Defense hacks. Homers. Biased. These are just a few of the labels we have applied to the authors of this Blog. While we recognize our leanings and strive to offer something more than just cheering a decision for the defense and jeering a decision for the plaintiff, we do see some cases as having an obvious right result, no matter how long it takes to get there. However, just because a case is from a “bad” jurisdiction does not mean that all the decisions will be bad. In Johnson & Johnson v. Fortenberry, No. 2015-CA-01369-SCT, 2017 Miss. LEXIS 421 (Miss. Oct. 19, 2017), the geriatric plaintiff was prescribed defendant’s antipsychotic medication for about two years before developing a mild oral tardive dyskinesia (something that had appeared with the second medication plaintiff had been on). This was the third medication that plaintiff took for her severe psychosis and it apparently worked well for her. Her prescribing physician was well aware of the risk of tardive dyskinesia with every antipsychotic at the time, considering that the medication had a lower risk of tardive dyskinesia and other extrapyramidal symptoms according to both the medical literature and defendant’s marketing materials. After pending for twelve years, the case went to trial in a notorious plaintiff-friendly jurisdiction before a similarly known judge. Plaintiff proceeded at trial on failure to warn and negligent misrepresentation theories and won a sizable compensatory verdict, although punitive damages did not go to the jury. An appeal and cross-appeal followed.

As we often do, we will focus on the parts of the decision that seem more relevant to us. First, the warnings claim. You may have already guessed that we think this should have been a slam dunk for the defense. You would be right. In addition to what we noted above about the prescriber’s knowledge and plaintiff’s medical course, the prescriber testified that specifically warned plaintiff and her daughter-caregiver (who later pursued the suit for plaintiff’s estate) of the risk of tardive dyskinesia and other extrapyramidal symptoms. Id. at *8. His awareness of the risk was consistent with the thorough warnings for tardive dyskinesia in the FDA-mandate class labeling for all antipsychotics, which he considered to be consistent with his understanding of the risk from other sources. Id. at **9-11. For plaintiff, the prescriber stood by his decision to prescribe the drug, noting “the psychotic symptoms which are terrible and unremitting and lead to very bad outcomes. And those are much more certain than the risks of possible side effects.” Id. at *19. Plaintiff attacked the class labeling as “cookie cutter” and the prescriber’s self-professed understanding of the risk as influenced by the marketing for the drug. Id. at **20-21.

The first question on appeal was whether the label itself was sufficient to warn of the risk of tardive dyskinesia. This was not a close call, as the “label unequivocally communicated the risk of tardive dyskinesia associated with the use of all antipsychotic drugs, including Risperdal.” Id. at *18. In addition, the prescriber “specifically testified that he considered the language of the Risperdal label adequate to warn him of the risk of tardive dyskinesia in Risperdal users at the time he prescribed it to Taylor.” Id. at **18-19. It does not appear that the plaintiff, despite an array of willing expert, had much to say about the adequacy of the label itself. This may have never featured in the trial court, but there would have been an obvious problem with saying that the defendant needed to change the class labeling to avoid liability—implied preemption. In this situation, the drug’s manufacturer could not have taken an independent action to change the already robust class labeling. That did not come up on appeal because the plaintiff argued that marketing undercut the actual content of the label. However, the Mississippi Products Liability Act limits the inquiry to the label itself and the Mississippi Supreme Court was unwilling to allow marketing evidence to be considered. Id. at **21-23. Thus, after fifteen years, an obviously flawed warnings claim—we have not even mentioned the obvious lack of proximate cause—went away.

The negligent misrepresentation claim was another matter, as marketing evidence counted. As an initial matter, the parties agreed that the focus on such a claim for a prescription drug was on the representations to the prescribing physician. From the summary of the evidence at trial, it does not appear that there was a specific representation ever made to the plaintiff’s prescriber that was proven to be false and relied upon in connection with plaintiff’s care. Instead, generic evidence purportedly showing that the manufacturer marketed the drug as having less of risk of tardive dyskinesia and other extrapyramidal symptoms than other drugs was not tied to the prescriber’s decisions with plaintiff. Id. at **26-32. There was no evidence that he saw any of the marketing pieces that plaintiff contended were misleading or acknowledged a specific representation that misled him.

Instead, plaintiff offered a less direct chain of purported proximate cause: 1) prescriber testimony that “I just remember the information about it, and I assume marketing as well as reading about it – I can’t always differentiate because I read journals and things, too – but all the information identified it as atypical and having fewer EPS side effects”; 2) his view from all sources was that the risk of tardive dyskinesia was lower with Risperdal than lower than with older antipsychotics; 3) that he probably would have prescribed another, unspecified medication if he believed the risk of tardive dyskinesia with Risperdal was actually equal to an older antipsychotic; and 4) expert testimony that plaintiff would not have developed tardive dyskinesia if she had been prescribed one of two other antipsychotic medications instead of switching to Risperdal. Id. at **26 & 33-37. For the court, this was enough to raise a jury question as to whether the marketing materials provided to the prescriber misrepresented “that the tardive dyskinesia risk was low and materially lower than the tardive dyskinesia risk from Haldol”—the drug plaintiff was initially prescribed, but not one of the drugs plaintiff’s expert said would have avoided her injury—whether the prescriber relied on such a misrepresentation, and whether it proximately caused plaintiff’s injury. Id. at **38-39.

Here are some problems with that analysis. For the same reason that an adequate pleading of a misrepresentation claim needs to include the who, what, where, and when of the representation, it is hard to see how a plaintiff can establish a misrepresentation without something more specific than what plaintiff offered here. Moreover, where the general representations to the prescriber were perceived as being consistent with what he understood from the medical literature and other sources, there does not seem to have been reliance on any misrepresentation. Any reliance also did not seem to result in the prescription to plaintiff, as the prescriber’s impression from medical literature also would have needed to have been different to affect the prescribing decision. Plaintiff’s evidence on proximate cause also did not seem to match up because the prescriber did not say he would have prescribed one of the two medications that plaintiff’s expert testified would have avoided her injury. That all does not sound like plaintiff established enough to get to a jury on a negligent misrepresentation claim, but, like we said, we might be a bit biased.

Part of why plaintiffs like misrepresentation claims is that they tend to be a better vehicle for punitive damages than failure to warn claims. Here, despite the broad evidence admitted on marketing, which plaintiff contended showed intent to justify punitive damages, the trial court did not let punitives go to the jury. Along the way, the court excluded the defendant’s guilty plea to allegations of improper marketing after plaintiff’s last prescription. Id. at *64. That is a correct decision, but still deserves some recognition. In Mississippi, the trial is supposed to evaluate all the evidence to see if a punitive damages claim should go to the jury. Id. at **65-66. Because the trial judge did that, the Mississippi Supreme Court affirmed. That deserves a little credit too.

 

It was over 32 years ago that we graduated from the University of Chicago Law School.  The three years in Hyde Park were a punishing experience.  There was one class in particular when Prof. Richard Epstein used the Socratic method to pummel our intellect and ego. By the end of the exercise, we were a puddle of incoherence.  The class was called Advanced Torts.  It is a bit funny that we today practice a form of Advanced Torts, even though Prof. Epstein long ago exposed our idiocy in the field.  But all is forgiven, if not quite forgotten, and we are grudgingly grateful for the hard lessons learned at his feet (from his vigorous kicking away at our preconceptions).  One of the things that Epstein did in that class was rip into the N.Y. Times v. Sullivan decision.  That case is usually thought of as one of the crown jewels of First Amendment jurisprudence, as it furnishes almost absolute protection to the press.  Basically, newspapers and other press media can skate past libel liability, no matter how false their publications, unless the press published with “actual malice” –  knowing the statement was false or acting in reckless disregard.   Epstein’s point was that while it was nice for the press that they would defend against most libel claims successfully, the state of mind inquiry was intrusive and complex, and the stakes involved, which could include punitive damages, were frighteningly high.  Such uncertainty and expense are not in society’s interest.  It sounds like heresy, but a simple standard of falsity, plus a cap on damages, would probably result in better outcomes and would certainly cabin discovery madness.

 

It occurs to us that punitive damages in mass tort cases suffer from the same, ahem, defect. Punitive damages require jurors to read the minds of corporate defendants, looking for bad intent or reckless disregard.  Conduct and documents that would otherwise be out of bounds for discovery and would never be paraded before the jury become fair game if punitive damages are available.  Moreover, due process considerations be damned, courts seem to permit jurors to flip around punitive damage figures in the tens or hundreds of millions of dollars as if they were nickels.  There is no consistency to the process.  One case might get halted by a judge who applies Daubert to preclude junk science, while another judge waves virtually the same case by and a jury socks the defendant with a $110 million verdict.  Or perhaps you have heard of jurors who conclude that the product did no real harm to a plaintiff, but are still sufficiently miffed at the company to award punitive damages.  It isn’t right. It makes no sense.  It probably won’t survive judicial scrutiny.  But the craziness happens.  No wonder our system of civil litigation looks like jackpot justice.  Pull the handle, watch wheels of inconsistent evidentiary rulings, inflammatory arguments, and jury lunacy spin, and see if the result is a shower of money.  If one pull comes up empty, never mind, keep pulling.  Whether or not you think the game is rigged, any rational defendant dragged into the courtroom casino knows it is a sucker’s game.  Better to pay a settlement and find the exit.

 

It turns out that we are hardly the only ones to rue the unfairness of punitive damages in mass torts.  A recent paper from the Cornell Law School  Legal Studies Research Paper Series (No. 17-33) by Cornell Law Professor James A. Henderson, Jr., “The Impropriety of Punitive Damages in Mass Torts,” dissects the issue nicely.   Other academics (think of Kip Viscusi) have exposed the wrongheadedness of punitive damages in mass torts, but Patterson’s paper is particularly compelling and timely.  He shows that punitive damages in mass torts are capricious, unfair, and unpredictable.  The joint justifications for punitive damages are retribution and deterrence.  But the retribution for any limited case at issue loses all sense of scale, and there is zero evidence that mass tort punitive damages actually improve corporate conduct or make anyone safer.  The problem is that the triggers for punitive damages, vague words such as “outrageous” that are meant to suggest “different levels of heinousness,”  are unclear to the point where jurors can do pretty much whatever they want.  That latitude is especially pernicious in the context of mass torts, where aggregation of claims is not just procedural, but substantive.  That is, the mass-ification of torts almost always prejudices the defendant by eroding defenses that would typically make the difference in a one-on-one case.  For certain industries, or whenever the government is involved, the law cheerfully dispenses with such niceties as fault, reliance, and causation.

 

Henderson takes us through some of the newer, non-traditional mass torts, such as asbestos, tobacco, lead paint, firearms, and no-injury economic loss cases where corporate defendants have been stripped of procedural and substantive defenses.  We’ve worked on a couple of these species of cases, and can vouch for the accuracy of Henderson’s analysis.  We’re by no means asbestos lawyers, but we once handled a couple of asbestos cases as a favor to a client.  We still occasionally bolt upright in the middle of the night, sweating from our memories of the asbestos docket call.  The client never manufactured anything with asbestos, but some of its products were later taken by a downstream manufacturer that placed some asbestos into the product before unleashing the products upon the populace.  The downstream manufacturer had shallow pockets, so the asbestos plaintiff lawyers added our client to the latest wave of defendants.  We proved to the plaintiff lawyer that our client had nothing to do with the asbestos, and the plaintiff lawyer shrugged and named some ludicrous figure for us to settle and get out of the case.  Sure – and then we’d be added to the asbestos sucker lists and face never-ending litigation.  We wanted to file a motion, but the insanity of the asbestos litigation “program” was that no defense motions would be considered until trial was only 30 days away.  Who wants to face that kind of brinksmanship?  Have you ever heard of the abomination called “near beer”?  Well, asbestos litigation is “near law.”  In fact, it is hardly law at all.  Rather, it is a system of taxing an unloved industry.

 

Viewing corporate conduct with hindsight, and assuming that corporations know everything and dwell purely on the bottom line, jurors are quick to reach for the spanking paddle.  That spanking means millions of dollars.  Risk averse corporate managers, and insurers worried about bad faith liability for failing to settle within policy limits, more often than not succumb to settlement blackmail.  The possibility of stratospheric punitive damages is simply a risk not worth taking.

 

Here are some other points that Henderson makes about punitive damages in mass tort cases:

 

  • Multiple successive punitive damages awards for the same alleged conduct are unfair to defendants.   (Maybe you could tell the jury that your company was already punished by another jury – but do you really want to do that?)
  • Any retribution is typically suffered by innocent, powerless shareholders, not the faulty managers.  Big surprise: expressing moral outrage toward corporations is unrealistic.
  • Punitive damages can deplete assets to the prejudice of later-filing plaintiffs.
  • Punitive damages are utterly unnecessary.  Large compensatory awards are more predictable and internalize social costs better than random punitive awards.

 

To quote a historical figure who clearly and devilishly believed in punishment, what is to be done?  Henderson mentions some marginal changes.  One idea is to require more specific triggers for punitive damages, such as criminal conduct (with a higher burden of proof).  Another idea, already existing in rare enlightened jurisdictions, is to let judges decide the amount of punitive damages.  It is well past time for courts to limit evidence of harm to that which was actually visited upon the particular plaintiff.  Henderson also discusses the possibility of limiting punitive damages to one case, which then creates a trust fund out of which later plaintiffs take their share.  But all of this is nibbling around the edges.  Henderson alludes to legislative changes, but seems pessimistic that our elected solons will ever risk displeasing a plaintiffs’ bar that is clever and promiscuous when it comes to slinging cash contributions to their favorite candidates.  That leaves the problem in the hands of judges, who will need to toss some troublesome precedents in the dustbin of history and start emphasizing the justice over the jackpot.

 

Henderson’s paper is clearly written and well-argued, and replaces our crankiness with a surfeit of citations.  It is well worth reading.

 

 

This post comes from the Cozen O’Connor side of the blog.

We’ve been following the Pinnacle MDL closely through the last two bellwether trials, starting with the news coming out of the second bellwether trial of particularly curious and prejudicial evidence being presented to the jury. Given that evidence, we expected a plaintiffs’ victory, an expectation that was borne out with a whopping $498 million verdict. It raised an immediate question: “What will the Fifth Circuit do?”

Well, we’re on our way to finding out. The defense recently filed their opening appellate brief. While it features the controversial evidentiary rulings, much more is in play. If you would like to take a look for yourself, here is the brief.  Below are some of the key issues, along with a quick description of the defense’s arguments:

Design Defect Claim against DePuy (Brief at 20-29): Claim that all metal-on-metal hip implants are defective is not viable under Texas law because a wholly different product cannot serve as a safer design; design claim is preempted because the FDA approved metal-on-metal hip implants; and design claim fails under Restatement (Second) of Torts 402A comment k (adopted in Texas), which recognizes that products like implantable devices are unavoidably unsafe and therefore not defective if properly made and warned about.

Continue Reading Briefing Underway in Appeal of Half-Billion-Dollar Verdict in Pinnacle MDL

This post is from the non-Reed Smith side of the blog.

We’ve put it off long enough – time to deal with the awful decision in C.R. Bard v. Cisson, __ F.3d __, 2016 WL 158814 (4th Cir. Jan. 14, 2016).  When we posted our 2015 Top Ten, we noted that we were watching Cisson because it had the potential to be among our top or bottom 10 of 2016.  Well, the top is definitely off the table and while it’s still early, the bottom is certainly in the running.

A quick background of the case.  Cisson is an appeal from the first trial in the massive Pelvic Mesh MDL.  Plaintiff underwent implantation of defendant’s pelvic mesh device and began experiencing pain.  Two years later, she had surgery to remove the device, but the “arms” of the device could not be removed.  Id. at *1.  In 2013, defendant won summary judgment on many of plaintiff’s claims leaving only design defect and failure to warn to proceed to trial.  Id. at *2.  The trial resulted in a plaintiff verdict, including a sizeable punitive damages award.  Id. at *1.

Continue Reading Fourth Circuit Flubs Admissibility of 510k Clearance

Back in 2009 – when the blog was still a Bexis/Herrmann operation – we wrote a catch-all punitive damages post entitled (oddly enough) “On Punitive Damages.”  That post identified and briefly discussed a variety of punitive damages-related issues, including what amount of increased risk is enough to justify an award of punitive damages under applicable state-law standards.  We pointed out a couple of Restatement sections, Restatement (Second) of Torts §§500, 908, that defined “recklessness” for punitive damages purposes in relation to a “high degree of risk.”

That’s an interesting question, because a product that increases the possibility of death or serious injury due to some particular risk from one in a zillion to two in a zillion has doubled the relative risk – but in absolute terms the increase is tiny.

Ever since that post we’ve been meaning to come back and examine that punitive damages issue in greater detail.  Today we finally get around to it.  Because doing the job right would require research well beyond prescription medical products, we looked for research help, and enterprising (pun intended) Reed Smith associate Kevin Hara stepped up to handle the initial spadework.  To put the question in the affirmative, can we defeat punitive damages, even where a relative increase in serious risk is high, where the absolute increase in risk remains minuscule?  What increase in the risk of injury enough to warrant sending punitive damages to the jury?  Is a one in 10,000, one in 5000 risk significant enough?  How about one in 1000?  One in 100?

Continue Reading Punitive Damages – How Much Increased Risk Is Enough?

We have not posted for a while—that day job can really get in the way sometimes—so we agreed to tackle the ridiculously long decision in Christiansen v. Wright Med. Tech. Inc., MDL No. 2329, 1:13-cv-297-WSD, 2015 U.S. Dist. LEXIS 115601 (N.D. Ga. Aug. 31, 2015), as a bit of penance.  This act may be appropriate given the recent Day of Atonement and, much like long Yom Kippur services during a fast, the decision drags on, repeats itself, has some highs and lows, and maybe induces some confusion and a touch of a headache.  While we are not looking for a scapegoat, some of the reasoning for why the issues were presented how they were presented and why they were decided is lost on the reader, at least this reader.  (Much like the original meaning of Azazel, to where/whom the original scapegoat was to be sent by Aaron.  Or maybe not at all like that.)  As a combination Daubert and summary judgment order on a bellwether case from an MDL for a product, a metal-on-metal hip implant, for which there is considerable litigation on similar products made by other manufacturers, there will likely to attempts to extend various parts of this decision to other cases.  So, we will resort to the dreaded use of subheadings in discussing it.

Background

Plaintiff had a left hip replacement in 1995 with a device that used a ceramic femoral ball, a polyethylene liner, and a metal acetabular shell.  In 2006, plaintiff had her right hip replaced with the defendant’s product, which utilized a ball and cup each made of cobalt-chromium with no liner.  In 2012, plaintiff started experiencing pain in her right hip and, within a week, had a revision surgery where the defendant’s product was explanted (and presumably something else was implanted).  All three surgeries were done by Dr. Lynn Rasmussen, who happened to have been consulting with defendant on designing hip implants in between the second and third surgeries.  In doing the third surgery, Dr. Rasmussen observed what he called “metallosis” (sometimes “metalosis” in the records and briefs), but did not send any explanted tissue or material for pathological evaluation.  Plaintiff sued under a range of product liability theories based on the risk of “metallosis.”  Thereafter, plaintiff named at least ten experts to weigh in on causation and defect in some form or other, most of whom relied to some degree on Dr. Rasmussen’s characterization of what he saw—and defendant filed a bunch of Daubert motions.  Plaintiff filed a “motion for partial summary judgment” that preemption and the learned intermediary doctrine did not apply to her claims and, at the court’s request, the defendant filed a motion for summary judgment on all the claims that plaintiff did not drop.  An affiliated defendant also filed for summary judgment on different grounds.  There were some other motions we are ignoring, but everything was addressed in one big decision.

Continue Reading Making Sense of the Daubert and Summary Judgment Orders in A Metal-on-Metal Hip Implant Bellwether Case

This post is from the non-Reed Smith side of the blog.

It can be difficult to have a completely consistent position on choice of law issues.  That’s because state law varies and sometimes you’ll find you are better served by the law of the forum state, other times by the law of the plaintiff’s home state, and sometimes by the law of the defendant’s home state. The issue, the facts, and the law all drive the parties’ preferences.

Typically, however, we tend to favor the notion that liability issues should be governed by the law of the plaintiff’s residence.  That is where the alleged treatment and injury occurred, and those factors are important in any choice of law analysis.  Such a rule also imposes some limit on blatant forum-shopping by plaintiffs.  But what law should apply to punitive damages?  This is where things can get a little fuzzy.  On punitive damages, the balance of interest between plaintiff’s residence and defendant’s residence is more even – making the analysis trickier and also affording more opportunity to craft an argument for the law of the state that is more defense-friendly.

Continue Reading Role Reversal – Plaintiff Asks for New Jersey Punitive Damages Law

Last month, we described the proposal by the American Bar Association’s Standing Committee on Medical Professional Liability concerning legislation on “defective medical products” and punitive damages for “patient harm allegedly caused” by them.  Over the last month, we have seen statements issued by a number of professional groups urging the ABA Delegates to reject the proposal.  We wanted to share these statements with our readers, who may be affiliated with some of these groups and/or may want to weigh in directly.  They come from AdvaMed, the ABA’s Products Liability Committee, PhRMA and the U.S. Chamber Institute for Legal Reform, and an alphabet soup of DRI, IADC, PLAC, the Federation of Defense & Corporate Counsel, the Association of Defense Trial Attorneys, and Lawyers for Civil Justice.  Feel free to forward us other oppositions so that we may post them to facilitate sharing and hopefully help defeat a truly bad proposal.

***

We later got the attached from the New Jersey Civil Justice Insitute.  We have heard of others in the works and will add them here as we get final copies.

Most of us are members of the American Bar Association.  Some of us are more active than others.  At one extreme, Bexis has been in what the ABA calls “leadership,” as editor of the Mass Torts Newsletter, for some 15 years.  While some ABA committees, such as Bexis’ Mass Torts, pursue a consensus approach to plaintiff/defendant issues, evidently others do not.

In particular, we’re concerned about blatant pro-plaintiff bias in an ABA committee we frankly hadn’t heard of before the other day, called the Standing Committee on Medical Professional Liability.  We looked it up.  That Committee’s “responsibilities” are stated in §37.1 of the ABA’s Constitution & Bylaws:

(a) To review pending and future proposals relating to medical professional liability in
light of existing ABA policies;
(b) To identify policy areas, if any, as to which new policy is needed; and
(c) To serve as a focal point for activity within the ABA on issues relating to medical
professional liability.

Id. page 40.

That seems neutral enough, but that is not how the nine members of this Committee views its mandate. Simply look at that Committee’s webpage, where it describes itself as “devoted to preserving and protecting the legal rights and remedies of persons injured while obtaining medical treatment.”  If this Committee gives a damn about the “rights” of defendants in such litigation, or about the system itself, it doesn’t appear on the website, which is limited to a diatribe (read it yourself – it’s under “malpractice resources” of all things) against medical malpractice tort reform.  Ordinarily we would shake our heads, but not care that much, but for that Committee’s latest frolic and detour – a draft resolution (#105) seeking to put the ABA on record as supporting unlimited punitive damages against our clients in products liability actions.  We quote the Committee’s current proposal in full:

RESOLVED, That the American Bar Association urges the federal government to adopt laws that protect patients and promote patient safety from defective medical products.
FURTHER RESOLVED, That the American Bar Association opposes legislation that limits and/or bans punitive damages for claims of patient harm allegedly caused by manufacturers of FDA-approved medical products or devices.

ABA Draft Resolution 105 (emphasis added).  Once this Standing Committee opted to exceed its explicit “medical professional liability” mandate and start offering its views about “FDA-approved medical products,” we here at DDLaw stood up and took notice.

We think our readers should stand up and take notice, too.  As of this point, this one-sided piece of malarkey will be on the agenda for consideration by the ABA House of Delegates at its meeting in Chicago on August 3 or 4, 2015.  That’s right, a 9-member standing committee can propose something extremely biased to the House of Delegates that would never pass muster in the much larger and more diverse ABA organs, such as the Sections on Litigation or Torts & Insurance Practice.  But that doesn’t mean it will pass, and that’s where our readers come in.

It doesn’t take a rocket scientist to figure out how this happened.  We googled the Medical Professional Liability Committee’s membership.  Almost half (4) appear to be plaintiff-side malpractice litigators.  Two appear to be defense-side malpractice litigators.  The other three are harder to classify, but they all share one thing in common – none of them represents our clients in product liability actions.  Not one, that we could tell.  The result, draft Resolution #105, could well be (depending Committee voting rules, which we don’t know) the ABA version of what all too often happens in the litigation of medical malpractice actions.  The plaintiff gets together with the malpractice defendant(s) to point the finger at the manufacturer of a prescription medical product that the plaintiff originally claimed was mishandled by his/her new defense-side collaborators.

As of the last time we looked, several states (AZ (A.R.S. §12-7010, NJ (N.J.S.A. §2A:58C-4), and UT (U.C.A. §78B-8-203(1)) as well as the federal Vaccine Act (42 U.S.C. §300aa-23(d)(2)) statutorily bar punitive damages where the product has obtained FDA approval.  Many other states either reach the same result through the common law, or have other statutory provisions that include prescription medical products within more broadly phrased protections against punitive damages, such as mandatory caps or ratios.  These statutes are eminently necessary to protect our clients from unconstitutional excesses.  See, e.g., In re Actos (Pioglitazone) Products Liability Litigation, 2014 WL 5461859, at *54-55 (W.D. La. Oct. 27, 2014) (absent any statute, reducing an absurd ($9 billion) punitive damages award to a still-ridiculous 25-1 ratio).

Thus, we urge our readers to take action.  If you know either your state ABA delegates, urge them – strongly – to vote against this biased resolution.  Better yet, if you know people who are active in more diverse ABA entities, such as Litigation, TIPS or the open-to-all membership committees, urge them to put their organizations on record in opposition to Resolution #105.  If that happens, it is possible that this one-sided resolution will never get to the point of being voted on at all.

“We’ve seen this movie before.”  That is something people say when they encounter something that seems simultaneously dreadful and predictable.  That is how we felt upon reading the latest dismal opinion out of the Drake Botox litigation in Vermont federal court.  We’ve blogged about this case several times before, bemoaning the blundering approach taken towards the learned intermediary, heeding presumption, and Daubert doctrines.  The result was that the jury heard all the wrong stuff in this case.  An avalanche of improper evidence swept over the jury box, and the plaintiff walked off with $2.7 million in compensatory damages and $4 million in punitives.  The defendant filed post-trial motions for judgment as a matter of law and, in the alternative, for a new trial.  The result was nothing if not consistent: a reiteration of earlier, rotten rulings and denial of the defendant’s post-trial motions.  You can read the bad news here:  Drake v. Allergan, Inc., 2015 U.S. Dist. LEXIS 66932 (D. Vt. May 22, 2015).

In our earlier posts we tried to say something nice about Vermont.  For instance, in 1777 it independently declared its independence from Britain and remained a separate “Vermont Republic” for 14 years before joining the union.  These days, it has a socialist senator with ambitions to be president.  But mostly, we stuck to the theme of cheese.  Sometimes we
mentioned other fine dairy products from Vermont.  That reminds us of a recent discussion we heard about what the world would be like if every man had to be named John.  You might think such a discussion is frivolous, but you’d be wrong.  It makes at least as much sense as the opinion we’ll be perusing today.  Be that as it may, perhaps the most profound
consequence of the John-only rule would be that Ben & Jerry’s ice cream would be called John & John’s.  How’s that for counterfactual scenarios that make you reconsider your worldview?

Today, we decided to go a different route.  We looked for movies that were set in Vermont, or at least had some connection to the Green Mountain State.  An odd pattern emerged.  For example, consider Mr. Deeds Goes to Town.  That Capra classic is about a rich yokel who visits New York City, handles the boozing and partying badly, tries to give away his money, and ultimately faces a commitment hearing.  Two spinsters from his Vermont hometown testify against him.  They say Mr. Deeds is “pixillated.”  On cross-examination, it turns out that these biddies believe that everyone is pixillated, including the judge.   Somewhat less classic and not nearly as good as Mr. Deeds Goes to Town was Funny Farm, a ‘comedy’ about a couple whose misadventures on a Vermont farm turn out to be everything but funny.  Chevy Chase had already entered his pointless mugging phase, and the movie is a perfectly miserable way to waste 101 minutes of your life.  But at least no one tells you that Funny Farm is any good.  By contrast, lots of people praise Dead Poets Society, even though it is purely pretentious twaddle.  Robin Williams plays a new poetry teacher (his name is Keating for crying out loud) at a Vermont prep school that is curiously full of future film and tv stars (Ethan Hawke, Robert Sean Leonard, Josh Charles, etc.)  There is a nice clue to the movie’s stupidity in the fact that the rallying cry is “O Captain, My Captain,” surely the worst poem Whitman wrote.  Teenage narcissism is never pretty, and Dead Poets Society wallows in it.  We end our tour of cinematic Vermont with a couple of Hitchcock’s lesser known efforts.  Spellbound was largely set in a Vermont insane asylum.  It is most famous for a dream sequence assembled by Salvador Dali.  Hitchcock’s personal favorite among all his movies was The Trouble With Harry.  Harry causes trouble by turning up dead in the Vermont countryside.  Nutty locals play a weird game of moving the body for no good reason.  The rubes exhibit a disquieting disinterest about disinterment.

A commitment hearing, a funny farm, neurotic adolescents, an insane asylum, and bucolic eccentrics.  Bernie Sanders.  Wyeth v. Levine.  On this evidence, we think that the two senior citizen witnesses in Mr. Deeds Goes to Town might be on to something:  everybody in Vermont really is crazy.  The Drake case is merely cumulative evidence on this point.

If you require a reminder about what happened in the Drake case, here goes.  The case was brought by parents on behalf of their son.  The son had cerebral palsy.  His doctor injected Botox into the boy’s calves to treat lower limb spasticity.  The law suit claims that these injections caused the boy to develop a seizure disorder.  After a thirteen-day trial, the jury found the defendant negligent and found that punitive damages were warranted.  One of the key plaintiff witnesses in the case was Dr. Hristova, who testified about medical causation.  One piece of evidence on which Dr. Hristova relied was a study that the defense lawyer thoroughly discredited during cross-examination.  The trial judge concluded that even though the plaintiff expert’s main support had been undercut, a reasonable jury could conceivably have found that Botox caused the seizures because Dr. Hristova relied on the “totality of circumstances.”  Those circumstances included seizure rates in clinical trials, a study, adverse event and anecdotal reports, biological plausibility, theoretical mechanisms of action, an FDA guidance, the Botox label, the temporal connection between Botox usage and the seizures, and the lack of an alternative explanation.  The court acknowledged that no single piece of this evidence would necessarily have been conclusive in isolation, but “together it paints a picture sufficient to support the jury’s finding on medical causation.”  That’s like saying that seven Vermont cowpies smell sweeter than one.  If any picture is being painted, it is a picture of a court letting pretty much everything in that the plaintiffs wanted, and then letting the jury do anything it wanted.

The case was about a failure to warn.  To borrow an overused phrase, the issue was what did the defendant know and when did it know it?  And what, exactly, did it fail to tell the doctor?  The evidence in the Drake case is astonishingly weak.  There was “evidence suggesting that the overall rate of seizures in Allergan’s clinical trials was higher in Botox groups than in placebo groups and that Allergan may have selected favorable data to make this fact less obvious in its reports to the FDA.”  That is not only speculative, but it seems to run afoul of Buckman preemption.  As the court phrases it, it sounds as if the failure to disclose arose from the company’s  communications with the FDA that, at least according to the plaintiffs, were less than candid.  That is a claim of fraud (if you could even call it that) on the FDA.  But such fraud would be for the FDA to pursue, not plaintiff lawyers masquerading as Green Mountain Boys.

And, anyway, what does that purported hoodwinking of the FDA have to do with the doctor’s decision to use Botox?  If you read our prior posts on the Drake case, you know that the treating doctor never-ever said that a different warning would have changed his risk-benefit calculation.  The doctor also said that such calculation was based on his own training and experience, not on anything the manufacturer said or did not say.  The judge did not care.  Even if the jurors believed the doctor’s testimony that he relied on his training and experience, “they could have nevertheless relied on a variety of evidence to conclude that Allegan’s promotional efforts over the years also played a substantial part in Dr. Benjamin’s choice to treat J.D. with Botox and to select the dose he administered.”  That is, the court speculated that the jury could have speculated about how promotional efforts could have somehow impacted the doctor’s decision, even if the doctor disclaimed such impact.  To be fair, the court would probably reject our characterization of this ‘reasoning’ as mere speculation.  After all, the plaintiffs had presented evidence that the defendant’s employees “had direct contact with Dr. Benjamin during two separate time periods.”  Not just contact, but direct contact.  Wow.  But where is the evidence that the nature of such contact amounted to fraudulent understatement of risk?  It gets worse.  The court also speculates that the “jury also could have reasonably inferred that doctors may be influenced by drug promotion but may not be consciously aware of how the promotion has influenced their behavior.”  Yikes.  Now the court is piling speculation on top of speculation.  We’re almost in the nutty world of subliminal advertising (which, by the way, has been as thoroughly discredited as Dr. Hristova’s basis for her medical causation opinion).  Was there any support for the notion that company promotions can overcome a doctor’s will without that doctor knowing it?  Of course there was, if you believe the testimony by plaintiff super-expert Dr. David Kessler, who “described a study by the World Health Organization and  Health Action International finding promotion influences attitudes more than doctors realize.”  Did Dr. Kessler tie that study to the treating doctor in this case?  We do not know.  And we bet that, as far as this court was concerned, it does not matter.

The court pointed out that the plaintiffs elicited testimony suggesting that the defendant affected medical literature in various ways, including the inevitable “ghost-writing.”  It does not sound as if any of these allegedly tainted publications (by the way – were they shown to be actually wrong?) were connected to the treating doctor’s decision.  The most that the plaintiffs’ lawyer could force the treater to say was that the defendant had “been a part of all the experiences, influence, and training he has had”  (undoubtedly true – but you could say the same thing about medical school, the evening news, the epic pronouncements of Dr. Kessler, and plaintiff lawyer ads), and that all of that together “would have had some influence in general over the practice.”  That isn’t causation, that is pantheism.  It has all the coherence of a Phish jam.  Nevertheless, the court tells us that the jury “could have inferred” that the defendant’s promotion activities influenced the doctor’s “dosing choices, whether consciously or unconsciously.“  Maybe the jury was influenced by the babblings in Dead Poets Society.  We don’t know.  We’re just guessing.  If you read the Drake opinion half as closely as you would read a Whitman poem, you’ll notice that almost every paragraph is heavily dosed with the word “infer.”  Substitute the word “speculate” for “infer” and you
will have a much more accurate appreciation for what this decision hath wrought.

Such judicial tolerance for speculation supports both the compensatory and punitive awards.  As an initial matter, the court acknowledges that the  Vermont Supreme Court jurisprudence on punitive damages “has not been a model of clarity.”  Luckily, this federal court will inject clarity and rigor into the topic, right?  Wrong. The plaintiffs were required to prove that the defendant’s conduct was outrageously reprehensible.  The court then alludes to the defendant’s 2010 guilty plea regarding off-label promotion.  That seems like dirty pool, given how fragile those governmental prosecutions for off-label promotion were.  To the extent they were premised on the False Claims Act, the causation theories had the consistency of maple syrup – a sticky mess.  And to the extent that the first amendment still exists in this country for commercial speech, the prosecutions were probably unlawful.  See United States v. Caronia, 703 F.3d 149 (2d Cir. 2012). But nobody wants to play chicken with the DOJ, so it is better to pay up than risk debarment at most or agency hostility at best. In any event, connecting the conduct at issue in the guilty plea with the particulars of the Drake case is another exercise in sheer speculation.  Almost to the point of monotony, the court tells us that the jury “could also have inferred Allergan’s promotional efforts reached Dr. Benjamin….  The jury also could have inferred Dr. Benjamin was influenced by [a website promotion] because he testified that he referred to their website in his practice and had seen the dosing schedule before.”  That is a lot of speculating – err, inferring – to get one to not quite proving any point, much less a point that would support punitive damages.  But the court concludes that a “reasonable jury could have felt morally outraged by a corporation’s desire to put its bottom line above children’s health, safety, and even lives.”   That line would  have fit snuggly into the plaintiff’s closing argument.  Heck, we’ll infer that it’s in there.

John & John’s — oops – Ben & Jerry’s offers a sundae called the Vermonster.  It consists of 20 scoops of ice cream, four bananas, and layers of brownies and other sweets.  Now replace those goodies with turnips, guano, and glass shards, and you’d have the sort of Vermonster that the federal court whipped up in the Drake case.  But let’s be realistic.  After all sorts of wrong, wretched evidentiary decisions, after having sat through a 13 day trial, and after hearing a jury deliver a Vermont spanking to an out of state corporate defendant, what are the odds that the court would own up to mistakes and fix things?  It sometimes happens, but it is darned rare.  That’s why we have appellate courts — such as the Second Circuit, which decided Caronia.