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Plaintiff lawyers must be mighty allergic to federal court.  They perform all sorts of maneuvers to avoid CAFA removal of mass actions.  For example, they will artificially subdivide their cases into groups of under 100.  And/or they will disclaim any intent to try the cases together.  Do these circumventions work?  Perhaps most important, since so many of these CAFA avoidances occur in California, will such circumventions work in the Ninth Circuit?

Maybe.

At first, the Ninth Circuit permitted these evasions in a couple of decisions, creating a split with the Seventh and Eighth Circuits.  But then the Ninth Circuit took the cases up en banc.  The Ninth Circuit is so large that an en banc panel does not include all of the judges.  But an entire en banc panel always includes the Chief Judge.  That turned out to be important in the 2014 Corber en banc case because the dissenter in one of the earlier panel decisions was Chief Judge Gould.  Guess who authored the Corber en banc opinion?  Chief Judge Gould took a pragmatic approach to what counts as a “joint trial” for purposes of CAFA. That approach put the Ninth Circuit in alignment with the Seventh and Eighth Circuits and concluded that a proposal for a joint trial may be made implicitly as well as explicitly. Yes, it would be simpler to administer a bright line rule requiring plaintiffs to utter the magic words “joint trial,” but such a rule “would ignore the real substance” of plaintiffs’ proposals.  The plaintiffs had sought coordination “for all purposes.”  They had argued in the California state court that coordination was needed to avoid “the danger of inconsistent judgments and conflicting determinations of liability.”  That smells like a request for something that would actually or functionally be a joint trial.  The Ninth Circuit held that CAFA removal was proper under such circumstances.

Goodbye circuit split, hello sanity.  We praised the Corber decision here.

But the Corber opinion possibly suggested a road map — or another set of magic words — that might work to make federal jurisdiction disappear.   What if plaintiffs explicitly limited their request for coordination “solely for pretrial purposes”?  We all know that such a statement would be disingenuous.  But would it work?  Would it keep the cases in the pro-plaintiff maw of California’s coordination process?

The other shoe has fallen (sort of), the magic words have been uttered (sort of), and plaintiffs followed the road map (sort of). In Dunson et al. v. Cordis Corp., 2017 U.S. App. LEXIS 6446 (9th Cir. April 14, 2017), the Ninth Circuit upheld a remand of a mass action because the plaintiffs had not proposed a joint trial. (We have written about the Dunson case before.) Instead, the plaintiffs had argued that consolidation “for purposes of pretrial discovery and proceedings, along with the formation of a bellwether-trial process, will avoid unnecessary duplication of evidence and procedures in all of the actions, avoid the risk of inconsistent adjudication, and avoid many of the same witnesses testifying on common issues in all actions, as well as promote judicial economy and convenience.” We think this should be enough for CAFA removal, but the Dunson court held otherwise.

As an initial matter, the court says the appeal would be easy to resolve if the plaintiffs had simply sought consideration for “all pretrial purposes, including discovery and other proceedings,” and stopped there.  The Dunson court would easily have held that there was no request for a joint trial and thus, no basis for CAFA jurisdiction.  But the plaintiffs did not stop there.  They went on to wax poetically about the virtues of a bellwether trial process.  Do we now have a request for a joint trial?

The Dunson court held that it all came down to what sort of bellwether trial was being sought.  Sometimes, rarely, the result of a bellwether trial will be binding on the other cases. (For the moment, we are using deliberately vague language on this point.  More to come.) That definitely would meet the definition of a joint trial.  If that is what the plaintiffs want, they must go to federal court.  But much more typical is a bellwether trial  that would not be binding, but would be merely illustrative.   Such a bellwether trial, according to the Dunson court, would not be a joint trial and would not support CAFA jurisdiction.  The Dunson court assumes that when plaintiffs ask for a bellwether trial, they are asking for the non-binding member of the species.  Putting the burden on the defendant to show that the plaintiffs were proposing a joint trial, the Dunson court held that such a showing had not been made, that the plaintiffs had not sought coordination “for all purposes” as in Corber, and that, thus, remand to state court was appropriate.  A dismal day for the defense.  (The Dunson court supported some of its reasoning by citing another less-than-delightful Ninth Circuit case, Briggs, which we dissected here.)

There are many problems with the Dunson decision, including its departure from the pragmatic approach of Corber.   Experienced defense counsel know precisely what the plaintiffs want. They want a process that permits asymmetrical discovery where the defendants have to cough up millions of pages and scores of company witness depositions, while most of the plaintiffs’ individual cases hardly get tested.  That is, plaintiffs want a settlement machine.  The Dunson court pooh-poohed the preclusive effect of a bellwether trial because it would not have such effect on other plaintiffs.  But the Dunson court was forced to acknowledge that, “True, a verdict favorable to the plaintiff in the bellwether trial might be binding on the defendant under ordinary principles of issue preclusion, but that is not enough” (emphasis in original). How fair is that?  Moreover, the Dunson court ignores the plaintiffs’ own admissions of what they were up to in their consolidation request.  The plaintiffs wanted to avoid the risk of “inconsistent adjudications” (we bet the plaintiffs are pretty selective when it comes to that aversion) and they defined that risk as “different results tried before different judge and jury, etc.” The Dunson court admitted that such language “does suggest that a joint trial would be needed to avoid the risk of inconsistent adjudication.”  Yes. Yes, it does.  But the plaintiffs parked that language in a portion of their briefs generally extolling the wonders of consolidation (and overlooking the massive prejudice to defendants that can arise from consolidation), and the plaintiffs did, after all, remember to insert a disclaimer that they were not seeking a joint trial.

Look, we clerked on the Ninth Circuit and will defend it against all the usual ideological attacks.  But this time, the Ninth Circuit got CAFA removal wrong.  It ignored the Supreme Court’s admonition in Standard Fire Ins. Co. v. Knowles — a case nowhere even cited in Dunson — not to “exalt form over substance” in assessing CAFA jurisdiction.  Perhaps another en banc decision will ride to the rescue.

 

However a drug/device product liability is styled, it will almost always be focused on a claim of failure to warn.  Why do plaintiffs insist on inserting a cause of action for manufacturing liability when there is not a whiff of evidence that anything went wrong on the production line?  Seldom do we see the pharma equivalent of a mouse in the Coke bottle or, thinking of a more recent case, a bat in the salad.  Similarly, a design defect claim is often a make-weight claim.  How should the design have been improved?  Not selling the product at all is hardly a design improvement.  An entirely different product is not a safer alternative under the law of any enlightened state.  Changing the molecule or the device design cannot be done without FDA approval, so preemption should apply (even if courts often miss this point).  No, failure to warn is where the action is.  In the wake of Wyeth v. Levine, it seemed that preemption would be a tough row to hoe in such cases, but keep hoeing that row because the preemption defense might still be available – as a motion to dismiss, summary judgment motion, directed verdict, or argument to the jury.

 

The recent case of Amos v. Biogen Idec, Inc. et al., 2017 WL 1316968 (W.D.N.Y. April 10, 2017), makes every one of these points for us.  The court granted summary judgment to the defendants in that case, holding that all of the claims were fundamentally about failure to warn, the warning was adequate as a matter of law, and the FDA’s earlier rejection of proposed warnings meant that the plaintiff’s claims were preempted.  The facts of Amos present the sort of situation defendants encounter all too often, but which make for a hard sell to a jury: something very sad happened to an innocent patient, but it was nobody’s fault.  The patient had Multiple Sclerosis too severe to respond well to the usual treatments.  Her doctor recommended Tysabri.  That medicine came with a black box warning that it might increase the risk of Progressive Multifocal Leukoencephalopathy (“PML”), a viral infection of the brain that is as incurable as MS is.  The patient eventually contracted PML and died.  Her estate filed a lawsuit that included claims for negligence, negligent misrepresentation, strict liability, and breach of implied warranty. 

 

From the recital of facts in the Amos case, it appears that the manufacturer of Tysabri was quite diligent and proactive.  It also appears that the defense attorneys did an excellent job of mining the administrative record.  The manufacturer continued to perform clinical trials after initial approval, and promptly alerted the FDA of whatever risks it observed.  Among other things, the company asked the FDA to add information in the label about screening for certain virus antibodies that might increase the risk of PML.  The FDA rejected this proposal a couple of times, finding insufficient evidence at those times to support the label change.  The FDA ultimately relented and approved a label change in 2012 – after the plaintiff’s decedent died.

 

In considering the defense motion for summary judgment, the court concluded that all of the plaintiff’s claims turned on the sufficiency of the warnings.  New York law applied, and there was ample precedent under New York law that adequate warnings precluded claims for negligence, strict liability, breach of warranties, or fraud.  What’s more, the learned intermediary applied to claims regarding prescription drug warnings, and the record was replete with evidence that the prescribing doctor was well aware of the increased risk of  PMI.  It certainly helped the defense that the defendant, in collaboration with the FDA, had created a program called Tysabri Outreach: Unified Commitment to Health (“TOUCH”), which required that, prior to prescribing Tysabri, a physician had to acknowledge in writing that he/she understood the risks of PML and obtained a written acknowledgment from the patient that the patient understands the PML risk. The existence of the TOUCH program was one of several facts that made Amos a hard case for the plaintiff to win.

 

Even so, we all know that no matter how comprehensive and informative a warning label is, a good plaintiff lawyer can flyspeck it and find, or make up, some gaps.  The plaintiff lawyers in the Amos case are well known to us, and are very, very good.  They argued that the Tysabri warnings were inadequate because they failed to include information regarding the correlation between the virus antibodies and PML, and failed to inform doctors of the risks associated with duration of treatment and prior treatment with an immunosuppressant.  To our eyes, the plaintiff lawyers made the best arguments they could.  In too many courts, such an argument would furnish enough of a crutch for a plaintiff-leaning (or lazy-leaning) judge to mutter ‘factual dispute’ and deny the motion in a post-card ruling.  But not this court.  The judge analyzed New York law and held that even without the details regarding specific risk factors, “when read as a whole, the warnings unmistakably conveyed the seriousness of PML and its association with Tysabri treatment.”  That “read as a whole” point is important.  Do not let a court tell you that it is the jury’s duty to read the warnings as a whole.  It is the court’s job to assess whether the warning is adequate as a matter of law, and plaintiff post hoc fly-specking should not be enough to plant a case in front of twelve citizens good and true (and half-asleep and inflamed with sympathy and anti-corporate hatred).    

 

Even aside from the conclusion that the Tysabri warnings were adequate as a matter of law, the court offered an alternative basis for dismissing the case:  the claims were preempted as a matter of law.  Wyeth v. Levine ruled against preemption on the (at least partially specious) ground that drug companies can unilaterally ramp up warnings through the Changes Being Effected (“CBE”) process.  But the Amos court accurately observed that CBE is not available in all situations, and definitely is not available to add or change a black box warning, which is what was at issue in this Tysabri case.  Moreover, “the evidence of record leads inescapably to the conclusion that the FDA would not have approved a change to Tysabri’s label prior to 2012.”  With respect to Tysabri, there were two “smoking gun” rejections from the FDA. 

 

Also notable in Amos:  a second defendant in the case, a distributor of Tysabri, received summary judgment on preemption grounds.  The distributor did not own the drug’s New Drug Application, and thus had no power under the FDA scheme to alter warnings in any way.  The distributor’s inability to act independently to change warnings meant that, under the Mensing and Bartlett decisions, all claims against it were preempted.

 

There have been other cases around the country where courts arrived at similar rulings that Tysabri warnings were adequate as a matter of law and that failure to warn claims were preempted.  Perhaps plaintiff lawyers will do their best to distinguish these cases on their facts.  We will, doubtless, hear that “smoking gun” has become the standard for the Wyeth v. Levine “clear evidence” standard. We heard something nearly as silly from our home appellate court recently.  But reading the Amos case in the same way that the Amos court read the Tysabri label – as a whole – there is an awful lot of comfort in that case for drug and device defendants.

   

 

 

We talk a lot on this blog about Buckman preemption. That isn’t just out of pride regarding Bexis’s role in the bone screw litigation that led up to the Buckman decision. The principle in Buckman is important. What happened in Buckman? Here is a nice summary: “In Buckman, the plaintiffs brought state law claims against a consultant for injuries caused by orthopedic bone screws alleging that the defendant made fraudulent representations to the Food and Drug Administration (‘FDA’) in the course of obtaining approval to market the screws. 531 U.S. at 343. The Supreme Court found that federal law preempted state-law tort claims for fraud on the FDA.” Meijer, Inc. v. Ranbaxy, Inc., 2017 U.S. Dist. LEXIS 45527 (D. Mass. March 28, 2017).

 

The Buckman principle is crucial for our drug and device clients because most lawsuits against them challenge products and/or communications that were approved or cleared by the FDA. If promises were made, they were made in both directions. FDA action or inaction gave rise to settled expectations. Are the plaintiffs saying that the FDA’s review and acquiescence meant nothing, or that the FDA erred? Usually not. More often, plaintiffs are prone to suggesting that the defendants somehow bamboozled the FDA. In the feverish dreams of a mass tort plaintiff lawyer, it is a two-fer: the defendant not only lied to the public, it lied to the FDA. Go ahead and read any mass tort complaint and count how many times that story is told.

 

Still, plaintiffs and their lawyers and their experts are also not shy about asserting that the FDA is not up to the job.  According to the plaintiffs’ parable, the FDA is overworked, lazy, and dumb.  By contrast, it is the regulated companies that hold up FDA personnel as being competent and well-intentioned.  But let’s stick to the fraud claim for a moment. How often do you really think that major drug and device companies intentionally withhold from the FDA material evidence about risks and benefits?  How often do these companies make affirmative misstatements to the FDA, hoping to pull the wool over the government’s eyes?  No individual product approval would be worth such a risk.  Companies try to do the right thing because it is the right thing, and also because it is good business.  A claim of fraud on the FDA is invariably itself fraudulent.

 
In Buckman, SCOTUS rightly decided that juries have no business determining whether the FDA was fooled. Rather, that is for the FDA to address. If FDA findings or conclusions could be undermined by juries, we would see inconsistent verdicts all around the country, and FDA processes would become virtually meaningless. So now, in the wake of Buckman, we are treated to plaintiff claims and arguments that tip-toe right up to the edge of asserting fraud on the FDA. The plaintiff lawyers want the benefit of nasty implications without blowing up their case with preemption dynamite. Oh, let’s not kid ourselves; edge-schmedge. Plaintiff lawyers cannot help vaulting over the edge and shouting fraud on the FDA. Buckman has given rise to kabuki theater on preemption. It calls to mind that curious phrase about something being “honored in the breach.”

 
The Meijer case is interesting, not in spite of the fact that it is not a tort claim, but because of it. Meijer is an action brought by a direct purchaser class. The class alleged claims under both the Sherman Antitrust Act and RICO. Surely, dear reader, you know that both statutes are federal. The Meijer opinion does not make it clear exactly why this is so, but everyone in the case agrees that “all of the plaintiffs’ claims are predicated on fraud on the FDA.” The issue, then, is whether the Buckman holding halts these claims in their tracks. It is not a matter of preemption, for all of the claims in Meijer are federal. The supremacy clause is not implicated. Rather, we are now talking about one statute precluding resort to another. The effect of preclusion would be the same as preemption – dismissal of claims.

 
The district court in Meijer held that the antitrust and RICO claims can proceed, but did so uneasily. The court agreed with the plaintiffs’ reading of the SCOTUS holding in POM Wonderful LLC v. Coca Cola, 134 S.Ct. 1228 (2012), which harmonized Lanham Act claims with the Food, Drug, and Cosmetic Act. But – and the district court acknowledged as much – SCOTUS did not really confront a defense of flat-out preclusion in POM Wonderful. (The phrase “primary jurisdiction” does not crop up in Meijer, but it is not hard to see its relevance here.)

 
Hence, even though the defendants lost their Buckman argument in Meijer, they convinced the court that the issue was a controlling question of law, that its disposition would materially advance the termination of the litigation (that is, application of Buckman would end the case completely), and there was substantial ground for a difference of opinion. The district court said that “this is the first time a party has brought antitrust claims predicated on fraud on the FDA.” Some of us here at the DDL blog are not so sure that is right.  Be that as it may, it is an open question whether Buckman preemption/preclusion affects claims based on other federal statutes. The POM case focused on statutory interpretation, and followed the maxim of finding consistency wherever possible. There was no reference to Buckman or its underlying principles. The issue was simply not on the High Court’s radar screen. Consequently, the Meijer defendant’s reliance on Buckman is “sufficiently novel,” is purely legal, and therefore warrants interlocutory review by the First Circuit. The very interesting issue of the scope of Buckman has been kicked upstairs.

 
It will be fascinating to see what the First Circuit does. Courts are loath to permit the mere form of an action to circumvent fundamental principles of jurisprudence. Buckman is fundamental in terms of protecting the integrity and reliability of administrative actions. Consistency and predictability for a vital part of our economy and healthcare are at stake. Dressing up a case in the garb of antitrust or RICO claims should not change things one bit.

Happy birthday to Eric Idle, one of the funniest members of the Monty Python troupe.  In addition to writing bizarre, hilarious comedy skits, Idle also wrote songs.  When he proposed a song for The Life of Brian,  he ran into resistance.  The song seemed insufficiently catchy.  That song was “Always Look on the Bright Side of Life,” one for the ages.  It manages to be simultaneously profound and absurd.   In honor of Idle, we decided today to discuss a case that is similarly profound and absurd.   The case is New York v. Richard Z., 20 I 7 N. Y. Misc. LEXIS 9 I 8; 20 I 7 N Y Slip Op 30498(U) (Oneida Cty March 9, 2017), and has nothing to do with product liability.  Or does it?

 

Our clients get vilified anytime there is a hint of off label use.  Never mind that off label use can be enormously beneficial for patients.  It can even be the standard of care.  We’ve said that several times and the point is made in Bexis’s book.   But now we have the ultimate proof: in Richard Z, a court ordered prison doctors to make off-label use of a medicine available to a prisoner.  The facts are weird and icky, but the point is nonetheless unmistakable.  The prisoner was apparently in prison for some sort of sexual assault.  The opinion supplies no details, but since the prisoner had been in civil confinement for over nine years, and in prison for 30 years before that, we are guessing he had done something(s) really bad.  It is well known that sexual assaulters have a very high rate of recidivism.  That probably accounts for all those years of civil confinement.      

 

The prisoner wanted to get out of stir, and requested a particular chemical therapy.  That therapy involved an antiandrogen that would substantially reduce his sexual urges, and that has been proven in scientific tests to assist in the reduction of recidivism to less than 3%.  A couple of outside experts supported the chemical treatment, opining that such treatment would likely place the prisoner “at a low risk for future sexual offense recidivism and violent recidivism to the point that he could be released to the community on strict supervision”.   But a prison doctor opposed administering the particular requested/recommended therapy, the use of which for these particular purposes would have been off label.  The prison scheduled an “informed consent” conference relative to the chemical treatment of the prisoner.  The prison doctor elicited responses that suggested the prisoner would be taking the drug under compulsion and that “he would not have chosen to take this medication by himself” and “that he knew he had other choices.”  But to the court it was “abundantly clear” that these responses were “coaxed” from the prisoner via  “a carefully guided inquiry” by the prison doctor in an effort to dissuade the prisoner from taking the off label treatment.  The doctor “was acting according to her own subjective views and beliefs thereby substituting those views and opinions” for the prisoner’s .  It was also clear to the court that the prisoner was intelligent, educated, and engaged, and that he “clearly understands the off-label use of this prescription and its risk.”

 

The court concluded that the prison doctor lacked “experience and training in this area,” had misinterpreted her duties in this case, and that she and the prison were attempting “to avoid compliance with the clear and unequivocal expert opinions.”  The court relied on “many studies that show that antiandrogens greatly assist in repressing sexual urges and allow release of sex offenders safely into the community.”  The prison doctor had “substituted her subjective opinion” for the prisoner’s informed consent, and was “both inexperienced in the field of treating sexual offenders and has not kept current with medical advancements and evolving scientific understanding.”  That evolving scientific understanding supported the off label use of the drug, and denying that off label use to the prisoner would be “precluding him from attaining his liberty.”

 

Off label use was not only permissible, it was ordered. 

Most of the cases we defend involve claims of inadequate warnings.  What makes a warning inadequate?  Falsehood is the first thing that comes to mind.  But the Pontius Pilate question of “What is truth?” continues to vex.  We have seen very few drug or device labels uttering an affirmative misrepresentation.  More often the complaint is about what the warning did not say, not what it did say.  If John Lennon sang “Gimme Some Truth,” plaintiff lawyers sing (off-key) “gimme some more truth.”  To our ears, it sounds like “gimme some more money.”  Whatever.  Plaintiffs allege that the product label did not disclose all of the serious side effects, or did not recite them with sufficient detail and drama.  There is a hierarchy of warning inadequacy.  A warning can ‘fail’ for any of various reasons.  You pays your money and you takes your choice.  Did the warning:

  • Fail to grab attention?
  • Fail to persuade?
  • Fail to change action?

The last test is a slam dunk.  If the consumer heeded the warning, we wouldn’t be enjoying each other’s company in the courtroom.  There would be no complaint.  Probably.

The first warnings we remember seeing were on cigarette packs.  The United States was the first country to require such warnings.  Back in 1966, the sides of cigarette packs were adorned with the following: “Caution:  Cigarette smoking may be hazardous to your health.”  That warning did not include the word “warning.”  Change came a couple of years later.  In 1970, packs reminded us that the Surgeon General had determined that cigarettes were “dangerous.”  Still later, smokers were treated to rotating warnings.  Some packs warned of cancer, emphysema, heart disease, and pregnancy complications.  Some stated that cigarette smoke contains carbon monoxide.  Some suggested that quitting now could improve one’s health.  And some warned pregnant smokers of possible fetal injury, premature birth, and low birth weight.  We heard that one fellow filed a lawsuit alleging that cigarettes had caused his lung cancer, while also claiming he had not been adequately warned, because he had made a point of buying only the packs that talked about pregnancy complications.  That case proved at least two things:  (a) no matter what, some people will smoke, and (b) no matter what, some people will file silly lawsuits.

Continue Reading Warning: Lawyers May Be Hazardous To Your Health

We’ve seen it before.  The Southern District of Illinois will certify class actions with no real cause of action and no real damages.  While not as bad as the drive-through-class-certification state courts in southern Illinois, the nearby federal court will also perform doctrinal somersaults to benefit the local plaintiffs’ bar.  With both the lower state and federal courts in that otherwise lovely corner of the Midwest, an out of state corporate defendant must tough out absurd hijinks, then cross its corporate fingers and seek relief from the (usually) more rational appellate courts.  The Seventh Circuit, in particular, makes a full-time job out of spotting and reversing errors.

That not only happened in Eike  v. Allergan, Inc., 2017 WL 881834 (7th Cir. March 6, 2017), it happened courtesy of the pen of Judge Richard Posner.  In nine short paragraphs, with his typical absence of footnotes, Judge Posner exposes the purported class actions for the exercises in silliness they were.  So devastating is the reversal, so sharp is his prose, that Judge Posner’s miniature masterpiece must be viewed as a judicial thumb in the eye of the lower court.  The Seventh Circuit not only reversed the district court’s certification of the classes, it also ordered the case dismissed with prejudice for lack of standing.

Illinois calls itself the Land of Lincoln.  Lincoln said a lot of famous things.  One was, “Never stir up litigation.  A worse man can scarcely be found than one who does this.”  Imagine what Lincoln would have said if he had a look at a claim as batty as the one in Eike.  The plaintiffs sued pharmaceutical manufacturers of eye drops used for the treatment of glaucoma because the drops were bigger than they needed to be.  The theory is that the plaintiffs were paying more than they would have if the drops were smaller.  The plaintiffs alleged no conspiracy among the defendants.  This was not an antitrust case.   (Woe unto the plaintiffs if it were, and then they drew Judge Posner on the panel!) Nor did the plaintiffs allege any misrepresentations.  Rather, the plaintiffs simply sought, because they thought it would be less expensive, a smaller dose product that nobody made.

Continue Reading There’ll Always Be Posner: Reversal of Class Certification in the Blink of an Eye

A multidistrict litigation (MDL) can be a sound way of managing a mass tort.  Efficiencies are available (e.g., deposing company witnesses only once) and the U. of Chicago part of us dreams of economies of scale.  Then again, an MDL can be vexing, as plaintiff lawyers park their weak cases in the MDL and find ways to push their relatively few strong cases up front.  Think of the MDL as a vast kennel, with all of the associated dangers and bad smells.  Then again, an MDL can be an out-and-out disaster, as the old If-you-build-it-they-will-come model oft-described by blogger emeritus Mark Herrmann takes hold.  The very existence of the MDL itself makes the mass tort massive.  The MDL becomes a magnet for the meritless.  Plaintiff lawyers resist any discovery of individual cases – there are too many! – and insist on dedicating the MDL to endless discovery of company conduct, as that is common to all cases and, viewed through the MDL lens, is always proportional, no matter how intrusive or expensive.  (At least that is the plaintiff argument.  But now some courts have finally grown weary of MDLs becoming festivals of discovery about discovery, and decided that proportionality applies even when the MDL case inventory has reached four or five digits.  See here, for example.)

We have gone through this evolution of thought in the course of a single MDL, watching good intentions morph into an extortion racket.  We have also seen courts gradually catch on to what has gone wrong with the MDL system.  Is this an instance of phylogeny recapitulating ontogeny? Legislation has been revived in Congress that aims to cabin the insanity of MDLs and class actions. And, mirabile dictu, some MDL judges have started to rein in asymmetrical discovery and have even demanded that plaintiff lawyers furnish evidence of such niceties as usage of the product and medical causation.  We’re not saying let’s make MDLs great again, but can we at least make them less miserable?  Or maybe just make them less.  Perhaps we don’t need an MDL every time there’s an alarming study or an uptick in adverse events.

Continue Reading JPML Refuses MDL for Proton Pump Inhibitor Kidney Injury Cases

Over the years, comedian Adam Carolla has played the “Germany or Florida” game on his various radio and tv programs and podcasts. The game is based on the observation that many of the most bizarre stories of human ineptitude come from Germany or Florida.  Callers describe News of the Weird headlines, and Carolla and guests try to guess whether the events happened in Germany or Florida.  You can listen to this segment from the old Loveline radio show.

Here are some examples of “Germany or Florida” clues:

  1. Man ate his dog.
  2. Carjacker forced to flee after realizing he could not drive a stick-shift.
  3. Trio shoots at imaginary foe, thereby attracting police to their homegrown meth lab.
  4. Naked swimmer hospitalized after angler hooks his penis.
  5. Man dies after blowing up condom machine.
  6. Sister assaults twin over sexy toy.
  7. Government creates blatant ex post facto law depriving tobacco companies of basic tort defenses.

Okay, you probably know about that last one.  The answers to the others are below.  By the way, Carolla is not alone in identifying The Sunshine State as also being The Sublimely Strange State.  30 Rock had a running gag about Florida craziness.  See examples here.  Also, Seth Meyers on the Late Show runs a “Fake or Florida” bit that can, at best, be charitably labeled as being derivative of Carolla’s gag.  On last Sunday’s Last Week Tonight, John Oliver reported a story about a Florida man who planned to bomb Target stores up and down the east coast, with  the idea of buying up Target stock on the cheap afterwards.  After pointing out how the story involved home-made explosives, a big box store, and a terrible get-rich-quick scheme, Oliver noted that if the story also had a snake on meth, we would have full-on Florida Bingo.

Even before we earned our law license, we were aware that there is something … different … about Florida’s legal system.  In our law school library, you could pull the 12 So. 2d volume off the shelf and it would automatically open up to the Lason v. State case, in which the Florida Supreme Court upheld the conviction of a 76 year old man for “abominable and detestable crimes against nature.”  Some law school libraries have needed to insert photocopies of the Lason case after the original pages were worn out completely.  Good times.

Last week there was a mini-eruption of Florida case law, and we will cover some of those opinions this week.  It is not quite Shark Week for our blog, but it is close.  Today’s case, Wolicki-Gables v. Doctors Same Day Surgery, Ltd., 2017 WL 603316 (Fla. DCA 2d Feb. 15, 2017), is unusual.  The case is ostensibly about spoliation, but it is really about preemption and the dreaded parallel claim exception.  Luckily, the case comes out the right way.  But getting there was like doing a couple of laps on Mr. Toad’s Wild Ride. (You didn’t think you were getting out of this blogpost without at least one Disney World reference, did you?)

Mrs. Wolicki-Gables claimed a physical injury from a failed pain pump system.  She and her husband initially sued the manufacturer of the pain pump, alleging causes of action for strict liability and negligence.  The case was filed in state court, but was then removed to federal court.  The pain pump system had received pre-market approval from the FDA.  Because of that fact, and because of the Supreme Court’s decision in Riegel, the federal court held that the Wolicki-Gables’ product liability claims against the manufacturer were preempted by federal law.  The Eleventh Circuit affirmed the summary judgment in favor of the manufacturer.

Continue Reading Spoiler Alert: Florida Appellate Court Upholds PMA Preemption and Rejects Parallel Claim

Last week three of our posts dealt with Daubert issues.  That was not intentional.  Chalk it up to coincidence.  Or was it?  We are not especially superstitious, but maybe the passing last week of the great “Professor” Irwin Corey had something to do with the Daubert eruption.  Corey was a comedian who pretended to be “the world’s foremost authority”.  As if to parody the parade of plaintiff experts in mass tort cases, Prof. Corey would enter the stage wearing an academic robe, awkwardly look around at the crowd and down at his sneakers, begin with the word “However,” and then proceed to spout gibberish and vague Big Ideas that made no sense.  (This is not the first time in this blog that we have cited the wisdom of Prof. Corey.)  Corey was 102 years old.  He was doing comedy into his 90s, and consistently made more sense than most plaintiff regulatory or causation expert witnesses.  Catch his act on Youtube.  You will find it more enlightening than any plaintiff expert, or even most court opinions discussing the Daubert test.

As if to trumpet one final honor to Prof. Corey, we have a wonderful, clear, compelling Daubert opinion.  This one, Nease v. Ford Motor Co., No. 15-1950 (4th Cir. Feb. 1, 2017), has nothing to do with drugs or devices.  However, [we normally hate starting a sentence with that word, but if it was good enough for Prof. Corey, who are we to stand on ceremony?], the Nease case contains reasoning and language you might want to cite against the next plaintiff exercise in pretentious hokum. That the opinion comes out of the Fourth Circuit is both important and, for the most part, expected.  There are a couple of mass torts in the Fourth Circuit, and the effect of the Nease opinion can only be beneficent.  The Fourth Circuit has long had a reputation for having smart judges who follow the law.  (That being said, we nearly wept over the poor reasoning in the Fourth Circuit’s Cisson decision.)  In this season of judicial nominations by a new administration, we will hear a lot about how judges should decide, rather than create, the law.  The Fourth Circuit has not had a lot of judges posing as philosopher kings.  They actually tend to follow precedent.  We have it on good authority that when the DOJ had an internal debate about where to bring the 9/11 prosecutions – whether S.D.N.Y. (World Trade Center) or E.D.Va. (Pentagon) would be better for the government – the winning argument for E.D.Va. was based not on the pluses or minuses of the district court (or jury pool), but on whether the government would rather face the inevitable appeal in the Second Circuit or the Fourth Circuit.  There was a perception that the Second Circuit was more capable of activism, lenience, and surprise, none of which was particularly welcome under such circumstances.

If you like to see the law interpreted and applied, rather than created, the Fourth Circuit is usually a good forum.  That was certainly true in Nease.   The plaintiff in Nease claimed serious injuries from an accident allegedly caused by a defect in the speed control system of the plaintiff’s pickup truck.  The plaintiff offered the testimony of an electrical engineering expert who maintained that the speed control cable in the truck was susceptible to getting stuck while the throttle was in the open position, thus preventing the driver from being able to slow the vehicle down.  The defendant filed a Daubert motion, challenging the plaintiff expert’s methodology. The district court (S.D.W.Va.) denied the Daubert motion, waved the expert’s testimony along to the jury, and the jury returned a verdict for the plaintiff on strict liability and awarded more than three million dollars.

Continue Reading Fourth Circuit Vigorously Applies Daubert

We have long suspected that the reason some judges are hostile to Daubert is because application of the doctrine involves so much work. Rather than merely count whether there are enough other experts out there who seem to be saying something similar to what the proffered expert would say, judges under Daubert must act as gatekeepers who scrutinize the reliability of the expert’s methods. Such an effort burns up pages, time, and calories. Is it any wonder that judicial opinions that simply wave junk science along to the jury, with the usual suggestion that cross-examination and juror common sense will separate the wheat from the chaff, are pretty short, whereas those judicial opinions that really test experts under Daubert and find them wanting can be as long as a Victor Hugo novel?

Recently, Judge Hopkins of the Northern District of Alabama issued a 119-page opinion throwing out a lot of plaintiff expert opinions in Jones v. Novartis Pharmaceuticals Corp., 2017 WL 372246 (N.D. Ala. Jan. 26, 2017). We read all 119 pages, so you don’t have to, though the opinion is clear and pleasant enough. It is definitely no Les Miserables. Indeed, any sense of misery vanished when we saw a heading early on in the opinion entitled “General Requirements – Judge as Gatekeeper.”

The plaintiff in the Jones case alleged that she experienced an atypical femur fracture (“AFF”) as a result of her treatment with a prescription osteoporosis medication, Reclast. The plaintiff proffered a variety of expert opinions. The ubiquitous Dr. Suzanne Parisian submitted the usual magnum opus about how the drug had a “causal association”with the AFFs, how the defendant was on notice of that fact, and how the defendant violated much of the Federal Register and slapped on an inadequate label, There were also two retained and two nonretained medical experts who would opine on medical causation.

The Jones court began by observing that, like Caesar’s Gaul, a Daubert analysis is divided into three parts: (1) whether the expert is qualified, (2) whether the expert’s methodology is reliable, and (3) whether the expert’s opinion would help the jury in determining scientific or technical issues. The Jones court also emphasized that the proponent of the expert bears the burden of satisfying this test. The existence of that burden should, by itself, prevent courts from issuing perfunctory blessings of junk science. But, too often, it does not.

Continue Reading Reclast Plaintiff Experts Hobbled by Daubert