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 went to ask your dad if you could go to the party, and he

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 the opportunity to submit comments in support of the Food and Drug Administration’s (FDA) proposed rule entitled, Supplemental Applications Proposing Labeling Changes

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 drugs.

The plaintiff in the case is a woman whose husband committed suicide after taking a medication called, paroxetine, which is

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 injustice for those injured by generic drugs.

While every plaintiff’s lawyer has secretly hoped that Congress would fix the law, we’re all savvy enough

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 correctly rejected petitioners’ contention that respondent’s failure-to-warn claims are categorically preempted by the FDCA, and its decision is consistent with the decision of the

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 constitutional law, but they’re also friends and, perhaps surprisingly, share essentially the same view in one, increasingly hard-fought area of constitutional

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 strongest warning possible on the product because it can cause tissue damage leading to amputation, the Food and Drug