Chew on This: Consumer Fraud Claim on Snack Bars Preempted

The Seventh Circuit ruled earlier this month that federal food labeling law expressly preempts state law claims seeking certain additional health-related disclosures on chewy bars. Turek v. General Mills Inc., No. 10-3267 (7th Cir. 10/17/11).

The bars have been around since at least the early 1980's, but have grown into a nearly $2 billion segment of the food industry.  Consumers love their portability, and relatively low calorie count.

Plaintiffs brought a diversity class action suit under the Illinois Consumer Fraud and Deceptive Business Practices Act, and the Illinois Uniform Deceptive Trade Practices Act, alleging that the label of certain "chewy bars" was misleading regarding fiber content.  Specifically, the complaint alleged that the principal fiber, by weight, in the bars was inulin extracted from chicory root. The complaint describes inulin so extracted as a processed, "non-natural” fiber which was not as beneficial to consumer health as other fiber.

Those state law claims ran smack into a provision of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 343-1(a)(5), added by the Nutrition Labeling and Education Act of 1990, which forbids states to impose “any requirement respecting any claim of the type described in section 343(r)(1)
[of the Food, Drug, and Cosmetic Act] . . . made in the label or labeling of food that is not identical to the requirement of section 343(r).”  A state thus can impose the identical requirement or requirements, and by doing so be enabled, because of the narrow scope of the preemption provision in the Nutrition Labeling and Education Act, to enforce a violation of the Act as a violation of state law. See also In re Pepsico, Inc. Bottled Water Marketing and Sales Practices Litigation, 588 F. Supp. 2d 527, 532 (S.D.N.Y. 2008); “Beverages: Bottled Water,” 60 Fed. Reg. 57076, 57120 (Final Rule, Nov. 13, 1995). This is important because the Food, Drug, and Cosmetic Act does not create a private right of action. Medtronic, Inc. v. Lohr, 518 U.S. 470, 487 (1996).

The question thus became what requirements the federal law imposes on the labeling of dietary fiber. Section 343(q)(1) of the Act contains a requirement that the “label or labeling” of food products intended for human consumption state “the amount of . . . dietary fiber . . . contained in each serving size or other unit of measure.” Other requirements for labeling claims relating to dietary fiber are set forth in implementing regulations.  

The labeling of the products challenged by the plaintiff was compliant with these regulations relating to health claims for dietary fiber. See, e.g., 21 C.F.R. § 101.76. All the FDA’s requirements relating to labeling dietary fiber are requirements to which any labeling disclosures required by a state must be identical.  But the disclaimers that the plaintiff wants added to the labeling of the defendants’ inulin-containing chewy bars were not identical to the labeling requirements imposed on such products by federal law, and so they were barred, held the court of appeals. The information required by federal law does not include disclosing that the fiber in the product includes inulin or that a product containing inulin allegedly produces fewer health benefits than a product that contains only product that contains only “natural” fiber, for example. 

Even if the disclaimers that the plaintiff wants added would be "consistent" with the requirements imposed, importantly, consistency is not the test. Identity is, said the court.

The Seventh Circuit thus affirmed dismissal of the case. But clarified, procedurally, that when a state law claim is expressly preempted under section 403A of the Federal Food, Drug, and Cosmetic Act,” a dismissal on the merits is the proper outcome, with prejudice like other merits judgments, not dismissal for want of federal jurisdiction, as the district court had ordered.

This is a victory for consumers when one considers why Congress did not want to allow states to impose disclosure requirements of their own on packaged food products, most of which are sold nationwide. Manufacturers might have to print 50 different labels, driving consumers who buy the food products crazy. A granola bar you buy in California ought to look just like the one you buy in Maine.

 

Competing Model of Plaintiff Class Action Bar Forthcoming

Readers of MassTortDefense are mostly from the defense bar, and are always thinking about what the other side is thinking about.

Visiting Professor Ratner of Harvard Law School is trying to give us a new view of plaintiff class action attorneys.  Since he practiced with Lieff Cabraser Heimann & Bernstein, readers can soon decide for themselves whether his view is descriptive or wishful thinking. See Ratner, Morris, A New Model of Plaintiffs' Class Action Attorneys (2011). Review of Litigation, Forthcoming.

According to the author, this article offers a new model for conceptualizing plaintiffs’ class action attorneys, and thus for understanding principal-agent problems in class action litigation. It responds to the work of Professor John C. Coffee, Jr., who, in a series of influential articles, demonstrated that principal-agent problems may be acute in class action litigation because class members lack the information or financial incentive to monitor class counsel; class counsel is thus free to pursue his own interests at the expense of the class members. But what are those interests, and how do they diverge from the class members’ interests? Professor Coffee provided one answer to this sub-set of questions, presenting an account of class counsel and the precise parameters of his disloyalty corresponding with three descriptive assertions: that class counsel is either a solo practitioner or in a small firm; that he is predominantly interested in maximizing his law firm profit; and he capably pursues his fee-maximizing goal by investing his time in cases based on confident predictions about expected fees.

In this article, the author offers a competing conception of the dominant class action attorneys and firms; he argues that the leading firms today are relatively large and internally complex; law firm structural complexity creates diverse incentives other than maximization of law firm profit; and class counsel invest time in cases for complex reasons other than the effect on expected fees, particularly because fees are notoriously difficult to predict. Modeling class counsel to recognize this complexity has three virtues, he claims: it better reflects the actual characteristics of the most significant class action attorneys, and hence is a more accurate descriptive tool; as such, it enables a more precise understanding of the extent and nature of agency or loyalty problems; and thus, finally, it provides a more solid basis for needed reforms. In particular, this new model, the author asserts, sheds insight on the importance of direct versus incentive-based regulation to manage agency costs in class actions. In light of the diverse incentives this new model reveals, direct regulation of outcomes by trial courts using enhanced final approval standards should be a central part of any package of reforms to manage agency costs in class litigation, argues the author.

We are looking forward to seeing the arguments.

EU Offers Standard Definition of Nanotechnology

One of the challenging aspects of attempts to regulate emerging nanotechnology is the definition.  Proposing a "definition" for nanotechnology is not as straightforward a process as it may seem; applying a strict, universal definition of nanotechnology to all applicable fields and products may not be an appropriate science-based approach.  Inclusion of nanometer-sized active ingredients or excipients in a product does not by itself determine a product's safety and efficacy (i.e. size alone is not always itself an indicator of toxicity).   Then there is the issue of distinguishing between engineered nanomaterials and those naturally occurring at the nanoscale.

Last week, the European Commission took another step in this debate, unveiling a new, common nanomaterial definition as a basis for regulation. Nanomaterials are defined as those whose main constituents measure between 1 and 100 billionth of a meter; that is, a natural, incidental or manufactured material containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50% or more of the particles in the number size distribution, one or more external dimensions is in the target size range.

Thus, the new EU definition is based on an approach that considers the size of the constituent particles, rather than any other indicia of potential risk.  The EU did note that there is no evidence that nanomaterials are inherently hazardous. Technological development and scientific progress continue with great speed, noted the report. The definition including descriptors will therefore be subject to a re-review by December 2014. In particular, the review will assess whether the number size distribution threshold of 50 % should be increased or decreased and whether to include materials with internal structure or surface structure in the nanoscale such as complex nano-component nanomaterials including nanoporous and nano-composite materials that are used in some product sectors.

 

Company "Doe" Files Suit Challenging the CPSC Database

Multiple reports indicate that an unnamed company filed a suit last week, under seal, to challenge aspects of the Consumer Product Safety Commission's new public database.

Readers may recall that the Consumer Product Safety Improvement Act of 2008 mandated the creation of a consumer product safety information database, and from the beginning, there was controversy about the absence of an adequate process for addressing false and inaccurate reports that will scare consumers, harm business, and generate no additional safety gains; the need to employ means to prevent the submission of fraudulent reports of harm while not discouraging the submission of valid reports; the importance of not putting the governmental imprimatur on voluntary data that has not been verified; and the absence of a sufficient time period allocated for manufacturers to evaluate and respond to any proposed report.

The suit was reportedly filed in federal court in Maryland, and relates to material inaccuracies with respect to a report of alleged injury that found its way into the database.  The suit apparently asks that the CPSC be enjoined from keeping the complaint about one of the company's products in the public database.

Almost anyone can file a “report of harm,” including consumers; government agencies; health care professionals; child service providers; and public safety entities. Consumers could include not just the purchaser of the product but their personal injury attorney, with their own agendas.

Manufacturers have only a limited opportunity to review and dispute information in incident reports before they are published on-line in the CPSC database. Manufacturers have limited control over what information can be removed or amended once posted. The two dissenting votes at the time the CPSC commissioners approved the database made an unsuccessful attempt to amend the final rule so as to give manufacturers more time to comment on or respond to the inaccuracy of postings before they are published to the database and to the public.

The database is accompanied by a weak disclaimer stipulating that CPSC has not verified the accuracy of any report. Observers continue to worry that the agency has not paid sufficient attention to legitimate issues of a manufacturer's goodwill and reputation, to the costs of unnecessary panic among product consumers, and the mischief that plaintiffs' lawyers might cause with unwarranted increase in litigation against manufacturers.

A recent U.S. Government Accountability Office report on the database found that of 1,800  published reports, manufacturers noted that 160, nearly 10%, had materially inaccurate information.

 

House Hearing on Food Marketing to Kids -- Seller Beware

Two subcommittees of the House Energy and Commerce Committee, the Subcommittee on Commerce, Manufacturing, and Trade and the Subcommittee on Health, held a joint hearing last week on the issue of “Food Marketing: Can ‘Voluntary’ Government Restrictions Improve Children’s Health?”

Speakers came from the CDC, the U.S. Department of Agriculture, the FTC, Campbell Soup Company, and the Association of National Advertisers.

The background of the hearing is that the 2009 Consolidated Appropriations Act contained report language forming an Interagency Working Group (IWG), comprised of the Federal Trade Commission, the Department of Health and Human Services, and the Department of Agriculture. The IWG was tasked with conducting a study and issuing a report to Congress concerning standards for marketing food to children.  Instead of conducting the prescribed study or providing a report to Congress, the IWG issued a document entitled “Preliminary Proposed Nutrition Principles to Guide Industry Self-Regulatory Efforts.”

The document presented a a sweeping set of “voluntary” principles for marketing foods to kids,  based on nutritional standards that exceed and conflict with those of other government programs. They also reflect a tenuous grasp of science, lacking evidence, critics say, showing that childhood obesity is related to advertising of food that doesn’t comply with the proposed principles.  The guidelines are so restrictive that many healthy foods, like low-fat yogurts, whole wheat bread, and 2% milk could not be marketed to those 17 and under. Even non-sweetened cereals would not meet the IWG guidelines.  According to one analysis, 88 out of the 100 most advertised foods and drinks would be in violation of these standards.

Regardless of whether a child sees a commercial for an item, the ultimate purchasing decision rests with the parent who purchases the groceries – and those groceries carry nutrition labels that every parent can read.  Of course, this is the nanny state rearing its head again. And there are serious issues of infringement of constitutionally protected commercial speech.

But a legitimate concern to our readers is that while these guidelines are labeled as voluntary, what happens when a litigious group sues a food manufacturer because it showed a commercial advertising a new kind of chocolate treat or drink that does not comply?  Our readers are surely familiar with example of courts allowing plaintiff experts to note "voluntary" or "recommended" guidelines.

Amicus Urges Supreme Court to Reverse Causation Junk Science Decision

DRI (the Defense Research Institute) last week submitted an amicus brief urging the Supreme Court to review a federal appeals court decision that threatens to undermine the gatekeeper role of the trial courts on expert testimony. United States Steel Corp. v. Milward v. Acuity Specialty Products Group Inc., No. 11-316 ( U.S., amicus petition filed 10/12/2011).

Most of our readers know that DRI is an international organization that includes more than 23,000 attorneys involved in the defense of civil litigation.  DRI has long been a voice in the ongoing effort to make the civil justice system more fair, efficient, and—where national issues are involved—consistent. (Your humble blogger is a member.)

In this case, the plaintiff alleged that he contracted a rare form of cancer, acute promyelocytic leukemia (APL), through exposure to benzene or benzene contaminants. The plaintiff’s expert acknowledged that science has not determined what causes or can cause APL, but opined that, based on his own "judgment," the "weight of evidence" supported a conclusion that APL could be caused by benzene exposure. After a four-day hearing, the district court excluded the expert testimony as unreliable under Daubert, and Gen. Elec. Co. v. Joiner, 522 U.S. 136 (1997)(district courts need to exclude proof that is connected to the data only by the ipse dixit of an expert), finding that it amounted to no more than a plausible hypothesis. The U.S. Court of Appeals for the First Circuit reversed and reinstated the case, holding that it was an abuse discretion to exclude this evidence as to possible causation.

The First Circuit in this case appeared to think that district courts not only may but must admit speculative expert testimony that rests on nothing more than the expert’s subjective judgment that an untested hypothesis is supported by the “weight of the evidence.”  That decision conflicts with Supreme Court guidance and with the decisions of other circuits holding that expert testimony is admissible only when it rests on a reliable scientific foundation, and that a district court is not required to accept an expert’s ipse dixit but must instead carefully examine the methods and data underlying the expert’s opinion to ensure that the expert has reliably applied valid scientific principles. Without such an inquiry, the “gatekeeper” function the Federal Rules of Evidence envision for the district court judge becomes meaningless.

DRI correctly points out that the weight-of-the-evidence methodology the court of appeals endorsed does not satisfy the criteria Daubert adopted for assessing the reliability of expert testimony. It is neither testable nor falsifiable; it is not governed by any objective standards; and it has not been generally accepted by the scientific community as a means to assess medical causation absent an observed association between the substance and disease at issue. The fact that some regulatory agencies use an arguably similar, lower bar, methodology to assess risks to public health based on the available data does not mean that it yields “scientific knowledge” admissible under the very different standards governing a court proceeding.

Moreover, the district court’s essential gate-keeping role is particularly important on the issue of medical causation. That issue is often dispositive in toxic tort and product liability cases, which can involve enormous stakes not only for the parties, but also for the national economy. The lay jurors who decide these complicated issues are likely to be greatly influenced by testimony that appears to be scientific in nature coming from a witness whom the court has admitted as an "expert." The decision by the First Circuit undermines the critical screening function district courts perform to prevent juries from being misled by speculation masquerading as scientific knowledge.

 

Class Member Lacks Standing to Appeal Fees to Class Counsel

Last week, the First Circuit dismissed for lack of standing a class member's challenge to the significant fee award to class counsel in the Volkswagen AG/Audi AG MDL. In re Volkswagen and Audi Warranty Extension Litigation, MDL No. 1790.
 

The MDL included litigation over alleged oil sludge buildup in engines in the vehicles, and involved about 480,000 cars. The parties reached a settlement under which the automakers had agreed to cover the sludge-related maintenance costs for owners or lessees of Audi A4s from certain model years and Volkswagen Passats from specific model years, if the owners could document required oil changes.

The court also approved an award of $30 million in fees to the firms representing the plaintiffs, which drew the fire of class member Ashley Birkeland.  Her appeal of this issue was rejected last week, however, by the 1st Circuit, which dismissed for lack of standing. The court concluded that appellant suffered no redressable injury from the fee award. She did not allege, for example, that class counsel sold the class short as part of a collusive fee agreement. See Glasser v.  Volkswagen of America, Inc., 645 F.3d 1084, 1088-89 (9th Cir. 2011). Nor did she allege any improper supplemental agreement between plaintiffs counsel and defendant. Cf. In re Cendant Corp. PRIDES Litig., 243 F.3d 722, 726 & n.4 (3d Cir. 2001).

The court held that Fed. R. Civ. P. 23(h)(2) does not effectively confer standing to appeal on such appellants. "The district court's jurisdiction to review fee applications with the input of objectors is one thing; our appellate jurisdiction is another."

The court's reasoning seemed to reflect the view that the defendants, Volkswagen and Audi, and not class members, would be paying class counsel's fees -- implicitly rejecting the notion that such settlements are a zero-sum game based on a total that a defendant is willing to pay (and calculates it will have to pay in total), so every dollar in fees is a dollar less to the class members. 

 

Defect Allegations Insufficient in Drug Case

We may be accustomed to talking about whether a product was "defective" and, as counsel for defendant sellers, working hard to show that the product contained no "defect."  Earlier this month came a decision reminding us that, in some contexts, a defect, even one that caused the injury, may not be all plaintiffs need to allege and prove. Mills v. Bristol-Myers Squibb Co., No. 11-00968 (D. Ariz., 10/7/11).

Plaintiff was prescribed Clopidogrel (branded as "Plavix") for the treatment of peripheral vascular disease.  Two years later, plaintiff initiated this action alleging that the drug caused excessive rectal bleeding. The court dismissed, and plaintiff eventually sought leave to file a Second Amended Complaint. Defendants argued that leave to amend should be denied as futile.  And the court agreed.

The interesting part of the opinion for our readers is the discussion of strict products  liability, premised on two theories: design defect and failure to warn. (Plaintiff also premised her negligence claim on these theories.)  For plaintiff to prevail under both theories she had to show that the product left the defendants' hands in a defective condition, the defect rendered the product unreasonably dangerous, and the defect was a proximate cause of plaintiff's injuries. Sw Pet Prods., Inc. v. Koch Indus., Inc., 273 F. Supp. 2d. 1041, 1051 (D. Ariz. 2003).

Plaintiff alleged that Plavix was allegedly defective when ingested along with aspirin by people who have peripheral vascular disease, and that the defect caused her injury.  So there you have it.   But wait... simply pleading a defect is not enough. To prevail on a design defect claim in Arizona, a plaintiff must also show that the defective product is unreasonably dangerous.  Although plaintiff's design defect claim was apparently pled pursuant to the Restatement (Second) of Torts § 402(a), the federal court concluded that Arizona would now use the Restatement (Third) of Torts, particularly its definition of an unreasonably safe prescription drug or medical device in a design defect claim.  Section 6(c) of the Third Restatement, noted the court, declares that a prescription drug or medical device is unreasonably unsafe due to defective design only if the foreseeable risks of harm posed by the drug or medical device are sufficiently great in relation to its foreseeable therapeutic benefits that reasonable health-care providers, knowing of such foreseeable risks and therapeutic benefits, would not prescribe the drug or medical device for any class of patients.

Here, although plaintiff alleged that no reasonable health-care provider would prescribe Plavix
for plaintiff knowing of the alleged risks to Caucasian patients who genetically are poor metabolizers of Plavix, and who are diagnosed with peripheral vascular disease and concomitantly ingest aspirin, nowhere did the plaintiff allege that Plavix would not be prescribed for any class of patients. (We leave for a later post the interesting and scary theory that the drug was defective because it had greater adverse effects among a narrow group with a genetic pre-disposition.)

And arguably even under a traditional risk/benefit analysis used to determine whether a product is unreasonably dangerous based on the Restatement (Second) of Torts, plaintiff's pleading did not state a plausible claim.  Although detailed factual allegations are not necessary in pleadings, "labels and conclusions" are insufficient. Bell Atlantic Corp v. Twombly, 550 U.S. 544, 555 (2007).  And that's what she offered on risk benefit elements.

As to the warning claim, plaintiff needed to allege, then show, that had a proper warning been given, the injury would not have happened. See Gosewisch v. Am. Honda Motor Co., Inc., 153 Ariz. 400, 403, 737 P.2d 376, 379 (1987) (superseded by statute on other grounds).  Here, plaintiff averred only on information and belief that her doctor would not have prescribed Plavix had he known of its true risks for patients like plaintiff.   But the court noted that plaintiff could simply have contacted her physician to determine the facts, which were not solely in the control of defendants. She did not do so, and her allegations thus fell short. This may be an important use of the clarified pleading standard, particularly in those jurisdictions in which defendants are precluded from informally contacting the plaintiff’s prescriber.  


 

State Supreme Court Directed to Reconsider Jurisdiction Over Foreign Defendant

The U.S. Supreme Court earlier this month instructed Oregon's supreme court to reconsider the state court's exercise of jurisdiction over a Taiwanese manufacturer.  See China Terminal & Electric Corp. v. Willemsen, No. 10-1262 (U.S.; order issued 10/3/11).

In the short order, the Court granted review, vacated the Oregon opinion denying the manufacturer's challenge to jurisdiction, and remanded the case for further consideration in light of J. McIntyre Machinery, Ltd. v. Nicastro.

Readers may recall from our earlier posts that Nicastro resulted in a plurality opinion which tracked Justice O'Connor's plurality opinion in Asahi Metal Industry Co. v. Superior Court of California, 480 U.S. 102 (1987), and two other concurring in the notion that the foreign product manufacturer lacked sufficient minimum contacts to allow a New Jersey court to exercise jurisdiction over it, but concluding that because this case did not present the new and special issues arising from recent changes in commerce and communication, it was unnecessary to get into full analysis of the steam of commerce issue as it might be applied to 21st century marketing. Rather, the outcome of the case could be determined by the Court’s existing precedents, which have held that a single isolated sale, even if accompanied by the kind of sales effort indicated in the record in the case, is not sufficient.

The Oregon case arise from a fire allegedly caused by a battery charger manufactured by CTE, a Taiwanese company;  the battery charger was incorporated into a motorized wheelchair. Plaintiffs allege that the fire began in the chair, bacuase of a defect in the charger. CTE sought dismissal on the grounds the state court lacked personal jurisdiction. The trial court denied the motion, and the Oregon Supreme Court denied defendant's petition for a writ of mandamus on the issue.

On remand, it will be interesting to see what the state court does, given what many observers see as their recent resistant approach on directions from the high Court on remands.

And Here's Another Reason....

...why medical monitoring often does not make sense.

In our posts on medical monitoring, we have pointed out that even in those jurisdictions which do recognize this type of claim/damages, plaintiffs typically must show that the proposed medical monitoring regime is reasonably medically necessary.  Some courts articulate the notion that the testing be consistent with the standard of care, while others require the monitoring be reasonably necessary according to contemporary scientific principles.

An essential result of this is that the screening cannot risk doing more harm than good.  While the pre-load of a typical jury pool may be that monitoring is always helpful, the reality is that many forms of screening have significant potential costs and risks, associated with the procedure or the inevitable follow-up response to a positive test finding --which may turn out to be a false positive finding.  If those (and other) costs are not outweighed by the decrease in disease mortality fostered by the testing, then the monitoring doesn't make sense medically, and should not be available in a legal setting.

That is why we read with some interest the recent reports that the U.S. Preventive Services Task Force, which studies health screening measures, is planning to downgrade its recommendation on a common form of prostate cancer screening (PSA).  The test now gets a "D," which wasn't good when MassTortDefense was in school, and actually means it recommends against the screening because there is moderate or high certainty that the screening has no net benefit or that the harms outweigh the benefits.

The Task Force recognized that high or increasing levels of PSA can indicate many things besides an increased risk for prostate cancer; PSA tests have resulted in high rates of false positives (10-15%) and thus over-treatment for small, slow-growing cancers that will never actually cause harm. Those treatments, surgery and radiation, are not benign. In contrast, the latest studies of those screened show no statistically significant benefit after 10 years.

The point here for our readers is that if a commonly used, widely accepted test can be shown after actual use to risk more harm than good, then how questionable are the new technologies, made-for-litigation screening programs that plaintiffs' hired experts concoct for a class action?

 

Plutonium Class Action in Supreme Court

The U.S. Supreme Court last week invited the Solicitor General to weigh in on the issues in a significant class action, in which the plaintiffs allege plutonium contamination. Merilyn Cook, et al. v. Rockwell International Corporation, et al., No. 10-1377 (U.S.).

The plaintiffs were more than 15,000 property owners near the former Rocky Flats Nuclear Weapons Plant in Colorado.  In 2006, a jury found against defendants Dow and Rockwell.  In 2008, the federal trial court ordered the companies to pay a total of $926 million in damages. The 10th Circuit reversed.

At issue now is whether state substantive law controls the standard of compensable harm in suits under the Price-Anderson Act, or whether the Act instead imposes a federal standard; and, secondly, whether, if a federal standard applies, a property owner whose land has been contaminated by plutonium must show some physical injury to the property beyond the contamination itself in order to recover.

The court of appeals had concluded that plutonium contamination by itself was not adequate under the Act. In particular, property owners’ fears that the plutonium might damage their health was not a sufficient basis to award damages.

The case raises the all-too-familiar scenario of trial courts dispensing with traditional elements of a cause of action in order to proceed with class litigation. Plaintiffs alleged that defendants were  responsible for plutonium emissions that diminished their property values. But they did not prove any present physical injury to person or property, or loss of use of property, on a class-wide basis. Rather, they vigorously --and successfully-- urged the district court to dispense with any such injury requirement. The district court allowed petitioners to recover based solely on a risk of injury to person or property, even if unverifiable or scientifically unfounded.

 

New Edition of Reference Manual on Scientific Evidence

The National Research Council and Federal Judicial center last week released the new edition of the Reference Manual on Scientific Evidence. Readers of MassTortDefense know   about this manual as a guide for judges searching for effective and fair ways to handle science-based issues, including assessing expert testimony. The Supreme Court has made clear that the law imposes on trial judges the duty, with respect to scientific evidence, to become evidentiary gatekeepers. The judge, without interfering with the jury’s role as trier of fact, must determine
whether purported scientific evidence is “reliable” and will “assist the trier of fact,” thereby keeping from juries testimony that  lacks the same level of intellectual rigor that characterizes the practice of an expert in the relevant field.

The manual is intended to assist judges in managing cases involving complex scientific and technical evidence by describing the basic tenets of key scientific fields from which legal evidence is typically derived and providing examples of cases in which that evidence has been used. As the introduction to the new edition notes, the search is not a search for scientific precision. Courts cannot hope to investigate all the subtleties that characterize good scientific work. A judge is not a scientist, and a courtroom is not a scientific laboratory. But the objective is to seek legal decisions that fall within the boundaries of scientifically sound knowledge.

The Manual includes general chapters such as on "The Admissibility of Expert Testimony" and "How Science Works," and specific chapters on (of interest to our readers) Exposure Science,  Epidemiology, and Toxicology, and new chapters on Neuroscience, and Mental Health Evidence. The authors note the new edition has a focus on two critical topics that judges frequently confront, causation and expert bias.

The new edition was produced by a committee of judges, scientific experts, attorneys and academics. Bu it will be interesting to see if readers, after getting a chance to review it, will find that this version inappropriately undermines the Daubert guidelines enunciated by the Supreme Court and overemphasizes the "discretion" of trial judges to "manage" their dockets despite the meaning of the Federal Rules of Evidence.

 

 

Substantial Cause Explored in Case of Multiple Exposures

The Sixth Circuit issues and interesting opinion last week, exploring plaintiff's burden to prove that exposure to defendant's product caused his injury in the context in which plaintiff was exposed to numerous other similar products. See Moeller v. Garlock Sealing Technologies LLC, No. 09-5670, (6th Cir., 9/28/11).

Plaintiff was a pipefitter who worked with asbestos-containing gaskets made by Garlock from about 1962 until about 1970. But from 1962 until about 1975, he also sustained significant exposure to asbestos insulation. He contracted mesothelioma and sued, alleging that his exposure to Garlock’s asbestos-containing gaskets was a substantial factor in causing his injuries.

At trial, plaintiff's expert testified that exposure to asbestos from Garlock gaskets, along with his other exposures, contributed to the mesothelioma. And one of the treating oncologists opined  that if plaintiff had worked for many years (as he did) scraping and grinding asbestos gaskets, and if plaintiff breathed those fibers, then that exposure would have caused his cancer. In rebuttal, Garlock presented evidence that plaintiff had sustained substantial exposure to asbestos insulation products for 13 years. It also presented evidence that whereas asbestos insulation was banned in the 1970s, leading asbestos safety authorities believed that gaskets, such as those sold by Garlock, posed “no health hazard,” and were sold lawfully in the United States. Garlock also suggested that the plaintiff had only installed Garlock gaskets (an activity that both parties agree did not create a risk of injury), and had not ever removed them (the activity that the plaintiff alleges caused the injuries).

The jury returned a verdict for plaintiff, and defendant appealed.

To prevail on a negligence claim, Kentucky law requires a plaintiff to prove that a defendant’s conduct was a substantial factor in bringing about the harm. Deutsch v. Shein, 597 S.W.2d 141, 144 (Ky. 1980). Causation requires a link between the specific defendant’s conduct and the plaintiff’s injuries. See Estes v. Gibson, 257 S.W.2d 604, 607 (Ky. 1953) . Substantial causation refers to the probable cause, as opposed to a possible cause. One measure of whether an action is a substantial factor is the number of other factors which contribute in producing the harm and the extent of the effect which they have in producing it.

The appeals court concluded that the plaintiff failed to prove that Garlock’s product was a substantial factor in bringing about the harm. The plaintiff presented various witnesses to support the claim that the mesothelioma was caused by his exposure to Garlock gaskets. But one expert never actually said that the exposure to Garlock gaskets was a substantial factor in causing the  cancer; the others testified that all types of asbestos can cause mesothelioma and that any asbestos exposure counts as a “contributing factor.”  That testimony does not establish that exposure to Garlock gaskets in and of itself was a substantial factor.

Moreover, the evidence presented was insufficient to allow a jury to infer that exposure to Garlock gaskets was a substantial cause of the cancer. Plaintiff here presented no evidence quantifying  exposure to asbestos from Garlock gaskets. There was testimony that he removed gaskets for several years, and that some of those gaskets were Garlock’s. But the plaintiff failed to establish how many Garlock gaskets he removed, or how frequently he removed—as opposed to installed—them. The record also shows that plaintiff regularly tore out asbestos insulation during the relevant years, and that his exposure to asbestos from insulation would have been thousands of times greater than his exposure from removing gaskets.

Thus, while his exposure to Garlock gaskets may have contributed to his mesothelioma, the record simply does not support an inference that it was a substantial cause of his mesothelioma. Given that the Plaintiff failed to quantify his exposure to asbestos from Garlock gaskets and that the Plaintiff concedes that he sustained massive exposure to asbestos from non-Garlock sources, there is simply insufficient evidence to infer that Garlock gaskets probably, as opposed to possibly, were a substantial cause of the injury.

The court summed it up: saying that exposure to Garlock gaskets was a substantial cause of plaintiff’s mesothelioma would be akin to saying that one who pours a bucket of water into the
ocean has substantially contributed to the ocean’s volume.