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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

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For so many reasons, we don’t usually blog about insurance coverage issues.  First, it’s not really our area of expertise.  Second, because of point number 1 we tend to find the issue a little dull.  Third, most tort litigators – on both sides of the v. – aren’t all that fond of insurance companies.  On the defense side, it is our clients who are often pitted against insurers who deny coverage.  And as our client’s advocates, from time to time we have concerns with insurance company’s micromanagement which can lead to conflicts regarding the best way to defend cases.  This is certainly an over-generalization and we don’t mean to lump all insurers in the same boat.  But, the disputes are what make it to the courtroom.

Disputes such as an insurer who declines to cover, under a “wrongful employment acts” policy, a qui tam False Claims Act action alleging off-label promotion.  If you’re thinking we couldn’t have just plucked that example out of thin air, you are correct.  It was the disputed issue in Eisai, Inc. v. Zurich American Insurance Co., 2014 U.S. Dist. LEXIS 90305 (D.N.J. Jul. 1, 2014).  And, with a favorable result for the insured pharmaceutical manufacturer from a fairly significant jurisdiction, we decided to make an exception today and talk insurance.

Continue Reading And Now for Something a Little Different – Insurance

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Today the World Cup takes another day off before it starts its semifinals to determine who will play for the Trophy on Sunday.  I know this only because other people have told me.  Left to my own predilections, I’d know none of it.  But other people’s interest and intense enthusiasm for these games has swept me into rooms where I’ve actually watched them.  And in so doing I’ve learned a few things about soccer.  The most important is that soccer players fall – much more than your average human.  They are extraordinary fallers.  And they never have a mundane fall.  All their falls are big productions.  Players drop all over the field, grab legs, rock in fetal positions, writhe in pain, and wince and wince some more.  Priests administer last rights to players doomed with shin injuries.  Soccer players are the eggshell plaintiffs of the sport world.  You should never walk in a crowded hallway full of soccer players.  You’ll be Godzilla going down Broadway.  A few unintentional shoulder brushes later and you’ll leave behind you a mass of human carnage the likes of which you have never seen before.
And, now, if a soccer player from Utah – say, someone who plays for Real Salt Lake – buys a non-prescription pain reliever at a pharmacy to help him with his life-threatening shin bruise, he may be able to sue the pharmacist for any bad advice that he’s given about the drug.  A federal court in Utah recently held that pharmacists can be sued for professional malpractice or negligence based on advice offered on the suitability of a non-prescription drug.  Whiting v. Rite Aid Pharmacy, 2014 U.S. Dist. LEXIS 87354 (D. Ut. June 24, 2014).
Before this decision, the state courts of Utah hadn’t authorized such an action.  Ordinarily, we’d be very critical of a federal court finding a state cause of action for the very first time.  But we won’t spend time on that today, mostly because the effect of this decision is limited.  This particular pharmacist offered (allegedly) affirmative advice on the suitability of the drug and, more important, offered it about a non-prescription drug, meaning that the interaction did not implicate the learned intermediary doctrine or a patient’s relationship with a prescribing doctor.  And there’s no question that Utah follows the learned intermediary doctrine in prescription drug cases.  The Whiting court itself recognized this.  Id. at *12-13.  It also recognized, as we’ve told you before, that in such cases there is no cause of action for failure to warn against a pharmacist.  It would invade the relationship between a patient and her or his doctor, and it would sidestep or vitiate the learned intermediary doctrine.  As such, the Whiting court made clear that its decision was not applicable to litigation involving prescription drugs.
Now, the main reason that we care about this decision is removal to federal court and diversity jurisdiction.  Plaintiffs in a state-court action often list a local pharmacy as a defendant in that action with the purpose (we believe) of defeating diversity between the plaintiff and the manufacturer defendant so that the defendant cannot remove the case to federal court.  But if the pharmacy is fraudulently joined (meaning, usually, that there is no viable claim against it), the defendant can still remove the case.  The Whiting decision changes none of that in cases involving prescription drugs and medical devices.  Local pharmacies remain improper defendants in such cases in Utah courts.  In fact, even in non-prescription drug litigation, the plaintiff must still allege that the pharmacist made affirmative representations about the suitability or safety of the drug.  And if the plaintiff’s doctor actually recommended that the plaintiff take the non-prescription drug, there may be an argument, under that scenario, that a claim against a local pharmacist does in fact invade the physician-patient relationship and is improper.
In short, the effect of Whiting outside of pharmacy-only litigation is limited.  But that’s probably not bad news for soccer players in Utah.  We doubt that they really needed the pain relievers.
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We are sometime not sure what to make of pharmacy monographs.  You know what we mean.  Those sheets that pharmacists print out and give us with our prescriptions.  They are not drug labeling, and they are not medication guides.  They are summaries intended for patient perusal, with information taken from the labeling, but digested in a fashion intended for the lay reader.  Notably, the FDA has not asserted any prerogative to review and approve pharmacy monographs, leaving publishers essentially self-regulated under an FDA action plan.

From time to time, we are surprised when a plaintiff produces a pharmacy monograph in discovery, one that he or she received from the pharmacy and has saved.  (We have not seen the data, but we expect that people who save pharmacy monographs are the same people who have their utility bills from the mid 1990s and who know where the instructions and warranties are for all their household appliances.)  But even when this happens, we are unsure how the monographs help us.  The parties we represent – drug manufacturers – do not publish these things, and they generally don’t have any duty to warn patients anyway.
In a way, pharmacy monographs are more useful to the other side because they give plaintiffs someone else to sue – the monograph publishers.  We have commented on this before (here and here) and noted that lawsuits against publishers have met with virtually no success, and for good reason.  Publishers do not make prescription drugs; they do not sell or dispense prescription drugs; and they have no relationship or contact with the plaintiffs.  That is to say, they owe plaintiffs no duty of care, which is and should be enough to stop litigation.

Continue Reading Pharmacy Monographs and an Illusory Duty of Care

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On the Drug and Device Law Son’s 13th birthday, back in 2008, we reflected on the contrast between his experience as a Philly sports fan versus that of a 13 year old in Boston.  Our son had no idea what a sports championship looked like.  Philly had not hoisted a banner since Moses Malone led the Sixers to the “Fo Five Fo” payoff run in 1983.  But a 13 year old New Englander probably had come to assume championships as a birthright.  The Celtics had a parade that Spring, the Patriots had won three Super Bowls (one against the Eagles), and even the Sawcks, who had dashed the hopes of the region for four score and six years, had managed to break the curse of the Babe and win the World Series in 2004 and 2007.  (In the 1915 World Series, the Red Sox demolished … Philadelphia.)  The Bruins had not won a championship in that 13 year period, but they would soon.

The Boston-Philly rivalry is an old one, and more one-sided than makes sense.  Even a Penn professor, Digby Baltzell, acknowledged that Boston seemed to overachieve while Philly persistently underachieved.  He thought that the historical Puritanism of Boston pointed the way toward public proofs of accomplishment and virtue, while the Quaker roots of Philly prompted people to tend to their own gardens and steer clear of the public sphere. The theory explained why Bostonians were braggarts and Philadelphians tended toward self-disparagement.  The Puritans hanged the Quakers, and both were happy.  Of course, it is hard to imagine how these old religious differences could say much about current mores.  We know some Quakers here, but not that many. In our four years in the Boston-area, we never encountered a Puritan.  Still, there are some odd points supporting Baltzell. Boston leaders are usually home-grown, but Philly has often chased away local high-achievers (Harvard’s main library came from a Philly-area fortune) and has frequently brought in outsiders to run things.  The most consequential Philly mayor in recent times hails from NYC.  We’re not sure how this fact fits in with Baltzell’s theory, but Ben Franklin fled Beantown and ended up doing fairly well in Philly.

We have no problem liking both cities a lot.  Both have great history, great schools, great museums, and great bars.  For many key criteria, Philly comes out ahead. Philly’s citizens get abused for their supposed hostility (throwing snowballs at Santa Claus, blah-blah-blah), but have you ever tried sharing a street with Boston drivers?  Philly is much better for bike riders.  Philly’s weather is okay; Boston’s is horrible.

Continue Reading Massachusetts Federal Court Applies Comment K; Rejects Pennsylvania Lance Folly

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This post is from the non-Reed Smith side of the blog.

We’re going to be right up front with you today.  It’s a work day.  It’s the World Cup.  The US is playing Belgium in the Round of 16 at 4:00 EDT.  We don’t want to miss it.  And soccer — unlike sports like football and baseball — has no time-outs, no 7th inning stretch.  There aren’t even any commercials.  You look away for a minute to answer an e-mail, you could miss the only goal of the game.  So, we’ll get right to the point.

Medtronic scored another InFuse victory in Dunbar v. Medtronic, No. 2:14-cv-01529-RGK-AJW, slip op. (C.D. Cal. Jun. 25, 2014).  The allegations in this complaint, like all of the others we’ve previously discussed, focus almost exclusively on off-label use of the Class III, PMA spinal fusion device.  Seeing Class III and PMA in the description of the medical device should almost certainly guarantee a defense win on preemption as most courts have acknowledged that there is only a “narrow gap” between Riegel preemption and Buckman preemption in which plaintiffs can state a claim.  And that is why the InFuse plaintiffs have tried, with only limited success, to get courts to recognize a preemption exception when a PMA device is used off-label.

Continue Reading Latest InFuse Win – Good on Negligence Per Se

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While most of the buzz late last week concerned the Darvocet affirmance, we also recommend that defense counsel check out this case:  Amos v. Biogen Idec, Inc., 2014 WL 2882104 (W.D.N.Y. June 25, 2014).  Amos involved the prescription drug Tysabri.  The allegation in Amos, as in most Tysabri, cases, is that the drug caused an opportunistic type of CNS infection.

That’s not what interests us about Amos, but rather the product being an innovator drug, not a generic.  That’s why we’re pleased with Amos’s first holding – that design defect claims are preempted.  Ever since our first reading of Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013), we have believed that Bartlett’s rationale mandates impossibility preemption of design defect claims with any drug.  That’s because no drug manufacturer, generic or innovator, can change the design of its drug in any way that alters its safety or effectiveness without getting prior FDA approval of the change.  That’s precisely what the court held in Amos, preemption of design defect claims as to any drug in “interstate commerce,” albeit without much resistance from the plaintiffs:

Continue Reading Interesting Case On A Couple Of Issues

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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

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The Sixth Circuit has just affirmed 99.9% of the defendants’ wins in the Darvocet litigation.  The result is the biggest one-two punch (generic preemption/no non-manufacturer liability for the innovator drug) decision to date.  The opinion involves 68 plaintiffs and the law in 22 states.

Here’s a link to the opinion, which is encaptioned In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, Nos. 12-5368, et al. (6th Cir. June 27, 2014).

Here’s a quick summary:

Continue Reading Breaking News: Big Darvocet Appellate Win – Multistate One-Two Punch

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Happy birthday, Justice Sotamayor.  Her autobiography, My Beloved World, is now in paperback and the Justice has been all over the airwaves for the inevitable promotional push.  Every time we see Justice Sotamayor interviewed, we like her more.  We learned that she shops at Costco, where she recently ran into Secretary Clinton, who was signing copies of her own book.  That makes us think that Justice Sotomayor is a real, down-to-earth person.  She is also smart and direct.  She reminds us of the old adage that the most effective politicians are tough liberals and cuddly conservatives.  Sotamayor was a prosecutor for a while, so we confess to harboring an undeniable bias in her favor.  She also makes a point of admitting her fallibility up front.  She points to retired Justice Stevens and his acknowledgment that he regrets some of his opinions and would now write them differently.  She says she fully expects to feel the same way about her judicial oeuvre in 20 years.

We do not have to wait so long to regret Justice Sotamayor’s opinions in an area close to our heart, FDA preemption.  Those opinions make for unpleasant reading. Luckily, they are dissents.  Justice Sotamayor wrote lengthy dissents in the Mensing and Bartlett cases.  Those dissents seem to turn on two fundamental notions: (1) hostility to conflict preemption, with a conviction that there is a conflict only when compliance with both federal and state law is impossible not only in a practical sense, but in a complete, almost metaphysical sense.  One gets the distinct impression that in Justice Sotamayor’s world view, it would be pretty much impossible for a manufacturer to show impossibility preemption. (2) Justice Sotamayor is irked that purchasers of generic products might be ousted from court while purchasers of branded products could still buy a ticket to the litigation lottery.  Big surprise: we think she is wrong about that, too.  Such distinct treatment of consumers of distinct products is not inherently unfair or illogical.  One could come up with a rational system where consumers could trade lower prices for reduced litigation options. Maybe that is what we have.  We certainly have it with respect to limited tort auto insurance policies.

Continue Reading Ninth Circuit Applies One-Two Punch to Prevent Claims against Brandeds, and Preempt Claims against Generics

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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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