2012

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Those of us who graduated from the University of Chicago are just a wee bit tired of the “place where fun goes to die” epithet. It’s true that U of C is an intensely intellectual place, and it’s true that Hyde Park is a long way from Chicago’s hot spots, and it’s true that the Cubs will continue to disappoint, and it’s true that when the Winter wind (“the Hawk”) blows in off Lake Michigan one prays for death, but … what was our point, anyway? Right – intellectual combat can be a fascinating spectator sport. It can be a moveable feast. It can even be, yes, fun.
In mid-February, the Law School put on a “Manhood in Law and Literature” conference. Here is part of what the conference announcement promised: “The conference will include two dramatic performances by members of the University of Chicago law School. The first scene, from the Caine Mutiny Court Martial by Herman Wouk, will feature Judge Richard Posner as Lt. Commander Queeg … and Judge Diane Wood as Captain Blakely. The second scene, from The Little Foxes by Lillian Hellman, will feature Professor Martha Nussbaum as Regina Hubbard Giddens and Professor Douglas Baird as her husband Horace. A musical interlude will be provided by Jajah Wu, Gary de Turck, and Martha Nussbaum.”
Sounds like fun, right? It gets better. An article describing the conference reveals that Professor Nussbaum sang “Can’t Help Lovin’ Dat Man” from Show Boat. Mind you, this is the same Martha Nussbaum who is one of the country’s most daring and creative philosophers, who is a hero to the Drug and Device Law Daughter because of her position on animal rights, and whose analysis of Plato’s Symposium has been stuck to our brain for over 25 years. We are genuinely sorry we missed this performance. Author Joyce Carol Oates also spoke (but did not sing) at the conference. She talked about Hemingway and boxing. Oates’s writings on boxing have given it an unexpected intellectual heft.Continue Reading There’ll Always Be Posner: Hemingway, Boxing, and Sanctions

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PARISIAN TRANSCRIPTS 2.0
We had a number of people send us material after our first post with out list of deposition transcripts (and various other items) concerning the testimony of the extremely active plaintiffs’ side expert, Dr. Suzanne Parisian. We are still awaiting promised materials from certain other folks, who will remain nameless.
One anonymous benefactor sent us a 30-page disclosure list (no transcripts, unfortunately) of Dr. Parisian’s appearances in court or at trial prior to early 2010.
Another anonymous benefactor sent us a Westlaw print out containing additional Parisian-related materials. We’ve added the Westlaw citations, both to new items and to those we’ve already had.  We haven’t looked at them all, but we did review some, and we caution that a lot of the Westlaw materials contain extensive omissions and thus might not be particularly helpful.  The Westlaw materials also included some of Parisian’s expert reports, so we’ve created a second list – after the first – of those.  Those are only on Westlaw; they weren’t included in any materials we received.
We’ve tried to synthesize this material and compile it into a single list.  If you thought our prior Parisian post was boring – well this one’s just as boring, but even longer.  If we have the actual transcript of the testimony, then the item is listed in black, as before, with or without a Westlaw citation. If we don’t have any transcript, then we’ve also listed it, but in red.  A red colored entry with a Westlaw cite means we don’t have a copy of the transcript, but there’s something available on Westlaw.Continue Reading Parisian Transcripts 2.0

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So The Artist won.  Some of us (maybe only one of us) didn’t even know it was a silent movie.  Imagine going to that movie without knowing it was silent.  That’s failure to warn.  At least when Mel Brooks made Silent Movie you knew what you were getting.  And in his movie the French guy

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            Suspicion.  It is the stuff of great movies.  We could name just about any Hitchcock movie here, but why not go with the aptly titled Suspicion starring Cary Grant and Joan Fontaine (who by the way won the Best Lead Actress Oscar for her role in this film).  After a chance meeting on a

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Last night we watched the Academy Awards presentations. We’re never sure why we do this. Why do we care about the film preferences of a notoriously unreliable, insular group whom you might meet at Nate n’ Al’s, but never at Home Depot? Then again, our whole business is built around other peoples’ opinions — judges,…

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In our recent post describing Salvio v. Amgen Inc., 2012 WL 517446 (W.D. Pa. Feb. 15, 2012), we mentioned the standard for punitive damages that the court applied – “punitive damages are unfounded where a manufacturer-defendant warns of the potential danger that resulted in injury to a plaintiff.”  2012 WL 517446, at *8.  Under…

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Does Buckman v. Plaintiff’s Legal Committee, 531 U.S. 341 (2001), apply any time that a plaintiff raises a fraud on the FDA allegation in litigation, or is it limited to causes of action denominated “fraud on the FDA?  Most courts have agreed with the Sixth Circuit that Buckman applies across the board.  See , 385 F.3d 961 (6th Cir. 2004).  A persistent minority, however, has limited Buckman to complete “fraud on the FDA” causes of action.  See Desiano v. Warner-Lambert & Co., 467 F.3d 85 (2d Cir. 2006).  The Supreme Court attempted, but failed, to close the split in Desiano, but failed – splitting 4-4.  See Warner Lambert LLC v. Kent, 552 U.S. 440 (2008). Garcia v. Wyeth-Ayerst Laboratories
Both Garcia and Desiano involved the “fraud on the FDA” exception to a Michigan tort reform statute that imposes a presumption of adequacy on warnings that are FDA approved – that is, just about every warning.  The Michigan statute was essentially dispositive.
Then Texas passed a similar presumption statute that is almost as dispositive in the ordinary case as Michigan’s.  It was only a matter of time before the Fifth Circuit would be called upon to decide the same question as in Garcia/Desiano.
Also in the mix is the Supreme Court’s later, extremely anti-preemption, decision in Wyeth v. Levine, 555 U.S 555 (2008).Continue Reading Fifth Circuit Breaks Buckman Tie

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Being invisible would be cool.  We all know that.  You could do things that you would otherwise be afraid or unable to do.  And no one would see you do it.  You’re hidden from criticism, retaliation and embarrassment.  It’s such an alluring idea that it has shown up in literature for thousands of years.  It’s in The Republic.  There’s H.G. Wells’ The Invisible Man.  The Lord of the Rings and Harry Potter had it.  Wonder Woman had an awesome invisible plane, though we never quite understood the advantage of an invisible plane while everything inside it, including the pilot, was visible.  Maybe it looks like the pilot can fly, which is obviously very cool.
A theme running through much of the literature, however, is that invisibility can corrupt.  In The Lord of the Rings, putting on the ring makes you invisible but also rots your soul and makes you visible to the evil that is coming for you.  In The Republic, a man with an invisibility ring is used as support for the argument that a person who can do injustice without ramifications will do it.
But the purpose of the Courts is to do justice.  To promote this goal, the public has a strong interest in the courts being an open forum with parties identified by name.  The courts don’t see invisibility as cool.  They see it as an invitation to corruption.  So we see in our everyday practice of law real names on both sides of the “v.”  Now, sometimes there’s a John or a Jane Doe, but we know that those are there as placeholders until the actual party is identified and then named.
This leads us to the recent decision in Doe v. Merck & Co., No. 11-cv-02680-RBJ-KLM (D. Colo. Feb. 17, 2012), a products liability action in which the plaintiff claimed that the drug Propecia, used to treat baldness, caused him significant sexual problems.  Given the “highly sensitive, intimate and personal nature” of the alleged side effects, the plaintiff brought a motion seeking to proceed anonymously.  Slip op. at 3.
Requests to proceed in court anonymously are rare.  We haven’t seen much of it.  The court noted that “[p]roceeding under a pseudonym in federal court is, by all accounts, unusual.”  Slip Op. at 2.  The Federal Rules of Civil Procedure don’t provide for it.  In fact, FRCP 10(a) requires that a complaint “name all the parties,” and FRCP 17(a) requires the action be prosecuted “in the name of the real party in interest.”  Id. at 2.  This is all to say that there is a presumption of open court proceedings and that the public has an interest in knowing the identities of those who use the courts.
In addressing plaintiff’s motion, the Court, considered the circumstances, including whether the plaintiff was a minor or was threatened with physical harm by proceeding under his name.  Importantly, the court also had to consider whether allowing the plaintiff to proceed anonymously would create “a unique threat of fundamental unfairness to the defendant.”  Id. at 4.
Continue Reading Invisibility and the Courts

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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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As promised, we have a second Enbrel case from last week to report on.  So we teased it as a sequel.  And, as it turns out, this case is itself a sequel.  We reported on the first dismissal of plaintiff’s complaint in Salvio v. Amgen Inc., 2011 U.S. Dist. LEXIS 92558 (W.D. Pa. Aug. 18, 2011) here.  The court gave plaintiff a chance to try again and like with so many sequels – plaintiff should have left it alone.  So, that got us thinking about the worst ever movie sequels.  Unlike yesterday’s list, this one could go on for pages.  Generally speaking, sequels are never as good as the original.  For instance, we can start at the same place we started yesterday, The Godfather.  While there is ample ammunition for either side of the debate over whether Godfather 1 or Godfather 2 is better, nobody disputes that Godfather 3 is the quintessential franchise killer.  While most critics like to attack Sofia Coppola, she is far from the worst thing about that movie.
Here is just a short-list (consider it a sampling), in no particular order, of sequels that are so bad, they might even make you forget what you loved about the original (we’re sure you can all add to the list):
The Sting II – with all due deference to Jackie Gleason’s comic genius, he and Mac Davis were no match for Redford and Newman.
The Matrix Reloaded and Revolutions – too long, too tedious, just a complete let down in every way.
Legally Blonde 2:  Red, White and Blonde – In the original a ditzy blonde takes the legal profession by storm in a funny and charming way.  In the sequel she goes looking for her pet Chihuahua’s birth mother.  Huh?
Dumb and Dumberer:  When Harry Met Lloyd – only good thing was a fairly spot-on impersonation of Jim Carey.
Jaws the Revenge – The original is one of the best horror movies ever made.   In this one, as if the plot – a shark that has already been blown to bits seeks revenge on the widow of the man who killed it – isn’t bad enough, the shark also roars.
Dirty Dancing:  Havana Nights – somebody should definitely have put this movie in a corner.
Speed 2: Cruise Control – Isn’t Keanu supposed to be the not too bright one?  So, what was Sandra’s excuse?
Blues Brothers 2000 – Where was Jim?  Not that having a Belushi in it would have saved it.  We are just happy brother John wasn’t around to witness this travesty.
Caddyshack II – who ever thought Jackie Mason and Robert Stack could fill the shoes of Dangerfield, Murray, Chase and Knight?  They headed in the right direction by casting Akroyd, but that’s about it.
Staying Alive – In this sequel to the unforgettable Saturday Night Fever, Sylvester Stallone directs John Travolta in a movie about a Broadway musical featuring the music of his brother Frank Stallone.  Need we say more?
Now for Salvio II.  Unlike the movies listed above that had their origins in greatness, Salvio II suffers from all the same plot pitfalls as the original.  As described in Scream 2 – there are rules to making a successful sequel (at least a horror sequel) – “Number one: the body count is always bigger. Number two: the death scenes are always much more elaborate – more blood, more gore – carnage candy. And number three: never, ever, under any circumstances, assume the killer is dead.”  Salvio II breaks all the rules.
Plaintiff took Enbrel to treat her rheumatoid arthritis.  She allegedly contracted a fungal infection of the sinuses, brain, and lungs, and died from complications related to her infection.  Salvio v. Amgen, Inc., 2012 U.S. Dist. LEXIS 19009, *2-3 (W.D. Pa. Feb. 15, 2012).  After the dismissal of her first complaint and being afforded an opportunity to amend, plaintiff filed an amended complaint alleging claims for negligent failure to warn, negligent design/manufacture, and punitive damages.  Id. at *4.Continue Reading Enbrel, Part 2 – A Sequel Within A Sequel

Drug & Device Resources

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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