular basis. Why? Because, usually, a generic brand product is...
View ArticleBrand-Name Drug Manufacturer can be Liable for Harm Caused by its Generic...
We are pleased with a recent order issued by a Federal District Judge in Illinois, which found that, under Illinois law, a brand-name manufacturer owes a duty to consumers of generic versions of its...
View ArticleOur Comment in Support of the FDA’s Proposed Rule: Supplemental Applications...
Janice L. Weiner Center for Drug Evaluation and Research Food and Drug Administration 10903 New Hampshire Ave. Bldg. 51, Room 6304 Silver Spring, MD 20993-0002 Dear Ms. Weiner, We are grateful for...
View ArticleUnderstanding Federal Preemption
What is federal preemption? It’s an easier concept to grasp than you might think. Think back to when you were a kid, and you asked your mom if you could go to a party. She clearly said, “no.” You then...
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