Photo of Stephen McConnell

Not even three weeks ago, back on July 28,  we discussed the court’s rigorous application of Daubert in excluding expert medical causation opinions in Smith v. Terumo Cardiovascular Sys. Corp., a federal case in the district of Utah.  The plaintiff had undergone a heart valve replacement surgery.  As is typical, the surgery required use of a perfusion heart/lung bypass machine.  At some point, the machine stopped working for 10-11 minutes.  The patient died of a heart attack 11 months later.    The decedent’s heirs brought suit against various defendants, including the manufacturer of the heart/lung bypass machine.

 

In the opinion we discussed on July 28, the court excluded most of the opinions of a cardiologist tendered by plaintiffs as an expert on causation.  That expert was refreshingly candid in acknowledging that he could not say for sure that the heart attack was caused by any machine malfunction, though he thought the malfunction probably played some role.  Because the cardiology expert himself acknowledged an “analytical gap,” because he was plainly unqualified to render opinions on neurologic issues, and because he relied on diagnostic methods that were not generally accepted, the court limited the cardiologist expert’s testimony to an opinion that the decedent’s heart was injured during the valve replacement surgery.  Not nothing, but not much, either. 

 

Today, we discuss the same litigation with the same Daubert issue with a different expert but a similar result.  Smith v. Terumo Cardiovascular Sys. Corp., 2017 U.S. Dist. LEXIS 124866 (D. Utah August 7, 2017), involves a different plaintiff expert proffered to opine on medical causation.  This expert was a licensed perfusionist.  No one disputed that this expert could opine on the standard of care applicable to perfusionists and facilities where perfusion services are offered.  What was disputed was whether the expert could testify about a potential defect in the heart/lung bypass machine that may or may not have exhibited during the surgery in question.  The expert was going to testify that a defect in the machine’s air bubble detection system led to the inadvertent 10-11 minute shutdown during the surgery.  The expert primarily relied upon a recall of the heart/lung bypass machine that occurred almost two years after the decedent’s surgery.

 

The court begins its analysis in the right place with Federal Rule of Evidence 702.  Then we get a paragraph on how the law favors admissibility of expert testimony.  We wince whenever we read about such a presumption, anticipating judicial abdication of the gatekeeping function.  But that was not the case here.  Rather, the court carefully assessed the expert’s qualifications and found them wanting.  The expert knew all about perfusion and how to operate the heart/lung bypass machine, but that does mean he possessed the requisite expertise to analyze the design and technical functionality of the machine.  The defense deposed the expert, and did a nice job of bringing out the expert’s lack of expertise in mechanical engineering or design.  The existence of the product recall might have been suggestive, but to explain why the recall was issued, and why the reason for the recall also accounted for the device’s stoppage during the surgery, required precisely the sort of engineering or design expertise that was lacking.

 

Even aside from the threshold issue of qualifications, the court concluded that the expert’s opinions were unreliable.  The expert’s report disclosed reliance on depositions, reports, system logs, and medical records.  That sounds pretty good.  But the expert never explained how the facts he reviewed, including the device recall, added up to a defect in the device that prompted the stoppage during the surgery. The expert theorized that the perfusion system might have issued a false alarm, which then resulted in the stoppage, but nothing concrete supported that theory.  Indeed, the expert admitted in deposition that no one could explain exactly how the alleged malfunction occurred.   (More refreshing candor!) The court seized upon something that plaintiffs usually emphasize: the failure to test.  The plaintiff’s expert had never attempted to test his defect theory.  Testing, of course, is one of the key Daubert factors.  In this case, the expert’s failure to test his theory kept him in the realm of speculation, and kept his opinions away from the jury.

 

 

 

 

We’re on vacation. The dog days of Summer are upon us. Time for our annual (okay – monthly) (okay- weekly) substance-less post. Our vacation began just a couple of days ago, yet we already rue its passing. Good times go by in the blink of an eye. We want to get away from the keyboard and back to the beach, so today we aim to keep this blogpost short. And that’s the point: short is good.

Short and sweet. Short and memorable. The Drug and Device Law Son, who recently earned a degree in marketing, reminds us that the best ad slogans are short. Just do it. Think. Coke is it. Think different. The same is true with art. It’s easier to watch half-hour sitcoms than hour-long dramas. We miss the early Woody Allen movies, which seldom lingered beyond 90 minutes. (We are not completely discounting the possibility that our recent obsession with short-form has something to do with bathroom breaks.). Our high school junior year English teacher told us that the two greatest American novels were Moby Dick and The Great Gatsby. We’ve read Gatsby seven or eight times. Moby Dick? Once. Shorter is more user-friendly.

In the law, too, short is good. The best bits of legal instruction ever done were the late Irving Younger’s lectures on cross-examination and evidence. You can find those lectures on YouTube. Younger announces the first rule of cross-examination by looking down to the ground, gathering his forces, then roaring, “Be brief!” Make no more than three points in your cross. Two is better. One is best of all. More than that, and you’re just flopping around. The jury will be bored and/or confused. Then they will punish you.

Think of the closing arguments you’ve seen in television shows (LA Law, Boston Legal, Goliath) or movies (To Kill a Mockingbird, The Verdict, The Client). They last under five minutes and are utterly compelling. Why don’t we see those short, snappy oral arguments in real life? We’re afraid of not making all the points we need, and not responding to all our opponent’s points. Whenever we walk out of an oral argument, what obsesses us are the arguments we did not make. But maybe we’ve got it all wrong. Maybe Irving Younger’s recommendation of brevity applies to oral arguments just as much as to cross-examinations. (It is amazing that this insight arrives as any sort of surprise to us. When we represented the United States of America in criminal cases, our best oral arguments went something like this: “No doubt your Honor has read the briefs. (Wait for a judicial nod.). Unless your Honor has any questions, the government submits on the papers.”).

Shortly before we embarked on our vacation, we attended an oral argument before the Joint Panel on Multidistrict Litigation, If you haven’t been to one of these arguments, you need to know they are unlike any other. The cases are huge but the arguments aren’t. The Panel typically affords a total of 20 minutes for argument. That’s 10 minutes per side – at most. In our case, there were multiple parties on each side, taking a variety of positions as to whether there should be an MDL at all, or who should be included, or where it should be located. Most parties were allocated one or two minutes to argue. One party, which apparently was taking the position that most interested the Panel, got a whopping four minutes.

Here’s the revelation: it worked. The arguments were all really good. One could assume the Panel had read the briefs carefully. The questioning by the judges proved as much. So the goal of argument was to update if need be, emphasize one or two crucial points, and, most important of all, answer the judges’ questions. Each and every lawyer was able to do that quite well. One plaintiff lawyer even used blow-up boards and effectively melded them into a two-minute argument. Sometimes the judges asked questions that took the speaker beyond the allocated time, but never by much. When it was over, no one felt cheated. It was a rebuke to the long-winded ness that too often prevails in our profession.

Right now we have a case set for trial in front of a judge who imposes mightily compressed time limits. The lawyers all chafe under the trial chess-clock, but there is reason to believe that the more concise the witness examinations are, the more they make an impact with the jury. The judge is probably correct that lawyers ramble on, perfectly oblivious to the law of diminishing returns. Still, we will probably grind our teeth and steam over the poor jury’s misfortune in being denied an extra hour or two of our eloquence.

There’s another part of our job that could benefit from brevity: writing. Briefs are ironically named. Lately we’ve been making a point of trying to get our briefs in under ten pages, even if the rules permit 20 or 25. We harbor a suspicion that anything longer taxes judicial patience, and perhaps even convinces the court that if we cannot make the point crisply and clearly, we don’t have much of a point. Accordingly, we put a lot of sweat equity in writing a one or two paragraph introduction that should, by itself, win the day for us. Then we will sprinkle the brief with headings and subheadings that make the merits of our position seem ineluctable. The supporting facts and law parked underneath those headings and subheadings should be just enough and no more. Anything that isn’t screamingly essential gets dropped to footnotes in the second draft. In the final draft, we will probably then delete almost all the footnotes. The life-cycle of marginal arguments and evidence is short and cruel.

The key is to know when to stop.


Last week, we summarized PhRMA’s comments on the FDA’s proposed amendments to regulations regarding “intended uses.”  PhRMA showed how the FDA’s insistence that it could read manufacturer’s minds about intended uses made no sense on an evidentiary basis and ran afoul of First Amendment considerations.  Today, we’ll tip our cyber caps to the Advanced Medical Technology Association (AdvaMed), which also issued well thought-out comments on the FDA’s proposal.  You can read the AdvaMed July 18, 2017 comments here

 

To begin with, the AdvaMed letter excels at doing that thing that judges yell at dumb litigators for not doing in their motions — stating what relief is sought.  AdvaMed puts it plainly: “FDA should abandon the Final Rule and instead return to its original and unambiguous proposal to remove the reference to ‘knowledge’ as set forth in FDA’s September 25, 2015 proposed rule regarding the definition of ‘intended uses.’”  What’s wrong with the FDA’s proposed rule?  It’s bad in its totality, including its reliance the “totality of the evidence” standard.  AdvaMed correctly states that “the ‘totality of the evidence’ standard is more outcome determinative than prescriptive.”  We are reminded of how Justice Black called judicial balancing tests pretentious cover-ups for courts doing whatever they felt like doing.  A totality of the evidence test would mean that the FDA would administer rough justice on a case-by-case basis, sans principle and sans predictability. 

 

That lack of predictability is particularly pernicious where the chilled communications are so critical to public health.  AdvaMed provides concrete examples of communications pertaining to both approved and unapproved medical devices that any right-minded person (and any person who thinks they might someday benefit from advanced drugs and devices – that is, everyone) would favor.  Such communications include training and technical support, educational meetings about clinical trials and development data, feedback from doctors on investigational development, information about real-world experiences with devices, and engagement with health care professionals on device innovation and improvement.  Plaintiff lawyers love to say that drug and device manufacturers have a duty to be the foremost experts on their own products.  The communications potentially chilled by the FDA’s vague, overbroad content-less regulation on “intended uses” are all necessary to facilitate such expertise.        

 

AdvaMed makes the same constitutional argument that PhRMA made, though with some different wrinkles.  AdvaMed discusses the Washington Legal Foundation case from 1998.  The FDA, which raps companies on the knuckles if they are poor at signal detection, should have seen that 1998 case as a very clear signal that its chokehold on truthful off-label communications was unconstitutional.  AdvaMed also does a fine job of applying the Central Hudson requirement that regulation of commercial speech must be narrowly-tailored to serve the governmental interest.   In its request for comments on the proposed rule, the FDA supplied examples of speech restrictions that mostly related to “activities and communications involving the distribution or promotion of illicit drugs.”  There are already non-speech sanctions (including the Controlled Substances act, as well as mail or wire fraud statutes) available to address such criminal activity. 

 

For one brief moment of lucidity, the FDA recognized that a manufacturer’s knowledge that a third party was using a product off-label was not the same thing as the manufacturer’s intent that such product be used off-label.  Then the FDA reversed field, and now we have this new proposed rule.  AdvaMed makes clear that “it is inappropriate to hold manufacturers responsible for the use of their products by third parties over whom they have no control.”  Fairness says as much.  So does a concern for unintended consequences.  The FDA has more than once acknowledged that collaboration between manufacturers and health care practitioners is essential to help develop new life-enhancing or –saving products.  But if manufacturers will be put on the hook for everything they know such collaborators are doing, how can the nature or frequency of such collaboration be unaffected?      

 

AdvaMed concludes its comments with a request that, if the FDA won’t do the right thing and completely back off its wrong-headed “totality of the evidence” test, it should at least issue three clarifications of what would NOT show an intended use: (1) legitimate scientific exchange, (2) truthful, nonmisleading communications, and (3) mere knowledge of third party unapproved uses.  In short, the AdvaMed comments are everything the FDA’s proposed rule is not: clear, fair, and protective of speech and scientific development.   

 

The FDA cannot get out of its own way on the issue of off-label communications. Its power to punish off-label promotion comes from an odd regulatory two-step, whereby off-label promotions are said to prove an indicated use not included in the label and, thus, not accompanied by adequate directions for use – making the product misbranded. The tortured path of this ‘logic’ should, by itself, render this off-label regulatory regime questionable, but the FDA’s recent reaffirmance of it amounts to incoherent defiance.

The FDA takes the position that a company’s truthful, non-misleading statements about off-label use can constitute evidence of an intended use outside the label.  Even while acknowledging that off-label use can be absolutely necessary for some maladies, and even while getting repeatedly clobbered by courts holding that truthful, non-misleading communications about off-label use are protected by the First Amendment, the FDA stubbornly asserts the power to clamp down on such speech.

The FDA’s effort to keep its clamp-down power has been clumsy.  In 2015, the FDA proposed a rule regarding the scope of intended use.  (We have been covering this issue all along. For example, here is a 2015 post by Bexis discussing how the FDA tip-toed into this area, hiding the off-label issue in a notice ostensibly about cigarettes.  Good idea.  After all, in the eyes of the anti-tobacco crowd, the First Amendment hardly exists for some companies.)  One silver lining in the FDA’s proposed rule was that the FDA would “not regard a firm as intending an unapproved new use for an approved or cleared medical product based solely on that firm’s knowledge that such product was being prescribed or used by doctors for such use.”  What a refreshing and rare connection to fairness and reality! It did not last. In the Final Rule published earlier this year, the FDA insists on its right to consider evidence of mere knowledge of off-label use as part of a dreaded “totality of the evidence” standard.  Let the chilling commence.

But the effective date of this misguided Final Rule has been postponed until March 19, 2018.  In the meantime, interested parties may comment.  An extraordinarily thoughtful comment comes from the PhRMA organization, which represents pharmaceutical manufacturers.  Perhaps some will resist reading PhRMA’s July 18, 2017 letter with objectivity, being biased about alleged bias, but you can read it here.  You can see for yourself how the FDA’s not-so Final Rule runs counter to reality and the rule of law.

Here, in summary, are PhRMA’s main points:

1.  FDA cannot establish an intended use absent an external statement by the manufacturer about that use.

The PhRMA letter does a nice job of marshaling precedent and historical practice to prove that the intended use of a product “can be manifested only if the manufacturer conveys that intent to someone who is in a position to buy” the product.  Without that limiting principle, the FDA could attempt to establish a broader intended use via various internal communications.  This is a concern we feel acutely when defending our clients against private party litigations.  One reason that discovery is so ludicrously expensive and burdensome is that plaintiffs want to collect every internal document mentioning the product at issue, looking for some stray someone at sometime saying something that sounds bad, even though it does not represent a final position, or the position of the company at all. Mind-reading is a fool’s errand.  The only reliable evidence is what the company actually said and did in terms of persuading others how to use its products.  Forest Gump might say that ‘off-label is as off-label does.’  A more limited approach focusing on external statements makes sense, serves fairness and judicial economy and, perhaps most important, is fully supported by cases going back at least as far as 1920, ranging to include foods, drugs, and tobacco. For example, in American Health Prods. Co. v. Hayes, 574 F. Supp. 1498, 1505 (S.D.N.Y. 1983), the court read the term “intended” to refer to specific marketing representations.  The PhRMA letter cites several other cases, and offers a compelling argument for a circumscribed interpretation of intended use – one based on reality rather than cynicism and innuendo.  Even aside from the FDA regulatory issue, we wonder whether PhRMA’s argument might support our side in discovery disputes, or might assist us in drafting jury instructions where plaintiffs managed to smuggle allegations of off-label promotion into the case.

2.  Overly restrictive regulation of truthful, non-misleading communications to health care practitioners about unapproved uses violates the First and Fifth Amendments.

Over the last decade-plus, courts have been constantly reminding all of us, including the FDA, that the First Amendment protects commercial speech, and that truthful, non-misleading communications about off-label uses are included in such protection.  The hits just keep on coming.  Not to put too fine a point on it, the FDA’s position on off-label communications has been thoroughly undermined by recent cases.  The FDA’s exercise in wish-fulfillment simply cannot coexist with the SCOTUS opinion in Sorrell, which applied heightened scrutiny in striking down a law that restricted pharmaceutical manufacturer communications with healthcare professionals. The FDA’s “totality of the evidence” standard, besides being vague and overbroad, is certainly not the least restrictive means to protect the integrity of its drug approval process.  The Second Circuit’s Caronia decision directly refutes the FDA’s policing of truthful, non-misleading communications about off-label uses.  Apparently, all that the FDA can do in the face of Caronia is wish that it would go away.  The SDNY decision in Amarin is similarly fatal to the FDA’s position.  The PhRMA letter rips into the FDA’s efforts to prop up the proposed rule, laying waste to dicta and distinguishing away the few cases cited by the FDA.  If this debate was a little league game, it would be called on the basis of the slaughter rule.  But our concern is whether the FDA will dispassionately listen to the arguments and pay attention to the law.  In truth, we are not certain that the FDA will approach this issue with even the fairness we expect to get in a little league game.

We depend on young associates to perform most of the legal research that supports the arguments we make on behalf of our clients.  By and large, those associates do an excellent job.  On those rare occasions when we find ourselves grousing about the quality of research, it usually has something to do with reliance on overly-specific computer searches.  Sometimes it seems as if the lawyers punch a search term into Lexis or Westlaw that would capture only cases that are precisely on point.  The problem with that approach is the possibility of missing cases that support general principles, or offer other oblique ammunition for one’s position.  Today’s case, Canale v. Colgate-Palmolive Co., 2017 U.S. Dist. LEXIS 97506 (S.D.N.Y. June 23, 2017), is an example of that kind of helpful, albeit indirect, authority.  The plaintiffs in Canale filed a class action attacking the defendant for allegedly overstating the whitening power of its toothpaste.  The toothpaste contained hydrogen peroxide, and its advertising bragged of deep whitening – more than three shades.  The plaintiffs asserted that the hydrogen peroxide was not strong enough and was not in contact with tooth enamel long enough to achieve the promised results.  The causes of action were based on breach of warranty and violations of New York’s General Business Law sections 349 and 350, which outlaw deceptive practices and false advertising.

What can this case possibly have to say for drug litigation?  To begin with, the toothpaste’s peroxide content meant that it was both a cosmetic and an over-the-counter (OTC) drug.  A product qualifying as both a cosmetic and drug is subject to the stricter requirements applicable to drugs.  Either way, such a product enjoys the preemption protections in the Food, Drug and Cosmetics Act,  21 U.S.C. sections 379r and 379s.  The FDCA forbids state law (including jury verdicts) or regulations that would impose a requirement on cosmetics or OTC drugs that are “different from or in addition to, or that is otherwise not identical with, a requirement specifically applicable” via the FDCA.  Thus, the defendant filed a motion to dismiss the case in its entirety, and preemption was one of the grounds. The plaintiffs ultimately evaded preemption because the court found no FDA requirement regarding the tooth whitening claim, so there was nothing federal that the state laws against deceptive advertising  contradicted.

Okay, you’re still probably wondering why a drug defense hack would care about this case.  If an associate failed to find this case in her research, who cares?

There are two preemption points in Canale that are valuable:

1. The plaintiffs’ opposition to the defendant’s motion rested solely on implied preemption cases.  That is, the plaintiffs argued that there was no impossibility preemption.  That is, the plaintiffs had completely missed the point.  The defendant was not arguing impossibility preemption.  Rather, the defendant argued that Congress had expressly manifested an intent to preempt state law.  The plaintiffs had confused express preemption with implied preemption, but the Canale court kept the distinction straight.  So should you.

2.  The plaintiffs, predictably, argued that there was a presumption against preemption.  But, consistent with point 1 above, the Canale court held that “where, as here, Congress has expressly manifested its intent to preempt state law, no presumption against preemption arises.”  It is nice to have in your pocket such a clear statement on this issue from SDNY.

Still, as we mentioned, the preemption argument did not carry the day for the defendant.  So was this a win for the plaintiffs?  Not at all.  The issue of whether or not the advertising for the whitening toothpaste was deceptive had already been addressed to the Federal Trade Commission.  The issue was pending. The FTC had at least as much expertise as the court in deciding whether the hydrogen peroxide in the toothpaste had sufficient whitening power (let’s face it, the FTC has more expertise), the FTC is specifically tasked with discretion to police allegedly deceptive labeling, there was a risk of inconsistent rulings, and the FTC had gotten the issue first.  Consequently, the Canale court – after observing that “primary jurisdiction” is something of a misnomer because it isn’t , strictly speaking, jurisdictional – decided to stay the litigation to allow the FTC to do its job and determine whether the toothpaste advertising really was deceptive.

Staying a class action is definitely a good result for the defendant.  Despite the setback on the preemption front, we bet the Canale result put smiles on the faces of the defendant and its lawyers – nice, big, shiny smiles.

New Mexico is called the Land of Enchantment, but when it comes to law it is the Land of You Can’t Make this Up.  You might think it weird that New Mexico’s state constitution (Article VII, section 1) specifies that idiots aren’t allowed to vote, but maybe it’s the other 49 states that have it wrong. Then again, New Mexico did give us the McDonald’s hot coffee case, which ranks right up there with poor Mrs. Palsgraf’s conked noggin among significant injuries in the history of American tort law.  If you don’t remember the facts of Palsgraf v. Long Island R.R., please enjoy this Lego version.  We’ve heard rumors (we haven’t bothered to scour the New Mexico statutes) that New Mexico law frowns on letting ladies pump their own gas, and one can apparently get in trouble with the authorities there by dancing either around or under a sombrero.  And let’s not forget that tv-dom’s number one lawyer is no longer Perry Mason, Ally McBeal, or any of the denizens of the McKenzie Brackman law firm in LA – no, it’s Saul Goodman of Albuquerque.  We first met Saul on Breaking Bad.  Saul had his charms, but it is hard to imagine a sleazier lawyer. Now he is the protagonist (?) in one of the best current shows, Better Call Saul.  If you haven’t yet taken a look at the show, do yourself a favor and give it a try.  The writing, the acting, the camera work — s’all good, man.
It’s good to know that idiots can’t vote in New Mexico.  Can they bring lawsuits?  Ponder that question.  Don’t ponder too long.
Today’s lesson centers on the recent case of Inge v. McClelland, ___ F. Supp. 3d ___, 2017 WL 2829696, 2017 U.S. Dist. LEXIS 98386 (D.N.M. June 26, 2017). The plaintiffs alleged that the defendant pharmacy wrongly sold them opioids, and that the result was that the plaintiffs got addicted and suffered all the terrible sequelae of said addiction.  The plaintiffs lost their jobs and lost custody of their children. The legal theories included federal RICO, various New Mexico common law torts, as well as violation of New Mexico’s Unfair Practices Act.  The factual assertions are rather arresting: the pharmacy dispensed thousands of opioid pills at potency levels given to end-stage cancer patients – which these plaintiffs most certainly and obviously were not.
Pretty strong case, right?
Oops, we left something out.  You see, the plaintiffs had conspired with a nurse practitioner to write up fraudulent prescriptions.  The plan was to find a pharmacist with flexible professional ethics or an exceedingly limited attention span. The plaintiffs would then procure the pills and split them with the nurse practitioner.  It’s not clear whether getting addicted and descending into a hellish fog was part of the plan, but that’s what happened.  Somehow the plaintiffs were able eventually to rouse themselves from their opioid torpor and file this lawsuit.
The defendant moved to dismiss the case because the claims were barred by the wrongful conduct rule and its corollary, the in pari delicto doctrine.  Anytime we can hearken back to our high school Latin days, we will.  In pari delicto is short for the phrase “in pari delicto melior est conditio possidentis,” which means, roughly, “in equal fault, better is the condition of the possessor.”  Great Caesar’s ghost, what does that mean?  Well, all is made crystal clear in a post that Bexis wrote nearly ten years ago setting forth the in pari delicto rule and supplying a list of cases from several jurisdictions.  (We wondered whether it was high time to update that list, but then Bexis told us that a reasonably current list of in pari delicto cases resides in his book.  Tell your librarian to get that book!)  The rule is based on a public policy to preclude anyone who injures him or herself in the course of criminal activity from recovering in tort for those injuries.  Put another way, perhaps more appetizing for those of you who delight in legal jargon, criminal conduct is an intervening act that cuts off liability.  In drug cases, that criminal activity usually involves plaintiffs who obtain prescription drugs under false pretenses. The drugs obtained are almost always some form of narcotics, as was so in the Inge case.

New Mexico law has a version of the wrongful conduct rule, and it operates as a complete bar to a plaintiff’s case.  Acquisition of narcotics through fraudulent prescriptions is a violation of both federal and state law.  So is narcotics trafficking, which the plaintiffs admitted to when they said they were going to split the pills with the nurse practitioner.  Most versions of the in pari delicto rule limit application to instances where the harm suffered is one that the violated criminal law was intended to avoid. In Inge, the alleged injury – addiction – was precisely the harm at which the criminal laws were aimed.

This case is a laydown, isn’t it?

Yes, it is.  But that’s not to say that the plaintiffs in Inge offered no resistance.  The plaintiffs argued that merely presenting false prescriptions was not, in itself, illegal.  Even assuming there is any force to that argument, the plaintiffs admitted that the scheme was to share the drugs with the prescribing nurse practitioner.  That is straight-up illegal.  (We prosecuted drug cases long ago.  We harbored no love for the crazy-long federal mandatory minimum sentences, but it was hard to shed a tear for the drug-dealers.  We wouldn’t have felt any sympathy for the Inge plaintiffs, and, based on the facts set forth in the court’s opinion, we would not even have considered a plea agreement that did not lock in some jail time.)  The Inge plaintiffs also argued that their conduct was less culpable than the defendant pharmacist, since nothing would have come to fruition without the defendant’s alleged agreement to fill obviously bogus prescriptions.  They also offered the inevitable argument that the defendant’s misconduct, as a licensed pharmacist, was worse than the misconduct of [supply your own epithet for drug-abusers and/or drug-dealers].  The court did not buy these arguments.  It is not as if the pharmacist forced the plaintiffs to concoct and follow through on this opioid abuse and distribution scheme. Moreover, however serious the pharmacist’s alleged breach of professional ethics was, it did not make the plaintiffs’ illegal conduct somehow legal.

Interestingly, the Inge plaintiffs also argued that, rather than operate as a full-blown bar to their action, the in pari delicto rule should come into play as an element of comparative fault that the jury could consider.  In support of this argument, the plaintiffs cited a case from West Virginia, which allowed a case very like the Inge case to proceed.  West Virginia, of course, has a significant opioid problem.  See Talbot, “The Addicts Next Door,”  The New Yorker (June 5/12, 2017).  You could quarrel with the West Virginia decision, and you could quarrel with the public policy view underlying such decision, but none of that mattered to the Inge court, because it wasn’t the law of New Mexico.
As a final, and somewhat comical point, the court dismissed the unfair practices claim along with all the others, because whatever else you might say about the defendant pharmacist, he did not make any misleading, false, or deceptive statement in dispensing the pills to the plaintiffs.  Nope, they got exactly what they asked for — and then they got into trouble.  But what they didn’t get was an opportunity to recover damages, including treble RICO damages, in a frivolous lawsuit.

Naturally, anytime you hear of a drug dealer case in New Mexico, you probably think of Breaking Bad.  This time, it’s more like Breaking Stupid.

More than once we’ve said that we read law review articles so you don’t have to.  We separate the wheat from the chaff. The wheat is scarce.  That is because law review articles usually drown the little bits of objective description of what the cases DO say with enormous chunks of pie-in-the-sky suggestions of what the cases SHOULD say.  Such suggestions almost always go nowhere.  When they do go somewhere, as in the famous long-ago Fordham Law Review article that advocated market-share liability, they go someplace very bad.  Have we mentioned that law review articles, whether written by professors or students, tend to be pro-plaintiff?

But the law review article at issue today, Conners, “Illuminating the Off-label Fable: How Off-label Promotion May Actually Help Patients,” 13 Journal of Law, Economics & Policy 91 (Winter 2017), is one you might actually want to read yourself.  It is a sane, clear-eyed appraisal of why off-label use of drugs or devices can be necessary, why truthful communication about benefits of off-label use can be necessary, and why current FDA regulation of off-label communications is incoherent and harmful to patients.

The first paragraph of the law review article sets the agenda nicely:

“The current framework of the off-label use of pharmaceuticals is as follows: physicians are free to prescribe off-label as they see fit; the Food and Drug Administration (“FDA”) acknowledges the value of off-label use (going so far as to say physicians could have an obligation to prescribe off-label in certain circumstances); but, per FDA policy, drug manufacturers are restricted from sharing truthful and non-misleading information about off-label uses.  The scheme, on its face, is inconsistent and, as could be expected, raises significant concerns regarding free speech, consumer protection, and public safety.”

The article sets forth –

* the importance of off-label prescriptions (one out of every five)
* the FDA’s position that “when a manufacturer promotes a drug for a use that has not been approved, the manufacturer is guilty of misbranding and as having an intent to defraud or mislead”
* the evolving protection of commercial speech promoting pharmaceuticals, from Virginia Board of Pharmacy to Thompson to Sorrell to Caronia to Amarin to Pacira.  Courts keep relying on the First Amendment to shut down the FDA’s efforts to shut down truthful off-label communications, and the FDA keeps pretending that the court rulings are case-specific and do not affect the FDA’s overall policy against off-label promotion.

The article makes the FDA seem either clueless or defiant.

Last week, we discussed a Ninth Circuit case about the intersection of the First Amendment and regulation of alcohol advertising.  We wondered whether the court’s ruling had any implications for regulation of drug marketing.  We also wondered whether the recent SCOTUS decision in Matal, which struck down the anti-disparagement provision in copyright law, had any implications for regulation of off-label communications.  We are still wondering.  The Conners article does not spend as much time wondering about the future path of first amendment jurisprudence.  Instead, it makes the point that the FDA’s truculence and incoherence on the issue are bad for patient welfare.  Here are the main points:

* barriers to truthful off-label communications ensure that poorer patients will get less access to life-saving medications.
* regulatory compliance has been reduced to guesswork
* uncertainty about the scope of regulation reduces investment in new drug research

The article reminded us of something we learned in our Elements of the Law class taught by Edward Levi at the University of Chicago Law School back in 1982.  Levi introduced us to the writings of Jeremy Bentham, the utilitarian philosopher.  Bentham favored freedom of expression, abolition of slavery, equal rights for women, and decriminalizing homosexual acts.  On the other side of the ledger, he wrote an article mocking the Declaration of Independence, and he called the concept of natural rights “nonsense upon stilts.”  We studied Bentham in our Elements class because Bentham eloquently made the point that the law needed clear ex ante rules to guide future conduct.  Otherwise, all we have is “dog law.”  When you come home from work and find that Fido has piddled on the kitchen floor, there is a temptation to whack Fido’s behind with a rolled up Times, Inquirer, or Picayune. Bad dog! But poor Fido does not put the punishment and offense together. FDA punishment of off-label communications is sort of like that. It is not predictable.

Or maybe we’ve got the analogy wrong.  Maybe it is the FDA that is piddling on the First Amendment.

Last week we bashed a Ninth Circuit Daubert decision.  We feel a little bit bad about that, not because the decision wasn’t bashworthy – no, Wendell really is a rotten precedent – but because we hate contributing to the chorus of defense hacks who bemoan the Ninth Circuit’s supposedly liberal, pro-plaintiff bias. You see, we began our legal career out West and would still be there but for a simple twist of fate.

When we clerked for the great and good Circuit Judge William A. Norris in Los Angeles, we were in the Ninth Circuit. Norris possessed both high principles and brilliant technical reasoning.  He grew up in a western Pennsylvania Gold Star family, served in the military, graduated from Princeton U. and Stanford Law, clerked for Justice Douglas, became a preeminent litigator who would beat you whether the issues were constitutional, administrative, or commercial, ran Bobby Kennedy’s 1968 California Primary campaign that saw success turn into tragedy, founded a major museum of contemporary art, and became a judicial giant who produced brilliant opinions and a lineup of SCOTUS clerks.

Norris did not fret over the Ninth Circuit’s reputation for SCOTUS reversals.  He tried to get things right.  Sometimes that meant getting out ahead of SCOTUS, as with his Watkins decision, which anticipated equal protection of gay rights. Working with Judge Norris was a privilege.  If there is an ounce of value to our legal writing, then most of that ounce comes from sessions sitting next to Norris in front of a computer screen, editing opinions word by word.  He insisted that the writing be concise and powerful.  He would bark out in joy whenever we eliminated unnecessary words.  Clear writing came from clear thinking, and Norris’s lightning fast brain always took a logical path through complexity.

Norris passed away this last January, filling us with grief and leaving us feeling like a judicial orphan.  A few months before his death, Judge Norris completed his autobiography, Liberal Opinions: My Life in the Stream of History.  It is a remarkable and uplifting story. Norris carved out a sparkling career in the law.  He also offered splendid advice, including the need to go with one’s gut.  (But do not follow this advice if your gut is an idiot.) We were startled to see on page 188 a quote from this blog defending the Ninth Circuit’s reputation.  Judge Norris’s approval meant – means – a lot to us.

The Ninth Circuit is vast.  It contains multitudes.  When we took our first deposition in San Diego, in a case involving (so help us) stolen dirt, we were in the Ninth Circuit.  When we interviewed a witness in the FBI’s Honolulu office, we were in the Ninth Circuit. When we traveled with DCIS agents and postal inspectors to Las Vegas to round up a check-stealing ring, we were in the Ninth Circuit.  When we did a presentation on litigation and pop culture at the hotel that was the setting for the Twin Peaks television show and movie (Snoqualmie Falls, Washington) we were in the Ninth Circuit.  When we took home the Drug and Device Law Infants from Cedars Sinai Hospital in Beverly Hills, we were in the Ninth Circuit. So were we when we carried those kids on backpacks through Yosemite Valley and, later, hiked alongside them past Yellowstone’s geysers.   (Now we’re just getting sentimental.). Here’s the point: is it any wonder that the Ninth Circuit has, not just the most opinions of any Circuit, but the broadest range of issues and a sometimes perplexing array of outcomes?  Petulant calls to divide this magnificent Circuit, which contains one-fifth the country’s population, make no sense.  How to divide?  Create a California-only Circuit? That would be unprecedented.  Plus, we’d certainly get more Circuit splits.  What’s good about that? Why do we insist on dwelling in echo-chambers, occasionally stepping outside only to hurl invectives? The Ninth Circuit is a model, not a problem.

Which is not to say that the Ninth Circuit is free from mistakes.  We already mentioned Wendell.  Today, we are discussing a case that seems headed for the Supreme Court.  We do not know if it contains mistakes – it turns on a nice issue of first amendment law, and we know just enough about that area to know there are plenty of people out there who know more.  Retail Digital Network, LLC v. Prieto, 2017 WL 2562047 (9th Cir. en banc June 14, 2017), matters to us because it turns on an interpretation of the SCOTUS Sorrell decision from 2011.  We have blogged about Sorrell several times.  For example, check out this post.

Here is a brief Sorrell refresher.  Vermont passed a law preventing pharma retailers from accessing information about which physicians prescribe which drugs. Data miners, who gathered and disseminated such information, challenged the Vermont statutes as violating the first amendment.  SCOTUS struck the statute down.  Our favorite part of the decision is that “[s]peech in aid of pharmaceutical marketing … is a form of expression protected by the Free Speech clause of the First Amendment.”  The Sorrell court held that the Vermont statute disfavored marketing, that is, speech with a particular content, and disfavored specific speakers, namely pharmaceutical manufacturers. In arriving at its result, the Sorrell court did not exactly follow the dance-steps set out in the Central Hudson commercial speech test.  The Sorrell court referenced “heightened scrutiny,” which is different terminology from the “intermediate scrutiny” in Central Hudson.

So what?  What indeed. When we first discussed the Sorrell case, we wondered what the case meant for constitutional protection of truthful off-label communications.  We also wondered whether Sorrell had expanded protection of free speech beyond Central Hudson.

It is that latter question that the Ninth Circuit en banc panel confronted in Retail Digital Network.  That case involved regulation of the marketing of alcohol, not pharmaceuticals, but the animating principles are potentially important for both.  California law prohibits alcohol manufacturers and wholesalers from providing anything of value to retailers in exchange for advertising their products.  In a pre-Sorrell Ninth Circuit case called Actimedia, the Ninth Circuit had applied the Central Hudson test to uphold California’s law, holding that it directly advanced important state interests in separating alcohol manufacturing, wholesale, and retail interests, as well as the state’s interest in temperance. The district court felt bound by Actimedia, and upheld the statute.  The original Ninth Circuit panel in Retail Digital Network held that Sorrell had created a more demanding first amendment test, that, consequently, Actimedia was no longer good law, and that the district court needed to consider whether the California statute could survive Sorrell‘s  “heightened scrutiny.”  The en banc panel reversed the original panel’s reversal of the district court. (Got that?).

The en banc panel reasoned that Sorrell had not really changed the Central Hudson test in any substantive way.  The “heightened scrutiny” phrase was merely intended by SCOTUS to mean more heightened than rational basis review.  In other words, “heightened” equals “intermediate.”  Thus, Actimedia was still good law.  Mostly.  The Retail Digital Network en banc panel concluded that Actimedia was correct that the California statute advanced the state’s interest in separating manufacturing, wholesale, and retail players in the alcohol industry.  California has a legitimate interest in ensuring that advertising payments are not disguised forms of kickbacks and methods of securing vertical and horizontal integration harmful to consumers.  But the en banc panel no longer bought the proposition that restriction of payments for retail advertising would reduce overall  alcohol consumption.  At best, such a restriction might indirectly serve the temperance goal, and that does not cut it under Central Hudson.  Still, the California statute survives.

What to think about the Retail Digital Network opinion?  From our point of view, whether applying “heightened” or “intermediate” scrutiny, we think truthful off-label statements should be protected speech.  The term “promotion,” which seems meant to be pejorative, should not alter the analysis.  We’re not sure that the en banc opinion pays enough attention to the Sorrell discussion of content- and speaker-specific regulations. It’s perhaps too simplistic to say that all commercial speech is content- and speaker-specific. The FDA would be the first to say that it is regulating what manufacturers say, but not what doctors or researchers say.  Will SCOTUS reverse the en banc panel’s reversal of the original panel’s reversal of the district court’s strike-down of the statute?  (Got that?). Keep in mind that the Ninth Circuit en banc panel is joining the Second, Fourth, Sixth, and Eighth Circuits in holding that the Central Hudson test for commercial speech lingers beyond the Sorrell holding.  Moreover, the make-up of the Ninth Circuit panel (remember, Ninth Circuit en banc panels do not include all the active judges in the Circuit) is interesting.  The only dissenter was Chief Judge Thomas. (The Chief Judge is always on en banc panels).  All the other judges voted that Central Hudson still supplies the test.  Among those judges in the majority were Kozinski and Reinhardt. When those two judges, universally considered among the most brilliant judges from the conservative and liberal schools, respectively (yes, we know that is a vast simplification, but forgive us), agree on something, one should be slow to predict SCOTUS reversal.

Then again, Monday’s SCOTUS decision in Matal v. Tam, which struck down the rule against trademarks that disparage persons, might have something to say about Retail Digital Network.  Most commentators have discussed what the Matal case means for the Washington D.C. National Football League team.  But Matal also applied a very muscular version of the Central Hudson test in holding that the non-disparagement provision was not a sufficiently “narrowly drawn” means of advancing “a substantial interest.”  One such asserted substantial interest in Matal was the orderly flow of commerce.  That is not exactly the same interest sustained by the Ninth Circuit in Retail Digital Network, but it is pretty close.  Stay tuned.

Let’s start with a shameless plug: the author of this post, along with Sean Wajert (Shook Hardy & Bacon), will present a Strafford webinar on June 21 entitled, “Daubert/Frye Motions in Product Liability Litigation: Bringing or Defending Challenges to Expert Witness Evidence.”  Here is the link.  We will cover a lot of areas and a lot of cases.  Odds are good that the most recent case covered will be Wendell v. GlaxoSmithKline, LLC, 2017 WL 2381122 (9th Cir. June 2, 2017).  That’s too bad, because it is not a well-reasoned case.  It is a backwards step in Daubert analysis. For people who favor rigorous application of Daubert to keep junk science out of the courtroom, the Ninth Circuit’s Wendell decision is the worst sort, because it reverses a district court’s exclusion of expert opinions lacking support in epidemiology, animal studies or biologicals plausibility — meaning Wendell said it was an abuse of discretion for the district court to exclude the opinions.  That is the kind of precedent that can turn nervous judges from gatekeepers to matadors who grimly wave junk science along to the jury.

The plaintiffs in Wendell alleged that their son died because medicines used to treat inflammatory bowel disease (IBD) caused him to develop cancer.  The plaintiffs proffered two causation experts, but the district court found their opinions unreliable and, therefore, inadmissible under Federal Rule of Evidence 702.  The court subsequently granted summary judgment in favor of the defendants.  A key issue on appeal was the district court’s exclusion of the plaintiff experts’ opinions.  The district court had identified several problems with those opinions.  Here are some:

– The opinions were litigation-driven, were based on no independent research, and would not satisfy the standards for peer-reviewed journals.
– No animal or epidemiological studies showed a causal link.
– The studies cited by the experts did not show that the specific combination of drugs prescribed to the plaintiffs’ decedent actually caused the injury at issue.
– The experts did not present any scientific evidence excluding IBD itself as a risk factor for the injury.

The Ninth Circuit called it “a close question” in concluding that the district court erred in excluding the expert testimony. In the eyes of the appellate court, the litigation-driven, non-study-supported, non-alternate-cause-excluding nature of the expert opinions should not overcome the facts that the experts were “highly qualified doctors” who had performed a “differential diagnosis” in arriving at their opinions.  The Ninth Circuit’s analysis is unsatisfactory.  First, the qualifications of the experts is a different issue from reliability of their methodologies.  Under Rule 702, a qualified expert may testify if her testimony would be helpful to the jury, if she relied upon the appropriate facts/data, if she employed reliable methods, and if she reasonably applied those methods to the facts of the case.  That is, qualifications are a precursor to reliability, not a substitute for it.  If a Nobel prize winner renders an opinion based on astrology or phrenology, that opinion should be excluded no matter how impressed we are to be in the presence of such a luminary.  Second, the Ninth Circuit looks at each of the methodological problems identified by the district court one-by-one, and repeatedly holds that the deficiency by itself (e.g., lack of animal studies), cannot exclude expert testimony.  Maybe so, but when the opinions of an expert (no matter how well qualified) are beset by so many deficiencies, how can it be an abuse of discretion for a diligent district court to decide that the opinions do not pass muster?  In truth, the Ninth Circuit did not apply anything close to an abuse of discretion standard of review.  Rather, it engaged in a de novo review of the expert opinion issue, and did so in a remarkably wrong-headed fashion.  The results of this precedent could be seriously damaging.  If sparkling CV’s and invocations of “differential diagnosis” (and that’s not what was done by the experts by the way, but that’s a different point) can get causation opinions and a case to a jury, then Daubert has been diluted to the point of meaninglessness.

We will mimic the style of the great television critic Alan Sepinwall and end with some random observations:

– Along with two Ninth Circuit judges, the Wendell panel included a Vermont district judge who had authored an outlier opinion predicting that Vermont would adopt innovator liability.

– The Wendell opinion cites the Ferebee opinion from the D.C. Circuit.  Ferebee is seldom a harbinger of anything good for defendants.

– The Wendell opinion is sufficiently bad and problematic to merit en banc or Supreme Court reversal.

 

In the annals of history, June 6 gets prime billing.  That’s understandable, because the successful Normandy landings on D-Day (June 6, 1944), probably saved Western Civilization.  (Or maybe that heroic endeavor simply preserved liberal democracy for another 75 years, now that we seem encircled by fanatics both home and abroad who view the Enlightenment with disdain.)  But June 7 is no slacker.  On June 7, 1776, Richard Henry Lee introduced the Lee Resolution, which later became the Declaration of Independence. 364 days before D-Day, the American Navy decisively won the Battle of Midway, which turned the tide of the Pacific War.  On June 7, 1892, Homer Ferguson refused to leave the whites-only part of a train.  He later lost his Supreme Court case, Plessy v. Ferguson.  That opinion upheld “separate but equal,” a nasty judicial stain that would not be scrubbed away until 1954.  (SCOTUS Lesson #1: Horrible Supreme Court precedents can be overturned, but it can take a terribly long time – almost as long as the interval between NBA Finals games.)  One year later, on June 7, 1893, an Indian barrister offered a very similar refusal in South Africa.  That refusal is usually counted as Gandhi’s first act of civil disobedience.  And on June 7, 1965, the Supreme Court issued its decision in Griswold v. Connecticut, holding that married couples have a constitutional right to contraception.  Maybe there are people in 2017 who regret that decision (see our overly political parenthetical above) but we’d be surprised to meet such people, just as we’d be surprised to meet people who regret Brown v. Board of Education.  Still, the High Court arrived at that sensible result via a fuzzy analysis (e.g., “penumbras” and “emanations”) that could justify just about anything.  (SCOTUS Lesson #2: Good results and good reasoning do not always operate in tandem.)

In the passage of time, whether viewed as a Hegelian movement of ideas or as merely One Damned Thing After Another, June 7 is a significant date.  Now here comes the inevitable strained segue: today’s case, In re Cook Medical, Inc. IVC Filters Marketing, Sales Practices and Product Litigation, 2017 U.S. Dist. LEXIS 82761 (S.D. Indiana May 31, 2017), is about the passage of time.  More specifically, it is about how statutes of repose apply in drug and device litigation.

We do not often get a chance to write about statutes of repose.  We get more opportunities to discuss statutes of limitations, though we infrequently seize those opportunities, because the issues are usually fact-specific and obvious.  By contrast, statutes of repose present interesting legal issues, and their force can be devastating to tardy claims.  In the In re Cook Medical case, the defendant made a motion on the pleadings to dismiss claims on the ground that they were precluded by statutes of repose.  The court wrestled with three different statutes of repose:  Georgia, Tennessee, and Texas.  The differences among those statutes resulted in different dispositions of the claims by the various IVC Filter plaintiffs’ claims.

Georgia

The Peach State bars claims for strict liability, negligence, or breach of warranty if the suit is not brought within ten years from the date of the first sale.  The Georgia plaintiffs’ claims in this case were filed more than ten years after the sale.  Buh-bye, right?  Not so fast.  Georgia’s statute of repose contains an exception if the defendant manufacturer engaged in conduct manifesting “willful, reckless, or wanton disregard for life or property.”  The plaintiffs argued that they had alleged such conduct.  How? it is not clear from the opinion.  Please excuse a slight rant.  It seems far too easy for drug and device plaintiffs to allege that any failure to warn equals reckless or wanton conduct.  Courts need to clamp down on this all-too-easy way to maintain settlement leverage or exploit jury anger.  Not adding a warning in the face of controversial or mixed studies should not be the stuff of punitive damages.  Maybe someday courts will wake up to this nonsensical hole in product liability law.  End of rant.  The In re Cook court was not such a court.  But it did limit the damage. It held that that the willful/reckless/wanton exception applied only to negligence claims, but not to strict liability and warranty claims.  Thus, the court dismissed the strict liability and warranty claims per the statute of repose.  The negligence claims remained.  So did the consumer fraud claim, which the court held was not subject to the statute of repose.

Tennessee

Tennessee also has a ten year statute of repose, though apparently not the willful/reckless/wanton exception.  At least no such exception was raised in this case.  The Tennessee plaintiffs conceded that the strict liability claims were doomed, but they tried to keep their negligence and warranty claims alive.  Nice try, said the court, but Tennessee’s Product Liability Act defines “product liability action” to include all of the plaintiffs’ claims.  That did not quite end the debate. The plaintiffs pointed out that Tennessee extended the statute of repose to 25 years for asbestos and silicone gel implant claims.  Why should those claims get such special treatment?  Never you mind, said the court, which applied the rational basis test and concluded that the Tennessee legislature was allowed to make such distinctions.  Sure, IVC Filters might pose risks of latency, but the constitution does not compel legislators to treat all latent defects the same.  Put another way, “[i]t is no requirement of equal protection that all evils of the same genus be eradicated or none at all.”  In re Cook Medical, IVC Filters Prods. Litig., 2017 U.S. Dist. LEXIS 82761 at *14, quoting other cases.  The court dismissed all of the Tennessee claims.

Texas

“T for Texas, T for Tennessee.”  Those two states go together musically (see Guy Clark, Willie & Waylon, Lynyrd Skynyrd, etc.).  Here, they also go together legally, as the defendant prevailed on the statutes of repose from both states.  The Texas statute of repose is for 15 years.  (Of course it is bigger.  This is Texas.)  But there is an exception if the manufacturer/seller explicitly warrants that the product has a useful life longer than 15 years. The Texas plaintiff attempted to save her claims by filing an affidavit, wherein she said she was told that the device was permanent, and the Patient Guide, which stated that the IVC Filter was “safe and effective as either a permanent or temporary device.”  But this was a motion on the pleadings.  Outside materials are not allowed.  Looking just at the complaint, there was no allegation that the IVC filters were marketed as permanent devices.  That is very, very bad for the plaintiff:  “As this is a motion for judgment on the pleadings, the omission of her specific warranty allegations is fatal.”  Id. at *18.  You might think that is an extraordinarily severe result.  No matter. The court observed that even if the allegations of permanence were included in the complaint, the claims would still not fly, because the plaintiff nowhere alleged any specific person who warranted permanence, and nowhere alleged any reliance on such warranty of permanence. As for the Patient Guide, the plaintiff did not allege in either her complaint or her affidavit that “she read the Guide before her surgery, much less that she relied on the Guide rather than her own doctor’s recommendation.”  Id. at *20.  Accordingly, the exception to Texas’s statute of repose did not apply, the statute of repose did apply, the claims were timed-out, and they had to be dismissed.