Over 11 years ago the blog published a post called “Anatomy of a Mass Tort,” which endeavored to explain the life cycle of this type of litigation.  We’ve decided to revisit and update that post, given the changes that have taken place over the intervening years.

And change it has.   Our original post mentioned class actions several times. It didn’t mention personal jurisdiction, multi-plaintiff complaints, third-party litigation funding, or plaintiff fact sheets.

So here is anatomy of a mass tort 2.0.

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Today, we’re stepping back.  Instead of analyzing specific doctrines or new cases, we’re going to give you a run down of the whole enchilada:  a mass tort, start to finish.

With a mass tort, the entire process can be described without ever typing these words:  “the product was defective” or “someone was hurt.”  Unfortunately, those words have become unnecessary to describe the anatomy of a mass tort.

A mass tort hardly needs a trigger anymore.  At bottom, all that’s necessary is a drug or device with a decent sized market and something to attract the other side’s lawyers.  Look, for example, at the best-selling drugs of 2007, when we first wrote the post. They include Lipitor, Nexium, Plavix, Seroquel, and more.  Of the top 20, just looking at the names, 15 of them resulted in easily recognizable mass torts.  Unless you’re inclined to believe that the FDA erroneously approves drugs three quarters of the time, then it’s pretty clear that all that’s really essential to a mass tort is “mass.”

Still there is usually some sort of trigger.  A number of events can set off the avalanche.

First, the most significant would be adverse regulatory action – a mandatory recall or a label change adding a boxed warning or a significant new risk.  Mass torts commonly follow in the wake of regulatory action; the idea that they somehow induce regulatory action is plaintiff-side propaganda 95% of the time.

Second, even in the absence of regulatory action, plaintiffs try to stir up trouble.  Thus, they try to generate bad press – something nasty said on 60 Minutes, or a similar program will rev up the clanking machinery of the litigation industry.  In Bone Screw it was David Kessler’s hysterical response on “20/20” to off-label, yet standard of care, spinal surgery.

Third, short of that, a voluntary recall, even though no government agency demanded it, whereby a manufacturer took its product off the market, has also led to mass tort action.  That was one of the things that happened with Vioxx.

Fourth, a significant verdict in what was once a one-off case can provide the necessary spark − nothing catches the eye of the plaintiff’s’ bar like big money.

Fifth, although it may be as much of an excuse as a true cause, a critical article in the scientific literature can prompt the other side to do its thing. That’s what happened with hormone therapy – a much anticipated scientific article didn’t show the expected advantages, but rather a moderate increased risk (less than double) as to a single (the highest) age group that wasn’t even the principal target population for that product.  In the mass-tort frenzy that followed, all these distinctions got lost in the shuffle. Since tort “market” was large, and the risk relatively common, it was off to the races and damn the details.

Finally, these days the trigger doesn’t even have to involve the product.  An adverse event befalling another product in the same group of drugs or devices can lead to copycat mass tort litigation against the entire group.  Plaintiffs are currently suing over every second generation anticoagulant, every IVC filter, and every conceivable kind of surgical mesh. Think Vioxx and Cox II analgesics, or Baycol and statins, or AcroMed’s pedicle screw device, with litigation spreading to every other device on the market that used similar bone screws.  Close used to count only in horse shoes, hand grenades, and H-bombs − you can add mass torts to that list, particularly if you can find a synonym beginning with “h.”  (We can think of one easily enough, but the Blog, unlike ATRA, isn’t allowed to use it.)

How much (if any) of this is really good policy?  We have to think that the litigenic effects of FDA regulatory action, and of all recalls, mandatory or voluntary, cannot help but to deter actions that proper public health policy should encourage.  We’re afraid that fear of litigation may deter companies from voluntarily undertaking (or acquiescing in a regulatory agency’s request for) a product recall or a label change.  That doesn’t mean we agree with it, though, since delay in such situations usually makes things worse in the end.

Back when product liability was shiny and new, strict liability was justified because it supposedly would causes companies to internalize risks and thereby reduce those risks. These days fear of mass tort litigation can also influence corporate decision-making, in ways that are harmful to the public.

But we digress.  Back to our anatomy lesson.

Regardless of what is the triggering event, the creation of the mass tort itself follows – almost entirely extra-legally.

Advertisements.

Since the courts discovered that lawyers have a constitutional right to use advertisements to solicit clients, they have done so – with a frequency that would no doubt have shocked the Founding Fathers.  Anybody who watches TV knows what we’re talking about.

And it’s not just lawyers, either.  Media specialists and third-party litigation funders also combine to run (with apologies to Marlowe) the race that launched 100,000 TV (and internet) ads.  Anyone who responds – and many do – becomes “inventory,” their claims available for sale in bulk to enterprising lawyers hoping to cash in on the next mass tort.

Thus, within hours after the triggering event, “law firm” websites will invite product users to sign on as potential clients.  Similar solicits in other forms of media follow.

This early stage is usually the point of no return.  The lawyers involved will freely buy, sell, and trade the would-be clients that have signed up – to the point where those clients often don’t know who their lawyers actually are.  But once they have clients, no matter how attenuated the relationship, lawyers cannot ethically let them go.  Regardless of the facts, the mass-tort litigation process takes on a life of its own.

So, counsel who specialize in representing plaintiffs in mass torts strike first in their favorite venues.  Some of these are in state court.  There, they try to keep their chosen courts by filing multi-plaintiff complaints – in numbers less than 100 to avoid a federal statute called “CAFA” – with people from all over the country, but at least one in the home state of at least one defendant to prevent defendants from being able to take the cases to federal court.

The only thing the plaintiffs in these massive complaints have in common is that they claim some injury from the same product (although sometimes they sue multiple manufacturers of the same kind of product).  The only thing the complaint tells the defendant about the plaintiffs is their state of residence.  Try filing an adverse event report (which the FDA requires for every litigation complaint no matter how weak) with that.

Defendants counter with “snap” removals.  If the only thing preventing removal of a case to federal court is a defendant from the place where the plaintiff chose to file suit, then removal before service is a good idea for defendants.  Monitoring the state-court dockets and taking action before the plaintiff gets around to serving that defendant gets such cases to federal court. The statute allows it, and so do a lot of courts.

Other plaintiffs want to be in federal court so they can create multi-district (“MDL”) litigation.  Even in federal court – heck, especially in federal court – the race is also on.  The big money in MDL litigation, for those lawyers who want to work, is to be on the Plaintiffs’ Steering Committee.  That requires knowledge of the obscure ins and outs of MDL procedure, but it also requires a client base.  So candidates for the steering committee work in league with the media solicitors to scoop up lots of inventory to file in federal courts that they think would make a good home for an MDL proceeding.  These are usually the most competent plaintiffs’ lawyers. They’re itching to do some work, to try some cases, and to maintain or to establish their reputations in the field.

The final decision on where an MDL is located rests with a committee of judges, and competing lawyers will file lots of cases in various places (usually their home federal courts).  Defendants also have some say, and often prefer to be where their principal place of business is located.  Where an MDL is located can be important for other reasons besides the composition of the plaintiffs’ steering committee.  Federal issues, like preemption, differ between the circuits, and in MDLs the law of the circuit where the MDL is located will apply.

At this point, our original post mentioned class actions.  They’re really not many of them in mass torts anymore – practically none in cases alleging personal injury.  Class actions still get filed in mass torts, mostly on behalf of insurance or government programs that supply drugs, but as our cheat sheets show, they are rarely certified and nowadays are the “tail” rather than the “dog” in mass torts.

These MDL specialist plaintiffs’ lawyers are very good at what they do, but because the written rules don’t apply, and the rules that do are esoteric and hidden, it’s mostly the same repeat players over and over again. That the resulting steering committees tend to be less diverse than the current crop of White House interns is an unfortunate consequence of the overall lack of rules and reliance on a good old boys network rather than the stringent competition conducted by our clients  Our clients actually care about this kind of thing, and unlike the inventory on the other side, our clients get to choose their lawyers, rather than vice versa.

But we digress again.

Most plaintiffs’ lawyers in mass torts, however, do not seek leadership positions, because that would require, well, work.  It’s far easier to collect some inventory from the advertisers, throw them in the judicial hopper, do nothing, watch how the litigation plays out, and then spring into action only after the parties announce a global settlement.  No muss; no fuss; just big bucks.

MDLs are perfect for these lawyers.  The federal rules largely don’t apply – at least to plaintiffs.  Defendants are precluded from challenging the adequacy of complaints that don’t contain basic information like whether the plaintiff actually used the product at issue or had the injury that is the subject of the MDL.  Defendants aren’t allowed to take so-called “case specific” discovery or to file “case-specific” motions.  With the rules becoming figments of the imagination, at most defendants get “fact sheets,” most of which contain incomplete or even downright false information.

So while defendants are spending tens of millions of dollars complying with the plaintiffs’ massive discovery (a mass tort largely eliminates “proportionality” from discovery directed at our clients), if they want any discovery at all from plaintiffs – they have to pay for that, too.  Defendants have to pay to check the accuracy of the fact sheets, and to collect the plaintiffs’ medical records.  Since this is information that, in non-mass-tort cases, plaintiffs would pay for in responding to discovery, it’s tailor-made for those plaintiffs’ attorneys who want a free ride until settlement.

And that’s just the core litigation.  Mass torts also spawn peripheral litigation. The target company (or industry) will probably be enmeshed in securities litigation, with shareholders seeking “stock drop” damages and alleging that the company knew all about what the product liability plaintiffs are suing over, but kept it hidden from investors.  If the company has insurance, the insurers will bail and seek to deny coverage.  State attorneys general, or even the federal government, might sue.  There could even be the odd False Claims Act case, or two.

It’s the American legal system in all its glory.  Mass torts are essentially a lawyer’s full employment act.  Mass torts are even counter-cyclical – they tend to rise when the economy doesn’t; when more people need money and more investors have underinvested funds lying around to underwrite litigation.

In any event, the mass tort proceeds.  Plaintiffs petition the MDL Panel to create a coordinated proceeding.  That gets sent somewhere, with or without the defendant’s acquiescence.  A significant number of MDL judges are also repeat players.  We’re sure that at least some of them enjoy the power and the notoriety – in addition to the relatively interesting work.

Non-MDL actions also proceed, to the extent that plaintiffs who want to be in state court are successful in staying there.  Personal jurisdiction developments are making this harder, as federal courts are less likely to tolerate the multi-plaintiff complaint jurisdictional dodge.  Several states are known for coordinated state-court mass tort proceedings, such as California, Pennsylvania, New Jersey, Missouri, and in some types of mass torts, New York, and Florida.

In the MDL proceeding, the target defendants search for a silver-bullet defense – one that can get rid of thousands of cases at once.  These are mostly preemption and Daubert expert witness exclusion, although occasionally other issues, such as warning adequacy as a matter of law, innovator liability, or even the statute of limitations, can serve that function in particular mass torts.  Preemption bars plaintiffs from recovering because federal law says “no.” It doesn’t matter how strong or weak a plaintiff’s state-law tort claim is on the merits.  A win on the (general causation) Daubert ground means that plaintiffs are barred from recovery because no legitimate scientific evidence links the defendant’s product to the plaintiffs’ alleged injury.  These are the kind of rulings that, when they happen, often wind up on our annual “best of” list.

In all-too-many mass torts, the defendant loses on the wholesale level, preemption doesn’t apply and at least one plaintiff-side causation expert gets through Daubert.  So the litigation continues.  The next bump comes just before the two-year mark. That is the statute of limitations for product liability claims in most states.  Plaintiffs’ lawyers who have been holding back cases, trying to determine whether the federal or state litigation will provide them the most recovery with the least work, have to fish or cut bait. If they don’t file complaints then, well, the strongest legal malpractice claims involve blown statutes of limitations.  So at two years, the rest of the inventory shows up.

At the two-year point defendants at last have a pretty good idea of the magnitude of the mass tort.  And, with most new cases time-barred, defendants can begin to think about what a global settlement might look like, now that news of settlement negotiations won’t just spark another round of advertising and still more litigation.  Defendants’ depressed stock prices may start to rebound.

But even now the tricks continue.  Litigation shifts to states with longer statutes of limitations, more lenient discovery rules, and no borrowing statutes.  New Jersey comes to mind.  Fights over conflict of laws arise.  Litigation tourists go to states where they think such arguments might win.  Defendants respond with personal jurisdiction challenges to cases filed in states where neither they nor the plaintiffs actually reside.  More side issues to keep lawyers busy.

Then what?  Maybe the parties try a few “bellwether” cases.  Here, plaintiffs open their bag of tricks wide.  MDL judges all-too-often view everything through the prism of settlement, and anything that puts pressure on defendants to fork over big bucks will be employed by at least some of them.  Repeat player MDL judges – especially lately – seem to get picked because they have a good settlement track record.  Settling judges tend to be what mass-tort plaintiffs like, and therefore these plaintiffs have forum shopped to get MDLs before them. It’s all about settlement leverage.  Settling MDL judges will routinely deny preemption, even where it’s widely recognized, look kindly on new and expansive causes of action, allow plaintiffs to manipulate the bellwether selection process so that only plaintiffs’ best cases get tried, make horrendous evidentiary rulings, and force defendants to try cases with multiple plaintiffs at the same time.

In most of these situations, if the defendant wins – presto – that’s a final judgment and the plaintiffs have an immediate right to appellate review.  If the plaintiffs win, well turnabout certainly isn’t fair play.  There’s no final order and no appeal.  Interlocutory appeals?  Rarer than hen’s teeth.  Why would an MDL judge pushing settlement do that?  In this one-way system, the only way a defendant ever gets to appeal a loss, is after losing a bellwether trial.  In that situation the appellate court has a Hobson’s choice, find a way to affirm or let “years of MDL time and effort go to waste.”

The actual safety of the product is largely irrelevant.  That the FDA reviewed the product and allowed it to be marketed is – if the plaintiffs have anything to say about it – is equally irrelevant. Plaintiff’s counsel, employing reptile litigation tactics, tells the jury in opening statement to, “Send a message to this company that put profits before safety!” or the other favorite, “This is the case of a company that stuck its head in the sand and refused to admit the truth!” Or perhaps. “In this case the defendant tried to hornswoggle the FDA.”  And it goes downhill from there.

Defense counsel responds:  “This is the case of Joe Blow, who:

Saw a doctor who knew everything about the risk at issue, and who didn’t need a warning to decide what to do.

Has expert witnesses who are liars and will say anything for money.

Didn’t [read][follow] the warnings.

Had so many prior risk factors that the injury was waiting to happen.

Recklessly misused the product, which was obtained illegally in any event.

Since we haven’t identified any particular product, we can’t be more specific about how a trial would look, so we picked a few of both sides’ greatest hits.   The jury – between six and twelve people from which any anybody with any relevant scientific background has been excluded − hears from (among many possibilities) neurosurgeons, epidemiologists, pharmacologists, pathologists, biostatisticians, and bioethicists.  Then the jury decides the critical issue:   Who is worse?  The evil defendant or the reckless plaintiff?

Then we start counting.  If the defendant wins most of the trials, the mass tort loses its value, the plaintiffs’ attorneys would rather litigate something else, and one way or another the mass tort goes away with a whimper rather than a bang.  If the plaintiffs ring the bell – often assisted by a punitive damages claim or a consolidation of multiple plaintiffs − the litigation continues for a while, until those awards are overturned on appeal (see Vioxx and testosterone, and we hope Pinnacle Hip) or the risk becomes too extreme for the defendant to continue (see Actos).

Eventually, everyone’s exhausted.  Counsel wrestle with inventories and the aggregate settlement rule, or perhaps cy pres and some sort of settlement class action that even more blatantly favors the plaintiffs’ lawyers over their clients than other forms of mass-tort settlements.  The steering committee gets paid for all the work it supposedly did on all plaintiffs’ behalf, even though they’re free to screw any plaintiffs that don’t settle − since they only owe fiduciary duties to their own clients.

Finally, everyone goes home and tries to figure what else to do for the first time in five years.  So they turn on the tube looking for bad news that’s good for them, or start googling product recalls.

Then the whole thing starts over again.

 

We are on vacation this week.  The aim was to stay in this hemisphere, yet get the feel of being in an old European city.  Less air travel, but still with the overcharging and the hard stares in response to our dodgy foreign language skills.  So with that hint, guess away as to our present location.  As part of vacation prep, we downloaded a bunch of movies on our Netflix account for viewing on the plane and in case of a rainy day.  A couple of days ago, with gritted teeth, we hit the play button for a documentary film called “The Bleeding Edge.”  We deal all the time with claims of failure to warn, but in this instance we have no such claim.  We had been fully warned that the film was a thoroughly one-sided screed against the medical device industry.  Pity the poor defense lawyer picking a jury tainted by this particular work of art.  The case studies in the film involve hip implants, a contraceptive, vaginal mesh, and robotic surgery.  Rotten Tomatoes gives the film a score of 100%.  This film must be a banger, right?

 

Well, it is certainly effective.  True to its title, it draws blood – emotionally, anyway. It conveys a series of stories, it makes you feel sorry for victims, and it makes you mad.  It feels very much like an extended 60 Minutes segment.  60 Minutes has been on the air for 50 years.  That’s 50 years of confronting corporate and government malefactors. 50 years of crooks scurrying away from cameras.  50 years of righteous indignation.  Many times over those 50 years, 60 Minutes worked its forensic magic on us.  We were just as swept up in the disillusionment and the urge to punish as any other viewer. 

 

And then, when we began our stint at a law firm, we worked on a case that received lots press coverage.  To our shock, the press got at least half the story wrong.  The account of who, what, where, when, why, and how was terribly tilted – more a morality play than factual reportage.  Eventually, it occurred to us that perhaps the press didn’t distort reality only for stories about our cases.  Maybe, just maybe, flaws riddle press stories fairly (or unfairly) often. 

 

We have worked on litigation involving only one of the products at issue in “The Bleeding Edge.” All of the stories are compelling, with human beings who earn sympathy.  Some suffered terrible physical injuries.  Even beyond that, some of their lives were ruined in other ways, with awful impacts on family members.  You’d have to have a heart of stone to be unmoved.  For the story dealing with the product we know a little something about, vaginal mesh, the story turns out to be a half-story.  The viewer will see nothing about the vast majority of patients who had their lives bettered by mesh – whose stress urinary continence, which had devastating, embarrassing consequences for quality of life, had been fixed. Instead, we hear from a plaintiff lawyer who delivers a mini-closing argument against mesh. He says that when the science conflicts with the marketing, “the marketing always wins out.”   That’s catchy, but that’s also a canard.  From what we have seen, medical device marketing claims must run the gauntlet of careful medical, regulatory, and legal scrutiny before any member of the public sees them.  We also hear from ubiquitous plaintiff expert David Kessler, a former head of the FDA, who rips into the 510(k) “loophole”.  You will not hear a hint of why that provision was deemed necessary and how there was at one time enormous discontent about undue delays in making beneficial medical devices available to patients.  If there is a legitimate, nuanced debate about whether the scope of the 510(k) process should be adjusted, or whether that regulatory pathway should be bolstered or adjusted when the underlying predicate devices are withdrawn, you won’t hear that nuanced debate here.  It’s all black and white, albeit in cinematic color.  Then we hear from another plaintiff expert who wields a rhetorical axe, not scalpel, against mesh.  Immediately afterward, we hear from a plaintiff. When she mouths a critique of vaginal mesh, she says she has heard it is like trying to remove rebar from concrete.  Guess where she heard that?  That is precisely the imagery used by the plaintiff medical expert in his trial testimony.  To our jaundiced eyes, these interviews were cleverly curated and assembled for maximum negative impact.  That is not documentary; it is choreography.

 

If “The Bleeding Edge” is one-sided – and it is – its defenders will say that is the fault of the companies.  At the end of the film, we get the typical screen notification that the filmmakers invited the companies to appear, but the invitation was declined.  Can you blame the companies?  First, it was clear that the filmmakers was dead set on putting scalps on the wall.  It was inevitable that the questioning and editing (more on the latter in a moment) would be deployed to make the companies look bad.  The filmmaker, not the interviewee, has final cut. Second, companies in litigation know that any public statement could be used against them.  By contrast, a plaintiff lawyer can say whatever he wants without worrying that an inaccurate statement might be used against one of his clients.  Thus, there is a structural reason why public reporting on matters in litigation usually favors plaintiffs.  There is also the same bias one sees in scientific journals in favor of finding significant results.  “Product Injures Thousands” will attract more eyeballs or clicks than “Company Responsibly Pursues Innovation.”  For good reason is the film entitled “The Bleeding Edge.”  If it bleeds, it leads.  

 

There is an appearance in the film by the CEO of AdvaMed, the medical device industry association.  We first see him making a presentation to the MedTech Conference.  In the excerpt selected by the Bleeding Edge filmmakers, the CEO says that medical device makers “have more power in this room than most governments around the world.”  End of excerpt.  As placed in the film, it sounds a wee bit sinister.  It is as if the documentary is trying to depict the CEO as a Bond villain.  Cue the terrifying henchmen, the white cat, the trap door, and the plan for world domination.  But context is all.  The speech was actually about the industry’s power to innovate.  Rather different, isn’t it?  Not that it makes a difference to the filmmakers.  After all, in more than one place in the film, the concept of innovation is belittled, even ridiculed. And yet, would anyone really prefer that the government stifle innovation?  We’ve read reviews of the film that conclude by advising viewers to question their doctors when innovative treatment is proposed.  It is good for patients to ask questions.  But it is not so good for them to be cynical.  Hello, vaccine-avoiders.  And it is not so good for patients or doctors to harbor preconceptions against innovation.  Later in the film, the AdvaMed representative submits to an interview by the filmmakers.  What he says is appropriate and above reproach.  But, again, something interesting happens with the editing.  After the AdvaMed rep answers the questions, the camera holds on him for an uncomfortable pause.  The fellow looks at the camera.  Then he looks around.  Then he lifts his paper cup of coffee.  Only after the camera plays its little trick of creating discomfort does it finally cut away. What is the purpose of that?  Whose bias is actually being exposed?  We are reminded of the scene in the Michael Moore movie where a government official is shown combing his hair before the interview.  Context can convey skepticism and derision.   

 

Needless to say, the film-makers employed no such editing maneuvers during the interviews of the plaintiff litigation team. 

 

Again, the film is effective at doing what it wants to do.  It makes a case.  But do not for a moment mistake it for what it is not – a balanced examination of the truth. 

 

[P.S.: Happy Birthday to the Drug and Device Law Son.  We will always be hopelessly biased in his favor.]

 

 

 

 

 

 


We’re not fans of dinner party chatter, especially when we’re berated for defending alleged corporate deviltry against widows and orphans.  We’d just as soon find another corner of the room and another stiff pour of Lagavulin.  But there is a point that seems to register with even our most self-righteous accusers: for every meritorious case, there are many, many more that are made-up money grabs.  The chattering classes agree that plaintiff lawyers are at least as greedy as occupants of the C-suites, and are, if anything, more prone to playing fast and loose with the facts.  Plaintiff lawyers overreach.  Everyone knows that.  Do courts?

 

Yes, at least some do.  A recent example can be found in Carroll v. E One Inc., et al, 2018 WL 3040757 (3d Cir. June 20, 2018).  Carroll is not a drug or device case, but it contains useful language about plaintiff lawyers who fail to do the minimal homework as to whether their clients actually have a case.  The plaintiffs in Carroll were firefighters who sued the manufacturer of fire sirens, alleging that they suffered occupational hearing loss due to the “omni-directional design” of the sirens, which “unnecessarily exposed the firefighters to dangerous levels of sound.”  This lawsuit was one of several filed around the country, all involving the same plaintiff lawyers, same defendant, and same theories. Results varied in those other cases. The plaintiffs won some, lost some, and dismissed some after it became clear that the cases were flat-out losers.  It became pretty clear pretty early in the Carroll case that it was in the loser category.  First, early discovery revealed the firefighters’ lawsuit to be time-barred. Since the 1990’s, the plaintiffs’ fire department conducted routine annual audiological screenings of all of its firefighters. Nearly all of the plaintiffs in this suit had been advised many years earlier that they had hearing loss that was very probably caused by the loud noises to which they were exposed on the job and that they should be wearing hearing protection. Consequently, the plaintiffs’ claims were “obviously” time-barred when they filed in or around January 2015. Second, one firefighter had not even suffered hearing loss attributable to noise exposure. Oops. As the district court observed, “had Plaintiffs’ counsel spoken with the individual plaintiffs or conducted any other type of investigation prior to commencing this litigation, [counsel] would have learned these facts.”

 

How could the plaintiff lawyers miss the obvious flaws in the case?  Let’s now perform a cinematic flashback and look at how the plaintiff counsel collected their plaintiffs. The firefighters received a notice at their fire departments either on a physical or web-based bulletin board that free hearing screening was being offered at the union hall. Many of those notices were prepared by the plaintiff counsel’s law firm.  Firefighters who decide to avail themselves of the free hearing test went to the union hall, then into a certain room, sometimes two firefighters at a time, where an audiologist puts headphones on them, played tones and directed the firefighters to raise their hands or push a button when they heard the sounds. You have probably heard of such tests before.  The firefighters were not informed of test results until months or sometimes years later, after they became part of a lawsuit. The firefighters were not referred to a doctor or advised to wear hearing protection.  Frequently the first contact a firefighter plaintiff had with someone from the plaintiffs’ counsel law firm was just before or even at their deposition. You have probably heard of this sort of thing before, too. 

 

So maybe it’s not such a surprise that the plaintiff lawyers took a while to catch on to the fact that their clients had no viable case.  Call those lawyers willfully deaf.  Nevertheless, even after learning the truth – and certainly well after they should have learned of the truth — the plaintiff lawyers pressed on.  They did so even after the defendant patiently laid out the defects in the case and invited the plaintiffs to dismiss before undue work was done (e.g., depositions) and undue expenses were incurred.  The plaintiffs said No thanks.  More work was done and more money was spent.  Then the plaintiff lawyers said, Never mind.  They grudgingly agreed to dismiss.  The defendant said Fine, but only if the plaintiffs paid appropriate attorney fees for all the waste.  The plaintiffs’ counsel ignored the counter-offer, and—without seeking leave from the district court—filed a “Notice of Dismissal,” asking the Clerk of Court to “mark the claims of all Plaintiffs as being dismissed without prejudice to all parties in this action.”  Nice try.  This “Notice of Dismissal” was improper under Federal Rule of Civil Procedure 41(a).  By that point, discovery had closed and the complaint had been answered.  The parties had not agreed to a stipulation of dismissal.  Accordingly, the defendant filed a motion seeking fees and costs and contested the plaintiffs’ counsel’s ability to “voluntarily” dismiss the firefighters’ claims without prejudice. The plaintiffs’ counsel continued to back-pedal, consenting to dismissal with prejudice, but still opposing the defendant’s request for fees and costs.

 

And now, we offer a brief primer on basic civil procedure law.  Under Federal Rule of Civil Procedure 41(a)(1), unilateral, voluntary dismissal is available only before the opposing party serves either an answer or motion for summary judgment. It was clearly too late for that in the Carroll case.  Thus, the plaintiffs’ effort to dismiss fell under Rule 41(a)(2), which allows an action to be “dismissed at the plaintiff’s request only by court order, on terms that the court considers proper.” Exercising that broad grant of discretion in the Carroll case, the district court concluded that its terms would include an award of attorneys’ fees and costs. The district court recognized the “general rule [that] defendants are not permitted to recover fees when a plaintiff dismisses an action with prejudice absent exceptional circumstances.”  The plaintiffs’ counsel was banking on that general rule to shield them from attorney’s fees.  But as the district court put it, “this case is unusual and it therefore calls for an unusual solution.” 

 

What was unusual about the Carroll case?  The district court conducted an evidentiary hearing regarding the fee request.  A defense attorney testified.  The plaintiffs put on no evidence.  The district court ended up pointing to the complete failure on the part of plaintiffs’ counsel to spot the weaknesses in their case.  The district court also took into account that the selfsame plaintiffs’ counsel had been similarly asleep at the wheel or indifferent to reality in other cases around the country.  The plaintiff lawyers felt aggrieved by the fee award, so they appealed to the Third Circuit.  They lost. 

 

The Third Circuit acknowledged that attorneys’ fees and costs are typically not awarded when a matter is voluntarily dismissed with prejudice.  But such an award may be granted when “exceptional” circumstances exist. Exceptional circumstances include pushing a case forward with utter indifference as to whether there is any there there.  The plaintiffs’ counsel argued that they were not put on notice of the time-barred nature of their clients’ claims until the deposition of a medical director of the police and fire clinic that provided annual hearing tests to the plaintiff firefighters.  But that evidence turned out to be more damning than exculpatory.  All it did was provide “further evidence of counsel’s failure to conduct a meaningful pre-suit investigation.” The plaintiff lawyer “could simply have asked his clients during a routine interview when they had first discovered that they were suffering from hearing loss attributable to their jobs as firefighters.”  Then came the quote that any decent defense hack might want to tack on the wall for future use: 

“It highlights the importance that counsel treat each individual case in this aggregate litigation as just that, its own individual case.”   

 

Save room on the wall.  There’s more:  

“[T]his case is an example of some of the excesses of modern mass tort litigation – when attention to an individual case is sacrificed for the sake of pursuing mass filings.” 

 

As our nerd friends would say, that sacrifice of paying attention to an individual case is not a bug in the mass tort system in this country, it is a feature.

 

The Third Circuit had no problem with the district court’s consideration of “circumstances that extended beyond the geographic boundaries that make up the Eastern District of Pennsylvania.”  Last minute dismissal of frail cases was arguably part of the plaintiff counsel’s modus operandi in this litigation.  The plaintiff counsel complained that the district court had “appoint[ed] itself the policeman of this nationwide litigation” by “unilaterally usurp[ing] the powers of the other courts.” The Third Circuit put the “overheated rhetoric,” and concluded that the district court had not abused its discretion when it explicitly considered the entirety of the nationwide litigation.  Rather, the district court “properly took notice of how the case before it fit within the larger network of cases brought by Plaintiffs’ counsel throughout the country.”  This pattern and practice of failure “to perform a meaningful pre-suit investigation, and a repeated practice of bringing claims and dismissing them with prejudice after inflicting substantial costs on the opposing party and the judicial system,”  with such failure and infliction of costs being especially egregious and unnecessary in the Carroll case, constituted the sort of “exceptional” circumstances that called for an award of attorney fees even in the wake of a voluntary dismissal with prejudice.

 

Chalk it up as a nice win for the defense.  Nevertheless, a question gnaws at our defense hack noggin:  what if the plaintiff lawyers’ failure to pre-screen the cases for merit really is not so “exceptional”?

 

 

Last week we discussed a federal court’s holding that mere fear of injury was not an actionable tort. In the run-up to the description of the case, we reminisced about the diet drug litigation, where many plaintiffs alleged heart valve injuries that had not yet manifested any physical symptoms. Those plaintiffs claimed they feared sudden death or open-heart surgery.  Would those scary things happen?  When?  Those cases produced wildly inconsistent results.  On essentially the same facts, some cases were dismissed by courts, some made it to a jury that would award zero or minimal damages (perhaps the cost of antibiotics for dental visits) and we can think of one trial that culminated in two verdicts of over $100 million because the Philadelphia trial judge permitted the plaintiff lawyers to make the case about the company’s funding of studies (where the studies were entirely legitimate and the company’s connection was disclosed, mind you) rather than about the particular plaintiff.  Not to put too fine point on it, but the diet drug litigation was not one of the glorious episodes in American jurisprudential history.

 

That is an understatement. It turns out that there were plenty of plaintiffs who did not even have actual heart valve injury.  The diet drug mass tort mostly settled, under threat of class certification (something that, thankfully, doesn’t happen anymore).  There were opt-outs, to be sure, but lots of plaintiffs signed onto a settlement process where plaintiffs’ payments depended on their placement on a grid, with extent of injury being the key factor.  How to determine extent of injury?  Ah, there’s the rub.  It turns out that some doctors working with/for some plaintiff lawyers sold their integrity and purposely misinterpreted echocardiograms to call valvular regurgitation moderate or severe when it was actually mild or did not even exist at all. That was fraud, it was ultimately found out, and medical licenses were lost.  Pretty bad, right?

 

Wouldn’t you know it that the day after our post last week the Sixth Circuit issued a decision, McGirr v. Rehme, ___ F.3d ___, No. 17-3519, 2018 WL 2437184 (6th Cir. May 31, 2018), that reminded us of another fraud associated with the diet drug mass tort litigation – this time involving the legal profession in a very ugly way.  The case was an effort by diet drug plaintiffs to recover money from a plaintiff lawyer who had stiffed them.  Their entitlement to the money had already been established.  The problem was collecting on the judgment, because the plaintiff lawyer was doing a nifty job of moving his assets around.  Because any further characterization by us will likely elicit accusations of schadenfreude on our part, we will rely on direct quotes from the Sixth Circuit’s opinion as much as possible.

 

Here is how the opinion begins:  “For years, plaintiffs’ attorney Stanley Chesley appears to have been orchestrating a high-stakes shell game in an effort to escape a long overdue multi-million dollar judgment. In the process, he has defrauded hundreds of judgment creditors, many of whom are plaintiffs here.”  2018 WL 2437184, at *1.  And we’re off.

 

What had happened? A diet drug settlement in 2001 gave the plaintiff lawyers $200 million, with the defendant leaving it to the plaintiff lawyers “to divvy up the settlement among the class members as they saw fit.  Trusting the attorneys with such a task proved to be a mistake.” Id. at *2.

 

Another understatement. Plaintiff lawyers told their clients they had received a settlement in a certain amount, but then reported a significantly higher amount to the defendant, and the plaintiff “lawyers kept the difference.” Id. In the end, clients received a total of $75 million when they should have received $134 million. Id. Easy money, but not an especially clever scheme.  Indeed, the Kentucky Bar authorities smelled something foul. To cover their tracks, the plaintiff lawyers found a compliant Kentucky judge who retroactively altered the terms of the fee deal and then sealed the record.  That judge also was set up as a director of a charitable organization created by the new fee deal.  That judge pocketed over $48,000 from the arrangement.  That judge has since been “permanently disbarred.” Id. at *3.

 

So far, clients were cheated and the judiciary was corrupted. But wait, there’s more.

 

The plaintiffs won a lawsuit in Kentucky and got a judgment in 2007 against their lawyers (and Chesley as a co-conspirator) in the amount of $42 million. Id. In 2011, the Kentucky Bar held that Chesley violated “eight separate rules of professional conduct and recommended his permanent disbarment” and the Kentucky Supreme Court upheld that decision.    Id. (footnote omitted). “Chesley’s time as an attorney in Kentucky had come to an end.” Id. Chesley’s home jurisdiction of Ohio “would likely impose reciprocal discipline” but it never got the chance because Chesley retired from the practice of law in 2013. Id.  He then executed a “wind-up” agreement with his law firm that “served as a vessel through which Chesley could move his assets.” Id.

 

The Kentucky plaintiffs, looking to execute on their judgment, “came knocking,” but Chesley found a helpful judge in Ohio who kept entering “unusual” orders that frustrated the execution efforts of the Kentucky plaintiffs. Id. at *3-4.  “This kicked off a jurisdictional turf war on either side of the Ohio River.” Id. at *4.  In 2015, the Kentucky judge ordered Chesley to cross the river and justify his noncompliance with the court’s order, but Chesley did not show, so an arrest warrant was issued.  No matter, because that helpful Ohio judge granted an injunction “preventing Chesley’s arrest.” Id.

 

This all happened in the United States of America.

 

Speaking of the United States, the plaintiffs got the bright idea to turn to the federal courts. They brought an action in S.D. Ohio “to get an order recognizing Chesley’s recent transfer transfers (including the wind-up agreement) as fraudulent and to unwind those transfers.” Id. The plaintiffs asked the Ohio federal court to enter “a preliminary injunction that would freeze Chesley’s assets to prevent him from moving those assets outside the court’s jurisdictional reach.” Id. at *5.  Before the court could enter any injunction, the assets moved yet again, via a maneuver in Ohio state probate court. The district court found the new transfer malodorous and issued a TRO, later converted to the preliminary injunction sought by the plaintiffs. Id. (This must have all seemed awkward to the court, as Chesley’s wife was a federal judge in the same courthouse.  Yikes.) The Ohio Supreme Court “validated the district court’s suspicions” and found the asset transfer to be fraudulent and an abuse of process. Id.

 

Meanwhile, the preliminary injunction was in place, and went up on appeal to the Sixth Circuit.   Because of the asset transfers, Chesley was not a party to the appeal.  This case was about following the money.  After reciting this sordid story, the Sixth Circuit applied the standard factors for assessing a preliminary injunction: (1) the movant’s likelihood of success on the merits, (2) whether the moving would suffer permanent harm absent an injunction, (3) whether the injunction would harm third parties, and (4) whether the injunction would serve the public interest. Id.

 

This was not a hard case. The Sixth Circuit concluded that the questionable asset transfer checked “virtually all of the … boxes” for the Ohio statute on fraudulent conveyances. Id. at *6.  The Ohio Supreme Court’s decision finding a transfer fraudulent made an easy decision even easier regarding the merits of the plaintiff’s action.  This blog is not about fraudulent conveyance law, so let’s leave it at this:  there was ample evidence of transferring assets to an insider, of Chesley’s retention of actual control of the money, of concealment, and of convenient timing.  Chesley and the other defendants offered explanations, of course.  But the Sixth Circuit kept its eyes on the big picture: “In the mid-2000s, after helping to steal millions of dollars from the Guard case plaintiffs, Chesley felt the walls closing in on him.  In 2005, his ex-clients used him.  In 2006, a Kentucky court found his accomplices liable.  In 2007, the same court entered a $42 million judgment against them.  All the while, the Kentucky Bar was investigating him.  Shortly after, Chesley began to move the majority of his assets around. Id. at *7-8.  This evidence suggests that Chesley has been carefully keeping his money just out of the plaintiffs’ reach, in the event that he was also found liable for the $42 million he had stolen.” Id. at *8.

 

As we said, this was an easy case.

 

Irreparable harm was obvious. The continuing shell game, if successful, would keep the money out of the plaintiffs’ hands.  The probate action “was just another move in that game.” Id..  Only the injunction could put an end to the game.  By contrast, Chesley could not demonstrate actual harm to other creditors. Id.  But it is the public interest prong where the Sixth Circuit opinion really sings.  The litigation “has been lumbering through federal and state courts for two decades.  In its wake, officers of the court have been disbarred and imprisoned; Kentucky and Ohio state courts have been pitted against each other; and Chesley has forced the federal courts to use judicial resources to try to stop it all.  There is a fundamental public interest in ending such abuse of the judicial system, in conserving judicial resources, and in preventing further confusion and disruption in this litigation.” Id. at *9.

 

The Sixth Circuit affirmed the district court’s entry of a preliminary injunction.

 

What are we to make of this concatenation of depressing facts? One could mutter a platitude about how the case offers a cautionary tale.  Fine. What is the caution?  Don’t cheat clients?  Don’t corrupt judges?  Any lawyer who really needs to hear those things is probably too far gone anyway.  No, the true caution is this: mass torts offer opportunities for massive frauds.  That is so not only because the large amounts of money are tempting and the large number of plaintiffs permits gamesmanship, but also because courts too often treat mass torts as settlements waiting to happen.  The litigation becomes a sausage grinder. The system grinds away, doing everything possible to encourage, or force, settlement.  But some cases shouldn’t be settled.  And the assumption that the plaintiff side is a good-guy David while the defendant side is a greedy malefactor Goliath is ridiculous and unfair.

 

It would be wrong to write off this case as an outlier. First, you have certainly heard of other mass tort settlement schemes that ended up being wracked with fraud.  Just in the past week we’ve read about allegations of questionable plaintiff-side conduct in both the NFL concussion and State Street foreign exchange mass/class litigations.  Second, what about the frauds you haven’t heard about?  Once a mass tort becomes a settlement waiting to happen, it becomes a fraud waiting to happen.  Rather than await the next awful morality tale that shames the legal profession and the judiciary, could we perhaps step back and check some of the assumptions plaguing the system?

Is fear of injury the same thing as injury?  The question answers itself.  At least it should.  They are not the same, and there are strong jurisprudential reasons for courts to throw out cases alleging mere fear of injury.  We have a No Injury scorecard documenting a pretty clear court consensus that fear of injury should not be enough to get a case to the jury.  Think of diet drug cases where the claim was an increased risk of heart valve injury.  Most courts concluded that such fear did not amount to actionable injury.  Considerations of Article III case or controversy or standing or ripeness usually persuaded courts that fear of physical injury simply did not cut it.  But not always.  So it is good that today’s case, Perez v. B. Braun Medical, Inc., 2018 WL 2316334 (S.D.N.Y. May 9, 2018), gets added to the defense side of the ledger.  In 2010, the plaintiff had been implanted with an IVC filter to treat her pulmonary embolism (PE) and deep vein thrombosis (DVT).  The implant was intended to be permanent.  In subsequent years there were reports of IVC filters causing problems via misalignment and migration.  In 2014, the FDA urged doctors to remove IVC filters within one to two months after the danger of PE subsides.  The plaintiffs alleged that the defendants in this case continued to market their IVC filter for long-term use — according to the court, the complaint alleged that the defendants were “defying the FDA’s general recommendations.”  Meanwhile, no doctor recommended that the plaintiff remove the IVC filter, even though in 2016 a CT scan showed that the tip of the IVC filter possibly had tilted.  That tipping point was apparently not enough to remove the filter, but was enough to file a lawsuit.  The complaint alleged that the IVC filter was defective and increased the risk that the plaintiff would suffer a serious injury. The plaintiff also referenced unspecified economic and psychological damages. The defendants moved to dismiss the complaint for failure to state a claim upon which relief can be granted, arguing that the complaint did not adequately allege that the plaintiff had suffered any cognizable injury.  The court granted the motion to dismiss.  It analyzed the personal injury, warranty, fraud, and New York Business law claims separately, so we will do likewise.

1. Personal Injury Claims

The plaintiff alleged that her physical injuries were the post-implant likely tilting of the IVC filter, psychological trauma of living with a defective product implanted in her body, and the increased risk of future injuries due to the IVC filter.  The problem for the plaintiff was that New York law is reasonably clear that a mere threat of future harm is insufficient to impose liability against a defendant in a tort context.  To be sure, the complaint also alleged that the plaintiff “sustained serious personal injuries,” “serious physical injuries,” and “severe injuries,” that she suffered “loss of enjoyment of life, disability, and other losses,” and that she “incurred substantial medical costs and expenses to treat and care for Plaintiff’s injuries described herein.”  But those are more rote formulas than factual allegations.  The complaint certainly never described the nature of the injuries.  New York law does recognize claims for emotional distress, but such claims must be premised on truly outrageous conduct, and nothing like that resided in the complaint.  Perhaps the best thing that the plaintiff had was an allegation that the defendants marketed permanent filters even after the “FDA warnings that caution generally against long-term implantation of IVC filters.” But because those warnings, whether or not they said what the plaintiff alleged, did not happen until after the plaintiff’s implant, they could not preserve the plaintiff’s claims.

2. Breach of Warranty Claims

The defendants had a strong statute of imitations argument, because the clock on warranty claims usually starts at the time delivery, which was in 2010, more than seven years before the complaint was filed.  New York’s statute of limitations for warranty claims is four years.  The plaintiff trued to dodge the statute of limitations by arguing that the warranty explicitly extended to future performance, and that existed here because the defendants had stated that the IVC filters were safe and effective for permanent implantation.  But the complaint did not explain how the plaintiff’s particular IVC filter had fallen short.  Again, the mere tilting of the IVC filter, even with a risk of future harm, did not equate to a cognizable injury,  New York courts (like most courts on planet Earth) have acknowledged a policy of protecting court dockets from “being clogged with frivolous and unfounded claims.”  Warranty claims often seem like add-ons in product liability cases, and here they were frail add-ons to already frail claims.

3. Fraud Based Claims

Fed. R. Civ. P. 9(b) requires that fraud claims be pleaded with specificity, and the Perez complaint did not come close to meeting this standard.  Again, the plaintiff leaned on the defendants’ representations that the IVC filters were safe and effective for their intended and reasonably foreseeable use.  But the plaintiff never explained why those statements are fraudulent. After all, the the complaint admitted that IVC filters can be used to reduce the risk of PE and DVT, and it nowhere alleges that the plaintiff’s filter performed in a manner different from how the defendants describe.  Whatever the complications and injuries that the defendants failed to warn the plaintiff about, the complaint did not specifically describe them, and could not allege that the plaintiff had sustained any such complications and injuries.  Moreover, the complaint lacked any facts showing that the alleged omissions were made with an intent to deceive.  The plaintiff simply had not made out a case for fraud.

4. New York General Business Law Claim

The complaint’s final count alleged that the defendants engaged in consumer fraud in violation of New York General Business Law Sections 349 and 350<http://www.westlaw.com/Link/Document/FullText?findType=L&pubNum=1000081&cite=NYGBS350&originatingDoc=Ib48241005e2b11e89868e3d0ed3e7ebe&refType=LQ&originationContext=document&vr=3.0&rs=cblt1.0&transitionType=DocumentItem&contextData=(sc.FindAndPrintPortal)>. Section 349 prohibits “[d]eceptive acts or practices in the conduct of any business, trade or commerce or in the furnishing of any service in this state.” Section 350 prohibits “[f]alse advertising.”  As with the plaintiff’s breach of warranty and fraud based claims, the New York Business Law claims failed to show what materially misleading representations the defendants made. That there are side effects associated with IVC filters that are implanted long-term, does not mean that the plaintiff’s IVC filter “had not been effective for implantation into the IVC to prevent PE and DVT for which it was designed or that it is not safer than the alternative.”

What is interesting about the Perez case is how the lack of a real injury did not just undermine the personal injury claims (seems obvious enough), but also undermined the representational claims.  What is doubly interesting about the Perez case is that the no-injury defense worked with respect to an implanted device.  Most of the good cases on our no injury scorecard involved drugs.  Arguably, a plaintiff has a little more to work with when there is a device implanted in the body.  There is a continuing exposure.  Nevertheless, mere fear of injury could not overcome the court’s fear of frivolous claims.

Bexis has lots of opinions on what’s wrong with mass-tort (especially drug/device) MDLs.  Heck, Bexis has even proposed amendments to the MDL statutes to correct the many severe problems that exist.  Now, Congress has before it possible statutory changes (not holding our breath) and Civil Rules Committee is looking into the same problems.  Maybe something will happen, although rules changes are notoriously protracted, and the cadre of MDL judges (15 judges control 18 MDLs that account for some 47% of the entire federal civil docket) and their plaintiff-side enablers will fight any attempts to curb MDL discretionary excesses.

In the midst of all this, the Duke Law School’s ongoing MDL best practices project held an invitation-only meeting recently, and Bexis was invited as one of the defense-oriented participants. This meeting was conducted under so-called “Chatham House” rules that preclude attributing particular statements to particular persons, so this post summarizing the meeting will not be of the “he said, she said” variety.

Early Dismissal of Meritless Cases

Defense-side participants produced a plethora of statistics that, in MDL after MDL, anywhere between 20% and 45% (eliminating outliers both ways) of all filed MDL cases are ultimately dismissed because the plaintiffs do not have evidence of the most basic information imaginable:  (a) that they actually encountered the product of the defendant being sued; (b) that they suffered one of the injuries that the MDL was about; and (c) that that the timing and amount of the plaintiff’s exposure was plausible under the plaintiffs’ own causation theories.  The missing information that was discussed was not anything expert-related, just product identification, injury, and plaintiffs fitting within whatever might be the plaintiffs’ own asserted parameters of causation.

Somewhat surprisingly, the plaintiff-side participants did not dispute the basic point – that meritless plaintiffs are widespread, running into the thousands of bogus plaintiffs in the larger MDLs.  Indeed, most of the plaintiff-side speakers professed not just their recognition of the meritless claim problem, but their own annoyance at this phenomenon.  The presence of large numbers of meritless cases artificially skewed who had what say on plaintiff steering committees, which partially depend on numbers of cases.  At the back end, meritless cases produced a bunch of left-over plaintiffs, abandoned by their counsel (who never intended to try cases), bumbling around pro se.

Not one plaintiff-side speaker denied that numerous meritless cases existed in MDLs, or that the absence of effective Rule 8/12/TwIqbal procedures encouraged meritless filings.  Evidently, the “park and ride” plaintiff-side lawyers who pump and dump cases into MDLs don’t attend conferences like this, or if they do, they keep quiet.  At most, the plaintiff-side speakers tolerated bad cases because they would “all work out in the end.”

The defense side vehemently rejected that no-harm, no-foul approach.  Defense participants argued that meritless cases weren’t harmless, but rather skewed MDL litigation from beginning to end – driving up discovery costs, forcing defendants to vet cases that plaintiffs should have done before filing, complicating random plaintiff selection for bellwether trials (more about such trials, below), and inflating settlement demands.  Artificially inflated plaintiff numbers increase the psychological impact of MDLs, given how those numbers find their way into press descriptions and plaintiff solicitations.  Masses of bogus plaintiffs also prevent proper resolution of “proportionality” issues in discovery, since they inflate P-side discovery arguments.

Further, FDA regulations do not contain any “bogus” case exception that would give defendants leeway not to report such cases in their adverse event filings.  Phony cases lead to phony “signals,” since even though adverse event reporting is (according to the FDA) not supposed to establish causation, plaintiff-side experts routinely try to misuse them − and sometimes get away with doing so.  When that happens, it’s garbage in, garbage out.  Inflated plaintiff numbers lead directly to inflated reports, so that meritless cases end up supporting junk science.  This effect is magnified by pleading that would be barred by TwIqbal in non-MDL cases that, such as use of “and/or,” that purport to sue multiple defendants when they could only have used one product, so that each defendant is obligated to report the “adverse event” to the FDA.

Matters livened up a bit further, with that morning’s report from 360 on the extreme position taken by plaintiffs in the Zofran MDL were taking on discovery – that discovery rules in MDLs only apply to defendants.  They were demanding that only 8 of over 400 plaintiffs should submit to any discovery at all – giving bogus Zofran cases a free ride all the way to remand.  The Zofran plaintiffs were so over the top that they even claimed an MDL judge lacked jurisdiction to order discovery.  That’s what Joe Biden would call “malarkey,” and not a single plaintiff-side speaker defended, let alone took, that position.

The problem of widespread filing of bogus cases received the most support for (or the least opposition to) a rules change to facilitate early dismissal of meritless cases.  A rules amendment would have to be simple – not a “Lone Pine” order, but rather something much more basic.  A plausible version could be along the lines of mandatory initial discovery, which exists in “pilot project” form in both the District of Arizona and the Northern District of Illinois.  The local rules could be adapted easily enough to require production of all evidence of product identification/exposure, diagnosis of an injury, and their relative timing within a relatively short fixed period (60-90 days would seem reasonable) after filing of a complaint.  If a plaintiff couldn’t produce any facts or records that plausibly establish a claim, then the meritless action would be dismissed with prejudice.  Maybe a mandatory initial disclosure rule would be limited to MDLs above a certain threshold (100? 500? 1000?) number of plaintiffs.

Defendants might have to compromise – giving something to get something.  MDLs are notorious for imposing onerous discovery obligations on defendants, anyway, so frankly our side wouldn’t be giving up much, except for possibly timing.  One possibility, discussed at the conference in a different context, could involve early technology-assisted review of some categories of electronic documents.  We like predictive coding anyway, so as long as the timing is doable, there might be the basis of a workable compromise here.

Another possibility would be to amend Rule 20 to prohibit joinder of plaintiffs in the same complaint who have nothing in common except suing over the same product.  These multi-plaintiff, misjoined complaints are the primary way that the “park and ride” lawyers file their cases, with practically no factual information about any of the plaintiffs.  Not only do these improper plaintiffs cheat courts out of filing fees, but they burden defendants with the expense of vetting the plaintiffs’ cases.  In addition to forbidding the practice, each misjoined plaintiff could also be required to make a non-refundable deposit into the MDL plaintiffs’ common benefit fund.

Finally, the issue of statute of limitations tolling agreements came up.  There could be a legitimate problem, when a plaintiff’s lawyer finds him/herself up against the statute of limitations with a new client.  We don’t have problems with tolling agreements, as long as they’re one-off, and not an excuse for further abuse.  Tolling agreements cannot be an excuse for rampant failure to vet claims – the example given being “I have 2000 new cases, can I have a tolling agreement for two years.”  Tolling agreements are only appropriate for a short period of time.  We think that the same 60-90 day period mentioned above should be long enough to accommodate counsel who would otherwise have a legitimate need for a tolling agreement.

Interlocutory Appeal of Significant MDL Rulings

Another candidate for a rules change – one meeting with significantly more opposition from our colleagues on the other side of the “v.’ – is the interlocutory appeal of the resolution of certain “significant” motions typically made in MDLs.  Such appeals would correct an imbalance in current practice in that, if defendants win a dispositive motion, it’s an appealable final order, but if defendants lose the same motion, no appeal is available because the denial isn’t final.  Thus, the litigation continues, and the dispositive issue is appealed, if at all, years later – after a bellwether trial or a remand (in the rare event that happens).

That imbalanced access to appellate review is acceptable in an individual case, because delay caused by piecemeal appeals isn’t offset by the need to get things right, right away.  What’s acceptable in a single case, becomes a much bigger problem when the downside of an erroneous denial of a dispositive motion could dispose of hundreds or thousands of cases, particularly an appeal much further down the road adds extraneous pressure to affirm, or else a great deal of MDL activity, based on the resolution defendants contend is erroneous, goes down the drain.

Attorneys on the plaintiffs’ side – as was the case throughout the conference – were content with the status quo.  They pointed to existing certification procedures, but current procedures require the assent of the trial judge that denied the motion in the first place.  If denial is intended to force settlement, which is often the case, that assent won’t be forthcoming.  Plaintiffs pointed to the New Jersey Accutane litigation which has (in)famously been around for some fifteen years.  But that analogy is poor.  Most, if not all, of the delay in Accutane is not due interlocutory appeals, but rather from an prior judge’s extremely poor bellwether trial performance (almost every trial verdict was been reversed), or from appeals concerning the grant of dispositive motions – neither of which have any bearing on the current proposal for a Rule 23(f)-like equivalent permitting interlocutory appeals from motion denials in MDLs whether or not the MDL judge wants to allow it.

Ironically, the Rule 23(f) analogy was attacked by the plaintiff side as a bad analogy, because class actions were mostly “negative value” cases that, unlike mass torts, would go away without certification.  We think the analogy, while not perfect, is better than the other side will admit, for reasons discussed in more detail when we turn to bellwether trials.  Lawyers are, by nature, competitive, and the raised stakes of mass tort MDLs only exacerbates that tendency.  Thus, both sides – but in particular the plaintiffs – pour more money into bellwether trials than the individual cases could possibly be worth.  In that way, bellwethers become “negative value” cases, too.

Once again, a bit of serendipity strengthened the defense arguments.  Just the day before, the Fifth Circuit reversed the bellwether trial verdict in the first of several consolidated trials in the Pinnacle Hip MDL. See In re DePuy Orthopaedics, Inc., Pinnacle Hip Implant Product Liability Litigation, ___ F.3d ___, 2018 WL 1954759 (5th Cir. April 25, 2018).  This was the same MDL where the defendants had tried everything to obtain appellate review of the trial court’s erroneous rulings, including mandamus.  Now, something like seven years of MDL activity in Pinnacle Hip has come to just about naught, largely because no interlocutory appeals process existed to provide timely review of repeated erroneous rulings.

We have to admit, though, the other side has a point that it would be difficult to create a one-size-fits-all interlocutory appeal rule defining exactly what “significant” MDL rulings would be subject to its purview.  Preemption, for sure − nobody on either side disputed that a single preemption motion could be dispositive of so much (up to and including “all”) of an MDL to qualify.  Everything else was subject to considerable debate.  Some Daubert motions can have the same MDL-wide preclusive effect; our 2016 top ten cases post discusses two (Mirena and Lipitor) of these (three (Zoloft) if you count the honorable mentions), but lots of other Daubert motions in MDLs would not come close.

Then there’s everything else. Choice of law was mentioned, so were punitive damages.  The jurisdictional issue in Pinnacle Hip was critical, but most MDL judges aren’t that overreaching.  So defining “significant” for the purposes of a rules change could well pose complex problems.

Having thought about all that, however, se say, “why bother?” Let defense lawyers in the particular MDL decide.  Call it the “upon further review” rule if you want.  In the NFL, the rules allow coaches a set number of challenges to just about any on-field calls, and if the team wins a challenge they get another one, up to some absolute limit.  NFL coaches get to pick what calls they consider important enough to challenge.  Let counsel do the same for MDL interlocutory review.  Preemption orders should be appealable, and a set number (probably two or three) of other orders could be subject to interlocutory review at each separately represented defendant’s option.  If the defendant wins the appeal, it gets another challenge.

We don’t think that approach will result in an undue number of appeals – especially since the Supreme Court just reduced the appellate courts’ workload by throwing out Alien Torts Claims Act cases against corporations, creating some give.  Delay might be a more serious concern, but as with Rule 23(f), the MDL isn’t being stayed, so discovery and other activity would continue in the meantime.

Another issue raised, which would be beyond the control of the federal rules, is whether interlocutory appeals would sufficiently delay MDLs so as to encourage plaintiffs to file in state court.  News flash – plaintiffs have been avoiding federal court for as long as we can remember.  In one of Bexis’ first MDLs, some 1500 Bone Screw plaintiffs tried to hide out in state court in Tennessee (where the target defendant was “at home” jurisdictionally).  They might even have gotten away with that, had Tennessee not had an unusually short one-year personal injury statute of limitations, which tripped up plaintiffs after they agreed to a universal discovery date that was more than a year before they filed all those multi-plaintiff complaints.  See Maestas v. Sofamor Danek Group, Inc., 33 S.W.3d 805 (Tenn. 2000) (plaintiffs lose on cross-jurisdictional class action tolling; all 1500 cases dismissed).  One more reason for plaintiffs to stay out of federal court doesn’t mean anything.  If anything, avoiding federal court is harder now than before because the Supreme Court decided to enforce constitutional limits on personal jurisdiction.

Bellwether Trials

There was considerable discussion of bellwether trials, but we have doubts that rules could solve the problems that were mentioned.  Our view is to interpret the MDL statute as written, and restrict MDLs to “coordinated or consolidated pretrial proceedings.”  28 U.S.C. §1407(a) (emphasis added).  A textualist approach to the MDL statute would, and we think should, mean no trials, “bellwether” or otherwise, in the MDL transferee court.  Simple.  No rules change needed.

But totally contrary to decades of MDL practice.  Don’t hold your breath – although if someone wants to preserve it for appeal, this issue could be the next Lexecon.

There was some discussion of how bellwether plaintiffs are selected.  The Manual for Complex Litigation favors random selection.  MCL §22.315.  We also lean towards random selection, although we recognize that the other side can game even a random system by either filing, or not filing, certain types of cases in the MDL.  So even random selection needs to be policed to prevent plaintiffs from attempting to skew the result.

We also think that, if the rules were changed to facilitate the early dismissal of facially meritless claims, that would go a long way to solving the problems with random selection.  Right now, any random selection process necessarily exposes the prevalence of meritless cases, so that plaintiffs are loathe to agree to what, abstractly, is the most statistically valid method of yielding a representative selection of cases.

Ensuring “representativeness” was also discussed, but we frankly think that’s futile.  As someone pointed out, “random does not necessarily mean representative.”  Even what might at the beginning be the most representative of cases ceases to be representative once both sides pour more resources into preparing and trying that case than it could possibly be worth if being tried outside of the MDL.  We agree with the comment of one of the plaintiff-side speakers that “spending a million to win $500,000 is not an economic business model.”  Both sides committing extraordinary resources to a bellwether trial is a sure way to ensure that the case for that reason alone ceases to have any representative value.

On the plaintiff side, keeping the business model economic, under MDL circumstances, only encourages the reduction of representativeness.  Instead, we see plaintiffs focused on “ringing the bell” – adding punitive damages or consolidated plaintiffs to the mix to make the case harder to defend.  That’s the practical (as opposed to the textual) reason we oppose bellwether trials.  At minimum, as we’ve discussed before, defendants should take care to craft any Lexecon waivers to exclude punitive damages or consolidations.  We didn’t hear any proposed rules changes that would meaningfully improve the bellwether trial system.

Third-Party Litigation Funding

The group discussed a proposal, pending in Congress, requiring automatic disclosure of third-party funding agreements.  Interestingly, plaintiff-side speakers admitted that they demand disclosure of that kind of information themselves when setting up their steering committees, because their membership must be able to “take the heat,” and lawyers controlled by a “hedge fund” can’t be shaping their strategy.  To at least some plaintiffs’ speakers, third-party funding meant “a dummy in the room and a ventriloquist outside.”  One of the judges in attendance likewise thought that disclosure of third-party funding was a good idea to prevent conflicts.  If both plaintiffs and the judiciary favor disclosure is necessary to prevent conflicts, then it is hard to justify not routinely disclosing it to all sides, as insurance is disclosed.

Proponents of such funding stated that it was only a “professionalization” of activities that had long gone on the plaintiff side of litigation.  Perhaps, but that justification brings the response of “what, then, do you have to hide?”  If third party litigation funding is truly professionalized, then again, it resembles insurance, which is subject to automatic disclosure.  To be considered “mainstream,” third-party litigation funders need to act the part.

Proponents also raised the issue of disclosure of confidential work product if funding agreements are discoverable.  This concern seems like a red herring to us, as the contracts are easily drafted to omit any attorney evaluations of litigation.

Proponents also distinguished two uses of litigation funding. The first, which is more similar to corporate litigation funding arrangements, involves loans to plaintiff-side law firms, secured either by their interests in specific litigation or by interests in their entire pending litigation inventory.  These tend to have lower interest rates and involve less influence over litigation strategies or settlement decisions.  Disclosure of such funding is, however, essential to gauging the relative resources of both sides in determining who is going to pay for what discovery in MDL situations.  Plaintiffs should not be able to play at being David when their funding lines of credit are actually Goliath-sized.

The flip side is what was sometimes referred to as “payday lending” litigation funding − where the plaintiff is receiving what amounts to an advance on possible recoveries.  A lengthy discussion was had of claimed abuses – covering the NFL concussion litigation and the recent New York Times exposé of what has gone on in the Pelvic Mesh litigation.  In either case, immediate disclosure of litigation funding agreements would have prevented, or at least reduced, improper conduct, as transparency in funding would have raised red flags about the terms and timing of the agreements in question.  Suspicious agreements could then have brought to the court’s attention, or been the subject of additional discovery into their provenance.

Additional discovery was another aspect of the third party litigation funding debate.  Proponents argued, with some force, that disclosure of agreements would not be the end of matters.  They raised potential use of discovery into litigation funding as a means of opening yet “another front” in MDL litigation and attempting to disrupt the opposing side’s ability to finance itself.  We think that concern could be valid, but is easily addressed.  Disclosure of insurance hasn’t (except in Louisiana) led to insurance companies being sued directly by opponents of their insureds.  The work product issue raised above provides a useful analogy with, anything beyond the contract subject to a similar “good cause shown” and “otherwise unavailable” standard.  There is no inherent reason that such funding should be the source of additional discovery, but requiring prior court approval serves as another check.

Finally, just as plaintiffs want a look at their opponent’s insurance to know how much defendants have available for settlement, or whether the other side has sufficiently deep pockets, defendants should be able to make similar judgments based on plaintiffs’ third-party litigation funding.  A plaintiff who has to satisfy a funder is unlikely to take in settlement an amount that the defendant believes is reasonable if that means zero dollars in the plaintiff’s pocket.  In this respect, discovery of litigation funding is justifiable for the same reason as third-party litigation liens.  Very few plaintiffs would argue that insurance, health care, and other liens can be kept secret from the other side.  Anyone who has a piece of the potential recovery is, in practice a real party in interest who should be at the table and whose identity should be known to all.  All sides should know who is the ventriloquist and who is the dummy.

*          *         *         *

Several other topics were also discussed at the Duke conference, but they overwhelmingly involved the plaintiff side − composition of a plaintiff-side steering committee, judicial efforts to increase diversity on such steering committees, and common fund assessments.  But this post is already quite long, and these other topics are of less interest to our defense-oriented audience.

Last week we attended our law firm’s partner retreat.  In between circuits on the lazy river, there was talk of synergies, branding, cross-selling, diversity, technology, and, mostly, collaboration.  You know – the usual stuff.  That last point, collaboration, is really the predicate for all of the others.  Collaboration today has a positive connotation of people working together to achieve a desirable result.  Collaboration came into the room with a much uglier aroma during the Second World War, of course.  See the 1969 film, The Sorrow and the Pity, for more on that sad story.  The nasty words today are collusion and conspiracy.  One is a specific criminal offense, while the other is mere invective.  But enough said about politics and criminal law.  In any event, a retreat is a perfectly fine place to discuss collaboration.  It is an opportunity for colleagues from all over the map to converge in a convivial setting to get to know each other,  trust each other, respect each other, and commit to work more closely with each other.  Luckily for us, as huge and global as our firm is, we do collaboration exceedingly well.  In fact, the very last thing that happened at the retreat was that a conference room of alpha lawyers punched into our phones real-time, word-one descriptions of the firm.  The results were instantaneously collected to create a word cloud.  Do you know what word ended up front and center and in the biggest font?  Collaboration.  So, yay.

 

Around the banquet table and around the pool there was a lot of talk about collaboration.  Law is a team sport.  It is much more like football or basketball than golf or tennis.  And yet, there is a lot of golf and tennis played at retreats, and no basketball or football.  A paradox?  Not really.  Even our golf and tennis games typically involve two-person teams – sort of like trial teams in the courtroom.   Collaboration is by no means limited to the partnership, even if the term partnership is peculiarly evocative of collaboration.  Tomorrow’s partners are today’s associates and counsel.  Unless we develop their talents and permit them to flourish, the law partnership’s institutional survival is a frail thing.  When we were laboring in our mid-associate years, there was a partner who was especially supportive.  He was generous with advice and generous with praise.  He used to say, “I need you to succeed, because you’ll be paying my pension someday.”  That was back in the days of defined benefit plans, which hardly exist anymore.  Nowadays, in the you’re-on-your-own economy,  we save up for our own retirements, so institutional survival perhaps does not seem as vital as it once was.  Surely, there is a cost to that transformation.  But forget about retirement – every law firm exists on a razor’s edge of intellectual supply and demand.  What Samuel Goldwyn said about movie studios is also true for law firms: it’s scary to think that the assets go home every night.  Without constant renewal from young lawyers who bring competence, commitment, and creativity, a law firm won’t live to see the next quarter. Further, the people who do so many of the things that keep the operations humming are the non-lawyers.  They are just as important and professional as the folks with J.D.s.  They often have the most to say about whether we will have a good or bad day.  And if we want to have an in-depth debate about whether the latest Star Wars movie made sense, we are far more likely to check in with some of our friends in IT than with other Life Sciences lawyers.  The constant collaboration animating our firm makes us better at what we do and happier about our lives. 

 

So far we have been talking about internal collaboration.  But it is more and more the case that mass tort lawsuits force firms to collaborate with others to mount vigorous and effective defenses of their clients.  Sometimes one client will assemble a virtual law firm, doling out different tasks to different firms.  (Pity the firm charged with responsibility for overseeing electronically stored information.  Talk about no-win propositions!) Sometimes codefendants need to align to thwart the predations of plaintiffs who seek to exploit potential fissures and induce the defendants to point fingers at each other, thereby doing much of the plaintiffs’ work for them.  Again, we count ourselves lucky to work in a firm that enjoys both the reputation and reality of playing nicely in the sandbox with others.   Sharp elbows simply aren’t a part of our culture.  There is no reason to horn in on others’ work, and certainly no reason to trash the effort of colleagues, even when they are competitors in the marketplace.  For one, that sort of backbiting does not work.  Clients hate it.  It reminds us of how our elementary school teachers used to tell us that they could see everything that happens in the classroom, every passed note, spitball, and droopy eyelid.  Naturally we doubted that at the time.  But then 20 years later we became a high school teacher and – what do you know – it was totally true that everything in the classroom was laid out in front of us with deep focus and clarity.  It’s the same with clients.  They see how their law firms cooperate or collide.  They hear every snide complaint, and it drives them crazy.  We once knew of two partners who would call the client to complain, not only about how other firms were allegedly shirking their responsibilities, but also about how much better they were than their ‘partners’ at the same firm.  Nice.  Guess what the client did?  She called up another partner at the firm and asked why he bothered to work with partners who were so insecure and disruptive, and also asked why the client should continue to employ a firm that brought too much chaos to the party. Good questions.   

 

One of our colleagues at the retreat told us about a trial last year that ended in a hung jury.  The result ended up not being so bad, as it was followed by a favorable settlement not long afterwards.  But our co-counsel saw the result as a cue to second-guess several trial decisions, such as doing a short opening statement, deciding not to call an expert witness they had worked up, and deploying ‘only’ 37 slides in the closing.  We know it was bad form for the other law firm to engage in such self-indulgent revisionism, but even beyond that, knowing nothing about the case, we suspect that the criticisms were unfounded.   As we mentioned in our post two weeks ago about our recent jury duty, we harbor deep doubts that overlong presentations with superabundant graphics are the best way to pierce a jury’s confusion and indifference.  The older we get, the more convinced we are that simpler and shorter are better.  (We’d dance a jig if depositions were shortened from seven hours to five,  if opening statements were capped at 30 minutes and closings at an hour, and if legal briefs were limited to 20 pages.  But we digress.)  And then we heard that the hypercritical colleague from another firm espoused more “fulsome” presentations.  That did it.  Now arose our antediluvian, pedantic hatred for the use of “fulsome” as a faux benign synonym for “full” or “complete,” when it really means “excessively flattering.”  By “really means” we mean that “fulsome” should be confined to its proper 1663 denotation.  Do not fight us on this one.  Consult the OED or Fowler’s.  Garner is mostly on our side here, though he calls “fulsome” a “skunked term” because the loose sense is now so common.  We don’t like skunks.  The philistine encroachments of the latter part of the last century and the early jabberings of this one do not persuade us.  Hmmm.  Perhaps there are limits to our own ability to collaborate.   And please do not get us started on the current fashion of beginning almost every answer with the word “So,” no matter how nonsensical. 

 

By the way, while we are talking about collaboration among law firms, we ought to acknowledge that this blog has always been a collaborative effort among lawyers from different, often competing, law firms.  It is possible that this fact makes the Drug and Device Law blog unique among Big Law blogs.      

 

Just before we left for the retreat, we got a call from a client who asked us to parachute in and do a product liability trial for them.  There was a catch.  The case had been worked up by another firm, discovery was closing in a week, and the other firm would file all the summary judgment papers and handle the experts.  All we would do is work up motions in limine, prepare for trial, and then do our parts of the trial.  Was that okay?  Ha! – that wasn’t just okay, that sounded splendid.  We couldn’t stop ourselves from telling the client that it sounded like just about the most perfect assignment we could ever get.  We were getting in on the fun bits.  Not only would we gladly take on this assignment, but we would offer gratis a profound promise:  not once would we utter a word of complaint about what had been done in the case before our arrival.  No mutterings about ‘why didn’t they depose the mother?’ ‘why didn’t they hire a better expert?’ ‘why didn’t they file a motion based on x?’ etc.  We are betting the other firm had its reasons for doing what it did.  Whatever.  What’s the use in whining?  Let’s treat this case as an exemplar for all litigation which is, in turn, an exemplar for the whole world.  Let’s take what’s given to us with gratitude and make the best of it.   We’re happy to join the team.  Maybe it took us a while to realize it, but practicing law can be a joy, but not so much when it is a solo activity.  The success and joy of it lies in collaboration.

 

 

Last week we served on a jury in a medical malpractice verdict.  To put it mildly, we were surprised that we made it through the peremptory gauntlet.  The verdict?  It was an enlightening and edifying experience.

 

The Selection

 

The fifth time was the charm.  On four prior occasions, we had marched to the county courthouse.  On four prior occasions, we were thanked and excused.  That is hardly a surprise.  As a former prosecutor and current defender of Fortune 100 companies, we offer lots of litigants a lot to dislike.  But this time was different.

 

Chester County, Pennsylvania is almost a hundred years older than the country. It has a historic courthouse.  That courthouse is splendid.  It is also cramped.  The jury assembly room was formerly located in its basement.  It was not an entirely wonderful place to await one’s service.  But the county put up a gigantic Justice Center ten years ago.  It is a gorgeous facility.  The hallways are wide and well lit.  The restrooms are large and clean.  The courtrooms are big, modern, and majestic without being intimidating. Even better are the people who run things in the courthouse.  Right from the start, as you pass through the metal detector and get wanded by Sheriff’s Deputies, everyone is polite and professional.  A fellow juror commented at the end of the case how all of the courthouse workers were quick to smile.  In particular, the folks who run the jury assembly room were relentlessly pleasant.  Jury service can seem like a bother, but it wasn’t such a big bother in beautiful, wise, fair-minded Chester County.

 

Approximately a hundred of us gathered in the assembly room.  By 9 am we were told that only one panel was required that day.  Fifty-six of us, including your correspondent, were chosen randomly, handed numbered 10×14 cards, and herded upstairs to a courtroom.  We weren’t worried.  It would be interesting to see more of the process before we were inevitably shown the exit. We were juror #14.  That meant that we were seated in the jury box, which had comfy chairs.  Jurors 15-56 squeezed themselves into pews.  Voir dire began.

 

We had completed a simple, one page questionnaire.  We disclosed our residence, marital status, and employment.  That was pretty much it.  We saw none of the attitudinal questions that litter the long-form questionnaires typical in mass tort cases.  The Judge – a calm, dignified man who commanded respect and affection from us throughout the case – briefly described the nature of the case.  A widow was bringing a wrongful death action because her husband died shortly after a medical operation at Paoli Hospital.  She alleged that the doctor might have performed the surgery well enough, but he did not pay attention to signs of an internal hemorrhage, thus permitting her husband to bleed to death two days after the surgery.  The parties and lawyers were introduced.  Then the plaintiff lawyer asked a series of general questions about experience with medical and legal issues.  Jurors raised their numbered cards to answer in the affirmative, their numbers were noted, and then there were individual follow-ups at sidebar.

 

The sidebars took a while.  Apparently, a big percentage of people in Chester County have had run-ins with the medical profession.  We were one of only two lawyers in the group.  The other did insurance and malpractice law, so she was a sure goner. We thought we were, too.   When we were called up to sidebar, we initiated the conversation with a jaunty “Good morning your Honor, and good morning counsel.”  It just came out naturally.  The defense lawyer said, “Oh that’s right, you’re a lawyer.”  When we described where we worked, the Judge smirked that he had never heard of our ‘little firm.’  The plaintiff lawyer asked if we mostly worked on MDLs.  Why, yes, that’s exactly right.   The Judge asked if we could be fair.  Yes, of course.  And then we were sent back to seat #14.

 

The sidebar sessions were halted after juror #30. The court had apparently calculated that it had enough jurors, taking into account whatever challenges for cause had been sustained and the number of peremptory challenges each side had.  Net of those, there would be 14 jurors (12 + 2 alternates).  Goodbye jurors 31-56.  Then the lawyers passed a piece of paper back and forth, each exchange interrupted by much pondering and furrowed brows. As far as we could tell, there were no jury consultants involved.  These lawyers were relying on experience and instinct in choosing which jurors to bounce.  Not for a moment did we think the plaintiff would allow us to remain on the jury.  Eventually, the piece of paper was handed to the court clerk.  He and the Judge scrutinized it and made some notations.  They were figuring out who was on the jury.  Then the clerk called out numbers, instructing those jurors to gather their effects and go home.  “Juror number 2, you may go.”  “Juror number 4, you may go.”  Etc.  “Juror, number 11 you may go.”  That made sense – Juror 11 was the other lawyer. Then we heard it.  “Juror number 14 -“ we bent down to collect our brief-bag.  “-please move to seat 2.”  Wait.  What?

 

Stunned, we plopped down in our new seat.  Soon, others filled the empty seats in the box.  A member of the Court’s tip staff (that is what court bailiffs are called in Pennsylvania – the plural is “tip-staves”) administered the oath to us. Then we went to the jury room and awkwardly introduced ourselves to each other.  The jury was split evenly between men and women.  Two of the women were nurses, and one was studying to prepare medical transcriptions.  The jurors seemed smart, nice, and conscientious.  We got along. We took turns bringing pastries in each morning.

 

Did we mention that Chester County has a reputation as a horrible place for plaintiffs in civil lawsuits?

 

The Case

 

Each side presented an opening statement.  Each lasted 20-25 minutes.  Each employed zero graphics (we do not know whether that was by choice or by order of the Court).  Despite the lack of graphics (or maybe because of it?) the opening statements were crystal clear and easy to follow.  The decedent’s hemoglobin level was 14.5 before the operation, which is about average.  The surgery was uneventful.  There were no complications.  Only about 75 cc of blood were lost, making this a relatively ‘dry’ operation.  There was no issue about whether the surgery was performed negligently.  Instead, the malpractice issue pertained to the post-op standard of care.

 

The decedent’s hemoglobin fell to 11.6 after the surgery, which is not unexpected.  Then it fell to 10 the next day, and 8.8 the morning of post-op day 2.  The decedent vomited a couple of times and fainted once, but his vital signs seemed stable.  There were some blips on the cardio strip, though nothing terribly alarming. A significant point of contention was whether observations of increasing abdominal firmness should have prompted investigation for internal bleeding.  The defendant doctor interpreted the distended abdomen, along with the absence of a bowel movement, to manifest an ileus – a problem with the bowels, but not anything to do with a possible bleed. The defendant doctor visited the decedent mid-day of post-op day 2, recommended ambulation, and headed back to his office.  About a half an hour after that, the plaintiff took a walk up and down the hallway, per instructions.  He returned to his room, collapsed, coded and died.

 

The plaintiff called the defendant doctor as the first witness.  It was an interesting beginning to the case.  In a way, it is like our mass tort cases where the plaintiff lawyer begins by torturing a company witness with reptile questions and insinuations of document spoliation.  In this case, the doctor held his own well, emphasizing the stable vital signs and the unforeseeability of the sudden collapse. He mostly agreed with the plaintiff lawyer’s questions.  There was no unseemly fencing.  But there was an interesting admission: the doctor testified that during his last visit to the decedent, he at least considered the possibility of bleeding.  But the doctor said he didn’t observe any reason to follow up on that thought.  Perhaps later in the day, depending on what he learned, he might enter orders to address that possibility.

 

The next witness was the county pathologist.  She performed the autopsy.  Her testimony came in via video.  She was credible and wasn’t being paid by anyone.  She found approximately 900cc of blood near the surgery site.  She also found that several of the decedent’s arteries were moderately blocked and that the left side of his heart was mildly enlarged, probably from years of hypertension.  Her conclusion was that the blood loss, in conjunction with pre-existing heart disease, had caused the sudden death.

 

The plaintiff presented two more video depositions.  One was of a causation witness, who agreed that blood loss contributed to the death, and the other was a standard-of-care witness, who opined that as soon as the hemoglobin continued to fall the day after the surgery there should have been intervention, such as a CT scan or transfusion.  The standard of care witness hit the required points, but he displayed some shortcomings.  He came from clear across the country and possessed no experience with the type of robotic surgery at issue in the trial.  Moreover, his initial report attributed the death to a heart attack.  One problem with that – there was no heart attack.  Also, this expert suggested that the decedent’s vomit should have been tested for blood because it was brown.  Two problems with that – the pathologist found no sign of blood loss in the upper GI system, and the plaintiff expert weirdly denied that vomit often is brown.  The defense lawyer enjoyed that last answer.  He paused and turned to look at the jurors, holding the moment nicely.

 

We were also treated to testimony from an expert economist, who laid out uncontroversial earnings and valuation numbers.  One set of numbers assumed retirement at 62 (the decedent was 60 years old when he died), and the other assumed retirement at 66.  The bottom-line difference between the two assumptions was over a million dollars.  There was some dispute as to which scenario applied, because the decedent’s brother reported a conversation in which the decedent mentioned the possibility of retiring early, but the decedent’s widow (who was also executrix of the state) was adamant that she and the decedent had planned for only her to retire early, with the decedent working at least to age 66.

 

The widow was the last plaintiff witness, and she presented very well.  She maintained complete dignity through her grief, and painted a picture of her late husband as an impressive, intelligent, fundamentally good man.  He had spent decades in the military, and then carved out a strong career as a Human Resources executive in corporate America.  The jury liked the plaintiff.  We felt terrible about what had happened to her and her husband.

 

The defense case was short and to the point.  A local critical care expert testified via video that an already diseased heart, not the bleeding, caused the death.  The plaintiff’s cross-examination scored some points. We learned that this expert had done a fair amount of testifying for the defense lawyer.  It also became clear that this expert was not much of an expert in the relevant fields.  So much for that.

 

But then another local expert doctor came into the courtroom with formidable credentials.  He testified forcefully that there was no reason to intervene until the hemoglobin level dropped below certain levels, 8.0 for someone with heart disease, and 7.0 otherwise.  Dropping hemoglobin levels could be consistent with hemodilution from administration of IV’s. The absence of disruptions in vital signs was significant.  The various accounts of the decedent’s abdomen and its softness, tenderness, or firmness were not so significant.  Further, transfusions carry their own risks.  That is why doctors must follow well-established standards before intervening.  On cross-examination, we learned that this expert’s price tag was also impressive.  He earned $6000 from reviewing records and another $5000 for the in-court testimony. More than once in the case, the plaintiff lawyer referred to the $11,000 man.  Sure.  Sometimes you get what you pay for.

 

The defense case concluded with a pair of fact witnesses.  An attending nurse seemed a bit nervous and genuinely shaken up by the sudden death.  She also seemed surprised by it.  Aside from the patient’s vomiting, the vital signs were not troubling.  Finally, the defendant doctor retook the stand.  First logically, and then passionately, he laid out his thinking as to why his patient did not appear to any reasonable eyes to be in danger.  He elaborated on the hemodilution theory.  He then held up well under a spirited cross-examination.

 

The lawyers conducting the direct and cross examinations mostly sat as they did so.  Very few graphics were employed.  It was all low-key.  We could not resist in our own mind the temptation to grade the performances of the lawyers.  We thought they were quite good.  They all seemed competent and relaxed.  They probably found themselves in court far more often than big-shot, national mass tort lawyers do.  There were no histrionics.  Everybody seemed to get along.  If we had any critique, it was that the editing of the video depositions was a bit clumsy.  Such videos are hard enough to endure, but when we had to sit through useless introductions by the videographer, you could hear the restless seat-shifting  in the jury box.  But that’s a minor quibble.  Both cases came in smoothly.

 

The closing arguments by the lawyers were as short as the opening statements, and mostly made points that were by now well inscribed in the juror’s heads. The lawyers agreed that the three questions the jury had to answer were: 1.  Did the doctor fall below the standard of care?  That is, was he negligent?  If we answered that question No, we were done.  2.  Was the negligence the cause of death?  3.  What were the appropriate damages?

 

The plaintiff lawyer addressed all three questions.  The doctor had a duty to take care of his patient and prevent harm.  The declining hemoglobin levels and firm abdomen should have prompted some form of intervention.  The independent county coroner had determined that the bleeding contributed to the death, and that simply made sense.  Finally, the plaintiff’s expert accountant was essentially unchallenged. That testimony established the economic damages.  Pain and suffering was up to us.

 

The defense lawyer did not address damages at all.  Rather, he devoted the bulk of his argument to showing how attentive the doctor was, how stable the patient’s vital signs were, how hemodilution could well account for the hemoglobin declines, and how the defense expert on standard of care had articulated the relevant standards that precluded any premature intervention.  On causation, the defense lawyer argued that the county coroner did not have access to all the relevant information, and that the defense causation expert offered a more complete picture that supported potential alternate causation.

 

After standard jury instructions (that even this lawyer has to admit were less  than pellucid on wrongful death vs. survival actions), the case was given to us.  The tip-staff personnel escorted us down the hall.

 

The Deliberations

 

The Judge ordered that juror #1 would be the foreperson.  Lucky choice.  Our foreperson was a quiet, calm fellow with no obvious agenda. He suggested that we take an initial vote.  6-6 on question 1 – negligence.  Gasps around the room.  One or two jurors muttered that there was no way they could be stuck in the courthouse all week.   It was around 11:30 am, so we ordered our first free lunch during our jury service and started sharing our perspectives.  It was immediately clear that the two nurses and the medical transcription student were locked into pro-defense positions.  They led the charge for their side and banged home that the vital signs were stable and the hemoglobin levels never descended below the magical number, whether that was 8.0 or 7.0.  The plaintiffy-leaners wished that the doctor had done something more to look into possible bleeding.  Everyone seemed to agree with the independent pathologist that bleeding played a causal role.  The difference was the extent to which this hindsight colored the assessment of standard of care.

 

We argued the salient points in a civil fashion for a couple of hours.  There weren’t many detours.  Several jurors commented that there was no evidence that the doctor intentionally did a poor job.  He certainly did not mean to visit any harm on his patient.  All well and good, but that plainly was not the issue.  The nurses were particularly active in the deliberations.  After we asked for certain medical records to be sent to us (interestingly, the Court refused to send us any testimony we requested), the nurses took the lead in translating them and telling us how they fit into the patient’s care.  As you might guess, the nurses were especially attentive to the nurse’s testimony.  The defense lawyer had done something clever at the end of his direct examination of the nurse.  He asked her what her opinion was regarding standard of care.  The plaintiff lawyer properly objected.   The nurse, after all, was not being tendered as an expert.  The Judge sustained the objection.  But the nurses on the jury construed all this to mean that the nurse thought the defendant doctor had not botched anything.  Other jurors pointed out that this was improper speculation, and the point never arose again.  But there it was.

 

At 3:30 pm we re-voted.  Still 6-6.  We went around the table and concluded we were deadlocked.  We sent a note to the Judge.  While waiting for a response, more than one juror wished aloud that the parties would settle.  It was a hard case and we hated the possibility of getting things wrong.  Then we were sent to the courtroom.  The Judge smiled at us, told us to get a good night’s sleep, change our clothes, and come back the next morning.  In truth, this was what we expected.   In a sense, we were merely making a record, so that if we reported a deadlock the next day, it would be more likely we would be dismissed.  Yes, sometimes jurors think strategically about these things.

 

When we arrived the next morning, we learned that one person had changed his vote from plaintiff to defense.  It was now 7-5.  Then the debate continued.  We asked for more medical records, which we got.  We asked for more testimony, which we did not get.  We were told that it was “unavailable.”  Huh?  Whatever.  We asked for an easel, which the tip-staff brought us with a rueful grin.  One of the nurses had nice, legible handwriting, so she became the easel artist.  We created a chronology that was better and more useful than anything we saw in the case.  It clarified our thinking.  But it did not change any minds.  At this point, one of the defense jurors suggested that we go around the table and have each juror try to state the strongest positions favoring the other side.  What a good idea!  But one of the nurses and the medical transcription student said that they could not engage in that exercise, as they saw no sense in the plaintiff position.  Ouch.  Still ,we never became Twelve Angry Men (and Women).

 

Several times the medical transcription student bemoaned the impossibility of our task.  How could we all, as non-doctors, evaluate the standard of care of a doctor?  Some of us grew frustrated with this dithering.  Applying her reasoning, maybe there shouldn’t be med-mal cases at all.  It seemed a useless, maybe even nihilistic, point.  And yet, it led to the breakthrough in deliberations.  We realized that our discussions on standard of care had involved grabbing hold of various bits of evidence and then asking how they fed into the analysis.  That is, our analysis. But, in truth, the way for non-expert, non-doctor jurors to answer the standard of care question was to look to the expert testimony on that specific point.  There were two expert witnesses, one from each side, who had directly addressed standard of care.  We then made a chart comparing those two experts.  The plaintiff expert said that as soon as the hemoglobin dropped to 10, the treating doctor needed to act.  The defense expert said that as long as the vital signs were stable and the hemoglobin stayed above 8.0 (relying upon a JAMA article), watchful waiting was all that was necessary.  We agreed that the plaintiff expert had some credibility problems, in terms of creds, experience, demeanor, and answering some questions in a way that made little sense, whereas the defense expert was consistently impressive, consistently forthright, and consistently, well, consistent.  A couple of the defense jurors looked at each other and grumbled that sometimes one has to render a decision one might not like.  Three flipped.  Now it was 10-2 for the defense.  We had a verdict.  The foreperson knocked on the door for the tip-staff.  A few minutes later, we walked back into the jury box.  Our faces were blank.  The foreperson read the verdict.  There was no visible reaction from the parties.  There was no request to poll the jury.  The Judge thanked us for our service.  He said that someday we might wonder whether we had done the right thing, but we should be assured that we had done the right thing, because we had gone about the process the right way.

 

And that was it.  The entire case began with jury selection on a Thursday and ended with a verdict just after lunch the following Wednesday.  Some jurors exclaimed at how long the whole thing took.  Hmmm.  They should try being a juror on one of our MDL trials.

 

Lessons Learned

 

Let’s be honest: as a litigator, we had always thought it would be useful to serve on a jury.  It would be a window into a process that had always seemed like a scary black box.  But we never thought we had a chance.  We continue to be amazed that a plaintiff lawyer would fail to exercise a peremptory challenge against us.  But here’s the thing: that plaintiff lawyer was not wrong.  Without getting into the specifics, let’s just say that this particular defense-hack-turned juror gave the plaintiff side a very fair hearing.  The jurors who really clobbered the plaintiff’s case were the three who had medical experience.  So let that be the first lesson.  Medical knowledge on the jury, whether real or pretended, can exercise an extraordinary influence.

 

Other lessons might not exactly arrive as newsflashes for most of our readers:

 

  • The quality of experts can be outcome-determinative.  The moneys paid had no impact on us, but the credentials, consistency, confidence, and reliance on authority all did.  It also helped for the expert to be local.
  • Sympathy played no role.  Maybe we were a hardhearted bunch, but our genuine respect for the plaintiff and her decedent played no role in rendering a verdict.  We all expressed sorrow afterwards, but that was it.
  • Use graphics judiciously.  Clear examinations and clear explanations can go a long way.  Two or three good graphics on important issues (especially timelines) can register more impact than 30 numbing PowerPoint slides.
  • There was very little snarkiness or overreaching in the case, which is all to the good, because the jury did not like even a hint of either.
  • The most important lesson is that jurors really try to do the right thing.  Permit us a moment of civic boosterism.  We already were coming around to the notion that Chester County, with its covered bridges, sad Wyeth landscapes, trout-filled streams, glorious Revolutionary War history, proximity to Philly, preeminent public schools, and low crime, was just about the perfect place to live.  It also might be the perfect place to try a case.

We’ve seen the latest affirmance of largely identical verdicts in a consolidated MDL trial in Campbell v. Boston Scientific Corp., ___ F.3d ___, 2018 WL 732371 (4th Cir. Feb. 6, 2018).  We’re not discussing Campbell’s merits today.  For present purposes, suffice it to say that the consolidation- and punitive damages-related rulings aren’t that much different from Eghnayem v. Boston Scientific Corp., 873 F.3d 1304 (11th Cir. 2017), about which we blogged, here.

More generally, both of those cases, as well as the course of the Pinnacle Hip litigation described in several of our prior posts as well as in In re Depuy Orthopaedics, Inc., 870 F.3d 345 (5th Cir. 2017) (“Pinnacle Hip”) (which we discussed, here), illustrate an adverse trend in MDLs.  That trend is to replace the traditional (if anything in MDL practice can be called traditional) bellwether trials with consolidated multi-plaintiff trials including allegations of punitive damages.  We’ve already expressed our jaundiced view towards consolidated product liability trials as inherently prejudicial against defendants, for a variety of reasons discussed in that post.  For obvious reasons, facing punitive damages is likewise not favorable to a defendant in a trial.

As our prior consolidation post discussed at some length, defendants saddled with consolidated trials in personal injury cases used to have reason to expect appellate relief.  Identical or nearly identical verdicts were considered evidence that the jury was either unable to keep multiple individual cases straight or overwhelmed by all the factual evidence, or both.  However, the recent Campbell decision, added to other recent events, makes us believe that the ability to obtain such relief has never been more questionable.

Hence, we offer an idea that has been percolating here ever since the decision in Pinnacle Hip.  We mentioned it at last December’s ACI Drug and Medical Device Litigation conference, and it was received as a good idea by most defense counsel we talked to, so here goes….

Only you can prevent multi-plaintiff consolidated punitive damages trials.

We recognize that such trials cannot always be prevented – this idea wouldn’t have worked in Campbell, for example − but MDL defendants should seriously consider limiting their so-called “Lexecon waivers,” to the extent they are willing to give them at all.

What does that mean?

Basically, Lexecon Inc. v. Milberg Weiss Bershad Hynes & Lerach, 523 U.S. 26 (1998), held that MDL judges can’t try cases transferred to them from another judicial district under the MDL statute, 28 U.S.C. §1407.  They can try cases properly filed in the same judicial district and then transferred to them as related cases (what happened in Campbell), but all other MDL trials require a Lexecon waiver of trial in the original transferor court.

The Fifth Circuit made clear in the Pinnacle Hip decision that a Lexecon waiver, like any other waiver, must be “clear and unambiguous” to be effective. Id. at 351.  Thus, we think it would be a good idea for MDL defendants to tailor any future Lexecon waivers so that they apply only to single-plaintiff trials, and exclude punitive damages.  As for consolidation, a Lexecon waiver excluding consolidation simply preserves the manner in which cases have been tried, including MDL bellwethers, for decades or longer.  As for punitive damages, bifurcating out such allegations has been commonplace in asbestos litigation, and has been employed in other mass torts as well, such as opt out cases in the Diet Drug litigation.

Even if courts seem less inclined to recognize it, everyone on the defense side knows how prejudicial multi-plaintiff consolidations and punitive damages allegations are during trials. To the extent possible, defendants should consider self-help, in the form of limited Lexecon waivers, to prevent such prejudicial procedures.

As we demonstrated in a post back in 2013, FDA compliance evidence generally − and the fact of a medical device’s clearance as “substantially equivalent” in safety and effectiveness to a predicate device under §510k of the Medical Device Amendments (now 21 U.S.C. §360c(f)(1)(A)) specifically – had for decades been admissible evidence in product liability litigation involving FDA-regulated drugs and devices.  In 2013 we found a half dozen §510k cases directly on point. Block v. Woo Young Medical Co., 937 F. Supp.2d 1028, 1047 (D. Minn. 2013); Placencia v. I-Flow Corp., 2012 WL 5877624, at *6 (D. Ariz. Nov. 20, 2012); Musgrave v. Breg, Inc., 2011 WL 4620767 (S.D. Ohio Oct. 3, 2011); Pritchett v. I-Flow Corp., 2012 WL 1340384, at *5 (D. Colo. Apr. 18, 2012); Miller v. Stryker Instruments, 2012 WL 1718825, at *9 (D. Ariz. Mar. 29, 2012); In re Guidant Corp. Implantable Defibrillators Products Liability Litigation, 2007 WL 1964337, at *7 (D. Minn. June 29, 2007); Corrigan v. Methodist Hospital, 874 F. Supp. 657, 658 (E.D. Pa. 1995); Strum v. Depuy Orthopaedics, Inc., 2013 WL 3184765, at *1 (Ill. Cir. March 8, 2013).

Then, in the Mesh litigation, rulings began to change the law on the premise that, because the United States Supreme Court in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), had held that §510k clearance was not preemptive – that is, not entitling a defendant to judgment as a matter of law – it was not even relevant in product liability litigation.  This argument turned on taking a phrase from Lohr out of context:  “[T]he 510(k) process is focused on equivalence, not safety” (id. at 493) and applying it in the evidence context.  As we had pointed out, so doing was contrary to the Supreme Court’s Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), decision holding that §510(k) clearance was intended “to ensure . . . that medical devices are reasonably safe and effective.” Id. at 349-50.  Our more recent blogposts have pointed out:  (1) that the FDA now considers §510k clearance to involve considerations of safety and effectiveness, and that (for a variety of reasons) the continued viability of Lohr itself is open to question.

Nonetheless, defendants in mesh litigation have largely been deprived of well-established FDA compliance evidence, and based on the capacious abuse of discretion standard applicable to evidentiary decisions at trial, such rulings have been upheld on appeal. See Eghnayem v. Boston Scientific Corp., 873 F.3d 1304, 1317-18 (11th Cir. 2017) (discussed here); In re C.R. Bard, Inc., MDL. No. 2187, Pelvic Repair Systems Products Liability Litigation, 810 F.3d 913, 921-22 (4th Cir. 2016) (discussed here) (“Cisson”); but see Winebarger v. Boston Scientific Corp., 2015 WL 5567578, at *7 (W.D.N.C. Sept. 22, 2015) (rejecting MDL rulings and admitting §510k clearance evidence in mesh case).

Yesterday, however another MDL judge considered the admissibility of §510k evidence, and held it admissible, flatly rejecting the Mesh decisions.  See In re Bard IVC Filters Products Liability Litigation, 2018 WL 582542 (D. Ariz. Jan. 29, 2018).  In IVC Filters, Judge David Campbell allowed the defendant’s “FDA defense,” ruling that the jury should be allowed to hear about §510k devices’ FDA pedigree.  Id. at *2.  Such evidence was doubly relevant under relevant state law:

  • “Georgia courts have adopted a risk-utility analysis for design defect claims. . . . One of the many factors a jury may consider in its reasonableness determination is the manufacturer’s compliance with federal regulations.” Id. at *2 (citation omitted).
  • “The evidence is also relevant to Plaintiff’s punitive damages claim. Under Georgia law, . . . [c]ompliance with federal regulations is not sufficient to preclude an award of punitive damages, but it is probative.” Id.

Coincidentally, Cisson also purported to interpret Georgia law, but reached a diametrically opposite conclusion.

IVC Filters rejected the false equivalence between preemption and relevance, and Mesh courts’ misapplication of Lohr:

Plaintiffs note, correctly, that the 510(k) process focuses on device equivalence, not device safety.  [Lohr citation omitted]  But this does not render evidence of the 510(k) process irrelevant to the reasonableness of [defendant’s] conduct.  The FDA grants 510(k) clearance only where the device “is as safe and effective as a [predicate device] and does not raise different questions of safety and efficacy than the predicate device.” Safe Medical Devices Act of 1990, Pub. L. No. 101-629, § 12(a)(1)(A)(ii).  The 510(k) process may not speak directly to the applicable standard of care . . ., but it does have probative value in the determination of this action.

Id. at *2 (citation omitted).  See also Id. at *3 n.2 (a preemption decision does “not address[] any evidentiary issue” and even as to preemption “the 510(k) process can in some circumstances preempt state law claims”) (citations omitted).

The excuses given for exclusion in Cisson, the jury giving clearance undue weight and a possible “mini-trial” regarding compliance, could “be adequately addressed without excluding relevant evidence to the detriment of Defendants.”  Id. at *3.  Reasonable “time limits” for each side’s evidence would prevent FDA issues from devolving into any “mini-trial.”  Id. at *4.  On the merits:

Both sides, through appropriate expert testimony or other admissible evidence, will be permitted to tell the jury about the role of the FDA in its oversight of medical device manufacturers, the regulatory clearance process for devices such as IVC filters, and [defendant’s] participation in the 510(k) process and its compliance (or lack thereof) with that process.

Id.  “[A]ny potential confusion” did not require exclusion, but only “a limiting instruction regarding the nature of the 510(k) process.”  Id. Indeed, IVC Filters correctly observed that the issue of jury confusion more likely cuts the other way – in favor of admission of FDA evidence:

[T]he absence of any evidence regarding the 510(k) process would run the risk of confusing the jury as well.  Many of the relevant events in this case occurred in the context of FDA 510(k) review, and much of the evidence is best understood in that context. Attempting to remove any references to the FDA from the trial would risk creating a misleading, incomplete, and confusing picture for the jury.

Id.  “[I]f the evidence was half-baked, containing some references to the FDA but not explaining what role the FDA played with respect to the [IVC] filters, the jury would be left to speculate about the FDA’s involvement and conclusions.”  Id.

Until IVC Filters, we had feared that a single mass tort, under a discretionary standard of review and with the unwillingness of appellate courts to require MDL do-overs, could tilt the evidentiary playing field towards what IVC Filters cogently described as “a misleading, incomplete, and confusing picture for the jury” that excluded §510k clearance evidence that previously been admissible almost as a matter of course.  Now our side has a clearly articulated and compelling opposing view to argue.