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A major basis for our criticism of the FDA’s still pending generic drug labeling proposal, and why we prefer industry’s EAR (“Expedited Agency Review”) system better, is that the FDA’s proposal would create festival-seating style label changes, with each competing generic producer (and any still-extant branded reference listed drug (“RLD”)), on its own in deciding

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Our occasional claims of dyspepsia may be attributed to various things.  Professional witnesses offering personal opinions from the stand, juries deciding based on emotion and bias, plaintiff lawyers being sleazy, and judges writing decisions driven by a predetermined result or just bad reasoning come to mind. Sometimes, we recognize that our discomfort stems, at least in part, from the subject matter of a case extending past the reasonable, yet wide and knowingly self-inflated, bounds of our expertise.  Among our hundreds of posts, more than a handful touch on Drug & Device Law in that they (1) involve cases with our clients’ products far from product liability or (2) involve issues we see in our cases being presented in very different types of cases.  While we may throw in some caveats about how we are treading beyond our usual bailiwick, we still offer our views and perhaps even a somewhat blind rant.  Here we are again—personally, this blogger has skipped the last three weeks for trial preparation and denouement—with a decision in a case that is far afield in some respects, but just does not feel right in about every respect.

The decision of the First Circuit in In re Nexium Antitrust Litig., Nos. 14-1521, 14-1522, 2015 U.S. App. LEXIS 968 (1st Cir. Jan. 21, 2015), affirming a class certification order from the District of Massachusetts is not too surprising if you just consider the courts involved and the name of a drug in the case caption. If you add that, broadly categorized, this is a third party payor case, then our view that the decision does not make much sense is even less surprising.  The allegation in the case, though, is something we find fairly novel and decidedly weird.  Plaintiffs are “union health and welfare funds that reimburse plan members for prescription drugs”—that is, a type of third party payor—and they claimed that the defendant branded manufacturer of a particular heartburn drug and three putative manufacturers of a generic form of the drug conspired to overcharge for the branded drug when they entered into settlements over patent infringement suits that paid the putative generic manufacturers to not try to get their ANDA approvals and sell their own versions for about six more years.  Are you with us so far?  Not being able to sue under federal antitrust laws because the Supreme Court says indirect purchasers are too remote to have a cognizable injury, the plaintiffs sued under state antitrust laws—adopted by half the union specifically to provide a claim not available under federal law—and state consumer protection laws.  They sued in one federal court (the E.D. Pa.) and the case was moved to another by the JPML. They sought a class on behalf of everybody in the U.S. or its territories who paid (or will have paid) any money for the drug, including generic versions not yet on the market, for their own use or use by anybody else.  With our caveat about the limits of our expertise, this lead in makes us start wondering about subject matter jurisdiction, personal jurisdiction post-Bauman (especially with the foreign defendants), how third party payors could be class reps for patients who bought their own drugs or for people who bought drugs for their relative, how a court-approved consent judgment could be considered anti-competitive behavior without running afoul of Noerr-Pennington doctrine,  and how there was not some preemption issue in basing state law liability on an assumption that FDA would have approved one to three ANDAs even if there were no patent issues.  Then we took a deep breath and realized that the Nexium decision did
not address any of that stuff.  It did note, however, that the defendants had already won a jury verdict at trial this past December, but “[t]his, of course, does not moot the case here given the possibility of further proceedings.”  Then we went back to bellyaching about what else was wrong with the basic premise of this case.  Then we had a drink.  And we don’t mean an antacid.Continue Reading Indigestion Inducing Treatment of Class Certification Requirements

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Third party payer plaintiffs (mostly insurance companies and union welfare funds in unholy alliance with plaintiff lawyers), have not been doing very well with their economic loss claims against (mostly) pharmaceutical companies – at least outside the rogue First Circuit − as anyone following our TPP topic posts can attest. So they’ve tried something new,

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Not too long ago we offered considerable criticism of certain aspects – specifically the treatment of Pennsylvania consumer fraud claims – in Sheet Metal Workers Local 441 Health & Welfare Plan v. GlaxoSmithKline, PLC, ___ F. Supp.2d ___, 2010 WL 3527601 (E.D. Pa. Sept. 7, 2010) (“SMW I”).  It turns out that the Rule 12 decision in SMW I was only prologue to the main event.  Several weeks later, the court outright denied class certification in the same litigation.  Sheet Metal Workers Local 441 Health & Welfare Plan v. GlaxoSmithKline, PLC, 2010 WL 3855552, slip op. (E.D. Pa. Sept. 30, 2010) (“SMW II”).
You might expect that, as defense attorneys, we’d think a lot more highly of SMW II than we did of SMW I.
You’d be right.  We agree with Lord Palmerston:  We have no permanent friends, or permanent enemies, only permanent interests – those of our clients.  Thus, we have no quarrel with any particular judge, we’d much rather praise any judge.  Our critiques are limited to legal reasoning and outcomes. We have no problem with either in SMW II.
That being said, we’re not going to delve too deeply into large portions of SMW II. A lot of it’s antitrust-specific economic analysis, involving a comparison between what actually happened in the real world versus what supposedly might have happened in this shadowy “but for world” postulated by the plaintiffs’ economic expert.  Antitrust economics is rather outside of our sweet spot, so as to that we can only hope that our colleagues for whom this kind of thing is a hanging slider over the middle of the plate eventually explain it to us.
However, SMW II does involve class actions, consumer fraud claims, and allegations about drug marketing.  That means there are things in it that are relevant to what we do.  We’ve extracted five take home points from the opinion that we think are worthy of comment.

Delay Can Be A Friend As Well As An Enemy

One of the things that immediately struck us about SMW II is how long the class certification motion had been pending.  The opinion candidly admits that right up front.  2010 WL 3855552, at *2 (“Plaintiffs’ class certification motion has been long pending”).  How long is “long”?
How about more than four years?Continue Reading Wellbutrin – Only Permanent Interests

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As readers of this blog know, Bexis’ firm is involved in the Vioxx litigation. This post, like all of the others about the Vioxx litigation, represents Herrmann’s work alone:

Many folks interpreted the Vioxx settlement agreement to require participating plaintiffs’ counsel to (1) recommend to all of their clients that they participate in the settlement,