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Today’s case is, we think (and certainly hope), unlike any other case we have discussed in 2018. To begin with, Duntsch v. State, 2018 Tex. App. LEXIS 10131, 2018 WL 6445369 (Texas Ct. App. 5th Dist. Dec. 10, 2018), is an appeal from a criminal conviction. Since we have droned on incessantly about how our happiest days as a lawyer were spent prosecuting crooks, everyone on the blog knows that we have first dibs on criminal cases. In Duntsch, the issue was whether a criminal assault statute could apply to a case of medical malpractice. The Texas court ended up affirming a neurosurgeon’s conviction for “intentionally or knowingly causing serious bodily injury to an elderly individual while using or exhibiting a deadly weapon” – the “deadly weapon” being his hands, surgical tools, and a medical implant. As described by the court, the defendant neurosurgeon comes across as not only incompetent, but also arrogant. Indeed, read a certain way, the court’s recital of the facts of the case portrays a sociopath. Nevertheless, a criminal conviction for assault with a deadly weapon against an actual surgeon, no matter how bad the surgeon’s conduct (and the court makes it sound bad bad bad bad), seems unprecedented.

We will confine ourselves to the facts in the Texas appellate decision, though this case has received extensive coverage. There is an article in D Magazine calling the defendant “Dr. Death.” There are several accounts on the web. There is a multi-part podcast devoted to this extraordinary story. One of the themes running through these accounts is the alleged failure of the medical system, in terms of credentialing, reporting, and med-mal limitations. The moral of the tale, so we are told, is that the criminal justice system was the last, best, necessary resort after other systems failed to protect patients. You can decide for yourself whether that moral is fitting here.

The particular offense involved back surgery on an elderly woman. It is an understatement to say that the result was not the desired reduction of pain. Rather, the patient’s pain dramatically increased. Even worse, the woman suffered from “drop foot” and incontinence. It appears that the defendant put the pedicle screw in exactly the wrong place. The surgery was a sequence of terrible errors. “There were holes where they shouldn’t be in the bone.” Further, there was testimony that the defendant was distracted during the surgery by the deteriorating condition of another back surgery patient, who subsequently died. The defendant got into an argument as to whether the other patient required a craniotomy. Meanwhile, the defendant’s surgical technique for the patient in front of him on the operating table was, according to doctors and nurses present during the surgery, abominable. One doctor characterized the procedure as a “catastrophic surgical misadventure.”

One of the eyewitnesses to the disastrous surgery was the device representative. We have written in the past (here, for example) on whether the presence of a device representative during a surgery can present problems for the manufacturer in a product liability case. But here, the device representative’s testimony was damning for the defendant doctor. The rep said that surgery was “chaos from the beginning,” that the pedicle screw erroneously was placed into soft tissue rather than bone, and that there was more bleeding during the operation than there should have been.

The jury heard not just about the subject surgery, and not just about the other back surgery that went fatally wrong and that distracted the defendant, but also about several other surgeries where the defendant committed awful malpractice. In one especially sad case, the defendant operated on old friend and managed to turn him into a quadriplegic. In another, a fellow surgeon described the defendant as operating at the level of first or second year neurosurgery resident. Multiple patients died from the defendant’s treatment. Think of how this evidence of other catastrophic results played out at trial. Every day in the courtroom the jurors must have seen injured people using crutches, walkers, wheelchairs and worse. They must have also seen loved ones overcome with grief and anger. Evidence of other acts is powerful stuff. Sometimes it can be too powerful.

The evidence of other acts did not come only from victims. An office manager who worked for the defendant acknowledged that the defendant “had an unusual number of bad outcomes” compared to other doctors for whom she had worked. She also described an instance where the defendant had asked her to alter some medical records after the fact. Perhaps even worse, a nurse practitioner who was also an ex-girlfriend of the defendant was quizzed about some incendiary emails the defendant had sent her, including one where the defendant described himself as a “stone-cold killer.” She did not interpret the email to reveal a criminal mind, but the jury was free to do so.

An expert doctor testified for the defense that the defendant’s errors were “known complications” that a “poorly-trained surgeon could do,” and that have, in fact, occurred in the past. In other words, the defense added up to arguing that the defendant was an idiot but not quite a criminal.

After all the evidence rolled in, the jury convicted the defendant. The sentence was life imprisonment. Let that sink in for a moment.

The two key issues on appeal were whether the other terrible surgery results should have been admitted into evidence and, most fundamentally, whether the evidence was enough to support a finding of criminal intent on the part of the defendant. The two issues have a lot to do with one another, of course. As we said up top, the criminal statute applies to someone who “intentionally or knowingly causes serious bodily injury” to an elderly person. The state did not claim that the defendant actually intended to inflict harm on the patient. Consequently, the issue was one of knowledge. A person acts “knowingly” with respect to a result of his conduct if “he is aware that his conduct is reasonably certain to cause the result.” The court concluded that a jury could reasonably find that the defendant was reasonably certain that his conduct would seriously injure his patient inasmuch as the defendant was aware of his recent track record of inflicting extremely rare and serious complications on his surgery patients, and was also told during the surgery in question that he was botching the operation.

The prior surgeries came into evidence not merely to show that the defendant was a rotten surgeon, but to show that the defendant had the knowledge of those results in his head, and that such knowledge added up to the requisite culpable state of mind (in law school we learned to call it mens rea). As the prosecution contended, the other acts here were contextual, not extraneous. The court agreed, and held that the other surgeries were properly admitted per Fed. R. Evidence 404(b). They were similar to the surgery at issue, and they shed light on the defendant’s state of mind.

The defendant offered a pretty good argument that there is something wrong with the fact that the evidence of the surgery in question took up less than a day of trial, while the evidence of the prior surgeries took up another twelve days. But the court reasoned that the prior surgeries were probative on a highly disputed point (the defendant’s mental state). Moreover, the trial court repeatedly instructed the jury that the prior surgeries were to be considered “only … in determining intent, knowledge, motive, absence of mistake or lack of action of the defendant, if any, alleged in the indictment in this case and for no other purpose.”

The appellate court also rejected the defendant’s argument that the “stone-cold killer” email was substantially more prejudicial than probative. The prosecutor certainly emphasized that email during closing argument. We can understand why the prosecutor would do that, but use of evidence in closing argument makes it that much harder to argue harmless error. The prosecutor’s bet paid off, given that the appellate court did not find error. We probably would have gone the more prudent route and kept mum about it in argument, trusting the jurors to seize upon it during deliberations. Maybe that’s why we are now a hypercautious civil defense hack.

One of the three appellate judges in Duntsch dissented, arguing that the evidence at trial did not prove the defendant’s “knowledge.” The dissenter believed that evidence of the prior bad surgeries at most showed what the defendant should have known, not what he actually knew, about his poor surgical skills. One passage in the dissent is particularly persuasive: “Appellant was not on trial for being a doctor generally or, more to the point, for being a doctor who lacked adequate training or technique – neither of those things is a crime. And, criminal trials are not reverse class actions.” The dissent makes other useful points, and suggests that the evidence could have supported a finding of recklessness, which would have been a lesser offense. But the dissent was only a dissent, so the majority’s affirmance of the conviction on the most serious offence charged held sway. Interestingly, the dissent agreed with the majority that there is no broad policy reason to exempt physicians from the reach of the criminal code when medical malpractice sinks to the defined level of culpability.

Duntsch is an extreme case. It is a memento mori painted on the edge of tort law, reminding us of what can happen when things go horrifically wrong.

Contrary to rumor, we are not on the verge of changing our name to the Filter Device Litigation blog. True, we are now on a several consecutive weeks run of sharing very good IVC opinions. In fact, we will likely have two this week. The recent outbreak of good sense largely emanates from Indiana, but today’s case, Broge v. ALN Int’l, Inc., 2018 U.S. Dist. LEXIS 204486 (N.D. Cal. Dec. 3, 2018), shows that logic can prevail even in (gasp) the Bay Area. Hold your nasty comments – we were born in the Bay Area and admire it endlessly. Our native-son regard for the place does not prevent us from acknowledging that defense-friendly product liability wins there are as rare as football wins this season on either side of the Bay. But the Raiders and 49ers both won last Sunday, and now we have a case from ND Cal. that insists that plaintiffs lob in the occasional fact in their complaints. Sometimes man bites dog. Sometimes Adam Sandler puts out a good movie. Sometimes a politician commits candor. Sometimes our kids answer our texts.

In Broge, the plaintiff’s IVC filter had become embedded in her vena cava wall. It took two surgeries to remove the filter. She sued in Santa Clara County Superior Court, alleging strict liability failure to warn and manufacturing defect, breach of warranty, negligent and fraudulent misrepresentation, and the inevitable violations of California Business & Professions Code sections 17200 and 17500. The only defendant was ALN International, though the complaint devoted a lot of space to the conduct and knowledge of other entities, including ALN Implants Chirurgicaux and ALN Implants. The case was removed to federal court on the basis of diversity of citizenship, and then the defendant filed a motion to dismiss. The court granted the motion in part, and its opinion noted that it was odd of the complaint to sue one entity based on alleged sins of another. That opinion can be found at Broge v. ALN Int’l, Inc., 2018 WL 2197524 (N.D. Cal. May 14, 2018). The plaintiff was given leave to amend and did so, but did not do so very well. The defendant filed another motion to dismiss. In scrutinizing the amended complaint, the Broge court did not merely cite the Twombly and Iqbal cases, it actually applied them. That spelled doom for the amended complaint, which did not contain much beyond bare conclusions.

Take the failure to warn claim, for example. The plaintiff alleged that another entity, ALN Implants, should have known and discovered the defects. That would not affix liability to the actual defendant in the case. Further, as is all too typical, the amended complaint contained mere conclusions that better warnings would have altered the physician’s decision to prescribe the IVC filter. The plaintiff’s curative amendment cured nothing.

The manufacturing defect claim fared no better. In an earlier complaint, the plaintiff simply said the product “contained manufacturing defects.” That is obviously not good enough. On the next go-round, the plaintiff said that the IVC filter at issue did not conform to a hook design that should have permitted easy removal. Well, that at least seems a bit better. But the amended complaint still failed to allege how the product deviated from the design – all it talked about was the result. Even worse, the amended complaint still, almost perversely, hung the alleged hook malfunction on an entity that was not in the lawsuit, ALN Implants.

The negligent misrepresentation claim offered no facts suggesting that the defendant lacked reasonable grounds to believe its safety and efficacy representations were not true, the warranty claim rested in part upon a representation by a third party, and the fraud claim lacked specificity on the who, what, when, where, and how. The Cal. Bus. Code claims were merely fraud claims in another guise, so they also did not make the grade. There was also a claim for punitive damages. Because that claim was derivative of the fraud claim, it, too, was a goner.

The Broge court dismissed the claims, but because California is a land of not just second, but third, chances, the plaintiff was given, again, leave to amend. Perhaps the court will eventually grow weary of reading threadbare complaints that contain more ambition than facts. As long as the court keeps coming out with precise, demanding opinion that respect pleading standards, we won’t grow weary of reading such opinions.

We typically steer clear of discussing any opioid cases for client reasons. But today we have a case that did not involve our client in any way and that involves a discrete and important issue. Accordingly, we hereby render a bare-bones report.

The case, Floyd v. Feygin, et al., No. 507458/17 (Kings County, N.Y. Supreme Court Nov. 28, 2018) (available here: https://www.druganddevicelawblog.com/wp-content/uploads/sites/30/2018/12/Dabiri.pdf) is a civil case, but it pretty much was a follow-on to a criminal investigation involving, among others, the DEA, the Brooklyn District Attorney’s office, and the Department of Health and Human Services. That criminal investigation culminated in indictments of doctors, nurse practitioners, and even a member of the New York Assembly, all charged with running pill mills that issued medically unnecessary painkiller prescriptions and bilked funds from the Medicaid program.

The plaintiff filed a complaint that mostly tracked the criminal case, while also adding some entities that were not part of the criminal case, including the pharma company and a drug store. Here is the theory of the plaintiff’s negligence claim against the pharma company:

“Plaintiff alleges that Actavis had a duty to ensure that its Oxycodone product was not being prescribed, dispensed, and used in a fraudulent and harmful manner. Plaintiff further alleges that Actavis breached its duty by failing to take appropriate action to stop and prevent Oxycodone from being prescribed for fraudulent and illegal purposes, and by failing to maintain effective controls against having prescriptions for Oxycodone being written where such prescriptions were not for legitimate medical purposes. Plaintiff also claims that Actavis breached its duty by failing to design, implement, and operate a system to disclose suspicious orders of Oxycodone, and by failing to establish, implement, and follow an abuse and diversion detection program consisting of internal procedures designed to identify potential suspicious prescriptions of Oxycodone. Plaintiff claims that he suffered injuries by improperly receiving Oxycodone and becoming addicted to it.”

The plaintiff also alleged that the pharma company “keeps a close eye on how many pills a doctor or practice is prescribing” and that it is required to report any suspicious prescribing, pursuant to the Controlled Substances Act (both federal and the New York equivalent). And there’s the rub. Actavis filed a motion to dismiss, arguing that the plaintiff’s negligence cause of action was an attempt at private enforcement of the Controlled Substances Act. Neither the federal nor New York statute provide for private enforcement. The plaintiff was forced to concede that there was no private right of action, and then tried to escape preemption by arguing that the statutes “created a responsibility that Actavis failed to meet.” But the plaintiff encountered additional problems. First, the statutes imposed reporting requirements, but did not compel manufacturers to stop or restrict distribution. Second, the distributions of painkillers at issue were all made pursuant to purportedly valid prescriptions by licensed physicians. Third, the creation of pill mills by other defendants “was an intervening act which was of an extraordinary and criminal nature so as to break any causal nexus between any reporting requirement on the part of Actavis and plaintiff’s addiction to Oxycodone.”

Seeing that his negligence cause of action against the pharma company was going down the drain, the plaintiff argued that he needed more discovery. The court denied this request, reasoning that the pharma company simply had not breached any duty owed to the plaintiff. Discovery was not going to change that.

This will be the third consecutive week for us to discuss a favorable expert ruling out of the Cook Medical IVC filter litigation in the Southern District of Indiana. By this point, we really do expect some sort of remuneration from the Indiana Chamber of Commerce – maybe tickets for the surprisingly impressive Colts, or a reuben sandwich from fabulous Shapiro’s delicatessen. (To our palate, the Shapiro’s outpost at the Indy airport offers better corned beef than any you can find at LaGuardia, JFK, Newark, O’Hare, or even our hometown PHL. How weird is that?). Today’s Daubert ruling is In re Cook Med., Inc., IVC Filters Mktg., Sales Practices & Prod. Liab. Litig., 2018 U.S. Dist. LEXIS 196637, 2018 WL 6047018 (S.D. Indiana Nov. 19, 2018), and, as with earlier orders from this court, is clear, concise, and eminently sensible. The Daubert motion at issue here was filed by the plaintiff, who wanted to shut down a defense psychiatrist from rendering opinions that the plaintiff’s emotional injuries were not caused by the IVC filter. We won’t make a secret of the fact that we think the plaintiff’s Daubert arguments were uncommonly silly. For example, the plaintiff contended that the defense experts opinions were not offered to a reasonable degree of certainty when, in fact … they were. Still, there are commonly silly courts out there that might have given some credence to some of the plaintiff’s arguments. Thankfully, though, there is nothing silly about the In re Cook court.

The plaintiff attempted to preclude the defense expert’s differential diagnosis because it listed several alternative causes, not just one, for the plaintiff’s injuries. That position is a misfire in several respects. To begin with, the etiology of the plaintiff’s injuries was multifactorial. If reality puts more than one cause in play, why must a defense expert be forced to pick one? Further, the defense, of course, does not bear the burden of showing any cause. That burden is on the plaintiff. It is powerful stuff for a defense expert to show that there are many other plausible causes out there for the plaintiff’s injury, and those other causes exist independently of the defendant’s product. Indeed, the defense expert does not even need to exclude the product as a possible cause; it is enough if the expert can show that there is no reasonable way to put the finger on the product as opposed to one of the other possible causes. The defendant has absolutely no obligation to alight upon only one alternative cause. At a minimum, the multiplicity of alternative causes is a multiplicity of confounders that undermines the plaintiff’s false certainty.

The plaintiff also objected to the defense expert’s differential diagnosis because that expert had never physically examined the plaintiff. First, the defense expert had done plenty of work to substantiate his opinions. He had reviewed the plaintiff’s medical records, the plaintiff’s two videotaped depositions, the depositions of five treating physicians, an independent medical examination, and the reports of the plaintiff’s experts. That would be enough in pretty much any court to get to the jury. If the plaintiff wanted to make something out of the lack of a physical exam, that is fine fodder for cross-examination. But there is an additional wrinkle here. The court tells us that the defense expert “was not given the opportunity for an appropriate, direct, clinical examination” of the plaintiff. Apparently, there is a dispute between the parties as to why, exactly, that was so. Reading between the lines, we suspect that the plaintiff objected to the exam, or at least to some aspect of the exam. Obviously, then, the plaintiff cannot be heard to object to the absence of a medical examination that the plaintiff refused. Call it estoppel or fairs-fair, or whatever. (At this point, we cannot resist raising one of our chief gripes with other defense lawyers. In almost every mass tort litigation we’ve seen, there will be some defense lawyers who oppose having their defense experts perform physical examinations on the plaintiffs. Why? They are afraid of what the expert might find. Huh? Do you believe in your case or not? Plus, a good expert will be able to work with whatever the facts are. More information is better than less information. Our job is to deal with the facts, not alter or ignore them. Finally, as the In re Cook case demonstrates, you are simply in a much better position if you at least tried to perform the examination. Plaintiff lawyers often oppose these exams. Make them pay for that opposition. Anyway, the next time we hear from a plaintiff lawyer that this blog does nothing but bash plaintiff lawyers, we’ll point them to this parenthetical.)

Finally, the plaintiff tendered a back-up position that, if the defense expert would be permitted to opine on alternative causes, then that expert should not mention opioid use disorder. Nice try. The court observed that the defense expert had found “ample evidence in the record” to suggest that the plaintiff met the criteria for opioid use disorder, and such condition could be a cause of the mental health injuries of which the plaintiff complained. As much as the plaintiff was trying to keep out evidence of alternative causes, this was the alternative cause that the plaintiff most feared. And with good reason. It is, no doubt, powerful evidence. It reminds us of the old prosecutor’s joke about criminal defense lawyers objecting “Prejudicial, your Honor – tends to show guilt.” The In re Cook court held that the evidence of opioid abuse was part of the plaintiff’s medical record and was “essential” to the defense expert’s differential diagnosis. It was, therefore, admissible.

Last week we praised the S.D Indiana court’s Daubert decision in the Cook IVC filters litigation. Apparently the court is an expert on experts, because it came out with another sensible decision on experts, this time on the use of treating physicians to offer causation opinions. In re Cook Medical IVC Filters Mktg., Sales Practices, & Prod. Liab. Litigation, 2018 WL 5926510 (S.D. Indiana Nov. 13, 2018).

We all know how the expert game works. Each side hires experts (sometimes through an ever-so-helpful expert service), spoon-feeds them the friendliest supporting materials, and plops these walking jukeboxes down in front of a jury to play a catchy tune. Expert testimony, done properly, ends up being a well-rehearsed preview of the closing argument. These experts are usually experienced story-tellers and can parry with the most cunning cross-examiners. The problem is that jurors have a pretty good sense of how this process works. And if they had any doubts that the expert witness is an advocate, such doubts are erased when they learn the expert is making more money that day in court than any juror makes in a month. Thus, it is not surprising to hear from jurors after a case is over that they discounted the expert testimony. (Yes, we acknowledge that the discount might not be as much as the jurors say. It is kind of like how everyone claims that advertising does not affect them.)

Enter the treating physician. Both sides try to enlist the treating physicians as oath-helpers. If a party does manage to get the treater on its side, you can bet that will be a huge point in the closing. E.g., “Throw out all the experts if you want, but you cannot throw out the treater’s opinion. Nobody paid the treater to testify. The only side the greater is on is the patient’s health.” Etc. That is why the depositions of the treating physician is one of the most important moments in a case. That is why we defense hacks hate being in jurisdictions where the defense is forbidden from contacting treaters, but plaintiff lawyers are free to meet with them, shower them with bad company documents, woodshed them, perhaps dangle threats or promises, and, in general, do their best to line up the treaters with their paid experts on crucial issues such as warnings, injuries, and, most of all, causation. The treater’s testimony seems credible precisely because the treater is not retained by either party.

Most of you are familiar with the concept of non-retained experts. But there is probably a non-trivial subset of lawyers unfamiliar with the 2010 amendment to Fed. R. Civ. P. 26(a)(2). That amendment added requirements for disclosing non-retained experts. More specifically, the 2010 amendment added 26(a)(2)(C), providing that a party designating a non-retained experts must issue a summary disclosure stating the subject matter and summary of the facts and opinions to which the witness will testify. Rule 26(a)(2)(C), eight years after its adoption, is still a trap for the unwary. There is a 50% chance that a plaintiff lawyer naming nonretained experts will fail to supply the summary disclosure required by Rule 26(a)(2)(C).

But that is not what happened in In re Cook. The plaintiff did, in fact, make a summary disclosure. That summary disclosure proffered the treating physicians’ opinions that several possible alternative causes did not play a role in the plaintiff’s injury. Those opinions would have been, of course, quite useful for the plaintiff. If the jury is persuaded to rule out alternate causes, the defendant’s product would look more and more like the culprit. So what’s the problem? The plaintiff followed all the rules, right? Wrong. There is an even more fundamental rule, antedating Rule 26(a)(2)(C): non-retained expert treating physicians are limited to opinions formed during the course of providing treatment. The In re Cook court cited a Seventh Circuit opinion, Meyers v. Nat’l R.R. Passenger Corp., 619 F.3d 729, 734-35 (7th Cir. 2010). You won’t have to look too hard to find a similar opinion in whatever jurisdiction houses your litigation. The plaintiff in Cook argued that the treaters were basing their causation opinions on “their training, expertise, and observations during treatment,” but that last bit rang untrue. As the Cook court put it, “The first time these opinions were introduced was during their deposition testimony for purposes of this litigation. It is, therefore, inadmissible.”

Perhaps the plaintiffs could have gotten around this problem by submitting the treaters’ opinions pursuant to the standard expert disclosure process in Rule 26(a)(2)(B) rather than the summary disclosure in 26(a)(2)(C), but that would mean that the plaintiffs would have had to retain the treaters. That probably also means that those treaters would be paid. Bye-bye neutrality/purity. Plus, most plaintiff lawyers are cheap. For that reason, and for the S.D. Indiana’s persistent reasonableness, we are thankful.

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We are also thankful for your attention, comments, and suggestions. We are thankful for another year of smart, supportive clients. We are thankful for judges who work hard, read all the papers, do their utmost to be fair, and, consequently, tell us that we won. Mostly, though, we are thankful for the mashed potatoes on our plate tomorrow. Sure, we adore the Drug and Device Law Family gathered around the table, but there is zero chance that the potatoes will start a political argument. Happy Holiday to you all.

A couple of years ago we penned a paean to Indiana and its cultural and legal triumphs. Now that another chunk of our family has decided to relocate to that happy state, our thoughts returned to Indiana’s many virtues. Sure, there’s the Indy 500, the fabulous covered bridges of Parke County, the Benjamin Harrison home, and a couple of our favorite in-house lawyers. And now there’s In re Cook Medical, Inc., IVC Filters Mktng., Sales Practices & Prod. Liab. Lit., 2018 U.S. Dist. LEXIS 190177 (S.D. Ind. Nov. 7, 2018).

Maybe plaintiff-files-Daubert-motion isn’t quite man-bites-dog, but it’s still pretty rare. Plaintiffs are usually all about getting to the jury, no matter how raggedy the case. In fact, the more raggedy, the better. Consequently, plaintiffs devote considerably more time fending off Daubert challenges than mounting their own. Maybe there’s a reason for that. Maybe plaintiffs tend to put up hack experts, while defendants put up good ones. Maybe we’re biased. Okay, definitely we’re biased. But take a look at what happened in In re Cook.

The defendants in Cook offered the testimony of a mechanical and materials science engineer who opined that the IVC filter design was not defective and that its benefits outweighed its risks. The expert was well qualified. It’s not as if it was a close call. The defense expert had the appropriate degrees from Cal Berkeley. He also had been a general manager at a company that made IVC filters. Federal Rule of Evidence 702 requires that an expert be qualified by knowledge, skill, experience, training, or education. Note the “or.” This expert had it all. Not only was this expert qualified, he had done the work. He looked at MAUDE adverse event data, peer-reviewed literature, the company’s testing records, the design and engineering records, the opinions of other experts in the case, and fact depositions. That is, the defense expert in Cook did far more homework than virtually any plaintiff design expert we have encountered. We’re not sure we’ve ever deposed a plaintiff design expert who has actually read the design history file. Indeed, we’re pretty sure that most plaintiff experts do not know what a design history file is.

The plaintiff’s main beef with the defense design expert in In re Cook concerns the opinions regarding the device’s benefits and risks. The main benefit of an IVC filter is prevention of pulmonary embolisms. How can a mere engineer opine on medical issues? (Dear Engineering Nerds: Please do not write angry comments; we are using the “mere” word sarcastically. We have endless respect for engineers. We utter a prayer of thanks to them every time we drive across the Benjamin Franklin Bridge. At parties, we always get next to the engineers in case a game of Jenga breaks out.) The court has no problem answering this question: “a biomedical engineer … can testify about the benefits and ability of the Celect IVC filter to catch blood clots from a biomedical design and engineering perspective.” The plaintiffs were asking the wrong question. No surprise there.

Then the plaintiffs raised other wrong questions: (1) Why doesn’t the expert quantify the number of filters that actually prevented pulmonary embolisms? (2) Why does the engineer rely on adverse event data without knowing what percent of adverse events are reported? (3) How dare the expert rely on the defendant’s own studies? The Cook court is untroubled by these wrong questions, and supplies clear, easy, right answers: (1) Quantification goes to weight, not admissibility. (2) No one knows the true adverse event reporting rate, so it’s hard to fault the expert. Also, and again, this criticism might go to weight, but not admissibility. (3) The company’s data might not be perfect, but it looks like valid evidence. The data’s short-comings constitute yet another issue of weight, not admissibility. Finally, the expert relied on lots of other data besides the company’s. In short, tell it to the jury.

We’re still in favor of federal judges acting as stout gate-keepers when it comes to expert testimony. Junk science should be excluded. But when an expert is so well qualified and so well informed as the one in Cook, and when that expert applies reliable methods, there’s no reason to exclude anything. Rather, it’s time for Hoosier hospitality.

A federal judge in one of our non-drug or device cases recently informed the parties that he was so busy with his criminal docket that it might be better to let the magistrate judge take over our case, including trial. We fretted over the prospect of losing a judge who had thus far been very attentive, careful, and rigorous, but the issue was mooted when the plaintiff swiftly said “No thanks.”

Over the years, we have had many good experiences with magistrate judges. Indeed, our last trial in Philly was in front of a magistrate judge, and it would be hard to imagine how it could have been any more fair or efficient. The case we are discussing today, Lynch v. Olympus Am., Inc., 2018 U.S. Dist. LEXIS 185595 (D. Colorado Oct. 30, 2018), was handled by a magistrate judge pursuant to the parties’ consent via 28 U.S.C. 636(c). The plaintiff might now regret such consent, in light of the magistrate judge’s decision, but the clarity and logic of that decision is undeniable.

In Lynch, the plaintiff sued three companies for making endoscopes that were allegedly too hard to clean, thereby causing the plaintiff to suffer an infection and illness. One of the companies was a Japanese parent, and the other two were affiliates that did business in the United States. The Japanese parent moved to dismiss the complaint for want of personal jurisdiction. The affiliates moved to dismiss the strict liability and negligence claims on substantive grounds, and to dismiss the misrepresentation claims for failure to plead with specificity.

The magistrate judge’s opinion is exquisitely organized, so we’ll follow its outline faithfully.

    Personal jurisdiction

The Lynch court considered whether the Japanese parent could be hailed into Colorado based on the stream of commerce theory. That theory is not one of our favorites, and the Lynch court correctly described its fuzziness. SCOTUS has not exactly been very exacting in setting forth the contours of the stream of commerce theory. The Tenth Circuit has been better in erecting this key guardrail: “specific jurisdiction must be based on actions by the defendant and not on events that are the result of actions taken by someone else.” Monge v. RG Petro-Machinery (Group) Co., 701 F.3d 598, 618 (10th Cir. 2012). The Tenth Circuit has also been unambiguous that mere corporate affiliation is insufficient to impute one company’s contacts to its parent corporation. Accordingly, the Lynch court did not feel “free to disregard corporate formalities when assessing whether it may properly exercise personal jurisdiction over a defendant.” What we end up with is another successful example of using marketing subsidiaries to insulate the foreign parent from suit.

Are we done with personal jurisdiction? Not yet. The plaintiff tried to invoke non-registration-related consent by the parent corporation, based on things that happened in other cases. Nice try. Not really. The Lynch court reasonably pointed out that other cases are other cases, and what happened in those other cases has no bearing on or similarity with this case. “A consent in one case does not affect the propriety of a court’s exercise of personal jurisdiction in another case, even if related and even if in the same forum.” The court agreed with the plaintiff that it might be entitled to some jurisdictional discovery — if it could successfully plead the substantive claims, but that, as we will see in a moment, is not so clear.

    Design Defect

Beyond bare conclusions, the plaintiff did not manage to allege that the risks of the endoscopes outweigh benefits in all patients. Potential problems with reuse do not affect all patients on whom new devices are used. “[M]erely being difficult to clean does not render the device unsafe for all all patients.” Moreover, causation requires more than the fact that the plaintiff fell ill after encountering the product. The allegations are too conclusory to state a claim for strict liability under a design defect theory.

    Failure to Warn

Lynch is the first case applying Colorado law to apply the learned intermediary rule to a medical device. No prior Colorado court had explicitly done so, though there was at least one case that generally treated prescription drugs and medical devices together. The plaintiff in Lynch contended that the endoscope was a nonprescription device. Even if that contention was “technically correct,” it did not matter. “Clearly, patients are not buying [endoscopes] over the counter” to administer the procedure to themselves at home. It is necessarily a doctor who “decides the procedure is required and performs it.” To our mind, the Lynch court analysis makes good sense. There are a variety of medical devices that might not technically require a prescription, but there is still no doubt that a doctor is a necessary (and learned) intermediary. Think of scalpels. The doctor, not the patient, selects the particular scalpels employed in a procedure. Would it make any sense to permit personal injury plaintiffs to complain that the scalpel manufacturer supplied inadequate warnings? Scalpels are, sharp, sure. But maybe the manufacturer should have warned that they are very, very sharp. Or maybe there is a materials safety data sheet for one of the scalpel’s raw materials that might give the dense or paranoid pause. The mind reels. For now, let’s content ourselves with the Lynch court’s application of the learned intermediary rule to endoscopes, and the court’s conclusion that the plaintiff did “not allege the failure to warn as applied to her physician.”

The Lynch court made another ruling that is pertinent to many drug and device cases: is the failure to warn really about warning at all? What exactly is the warning and what would be the effect of the warning? In Lynch, the warning allegedly lacking seems to be nothing more than telling doctors that the product is defective. “Plaintiff’s claim is, in essence, that the product was defectively designed and therefore the warning was inadequate; as pled, the failure to warn claim cannot be distinguished from the design defect claim.” Thus, the warning claim boils down to, or takes back to, the design defect claim. And we know how that turned out.

    Negligence and Products Liability

The complaint contained “inadequate factual allegations establishing causation. Absent plausible allegations linking the Defendants’ actions to the Plaintiff’s harms, there is no plausible claim for relief.” Well, okay then.

    Misrepresentation

The plaintiff alleged both fraud and negligent misrepresentation, but the Lynch court correctly points out that there was no real difference between those claims. The negligent misrepresentation claim was replete with all sorts of intentionality. The court concluded that both claims needed specificity and both claims lacked it. The acts of the various defendants were jumbled together, and specifics on who, what, where, and when were wholly absent.

*********************

The plaintiff will get a chance to try again. The magistrate judge was perhaps a bit charitable. But she was also smart and careful, so the plaintiff had better do a much better job on the next go around.

Happy Halloween. We are very old school when it comes to this spooky holiday. Our pumpkins are orange, our candy bowl is full of Kit Kats, and our favorite horror movies are black and white Universal monster movies from the 1930’s and 40’s. To our ears, nothing screams Halloween quite like the great Una O’Connor screaming. See and listen here for examples of her wonderful performances in The Invisible Man and Bride of Frankenstein as a proper lady properly terrorized by creepy creatures. (O’Connor’s last film role was in Witness for the Prosecution as an ear-witness who resisted impeachment.) The Invisible Man, Bride of Frankenstein, and the original Frankenstein movie were all directed by James Whale, a man of enormous talents and humor, as well as enormous tortures. The Gods and Monsters film portrays Whale in his uneasy later days.

At this point, we cannot resist a Halloween joke, this one by Dana Gould. It goes like this: In this country we celebrate a holiday where frightening strangers come to our homes and take goodies from us. We call it Halloween. A month later, the next big holiday arrives – Thanksgiving. But Native Americans have another name for that holiday; they call it … Halloween.

Recently, we found ourselves screaming like Una O’Connor after a plaintiff filed a summary judgment motion against us. That plaintiff had the temerity to argue that her failure to warn claim was a foregone conclusion. Our screams arose from surprise, indignation, and, finally, laughter. With one brain tied behind our back, we could scare up a genuine factual dispute. Take a look at the report by our expert, who is very smart and says our warning was adequate and no reasonable doctor would have been misled. While you’re at it, read our Daubert motion, wherein we demonstrate that the plaintiff experts are about as scientific as Colin Clive in Frankenstein, dancing under the lightning and proclaiming, “It’s alive, alive!” Not quite. Our expert marshals the data and literature and says this about the lawsuit: “It’s dead, dead!”

Plaintiff motions for summary judgment are menacing, but miss the mark more often than not. That was certainly true in Nielsen v. Smith & Nephew Inc. et al., 2018 WL 5282901 (E.D. Wisc. Oct. 24, 2018). If anyone is screaming in this case, it is the judge, obviously pained by bad briefing. The plaintiff alleged that a hip replacement device fractured ten years after it had been implanted. The complaint’s main target was the distributor of the implants, because the manufacturer had gone under. There were 11 causes of action, but a defense summary judgment motion prompted the plaintiff to concede that almost all were pure hooey. Not a great start for the plaintiff. The only real motion fight was on the negligence claim against the distributor. Meanwhile, the plaintiff moved for summary judgment against the distributor on two grounds: (1) that the distributor of the hip devices could be liable under Wisconsin law because the manufacturer had gone bankrupt and lacked insurance coverage, and (2) the device lacked adequate warnings.

To put it mildly, the Nielsen judge was not impressed by the plaintiff’s motion. The plaintiff supported his motion by attaching letters and emails from the manufacturer’s counsel and insurer. That’s all inadmissible hearsay. Consequently, the solvency of the manufacturer — and, therefore, whether the distributor could be a proper defendant — would need to be decided at trial, not on summary judgment. The plaintiff’s summary judgment on product warnings fared no better. The plaintiff’s expert did, predictably, say the warnings should have been more explicit and petrifying. But just as predictably, the defense expert pronounced the warnings to be just peachy. We in the business call this sort of thing a factual dispute. That’s also what the court called it. It was not a close call, as far the court was concerned. The plaintiff “inexplicably declined to dispute any of [the distributor defendant’s] statements of additional facts.” Moreover, the plaintiff offered no relevant case law under Wisconsin’s product liability act. Rather, the plaintiff “seems content to leave it to the Court to find the law that supports his arguments. It will not do so.” Ouch.

The distributor defendant’s motion for summary judgment was more successful than the plaintiff’s motion. (Frankly, it is unimaginable how it could be less successful.) The plaintiff’s motion was premised on his expert’s opinion about what the warnings should have included. But the issue was the warning obligation of a “reasonable distributor.” Amazingly, the plaintiff’s expert addressed only manufacturer duties. Those duties were plainly inapplicable to the distributor defendant, which was “simply a middle man.” The complete failure of the plaintiff to join issue mightily annoyed the judge, who wrote as follows: “Such minimal effort, devoid of any citation to law or meaningful discussion of evidence, is an insult to the Court.” Double ouch. The plaintiff basically brought motions and then made no attempt to prove what he had to prove.

The distributor defendant did not cross-move on every claim. There is still a strict liability claim against it, and that claim will go to trial in November. But based on what happened with the cross motions for summary judgment, if we were the Nielsen plaintiff we would not be sanguine. Nope. We’d be scared.

Happy birthday, Aubrey Drake Graham.  Most people know Mr. Graham strictly by his middle name.  The Canadian rapper Drake has carved out a hugely successful career for himself.  He sells lots and lots of records – or whatever it is that they sell in the music business these days.  Surprise: Drake’s music isn’t exactly our thing.  We still play the Beatles more than anything else, we sing along with Crosby, Stills, & Nash in the car, and we have difficulty naming songs post-dating Nirvana.  (Seinfeld once famously asked, “How could you not like the Drake?”  He was talking about somebody else.  Still, it’s a question we hear frequently from friends and family, chiding us for our retrograde taste in music.) Nevertheless, it’s impossible to swim in this culture without getting at least a little wet from Drake’s songs.  With “Worst Behavior,” for example, we got doused with language that you won’t hear in “Hello/Goodbye,” “Suite: Judy Blue Eyes,” or even “Come as You Are.” The main lyrics in “Worst Behavior” are about remembering how some bad, um, person, didn’t love Drake enough.  Anyway, thinking about that song made us review instances of the worst behavior by plaintiffs we have known and not loved.  There’s outright lying, cheating, and stealing.  And that’s looking only at the Plaintiff’s Fact Sheet.  Sometimes it goes beyond that.  Way beyond that.  Sometimes there’s hiding assets, including one’s pending tort claims, in bankruptcy.  It’s a swell way to stiff creditors.

This is not the first time we’ve encountered a case where a plaintiff neglected to list a mass tort claim as an asset in a bankruptcy proceeding.  See our blogposts here and here, for example.  Such neglect can have serious consequences, including staying or even dismissing the tort claim.  In today’s case, Kinderline v. Accord Healthcare, Inc., (In re Taxotere Prod. Liab. litigation), 2018 WL 5016219 (E.D. Louisiana Oct. 16, 2018), the plaintiff declared bankruptcy first, and two months later brought the mass tort action.  The plaintiff did not amend the bankruptcy papers to identify the claim.  The mass tort being an MDL, it dragged on, and the plaintiff’s bankruptcy closed with the trustee not hearing about the pending mass tort claim.  The plaintiff received a “no asset” discharge from bankruptcy. A fresh start! The plaintiff’s failure to include the tort claim in the bankruptcy proceeding was caught only after she was deposed by the defendant in the MDL.  (See – there’s a reason why that bankruptcy question shows up in your depo outlines.). The plaintiff then belatedly reopened the bankruptcy proceeding to list the tort claim.  The issue was whether the plaintiff was collaterally estopped from pursuing the tort claim in the MDL.

First things first.  Which law governed the estoppel issue? The plaintiff wanted to apply the law of her home jurisdiction, Ohio.   But the application of judicial estoppel is a matter of federal common law, and the case had been transferred to the MDL court in Louisiana, which is part of the Fifth Circuit.    There is precedent, though not by the Fifth Circuit, holding that application of federal (Constitutional, statutory, or common) law is governed by the law of the transferee court.  Judge Fallon in E.D. Louisiana went that route in the Vioxx MDL.  It certainly makes administration of the MDL easier.  (That’s not the same thing as saying it is right.) Even without Fifth Circuit precedent squarely on point, the Taxotere MDL court was convinced that the circuit law of the transferee court held sway, and therefore applied Fifth Circuit, not Sixth Circuit, law.  We’re not sure there is any difference in terms of application of judicial estoppel.  That is usually the threshold issue in a choice of law analysis.  Not so here.

This choice of law rule might be important to you when you are deciding what court you will argue for when it comes to creating an MDL.  Most lawyers tend to focus on the particular judge and district court they like better (or which particular judge and district court most terrifies them), but we should also think about the circuit court.   For instance, we recently argued for sending an MDL to the district of New Jersey.   The judge there seemed quite good.   But we were not blind to the fact that Third Circuit Law on preemption, in the form of the dreaded Fosamax decision, was bad bad bad.  We ended up concluding that Fosamax was so obviously bad that SCOTUS would reverse it.  That’s a heck of a gamble.  Right now, as we mentioned recently when we reviewed the Solicitor General’s amicus brief in Fosamax, it looks like a good gamble.  To quote a musician much more likely to be found in our playlist (and much more likely to be found in the Third Circuit), Fosamax is “going down, down, down, down.”

Back to Kinderline.  The court held that the plaintiff was, indeed, estopped.  Fifth Circuit law on estoppel, like the law in most places, looks at three elements: (1) the party against whom estoppel is sought has asserted a position plainly inconsistent with a prior position; (2) a court accepted the prior position; and (3) the party did not act inadvertently.  The first element was met here because the plaintiff failed to amend her bankruptcy petition to disclose a claim pursued after filing the petition.  The duty to disclose claims/assets in bankruptcy is an ongoing obligation. The second element is straightforward and obviously satisfied, because the court accepted the prior position – hence the no-asset discharge.  Now comes the third element, inadvertence.  To establish a defense of inadvertence, a party must prove (1) that she did not know about the inconsistency, or (2) that she lacked a motive for concealment.  There is no help for the plaintiff in Kinderline there, as there is no evidence she was oblivious to the inconsistency between the filing of the lawsuit and the failure to list it in bankruptcy, and the motive for concealment, keeping creditors away from any proceeds of the lawsuit, is undeniable and has, in fact, been recognized by the Fifth Circuit in another judicial estoppel case.  The plaintiff “would have reaped a windfall if she had been able to pursue this claim and collect a judgment from Accord without having to share the judgment with her creditors.”

The best fact the Kinderline plaintiff had going for her was that she reopened the bankruptcy proceeding before the defendant managed to move for estoppel.  She won the race to the courthouse.  Whoopee.  Not good enough.  The plaintiff did not seek to correct the record until being caught at her deposition and until almost a year after she knew of the lawsuit as asset.  Borrowing from Fifth Circuit precedent, it is clear that to bless the plaintiff’s gamesmanship by allowing the debtor to “back-up, reopen the bankruptcy case, and amend [her] bankruptcy filings, only after [her] omission has been challenged by an adversary, suggests that a debtor should consider disclosing personal assets only if [she] is caught concealing them.”   In other words, there must be consequences for the plaintiff’s bad behavior.  The plaintiff claimed that her delay was caused by her decision to wait to confirm product identification to ensure she was suing the correct party.  Hmmm. Such carefulness on the part of the plaintiff and her attorneys!  Yet it did not stop her from filing the tort lawsuit.  Nor did it account for all of the year-long delay. The plaintiff is not innocent.  For that reason, judicial estoppel means that she cannot pursue her lawsuit in the MDL.

But the Chapter 7 trustee is innocent and is the real party in interest.  The Trustee did not hide assets.  For that reason, the bankruptcy trustee could pursue the plaintiff’s claim.   But here’s an odd wrinkle:  the rejection of the plaintiff’s right to claim on her own behalf meant that her husband’s consortium claim was extinguished, as it was purely derivative of his wife’s claim.  To allude to the title of another Drake song, the husband’s claim was “Over.”

We would be hard pressed to think of a recent judicial decision we have blasted as hard or often as the Third Circuit’s Fosamax opinion.  We deemed it the worst case of 2017.  It was bad enough that our hometown federal appellate court held that it was up to a jury whether the FDA would have rejected a stronger drug warning.  It was worse that the court held that a defendant had to prove by clear and convincing evidence that the FDA would have rejected the warning.  And it was still worse, and kind of weird, that the Third Circuit arrived at this holding in a case where the FDA actually had rejected a stronger warning.  The result of the Fosamax decision was that summary judgement in favor of the defense on preemption became a pipe dream, and ultimate victory at trial became a lot tougher.

Right from the start, we thought Fosamax was reversal bait.  The excellent certiorari briefing made us more sure of that.  Then, when SCOTUS invited the government to lob in an amicus brief, we became still surer.  Now that we have read the government’s brief, we are even surer. Lawyers from the Solicitor General’s office and the Department of Health and Human Services are on the brief.  These lawyers are typically brilliant and the positions they stake out typically command a lot of respect from courts.

When we clerked, our Judge always paid a lot of attention to government amicus briefs.  In the last SCOTUS case we worked on, the government’s position turned out to be pretty much dispositive.  We represented a father who had been tossed in the clink because he had failed to pay child support.  It was a civil contempt proceeding that ushered him into jail.  The state (South Carolina) did not provide him counsel because it wasn’t a criminal case.  We argued that however the case was styled, if imprisonment was a possibility, the right to counsel was implicated.  The other side was represented by then Penn Law professor, now Third Circuit Judge, Stephanos Bibas, who was an amazingly effective advocate for what we thought was a weak position.  We argued that counsel had to be provided and he argued not so.  Then the SG’s office filed a brief, and its answer split the difference: sometimes.  Guess what SCOTUS decided?  Sometimes won.

What do we have here with the government’s Fosamax brief?  The headline is that the government argues for reversal of Fosamax.  It argues that the Third Circuit erred in holding that, under Wyeth v. Levine, a jury must resolve the preemption defense “As a factual matter subject to a clear-and-convincing evidence standard.”  Yay. But is there a ‘sometimes’ aspect to the government’s position that makes us a bit uneasy?  Yes, there is.

As always, the statement of the Question Presented sets the tone.  Here is how the government frames the inquiry:  “Whether a state failure-to-warn claim alleging the insufficiency of brand-name drug labeling is preempted by the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 301 et seq., when the Food and Drug Administration, after the drug manufacturer provided it with the relevant scientific data, rejected the manufacturer’s application to modify its labeling to warn about the risk underlying the tort claim.”

The first thing we notice is that the government is focusing on the fact that the FDA did actually reject a proposed warning.  That rejection came in the form of a Complete Response Letter in 2009.  The central point in the government’s brief is that the meaning and effect of that Complete Response Letter presents legal questions that a judge, not jury, must resolve. It was a federal agency decision, and courts, not juries, interpret agency decisions.  Even if factual findings are necessary to interpret the federal agency decision, such factual findings are decided by the court, not the jury.

The government’s arguments on these points are compelling, and it is hard to see how reversal can be avoided.  But how useful would reversal on this ground be for the rest of us?  Whenever the FDA actually rejects an enhanced warning, there will be an agency decision, and the government’s analysis would kick in and make the issue legal, not factual.  But what if there is no rejection?  What if the defendant wants to argue that there are other circumstances, not quite reaching the level of an actual agency rejection, that demonstrate that such rejection would have been inevitable?  Are we still in fact-land, as opposed to legal-land?  The ruling in Fosamax might end up a little narrower than we’d like.

Let’s not dwell on these questions for now.  No point in being a nervous Nellie.  There are other goodies in the government’s brief.  For instance, while the Third Circuit in Fosamax speculated that possibly the FDA’s rejection was a result of dissatisfaction with the specific language proposed by the pharmaceutical company, the government smacks that position down and restores the focus to the proper place: the state of the scientific evidence. Look again at the Question Presented.  Hone in on this language:  “relevant scientific data.” The FDA looked at the data in the available literature and adverse events reports.  “No sound basis thus exists for concluding that the FDA determined in May 2009 that the data was sufficient to warrant a warning but that it rejected petitioner’s proposal because of petitioner’s proposed text.”  If SCOTUS adopts this reasoning, as it should, plaintiffs will have one less arrow in their speculative quiver to stave off summary judgment on preemption.

Even better is how the government brief eviscerates the clear-and-convincing evidence standard.  First, the brief makes the undeniable point that the Wyeth v. Levine decision simply did not address this issue.  Thus, we are thrust upon first principles.  This is a product liability case. It is a civil action for money damages, and “nothing warrants a higher standard of proof to resolve the preemption question here.”  Absent legislative specification, there is no basis to impose a higher evidentiary standard on defendants seeking to available themselves of SCOTUS preemption doctrine.  We are not entirely fond of the government’s explanation of the Wyeth “clear evidence” language, seeming to tie it into a presumption against preemption, but we are trying not to be churlish.  In any event, we are content with the government’s fundamental point that the Wyeth v. Levine  “clear evidence” formulation was not intended “as a shorthand for a formal clear-and-convincing evidentiary standard, but merely to indicate that a manufacturer asserting preemption must show that a labeling charge was not warranted under the relevant statutory and regulatory framework.”

Once the government shows that resolving the Fosamax case requires resolving a legal issue, that no factual findings are required, and that the preponderance of the evidence standard applies, the case becomes easy.  The FDA rejected the proposed warning because the data was not yet in place to justify the warning.  The Third Circuit got it wrong, the district court got it right, and the litigation should be over.