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We recently gave a talk on things in MDLs that drive us crazy. Discovery is front and center. The asymmetry of discovery is a huge source of unfairness. If plaintiffs have their way, all discovery would be about company conduct, and we’d never get to find out if those 8,000 plaintiffs used the product or suffered an injury. Mere details. And don’t get us started on a plaintiffs’ insistence that we “certify” that our discovery is complete. That certification is both an insult and a departure from the Rules. Plaintiff lawyers might seek such certification in any case, but they definitely will seek it in an MDL, where discovery is most difficult, one-sided, and expensive.

Okay, now you went and got us started. Federal Rule of Civil Procedure 26(g)(1) requires that “every discovery request, response, or objection must be signed by at least one attorney of record … [to certify] that to the best of the person’s knowledge, information, and belief formed after a reasonable inquiry (A) with respect to disclosure, it is complete and correct as of the time it is made …” Although some enterprising plaintiff lawyers have argued that this language should mean parties are required to certify that discovery responses are complete, this Rule is limited to disclosures required by Rule 26(a)(1) – not discovery responses.

The comments to subsection (g)(l) tell us that Rule 26(g) “imposes an affirmative duty to engage in pretrial discovery in a responsible manner that is consistent with the spirit and the purposes of Rules 26-37.” Fed. R. Civ. P. 26(g) advisory committee’s note. Additionally, “the signature certifies that the lawyer has made a reasonable effort to assure that the client has provided all the information and documents available to him that are responsive to the discovery demand.” Id. Although there is a duty to make a reasonable inquiry to ensure that discovery responses are complete, there is no duty to certify complete discovery. United States v. Fresenius Medical Care Holdings, Inc., No. 1:10-CV-1614-AT, 2014 WL 11517841, at *5-6 (N.D. Ga. May 13, 2014). The “complete and correct” language applies only to initial disclosures required by Rule 26(a) (l). Moore v. Publicis Groupe, 287 F.R.D. 182, 188 (S.D.N.Y. 2012).

In Moore, the plaintiff relied on Rule 26(g)(l )(A) to argue that the defendant’s counsel was required to certify that the client’s document production was complete and correct at the time it was made. Id. The court disagreed, pointing out that Rule 26(g)(l)(A) specifically applies “with respect to disclosure” and that Rule 26(g)(l)(B) applies to discovery responses and does not call for certification. Id. The court acknowledged that “[i]n large-data cases … no lawyer using any search method could honestly certify that its production is ‘complete.”‘ Id. True enough.

Similarly, in Fresenius, the plaintiff argued that the defendant’s counsel was required to certify complete document production and that the court must impose sanctions under Rule 26(g)(3) for providing a certification that violates the Rule. Fresenius, 2014 WL 11517841, at *5-6. Looking at the language of Rule 26(g)(l), the court stated that there is no certification requirement for complete document production. Id. at *6.

In conclusion, while lawyers should make a reasonable effort to ensure that a client has provided all the information and documents available that are responsive to the discovery demand, there is no requirement to certify complete document production. Such certification finds no support in the law. Let’s call such certification what it truly is: a sanctions trap.

A little over a year ago, we reported on a decision by Judge Rufe (E.D. Pa.) dismissing an Avandia heart attack case on the grounds of the learned intermediary rule (Utah law). All of the plaintiff’s claims boiled down to an alleged failure to warn, and that was a problem for the plaintiff, as the plaintiff’s proposed enhanced warning ended up being discredited by the science after the case was filed. Thus, even though the prescriber had stopped prescribing the product for a period of time after some adverse data came out, by the time of the prescriber’s deposition he testified that he felt comfortable with his decision to prescribe the medicine to the plaintiff. That evidence prompted the district court to bid adieu to the claims. Our defense hack hearts were gladdened by this result.

Those defense hack hearts are even more gladdened by the Third Circuit’s recent affirmance of the district court’s decision. In re: Avandia Marketing, Sales Practices and Products Liability Litigation (Siddoway), 2018 WL 6828423 (3d Cir. Dec. 28, 2018). The Third Circuit did not see fit to publish the affirmance in the West Reporter, but we see fit to publicize it.

As the Third Circuit reminds us, the plaintiff’s claims in Siddoway drew a causal link between prescriptions for Avandia prescribed in 2001 and 2002 and the plaintiff’s two heart attacks in 2003. The case hinges on what the prescribing doctor would have done, with regard to prescribing Avandia, if he had seen the warning the plaintiff preferred. The prescriber testified that he stopped prescribing the drug after learning of a 2007 meta-analysis of 42 clinical trials by Dr. Steven Nissen – a familiar name to many of us — that associated Avandia with an increased risk of heart attack. The prescriber testified that he would have “thought twice” and would have been “much more thoughtful” about prescribing Avandia and would not have prescribed the drug to the plaintiff “in the middle of all these heart attacks” if he knew this information in early 2003.

That testimony is mildly interesting, but does not really mean much because (a) the undisputed record shows that the actual prescription occurred one year before the plaintiff’s heart attacks, not “in the middle” of them, and (b) for the prescriber to say he would have been “much more thoughtful” and would have “thought twice” about prescribing Avandia if he knew in early 2003 the risk information that arose in 2007 does not cut it. The Third Circuit concluded that “the vague and highly speculative nature” of the prescriber’s testimony “suggests no concrete action and it is tied to hypothetical knowledge in 2003.” That is an important ruling, because it is exactly that sort of general, speculative, might’ve-thought-more stuff that plaintiff attorneys usually elicit from prescribers. The plaintiff lawyers then pack up their papers and smugly climb aboard their private jets, sure that they have staved off summary judgment. But they have not (or should not have) staved off summary judgment. Rather, they have walked right into it.

And then there is the inconvenient (for the plaintiff) fact that the prescriber in Siddoway also testified that if he had also known in 2001 and 2002 about the exculpatory information available in 2015, the time of his deposition, when the Food and Drug Administration removed the link between Avandia and an elevated risk of heart attack, he would have made the same choice to prescribe the drug to Siddoway. As we wrote a little more than a year ago, the result in Siddoway seemed “inevitable.” The Third Circuit saw it the same way.

It is now 2019, but we are still finding bits of leftover 2018 business on our desk and in our emails. Towards the end of last year, we encountered an avalanche of good rulings from the Southern District of Indiana in the Cook IVC filters litigation. Here is one we found hidden in the toe of our Christmas stocking: In re Cook Medical, Inc., IVC Filters Marketing, Sales Practices and Product Liability Litigation, 2018 WL 6617375 (S.D. Ind. Dec. 18, 2018). It is nice enough; it is not as if we are going to drive to the mall and return it. But there are some parts to it that we don’t love so much. Those parts are like ugly socks that we deposit in the bottom of a drawer and hope never to see again.

The plaintiff moved in limine to preclude evidence of 510(k) clearance of the medical device. The primary basis for such preclusion was Federal Rule of Evidence 402 – lack of relevance because the 510(k) process does not provide a reasonable assurance of the device’s safety and efficacy. That’s the argument, anyway. Prior to the pelvic mesh litigation, that argument was a sure loser. But, sadly, a couple of the pelvic mesh courts have swallowed this bogus argument hook, line and stinker. (Then again, we know of at least one recent non-mesh decision that rejected the no-510(k) argument, and we were so pleased that we deemed that decision one of the ten best of last year.)

As we have shown in a previous walk-through of this issue, the exclusion of 510(k) clearance is based on an over- or misreading of the SCOTUS Lohr decision, where the High Court contrasted the less rigorous 510(k) process with the Pre-Market Approval process. Lohr included loose language about how 510(k) clearance was limited to substantial equivalence with a predicate, rather than an independent demonstration of safety and efficacy. But SCOTUS itself subsequently reeled in that loose language in Buckman, recognizing that substantial equivalence was, in fact, a way of establishing safety. Moreover, the FDA itself subsequently tinkered with the 510(k) process and its characterization of it so as to make clear that 510(k) clearance is about safety. It is not as if the FDA would clear products it does not believe are safe. So where are we, or where should we be, when it comes to 510(k) clearance? Such clearance might not be enough to preempt a state law tort, but it is still relevant to legitimate defenses and should, therefore, be admissible.

Where does the S.D. Indiana Cook decision fit on the spectrum? It is probably more to the good (pro-defense) side, but not quite as far as we would like. The fact of FDA 510(k) clearance comes in. That’s good. At least the jury will not be under the misimpression that the company unleashed a product on the populace willy-nilly, with no governmental oversight. But … well there’s a big but. (We knew a fellow defense hack who never missed an opportunity to use that phrase in diet drug litigation to get a cheap laugh).

Interestingly, the S.D. Indiana analysis turned on an interpretation of Georgia’s risk utility test for design defect cases, and Georgia law was also at issue in one of the very bad mesh decisions in this area (that we will not and, for reasons of our existing litigation entanglements, cannot name.) Georgia law incorporates the concept of ‘reasonableness,’ i.e., whether the manufacturer acted reasonably in choosing a particular product design. FDA clearance is relevant to such reasonableness. The S.D. Indiana court held that both the plaintiff and the defendant, through appropriate expert testimony, “will be permitted to tell the jury about the role of the FDA in its oversight of medical device manufacturers, the regulatory clearance process for devices like IVC filters, and [Cook’s] participation in the 510(k) process and its compliance (or lack thereof) with the process.”

What do we think of this ruling? It is both good and bad. It is good (and absolutely correct) that clearance comes in. But it is bad, because it seems to welcome plaintiff ‘expert’ testimony that instructs the jury on the law. Why should an expert be able to tell the jury that the company did not comply with the FDA process? Isn’t the fact of clearance itself proof that there was compliance? Is the plaintiff arguing that the FDA erred when it cleared product? Shouldn’t that be up to the FDA? Given the extensive publicity accompanying any mass tort litigation, wouldn’t the FDA have corrected its error, if there really was error? Or is the plaintiff arguing that the FDA cleared the product only because the company hid data and hoodwinked the FDA? If we are not squarely in Buckman-land, are we not at least Buckman-adjacent? Don’t the selfsame policies of deferring to the FDA apply? In other words, isn’t plaintiff’s anti-clearance position preempted?

Thus there is a part of the S.D. Indiana’s ruling that reeks to our (admittedly oversensitive) noses. The defendant is not permitted to present evidence or argument that the FDA’s 510(k) clearance of the device constitutes a finding by the FDA that the device is safe and effective. As set forth above, that ruling is factually incorrect. By contrast, the plaintiff “may present evidence that the FDA clearance process only requires substantial equivalence to a predicate device, that 501(k) regulations are not safety regulations, that Plaintiff’s filter placement was “off label,” and the like.” Wrong, wrong, and whatever “the like” means, we’re sure that’s wrong, too. The 510(k) process does, indeed, address safety. The notion is that relying on a predicate device that was already approved or cleared is a good proxy for safety. There is plenty of regulatory history showing that by devising the 510(k) process, the FDA was not waving bye-bye to the value of safety. Meanwhile, we will all be treated to a blow-hard plaintiff regulatory expert who will take us on a tour of FDA regulations and company documents to tell a tale of a bad company and an overmatched federal government. Some fun. This expert testimony amounts to a preview of the plaintiff’s closing argument. It is so gruesome that we have heard some defense lawyers say that they would just as soon omit the regulatory story altogether. But that’s defeatism. The right result would be for the fact of 510(k) clearance to come in, and then full-stop. There is no need for expert interpretation or interpolation. So for all the trial judges out there who complain that drug and device trials go on too long, here’s an answer: shut down the expert testimony that purports to teach the jury about the regulatory process “and the like.” Always beware of “the like.” And be on guard against “etc.” and “whatnot” as well.

But let’s get back to the good bits of the S.D. Indiana Cook decision. The defendant will be allowed to offer evidence that the device was never recalled by the FDA, that the FDA never observed any violation of the company’s quality system during its inspection between 2000 and 2014, and that the FDA never took any enforcement action against the company. This evidence is relevant to the defense that the design and development decisions were reasonable and that the product is safe. At least this court had some sense of balance.

The S.D. Indiana decision also dealt with the defendant’s effort to use an expert biomedical engineer to talk about the low rate of complaints. She worked at the FDA for over twenty years in various positions and currently serves as a consultant to companies seeking to obtain FDA approval or clearance of medical devices. The expert cited evidence that the device had a fracture rate of 0.066% and perforation rate of 0.153%. The defense expert calculated the occurrence rate by dividing the total number of complaints received by the company (numerator) by the product’s total sales (the denominator).

The plaintiff challenged this expert testimony because “there is no way to know whether these numbers are accurate. Some patients/hospitals may not report adverse events, and some IVC filters may have been sold to hospitals but not used in patients.” The company responded that it did not intend to offer the complaint/occurrence rates as the actual complication rates for the product. With that limitation, the Cook court held that the defense expert’s testimony was admissible.

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.

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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.