Not terribly long ago, we had a series of posts—too many to link—that recounted court decisions rejecting efforts to impose liability on a generic manufacturer for the standard design and labeling claims and/or on an NDA holder for injuries allegedly caused by the use of the generic version of its drug. When the conjunctive

Aren’t we all guilty of having that drawer, that shelf, that cabinet, maybe even a whole closet where things just get dumped. And as new stuff gets dumped, the old stuff gets pushed to the back. Then one day the space simply can’t hold anymore and you reach to the back to see just what’s

This post is not from the Dechert side of the blog.

The United States Supreme Court has said it – the test for implied preemption under 21 U.S.C. §337(a) (the FDCA’s no-private-enforcement provision) is whether the purported state-law cause of action would exist even in the absence of the FDCA/FDA: Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341, 353 (2001) (preemption applies to “claims exist solely by virtue of the FDCA disclosure requirements” and to all claims where “existence of these federal enactments is a critical element”).  So have federal courts of appeals.

If the claim would not exist in the absence of the FDCA, it is impliedly preempted. In other words the conduct on which the claim is premised must be the type of conduct that would traditionally give rise to liability under state law − and that would give rise to liability under state law even if the FDCA had never been enacted.

Loreto v. Procter & Gamble Co., 515 F. Appx. 576, 579 (6th Cir. 2013) (citations and quotation marks omitted). Accord Caplinger v. Medtronic, Inc., 784 F.3d 1335, 1339 (10th Cir. 2015) (“§337(a) preempts any state tort claim that exists ‘solely by virtue’ of an FDCA violation”); Perez v. Nidek Co., 711 F.3d 1109, 1119 (9th Cir. 2013) (preempting a “fraud by omission claim [that] exists solely by virtue of the FDCA  requirements”) (citation and quotation marks omitted); Lofton v. McNeil Consumer & Specialty Pharmaceuticals, 672 F.3d 372, 379 (5th Cir. 2012) (following Buckman; “tort claims are impermissible if they existing solely by virtue of the FDCA disclosure requirements”).


Continue Reading Another Make Work Project In New Jersey – Duty To Update Claims

When we were young(er), we had a pretty good memory. It is not bad now, as far as we recall, particularly when it comes to pulling up bits of esoteric nonsense.  For more important stuff, we find qualifiers like “vague” and “fuzzy” being applied more often to our own characterization of what we think we recall.  (We can only imagine how different things will be should be advance to the current age of McConnell, Bexis, or Weil.)  Buried somewhere between esoteric and important would be the question of whether we have seen a certain issue before in cases that have been the subject of past posts.  With a caveat about our memory, supplemented by a less than exhaustive search of prior posts, we thought we could present a decision addressing an issue we have never talked about before—and we have talked about a boatload of issues through the years.  (No, “boatload” was not our first choice, but we try to keep it clean here.)

The silly Conte case popularized the idea that a company that developed and brought a drug to the market could be liable for injuries allegedly caused by a generic version of the drug sold by a competitor. Conte was itself a reaction to the realization, even before Mensing and Bartlett, that most traditional product liability theories against the makers of generic drugs would be preempted.  When plaintiffs have tried to sue both the manufacturers of the generic drug they took and the company that “innovated” the drug and a single decision rejected the claims against both sets of defendants, we have called that a one-two punch.  Because plaintiff lawyers are stubborn in their pursuit of ways to pin liability on defendants with money—or get far enough along in the case to take some of that money to go away—we have described a number of varieties of these one-two punch cases. Just skimming our scoresheets on these issues should give some idea of that variety.

While off-label promotion allegations feature prominently in a range of cases involving prescription drugs, we have not seen them much in innovator liability or generic drug cases.  That might be because NDA holders tend not to do much promotion at all on their drug once generic drugs have entered the market and ANDA holders tend not to promote their generic drugs much at all, especially when there are multiple generics available.  This is not a matter of on-label or off-label promotion as much as it is of economics.  So, when we saw that Perdue v. Wyeth Pharms., Inc., No. 4:15-CV-208-FL, slip op. (E.D.N.C. July 20, 2016), delivered a one-two punch in a case where both the branded manufacturer and three generic manufacturers were alleged to have promoted off-label, we thought we might have a chance to talk about something novel.  We were wrong.  We wrote about another case last year.   Twice.  Involving the same drug as in Perdue.  One post even talked about elephants, known not just for their girth but for their memories.  Oh, the irony.  But that will not stop us from talking about the good result in Perdue.


Continue Reading A One-Two Punch Case With An Off-Label Twist

On May 18, the FDA extended the comment period for its proposed generic drug labeling rule until April 2017 – that is, until after the next presidential election.  We believe that, for all practical purposes, this means that the proposed rule is dead.  Here’s why we think that.

As we have maintained from the beginning, the statute, which requires generic labeling to be the “same” as innovator labeling, simply does not support the FDA proposal to allow CBE labeling changes that would result in generic labeling that is not the “same.”  The FDA can do a lot of things, but it can’t do that – the opposite of what its organic statute specifically requires.  The generic drug industry knows this, too, and from day one has vowed an administrative challenge to any rule that violates statutorily-mandated sameness.

As we have also maintained almost from the beginning, the FDA’s proposed rule has been driven by the desire of the political FDA leadership (who broke the rules regarding impartial communication with outside groups) to overturn the generic preemption decisions, PLIVA v. Mensing, 131 S. Ct. 2567 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013).  They are doing this as affirmative political payback to satisfy the plaintiffs’ trial bar, for whom they broke the aforesaid rules.  The plaintiffs’ trial bar have, of course, been major political supporters of the current administration, and as long as they tell the FDA’s political leadership to jump, during this administration the response will be “how high.”


Continue Reading Stick a Fork in It – FDA Anti-Generic Drug Preemption Proposal Postponed Until After the Presidential Election