Search caronia

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…

Here’s the second case that was sent to us by our readers.  It is a favorable decision on one of our many pet peeves, off-label promotion, In re Celexa & Lexapro Marketing & Sales Practices Litigation, 2014 WL 3908126 (D. Mass. Aug. 8, 2014).  On this one, the congratulations belong to Debevoise for winning it, and our thanks to J. Robert Abraham for being so kind as to send us a copy of the decision.

In C&L (the official title is too much of a mouthful) the defendant was sued under the California unfair competition statute (“UCL”) for “restitution” of co-payment the plaintiffs paid for Celexa.  The case was initially brought as a class action (most UCL cases these days are), but certification had been denied earlier because of the predominance of individualized issues.  Among other things, C&L demonstrates the correctness of that determination, since the reliance facts were quite peculiar.

Other than the peculiar UCL damages (personal injury is not recoverable), C&L reads like a learned intermediary rule warning causation case and applies largely the same principles.

Continue Reading Interesting Cases Sent By Users (Part II) Off-Label Promotion

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:

  1. Manufacturer responses to unsolicited requests;
  2. Scientific exchange;
  3. Interactions with formulary committees, payors, and similar entities; and
  4. Dissemination of third-party clinical practice guidelines.

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:

  • enshrinement of proportionality in Rule 26(b)(1);
  • curtailment of the capacious “reasonably calculated” standard for the scope of discovery in the same subsection;
  • Explicit rejection of the negligence-based standard for ediscovery sanctions in Residential Funding Corp. v. DeGeorge Financial Corp., 306 F.3d 99 (2d Cir. 2002), and thus by necessary implication of other precedent in that circuit following that standard (this means you, Zubulake); and
  • Requiring a finding of specific “intent to deprive another party of the information’s use in the litigation,” under Rule 37(e)(2) before any federal jury can be instructed on evidentiary presumptions from loss of electronic information.

Continue Reading Bexis’ Inbox 2014

This post is from the non-Reed Smith side of the blog only.

Since September we’ve been bringing you news from the Infuse litigation on about a monthly basis.  The overwhelming majority of that news has been positive.  And, when you’ve got a good thing going, you want to keep it going.  You also don’t want…

In Bertini v. Smith & Nephew, Inc., 2014 U.S. Dist. LEXIS 35837 (E .D.N.Y. March 17, 2014), the Eastern District of New York applied preemption to a device case that involved off-label use, even though the device didn’t receive FDA Pre-Market Approval (“PMA”) and wasn’t really used off-label.  Confusing?  Maybe. But once untangled, it’s…

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…

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