Ever since the FDA decided that discretion was the better part of valor – or read the handwriting on the wall – and decided not to appeal United States v. Caronia, 703 F.3d 149 (2d Cir. 2012), to the United States Supreme Court, we’ve been wondering where the next First Amendment opportunity is going
We’ve blogged a number of times about the illogical, and often downright counterproductive, nature of the FDA’s position that regulated manufacturers are generally banned from providing the medical community (or the public) with truthful information about the off-label uses of their products. Even information about the risks of off-label uses cannot be included on a
In July, 2011 we posted about the post-Sorrell citizen petition that seven major drug companies filed with the FDA concerning the Agency’s restrictions on truthful off-label promotion.
On June 6, 2014, the FDA “granted” the petition. It’s nothing like D-Day, however. Nothing earth-shattering here. The FDA’s “grant” is more like a “dodge.”
That being said, the FDA’s response is still interesting, sometimes as much for what the Agency didn’t say as for what it did. The petition dealt with the FDA’s convoluted regulatory positions on four situations involving the dissemination of medical and scientific information about off-label uses:
FDA Response at 2. The petitioners also asked in a 2013 supplement (that is, after the Caronia decision) “that [FDA] provide clear interpretations of key definitions to assure that our regulatory scheme better aligns with . . . the limitations under the First and Fifth Amendments.” Id. at 3.Continue Reading Less To This “Grant” Than Meets The Eye
As one of our other bloggers have recently revealed, Bexis recently went on vacation for two weeks. He was diligent, however, and pre-wrote two posts (not time sensitive) that appeared in his absence. As for the co-blogger’s quip about Bexis’ “active, muscular vacations” well, in this instance that’s probably right. For most of Bexis’ two-week absence, he was rafting through the Grand Canyon.
With Bexis otherwise occupied, the blog’s other denizens did an admirable job of keeping up with current developments in case law, but nonetheless items piled up in Bexis’ inbox awaiting his return. Most of them weren’t even judicial opinions. It’s time to empty that inbox.
Perhaps the most important development was the approval, on May 29, by the full Federal Judicial Conference’s Standing Committee on Rules of Practice and Procedure, of the discovery-related rules changes that we’ve been covering on the blog. Bexis has been heavily involved in this effort through the Lawyers for Civil Justice (“LCJ”), and LCJ sent him notice of the approval. We’d pass it along, except it includes internal LCJ business as well. So we’ll just hit the highlights.
First, there were no changes to the language of the proposed amendments themselves, which we have previously discussed. The only changes from the version published in the subcommittee’s agenda book were: (1) a new sentence in Note for Rule 26(b)(1) encouraging computer search technology (that is to say, predictive coding), and (2) modifying the Note for Rule 37(e) concerning the role of prejudice in subsection (e)(2). Thus, the main benefits of the amendments from our perspective remain:
We were recently asked if we had anything on the blog about taking depositions of active FDA personnel – active as opposed to former (many of whom are available to be hired as litigation “experts”). It turns out we hadn’t, so we thought we’d take a shot.
We know this is pretty hard to do
We have seen a few decisions on discovery issues out of the In re Pradaxa MDL. By and large, they have been pretty bad. Sanctions of almost $1 million and other “remedies yet to be addressed” bad. The latest decision on a Pradaxa discovery dispute is not so bad and, important to us in
Not too long ago (March 28, and April 2) we read with interest a couple of articles on 360 that brought back unpleasant memories. The articles discussed congressional inquiries to the FDA (including “pointed questioning” of FDA Commissioner Margaret Hamburg) about undisclosed (to the public, anyway) meetings between “FDA officials” and the plaintiff’s bar concerning
This guest post is from Reed Smith’s Lindsey Harteis, who as always gets all the credit and shoulders all the blame for what follows. Her post is about the First Amendment implications of the FDA’s recent draft guidance on manufacturer distribution of scientific articles and textbooks, a proposal that alters, but does not fundamentally change
This is a guest post by Reed Smith partner Larry Sher, who was part of a team successfully representing Omnicare on a civil False Claims Act case before the United States District Court for the District of Maryland and the Fourth Circuit. The rest of the defense team included Eric Dubelier, Katherine Seikaly, James Martin and Colin Wrabley. As we have noted previously, there has been increasing overlap between the issues presented in cases under the False Claims Act (and state law mimics) and the sort of product liability cases we usually talk about here.
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Over the last few years, counsel for defendants in civil False Claims Act (“FCA”) cases have increasingly seen relators (the FCA version of plaintiffs) pushing the limits of the FCA to attempt to pressure defendants into costly settlements based on allegations that the defendant violated some regulation that really has nothing to do with the submission of any claim for money from the government, false or otherwise. Last week the United States Court of Appeals for the Fourth Circuit confirmed that the FCA is meant to combat fraud and is not a “sweeping” catch-all mechanism to address all regulatory violations in the absence of actual fraud.
In United States ex rel. Rostholder v. Omnicare, Inc., No. 12-2431, the Fourth Circuit affirmed the dismissal of a relator’s FCA complaint (and denied leave to amend) under Fed. R. Civ. P. 12(b)(6) in a case that may have a significant impact on the future of healthcare related FCA actions in the Fourth Circuit and maybe elsewhere. The Rostholder court held that because compliance with the Food and Drug Administration’s (FDA) Current Good Manufacturing Practices (cGMP) regulations is not a precondition for reimbursement under Medicare and Medicaid, violations of the cGMP regulations by themselves cannot form the basis for False Claims FCA claims. No. 12-2431, slip op. (4th Cir. Feb. 21, 2014).Continue Reading Guest Post — The Fourth Circuit Weighs In: False Claims Act Liability Under Medicare and Medicaid Cannot be Based Merely on Regulatory Violations
The FDA issued last month a draft guidance on “Regulatory Requirements for Postmarketing Submissions to the FDA of Interactive Promotional Materials.” In other words, it’s a draft guidance on which of the materials that a company intends to use on social media and similar platforms should be filed with the FDA and how