New Product Liability Case Book

Although my teaching days are in the past (10 years as an adjunct at the University of Pennsylvania Law School), I still like to keep one eye on the literature. Interested readers may want to check out a new case book from Carolina Academic Press.  It is entitled  Products Liability Law: Cases, Commentary, and Conundra by Tim Kaye, a professor of law at Stetson University College of Law, a British lawyer bu original training.

The publisher notes: Products liability law is often confusing because it is in a state of constant flux as it confronts a number of challenges. Some such challenges are well known, such as the battle over the comparative merits of the Second and Third Restatements of Torts. Other equally important challenges may have, however, been somewhat overlooked by other texts, such as the growing use of bankruptcy protection laws to limit the consequences of supplying defective products, "and this book sets out to rectify such omissions."

While some other books leave the reader to sink or swim in a swamp of apparently contradictory doctrine, Products Liability Law promises to lay out from the beginning the elements common to all products liability claims. It then builds on this foundation by tackling each new area of the law in a lucid and reader-friendly manner, while explaining how each doctrine relates to the politico-economic and historical context in which the law operates, promises the publisher.

It was nice to see some old nuggets I used, like Boatland of Houston, Inc. v. Valerie Bailey on state of the art, and Borel v. Fibreboard Paper Products Corp. as an introduction to toxic tort product cases, side by side with newer cases, like Conte v. Wyeth, used here on the concept of reliance.
 

Supplementing the text with numerous original flowcharts, tables, and other diagrams—as well as asking thoughtful questions along the way—this book charts a careful and comprehensible course through the often tempestuous battleground of products liability law, says the publisher.  See if you agree.

 

Report Issued on Use of Science in Regulatory Decisions

Scientists and policy experts from industry, government, and various nonprofit sectors worked on a report released recently by the Research Integrity Roundtable, designed to offer ways to improve the scientific analysis and independent expert reviews which underpin many important regulatory decisions. The primary audience for the report is federal agencies and their scientific advisory committees, but the ideas in the report may be relevant to others who work at the intersection of science and regulatory policy, including in Congress, the judiciary, and readers of MassTortDefense.  These issues can have important implications for persons interested in issues associated with chemicals, energy, land use, natural resources, agriculture, pharmaceuticals, and other areas in which science informs public policy.

Critics of the manner in which science is used in regulatory decision-making processes tend to raise two kinds of concerns. They question the composition of committees that are empaneled to recommend or review the science behind a possible regulatory decision and they question the way an agency or committee has reviewed the relevant scientific literature, charging that the reviewers used or omitted the wrong studies, and/or that the studies were not appraised appropriately. Obviously, some disputes over the "politicization" of science actually arise over differences about policy choices that science can inform, but not determine.

With that in mind, this report attempts to lay out some broad principles, guidelines, and practices designed in the view of the authors to limit the battling over conflict of interest and bias, and systematic reviews.  Accordingly, this report focuses on:

 How should panels be composed and the qualifications of prospective advisory panelists be vetted?
 How should concerns about biases and conflicts of interest of advisory panelists be handled?
 Which studies should agencies review when examining the scientific literature related to a regulatory policy issue?
 How should contending views regarding the relevance of particular scientific results to a regulatory issue and the credibility of those results be addressed?

For panel formation, the report concludes that a reasonable balance must be established between transparency and privacy. In the realm of qualifications, for example, balancing how much personal information should be revealed to the public by a prospective panelist who may be willing to serve in an advisory capacity, but may not want every aspect of his or her personal life or financial status released to the public.

In dealing with scientific studies, the report suggests a balance must be established in developing and applying objective and transparent criteria for establishing data relevance and reliability between the desire for complete data-sets and the reality that the relevant scientific literature is populated with studies from a wide variety of sources with varying degrees of data availability. In some cases, when proprietary information is involved, an appropriate balance must be struck between the public’s right to know and the legally based need to protect proprietary formulas, production processes, and related intellectual property. 

Challenge to Federal-State Court Coordination Overture Prompts Response

One of the challenges of our system of federalism, and dual jurisdiction between state and federal courts, is the coordination of related cases pending in the two systems.  Perhaps nowhere does this happen more regularly than in the realm of mass torts.  Federal cases may be coordinated in an MDL, and several states, such as New Jersey, have a procedure to centralize mass tort filings in their state court system. See Hermann, et al. Statewide Coordinated Proceedings (2d ed. West 2004). But coordination between the state and federal level has been more difficult, more informal, more experimental. That is, state and federal judges, faced with the lack of a comprehensive statutory scheme, have undertaken innovative efforts to coordinate parallel or related litigation so as to try to reduce the costs, delays, and duplication of effort that can stem from such dispersed litigation. State judges, for example, can bring additional resources that might enable an MDL transferee court to implement a nationwide discovery plan or a coordinated national calendar

Recently, plaintiffs in state court cases in the Actos litigation sent the Actos federal MDL court a letter complaining that the judge improperly "intervened" by discussing the litigation "ex parte" with the state court judge.  The plaintiffs asserted that the federal court persuaded the state court judge to rule in a certain fashion on scheduling issues, including the time for discovery and trial dates. Plaintiffs complained that such "intervention" would prevent them from properly litigating their cases; violated the important policy of comity (citing the Anti-Injunction Act); and raised "objectivity" concerns.  Plaintiffs requested the federal court refrain from such communications in the future with any state court judges handling Actos cases, citing the Canons of Judicial Ethics.  Finally, the letter asked that plaintiffs further be heard on this issue at an upcoming MDL hearing.

At first blush, this seemed like an over-reaction by plaintiffs, and perhaps an attempt to intimidate the court into not doing what seems like a perfectly acceptable thing, informally coordinating litigation which raises similar issues, involves many of the same counsel, and likely will implicate many of the same discovery requests, fact and expert witnesses. We leave it to the loyal readers of MassTortDefense to decide for themselves about the tone of this letter.

So how did the federal court react? Judge Doherty is overseeing the federal multidistrict litigation, In re: Actos (Pioglitazone) Products Liability Litigation (MDL-2299). Her reaction came in the form of a "Memorandum Response." The court read the original letter as possibly alleging improper and unethical conduct by both the federal and state court judges, and doing so by making "completely specious" arguments. On the merits, the court began by noting that the Manual for Complex Litigation recommends cooperation and coordination among federal and state court judges in these mass tort contexts.  So does the state court-focused manual, Managing Mass Tort Cases: A Resource for State Court Judges, published by the Conference of Chief Justices. The important notion of comity was respected because the communication from the MDL court was merely an invitation asking whether state courts might see any benefit in talking about the litigation posture. An invitation to chat is not an "intervention." And any communications were in that same spirit.

The court's memorandum turned to the MDL schedule, its internal logic and consistency, and the ample opportunity all parties had to comment on and object to any of its provisions. The court then points out, logically, that an improper ex parte conversation involves a communication between the court and one , but not all parties -- not a conversation between two independent judges.

The court than labeled a "cautionary tale" those cases that warn attorneys against unsubstantiated allegations that bring the judiciary into disrepute. Finally, the court noted that the letter inaccurately cites the Code of Judicial Conduct. The canons clearly do not prohibit a judge from consulting with other judges to aid the judge in carrying out his or her responsibilities.

The court gave the authors the benefit of the doubt, deciding ultimately to view the letter as over-zealous, ill-advised, poorly thought out, regrettable hyperbole, and empty rhetoric, as opposed to something more troubling.   An interesting read for all our readers, especially those with MDL practices.

 

Local Product Warning Ordinance Violates First Amendment

When we touch on Constitutional issues, most often we are posting about due process concerns raised by procedural shortcuts, proposed for administrative or efficiency reasons, at the potential expense of a defendant's rights.  Today we get to actually write about a First Amendment issue, as the Ninth Circuit recently blocked San Francisco’s attempt to implement its local cellphone radiation warning ordinance because it violates the First Amendment. See CTIA – The Wireless Association v. City and County of San Francisco, Calif., No. 11-17773 (9th Cir.).  It is a wonderful reminder about this freedom, which separates our nation from much of the world. 

San Fransisco passed an ordinance imposing warning language standards on cell phone retailers, specifically requiring cell phone sellers to make certain disclosures to consumers about radio-frequency energy emissions from cell phones. S.F. Ordinance 156-11 was originally set to take effect in October 2011, but CTIA – The Wireless Association filed suit challenging the constitutionality of the law. CTIA contended the San Francisco law conflicted with the FCC's safety standards and violated rights of free speech by forcing retailers to communicate alarmist messages about cellphone radiation. 

The district court enjoined enforcement of part of the ordinance, and both sides appealed.  The Ninth Circuit panel affirmed the injunction and noted two problems with the ordinance. First, under the standard established in Zauderer v. Office of Disciplinary Counsel, 471 U.S. 626 (1986), any governmentally compelled disclosures to consumers must be “purely factual and uncontroversial.” Id. at 651. The law here required cellphone retailers to provide every customer with an informational "fact sheet" about the possible health risks of radio-frequency energy emissions from cellphones.  That fact sheet contained more than just facts. It also contained San Francisco’s recommendations as to what consumers should do if they want to reduce exposure to radio-frequency energy emissions. This language could be interpreted by consumers as expressing San Francisco’s opinion that using cell phones is dangerous. The FCC, however, has established limits of radio-frequency energy exposure, within which it has concluded using cell phones is safe. See, e.g., Guidelines for Evaluating the Envt’l Effects of Radio-frequency Radiation, 11 F.C.C.R. 15123, 15184 (1996).  Even the findings made by the San Francisco Board of Supervisors on which the challenged ordinance was predicated acknowledged that there "is a debate in the scientific community about the health effects of cell phones,” and the district court observed that “San Francisco concedes that there is no evidence of cancer caused by cell phones.” The court of appeals could not say on the basis of this record that the fact sheet was both “purely factual and uncontroversial.” Zauderer, 471 U.S. at 651.

The ordinance also required retailers to prominently display an informational poster in their stores, and to paste an informational sticker on all display literature for cellphones warning about the possible health risks of radio-frequency energy emissions from cellphones. The district court enjoined the original ordinance compelling distribution of these broader materials.  Since the ordinance sought to compel statements that are even more misleading and controversial than the  fact sheet, the original injunction must be affirmed, said the appeals court.

"Go" Power Defeats Proposed Class Action

We have posted several times on the disturbing trend of plaintiffs seeking to turn virtually every advertising claim, label statement, or good old fashioned "puffing" about a product into an expensive consumer fraud class action. It is with great interest that we note for the loyal readers of MassTortDefense those putative class actions in which the courts require plaintiffs to fully meet all the underlying elements of the claim, and apply some common sense to those elements.

Recently, a New Jersey federal court dismissed a putative class action that alleged that the manufacturer overstated a cereal's ability to help lower cholesterol. Myers et al. v. General Mills Inc., No. 3:09-cv-02413 (D.N.J.).

Plaintiffs were consumers of Cheerios who resided in California, New Jersey, and New York, seeking to sue on behalf of all similarly situated individuals in the United States. Plaintiffs alleged General Mills deceived customers by marketing, advertising and promoting Cheerios as having the ability to prevent, mitigate, or treat high cholesterol. According to plaintiffs, defendant advertised that Cheerios could help lower a person’s cholesterol by 4% in six weeks when part of a healthy breakfast.  (We fondly remember the simple days of  "Big G, Little O. Get "Go" power with Cheerios!")

Defendant moved for summary judgment, alleging that plaintiffs did not suffer any concrete or particularized injury and thus did not have standing to sue. See Koronthaly v. L’Oreal USA, Inc., 374 Fed. Appx. 257 (2010). To prove constitutional standing, a plaintiff must demonstrate (1) an injury-in-fact that is actual or imminent and concrete and particularized, not conjectural or hypothetical, (2) that is fairly traceable to the defendant’s challenged conduct, and (3) is likely to be redressed by a favorable judicial decision. Summers v. Earth Island Inst., 129 S.Ct. 1142, 1149 (2009). 

Plaintiffs sought a full refund for all boxes of Cheerios that plaintiffs purchased during the relevant time-frame, on the typical theory that plaintiffs “would not have purchased Cheerios” but for defendant’s alleged deceptive practices. That assertion, however, did not comport with the testimony of the plaintiffs themselves.  Generally, the out-of-pocket theory applies only when the seller's misrepresentations render the product essentially worthless. Plaintiffs admitted they purchased their Cheerios for crunchiness, taste, convenience, as well as to help lower their cholesterol. Moreover, Ms. Theodore, like many mothers, selected Cheerios due to its healthy, simple ingredients for her children. The contention that these plaintiffs would not have purchased Cheerios but for defendant’s alleged misrepresentation was also contradicted by the testimony that Mr. Myers, Ms. Acevedo and Ms. Theodore still eat or purchase Cheerios today, and for various reasons including the ingredients (Theodore), and the taste (Myers and Acevedo) and convenience.  As such, plaintiffs failed to adequately show that they were entitled to full purchase price refunds, especially when they ate the Cheerios after learning of the alleged issues, and are still eating them today for other reasons.
 

Plaintiffs alternatively sought the difference between what plaintiffs paid for Cheerios and the price that plaintiffs supposedly would have paid for Cheerios, if defendant had not engaged in the alleged misrepresentation; readers will recognize this as the other typical injury theory, the so-called benefit of the bargain approach. This theory of relief was equally flawed, said the court. Plaintiffs purchased a food product, and got the exact product with the exact ingredients listed on the label.  At most, plaintiffs simply claimed that their expectations of the cereal were disappointed. Dissatisfaction with a product, however, is not a quantifiable loss that can be remedied under the CFActs. Even a technical alleged violation of FDA food labeling regulations would not show that plaintiffs purchased boxes of Cheerios that did not contain the ingredients listed on the Cheerios boxes. And, again, several plaintiffs consumed all of the Cheerios purchased for various other reasons such as convenience and crunchiness. Plaintiffs therefore failed to adequately allege that they suffered “benefit of the bargain” damages.
 

The court granted summary judgment, including on the class allegations, which clearly failed on typicality and commonality. 

State Supreme Court Affirms Exclusion of Experts' Inferential Opinions

Follow our train of thought: we have posted about the misuse of the differential diagnosis concept, as plaintiff experts morph it from an accepted tool for deciding what is wrong with a patient to a method for explaining why and how the patient suffered his injury/illness.  Now, three computer experts sought to opine that a software flaw prevented a health monitor alarm from sounding, claiming their methodology was just "like a medical differential diagnosis"!  Fortunately, the South Carolina Supreme Court rejected that attempt last week.  See Graves v. CAS Medical Systems Inc., No. 27168 (S.C., 8/29/12).

Their doctor ordered that the plaintiffs use a monitor manufactured by CAS to track their infant child's breathing and heart rates as a precaution. The monitor was designed to sound an alarm, if the subject were to experience an apneic, bradycardia, or tachycardia event. Once the breathing or heart rate returns to normal, the alarm stops. Each machine also keeps a log of any events, which is the term for when the alarm sounds, and records the pertinent data and vital signs. As an additional safety measure, CAS installed not only a back-up alarm, but also a feature that records whether the alarm sounded. This system operates primarily through an independent and separate microphone specifically designed to listen for the alarm. If it hears the alarm, it then makes a notation in the monitor's internal log. If it does not hear the alarm, then it records "Front alarm not heard," and the monitor will sound the backup alarm. A microphone listens for this back-up alarm as well and records whether it was heard. If the back-up alarm fails, all the lights on the front of the monitor flash.

Tragically, the child died from Sudden Infant Death Syndrome (SIDS), which essentially means that no attributable cause of death exists. Plaintiffs claimed the monitor's alarm never sounded that night. Additionally, they testified that all the lights on the front of the monitor were on, although they were solid and not flashing. Another family member who was asleep downstairs also allegedly could not recall hearing the alarm go off.  Plaintiffs further testified the machine was not turned off until the next day, when the monitor was removed for testing.

Plaintiffs filed a strict liability design defect claim against CAS, contending the monitor's software design caused the alarm to fail.  Their claim revolved around what is known as "spaghetti code," which is when computer code is unstructured and can result from the overuse of "goto" or "unconditional branch" statements, which causes a signal working its way through the code to jump around instead of following a linear path.  This in turn caused the signal to be pushed off course and never reach its destination.

To support this theory, the Graves designated three software experts to testify regarding the alarm's alleged failure. In arriving at their conclusions that a software defect caused the alarm to fail, none of the experts did much actual testing of the software. Instead, they used a "reasoning to the best inference" analysis, which was "similar to a differential diagnosis" in the medical field. In this case, three potential causes were identified: hardware error, complaint error, and software error. Complaint error means that the monitor was misused or the alarm did sound and the Graves failed to hear it.  All the experts were able to dismiss hardware error as a cause because the machine was tested and shown to be functioning properly. Thus, the question became whether complaint error or a software error occurred.

The experts excluded complaint error because the machine was hooked up properly, and they did not believe anyone would sleep through the alarm. In other words, because the Graves claimed the alarm did not wake them, that means it must not have gone off. After being confronted with the fact that the monitor listens for the alarm and separately records whether it was sounded, the experts opined that it must be "certain" the internal logs showing the alarm actually did sound were not reliable "in light of the undisputed testimony that the alarm did not function." That left software error as the most likely cause of the alleged failure, they opined.

Defendant moved to have all these experts excluded, arguing none of them met the reliability factors for scientific testimony set forth in State v. Council, 335 S.C. 1, 515 S.E.2d 508 (1999). CAS also moved for summary judgment, contending that without this expert testimony plaintiffs had no evidence of a design defect. The trial court agreed that their opinions were unreliable both as scientific evidence and as nonscientific evidence and thus were inadmissible. Having excluded the opinions of all the Graves' experts, the lower court granted CAS's motion for summary judgment.

The state Supreme Court noted that this was its first opportunity to assess the reliability of an opinion rendered using the "reasoning to the best inference" methodology, so looked for guidance to the analysis of the United States Court of Appeals for the Tenth Circuit, which had already done so. In Bitler v. A.O. Smith Corp., 400 F.3d 1227 (10th Cir. 2004), the court held that "[e]xperts must provide objective reasons for eliminating alternative causes" when engaging in this analysis. Id. at 1237. Furthermore, "an inference to the best explanation for the cause of an accident must eliminate other possible sources as highly improbable, and must demonstrate that the cause identified is highly probable." Id. at 1238. Although the expert need not categorically exclude all alternate causes, that does not relieve the expert of his burden to prove the alternate cause is at least highly improbable based on an objective analysis. See id. at 1237–38 & n.6. The court found this objectivity requirement consistent with the quality control element of State v. Council.

Here, there was evidence that the alarm worked properly and the plaintiffs failed to hear it. In addition to the monitor's recordation of hearing the alarm sound, the family pediatrician testified he believed plaintiffs slept through it, the court noted. The doctor was aware of just how exhausted the parents were. Although the alarm is loud, if one is tired enough, he testified that it is possible to sleep through it. His opinion was bolstered by the fact that the machine seems to have worked just as it was supposed to and recorded the breathing issues perfectly. The log also seems to show the alarm managed to stimulate the baby into breathing normally at times.

This evidence does not mean that is exactly what happened.  But there was enough that an expert needed to take it into account.. Instead, the experts simply assumed the alarm did not sound and provided no reason for discounting the evidence to the contrary other than the assertion of the persons alleging a failure. Thus, they did not objectively discount the evidence of complaint error as required. See Clark v. Takata Corp., 192 F.3d 750, 757 (7th Cir. 1999) ("Simply put, an expert does not assist the trier of fact in determining whether a product failed if he starts his analysis based upon the assumption that the product failed (the very question that he was called upon to resolve), and thus, the court's refusal to accept and give credence to [the expert's] opinion was proper.").

The trial court did not abuse its discretion in excluding the opinions, and summary judgment was warranted. 

Supreme Court Grants Cert in CAFA Case

Here is one to watch, especially for our readers with a class action practice. The U.S. Supreme Court granted certiorari last week in a case raising the issue whether class plaintiffs may stipulate to a damages amount below the jurisdictional threshold of the Class Action Fairness Act to avoid removal of the case to federal court. See Standard Fire Insurance Co. v. Knowles, No. 11-1450, U.S., certiorari granted 8/31/12).

Since the Act was passed in 2005, as surely as one end of a balloon expands when you squeeze the other end, litigants have reacted to the Congressional effort to expand federal jurisdiction over class actions by seeking exceptions and loopholes to keep the cases in state court.  This case will be the first time the Supreme Court considers a case arising under CAFA, and one of those creative efforts to avoid its reach.

Readers will recall that CAFA allows for removal of class actions in which just minimal diversity exists and the amount in controversy exceeds $5 million. A number of class plaintiffs have attempted to defeat the defendant's removal under the Class Action Fairness Act by filing a stipulation that purports to limit the damages sought to less than the $5 million threshold for federal jurisdiction.  A key question is whether that stipulation can be binding on absent class members, and thus possibly impact federal jurisdiction, when the Court recently reaffirmed that in a putative class action "the mere proposal of a class ... could not bind persons who were not parties." Smith v. Bayer Corp., 131 S. Ct. 2368, 2382 (2011).  In light of that holding, the question presented in this case is:

When a named plaintiff attempts to defeat a defendant's right of removal under the Class Action Fairness Act of 2005 by filing with a class action complaint a "stipulation" that attempts to limit the damages he "seeks" for the absent putative class members to less than the $5 million threshold for federal jurisdiction, and the defendant establishes that the actual amount in controversy, absent the "stipulation," exceeds $5 million, is the "stipulation" binding on absent class members so as to destroy federal jurisdiction?


The facts of the case involve a putative class action in Arkansas state court alleging that defendant Standard Fire Insurance Co. breached homeowners insurance policies by failing to fully  reimburse losses.  Standard Fire attempted to remove the case under CAFA but the federal district court remanded the case pursuant to the stipulation that plaintiffs would not seek damages above $5 million.   The Eighth Circuit denied Standard Fire's petition to appeal the remand order. Defendant then petitioned the Supreme Court for certiorari.  The U.S. Chamber of Commerce weighed in with an amicus brief in favor of the petition.


The petition argued that putative class members are not bound by such actions taken by the named plaintiffs before class certification. Such a limitation, if effective at the time suit is filed, would violate the due process rights of the proposed class members.  The Chamber echoed that district courts must conduct a meaningful analysis to determine with legal certainty whether the stipulation will truly limit the ability of absent class members to recover no more than the stipulated amount, and whether the stipulation is consistent with due process. If allowed to stand, the lower court's decision could result in an enormous CAFA loophole allowing plaintiffs to drag businesses into class action-friendly state court systems.  Plaintiff argued that the petition was premature because the issue could be considered at the class certification stage within the adequacy of representation prong. 

Definitely one to watch.

Court of Appeals Reverses Daubert Decision

A tip of the hat to our DRI colleague Mike Weston for alerting us to an interesting 10th Circuit opinion from a couple weeks ago, Hoffman v. Ford Motor Co., 2012 WL 3518997 (10th Cir. Aug. 16, 2012).

Plaintiff was injured in a rollover car accident, and sued the car manufacturer alleging that a defect in the seat belt buckle caused it to release during the accident and allow her to be ejected from the vehicle.  In support of this theory, plaintiff presented the opinion of Dr. Good, a mechanical engineer, who theorized that the buckle most probably inertially unlatched during the accident due to an alleged design defect.  He ran a series of tests on buckles allegedly similar to the one in the accident, but ran into issues when he needed to make a comparison of the data from his lab tests to data from crash rollover tests to determine if the situation measured in the lab could actually occur in the real world.  Specifically, there was an absence of available data from relevant rollover crash tests (which present dynamic, multi-dimensional forces working on the component), and so he compared his results to data from planar crash data -- ones focused on only the horizontal plane (for example, a frontal car crash).

Ford moved to exclude the opinions as unreliable under Daubert, but the district court  (without a hearing) denied the motion, concluding Ford had failed to prove that the differences between the lab test results and the real world rollover accidents were significant.  Defendant appealed. (Note, whether she was even wearing her seat belt at all was hotly contested at trial. For purposes of the Daubert issue, the court assumed she was.) 

The court of appeals concluded that in permitting the testimony, the district court had not been "a sufficiently exacting gatekeeper; Daubert requires more precision."  Plaintiff failed to present a sufficient scientific connection between the accelerations and forces the expert found necessary to unlatch the buckles in the lab, and the acceleration and forces that would have occurred in the actual accident on the street. 

Specifically, the court of appeals held that the trial court should NOT have chastised the defendant for failing to show how the deficiency mattered, the failure to use rollover crash data. And the trial court should not have deemed it "unfair" for Ford to criticize the plaintiff because of the limited amount of rollover crash data available to the expert.  The state of the science is what it is.  And Ford did more than point out a deficiency in the method; it also explained why the deficiency rendered the testing and comparison suspect.  More importantly for our readers, "it was not Ford's burden to show Good's inertial unlatch opinion was unreliable and irrelevant.  Rather, it was plaintiff's burden to show reliability and relevancy."

It was undisputed engineering science that once a component is tested, the results must be applied to the whole vehicle setting; the lab results must be compared to data from the real world. Merely showing that similar buckles can be made to unlatch under certain lab conditions is irrelevant to whether the buckle at issue unlatched in the accident absent proof that the lab conditions were present and can be adequately and accurately related to the actual rollover-type accident.  Plaintiff's expert failed to explain adequately how the acceleration and forces present in the planar crash tests were similar enough to those present in a rollover accident. Nowhere did he show how his comparison was scientifically valid. Thus, his opinion was based on mere speculation, or on the assumption, that the levels of forces he found necessary to unlatch buckles in the lab were substantially similar to those that occurred in the subject accident.

Absent such evidence, plaintiff could not meet her burden.  Since plaintiff had a full and fair opportunity to present the case, and made no attempt to add or substitute other evidence, the court of appeals remanded with instruction for the district court to enter judgment as a matter of law for defendant.