Law

Put quotes around the phrase "litigation science" and Google it.  Go ahead, we'll wait. . . . . What did you find?  Not good, right.  You found a lot.  Too much.  The first Google page alone shows how controversial this subject is.  For instance, you'll find references to Ninth Circuit Judge Alexi Kozinski's uncertainly that "what's going on here is not science at all, but litigation," in the Daubert case that produced the Supreme Court's famous Daubert decision.  You'll find agendas for legal conferences—or are they scientific conferences?—on litigation science, with some scientists suggesting that sparring between experts and lawyers might produce better scientific results than scientific peer review.  Really.  If you Google some more, you'll find that some of the scientists saying that are themselves experts in litigation.  You'll even find a Wikipedia entry on forensic science with a subheading for "Litigation Science."  That's disappointing.  Are there those in the scientific community who actually believe that science is better developed in a courtroom than a lab?  Take it from us, it's not. 

Daubert is intended to curtail litigation science, not encourage it.  Judges must be the gatekeepers to the courtroom, closing those gates to unreliable opinions based on methodologies that are neither scientific nor based on appropriate data.  Courts must consider peer review, not lawyer review.  

This Daubert standard updated the Frye standard, which has been around much longer and is still applied by many state courts.  Most believe that Daubert is more exacting.  And for the most part it is.  But there is an attractive simplicity to the Frye standard.  While Daubert sets out a multi-prong test that lowers the microscope on an expert's data and scientific methodology, Frye simply announces its distaste for litigation science.  Frye requires science to be generally accepted in the scientific community.  So, while Daubert is more popular with defense lawyers, Frye still provides a lot to work with. 

The New York Court of Appeals' recent opinion in Sean R. v. BMW of North America, 2016 WL 527107 (N.Y. Ct. App. Feb. 7, 2016), illustrates this.  The plaintiff was a minor who claimed that, years earlier, a defective fuel hose in his parents' BMW 525i caused him to suffer lasting injuries while in utero.  Plaintiff's experts (a Dr. Frazier and a Dr. Kramer) determined that plaintiff's mother had been exposed to toxic levels of unleaded gasoline vapor while pregnant with plaintiff—in particular, toluene and benzene contained in the vapor—and that this exposure caused plaintiff's injuries.  The experts pointed to BMW's recall of the 525i due to defective fuel hoses and the fact that plaintiff's mother and grandmother smelled a gasoline odor while in the car and at times suffered headaches, nausea and throat irritation. 

The experts concluded that the odor and physical reactions established that the mother, and thereby the plaintiff, had been exposed to sufficient levels of the gasoline vapor to cause plaintiff's injuries.  They based this conclusion on controlled studies showing that, "for symptoms such as these to occur immediately, a gasoline vapor concentration of at least 1000 ppm ... is required."  One expert applied the Bradford-Hill criteria to establish general causation—i.e., that unleaded gasoline can cause birth defects—and the other expert applied a "weight of the evidence" analysis to determine specific causation—that the mother's exposure to gasoline vapor was a "substantial causative factor" in plaintiff's birth defects. 

And that's how it happens.  In the blink of an eye, experts in the courtroom established the science and the plaintiff asked the court to accept it.

But the Frye standard wouldn't allow it.  The Court of Appeals seized on the experts' failure to establish specific causation through science that was generally accepted in the scientific community—that is, science that was developed and appropriately reviewed outside the courtroom.  While controlled studies can produce reliable science, experts in the courtroom can't draw conclusions from them that the scientific community has not.  So, while the controlled studies on which plaintiff's experts relied sufficiently established that symptoms can occur at certain exposures levels, it is a very different thing to reverse that relationship and announce that claimed symptoms thereby determine the level of exposure.   

Applying the Frye standard, the court concluded that the experts' methods were not generally accepted in the scientific community:

Although unanimity is not required, the proponent must show consensus in the scientific community as to the [methodology's] reliability. . . .

Plaintiff and his experts have failed to make that showing in this case. Dr. Frazier and Dr. Kramer concluded that plaintiff was exposed to a sufficient amount of gasoline vapor to have caused his injuries based on the reports by plaintiff's mother and grandmother that the smell of gasoline occasionally caused them nausea, dizziness, headaches and throat irritation. Plaintiff and his experts have not identified any text, scholarly article or scientific study, however, that approves of or applies this type of methodology, let alone a "consensus" as to its reliability. . . .

Dr. Frazier claims that it is accepted practice in occupational medicine to use standardized studies of symptoms as a guide when assessing exposures retrospectively. For support, she cites to the documentation report for gasoline by the American Conference of Governmental and Industrial Hygienists (ACGIH), which synthesizes the results of controlled studies and states that the threshold for immediate, mild toxic effect is approximately 1,000 ppm. She also cites to a 1991 study in which subjects exposed to known quantities of toluene and ethanol experienced an increase in headaches as their exposure level increased, as well as a 2008 report on the safety of n-Butyl alcohol in cosmetic products.

None of those sources, however, establish that Dr. Frazier's methodology, "when properly performed, generate[s] results accepted as reliable within the scientific community generally" (Wesley, 83 N.Y.2d at 423, 611 N.Y.S.2d 97, 633 N.E.2d 451).

BMW of North America (Slip Op.) (emphasis added).

The court further rejected the experts' argument that their courtroom-created methodology was similar to an odor threshold methodology used in some toxic tort cases:

Defendants state, and plaintiff does not dispute, that unleaded gasoline in the early 1990s had a very low odor threshold of between 0.50 and 0.76 ppm.  Assuming that is correct, a person would have been able to detect the odor of unleaded gasoline vapor at less than 1 ppm.  Had Dr. Frazier applied a true odor threshold methodology in this case . . . the only conclusion she could have reached was that plaintiff was exposed to at least 1 ppm of unleaded gasoline—the minimum level at which gasoline is detectable by human smell.  Instead, Dr. Frazier averred that there is a minimum threshold of gasoline vapor beneath which individuals do not experience headache, nausea or dizziness.  And because [the mother] experienced headaches, nausea and dizziness, Dr. Frazier concluded she must have been exposed to at least that concentration.  Plaintiff has not shown that such a "symptom-threshold" methodology, unlike the odor threshold methodology admitted in other cases, has been generally accepted in the scientific community.

Id.  (emphasis added).

This decision is spot on, and it illustrates that defendants don't need Daubert to keep unreliable science out of the courtroom.  In fact, every court in this particular litigation, from the trial court to New York's Court of Appeals, rejected this litigation science under the Frye standard.  This is a decision worth keeping in the quiver for the next time you are moving to exclude an expert's opinion in a Frye state.  It's a good one.

Two of our favorite themes in the drug and device world intersected a few weeks ago in the Third Circuit—class actions and "no injury" lawsuits.  We don't see many drug and device class actions these days, which we view as one of the more notable accomplishments of the drug and device defense bar over the last 20 years.  In fact, it is difficult to understand why anyone ever thought that personal injury class actions would be a good idea in the first place.  Personal injury cases are different—everything from the patients, to the doctors, to the information available, to the products used, and the injuries alleged.  Those facts leave you with a Hobson's choice:  Either you take all the individual factors into account, in which case you have defeated the whole point of a class action; or you gloss over it all and pretend everyone is the same, which violates the rules and is downright unfair to everyone involved.  Either way, class actions don't work.

"No injury" lawsuits are similarly vexing.  They generally come in two forms—medical monitoring lawsuits, where the plaintiff has experienced no drug or device complication but wants the defendant to pay for future medical care anyway, and lawsuits alleging only some form of economic loss.  At the risk of oversimplifying, we generally view these cases with a "no harm, no foul" attitude.  It particularly grabs our attention when "no injury" claims are brought as class actions.  You might call it a mashup of bad ideas, which adds up to a really bad idea.  Sort of like Kim Kardashian marrying Kanye West.  Or Donald Trump using Twitter.  Or the upcoming Superman v. Batman movie.  (Actually, that would be two good ideas adding up to a really bad idea, but we digress.) 

Two bad ideas added up to a really bad idea in the Avandia MDL, and the district court and the Third Circuit correctly shut it down.  In In re Avandia Marketing & Sales Practices and Product Liability Litigation, No. 15-2145, 2016 WL 559216 (3d Cir. Feb. 12, 2016), the plaintiff used Avandia to treat her Type II diabetes, and the drug worked as it should have with no complications.  You might think that this individual would be focused on living a healthy life, but instead she filed a lawsuit.  Worse yet, she filed a class action on behalf of herself and other Avandia users, who also experienced no complications.  Her claim was that the manufacturer knew the drug had "dangerous propensities" and "engaged in misrepresentations, and failed to adequately advise consumers and medical providers of the risks."  Id. at *1. 

Although styled as a consumer protection action under the Missouri Merchandising Practices Act ("MMPA"), this looks a lot like a failure-to-warn case.  But what was the alleged injury?  Because the "actual value" of the drug allegedly was less than the value "as represented" by the manufacturer, the plaintiff claimed the difference between the drug's "actual value" and the value "as represented."  Id.  Query how that damages theory could ever be proved for one person, let alone an entire class.  Fortunately, we don't need to go there because the manufacturer moved to dismiss for lack of standing and for failure to state a claim, and the district court granted the motion.  According to the district court, the plaintiff had no claim because she "received all of the benefits of taking Avandia without suffering any harm and thereby sustained no ascertainable loss."  Id.  The district court called the case "absurd" and denied leave to amend.  We commented on that order here. 

The Third Circuit affirmed the dismissal, and it did so on the incredibly straightforward basis that the plaintiff received everything she could have expected.  As the Court held,

[The plaintiff] received the drug she was prescribed, the drug did the job it was meant to do (i.e., controlled her blood sugar levels), and it caused no apparent physical injuries.  Under such circumstances, there could be no ascertainable loss.  "[S]he 'received all the benefits [she] desired and [was] unaffected by Defendants' alleged concealment.'" . . .  In short, [the plaintiff] received the benefit of the bargain and accordingly sustained no ascertainable damages under the MMPA.

Id. at *3 (quoting the district court).  This holding is couched in terms of the Missouri statute, but its reasoning has broader appeal.  This plaintiff was prescribed medicine that effectively treated her Type II diabetes with no ill effects.  That is to say, the drug worked—as it did with all other "similarly situated" members of the plaintiff's proposed class.  Even placing the issue into a "consumer fraud" context, the plaintiff got what she (or her insurer) paid for.  Imagine the alternative of no treatment at all, under which her Type II diabetes would have been uncontrolled, placing her health actually at risk.  Regardless of the applicable law, the district court's and Third Circuit's reasoning should apply to cut off these kinds of claims. 

The Third Circuit also affirmed the denial of leave to amend because the plaintiff could not say how an amendment could correct the "fundamental 'ascertainable loss' deficiency."  Id. at *3.  This is the correct result, too.  Count this one in the win column, and call it a lawsuit that never should have been filed. 

We were not able to make our annual pilgrimage to the Westminster Kennel Club Dog Show this year, so we had to settle for watching the televised portions on the couch with the Drug and Device Law Rescued Ragamuffins.  And the cat.  (We mostly resisted the all-day live feed of the breed judging.)   Since the Best in Show lineup didn't include a Standard Poodle, our "breed of the heart" (a cute Bulldog named Annabelle beat Ricky, the stunning black Standard Poodle, in the Nonsporting Group), and being nothing if not bandwagon jumpers, we were rooting for "Rumor" a gorgeous German Shepherd who was the top winning show dog of 2015 by many, many points.  And she showed beautifully.  But she was defeated by "C.J.," a German Shorthaired Pointer.  While we don't count ourselves as sporting breed fanciers, C.J. is a cool dog.  And, most interestingly (maybe not, but it gives us a hook to transition to our case in a minute), C. J.'s grandmother, Carlee, was Best in Show in 2005.  Carlee was known for her flawless "free stack" – instead of needing her handler to place her feet in the right positions and stretch out her neck – "stack" her – for the judge's examination, she did it all by herself in the most striking of fashions.   Westminster trivia:  like the Adamses and the Bushes, Westminster can count one example of a father siring his eventual successor:  Robert, the English Springer Spaniel, was Best in Show in 1993.  His daughter, Samantha, "took the Garden" seven years later.  The ostensible point of dog shows is to reward the best specimens of each breed so they will pass their genes to future generations, so it is neat when a judge's good decision is affirmed.  

And so it was recently in the Third Circuit.  In In re Avandia Marketing, Sales Practices and Products Liability Litigation (Linda and John Schatz, appellants), -- Fed. Appx, --, 2016 WL 574074 (3d Cir. Feb. 12, 2016), the panel considered Judge Cynthia Rufe's grant of summary judgment to the defendant manufacturer in a case in the Avandia MDL.   The plaintiff, who had taken Avandia, sustained bone fractures in two accidents and alleged that the manufacturer had failed to adequately warn of the risk of such fractures.  The manufacturer had informed doctors of this risk and, shortly thereafter, updated its warnings to include this information.  While it was not clear whether the plaintiff had already stopped taking the drug at this time, it was undisputed that she resumed taking it for a short time after the "bone fractures" warning was added to the label.

At his deposition, the plaintiff's treating physician testified that an earlier warning would not have made any difference – that he would have prescribed the drug for the plaintiff even if a "bone fractures" warning had been included.   (He couldn't remember whether he read the new warning before he wrote the final prescription, but acknowledged that it was available to him.)  His lawyers asked no questions.  Defendant moved for summary judgment on warnings causation – if a stronger warning wouldn't have changed the prescribing decision, there was no causal link between the allegedly inadequate warning and the plaintiff's injuries.  Whereupon ensued a procedural circus.  Without seeking leave, as the Rules require, the plaintiff filed a sur-reply brief attaching a classic "sham affidavit" in which the doctor changed the sworn warnings causation testimony he had given at his deposition.   The judge struck the sur-reply and granted summary judgment, and the plaintiff appealed both orders to the Third Circuit. 

The panel noted that it was within the trial court's discretion to strike filings for failing to comply with the Rules.  Schatz, 2016 WL 574074 at *2.  Moreover, the panel confirmed: 

When a deponent's post-deposition affidavit conflicts with his prior testimony [without explanation], a district court may disregard the affidavit to prevent a party from creating a material issue of fact to defeat summary judgment . . . ."  Id. (internal punctuation and citations omitted).  The panel explained, "The . . . Affidavit was produced more than seven months after the doctor's deposition.  Moreover, the [plaintiffs] could have, but did not, question [the doctor] at his deposition.  Furthermore, [the doctor] was informed that he had thirty days to review his deposition transcript and submit any changes.  He submitted none, . . . [but authored] his affidavit [without explaining the change in his testimony] the day before [plaintiffs] filed their sur-reply.

Id. at *3.  As such, "the District Court did not abuse its discretion in striking the . . . sur-reply and the . . . Affidavit."  Id. 

In the absence of the sham affidavit, the record was clear.  Though the doctor testified that a black box warning "certainly would have caught his eye," id. at 4, he went on to testify that no warning would have changed his prescribing decision, that he prescribed a new round of the drug to the plaintiff after the new warnings were implemented, and that he would still prescribe the drug today, with full knowledge of the new warnings, to a patient with the same clinical course as the plaintiff.  Id. at *4.  (With respect to the "black box" issue, the panel explained, in a footnote, that "[o]nly the FDA may issue a black box warning," so the manufacturer "could not have included such a warning absent a directive from the FDA."  As such, any argument that the manufacture should have included such a warning was preempted by Pliva v. Mensing.  Id. at *4, n.9.)  The panel affirmed the grant of summary judgment, holding that plaintiffs "failed to adduce evidence sufficient to establish some reasonable likelihood that an adequate warning would have prevented [the plaintiff] from receiving the drug."  Id. (internal punctuation and citations omitted).

We love the "sham affidavit doctrine."  We have had fun, in the past, using it to take apart the cases of unscrupulous plaintiffs' lawyers.  And judges who understand and enforce the "warnings causation" requirement (for not all do) – and understand Mensing preemption to boot – earn our eternal respect.  A clear decision, an easy affirmance, and a satisfying decision all around.  As for Westminster, we love 'em all and we will happily await next year's showdown.