Returning to a Favorite Spot

            One member of our blogging team (we’ll let you guess who) recently returned from her (well, that narrows it down a bit) first real camping trip.  The kind with a tent, sleeping bags, no electricity.  You get the idea.  This wasn’t just a step, but rather a huge leap outside this blogger’s comfort zone – which runs more toward poolside bar service somewhere where the view is only obstructed by palm trees.  Before the trip images of big red welts from mosquito bites, spiders and ticks taking up residence in our hair, and critters of any size wandering around at night left us more than a little disconcerted.  An ample supply of wine was stowed with the gear.  A Google maps search had located nearby hotels.  And the iPhone car charger was packed.  We were ready for anything.

            Most importantly, as it turns out, we were ready for some fun.  The weather near the Appalachian Trail in Pennsylvania was almost perfect.  Sunny and warm during the day.  Just chilly enough at night to make you want to huddle around the camp fire.  Perfect weather for hiking, fishing, roasting marshmallows and hot dogs, and telling ghost stories.  The perfect environment for separating the kids from their DVD players, iPads and assorted other portable electronic devices – something we quickly realized was necessary when, as we drove into the mountains we heard from the back seat:  Wow, it’s like a real life 3D movie.  Yikes! (But don’t tell them about the car charger). 

            Perhaps best of all was the stillness of the early mornings.  No alarms going off.  No sounds of traffic congestion.  No being bombarded by streaming bad news from all over the world.  Just big, deep breaths of fresh air.  It made us think of …well, of camping again.  Much like the sandy beaches and umbrella drinks (which remain our top destination for relaxing) – when you discover a place you like, you find yourself wanting to return.  Even on the ride home, you start thinking about the next time.  Fun places are fun places.  So, we revisit them with fond memories of the last trip and anticipation that more fun is right around the corner.

            That’s sort of how we feel about the Aredia/Zometa litigation.  We’ve been there before, we generally like it, and so we go back again. 

            This week, the A/Z litigation added to its lengthy string of successes (see prior posts on A/Z cases here) with a Daubert (slip op.) and a summary judgment (slip op.) win all rolled into one in the case of Conklin v. Novartis Pharmaceuticals Corporation, No. 9:11-cv-00178-RC, (E.D. Tex. Sept. 19, 2012).  

While the case was pending in the Aredia/Zometa MDL, the court granted defendant’s motion for summary judgment on plaintiff’s (and 7 other TX residents’) failure to warn claims.  Daubert slip op. at 5.  Shortly after remand, in an attempt to avoid the implications of the MDL court’s ruling, plaintiff notified the remand court that the case would proceed on “design defect under Texas law.”  Id. at 8.  Plaintiff claimed that Dr. Robert Marx, an oral surgeon and one of plaintiffs’ leading MDL experts, had an alternative design theory that saved her remaining claims.  Id.   As Dr. Marx’s declaration was plaintiff’s sole support for those remaining design defect claims, the court first ruled on defendant’s motion to strike under Daubert.

Dr. Marx’s opinion was that a decreased dosage and/or frequency of Zometa administration would both reduce the risk of the side effect suffered by plaintiff (ONJ) and still efficaciously treat cancer-related bone damage.  Id. at 16.  Unfortunately for plaintiff, the court found both that Dr. Marx was unqualified to render such an opinion and that the opinion itself was unsupported.  First, the court noted that Dr. Marx is neither an oncologist nor pharmacologist and therefore not qualified to offer an opinion on what dosage of Zometa would effectively treat cancer-related bone damage.  Further, in disqualifying Dr. Marx, the court noted that he “had to rely on studies or opinions of other experts to opine of the efficacy or utility of his ‘safe alternative design.’”  Id.

But the court didn’t stop there.  Delving deeper into the shaky foundation of Dr. Marx’s opinion, the court stated:

The analytical gap, in Dr. Marx’s opinion is demonstrated by setting out his premises and conclusions:

Premise: Studies show that a certain regimen of Zometa helps treat cancer-related bone conditions, but may cause ONJ.  

Premise: Other studies show that less Zometa will result in less ONJ.

Conclusion: A regimen using less Zometa will help treat cancer-related bone conditions.

This is a classic logical fallacy—an irrelevant conclusion.

It is not helpful to the finder of fact for Dr. Marx to state that a drug used to fight cancer related diseases has a particular negative side effect, and that reducing the dosage and/or frequency of that drug will reduce the occurrence of the negative side effect. Rather, Dr. Marx must also provide some factual support that reducing the dosage and/or frequency of that drug will not only reduce the occurrence of the negative side effect, but will also be effective at fighting cancer-related diseases. Unfortunately, Dr. Marx offers no evidence as to the efficacy of a reduced Zometa regimen . . .

Id. at 18.  Based upon Dr. Marx’s inability to show that a reduced dose or duration of Zometa treatment would be as efficacious as the FDA-approved dose or duration, Dr. Marx’s “alternative design” opinion was stricken.

          The court then turned to defendant’s motion for summary judgment.  The MDL court having done away with plaintiff’s failure to warn, and by extension her breach of express warranty claims, Summary judgment slip op. at 8, the remand court was left to consider strict liability design defect, negligence per se and breach of implied warranty.  First, the court quickly recognized that plaintiff’s negligence per se and breach of implied warranty claims were “re-packaged design defect or failure to warn claims.”  Id.   Since the MDL court had ruled that plaintiff’s failure-to-warn claims were foreclosed, and since plaintiff had offered no admissible evidence of a safer alternative design -- the court granted summary judgment for defendant.  Id. at 9-11.    Two wins, no waiting.

          As you know from our prior posts, the Conklin decision is just the latest in a string of defense wins in the Aredia/Zometa litigation.  But just like a good vacation – we don’t mind revisiting if the trip brings a smile to our face.

          As always congratulations and thanks to our friend Joe Hollingsworth for keeping us up to speed on this litigation.

Any Exposure ≠ Enough Exposure

It would be a remarkable business plan to win product liability lawsuits.  Locate a potential plaintiff who has the disease and who also has had some – any – exposure to the product or toxic substance.  That’s it.  You win.  No need to worry about the other side ruling out the product or substance as a cause.  They can’t.  Once there’s exposure, it’s a cause.  No need to worry about your side ruling out other potential causes of the disease.  That doesn’t matter.  The plaintiff has the disease, and the plaintiff was exposed: you win.

It’s a plaintiffs’ lawyer’s dream.  Case specific facts for the most part become irrelevant.  You don’t have to worry about alternative causes, other risk factors or evidence of low exposure.  You don’t need to sweat the science.  Specific causation expert opinions are simple and almost unassailable.  No worrying your way through tense depositions dissecting your expert’s opinions on the necessary levels of exposure or the effect of exposure at low levels.  It just doesn’t matter.  Any exposure is enough exposure.  You win.

Of course, this dream business plan would be a nightmare for defendants, and the courts.  Fortunately, all this remains in the world of dreams and nightmares.  Because it isn’t reality.

The decision in Schultz v. Glidden Co., No. 08-C-919, 2012 U.S. Dist. LEXIS 38163 (E.D. Wi. Mar. 20, 2002), is a good example of this.  In Schulz, the plaintiff claimed that her deceased husband got Acute Myeloid Leukemia (“AML”) from exposure to the defendants’ products, which contained benzene.  The plaintiff had a case-specific expert who opined that the husband had been exposed to 20 ppm-years of benzene, and the defense had an expert who opined that almost twice that exposure was necessary to cause AML.  Id. at *6-7.  Those types of opinions are fairly standard in product liability litigation.

But what makes this case interesting is that neither of those opinions really mattered because the plaintiff offered a general causation expert who said that any non-trivial exposure to benzene was enough to cause the deceased’s AML:

When no safe threshold of exposure to a carcinogen has been established, this means that each and every exposure to the chemical will increase the risk of development of the types of cancer that the carcinogen is capable of causing.  To the extent that an individual has developed a type of cancer caused by the carcinogen in question, then any non-trivial exposure to that carcinogen during a time frame consistent with the range of latency periods with the disease should be considered as a probable substantial factor that contributed to the development of the individual’s cancer.

Id. at *8-9.  In other words, it didn’t matter whether the deceased had been exposed to 24 ppm-years of benzene, or 5, or 100.  Any non-negligible, non-trivial exposure was enough. 

That’s not all.  The expert also opined that, once you find this exposure to benzene, you cannot exclude benzene as a possible cause of the deceased’s AML.  Not ever:

To the extent a known risk factor for a particular type of cancer has been identified in an individual who has developed that form of cancer, exclusion of that risk factor as one of the probable causes contributing to the cancer is not scientifically possible.

Id. at *9.  So, not only is any non-trivial exposure enough, but once you’ve got it you can’t rule it out.

There’s still more.  According to this expert, even if there were sufficient and present alternative causes of the deceased’s AML, that wouldn’t matter.  Alternative causes “in no way undermine[]”that benzene played a “substantial role in the development” of the deceased’s AML.  Id. at *13.   

Well, that’s a non-trivial amount to swallow.  Any non-negligible exposure to benzene and the case is essentially over.  Benzene becomes a cause that cannot be eliminated.  None of the other causes – even if present – can change that.  No further evidence or explanations are needed.  That’s a bad place for the defense to be.  

Fortunately – science, Daubert and common sense to the rescue.  The Schultz court found plenty of reasoning in previous benzene cases that the science just doesn’t work this way.  It doesn’t support this “no-threshold” or “one-hit” theory of causation:

The theory that any amount of exposure more than negligible should be considered substantial risk factor for AML flies in the face of the scientific literature reviewed and other expert testimony in this case that there is a threshold or dose below which you do not see a statistically significant risk of developing AML.  Even though benzene has been shown to cause AML, it is too difficult a leap to allow testimony that says any amount of exposure . . . to this toxin can cause AML and caused AML in the plaintiff.

Id. at *9-10 (quoting Henricksen v. ConocoPhillips Co., 605 F. Supp. 2d 1142, 1166 (E.D. Wash. 2009); citing Baker v. Chevron USA, Inc., 680 F. Supp. 2d 865, 878 n.9 (S.D. Ohio 2010) (“The ‘one-hit’ or ‘no threshold’ theory of causation in which exposure to one molecule of a cancer-causing agent has some finite possibility of causing a genetic mutation leading to cancer is not a reliable theory for causation under Daubert standards.”))

The court also properly found that this “no-threshold” theory of causation fails every Daubert smell test there is: 

The linear non-threshold model cannot be falsified, nor can it be validated.  To the extent that it has been subjected to peer review and publication, it has been rejected by the overwhelming majority of the scientific community. It has no known or potential rate of error.  It is merely a hypothesis.

Id. at *10-11 (quoting Whiting v. Bos. Edison Co., 891 F. Supp. 12, 25 (D. Mass. 1995); citing Sutera v. Perrier Grp. of Am., Inc., 986 F. Supp. 655, 666 (D. Mass. 1997) (“There is no scientific evidence that the linear no-safe threshold analysis is an acceptable scientific technique used by experts in determining causation in an individual instance”)).

The Schulz court was on a roll.  Not only did the non-threshold test fall in the face of science and Daubert, the expert’s opinion that he didn’t need to address or disprove other alternative causes was also a Daubert loser: “if an expert utterly fails to consider alternative causes or fails to offer an explanation for why the proffered alternative cause was not the sole cause, a district court is justified in excluding the expert’s testimony.”  Id. at *12.  This comports with our common sense: if something else caused the AML, then it wasn’t the benzene.  This isn’t reasoning that can be dispensed with simply because it makes things more complicated or more difficult for the plaintiff or the court.  It must be dealt with head on and, if not, plaintiff’s claim must fall.

Science in the courtroom isn’t, or shouldn’t be, a process that can be gamed. The idea is not to put forward expert opinions that will work for every case and that resist testing and evaluation. It is in fact the opposite. The science must be the science, not a strategy. The nature of science is testing, probing and questioning, not insulation from these things. The no-threshold, no alternative cause approach defies all of this.

So, while these types of expert opinions may seem like a dream to some plaintiff’s attorneys, in reality they’re straight-up losers. The Schulz court granted summary judgment to the defendants and dismissed the case.

Parisian in the Spring, and the Winter of Our Discontent

With the arrival of Spring, we flipped the mattresses, moved the snowblower behind the lawnmower, and refilled the bird-feeder. We sprayed deer repellent on the tulips. It did not work, but at least now our front yard smells like coyote urine. Sadly, our poor plantings, unlike the daisies and violets in Shakespeare’s “Spring,” shall never “paint the meadows with delight.” We also made a brief pilgrimage to Clearwater, Florida to view the 2012 version of the Phillies. Hope Springs eternal. Yes, Spring brings taxes. And Spring brings mud. But Spring mostly brings good things.

Spring was only a day old when we received yet another judicial opinion curtailing the purported testimony of that World’s Foremost Authority, Suzanne Parisian. On March 21, 2012, Judge Graham Mullen ruled on Novartis’s Daubert motion in a Zometa case, excluding large portions of the opinions of Dr. Parisian. Lemons v. Novartis Pharms. Corp., No. 3:08-cv-00361 (W.D.N.C. Order March 21, 2012). We’re not stalkers or anything like that, but you probably know that we’ve been compiling a list of Dr. Parisian’s recurring performances as a plaintiff’s expert, with a view toward highlighting those courts that decided Dr. Parisian was not qualified or that her opinions flunked Daubert, Frye, Fraubert, or the judicial smell-test. The Lemons case comes out of the Aredia-Zometa MDL. Judge Mullen refused to preclude the entirety of Dr. Parisian’s opinions. It goes without saying that the authors of this blog would have granted the defense motion in a nanosecond. Heck, Bexis would probably have ordered the witness manacled and placed in an orange jumpsuit.

But the court turned Lemons into lemonade when, after conducting a Daubert hearing where Dr. Parisian was cross-examined, it disallowed any testimony from Dr. Parisian about Novartis’s conduct in interacting with the FDA because “Dr. Parisian does not possess the requisite experience or expertise, as an employee or insider of a pharmaceutical drug sponsor, to opine on the conduct of Novartis.” Slip op. at 10. For the same reason, the court barred Dr. Parisian from commenting on Novartis’s communication of the risks at issue in the litigation to health care providers. Id. The Court also found that Dr. Parisian was not qualified to testify regarding Novartis’s pharmacovigilance efforts or its internal investigation of the alleged association of its drug with the adverse event. Dr. Parisian was further barred from offering testimony “regarding NPC’s intent, NPC’s monitoring of its clinical trials, ghostwriting, legal conclusions, or causation.” Id. at 12. Dr. Parisian’s testimony was limited to a generic discussion of the role of the FDA and the responsibilities of pharmaceutical companies and to commenting on Novartis’s interactions with the FDA on the subject of labeling. We call that a win and congratulate the good folks at Hollingsworth LLP and Faegre.

We’d like to forget Winter. We don’t mean the season; this year, Winter seemed almost tropical. The only really bad snowstorm took place on Halloween. No, we mean the wretched case of Winter v. Novartis Pharms. Corp., No. 06-4049-CV (W.D. Mo. March 8, 2012). Same defendant. Same expert (plus some others). Same Daubert issue. Different result. And it is not as if the court keeps you in suspense. When the court up front emphasizes how “Daubert was not written as a barrier to the admission of expert testimony, but as the rejection of a rigid prerequisite to admissibility incompatible with Rule 702” (a half-truth, at best) and how “we can neither rule out, nor rule in, for all cases and for all time the applicability of the factors mentioned in Daubert, nor can we now do so for subsets of cases categorized by category of expert or by kind of evidence” -- well, we know we are in for some nasty weather. Slip op. at 3. Thus, with hardly a raindrop’s worth of reasoning, the court “denies NPC’s motion to preclude Dr. Parisian from quoting or summarizing documents. She may testify about industry standards for the pharmaceutical industry and whether … NPC may have violated industry standards.” Id. at 7. Thus, the court “denies NPC’s motion to exclude Dr. Parisian’s testimony about labeling and warnings.” Id. Thus, the court “denies, in part, NPC’s motion to exclude discussion by Dr. Parisian of clinical trials and other bisphonate drugs regulated by the FDA.” Id. The court “may reconsider its ruling in this area if Dr. Parisian’s testimony strays too far from the issues the jury here must decide and a timely objection is made at trial.” Id.

Here’s the thing: Dr. Parisian is guaranteed to “stray.” That is what she is really expert in doing. Still, even in the slush, a lonely crocus flower sprouts. The court granted NPC’s motion to “exclude Dr. Parisian’s opinions about NPC’s intent and personal opinions about NPC’s and its employees’ states of mind, motivations, or subjective intent.” Id. As the Classics scholars would say, mirabile dictu! Somehow Dr. Parisian failed to convince this generous judge that she was a mind-reader. Perhaps one should be grateful for small favors.

We’re certainly not mind-readers, so there’s little point in trying to figure out how the Winter court got it so wrong. In “Winter in America,” Gil Scott-Heron sang about vultures circling under dark skies. Those vultures would circle over the Winter opinion forever without finding a morsel of Daubert logic. We suspect it is significant that the court did “not believe a Daubert hearing at this late stage would be helpful or is necessary in order to rule.” Slip op. at 5. Sometimes it helps to see a witness to disbelieve her. There have been cases (like this one) where it was Dr. Parisian’s live Daubert testimony -- utterly evasive and adversarial -- that sunk her. It’s a pity that the Winter court did not even take a look and get a preview of what Dr. Parisian would try to do on the witness stand. But we should not be too surprised at anything the Winter court does. As we reported here last year, the Winter court has already produced a ghastly ruling on the significance of Dear Doctor letters. As in Game of Thrones, we are seized with dread at the thought that Winter is coming.

The Artist and a Daubert Opinion

So The Artist won.  Some of us (maybe only one of us) didn’t even know it was a silent movie.  Imagine going to that movie without knowing it was silent.  That’s failure to warn.  At least when Mel Brooks made Silent Movie you knew what you were getting.  And in his movie the French guy spoke. 

Alright, on to legal stuff.  We found a number of interesting Daubert decisions in the court’s opinion in Hershberger v. Ethicon Endo-Surgery, Inc., No. 2:10-cv-00837, 2012 U.S. Dist. LEXIS 18799 (S.D.W. Va. Feb. 15, 2012), so we thought we’d discuss a few of them here.  This is a device case.  The plaintiff claimed that a stapler used during her colostomy reversal procedure was defectively manufactured because it didn’t contain the staples that it was supposed to contain, requiring a second stapling procedure.  Id. at *2-4.  The defense, on other hand, argued that the stapler did in fact contain staples but one of the surgeons prematurely and negligently discharged the stapler.  Id.  As trial approached, the parties filed a number of motions in limine to exclude testimony from experts and treating physicians related in one way or the other to this issue. 

The attending surgeon sought to testify that no staple was discharged at all during the first firing of the stapler – supporting plaintiff’s claim that it was defective – but rather a staple found in the plaintiff instead got there during a second stapling.  Id. at *16-19.  The defense’s response was based on a simple and seemingly effective argument.  The attending physician had already admitted that he didn’t see any staples inside the plaintiff during the procedures so he could not testify on when it got there.  The court allowed the testimony, however, ruling that the doctor’s opinion was “a product of [the doctor’s] experience and observations in the role of treating physician.”  Id. at *18.  We aren’t too surprised by this.  This ruling falls into a category that we’ve often seen at trial, whether appropriate or not: treating doctors get to testify about an awful lot of things as long as the testimony can be linked to their treatment of the plaintiff.

But in this case the plaintiffs wanted it all.  They not only wanted to be allowed to use the treating surgeon’s testimony to support their claim but also to exclude the defendant from offering testimony from an expert disagreeing with the conclusions and reports of the treating surgeons.  No go, said the Court:

In formulating their opinions, expert witnesses may be called upon to sift through conflicting testimony and data to arrive at an opinion of the most likely course of events. Such determinations of judgment, provided they are well-reasoned and explained, do not render expert testimony inadmissible. . . . [The defense expert’s] choice to credit some facts contained in the treating physicians' reports and testimony but not other facts is an issue for cross-examination, not a threshold question of admissibility.

Id. at *11.  In fact, the court went on to say that the defense expert’s choices on which testimony and data to credit and which to discredit appeared “well founded.”  Id. at *11 n.5.

Maybe the most interesting decision contained in this opinion, however, was on the defense’s motion to exclude a plaintiff’s expert from testifying that “based upon the lack of staples in the stapler [reported by the treating physicians], the stapler was defective.”  Id. at *22.  Defendant’s argument to exclude this opinion was simple and one we like: this is no expert opinion at all.  The testimony would simply credit or parrot the treating surgeons’ testimony on the absence of staples and use that to then give an opinion that a stapler without staples is defective, which calls upon no specialized expertise.  Id. at *23.  In fact, the plaintiffs inadvertently conceded this point.  They defended this opinion by arguing that it was “a matter of common sense.”  Id. at *23.  Exactly.  Jurors have common sense and no need for an expert to help them with it. 

As we have often had to argue at trial, expert opinion is not meant to parrot or cheerlead the testimony of others, and it isn’t needed to tell jurors things that they can figure out themselves.  And this court got it right.  It ordered the expert to remain silent.  Id. at *24.  That’s the kind of silent movie we like.

OTC Drug Plaintiff Fit To Be Fryed In New York

Just when we’re disgruntledly packing away our “Fry Mumia” buttons for the last time (guilty as sin, that one was), we get word from New York that the plaintiff in one of Dechert’s Tylenol cases lost a Frye-based appeal.  Unfortunately, because Ratner v. McNeil-PPC, Inc., ___ N.Y.S.2d ___, 2011 WL 5865657 (N.Y.A.D. Nov. 22, 2011), is one of our cases, we can’t supersize this post.  But we can give you an outline of what happened.


First, Ratner is an example of the philosophy behind this blog – that a defense win anywhere helps defendants everywhere.  A few years ago we (well, Bexis) participated in an amicus brief filed by the Product Liability Advisory Council, Inc. (“PLAC”) in a case called Parker v. Mobil Oil.  That appeal turned out well, producing an excellent Frye-based expert opinion – Parker v Mobil Oil Corp., 857 N.E.2d 1114 (N.Y. 2006).  Parker, in turn became the foundation for the recent win in Ratner.

So what happened?

Ratner involved a drug containing acetaminophen.  Massive overdoses of this drug can cause liver failure, which is not disputed.  Ratner, however, did not involve any sort of overdose – plaintiff claimed only routine, therapeutic doses of the drug, significantly expanding the scope of liability, if allowed .  Fortunately, the trial court found no valid scientific basis for the claim and granted summary judgment.  In Ratner, the Appellate Division affirmed, holding that none of the plaintiffs’ four experts had scientifically valid causation opinions.

The key issue in Ratner was not any particular test or technique used by the plaintiffs’ experts, but rather whether those tests could even be applied, given a fundamental lack of underlying scientific evidence.  The court recognized this hurdle as a “separate inquiry” not tied to novelty:

[W]here there is no novel or innovative science involved, or where the tendered scientific deduction has been deemed generally accepted as reliable, there remains a separate inquiry applied to all evidence. This inquiry is “whether there is a proper foundation – to determine whether the accepted methods were appropriately employed in a particular case.”

Ratner, 2011 WL 5865657, at *7 (quoting Parker).  The plaintiff’s “novel theory of cauastion” – “that therapeutic acetaminophen use caused the plaintiff's liver cirrhosis” – not any particular methodology, was at issue.  Id. at *8

The plaintiff’s experts claimed to be relying on “extrapolation” from the known hepatic risks of the drug in overdose situations.  Id.  The court held that there was nothing from which to extrapolate.  Absent adequate underlying data, the claimed “extrapolation” was simply an expert’s “ipse dixit.”  Ratner, 2011 WL 5865657, at *9.  All the plaintiff really offered was a pair of widely separated case reports of people who, after taking the drug in therapeutic quantities, later suffered liver trouble.  That was not enough:

[O]bservational studies or case reports are not generally accepted in the scientific community on questions of causation. . . . [T]he two aforementioned case studies relied upon by the plaintiff constitute merely observational data which are of a lesser caliber than controlled clinical studies from which results can be reviewed and verified.

Id. at *10.

Not only were case studies inherently insufficient, but these (even for case studies) were pretty weak.  For one thing, their authors did not reach causation conclusions.  “The two studies merely hypothesized that the liver injuries sustained by the patients therein were related to ingestion of therapeutic doses of acetaminophen and that further study was warranted.”  Id.  Or, as another author:

state[d] that the clinical importance . . . was unclear, and the authors of the study did not interpret the finding . . . to be indicative of serious liver injury.

Id. at *10.  Thus, the plaintiff’s experts were attempting to draw conclusions from purported bases of their opinions that went well beyond what those initial authors felt was justified.

And more.  Because acetaminophen had been around for a long time, there were plenty of (and much better) contrary data – “thousands of journal articles” – that “acetaminophen is safe in therapeutic doses, even for individuals suffering from liver disease."  Ratner, 2011 WL 5865657, at *10.

Since the plaintiffs’ experts’ opinions were:  (1) based upon minimal and comparatively weak data, (2) that was contradicted by large amounts of more powerful data, and (3) went beyond the conclusions that even the reporters of that weak data felt was justified, those opinions were “fundamentally speculative.”  Id. at *11.  Thus, the trial court had properly excluded those opinions and entered summary judgment:

[W]hen an expert seeks to introduce a novel theory of medical causation without relying on a novel test or technique, the proper inquiry begins with whether the opinion is properly founded on generally accepted methodology, rather than whether the causal theory is generally accepted in the relevant scientific community. Here, the plaintiff failed to meet that burden.

Id.

A View from the Bench on MDLs

Last week we attended ACI’s Annual Drug and Medical Device Litigation Conference. As always, it was nice to be in New York City during the holiday season (though the persistent drizzle was less than festive) and even nicer to see so many friends.

The presentations were quite good and up-to-date. The Mensing discussion was especially enlightening. As usual, we were most eager for the judicial panel, and it did not disappoint. In fact, it was so good, we’re calling it an early Christmas gift.

The topic for the judges was recent MDL litigation. Judges Cogen, Cote, Herndon, Montgomery, and Waxse were all engaging and thoughtful. Here are a few of the highlights:

• The judges realize that there is virtually no agreement as to how much a transferee judge must accomplish prior to remand. (Well, maybe we already knew that).

• There are also a variety of approaches to selecting bellwether trials. Permitting the parties to select their strongest cases, even with vetoes, does not ensure trials of representative cases. And if they’re not representative, where’s the value for settlement? One judge tells each party to proffer cases along with arguments for why they are truly representative. He then chooses the most representative case. Like baseball arbitration, it builds in an incentive for each party to be reasonable.

• As that old Barbie doll said, “Math is hard.” So is science. But all the judges believe that Daubert forces judges to act as real gatekeepers. Consequently, judges – with plenty of help from the parties, lawyers, and experts – must do the homework to keep junk science away from the jury. It was pretty clear that all of the judges on the panel were hard workers and quick studies, and that they would not be the least bit shy to police expert evidence.

• It’s no surprise that all the judges dislike discovery disputes. What is a surprise is the array of creative techniques the judges use to resolve or curtail these disputes. Our favorite? Ordering the parties to videotape a follow-up meet-and-confer session. If the dispute isn’t resolved, the parties must send the tape to the judge. Guess what? Not a single tape has yet arrived.

• Fed.R.Civ.P. 26 has a couple of subsections that lawyers might want to read again (or, maybe, read for the first time). Here is what Rule 26(b)(2)(C) provides:

On motion or on its own, the court must limit the frequency or extent of discovery otherwise allowed by these rules or by local rule if it determines that:

(i) the discovery sought is unreasonably cumulative or duplicative, or can be obtained from some other source that is more convenient, less burdensome, or less expensive;
(ii) the party seeking discovery has had ample opportunity to obtain the information by discovery in the action; or
(iii) the burden or expense of the proposed discovery outweighs its likely benefit, considering the needs of the case, the amount in controversy, the parties’ resources, the importance of the issues at stake in the action, and the importance of the discovery in resolving the issues.

Thus, either in considering a party’s motion, or on its own, a court must limit discovery that isn’t worth the effort or expense. Proportionality matters. Wow. That’s an issue with most of the discovery we see. And here’s the kicker: Rule 26(g)(1)(B) requires lawyers to sign discovery requests and responses certifying that either they are complying with the discovery rules (including 26(b)(2)(C), and that what they are doing is

(iii) neither unreasonable nor unduly burdensome or expensive, considering the needs of the case, prior discovery in the case, the amount in controversy, and the importance of the issues at stake in the action.

If a certification violates Rule 26, the court “must impose an appropriate sanction on the signer, the party on whose behalf the signer was acting, or both.” Fed.R.Civ.P. 26(g)(3). It’s like a Rule 11 for discovery. One judge said that pretty much every discovery request and response he’s seen violates 26(b)(2)(C) and could conceivably warrant sanctions.

Take a look at the Notes to these provisions. Maybe courts seldom invoke these provisions, halt disproportionate discovery, and impose sanctions, but it’s clear that active judicial involvement was contemplated. For our part, we’re happy to have a judge engage in that proportionality analysis. We’re even happier when it’s done by judges who are smart, fair, and conscientious. Based on what we saw last week, we’re optimistic.

• We’re not sure this last point is the most significant in terms of jurisprudence, but it produced the single most lasting image from the conference. One judge said that looking through the activities in an MDL can be like going through the refrigerator, opening up Tupperware containers, and gaping in puzzlement and/or horror at the goodies within. Yeah – we’ve been there, both actually and metaphorically.

Guest Post - Chew on This

Last week we posted about the end of the Digitek MDL, and with it one of the most utterly meritless mass torts that we'd ever seen.  We mentioned, very much in passing, that the court's opinion also contained some interesting Daubert questions, without going into any detail.  We were busy, true, but frankly we also weren't familiar with the science underlying that part of the opinion.

Anyway, we got called out for that omission by Dick Dean and Matt Moriarty of Tucker Ellis & West, who have been co-lead counsel for the principal Digitek defendants.  So we called them out right back.  Since they obviously knew the Daubert aspects (and everything else) of the Digitek litigation better than we did, we invited them to prepare a guest post on the subject.

Well, they accepted, and here it is - what's behind the favorable Daubert rulings that closed out Digitek, and why they're important.  As with every guest post, the guest authors get all the credit and all the blame....

***********

In the original blog posting about the Digitek® decision issued on November 3rd, Bexis correctly notes that the Digitek MDL was singularly meritless.  Indeed, plaintiffs’ cases were all sizzle and no steak.  But the order that put them down has a lot of meat on its bones.  In both of the two remaining cases in that MDL, the Court excluded expert testimony, digging into differential diagnosis under Daubert.  The Court focused on the experts’ reliance on “questionable scientific principles,” “unsubstantiated analogies,” and “overreaching or speculative methodologies.”  What makes the opinion so delicious is that the Court offered a rare decision about the reliability of post-mortem blood levels, in one case, and, in the other case, excluded a very well-qualified cardiologist from offering an expert opinion about his own patient.


McCornack was a wrongful death case claiming death due to digoxin toxicity.  The decedent’s blood sample was not taken until 79 hours after death.  It revealed a blood digoxin level – 3.6 ng/ml – above the upper end of the normal therapeutic range of 0.8 – 2.0 ng/ml.  But there is a phenomenon with some drugs – not all – called postmortem redistribution ("PMR").  Some drugs are stored in tissue to work properly.  At the time of death, postmortem redistribution begins, and they are released from the tissue and returned to the blood stream.  This results in a higher level of drug in the blood after death than was present during life.  This is an interesting subset of toxicology.

Plaintiffs had two experts who opined that the decedent, while living, had an elevated digoxin level.  They based their opinions on the 3.6 ng/ml postmortem level.  In their brief, the Digitek defendants challenged not only their ability to express those opinions, but also the admissibility of the underlying test result itself.   Defendants argued that there was no reliable basis on which to conclude what the decedent’s level of digoxin was just before he died.

While there has been significant comment in the toxicology literature about problems with interpreting the meaning of postmortem blood results with some drugs (see Defendants’ brief), there is relatively little case law on this issue. See, e.g., Bourne, v. E.I. DuPont de Nemours & Co., 189 F. Supp.2d 482, 499 (S.D.W. Va. 2002); Battle v. Gold Kist, Inc., 2008 WL 4097717, at *3 (M.D. Fla. Sept. 2, 2008).

It is generally recognized by reputable toxicologists that one cannot calculate back from a postmortem level to determine the level before the time of death with any degree of reliability.  A multiplicity of factors can compromise the value of a blood result when postmortem redistribution is at play.  These particular Plaintiffs’ experts had no reliable way of determining the decedent’s digoxin level at the time he died, and they were barred as a result.  In a nutshell, Judge Goodwin found – “It is Plaintiffs who must produce evidence to support the admissibility of that finding and the opinions related to it. They have produced a pittance. The key problem with the opinions of Dr. Mason and Mr. Gibson is that they did not adequately account for the PMR effect.” Page 28 of Opinion. He quoted the two experts:

Mason: “It would be some esoteric fudge factor for me to say how much was redistributed. I don’t know.”

Gibson: “I mean, I think Dig levels with postmortem redistribution do tell you stuff, but I don’t think you can extrapolate backwards on one data point.”

The Court viewed this as a classic case of ipse dixit.  In addition to barring their testimony, the Court excluded the blood result itself.  It should be noted that Plaintiffs had a third expert who conceded that it was “more likely than not” that the decedent’s pre-death blood digoxin concentration was “substantially lower” than the 3.6 ng/ml level.  That same expert would not have concluded that Mr. McCornack died of digoxin toxicity.  The decision is a significant step forward in a very narrow area of toxicology.

In the Vega action, the Plaintiff offered Dr. Reynolds Delgado to opine on defect and causation.  Dr. Delgado is “a world-renowned, board-certified cardiologist that practices in one of the world’s best heart institutes,” and who had treated the decedent for the last six years of her life. But his litigation opinion, implicating digoxin toxicity from defective Digitek® as a causal factor in the decedent’s death, was at odds with the contemporaneous medical records and his own treatment of the decedent.

The defendants challenged Dr. Delgado on several grounds.  First, he had no qualifications to opine on product defect; second, he concluded that there was a defect without using any methodology (insufficient facts and data); and third, he had no basis for concluding that digoxin toxicity caused the decedent to die.

Judge Goodwin went for the third challenge on Dr. Delgado’s causation opinion – the “lack of a proper differential diagnosis is decisive.”  The Court emphasized that the decedent “was in terrible health,” noting that “just a sampling” of her “serious issues” included: obesity and hypertension, “congestive heart failure spanning over a decade,” and a heart transplant, to name a few.  Given this history, it was fatal that Dr. Delgado did not “adequately account for the many other conditions that might have caused [the decedent’s] decline and death.”

Further, the Court rejected Dr. Delgado’s reliance on a study of outcomes associated with blood digoxin levels.  The Court observed that the decedent’s “progressive heart failure was more severe than the study participants” and that the study did not show a statistically significant increase in digoxin-related death at the blood digoxin level at issue in this case.  The Court regarded this as a failed analogy.

The Court could have excluded the McCornack and Vega experts on qualifications grounds alone and disposed of the cases without digesting the central scientific issues.  But the Court ate these experts for lunch, ultimately finding that their approaches were “inconsistent with good science.”  Kudos to Judge Goodwin.

Heading for the Light: Something for Everyone in Recent Pain Pump In Limine Rulings

Last week, the court in a pain pump case, Musgrave v. Breg, Inc., 2011 U.S. Dist. LEXIS 113661 (S.D. Ohio Oct. 3, 2011), denied ten plaintiff motions in limine. That, in itself, is good news. The rulings aren't especially intricate. You might even call them easy. Some of the language employed by the court to explain why the rulings were so easy might give some of us defense hacks reason to pause. We'll get to that in a moment.

We're not saying the Musgrave case isn't interesting -- it is. But we have to admit that it's not nearly as interesting as the Martin Scorsese documentary on George Harrison that aired on HBO last week: Living in the Material World. Harrison is the Drug and Device Daughter's favorite Beatle, and it's easy to respect that choice. The Quiet Beatle was spiritual and cool. It was inevitable that he would be overshadowed by the Lennon/McCartney songwriting juggernaut, but Harrison did pretty well in his own write. "Don't Bother Me" was a great early Beatles song, and "Something" was a great late one. Moreover, Harrison's post Beatles career suggests that he was a better collaborator than the others. George worked successfully with Clapton, Dylan, Petty, and Orbison. By contrast, John worked with Yoko. Paul worked with Linda. Ringo has worked with assemblies of All Stars, but only to redo old hits, not to create something new. And Harrison single-handedly saved Monty Python's Life of Brian.

So as a silly way of honoring Harrison and keeping ourselves amused, we're going to 'cite' some Harrison songs while discussing the Musgrave rulings.

It Don't Come Easy - Yes, it's a Ringo song, and Harrison isn't credited, but Harrison actually co-wrote it and a demo exists of George performing it with a guide vocal for Ringo. Before the Musgrave court issued its rulings, it spent time - way too much time - emphasizing how tough it is to preclude evidence via in limine motions: "To obtain the exclusion of evidence under such a motion, a party must prove that the evidence is clearly inadmissible on all potential grounds." 2011 U.S. Dist. LEXIS 113661 at *5. The court expressed a strong preference not to issue in limine rulings but, rather, to wait for trial proceedings to supply "proper context." Id. at *6. It almost sounds like a presumption against in limine rulings. But waiting for "context" isn't always necessary. It can make trial preparation and/or settlement more difficult, and that "context" might mean that the inadmissible, prejudicial material has already been paraded in front of the jury. So while we like this court's rulings, we aren't fans of the prologue.

Handle with Care - This was the hit single from the first Traveling Wilburys album. Harrison sang the lead, but Dylan, Petty, Orbison, and Jeff Lynne (of ELO fame) all chimed in nicely. Great team effort. Harrison took the title from a label on a nearby box when the band was rehearsing the song. The first motion in limine in Musgrave is the most interesting. The plaintiff sought to exclude evidence that the FDA had cleared or considered the pain pumps for intra-articular use, or that the FDA had never expressed any concern regarding the pain pumps. That's a breathtakingly bold and crazy motion, and one would be thunderstruck by a court that would keep such crucial information from the jury. Talk about context! Luckily, the Musgrave court did the right thing, concluding that the probative value of FDA approval was not outweighed by whatever prejudice the plaintiff claimed. The plaintiff argued that if FDA approval and lack of concern were admissible, then also admissible should be the fact that a U.S. Attorney's office had subpoenaed documents from the defendant as part of an investigation regarding possible off-label marketing of the pain pumps. The Musgrave court correctly held that the issuance of subpoenas was simply not relevant. Id. at *9. All a subpoena means is that an agent and a prosecutor think there is something worth reviewing. There might be no there there.

In Spite of all the Danger - This is a pre-Beatles song. It was performed by the Quarrymen and is credited to McCartney/Harrison. You can hear it on Anthology, volume 1. The plaintiff in Musgrave asked "the Court to prohibit Breg from utilizing the learned intermediary doctrine." Id. at *10. Why? The plaintiff argued that "at no time did Breg fulfill its duty to warn physicians." Id. Well, plaintiffs always argue that, don't they? And defendants always dispute that. They usually have some facts to back up that dispute. That, according to the court, was the case here. Whether the warning was adequate, and whether the learned intermediary had decided to use the pain pump after receiving the adequate warning, were questions for the jury.

Isn't it a Pity - A quintessential Harrison song from All Things Must Pass. It's deep and caring, and it grows on you. Sometimes for years. In the third motion in limine, the plaintiff sought to preclude evidence that any doctor negligence in implanting the device constituted an intervening or superseding cause. It turns out that the defendant wasn't intending to make that argument, so the issue was moot. But the defendant asked the court to make clear that it would admit evidence "of plausible alternative causes" of the shoulder condition, including the shoulder injury itself. Sad to say, but, according to some experts, the surgery itself can cause cartilage damage, and there's no reason why a defendant shouldn't be able to put that testimony and evidence in front of a jury. It's "relevant to causation" and is admissible. Id. at *12.

Beware of Darkness - Another underrated song from All Things Must Pass. Clapton does a superb version of it in the 2002 Concert for George. The plaintiff requested exclusion of the defendant's experts on general and specific causation. The court denied that motion, and we are fine with that. But the court's explanation is the usual thin gruel that gets dished out in rejecting defense motions to exclude plaintiff experts: the experts are qualified, the arguments go to weight, not admissibility, you can cross-examine ... blah blah blah. The court views its role as "simply to keep unreliable and irrelevant information from the jury because of its inability to assist in factual determinations, its potential to create confusion, and its lack of probative value." Id. at 13. Again, we like the ruling here, but, like the court's discussion on motions in limine generally, it sounds a little as if the court's general predilection is to wave things by. The court doesn't appear to have done a detailed analysis of the experts' opinions. If it had, it probably would've arrived at the same result. But sometimes that sort of detailed analysis is necessary to discharge the court's gatekeeping function to keep out plaintiff experts with threadbare data and 'flexible' methodologies.

Wah Wah - Harrison wrote this during the Let it Be sessions, when the Beatles were at each other's throats. Nice guitar riff. The Musgrave plaintiff asked the court to exclude evidence of his prior injuries. Unsurprisingly, the defendant argued that the plaintiff's "medical history and any past shoulder injuries bears directly upon whether his use of the Breg pump caused his shoulder condition." Id. at *13. The court agreed with the defendant that evidence of the plaintiff's "past shoulder injuries is relevant and probative of the issue of causation." Id. Nor was such probative value outweighed by prejudice. Id. at *14. What prejudice? It's like the criminal defense lawyer who sputters, "Objection your Honor, that's prejudicial - it tends to show guilt." It's whining. (The British call it "whinging," don't they?)


It's All Too Much - This one's from The Yellow Submarine LP. Probably one of the better songs on the group's worst effort. The plaintiff objected to introduction of "any evidence to compare the number of times pain pumps have been used with the number of patients who have developed chondrolysis." Id. at *14. It's hard to blame the plaintiff, because the evidence he was trying to exclude is so powerful. Plaintiffs like to focus on the numerator: the case at hand, plus, maybe, other instances of injury, perhaps in the form of adverse event reports. But how is it fair to look at the numerator without looking at the denominator -- all those times when nothing bad happened? We know this is powerful evidence because jurors have repeatedly told us so. For example, twenty adverse events don't look so bad, and the company doesn't look so negligent, when there are millions of successful uses of the product. Anyway, we think it's a no-brainer that the plaintiff's effort to exclude the denominator should fail. The court comes out the right way on this important issue, but adds an interesting reason for its ruling: the plaintiff experts "considered the nonoccurrence of cases of chondrolysis following discontinuation of intra-articular pump use" and made much of the temporal relationship. Id. Apparently the court is saying that if the plaintiff experts want to exploit non-occurrence of injuries, so should the defense experts. That's all well and good, but the denominator needs to be admitted no matter what the plaintiff experts' approach was.

The Answer's At the End - From Extra Texture (Read All About It) (1975). The plaintiff anticipated that the defendant would attempt to "suggest to the jury that it is a 'good corporate citizen' that benefits society by making products that are life-saving or improve the quality of peoples' lives." Id. at *15. The defendant argued that it was premature to rule on this issue. Not surprisingly (given some of the other things the court says in its opinion), the court agreed. This time we have to agree with the court. What most courts end up saying is that the defendant can bring in its good conduct evidence, including wonderful things it has done in general, but then the plaintiff might get more latitude in introducing some not-so-wonderful things. It can be a tough choice for the defendant in terms of how many doors it want to open, or how wide. But in any event the decision does not need to be made before the trial begins.

Sue Me, Sue You Blues - The thing about Harrison is that he mostly seemed like a sweet, gentle guy, but he could also be incredibly cranky. By all accounts, he didn't suffer fools gladly. That comes across in the film A Hard Day's Night, where Harrison gets off many of the snarkiest lines. It also came across with the first song on the great Revolver LP, Harrison's angry masterpiece, "Taxman." And Harrison had his fill of the legal system. He lost a lawsuit where it was claimed that his "My Sweet Lord" was cribbed from "He's So Fine." Harrison later wrote yet another angry song, "This Song," as a commentary on how the legal system had hosed him. All of which is to say that we think Harrison would have liked us and would have agreed with everything we've ever written in this blog. We're just saying. We also think that George would have been amused by the final three motions in limine in the Musgrave case, where the plaintiff asked the court to prohibit the defendant from referencing the results in other pain pump cases (mostly defense wins), or referencing "lawyer-made" lawsuits, or in painting plainjtiff lawyers in a negative light. Id. at * 16. Those motions in limine were deemed moot because the defendant said it did not intend to make any such references. We suspect that George might not have been so charitable to plaintiff attorneys.

Addendum

Last Friday, we put up a bare bones post about some expert rulings in HT (bareboned because our involvement in the litigation limits what we can say).  We've now learned that the third order has been - not exactly modified but supplemented - and we don't want any readers not getting fully accurate information.  None of the prior rulings of #3 were changed, but some FDA-related testimony, not ruled on in order #3, was allowed.

Here's a copy of the supplemental order.

Plaintiff HT Experts Excluded

We can’t provide any commentary or analysis, because of our firm’s involvement in the litigation.  But we thought our readers would benefit from knowing about three recent opinions excluding certain plaintiff experts in an HT case.


Just the holdings, then:

Opinion #1:  Hines v. Wyeth, 2011 WL 2680814 (S.D.W. Va. July 8, 2011).  Experts:  Drs. Wayne Tilley and Donald Austin.  Opinions:  Oral micronized progesterone as an alternative safer design.  Result: Excluded.  Reasons:  Reliance on statistically insignificant evidence.  Reliance on animal studies.

Opinion #2:  Hines v. Wyeth, 2011 WL 2680834 (S.D.W. Va. July 8, 2011).  Expert:  Dr. Matthew Hollon (Dr. Adriane Fugh-Berman withdrawn).  Opinions:  Negligent promotional activities.  Result:  Excluded.  Reasons:  Irrelevance – no evidence that promotion influenced conduct of prescribing physician.

Opinion #3:  Hines v. Wyeth, 2011 WL 2680842 (S.D.W. Va. July 8, 2011).  Experts:  Drs. Suzanne Parisian and Cheryl Blume (Dr. Donald Austin withdrawn).  Opinions:  Numerous, mostly concerning compliance with FDA or industry standards.  Result:  Excluded.  Reasons:  Conclusory nature of opinions.  Personal beliefs/failure to identify standard of care.  Corporate motive/state of mind not a proper subject/not within expert qualifications.  Narrative not helpful to jury.

We’d like to say more, but our first obligation is to our client.  Nonetheless we hope our readers find these summaries useful.

Phony Choices

It's hard to draft the Monday post without being unduly influenced by the weekend's bloviations and dissipations. Between the WSJ weekend review section, the NYT Week in Review, the television parade of talking heads, and the requisite pitcher of mojitos on the deck, at least one random and silly Big Thought is certain to weasel its way into our case discussion. This week's semi-pertinent idea comes from a WSJ article on the "Death of Duopoly." The article discusses how binary power is bad for business (e.g., it wasn't good when photographers were stuck with just Kodak or Fuji for their film needs) and also probably bad for the public interest. The focus was on the phony or feckless choices presented by Republicans vs. Democrats. The WSJ presented some of those creepy photo merges, such as Obama and W, Carter and Reagan, and Nixon and Kennedy. The point seemed to be that the two choices are inadequate and usually crumble after a long enough period of consumer dissatisfaction. Thus, digital photography wrecked the Kodak-Fuji duopoly. And wither the Whigs?

Of course, we usually don't see the Next Thing coming. We are plagued by something that has to go down as the best phrase we've heard so far this year: "existence bias." People assume that the status quo will endure. The ultimate point of the WSJ article seemed to be that something new will emerge from the current political gridlock and might already be slouching toward us. Frankly, we were more interested in other examples of sticky choices, such as Celtics-Lakers or Beatles-Stones. (When we were in college, you were supposed to pick sides between the Talking Heads or Springsteen. Decades later, that choice seems as dumb and pointless as Beatles-Stones and now it's obvious from the calm perch of middle age that one can like them both. And for those of us who do, the recent passing of Clarence Clemons is as sad as the long, wailing sax note near the end of "Jungleland." It was, indeed, momentous when the Big Man joined the Band.)

There's a phony choice in the middle of the recent opinion in In re Zicam Cold Remedy, 2011 WL 2181188 (D. Ariz. June 3, 2011). It results in a ruling that is weaker than the mojito from the bottom of the pitcher after most of the ice has melted. The defendant moved for summary judgment on general causation grounds. The plaintiffs claimed that Zicam results in loss of the sense of smell. And if "existence bias" is the phrase of the day, then "anosmia" is the word of the day.

A friend has lacked a sense of smell since she was an infant. She claims it's an advantage, on the theory that people are more likely to complain about smells rather than praise them. We're not so sure. Maybe the smell of freshly baked madeleines won't inspire us to write a novel, but certainly among life's riches are the aroma of coffee in the morning, a gas station stop on the way to the Shore, and our kids' sweaty feet while running around the maze at Chuck E. Cheese. (When they were toddlers. Not now. Definitely not now.) So, yes, we side with the plaintiffs on this one.

So much for the olfactory sense. The legal issue is "whether plaintiffs must introduce evidence of the level of exposure that could cause anosmia, i.e., whether they must demonstrate a toxic dose." In re Zicam, 2011 WL 2181188 at *2.

Our answer to that question: Of course! The court's: 'Nah.' The court acknowledges the central tenet of toxicology about how "the dose makes the poison." For some reason, we've seen lots of defendants trot that out before juries over and over. Sure, the point is valid and important. But we squirm when a defendant calls its own product "poison." Surely, there's a better way of making the point that anything -- including water -- is potentially harmful if you take too much.

How much is too much? That’s the question.

Anyway, given that nobody disputes that central tenet of toxicology, how can someone claim that a product is harmful without establishing what amount it takes to cause the harm?

The Zicam court erects a straw man about how plaintiffs need not offer a "mathematically precise table equating levels of exposure with levels of harm." Id. at *5, quoting Wright v. Willamette Indus. Inc., 91 F.3d 1105, 1107 (8th Cir. 1996). Okay, but how about at least offering evidence that there's some dose that causes the harm -- maybe even the standard dose that people take? Here's where the court builds its decision on a false dichotomy. The court says there should be different standards for "products liability" and a "toxic tort." The latter requires proof of a harmful dose, but the latter does not. Id. at *3.

Say what? Well, why? No good answer that we can think of.

Even here, the court is confronted with two product liability cases that require proof of toxic dose: (1) McClain v. Metabolife Intern, Inc., 401 F.3d 1233, 1236 (11th Cir. 2005), and (2) In re Bextra & Celebrex, 524 F. Supp. 2d 166 (N.D. Cal. 2007). Here's what the Zicam court says about those cases: "Insofar as McClain and Bextra applied the 'toxic dose' requirement from environmental exposure litigation to drug products liability actions, they appear to be unique." In re Zicam, 2011 WL 2181188 at * 4. Even if that's true, why are they wrong?

Well, "Toxicology and pharmacology are distinct disciplines." Id. at *5. Fine. (Though not enough courts remember that sort of thing when we file Daubert challenges against plaintiff omnibus experts. But we digress. Again.) Also: "[i]n environmental exposure litigation, plaintiff s may allege injury caused by a substance with which many people interact harmlessly at lesser degrees of exposure. In order to explain how a pervasive substance is harmful, one must show that at a particular level of exposure, the substance becomes toxic. Without requiring this kind of evidence, the door is open to meritless claims based on generally harmless levels of exposure." Id.

That, friends, is a distinction without a difference. The idea behind prescription drugs is that “many people interact harmlessly” with them – at their approved doses. The problem is when those doses aren’t harmless. Unless the plaintiff has an overdose case – or is just plain bizarre like the lady that used almost 200 pounds of denture cream – that’s precisely what the plaintiff has to prove.

Note how the court does even try to suggest that it is any harder to prove toxic dose in a "toxic tort" than in a "product liability" case. Instead the court says it shouldn't be necessary in a product liability case because there aren't as many potential plaintiffs or specious claims. Really? Have you counted the thousands of plaintiffs in "product liability" - not "toxic tort" - MDLs? Or seen how many, after just a little nudge of discovery, had minimal exposure to the product? Or had Daubert motions defeat the plaintiffs’ hand-picked best case? Why should the door be any more open in a case involving products that help thousands of people than in a toxic tort case?

More fundamentally, you won't find the "product liability" vs. "toxic tort" distinction in Daubert or the Rules. Science is science. Proof is proof. The binary analysis in the Zicam case makes no sense. When it derides the need for "precision" it is inviting the sort of sloppy science that Daubert was meant to foreclose. The court posed a false choice and then made the wrong choice. You might even say it stinks.

Denture Cream Myelopathy Claims Found Toothless

If there’s a better place for filing Daubert motions than in the Eleventh Circuit, we don't know of it.  Of course, we’re biased – we had great success with them ourselves in the Seroquel litigation and in the Ephedra litigation before that.  Building on the Eleventh Circuit’s landmark decision in McClain v. Metabolife, International, Inc., 401 F.3d 1233 (11th Cir. 2005), defendants have had a lot of success fighting “junk science” peddlers in Eleventh Circuit courts.

And so it was with yesterday’s decision in In re Denture Cream Products Liability Litigation, No. 09-2051-MD-Altonaga, slip op. (S.D. Fla. June 16, 2011).  The product is (surprise) a denture cream, Fixodent.  The alleged defect is failure to warn that zinc compounds allegedly reduce the amount of copper in the blood, which in turn purportedly cause something called “copper deficiency myelopathy” (called a lot of other things, too, see slip op. at 2 n.3) – which we’ll call “CDM” for short.  The very existence of such a thing as CDM is controversial.  The court in Denture Cream found that the claims didn’t pass Daubert scrutiny.

The Denture Cream defense team went after this MDL pretty much using the Seroquel model – that is, take the MDL plaintiffs’ best case and beat it on Daubert grounds.  The test plaintiff in Denture Cream claimed numbness in her hands and feet (a description suspiciously like diabetic neuropathy) leading to loss of function in her arms and legs, along with various blood abnormalities.  Slip op. at 2-3.

These symptoms appeared after the test plaintiff allegedly used Fixodent – a lot of Fixodent.

How much Fixodent?

From the Denture Cream opinion:  The test plaintiff supposedly “use[d . . .] two to four 68-gram tubes of Fixodent denture adhesive every week for eight years to hold her dentures in place.”  Slip op. at 3.

Say what?  That’s between two and four toothpaste-tube-sized tubes of Fixodent a week, just to hold dentures in place.

For eight years.

We did the math.  Using an average of three tubes a week, that’s 68 X 3 X 52 X 8 = 84,864 grams of Fixodent over eight years.  Thus, according to plaintiffs, then, the test plaintiff consumed over 187 pounds of the stuff.  That works out to three fifths of a pound a week.  Slip op. at 9 n.15.

Anyway, the basis of the defendant’s motion wasn’t the credibility of the test plaintiff’s claimed consumption.  So we’d have to say that, from an exposure standpoint, this test plaintiff has to rank as the Denture Cream plaintiffs’ best case.  She was literally worth her weight in Fixodent (give or take a few pounds).

The Denture Cream MDL has attracted the usual flock of plaintiff’s experts willing to say anything if paid enough.  It was a case of garbage in, garbage out.  As the court observed, they relied "predominately [on] case studies” to claim that exposure to “very large” (we’ll say) amounts of Fixodent caused CDM.  Slip op. at 6.  Reliance on case studies is an immediate red flag.  That’s scraping the bottom of the scientific barrel.  It’s doubly suspicious when the claimed condition itself is questionable.  In short, “there is no reliable basis to conclude either Fixodent or zinc can cause copper deficiency myelopathy.”  Id. at 7.

Why?

Well for one thing, the experts’ data – to use a technical term – stank.  The court posed five questions: (1) was there a dose-response relationship, (2) was there supporting epidemiology, (3) what was the background risk of this type of injury, (4) was there a plausible physiological mechanism, and (5) what type of clinical studies and tests supported the claimed diagnosis?  Slip op. at 8.  Briefly, and without the jargon, here’s what the Denture Cream court found when it drained this particular litigation swamp:

• Plaintiffs proved no dose-response relationship at all.  They didn’t establish how much for how long caused the claimed CDM.  They had one wildly unusual plaintiff . . . and then, nothing – neither an estimate for how much zinc causes the purported reduction in copper, nor how much reduction in copper is needed for how long to cause the alleged injury.  Apparently, the experts didn’t even study the right chemical, looking at zinc acetate rather than the zinc compound actually in Fixodent.  Slip op. at 9-12.
• There was no analytical epidemiology, only descriptive case reports.  Plaintiffs didn’t meet the gold standard, or even the zinc standard, but rather a bilge standard of the lowest form of medical “evidence.”  Here is where good Eleventh Circuit law comes in, since case reports can only be supportive and not sufficient.  Slip op. at 12-14.
• Plaintiffs’ experts admitted “they did not know the background risk of [CDM].”  Slip op. at 14-15.  Not only that, they didn’t know the background risk of myelopathy generally.  Id. at 15.  As the court observed, “[t]his is not even good lay reasoning, much less reliable scientific reasoning.”  Id. at 17.  Simply deciding to study something isn’t evidence of causation.
• While plaintiffs could show how zinc can reduce copper, they don’t have any plausible biological model for either end of their causal equation.  They couldn’t explain either the bioavailability of zinc (how it does or doesn't get absorbed into the body), on the front end, or how low copper supposedly causes neurologic damage, on the back end.  Slip op. at 18-19.
• Clinical studies?  There ain’t no clinical studies of zinc and CDM.  Slip op. at 20-19.  Plaintiffs claimed they’d be unethical, but the court held that certain useful studies could be run.

With this little valid data, then there isn't much there for any kind of scientific methodology to work with.  Not surprisingly, the plaintiffs’ methodology wasn’t any more scientific than their data.  First of all, the experts’ causal syllogism – the process by which they reasoned from exposure to injury – skipped or assumed several essential logical steps.  Denture Cream, slip op. at 20-23 (we’ll skip the very case-specific details).

Second, they placed far more causal weight on case reports than such weak data could possibly support.  The reports themselves did not claim causation.  Slip op. at 29 (“[b]ecause the authors . . . do not conclude there is a causal relationship . . ., it is inappropriate for Plaintiffs’ experts to draw that conclusion for them”).  Not only are case reports inherently weak, but of the total universe of 21, only one (one!) involved only the precise product at issue.  Id. at 25-26, 31.  Nor is there any generally accepted definition of CDM, so plaintiffs couldn't show that the motley 21 case reports involved the same condition, or even any coherently classified illness at all.  Id. at 26-28 (analyzing discrepancies in the case reports).  Finally, some of the articles were just plain sloppy.  Id. at 29-31, 31-32.

Third, plaintiffs' claims of “dechallenge” (that’s medical jargon for “when you take the stuff away, the symptoms go away, too”) weren’t in fact accurate.  Plenty of the patients in the case studies continued to have copper or zinc abnormalities in their blood after they stopped using denture creams containing zinc.  Slip op. at 32.  Ditto with the injury itself.  Removal of the source of zinc exposure didn’t reliably improve neurological condition in the case reports.  Id.

Fourth, to the extent plaintiffs’ experts relied on animal studies (whether they did at all was unclear), they didn’t prove anything in humans.  Slip op. at 32-33.

Fifth, an FDA notice didn’t prove anything (except, we’d say, how plaintiff recruitment creates MDLs), because the FDA as an administrative agency can act on much less of a scientific basis than needed to establish causation in a court of law.  We blogged about this point at some length before, so you can add Denture Cream to our list:

[R]egulatory agencies follow different standards than courts in toxic-tort cases.  The risk-utility analysis involves a much lower standard than that which is demanded by a court of law.  A regulatory agency such as the FDA may choose to err on the side of caution.  Courts, however, are required under the Daubert trilogy to engage in an objective review of evidence to determine whether it has sufficient basis to be considered reliable.  Accordingly, Plaintiffs’ experts may not establish causation by reliance on the FDA Notice.

Slip op. at 33-34 (citation to McClain omitted).

Thus died plaintiffs’ “general causation” (that is, in general, can this stuff ever cause that problem?) evidence.

Without ever proving general causation, it was probably unnecessary for Denture Cream even to consider plaintiffs’ “specific causation” (that is, did the stuff cause the problem in this person?) evidence, but the court took a quick peek anyway.  Plaintiffs offered the usual mush – a purported “differential diagnosis” – accompanied with the usual problems.  First, the plaintiffs’ experts couldn’t legitimately “rule in” CDM, since they hadn’t proven general causation:

Without a reliable basis to infer Fixodent causes copper-deficiency myelopathy, a differential diagnosis reaching that conclusion is, in effect, a detailed, unpublished case report.

Slip op. at 35.

Beyond that, as is true with almost all litigation-generated claimed differential diagnoses, the plaintiffs’ experts didn’t rule out anywhere near all the other plausible causes of neurological injury.  See Slip op. at 36 (listing a dozen things plaintiffs’ experts didn’t even consider).  The possible causes that the purported differential diagnosis ignored were “far more common” myelopathies than CDM (assuming CDM exists at all).  Id.  Denture Cream involved a classic case of a doctor using a much looser methodology in litigation than s/he would dream of doing with a real patient.  Id. at 37 (“failure to perform a test [the expert] considered reasonable before opining on the cause of [plaintiff’] disease shows a lack of methodological rigor in reaching the diagnosis”).

That did it.  What we have to think was the Denture Cream MDL’s “best” (certainly the most thoroughly exposed) plaintiff couldn’t produce scientifically sound evidence of causation.  If not her, then who?

Now cometh the inevitable appeal.

Congrats to Frank Woodside at Dinsmore & Shohl for winning the motion, and thanks to Dave Walz of Carlton Fields for passing the decision along to us.

Daubert Done Right

We were at a conference in Chicago last week where, as usual, the most interesting part was the panel of judges. Whether you agree or disagree with what the judges say, their every word is important and interesting. The focus of last week's panel was Daubert motions. Not to put too fine a point on it it, these judges were annoyed by burdensome Daubert motions. These judges thought most Daubert motions were a waste of time. Such motions often amount to huge stacks of paper full of science and peer-reviewed literature> If things are that complicated -- so the thinking goes -- maybe the jury should sort it out.

One of the lawyers in the audience had the temerity to ask the judges about the value of using Daubert motions to "educate" the judge, even if the motion is not ultimately successful. For a moment, we could have sworn that the panel morphed into Pink Floyd singing "we don't need no education." One of the judges said that maybe they only thing they'd be "educated" on is that the lawyer is a jerk for subjecting the judge to a difficult, mind-numbing exercise for no good reason. Here is what the judges tried to "educate" us on: judges are really, really busy. And not terribly patient.

Well, that's a tad depressing to lions of the defense bar, isn't it? We tend to view these cases as a magical mystery tour through preemption-learned intermediary-Daubert-summary judgment. Maybe the takeaway from what the judges said -- for that matter, the takeaway if one just applies a little common sense -- is to choose one's battles carefully and wisely. Instead of robotically following the dance-steps laid out on the floor, or doing something just because that's how we did it in the last case, we need to look through fresh eyes and do what's appropriate for that particular case. Daubert might not work in every case. In fact, we might end up "educating" the plaintiff lawyers and their experts.

But sometimes Daubert is the right way to go. Sometimes it really does help the court to streamline a case. Sometimes it can be a well-thought out response to plaintiff experts who (speaking of doing things robotically) trot in to say pretty much whay they say in every case -- the actual science and facts be damned.

We saw an example of a shrewd use of Daubert last week in Hogan v. Novartis Pharmaceuticals Corp., No. 06-Civ-0260 (BMC) (EDNY April 24, 2011). In Hogan the plaintiff claimed breach of implied warranty and failure to warn of the risk of developing osteonecrosis of the jaw from the defendant's intravenous drug, Zometa. The case presents an example of why the judges' criticism of Daubert motions is so maddening. If defense lawyers are to be lambasted for filing overreaching Daubert motions, what about plaintiff lawyers who file overreaching expert designations? And is it possible to talk about overreaching plaintiff expert designations without mentioning Dr. Parisian?

In Hogan, the defendant used a Daubert motion to get Dr. Parisian completely excluded. You know things are going well when the court begins its analysis by by observing that it's "[u]nclear … where Dr. Suzanne Parisian's testimomny fits." Slip op. at 2. Turns out that Dr. Parisian's testimony fit in nowhere. Dr. Parisian stated that "I'm here not as … the expert in Aredia and Zometa. I am here as the expert on FDA issues involving Aredia and Zometa." Id. at 2-3. That testimony was irrelevant. The plaintiff did not assert any violations of FDA regulations (different from some other cases we've discussed recently). The preemption defense bridge had already been crossed. By this point, the case was about causation and knowledge of causation. So what could Dr. Parisian say about that? The court allowed that "expert testimony on the topic of pharmacovigilance may help the jury understand what pharmaceutical companies generally do to anticipate and prevent adverse drug reaqctions." Id. at 5. But Dr. Parisian "has never worked for a pharmaceutical company" and was, therefore, "unqualified to opine on the potentially relevant testimony she offers in her report regarding pharmaceutical companies' internal operating procedures and other standards with which she claims manufacturers voluntarily elect to comply." Id. at 6. The court decided to exclude Dr. Parisian's proffered testimony "in its entirety" because the "FDA's role in this litigation … would be a sideshow." Id. at 7. Under that theory, Dr. Parisian would hardly ever be allowed to testify.

There are many other Daubert rulings in the Hogan case. We'll just mention some favorites. Another expert wanted to blather on about how "the defendant's efforts in manipulating publication of an article … 'demonstrated bad faith.'" Id. at 8. Since punitive damages weren't in the case, "testimony of bad faith conduct is excluded as irrelevant." Id. Yet another plaintiff expert wanted to interpret the defendant's documents to say that the defendant should have known about causation by a certain point in time. The court excluded such testimony, because the methodology was weak and the testimony had the "potential to sway the jury all by itself." Id. at 14.

The Hogan court noticed something that we've been saying about plaintiff experts for years: "all of plaintiff's experts, to some degree, are being proffered as 'superlawyers' to serve as scientifically informed advocates of conclusions that plaintiff wants the jury to reach and which belong only in summation, not expert testimony." Id. That's completely true and that thought was completely absent from the panel discussion last week. And it's not as if that's the sort of thing that can be handled on the fly during trial. Before the word "objection" exits the lips, the damage has been done and the jury has been influenced.

Along the same lines, the court prevented a plaintiff expert from taking the defendant's documents and explaining to the jury why they showed causation. An expert "cannot be presented to the jury solely for the purpose of constructing a factual narrative based upon record evidence." Id. at 10 (quoting Highland Capital Mgmt., L.P. v. Schneider, 379 F. Supp. 2d 461, 469 (S.D.N.Y. 2005)). The same expert was precluded from criticizing the defendant's clinical trials, because he wasn't qualified to do it. Id. at 11.

Just for the sake of balance, we want this judge on the next panel that talks about Daubert.

We extend a tip of the cyber cap to Joe Hollingsworth for sending us this opinion. It is a timely reminder of the benefits of Daubert done right.