Saturday, April 2, 2011

Comments on oral argument in case re preemption on claims for damages caused by generic drugs

As I mentioned a few days ago, the Supreme Court heard oral arguments on PLIVA v. Mensing, Actavis v. Mensing, and Actavis v. Demahy on the right to sue in state court when a generic drug maker fails to change its label to warn consumers of new harmful side-effects. For some background information on this case, go to my previous post on it here. For all the relevant documents, lower court opinions and briefs go here.

The defendants claim federal law preempts state lawsuits because their effect could be to force the defendants to offer labeling that is different from what appears on the label of the brand-name drug. For more on the case go to Pharmalot and for a preview of the oral argument go here.

For the transcript of the oral argument go here. To listen to the oral argument, go here.

Steven Schwinn has a good summary here at the SCOTUS blog.

Obviously, the oral argument has generated a lot of attention. Here are some of the links:

The FDA Law Blog has a short comment. Bloomberg’s Greg Stohr notes that “[t]he case may turn on which of of two precedents the court concludes should apply — the 2009 ruling in a case involving Wyeth or a 2001 decision that barred suits claiming FDA product approval was obtained by fraud.” The New York Times, CNN, and the Associated Press have additional coverage of the argument.

The Drug and Device blog has a long comment on the case, which they start by admitting that they are "conflicted" on the issue.

Kali Borkoski of the SCOTUS blog reports that At the Constitutional Accountability Center’s Text and History blog, Elizabeth Wydra suggests that – just as it did in its 2009 decision in Wyeth v. Levine, which dealt with a similar question for brand-name drugs – the Court seems likely to divide five-four. The Times-Picayune and the ABA Journal also have coverage of the case, with both reporting that the Court seemed “evenly divided”; both also focus on a question by Justice Sonia Sotomayor, who asked PLIVA’s counsel whether he thought that ”Congress really intended to create a market in which consumers can only sue brand-name products? Because if that’s the case, why would anyone ever take a generic?” Finally, the Minneapolis Star Tribune (thanks to How Appealing for the link) has a story on the case that focuses on Gladys Mensing, the respondent in the case.

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