Search We the Jury

We are pleased to have left the bullpen and joined the starting rotation of contributors to this blog. We will strive for the relevance and style our colleagues’ posts consistently display.

We adopted a Drug and Device Rescue Cat this week.  Her housemates, two Drug and Device Rescue Dogs, are poodle mixes, so we haven’t dealt with the issue of shedding since we last had cats, years ago.   We have discovered a nifty tool that claims to dramatically reduce the hair deposited on furniture and clothing, reminding us of our fondness for anything that strips away the clutter of useless underbrush and leaves only what is neat and firmly rooted.   And that is the (admittedly tenuous) segue to today’s case, in which the United States District Court for the Northern District of West Virginia bushwhacks through plaintiff’s detritus to arrive at a solid holding and a (mostly) tidy opinion.

In Muzichuck v. Forest Laboratories, Inc., No. 1:07-CV-16, 2015 U.S. Dist. LEXIS 5440 (N.D.W.Va. Jan. 16, 2015), the Court considered defendant’s Motion for Summary Judgment in a Lexapro suicide case.   Plaintiff, who opted out of the global Lexapro settlement, alleged that defendants, Forest Laboratories, Inc. and Forest Pharmaceuticals, Inc. (“Forest”) failed to warn her decedent-husband and his prescribing physicians of the risk of suicide associated with the antidepressant Lexapro.Continue Reading Opt-out Out of Court: Northern District of West Virginia Dispatches Lexapro Warnings Case

This past week you probably heard the low monotone sound that emanates from Patriot head coach Bill Belichick’s mouth whenever he’s explaining deflate-gate and trying to muster up the energy to drool out words that ultimately reveal only that he’s not interested in saying them. His barely operating mouth doesn’t tell you what his eyes so clearly communicate: “This is stupid.  It was a blowout.  It’s stupid, stupid, stupid.  Really stupid.”  His eyes make a better point than his mouth.  It was a blowout and was always going to be.

The same is true of Becker v. Smith & Nephew, Inc., 2015 U.S. Dist. LEXIS 6853 (D.N.J. Jan. 20, 2015).  Like most blowouts, you knew it early on.  Before the court even began analyzing the defendant’s motion to dismiss, it said this, which we describe as foreshadowing with a mallet:

Plaintiffs did not timely respond to the motion.  On December 3, 2014, after their response to the motion was due, Plaintiffs mailed the Court a short letter asking the Court to deny the motion.  Citing no case or other authority, the letter attached what it alleged were medical records of Deborah Becker and an earlier letter from Plaintiffs’ counsel to Defendant’s counsel describing those records.  Plaintiffs later filed the letter and attachments on ECF.

Id. at *3.  Uh-oh.  This was a mismatch from the start.  On one side, we have no cases, no authority, an almost fact-less complaint, and a letter to the opponent that attaches some medical records that was later filed with the court in lieu of a brief, amended complaint or something legal sounding like that.  On the other side, we have TwIqbal and New Jersey product liability law.  If you deflated defendant’s brief by removing half the authorities, you’d still get a blowout.Continue Reading Deflate-Gate Wasn’t the Only Blowout Last Week

If all Vermont had given us was fantastic cheese and Ben & Jerry’s ice cream, that would have been plenty.  But the 14th state has also given us some interesting politicians (Calvin Coolidge, Howard Dean, Bernie Sanders), some riveting fictional characters (Simon LeGree, Pollyanna, Hawkeye Pierce), the setting for the sitcom that stuck the landing better than any other, Newhart, and, of course, perfect Autumn foliage.  Vermont has been called home by one of our greatest playwrights, David Mamet, and one of our finest character actors, Luis Guzman (Out of Sight, Carlito’s Way, etc.).  We hear that Guzman does ads for Cabot Creamery.  We’d love to see those ads.  Wait a minute – maybe through this internet thing we can do just that.  Hold on a second.  Okay, here you go.  Please please please, do yourself a favor and see Out of Sight if you haven’t already.  It might be Soderbergh’s and Clooney’s best movie.  It is certainly J Lo’s best.  It has a wonderful array of character actors: Ving Rhames, Steve Zahn, Dennis Farina, Don Cheadle, Albert Brooks, and the aforementioned Mr. Guzman.  The romance scene between Clooney and J Lo is perfect, melding expectation and experience into a sensory now-now-now.  See it!  Now back to the law biz.  By the way, the lawyer we most admire graduated from U. Vermont’s law school.

For the moment, let’s put aside the fact that Vermont gave us Wyeth v. Levine.  (Sigh.)

The opinion we are cheddaring about today, Drake v. Allegan, Inc., 2014 U.S. Dist. LEXIS 151830 (D. Vermont October 23, 2014), comes from Vermont and it isn’t half bad. But it might be close to that.  The plaintiff sued the defendant, alleging that its Botox product injured him. Both parties filed Daubert motions to exclude the other side’s experts. The court ended up entirely denying the plaintiff’s motion to exclude the defendant’s medical causation expert and partly granting the defendant’s motions to exclude the plaintiff’s regulatory and medical experts.  If we were defense counsel in the Drake case, we’d call that a good day and reward ourselves with a dish of Vermont’s state pie (apple) drizzled with maple syrup, with a side of Vermont’s state beverage (milk, of course).  And there would be fromage.Continue Reading D. Vermont Rule 702 Rulings: Some are Gouda; Some are So Grating We Camembert Them

We typically leave it to others to review movies or television shows in the course of a post.  Sure, we will throw in a quote or reference from time to time, but that is about it.  We had the misfortune to watch the purported “thriller” I, Frankenstein recently and we thought we should share.  The film had more holes than a hunk of emmentaler.  It featured Aaron Eckhardt in another film with his face disfigured and Miranda Otto in a role not befitting a shieldmaiden of Rohan.  Its plot was tied loosely to the familiar Frankenstein story, itself based on older golem tales. Doctor Victor Frankenstein combined parts of corpses into a monster, which he animated with the charge from electric eels (without explanation of their importation to Eastern Europe).  The monster is not human, mortal, or terribly pleased to exist at all.  (He also does not enjoy hot soup ladled into his lap.)  Things go wrong, many years pass, and there is some ludicrous eternal battle between demons and gargoyles/angels into which the monster becomes embroiled.  Anyway, with omitted air quotes throughout, the monster is special because he was dead, is now alive, lacks a soul, and cannot die (except maybe if a demon skewers him).  The movie ends without anything particularly surprising or interesting happening, let alone anything that would make the viewer care about any character in it.

The plaintiff in Keeton v. Ethicon, Inc., No. 2:13-cv-24276, 2014 U.S. Dist. LEXIS 135327 (S.D. W. Va. Aug. 8, 2014), tried to reanimate her claim with a “Frankensteined” complaint—the court’s novel term and inspiration for our oh-so-clever post.  In, perhaps, a mild surprise, she was utterly unsuccessful, at least if the Report and Recommendation (R&R) of the Magistrate is followed.  It looks like it took more effort that it should have, in part because the plaintiff was now going pro se, and the recommended dismissal of the pending case would be without prejudice for some reason, but res judicata acted as monster bane.Continue Reading Pre-Halloween Demise of a Frankenstein Plaintiff

Before Bryan Cranston was Walter White, terminally ill chemistry teacher turned murderous meth manufacturer; before he was Hal, the clumsy and loving husband on Malcolm in the Middle – he was Tim Whatley.  Jerry Seinfeld’s re-gifting dentist who converted to Judaism just “for the jokes.” So affronted is Jerry for his profession, that Kramer –…

The Alabama Supreme Court redecided Weeks v. Wyeth, Inc., No. 1101397, slip op. (Ala. Aug. 15, 2014), today.  It’s not all that much different than the original “Weeks Reasoning” decision that we excoriated here.  In fact, the first 54 pages of Weeks II (out of a “pithy” 145 pages, one observer noted) are almost verbatim identical to Weeks I.  So we simply reiterate here everything we said in our original post about what we’ll now call “Weeks I.”  Weeks II made only the following changes to Weeks I:

  • Changing “Wyeth Defendants” to “Wyeth” (causing a lot of spacing differences).
  • Adding footnote 2, trying to deny the magnitude of what the court has done – claiming not to “plow new ground.”  Positively Freudian, that.  This footnote would sound less defensive if it could cite some prior Alabama case doing even remotely the same thing.  It doesn’t, because no such opinion exists.
  • Spending a couple of pages distinguishing Pfizer, Inc. v. Farsian, 682 So. 2d 405 (Ala. 1996), a case in which it had equated fraud and product liability claims, essentially because, Farsian involved cognizable injury and Weeks involves, not a “defect,” but “what [defendant] said or did not say about [the drug].”  Weeks II, at 12.  Funny, that’s one spot on way of describing what’s otherwise known as a “warning defect.”
  • New footnote 6 admitting – contrary to new footnote 2 – that “this is the first time the highest court of a state has addressed the issue.”  Except they then admit that’s not so either, because of Huck v. Wyeth, Inc., ___ N.W.2d ___, 2014 WL 3377071 (Iowa July 11, 2014).  In an exhibition of sheer profundity, Weeks II distinguishes Huck because “Iowa law differs from Alabama law” in precisely the way they are changing Alabama law to become.
  • A non-substantive new paragraph break (the opinion could use a lot more) on page 46.

Continue Reading Breaking News: Weeks II – Lipstick (and Not All That Much) on a Pig

A bit of a rant today.

We’ve just read Gibson v. American Cyanamid Co., ___ F.3d ___, 2014 WL 3643353 (7th Cir. July 24, 2014), and we have to say that it’s one of the most constitutionally arrogant decisions we’ve ever read.  Stripped to its essentials, Gibson is the judicial branch thumbing its nose at the supposedly co-equal legislative branch and saying “we can do it but you can’t.”

Gibson involves one of these seemingly one-way legal doctrines that only protects plaintiffs, but for some reason never defendants, the concept of so-called “vested rights.”  Here’s the back-story.

Thirty years ago, the Wisconsin Supreme Court, in a judicial exercise of social policymaking, decided to adopt a peculiar form of an already peculiar doctrine – market share liability.  See Collins v. Eli Lilly Co., 342 N.W.2d 37 (1984).  The court breached a hitherto (mostly) sacrosanct defense – product identification − that a defendant can’t be liable unless the plaintiff first proves that s/he actually used the defendant’s product.  The reason was … well, the usual fuzzy-headed logic that the common law can change and we think it’s better that the plaintiff wins.  Id. at 45 (we can change the common law), 49 (we’re gonna change the law and let the plaintiffs win because of “interests of justice and fundamental fairness”).  Despite the fact that the product was off the market and plaintiffs had taken it many years earlier, the court in Collins had no compunction in extending this new theory of liability retroactively to defendants whose conduct had previously been protected by the product identification defense.

Collins, as most of our readers probably already know, was a DES case.  DES was, for all intents and purposes, the world’s first generic drug.  Its patent had expired, so anybody who wanted to go to the time and effort to do so (this was the pre-1962 FDA, before NDA requirements were made a lot tougher) could set up shop and make the drug.  Scores of companies did, and “DES” became the reference of choice for most doctors and pharmacists.  Given the peculiarly long latency period for the peculiar injury – suffered in utero − in DES cases, product identification was a mess.  Collins decided to let the plaintiffs win anyway by shifting the burden of proof, contrary to decades (at least) of precedent.

At least in Collins there was a real product identification problem.  In the next case (the one ultimately at issue in Gibson), a bunch of class action lawyers decided to gin up a product identification problem.  They wanted to sue on behalf of everybody theoretically injured by lead paint, which had been off the market for a quite a while by the time suit was brought.  Since causation was an individualized issue that could defeat aggregated litigation, they created an impossible ID problem by skipping over the manufacturers of lead paint (some of whom might have been identifiable in building maintenance records) and sued only the bulk suppliers of lead paint pigment.Continue Reading Court: It’s Only Unconstitutional If You, Not We, Do It

It’s about time we got a Summer movie worthy of adult eyes.  Roger Ebert called the cinema a “machine for generating empathy.”  (The Life Itself biopic of Ebert is out now in theaters and available at home on demand.)  Not much empathy washes over us as we turn our eyes to Transformers or superheroes. All those explosions and flattened cities leave us feeling tired and hopeless, or feeling nothing at all.  Those films are about nothing.  The celluloid – or, more likely, the digital 0’s and 1’s – are full of sound and fury, signifying … well, you know.  It is life itself that offers thrills, mystery, and passion.  Where is that in the midst of the inevitable June-July CGI orgy?

It’s about time we got something to look at that said something about life itself.  And with Richard Linklater’s Boyhood, we’ve got it.  It’s about time.  Literally.  Linklater filmed a kid and his family over a 12 year period.  We see the actors age, which might sound like grim stuff, like watching our friends and, therefore, ourselves, slouch toward mortality.  But there is nothing grim about seeing a six year old emerge into adulthood.  That is life.  Dreams, experience, and memories collide and conspire to produce some luminescent thing that seems simultaneously transient and immortal.  It is more arresting and miraculous than cosmic warfare among the exoskeletons.  It stays with us long after the hobbits and avatars exit stage right.  As with Michael Apted’s Up series, or Linklater’s own Before series, Boyhood reminds us what life is about and what movies can do.  The film theorist Siegfried Kracauer said that the function of film is to do what no other art form can do – show light and movement.  We can see the leaves blowing in the wind, flaunting different shades of green as they flutter in sunlight.  We see things live and change in time.  Perhaps everything takes place under the eyes of eternity, but those are not our eyes.  Ours blink.  Ours close.

Time is the big subject today.   It always is.  The most important philosophical work of the 20th Century is not A Theory of Justice by that very nice Rawls fellow, but Being and Time by that not very nice Heidegger fellow.  Our favorite poem of the 20th Century, Auden’s “As I Walked Out One Evening,” is about time.  “Oh let not time deceive you/you cannot conquer time.”  Our favorite beach-reading book that we could not finish was A Brief History of Time.  Our favorite rock song is “A Day in the Life.”  Our favorite baseball team stinks because the star players all got old at once.  Father Time is undefeated.  Time marks victories and defeats.  Time marks births and deaths.  Time marks us.  Time also marks lawsuits.

We do not too often write about statute of limitations decisions.  They are fact-bound.  The people behind Seinfeld (which premiered 25(!)  years ago) vowed that their show would have no learning and no hugging.  Maybe we here at DDL won’t force a hug on you, but we do hope for some learning.  With statute of limitation decisions, we are usually unsure as to what we can learn from any particular case.   Not so with today’s case, Truitt v. Bayer, No. 13-CV-7811, (SDNY July 2, 2014).  A copy of the opinion can be found here.Continue Reading Knowledge of Injury is Enough to Start the Statute of Limitations

We have discussed before (here and here) how the defendant manufacturer in Fosamax litigation took advantage of a fairly unique regulatory history to meet the Supreme Court’s unprecedentedly high “clear evidence” standard from Levine and preempt an entire MDL’s worth of warnings claims from before the drug’s label changed in 2011. For us, this was noteworthy and welcome. Prescription drug cases are fundamentally about warnings and many plaintiffs base their claims on the purported need for labeling that never would have been approved in the real world. Without devolving into a Bexisish rant on why Levine was wrong and many courts have been unduly frightened away from applying preemption because of facile readings of Levine—our own version of Charybdis—we can say that a clean preemption win in a prescription drug case was long overdue.

The Fosamax plaintiffs, not surprisingly, did not share our view and persisted in trying to keep their litigation going with post-labeling change cases. Well, they kind of persisted. Mostly, it seems that they desperately wanted to avoid a consideration of the merits of their remaining claims while keeping the litigation pending. This required a series of maneuvers that ultimately ended up with the plaintiff in In re Fosamax (Alendronate Sodium) Prods. Liab. Litig., No. 12-1492, 08-08, 2014 U.S. Dist. LEXIS 82003 (D.N.J. June 17, 2014), squarely between—you guessed it—a rock and a hard place when the defendant moved for summary judgment. We suspect many other plaintiffs in the litigation will end up in the same place.

A brief recap of the labeling and litigation history is in order. The drug had been on the marker for osteoporosis for more than a dozen years when FDA asked all manufacturers of the class of drugs to report back on the issue of atypical femur fractures (AFF) based on adverse events it had received. Even though defendant and FDA agreed there was no evidence that Fosamax increased the risk of such fractures, in September 2008, the defendant proposed to revise its label to add Precautions and Adverse Reactions information about reports of them. FDA allowed the Adverse Reactions change, but rejected the Precautions change in May 2009. By this point, it looks like the plaintiffs had already started bringing their AFF suits. In 2010, FDA issued three Drug Safety Communications on AFF with the class of defendant’s drug, shifting from a position of no established increased risk to requiring manufacturers to add Precautions on AFF and limit the duration of use in the Indications and Usage section based on a report from the American Society of Bone and Mineral Research stating there was an association between long term use of the drugs and AFF. Defendant responded in January 2011 by adding a detailed section in Warnings and Precautions—we assume PLR reformatting was due—in the physician label and language in the patient Medication Guide. Based on this, in a two-step process, all labeling claims for AFF before the 2011 labeling change were held to be preempted. Thereafter, the court wanted to bring to a head the issue of whether there could be a warnings claim for cases where the plaintiff took the drug with the revised label. And then the plaintiffs started dancing.Continue Reading Fosamax Plaintiffs Between A Rock And A Hard Place

We’ve been reviewing the (relatively, in Internet time) recent Supreme Court decision in Daimler AG v. Bauman, 134 S.Ct. 746 (2014), and having done so we recommend it to anyone representing overseas clients worried about being swept into the maw of the over-lawyered legal climate in the United States.  But more than overseas companies are affected.  All companies should give Bauman a thorough look.  It may portend a sea change – and a favorable one – in the concept of “general” personal jurisdiction.

The underlying litigation was ridiculous, involving Argentinian nationals whose relatives were injured (often “disappeared”) in Argentina’s quasi-civil war between 1976 and 1983 (Statute of limitations?  We don’t need no stinkin’ statute of limitations!). Allegedly the Argentinian government of the time collaborated with the Argentinian subsidiary (Mercedes-Benz Argentina) of a German corporation (Daimler AG) in committing nefarious acts – on Argentinian soil.  From this brief description of the facts, it should be immediately obvious why the proper venue for this action (according to plaintiffs) was – wait for it – San Francisco.

We don’t know, and it would take too much time for us to figure out, whether Bauman was actually mooted on the merits by Kiobel v. Royal Dutch Petroleum Co., 133 S. Ct. 1659 (2013), instructing American courts to keep their noses out of disputes arising from overseas activities, but it should be.  Bauman is another example of the same type of “we can tell the rest of the world what to do” hubris that we decried in connection with Kiobel.

Sorry for the tangent.  Back to personal jurisdiction.

The trial court quite reasonably found no personal jurisdiction over a German company for actions in Argentina.  However, the schizophrenic Ninth Circuit – assuming its “Ninth Circus” persona in this matter – reversed.  In a ruling that sent shivers up the spine of many of our overseas clients, it held that general personal jurisdiction, that is, where a defendant is sufficiently ensconced in a forum to be sued for anything, no matter where the claim arose, could be established merely because the German parent controlled a subsidiary (not alleged to have anything to do with long-ago Argentinian events) that did business in the forum state.  No, this wasn’t a form of “piercing the corporate veil.”  There was no allegation that either parent or subsidiary messed up any of the details of corporate separation.  Nope, the Ninth Circuit found jurisdiction on an “agency” theory: essentially that a subsidiary controlled by a parent (as almost all of them, by definition, are) can be considered an agent of the parent and their forum contacts aggregated for jurisdictional purposes.  Bauman v. DaimlerChrysler Corp., 644 F.3d 909, 923-24 (9th Cir. 2011), rev’d, 134 S. Ct. 746 (2014).Continue Reading Sweet Home [Fill in the Blank] − A Sea Change In Personal Jurisdiction?

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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