Like many of you, on Friday mornings we turn to the “Legal Lions and Lambs” section of Law360.  It is not only voyeurism.  We are constantly working on things in media res (the middle of things), building slowly and gradually to a climax that  hardly ever arrives.  Ninety percent of cases settle, and that is seldom the stuff of Lions or Lambs. Nope: the Lions vs Lambs dichotomy is about winning and losing.  Not in any subtle sense, either.  The Law360 column focuses on trial verdicts or dispositive motions.  Those outcomes furnish teaching moments, points of inspiration, object lessons, or cautionary tales.  We have never personally shown up on either side of the list as far as we know, mirabile dictu (wonder to say – surely mastery of Latin is a mark of a Legal Lion, no?), given that we played a minor role in that vast stain on Anglo-American jurisprudence not-so-fondly remembered as the Engle tobacco litigation in Miami).
We know this much: we’d rather be a Lion than a Lamb. The Lion is king of the jungle. MGM pictures start majestically with a roaring lion.  King Richard was lion-hearted.  The hero in the best Disney animated movie was a lion. So was Barry Sanders.  By contrast, Lambs get led to the slaughter.  We count them as we try to fall asleep.  Their silence is the central image to the creepiest movie we have ever seen.  Worst of all, we garnish lamb chops with mint jelly.
Over the last couple of weeks, we saw some entries in the “Lambs” section that caught our attention because they involved lawyers we know and respect.  These lawyers defended drug or device companies that got tagged by juries with eye-popping verdicts.  These defense lawyers are, to put it plainly, great lawyers.  We co-tried, and won, a case with one of them, and counted two others as colleagues in the US Attorney’s office a long time ago.  Their skills are extraordinary.  They possess exquisite judgment, work hard, and give their clients the best possible representation.
And they lost the cases that landed them in Law360.  (One of them, by the way, had won a similar case a couple of months before – the first defense lawyer to do so.  Before he was a Lamb, this lawyer was a Lion). Suddenly, we decided that we disliked the “Lambs” label.  Law360 surely does not mean to insult anyone in the Friday column, but there is something undeniably negative about the “Lambs” term, and undeniably unfair.  We bet those lawyers on the losing end went down, not meekly, but swinging.
The fact is that great lawyers occasionally lose cases.  Why?  To begin with, great lawyers are given the hardest and most important cases.  We know a very smart in-house lawyer (in fact his company was involved with one of the cases that caught our attention in the Lions and Lambs column) who likes to ask lawyers begging for business from him to name their worst loss.  Too many lawyers pretend they have never lost, or immediately show their insecurity by ladling on the excuses. But think of the two or three best trial lawyers you have ever encountered.  Maybe there is a plaintiff lawyer in Houston with a photographic memory and unsurpassable eloquence. Maybe there is a corporate defense lawyer in Chicago who possesses laser-like focus and terrifying tenacity.  They have both been brutalized by juries. That is true for just about every other trial lawyer who has earned a glistening national reputation. Some cases are simply too hard. Some judges are simply too biased.  Or, most often, some juries are simply too batty.
When we consider our worst loss, we usually reflect on a near miss. (Right – we are cheating.)  We tried a case against one of the most unpleasant lawyers we have ever met.  You couldn’t trust his word.  He said things in open court that the Judge had explicitly ruled out of bounds.  But before violating the ruling, this lawyer would keep challenging it.  Again and again.  Every day was a new day.  (The rotten thing was that half the time the judge would give him something, as if that mollification would buy peace instead of inviting additional rounds of revisitations and defiance). He wasn’t a Lion or a Lamb.  He was a Weasel. The case was hard-fought, but we were sure we gave a bit better than we got, and our closing argument echoed Pericles (so we thought) while our villainous opponent cribbed his best lines from one of his competitor Texas plaintiff lawyers. His appeals to prejudice were utterly unoriginal. And plagiarism was the least of this scoundrel’s sins.  Be that as it may, it was now time to wait for the jury.  Our client, who was doubtless the smartest person in the room, took the plaintiff lawyer aside. They huddled and talked intently. One or two perplexing questions came from the jury.  Those questions were so unsettling as to provoke settlement. The in-house lawyer struck a deal with our adversary.  It seemed to us like a lot of money.   But there it was.

 

We informed the Judge. The Judge then informed the jury.  We then talked to the jury.  What they told us made none of us happy.  It seems that the jury was leaning toward awarding a verdict about ten times higher than the settlement. One member of the jury had been a bit, um, stealthy.  In voir dire she had disclaimed any relevant prior history at all.  It turned out that she had a daughter who suffered from a condition pretty similar to what the plaintiff claimed.  This juror pushed hard to become foreperson, and then pushed even harder for a punishing verdict.  We (the defense) were stunned.  But perhaps we weren’t quite as stunned as the plaintiff lawyer, who had bargained away his next vacation home.
We were almost Lambs.

 

There are lots of reasons why cases are won or lost, or settled.  We hate it when judges are outcome-oriented, and we should beware of that fault in ourselves, too.  The best lawyers don’t always get the best results.  We can think of a case where one of the finest, smartest, smoothest two or three trial lawyers we ever saw lost to one of the two or three dopiest, clumsiest ones we ever saw. The jury was moved by undeniable facts and unavoidable sympathy.
Let’s have a little sympathy for those Legal Lambs.  They might very well be much better than the Lions, and they probably did a better  job than most of us would have done.  Heck, they probably don’t want our sympathy.  They are much too tough for that.  They are not Lambs at all.

Come visit us in our office whilst we are poring over a brief and, with minimal provocation, we will put aside the task at hand and start gabbing about our days as a prosecutor. Come sit next to us while we are pouring a brown adult beverage and we will get to that point even quicker. Once a prosecutor, always a prosecutor. Any lawyer who spent some part of his or her career in the criminal justice system will tell you that cases involving true force or fraud, with jail time in play, are much more emotionally gripping than any mass tort. Criminal cases came freighted with human tragedy, with bad decisions leading to ruined lives.  Yes, we can now hear some smooth plaintiff lawyer saying that precisely the same thing happens in personal injury cases, but the degree of passion and venality is not nearly the same.  At the same time, comedy crops up in criminal cases more often than you’d expect, usually as a weird contrapuntal note. In our day, many Assistant U.S. Attorney office doors were adorned with transcript inanities. We remember the late, great Jeff Rawitz (a fearless lawyer who left us way too soon) having an awkward moment with newly-enrobed Judge Lourdes Baird.  Judge Baird had been our boss only a few months before.  She was a splendid U.S. Attorney, and was a graceful, regal figure. You didn’t want to let her down – not ever, not even a little.  And you craved her respect.  Anyway, Rawitz was about to commence a cross-examination of an alibi witness.  He told Judge Baird that he needed a bathroom break.  Okay, said the Judge.  Then she asked Rawitz how long he’d be.  That is, she wanted to know how long the cross-examination was expected to be. That’s not how Rawitz heard it. Rawitz fidgeted, then said, “Not long, Your Honor.  [Pause]  Number one.”  When Judge Baird heard poor Rawitz stammer about the length of his bathroom break, she turned a bit red, then did her best to restore dignity to the trial. That exchange was taped on Rawitz’s door by some colleague/wag.

Once we start on these stories, it’s hard to stop. We remember one revocation of probation proceeding that supplied more mirth than usual.  The defendant had submitted to a drug test, and his urine had a super-high concentration of H2O. Clearly, the defendant had over-hydrated just before the test, a well-known way to avoid a positive drug test.  There was a contested evidentiary hearing.  The defendant denied any drug use, naturally.  The expert witness for the government, a septuagenarian who harbored no love for those he called “drug fiends,” was adamant that the defendant had gamed the system.  Now came time for the judge’s decision.  After uttering a few preliminary observations, the judge was suddenly interrupted by the defendant.  Though he was represented by an experienced public defender, the defendant, apparently unimpressed by the level of advocacy, grabbed the microphone and delivered a jumbled thesis on burden of proof.  Then, perhaps manifesting less than complete confidence in his position, the defendant purported to school the judge on possible sentences short of returning the defendant to the care of the Bureau of Prisons.  The judge cut in: “Hold on.  You really don’t need to explain all this to me.  I’ve been a judge for 15 years.”  The defendant’s riposte was swift:  “Okay, Judge, but I’ve been a criminal for 20.”  That also made it onto an AUSA’s door.

All of which is to explain why we will grab hold of any criminal case that has even the remotest connection to drug and device litigation, in this case the use (and misuse) of pharmocogenomic information.  Today’s case, Nebraska v. Robbins, 297 Neb. 503, 2017 Neb. LEXIS 148 (Neb. Aug. 18, 2017), is, indeed, fairly remote from our day-to-day doings, but is interesting nonetheless. Let’s begin with the fact that immediately distinguishes Robbins from the typical drug/device label nit-pickery littering our desk: the defendant in Robbins had strangled his girlfriend to death.  He was charged with first degree murder.  Just as almost all tort cases settle, the same is true with criminal cases.  The defendant in Robbins ultimately entered a plea of guilty to a reduced charge of second degree murder. The court sentenced the defendant to 40-60 years of incarceration. In an episode of Law & Order or Perry Mason (notice how there are no tv shows on mass torts?), that would be the end of the story.  Here, it is the beginning.  Prisons have good law libraries and some good jailhouse lawyers  As much as ex-prosecutors look back on their days in the criminal justice system with fondness, they will always report that the worst part of their job was responding to habeas petitions and other post-conviction flotsam and jetsam. Prisoner briefs are almost always nearly incomprehensible, so the first part of opposing such a motion is to translate it into something approaching rationality, and then refuting it.  It is a lot of work.  If you lose, all your fellow prosecutors up and down the hall will make fun of you.

The defendant in Robbins filed a motion for post-conviction relief, demanding a DNA test to determine whether he was a slow metabolizer of the anti-anxiety drug he had been taking. Huh?  Why? At the time of the murder, the defendant had been taking a standard dose of an anti-anxiety drug. Now he argued that the dose was too high for his metabolism, thereby rendering him homicidal.  To prove up this defense, if that’s what it was, the defendant sought relief under the state’s DNA Testing Act.  The lower court granted this relief, which must have driven the prosecutor crazy, but the Nebraska Supreme Court held this ruling to be plain error. The issue was whether pharmacogenomic DNC evidence that the defendant was a slow metabolizer would constitute exculpatory evidence. The defendant contended that evidence of his slow metabolism might function as mitigation for sentencing, and could also have established defenses at trial regarding inability to formulate the requisite intent, or could have established intoxication or insanity.  But remember, there was no trial.

The post-conviction use of DNA testing to get people out of prison is, by now, old hat.  You’ve no doubt read about such cases many times – perhaps enough to make you squirm about the imperfections of our justice system.  Fair enough.  But think about what was going on in those high-profile cases.  Those DNA tests truly exonerated the prisoner. They showed that the prisoner shouldn’t be in prison at all because he or she didn’t do the crime.  The court in Robbins reasoned that Nebraska’s DNA Testing Act was limited to proof of factual innocence, not the type of mitigation or excuse that the Robbins defendant was trying to demonstrate.  Semi-cleverly, the defendant argued that DNA testing would involve the same issue of identity afoot in the ‘classic’ DNA exoneration cases, on the theory that he was a “different person” while on the anti-anxiety drug.  The court did not buy it.  Here is the court’s bottom line:  “Because the Act is intended to assist in proving the innocence of a convicted person through establishing the person’s identity, it cannot be said that evidence from the DNA testing probably would have produced a substantially different result at trial.  As such, the evidence is not exculpatory under the Act.”  Fundamentally, the Robbins case is about statutory interpretation.  The court interpreted the DNA Testing Act narrowly, limiting it to issues of identity that might completely exculpate a defendant.
On behalf of prosecutors and taxpayers everywhere, we breathe a sigh of relief over the Robbins court decision.  To have granted the prisoner’s petition would have amplified what is already an imbecility in the law.  To our mind, the only mental state issue that should be relevant in criminal cases should be the classic mens rea: did the defendant intend the crime?  Here, did the defendant intend to strangle his girlfriend?  If he thought he was opening a pickle jar, then there really is an insanity defense.  But too many of the insanity tests that have had their moments over the centuries were detours into the ridiculous.  Why should it matter whether the defendant knew what he or she was doing was wrong? (The dreaded M’Naghten test.)  If someone thinks that murder is not wrong, that’s all the more reason to put them behind bars.  Sure, administer psychiatric treatment (the federal prison in Springfield, Missouri specializes in that sort of thing), but by all means keep amoral, psychopathic, sociopathic (or whatever) killers away from the rest of us.  The same is true of irresistible impulse, or any other species of craziness seized upon by silly academics or judges to excuse or even (gasp) exonerate a murderer.  Look, we can always come up with a reason for anything.  But reasons are not necessarily excuses.  Whether one’s metabolism is too fast, too slow, or just right, murder is murder.  Maybe you think that is a primitive view.  Like we told you, once a prosecutor, always a prosecutor.

We have been following issues related to the interplay of off-label use, manufacturer statements about off-label use, the First Amendment, and FDA enforcement for a long time.  (Like here, here, and here, among many posts.)  The court battles that have garnered so much attention recently can be traced back to at least the 1990s, with the famed decision in Washington Legal Foundation v. Henney, 56 F. Supp. 2d 81, 85 (D.D.C. 1999), vacated as moot by 202 F.3d 331 (D.C. Cir. 2000).  There can be lots of talk about what FDA’s policy is on what a manufacturer can and cannot say about unapproved uses for its drug or device.  Discussions about changing 21 C.F.R. § 201.128 (drugs) & 801.4 (devices) have dragged on for a while, even with the Amarin settlement and with other FDA statements suggesting that the regs do not reflect current policy.  FDA policy, of course, involves more than just a few sentences in a regulation or guidance document.  Particularly for a prohibition that has long been the crux of FDA enforcement—like warning letters and prosecutions—and has spawned or played a major role in subsidiary FCA, RICO, and product liability litigation, a decision to stop prohibiting truthful, non-misleading statements about unapproved uses for drugs and devices is not exactly the end of the story.  For one thing, criminal prosecutions that are based at least in part on manufacturer statements about unapproved uses are always on-going and U.S. cannot just hit the reset button in those cases.

We do not often post about decisions from, let alone briefs filed in, criminal cases brought pursuant to the FDCA.  That FDA enforcement sometimes results in prosecutions is something that comes up in our cases and posts, often in the context of preemption and primary jurisdiction—the FDA does not just have the authority to root out misbranded and adulterated medical products and fraud in connection with approval or post-approval reporting, but companies and individuals get prosecuted, so you should be comfortable respecting FDA’s authority, Your Honor.  It also comes up sometimes when there has been a prosecution that resulted in an indictment, plea, conviction, or sentencing memorandum that the plaintiffs want to use as evidence of something—or for issue preclusion—in a separate case.  When it comes to prosecutions based at least in part on manufacturers or their representative making statements about unapproved uses, we have an opportunity to see what FDA’s policy on off-label promotion really is these days and how it might affect behavior.  While we generally think manufacturers and their representatives try to follow applicable guidance documents, they definitely want to avoid being convicted.

Today, we take a look at two criminal prosecutions involving off-label promotion allegations, each of which has now been tried to a jury verdict.  In the first, the court denied all of the defendants’ motions in limine before the case proceeded to a defense verdict at trial. See U.S. v. Vascular Solutions, Inc., No. SA-14-CR-926-RCL, 2016 U.S. Dist. LEXIS 133717 (W.D. Tex. Jan. 27, 2016).  That opinion showed up in our searches recently, well after the acquittal of the device manufacturer and its CEO produced its own fall out, including a letter from Senator Grassley—hardly a known industry champion—to DOJ about prosecutorial misconduct.  The Vascular Solutions defendants were charged with misbranding (and conspiracy to misbrand) of its Vari-Lase device.  This device was cleared—the opinion says “approved”—for treatment of varicose veins, specifically, per the indictment’s allegations, superficial veins and not deeper perforator veins.  The U.S. contended that the company failed to seek an expanded indication and failed to provide revised labeling to account for the use of the device to treat perforator veins. Id. at *3.  Defendants filed various motions in limine based on the First Amendment and the definition of “intended use” in § 801.4.  We will discuss only two of them, particularly the government’s position.  The government announced that it would not “use promotional speech to doctors to prove the intended use of the devices for perforator vein ablation” to avoid the “possibility that the misbranding offenses criminalize promotional speech.” Id. at **6-7.  It planned, however, to use such promotional speech as an overt act in furtherance of a conspiracy.  The court agreed with the government that a lawful act, including constitutionally protected truthful commercial speech, could be used as an overt act. Id. at **7-8.

Continue Reading Update on Prosecution for Truthful Off-Label Promotion

Tell us that that the feds prosecuted a doctor for using a medical device off-label, and the hairs on the back of our neck start to rise and do the samba.  After all, off-label use can be good medicine, even the best.  Then tell us that the same doctor also faced the music for using an “adulterated” device and our knees grow weak.  The word “adulterated” gets thrown around an awful lot in the FDA regulations.  You (and most jurors) might think of the old Upton Sinclair investigative journalism reports about fingers turning up in tubs of margarine, but “adulterated” can also refer to technical issues, such as labels that do not say quite enough.   The recent case of U.S.  v. Kaplan, 2016 WL 4709870  (9th Cir. Sept. 9, 2016), is arresting because it makes us wonder whether good facts (Bad facts?  Weird facts?) might make bad law.

The defendant in the Kaplan case was a medical doctor accused of conspiring to violate 18 USC section 331(k) – using an adulterated medical device held for sale.  Like the semi-adequate federal prosecutor we used to be, let’s start with the factual headline:  this doctor reused single use prostate biopsy needles.  Think for a moment about how prostate biopsy needles are used, then think about the impact of expert testimony to the effect that cleaning single use needles would not do the trick, and that the needles became discolored after use.  Yuck.  Then think about the effect of evidence that the doctor started reusing the single use needles for purely economic reasons, that he did not pass any savings along to the patients, and that other people in his medical practice told him to stop reusing the needles.

Continue Reading Has the Ninth Circuit Criminalized Malpractice, Adulteration, and Off-Label Use?