Update on BPA

Several recent developments concerning BPA.

The Canadian government announced earlier this month that it intends to draft new regulations to prohibit the importation, sale, and advertising of baby bottles containing bisphenol A; the proposed bans are to take effect in 2009.

Environment Canada and Health Canada have released a scientific assessment, concluding that bisphenol A poses no danger to the general public, but expressing some uncertainty about its potential impact on infants up to 18 months of age. The scientific evidence of the neuro-developmental and behavioral impact of bisphenol A on rodent test subjects, although highly uncertain and not capable of easy extrapolation to humans, is apparently providing the basis for taking action to limit exposure to the substance for newborns and infants. The government plans also to allocate almost $2 million to support additional research on bisphenol A.

The first regulatory step comes as Environment Canada and Health Canada published a notice of their intention to designate bisphenol A as toxic under the Canadian Environmental Protection Act, a first step that allows the government to take regulatory action on the chemical. The agencies also issued a draft risk management approach for the chemical that aims to reduce releases of the substance into the environment. The proposed risk management plan, which is open to a 60-day public comment period that started on Oct. 18, said that BPA should be managed using a life cycle approach that prevents or minimizes its release into the environment.

The Canadian draft plan incorporates a regulatory ban on the import, sale, and advertising of polycarbonate baby bottles made with bisphenol A. It calls for the adoption of an “as low as reasonably achievable” principle in the packaging of canned infant formula, and indicates that the government will develop migration target levels for bisphenol A from infant formula cans to the formula they contain. The government proposes exploration of imposing migration targets for bisphenol A in canned foods in general.  The regulations will establish maximum bisphenol A concentrations in industrial effluents and will require the implementation of management systems for facilities where the substance is used, the draft plan said.

In addition, the plan calls for a survey on the content of bisphenol A in medical devices, further research on exposure of pregnant women to the substance, monitoring through the Canadian Total Diet Study, and additional environmental monitoring in waste water effluents and waters downstream from waste water treatment plants.

Meanwhile, back in the States…
State attorneys general from Connecticut, Delaware, and New Jersey called on manufacturers of baby bottles and baby formula to stop using BPA in their products. The AGs cite the recent studies in letters to the companies urging them to stop putting BPA into infant formula containers. “Mounting evidence suggests that BPA from the lining of these cans leaches directly into the infant formula,” claimed the AGs.

The AGs cited a February 2008 publication of the Work Group for Safe Markets, a coalition of liberal public health and environmental advocacy organizations, advocating without much support  that low levels of exposure to BPA may cause damage to reproductive, neurological, and immune systems during stages of fetal and infant development. They also cite the study released by Yale School of Medicine on BPA exposure and effects on brain function and mood disorders in monkeys.

The letters were reportedly sent to: Avent, Disney First Years, Gerber, Dr. Brown, Playtex, Evenflo, Abbott, Mead Johnson, PBM Products, Nature's One, and Wyeth.

Finally, the FDA Science Board Subcommittee on Bisphenol A has just released comments on the FDA’s draft exposure assessment of BPA. The Science Board provides advice primarily to the Commissioner of the FDA and other appropriate officials on specific complex and technical issues as well as emerging issues within the scientific community. This temporary Subcommittee was established by the Science Board and consists of two members of the Science Advisory Board and five scientists drawn from academia and government agencies. The focus of this Subcommittee is the scientific peer-review of the draft assessment prepared by the FDA of bisphenol A for use in food contact applications.

While the Subcommittee agrees with the focus of the draft assessment on dietary exposures to children, they believe that the FDA assessment would be strengthened by considering cumulative exposures and differential risk in neonates. They also recommend that the FDA exposure assessment be expanded to include a larger number of infant formula samples and that it rely on mean values rather than accounting for the variability in samples. Until the qualitative and quantitative information (including application of uncertainty factors) is revised, the Subcommittee cannot yet agree that the Margins of Safety defined by FDA are adequate.

MDL Court Issues Daubert and Summary Judgement Ruling

The MDL court in the Human Tissue mass tort litigation has issued a noteworthy Daubert and summary judgment decision. In re Human Tissue Products Liability Litigation, MDL No. 1763, 2008 WL 4665765 (D.N.J. Oct. 22, 2008). This multidistrict litigation arises from an alleged criminal enterprise to harvest tissue from human corpses without obtaining proper consents and without following appropriate regulations. The plaintiffs in this litigation include the recipients of processed tissue who allegedly suffered harm from the processed tissue product, as well as relatives of the deceased donors.

Certain defendants moved for summary judgment on the issue of general causation of the relevant infectious diseases of human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), syphilis, cancer, and prion disease. General causation, of course, refers to whether a substance is capable of causing a particular injury or condition in the general population. See Perry v. Novartis Pharms. Corp., 564 F.Supp.2d 452, 463 (E.D.Pa.2008); Reference Guide on Medical Testimony, in Reference Manual On Scientific Evidence 439, 444 (Fed. Jud. Ctr., 2d ed.2000).

Defendants argued generally that the tissue at issue was incapable of infecting recipients with certain diseases due to the methods employed by the processing companies to disinfect and sterilize the allografts. But the motion only attacked the potential for the transmission of diseases short of sterilization.

Defendants also moved to exclude the proposed testimonies of several of plaintiffs’ experts. The central conflict among the experts involved time, not capacity. There appeared to be no genuine conflict among the parties that unprocessed bone tissue stored at room temperature can transmit HIV, HBV, HCV, syphilis, and cancer. Rather, the real issue was for what period of time can such bone tissue transmit these diseases-- is it a matter of hours, days, months, or years? Defendants contend that the transmission of disease cannot occur after thirty days, and plaintiffs have sought to extend the period of transmission beyond thirty days. After a comprehensive review of the scientific literature, including epidemiology, animal, and in vitro studies, the court struck plaintiffs' proposed expert testimony where they sought to opine that: (1) unprocessed bone tissue kept at room temperature for thirty days or longer can transmit HIV, HBV, HCV, syphilis, or cancer; (2) unprocessed bone tissue is a transmitter of prion diseases; and (3) the incubation periods of hepatitis and HIV are longer than six months.

Plaintiffs’ expert opinions regarding unprocessed bone tissue stored at room temperature for thirty days or more did not appear to meet the second and third parts of the Daubert and Fed.R.Evid. 702 inquiry-- reliability of methodology and “fit.” The court noted that the opinions were derived from a literature review. When proposed expert testimony is not based upon the expert's own independent research, but instead on such a literature review, the party proffering such testimony must come forward with other objective, verifiable evidence that the testimony is based on scientifically valid principles. The court did not question the reliability of the underlying studies, but rather the plaintiffs’ extrapolations from those studies to the ultimate conclusion. The extrapolations from these studies were not tested, were not subject to peer review, and had no known rate of error. The theory that these studies suggest the existence of general causation as framed in this litigation has not been generally accepted. Without plaintiff's expert evidence, there was no evidence supporting plaintiffs' theories of causation.

In an observation of special interest to readers of MassTortDefense, the court addressed the claim that the science was still evolving and an MDL court should not truncate the mass litigation before it develops. Multidistrict litigation courts are often confronted with evaluating limited or evolving scientific and medical theories and evidence. The absence of definitive scientific or medical knowledge is, said the court, a reality in some cases. Nevertheless, district courts are charged with the role of gatekeeper and can only allow presently reliable evidence. As courts have recognized, the Rules of Evidence may, on occasion, prevent the jury from learning about promising or potential clinically relevant information. See In re Reuzulin Products Liability Litigation, 369 F.Supp.2d 398, 438 (S.D.N.Y.2005). The Rules of Evidence, however, cannot be disregarded even if at a future date, medical and scientific literature proves the contrary. As Judge Richard Posner put it, “the courtroom is not the place for scientific guesswork, even of the inspired sort. Law lags science; it does not lead it.”  Rosen v. Ciba-Geigy Corp., 78 F.3d 316, 319 (7th Cir.1996).

While MassTortDefense does not typically blog about non-legal or personal issues, we cannot help but say Congratulations to our Philadelphia Phillies, 2008 World Series Champions

Federal Court Dismisses Class Action Seeking Medical Monitoring for Beryllium Exposure

The U.S. District Court for the Eastern District of Pennsylvania has recently dismissed a class action seeking a medical monitoring program for employees at a beryllium plant alleging exposure to airborne beryllium. Anthony v. Small Tube Manufacturing Corp., 2008 WL 4443896 (E.D.Pa.).

Gary Anthony, as sole class representative, asserted a claim of negligence on behalf of himself and a class of employees and former employees at the U.S. Gauge facility in Sellersville, Pa. The complaint alleged that the employees were exposed to airborne beryllium while working at the plant. The class was alleged to include several thousand members. The workers allegedly faced an increased risk of contracting “chronic beryllium disease” as a result of their exposure to airborne beryllium. CBD is a lung disorder which occurs when a person's immune system over-reacts to inhaled particles of beryllium and produces pathological changes in the lungs called granulomas.

Beryllium is a strong, lightweight metal with a high melting point, high stiffness-to-weight ratio, and excellent thermal and electrical conductivity. Beryllium is used as a pure metal, but more frequently it is incorporated at low levels into alloys. Beryllium copper is the most widely used alloy, but beryllium is also combined with aluminum, nickel and magnesium, to produce a panoply of products from non-sparking tools, and aircraft brakes, to laser targeting systems and nuclear weapons.

The putative class sought the establishment of a medical monitoring program funded by defendants, and administered under court supervision. As readers of MassTortDefense may recall, a claim for medical monitoring under Pennsylvania law, requires a plaintiff to prove:

(1) exposure greater than normal background levels;

(2) to a proven hazardous substance;

(3) caused by the defendant's negligence;

(4) as a proximate result of the exposure, plaintiff has a significantly increased risk of contracting a serious latent disease;

(5) a monitoring procedure exists that makes early detection of the disease possible;

(6) the prescribed monitoring regime is different from that normally recommended in the absence of the exposure; and

(7) the prescribed monitoring regime is reasonably necessary according to contemporary scientific principles.

Redland Soccer v. Department of the Army, 548 Pa. 178, 195-196, 696 A.2d 137, 145-146 (1997).

Defendants here sought summary judgment, attacking the validity of the claim of the named representative. (And if he did not have a viable claim, he was not an adequate class rep.). Plaintiff could not show he was “sensitized” to beryllium. Defendants averred that beryllium sensitization is required to sustain a claim for medical monitoring based on exposure to beryllium. That is, without being sensitized to beryllium, a plaintiff cannot demonstrate that he is at a significantly increased risk of contracting chronic beryllium disease (CBD), the only known latent disease which results from beryllium exposure. A person becomes sensitized to beryllium when his immune system recognizes beryllium as a foreign agent and builds cells in the bloodstream to react against it. The defendants contended that this sensitization is a necessary precondition to the development of chronic beryllium disease.

Plaintiff argued that all individuals sufficiently exposed to beryllium are at risk for the development of beryllium-related health effects. The putative class, having been exposed, was at a significantly increased risk of contracting CBD and should be medically monitored for the development of beryllium sensitivity. Plaintiff contended that it has “long been known” that machinists of beryllium are at a significantly increased risk of contracting CBD, and, therefore, summary judgment was inappropriate in this case.

Defendants further asserted that the Pennsylvania intermediate appellate court’s decision in Pohl v. NGK Metals Corporation, 936 A.2d 43 (Pa.Super.2007), allocatur denied, 952 A.2d 678 (Pa.2008) (per curiam), specifically rejected a plaintiff's experts' conclusions that mere exposure to beryllium is sufficient to create a significantly increased risk of contracting CBD. Plaintiff responded that, at best, Pohl stands for the proposition that the plaintiffs in that case were unable to demonstrate that their specific exposures to beryllium rose to the level of creating a significantly increased risk of harm.

The federal court did not read the Superior Court decision in Pohl as establishing a positive rule of law that a plaintiff must prove that he or she is beryllium sensitized in all cases seeking medical monitoring for beryllium exposure. However, as a matter of expert proof, it was clear to the court that to be diagnosed with CBD one must in fact be both beryllium sensitized (as demonstrated by a positive test result) and have a positive pulmonary biopsy indicating the presence of granulomas. Without being sensitized to beryllium, plaintiff cannot ever have a diagnosis of chronic beryllium disease. Therefore, plaintiff cannot demonstrate he is at a significantly increased risk of developing CBD, the only latent disease which results from exposure to beryllium.

While plaintiffs’ experts opined that all individuals exposed to beryllium, including machinists like plaintiff, were at a significantly increased risk of contracting chronic beryllium disease, even before they become beryllium sensitized, the court found that the experts did not have the data necessary to support their conclusions in this regard. The “opinions” were “merely assumptions and speculation.” Specifically, they did not have, or base their opinions upon, any beryllium readings, measurements, or other exposure data from the U.S. Gauge plant.


Food Allergies In Kids

According to some media outlets, food allergies in American children are on the rise, now affecting about 3 million kids. The media is citing a recent report by the CDC, a comprehensive federal study of the problem. Branum and Lukacs, NCHS Data Brief No. 10, “Food Allergy Among U.S. Children: Trends in Prevalence and Hospitalizations,” (October 2008). The study reports that about 1 in 26 children had food allergies last year, up from 1 in 30 kids in 1997.

Food allergy is a potentially serious immune response to eating specific foods or food additives. Eight types of food account for over 90% of allergic reactions in affected individuals: milk, eggs, peanuts, tree nuts, fish, shellfish, soy, and wheat. About 1 in 50 are allergic to shellfish and nearly 1 in 100 react to peanuts. Other research suggests that about 1 in 40 Americans will have a milk allergy at some point in their lives, and 1 in 50 percent will be allergic to eggs. Reactions to these foods by an allergic person can range from a tingling sensation around the mouth and lips to hives to death, depending on the severity of the allergy.

The report:
• In 2007, approximately 3 million children under age 18 years (3.9%) were reported to have a food or digestive allergy in the previous 12 months.
• From 1997 to 2007, the prevalence of reported food allergy increased 18% among children under age 18 years.
• Children with food allergy are two to four times more likely to have other related conditions such as asthma and other allergies, compared with children without food allergies.
• From 2004 to 2006, there were approximately 9,500 hospital discharges per year with a diagnosis related to food allergy among children under age 18 years.

While some are quick to blame product manufacturers, nobody knows for sure what's driving the increase. The mechanisms by which a person develops an allergy to specific foods are largely unknown. Food allergy is more prevalent in children than adults, and a majority of affected children will "outgrow” food allergies with age.

A likely big part of the explanation of the new data is a from of reporting bias, as parents are more aware and quicker to have their kids checked out by a doctor these days. Parents and doctors are both more likely to consider food as the trigger for generic symptoms like vomiting, skin rashes and breathing problems. Parents today are quicker to take their kids to specialists to check out the possibility of food allergies. Thus, the findings could be related to increased awareness, reporting, and use of specific medical diagnostic codes for food allergy rather than a real increase in the number children who are experiencing food-allergic reactions.

The fact that a small number of the population is so constituted that they may suffer severe reactions to products which may be harmless or generally beneficial to others poses a dilemma to the legal scholars and courts. Generally speaking, the allergic or unusually susceptible plaintiff has found the road to financial recovery a difficult one, irrespective of the theory of recovery, the manufacturer of a reasonably safe product generally having been held not liable for damages where the basis of the injury was an allergy, hypersensitivity, or unusual susceptibility on the part of the user. See 63 Am. Jur. 2d, Products Liability § 1453. Plaintiffs’ main theory in allergy cases is that the supplier should be liable for damages arising from an allergenic, idiosyncratic reaction to its product where it has failed to give adequate and timely warning. E.g., Livingston v. Marie Callender's, Inc., 85 Cal. Rptr. 2d 528, 533 (Cal. App. 1999) (warning for allergy to MSG); Brown v. McDonald's Corp., 655 N.E.2d 440, 444 (Ohio App. 1995) (warning for allergy to seaweed); Advance Chem. Co. v. Harter, 478 So.2d 444, 448 (Fla. App. 1985) (warning for allergy to ammonia); Gober v. Revlon, Inc., 317 F.2d 47, 50 (4th Cir. 1963) (warning for allergy to nail polish). At times, plaintiffs will also try to add a manufacturing defect claim in the nature of an alleged failure to reduce or minimize the amount of the allergen in the product by washing, for example. This was seen in the latex glove mass tort.

Secrecy in Mass Tort Settlement Agreements

Settlement agreements that require a plaintiff not to disclose or publicize any information about her claim are common in mass tort and product liability cases, and sometimes controversial. See generally Bechamps, Sealed Out-of-Court Settlements: When Does the Public Have a Right to Know, 66 Notre Dame L. Rev. 117 (1990); Dore,  Settlement, Secrecy, and Judicial Discretion: South Carolina’s New Rules Governing the Sealing of Settlements, 55 S.C. L. Rev. 791 (2004); Drahozal & Hines, Secret Settlement Restrictions and Unintended Consequences, 54 Kan. L. Rev. 1457 (2006); Moss, Illuminating Secrecy: A New Economic Analysis of Confidential Settlements, 105 Mich. L. Rev. 867 (2007).

The conventional wisdom is that confidential settlement agreements aid defendants. Confidentiality minimizes bad publicity for the corporate defendant which is important to the defendant both for its own sake and to minimize additional claims. But both the defendant and an early claimant - a claimant who discovers that he or she has a claim before other claimants do - may have a strong incentive to maintain confidentiality. And they have a variety of means by which they might do so.  

Nevertheless, several commentators and academics have called for restrictions on secret settlements. Such attempted restrictions on secret settlements may be ineffective: a claimant may circumvent restrictions adopted by a single state or federal court by filing suit in a state or court without such restrictions. Second, parties might circumvent secret settlement restrictions adopted by a single state by choosing another state's law to govern the settlement. Third, parties could avoid restrictions on secret settlements in court by settling before the claimant files suit. Finally, many parties could try to accomplish much the same result as a secret settlement by use of pre-dispute or post-dispute arbitration agreements, taking advantage of the privacy of the arbitration process. See generally, Drahozal and Hines, Secret Settlement Restrictions and Unintended Consequences, 54 Kansas Law Rev. 1457 (2006).

An interesting recent paper by James Anderson observes that under some conditions, however, a mass tort defendant will rationally choose to discourage such secrecy. A defendant can use publicity to act as a commitment device akin to a most-favored-nation agreement to increase its bargaining power with plaintiffs. The paper uses the real world example of a drug (statin) litigation as a case study to illustrate this theory in practice and to explore the public policy implications of this finding. The paper is Understanding Mass Tort Defendant Incentives for Confidential Settlements, published by the RAND Institute for Civil Justice.  An interesting read, worth a look.

Group Demands Regulation Of Energy Drinks

A group of scientists and physicians have petitioned the Food and Drug Administration asking for more regulation of popular energy drinks, because their caffeine content. The group contends the ingredient puts drinkers at possible risk for caffeine intoxication and other ailments. The letter was written by Dr. Roland Griffiths, of the Johns Hopkins School of Medicine.

The United States is the world's largest consumer by volume of energy drinks, roughly 290 million gallons in 2007. That works out to about 3.8 quarts per person per year. The U.S. market for the drinks is estimated at $5.4 billion. Pretty much any successful product these days is likely to become a target of plaintiffs’ attorneys or Big Brother regulations designed to prevent people from making voluntary choices and excusing them from taking responsibility for their choices.
Caffeine is found in coffee beans, tea leaves, cocoa beans and other plants. Caffeine is an ingredient that consumers have enjoyed in many drinks for more than 100 years. The beverage industry offers both caffeine-free and caffeinated drinks. And customers are free to choose their drink of choice, whether caffeinated or non-caffeinated.

Caffeine is one of the most comprehensively studied ingredients in the food supply, with centuries of safe consumption in foods and beverages. In 1959, the FDA designated caffeine in cola drinks as "Generally Recognized As Safe" (GRAS). The FDA considers caffeine safe for all consumers, including children. In 1987, following extensive review, the FDA "found no evidence to show that the use of caffeine in carbonated beverages would render these products injurious to health." More than 140 countries have specifically considered the safety of caffeine and allow its use in beverages at various levels.

Red Bull, the best-selling energy drink in the USA, contains 80 milligrams of caffeine per 8.3-ounce can, about the equivalent of a cup of coffee. The "pick me up" quality long associated with many drinks reflects a complex mix of ingredients, including caffeine. The bitter taste of caffeine also adds to the complex overall flavor profile of soft drinks.

Consumers can easily find out how much caffeine is in a beverage by calling a company's 1-800 number or visiting its website for those drinks that don't list content on their labels. As with all foods and beverages, parents should use common sense in deciding whether to give their children caffeinated foods and beverages, and how much. That’s a parent’s job, not the government’s.
In the most recent version of the Diagnostic and Statistical Manual of Mental Disorders, caffeine is specifically excluded from the category of substances classified as causing "substance dependence." Unlike drugs of abuse, people who choose to consume foods and beverages that contain caffeine can control or moderate their caffeine intake. Scientific studies confirm that although many people enjoy caffeinated products, those who choose to stop consuming or reduce caffeine in their diets can do so without difficulty.

State Supreme Court Upholds Asbestos Reform Statute

The Supreme Court of Ohio ruled last week that a 2004 state law imposing limits on asbestos litigation should be applied retroactively. Ackison v. Anchor Packing Co., et al., 2008 WL 4601676 (Ohio Oct. 15, 2008). The ruling could affect the 40,000 claims pending in that state, as well as provide a possible precedent for other states considering the same kind of tort reform.

The 2004 Ohio statute extensively revised state laws governing asbestos litigation and was in response to a legislative finding that the current asbestos personal injury litigation system is unfair and inefficient, imposing a severe burden on litigants and taxpayers alike. The bill established certain threshold requirements, including that no person shall bring or maintain certain kinds of asbestos claims (including claims alleging a nonmalignant condition) without filing with the court certain qualifying medical evidence of physical impairment; further, such evidence must be supported by the written opinion of a competent medical authority stating that the claimant's exposure to asbestos was a substantial contributing factor to his medical condition. The claim of any plaintiff who does not file the required preliminary medical evidence and physician's statement is to be administratively dismissed “without prejudice” with the court retaining jurisdiction, meaning that a plaintiff would not be barred from reinstating the claim in the future when and if the plaintiff could meet the threshold evidentiary requirements.

The court of appeals found the statute could not constitutionally be applied to any suit that had been filed prior to the effective date of the statutory changes, as such plaintiffs had a vested substantive right to pursue recovery for injury under the statutes that were in effect at the time their complaint was filed.

The supreme court disagreed. In this case, the Ohio General Assembly expressly directed that the prima facie filing requirements at issue apply to cases pending on -and thus filed before- the effective date of the legislation. Because the General Assembly so specified, the issue becomes “whether the statute is substantive, rendering it unconstitutionally retroactive, as opposed to merely remedial.” Under Ohio law, and this is fairly  typical, a statute is substantive if it impairs or takes away vested rights, affects an accrued substantive right, imposes new or additional burdens, duties, obligations, or liabilities as to a past transaction, or creates a new right. Conversely, remedial laws are those affecting only the remedy provided, and include laws that merely substitute a new or more appropriate remedy for the enforcement of an existing right.

The court found that the new law is remedial and procedural in nature and, therefore, not unconstitutionally retroactive. The reform established “a procedural prioritization” of asbestos-related cases, a procedure to prioritize the administration and resolution of a cause of action that already exists. No new substantive burdens are placed on claimants.

Clearly, the types of asbestos claims most impacted by the reform statute are the non-malignant claims, short of true asbestosis which is rare anymore, where some radiographic minor finding is alleged to be an injury. While some lower courts in Ohio had stated that pleural plaque or pleural thickening meets the definition of bodily harm which is a subspecies of physical harm and thus satisfies the injury requirements of Sections 388 and 402A of the Restatement of the Law 2d, Torts. E.g., Verbryke v. Owens-Corning Fiberglas Corp., 84 Ohio App.3d 388, 616 N.E.2d 1162 (1992). The supreme court determined that the Maryland court's approach is the better reasoned one: in Owens-Illinois, Inc. v. Armstrong, 87 Md.App. 699, 591 A.2d 544 (Md.App.1991), reversed in part on other grounds 326 Md. 107, 604 A.2d 47 (1992), the Court of Special Appeals of Maryland held that the Restatement did not support the conclusion that pleural plaques and pleural thickening alone were sufficient to constitute harm.

Plaintiffs also attacked the statute’s definition of “competent medical authority” which previously had not been defined by either statute or Ohio case law. By choosing to define that term, said the court, the legislature did not take away Ackison's right to pursue a claim. Nor did the definition alter the quantum of proof necessary for a plaintiff to prevail in an asbestos-related claim. Rather, it merely defined the procedural framework by which trial courts are to adjudicate such claims. The definition of competent medical authority pertains to the witness's competency to testify and is, in essence, more akin to a rule of evidence. As such, it is procedural in nature.

FDA Updates Plans For Foreign Offices

The Food & Drug Administration (FDA) should be opening its new China office later in 2008. In the past couple years, as posted here at MassTortDefense, multiple imports from China have been at the center of safety concerns. Earlier this year, heparin allegedly contaminated with a counterfeit ingredient was blamed by some plainitff attorneys for some patient deaths; FDA has issued recalls of several foods imported from China that may have apparently been tainted with the industrial chemical melamine, which has been added to dairy products and resulted in hospitalization of thousands of children in China.

FDA staff posted at the China office will inspect facilities, provide guidance on U.S. quality standards, and later train local experts to conduct inspections on behalf of the FDA. The FDA will eventually open offices in the Chinese cities of Shanghai and Guangzhou, for a total of eight planned FDA staffers. The agency hopes a greater on the ground presence in China will help prevent unsafe imports, and the opening of a Beijing, China office later this year is just the first step in the FDA’s plan to expand its presence overseas. Over the next year, the agency plans to place as many as 60 food and drug regulators in offices worldwide, focusing on India, Latin America and the Middle East. The plan for permanent outposts marks a break from the agency's current practice of sending inspectors abroad on individual assignments.

Part of an updated import inspection plan may be to allow voluntary inspection, where manufacturers would pay third-party inspectors to verify that their plants meet FDA standards, although past attempts at a voluntary inspections system haven’t been well received by some overseas manufacturers. Democrats in the House of Representatives, offering yet another alternative, have proposed a program that would require companies to pay mandatory user fees to help finance additional FDA inspections.

Health and Human Services Secretary Michael Levitt is scheduled to travel to China next month to meet with health officials there to review joint efforts to ensure the safety of food and medical imports. The Consumer Product Safety Commission also worked to get people stationed in China. Under the current plan, the CPSC staffers who will be sent there eventually are not full inspectors. Their purpose will be to provide technical assistance to Chinese manufacturers and regulators.

FDA Requests BPA Info; BPA Science Review Released

The Food and Drug Administration is requesting assistance in the identification of types
of FDA-regulated products that contain Bisphenol A (BPA), whether as a component of the product or its packaging, and any information relating to the possible leaching of BPA from the packaging to the product and/or from the product from the product following human administration.

BPA is a chemical commodity used primarily in the production of polycarbonate plastics and epoxy resins. Such plastics and resins have many valuable applications, including as components of
packaging for food and drink, and as components of certain medical products and their packaging. Consequently, low levels of residual BPA may be present in such products. On April 14, 2008, the
National Toxicology Program (NTP) released a draft brief on BPA for public comment and peer review. MassTortDefense posted about that.  The NTP draft brief raised some possible concerns that exposure to BPA could be linked to developmental problems of the endocrine system in infants and young children. The NTP draft brief also contains an exposure estimate to BPA  for infants and young children due to leaching of BPA to food from plastic  baby bottles and the linings of certain baby food containers. NTP has subsequently released a final report on  BPA on September 3, 2008.

In response to the NTP draft brief, FDA Commissioner von Eschenbach convened an agency-wide task force to facilitate cross-agency review of current research and new information on BPA for all FDA-regulated products. The review will include the NTP brief and all other available information on the exposure of US consumers to BPA from FDA-regulated products.

During the course of this process the task force has been making an inventory of all FDA-regulated products that are known to contain BPA. The task force has already completed a thorough
assessment of the potential exposure to BPA due to leaching from food-contact materials and is now expressing interest in additional information on other types of products, specifically medical devices, biological products (including blood, blood products, vaccines, and cell and gene therapies, and drugs.

For devices, in particular, FDA is asking about:

  • The rate and extent of BPA release from devices under clinically relevant extraction conditions.
  • What conditions affect the release and leaching of BPA?
  • Estimates of patient exposure to BPA from use of the device.
  • Possible alternatives to BPA and any associated risks.


In other BPA news, to address the “low-dose” issues that have been raised in some quarters, the Harvard Center for Risk Analysis convened a panel of scientific experts to critically review the relevant low-dose BPA studies of reproductive and developmental effects. In 2004, the Harvard Panel “found no consistent affirmative evidence of low-dose BPA effects for any endpoint.”  In 2006, the Gradient Corp. consulting group organized and participated in an expert scientific panel that conducted an updated weight-of-evidence evaluation, looking at articles published since the Harvard review and using the same methodology as the Harvard Panel.

This year, Gradient conducted yet another expert scientific panel review, again using the same methodology as the Harvard Panel, and including literature published through July, 2008. The effort was funded by the Polycarbonate/BPA Global Group and the panel’s report has been published in the peer-reviewed journal, Critical Reviews in Toxicology (Goodman et al., Weight-of-evidence evaluation of reproductive and developmental effects of low doses of bisphenol A, Critical Reviews in Toxicology, 2008). The findings of all three reviews were consistent with one another and with reviews conducted by most government bodies worldwide. As concluded overall, “The weight of evidence does not support the hypothesis that low oral doses of BPA adversely affect human reproductive and developmental health.”

"Science Day" In Mass Torts

Many mass torts involve complex medical and scientific issues.  Typically, general causation (can the product cause the injury alleged) and/or specific causation (did the product cause this injury) are debated.  Such questions often spawn Daubert or Frye challenges to expert opinion testimony,  motions in limine, and summary judgment motions that the trial court must wrestle with.

Accordingly, the notion of "educating the court" on the foundation of scientific issues often looms as an important task for defense counsel in mass torts.  One solution to this dilemma may be the "science day" on which the parties present an overview of the issues for the court.

The ABA CIVIL TRIAL PRACTICE STANDARDS note that in cases involving complex technology or other complex subject matter which may be especially difficult for non-specialists to comprehend, the court may permit or require the use of tutorials to educate the court. Tutorials are intended to provide the court with background information to assist the court in understanding the technology or other complex subject matter involved in the case. Tutorials may, but need not, seek to explain the contentions or arguments made by each party with respect to the technology or complex scientific subject matter.

In any case in which the court believes one or more tutorials might be useful in assisting it in understanding the complex technology or other scientific subject matter, the court should invite the parties to express their views on the desirability of one or more tutorials. Once the court decides to permit or require one or more tutorials, it should invite the parties to suggest the subject matter and format of each tutorial, notes the ABA.

If the parties cannot agree on the subject matter and format, the court should invite each party to submit a description of any tutorial it proposes and to explain how that tutorial will assist the court and why it is preferable to the tutorial proposed by another party. The court may approve one or more tutorials proposed by the parties, or the court may fashion its own tutorial after providing the parties with an opportunity to comment on the court's proposed subject matter and format.

A court may consider the following procedures for the presentation of tutorials:

  • An in-court or recorded presentation by an expert jointly selected by the parties;
  • an in-court or recorded presentation by one or more experts on behalf of each party;
  • an in-court or recorded presentation by counsel for each party;
  • a combined in-court or recorded presentation by counsel and one or more experts on behalf of each party;
  • an in-court or recorded presentation by an expert appointed by the court, which may include cross-examination by counsel for each party;
  • recorded presentations that have been prepared for generic use in particular kinds of cases by reliable sources such as the Federal Judicial Center.

In the context of patent cases, it is well recognized that the court may conduct a tutorial, the purpose of which is to receive expert testimony for background and education on the technology implicated by the presented claim construction issues in assisting the court in the task of construing the patent. See, e.g., Starpay.com L.L.C. v. Visa Int'l Serv. Assoc., 2005 WL 1552769, at *1 (N.D. Tex.).

The use of tutorials is not, however, limited to patent cases, or even to technology cases. See, e.g., In Re Pharmaceutical Industry Average Wholesale Price Litigation, 230 F.R.D. 61, 67 (D. Mass. 2005).

Some courts will use them as a pre-curser to Daubert hearings. Generally, they are with no cross-examination; no-transcripts and an agreement that no testimony can be used in subsequent Daubert hearings.

Courts may find them very helpful. See Hall v. Baxter Healthcare Corp., 947 F.Supp. 1387 (at the outset of proceedings after remand from the MDL, counsel for all sides presented an all-day “tutorial” to the court on the complex science involved in these cases. The tutorial demonstrated the need for and prompted the court to appoint the technical advisors).


California Court Upholds Class Certification of Potentially Invalid Consumer Fraud Act Claims

The California court of appeals has upheld class certification of claims that Hewlett Packard laptops were defective because an allegedly flawed component caused the screens to dim. Hewlett-Packard Co. v. Superior Court of Santa Clara County (Rutledge), 2008 WL 4368563 (Cal.App. 6 Dist. 9/26/08).

Plaintiffs alleged violations of the California Bus. & Prof. Code Section 17200, the unfair competition law; and the Consumer Legal Remedies Act, Civ. Code Section 1750; and also made claims for breach of express warranty. In August 2005, plaintiffs filed a motion for certification of a class consisting of all persons and entities who own or owned certain HP computers, listed by product number, “who contacted HP about a lack of visibility of the display screen.”  HP opposed the motion, contending plaintiffs had not shown either that common issues of fact and law predominated or that there was an ascertainable class. Specifically, HP presented evidence that of the approximately 118,514 class model computers sold under the Pavilion brand name, only approximately 4,716 were reported to need repairs due to display screen problems. And that the causes were individual.

In November, 2005, the court determined that the proposed class definition was flawed, but that it would consider a subsequent motion should plaintiffs cure the defect. On August 30, 2006, plaintiffs filed a supplemental memorandum in support of their motion for class certification. Plaintiffs re-defined their proposed class as “[a]ll persons or entities who own or owned one or more of the following HP Pavilion notebook models: [model numbers]; [a]nd the computer contained or contains [a certain specific] inverter, [part numbers].”  The crux of the plaintiffs' claim was that the HP notebook computers contained types of inverters that would likely fail and cause the screens to dim and darken at some time before the end of the notebooks' "useful life," according to the court.  Inverters regulate electricity flowing to the display screen.

At the November, 2006 hearing on the supplemental motion, the court asked the parties to provide briefing on the effect of Daugherty v. American Honda Motor Co., Inc., 144 Cal.App.4th 824, 51 Cal.Rptr.3d 118 (2006), a case involving express warranties that had just been decided in October, 2006.

Eventually, the trial court certified the class. In its order certifying the class, the court stated that it was not ruling on the effect of the principles set forth in the Daugherty case. Following the California Supreme Court's denial of the petition for review in Daugherty, HP filed a motion for decertification on February 27, 2007, requesting the trial court rule on the effect that Daugherty had on the class certification. The court denied the motion in March, 2007, saying it was premature, so HP filed a petition for peremptory writ of mandate with the appeals court, which stayed the matter.

In Daugherty, the California Court of Appeal, Second District, held there can be no claim for breach of express warranty or unfair competition law violations arising from proof that "the manufacturer knew at the time of the sale that the component part might fail at some point in the future." HP focused on its holding that an express warranty does not extend the claims of defect beyond the warranty period. HP asserted Daugherty's rationale specifically limits its potential liability for the allegations set forth by plaintiff, making the issues individual, rather than subject to common proof. Moreover, HP argued the trial court erred in refusing to apply the principals of Daugherty to the determination of class certification.

In Daugherty, the plaintiffs were owners of Honda automobiles with an allegedly defective engine. The plaintiffs alleged that Honda had actual notice that the engines were experiencing severe mechanical problems due to oil leaks, but failed to provide adequate notice of the defect to owners of affected models. The plaintiffs first discovered the defects in their cars after the express warranty term of three years or 36,000 miles. The plaintiffs contended that “because the language of Honda's express warranty did not state that the defect must be ‘found,’ ‘discovered’ or ‘manifest’ during the warranty period, the warranty covers any defect that ‘exists' during the warranty period, no matter when or whether a malfunction occurs.” But the Daugherty court held: “[w]e agree with the trial court that, as a matter of law, in giving its promise to repair or replace any part that was defective in material or workmanship and stating the car was covered for three years or 36,000 miles, Honda did not agree, and plaintiffs did not understand it to agree, to repair latent defects that lead to a malfunction after the term of the warranty.”

Thus, Daugherty holds that failure of a component part after the expiration of the express warranty does not support a claim for relief under an express warranty claim. Daugherty holds there can be no claim for breach of express warranty or UCL violations arising from proof that the manufacturer knew at the time of the sale that the component part might fail at some point in the future. This would seem to cover plaintiffs' claim that certain HP notebook computers contained types of inverters that HP knew would likely fail and cause the screens to dim and darken at some time after warranty but before the end of the notebook's “useful life.”

However, the court of appeals found that while Daugherty may have implications for the merits of the underlying HP action, and indeed may serve to bar claims by plaintiffs that occurred outside the warranty period, it does not affect a determination of class certification. Daugherty was distinguished from the present action because it related to a substantive question on demurrer rather than a procedural question as here on a motion for class certification.

The court felt that if it were to accept HP's argument regarding the application of Daugherty to the present action, it would be considering the merits of the underlying action. And the question of class certification “does not ask whether an action is legally or factually meritorious.”

The court of appeals seemed to miss the point. While a court generally should not determine the merits of a claim at the class certification stage, it is appropriate to consider the merits of the case to the degree necessary to determine whether the requirements of class action rule will be satisfied. It may be necessary to analyze the plaintiff's factual allegations, the record evidence pertinent to class issues, and the applicable law in order to understand and evaluate the propriety of the class device. A court should look past the pleadings in order to determine whether a plaintiff's case meets the technical requirements for class certification. A court does not probe the merits when it probes behind a plaintiff's allegations because it is necessary to determine whether, if the class were certified, the issues presented could fairly and efficiently be resolved with respect to all the absent class members, based on the proof offered on behalf of only the named plaintiffs. Some inquiry into the substance of the plaintiff's case may be necessary for identifying the issues in the case and determining whether the complaint meets the requirements of commonality, typicality, and adequacy of representation, and what California calls community of interest. Evidence relevant to the class issues is often intertwined with the merits.

FDA Releases Melamine Risk Assessment

The FDA has issued the results of its interim safety and risk assessment of melamine and melamine-related compounds in food, including infant formula. The purpose of the FDA interim safety/risk assessment, which was conducted by scientists in the Center for Food Safety and Applied Nutrition, was to identify the level of melamine and melamine-related compounds in food which would not raise public health concerns.

For infant formula, the safety/risk assessment concludes that at this time FDA is unable to establish any level of melamine and melamine-related compounds in infant formula that does not raise public health concerns. Melamine in baby formula has sickened more than 54,000 infants in China. The government there ordered the recall of more than 10,000 tons of formula. Last week, 12 more Chinese dairy companies were named as violators after tests found 31 batches of milk powder contaminated with melamine.Chinese officials believe that the contamination was intentional and  occurred at milk collecting stations, rather than on dairy farms. MassTortDefense has posted on this before.

In food products other than infant formula, the safety/risk assessment concludes that levels of melamine and melamine-related compounds below 2.5 ppm do not raise public health concerns. This conclusion assumes a worst case exposure scenario in which 50% of the diet is contaminated at this level, and applies a 10-fold safety factor to the Tolerable Daily Intake (TDI) to account for uncertainties.

According to the CDC, melamine is a synthetic chemical with a variety of industrial uses including the production of resins and foams, cleaning products, fertilizers and pesticides. It does not occur naturally in food. Animal studies have demonstrated that exposure to low levels of melamine produced no observable toxic effects. Exposures to high levels of melamine, or exposures to lower doses of melamine together with certain other chemicals, have caused urinary tract problems in animals. These have included urinary tract and kidney crystal and stone formation, and kidney failure. Exposures of animals to high doses of melamine over long time periods (years) have been associated with cancer of the bladder.

Because melamine is a component in plastics, there may be melamine in dinnerware, cups, and even Formica counter tops. But the amount of melamine that actually transfers from those products into food is very, very small, according to FDA.

Several melamine-contaminated foods found in recent weeks in the United States had far more than that amount of the chemical. White Rabbit candies from China were recalled after authorities in at least two states found melamine. And a New Jersey company announced that it was recalling Blue Cat Flavor Drink, after FDA testing found melamine. The chemical has also turned up in dairy products sold across Asia and, to a lesser extent, Europe.

The FDA guidelines were issued to help federal and state investigators checking for contaminated Chinese products as they enter the country and in grocery stores. To date, there have been no reports of illness from contaminated Chinese milk products in the United States. There are no approved uses for melamine to be added to food in the United States.

Melamine contamination was at the center of the tainted pet food scandal that resulted in more than 80 class actions and the creation of MDL 1850.  The federal judge overseeing the multidistrict pet food litigation has just issued final approval of a $24 million settlement that seeks to resolve claims over a massive recall of more than 90 contaminated dog and cat foods last year.


NSF Awards Grants For Nanotechnology Research Centers

The National Science Foundation (NSF) and the U.S. Environmental Protection Agency (EPA) have made awards to establish two Centers for the Environmental Implications of Nanotechnology (CEIN). The centers, led by UCLA and Duke University, will study how nanomaterials interact with the environment and with living systems, and will translate this knowledge into risk assessment and mitigation strategies useful in the development of nanotechnology.

The NSF is an independent federal agency that supports fundamental research and education across all fields of science and engineering, with an annual budget of $6 billion.

The centers are to work as a network, connected to other research organizations, industry and government agencies, and will emphasize interdisciplinary research and education. Their challenge is to better integrate materials science and engineering with molecular, cellular, organismal and ecological biology and environmental science.

As posted about on MassTortDefense before, nanoparticles are as much as a million times smaller than the head of a pin, and have unusual properties compared with larger objects made from the same material. These unusual properties make nanomaterials attractive for use in everything from computer hard-drives to sunscreens, cosmetics and medical technologies. And with the rapid development of nanotechnology and its applications, a wide variety of nanomaterials are now used in clothing, electronic devices, cosmetics, pharmaceuticals and other biomedical products.

The potential interactions of nanomaterials with living systems and the environment have attracted increasing attention from the public as well as manufacturers of nanomaterial-based products, academic researchers, and policy makers. Nanotechnology is expected by some observers to become a $1 trillion industry within the next decade.

A major effort for the research team over the coming year is to develop 32 tightly instrumented ecosystems in the Duke Forest in Durham, N.C. Known as mesocosms, these living laboratories provide areas where researchers can add nanoparticles and study the resulting interactions and effects on plants, fish, bacteria and other elements.

FDA Announces Meeting On BPA

The FDA has announced a forthcoming meeting of the Science Board to the Food and Drug Administration, on the topic of BPA. The Science Board provides advice primarily to the Commissioner of Food and Drugs and other appropriate officials on specific complex and
technical issues as well as emerging issues within the scientific community in industry and academia.  At the meeting, on October 31, 2008, the Science Board will hear about and discuss a review of the draft assessment of Bisphenol A for use in food contact applications by the Science Board BPA Subcommittee. The Board will also hear an overview of current methods for detection of contaminants in FDA-regulated products.

In early 2008, FDA formed an agency-wide BPA task force to facilitate cross-agency review of current research and new information on BPA for all FDA regulated products. Medical devices containing the chemical are now also on the FDA’s radar screen. See the note in FDA News.  BPA is used in dialysis tubing, blood oxygenators, and dental sealants. And now that an evaluation examining migration of BPA from food contact materials has been drafted, the agency is apparently planning to publish a document assessing the safety of BPA exposure from regulated devices, biologics and pharmaceuticals.

The FDA's recent assessment was particularly focused on the concerns for developmental toxicity identified in recent assessments of BPA, including those of the National Toxicology Program and their expert panel, based on animal data. FDA concluded that this data was insufficient to merit a change in the exposure levels the agency currently allows for BPA. FDA concluded that an adequate margin of safety exists for BPA at current levels of exposure from food contact uses, for infants and adults. This assessment represents a full examination of data considered pivotal to the relevant exposure levels associated with food contact substances, the FDA said.


Preventive Services Task Force: Sometimes Risks Exceeds Benefits

The U.S. Preventive Services Task Force has released its recommendations for colon cancer screening, suggesting that most people over age 75 should stop getting routine colon cancer tests. In a decision at odds with some traditional views, the USPSTF opted not to give its approval to CT colonography, virtual colonoscopy, and the stool DNA test. (The 2002 guidelines did not give an age limit for screening.)

What is significant to readers of MassTortDefense is not the specific review of these tests, but the important recognition underlying the decision: that risks of screening at that age are too great to justify any possible benefit. After reviewing research on the tests, the government-appointed panel of independent medical experts concluded that the benefits of detecting and treating colon cancer decline after age 75 and the risks rise too much.

The U.S. Preventive Services Task Force (USPSTF), first convened by the U.S. Public Health Service in 1984, and since 1998 sponsored by the Agency for Healthcare Research and Quality (AHRQ), is perhaps the leading independent panel of private-sector experts in prevention and primary care. The USPSTF conducts rigorous assessments of the scientific evidence for the effectiveness of a broad range of clinical preventive services, including screening, counseling, and preventive medications. Its recommendations are considered in some circles the "gold standard" for clinical preventive services.

In medical monitoring claims, typically a plaintiff must prove that screening tests are reasonably medically necessary for plaintiffs because of the risks of the allegedly tortuous exposure. Despite plaintiffs’ typical theme about early detection always being efficacious, the reality is that many “routine” screening procedures have their own risks and potential side effects. As the Task Force said, “The risks and benefits of these screening methods vary.”  Where doctors must assess the risks and benefits, a powerful individual issue may emerge, affecting class certification. Even in a class setting, on the merits, the risks of procedures sought by the plaintiffs may outweigh the benefits. Thus, in this context, the Task Force noted, “The primary established harms of colorectal cancer screening are due to the use of invasive procedures initially or in the evaluation sequence. Harms may arise from the preparation the patient undergoes to have the procedure, the sedation used during the procedure, and the procedure itself.”  Colonoscopy is considered the gold standard but it is not perfect. A long, thin tube with a small video camera is snaked through the large intestine to view the lining and any growths are removed.

Defendants in medical monitoring claims will want to assess the state of the art recommendations of bodies such as the USPSTF, as well as the specific literature on the risks of proposed screening tests.


FDA Holds Public Hearing on OTC Cough and Cold Medications In Kids

As previewed by MassTortDefense, the Food and Drug Administration held a public hearing on October 2, 2008, to obtain input regarding over-the-counter (OTC) cough and cold drugs marketed for pediatric use. Many of these nonprescription cough and cold drug products are marketed under the OTC Drug Review, which published a monograph describing the conditions under which certain OTC ingredients are considered to be generally recognized as safe and effective. These products contain ingredients that have been classified by the FDA as generally recognized as safe and effective since the 1970’s Recently, some potential safety and efficacy concerns have been raised regarding the pediatric dosing and use of certain active ingredients in OTC cough and cold drug products.

FDA is developing a proposed rule to revise the pediatric labeling guidance contained in the Final Monograph for Cough, Cold, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use.  Each year, U.S. consumers buy about 95 million packages of oral pediatric cough and cold medicines. 

Some doctors at the hearing urged regulators to seek removal of children's cough and cold medicines from store shelves until the products are found safe and effective. For example, Dr. Michael Shannon, professor at Harvard Medical School, testified that it is time for these products to be re-evaluated regarding their risk-benefit ratio. The American Academy of Pediatrics doesn't recommend any use of OTC cold and cough  medicines in children. In January, the FDA recommended against their use in children up to 2 years old. Treatment alternatives include providing fluids, nose drops, humid air and appropriate pain relievers.

The Consumer Healthcare Products Association pointed out that most reported side effects are caused by accidental overdose and misuse, which might suggest that changed packaging and improved education, rather than other measures, might be appropriate. The Association has begun a comprehensive, national education program that focuses on the root causes of adverse events and speaks directly to parents, day care providers, healthcare providers, and other caregivers. CHPA is partnering with a number of organizations in these efforts, including the American Pharmacists Association and the American Association of Family Physicians. These education campaigns underscore the importance of following the directions on the label, using the correct dose, storing medicines safely and consulting with a doctor if there are any questions.

Arguably, if pediatric cough and cold products are no longer available over the counter, parents may turn to other alternatives that may result in even more dangerous consequences for children. The industry is undertaking a comprehensive and scientifically rigorous efficacy and safety program for children age 2 to 12 in order to advance the science and ensure the highest level of scientific rigor. This program includes pharmacokinetic studies to confirm the dosing for the eight most commonly used OTC oral cough and cold ingredients. Once these dosing studies are finalized, they will begin other studies to revalidate the effectiveness of these medicines.

In reaction to the public hearing, FDA did not call for an immediate ban on over-the-counter cough and cold medicines for young children. John Jenkins, director of the FDA's Office of New Drugs, said the agency will propose changing its rules which could further restrict use of the products in children.

In response to the issues, following the hearing, makers of OTC cold and cough drugs announced they would start adding warnings against use in children younger than 4 years. That is, the leading manufacturers of these medicines are voluntarily transitioning the labeling on oral OTC pediatric cough and cold medicines to state “do not use” in children under four years of age.  (The risk of overdose is greatest in 2- and 3-year-olds, according to the Consumer Healthcare Products Association.) Pediatric antihistamines will also carry new labels telling parents not to use the medicines to sedate children of any age. The move comes out of an abundance of caution in an effort to promote the safe and effective use of these medicines.  FDA was quoted as being in support of these voluntary actions by CHPA, in part because the rulemaking process can take significant time.

CPSC Holds Public Meeting On New Legislation

The Consumer Product Safety Commission held a public meeting last week to discuss issues of testing and certification under the Consumer Product Safety Improvement Act (CPSIA). The meeting followed up on a September meeting regarding the accreditation of laboratories for third-party testing.

Readers of MassTortDefense will recall from other posts that the legislation increased CPSC budget, staff, and enforcement powers. The law mandates reduction of the amount of lead in toys; calls for third-party testing of certain children's products; raises allowable penalties for violations. And the Act has a number of potentially vexatious provisions for product sellers, including a broad protection of so-called employee whistleblowers. Such employees falling under the Act can seek to get their job back temporarily, and then after a hearing, permanently, with back pay, attorney fees, expert witness fees, and undefined compensatory damages. The former employee apparently needs to show that one, but not the only, reason for the firing was probably that the worker was or was about to start complaining about a product safety issue. It may be that prudent sellers will want train their management teams about the new provisions.

A second controversial provision was the move that state attorneys general can now take enforcement actions and seek the penalties that the commission could have. The aggressive approach of the National Association of Attorneys General (NAAG) members in the past may suggest that prudent national manufacturers who learn of a potentially substantial product safety situation will be better off negotiating a settlement with the federal agency rather than have the issue battled out in multiple state courts.

Third, the Act’s emphasis on independent lab certification of various products has caused some larger companies that have their own testing laboratories to consider divesting in-house laboratories.

At the meeting, participants discussed the requirement for certification of general conformity with all applicable requirements under any of the Acts administered by the CPSC, which becomes effective in November of this year. In response to questions on what the certificates should look like, CPSC plans to post a sample certificate on its Web site.

Officials of the CPSC assured attendees they are not out to play "gotcha" with manufacturers and importers, but the agency wants to ensure full compliance with the product certification requirements of the new law. There are significant penalties for noncompliance, including the destruction of imported goods that are not certified. When a product is imported, the foreign manufacturer and the importer both must certify that the product complies with all requirements, unless the commission exempts one or the other. Certification is required for products that are subject to a standard or ban, and are imported into the United States for consumption or warehousing. The Act provides that if there is no certificate, or a false certificate is furnished, the products will be refused entry. If the products are refused admittance into the United States, they may be destroyed, and the costs of destroying the products will be paid by the owner or consignee.

CPSC Acting Chairman Nancy A. Nord has agreed that the new law is "incredibly complex," and the agency will have to undertake about 40 new rulemakings to flesh out its provisions.  Among the likely forthcoming rules that will require certification are lead content, infant and toddler products, toys, phthalate, ATVs, drain covers for pools, and others.

State Supreme Court Upholds Verdict For Chemical Defendant In PCB Case

The Pennsylvania Supreme Court last week affirmed a jury's finding that a manufacturer of chemical-containing building materials was not liable for contaminating a building with polychlorinated biphenyls (PCBs) because the alleged pollutants were spread by fire and not by any intended use of the materials. See Commonwealth of Pennsylvania v. U.S. Mineral Products Co., 2008 WL 4368569 (Pa., September 26, 2008).

The case was a product liability action arising out of alleged chemical contamination at the former Transportation and Safety Building in the Capitol Complex in Harrisburg, PA, following a fire. Plaintiff had initially secured a $90 million verdict at the conclusion of a lengthy jury trial, a decision reversed, in part, because an erroneous jury charge as to whether PCBs were distributed to surfaces throughout the T & S Building in the ordinary use of PCB-containing products, or whether the chemical was spread in smoke and soot during the severe fire. The court ruled that strict liability is available only for harm that occurs in connection with a product's intended use by an intended user, and that the incineration of building materials is not an intended use.

The second trial culminated in a defense verdict, upon a jury finding that Monsanto's product was not defective. Appeal ensued.

The court reaffirmed its ruling on strict liability and intended use. At the second trial there was substantial evidence to the effect that the PCBs found on surfaces within the T & S Building were not from the intended use of the building materials, but were spread by smoke and soot during the fire. For example, tests commissioned by defendant’s expert on pre-fire building materials showed only nominal PCB bulk-sample levels (measured in parts per million) that were many times lower than those found in similar building materials after the fire; Monsanto also offered evidence contradicting appellants' experts' theories of dissemination through ductwork operation and fabrication.

Based on this and other items of Monsanto's evidence, the jurors reasonably may have concluded that it was the fire, and not any intended use of PCBs, that was the vehicle by which PCBs were distributed to surfaces throughout the Building.

On a second issue, plaintiff below challenged the admission of evidence of its own conduct with respect to the building before the fire. Although evidence of negligence has no place in strict liability actions, Kimco Development Corp. v. Michael D.'s Carpet Outlets, 536 Pa. 1, 7-9, 637 A.2d 603, 608 (1993), evidence which is inadmissible for one purpose may be admissible for another. In this regard, the court determined that the contested evidence was relevant primarily to rebut appellants' damage claims. According to the court, the evidence of lack of a sprinkler system and other safety features was admitted to show the condition of the Building prior to the 1994 fire and detection of PCBs. The trial court had discretion to admit evidence of a lack of fire-safety features as relevant to market value.

Defense verdict affirmed.

Federal Court Denies Certification of PFOA Medical Monitoring Class

A federal court in West Virginia has denied class certification in a claim brought against DuPont for the alleged release of perfluoroctanoic acid, a substance also known as PFOA or C-8, from its Washington Works plant in Wood County, West Virginia, into drinking water. See Rhodes v. E.I. DuPont De Nemours and Co., 2008 WL 4414720 (S.D. W.Va., September 30, 2008). According to the court, plaintiffs had presented sufficient evidence that exposure to C-8 may be harmful to human health, but what “the plaintiffs misunderstand, however, is what they must show in order for me to certify the class. I cannot certify a class based on some potential harm to the general public, rather, there must be specific injuries to each member of the proposed class. The fact that a public health risk may exist … does not show the common individual injuries needed to certify a class action.”

The court viewed the plaintiffs as seeking primarily injunctive or declaratory relief in the form of a court-supervised medical monitoring program. While the likelihood of the plaintiffs' success on the merits is not relevant, the court must still engage in “rigorous analysis” to determine whether the proposed class meets the Rule 23 requirements. Gen. Tel. Co. v. Falcon, 457 U.S. 147, 161 (1982). A court may “probe behind the pleadings” to determine whether class certification is appropriate. Id.

A proposed class must be “cohesive” to be certified under Rule 23(b)(2). See Barnes v. Am. Tobacco Co., 161 F.3d 127,143 (3d. Cir.1998). This is particularly so because in a (b)(2) action, unnamed members are bound by the action without the opportunity to opt out. Barnes, 161 F.3d at 142-43. The cohesiveness requirement is similar to but “more stringent” than the commonality requirement of Rule 23(a). See Lienhart v. Dryvit Syst., Inc., 255 F.3d 138,147 n. 4 (4th Cir.2001); Barnes, 161 F.3d at 142-43.

Under West Virgina law, medical monitoring plaintiffs must first show a significant exposure. In a class action, if significant exposure is not a common issue, cohesiveness will be lacking. Exposure is significant if a plaintiff has been exposed to a larger quantity of the toxic substance or has been exposed for a longer duration than the general population. Thus, a plaintiff must be able to demonstrate that his exposure was somehow greater than what would normally be encountered by a person in everyday life.

Here, while the plaintiffs had evidence of the levels of chemical released, that evidence told the court nothing about how the plaintiffs’ C-8 exposure level compares to the level of C-8 exposure experienced by the general population. Evidence of the elevated C-8 concentrations in the named plaintiffs' blood likewise fails to show common exposure on a class-wide basis. The evidence of the higher C-8 concentration in the named plaintiffs' blood as compared to the general population suggests only that the named plaintiffs have possibly been “significantly exposed.”  Plaintiffs’ expert testimony did not provide a relevant comparison between the plaintiffs' exposure and the exposure of the general population. On this record, the general population's level of exposure to C-8 in their drinking water was unknown.

Under the second pertinent element of the medical monitoring cause of action, a plaintiff must demonstrate that her or she has suffered a significantly increased risk of contracting a particular disease relative to what would be the case in the absence of exposure. Furthermore, a plaintiff must also show that the exposure caused by the defendant was the proximate cause of that increased risk. In other words, the risk must be different and greater than it would have been absent the significant exposure at issue. Common proof of this element is always complicated because the plaintiffs must not only show that the class members have experienced a significantly increased risk but also that: 1) the risk is of a serious latent disease, 2) the defendant proximately caused that risk to each class member, and 3) the risk is significant relative to what it would have been absent the exposure.

The court agreed with DuPont’s argument that the plaintiffs could not show an increased risk of disease with class-wide proof because each class member's risk of disease will vary based upon: (a) variations in C-8 exposure and dose, and (b) variations in an individual's background risk of disease absent C-8 exposure. Plaintiffs had to concede that individual characteristics and habits will affect the level of risk experienced by each class member.

In a useful analysis, the court also explained why a regulatory risk assessment cannot and does not support an opinion that each individual class member had experienced a significantly increased risk of disease. In fact, a risk assessment is of limited utility in a toxic tort case, especially for the issue of causation, because of the risk assessment's distinct purpose. Risk assessments have largely been developed for regulatory purposes and thus serve a protection function in providing a level below which there is no appreciable risk to the general population. They do not provide information about actual risk or causation. See Bernard D. Goldstein & Mary Sue Henifin, Reference Guide on Toxicology in Federal Judicial Center Reference Manual on Scientific Evidence 413 (2d ed. 2000). Because of their appropriately prudent assumptions when there are limited data, risk assessments intentionally encompass the upper range of possible risks. Id.; see also Sutera v. Perrier Group of Am. Inc., 986 F.Supp. 655, 664 (D.Mass.1997) (rejecting regulatory standards as a measure of causation because the purpose of regulatory standards is to reduce public exposure to harmful substances); Allen v. Pa. Eng'g Corp., 102 F.3d 194, 198 (5th Cir.1996)); O'Neal v. Dep't of the Army, 852 F.Supp. 327, 333 (M.D.Pa.1994) (determining that risk figures based on the EPA's upper-bound estimates for another chemical are appropriate for regulatory purposes in which the goal is to be particularly cautious but overstate the actual risk and so, are inappropriate for use in determining whether medical monitoring should be instituted.).

Because a risk assessment overstates the risk to a population to achieve its protective and generalized goals, it is impossible to conclude with reasonable certainty that any one person exposed to a substance above the criterion established by the risk assessment has suffered a significantly increased risk. Precautionary measures to keep the general population safer are fundamentally distinct from the medical monitoring cause of action which provides relief to individuals that have already been “injured.”

Finally, on the element of need for medical monitoring, the court again found an absence of cohesion because if the individual nature of the inquiry. Plaintiffs’ expert seemed to assume that a member of the proposed medical monitoring class can have the determination of their particular and individualized diagnostic needs deferred until after the implementation of the medical monitoring protocol. While the proposed medical monitoring program was to be set up based on the “common” exposure, the implementation would be individualized. But while individualized implementation may be standard in public health monitoring programs, the tort of medical monitoring requires that determination to occur prior to a finding of liability. Plaintiffs were thus recommending a public health medical monitoring program rather than medical monitoring addressing tortious injuries to individuals. Plaintiffs thus merely deferred the individual issues that meant the class was not cohesive.

Nano-Technology Conference Held In Europe

At a recent nano-technology conference in Switzerland, officials from the U.S. and the U.K. reported mixed experiences with voluntary reporting schemes for the production and use of nanoscale materials. The event was NanoEurope 2008, an international specialist nanotechnology congress which attracted more than 3000 people from 22 countries. Experts from major industry segments such as Life Science, Energy, Automotive, Electronics and Textiles spoke about the latest developments in the field of material functions and processes and already established products. Also on the agenda was a Nano Regulation Conference.

Nanotechnologies are hailed by many as the next industrial revolution. They promise to change everything from the cars we drive to the clothes we wear, from the medical treatments our doctors can offer to our energy sources and workplaces. Although focused on very small particles, nanotechnologies offer large potential benefits. From new cancer therapies to pollution-eating compounds, from more durable consumer products to detectors for bio-hazards like anthrax, from novel foods to more efficient solar cells, nanotechnologies are changing the way people think about the future.Nanotechnology is unfolding enormous innovation opportunities, but also poses potential risks for humans and the environment. MassTortDefense has posted on this here and here.

In the recent past, a variety of voluntary measures such as risk management systems, codes of conduct, or disclosure agreements have emerged. The conference offered an overview of different aspects of and experiences with voluntary measures. Speakers noted variations in the quality of the reports submitted, low participation rates, and concerns about the protection of confidential business information.

For example, James Alwood, program officer in the U.S. Environmental Protection Agency's Office of Pollution Prevention and Toxics' Chemical Control Division, noted that the initial experience with EPA's Nanoscale Materials Stewardship Program (NMSP) has been positive, although the quality of the responses received has been mixed.

EPA is developing the Nanoscale Materials Stewardship Program to complement and support its new and existing chemical efforts on nanoscale materials. The program is intended to:

• Help the Agency assemble existing data and information from manufacturers and processors of existing chemical nanoscale materials;
• Identify and encourage use of risk management practices in developing and commercializing nanoscale materials; and
• Encourage the development of test data needed to provide a firmer scientific foundation for future work and regulatory/policy decisions.
• Encourage responsible development.

A total of 22 organizations have participated in the NMSP to date, submitting information on more than 93 nanomaterials. But EPA still needs better data to make decisions on basic issues such as the definition of nanostructure material. An interim report is due early 2009.

Steven Morgan, nanotechnologies policy advisor with the U.K. Department for Environment, Food, and Rural Affairs, described the Voluntary Reporting Scheme (VRS) for Engineered Nanoscale Materials established in the UK. Launched in September 2006, the scheme has resulted in 12 submissions to date, out of an estimated 35 British commercial businesses and 55 research institutes involved in nanotechnology. Business confidentiality remains an issue, particularly with a such a hot new technology. U.K. authorities apparently are already looking to bring the nanotechnology sector within the EU’s REACH regulations ("registration, evaluation, and authorization of chemicals") by 2012.

Third Circuit Rejects Vaccine Plaintiffs' General Causation Expert Opinion

The Third Circuit recently upheld a judgment for the U.S. following a bench trial, in a suit by a couple who alleged that contaminated polio vaccine caused the husband's brain cancer. Gannon v. United States, 2008 WL 4151665 (3d Cir. 2008).

Plaintiffs alleged that an oral polio vaccine (OPV) received between 1973 and 1976 was contaminated with SV40, a simian virus found in both monkeys and humans. The Gannons claimed that the government was negligent in failing to prevent the manufacturer from making the OPV available to the public, and as a result, the contaminated vaccine caused Mr. Gannon to develop a form of brain cancer. Gannon and his wife filed an administrative claim against the government under the Federal Tort Claims Act and, later, a suit in the Eastern District of Pennsylvania.

The Court, for the convenience of the witnesses and to prevent recalling the experts later in the trial, decided to combine a Daubert hearing with the expert bench trial testimony on the issue of causation. Thus, the trial began with the Daubert examination of plaintiffs' expert, Dr. Adi Gazdar, who presented his full testimony on the issue of causation. He testified that SV40 plays a causal role in this type of cancer.

The district court denied the Daubert motion, but rejected the testimony as insufficient on the issue of general causation.  Safe approach in a bench trial, here it and then decide. The ruling came pursuant to Rule 52(c), which states that a trial court can enter judgment after hearing evidence on only one issue, provided the party against whom judgment has been entered is fully heard. (The appeals court rejected the plaintiffs' argument that they were not fully heard on causation: The plaintiffs asserted they would have called two other witnesses to testify, but those witnesses were not relevant to causation because their testimony would principally address the issue of contamination.) Interestingly, the United States did not offer an alternate source of causation but merely asserted that SV40 did not cause brain tumors and offered expert testimony to that effect.

Although Dr. Gazdar testified that it was his opinion that to a reasonable degree of medical certainty SV40 plays a causal role in the formation of medulloblastomas, the Court decided that the plaintiffs had not met their burden of proof on causation. Specifically, the Court found that Dr. Gazdar's testimony failed to satisfy the “Bradford Hill” criteria. The Bradford Hill criteria are broadly accepted criteria for evaluating general causation based on epidemiology;  they are: (1) Strength of Association, (2) Consistency, (3) Specificity, (4) Temporality, (5) Biologic Gradient, (6) Plausibility, (7) Coherence, (8) Experimental Evidence, and (9) Analogy.

On appeal, the Third Circuit observed that causation is an essential part of the plaintiffs' negligence claim. Based upon its thorough consideration of the record evidence, the Third Circuit could not say that the district court clearly erred in its findings of fact or that it erred in concluding that the Gannons had not met their burden of proof on the issue of causation.

  • The Court relied upon the fact that all three defense experts used established scientific frameworks and cited both biological and epidemiological evidence. Each of those experts opined that the evidence did not support the conclusion that SV40 causes human cancer.
  • The Court relied upon a 2003 Institute of Medicine report, which concluded that “ ‘the evidence is inadequate to accept or reject a causal relationship’ “ between SV40 and cancer.
  • Dr. Gazdar, the plaintiffs' expert, testified that he agreed that current epidemiological evidence does not support the conclusion that SV40 causes brain cancer.
  • He relied upon testing on rodents, which defense experts stated were not a good brain model for humans; even Dr. Gazdar admitted the results could not necessarily be extrapolated to humans.

Most importantly, the court considered each of the nine Bradford Hill criteria for causation and found that Dr. Gazdar's opinion did not meet the criteria.  The general causation opinion was thus rejected on the merits.

Discovery Battles Continue In Zyprexa MDL

Two interesting developments in the ongoing discovery battles in the Zyprexa MDL, which involves claims by several states and health entities alleging that defendant Eli Lilly made misleading statements about the medication. The states allege that they would not have funded Medicaid patients taking Zyprexa had they known about the risks of the drug...But don't seem eager to prove it.

First, the magistrate judge denied defendant’s motion for sanctions against Montana, New Mexico, Louisiana, and Mississippi, but ordered the states that have not yet produced their complete Medicaid databases as requested to do so on pain of sanctions.

Second, the court ordered the states to produce non-party medical records requested by Lilly. The defendant, not surprisingly, wanted to be able to compare the records of other antipsychotic medications in the relevant periods. As the court said, "the records are in fact relevant to Lilly’s defenses. For example, as Lilly notes, the use of a statistically significant sample of Medicaid patient records can help to explain information obtained from Medicaid databases, and may provide information on potential confounding variables."

The states argued that their respective physician-patient privilege laws prohibited discovery of the patient medical records. It is axiomatic that state privilege laws do not govern in federal question cases. Although several of the plaintiff states did not allege violations of federal law in their
complaints, and each has vigorously challenged the basis for federal jurisdiction, Judge
Weinstein has held that jurisdiction lies under federal law. 

The court also felt that the states’ doctor-patient privilege argument was not well taken, because the order was for the production of de-identified medical records with patient names redacted. Federal statutes and regulations make clear that de-identified health information is discoverable in litigation in federal court, with or without patient consent, and it appears that the states’
respective privilege laws would not apply to de-identified information either.

The court also denied the states' request that Lilly subpoena the records, as a step that would needlessly prolong discovery.  Significantly, Lilly does not know the identities of the patients whose medical records it seeks. Moreover, the states are in a better position to ensure that the medical records produced are a randomly selected, statistically significant sample. If Lilly were constrained to subpoena the medical records, it would likely target only certain records, which would inevitably lead to protracted argument over whether the records subpoenaed represent a statistically significant sample, said the court.

MassTortDefense has posted on this litigation before. It continues to be an excellent example of the type of attenuated and indirect injury claim that requires in-depth and detailed discovery to defend. Also an example of plaintiffs who are more willing to assert complex damages theories than to provide the evidence to test those claims.

Ninth Circuit Rejects Claim for Subcellular Damage Under Radiation Exposure Law

Mere damage to cells or DNA does not constitute a "bodily injury" under the federal law governing nuclear radiation exposure, according to the Ninth Circuit. Dumontier v. Schlumberger Technology Corp., 2008 WL 4166406 (9th Cir. September 11, 2008).

The issue of subcellular damage is one aspect of how advances in medical science, particularly our understanding of the mechanism of disease, can impact and even potentially render obsolete long-standing legal notions. The idea that subcellular damage can be detected and may constitute a legally cognizable injury can impact triggering of the statute of limitations, the two-injury rule, medical monitoring and other inchoate torts.

The issue was whether subcellular damage amounts to bodily injury under the Price-Anderson Act. Plaintiffs were allegedly exposed to cesium-137 on a drilling rig. Though less well known than uranium or plutonium, cesium isn't a substance to be toyed with. Plaintiffs have not developed cancer or any other illness. Nevertheless they sued Schlumberger, claiming that the radiation caused subcellular damage, including to their DNA. The Ninth Circuit disagreed with the Sixth, which relies on state law to interpret bodily injury under this Act. The Act doesn't call for the federal court to apply state law in its interpretation; only for “the substantive rules for decision” -i.e., the available causes of action, according to the Ninth. The Act prohibits recovery when plaintiffs haven't suffered “bodily injury, sickness, disease, or death” -even when the state cause of action doesn't have that limitation.

Plaintiffs argued that the slightest exposure to radiation damages cells by denaturing proteins and modifying DNA. But, said the court, not every alteration of the body is an injury. The process of thinking causes synapses to fire and the brain to experience tiny electric shocks; fear stimulates the production of chemicals associated with the fight-or-flight response. All life is about change, but all change is not injurious. Adopting plaintiffs' interpretation of bodily injury would render the term surplusage, as every exposure to radiation would perforce cause injury.

Plaintiffs also argued that exposure to radiation surely causes bodily injury if it exceeds the federal dose limit for members of the public. But the various limits in NRC regulations have been set at a level which is conservatively arrived at by incorporating a significant safety factor. Thus, a discharge or dispersal which exceeds the limits in NRC regulations, although possible cause for concern, is not one which would be expected to automatically cause substantial injury or damage unless it exceeds by some significant multiple the appropriate regulatory limit. X-ray technicians, for example, are routinely exposed to more radiation than the public dose limit allows.

The Ninth Circuit also pointed out the difficulty in assessing damages for mere subcellular impact. Plaintiffs’ “reading would make exceeding the federal dose limit a strict liability offense, with damages determined by the extent of emotional distress. The Act would cease to be a liability limit and become an unlocked cash register.” Id. at *2.