Personal Injury Law

AEI Program On Off-Label Use

By James M. Beck and Mark Herrmann

We don't just practice law; we blog, too.

And we don't just blog. We also get flattered when folks ask us to write and speak about issues that concern us, so we often accept writing or speaking invitations.

The American Enterprise Institute nabbed us both this time around.

The AEI is hosting a day-long seminar about the off-label use of drugs and devices in Washington, D.C., on Wednesday, May 21, 2008. Here's a link to the description of the program.

With two obvious exceptions, the day will feature an all-star cast, including former FDA chief counsel Daniel Troy, former deputy attorney general George Terwilliger, acting assistant attorney general for the Civil Division Jeff Bucholtz, and others.

Among the others are the two exceptions -- both of your foolish blogging duo. Bexis contributed a paper called "First Amendment Implications of Restrictions Upon Truthful Promotion of Off-Label Use," in which he argues, shockingly enough, that the First Amendment permits manufacturers to say true things about the off-label uses of their products.

Herrmann (and co-author Pearson Bownas) contributed a paper called "Keeping The Label Out of the Case," which argues that a package insert may be admissible in a medical malpractice case where a particular use of a drug or device is, for example, contraindicated. But if a use is simply off-label, then the package insert is irrelevant and more prejudicial than probative, and it should be excluded from evidence.

In addition to having contributed papers, we'll both be speaking at the seminar -- and on the same panel toward the end of the day.

What a rare treat for us to be together in the same city.

It would be a treat for us to meet you, too, if you happen to be there. Please don't be a stranger.

Full post as published by Drug and Device Law on May 09, 2008 (boomark / email).