Does Buckman v. Plaintiff's Legal Commmittee, 531 U.S. 341 (2001), apply any time that a plaintiff raises a fraud on the FDA allegation in litigation, or is it limited to causes of action denominated "fraud on the FDA? Most courts have agreed with the Sixth Circuit that Buckman applies across the board. See , 385 F.3d 961 (6th Cir. 2004). A persistent minority, however, has limited Buckman to complete "fraud on the FDA" causes of action. See Desiano v. Warner-Lambert & Co., 467 F.3d 85 (2d Cir. 2006). The Supreme Court attempted, but failed, to close the split in Desiano, but failed - splitting 4-4. See Warner Lambert LLC v. Kent, 552 U.S. 440 (2008). Garcia v. Wyeth-Ayerst Laboratories
Both Garcia and Desiano involved the "fraud on the FDA" exception to a Michigan tort reform statute that imposes a presumption of adequacy on warnings that are FDA approved - that is, just about every warning. The Michigan statute was essentially dispositive.
Then Texas passed a similar presumption statute that is almost as dispositive in the ordinary case as Michigan's. It was only a matter of time before the Fifth Circuit would be called upon to decide the same question as in Garcia/Desiano.
Also in the mix is the Supreme Court's later, extremely anti-preemption, decision in Wyeth v. Levine, 555 U.S 555 (2008).
We're pleased to be able to report that, unanimously, the Fifth Circuit has agreed with Garcia and given Buckman a broad reading that can't be avoided by simple pleading strategems. The rationale of Buckman applies anytime fraud on the FDA is asserted by a civil litigant.
Please see full article below for more information.
Firefox recommends the PDF Plugin for Mac OS X for viewing PDF documents in your browser.
We can also show you Legal Updates using the Google Viewer; however, you will need to be logged into Google Docs to view them.
Please choose one of the above to proceed!
LOADING PDF: If there are any problems, click here to download the file.