Update on Proposed Amendment to Federal Rules on Expert Discovery

Experts play a vital role in mass tort defense.  Selection, preparation, and discovery of experts are crucial pre-trial tasks of the defense attorney.  Thus, the rules of civil procedure governing those tasks really matter.

The end of the time period for public comment on proposed changes to Federal Rule of Civil Procedure 26 is rapidly approaching. The formal process to amend the rule governing expert discovery began in early 2008 when the Advisory Committee on civil rules met to consider rule changes recommended by the American Bar Association. After drafting a proposed rule, the committee published the changes for public comment. Written comments are due by February 17, 2009.  There will be a final public Judicial Conference hearing in San Francisco, California, on February 2, 2009.  Guidelines for submitting comments can be found here.

After the comment period ends in February, the advisory committee is expected to consider comments and, if needed, redraft the rule.  Under the Rules Enabling Act, the rule will then be forwarded to the Standing Committee on Rules of Practice and Procedure, which must consider the changes. The standing committee would review the rule at a meeting planned for June, and submit it to the Judicial Conference for consideration at its September session. The proposed changes could go to the U.S. Supreme Court in time for the October session. Assuming this timeline holds up, the Supreme Court must act on the changes by May, 2010. The final step will require consideration by Congress, which will have seven months to act on the proposal. By statute, non-action would allow the rule changes to take effect early as December, 2010.

But the first deadline is the looming end to the public comment period.

What would the rule do?

The key changes extend work-product protection to drafts of Rule 26(a)(2)(B) expert reports and 26(a)(2)(C) party disclosures, and also to certain attorney-expert communications. The proposed amendments are designed to reflect what the Standing Committee calls the “lessons of experience” as opposed to theory, and to provide useful discovery while reducing practices that now impede the best use of expert trial witnesses.

Under the proposal, Rule 26(b)(4) would be amended to extend work-product protection to drafts of expert reports, drafts of party disclosures, and communications between expert witnesses and counsel. Exceptions are carved out for discovery of compensation, identification of facts or data the attorney provided to the expert and that the expert considered in forming the opinions to be expressed; and any assumptions that the attorney provided to the expert and that the expert relied upon in forming opinions.

Some courts have interpreted the Advisory Committee note on existing Rule 26(a)(2)(B) to allow parties to inquire into all communications between experts and counsel, multiplying expenses with little benefit to the parties, and impeding the way cases are actually prepared for trial. This approach has also contributed to the practice of retaining two experts, one to testify and the other to consult. Many lawyers will stipulate out of discovery of draft reports and attorney-expert communication because the costs of such discovery seem higher than the infrequent, small benefits that may be gained. The changes thus are needed to create efficiencies and to reduce litigation costs.

Some academics and the plaintiffs’ bar argue, however, that any restriction on inquiry into the expert's relationship with retaining counsel is a bad idea. Some have even started a letter-writing campaign opposing the proposed amendments. Comments from DRI, on the other hand, suggest that the protections should extend to communications between attorneys and the expert's staff as well.

Fifth Circuit Affirms Summary Judgment: Exposure and Risk Are Not Injury

The Fifth Circuit has affirmed a trial court decision that a group of space center workers in Mississippi cannot pursue personal injury claims for their alleged exposure to beryllium-containing products because they could not show any “compensable injury.” Paz v. Brush Engineered Materials Inc., 2009 WL 73874 (5th Cir. 2009).

Pursuant to Mississippi law, claims of negligence, products liability, and breach of warranty all require an identifiable injury. Plaintiffs alleged that they had beryllium sensitization (BeS), i.e., an increased sensitivity to the potentially toxic substance. According to their expert, BeS is by definition the demonstration of an abnormal immune response to beryllium, usually, though not always based on an abnormal challenge test.

The issue was whether the BeS was a compensable injury pursuant to Mississippi law. The employees argued BeS is a present injury and “the beginning of an actual disease process,” specifically the beginning stage of Chronic Beryllium Disease;  therefore there is a reasonable probability of future consequences from BeS. Plaintiff experts’ published work, however, stated that “BeS precedes the formation of … clinical illness.”  And it indicates that individuals with BeS exhibit evidence of an immune response to beryllium but have no evidence of lung pathology or impairment. Further, there was no dispute that the rate of progression from BeS to CBD is unknown to any degree of reasonable medical certainty.

The expert evidence from both sides clearly established that excessive exposure to beryllium provokes a physical change in the body, causing BeS. The quintessential issue, said the 5th Circuit, is whether any or every physiologic change in the body rises to the level of compensable injury pursuant to Mississippi law. The federal court found guidance in the state court’s recent decision in this same case on medical monitoring, which we have mentioned before. In answering the 5th Circuit's certified question, the Mississippi Supreme Court stated “a claim for medical monitoring, as Plaintiffs present it, lacks an injury.” 949 So.2d at 3. The Mississippi Supreme Court concluded that because “Mississippi requires the traditional elements of proof in a tort action, it has refused to recognize a category of potential illness actions.” The Mississippi Supreme Court noted “[n]one of the plaintiffs ha[d] suffered physical injury from the alleged exposure.” Pursuant to Mississippi law, “exposure” is “a claim for harm which is not compensable under Mississippi law.”

The sub-clinical and sub-cellular changes, which none of the parties disputed, are akin to what the Mississippi Supreme Court refused to recognize as physical injuries. Thus, the logical conclusion is BeS is not a compensable injury pursuant to Mississippi law. This seems to be the Mississippi Supreme Court's “line in the sand" for a plaintiff's legally protected interest.  Summary judgment affirmed.

While states vary on the point, this is an important issue: as medical technology advances, the ability to show some sub-clinical or sub-cellular impact on the body becomes increasingly common.  Will every such change, what traditionally has been seen as mere exposure lacking sufficient impact, impairment, symptom, be an injury?  Plaintiffs may like to think so in some cases, but won't the single injury rule and statute of limitations bite them in others?

Supreme Court Denies Cert In Nationwide Class Despite Absence of Choice Of Law Analysis

The U.S. Supreme Court has denied General Motor's cert petition seeking review of the Arkansas Supreme Court's affirmation of a nationwide class of owners of pickup trucks and sports utility vehicles with allegedly defectively designed parking brakes. General. Motors Corp. v. Bryant, U.S., No. 08-349, certiorari denied 1/12/09.

GM filed the petition after the Arkansas Supreme Court ruled, in June, 2008, that an Arkansas circuit court was not required to conduct a choice-of-law analysis before certifying a multi-state class action.

Last June, we called this a “disturbing” opinion. General Motors had noted that the significant variations among the fifty-one pertinent product defect laws should defeat predominance. [Most courts have accepted this notion.] But the trial court provided four reasons for its finding that the potential application of multiple states’ law did not create predominance concerns. First, the court noted that, unlike the federal rule which requires a rigorous analysis of class certification factors including the impact state law variations may have on predominance, no such rigorous analysis is required in Arkansas. Second, the potential application of many states’ laws was not germane to class certification, but was instead a task for the trial court to undertake later in the course of exercising its autonomy and substantial powers to manage the class action. Third, the trial court found that assessing choice of law was a merits-intensive determination and thus inappropriate at the certification stage. “It would be premature for the Court, at this stage in the case, to make the call on choice of law.” Fourth, if application of multiple states’ laws was eventually required, and it proved too cumbersome or problematic, the circuit court could always consider decertifying the class. The state supreme court agreed.

MassTortDefense would suggest that most courts and commentators do not equate a choice of law analysis with an impermissible examination of the merits of the plaintiffs’ claims. Choice of law is a threshold question that ultimately permits a court to reach the merits of the dispute by establishing the governing legal rules. The selection of the proper law cannot fairly be termed a “merits-intensive determination.”  Moreover, the trial court need not make any determination about the merits of the causes of actions alleged in order to assess, based on relevant contacts, which state’s law ought to apply to those claims. Nor does the trial court even have to “make the final call” on what law will apply to each and every claim by every class member. It is sufficient for class certification for the trial court to discover that the law of many other states will likely have to be applied to many class members’ claims, and factor that into superiority and manageability of the proposed class.

The repeated references to the trial court’s ability to later decertify the class smacks of the improper, rejected, concept of conditional certification – a practice that has been soundly rejected in recent years by state and federal courts and is now prohibited under both the Arkansas Rules of Civil Procedure and the federal rules on which they are modeled. After considerable time and effort is expended, courts are reluctant to decertify. Here, for example, GM presented the court with a thorough analysis of conflicts of laws regarding the state-law fraud claims, breach of warranty, applicable statutes of limitations, and unjust enrichment. It seems unlikely that the trial court (after its certification was affirmed) will ever seriously revisit this issue in the context of a new predominance determination. If the Arkansas court’s approach were correct, class certification would be a meaningless exercise since courts would not address the most difficult and important class certification-related questions – i.e., whether a class trial is fair or feasible – until long after certification. 

Perhaps it is not surprising that the Supreme Court would decline to weigh in on a state procedural law issue, particularly one billed by respondents as a preliminary determination, but a shame that resources will be wasted on a clearly inappropriate class action.  And let's not forget the "blackmail settlement" pressure that these types of cases create.  Castano v. American Tobacco Co., 84 F.3d 734, 746 (5th Cir. 1996); In re Rhone-Poulenc Rorer, Inc., 51 F.3d 1293, 1298-99 (7th Cir.1995); Bruce L. Hay & David Rosenberg, “ ‘Sweetheart’ and ‘Blackmail’ Settlements in Class Actions,” 75 Notre Dame L.Rev. 1377, 1389-92 (2000).

China Melamine Update

Readers of MassTortDefense have been following the issues surrounding the dairy product contamination scandal in China, which we have posted on before.

Two recent developments: The families of 213 children who were sickened by tainted infant formula and milk have now filed a class-action lawsuit with China's highest court, seeking damages from 22 dairy producers. Class actions are rare in China; this one seeks damages mainly for parents whose children were made ill by melamine-laden dairy products, but who were offered what they saw as inadequate compensation by dairy companies. Under that plan, most received $292, while wrongful death cases were offered $29,200. Plaintiffs assert that the lower amounts were not enough to cover what they paid for doctors, medicines and other expenses.

According to the Chinese Health Ministry, nearly 300,000 children were made ill by tainted milk and at least six died. Melamine was reportedly added to milk products to fool protein-content tests.
In order for the class suit to proceed, the China Supreme Court must first agree to hear the case. Court filings in China must be accepted by the courts before they are considered on the merits.

On the criminal side, media reports are that 12 dairy officials were found guilty of charges related to the melamine issue; 2 were sentenced to death, and the highest ranking official was sentenced to life in prison as part of a plea bargain deal. Prosecutors showed that officials at the companies involved learned of the problem in 2007 but did not recall any products until September, 2008. 

In its latest update, FDA notes that there is no known threat of contamination in infant formula manufactured by companies that have met the requirements to sell such products in the United States.  In addition, the FDA -– in conjunction with state and local officials – continues to check Asian markets for food items that are imported from China and that could contain a significant amount of milk or milk proteins.

The FDA has broadened its domestic and import sampling and testing of milk-derived ingredients and finished food products containing milk or milk-derived ingredients from Chinese sources. FDA has recommended that consumers not consume certain products because of possible contamination with melamine.


GAO Adds To Critiques of FDA

The Government Accountability Office issued a report last week that listed the FDA as a "high-risk" area of the federal government. The GAO said the U.S. Food and Drug Administration was being hampered by globalization, more complex products, and laws that have made it more difficult for the FDA to ensure the safety of pharmaceuticals, biologic drugs, and medical devices. GAO says its work examining a variety of issues at FDA echoes the conclusions reached by others (think IOM) that the agency is facing significant challenges that compromise its ability to protect Americans from unsafe and ineffective products. FDA needs to, among other things, improve the data it uses to manage the foreign drug inspection program, conduct more inspections of foreign establishments, systematically prioritize and track promotional materials for review, and adopt management tools to ensure that drug sponsors comply with regulations on the presentation of clinical trial results.

The perception of the FDA and its ability to do an effective job is a crucial underlying feature in product liability litigation involving regulated drugs, devices, and food products. Jurors’ perceptions of the agency can affect a myriad of issues and themes the defense may wish to present.

Meanwhile, the Pharmaceutical Research and Manufacturers of America (PhRMA) asserts that the issue is a need for more resources for the FDA, to keep drugs safe. The agency “is being asked to do more than it can do” with current resources, the trade group says. Specifically, FDA needs more resources to conduct foreign inspections so the drug supply can be kept safe. PhRMA also said that FDA needs more resources to modernize because, for example, the agency still looks at clinical trial information on paper.

FDA Reports on Salmonella Outbreak

The FDA has reported on its investigation into the source of the recent Salmonella Typhimurium outbreak. At this time, the FDA and the Centers for Disease Control and Prevention (CDC) say they have traced sources of Salmonella Typhimurium contamination to a plant owned by Peanut Corporation of America (PCA), which manufactures peanut butter and peanut paste—a concentrated product consisting of ground, roasted peanuts—that are both distributed to food manufacturers to be used as an ingredient in many commercially produced products including cakes, cookies, crackers, candies, cereal and ice cream. In addition, PCA peanut butter is reportedly distributed to and institutionally served in such settings as long-term care facilities and cafeterias.

The FDA has notified PCA that product samples originating from its Blakely, Georgia processing plant have been tested and found positive for Salmonella by laboratories in the states of Minnesota and Connecticut. Connecticut and Minnesota have reported to FDA that samples of King Nut peanut butter tested in those states are a genetic match to the strain of Salmonella associated with the nationwide outbreak of Salmonella Typhimurium. The results from the Connecticut Department of Health Laboratory are from an unopened container of King Nut peanut butter.

On January 18, PCA expanded its previous voluntary recall to include more products and lot numbers relating to peanut butter and peanut paste products manufactured on or after July 1, 2008, at its plant because of potential Salmonella contamination. The peanut butter products being recalled are sold by PCA in bulk containers ranging in size from five (5) to 1700 pounds. The peanut paste is sold in sizes ranging from 35-pound containers to product sold by the tanker container. These products are not sold directly to consumers. PCA has stopped all production at its Blakely, Ga. plant as the FDA continues its investigation.

At least 85 companies bought peanut butter and peanut paste produced in the Georgia plant. More than 125 products including cookies, crackers, ice cream and even some pet food have been recalled in connection with the outbreak. Six deaths may be associated with the outbreak, the U.S. Centers for Disease Control and Prevention has said. The CDC said at least 486 people from 43 states and one person in Canada have been reported ill from the outbreak of the Salmonella typhimurium strain, with 107 of them being hospitalized. Salmonella can cause abdominal cramping, diarrhea and fever. 

Litigation has ensued, with at least one products liability suit in the Middle District of Georgia.


Ohio Appeals Court Affirms Retroactive Application Of Asbestos Reform Act

Asbestos plaintiffs in Ohio continue to have to adjust to the provisions of Ohio’s asbestos reform legislation. In Neal v. A-Best Products Co., et al., 2008 WL 5423494 (Ohio App. 2 Dist.), the appellate court recently rejected the plaintiffs’ latest arguments that retroactive application of the statute was unconstitutional.

According to the state's General Assembly, Ohio had become a haven for asbestos claims and, as a result, is one of the top five state court venues for asbestos filings. At the time the legislation was being considered, Ohio had 35,000 pending cases, and dockets were increasing at an exponential rate. For example, between 1999 and 2003, the number of pending asbestos cases increased from 12,800 to 39,000, and 200 new asbestos cases were being filed in Cuyahoga County alone every month. In response, the General Assembly developed a system in which claimants must meet certain prima facie requirements in order to maintain tort actions that involve asbestos claims. For example, in a wrongful death case, plaintiff must make a prima-facie showing of a diagnosis by a competent medical authority that exposure to asbestos was a substantial contributing factor to the death of the exposed person. If the trial court finds that a claimant cannot meet this prima facie burden, the court must administratively dismiss the claim without prejudice.

Here, the appeals court concluded that the trial court was incorrect in finding that the statute cannot be retroactively applied to claims pending when the law was passed. Under the reasoning of  Ackison v. Anchor Packing Co., Slip Opinion No.2008-Ohio-5243, 2008 WL 4601676, these statutes do not impair substantive rights, and therefore do not run afoul of the prohibition against retroactive laws found in the Ohio Constitution. MassTortDefense discussed the Ackison case before.

Generally speaking, 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.

Interestingly, the appeals court, while noting it was bound to follow Ackison, repeatedly implicitly criticized the reasoning of the state supreme court and quoted the dissent.

FDA Issues Guidelines and Rule On Institutional Review Boards

FDA issued guidelines last week that identify which adverse events arising during clinical studies need to be reported to institutional review boards (IRBs) and that clarify the process for reporting unanticipated events. FDA also released a final rule requiring all U.S. IRBs that review FDA-regulated trials to register with FDA. Adverse events often become fodder for plaintiff attorneys in mass tort litigation concerning approved products, as plaintiffs attempt to argue that early risk “signals” were missed or downplayed-- as they employ the benefit of 20-20 hindsight.

FDA regulates clinical studies under sections 505(i) (drugs and biologics) and 520(g) (devices) of the Food, Drug, and Cosmetic Act. All such clinical studies must be reviewed and approved by an IRB before the study is initiated, in accordance with the requirements of 21 CFR part 50 (Protection of Human Subjects), part 56 (Institutional Review Boards), and either part 312 (Investigational New Drug Application) or part 812 (Investigational Device Exemptions) (see §§ 50.1, 56.101, 312.23(a)(1)(iv), 312.40(a), 812.2(b)(1)(ii), 812.2(c) and 812.62(a)).

After the initial review and approval of a clinical study, an IRB must conduct continuing review of the study at intervals appropriate to the degree of risk presented by the study, but at least annually. The primary purpose of both initial and continuing review of the study is to assure the protection of the rights and welfare of the human subjects. To fulfill its obligations during the conduct of a clinical study, an IRB must have, among other things, information concerning unanticipated problems involving risk to human subjects in the study, including adverse events that are considered unanticipated problems

This new guidance is intended to assist the research community in interpreting requirements for submitting reports of unanticipated problems, including certain adverse events reports, to the institutional review board. FDA developed this guidance in response to concerns raised by the IRB community, including concerns raised at a March, 2005 public hearing, that increasingly large volumes of individual adverse event reports submitted to IRBs—often lacking in context and detail—are inhibiting, rather than enhancing, the ability of IRBs to protect human subjects.


Current ABA Leader Wrong On Preemption

The president of the ABA recently wrote to leaders of the House and Senate to express his personal support for H.R. 6381, the so-called “Medical Device Safety Act” that was introduced in the 110th Congress. The letters urged Congress to reintroduce in 2009 this legislation, which is designed to overturn the Supreme Court’s decision in Riegel v. Medtronic that a product liability lawsuit filed against Medtronic in state court was pre-empted because the device had received approval from the FDA.

Among the inaccurate and misleading statements in the letters is the claim that the plea is “on behalf of the American Bar Association and its over 400,000 members.” In fact, MassTortDefense knows a number of members of the ABA who understand the appropriate role of the preemption doctrine, its constitutional basis, and the need for a national test balancing risks and benefits.

As the Supreme Court has noted, state tort law that requires a manufacturer’s catheters to be “safer” in the eyes of a lay jury may require them to be less effective than the model the FDA has approved. State court juries do not ask how many more lives will be saved by a device which, along with its greater effectiveness, brings a greater risk of harm. A jury sees only the cost of a more dangerous design, and is not concerned with its benefits; the patients who reaped those benefits are not represented in court. Why is it that the understandable solicitude for those few injured by FDA-approved devices must necessarily overcome a solicitude for those many patients who would suffer without new medical devices if juries were allowed to apply the tort law of 50 States to all innovations?

FDA Issues Guidance On Distribution Of Medical And Scientific Articles Regarding Off-Label Usage

The FDA has finalized guidelines for how manufacturers can distribute information to doctors about unapproved uses for drugs or medical devices. The ‘‘Good Reprint Practices for the
Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices’’
allows for the limited dissemination of medical journal articles describing off-label uses. The FDA proposed the guidelines in February, 2008 and took public comments before finalizing them.

Allegations of off-label promotion are common in mass tort litigation involving drugs and medical devices. Off-label promotion is illegal, but many critics of the industry and plaintiff lawyers seem to forget that doctors can prescribe drugs for any use they see as medically appropriate. The FDA in its guidelines confirms that the public health can be served when health-care professionals receive truthful and non-misleading scientific and medical information on unapproved uses. It will likely help practitioners to receive timely and accurate medical information in an environment where off-label use is common. The FDA's guidance will help assure that medical professionals receive timely and accurate medical information prior to the lengthy process of securing FDA approval for wider use. Such off-label use can save lives, especially in practice areas where there are few effective treatments. These off-label uses or treatment regimens thus may be quite important and may even constitute the medically recognized standard of care. Accordingly, the public health may be advanced by healthcare professionals' receipt of medical journal articles and medical or scientific reference publications on unapproved new uses of approved or cleared medical products that are truthful and not misleading.

This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115), and suggest that the distribution be in the form of an unabridged reprint, copy of an article, or reference publication;  not be marked, highlighted, summarized, or characterized by the manufacturer in any way (except to provide the accompanying disclosures discussed in the guidance), and be accompanied by the approved labeling for the drug or medical device.

The guidance represents the agency’s current thinking on the dissemination of medical journal articles and medical or scientific reference publications on unapproved uses of approved drugs and approved or cleared medical devices to healthcare professionals and healthcare entities.

Nanotechnology Resources

MassTortDefense has posted on nanotechnology issues before.  In the past few months, the EPA has clarified its view of carbon nanotubes, 73 Fed. reg. 64946 (Oct. 31, 2008); has issued a new rule affecting 50 or more nanoparticles in use in industry, 73 Fed.Reg. 65743 (Nov.5, 2008); and has asked for public comment on a petition for rulemaking submitted concerning nanoscale silver. 73 Fed.Reg. 69644 (Nov.19, 2008).

These actions may be a precursor of a flood of government actions affecting nanotechnology by a new Administration.  Here are some links to help interested readers stay on top of these issues (no endorsement of content, as usual):

Centers for Disease Control and Prevention / NIOSH
U.S. Environmental Protection Agency
U.S. Food and Drug Administration
National Nanotechnology Initiative (NNI)
Dept. of Health and Human Services National Toxicology Program

Woodrow Wilson Center, Project on Emerging Nanotechnologies

International Council on Nanotechnology (ICON), Environmental, Health and Safety database: Nano Science and Technology Institute (NSTI)

NanoBusiness Alliance

European Commission
Cluster Science, including Nanoclusters and Nanoparticles
Virtual Journal of Nanoscience and Nanotechnology
NanoScience Today Imagazine  

MDL Court Permits ESI Discovery

Readers of MassTortDefense are aware of the significant risks that plaintiff e-discovery tactics pose in product liability and toxic tort contexts. Rather than a device to uncover relevant facts for the litigation, e-discovery often is about plaintiffs’ attempt to find some alleged misstep by the defendant that will bring sanctions.

In multi-district litigation arising out of the manufacture of allegedly defective plumbing fittings, the U.S. District Court for the District of Minnesota recently ordered the defendant to name a witness to be deposed on whether it preserved evidence dating back to its notice of likely litigation, before a putative class suit was filed. In re: Zurn Pex Plumbing Products Liability Litigation, D. Minn., MDL No. 08-1958.

Plaintiffs allege that the defendant erred in its document preservation efforts three years before any litigation was actually filed, claiming that the number of warranty claims to the company somehow triggered a duty to preserve. However, in late October 2007, the parties were ordered to engage in focused discovery on the issue of class certification, and discovery of electronically stored information was limited, absent a showing of easy accessibility at an affordable cost.

Plaintiffs moved to compel a Rule 30(b)(6) deposition and identification of a 30(b)(1) deponent as they sought to depose a corporate representative regarding document retention practices and possible spoliation of evidence. Defendant resisted, arguing that plaintiffs have no reason to believe evidence has been destroyed; the requests are unreasonably burdensome; and the requests violate the prior discovery orders.

The court, however, permitted the deposition limited to determining whether discoverable evidence had been inadvertently destroyed. The court noted that case law requires plaintiffs to designate, with painstaking specificity, the particular subject areas that are intended to be questioned, and that are relevant to the issues in dispute,” but found somehow that plaintiffs had done so by "circumscribing" their request to information concerning the identified risk of litigation for Zurn Pex, Inc. with respect to its brass fittings.

Yet another cautionary tale from the world of ESI.  It is crucial for defendants to retain counsel who can assess and advise on the e-discovery issues.


Federal Court Denies Certification in PFOA Medical Monitoring Class

A couple months ago, MassTortDefense posted about a decision in which the federal court in West Virginia 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). Plaintiffs are appealing that.

Now, the federal district court in New Jersey has similarly rejected class certification in two consolidated suits in which state residents argued that DuPont should pay for a medical monitoring program because their drinking water was allegedly contaminated with a Teflon-related chemical. See Rowe v. E.I. du Pont de Nemours & Co., D.N.J., No. 06-1810; Scott v. E.I. du Pont de Nemours & Co., D.N.J., No. 06-3080.

PFOA, also known as C-8, is made by DuPont for use in a variety of consumer products, including in non-stick cookware. Plaintiff sought medical monitoring to detect disease in the future they were allegedly put at risk for based on exposure to the chemical. But to recover medical monitoring costs, plaintiffs must show “significant exposure” to a chemical. Plaintiffs argued they had sufficient common proof of “significant exposure” to PFOA because tests revealed that the water supply around DuPont's Chambers Works Plant in New Jersey allegedly exceeded .04 parts per billion (ppb) for the substance, and the New Jersey Department of Environmental Protection recommended .04 ppb as the “safe” level of exposure. The plaintiffs also offered Dr. David Gray, a toxicologist, to testify that .02 ppb was actually the level at which negative health affects may start showing up in individuals.

The court first rejected any use of the settlement by DuPont of previous PFOA claims to show the existence of common issues. The other case was ultimately resolved through “voluntary settlement,” the court said. DuPont's statements cannot be considered admissions of liability, causation, or appropriate damages.

The court also rejected plaintiffs use of regulatory-based risk assessments. While they may be an appropriate way to determine for the public what health and environmental officials believe are “safe” levels of a chemical in drinking water, they are not themselves an adequate means of showing the kind of significant exposure to a substance that is required to support medical monitoring claims. There is a difference between a “safe” level for public policy and regulatory purposes and the “significant exposure” that creates the sufficiently excessive risk needed to trigger medical monitoring. “Such methodology does not work in the tort litigation context, where a plaintiff must prove that he has suffered an actual increased risk of disease in order to merit recovery in the form of medical monitoring.”

Also affecting their utility in the class context, the risk assessments are based on assumptions about the general population, and are thus not applicable to show class-wide significant exposure. Plaintiffs’ expert merely assumed that class members all weighed a certain amount and consumed a certain amount of allegedly contaminated water. Those assumptions are not necessarily true for all class members—indeed, they are undoubtedly false, as the class contained thousands of individuals who are different sizes and have different water consumption habits.

Importantly, given plaintiff’ counsel refrain about the cost of pre-complaint, pre-certification homework, and the frequent "we'll deal with that later" mentality, the court noted while it would take significant investigative efforts to obtain information specific to each individual in the proposed class, the difficulty of this task does not excuse plaintiffs from doing it. A class action is not intended to be an easy way around research problems. Plaintiffs have the burden of proving that each class member has suffered significant exposure to PFOA—they cannot circumvent this requirement by simply relying on assumptions about the general population.

Eighth Circuit Affirms Dismissal of Nuisance Claim Against OTC Drug Makers

The 8th Circuit has affirmed the dismissal of nuisance claims against the makers of over-the-counter cold and cough medicines containing ephedrine or pseudoephedrine. Ashley County v. Pfizer, No. 08-1491, slip op. (8th Cir. Jan. 5, 2009) (here's a link to the opinion at the Eighth Circuit website).  Important to readers of MassTortDefense, this may be the first appellate court to address whether the lawful distribution of an FDA-approved product can be actionable under a nuisance theory.

Several Arkansas Counties sought to hold the drug companies liable because the lawful cold medicines were being converted by criminals into methamphetamine, an addictive illegal drug. The Counties pleaded theories of unjust enrichment, statutory unfair trade practices, nuisance, and the Arkansas crime victims civil liability statute.

The Counties claimed that the defendants were unjustly enriched at the Counties' expense when methamphetamine cooks purchased the defendants' products for use in the illegal manufacture of methamphetamine. Unjust enrichment is an equitable doctrine that allows a party to recover for benefits conferred on another. It is restitutionary in nature and focuses on the benefit received. It is not enough, however, to establish a benefit received by another party. There must also be some operative act, intent, or situation to make the enrichment unjust and compensable. A party who is free from fault cannot be held to be unjustly enriched merely because it has chosen to exercise a legal or contractual right.

Here, the Counties did not provide the services for which they sought compensation, i.e., law enforcement, inmate housing, social services, and treatment, with the expectation that the defendants–manufacturers and wholesalers of products containing pseudoephedrine–would pay for those services. In other words, the cold medicine manufacturers cannot be said to be the beneficiaries of the services provided by the Counties. The circumstances connecting the sales of cold medication to the provision of these government services were simply too attenuated to give rise to an implied contract between the manufacturers and the county providers to state a cause of action for unjust enrichment.

The remaining nuisance and statutory claims all failed for lack of proximate cause. Arkansas law incorporates the doctrine of intervening acts, which reflects the limits that society places on a defendant's liability for his actions. An original act is eliminated as a proximate cause by an intervening cause if the latter is of itself sufficient to stand as the cause of the injury, and the intervening act is independent of the original act. On this, the Eighth Circuit relied on a Third Circuit gun case, City of Philadelphia v. Beretta U.S.A. Corp., 277 F.3d 415 (3d Cir. 2002), to hold that intervening criminal misconduct can break the chain of proximate cause to product manufacturers. The allegations in the Third Circuit case were nearly identical to the allegations here–that the defendant manufacturers failed to take steps to restrict access to the products containing pseudoephedrine when they knew (an alleged fact the court had to take as true at the judgment on the pleadings stage) that the pseudoephedrine-containing products were being purchased and used illegally to make methamphetamine. "The criminal actions of the methamphetamine cooks and those further down the illegal line of manufacturing and distributing methamphetamine are 'sufficient to stand as the cause of the injury' to the Counties in the form of increased government services, and they are 'totally independent' of the Defendants' actions of selling cold medicine to retail stores . . . . " Slip opin. at 15.


China Melamine Update

China's Dairy Industry Association announced last week that the Chinese dairy companies accused of producing contaminated milk-containing products have agreed to pay compensation.  Reports are that nearly 300,000 people (mostly kids) were sickened, and six reportedly died.  Baby formula was contaminated with melamine, apparently an intentional act to deceive protein quality control testing.  Melamine artificially increases the protein profile of the milk, but can cause kidney damage at higher doses.

MassTortDefense has posted on the issues before.

The settlement includes an immediate payment of $130 million, and $30 million to cover future medical bills for related health problems.  Wrongful death cases will receive a reported $30,000, and seriously sick kids' families will get $4000.  Some 28,000 product users were hospitalized.

Many officials responsible for quality control and inspection of the dairy industry have been fired or indicted.  Trials are ongoing for 17 such defendants, and the former head of the largest dairy outfit was to be charged last week with manufacturing and selling counterfeit goods. That company, the Sanlu Group, ceased operations and filed for the equivalent of bankruptcy in the Fall.

China is also reportedly revising its regulatory approach to the dairy industry, with new safety and quality standards, new testing approaches, and more tools to enable local governments to catch issues.


Coming Attractions: Redish On Class Action Flaws

Here's one to keep an eye out for: Wholesale Justice,Constitutional Democracy and the Problem of the Class Action Lawsuit by Martin H. Redish.  Coming in the Spring from Stanford Univ. Press.

In recent years, much political and legal debate has centered on the class action lawsuit. Many lawyers and judges have noted the intense pressure to settle caused by the very filing of a class suit. Some contend that the procedure amounts to a form of judicial blackmail. The risk is greater when the number of claims aggregated in the class action is so large great that an adverse verdict would push the defendant into bankruptcy, for then the defendant will be under great pressure to settle even if the merits of the case are slight. Castano v. American Tobacco Co., 84 F.3d 734, 746 (5th Cir. 1996); In re Rhone-Poulenc Rorer, Inc., 51 F.3d 1293, 1298-99 (7th Cir.1995); Bruce L. Hay & David Rosenberg, “ ‘Sweetheart’ and ‘Blackmail’ Settlements in Class Actions,” 75 Notre Dame L.Rev. 1377, 1389-92 (2000). Plaintiffs counter that it is an effective means of policing corporate behavior and assuring injured victims' fair compensation.

According to the previews, this book represents a scholarly effort to view the modern class action comprehensively through the lenses of American political and constitutional theory. Redish argues that the modern class action undermines foundational constitutional principles, including procedural due process and separation of powers. He also asserts that the class action has been improperly transformed from its origins as a complex procedural device into a means for altering the controlling substantive law in highly undemocratic ways.  This despite the admonitions of a number of courts that the procedural device of Rule 23 should not be allowed to expand the substance of the claims of class members. Broussard v. Meineke Discount Muffler Shops, Inc., 155 F.3d 331 (4th Cir. 1998); see Cummings v. Connell, 402 F.3d 936, 944 (9th Cir.2005)(“It is axiomatic that Rule 23 cannot ‘abridge, enlarge or modify any substantive right’ of any party to the litigation.”); Blaz v. Belfer, 368 F.3d 501, 504 (5th Cir.2004)(“A class action is merely a procedural device; it does not create new substantive rights.” (quoting Frazar v. Gilbert, 300 F.3d 530, 545 (5th Cir.2002)), rev'd on other grounds sub nom., Frew ex rel. Frew v. Hawkins, 540 U.S. 431, 124 S.Ct. 899, 157 L.Ed.2d 855 (2004)); Mace v. Van Ru Credit Corp., 109 F.3d 338, 346 (7th Cir.1997)(stating that “[t]he application of Rule 23 does not abridge, enlarge or modify any substantive right”); In re Baldwin-United Corp., 770 F.2d 328, 335 (2d Cir.1985)(stating that the federal class-action procedure set forth in Rule 23 “is a rule of procedure and creates no substantive rights or remedies enforceable in federal court”); Southwestern Refining Co. v. Bernal, 22 S.W.3d 425, 437 (Tex.2000) (holding that class action is procedural device which does not alter the substantive requirements of the underlying substantive claim); Winters v. Kan. Hosp. Serv. Ass'n, 1 Kan.App.2d 64, 562 P.2d 98, 101 (1977)(stating that Kansas' class-action statute “is a procedural statute” that “creates no substantive rights”).

Redish goes on to propose an alternative vision of the class action lawsuit, one that is designed to enable the device to serve its potentially  valuable procedural purposes in certain contexts without simultaneously contravening core precepts of American constitutional democracy.

Martin Redish is the Louis and Harriet Ancel Professor of Law and Public Policy at the Northwestern University School of Law.


FDA Issues Letter on Further BPA Research

The U.S. Food and Drug Administration has decided to support additional research with regard to its analysis of BPA safety in plastic baby bottles and food and drink containers. The FDA’s basic position is that current human exposure to BPA in food-packaging materials provides an adequate margin of safety. The FDA’s draft risk assessment on this issue was released in August, finding the chemical safe as it is now used. However, after an FDA advisory committee on the subject questioned some of the FDA methodology and data sources, the FDA has now decided to conduct additional research, as cited in a letter to the advisory committee.

FDA is re-evaluating available data and planning for the acquisition of additional data that will strengthen the exposure estimates from all dietary sources of BPA, with particular attention to dietary sources relevant to infants and children. FDA also will study the cumulative effects of BPA in humans.

Makers of BPA say that the chemical poses no known risk to human health. In response to public demand, some manufacturers have begun introducing products for infants and children that are BPA-free. The Environmental Protection Agency has calculated that adults and infants can consume 50 micrograms of BPA per kilogram of body weight every day over a lifetime with little appreciable risk of harm.

One of the underlying issues is the use of animal studies. There is no epidemiological evidence that human beings of any age or developmental stage have been harmed in any way by common exposure to BPA. Even workers using the chemical in manufacturing have not been shown to have suffered any harm. The fact that rodents suffer effects at high doses of the chemical may have nothing to do with human health: the same animal tests performed on things we eat and drink every day give the same "toxicity" results. Nevertheless, the planned "large research effort," with studies lasting years that will assess the effects of the chemical in laboratory animals including rodents and monkeys. FDA is planning to conduct these studies in its laboratories using representative dose ranges and multiple animal models.

MassTortDefense has posted on BPA before.

Class Certification Denied In FEMA Trailers MDL (Part II)

The federal court in the FEMA Trailer MDL has denied class certification to a class of plaintiffs alleging that they were harmed or put at risk of future harm by formaldehyde exposure after residing in Federal Emergency Management Agency trailers following Hurricanes Rita and Katrina. See In re FEMA Trailer Formaldehyde Products Liability Litigation, MDL No.1873 (E.D. La., class certification denied 12/29/08).

In a previous post, MassTortDefense reported on the court’s analysis of the personal injury class claims. Today, we look at the medical monitoring class claims, a topic about which we have posted before.

In addition to all the general reasons set forth for why class certification was inappropriate, the court offered additional analysis as to why certification of the medical monitoring class (the "future medical services sub-class" ) was inappropriate.

Plaintiffs contended that class-wide common issues of law and fact included: (1) whether certain plaintiffs were significantly exposed to formaldehyde, an allegedly hazardous substance; (2) whether certain plaintiffs now suffer a significantly increased risk of contracting a serious latent disease, associated with formaldehyde exposure; (3) whether certain plaintiffs’ risk of contracting such a disease is greater than (a) the risk of contracting the same disease had there been no exposure, and (b) the chances of members of the public at large of developing the disease; (4) whether a medical procedure exists that makes the early detection of any such diseases possible; (5) whether the future medical services regime for such detection is different from medical services recommended in the absence of exposure; and (6) whether there is some demonstrated clinical value in the early detection and diagnosis of any such diseases. In essence, plaintiffs alleged that most of the elements of a medical monitoring claim were common.

The Court felt, however, that the first two allegedly class-wide issues, exposure and increased risk, were actually individual issues. Whether an individual has been “significantly exposed” to formaldehyde will differ depending on several variables, including other exposures, past and present cigarette use, formaldehyde-containing cosmetics use, etc. Thus, an accurate exposure level for a class representative has no bearing on an accurate exposure level for any other member of the proposed class because of these differing variables. Similarly, determining an individual’s risk of developing a particular formaldehyde-related disease or injury is keyed to several individual factors, including level of exposure, duration of exposure, and other individual characteristics such as whether the person has other risk factors for contracting a particular injury or disease.

Second, while the proposed medical monitoring sub-class would require the application of laws of “only” four different states, plaintiffs failed to make any substantial attempt to explain whether any individual variations in those states’ laws are manageable here, or whether they would “swamp common issues of law and fact.”

Next, the court found that plaintiffs’ proposed class was unorthodox in that it sought an order to monitor and treat the injuries that have resulted from that exposure. That is, a future medical services subclass should be certified to set up and maintain a program by which plaintiffs’ injuries may be detected and treated. Seemingly, plaintiffs went beyond the usual talk of treatment in the context of whether treatment exists such that monitoring could be beneficial, to essentially call for the development of a program aimed at also providing treatment to individuals (especially children) who have been adversely affected by hazardous levels of formaldehyde in the units.

But, by essentially requesting monitoring and treatment in the class, subclass members would arguably be relieved of the burden that they would bear in an individual suit, relative to proving any current manifest injury or disease. The court agrees found that plaintiffs were indeed attempting to skip over the process of obtaining the requisite liability finding against the manufacturing defendants, by holding them responsible for funding a monitoring and treatment service for injuries that a jury may later deem was never their responsibility. In other words, the monitoring program requested by plaintiffs seems to bypass a liability finding on injury in favor of immediate medical monitoring and treatment, both. Plaintiffs failed to demonstrate to the court why defendants should be asked to pay for such a program without, first, a finding of liability against them.

Finally, defendants contended that plaintiffs, as a group, did not meet the “manifest physical injury” requirement, which they asserted is a prerequisite for medical monitoring in Texas, Louisiana, Mississippi, and Alabama. Plaintiffs, on the other hand, asserted that they meet this requirement because the physical injury they claim to have suffered is in the form of “cellular and molecular” damage. Even without addressing the issue whether such cellular damage qualifies as a manifest present injury, the court felt it would still be faced with the individualized inquiry of whether formaldehyde exposure resulting from the units caused those "injuries." This is not an issue that can be determined on a class-wide basis.

Accordingly, the medical monitoring class claims involved too many individual issues. 


Class Certification Denied In FEMA Trailers MDL

The federal court in the FEMA Trailer MDL has denied class certification to a class of plaintiffs alleging that they were harmed by formaldehyde exposure after residing in Federal Emergency Management Agency trailers following Hurricanes Rita and Katrina. See In re FEMA Trailer Formaldehyde Products Liability Litigation, MDL No.1873 (E.D. La., class certification denied 12/29/08).

The plaintiffs had filed claims against the United States and several manufacturers alleging that they were exposed to high levels of formaldehyde contained in emergency housing provided to them by FEMA. The plaintiffs proposed six subclasses, including four subclasses for residents divided by state (Louisiana, Alabama, Texas, and Mississippi), a medical monitoring (“future medical services”) subclass, and an economic loss subclass.

More on the medical monitoirng in a later post.  Today, the focus is the current injruy claims.

Judge Engelhart found that the proposed subclasses did not meet the requirements of Federal Rule of Civil Procedure 23(a) or 23(b)(3).


Interestingly, the court found that the plaintiffs had not met the commonality requirement of 23(a), usually not a demanding test. Plaintiffs alleged that common questions existed relating to why and how formaldehyde exposure occurred, what level of formaldehyde exposure was experienced, and who was exposed to the formaldehyde. Plaintiffs, as is typical, claim that defendants’ conduct or fault was a central and common issue. Plaintiffs argued that common issues of fact also relate to the scientific nature and behavior of formaldehyde. On the other hand, defendants argued that there is no commonality because plaintiffs lived in different units, and the court agreed. This case did not involve one single product that is alleged to have caused plaintiffs damage. Instead, plaintiffs have alleged that dozens of different manufacturing defendants have manufactured products that have caused them harm. The court found that the question of defendants’ conduct or fault in the failure to exercise reasonable care is clearly not a common issue because there are dozens of defendants who have manufactured numerous different products that have allegedly caused harm to plaintiffs. In that regard, a determination of fault as to one defendant will not answer the question as to any other defendant. Last, a determination relating to the scientific nature and behavior of formaldehyde is not common as to all class members as the true issue relates to the specific level of formaldehyde that each plaintiff experienced in his/her unit and the resulting symptoms allegedly suffered by that particular plaintiff.


A second significant part of the analysis focused on 23(a)’s requirement of typicality. defendants noted that the proposed class representatives claim a myriad of symptoms and conditions, including unconsciousness, convulsions, nephritis, and hypothermia. Indeed, the Plaintiff Fact Sheet (“PFS”) designated a total of 47 alleged formaldehyde-related symptoms, ranging from low blood pressure to miscarriage and stillbirth. Plaintiffs have diverse medical histories, symptoms, and alleged exposures. Typicality is not satisfied where plaintiffs’ claims and defenses will be dominated by individual evidence. Thus, this MDL involves factual variations as to each plaintiff and proposed class representative which spawn individual issues relating to injury and causation as to each individual. Each plaintiffs’ claims and alleged injuries will require an examination of individual evidence, precluding the satisfaction of the typicality requirement for class certification. For example, plaintiffs admitted that a child’s lungs react differently to formaldehyde exposure than an adult’s lungs. Plaintiffs’ counsel also admitted that temperature, humidity, and ventilation affect and contribute to differences in formaldehyde levels in the units.


Turning to Rule 23(b)(3), the court found common issues did not predominate and the class method was not superior: this MDL involves hundreds of models of trailers, produced by dozens of different manufacturers. Moreover, even units of the same make and model, made by the same manufacturer, can differ in regards to what components parts were used and when it was manufactured. Further complicating this aspect of these claims, exposure to formaldehyde (at certain levels) is fairly common in today’s society and the chemical is produced by the human body itself. Each plaintiffs’ potential formaldehyde exposure and any resulting health effects vary according to several different factors. Each plaintiff’s habits vary greatly, resulting in the necessity for individualized inquiries delving into the use of heating and air conditioning, and also window or door use (important to how ventilated a particular unit was). Some
plaintiffs are exposed to sources of formaldehyde and eye/nose/throat irritants unrelated to that said to be found in the units (resulting from contact with air pollution, pesticides, pets, cleaning agents, mold, bacteria, and viruses).

Further, as for the alleged injuries to the plaintiffs themselves, the court said that each one has suffered an individual physical injury that is specific to that particular individual, precluding the predominance of issues relating to the plaintiffs themselves. Also, the personal injury claims among plaintiffs vary greatly.

The Court concluded that plaintiffs’ claims will, to a significant degree, be individualized with respect to causation and will include individual issues of exposure, susceptibility to illness, and types of physical injuries. Hence, no class action.


Happy New Year

No post today, except to wish the readers of MassTortDefense a very Happy New Year!

From our humble beginnings last May, we have posted more than 200 stories on a range of interesting topics: pharmaceuticals and medical devices; toxic torts and consumer products; class actions, discovery, trials, and appeals; experts and regulations; everything mass tort from asbestos to Zyprexa.

We have had more than 12,000 readers, and the number has grown each month.  We will do our best in 2009 to bring you interesting ideas and developments relevant to the defense of mass torts and significant product liability claims.