The Cross-Border Biotech Blog

Biotechnology, Health and Business in Canada, the United States and Worldwide

Tag Archives: Preemption

No Preemption No Problem: State Courts Step Up

For anyone following the U.S. Supreme Court’s emerging case law on FDA approval and preemption (as we have been here, here, here, and here), it looks like the next frontier is going to be state law. With the Supreme Court’s ruling that drug manufacturers are subject to state tort claims even if they have undergone a full FDA review, liability depends on individual decisions by state legislatures and courts, which still have the power to exempt FDA approved drugs and 510(k) medical devices from tort liability in their states.

A recent decision by the Supreme Court of Arkansas has done just that. In DePriest v. AstraZeneca, the court dismissed claims brought under Arkansas’ Deceptive Trade Practices Act, holding that the Act contains a safe harbor that:

“specifically permits drug manufacturers to promote their drugs to consumers in a manner that is consistent with and supported by the labelling approved by the Food and Drug Administration.”

The court also dismissed the common law claims against the manufacturer on the grounds that FDA approval was sufficient to show that the manufacturer’s statements were not false or misleading.

Read the full opinion here (pdf).

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Corporate Liability Journal Article on Wyeth v. Levine, Reigel v. Medtronic and Medtronic v. Lohr

Check out Jeremy’s latest article, published in the current issue of Corporate Liability Journal.

In The Changing Landscape of U.S. State Tort Liability for FDA-Approved Drugs and Medical Devices (pdf), Jeremy and his co-author, Alison Varga, take a more detailed look at this year’s U.S. Supreme Court decisions in Wyeth v. Levine and Reigel v. Medtronic, which Jeremy has been following on the blog.

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News: FDA Off-Label Guidance

The FDA released updated guidance today on the use of journal articles to promote off-label uses.  Here is a link directly to the FDA guidance.

Here is the Reuters story, which notes some Congressional (Waxman) and consumer (Public Citizen’s Health Research Group) opposition, and PhRMA support.

One concern is that a permissive approach to off-label promotion will decrease incentives to file for approval of new uses.  We’re watching  to see if Wyeth v Levine will provide some new incentives in the opposite direction.

Comments on the new guidance?  Do you think it will survive in the new administration?  Discuss…

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