WHO Discusses Food-borne Disease

MassTortDefense has posted about a number of food-related product issues, including the recent China dairy crisis. Now the World Health Organization (WHO) reports that food-borne illnesses are increasing, and not just in the developing world. In the US, food poisoning causes about 76 million illnesses, 325,000 hospitalizations, and up to 5,000 deaths, annually, according to the federal Centers for Disease Control and Prevention (CDC). There is some indication that the problem is increasing. Approximately one-third of new infectious diseases originate in bacteria, viruses, parasites, chemicals, and toxins introduced along food production chains.

The WHO is the coordinating authority for health within the United Nations system. Their view is that eradication of food-borne diseases requires a concerted effort on the part of the three principal partners: governments, the food industry, and consumers.  WHO is urging monitoring of the entire food chain, citing the emerging so-called “farm to fork” approach. WHO rejects the notion that you can deal with it at the end of the food chain. Often, there is a lack of collaboration, organization, or cooperation is problematic. In China, for example, there are 16 different authorities involved in some way in dealing with the melamine crisis.

Experts are also concerned about the long-term consequences of food problems. For example, E. coli is now known to cause pediatric kidney failure. This issue can implicate medical monitoring claims.

In the United States, food-borne disease outbreaks are typically linked to eggs, poultry and dairy products, but they have recently been caused by fresh produce. Tomatoes were suspected in the U.S. outbreak before the salmonella was traced to peppers from Mexico. The FDA, last week, announced the formal opening of the first of several offices in China, which are designed to place experts “on the ground” in the areas of China where many food and other imported products originate.
 

Digitek MDL Proceeds And State Mass Tort Designation Looms

Certain plaintiffs in the Digitek litigation have filed for mass tort designation in the State of New Jersey, according to a notice filed on the New Jersey Judiciary mass tort web site. Earlier this year, defendant initiated a nationwide recall of Digitek products, stating that tablets with double the appropriate dosage had possibly been released to the public. It said digitalis toxicity was possible in patients with renal failure.

Previously, some plaintiffs had moved for centralized management, but not mass tort designation, of all New Jersey state-court litigation involving the drug Digitek and assignment of that litigation to Bergen County. Anyone wishing to comment on or object to this second application regarding the Digitek  state-court litigation is to provide such comments or objections in writing, with relevant supporting documentation, to the Administrative Office of the Courts, by December 1, 2008. After that date the N.J. Supreme Court will consider and act on both applications regarding Digitek and any comments received.

At the federal level, the judge in the newly-created Digitek federal multidistrict litigation issued an order appointing lead and liaison counsel for the plaintiffs as well as the Plaintiffs' Steering Committee. See In Re: Digitek Products Liability Litigation, MDL No. 1968, JPMDL.; No. 08-md-1968, S.D. W.Va.). Chief Judge Joseph R. Goodwin of the Southern District of West Virginia appointed Carl N. Frankovitch of Frankovitch, Anetakis, Conatonio & Simon, Fred Thompson III of Motley Rice, and Harry F. Bell Jr. of Bell & Bands, as co-lead counsel for the plaintiffs. Bell is also liaison counsel for the plaintiffs. Previously, Chief Judge Goodwin appointed Rebecca A. Betts of Allen, Guthrie & Thomas as defendants' liaison counsel.


Earlier in the fall, the federal court held a pretrial conference jointly with Magistrate Judge Mary E. Stanley and advised the parties of its intention to coordinate heavily with the judges and counsel involved in the state Digitek cases, especially in West Virginia and New Jersey where a majority of the state cases have been filed.
 

U.S. Tort Costs Rise: No Surprise

The global consultants Towers Perrin have released their 2008 Update on U.S. Tort Cost Trends.  This represents the 12th study of  U.S. tort costs published by Towers Perrin. The first study was completed in 1985.

This study takes no position on whether tort costs are too high or too low. (MassTortDefense votes too high.) Its stated purpose is to attempt to quantify the costs. 

The study's definition of tort cost is largely governed by traditional liability insurance coverages. Thus, it understates the true cost of torts.  For example, it has excluded things like the tobacco settlements with the state AG's.  It also does not appear to cover punitive damages.  Certain indirect costs are also omitted, such as those associated with litigation avoidance. These costs range from potentially unnecessary and duplicative medical tests ordered by doctors as a defense against possible malpractice allegations, to the disappearance of certain products or whole industries from the marketplace because of high product liability cost.

Key results:

  • U.S. tort costs increased by 2.1% in 2007. 
  • This is the largest increase in personal tort costs since 2003.
  •  The increase in personal tort costs was at least partly the result of a rise in auto accident frequency, the first such rise since 1999.
  • The U.S. tort system cost $252 billion in 2007, which translates to $835 per person or $9 per person more than in 2006.
  • Since 1950, growth in tort costs has exceeded growth in GDP by an average of  approximately two percentage points.

Towers is forecasting growth in U.S. tort costs of 4.0% in 2008, with higher growth (5.0%) in 2009 and 2010. There are several issues that will impact the future trends in U.S. tort costs, including:
the change in administration as well as shifts in the U.S Congressional makeup.  This may well lead to modifications in the federal government’s behavior and attitudes toward litigation.

Other emerging issues noted by the report:  global warming and obesity continue to be potential areas for significant tort costs, they say, as well as claims related to data security breaches.

Summary Judgment In Benzene Case: Failure To Prove Dose

A federal court has granted summary judgment in a toxic tort suit in which plaintiff alleged he contracted a bone disease because of his long-term exposure to trace amounts of benzene in oil-based paint. Smolowitz v. The Sherwin-Williams Co., 2008 WL 4862981 (E.D.N.Y. Nov. 10, 2008). Plaintiff failed to offer sufficient evidence under New York law of exposure level.


In order to prevail in a toxic tort case, plaintiffs must present sufficient evidence to support a finding that defendants' products caused plaintiffs' injuries. Proof of causation requires establishing both “general” causation and “specific” causation.  General causation bears on whether the type of injury at issue can be caused or exacerbated by the defendant's product. Specific causation bears on whether, in the particular instance, the injury actually was caused or exacerbated by the defendant's product.  The fundamental principle of toxicology is that the dose makes the poison: substances that are benign or even beneficial at a certain level can be toxic at another. Even when general causation is clear, a plaintiff must show that he or she was exposed to a sufficient dose of the substance to have caused the disease. Under New York law, plaintiffs must establish both general and specific causation through expert testimony

Plaintiff Richard Smolowitz worked as a drywall taper and spackler over a thirty year period beginning in the 1950s and ending in the early 1980s. Plaintiff alleges that his exposure to benzene in paints caused him to contract myelodysplastic syndrome (“MDS”).  A central factual issue in this case, said the court, was the level of exposure to which plaintiff was subject, and whether that level of exposure can cause MDS. First, plaintiff was not a painter, but alleged he worked in areas where paint products were regularly used. Second, the solvents used in defendants' oil based paints contained only a trace contamination of benzene due to the fact that the products are based on petroleum, and it is not always possible to remove all of the benzene during the manufacturing process.

In early motion practice, plaintiff's counsel represented that he would provide the testimony of expert witnesses who could prove that plaintiff was exposed to oil based paints with sufficient levels of benzene to cause his illness. Eventually, he relied on the opinions of plaintiff's treating physician, Dr. Silverman, to provide expert testimony on issues of general and specific causation. The doctor reported he was currently treating plaintiff for MDS; that Smolowitz reported a history of exposure to oil based paints, thinners and benzene during a 35-year period; and that in his opinion it was “likely to a reasonable medical probability, that Mr. Smolowitz's exposure to benzene during the years that he worked as a dry-wall mechanic is causative for his current hematologic condition.”

The court concluded that Dr. Silverman's testimony was inadequate to prove either general or specific causation. The conclusory statement that based upon plaintiff's reported history it was likely to a reasonable medical probability that Mr. Smolowitz's exposure to benzene during the years that he worked as a dry-wall mechanic is causative for his current hematologic condition, had substantial deficiencies. First, there was nothing in this statement that suggests that Dr. Silverman was aware of or had quantified the precise amount of benzene to which plaintiff was exposed. No proof of dose. Second, Dr. Silverman did not offer any opinion as to whether that limited level of benzene exposure, whatever it was, can cause the disease. In the absence of sufficient evidence from an expert or a treating physician of the plaintiff's exposure level, plaintiff could not prove the essential causation element of the claim.
 

Modified Rice MDL Court Proposes Settlement Master

The federal judge overseeing the MDL involving claims over allegedly mishandled genetically modified rice has appointed a special master to assist with settlement talks. In re Genetically Modified Rice Litigation, MDL No.1811.
 

The order comes as the parties prepare for the process of selecting the bellwether trials currently slated to begin in November, 2009. The parties are to select plaintiff claims from each of 5 affected states for the initial trial pool. The bellwether trial plan approach follows the court's denial of class certification.

The bulk of plaintiffs are long grain rice producers who allege that defendants developed and tested a genetically modified strain of rice that contaminated the U.S. commercial rice supply. When rice importers banned the importation of U.S. rice, prices dropped and plaintiffs sued. Defendants have argued that such damages are too legally remote and speculative to be recovered.

The court noted that it “is important that the parties continue to explore settlement while preparing the cases for trial or remand to the transferor districts.” Because the MDL court did not have time to address settlement in as an effective and timely manner as is needed, the court proposed appointment of Hon. Steven N. Limbaugh, Sr., who has recently retired from the bench, and is available and willing to serve as a settlement special master for this case.

The court is giving the parties notice and an opportunity to be heard, and the opportunity to suggest alternative candidates for appointment. If no party files objections by Nov. 20, any objections will be waived, and the court will enter an order appointing him as Special Master.
 

 

Punitive Damages Claim Against Patch Maker Found Preempted

A federal court has found that federal law preempts a state law that allows plaintiffs to seek punitive damages from the makers of defective drug products if the drug company knowingly withheld information from the Food and Drug Administration. Grange v. Mylan Laboratories Inc., 2008 WL 4813311 (D.Utah 10/31/08).

Plaintiffs’ estate sued over an allegedly defective drug patch. Defendants sold the Fentanyl Patch, which is applied directly to the skin to deliver fentanyl, a strong pain medicine. Doctors prescribe the Fentanyl Patch to relieve chronic moderate to severe pain. The patch should be worn for seventy-two hours and is supposed to deliver the medicine at a regulated rate. Plaintiff alleged that due to a design and/or manufacturing defect, some Fentanyl Patches contain and deliver fentanyl in amounts far in excess of what is advertised. Plaintiff alleged that defendants knew that the Fentanyl Patch was defective, but did not warn of the potential risk of overdose.

Defendants moved to dismiss the claims for punitive damages. A Utah statute, Utah Code Ann. § 78B-8-203, completely bars punitive damages for harm caused by FDA approved drugs. But that statute has an exception for cases where a plaintiff can show that a defendant withheld information from the FDA. Plaintiffs, of course, alleged that the exception applied here. But defendants contended that this exception is preempted by federal law.

As the court noted, this statutory limitation on liability for punitive damages does not apply if it is shown by clear and convincing evidence that the drug manufacturer knowingly withheld or misrepresented information required to be submitted to the Federal Food and Drug Administration under its regulations, which information was material and relevant to the claimant's harm. Defendants contended that the statutory exception amounts to a de facto “fraud on the FDA” claim, which is preempted by federal law.

In support of this argument, defendants relied on Buckman Co. v. Plaintiff's Legal Comm'n., 531 U.S. 341, 348 (2000), which held that state law fraud-on-the-FDA claims conflict with, and are therefore impliedly preempted by, federal law. The Buckman Court gave two primary reasons for this holding. First, allowing state law claims of fraud on the FDA would interfere with the FDA's objectives and judgment. See id. at 350-51. Second, such claims could cause the FDA to face a deluge of unnecessary information in the approval process by drug companies attempting to avoid state law liability, jamming up the regulatory system.

The court decided that the decision in Buckman did not directly reach the issue presented here. In this case, unlike in Buckman, the state statute does not predicate liability on fraud on the FDA, but rather would allow certian damages based on such fraud. The question of whether this type of statute is preempted, said the court, has created a split of authority. Compare Garcia v. Wyeth-Ayerst Labs., 385 F.3d 961 (6th Cir.2004)(extending Buckman's logic to a statute similar to Utah's), with Desiano v. Warner-Lambert & Co., 467 F.3d 85, 97 (2d Cir.2006)(same Michigan statute was not preempted by Buckman), affirmed sub nom, Warner-Lambert Co., LLC v. Kent, 128 S.Ct. 1168 (2008)(4-4 vote).

Despite a mention of the so-called presumption against preemption, the court found that the Sixth Circuit's decision in Garcia was more persuasive here. The chief problems that Buckman sought to counteract are present whenever a plaintiff, as a prerequisite to collecting damages, is required to put on evidence that there was what amounts to fraud on the FDA. When such evidence is considered, state courts are essentially second-guessing the FDA, and drug companies, nervous about state litigation, will have an incentive to flood the FDA with information. To the extent that the Utah law allows for an exception in cases where a plaintiff puts on his or her own independent evidence of information being withheld from the FDA, this statute was found to be preempted. There is no preemption, however, in a situation where a plaintiff invokes the Act to seek punitive damages in cases where the FDA itself has found that there was fraud in the application process.
 

Federal Court Grants Summary Judgment To Defense On Accutane Warnings

A federal district court has granted summary judgment to drugmaker defendants Hoffmann-LaRoche Inc. and Roche Laboratories Inc. in an Accutane failure to warn case. Snyder v. Hoffman-LaRoche, Inc., 2008 WL 4790666 (M.D.Fla., October 30, 2008). Plaintiffs alleged their teenage son was prescribed Accutane in 2000 to treat young Snyder's severe acne condition. He had three courses of treatment through April, 2003. On February 28, 2005, Snyder committed suicide.

Prior to prescribing Snyder's first course of Accutane treatment, Dr. Kalb received and reviewed the drug’s 1998 Package Insert, the 1998 Dear Doctor Letter, the 1999 issue of the PDR, the February 25, 1998 FDA Talk Paper, and the Seventh Edition of the Accutane Brochure, all of which discussed the potential suicide risks. Dr. Kalb testified that he discussed the risks and benefits of Accutane with Snyder before prescribing the drug, including specifically the potential risk of depression and suicide. Such discussion was consistent with his regular practice, as was his practice of providing each patient with a copy of the then current Accutane Brochure. Throughout Snyder's courses of treatment, Dr. Kalb continued to monitor him for symptoms of depression.  According to Dr. Kalb, who would know, no symptoms of depression were reported or observed while Snyder was taking Accutane.

Plaintiff's Complaint included claims for negligence, strict products liability, breach of implied warranty, and negligent and fraudulent misrepresentation. Each of these claims was predicated upon defendants' alleged failure to warn that Accutane could cause Snyder to commit suicide. Defendants moved for summary judgment on the issue of the adequacy of the warnings. Snyder resided and was prescribed Accutane in the State of New York. Accordingly, the Court considered whether Defendant's warnings were adequate under New York law.

Under New York law, a prescription drug manufacturer may avoid liability for injuries that would ordinarily render the manufacturer strictly liable by distributing proper directions and warnings with the drug. To avoid liability, a manufacturer must warn of all potential dangers in its prescription drugs that it knew, or, in the exercise of reasonable care, should have known to exist. New York employs the learned intermediary doctrine, under which physicians act as “informed intermediaries” between manufacturers and patients regarding warnings for prescription drugs. Thus, a manufacturer's duty to caution against a drug's side effects is fulfilled by giving adequate warning through the prescribing physician, not directly to the patient.

Because the defendant had issued a warning about this specific risk, plaintiffs were left to try to argue that defendant's warnings were not direct, unequivocal and sufficiently forceful to convey the risk of suicide. Plaintiff argued defendants' warnings equivocated in stating that Accutane “may” cause depression and suicidal ideation, that emotional instability “may” bear no relation to therapy, and that the side effect of suicide is “uncommon” and/or “rarely” occurs. Moreover, Plaintiff argued that the defendants' statement that “no one knows if Accutane caused these suicidal behaviors” further dilutes the warning.

The Court disagreed with plaintiffs. The February 1998 warnings specifically warned that Accutane treatment may cause suicide. MassTortDefense notes that the drug does not always cause suicide, if it ever does (which is unproven), so “may” is perfectly accurate. The statements that Accutane “may” cause suicide, or that such a result “rarely” occurs, do not inappropriately diminish the seriousness of the warning; rather they describe the medical record. The Court properly viewed the extensive warning language as a prescriber would, in full context, not isolating a word or phrase. Taken as a whole, the warnings clearly, accurately, and consistently conveyed to Dr. Kalb that Accutane might cause suicide, with or without prior symptoms of depression. Accordingly, the Court concluded that defendants' warnings were adequate as a matter of law. Defendants were entitled to summary judgment as to plaintiff's failure to warn claims

 

FDA Issues Import Alert For China Dairy Products

The FDA continues to take action to attempt to limit the impact of the China milk scandal on U.S. consumers. As part of its ongoing strategy to address the present problem with melamine contamination of consumer products exported from the People’s Republic of China, FDA has expanded its import controls on Chinese dairy products, and food and feed products manufactured in China that contain dairy ingredients. Candy, snacks, bakery products, pet food and other Chinese products that contain milk will now be detained at the border until tests prove that they are not contaminated. This action was taken to help ensure that only those Chinese dairy products (and food and feed products manufactured in China that contain dairy ingredients) which are not contaminated with melamine and melamine-related compounds reach U.S. consumers.

No adverse health effects have been reported in the United States from contamination with melamine of dairy products or dairy containing products. But melamine is not approved for direct addition to human or animal foods and no manufacturer is allowed to deliberately add it to any food for U.S. consumers.  Since melamine was discovered in infant formula in September it apparently has sickened more than 50,000 infants in China and killed at least four. Since that time, melamine has been found in a wide range of other products, including milk, eggs and fish feed. Testing by the FDA has detected melamine and cyanuric acid, a related contaminant, in a number of products that contain milk or milk-derived ingredients, including candy and beverages, according to the FDA alert. China is also one of the world’s biggest makers of supplements, and some protein powders and shakes are made largely with powdered milk.


The agency has at times blocked imports of individual food products, but it is rare for it to block an entire category of one country’s foods. The widely spread assessment is that food and feed dealers in China added melamine to their products because it increases nitrogen content to give the appearance in testing that protein levels meet specifications.

Concern has been expressed about delays spilling over to other food imports, but the FDA said the percentage of food subject to the import alert is small. Another possible issue is that private laboratories which perform product tests for FDA compliance already reportedly have long waiting lists. The agency said it won't release the imported food unless an independent laboratory verifies that representative samples contain no melamine or cyanuric acid, a melamine derivative.
At a broader level, one wonders what the alert may do to the recently negotiated opening of FDA offices in China. The timing of the FDA alert coincides with an upcoming  meeting between Health and Human Services Secretary Michael Leavitt and top Chinese health officials in Beijing.
 

Survey On The State Of E-Discovery In Civil Litigation

Readers of MassTortDefense know that the burden of today's e-discovery can be a significant cost factor in mass torts. Moreover, any failure to execute a good e-discovery strategy can have significant substantive effects on the litigation, even beyond the threat of monetary sanctions. Some of these issues were recently explored as the U.S. Chamber of Commerce Institute for Legal Reform surveyed chief legal officers at Fortune 100 companies. The survey provides some insights into the views and experiences of the largest U.S. corporations with discovery in civil litigation:

-On average, 45‐50% of respondents’ civil litigation costs in 2007 related to discovery activities.

-Discovery of ESI accounted for, on average, a significant share (between 33‐39%) of total discovery costs.

-Costs associated with e‐discovery vendors were reported in 63% of large cases. When used, e‐discovery vendors accounted for, on average, 10‐12% of total costs.

-About 61% of case respondents felt that certain discovery requests received from the opposing party were designed to impose undue settlement pressure by increasing the costs to continue the litigation.

-In both state and federal court, the company respondents reported that more than half of their civil litigation matters involved the receipt of discovery requests that sought information beyond the claims or defenses at issue.

- About 31% of company respondents reported that at least 40% of the time ESI requested from them by the opposing party is not reasonably accessible.

- Most company respondents see cost shifting related to e‐discovery on an infrequent basis. But, when cost shifting occurs, many feel the burdens are unevenly placed on themselves vis‐à‐vis the opposing party.

 

The ILR notes that compared to paper‐based records, discovery involving business records maintained as ESI is still in its relative infancy. Many companies are wrestling with the cost and logistical considerations associated with discovery of ESI.  Rule 26(f) meetings, which require parties to meet and discuss issues related to preserving ESI, do not seem to be making significant strides in alleviating the potential abuse issues. MassTortDefense has posted about new Federal Rule 502, dealing with inadvertant disclosure of privileged materials.
 

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Feds Announce Pilot Safety Program For Imports

The United States currently imports approximately $2 trillion of goods from 825,000 offshore companies. As noted here at MassTortDefense, the safety of numerous of those products has been challenged recently, with recalls and litigation. The U.S. Customs and Border Protection (CBP) has recently announced the expansion of a program designed to enhance the safety of such imports. Specifically, the U.S. will expand its Importer Self Assessment program to include the Importer Self Assessment Product Safety Pilot program. The ISA-PS is a partnership that will be created among CBP, the Consumer Product Safety Commission, and importers, which will strive to maintain a high level of product safety compliance, and to achieve the goals of the federal government’s Interagency Working Group on Import Safety by working collaboratively to prevent unsafe imports.

The ISA program is a partnership program that recruits highly compliant trade companies in order to reduce both CBP and company resources required during entry and post entry, and to build cooperative relationships that strengthen company compliance with trade laws. The ISA program is based on the premise that importers with strong internal controls achieve the highest level of compliance with CBP laws and regulations, and provides a means to recognize and support importers that have implemented such systems. Since the ISA program started in 2002, over 172 importers under 760 different Importer of Record numbers have been approved to participate in the program. In fiscal year 2007, merchandise imported by ISA participants made up 15% of the total value imported into the U.S., and the compliance rate for those importers was 99.4%, the CBP reported.


Now, as a voluntary pilot program, ISA has been open to qualified importers on safety issues, offering less oversight to trade-compliant companies in exchange for those companies assuming extra responsibility for managing their own product safety compliance in accordance with strict requirements. CBP and the CPSC staff have developed a list of best practices to ensure compliance with CPSC's current regulations.

Within the realm of their respective authorities, CBP and CPSC will verify that companies have adequate controls and processes in place to ensure product safety at all points in the product life-cycle of imported products and to comply with these mandatory standards. CPSC staff and CBP have worked to develop CPSC-based benefits to encourage participation in this expanded pilot program. Acceptance into the program is by mutual agreement of CPSC and CBP.

The agencies will review the pilot program after two years to determine whether to implement a permanent version.
 

PMA Device Preemption Recognized Despite "Parallel" Allegation

Those readers defending PMA medical device defendants should review Parker v. Stryker Corp., 2008 WL 4716879 (D. Colo. Oct. 22, 2008); the district court granted a preemption-based Rule 12(b)(6) motion to dismiss.

Plaintiff underwent a total hip arthroplasty during which she was implanted with the Trident Ceramic Acetabular System, an artificial hip implant device developed, manufactured, and sold by defendants. After the surgery, plaintiff claims she noticed an audible sound coming from the device. She alleges that she had experienced constant irritation and discomfort, as well as “additional and resultant bone loss,” and that she was at an increased risk for requiring a premature revision surgery. She sued under Colorado state law for failure to warn, manufacturing defect, design defect, breach of express and implied warranties, breach of implied warranty of fitness, breach of implied warranty of merchantability, and negligence. Defendants moved to dismiss, claiming that all of plaintiff's state law causes of action were preempted.

Resolution of the motion turned in part on the recent Supreme Court decision interpreting the preemptive scope of the 1976 Medical Device Amendments (“MDA”), 21 U.S.C. §§ 360c-360n, to the Federal Food, Drug and Cosmetic Act of 1938 (“FDCA”), 21 U.S.C. §§ 301-399a, Reigel v. Medtronic, Inc., 128 S.Ct. 999 (2008). In that case, the Court concluded that state claims that would impose on manufacturers requirements that are different from, or in addition to, those prescribed by the MDA are preempted. Id. at 1011.

Plaintiff, however, insisted that her claims were not preempted because they did not seek to impose different or additional requirements, but only those parallel to the federal requirements of the MDA. The court here noted first that a "parallel" violation claim is not stated by reference to provisions of the FDCA that govern the sale of adulterated and misbranded devices, because there is no private right of action under the FDCA.

The district court found, second,  that although so-called parallel claims may be recognized, plaintiff had not properly pled them here. Conclusory allegations or legal conclusions masquerading as factual conclusions will not suffice to prevent a motion to dismiss.  Fernandez-Montes v. Allied Pilots Association, 987 F.2d 278, 284 (5th Cir.1993); see also Ruiz v. McDonnell, 299 F.3d 1173, 1181 (10th Cir. 2002), cert. denied, 538 U.S. 999 (2003). Plaintiffs’ conclusory allegations standing alone were not sufficient to sustain plaintiff's burden of pleading under Bell Atlantic Corp. v. Twombly, 127 S.Ct. 1955, 1969, 1974 (2007). Specifically, under Twombly a plaintiff can't state a claim simply by alleging that the defendant violated FDA regulations without alleging sufficient facts to back up the claim. And citing FDA warning letters is not sufficient to state a claim without some facts tying the letters to the plaintiff's case.

The only claim not clearly preempted by Reigel was plaintiff's breach of express warranty claim. Federal courts are divided as to whether breach of express warranty claims are preempted. The Third and Seventh Circuits have held that such claims are not preempted because any “requirements” imposed by the warranty are voluntarily assumed by the warrantor, not imposed by the state. See Mitchell v. Collagen Corp., 126 F.3d 902, 915 (7th Cir.1997), cert. denied, 523 U.S. 1020, (1998); Michael v. Shiley, Inc., 46 F.3d 1316, 1327-28 (3rd Cir.), cert. denied, 516 U.S. 815 (1995), overruled on other grounds as stated in In re Orthopedic Bone Screw Products Liability Litigation, 159 F.3d 817, 825 (3rd Cir.1998). See also In re Medtronic, Inc. Implantable Defibrillators Litigation, 465 F.Supp.2d 886, 898 (D.Min.2006); Davenport v. Medtronic, Inc., 302 F.Supp.2d 419, 433 (E.D.Pa.2004); Steele v. Depuy Orthopaedics, Inc., 295 F.Supp.2d 439, 455-56 (D.N.J.2003). Other courts have found this reasoning unpersuasive given the comprehensive nature of the PMA process. Because all representations regarding the device in its labeling must be approved by the FDA as part of the PMA process, these courts have held that any claim that such representations are inadequate is preempted. See Enlow v. St. Jude Medical, Inc., 210 F.Supp.2d 853, 861-62 (W.D.Ky.2001) (citing Martin v. Telectronics Pacing Systems, Inc., 105 F.3d 1090, 1100 (6th Cir.1997), cert. denied, 522 U.S. 1075 (1998)).

None of these cases was decided with the benefit of the Supreme Court's decision in Reigel. In light of that decision, the district court decided that the better-reasoned approach would find plaintiff's breach of express warranty claims based on the labeling of the Trident System preempted. The FDA evaluates labeling as part of the PMA process, it noted. Moreover, once approved, labels cannot be changed without FDA approval. Parker's express warranty claim would contradict the FDA's determination that the representations made on the label were adequate and appropriate and, thus, impose requirements different from or in addition to the federal requirements.
 

Drug And Medical Device Conference

The second week of December in New York marks the return of one of the premier products liability litigation events, geared to the pharmaceutical and medical device industries. Now in its 13th year, ACI’s DRUG AND MEDICAL DEVICE LITIGATION is a gathering of many of those involved in defense of product liability litigation, with a faculty of in-house and outside counsel (including your faithful blogger) and 8 renowned federal and state jurists.

Readers of MassTortDefense know that in the past year, the Supreme Court ruled in favor of preemption for PMA-approved medical devices, and it is now poised to make a potentially significant decision on preemption for drugs that could change that aspect of the product liability landscape. The liberal Democratic Congressional backlash against preemption has already started, with attempts to legislatively overturn the Reigel decision. In addition, government enforcement agencies and State Attorneys General have stepped-up investigations against drug and device manufacturers, and plaintiffs’ attorneys are taking every opportunity to highlight this fact in civil litigation. So, plenty to talk about.

This year’s conference takes place in the 1903 landmark Hudson Theatre at the Millennium Broadway Hotel. And MassTortDefense is looking forward to the visit the the Big Apple.
 

Class Counsel Fees Approved, But Reluctantly

At MassTortDefense, we typically focus on product liability, toxic tort, and consumer fraud litigation. But a recent decision arising from the largest retail security breach in history, where, the intruders made off with data relating to over 45,000,000 credit and debit cards, raises important class action issues for our readers. In re TJX Companies Retail Security Breach Litigation, 2008 WL 4786658 (D.Mass. November 03, 2008).

Consumers made several complaints, many of them putative class actions. The federal court consolidated these cases, and later received additional cases by order of the Judicial Panel on Multidistrict Litigation, see In re TJX Cos. Customer Data Security Breach Litig., 493 F.Supp.2d 1382, 1383 (J.P.M.L.2007). By September, 2007, TJX and counsel for the consolidated putative class action reached an agreement on settlement. After reviewing objections to the Agreement and holding a fairness hearing, the court gave final approval to the agreement on July 15, 2008. The court then considered class counsel's petition for attorneys' fees.

Determining whether a requested fee is reasonable requires consideration of a variety of factors. Some of the most typical include (1) the reaction of the class members to the settlement and proposed attorneys' fees; (2) the skill and efficiency of the attorneys involved; (3) the complexity and duration of the litigation; (4) the risk that the litigation will be unsuccessful; (5) the amount of time devoted to the case by counsel, and (6) the extent of the benefit obtained. The potential problem here was with the last item. Plaintiffs’ counsel asked for $6.5 million in fees, but as of October 30, 2008, class members had claimed just over $6,100,000 in benefits, a figure unlikely significantly to increase. To grant the petition would thus put more money in the pockets of the attorneys than in those of the wronged clients in whose name the suit was brought. When viewed through this prism, the benefits obtained for the class seem “virtual rather than real,” said the court. At bottom, said the court, class action litigation should benefit the individuals who have been harmed.

Simply awarding fees by reference to the valuation of the settlement presented by counsel requires a court to ignore two interrelated realities about class action litigation. First, only a fraction of any given class is likely to claim the benefits provided for in a settlement. Indeed, it is not unusual for only 10-15% of the class members to bother filing claims, and when settlements require class members to file statements or proofs of claim in order to receive their share response rates rarely exceed 50%. See Leslie, The Significance of Silence: Collective Action Problems and Class Action Settlements, 59 Fla. L. Rev. 71, 119-20 (2007)

The weakness in the approach of awarding fees based on benefits made available rather than actually utilized is that it arguably sets up a conflict between counsel and the class by creating an incentive for counsel to accept a settlement unlikely to yield a high claiming rate, for example, a coupon-in exchange for being guaranteed a percentage of the fund made available, not claimed. Similarly, some class counsel may agree to conditions on a settlement -- such as a short time frame in which to make claims or a burdensome claims procedure --in order to obtain additional concessions from the defendant that purportedly increase the value created by the litigation and that support an enhanced fee award.

“Simply put, the class action vehicle is broken,” opined the court.  And tying the award of attorneys' fees to claims actually made by class members is one step that judges can take toward repair. This approach will not only encourage more realistic settlement negotiations and agreements, but also will drive class counsel to devise ways to improve how class action suits and settlements operate. Class counsel would have an incentive to pay attention to the needs and desires of the class and to “think outside the box” to devise better notice programs, settlement terms, and claim procedures, all to the benefit of the consumers.

Linking attorneys' fees to claims would serve two additional objectives, thought the court. First, it might prevent “windfalls” for attorneys created by “class apathy.” Second, the court noted that there are surely plaintiffs' lawyers who bring putative class action lawsuits without merit, assuming, correctly, that in many cases the defendant will bw forced to settle the case to avoid a small probability of a substantial judgment. The failure to link fees to benefits claimed thus could encourage the filing of needless lawsuits.

Class counsel may argue that “You can lead a horse to water, but you can't make him drink.”   But the court responded that while this may be true, it stands to reason that one can maximize the chances that a horse will drink by, for example, verifying the horse can see the water; choosing clear, fresh, and cold water so that the horse is given the utmost incentive to drink; and making sure there are no obstacles in the horse's path.  (Gotta love it when a court takes a lawyer's analogy and runs with it!)

 

Nanotechnology Update

Many readers of MassTortDefense know that nanotechnology refers to a new field of technology that seeks to manipulate and control products, really matter, on the atomic and molecular scale, typically 100 nanometers or smaller. To give some sense of scale, one nanometer is one billionth, or 10-9 of a meter. A nanometer compared to a meter is the roughly the same ratio as that of a baseball to the size of the Earth. Or another analogy, a nanometer is the length a man's whiskers grow in the time it takes him to lift his razor to his face to shave.

First, the European Food Safety Authority (EFSA) recently called for public comments on its draft scientific opinion document assessing the potential risks of engineered nanomaterials used in food and feed. EFSA opinions provide guidance for the European Commission and European Union member state food safety organizations.

EFSA has noted that complete information about engineered nanomaterials in food is lacking, leading to uncertainties in risk assessment. In particular, the agency said knowledge is limited about how engineered nanomaterials in food should be characterized, detected, and measured. It also said more information is needed on the toxicological and environmental impacts of using such nanomaterials.

The comment period on the draft opinion is open until Dec. 1, after which the scientific opinion will be revised and finalized, taking the comments into account.

Second, back in the US, the activist group Consumers Union released new product tests this week, claiming to show that some sunscreens claiming not to contain nanoparticles appeared to contain them.
 
The group is concerned because nano-size particles are known in some applications to have different properties than the conventional versions of these chemicals. Sunscreen manufacturers use nano-size particles of these ingredients for several reason, including because they help make the products clear rather than opaque, something consumers prefer. The European Union has required manufacturers to submit data on sunscreens containing nanoparticles.

Third, the EPA has issued an announcement intended to give notice of the potential application of the Toxic Substances Control Act (TSCA) requirements to carbon nanotubes (CNTs). Carbon nanotubes are generally made from sheets of graphite no thicker than an atom—about a nanometer, or one billionth of a meter wide—and formed into cylinders, with the diameter varying from a few nanometers up to tens of nanometers. They are excellent conductors of electricity. Carbon nanotubes can also be used to reinforce polymers to create very strong plastics. Carbon nanotubes show promise as building blocks for computer chips that are smaller and faster than those made of silicon. Economists predict that the market for carbon nanotubes will grow to more than $1 billion by 2014.

EPA generally considers CNTs to be chemical substances distinct from graphite or other allotropes of carbon already listed on the TSCA Inventory. Many CNTs may therefore be new chemicals under TSCA. If a particular CNT is not on the TSCA Inventory, anyone who intends to manufacture or import that CNT is required to submit a premanufacture notice (PMN) at least 90 days before commencing manufacture. MassTortDefense has posted about carbon nanotubes before.

Apparently, inquiries to the Agency and questions in public forums indicated a lack of clarity on this issue. Some of the misunderstanding may be the result of an EPA communication to a chemical manufacturer a number of years ago pertaining to a substance the Agency now considers to be a carbon nanotube material. EPA understands that the earlier communication may have been misunderstood by some companies as a possible indication that all CNTs may be equivalent to other allotropes of carbon already on the TSCA Inventory. Hence the clarification.
 

U.S. Tort System Deters Foreign Investment

A new report by the U.S. Department of Commerce, “The U.S. Litigation Environment And Foreign Direct Investment,” calls for supporting U.S. economic competitiveness by reducing legal costs and uncertainty in the tort system.

The report notes that foreign direct investment plays a major role as a key driver of the U.S. economy and as an important source of innovation, exports, and jobs. Because the U.S. share of global FDI inflows has declined since the late 1980s and the competition to attract FDI has grown more intense, the United States must strive to maintain its ability to attract FDI. Fear of litigation and potential liability under the U.S. legal system are among the more important concerns to those interested in investing in the United States.

There is an international perception that the pervasive nature of litigation in the United States and other related aspects of the legal system increase the costs of doing business and add uncertainty. The United States is increasingly seen from abroad as a nation where lawsuits are too commonplace.

Such perceptions are accurate, Between 1950 and 2006, total U.S. tort costs increased from $13 billion to $247 billion per year (in 2006 dollars), rising from 0.62 percent to 1.87 percent of U.S. GDP. And U.S. tort costs as a percentage of GDP are triple that of France and the United Kingdom and at least double that of Germany, Japan, and Switzerland. Such numbers make this issue an important U.S. competitiveness concern.

Fear of litigation is among the top issues listed by senior executives who manage internationally owned U.S. businesses. Significantly, U.S.–owned companies that operate in other advanced economies do not express a similar concern. Also, there is the perception that, at least in some contexts, other countries’ legal systems are more predictable and that the legal costs of doing business are substantially less.

Certain aspects of the U.S. legal system stand out to foreign investors, including punitive damages, class action litigation, high legal costs, joint and several liability, and contingency fee structures. One major source of consternation, perhaps because it is so unique to the U.S., is the problem with forum shopping. Most tort cases are brought in state courts, and there are specific courts within even well-regarded state legal systems that are seen as being overly favorable to plaintiffs. Such courts have sometimes been described as judicial hellholes or magic or jackpot jurisdictions.

The report calls for more economic research, and, appropriately, tort reform in these important areas.
 

Seventh Circuit Rejects Consumer Fraud Act Class Action

The Seventh Circuit has rejected a national consumer fraud class action. Thorogood v. Sears, Roebuck and Co., 2008 WL 4709500 (7th Cir. October 28, 2008).

As explained in the opinion of Judge Posner, plaintiff bought a Kenmore-brand clothes dryer from Sears Roebuck (Kenmore is a Sears brand name). The words “stainless steel” were imprinted on the dryer, and point of sale advertising explained that this meant that the drum in which the clothes are dried inside the dryer was made of stainless steel. The plaintiff says he thought it meant that the drum was made entirely of stainless steel. The plaintiff alleged that part of the drum rusted and stained the clothes that he dried in his dryer.

He filed a class action suit on behalf of himself and the other purchasers, scattered across 28 states plus the District of Columbia, of the half million or so Kenmore dryers advertised as containing stainless steel drums. He claims that the sale of a dryer so advertised is deceptive unless the drum is made entirely of stainless steel, since if it is not it may rust and cause rust stains on the clothes in the dryer. His individual claim is that the representation violated the Tennessee Consumer Protection Act. Although some members of the huge class are citizens of the states of which Sears is a corporate citizen (New York and Illinois), so that diversity of citizenship is not complete, the suit properly invoked federal jurisdiction under the Class Action Fairness Act, since the amount in controversy exceeds $5 million. The district court certified the class, but the 7th Circuit reversed.

After noting the potential benefits of a class action, especially where individual damages are small, the court noted that the class action device has its downsides. There is first of all a much greater conflict of interest between the members of the class and the class lawyers than there is between an individual client and his lawyer. The class members are interested in relief for the class, but the lawyers are interested in their fees, and the class members' stakes in the litigation may be too small to motivate them to supervise the lawyers in an effort to make sure that the lawyers will act in their best interests.

A further problem with the class action is the enhanced risk of costly error. When enormous consequences turn on the correct resolution of a complex factual question, the risk of error in having it decided once and for all by one trier of fact rather than letting a consensus emerge from several trials may be undue. Mejdrech v. Met-Coil Systems Corp., 319 F.3d 910, 912 (7th Cir.2003); see also Castano v. American Tobacco Co., 84 F.3d 734, 746 (5th Cir.1996); McMillian, “The Nuisance Settlement  Problem,“ 31 Am. J. Trial Advoc. 221, 252-53 (2007); Stempel, “Class Actions and Limited Vision,” 83 Wash. U. L.Q. 1127, 1213-14 (2005). If a company is sued in a number of different cases for selling a defective product, and then it ins some of the cases and loses some, the aggregate outcome may be a fair reflection of the uncertainty of the plaintiffs' claims. But when the central issue in a case is given class treatment and so resolved by a single trier of fact, a trial becomes a roll of the dice; a single throw will determine the outcome of a large number of separate claims-there is no averaging of divergent responses from a number of triers of fact having different abilities, priors, and biases.

The risk is asymmetric when the number of claims aggregated in the class action is so great that an adverse verdict would push the defendant into bankruptcy, for then the defendant will be under great pressure to settle even if the merits of the case are slight. In re Rhone-Poulenc Rorer, Inc., 51 F.3d 1293, 1298-99 (7th Cir.1995).

There is still another downside to the class action, and it is the tendency, when the claims in a federal class action are based on state law, to undermine federalism. In re Bridgestone/Firestone, Inc., 288 F.3d 1012, 1020-21 (7th Cir.2002); Elizabeth M. v. Montenez, 458 F.3d 779, 788 (8th Cir.2006). Here, the instructions to the jury on the law it is to apply would have to be an amalgam of the consumer protection laws of the 29 jurisdictions, and procedural rules by which particular jurisdictions expand or contract relief will be ignored. The Tennessee Consumer Protection Act, for example, does not authorize class actions.

Judge Posner felt that this case turns out to be a notably weak candidate for class treatment. “Apart from the usual negatives, there are no positives.” Common issues of law or fact not predominate over the issues particular to each purchase and purchaser of a “stainless steel” Kenmore dryer. The plaintiff claims to believe that when a dryer is labeled or advertised as having a stainless steel drum, this implies, without more, that the drum is 100 percent stainless steel because otherwise it might rust and cause rust stains in the clothes dried in the dryer. Do the other 500,000 members of the class believe this, asked the court? Does anyone believe this besides Mr. Thorogood? It is not as if Sears advertised the dryers as eliminating a problem of rust stains by having a stainless steel drum. There is no suggestion of that. It is not as if rust stains were a common concern of owners of clothes dryers. There is no suggestion of that either, and it certainly is not common knowledge.

Accordingly, the evaluation of the class members' claims will require individual hearings. Each class member who wants to pursue relief against Sears will have to testify to what he understands to be the meaning of a label or advertisement that identifies a clothes dryer as containing a stainless steel drum. Does he think it means that the drum is 100 percent stainless steel because otherwise his clothes might have rust stains, or does he choose such a dryer because he likes stainless steel for reasons unrelated to rust stains and is indifferent to whether a part of the drum not easily seen is made of a different material? In granting class certification, the district judge said that because “Sears marketed its dryers on a class wide basis ... reliance can be presumed.” Reliance on what? On stainless steel preventing rust stains on clothes? Since rust stains on clothes do not appear to be one of the hazards of clothes dryers, and since Sears did not advertise its stainless steel dryers as preventing such stains, the proposition that the other half million buyers, apart from Thorogood, all shared this understanding of Sears's representations and paid a premium to avoid rust stains is, to put it mildly, implausible, and so would require individual hearings to verify.
 

Oral Argument In Wyeth v. Levine

The much anticipated preemption case, Wyeth v. Levine, was argued yesterday before the US Supreme Court. Seth P. Waxman argued for Wyeth; Ed Kneedler for the FDA as amicus; and David Frederick for Ms. Levine.

While veteran Court watchers know it can be risky to read too much into questions asked, here is what jumped out at MassTortDefense from the oral argument.

1. Justice Kennedy: making a “comment” that it was not necessarily impossible for Wyeth to comply with the State law and at the same time the Federal label, as a textual matter, as a logical matter.

2. Each of the advocates being asked by multiple Justices, beginning with Justice Ginsberg, whether and to what degree the FDA specifically considered the risks and benefits of IV push versus IV administered the usual way by a drip bag. Frederick eventually agreeing with Chief Justice Roberts that if there was specific consideration of IV push as opposed to simply arterial exposure, then plaintiff below should lose.

3. Justice Ginsberg seemingly second-guessing the FDA’s assessments of risk and benefit because the drug was not a life-saving drug, and on the risk side you have the risk of gangrene. “No matter what benefit there was, how could the benefit outweigh that substantial risk?” Waxman responded that the right question was would this method ever be medically warranted? The testimony in this case and in the administrative record was “yes.”

Frederick told the Chief Justice that there was no way FDA could have made this determination because the risks of IV push are so catastrophic compared to the benefit. But Justice Scalia chimed in that he was “just contradicting the label. The fact is they could not have approved that label unless they made that determination.”


4. Waxman offered the Court a way to think about a narrow reversal: “members of this Court are concerned about applying a broad, vague, or free-wheeling analysis of implied conflict pre-emption, but this case is heartland. A jury was asked to look at the same information and conclude that the precise language that the FDA just didn't allow, the FDA required Wyeth to use, rendered that drug unreasonably unsafe.”

5. Kneedler conceding that there would be no preemption if the state law failure-to-warn claim was based on new information that the company didn’t furnish the FDA. Which got him into the quandary of when the information is brought it to the FDA's attention and the FDA just hasn't acted on it. He had some trouble with that one.

6. Frederick had a hard time clarifying whether his case depended upon the Court determining that the risk at issue here was a new risk that the FDA did not consider.

7. Frederick more or less conceded to Justice Alito that a claim would be pre-empted when the FDA considered and rejected a label change proposed on the basis of the same information or similar information that underlies the State claim.

8. Justice Scalia pointed out the difference between what juries do and the promotion of public safety through a balancing of benefits and costs. The former may be simply eliminating certain drugs which people could be benefited by.

9. Waxman doing an effective job of contrasting plaintiff’s current argument with what Levine argued to the jury. Plaintiff had not argued that the FDA hadn’t gotten information about the risks. Plaintiff below “stood up and said the FDA doesn't decide this question. You [the jury] decide this question. And there was never, ever a suggestion in the record in this case, nor could there have been, that Wyeth ever failed to bring every single adverse-event report to the FDA's attention, every analysis that it did to the FDA's attention.”

10.  Justices Breyer and Scalia indirectly sparring through questions about who would have the "burden of proof" of bringing up new risk information, and who should lose if they did not do so. Justice Scalia noted that new information was not brought up by either side below, and he clearly did not buy the notion that it is the burden of the drug company to show an absence of new information.

It is always difficult to predict Supreme Court decisions. That being said, given the tenor of the Court’s questions, and some of the arguments advanced, the Court has plenty of ammunition to arrive at a relatively narrow decision, which could result in additional litigation concerning whether preemption is available under any different set of facts. 

Class Representative But Not Member Of The Class

The recent decision in Boyd v. Allied Signal, Inc., 2008 WL 4603401 (La.App. 1st Cir., October 17, 2008), illustrates a distressingly common feature of class actions, particularly those in the toxic tort context. Class representatives who are not injured, and not even members of the class.

The basic facts: a compressed gas trailer owned by Allied Signal, Inc. and loaded with boron trifluoride developed a leak from one of its tubes while being transported as a tractor-trailer unit. After the leak was discovered, the tractor-trailer unit stopped around noon on the westbound shoulder of I-12 on or near its overpass for Cedarcrest Avenue in Baton Rouge, where the tube continued to leak and dispersed BF3 in the air. Mitigation efforts ensued, and were completed approximately eighteen hours later.

A number of civil actions seeking class action status were subsequently filed by those allegedly impacted by the leak. The trial court consolidated the various actions and ultimately certified a class action as to the issue of liability, establishing geographic boundaries approximately corresponding to those of an emergency “shelter in place” plan for nearby residents and to various gas dispersion plumes or isopleths estimated on a successive hourly basis by the plaintiffs' expert in atmospheric dispersion. The Louisiana court of appeals affirmed the trial court's decision to certify the class action. Boyd v. Allied Signal, Inc., 898 So.2d 450, 453-54 (La.App. 1st Cir.12/30/04), writ denied, 897 So.2d 606 (La.4/1/05).

One of the class reps claimed she had entered the westbound portion of Interstate Highway 12, and about five to ten minutes later encountered stalled traffic and observed a police officer some distance ahead, standing outside his unit. After pulling her vehicle onto the shoulder, she and her husband allegedly exited the vehicle and walked to the side of the highway, where she observed a truck ahead, surrounded by a haze. Ms. Smith claimed that she experienced eye irritation and coughing during the course of events, and washed her eyes with eyewash after arriving at her destination. She did not seek medical treatment for those claimed symptoms.

Ms. Smith was confirmed as a class representative. But identification of members of the class based upon their claims of physical presence in its geographic and temporal limits is an issue separate from proof of the veracity of such claims. Ms. Smith was not thereby relieved of her burden of proof on the issues of causation and damages by virtue of her status as a class representative. Defendants appealed the judgment in favor of Ms. Smith.

Under cross-examination, Ms. Smith had acknowledged there was nothing that prevented her from using an exit to get off I-12, rather than remain on the shoulder. Her husband admitted they were told to get back in their vehicle. In deposition he admitted that they never drove past the leaking tractor-trailer. Thus, during the time she was on I-12, she never closely approached the class geographic boundaries. The geographic boundaries of the class were carefully drawn to coincide as closely as practicable with a circle defined by the quarter-mile “shelter-in-place” radius centered on “ground zero” and the BF3 dispersion plumes postulated by the plaintiffs' expert in air dispersion in his air modeling.

At the conclusion of Ms. Smith's presentation of evidence, the defendants moved for involuntary dismissal of Ms. Smith's cause of action on the grounds that she failed to prove any symptomatic exposure to BF3. The defendants emphasized that the plaintiffs' own expert testified that the exit plaintiff used was outside the area of his air modeling, and that any concentration at that location “was so low that it would not have any significance from the point of view of a toxicologist.”

The trial court clearly erred in finding that Ms. Smith sustained symptomatic BF3 exposure while traveling on I-12. There was no testimony or other evidence supporting that finding. The court of appeals carefully reviewed the maps, diagrams, and aerial photographs showing the geographic boundaries of the class. That review leads to the inescapable conclusion that Ms. Smith failed to prove that she was within the class geographic boundaries and that she suffered any exposure to airborne BF3 sufficient to cause any symptoms.
 

It is amazing that the claim was handled properly only on appeal, for a plaintiff who was not exposed, not injured, should never have been a class rep, was not a class member, and had no business obtaining a judgment at trial.