This guest post, by long-time friend of the blog, Terry Henry of Blank Rome, is a little different than most.  It was invited.  We read an article Terry wrote, which, at the end (it was mostly about other stuff), advised “[a] brand manufacturer defending itself [against innovator liability] should consider, at the appropriate time, a motion to dismiss any potential claims related to innovator liability on lack of jurisdiction.”  It just so happens that we (well, Bexis) had been thinking about precisely that – the “suit-related conduct” in innovator liability cases does not take place in the plaintiff’s forum state (MA or CA) because the branded defendant didn’t sell the injurious product, so unless that defendant is unfortunate enough to be “at home” in those states, there shouldn’t be case-specific personal jurisdiction either.  Without a product sale there’s not even a stream of commerce argument.  Wishing to encourage innovative thinking by defense counsel, we reached out to Terry and invited him to write a full blogpost devoted solely to personal jurisdiction in innovator liability cases.  Here it is.  As always our guest posters deserve 100% of the credit, and any blame, for their posts.

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Friday evening this writer and his son were to catch a flight from Philadelphia to Denver so that the boy could attend his scheduled tour of University of Colorado, Boulder.  As the time to board our 6:00 pm flight approached, the gate agent announced a delay. The aircraft coming in from Boston had a mechanical problem and our flight was now pushed back to 10:45!  We quickly investigated other options, but the two remaining flights were booked solid.  The situation looked bleak.  Experience told me that our flight was probably going to cancel and that our weekend in Boulder would not happen.  But how can you look your hopeful teenager in the eyes and dash his expectations?  So we decided to be optimistic and set up camp for the long wait.  When my Flight Aware app updated to let us know our incoming aircraft had finally taken off from Boston, we could see a ray of hope.  And so too, should branded drug manufacturers facing innovator liability claims.

Readers of this blog are familiar with the bleak prospects for branded manufacturers facing innovator liability claims in California; that distorted theory that holds a branded manufacturer liable for an allegedly inadequate label on the generic version of the branded manufacturer’s drug.  Innovator liability has hit the headlines again because the Massachusetts Supreme Court recently adopted it in Rafferty v. Merck . Innovator liability also snuck past the district court and is pending before the Seventh Circuit in Dolin v. GSK.  What seemed like an aberration when Conte v. Wyeth first gave life to the theory in 2008 may be gaining ground with courts looking to provide a remedy to plaintiffs that took the generic form of a drug. The blog warned us this could happen.

So where can a brand drug manufacturer find a little ray of hope in what appears to be expanding exposure from innovator liability?  Two words – specific jurisdiction.  In addition to the usual substantive arguments for why innovator liability is not a valid claim, a brand manufacturer should also assert lack of jurisdiction.

If the brand manufacturer defendant is not “at home” in the jurisdiction where the case is pending, the court cannot exercise general jurisdiction over the brand manufacturer.  “At-home” status is determined by where the manufacturer is incorporated or where it has its principal place of business.  Daimler AG v. Bauman, 134 S. Ct. 746 (2014). State of incorporation is usually a pretty straight forward determination, but principal place of business can be a bit murky.  The reality of today’s business organizations mean that companies may have operations in many states and employ senior officers in a variety of locations. Hertz Corp. v. Friend, 599 U.S. 77 (2010), explains how to determine a corporation’s nerve center, which is how Hertz defines principal place of business.  If a branded manufacturer is facing potential innovator liability, it should establish early, by affidavit or declaration, the facts showing that the defendant is not at-home in any innovator liability state. This will limit the Court’s jurisdiction over the brand manufacturer to specific jurisdiction.

Specific jurisdiction depends on an affiliation between the forum and the underlying controversy.  Goodyear Dunlop Tires Operations, S.A. v. Brown, 131 S. Ct. 2846, 2851 (2011).  A defendant’s suit-related conduct must create a substantial connection with the forum State.  Walden v. Fiore, 134 S. Ct. 1115, 1121 (2014).  For a court to exercise specific jurisdiction over a branded manufacturer, there must be a relationship between the branded manufacturer, the forum, and the litigation, and it must be the branded manufacturer, not the plaintiff or generic manufacturer, who creates the suit-related contact with the forum state.  Id. at 1126.   See also Bristol-Myers Squibb Co. v. Superior Court of California, San Francisco County, 137 S. Ct. 1773, 1783 (2017).  That the brand manufacturer may generally sell its branded version of the drug in the forum state is irrelevant for purposes of specific jurisdiction, because there is no connection between general in-state sales and some other manufacturer’s competing generic version of the drug taken by plaintiff.  See generally Bristol-Myers Squibb Co., 137 S. Ct. at 1773.  Similarly, the fact that a plaintiff may have been injured in the forum is irrelevant because there must be a connection between the injury and the branded manufacturer’s in-state conduct.  Walden, 134 S. Ct. at 1121.

In the context of innovator liability, the brand manufacturer’s case-linked conduct will be its internal decision making with respect to its drug label and its communications with FDA about the label.  That conduct likely took place at the manufacturer’s headquarters or in its dealings with FDA, not in the forum state.  Under BMS, a court cannot exercise specific jurisdiction over that out-of-state conduct.  Plaintiffs argue. and courts have speculated, that a brand manufacturer should have known that generic manufacturers were required to adopt its label, and should have foreseen that the information in their branded label would be communicated to plaintiffs by way of the generic drug being sold in-state.  If at all, that knowledge exists at corporate headquarters.  Using foreseeability to analyze minimum contacts impermissibly allows plaintiff’s contacts (or the generic manufacturer’s contacts) to drive the jurisdictional analysis.  Walden 134 S. Ct. at 1125.  Foreseeability attributes another person’s forum connections to the branded manufacturer “and makes those connections ‘decisive’ in the jurisdictional analysis,” obscuring the reality that none of the branded manufacturer’s challenged conduct (related to the label) took place in the forum state.  Id.

This jurisdictional analysis addresses innovator liability claims filed in a state where the branded manufacturer is not at-home, but not claims filed in the branded manufacturer’s home state.  In such a situation, the court would be able to exercise general jurisdiction over the branded manufacturer, but would have to undertake a choice of law analysis – including application of “public policy,” see Restatement (Second) of Conflict of Laws §187(2)(b) − to determine if the plaintiff would get the benefit of innovator liability imported from his or her home state (presumably Massachusetts or California).  That is a discussion for another blog.

The end of our story is all good. Our flight finally pushed back at 11:00 pm and we were pretty exhausted arriving in Boulder at 3:00 am (5:00 am east coast time).  But when the sun crested over Folsom Field just a few hours later, with the majestic cloud capped Rockies towering over campus, we were glad that we remained optimistic.  And so, as we fly back east with the sun setting behind us, it is good to know that the requirements of due process can provide that light of hope for branded manufacturers by precluding courts from exercising jurisdiction over allegations of innovator liability.

Anyone interested in what’s wrong with mass torts in today’s litigation landscape should read the recent article in the New York Times, “How Profiteers Lure Women Into Often-Unneeded Surgery,” which ran in the paper on April 14, 2018, and is available online here.  Briefly, the article exposes litigation (and pre-litigation) conduct that amounts, at best, to unnecessary surgery, and, at worst, to certain doctors, lawyers, and litigation funders conniving to bring about harmful surgeries that caused additional injury to their own supposed clients.  Here are some excerpts from the article – there’s lots more, but we have to limit ourselves to fair use:

  • “[A] growing industry that makes money by coaxing women into having surgery − sometimes unnecessarily − so that they are more lucrative plaintiffs in lawsuits against medical device manufacturers.”
  • “Lawyers building [vaginal mesh] cases . . . turn[ing] to marketing firms to drum up clients.”
  • “Women with mesh implants . . . receiving torrents of unsolicited phone calls, some originating overseas” from telemarketers who “seemed to know their medical histories.”
  • “[M]arketers turn[ing] to finance companies to provide high-interest loans to the [women] that have to be repaid only if the [women] receive money from the case.”
  • “Those loans are then used to pay for surgery performed by doctors who are often lined up by the marketers.”
  • Promises that “all [a woman’s] expenses would be covered and that she would be set up with a lawyer to help her sue the mesh manufacturer.”
  • “[M]iddlemen” arranging for surgery in “walk-up clinics” in “shopping malls.”
  • Doctors performing “four or five removals in a day” and pocketing as much as $14,000 a day.
  • “The women generally didn’t meet the doctors who would be operating on them until shortly before the procedure.”
  • Women charged $21,000 per surgery, “at a double-digit interest rate,” to be paid for from “lawsuits brought by women against the mesh manufacturers.”
  • “[H]undreds, perhaps thousands, of women . . . sucked into this assembly-line-like system. . . .  The profits are immense.”
  • “[P]laintiffs who do collect settlements see much of the money go to the financing firms.  Another large slice goes to their lawyers.”

Other than what’s obviously disturbing about reports of such dubious goings on, the Times article leads us to two observations:

First, the conduct described in the Times article provides further support, in the form of a compelling example, for the increasing calls for some sort of mandatory disclosure of litigation financing, at least in mass torts.  The abuses described in the article show how both the integrity of the mass tort litigation process, and the reputation of litigation financing generally, can be harmed by litigation solicitation and financing arrangements not being transparent, particularly where the litigation itself is largely solicitation-driven, as in most mass torts.

As the Times article demonstrates, solicitation, while constitutional under the First Amendment, is rife with potential for abuse.  Our colleagues on the other side might counter that so is pharmaceutical detailing.  Well, precisely to prevent abuse, the sales practices of our clients are regulated in multiple ways − including disclosure of financial arrangements between them and physicians that prescribe/use their products.  Those on the P-side with nothing to hide have nothing to fear from disclosure.  Thus, if litigation financing wants to be considered as legitimate as, say, insurance, that supports the case for routine disclosure of such arrangements in the same fashion as insurance, as Wisconsin recently decided to do:

Except as otherwise stipulated or ordered by the court, a party shall, without awaiting a discovery request, provide to the other parties any agreement under which any person, other than an attorney permitted to charge a contingent fee representing a party, has a right to receive compensation that is contingent on and sourced from any proceeds of the civil action, by settlement, judgment, or otherwise.

Wis. Eng. Asbly Bill 773 §12 (new §804.01 (2)).  Whatever the merits of the Wisconsin approach, or whether it’s necessary outside of the mass tort context, that approach has the advantage of being a simple, bright line standard.

Certainly, disclosure would be a sure and quick way to expose the kind of deals described in the Times article that women have been enticed into in the Vaginal Mesh litigation.  Existence of this kind of financing would be a red flag that the injury claims in such cases required careful investigation.

Which brings us to….

Second, the Times article strongly suggests that these abuses are widespread in the Vaginal Mesh MDL litigation.  Arrangements this elaborate are not worth the trouble for only a small number of cases.  According to the Times article, “perhaps thousands” of lawsuits have been tampered with in the ways that the article describes.

Without disclosure, the kind of aggravation of damages described in the Times article – ironically, the opposite of the accepted common-law duty to mitigate − is hard to unearth.  The Times article quotes “Magistrate Judge Cheryl Eifert in West Virginia”:

“People are claiming the Fifth [Amendment privilege against self-incrimination] and so on and so forth.  They don’t have to talk about necessarily how much money they make, per se, but if someone would just give them an idea of how the arrangement works.  But nobody’s willing to do that.”

Magistrate Judge Eifert has been overseeing aspects of the Vaginal Mesh MDLs.  E.g., In re American Medical Systems, Inc. Pelvic Repair Systems Products Liability Litigation, 946 F. Supp. 2d 512 (Mag. S.D.W. Va. 2013) (opinion by Eifert).

That’s concerning because, as we pointed out a couple of months ago, discovery in the remaining 23,000 cases in the Mesh MDLs has been ordered to be completed with:  (1) extreme haste, and (2) significant limitations on the number of interrogatories that can be propounded and witnesses deposed (see paragraph 2 of the four PTOs linked to in the prior post).  Since there may well be hundreds (if not more) of those 23,000 cases involving questionable surgeries conducted under questionable circumstances, the current rush to remand – combined with the obstructive tactics described in the Times article – creates a considerable risk of miscarriage of justice.  Defendants do not appear to have been given the time or the discovery tools needed to unearth plaintiff-side shenanigans on the scale described in the Times article.  There comes a point at which the efficiency objectives of multi-district litigation have to yield to the higher objectives of justice.

In the Diet Drug litigation – a mass tort of comparable scope – all kinds of problems arose with “the District Court [being] inundated with fraudulent benefits claims.”  In re Diet Drugs (Phentermine/Fenfluramine/Dexfenfluramine) Products Liability Litigation, 573 Fed. Appx. 184, 185 (3d Cir. 2014).  Unfortunately, the widespread fraud perpetrated in Diet Drug only became apparent after settlement – as would eventually be the case here, since contingent fee surgeries will almost surely be a topic of inquiry after the Times article.  The opportunity still exists in the Pelvic Mesh MDLs for diligent discovery to ferret out the false or inflated claims, but that can only happen if adequate discovery is permitted to occur.

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.

This one comes from Alabama and it’s pretty straightforward – plaintiff’s claims are preempted and therefore dismissed with a little wiggle room left for an attempted amended complaint. But as we know, for Pre-Market Approved (PMA) devices, there is only a “narrow gap” between express and implied preemption through which a claim must fit to survive. And so far, plaintiff has been ping-ponging off the sides but hasn’t made it through the gap.

The case is Rice v. Allergan USA, Inc., 2018 WL 1618036 (N.D. Ala. Apr. 4, 2018). Plaintiff had LAP-BAND surgery to aid with weight loss. The LAP-BAND is a PMA device. After seven years, plaintiff started to experience difficulty swallowing and frequent vomiting and upon investigation it was discovered that the LAP-BAND had eroded into plaintiff’s stomach and had to be removed. Id. at *2. Plaintiff conceded several of her claims. Those that remained for ruling by the court were negligence, failure to warn, and negligent or fraudulent misrepresentation. Id. at *3. Plaintiff’s primary allegation in support of these claims was that while defendant’s label reported a 1% risk of erosion, studies revealed a higher complication rate. Id. at *2.

Because the LAP-BAND went through the PMA process, plaintiff’s claims are preempted unless they satisfy the “parallel claim doctrine.” That means plaintiff has to show that the state law duties she alleges defendant violated and for which she seeks damages are “genuinely equivalent” to the federal requirements imposed on the device. Id. at *5. Only when the state and federal duties are parallel will plaintiff’s claim not run afoul of the provision of the Medical Device Amendments (“MDA”) that a state not impose requirements that are “different from or in addition to” federal requirements. Id.

Plaintiff’s first negligence claim was for negligent design and manufacture. However, while she made several allegations about the device having significant risks, nowhere did plaintiff allege how the manufacturer’s duty of care under state law “parallels the federal requirement that the [device] be manufactured according to the approved specifications for the medical device.” Id. at *6. If the device was designed and manufactured according to its PMA specifications, then allowing a jury to find it was negligently designed or manufactured would be imposing a different or additional requirement on the manufacturer. Therefore, claim preempted.

Next up was plaintiff’s negligent failure to warn claim. The court actually broke the claim down into 5 theories on which failure to warn was premised: negligent marketing, negligent labeling, negligent failure to update labeling, negligent reporting, and negligent surveillance. Id. It’s worth noting here that the court applies all the same reasoning in concluding that plaintiff’s strict liability failure to warn claim is similarly preempted. Id. at *8.

Here plaintiff did cite federal regulations but still missed the mark. For instance, plaintiff cited 21 C.F.R. §99.101 which provides:

[a] manufacturer may disseminate written information concerning the safety, effectiveness, or benefit of a use not described in the approved labeling…provided that the manufacturer complies with all other relevant requirements under this part.

Plaintiff alleges that the defendant violated this federal regulation by failing to provide additional risk information about the device. But all this section does is provide a guideline should a manufacturer choose to disseminate additional information. Choosing not to do so doesn’t violate the provision. Id. at *6.

Plaintiff also cites to the Changes Being Effected (“CBE”) provisions arguing that the defendant violated those provisions by failing to implement a CBE warning. However, a CBE labeling-change is permission to change a label “while a manufacturer awaits a written FDA order approving the PMA supplement.” Id. at *7. But plaintiff did not allege that the defendant was awaiting an FDA order on a PMA supplement, so it is unknown if the provision even applies.

Plaintiff also tried to base her failure to warn claim on an alleged violation of defendant’s federal duties to report adverse events to the FDA and to conduct post-market surveillance. Id. But the court considered both of those claims impliedly preempted on the grounds that they were unlawful attempts to privately enforce the FDCA. The court said failure to report sounds like it could be failure to warn, but the requirement is to report to the FDA, not to plaintiff. And there simply is no state law cause of action for post-market surveillance. Id.

Finally, the court had to dismiss plaintiff’s misrepresentation claim based on plaintiff’s vague pleadings. If what plaintiff was alleging is that defendant should have disclosed additional information and such a disclosure requirement exceeded FDA’s requirements, the claim would be preempted as not parallel. If, on the other hand, plaintiff was alleging that the defendant “held its product out as meeting a higher standard than that required by the FDA,” such a claim would not be preempted. Id. Since the former is more likely, it appears that a properly pleaded claim is likely preempted.

Yesterday happened to be the deadline for plaintiff to file an amended complaint, which she did. A quick skim of the amended complaint leads us to believe it contains most of the same allegations and therefore deficiencies the court has already addressed. And, plaintiff re-pleaded the claims she conceded as insufficiently pleaded the first time around. We suspect another round of preemption briefing in this case’s future.

We wrote a post not too long ago recommending that MDL defendants seriously consider limiting so called “Lexecon (read the prior post if you don’t know what that means) waivers” to single plaintiff trials and to exclude punitive damages.  We included a caveat that “this idea wouldn’t have worked” in all situations, if the MDL judge is bound and determined to chase down a non-waiving defendant in the original transferor district.  See Eghnayem v. Boston Scientific Corp., 873 F.3d 1304 (11th Cir. 2017) (MDL judge trying out-of-district case as visiting judge).

We were assuming, of course, that the MDL court could engineer a temporary appointment as a visiting judge under 28 U.S.C. §292(d) – something we’d first brought up a long time ago.  Indeed, the Manual for Complex Litigation (4th) mentions this possibility.  See Id. §20.132, at 247 (Fed. Jud. Ctr. 2005).

We should have researched that assumption first, or at least gone back through our own old posts.  It turns out that the only appellate authority on MDL judges trying cases as visiting judges says you can’t do it.  See In re Motor Fuel Temperature Sales Practices Litigation, 711 F.3d 1050 (9th Cir. 2013) (“MFT”).  Not only that, we actually blogged about the MFT ruling when it was decided.  If we hadn’t been preparing an MDL best practices project for Duke Law School, our forgetful ignorance would have continued.

Anyway, we figure if we can forget something like that – although we actually wrote about it – you might, too.  So with the problem of multi-plaintiff consolidated punitive damages MDL show trials fresh in our minds, here’s a refresher:

MFT refused to approve a “temporary assignment” designation sought by an MDL judge to try a case that was otherwise precluded by Lexecon, even though Lexecon was not totally on point

Lexecon dealt with venue, not judicial case assignment.  The Lexecon Court held that a plaintiff is entitled to select the venue where the case will be tried, and this right can’t be undermined by having the case transferred for pre-trial proceedings under the MDL process.  Venue is important for a number of practical reasons, such as ease of access to the forum by plaintiffs and their lawyers and, perhaps most important, selection of the jury pool.  Venue does bear on which judge will be assigned to the case, as one of the judges of that district will normally preside, but there’s no guarantee of that.

711 F.3d at 1054.  Nonetheless there was “some force” to the argument “that allowing the MDL judge to follow the cases after the conclusion of pre-trial proceedings resuscitates the self-referral practice that the Supreme Court unanimously repudiated in Lexecon.”  Id.  Just not enough force to win the point on that basis, since Lexecon itself did not dictate the outcome.

Instead, MFT looked to the Guidelines for the Intercircuit Assignment of Article III Judges promulgated under the Chief Justice’s authority the year before.  These guidelines set out specific criteria for allowance of intercircuit transfers, and letting an MDL judge try cases s/he otherwise couldn’t wasn’t one of them.  Rather such transfers are permitted only under very specific circumstances.  “Only severe or unexpected over-burdening, as happens when a judge dies or retires, when the district is experiencing a judicial emergency or when all the judges are recused because of a conflict, will warrant bringing in a visiting judge.”  MFT, 711 F.3d at 1053.

While we would ordinarily include a link to the guidelines themselves, they’re not independently available either on the Internet or on the Federal Judicial Center’s website. Helpfully, they are attached as “Appendix A” to the MFT decision.  These guidelines do not provide any support for an MDL judge taking the initiative to ride shotgun on remanded cases:

  • The “primary source of intercircuit assignments should be senior judges.”
  • The first choice for designating a visiting judge is “from another court within the circuit.”
  • Assignments are not controlled by the would-be visiting judge, but rather selected by the chief justice and the Committee on Intercircuit Assignments, in order “to avoid the appearance of impropriety or conflict of interest.”
  • “The appropriate way to initiate a formal request for an intercircuit assignment is for the circuit chief judge to send a Certificate of Necessity to the Chair [of the Committee on Intercircuit Assignments].”

Thus MFT rejected the request of an MDL judge to retain authority over a remanded case:

[T]he process of transferring judges between circuits, as delimited by the Chief Justice’s Guidelines, is directed strictly toward meeting judicial necessities, whereas the transfer in this case would serve a different purpose. . . .  [H]aving the district judge who conducted MDL pre-trial proceedings also preside over the trial of the case can improve judicial efficiency, preserve scarce judicial resources and enhance MDL judges’ control over their proceedings.  These are worthy goals, to be sure, but not ones in any way reflected in the Guidelines.

MFT, 711 F.3d at 1054.  Allowing a transfer would effectively divest the judges of the transferor district of cases ordinarily assigned to them.  There is “no authority empowering the chief judge of the circuit to re-assign cases pending before other judges, or to remove cases from the district’s assignment wheel” in the absence of recusal.  Id. Short of amending the guidelines (which doesn’t seem to have happened since 2013) there wasn’t “any way” to “constru[e]” them to allow an MDL judge to engineer his or her own assignment to a specific post-remand case.  Id. at 1055.

Since it was decided in 2014, MFT hasn’t been cited except in the Ninth Circuit – as we suppose befits such an arcane decision.  It may well be, as a commentator has commented, that visiting judge “requests are often granted routinely by circuit chief judges” in MDL situations.  Sherman, “When Remand Is Appropriate in Multidistrict Litigation,” 75 La. L. R. 455, 460 (2014).  However, “intercircuit transfers based on efficiency could encroach on the authority of transferor judges to resume rightful control over their cases upon completion of pretrial proceedings.”  Id.  See MacFarlane, “The Danger of Nonrandom Case Assignment:  How the Southern District of New York’s ‘Related Cases’ Rule Shaped Stop-and-Frisk Rulings,” 19 Mich. J. Race & L. 199, 213 (2014) (“the visiting judge [under §292(d)] would be expected to help relieve that burden, rather than dictate what types and number of cases he or she is willing to hear”).

It may seem extreme that an MDL judge would react to Lexecon – and lack of an appropriate waiver − by seeking to chase the parties back to their home districts, but such an extreme situation is precisely when our clients may feel compelled to invoke MFT to try to end the chase.  We hope our clients never need it, but if they do, remember that the only actual precedent out there rejects letting MDL judges maintain control over cases after remand.

We have made some technical upgrades to the blog that should help you access our research posts more quickly and efficiently. Now, at the very top of the blog – above even our “Drug and Device Law” caption, you will find several new category titles: Scorecards, General Research, State-By-State Research, and Cheat Sheets. If you click on them, or on the hyperlinks in this post, which lead to the same place, you will be taken to lists – with hyperlinks – for all of our research posts that fit in each of these categories.

These lists are organized identically to the lists in our “Where to Find Our Research 3.0” post we published at the beginning of 2018, except that these are more up to date, and you don’t have to worry about finding the individual posts that contains the list. Check them out and tell us what you think. You can save your clients a lot of money by seeing what we have on any given topic before starting your own research from scratch. Re-inventing the wheel does nobody any good.

We are back in the trenches today after spending a wonderful day in New York with our lifelong best friend, in yet another of the blissfully endless celebrations of the milestone birthday we marked in December. We saw “The Band’s Visit,” a new musical based on a 2007 movie about eight members of an Egyptian police orchestra stranded overnight in a remote Israeli town.  The band members accept a local resident’s invitation to bunk overnight in her café, setting the stage for lovely intersections of hearts, minds, and cultures.  It is short, sweet, and very satisfying.

As is today’s case, for those of us who defend prescription drug and device manufacturers. In Kwasniewski v. Sanofi-Aventis, LLC, 2018 WL 1567851 (D. Nev. Mar. 30, 2018), the plaintiffs alleged that the defendant’s prescription sleep medication caused their decedent to commit suicide.  The opinion includes the judge’s decisions on objections to several earlier rulings by the magistrate judge and her decision on the defendant’s motion to dismiss the plaintiffs’ design defect claims.

Objections to Magistrate’s Rulings

First, the plaintiffs objected to the magistrate’s refusal to stay discovery – and relieve the plaintiffs of their obligation to respond to the defendant’s pending discovery requests – while the defendant’s Motion to Dismiss was pending. The court agreed with the magistrate, emphasizing that “[t]he Federal Rules of Civil Procedure do not provide for automatic or blanket stays of discovery when a potentially dispositive motion is pending.” Kwasniewski, 2018 WL 1567851 at *2.

Second, the plaintiffs objected to the magistrate’s application of Nevada’s learned intermediary doctrine.   In a 30(b)(6) deposition notice, the plaintiffs included topics concerning “information about direct to consumer advertising.”  Because, under the learned intermediary doctrine, the defendant had a duty to warn only “medical experts, not consumers, about the dangers of [its prescription drug],” id. at *4, the magistrate ruled that deposition testimony about direct-to-consumer advertising was irrelevant.  As such, she limited the plaintiffs’ Rule 30(b)(6) deposition topics to the defendant’s “representations to the medical community.”  The plaintiffs argued that the magistrate had “effectively decided a dispositive motion” by applying the learned intermediary doctrine, and that the doctrine was an affirmative defense that had not yet been pled.  The court again affirmed the magistrate and barred the plaintiffs from discovering information  that the defendant had disseminated directly to consumers. We like this ruling and applaud the court’s adherence to the standard imposed by Fed. R. Civ. P. 26, requiring discovery to be “relevant to [a] party’s claim or defense and proportional to the needs of the case,” and its refusal to sanction a meaningless and abusive fishing expedition.

Defendant’s Motion to Dismiss

The defendant moved to dismiss the plaintiffs’ design defect claims sounding in both strict liability and negligence, arguing that “any claim that [the defendant] should have changed the formulation of [the product] or that the product should simply not have been marketed are preempted by Federal Law.” Id. at *5.  In their response, the plaintiffs conceded that they were “not arguing that that [the defendant] should have reformulated the drug – just simply that [the defendant] should have” included adequate warnings of the drugs alleged suicidality risk. Id. As such, the court was able to grant the defendant’s motion, and foreclose the plaintiff’s from alleging a design defect claim at a later date, without addressing the preemption argument.. (Given this court’s clear-headed, correct-leaning rulings, we suspect that its preemption decision would have been fun to read.)

Kwasniewski is a tidy, no-nonsense, defense-friendly opinion.. If, on this beautiful spring day, we are confined to an office and not roaming the Great White Way, we are pleased that this case crossed our desk.

Breaking news. This just in. Prescriber’s testimony linchpin in manufacturer’s victory over failure to warn claims. And the crowd gasped at this startling news. Actually, this news might be more the equivalent of an announcement that a 13 year-old boy made a snarky comment to his parents (current daily experience for this blogger). Not exactly a revelation. But we will say that the opinion entered by the magistrate in Harper v. Janssen Pharmaceuticals, Inc., 2018 U.S. Dist. LEXIS 58298 (M.D. Ala. Apr. 4, 2018) is strong and well-reasoned. A good addition to any learned intermediary library.

Plaintiff is the mother of a boy who was diagnosed with autism at the age of 4. From the age of around 5 or 6 until he was 10, plaintiff’s son was prescribed Risperdal among other medications. During that time he began gaining weight and experienced high prolactin levels. At the age of 16, plaintiff’s son was diagnosed with gynecomastia, an abnormal development of breasts in males. Id. at *5-8. Plaintiff filed suit alleging claims for failure to warn under common law and under the Alabama Extended Manufacturer’s Liability Doctrine (“AEMLD”), negligence, wanton misconduct, breach of implied warranty of merchantability, fraud, and negligent misrepresentation. Id. at *5.

At the core of all of plaintiff’s claims is an allegation that the manufacturer failed to provide accurate or complete information about the risk of gynecomastia with the use of Risperdal. So, there are two key areas of inquiry – what information did the manufacturer provide and what did the prescribing physician know. Starting with the Risperdal label, throughout the time plaintiff’s son was taking Risperdal, elevated prolactin levels and gynecomastia were included in the precautions section of the label. Further, at all relevant times, the label included a warning that “safety and effectiveness in children have not been established.” Id. at *9-10. Plaintiff focuses on studies done by the manufacturer that allegedly show that Risperdal had a greater risk of increasing prolactin levels than other anti-psychotic drugs in the same class and argue that this information was available to defendant at the time plaintiff’s son was prescribed the drug and it should have been part of the warning. Id. at *12-14.

Moving on to the prescribers – the first doctor to prescribe Risperdal to plaintiff’s son testified that at the time he prescribed he knew that safety and effectiveness had not been established for children, that he took that into consideration when prescribing, and that it was his practice to discuss with the parents of child patients that this was an off-label use. Id. at *15. He was also aware that the label called for periodic re-evaluations if the drug was used long-term and again it was his practice to do so and that he only continued patients on medications if he felt the benefits outweighed the risks. Id. at *16. And, the prescriber was aware that Risperdal was associated with weight gain and was also aware that prolactin-elevating compounds could lead to gynecomastia. He took both into account when prescribing Risperdal. Id. at *16-17. The second prescriber was likewise aware that Risperdal was not approved as safe and effective for use in children and would have considered that at the time he prescribed to plaintiff’s son. Id. at *19.

Before jumping into its legal analysis, the court made a few astute observations about the intersection between science and the law and in particular the uncertainty of medicine that are uncommon in legal opinions and so we decided to provide for you directly here:

To a significant degree, this case epitomizes the limitations of medical science, the law, and their interaction. The course of human history has seen profound improvements in our understanding of health, disease, and other afflictions. Recent advances in diagnosis and treatment of medical conditions, both physical and mental, are often little short of miraculous. Despite these advances, our understanding of maladies and their safe and effective treatment remains incomplete and imperfect. This is especially and poignantly true with respect to the broad category of mental health conditions. Doctors and the pharmaceutical industry have developed any number of powerful medicines for treatment of many of those conditions, with varying levels of effectiveness. All these medicines carry the burden of potential side effects for some or all users. Determining the origin of adverse conditions associated with certain drugs is often difficult.

Measuring the breadth and fixing the limits of legal liability for adverse drug reaction requires development and application of legal principles in an area of great medical uncertainty and conflicting economic and societal goals. Through federal and state legislation, administrative regulation and approvals, and the common law, we establish standards for patients, doctors, and pharmaceutical companies to govern their affairs. Legal concepts of proof and causation are often not readily applied where scientific knowledge is incomplete and uncertain. The twin aims of providing appropriate compensation to individuals injured by others while encouraging doctors and drug companies to advance the field of medicine frequently conflict, as in this case.

Id. at *21-22. We’ve blogged on occasion about the pitfalls of the law getting too far ahead of science and how making the two fields meet can be quite tricky – nice to see it in an opinion.

So, faced with a label that warned of the risk, and prescribers who knew and considered the risk, and imperfect scientific knowledge – what was left for the judge was to enter summary judgment. Plaintiff argued that while the Risperdal label contained some warnings, those warnings were incomplete or misleading about the extent of the risk (the studies noted above). However, the label was “not intended to be a risk profile for adolescents.” Id. at *28. The label explicitly stated the drug’s safety and effectiveness had not been established for pediatric patients and also went on to include both increased prolactin and gynecomastia in the precautions. More importantly, as noted above, the prescribers were aware of the risks. “The prescribing decisions of [plaintiff’s son’s] health care providers were made after weighing the risks and benefits of the medication. Critical to a plaintiff avoiding the learned-intermediary doctrine is a demonstration that the manufacturer failed to warn the physician of a risk not otherwise known to the physician.” Id. at *30 (citation and quotation marks omitted).

Further, as to the studies showing increased risk upon which plaintiff relies, plaintiff’s initial prescriber testified “that until a study is completed and the data analyzed, it is not available to him to rely upon in making his prescribing decision.” Id. at *29. Great support from the prescriber for keeping out science that post-dates prescription and usage of the drug. If the studies weren’t published until after the doctor stopped prescribing, they couldn’t factor into his prescribing decision and they shouldn’t factor into the court’s failure to warn analysis.  Putting all this together, the court concluded both that the defendant provided adequate warnings and that the “prescribing physicians knew use of Risperdal in children was an “off-label” use, independently knew of the risks associated with the medication or researched them prior to prescribing the medication, and chose to prescribe it anyway.” Id. at *31. Learned intermediary doctrine bars any failure to warn claim.

Plaintiff’s remaining claims fell away quickly as well. Wanton disregard requires a showing of recklessness or conscious disregard for the safety of others. Again plaintiff’s pointed to the label and argued it wasn’t enough. “The fact that the warnings could have been broader or stronger does not equate to reckless disregard or an indifference toward safety.” Id. at *33.  The label contained a warning of the very risk at issue, therefore, defendant was not indifferent to safety. Breach of implied warranty failed because (a) Alabama doesn’t recognize it for inherently dangerous products and (b) the drug served its purpose of treating mental health. Id. at *35-36. Finally, plaintiff’s fraud and misrepresentation claims fail because even if you assume all facts in the favor of plaintiff, she hasn’t established reliance by her son’s treaters or causation where the treaters knew of the risk and prescribed anyway. Id. at *38.

Learned intermediary may not be a hot new topic, but this testimony and the analysis by the court is pretty top-notch.

Today’s guest post by Reed Smith associate Jennifer Eppensteiner concerns an interesting First Amendment development.  Everybody knows how California’s wildly overwrought Proposition 65 has turned that state’s products, from beer to bacon, into billboards for remote and scientifically suspect cancer warnings.  Well, how about a ruling that requiring scientifically unsound warnings on products is compelled false speech in violation of the First Amendment?  As always our guest posters deserve 100% of the credit (and any blame) for their posts.

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It is probably a safe bet to say that many of the blog’s readers settle in to enjoy these posts with a cup (or, on anticipated longer days after long nights, carafe) of coffee.  Readers in California may soon be drinking coffees with warning labels – no, not of the Jackie Chiles Java World “Caution: Hot!” variety – but a cancer warning, courtesy of Proposition 65 (“Prop 65”).  Coffee consumers are a passionate bunch, so the recent Los Angeles Superior Court proposed ruling to this effect has been widely publicized.  Readers may not be familiar, however, with another recent Prop 65 ruling, one with an arguably better outcome for product manufacturers.  That’s why I’m here today.

The outcomes in drug and medical device litigation often turn on the label. Regardless of how detailed a warning is, in what font and size it’s printed, and whether it comes in a bold, black box, plaintiffs always insist that the warnings were insufficient.  They sometimes base their position on nothing more than attorney argument, and often they cite isolated information that is against the great weight of authority, such as an anecdotal case report or an outlier study with small sample sizes and inconclusive results.

Thankfully, the Eastern District of California recently recognized that requiring a manufacturer to include a cancer warning based on the questionable finding of a single organization, when all other regulatory and governmental bodies had found the opposite, would violate the manufacturer’s First Amendment rights by forcing it to say something that was false, and with which it disagreed. Nat’l Assoc. of Wheat Growers v. Zeise, et al., Civ. No. 2:17-2401, 2018 WL 1071168, at *7 (E.D. Cal. Feb. 26, 2018).  Before the court was a motion for preliminary injunction, requesting the court do two things:  (1) stop the State of California from identifying glyphosate on a list of cancer-causing products; and (2) enjoin the warning requirement of Prop 65 from being enforced against Plaintiffs with regards to glyphosate.  Id. at *1.

Before we get into the court’s reasoning, some background on Prop 65. Officially known as the Safe Drinking Water and Toxic Enforcement Act of 1986, Prop 65 purports to protect California’s drinking water sources from being contaminated with chemicals known to cause cancer, birth defects or other reproductive harm, and requires businesses to inform Californians about exposures to such chemicals.  Under Prop 65, the Governor of California is required to publish a list of chemicals “known to the State” to cause cancer, as determined by certain outside entities.  Id.  Prop 65 also prohibits any person in the course of doing business from knowingly and intentionally exposing anyone to the listed chemicals without a prior “clear and reasonable” warning.  Id.  The prohibition, and corresponding warning requirement, takes effect 12 months after the chemical has been listed.  Id.  Private persons are authorized to file suit to enforce Prop 65, adding to the overwarning problem.

Glyphosate is a widely-used herbicide used to control weeds in various settings.  Id. at *1, n.1.  Glyphosate can even be used on coffee plantations.  But I digress.  Plaintiffs or their members sell glyphosate-based herbicides, use glyphosate in their cultivation of crops that are incorporated into food products sold in California, or process such crops into food products sold in California.  Id.  In 2015, the International Agency for Research on Cancer (“IARC”) of the World Health Organization (“WHO”) classified glyphosate as “probably carcinogenic” to humans based on evidence that it increased cancer rates in animal studies and limited evidence that it could cause cancer in humans.  Id. at *2.  In this case, the IARC is the outlier.  Several other organizations, including the United States Environmental Protection Agency (“EPA”) and other agencies within WHO found no evidence that glyphosate causes cancer.  Id.  Still, relying on the IARC’s “probably carcinogenic” classification, California’s Office of Environmental Health Hazard Assessment (“OEHHA”) issued a Notice of Intent to List Glyphosate in November 2015 and subsequently began listing glyphosate as a chemical known to state of California to cause cancer in July 2017.  Id.  The warning requirement would therefore take effect in July 2018.  Id.

After finding that Plaintiffs’ First Amendment claim was ripe for the court’s consideration, the court turned to the issue of injunctive relief. Injunctive relief, “an extraordinary and drastic remedy,” requires that the moving party establish several familiar elements:  (1) it is likely to succeed on the merits, (2) it is likely to suffer irreparable harm in the absence of preliminary relief, (3) the balance of equities in tips in its favor, and (4) an injunction is in the public interest.  Id.

Regarding the likelihood of success on the merits, the court first distinguished between the State’s listing of glyphosate as a chemical “known to” cause cancer and the subsequent warning requirement.  The former is government speech; the latter is commercial speech.  Id. at *5.  This distinction is significant because the “[t]he Free Speech Clause restricts government regulation of private speech; it does not regulate government speech.”  Id. (citing Pleasant Grove City v. Summum, 555 U.S. 460, 467 (2009).  So, while Plaintiffs could not demonstrate likelihood of success on the merits with regards to the listing of glyphosate, a different analysis was required for the warning requirement itself, which would have the effect of compelling commercial speech – the labeling of a product.  Id.

Commercial speakers receive protection of the First Amendment, subject to some limitations.  The government may require commercial speakers to disclose “purely factual and uncontroversial information” about commercial products or services, as long as the “disclosure requirements are reasonably related” to a substantial government interest and are neither “unjustified [n]or unduly burdensome.”  Id. (citing In Zauderer v. Office of Disciplinary Counsel of Supreme Court of Ohio, 471 U.S. 626, 651 (1985)).  As explained above, only the IARC found that the evidence warranted branding glyphosate as “probably carcinogenic.”  On the other hand, the court noted that

…the EPA has reviewed studies regarding the carcinogenicity of glyphosate multiple times and has determined each time that there was no or insufficient evidence that glyphosate causes cancer, most recently in September 2016. Several international agencies have likewise concluded that there is insufficient evidence that glyphosate causes cancer, including the European Commission’s Health and Consumer Protection Directorate–General, multiple divisions of the World Health Organization besides the IARC, and Germany’s lead consumer health and safety regulator.

Id. at *7.  Based on the great preponderance of scientific opinion, the court reasoned that it was “inherently misleading for a warning to state that a chemical is known to the state of California to cause cancer based on the finding of one organization … when apparently all other regulatory and governmental bodies have found the opposite, including the EPA.”  Id.  Accordingly, the court found that “here, given the heavy weight of evidence in the record that glyphosate is not in fact known to cause cancer, the required warning is factually inaccurate and controversial.”  Id.

After finding that the required warning would be false and misleading, the court found the scales tipped in Plaintiffs’ favor on the issues of irreparable harm, balancing of the equities, and public interest factors.  The court granted Plaintiffs’ request for a preliminary injunction enjoining the warning requirement of Prop 65.  Jackie Chiles would agree that requiring such a warning would be an infringement on Plaintiffs’ constitutional rights.  That’s outrageous, egregious, preposterous!

Remember, as well, that the First Amendment equally applies to tort litigation.  The blog has discussed the product liability implications of New York Times Co. v. Sullivan, 376 U.S. 254, 265 (1964), several times.  This is another such instance.  To the extent that, as in Nat’l Assoc. of Wheat Growers v. Zeise, the First Amendment prevents the government from forcing a product manufacturer to “speak” falsely based on the results of an outlier study, it equally precludes private plaintiffs from seeking damages for a manufacturer’s failure to include the same false information on a product warning.

Where might that come in useful?

In Looney v. Moore, 2018 WL 1547260 (11th Circuit Mar. 30, 2018), the Eleventh Circuit confirmed Alabama law’s rejection of an “increased risk of harm causation standard and established that lack of informed consent plaintiffs must have a physical injury.

Looney is a clinical trial case. Parents of several infants who were born prematurely claimed that the infants suffered injuries as a result of their participation in a clinical trial aimed at analyzing the effects of differing oxygen saturation levels on premature infants. Plaintiffs made negligence, negligence per se, product liability, breach of fiduciary duty and lack of informed consent claims, and they sued the doctors involved in the study, as well as the independent review board and the company that made the medical equipment for the study. Defendants won at the summary judgment stage, and the Eleventh Circuit affirmed.

The simplest issue was causation. The Eleventh Circuit applied Alabama’s strict requirement that a plaintiff making a negligence claim must show that the negligence more than likely caused plaintiff’s injury. An “increase risk of harm” is insufficient:

The Alabama Supreme Court has made clear that, “to present a jury question, the plaintiff in a medical-malpractice action must adduce some evidence indicating that the alleged negligence (the breach of the appropriate standard of care) probably caused the injury. A mere possibility is insufficient. . . . . An alleged “increased risk of harm” is not sufficient to survive summary judgment under Alabama law, which requires proof that the alleged negligence probably caused the injury.

Id. at *3.

Confirming this standard turned out to be the end of plaintiffs’ negligence claims. That’s because no expert, whether it be for plaintiffs or defendants, was willing to say that the defendants’ negligence during the clinical trial probably caused any of the infants’ injuries. At their depositions, defendants’ experts said that the infants’ premature births probably caused their injuries, not participation in the study. Id. Plaintiffs’ own expert could only manage to say that the clinical trial “increased the risk of harm” to the infants, not that it more likely than not injured them. Id. This testimony gave a jury no basis to find for plaintiffs, and the Eleventh Circuit affirmed defendants’ summary judgment victory. Id. at *4.

Plaintiffs’ informed consent claim was a bit trickier. Plaintiffs argued that they did not need a physical injury to make this claim, something that Alabama law had not directly addressed. Id. The Eleventh Circuit sought help on this, certifying a question to the Alabama Supreme Court. But the Alabama Supreme Court declined to answer. Id. This left the Eleventh Circuit in the position of having to predict how Alabama law would decide the issue. Id.

To do this, the Eleventh Circuit first considered the Alabama Medical Liability Act. It required an injury. The Eleventh Circuit also considered Alabama Supreme Court informed consent decisions. In each instance, the court laid out the elements of any informed consent claim, but they did not explicitly include injury. The Eleventh Circuit was not troubled by this because, in each case, the plaintiff not only suffered an injury, but a serious one. Id. at *5.

Left looking for any support for their theory of a claim without physical injury, plaintiffs pointed to battery claims, in particular medical battery claims, which in Alabama do not require physical injury. Id. at *7. The Eleventh Circuit distinguished these claims. Battery claims are not based in negligence, but instead on a lack of any consent at all. Id. On the other hand, plaintiffs in lack of informed consent claims actually give consent to the procedure. They just claim that their consent was ill informed. Id. at *8. In other words, their claims are based on the negligence of the medical providers. And that brings us back to the strict requirement under Alabama law that a plaintiff making a negligence claim must establish that the negligence probably caused an injury. With that, the Eleventh Circuit upheld summary judgment against plaintiffs’ informed consent claims. Id. at *9.