Constitutional Law

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Bexis had been on the road a lot lately – it seems blogging attract speaking engagements – and at both the recent PLAC fall meeting and the ACI’s FDA Boot Camp, speakers discussed the recent Supreme Court decision in FCC v. Fox Television Stations, Inc., 132 S. Ct. 2307 (2012), as having implications for product liability actions involving regulatory allegation claims.  We’d particularly like to thank Mike Walsh from Strasburger for sharing his thoughts (and some nice PowerPoint slides) on this issue.
Fox Television is a Due Process case, and the way Due Process intersects with product liability, at least in this context, is whether there are Due Process constraints on plaintiffs ginning up FDA (or, indeed, other federal) regulatory violation claims based on weird interpretations by paid FDA “experts.”
Can you say “parallel violation” claims?
What do we learn from Fox Television?  The case involved the regulation of purported “indecency” on television – no, it doesn’t involve Quentin Tarantino movies, but rather a far more serious problem than blood-soaked megadeath.  We mean “fleeting expletives.”  On prime time, broadcasters can show as much killing as they want, but the actors can’t swear as they get killed (or about anything else).  So the FCC has decreed – but not very well, the Supreme Court held.
The FCC held that an unscripted f-bomb on live TV was a no-no (ditto fleeting nudity (not the Superbowl wardrobe malfunction; that was another case)) and fined the TV networks.  This was something of a regulatory flip-flop, so the networks sued alleging that their Due Process rights were violated by the arbitrary and capricious actions of the FCC.  The Supreme Court agreed, sort of.Continue Reading A Step Beyond – Due Process and the FDA

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We recently came across a post on a Bricker & Eckler blog, about a slightly less recent Ohio Supreme Court case, Havel v. Villa St. Joseph, 963 N.E.2d 1270 (Ohio 2012), upholding the constitutionality of Ohio’s statute imposing mandatory bifurcation in punitive damages cases.  Havel held, after considerable back and forth:

[The statute] does not violate the Ohio Constitution and is constitutional because it is a substantive law that prevails over a procedural rule.  Inherent in our conclusion is rejection of the argument that dicta contained in Sheward [an infamous anti-tort reform decision], which described the former version of [the statute] as governing a procedural matter. . . . Sheward never considered the bifurcation question we confront in this case. Thus, we are not required to follow out-of-context dicta as precedent.

Havel, 963 N.E.2d 1279 (quoting and following Arbino v. Johnson & Johnson, 880 N.E.2d 420, 443 (2007)).  That’s an excellent result, but by addressing the constitutional issue in this way the Court did not have to pass on a more fundamental question that we’ve been pondering, which is whether a plaintiff has any constitutional right punitive damages in the first place.
In that regard, the Bricker post helped us out.  In discussing Havel, it mentioned that “Ohio’s caps on punitive damages have been upheld as constitutional (in Arbino v. Johnson & Johnson).”
There’s that case again.Continue Reading Is There A Constitutional Right To Punitive Damages?

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This is the first guest post that DDL has had by a law student in its five+ year history.  We weren’t sure at first, when the offer to post was made, but once we read it, our concerns vanished.  Heck, it’s probably better written than half the stuff we throw out there.
So all of what follows – and all credit or blame therefor – belongs to Brenna Jenny, a Harvard Law 3L whom we now know is a dedicated fan of the blog.
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The most topical constitutional issue implicated by the pharmaceutical industry has been the intersection between off-label promotion and the First Amendment.  While we continue to await the Second Circuit’s decision in United States v. Caronia, a new constitutional consideration has been receiving increased attention: the Takings Clause.  In a recent article in Food and Drug Law Journal, Professor Richard Epstein argues that the Biologics Price Competition and Innovation Act of 2009 (“Biosimilars Act”) raises Fifth Amendment concerns.  66 Food & Drug L.J. 285 (2011).  Professor Epstein’s argument may have force against other legislative fixes Congress would seek to apply to the pharmaceutical industry, such as Representative Bobby Rush’s (D-IL) recent proposal (HR 3995) to ban all reverse payment settlements between brand and generic drug manufacturers.
First some background on the Biosimilars Act.  In order to facilitate FDA approval of “biosimilar” biological products (the analogue to generic drugs in the Hatch-Waxman context), the Biosimilars Act allows the FDA to rely on the pioneer’s biologics license application (:BLA”) when determining whether a new entrant’s product is “highly similar” to the existing version.  (The FDA earlier this month released some much-anticipated draft guidance on this, and other, topics).  As under Hatch-Waxman, the second-comer is allowed to introduce far less clinical data than the innovator, and this shortcut allows the copycat product to make it to market sooner, with lower cost.  The Biosimilars Act mirrors the quid pro quo created in the Hatch-Waxman Act:  although innovators lose on one hand (the trade secrets disclosed in their applications are used by the FDA in approving a competitor’s products) they gain on the other (the innovator not only is granted a twelve-year period of exclusivity, but the filing of a biosimilar application is considered an artificial act of infringement, allowing the innovator to file suit and litigate any patent claims before the biosimilar reaches the market.)Continue Reading Guest Post – Pay For Delay, There For The Taking?

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On Wednesday, we discussed the relevant parts of pending tort reform legislation.  Earlier in the month we updated our favorite federalist point, which is that federal courts should not issue expansive interpretations of state tort law when sitting in diversity jurisdiction.

OK, what do those two things have to do with one another.

Well,…

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The two of us have been practicing law now for a little over 25 years. Bexis graduated law school in 1982 and Herrmann a year later (see our bios – links at the top – for the gory details). At big firms it takes a few years – five at least – before we could…

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Upon additional reflection, it seems likely that the recent Supreme Court decision concerning the constitutional pitfalls of punitive damages awards, Philip Morris USA v. Williams, 127 S.Ct. 1057 (2007), signals the end of class actions for punitive damages.

Even before Williams, the great bulk of recent precedent had concluded that aggregation of punitive…

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Now we’ve read it, and we’re applauding. The Supreme Court spoke loud and clear today in Williams v. Philip Morris USA, No. 05-1256 (U.S. Feb. 20, 2007). It ruled that for a jury “to base that award [of punitive damages] in part upon his desire to punish the defendant for harming persons who are…

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You’d probably expect that two guys whose idea of recreation includes commenting on drug and medical device product liability litigation would be members of the American Law Institute – and you’d be right. We both are ALI members, and it’s an outstanding organization through which many really smart and really dedicated people to donate huge…

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Bexis’ Book

FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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