Summary Judgment for Defendant in Drug Case

A federal court recently granted summary judgment against Illinois plaintiffs who alleged that the blood clotting drug Trasylol caused the husband's kidney failure. See Miller v. Bayer Corp., No. 09-81262 (S.D. Fla., 7/3/13). (One of the remaining cases in the MDL.)

Plaintiff underwent double coronary artery bypass graft and aortic valve replacement surgery. At the time of his surgery, he was a former smoker with a lengthy medical history which included hypertension, hyper-lipidemia, chronic renal insufficiency, and coronary artery disease. The surgeon used Trasylol during the surgery to help control the bleeding. Plaintiff had signed an informed consent which enumerated the potential risks and benefits of cardiac surgery including infection, bleeding, heart damage, stroke, kidney damage, or even death.

After his surgery, Mr. Miller experienced a small acute left hemispheric stroke;  he also experienced a transient rise in his serum creatinine which peaked at 2.4 on postoperative day eight. (Creatinine is a waste product formed by the breakdown of a substance important for converting food into energy; if the kidneys are damaged and cannot function normally, the amount creatinine in the blood can increase.)

Plaintiffs sued for personal injuries allegedly caused by the use of the drug during surgery. Defendant moved for summary judgment as to each of Plaintiffs’ claims, asserting (1) under Illinois law, causation is an element of each of Plaintiff’s claims, and Plaintiffs’ expert’s causation testimony was inadmissible; (2) even if Plaintiffs’ expert’s testimony were admissible, their apparent claims failed because they were seeking damages for Mr. Miller’s stroke, and their
expert was not qualified to render an opinion as to the cause of the stroke. Plaintiffs responded that despite some confusion, ultimately they were not seeking damages due to Mr. Miller’s stroke, but for his “acute renal failure”; that the expert was qualified to testify; and “the temporal connection" between Mr. Miller’s acute renal failure and the injection of Trasylol, together with the alleged absence of renal issues prior to the surgery and the fact that Trasylol is supposedly a nephrotoxic agent, were sufficient to support an opinion that Trasylol was a substantial contributing factor in causing Mr. Miller’s injuries. 

The court noted that expert medical opinion evidence is usually required to show the cause of an injury or disease because the medical effect on the human system of the infliction of injuries is generally not within the sphere of the “common knowledge of the lay person.” See Fuesting v. Zimmer, Inc., 421 F.3d 528, 536 (7th Cir. 2005), rev’d on other grounds by Fuesting v. Zimmer, Inc., 448 F.3d 936 (7th Cir. 2006); Ancho v. Pentek Corp., 157 F.3d 512, 519 (7th Cir. 1998); Goffman v. Gross, 59 F.3d 668, 672 (7th Cir. 1995); Wallace v. McGlothan, 606 F.3d 410, 420 (7th Cir. 2010). Claims for negligence, strict liability, breach of express warranty, breach of implied warranty, fraudulent misrepresentation, fraudulent concealment, violation of consumer protection statutes, wrongful death, and loss of companionship, as well as a survival claim  all will fail where a plaintiff has no evidence of specific causation. See Schrott v. Bristol-Myers Squibb Co., 403 F.3d 940 (7th Cir. 2005). To avoid summary judgment, the Plaintiffs therefore must come forward with evidence that would allow a reasonable jury to find causation. Causation must be established by provable facts; it cannot be based on guess, conjecture, surmise, possibility, speculation, or mere allegation. 

In summary, plaintiffs' expert opined that in all medical certainty causation of Mr. Miller’s
alleged renal failure was likely multifactorial, with significant contributing factors including
cardiopulmonary bypass surgery, associated blood pressure fluctuations, and the use of the medication.  The drug, he said, "in all medical certainty, was a significant contributing factor.”
Additionally  he opined that the physicians caring for Mr. Miller “would not have used” this drug
had they been aware of the association of mortality and acute kidney injury.  Plaintiffs argued the expert had conducted a legally sufficient differential diagnosis which emphasized the  "temporal connection between Mr. Miller’s acute renal failure and the injection of Trasylol, together with the absence of renal disease or issues prior to the surgery.

This court falls in the camp of those who conclude that a differential diagnosis, properly performed, constitutes a reliable methodology for determining medical causation under Daubert. See Guinn v. Astrazeneca Pharms. LP, 602 F.3d 145, 153 (11th Cir. 2010); Ervin v. Johnson & Johnson, Inc., 492 F.3d 901, 904 (7th Cir. 2007).  Readers will recall that we have explained how plaintiffs have mis-used the notion of differential diagnosis, jumping from a medical method to figure out what disease a patient has to a legal method to figure out why the patient has the disease.  In any event, the court noted that an expert does not establish the reliability of his techniques or the validity of his conclusions simply by claiming that he performed a differential diagnosis on a patient.  Instead, a court must examine whether the expert correctly applied the differential diagnosis methodology. 

As applied in several courts, the method requires an expert to rule in all the potential causes of a patient’s ailment and then by systematically ruling out causes that would not apply to the patient, the physician arrives at what is the likely cause of the ailment. Westberry v. Gislaved Gummi AB, 178 F.3d 257, 262 (4th Cir. 1999)).  Plaintiff experts routinely make a couple mistakes:  Expert testimony that rules in a potential cause of a patient’s symptoms that is not so capable is unreliable.  At the rule out step, the expert must at least consider the other causes that could have given rise to Plaintiffs’ injury.  Courts vary on whether the expert must rule out all possible alternative causes, or the most likely ones, or at least consider other factors that could have been the sole cause of the plaintiff's injury.  A differential diagnosis that fails to take serious account of other potential causes may be so lacking that it cannot provide a reliable basis for an opinion on causation.  And an expert must provide a reasonable explanation as to why he or she has concluded that any alternative cause suggested by the defense was not the sole cause of the plaintiff’s injury.

The court then noted that  a temporal connection between exposure to chemicals and an onset of
symptoms, standing alone, is entitled to little weight in determining causation. See McClain v.
Metabolife Int’l, Inc., 401 F.3d 1233, 1254 (11th Cir. 2005); Happel v. Walmart Stores, Inc., 602 F.3d 820 (7th Cir. 2010).  Temporal proximity is especially unreliable where conditions independent of
exposure to the drug could have been the sole cause of the plaintiff’s injury, and the expert fails to
explain the relative contribution of the drug to the injury.  Here, one flaw in the expert's methodology was his failure to account for or appropriately address numerous risk factors at both the rule in and rule out stage., factors which either alone or in combination could explain Mr. Miller’s alleged renal injury. These factors include, but were not limited to: pressure stabilizing medications; extended pre-surgical and post-operative hypertension; and pre-surgical chronic renal failure. Even to those factors which the expert did rule in, he either gave them short shrift at the rule-out stage, or dismissed them without discussion.  In neither his report nor deposition did the expert provide any explanation for why he concluded that Mr. Miller’s various risk factors other than exposure to Trasylol were not the sole cause of his injuries. In fact, during his deposition, he conceded several additional risk factors for Mr. Miller that he had failed to consider in rendering his opinion, and further testified that many of those risk factors, either alone or in concert, could have caused Mr. Miller’s transient creatinine rise. He was forced to admit that Mr. Miller, without Trasylol, “could have had the same postoperative course.”


Thus there was no way to determine that one factor had more of an effect than the others. That led plaintiff to argue that Trasylol somehow tipped the scales causing his renal injury (the so-called straw that broke the camel's back).  But after sorting through these opinions and the Plaintiffs’ response to Defendants’ Motion, the court found that exclusion of the expert was warranted because of the absence of a reliable methodology, the failure to provide a plausible explanation for why he concluded that Mr. Miller’s various risk factors other than exposure to Trasylol were not the sole cause of his renal injury. Under Illinois law, a party cannot create a genuine issue of fact merely by presenting an expert witness who is willing to express an unsupported opinion that favors the party’s position. See Lewis v. CITGO Petroleum Corp, 561 F.3d 698, 705 (7th Cir. 2009).

 

 

 


 

Recommend Top Blawgs

The ABA Journal is embarking on its annual quest to identify the top law blogs.  The criteria and form are here, if any of our wonderful readers are inclined to identify MassTortDefense as one that you read regularly and think other lawyers should know about. 

Friend-of-the-blawg briefs are due no later than Aug. 9, 2013, says the Journal.

Might I also suggest you think about the Mass Tort Litigation Professors' Blog? Another worth a look is the FDA Law Blog.  And of course Abnormal Use.

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DRI Class Action Seminar Continues

A highlight of the afternoon session was the panel involving "A Wide-Ranging Discussion of Class Actions from the Client’s Perspective."  Hosted by my partner Tim Congrove, doing his best Phil Donahue impersonation, the panel included experienced, articulate in-house counsel. Specifically, the panel brought to the stage Michael G. McQueeney , The Coca-Cola Company, Malini Moorthy , Pfizer Inc., and Laura E. Proctor , LP Building Products.  Each of these highly accomplished in house counsel manages a complex civil litigation docket that includes active proposed class actions, certified classes, settled classes, and/or other aggregate litigation.

The panelists shared class-related issues of importance to them and their companies, including tactics for defending multiple class actions across jurisdictions, addressing no-injury classes, and resolution strategies.  They talked a bit about what they expect from their outside counsel (thank goodness your humble blogger qualified on all accounts), and the important factors they consider in deciding to try a case where a class has been certified.

A particularly interesting part of the discussion was the panel's thoughts on tort reform, civil justice reform, and what to do about the many vacancies currently on the federal courts.

On the last point, Congress passed legislation authorizing additional judgeships in 1990. Since that time the district courts have experienced a 38 percent growth in caseload, but only a 4 percent growth in judgeships. In five especially busy federal districts, the Eastern District of California, the Eastern District of Texas, the Western District of Texas, the District of Arizona, and the District of Delaware, the judges face weighted caseloads that exceed 700 cases per judge. The Judicial Conference recommends a weighted caseload of 430 per judgeship. 

In August the ABA House of Delegates will vote on a proposed resolution supporting enactment of comprehensive legislation to authorize needed permanent and temporary federal judgeships, and urging the President to advance nominees for current vacancies for federal judicial positions promptly and the United States Senate to hear and vote on those nominations expeditiously.

 

DRI Class Action Seminar Underway

Your humble blogger is attending the DRI CLE seminar on class actions in our nation's capital, organized by my pal Jeff Holmstrand and my partner Tim Congrove, outstanding class action practitioners. 

The lead off speaker was Miguel Estrada, speaking on Comcast, which we have posted on before, as well as the aftermath

He offered some interesting personal observations about this important class action decision. Key take aways: individual damage questions can be a significant barrier to class certification under Rule 23(b)(3). A district court considering class certification must look at how damages will be tried and managed if a class is certified.  Is it a mere mathematical exercise, or are there factual issues that vary by class members? And the district court must conduct a rigorous analysis of the class plaintiff's proposed method for computing damages allegedly on a class-wide basis (which almost certainly will require a Daubert analysis in most cases).

Interesting observation: while it is unusual for a dissenting justice to read the dissent from the bench, in this case two justices did so.  One wonders whether that emphasis on the intensity of the dissent is inconsistent with the content of the dissent, which tried to argue that the decision could be limited to its facts, nothing big happened here, nothing to look at, keep moving...

Most lower courts are following and applying the Comcast decision.  E.g., Forrand, 2013 WL 1793951 (C.D. Cal.); TL Cannon, 2013 WL 1316452 (N.D.N.Y.).  see also the Martin case we posted on here.

One going the other way is Leyva in the 9th Circuit, 2013 WL 2306567, which performs gymnastics to read Comcast as stating only the proposition that a plaintiff must show the damages flow from the alleged illegal acts of the defendant.

 

 

ABA's Top Blawgs

The ABA Journal is embarking on its annual quest to identify the top law blogs.  The criteria and form are here, if any of our wonderful readers are inclined to identify MassTortDefense as one that you read regularly and think other lawyers should know about. 

Friend-of-the-blawg briefs are due no later than Aug. 9, 2013, says the Journal.

Might I also suggest you think about Lowering the Bar, the humorous blog of my colleague Kevin Underhill? wide ranging, funny, a welcome break from the serious side of the law.

Another worthy of consideration is the Drug and Device Law blog, of my former colleagues Jim Beck, Steve McConnell, et al. Comprehensive, pithy, timely, opinionated. Well deserved winner of several awards. 

 

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Failure of General Causation Proof Leads to Summary Judgment in Chemical Case

The Ohio appeals court ruled recently that a plaintiff could not pursue her chemical exposure toxic tort suit since her sole general causation expert's testimony was properly deemed unreliable by the lower court.  See Cooper v. BASF Inc., No. 26324 (Ohio Ct. App. 6/28/13).

The plaintiffs alleged they contacted a defendant Pest Control Company due to a termite infestation in various parts of their home, and the company applied Termidor SC, which contains the chemical fipronil, inside an open wall in the Coopers' bedroom, underneath a bathroom drain which is accessed through an opening under a sink cabinet, and around the perimeter of the house. A few months later, Mrs. Cooper was hospitalized complaining of various symptoms and was diagnosed with hypothyroidism and related encephalopathy, of unknown etiology. The plaintiffs claimed that the symptoms were caused by alleged exposure to pesticides.  The Coopers filed a complaint alleging: (1) negligence against the chemical manufacturer and the Pest Control Company; (2) strict products liability claims; and (3) fraud against the Pest Control Company.

The trial court ordered the Coopers to identify one or more expert witnesses who would support their theory of general and specific causation in this matter, and to make a submission that the expert was prepared to testify that  the chemical generally is capable of causing the medical conditions about which plaintiff complained and that in this specific instance there was a good faith basis for believing that her conditions were caused by her exposure to this chemical.  The Coopers identified Richard L. Lipsey, Ph.D., as their general causation expert.  Defendants moved to exclude the expert and for summary judgment.

The trial court granted the motions, finding that the expert had not based his opinion regarding general medical causation on reliable scientific, technical, or other specialized information. None of the articles or studies he reviewed showed a causal connection between Fipronil exposure and plaintiff's disease. The key epidemiological study of 103 workers exposed to Fipronil in the factory manufacturing flea collars found that symptoms associated with Fipronil exposure were temporary, and workers' conditions improved when no longer exposed. The animal studies cited by Dr. Lipsey failed to establish any correlation across species, and the expert had to admit that the animals used were not appropriate models for humans.

The court of appeals affirmed.  Ohio follows the Daubert test. And here the expert reached this conclusion without adequate scientific proof of a causal link between fipronil and hypothyroidism in humans. The record contained no evidence of any generally accepted methodology that has been adopted by the scientific community to establish a causal link between fipronil and hypothyroidism in humans. The court also noted, beyond the factors stressed by the lower court, that the expert testified that: (1) he had never written any peer-reviewed articles concerning the effects of pesticides on the human thyroid, (2) he had not done a dose reconstruction as to the amount of fipronil Mrs. Cooper was allegedly exposed to, and (3) there was no biological sampling done on Mrs. Cooper's blood or fatty tissue to prove that she had been exposed to a significant level of the chemical.

Without an expert opinion, summary judgment was appropriate as plaintiff could not prove the causation element of each cause of action.

ABA Journal Searching for Top Blawgs

The ABA Journal is embarking on its annual quest to identify the top law blogs.  The criteria and form are here, if any of our wonderful readers are inclined to identify MassTortDefense as one that you read regularly and think other lawyers should know about. 

Friend-of-the-blawg briefs are due no later than Aug. 9, 2013, says the Journal.

Can't say being selected would make up for losing that student council election in 8th grade, but it would surely help!

In a later post I will note a couple other blogs that I think are very worthy of your consideration.


 

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Class Certification Denied in Minivan Case

A federal court last week denied class certification in a case alleging that vehicle axles were allegedly prone to cracking.   See Martin v. Ford Motor Co., No. 2:10-cv-02203 (E.D. Pa., 7/2/13).

Plaintiff filed suit against Ford on behalf of himself and others similarly situated claiming breach of express and implied warranties, unjust enrichment, and violations of state consumer protection laws. The claim related to alleged issues with the rear axle installed on 1998½ -2003 Ford Windstars.  Plaintiff moved to certify four classes of Windstar owners: an express warranty class, an implied warranty class, a consumer protection act class, and an unjust enrichment class.  Each included owners from several different states. Plaintiff moved to certify these four classes pursuant to Federal Rule of Civil Procedure 23(b)(2) and (b)(3), seeking injunctive relief and monetary damages on behalf of class members.

The court denied class certification in a lengthy and comprehensive opinion.  For our post, let's focus on the b(3) claim and the predominance element. Failure to satisfy the predominance requirement has doomed many an automotive defect cases. Federal courts have recognized that suits alleging defects involving motor vehicles often involve complicated issues of individual causation that predominate over common questions regarding the existence of a defect.

When a proposed class includes members from different states, there may be a choice of law problem that relates to predominance (as well as superiority and manageability). Several of the states in the express warranty class contain material differences in their legal definition of a breach of express warranty claim. Some of the group, but not all, required that a buyer show reliance on a statement or representation made by the seller as condition for recovery on a breach of express warranty claim. These differences undermine any finding of predominance. 

The court also found that a breach could not be proven without also inquiring into each individual class member’s Windstar experience, since the vast majority of Class members —approximately 83.2% — had not experienced any problems with their rear axles seven to twelve years after their vehicles were manufactured. In deciding whether Ford breached the express warranty that Windstars were “free from defects in material and workmanship,” a trier-of-fact could not solely look at evidence of Ford’s knowledge of the rear axle issues from 1997 through 2003, but must also consider how each axle performed through 2010. For example, a class member might own a 1998 Ford Windstar with 160,000 miles, which has been driven daily for twelve years without a problem. A second class member may have used his 2000 Windstar to travel constantly for business, putting 200,000 miles on the vehicle. A third class member may have only 50,000 miles on a 2003 Windstar because the class member drives the vehicle only on weekends. A fourth class member may have been forced to replace his original axle after only three months of use -- but because of a serious rear-end collision. None of these class members suffered an axle fracture. Were not these vehicles of different ages, with different mileage, in different conditions, which have been driven without a problem “free from defects”? These matters cannot be addressed by a trier-of-fact without consideration of the individual factual scenarios, said the court.

Even assuming breach could be proven on a class-wide basis, the calculation of damages for express warranty class members would be impossible without individualized inquiries into each claim.  The court cited to the Supreme Court's recent decision in Comcast Corp. v. Behrend that a model purporting to serve as evidence of damages in a class action must measure only those damages attributable to the theory of the case. If the model does not even attempt to do that, it cannot possibly establish that damages are susceptible of measurement across the entire class for purposes of Rule 23(b)(3). 133 S. Ct. 1426, 1433 (2013). Here, plaintiffs' damages model was based on injury to the resale price of a used Windstar; but that price would be based on a multitude of factors, of which the allegedly defective rear axle is but one. See, e.g., Carpenter v. BMW of N. Am., Inc., 1999 WL 415390, at *4 (E.D. Pa. June 21, 1999) (value of a vehicle is dependent on a "whole host of individualized factors including age, mileage, repair and maintenance history and accidents or damage.’”); see also Chin v. Chrysler Corp., 182 F.R.D. 448, 463 (D.N.J. 1998)). The need to take into account this multitude of factors creates a proximate cause issue, and required individual proof. Good to see the lower courts applying this important Supreme Court guidance.

Similarly, proving breach of implied warranty, that the Ford Windstars were not “fit for the ordinary purposes for which such goods are used,” was a question of fact with multiple relevant factors raising individual issues. Facts relevant to this inquiry would include not only the allegedly common testing and
monitoring of the axle but, as stated above in discussing the express warranty class, the experience of each individual Class member with the Ford Windstar.  And even if breach could be proven by using only common facts, the calculation of damages for the implied warranty class would face the exact same obstacle; again, approximately 83.2% of Windstar owners have not experienced any problems with
their rear axles. Plaintiff claimed that these Class members suffered damages through a reduction
in the resale value of their vehicles after a safety recall was initiated. Even assuming the recall did affect the market price for used Windstars, plaintiff had not provided a method to calculate the decrease in value on a class-wide basis.

Next the consumer protection claim required plaintiffs to prove each class member suffered a cognizable injury. To determine whether a class member suffered an “ascertainable loss,” and whether that loss was “as a result of” Ford’s alleged concealment or omission of information regarding the Windstar’s rear axle, would require the trier-of-fact to consider facts unique to each individual class member.  That is, plaintiff would encounter the same insurmountable obstacles in his attempt to prove a class-wide “ascertainable loss” suffered “as a result of” Ford’s conduct as he would encounter attempting to prove class-wide damages for the express and implied warranty classes.  Simply put, for a class member whose rear axle has not fractured — which was the vast majority of class members — proving a used Windstar suffered a loss in value because of Ford’s safety recall requires an inquiry into the age, mileage, and overall condition of the vehicle. This individual fact-gathering process would be essential to a consumer protection claim, and therefore fatal to the predominance requirement for class certification under Rule 23(b)(3).

Finally, the first element of an unjust enrichment claim — whether a class member conferred a benefit on Ford — again required an inquiry into each class member’s experience with the Windstar. Moreover, another element — whether it would be unjust for Ford to retain money provided by class members in view of the allegedly defective rear axle — was also incapable of proof without reference to individual facts. Ford’s actions could only be considered unjust if money was retained after selling a defective product. To prove a defect required the trier-of-fact to consider Ford’s conduct alongside each class member’s experience with the Windstar. The vast majority of class members have had no problems with their rear axles. The trier-of-fact would therefore have to consider whether Ford’s retention of the full purchase price of a 1998 Windstar, for example, was "unjust" in a situation where the Windstar has been driven by a class member for twelve years without incident.

Certification denied.

Maryland Retains Contributory Negligence

In an interesting decision, the Maryland Court of Appeals decided to retain the traditional doctrine of contributory rather than comparative fault.  See Coleman v. Soccer Association of Columbia, No. 9-2012 (Md. July 9, 2013). 

Several decades ago, the court in Harrison v. Montgomery County Bd. of Educ., 295 Md. 442, 444, 456 A.2d 894 (1983), addressed whether the common law doctrine of contributory negligence should be judicially abrogated in Maryland and the doctrine of comparative negligence adopted in its place.  The court declined to abandon the doctrine of contributory negligence in favor of comparative negligence, pointing out that such change “involves fundamental and basic public policy considerations properly to be addressed by the legislature.”

In Coleman, the petitioner presented the same issue that was presented in Harrison, namely whether the court should change the common law and abrogate the defense of contributory negligence in certain types of tort actions. After reviewing the issue again, the court arrived at the same conclusion: that, although the court had the authority to change the common law rule of contributory negligence, it would decline to abrogate Maryland’s long-established common law principle of contributory negligence.

The opinion provides an interesting dialog as to which branch of government should decide such a substantial change to the tort law.  The majority and concurring opinions say that the issue of adoption of comparative fault is really one for the legislature to decide. Note my colleagues filed an amicus brief in the case on behalf of the American Tort Reform Association, Chamber of Commerce of the United States of America, and others, arguing for continued application of the contributory negligence doctrine.

 

Second Circuit Rejects Claims Over Scientific Literature

The Second Circuit recently held that scientific opinions voiced during debate of unsettled questions generally cannot support false advertising or deceptive business practices claims. See ONY Inc. v. Cornerstone Therapeutics Inc., No.12-2414 (2d Cir. June 26, 2013).

Defendants in this case were various corporate sponsors, authors, and publishers of a scientific journal article comparing the effectiveness of several types of medical surfactants -- biological substances that line the surface of human lungs. Surfactants are critical to lung function: they facilitate the transfer of oxygen from inhaled air into the blood stream.  Plaintiff ONY and defendant Chiesi Farmaceutici are two of the biggest producers of surfactants for medical treatment.  These parties vigorously contested the relative effectiveness of their products – in the marketplace, in the scientific literature, and in this lawsuit. The parties agreed that two variables are particularly relevant to this comparison: mortality rate and length of stay. Mortality rate means the percentage of patients (typically infants) treated with a particular surfactant who do not survive. Length of stay refers to the amount of time a patient infant remains in the hospital for treatment.

The dispute stemmed from a study funded by Chiesi, carried out by a private research firm, and then promoted and ultimately published by three doctors, which concluded that Chiesi's surfactant product allegedly led to lower infant mortality rates than ONY's product. The doctors submitted their article to the Journal of Perinatology, a leading journal in the field of neonatology. .After the article’s publication, Chiesi issued a press release touting its conclusions and distributed promotional materials that cited the article’s findings.  Plaintiff complained that the article – and the distribution of selections from it – violated the Lanham Act and New York General Business Law § 349, and also constituted tortious injurious falsehood and interference with prospective economic advantage.

The district court concluded that plaintiff failed to state a claim based on publication of the article because the challenged statements were protected scientific opinion. The Second Circuit agreed, concluding that, as a matter of law, statements of scientific conclusions about unsettled matters of scientific debate cannot give rise to liability for damages sounding in defamation.

Plaintiff claimed that the article made statements about scientific findings that were intentionally deceptive and misleading, and that it therefore constituted false advertising. Plaintiff’s theory was that scientific claims made in print purport to be statements of fact that are falsifiable, and such statements can be defamatory or represent false advertising if known to be false when made. Plaintiff argued on appeal that the district court based its conclusion that the article’s statements were non-actionable solely on its determination that the assertions were statements of opinion, without conducting a more vigorous inquiry. 

The court of appeals noted that scientific academic discourse poses several problems for the fact-opinion paradigm of traditional First Amendment jurisprudence. Many conclusions contained in a scientific journal article are, in principle, “capable of verification or refutation by means of objective proof,” Phantom Touring, Inc. v. Affiliated Publ’ns, 953 F.2d 724, 728 n.7 (1st Cir. 1992). Indeed, it is the very premise of the scientific enterprise that it engages with empirically verifiable facts about the universe. At the same time, however, it is the essence of the scientific method that the conclusions of empirical research are tentative and subject to revision, because they represent inferences about the nature of reality based on the results of experimentation and observation. Importantly, those conclusions are presented in publications directed to the relevant scientific community, ideally in peer reviewed academic journals that warrant that research approved for publication demonstrates at least some degree of basic scientific competence. These conclusions are then available to other scientists who may respond by attempting to replicate the described experiments, conducting their own experiments, or analyzing or refuting the soundness of the experimental design or the validity of the inferences drawn from the results.

In a sufficiently novel area of research, propositions of empirical “fact” advanced in the literature may be highly controversial and subject to rigorous debate by qualified experts. Needless to say, courts are ill-equipped to undertake to referee such controversies. Instead, the trial of ideas plays out in the pages of peer-reviewed journals, and the scientific public sits as the jury.

Where, as here, a statement is made as part of an ongoing scientific discourse about which there is considerable disagreement, the traditional dividing line between fact and opinion is not entirely helpful. While statements about contested and contestable scientific hypotheses constitute assertions about the world that are in principle matters of verifiable “fact,” for purposes of the First Amendment and the
laws relating to fair competition and defamation, they are more closely akin to matters of opinion, and are so understood by the relevant scientific communities.

In that regard, said the court, it was relevant that plaintiff did not allege that the data presented in the article were fabricated or fraudulently created. If the data were falsified, the fraud might not be easily detectable by even the most informed members of the relevant scientific community. Rather, plaintiff here alleged that the inferences drawn from those data were the wrong ones, and that competent scientists would have included other data that were available to the defendant authors but that were not sufficiently taken into account in their analysis.

But when the conclusions reached by experiments are presented alongside an accurate description of the data taken into account and the methods used, the validity of the authors’ conclusions may be
assessed on their face by other members of the relevant discipline or specialty.The appeals panel therefore concluded that, to the extent a speaker or author draws conclusions from non-fraudulent data, based on accurate descriptions of the data and methodology underlying those conclusions, on subjects about which there is legitimate ongoing scientific disagreement, those statements are not grounds for a claim of false advertising. Even if the conclusions that the authors drew from the results of their data could be actionable, such claims would be suspect when, as here, the authors readily disclosed the potential shortcomings of their methodology and their potential conflicts of interest

This analysis properly reflected a worry about the chilling impact on crucial and valuable research, including comparative effectiveness research, of lawsuits by competitors who are unhappy with or disagree with the results of such studies. Such a debate belongs in the marketplace of scientific ideas, not in the court room. 

State Supreme Court Issues Opinion on Management of Discovery

Recently, the Colorado Supreme Court issued an opinion reaffirming that trial courts need to take an active, hands-on role in managing discovery and should consider cost-benefit and proportionality factors  to control excessive discovery. DCP Midstream, LP v. Anadarko Petroleum Corp., et al., Case No. 12SA307 (Colo. June 24, 2013). Note my colleagues at SHB filed an amicus brief on behalf of NAM in this matter. The decision is a victory for efforts to encourage a rule of reasonableness in discovery.

Plaintiff sued for breach of contract and other claims. During discovery, DCP sent Anadarko fifty-eight requests for production seeking millions of pages of paper and electronic documents and many of Anadarko's "title opinions"— attorney-authored opinions about the state of title to land or mineral interests. Anadarko refused to produce many of the requested documents. DCP then filed a motion to compel. Without holding a hearing, the trial court granted DCP's motion. The trial court did not address any of Anadarko's specific objections, nor did it provide any analysis under C.R.C.P. 26(b) in support of its conclusions. In a later written order, the trial court reasoned that DCP was entitled to discovery on any issue that is or may become relevant and ruled that Anadarko's title opinions were not privileged because they were based on public information.

Appeal ensued. The state Supreme Court noted that this proceeding raised important questions about the scope of discovery and the extent to which trial courts must manage the discovery phase of a case to accomplish the overriding purpose of the civil rules—"the just, speedy, and inexpensive determination of every action." C.R.C.P. 1. The state civil rules, and cases interpreting them, reflect an evolving effort to require active judicial management of pretrial matters to curb discovery abuses, reduce delay, and decrease litigation costs. See C.R.C.P. 16 committee comment ("It is expected that trial judges will assertively lead the management of cases to ensure that justice is served.").

This principle of active judicial management is reflected in the comments to the rules, and throughout the civil rules: e.g., C.R.C.P. 26(b) restricts the scope of discovery available as a matter of right; some material is limited to "good cause;" C.R.C.P. 26(b)(2) imposes limits on the number of depositions, interrogatories, and requests for production, and these limits can also be modified for "good cause."

The rules suggest that if a party objects to discovery because it is not relevant to a claim or defense, then the trial court must become involved. C.R.C.P. 26(b) requires trial courts to take an active role managing discovery when a scope objection is raised. When faced with a scope objection, the trial court must determine the appropriate scope of discovery in light of the reasonable needs of the case and tailor discovery to those needs. Because each case is unique and deserves unique treatment, the reasonable needs of the case will necessarily vary, depending on the subject matter and complexity of the case, the nature of the parties' claims or defenses, and the discovery necessary to resolve the dispute. To tailor discovery to the specific needs of the case, the Court said that the cost-benefit and proportionality factors listed in C.R.C.P. 26(b)(2)(F) will be helpful. These factors require active judicial management to control excessive discovery.

Bottom line, to resolve a dispute regarding the proper scope of discovery in a particular case, the trial court should, at a minimum, consider the cost-benefit and proportionality factors set forth in C.R.C.P. 26(b)(2)(F). When tailoring discovery, the factors relevant to a trial court's decision will vary depending on the circumstances of the case, and trial courts always possess discretion to consider any or all of the factors listed—or any other pertinent factors—as the needs of the case require.

So this one was vacated and remanded to the lower court for reconsideration.

Happy Independence Day

We want to wish all our faithful readers a happy and safe Independence Day.  As a new, young lawyer, your humble blogger had the privilege of walking through the Independence Hall courtyard and past the Liberty Bell each day on the way to and from work, and it never ceased to inspire with its rich history.  

The Summer events on old Chestnut Street (back then it was the State House), from the adoption of the Declaration of Independence, to the creation of the Constitution, remind each of us in the legal profession of the vital role lawyers had in the creation of our young nation, and of our duty to this great republic founded on liberty and the rule of law.

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Florida Adopts Daubert Test

Last month, Florida Gov. Rick Scott (R) signed into law legislation (H.B. 7015) concerning the qualifications of expert witnesses and replacing the the state admissibility standard under Frye to the Daubert standard. The law kicks in this month.


Currently, Florida courts employ the standard articulated in Frye v. United States, 293 F. 1013 (D.C. Cir. 1923) and progeny, to determine whether to admit expert testimony. Under the Frye standard, the methodology or principle on which expert opinion testimony is based must be generally accepted in the field in which it belongs.  The bill replaces the Frye standard with the Daubert standard. Under the Daubert test, when there is a proffer of expert testimony, the trial judge as a gatekeeper must make a preliminary assessment of whether the reasoning or methodology properly can be applied to the underlying facts at issue. The bill adopts the Daubert standard by amending Florida law to prohibit an expert witness from testifying in the form of an opinion or otherwise, including pure opinion testimony, unless:

The testimony is based on sufficient facts or data;
The testimony is the product of reliable principles and methods; and
The witness has applied the principles and methods reliably to the facts of the case.


Additionally, the preamble further states that the Legislature intended to adopt the standards provided in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), General Electric Co. v. Joiner, 522 U.S. 136 (1997), and Kumho Tire Co. v. Carmichael, 526 U.S. 137 (1999) and to prohibit pure opinion testimony as provided in Marsh v. Valyou, 997 So. 2d 543 (Fla. 2007).


The vote in the Senate was 30-9; in the state House 70-41.  Florida business groups supported the change as one making the state's legal climate more friendly to businesses by helping to keep junk science out of the court room.

Supreme Court Issues Important Preemption Ruling

The Supreme Court last week reversed the First Circuit decision in Mutual Pharmaceutical Co. v. Bartlett, No. 12-142 (U.S., 6/24/13).

Readers will recall that in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), the Supreme Court held that state tort law claims against generic drug manufacturers based on the alleged inadequacy of the drug labeling are preempted; under the Hatch-Waxman Amendments to the Food, Drug and Cosmetic Act, generic drug labeling must be the same as the labeling of the reference-listed drug. Because generic drug manufacturers cannot independently change the labeling, state law failure to warn claims are preempted.

Plaintiffs proceeded to hunt for exceptions, ways around the ruling.  One of the strategies was to resurrect design defect theories, which traditionally were not a major aspect of most drug plaintiff claims. This case was tried on a design defect theory of liability after the plaintiff’s failure to warn claims were dismissed prior to trial and the district court rejected the generic manufacturer’s preemption defense on the design claim.  The jury found for plaintiff, and defendant appealed, arguing that just as the manufacturer cannot alter the label, once a drug—whether generic or brand-name—is approved, the manufacturer is prohibited from making any major changes to the qualitative or quantitative formulation of the drug product, including active ingredients, or in the specifications provided in the approved new drug application.  In Bartlett, the First Circuit held that the plaintiff’s state law theory of liability could nevertheless be reconciled with federal law because, although the generic manufacturer could change neither the design nor the labeling, it could avoid liability if it stopped selling the drug entirely within the state.

The Supreme Court reversed.

New Hampshire imposes design defect liability where the design of the product created a defective condition unreasonably dangerous to the user. To determine whether a product is “unreasonably dangerous,” the New Hampshire Supreme Court employs a risk/utility approach under which a product is defective as designed if the magnitude of the danger outweighs the utility of the product. The New Hampshire Supreme Court has repeatedly identified three factors as germane to the risk-utility inquiry: the usefulness and desirability of the product to the public as a whole, whether the risk of danger could have been reduced without significantly affecting either the product’s effectiveness or manufacturing cost, and the presence and efficacy of a warning to avoid an unreasonable risk of harm from hidden dangers or from foreseeable uses.  

In the drug context, either increasing the “usefulness” of a product or reducing its “risk of danger” would require redesigning the drug: a drug’s usefulness and its risk of danger are both direct results of its chemical design and, most saliently, its active ingredients. Here, said the Supreme Court, redesign was not possible, as the FDCA requires a generic drug to have the same active ingredients, route of administration, dosage form, strength, as the brand-name drug on which it is based. Given the impossibility of redesigning the drug, the only way for the defendant to ameliorate the drug’s “risk-utility” profile—and thus to escape liability—was to strengthen the presence and efficacy of the warning in such a way that the warning avoided an unreasonable risk of harm from hidden dangers or from foreseeable uses.

That was, of course, preempted.  When federal law forbids an action that state law requires, the state law is “without effect.” Because it is impossible for generic manufacturers to comply with both state and federal law, New Hampshire’s warning-infused design defect cause of action was pre-empted with respect to FDA-approved drugs sold in interstate commerce.

The Supreme Court rejected the argument that a defendant could satisfy both laws by paying tort judgments or refraining from selling its product in that particular state. And rejected the “stop-selling” rationale as incompatible with its pre-emption jurisprudence. The Court's pre-emption cases presume that an actor seeking to satisfy both his federal and state law obligations is not required to cease acting altogether in order to avoid liability. Indeed, if the option of ceasing to act defeated a claim of impossibility, impossibility pre-emption would be all but meaningless. The incoherence of the stop-selling theory becomes plain when viewed through the lens of the previous cases. In every instance in which the Court has found impossibility pre-emption, the direct conflict between federal and state law duties could easily have been avoided if the regulated actor had simply ceased acting.

Interestingly, there is nothing in the Court's rejection of “stop-selling” limiting it to generic drugs; the rejection seems applicable to all federally regulated products because it's not based on the FDCA but is an argument “incompatible with our pre-emption jurisprudence.”