FDA On Preemption

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It’s been a little slow over the holidays so we’ll go back to something that happened last year.  On December 16, 2014 – almost three whole weeks ago – the Solicitor General filed his brief responding the Supreme Court’s request for the government’s views in the case called Teva Pharmaceuticals USA, Inc., v. Superior Court Of California, Orange County, No. 13-956.  Here’s a link to the case’s SCOTUSBlog page.  The prior published opinion in this case, Teva Pharmaceuticals USA, Inc. v. Superior Court, 158 Cal. Rptr.3d 150 (Cal. App. 2013) (which we’ll call “Pikerie” because that’s the plaintiff’s name), involved preemption in the generic drug context.  Here’s our description of Pikerie from the blog’s generic preemption scorecard:

Overruling of demurrer affirmed.  A duty to update claim is not preempted.  It is not impossible to update warnings that the FDA has ordered changed, it is required. Following Fulgenzi.  A “Dear Doctor” letter claim is not preempted, to the extent that the communication followed FDA-approved updates in the labeling.

Long-time readers might recall that the last time the SG’s office was invited to weigh on the FDCA and preemption of product liability litigation, in the Stengel case, it produced a ridiculously cramped version of PMA preemption that sought to emasculate Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), and would have allowed virtually every claim to escape preemption.  We reported on that here.  Equally bizarrely, after explicitly stating that “every” court of appeals since Riegel had (in his view) gotten Riegel wrong, the SG in Stengel nonetheless recommended that certiorari be denied – hardly the a position taken by a litigant confident that the Court would agree with its position.

Then we have the FDA trying to amend the FDCA administratively to eliminate generic drug preemption altogether, which we have discussed on
several occasions.

Thus, we know that this administration is at least as hostile to FDCA-related preemption as the prior administration was supportive. Given that “duty to update” cases are really lousy cases for plaintiffs for a host of reasons unrelated to preemption (that’s why they’ve never been brought before), we’d have to think long and hard before doing something that would give this same crew a chance to take shots as preemption under Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001).  But the generic industry seems to have concluded it’s worth it, and their lawyers aren’t dumb.Continue Reading SG’s Reign of Error Continues

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Last Friday, we provided our readers with a “breaking news” (that is to say, quick and dirty) overview of the FDA’s just-released proposal to require manufacturers of generic drugs to use the “changes being effected” (“CBE”) process (also referred by the FDA as “CBE-0”) to update their labels in the same fashion as innovator/reference listed drug manufacturers.  That proposal appeared in the Federal Register on November 13, 2013 (pages 67985–67999), and here are links to it online and exactly as it appears in the hard copy of the Federal Register.  The 60-day comment period (unless extended) thus runs from 11/13.  Let’s see, 30 days hath November….  We think that the comment period ends on January 13 (the 12th is a Sunday), 2014.

Today we’re taking a closer look as a couple of places where we think the FDA’s proposal comes up short because it fails to address significant problems.  Those are:  (1) the Agency’s rather terse cost benefit analysis, and (2) the FDA’s failure to evaluate the relevant portion of Hatch/Waxman, 21 U.S.C. §355(j) – or indeed any part of Hatch/Waxman at all − in its analysis of its legal authority to make these changes without any Congressional amendments to the statute
itself.

As far as the merits of the proposal, we’ve already discussed what we think should be done to fix the inconsistent and backwards application of preemption to the FDCA under Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), Wyeth v. Levine, 555 U.S. 555 (2009), and PLIVA v. Mensing, 131 S. Ct. 2567 (2011), so we’re not going over that again.  The FDA didn’t go that route, nor did we expect it to.  Instead, it lunged for whatever it could devise to reduce preemption the most.  We’ll leave to others to comment on why that was the case, but we must admit that we’re disappointed.  For decades the FDA has taken the position that it does not tailor its regulations to affect civil liability:

  • “Tort liability cannot be a major consideration for FDA which must be guided by the basic principles and requirements of the act in its regulatory activities.”  63 Fed. Reg. 66378, 66383 (FDA Dec. 1, 1998).
  • “It is not the intent of FDA to influence the civil tort liability of the manufacturer or the physician.”  44 Fed. Reg. 37434, 37437 (FDA June 26, 1979).
  • “[W]hether particular labeling may alter a manufacturer’s liability in a given instance cannot be considered as a dispositive factor by the Commissioner in reaching a decision.”  42 Fed. Reg. 37636, 37637 (FDA July 22, 1977).

Now, the FDA has done a screeching four-wheel drift 180 and proposes to modify its regulations explicitly for the purpose of changing the scope of civil tort liability – in order to eliminate preemption of generic product liability warning (but not design) claims recognized by the Supreme Court under Hatch/Waxman in Mensing and recently reaffirmed in Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013).  See 78 Fed. Reg. 67985, 67988-89 (FDA Nov. 13, 2013) (discussing “recent court decisions”).Continue Reading A Closer Look At Some Aspects Of The FDA’s Generic Drug CBE Proposal

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We haven’t done anything more than skim it, but we thought our readers would like to know that the FDA released its long-awaited proposal to allow generic drugmakers to use the CBE process to change their labels today – as it common, on a Friday afternoon.  Here’s a link to it.  This is just a preliminary draft that will open the proposal to a comment period.  Here’s the FDA’s description:

We are proposing to change our regulations to expressly provide that ANDA holders may distribute revised labeling that differs from the RLD upon submission of a CBE-0 supplement to FDA.  FDA’s proposed revisions to its regulations would create parity between NDA holders and ANDA holders with respect to submission of CBE-0 supplements for safety-related labeling changes based on newly acquired information.  This proposal is also intended to ensure that generic drug companies actively participate with FDA in ensuring the timeliness, accuracy, and completeness of drug safety labeling in accordance with current regulatory requirements.  If this proposed regulatory change is adopted, it may eliminate the preemption of certain failure-to-warn claims with respect to generic drugs.

FDA, “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products,” at 16-17 (emphasis added).  Note that, this reference is limited to warning claims, and does not purport to reduce preemption with respect to design defect claims recognized in Bartlett.  Even so, it seems like a huge flip-flop from prior FDA statements in various contexts (some of which are discussed here) that it does not intend to affect civil litigation.  It sure intends to affect it now.
Continue Reading Breaking News – FDA Proposal for Generic CBE Label Changes Released

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Here’s a shocker: your average drug and device law lawyer seldom hoists more weight at any one time than 22 ounces of F.3d or three ounces of The Glenlivet. There is usually a long, nerdy history behind this state of indolence. For example, when we were in high school, we got a varsity letter for…

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We commented on the Obama Administration’s anti-preemption search and destroy mission at the time, back in 2009.  To recap, a presidential memorandum directed all federal administrative agencies to seek out, identify, and correct any “unjustified” statements about preemption that took place during the prior ten years (read: during the Bush administration).  The FDA was, of…

A couple weeks ago, we took a look at the brief submitted by the Solicitor General in the Mensing generic preemption case. If you didn’t have time to read that brief, or our slightly shorter post summarizing that brief, here’s an even shorter recap of the government’s position: the 8th Circuit was right to reject…

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While we were at ALI yesterday, the administration released a presidential memorandum (technically not an Executive Order, if it makes any difference) regarding administrative agency statements regarding preemption. Not that we were expecting to be, but we won’t be surprised by agency preemption declarations any time soon. Preemption determinations must be accompanied by codified regulations…

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The Solicitor General just submitted a letter to the Third Circuit in Colacicco v. Apotex giving the government’s position on the preemption question in light of the Supreme Court’s decision in Wyeth v. Levine.

The SG says that the FDA “has not yet conducted the sort of reexamination of various preemption issues following the Supreme…

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First, a minor correction. We lost by 6-3, not 6-2 (when you’re typing fast you’re all thumbs). We lost Kennedy, Thomas, and Breyer. We needed to win at least two of them.
The court relied on two facts established by the trial: (1) that a stronger warning would have made a factual difference (eliminating consideration…

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