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.

Today’s post is another guest post from Kevin Hara, of Reed Smith, who is on his way to becoming a semi-regular blog contributor.  This post is about forum non conveniens, which is more discretionary, and less enforceable than personal jurisdiction as a limitation on plaintiff-side (or even defense-side) forum shopping, but which, as Kevin’s post demonstrates, is still better than nothing.  As always with our guest posts, the author deserves 100% of the credit, and any blame, for what follows.

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As a child of the 80s (slight pause for the chuckling and/or groaning here), there are so many images that flash through one’s mind as we reflect, fondly, for the most part, on that decade in discussing an Illinois appellate court’s decision in McIver, et al., v. American Medical Systems, Inc., et al., 2017 IL App (5th) 170011-U, 2017 WL 6327143 (Ill. App. Dec. 8, 2017), sending litigation tourists on an about-face based on the doctrine of forum non conveniens.  Though spelled differently, this McIver case makes us recall another MacGyver, the hit 80s television show (which, incidentally, my wife and I enjoy watching together in reruns.)  However, before delving into MacGyver/McIver, it is impossible to not to discuss some pop culture references from that era, even though we could not explore even the tip of the 80s iceberg: but there was the music – from pop, Michael Jackson, Madonna, Prince, to rock bands known for ballads, a la Journey, Bon Jovi, Van Halen, Duran Duran and too many others to name, including the hair bands, the rise of rap music, heavy metal, and a bevy of one-hit wonders.  There was the fashion – perhaps stretching that word a bit – legwarmers, parachute pants, camouflage, perms, bangles, hairspray, and shoulder pads!  Who can forget the movies? Back to the Future, the Indiana Jones trilogy (not including Crystal Skull which came much later, apologies Shia Labeouf), ET, The Shining, Empire Strikes Back, Return of the Jedi, Wall Street, The Color Purple, Beverly Hills Cop, Karate Kid, Sly, Arnie, Bruce Willis, all things explosions and action! and far more.  The events.  Lakers v. Celtics.  Air Jordan. The tragic Challenger explosion.  Chernobyl.  Mount Saint Helens (not all the explosions were in the movies, unfortunately).  Macintosh Computers.  Windows.  The fall of the Berlin Wall.  Perestroika.  Prozac.  CDs.  The Oprah Winfrey Show.  Rubik’s Cube.  All of the above, and so much more.

Before we disappear down a virtual “Who Framed Roger Rabbit?” hole, let’s revisit the classic 80s television series, “MacGyver,” starring Richard Dean Anderson that is apropos to our discussion today.  MacGyver was iconic for numerous reasons, with Anderson as the title character, a secret agent for the fictional Department of External Services, physicist, special forces veteran, and problem solver extraordinaire.  Although MacGyver undoubtedly qualifies as campy, far-fetched, and perhaps melodramatic, it was also imaginative, witty, clever, fun, and at times, touching.  MacGyver famously extricated himself –  and the world – from the brink of doom on countless occasions using ordinary objects, often including his ever-trusty Swiss Army knife (rather than, say, a sonic screwdriver), to perform extraordinary feats.  For instance, MacGyver is now officially defined in the Oxford English Dictionary, as a verb meaning “Make or repair (an object) in an improvised or inventive way, making use of whatever items are at hand.”  See, perhaps the most notable real-world example, here.  Some of MacGyver’s most amazing inventions or accomplishments included using candlesticks, a rubber mat, and an electrical cord to improvise a defibrillator; smashing a pair of binoculars, removing a prism, and deflecting a laser beam back to the emitter, destroying it; plugging a sulfuric acid leak with chocolate, containing sugars which react with acid to form elemental carbon, and a gummy residue (tested successfully by mythbusters); and using jumper cables with coins in the teeth, wiring them to a generator, an creating an arc welder (which, incidentally also proved to be functional.)

But not even MacGyver, despite his quick thinking and unparalleled toolbox, could “MacGyver” jurisdiction over the defendant in the McIver case for the Maryland resident plaintiffs.  McIver was yet another multi-plaintiff complaint filed in 2012 in Illinois state court, involving 75 plaintiffs from 23 states, (only one from Illinois), joined in a single action, alleging product liability claims in connection with prescription pelvic mesh products manufactured by AMS.  Id. at *1.  As with most other multi-plaintiff complaints, the only connection among plaintiffs is that they all received pelvic mesh implants.  The defendant filed a motion to sever the claims of the non-resident plaintiffs, arguing misjoinder, and concurrently filed a motion to dismiss for wrongful venue.  Id.  The parties agreed that the defendant would answer or respond to the complaint after resolution of the motions, as ordered by the court.  In March 2013, the trial court denied defendant’s motion to sever, apparently reasoning that venue was proper based solely on the presence of one Illinois plaintiff, with the order stating “that AMS would have to defend a case in St. Clair County regardless of whether the motion to sever were granted.”  Id.  Shades of the reversed California Supreme Court BMS decision.  The plaintiffs prepared the order, which significantly failed to provide a deadline for the defendant to answer or respond to the complaint, nor did the court order such an answer.  As an aside, given what we know of St. Clair County, it comes as no surprise that the trial court denied the motions to sever or dismiss.  As indicated, had plaintiffs filed McIver this year, the defendant very well could have moved to dismiss for lack of jurisdiction under BMS.

Time passed, and 73 of the 75 plaintiffs settled with the defendant, leaving only Paula and Earl Conway of Essex, Maryland.  Id. at *2.  After the court set the case for trial, the defendant, now faced with only nonresident plaintiffs, filed a motion to dismiss based on forum non conveniens (this was still pre-BMS), arguing that “’the public and private interest factors relevant to the consideration of its motion strongly favored dismissing [plaintiffs’ action]’” such that it could be refiled in Maryland.  Id.  The overwhelming majority of relevant events, including plaintiff’s mesh implant, her treating physicians, and medical records were located in Baltimore, and fact witnesses including friends, family, and coworkers “would be expected to live in or around Baltimore County.”  Id.  After receiving answers to interrogatories confirming that plaintiffs’ fact witnesses all resided outside the state of Illinois, the defendant supplemented its motion, asserting that plaintiffs’ case had “absolutely no connection” to Illinois.  Id. at *3.

It being St. Clair County, the defense lost again, as the trial court denied the motion without explanation.  Id.

On appeal, the defendant argued that the trial court abused its discretion in denying the forum non motion (with which we wholeheartedly agree), and plaintiffs claimed that the motion was untimely under Illinois Supreme Court Rule 187(a).  That rule mandates that any forum non conveniens (“FNC”) motion must be filed not later than 90 days after the last day that a party may file its answer.  Id.  The appellate court noted that the trial court ordered the parties to meet and confer, but did not order the defendant to file an answer and, since no answer was filed, the FNC motion was timely under Rule 187(a)’s “unambiguous” deadline. Id.

Strike one.

Plaintiffs claimed defense-side “gamesmanship” despite their own drafting the scheduling order at issue, claiming that the defendants should have filed the FNC motion at the “earliest opportunity.”  Id. at *4.  Again, the appellate court disagreed, finding that the defendant brought the motion with “reasonable and appropriate promptness,” noting that the parties had tentatively agreed to the filing deadline for AMS’s answer, but “[a]t no point did the plaintiffs seek an order requiring” the defendant to answer by a specific date.  Id.

Strike two.

Ultimately, the court went further, and stated that “even assuming that [the defendant] had filed an answer in 2013,” it would still conclude that the 2016 forum non conveniens motion was timely.  Id.  The court’s reasoning was simple – the case started with 75 plaintiffs from 23 states, and only after all but the two Maryland plaintiffs were dismissed, could the defendant have “had a clear and valid basis for seeking” transfer to that forum.  Id. at *5.

Strike three.

Additionally, the appellate court found no prejudice to the plaintiffs, despite their case being pending more than four years when the defendant filed motion.  Plaintiffs provided no discovery during all that time, and only later – more than four years after filing – did plaintiffs’ initial discovery responses confirm that plaintiffs’ witnesses resided predominantly in Maryland.  Id.

Nor was the court sympathetic to plaintiffs’ claim that transfer would cause delay.  Plaintiffs’ own fault, the court found, because any plaintiff filing in a foreign jurisdiction (litigation tourists) and combining his/her claims with other claimants in one action takes a “calculated risk” that those choices might result in dismissal or delay.  Id.  The court put it bluntly: “[t]o the extent that the present case languished in the circuit court, it did so without objection and with the plaintiffs’ implicit consent.”  Id. (emphasis added)

Finally, reaching the merits of the FNC issue, the court considered both the private and public interest factors, along with plaintiffs’ choice of forum, which was “much less reasonable,” because the vast majority of relevant events occurred outside of St. Clair County.  Id. at *7.  Neither the defendant nor the plaintiffs were Illinois residents, and the convenience of the parties was neutral.  Id.  However, access to evidence “strongly favor[ed] a transfer” to Maryland, given the location of most of the witnesses in that state.  Id.  Likewise, compulsory process would be impossible in Illinois, and the costs of securing witnesses overwhelmingly supported transfer.  Id.  Finding that the practical applications of the trial were a nonfactor, the court turned to the public interest factors, concentrating on which state, Illinois or Maryland, had a greater interest in the litigation.  Id. at *8.  The fact that the plaintiff’s mesh implant surgery occurred in Maryland, combined with the unfairness of imposing jury duty on Illinois residents, favored transfer to avoid burdening its taxpayers with a matter “otherwise unrelated to their state.”  Id. In sum, the appellate court ruled that the trial court erred in denying the forum non conveniens motion because Illinois had “no relevant or significant factual connections to the case.”  Id. at *9.

Thankfully, the appellate court considered the facts – in conjunction with some common sense – and the applicable law, and reversed and remanded with instructions to dismiss the case.  Even though this decision is non-precedential, it puts some handwriting on the wall.  Litigation Tourists Go Home, even from St. Clair County.  And if not FNC, personal jurisdiction under BMS is waiting in the wings.  Not even MacGyver, with his remarkable ingenuity, endless amounts of duct tape, Swiss Army knives, and any assortment of household items, could craft a way back into Illinois state court for these litigation tourist plaintiffs.

Summary judgment isn’t normally available for credibility issues.  During the “summary judgment trilogy” of 1986, the Supreme Court stated, “[c]redibility determinations, the weighing of the evidence, and the drawing of legitimate inferences from the facts are jury functions, not those of a judge . . . ruling on a motion for summary judgment.”  Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 255 (1986).  Or, more recently, “[a] district court generally cannot grant summary judgment based on its assessment of the credibility of the evidence presented.”  Schlup v. Delo, 513 U.S. 298, 332 (1995).  But every rule has its exceptions for extreme circumstances.

The key word from Schlup is “generally,” and in today’s case, Gill v. Teva Respiratory, LLC, 2017 WL 6614228 (D. Conn. Dec. 27, 2017), the plaintiff’s own testimony was simply too unbelievable and contrary to all other evidence (and common sense) to defeat summary judgment.  The plaintiff claimed to have inhaled a thumb tack – that’s right, a thumb tack – from the defendant’s allegedly sealed medical device (an inhaler).  She sued both the maker of the inhaler and the intermediate seller (a pharmacy).  Both received summary judgment.

There were a lot of problems with her story.  For one thing, after she inhaled the thumb tack, she didn’t seek medical attention for “several days,” despite the problem being serious enough to require surgery.  Id. at *1.  But that wasn’t even the basis for the ruling.

  • Plaintiff claimed that she put the product in her car’s “glove compartment” for about a “week” before ever using it, leaving it in its original packaging.  Id. at *1.
  • The manufacturer produced extensive “evidence about its manufacturing and inspection process to preclude any inference that it could have allowed the thumbtack to enter the inhaler.”  Id.; see also id. at *2 (further describing process).
  • Plaintiff’s medical records refuted her testimony, indicating that she had kept the product “in her purse” and “not [in] her glove compartment.”  Id. at *1.
  • While in her purse, the product’s “cap had fallen off,” and “her children had put the thumbtack inside the inhaler.”  Id.
  • While plaintiff claimed she had used the product only once, the product’s “mechanical counter” indicated that it had been used 34 times.  Id. at *2.

In response, plaintiff did nothing. She “did not conduct any discovery.”  She “neither disputed defendants’ evidence” nor submitted any opposing “statement of material facts” as the rules required.  Id.  Plaintiff’s lassitude resulted in the defendant’s factual statement being “deem[ed]” “true.”  Id.  Most importantly, plaintiff “had no explanation for the[] statements as reported in her medical records.” Id. at *2.

Thus, the facts about manufacturer’s quality control systems were deemed true, the plaintiff’s testimony was refuted by her own medical records, and plaintiff offered no explanation for anything. “It is not simply that plaintiff has failed to rebut defendants’ evidence” about its quality control; it was the weakness of plaintiff’s own testimony.  Id. at *3.

This situation was sufficiently extreme to support entry of summary judgment on the basis of the plaintiff’s testimony offered in support of an injury from an alleged defect in the device being incredible and unworthy of belief.

[I]n rare circumstances a court must necessarily undertake some evaluation of a plaintiff’s credibility at the summary judgment stage. . . .  [W]here the plaintiff relies almost exclusively on his own testimony, much of which is contradictory and incomplete, it will be impossible for a district court to determine whether the jury could reasonably find for the plaintiff, and thus whether there are any “genuine” issues of material fact, without making some assessment of the plaintiff’s account.

Id. at *2 (quoting Rojas v. Roman Catholic Dioceses, 660 F.3d 98, 105 (2d Cir. 2011)).  “[T]here may be certain extraordinary cases, where ‘the facts alleged are so contradictory that doubt is cast upon their plausibility, [for which] the court may pierce the veil of the complaint’s factual allegations and dismiss the claim.” Id. (quoting Jeffreys v. City of New York, 426 F.3d 549, 555 (2d Cir. 2005)).

Those “rare circumstances” were present in Gill:

[P]laintiff’s own account of the facts − which is the only evidence relied on by plaintiff to sustain her claim − is rife with irreconcilable contradiction.  Plaintiff has no explanation for the multiple medical notes . . . reflecting that the inhaler was in her purse with the cap off and accessible to her children, rather than in its original packaging in her glove compartment as plaintiff claimed.  Nor does plaintiff have any explanation for why the inhaler’s dosage count reflected its prior use 34 times, rather than her initial use of a new inhaler as plaintiff self-servingly claimed.

Id. at *3.  Summary judgment was therefore appropriate, since “the manifest contradictions and discrepancies in plaintiff’s own account, no reasonable jury could conclude that the thumbtack entered the inhaler at any time that the inhaler was in the possession or control of either one of the defendants.”  Id.

The alternative – letting juries decide every “credibility” dispute, no matter how far-fetched of fanciful the plaintiff’s testimony might be – was not sound jurisprudence. To “require district courts to allow parties to defeat summary judgment simply by testifying to the allegations in their pleadings would license the mendacious to seek windfalls in the litigation lottery.” Id.

Having seen far too many “mendacious” plaintiffs obtain “windfalls” in “litigation lottery” settlements, we could not agree more.

This week saw the birthdays of two folks who were sort of prominent in our youth.  First, Uri Geller, the Israeli ‘psychic’, turned 71.  He showed up on our tv constantly in the 1970s and 80s, bending spoons with his mind.  Was this guy on the level? Can you read our mind and discern our opinion on that score?  A court once ordered Geller to refund an audience member’s money and pay costs, finding that Geller’s feats of telepathy … weren’t.   Also this week, the great film director George Roy Hill would have reached the ripe old age of 96, had he not inconveniently passed away in 2002.  We remember Hill fondly for a pair of movies he directed that starred Paul Newman and Robert Redford:  Butch Cassidy and the Sundance Kid (1969) and The Sting (1973).  The latter ruled the Academy Awards its year, receiving ten nominations and winning seven, including Best Picture, as well as a Best Director nod for Hill.  Besides boasting a stellar cast (Robert Shaw played the villain), The Sting was blessed with intricate plotting – how to con a crook out of his money without his even knowing he had been conned – and a bouncy (though somewhat anachronistic) ragtime score by Marvin Hamlisch.  With all its virtues, The Sting did feel a bit overlong, which led to our single favorite all time film critic witticism: “Oh Sting, where is thy death?”

For some reason, today we have scams on our mind.

And thus we turn to the case of Eastman v. Biomet, Inc., 2017 WL 5257130 (N.D. Ind. Nov. 9, 2017).  The plaintiff had alleged injuries from a metal-on-metal hip implant.  He entered into a master settlement agreement that provided a procedure for categorizing case values.  He signed a release and received $25,000, which the release said constituted full payment.   End of story, right?  Well, as in The Sting, we have a false ending.  For the plaintiff made a few modifications in the release he signed.  These were just little stylistic flourishes, mind you, such as changing “binding” to “nonbinding,” “irrevocable” to “revocable,” and moving the governing law from Indiana to Arkansas.  Having improved the release in those minor ways, the plaintiff deposited the check, waited a decent interval, and then filed another lawsuit versus the defendant, seeking the difference between the $25,000 and what he thought he should have received in settlement.

This subsequent lawsuit was filed pro se, so at least we can say that no lawyer played a role in rigging this unpleasant exercise.  Both (!) parties moved for summary judgment.  And because the world is round(ash), gravity makes things fall down, the Patriots (sigh – what’s today’s theme again?) are once again headed for the Super Bowl, and the Judge was a sentient being, the defendant won and the plaintiff lost.  One cannot settle a case and eat it too.  Or something like that.  The court was plainly irked with the plaintiff for “secretly modifying” the release and changing three words “surreptitiously.”  We do not know the details as to how the paperwork was handled, so it is hard to see how the changes were secret.  Wasn’t the signed release sent to someone?  Be that as it may, there is something undeniably improper about pocketing settlement money and then filing another lawsuit on the same claim.

The Eastman plaintiff claimed that he had merely “conditionally signed” the release.  He agreed in principle with the defendant that he should receive some money.  So far so good. The remaining dispute was confined to the trivial issue of how much.  Under this rationale, settlements are astonishingly easy.  It’s a wonder that our courts are clogged with so many unsettled cases. Perhaps this clever plaintiff has discovered a way to thin out the civil dockets.

Here, the plaintiff had a beef with the defendant over the categorization of his injury.  The defense reduced the plaintiff’s award based upon evidence of an alternative cause for the implant failure. The plaintiff disagreed with said reduction.  What to do about such a disagreement?  The folks who drafted the master settlement agreement were sufficiently farsighted to provide for a mediation process for resolving such disputes.  But rather than avail himself of that mediation process, the plaintiff simply changed a few words in the release and took the money.  That, it turns out, is not quite kosher.  One cannot seize the benefits of a settlement whilst rejecting the annoying bits. The defendant never agreed to any of the plaintiff’s editorial innovations.  Clearly, no defendant would enter into the one-way ratchet sort of deal that the plaintiff favored.  The plaintiff had the choice to enter into the settlement and mediate, or proceed to trial on the merits.  His preferred hybrid of take-some-money-and-still-litigate was not on offer.

If there is one thing we have learned over our years in litigation, it is this: courts like settlements.  Twice in our career we have won motions to enforce settlements.  We have never lost such a motion, nor ever heard of anyone else losing such a motion.  The Eastman plaintiff’s maneuvers posed a threat to the settlement process in that case, and, for that matter, that entire form of settlement in other cases.  Consequently, it is unsurprising that he lost.  The court granted summary judgment in favor of the defendant.  The plaintiff’s maneuvers also were an insult to fair-dealing – period.  Movies are one thing, but in real life, we root against an attempted sting.

This guest post is by Kevin Hara, an associate at Reed Smith and relatively frequent contributor to the Blog.  Here, he discusses two recent favorable procedural developments in further appeals from two really awful decisions by intermediate courts of appeals.  As always, our guest posters are 100% responsible for what they write – due 100% of the credit, as well as any blame.  Take it away Kevin.

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SCOTUS Calls For Solicitor General’s Views In Third Circuit Fosamax Case

Friday December 8 was a day with two items that are particularly noteworthy because of their potentially momentous implications. Remember the Blog’s previous lambasting of the Third Circuit’s unprecedented Fosamax preemption decision and the haymaker that court unleashed on the drug and device industry, in In re Fosamax (Alendronate Sodium) Products Liability Litigation, 852 F.3d 268 (3d Cir. 2017)?  Now, there is positive news to report. The Supreme Court has invited the Solicitor General “to file a brief in this case expressing the views of the United States.” Merck, Sharp & Dohme Corp. v. Albrecht, et al., No. 14-1900 (Order, Dec. 8, 2017).

What is that? Here is SCOTUSBlog’s description:

“CVSG” stands for “call for the views of the Solicitor General.”  In most cases in which someone is seeking review of the lower courts’ decision, the Court will issue a straightforward grant or denial.  But sometimes the Court will want the government’s views on what it should do in a case in which the government isn’t a party but may still have an interest — for example, because the interpretation of a federal statute is involved.  So the Court will issue an order in which it “invites the Solicitor General to file a brief expressing the views of the United States.”  It isn’t an “invitation” in the sense that the federal government gets to decide whether it wants to file a brief at all, because the Court expects the government to file.  There is no deadline by which the government is required to file the brief, however.  And the government’s recommendation, although not dispositive, will carry significant weight with the Court.

In Fosamax, this development is important because it signals that the case stands out from the general certiorari pool, meaning that review is more likely to be granted.  Statistics are surprisingly hard to come by, but a law review article, Thompson & Wachtell, “An Empirical Analysis of Supreme Court Certiorari Petition Procedures:  The Call for Response and the Call for the Views of the Solicitor General,” 16:2 G. Mason L.R. 237 (2009), analyzed ten years of Supreme Court cases (1994-2004) and concluded:

The overall grant rate increases from 0.9% to 34% following a CVSG from the Court; in other words, the Court is 37 times more likely to grant a petition following a CVSG.  For petitions on the paid docket, the grant rate increases even more, to 42%; a paid petition is 47 times more likely to be granted following a CVSG.

Id. at 245 (emphasis added).  If those somewhat dated statistics are even close to currently accurate, the Fosamax CVSG is a big deal.

Recall that the Third Circuit grossly misinterpreted the “clear evidence” preemption test from Wyeth v. Levine, which held that without clear evidence that the FDA would not have approved the label change, a court cannot rule a manufacturer’s compliance with federal and state law is impossible, and thereby preempted, already an exacting defense.  As the Blog explained in praising the petition for certiorari, the Third Circuit distorted Levine, applied an unprecedented standard, and ruled that a manufacturer could not invoke preemption without “clear and convincing” evidence that the FDA would have rejected a proposed warning.  Thus, not only did the Third Circuit reverse summary judgment for the manufacturer in more than 1000 cases, it rendered impossibility preemption even more difficult than the anti-preemption justices in Levine intended.  The Blog also discussed the Product Liability Advisory Council’s amicus brief in support of the petition here, which explained that the Third Circuit’s decision invites further lower court confusion, obliterates the district court’s ruling that was supported by undisputed evidence, encourages pharmaceutical manufacturers to flood the FDA with proposed label changes, and threatens to stifle the innovation necessary to develop new, potentially life-saving drugs.

This latest development raises defense hopes that SCOTUS will grant the petition, and finally reverse one of the worst decisions of 2017, which would be a huge win for the manufacturer in particular, and of greater significance for the big picture for pharmaceutical companies and consumers in general. Stay tuned.

New Jersey Supreme Court Grants Review of Accutane Cases

Also on December 8, the New Jersey Supreme Court granted the appeals in all of the Accutane cases that the appellate court revived back in July. The Blog has monitored the Accutane litigation through many of the twists and turns of its tortuous existence for more than a decade, first with the Accutane MDL, and then with the New Jersey cases.  As a resident of the San Francisco Bay Area, when I think of the Accutane litigation, I automatically picture Lombard Street, often touted “The Crookedest Street In The World,” with its eight hairpin turns and switchbacks that span the 600 feet of the street’s natural 27° grade.  In fact, Lombard Street is not even the most crooked street in San Francisco, because Vermont Street, has a greater sinuosity at 1.56 versus 1.2 for Lombard, though Vermont at seven turns, has one fewer than its more famous cousin.   Lombard Street and its adornment of brick red and beautiful flowers attracts thousands of tourists per year.  This meandering avenue is difficult to traverse, requires careful navigation, has been around a long time, and produced extreme frustration for those who occupy it: if it sounds familiar, bear in mind that the Accutane litigation likewise has a lengthy history, ongoing since 2003, has zigged and zagged, and neither side is particularly thrilled with the results.  The Blog has discussed many of the good aspects here, (vacating plaintiff verdicts) here, (dismissals based on learned intermediary doctrine) here, (MSJ granted) and here (warnings adequate as a matter of law), as well as the very bad Appellate Division decisions earlier this summer, when the court reinstated more than 2000 causation based dismissals.

With that in mind, here is a very brief summary of the mind-bending history of the Accutane saga and the battle over the proper expert testimony that has hopefully neared its dénouement.  As already discussed at length, the Appellate Division reversed the trial court’s decision that excluded plaintiffs’ expert causation testimony, reviving more than 2000 lawsuits.  Not surprisingly, the manufacturer appealed, supported by amicus briefs from 21 of New Jersey’s largest employers, including many Roche competitors, the HealthCare Institute of New Jersey, the New Jersey Chamber of Commerce, the American Medical Association, and eight scholars and professors of law.  When it comes to expert testimony, New Jersey unfortunately travels The Road Not Taken, applying a “relaxed” standard of expert testimony in toxic tort cases, as set forth in Rubanick v. Witco Chemical Corp., 125 N.J. 421 (1991), rather than the more rigorous federal Daubert standard.  Under Rubanick, expert testimony may be admitted “even though it is controversial and its acceptance is not widespread,” only if “it is based on a sound methodology that draws on scientific studies reasonably relied on in the scientific community and has actually been used and applied by responsible experts or practitioners in the particular field.”  Id. at 447.  In Kemp v. State, 174 N.J. 412, 425-426 (2002), the court ruled that the inquiry was not based on reasonableness, but instead examines “whether comparable experts in the field [would] actually rely on that information.  Kemp, 174 N.J. at 426 (citations and quotations omitted).  Since Rubanick and Kemp, New Jersey courts have continued the state’s unique application of scientific expert testimony with an approach distinct from the more exacting federal standard, resulting in inconsistency, confusion, and the morass of the Accutane litigation.

As the Blog discussed, and the amici explained, the Accutane trial judge applied a standard similar to Daubert, but the Appellate Division reversed the decision based on Rubanick. In so doing, the appellate court essentially ignored the gold standard of scientific evidence, epidemiological studies all but one which failed to “demonstrate[] a statistically significant increased risk of developing Crohn’s disease.”  In re Accutane Litigation, 451 N.J. Super. 153, 168  (App. Div. July 28, 2017).  Nonetheless, the Appellate Division allowed the plaintiffs’ experts to rely on evidence that should have been excluded as unreliable, such as animal studies, anecdotal case reports, and analogous medicines – in other words, scientifically unsound data.  Id. at 165-166.  Similarly to the Fosamax decision, this represents not only bad law and bad precedent, but also has far-reaching implications.  Pharmaceutical manufacturers and health professionals resoundingly decried the Accutane decision as one that will stifle research and development, and the practice of medicine out of the uncertainty of scientific evidence, and fear of legal reprisals.  The amici implored the New Jersey Supreme Court to adopt Daubert’s methodology to reaffirm the trial court’s role as a gatekeeper to ensure that only reliable scientific evidence informs the jury’s decision.  Again, the industry can take heart in the court’s order granting review of the Appellate Division’s abysmal decision, and hope that the New Jersey Supreme Court will allow modern scientific principles, rather than the unreliable and questionable methods, to govern expert testimony.  If that occurs, no doubt will the New Jersey high court reinstate the trial court’s ruling, and order dismissal of the more than 2000 cases for lack of  causation evidence.

Just two days ago, Bexis lowered the boom on the Third Circuit’s recent decision in Cottrell v. Alcon Labs, ___ F.3d ___, 2017 WL 4657402 (3d Cir. Oct. 18, 2017).   In a 2-1 decision, the Cottrell court permitted the plaintiffs to proceed on the notion that making eye drop drips bigger than they have to be is a consumer protection violation.  To Bexis’s eyes, that decision was blind to the lack of standing, the absence of any “substantial economic injury,”  and the FDA’s non-approval of eye drop drips of the “smaller” size plaintiffs claim it is somehow illegal not to make under state law.  It turns out that there is someone else out there even more unhappy with the Cottrell decision than Bexis: the defendant.  Now we have the defendant’s Petition for Rehearing and Rehearing En Banc,  https://www.druganddevicelawblog.com/wp-content/uploads/sites/30/2017/11/Cottrell-rehearing-petition.pdf which makes an insightful and compelling case for undoing the panel’s decision.

 

Two preliminary matters are worthy of comment before we tell you what the Petition said. First, we have been so unkind about the Third Circuit’s error in the Fosamax case that we managed to attract the attention of the excellent CA3 blog.   In that blog, the author wondered whether our dissection of Fosamax was perhaps a bit more violent than necessary.  The author also wondered whether we were coming close to accusing the court of bad faith.  Yes to the former, but definitely No to the latter.  As we told the CA3 blog, we took issue with what we saw as bad reasoning, but never-ever thought there was any bad faith.  (The CA3 blog was generous enough to print our disclaimer.  Thanks for that.)  By and large, we are mighty proud of our home circuit.  We know several of the judges, and every one of them is honorable, hard-working, and much smarter than we are.  Sometimes we are not going to agree with the court’s decisions.  Luckily for us we work in a profession and live in a country where debate and criticism are allowed.  Second, succeeding on a petition for rehearing and rehearing en banc is not easy.  When we clerked for Ninth Circuit Judge William Norris, it seemed there was a presumption against such petitions.  Who wants to admit they were wrong?  And yet we remember one time our judge was on a panel where things strayed from the norm.  Another member of the panel (who will remain unnamed) loved to decide cases before oral argument and draft a memorandum disposition rather than a bench memorandum.  This judge prided himself on having almost no backlog.  He pushed for deciding a particular contract dispute via a mere memorandum disposition, not a published opinion, because he saw the issues as being too obvious and insignificant for the Federal Reporter.  And so a memo dispo issued.  But then the losing party filed a petition for rehearing that was not only insistent, but it made a lot of sense.  We met with our Judge in his chambers to talk it over.  The telephone rang.  It was the third member of the panel, who began by saying, “Bill, I think maybe we got one wrong.”  The two judges confabbed, and then set about persuading the third to change his mind and change the outcome.  It took some arm-twisting, but in the end, justice was done.  A mistake led to a proud moment.  By the way, the Ninth Circuit Judge who called our Judge was Anthony Kennedy.  He is now on the U.S. Supreme Court.  So whenever we hear criticisms of Justice Kennedy for fence-sitting, or for grounding some of his opinions in “the right to define one’s own concept of existence, of meaning, of the universe, and of the mystery of human life” or, much worse, international law, we recall his extraordinary integrity and modesty, and how he was supremely interested in getting things right.

 

Back to the Cottrell Petition. The main points in favor of revisiting the Third Circuit’s decision are that it is contrary to Finkelman v. National Football League, 810 F.3d 187 (3d Cir. 2016), it “radically expands Article III standing,” and that it directly conflicts with Eike v. Allergan, Inc., 850 F.3d 315 (7th Cir. 2017).  Moreover, the plaintiff’s inherently speculative theory of injury in fact was rejected by federal courts in Massachusetts and Missouri.  (When a court comes out with a more pro-plaintiffy position than courts in Massachusetts and Missouri, that’s really saying something.)  That theory was also rejected by the district court in Cottrell.  And then the Third Circuit reversed that rejection.  

 

Remember that the Cottrell plaintiffs did not claim that the medications caused them physical harm or were ineffective in treating their eye conditions, or that the defendants misrepresented or omitted any information about the medications or the number of doses expected.  Rather, the plaintiffs simply insist that smaller eye drops would have cost them less.  How is that any different from the Third Circuit’s earlier, controlling Finkelman case, where the plaintiffs had purchased two Super Bowl tickets on the resale market for $2,000 each, and contended that the National Football League had violated New Jersey’s ticket law by not offering at least 95% of tickets to the general public and instead withholding most tickets for league insiders?  The plaintiff in Finkelman alleged that the NFL’s conduct had caused him injury by reducing the supply of tickets, thereby driving up the cost of tickets on the resale market.  The Third Circuit in Finkelman held that the plaintiff lacked standing because the injury was wholly speculative.  Sure, maybe the NFL’s withholding of tickets increased prices on the resale market, but “it might also be the case that it had no effect on the resale market,” and indeed tickets might even have been more expensive in plaintiff’s hypothetical resale market, as members of the general public may have greater incentives than league insiders to resell at high prices.  (We have to admit that, as residents of Philadelphia, where the local team has the best record in the entire NFL, the availability of Super Bowl tickets is a much, much bigger issue to us right now than the size of eye drops.)

The Petition makes the point that, just as in Finkelman, other market effects might have produced a result very different from what the plaintiffs theorized.  In Cottrell, the plaintiffs essentially presumed that the defendants price their products solely according to volume, such that “changing the eyedropper size would not change the price of the medicine, while extending the useful lifespan of each bottle, driving down [the plaintiffs’] aggregate costs.” But it is just as likely that use of smaller drops would prompt use of different sized containers, or that smaller drops would result in a higher price – because of more doses – for the same container.  Who knows?  All we do know is that the allegations of the complaint do not “affirmatively and plausibly” add up to an “injury” caused by the defendant’s conduct.  

The Petition nicely captures the absurdity of the Third Circuit’s analysis, under which consumers suffer Article III injury from “unfairness” whenever they “walk into a supermarket and buy a product — from toothpaste, to ketchup, to deodorant, to hairspray — so long as they can then conceive of a way that the product might be dispensed more efficiently.”  The Petition also nicely exposes the weakness in the Third Circuit’s effort to distinguish away the Seventh Circuit decision in Eike.  According to the Cottrell majority, Eike “seemed to begin its standing analysis with a determination that the plaintiffs had ‘no cause of action.’” But while it is true that the Seventh Circuit did (correctly) conclude that the plaintiffs had “no cause of action,” the Seventh Circuit also separately held that there was no Article III injury, without ever suggesting a causal connection between the two.  Eike, 850 F.3d at 318.  The Seventh Circuit got it fundamentally right when it held that the fact that a seller does not sell the product that you want, or at the price you’d like to pay, is not an actionable injury; “it is just a regret or disappointment.” 

As residents in, and fans of, the Third Circuit, the Cottrell decision certainly is cause for “regret and disappointment.” We called this post a “second look” at the eye-drop litigation.  It is the second look we have taken at the Cottrell case.  We hope that the Third Circuit takes a second look.