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Category Archives: Preemption

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Understanding Federal Preemption

Posted in 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 went to ask your dad if you could go to the party, and he clearly… Continue Reading

Our Comment in Support of the FDA’s Proposed Rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985)

Posted in Generic Drugs, Preemption

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… Continue Reading

Will consumers once again be able to sue generic drug manufacturers?

Posted in Generic Drugs, Preemption

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… Continue Reading

Solicitor General Files Brief in Pliva v. Mensing, Rejects Preemption

Posted in 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 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… Continue Reading

Another Wyeth Preemption Case Goes to the Supreme Court

Posted in Preemption

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… Continue Reading