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.

It is the time of year for reflection and resolutions. We look back on the ups and downs of the year that is about to end and look forward to the New Year with hope, promises and predictions.  As for 2015 here at the DDL Blog – we hope we will continue to be helpful and informative to our readers, we promise that Bexis will find at least one decision a quarter worthy of a full-blown tirade, and we predict that McConnell will keep us up-to-date on both legal trends and what’s hot on TV and at the movies.

As for 2014, Bexis is posting his annual Best Of and Worst Of lists.  Keeping with that theme, we decided to post about a case that has some of both, the good and the bad.  The case is Brown v. Johnson & Johnson, 2014 U.S. Dist. LEXIS 173800 (E.D. Pa. Dec. 9, 2014) and it involves the over-the-counter drug Children’s Motrin.  Wanting to end on a high note, we’ll dispense with the low points of the decision first.

First up, the preemption rulings.  The court held that plaintiff’s failure to warn claim was not preempted because the defendant had not shown that it could not have used the CBE process to change the warning label.  Establishing warning preemption in a drug case is an “exacting burden” for defendants requiring clear and convincing evidence that the FDA would have rejected the warning proposed by plaintiff.  Id. at *2-3.  The court applied the same “exacting burden” to defendant’s design-related preemption defense, finding a lack of evidence that the FDA would have rejected a proposed design change as well.  Id. at *6.

Continue Reading Celebrating the Highs and Lows

Holism is a concept modernly used most commonly in medicine –treating both the body and the mind.  We don’t see it too often in legal parlance as it’s come to be associated with a somewhat touchy-feely approach.  Not something litigators are often accused of being.  At its core, holism is a philosophy based on treating something as more than the sum of its parts.  So when we read in Schmidt v. C.R. Bard, 2014 U.S. Dist. LEXIS 146459 (S.D. Ga. Oct. 14, 2014) that on a motion to dismiss, the judge was “[r]eading Plaintiff’s Complaint holistically,” we were fairly sure we weren’t going to be happy with the results.  And we were right.

A holistic approach to pleadings is precisely what TwIqbal aims to prevent.  Either the complaint contains sufficient and specific factual allegations that go beyond speculation and legal conclusions or it doesn’t.  Using the TwIqbal standard, a complaint is only as good as its parts; its allegations. You can’t fix bad pleadings by reading into them more than what is there.  But we think that is exactly what the court did in this case.

The suit involves the implantation of a mesh device to repair a hernia.  Plaintiff ultimately had to have the device removed and alleges permanent injury as a result.  Id. at *1-2.  Assessing whether plaintiff sufficiently pleaded a design defect claim, the court starts off with a general statement we support:  “a bald assertion that the [device] was defective in design . . ., was unreasonably dangerous, and the foreseeable risks outweighed the [] benefits would be insufficient to survive a motion to dismiss.”  Id. at *8.  But then the court goes on to conclude, and repeatedly state, that plaintiff listed 9 possible design defects and therefore survives a motion to dismiss.  The court never identified what those 9 “defects” were, so we looked at the complaint ourselves.

Continue Reading Georgia Court Takes a Holistic Approach to Pleading

From our ivory tower in the kingdom of blogdom, we track cases and litigations from afar, peeking in on them from decisions rendered at specific points in time.  Sometimes, from a single decision, we venture on what will happen next, like whether claims that survived dismissal will make it past summary judgment or whether a judgment will survive appeal.  Other times, we look at multiple decisions in the same case or litigation and make a somewhat more intelligent guess as to where things are headed. Every once in a while, we have looked at several pre-trial rulings from the same case that consistently favor one side or position that it is fairly easy to guess what the judge will do at trial. What the jury will do is always less predictable.

In In re Actos (Pioglitazone) Prods. Liab. Litig. (Allen v. Takeda Pharms. N. Am., Inc.), MDL No. 6:11-md-2299, No. 12-cv-000064-RFD-PJH, 2014 U.S. Dist. LEXIS 121648 (W.D. La. Aug. 28, 2014), we have the culmination of several bad decisions. Back in January, we questioned the court’s rejection of conflict preemption for failure to warn claims in the absence of evidence that the FDA had rejected a request to strengthen a warning of an approved drug.  We also suggested that the court’s requirement of only a prima facie showing by the plaintiff allowed it five experts to stroll through the Daubert gate without any real challenge by its purported keeper.  Later, we have posted on rulings on spoliation and a request for default judgment because a witness answered “I don’t know” a number of times. Along the way, we noted that the first MDL bellwether trial had resulted in a very high plaintiff verdict with lots of punitive damages thrown in.  After several months, the court has now ruled on the defendants’ Rule 50(b) motion made during trial and re-urged after the verdict.  In a surprise to nobody following the case, the court denied the motion in its entirety.  And nobody who follows this blog will be surprised to hear that we think that the decision was wrong and that the reasoning of the opinion was lacking.

We start by what the reader will not find in the opinion—what the jury awarded to the plaintiff.  That was $1.5 million in compensatory damages and $9 billion (with a “b”) in punitive damages.  While there is plenty of discussion of money in the opinion, the profits from the sale of the drug and how profits allegedly motivated the NDA holder and co-marketer to take various actions concerning the drug and its bladder cancer risk, but nothing about what the jury awarded, whether it bore any relation to the evidence, or whether it provided any basis to suspect that something had gone wrong with the trial.  While the opinion did not address any challenge to the amount of the punitive award—just to whether there was sufficient evidence to support any award (particularly against a mere co-promoter)—it does seem strange to omit the amount of the award from a very long decision.  It also seems weird that the court repeatedly expressed its misgivings about having to address issues it had addressed in different procedural postures when, as it said, the “jurisprudential support” had not changed. This is, of course, how the Federal Rules of Civil Procedure work.  A motion to dismiss may be followed by a motion for summary judgment, which may be followed by motions for judgment as a matter of law during and after trial, all of which may address the same issue (e.g., preemption) without the controlling law changing.  Much like the analysis of whether the amount of punitive damages comports with constitutional requirements involves looking at proportionality in regard to the amount of actual damages, there is some notion that very jury large awards, jury decisions involving many plaintiffs, and even defense verdicts in cases where the plaintiff had substantial injuries should receive extra scrutiny from the presiding judge.  An opinion that conveys a sense of anger at some of the parties (or their lawyers) or a reluctance to consider all the arguments at face value does not increase confidence in our civil courts.

As we have said, the opinion is quite long, in part because it recaps the plaintiff’s version of the evidence he offered in more than two months of trial.  We are not in a position to begin to question whether the evidence was as described in the opinion, but a few things are obvious from reviewing the recap and how it is used.  First, lots of evidence came in that was focused solely on whether defendants defrauded the FDA.  Second, lots of evidence came in that blurred the lines between which defendant did what and when they did it in relation to when plaintiff was prescribed the drug. Third, although Dr. Kessler was plaintiff’s mouthpiece for why the label should have been changed earlier and how discussions with FDA on labeling should have been different, there does not appear to have been any evidence that the label could have been changed unilaterally or that FDA would have acceded to the labeling change plaintiff urged. Fourth, in discussions about what the co-marketer’s sales representatives did not say, there was no attention to whether the additional information that plaintiff urged could have been legally disclosed before the label had changed.  These observations tie in to the court’s ultimate rejection of the defendants’ preemption and punitive damages arguments.  There is certainly more to the opinion, but we can only address so much in one post before the Oscar wrap-it-up music starts playing in our head.

We would be remiss if we discussed the rejection of defendants’ preemption and punitive damages challenges without noting that the opinion does not mention Buckman, which held:

[T]he plaintiffs’ state-law fraud-on-the-FDA claims conflict with, and are therefore impliedly pre-empted by federal law. The conflict stems from the fact that the federal statutory scheme amply empowers the FDA to punish and deter fraud against the Agency, and that this authority is used by the Agency to achieve a somewhat delicate balance of statutory objectives. The balance sought by the Agency can be skewed by allowing fraud-on-the-FDA claims under state tort law.

531 U.S. 341, 348 (2001). This ruling was not based on the express preemption provisions of the Medical Device Amendment and has been applied to drug cases fairly often.  See, e.g., Garcia v. Wyeth-Ayerst Labs., 385 F.3d 961, 965-966 (6th Cir. 2004); Bouchard v. American Home Prods. Corp., 213 F. Supp. 2d 802, 811 (N.D. Ohio 2002). Even from an account of the evidence that is avowedly from plaintiff’s perspective, the plaintiff’s case was about as focused on whether defendants had defrauded the FDA as any we have seen since Buckman.  Deciding issues of preemption and punitive damages without addressing whether plaintiff was advancing fraud-on-the-FDA claims, however he titled them, makes no sense to us.  Indeed, the opinion’s repeated citation of plaintiff’s evidence that allegedly showed defendants had concealed relevant information from the FDA as a justification for why there was no preemption of claims or why plaintiff could recover punitive damages against both defendants just reinforces that these were fraud-on-the-FDA claims that should have been preempted.

As we have said many times, a conflict preemption analysis should start with identifying whether there is a properly asserted and supported claim under a recognized state law theory of recovery and what the regulated defendant needed to do to comply with the state law duty.  Then, the analysis should go on to whether the defendant can comply with the state law duty while simultaneously complying with its federal duties.  (There are many in-depth discussions of preemption principles in prior posts, including this one on Bartlett, another Supreme Court preemption decision not discussed in the opinion.)  In analyzing whether the claims asserted against the co-marketer were impliedly preempted, the opinion neither cites the state law providing for such a claim nor what plaintiff contended the co-marketer was supposed to have do meet its state law duties.  2014 U.S. Dist. LEXIS 121648, **69-79.  In fairness—we do want to be fair sometimes—there are cites in two other sections to a single intermediate appellate decision “that visits liability on companies . . . that are responsible for placing a drug into the marketplace.”  Id. at **59 & 175 (citing Brumbaugh v. CEJJ, Inc., 152 A.D.2d 69, 71, 547 N.W.S.2d 699 (N.Y. Sup. Ct. – App. Div. 3d Dept. 1989)).  That is not the same thing as saying the state law imposes duties on co-marketers, the breach thereof can result in liability for failure to warn and implied warranty of merchantability, the two claims plaintiff apparently advanced at trial. Similarly, for all the citation to plaintiff’s evidence that the co-marketer did not disclose the true risk of bladder cancer in the years before the FDA-approved label did (from plaintiff’s perspective), there is nothing in the opinion saying what an adequate warning would have been.  This matters because the opinion’s analysis of preemption boiled down to whether the co-marketer was precluded by federal law from conveying to physicians “any information or warning language beyond the actual language included on the insert label approved by the FDA.”  Id. at *70.  Concluding that the regulations afforded some leeway to present marketing materials that were different than, but still consistent with, the approved label, and pointing to evidence that the co-marketer consulted with the NDA holder on the label and did have some marketing materials that were different than the label, the court found no preemption.  This is not the right inquiry.  Did state law impose a duty on the co-marketer to provide physicians with information about the risk of the product?  If it did, then  could the co-marketer have complied with federal requirements of keeping marketing materials and statements consistent with the approved label while including whatever extra-label statements about a bladder cancer risk that the plaintiff urged? Those are the questions that should have been answered.

The opinion’s consideration of the broader preemption challenge made by both defendants followed a similar pattern. The issue was whether FDA would have approved the labeling change that plaintiff urged—whatever that actually was—before plaintiff allegedly developed bladder cancer from using the drug.  This would be evaluated under the singular “clear evidence” standard from Levine, but with a free hand for plaintiff to ignore Buckman and contend that defendants kept FDA in the dark on the risk of bladder cancer.  Defendants had evidence that FDA determined, in the year plaintiff started the drug and the co-marketer stopped co-marketing it, that a bladder cancer warning belonged in the Precautions section of the label, did not request a revision upon receipt of study data three years later, and only approved a label with information on bladder cancer in the Warnings section two years after that. Plaintiff countered with evidence that the defendants allegedly withheld information from the FDA and that defendants negotiated with FDA over the label, but nothing about whether the FDA would have approved the warning plaintiff wanted when plaintiff wanted them.

In weighing this evidence, the court seemed to endorse the ludicrous notion, advanced by Dr. Kessler, that language in a drug label about a risk of the drug does not count as a “warning” (a state law concept) unless it is in the “Warning” section of the label.  Id. at **47-48; but see id. at *168 (“The Defendants are, however, correct that New York law does not require a warning to be located in the “Warnings” section of a medication label in order for the warning to comply with the duty to warn individuals considering taking the medication, or physicians considering prescribing the medication.  However, [plaintiff says none of the information about bladder cancer in the label should be considered a warning].”). Setting aside how the format of drug labels changed during the time at issue in this case due to the Physician Labeling Rule so that the old “Warnings” and “Precautions” sections have been merged into one section called “Warnings and Precautions,” this is just a naïve view prescription drugs.  Language in other sections of drug labeling, like Contraindications, may be key to individual prescribing decisions and the focus of allegations by product liability plaintiffs.  In addition to this misimpression, the opinion ignored the possibility that the FDA would ever find a proposed warning to be excessive in light of the scientific evidence available.

Finally, in light of the evidence pointed to by Plaintiffs as presented at trial, this Court cannot find Defend-ants’ argument that the FDA, had it been presented with a complete, accurate, and forthright description of the evidence, would have chosen to hide from the medical community and the general public the possibility of an increased risk of the very serious side effect of bladder cancer by not allowing the very warning they made overture to explore, persuasive.

Id. at *85 (emphasis in original).  We could go on, but we think you get the gist.

The rejection of all arguments as to the punitive award (amount hidden from the reader) built on the evidence of fraud-on-the-FDA and of the defendants failure to do things they may not have been permitted to do by applicable regulations.  It also looked to evidence of what you read as general alleged “bad conduct” evidence not tied to the underlying theories of recovery, which is generally frowned upon when it comes to punitive damages.  On top of this morass of evidence that the court stated (several times) showed that the defendants intentionally picked profits over safety, the jury got to hear about the alleged spoliation of records by the NDA holder, which we have already said mostly involved missing from sales representatives who left the company five or more years before the litigation started. The NDA holder’s “conduct in destroying files of key employees involved in the development, marketing, and management of Actos® could be one fact the jury might have considered in assessing Takeda’s intent.”  Id. at *179 (emphasis in original).  The jury was also, apparently, permitted to infer something about the co-marketer’s intent from this “fact.”  There was nothing wrong with that, because the co-marketer had apparently not requested a limiting instruction when the jury was informed of court’s view on spoliation.  Id. at **180-81.  The court took no responsibility for informing the jury of spoliation by one defendant without making it clear that the other defendant was not implicated.

We will have to wait and see if the court can find some way under Rule 59 (motion still pending) to justify a punitive damages award that was 6000 times higher than the actual damages award.  We will also have to wait and see what, if anything, the Fifth Circuit has to say about all of this.  We do know its decision in Lofton v. McNeil Consumer & Specialty Pharms., 672 F.3d 372 (5th Cir. 2012), embraced Buckman, so we are optimistic that a panel of cooler heads would prevail.