Defense Use Of Plaintiffs' Treaters As Experts In MDL Disallowed

The Magistrate Judge in the Kugel Mesh Hernia Repair Patch MDL has refused to allow defendants to retain as experts any physicians who have treated any of the plaintiffs. See In re: Kugel Mesh Hernia Repair Patch Litigation, MDL Docket No. 07-1842ML (Order 9/19/08).

The Court had previously ordered that defendants were precluded from engaging in substantive ex parte communications with plaintiffs’ treating physicians. Defendants proposed, however, to have the ability to retain a plaintiff’s treating physician as a consulting or testifying expert as long as they do not call the expert in his/her patient’s case and refrained from discussing with him/her the medical history of that patient/plaintiff.

The Court saw the motion as requiring it to balance the trust and confidentiality embodied
in the physician-patient relationship against a litigant’s right to reasonably assemble and present a defense.

The reality of some mass torts is that:

-the sheer number of plaintiffs may preclude defendants from retaining any consultants who are not also treating physicians of some plaintiffs;

-this is especially true in the case of medical devices in which the experts in the devices are experts mainly because they treat people using those devices;

-in mass torts, with thousands of cases in multiple venues, defendants need multiple experts;

-allowing defendants access to treaters -- who are not automatically experts for the plaintiff, but who possess knowledge needed by both sides – may accelerate the discovery process.

The Court here, however, adopted the balancing performed by the Rhode Island Superior Court, which currently sees more than 1000 of these cases. See In re: All Individual Kugel Mesh Cases, 2008 R.I. Super. LEXIS 101 (R.I. Super. August 26, 2008). The state court concluded that any “potential inconvenience” to defendants in engaging experts was “significantly outweighed” by plaintiffs’ right to confidentiality in their medical matters. Id. at *9.

The Court may have given insufficient weight to the protection available from the fact that the treater, if consulted by the defense on plaintiff X, is under an independent ethical duty not to disclose confidential information about patient Y. And the doctor is always available to be deposed about whether he or she was even asked any questions about a patient.

The Court criticized the defendants for not specifically identifying the “small group of hernia repair specialists” who were inevitable, likely treaters of one or more plaintiffs. (“The fact that only one surgeon to date has fallen into the consultant/treating physician category belies Defendants’ claims of prejudice.”) However, generally, and without any knowledge of this specific MDL, MassTortDefense would assert that the issue was not whether defendants had already identified many potential experts who were also treaters. The prejudice comes when defendants cannot find qualified experts who are not treaters and thus must turn to the treater pool –even if they haven’t already done so and thus cannot identify the specific overlapping people. Defendant has no easy way, absent revealing substantial confidential work product, of showing that it cannot find adequate and sufficient experts without resort to the treater pool. Courts, particularly MDL courts, may need to seek a deeper understanding of the reality of expert retention.
 

China Dairy Product and Infant Formula Issues Grow

Quality control investigators in China have announced they had found a dangerous protein substitute in dairy products produced by 20% of the Chinese companies that make infant formula. Reports are that more than 12,000 children had been hospitalized, most with kidney ailments, and 40,000 with less severe symptoms have been treated without admission. At least three have been killed.

Melamine, a protein imitator that is toxic, was used as a cheaper fill, and was found in the test samples. Melamine is the same protein replacement used in the Chinese-made pet food that killed thousands of cats and dogs last year.

What is the impact for readers of MassTortDefense? Several major Chinese dairy companies involved have international investors. But none of the formula products were exported to North America. The FDA said there is no known threat of contamination in infant formula manufactured by companies that have met requirements to sell the formula in the United States. However, FDA is investigating whether infant formula manufactured in China is being sold in markets here that serve the Asian community. And the FDA is alerting consumers that seven "Mr. Brown" instant coffee and milk tea products are being recalled by a Taiwanese company, due to possible contamination with melamine.

The developing food safety scandal has called into question, yet again, the effectiveness of China’s quality control system in general, and the country's new food safety regime in particular. Last year’s spate of product recalls, including drugs, toys, pet food and tires, placed the spotlight on China's quality control problems. MassTortDefense has posted on this here and here. Now comes the news that the newly enacted food safety recall system was not activated for at least two weeks after the problem became known to local officials, and the prime minister of New Zealand (an importer) charged the matter was covered up for several weeks while the Beijing Olympics were underway. Thus, thoughts naturally turn to efforts importers may mitigate the risks. A recent article in Risk Management Magazine offers a broad perspective on this. (Kent Kedl, Risk Strategies for the Chinese Market , published by the Risk and Insurance Management Society, which targets corporate risk managers.) At bottom, it is risk management to avoid a potential mass tort.

First, plan Strategy before Structure. In recent years, the Chinese government has changed its investment regulations to allow --and even encourage-- a variety of business arrangements, from strategic partnerships to wholly foreign-owned enterprises, to full acquisitions. RM suggests that companies coming to China must first ignore the "how" of structure and first focus on the "why" of their strategic intent for China: What products will have the most play? What segments of the market should they target? What distribution channels should they use? Who will be the major competition and how can they structure a defensible and sustainable value proposition?

Second, they advise companies to Get Close to the Market. Clearly, there are Chinese factories that have had quality issues, but the fact remains that there are millions of products coming out of China every month, most of which have no problems whatsoever. Maybe, then, the question should be how best to manage product quality, because someone is doing it right. Kedl and RM suggest that foreign companies need to manage their vendors on an ongoing basis. Meet with suppliers; validate the supply chain; don’t worry about price and on-time delivery to the exclusion of all else. Companies sourcing from China should consider putting their own people on the ground to manage their supply chain, establish and monitor their own quality systems, and maintain ongoing relationships with the vendors. This approach may raise a company's fixed costs but, in the long run, may greatly lower the risk associated with having products made in an emerging market.

Third, recognize that Relationships Matter. Early successful foreign entrants to China worked hard to build a relationship network for themselves. As China has developed a more credible legal framework and a more predictable market environment, however, foreign companies too often have believed they no longer need that social network and that, instead, they can do it on their own. RM suggests that may be a mistake.

Ongoing events put a premium on efforts by both China and the U.S. in implementing the 2007 Memorandum of Agreement (MOA) on food and feed safety. The MOA established a bilateral mechanism to provide greater information and other assurances to enhance the safety of food and feed products traded between the two countries. The countries have improved the exchange of information on food safety and on the relevant regulatory systems. The U.S. has agreed to conduct training for Chinese officials on U.S. regulatory standards. Each has designated new emergency contacts and notification thresholds for import safety issues. The two countries have also been working towards an electronic certification system between the FDA and China's General Administration of Quality Supervision, Inspection and Quarantine to ensure that Chinese exports meet FDA standards for safety and manufacturing quality. The countries also agreed to increase their focus on inspection, supervision and laboratory testing of Chinese imports. Finally, the report described the establishment of a cooperative mechanism to notify each other of significant risks to public health related to product safety or the gross deception of consumers, and to share information to facilitate each other’s investigation.
 

Maryland Court Resists Imposing "Duty To The World" On Pharmaceutical Maker

Maryland's top court recently affirmed summary judgment for defendant Eli Lilly & Co., in a case brought by a widow whose husband was killed in an auto accident. His car was allegedly hit by a diabetic who blacked out while under treatment with two insulin medications. Gourdine v. Crews, No. 134 (Md. Ct. App. 9/4/08).

Background
Ellen Crews, a Type I diabetic who was taking a combination of insulin medications from Lilly, while operating her car, allegedly suffered some kind of debilitating episode and struck a vehicle driven by Isaac Gourdine, resulting in his death. The issue for the Court was whether Lilly owed a duty to Mr. Gourdine, the third-party who did not ingest the drugs. Plaintiff, the wife of Mr. Gourdine, argued that it was somehow foreseeable to Lilly that Ms. Crews, might allegedly suffer an adverse reaction to the medications, which in turn would cause injury and death to third persons while she was operating a motor vehicle. If she had not been adequately warned about the dangers that allegedly were associated with the specified medications, that would supposedly impact a duty owed to Mr. Gourdine.

Specifically, Ms. Crews took a combination of Humalog, a quick-acting form of insulin taken with meals, and Humulin N, a medication designed to supply a constant source of insulin to the body. Ms. Gourdine contended that, at the time of the accident, Ms. Crews suffered a hypoglycemic reaction and experienced a “blackout” causing her to lose control of her vehicle. Defendant Lilly, plaintiff alleged, owed a duty to protect users of the highway from drivers suffering from hypoglycemia induced by the allegedly misbranded drug.

Lilly sought and obtained summary judgment below on the basis it owed no duty to decedent Gourdine, a nonuser of the drug, to warn about alleged risks associated with the medications. Plaintiff appealed, and the Maryland Court of Special Appeals affirmed; the case then went up again.

Reasoning
The Court began with a discussion of the elements of plaintiff’s causes of action, noting that duty is an essential element of both negligence and strict liability causes of action for failure to warn. In contrast to the reasoning of the lower courts, however, the Court stated that the duty issue should not be analyzed in the context of the learned intermediary rule – which holds that the manufacturer’s duty to warn is to the prescriber – but as an issue of the common law of torts.

At its core, the determination of whether a duty exists represents a policy question whether the specific plaintiff is entitled to protection from the acts of the defendant; ultimately, the determination of whether a duty should be imposed is made by weighing the various policy considerations and reaching a conclusion that the plaintiff's interests are, or are not, entitled to legal protection against the conduct of the defendant. The foreseeability test relied on by plaintiff  “is simply intended to reflect current societal standards with respect to an acceptable nexus between the negligent act and the ensuing harm.”  While foreseeability is often considered among the most important of the relevant factors, its existence alone does not suffice to establish a duty under Maryland law.

In this case, there was no direct connection between Lilly’s warnings, or the alleged lack thereof, and Mr. Gourdine’s in jury. In fact, there was no contact between Lilly and Mr. Gourdine whatsoever. To impose the requested duty from Lilly to Mr. Gourdine would expand traditional tort concepts beyond manageable bounds, because such duty could apply to all individuals who could have been affected by Mr. Crews after her ingestion of the drugs. Essentially, Lilly would owe a duty to the world, an indeterminate class of people, for which the Court has “resisted the establishment of duties of care.”

Gourdine attempted to draw support from cases in other jurisdictions, in which she asserted that a doctor's duty to warn his or her patient of the risks associated with medication extends to nonpatients who are foreseeably at risk. The Court responded that it has not historically embraced the belief that duty should be defined mainly with regard to foreseeability, without regard to the size of the group to which the duty would be owed, which the courts in Alabama, Hawaii, and Washington, according to plaintiff, have.

On the other hand, numerous jurisdiction had rejected this kind of universal duty, the Court noted. See Kirk v. Michael Reese Hospital & Medical Center, 513 N.E.2d 387 (Ill. 1987); Gilhuly v. Dockery, 615 S.E.2d 237, 239 (Ga. Ct. App. 2005) (patient who was involved in a car accident in which sons were injured filed suit on their behalf based on physician’s alleged failure to warn patient not to drive after taking certain medications; the Court of Appeals of Georgia rejected the claims on behalf of the sons because “[t]o expand a doctor’s duty to his patient to generally include members of the public at large in a case such as this one would be contrary to Georgia public policy”); Lester ex rel. Mavrogenis v . Hall, 970 P.2d 590, 597 (N.M. 1998) (holding that physician owed no duty non-patient injured in automobile accident with patient because the “consequences of placing a legal duty on physicians to warn may subject them to substantial liability even though their warnings may not be effective to eliminate the risk in many cases”); Rebollal v. Payne, 145 A.D.2d 617, 618 (N.Y. App. Div. 1988) (“There is no duty on the part of the operator of a methadone clinic to control the travel activities of a methadone patient giving rise to liability for accidents to a third party such as plaintiff’s decedent.”); Praesel v. Johnson, 967 S.W.2d 391, 398 (Tex. 1998) (stating that treating physicians do not owe a duty to third parties to warn epileptic patients not to drive, for purposes of negligence claims against physicians for failure to warn if patient has accident and injures third party during seizure; “Balancing both the need for and the effectiveness of a warning to a patient who already knows that he or she suffers from seizures against the burden of liability to third parties, we conclude that the benefit of warning an epileptic not to drive is incremental but that the consequences of imposing a duty are great.”).

Gourdine also argued that the Federal Food, Drug, and Cosmetic Act, which prohibits drug manufacturers from placing a misbranded product into interstate commerce, conferred a duty on Lilly. This statute and its regulations, however, are framed to protect the public in general, and, a statutory obligation which “runs to everyone in general and no one in particular” cannot impose a duty between two parties.
 

Senate Panel Holds Hearing on DTC Advertising of Medical Devices

The U.S. Senate Special Committee on Aging held a hearing last week to examine issues related to direct-to-consumer (DTC) advertising for medical devices. The amount of medical device advertising directed to consumers on television or over the Internet was an estimated $193 million last year, a figure that is a small fraction of the volume of consumer advertising for prescription drugs. Yet, device DTC is getting increased attention.

At the hearing, medical, advertising, and consumer experts shared with the committee their opinions about DTC medical device advertisements, including whether health risks are appropriately conveyed to consumers. The hearing was called by liberal Democratic Committee Chairman Herb Kohl (D-WI), who has apparently already decided that Congress ought to be prepared to call for a future moratorium on DTC ads for new medical devices.

Dr. Daniel Schultz, the director of the Center for the Center for Devices and Radiological Health (CDRH) at the FDA, discussed the current status of their enforcement activities related to DTCA for medical devices. The CDRH is the division of the FDA responsible for the regulation of restricted medical device advertisements.

The head of Advanced Medical Technology Association (AdvaMed), related the organization’s current policy on DTC advertising and reaffirmed the medical technology industry’s strong support for truthful, non-misleading advertising of its innovative products. AdvaMed believes that in addition to being truthful and not misleading, all DTC advertising should use consumer-friendly language, disclose relevant risk information, and encourage patients to speak with their doctors in more detail. Current FDA rules governing direct-to-consumer advertising are adequate. FDA and FTC already have extensive legal authority to regulate false or misleading advertising for medical devices. FDA has a full range of potential remedies it can bring to bear, from issuing a warning letter to removing a product from the marketplace.

Indeed, while it is unproven that any advertisement will cause a patient to take a drug – as opposed to discuss a possible prescription with a physician – it seems even less likely that a medical device ad will do anything other than stimulate a patient to ask a doctor about a device: a patient does not agree to undergo surgery unless they think they have a serious need for it.

Direct to consumer advertising is a powerful educational tool that allows patients to learn of new technologies and treatment options in a timely fashion and can help to initiate important discussions between physicians and patients. DTC advertising is an invaluable tool to enhance the exchange of information and empower patients to ask questions about their own health. 
 

Nevertheless, the rest of the hearing lineup was stacked with opponents of DTC advertising: Dr. Kevin Bozic, a professor of orthopedic surgery at the University of California, San Francisco, provided an opinion of how DTC advertising supposedly has the potential to adversely impact the doctor-patient relationship, patient education, and health care costs and quality. Next, Dr. William Boden, a professor of medicine and public health at the University of Buffalo, and Dr. George Diamond, a senior research scientist at the Cedars-Sinai Medical Center, shared the findings of their recent article in the New England Journal of Medicine, offering their opinions about how DTC advertising can theoretically affect patient understanding of medical device effectiveness and risks.

Dr. Ruth Day presented expert testimony on how DTC advertising may influence consumer behavior. Also on the first panel was Ami Gadhia, policy counsel for the Consumers Union, who testified about her organization’s petition to the FDA in December, 2007 for pre-review and specific risk disclosures for medical device advertisements.
 

Latest BPA Update

Here is the latest on BPA:

1. NTP Issues Final Report

The National Toxicology Program issued its final report on bisphenol A (BPA) earlier this month. NTP continued its position from a much publicized draft report (see the post here) that it has some concern that the chemical – used in plastic bottles and other packaging -- could affect the development of the prostate gland and brain and potentially affect the behavior of fetuses, infants, and children. See The Monograph on the Potential Human Reproductive and Developmental Effects of Bisphenol A.

The report provides the NTP’s current opinion on BPA’s potential to cause harm to human reproduction or development. The report is part of a review of the scientific literature on BPA and takes into consideration public and peer review comments received on the earlier draft report. According to NTP, about 2.3 billion pounds were produced in the United States in 2004, with more than 90 percent of the population being exposed to the substance.

The conclusions are based primarily on animal studies. The literature on experimental animal studies is filled with many conflicting findings, NTP says. And NTP admits that there remains considerable uncertainty whether the changes seen in the animal studies are directly applicable to humans, and whether they would result in clear adverse health effects. NTP also states that more research is clearly needed to understand exactly how these findings relate to human health and development. There are a number of remaining uncertainties in the scientific information on BPA, according to the report.

The NTP is an interagency federal research program at the National Institute of Environmental Health Sciences, part of the National Institutes of Health. The report uses a five-level scale ranging from negligible risk to serious concern.

The report expresses “minimal concern” that BPA exposure will affect development of the mammary gland or accelerate puberty in females. (Previously, NTP said it had some concerns about those effects, but a panel of experts concluded that the program overstated its concerns about mammary gland effects and early puberty.) The NTP expressed “negligible concern” that exposure of pregnant woman to BPA will result in fetal or neonatal mortality, birth defects or reduced birth weight and growth in their offspring. And the report also expressed “negligible concern” that exposure to BPA causes reproductive effects in non-occupationally exposed adults and “minimal concern” for workers exposed to higher levels in occupational settings.


The FDA responded to the final report, noting that it would consider this final report at FDA's Science Board meeting concerning the FDA’s draft assessment of bisphenol A.  Which brings us to development No.2.

2. FDA Meeting
FDA held a public meeting last week, with a range of scientists, industry representatives, and consumer advocates debating aspect of bisphenol A usage.

The focus of the meeting was the FDA’s draft risk assessment that found continued use of bisphenol A in food-contact materials would be safe. Among the highlights:

An EPA toxicologist who served on NTP's expert panel said the NTP's statements that it has "some concern" meant more research was needed. It did not imply that the NTP expert panel had concluded that harm was being caused by the chemical.

A toxicologist working at the National Institute of Environmental Health Sciences said that NTP reported it had "some concern" about neurological, behavioral, and prostate effects because the animal studies that found those effects involved exposures at levels similar to those expected for infants.

The head of the pediatrics department of the Medical College of Wisconsin suggested that FDA conduct or fund more exposure research to get a better understanding of infants' exposure. FDA’s estimates and NTP’s estimates of typical exposure were slightly different.

A representative of the polycarbonate business unit of the American Plastics Council noted that there have been at least two studies of bisphenol A levels in infant formula since FDA completed its study, including one by the Environmental Working Group. All have found levels comparable to what FDA used.

Other speakers noted that BPA is a relatively well studied chemical, and compounds that could be used as substitutes are unlikely to have as much information available about their safety. Clearly, some uses of bisphenol A, such as in children's bicycle helmets, provide many safety benefits. BPA has also been found to be safe with an unmatched performance in lining cans. The Environmental Working Group, said there are substitutes, in their view, already on the market for uses such as in baby bottles.

A toxicologist from the University of Missouri-Columbia worried that FDA's recommended tests might mean it would take many more years before the agency might take any necessary regulatory action to reduce exposure.

John van Miller of the American Chemistry Council, cited the multi-dose, multigenerational, significant studies conducted in accordance with internationally agreed-upon protocols that have found bisphenol A to be safe. The "Reproductive Health Technologies Project" disagreed and underscored the need for studies in their view.

The Bisphenol A Subcommittee is to brief FDA's Science Board later this Fall on the subcommittee's recommendations. The Science Board will then develop its own recommendations for BPA.


3. JAMA Study
The Journal of the American Medical Association published a study last week which has been reported in the popular press as showing that subjects with higher levels of bisphenol A in their urine were more likely to report that they had heart disease or diabetes. See Association of Urinary Bisphenol A Concentration with Medical Disorders and Laboratory Abnormalities in Adults.

Higher levels of human urinary BPA were reportedly associated with cardiovascular disease, type 2 diabetes, and liver-enzyme abnormalities, according to the study, which was discussed at the FDA public meeting. The study used data from the National Health and Nutrition Examination Survey (NHANES) 2003-2004. The survey involved the measured urinary bisphenol A concentrations of 1,455 adults, ages 18 through 74 years. 
 

The investigators noted that orally administered BPA is rapidly and completely excreted by humans.  On of the limitations of the analysis is its cross-sectional nature: it does not offer longitudinal data demonstrating that BPA concentrations predict later onsets of biochemical change or disease. The authors cautioned that their method may have resulted in false-positive associations. The authors have recommended an independent replication of the study, and follow-up studies to explore their findings and to provide evidence on whether the associations are causal. Not well reported in the media is the fact that the research team used four methods to measure whether bisphenol A was associated with diabetes, but found that association in only one of the four methods. The study thus is primarily useful for generating hypotheses that can be tested, not for drawing any conclusions on human health effects.

 

National Juries For National Cases?

At MassTortDefense we typically focus on cases, statutes, and the like, but certainly can make room for a thought-provoking academic piece. Professor Laura G. Dooley, Valparaiso University, has written National Juries For National Cases: Preserving Citizen Participation In Large-Scale Litigation in the NYU Law Review. Her observation: procedural evolution in complex cases seems to have left the civil jury behind. The trend toward centralization of cases pending on the same topic in one court results in cases of national scope being tried by local juries; this reality is a catalyst for forum shopping and a frequent justification for calls to eliminate jury trial in complex cases altogether. Yet, the jury is at the heart of a uniquely American understanding of civil justice, and the Seventh Amendment still mandates its use in federal cases. This article makes a new proposal designed to the constitutional and functional value of citizen participation in the civil justice system by aligning the jury assembly mechanism with the scope of the litigation.

When parties litigate a case of national scope, often a mass tort, this article argues
that the proper jury pool is neither local (as in state court, where jury pools are typically defined along county lines) nor regional (as might be true in a federal district), but rather a national jury drawn from a national pool.

The professor argues that this idea would eliminate incentives to forum-shop into local jury pools, and would make the decision-making body commensurate with the polity that will feel the effects of its decisions. She also postulates a higher level of legitimacy for decisions rendered by a national jury in national cases because they would not be subject to the criticism that a local jury is imposing its values on the rest of the country, and because geographical diversification of the jury would enhance the quality of decision-making. She asserts that the allegedly waning legitimacy of the civil jury in large-scale litigation reflects the disparity between the scope of the local jury pool and the scope of the cases. Moreover, the democratic values animating the Seventh Amendment can best be realized in large-scale litigation by empaneling a national jury, she says.

Interesting. In mass torts, we certainly have seen considerable forum shopping by plaintiffs; frequent attempts by defendants to remove to federal court because of jury pool issues; much anxiety over the use and selection of bellwether trials; and ongoing debate about the role of MDL courts in the early trials in consolidated federal litigation. Readers may have some comments on this one....
 

California Moves Forward With "Green Chemistry" Bills

California – already one of the most aggressive states in regulating chemicals – has passed legislation designed to give state regulators new authority to regulate chemicals in consumer products. The bills are the companion measures, A.B. 1879 and S.B. 509. The state Senate approved its bill late last month. The Governator is expected to sign them in the near future.

The legislation is part of a so-called “green chemistry” initiative, launched more than a year ago. The program is designed to change the state's current chemical-by-chemical regulatory approach and focus on identifying chemicals of concern and exploring opportunities for safer alternatives before they are in widespread use.

The state Department of Toxic Substances Control conducted a series of public workshops and expert meetings to gather ideas on how to implement the initiative. One of the outcomes is the new legislation.  The bills, first, would give the state Department of Toxic Substances Control two years to develop a plan to identify and evaluate chemicals of concern and study alternatives to the chemicals. The measure requires the creation of a "Green Ribbon Science Panel" to advise the department in this task.

Second, the state would have authority to restrict use or ban chemicals from being used in consumer products in the first place – as opposed to regulating a chemical after it has been used as an ingredient. The bill proposes creation of a process to evaluate products for green chemistry regulation, including a multi-factorial life-cycle set of criteria to be considered, including the product’s manufacturing process, use characteristics, and its waste and end-of-cycle disposal.  Specific regulatory outcomes might range from disclosure of additional information regarding a chemical of concern and its potential alternatives; labeling or other types of consumer product information sharing; restrictions on the use of the chemical; to outright prohibition of the use of the chemical.

Third, the bills would require the department to create an Internet-based, publicly accessible Toxics Information Clearinghouse for data on chemicals and potential hazards. 

Some lawmakers supported the legislation because it would take the job of banning chemicals out of the hands of the state legislature. Clearly, the proactive philosophy of the legislation, as opposed to reacting to possible risks after the fact, appealed to some others. If the approach, and particularly the expert panel, takes some of the public hysteria and media frenzy out of the process, there may be an improvement to the rationality of the process. The product’s potential functions and the economic impact of regulating the chemical are supposed to be relevant factors considered.

Whether the green chemistry initiative has a significant impact on mass tort and toxic tort litigation remains to be seen. A more rational, science-based approach could curtail risks and undermine frivolous suits where general causation – the ability of the chemical to cause a disease – is far from clear.

The text of A.B. 1879 and S.B. 509 is available here.  

Wyeth Files Reply Brief in Levine Preemption Case

Wyeth has filed its reply brief in the Levine case.

The reply stresses that this case is not a conventional failure to warn case, but an alleged failure to contraindicate case. Thus, plaintiff is directly challenging the FDA’s balancing of the risks and benefits of a labeled, warned-about indication. State law cannot obstruct federal regulation of pharmaceuticals by seeking to impose a different outcome to this balancing process than the one reached by the FDA.

When the FDA did address the risks and benefits of the particular method of drug delivery at issue, the agency told the defendant to use labeling which the state court jury held was inadequate under state law. 

Wyeth also stressed what the case was not: no allegations of concealment from the agency or of failure to make a label change in response to any new risk information. The FDA had all the important information, and made a regulatory decision, which plaintiffs told the jury they could, and should, simply reject.

Note also an interesting discussion of CBE issues, with the arguments that this was not a CBE case, especially where methods of use are at issue, and that the FDA's interpretation of the CBE is entitled to Auer- level deference. (As noted in a post by MassTortDefense, the CBE regulation was always intended to apply solely to new, emerging, significant information.) Finally the plaintiff’s argument that the defendant must prove that a CBE submission would have been unsuccessful before qualifying for preemption would create the untenable and frequently dis-approved situation in which juries are deciding hypothetical situations full of what-ifs.
 

FDA Meeting On Nano-Technology Spurs Debate

The FDA held a public meeting on September 8, 2008, to gather information that will assist the agency in further implementing the recommendations of the Nanotechnology Task Force Report relating to the development of agency guidance documents concerning nanotechnology. In July 2007, FDA had issued a report analyzing scientific and regulatory considerations relating to the safety and effectiveness of FDA-regulated products containing nanoscale materials regulated by FDA, and making recommendations regarding these considerations. The Nanotechnology Task Force Report made recommendations which covered foods (including dietary supplements), food and color additives (including food contact substances), animal drugs and feeds, cosmetics, human drugs and biologics, and medical devices. Additionally, the Report summarized the state of the science for biological interactions with nanoscale materials.

The meeting included a plenary session led by Dr. Norris Alderson, head of the FDA Nanotechnology Task Force, followed by separate sessions for prescription and OTC drugs, cosmetics, medical devices, food additives, and others. FDA speakers reportedly were interested in comments on the circumstances under which the regulatory status of a product might change if nanoscale materials were utilized instead of the traditionally sized materials evaluated by regulatory officials when the product was first approved. 

Andrew Maynard, the chief science adviser for the Project on Emerging Nanotechnologies, told the FDA at the September meeting that they should view products containing nanomaterials as potentially "risk-added." Maynard said that materials with a dimension less than 100 nanometers exhibit unique properties due to their small size, and thus are “value-added." But, Maynard said, the unique properties exhibited by nanomaterials might also carry special risks. Francis Quinn, speaking on behalf of the Personal Care Products Council, offered a different perspective. For example, while nanoparticles are used in the early stages of developing sunscreens, by the time they are mixed with other ingredients they are no longer nanoscale and present no different risks than traditional sunscreens. Jay Ansell, senior director of the council, said no special labeling of nanoscale ingredients in cosmetics is needed.

But other speakers said the FDA needs to take a different approach as it contemplates regulating products containing nanoscale ingredients. The Conservation Law Foundation said that existing frameworks for assessing risks need to be updated to address nano-specific attributes such as particle characteristics. And a researcher from The George Washington University urged caution about the use of nanomaterials in dietary supplements.


As an aside, the latest report from the Project on Emerging Nanotechnologies addresses nano-scale silver. Silver Nanotechnologies and the Environment: Old Problems or New Challenges. The most common nanotechnology material currently used in the products is silver, which is mentioned in 235 product descriptions, such as silver-containing socks, baby carriages, air filters, coin-operated washing machines, and swimming pool treatments. 

The report asserts that widespread use of nanoscale silver will challenge regulatory agencies to balance important potential benefits against the possibility of significant environmental risk, highlighting the need to identify research priorities concerning this emerging technology. The issue of assessing the risks posed by nanoscale silver was highlighted after the Environmental Protection Agency’s (EPA) San Francisco office earlier this year imposed a fine of $200,000 on a California company selling computer keyboards and mouses coated with nanosilver. EPA issued the fine on the basis that the products should have been registered under federal pesticide law because of the company’s germ-killing claims. Due to its antibacterial properties, some have argued that the Federal Insecticide, Fungicide, and Rodenticide Act may be used to regulate many uses of nanoscale silver.

Nanosilver is a new challenge, says the report, a problem that fits poorly into the old boxes of the existing regulatory system. EPA is crafting a Federal Register notice that will invite comment on a citizen’s petition on nanoscale silver. EPA also has a 2007 white paper on nanotechnology.
 

To Stay Or Not To Stay?

The large shadow being cast by the Levine v. Wyeth case pending before the U.S. Supreme Court covers a multitude of issues in ongoing pharmaceutical cases.  One is the question whether to stay pending litigation until the Court reaches a decision. See Forst v. Smithkline Beecham Corp., 2008 WL 2337283 (E.D.Wis., 2008)(denying plaintiff's opposed motion for stay); Horne v. Novartis Pharmaceuticals Corp., 2008 WL 1847077 (W.D.N.C. 2008)(denying parties' Joint Motion to Stay Proceedings without prejudice to renewal of said motion after the completion of discovery).

Stay requests assume that defendant will file, or follow the filing of, a dispositive motion asserting that the Food, Drug, and Cosmetic Act, 21 U.S.C. § 301, et. seq., preempts plaintiffs’ state law claims that a prescription drug manufactured by defendant lacked adequate warnings. The argument would be that the Supreme Court’s decision in the Levine v. Wyeth case may have a potentially significant impact on the pending case. A stay may conserve defendant’s resources and avoid an expensive trial which would then need to be repeated following the Supreme Court’s ruling.

So why not file such a stay motion? Why might a defendant oppose one?

Putting aside those situations in which the preemption issue seems not central to the pertinent drug case, and putting aside the impossible to know for sure chance that the Supreme Court’s ruling will be narrow and have no direct impact on some cases, other potential issues exist that defendants need to contemplate.

One factor is that defendants may want and need to develop facts during discovery that support dispositive motions based on other, independent grounds. One example may be the learned intermediary doctrine. A stay may, in some cases, hamper the defendant’s ability to conduct the discovery necessary for developing motions on non-preemption issues, upon which Levine has no bearing. A stay might prevent the defendant from developing the record and preserving evidence. 

It will thus be a weighing process, a cost/benefit analysis each defendant must make, factoring in the time and costs, status of the case, proximity of trial, relationship of the specific preemption issues to those before the Court, nature of the forum, etc.
 


 

E-Discovery Relief?: Congress Passes Bill To Reduce Risk Of Inadvertant Disclosure Of Privileged Material

Congress has passed and sent to the President a bill that amends the Federal Rules of Evidence with respect to the disclosure of a communication or information covered by the attorney-client privilege or work product protection. The bills S. 2450/H.R. 6610 limit the effect of inadvertent disclosure of privileged materials. The Senate passed S.2450 in February, 2008, and the House passed the identical H.R. 6610 last week.

One unfortunate aspect of the new e-discovery rules has been a tremendous cost due to the need to review ESI, particularly emails, to make sure that privileged information is not given to the other side. Mass tort defendants, in particular, must often sift through a mountain of documents to ensure that privileged material is not inadvertently released. While most documents produced during discovery have little value, attorneys must still conduct exhaustive reviews to prevent disclosures of the needle in a haystack that reveals confidential information. The cost to litigants is staggering and the time consumed by courts to supervise these activities can get excessive.

The bill impacts this problem not by changing the law on the attorney-client privilege or the work product doctrine, but by modifying the consequences of an inadvertent disclosure once a privilege exists, through creation of new Federal Rule of Evidence 502. The federal rules committees studied this problem in connection with various proposals to change the discovery rules. The rules committee concluded that the need for exhaustive preproduction privilege reviews could be significantly reduced if the risks of waiver were clarified and limited, and thus recommended the bill’s changes.

The bill provides that, in new Rule 502(a), when a disclosure is made in a federal proceeding (or to a federal office or agency), and that disclosure waives the attorney-client privilege or work-product protection, the waiver extends to an undisclosed communication or information only if: (1) the waiver is intentional; (2) the disclosed and undisclosed communications or information concern the same subject matter; and (3) they ought in fairness to be considered together. When the disclosure is made in a federal proceeding (or to a federal office or agency), under new Rule 502(b), it does not operate as a waiver in a federal or state proceeding if: (1) the disclosure is inadvertent; (2) the holder of the privilege or protection took reasonable steps to prevent disclosure; and (3) the holder promptly took reasonable steps to rectify the error. 

Maybe a small step in the right direction.
 

Issue Preclusion in Mass Torts

Professor Byron Stier, of Southwestern Law School, has written an interesting article entitled, Another Jackpot (In)Justice: Verdict Variability and Issue Preclusion in Mass Torts.

In it, he notes that if there are no prior inconsistent verdicts, non-mutual offensive issue preclusion generally allows a finding by a single jury to bar re-litigation, in future cases, of the issue by the defendant who lost in the prior case. This approach, however, ignores the possibility that the first verdict delivered may have been an outlier, a fact that would be shown only if further verdicts were permitted to be delivered. In mass tort litigation, such a flawed approach may result in critical issues such as defect or negligence being resolved by only six jurors, when the potentially outlier verdict is then potentially applied to resolve the cases of thousands, perhaps bankrupting a company or an industry -- even when most juries would not so hold.

Focusing on mass tort litigation, this article by Professor Stier presents some growing empirical evidence of verdict variability and then critiques the use of issue preclusion, whose downside is applied only against defendants, not plaintiffs, because only defendants were parties to the prior action. As a result, the article argues, courts should exercise their discretion to deny issue preclusion in mass tort litigation. Instead, he asserts, courts should join the emerging consensus of mass tort management that ultimately better serves the goals of efficiency and public respect supposedly underlying issue preclusion: allow multiple verdicts to unfold a more balanced view of liability that will frequently be used for well-informed and far-reaching settlements. 

Given the administrative burden that mass torts can place on the courts, even with the use of management techniques such as an MDL, the temptation to use short-cuts to the traditional day in court promised all litigants and demanded by fundamental fairness can be immense. The professor offers some powerful arguments against one such short-cut.
 

Federal Court Rejects Toxic Tort Class Action

A federal district court has declined to certify a proposed class action involving as many as 33,000 residents living near a Kentucky manufacturing plant. Cochran v. Oxy Vinyls, 2008 WL 4146383 (W.D. Ky. Sept. 2, 2008). For readers of MassTortDefense, an interesting feature of this proposed toxic tort class action was the court’s focus on the proposed class definition.

Plaintiffs, residents of neighborhoods surrounding an industrial area known as “Rubbertown,” alleged that emissions from defendant's operations in its nearby plant invaded their property in the form of particulate matter fallout and noxious odors. Defendant operated a plant in the Rubbertown area, at which it manufactured polyvinyl chloride resins (“PVC”); but defendant's plant is only one of several industrial facilities in the Rubbertown area.

Plaintiffs filed their complaint in 2006, alleging nuisance, negligence and/or gross negligence, strict liability for ultrahazardous activities, and trespass. Plaintiffs moved for class certification under Federal Rules of Civil Procedure 23(b)(2) and 23(b)(3), for a class defined as including owners or residents of single family residences within two miles of the Oxy Vinyls facility, who allege the invasion of their property….a circular and largely geographic-based definition.

The court rejected this proposed definition. Although not specifically mentioned in Rule 23, the proper definition of the class is an essential prerequisite to maintaining a class action. The class must be sufficiently definite that it is administratively feasible for the court to determine whether a particular individual is a member. Courts have rejected certifying proposed classes where plaintiffs failed to identify any logical reason for drawing the class boundaries where they did. See, e.g., Daigle v. Shell Oil Co., 133 F.R.D. 600, 602-03 (D .Colo.1990) (holding that the plaintiffs had “failed to identify a class” where the proposed boundaries did not appear to “relate to the defendants' activities,” but were instead “arbitrarily ... drawn lines on a map”).

After an initial failed stab at certification, plaintiffs supplemented their effort with the expert report of an industrial hygienist, Roger Wabeke, who spent two days collecting air and settled dust samples in the neighborhoods immediately around the plant operated by Oxy Vinyls in an effort to tie the plant's alleged particulate pollution to the proposed class. The court's review of the record, even as supplemented by Mr. Wabeke's report, revealed an insufficient relationship between the proposed class definition and the evidence provided regarding the alleged emissions of the facility. The court concluded that Mr. Wabeke's report utterly failed to substantiate any sort of evidentiary relationship among the proposed class members that would justify certification of the proposed class.

The Wabeke report had numerous infirmities, but the most significant to the court was that the dust and air samples he collected were "virtually meaningless." The court noted that its rigorous review of the scientific evidence was not an inquiry into the merits, but rather a careful analysis of the Rule 23 prerequisites. Mr. Wabeke's report was “stunningly inadequate.” Far from a proposed class definition that was “objectively reasonable,” plaintiffs had offered no meaningful evidence that airborne contaminants from Oxy Vinyls spread in a uniform fashion in all directions from defendants' facility for a distance of up to two miles, or really that they spread that far from Oxy Vinyls at all. Therefore, the court was left without a basis upon which it could properly conclude that the members of the proposed class were distinguishable from the general public. For example, plaintiffs offered no way in which the proposed class members would be distinguished from those whose property may have been damaged by similar emissions from other facilities.

The faulty class definition also infected other elements of the Rule 23 analysis. Numerosity is inextricably bound up in the question of class definition. Thus, a flawed class definition can make it difficult to determine whether a class defined by geographical boundaries satisfies the numerosity requirement; indeed, courts faced with overbroad proposed classes have rejected plaintiffs' numerosity arguments due to this difficulty.

Similarly, the court was unable to conclude that named plaintiffs represented an adequate cross-section of the proposed class. For example, a proposed class member's lesser proximity to defendant's facility or closer proximity to one of the other facilities in the area may completely eliminate defendant's liability for the alleged harm they experienced. Mr. Wabeke's report provided no assurance of typicality, since the samples taken of settled dust were clearly and admittedly not “typical” of anything.

As for Rule 23(b)(3), the critical evidence of causation would be based upon highly individualized testimony. Thus, the Court was not at all convinced that defendant's liability to the class would involve predominating common issues or that a class action would be the superior method of adjudicating plaintiffs' claims.

The court concluded that Rule 23 and the vast majority of other mass tort cases “do not support the idea that simply by demanding a class and filing a document styled as an expert report a group of plaintiffs are thereby entitled to certification of whatever class they propose.”
 

FDA Releases First Quarterly Safety Signals Report

The U.S. Food and Drug Administration has posted on its website its first quarterly report listing certain drugs that are being evaluated for potential safety issues. FDA posted the reports in accordance with Section 921 of the Food and Drug Administration Amendments Act of 2007, which, among other things, directs FDA to inform the public each quarter of new safety information or potential signals of serious risk, based on the agency's review of adverse event reports. Specifically, FDA is to "conduct regular, bi-weekly screening of the Adverse Event Reporting System [AERS] database and post a quarterly report on the Adverse Event Reporting System Web site of any new safety information or potential signal of a serious risk identified by Adverse Event Reporting System within the last quarter."

FDA released the first quarterly report, listing 20 drugs. The information is provided based on a review of reports in AERS. The FDA staff in the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) regularly examine the AERS database as part of routine safety monitoring. When a potential signal of a possible risk is identified from AERS data, it is entered as a possible safety issue into CDER's Document Archiving, Reporting, and Regulatory Tracking System (DARRTS) or into CBER's Therapeutics and Blood Safety Branch Safety Signal Tracking (SST) system. Potential signals of serious risks are normally based upon groups of AERS reports.

Drugs that appear on the agency's new "Potential Signals of Serious Risks/New Safety Information," are thus identified by FDA reviewers based on reports from the FDA's AERS database, which contains millions of reports of adverse events submitted to FDA by drug manufacturers, health care professionals and patients. For a drug to appear on this report, an FDA reviewer will have determined there is some reason to examine a drug more closely based on either the seriousness or number of AERS reports associated with the drug. The drugs for which issues have been identified are under evaluation for the listed potential risk. Each year, FDA receives about 400,000 reports of adverse events that people experienced around the same time period in which they were taking a drug.

An adverse event report does not establish a causal relationship between the drug and a particular event. The FDA itself has warned that for any given ADE case, there is no certainty that the suspected drug caused the event. This is because physicians and consumers are encouraged to report all suspected ADEs, not just those that are known or even suspected to be caused by the drug. The adverse event may have been related to an underlying disease for which the drug was given, to other concomitant drug usage, or may have occurred by chance at the same time the suspect drug was administered. The courts have characterized ADEs as “complaints called in by product consumers without any medical controls or scientific assessment.” McClain v. Metabolife Intern., Inc., 401 F. 3d 1233, 1250 (11th Cir. 2005). Because the reporting system is not subject to scientific controls, data from it is subject to various statistical biases. It is likely that the mix of reported events does not represent an accurate sampling of those events that can occur while a person is taking any medication. Moreover, medical or media attention can stimulate reporting in a distorted manner, and known adverse reactions are more likely to be diagnosed and reported than others. See DeLuca v. Merrell Dow Pharmaceuticals, Inc., 791 F. Supp. 1042, 1050 (D. N.J. 1992), aff’d 6 F. 3d 778 (3d Cir. 1993), cert. denied, 510 U.S. 1044 (1994) (ADEs “have inherent biases as they are second-or-third hand reports, are affected by medical or mass media attention, and are subject to other distortions.”).

MassTortDefense notes, that in contrast to how plaintiff attorneys seek to use the adverse event reports, or how the media has portrayed this new list, the appearance of a drug on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but does not mean that FDA has identified a causal relationship between the drug and the listed risk. It may be too early to know whether there is an actual safety problem, and FDA’s analysis may ultimately conclude that there is no safety problem. If after further evaluation the FDA determines that the drug is associated with the risk, it may take a variety of actions including requiring changes to the labeling of the drug, requiring development of a Risk Evaluation and Mitigation Strategy (REMS), or gathering additional data to better characterize the risk. FDA also emphasizes that the listing of a drug does not mean that FDA is suggesting that prescribers should not prescribe the drug or that patients taking the drug should stop taking the medication. 

Thus, the new quarterly reports should not change the existing view of the majority of courts that adverse event reports are ordinarily too unreliable to be used as proof of causation. See McClain, 401 F. 3d at 1250; Hollander v. Sandoz Pharmaceuticals Corp., 289 F. 3d 1193, 1211 (10th Cir. 2001); cert. denied, 537 U.S. 1088 (2002) (characterizing the case reports before the court as unreliable evidence of causation); Haggerty v. Upjohn Co., 950 F.Supp. 1160, 1165 (S.D. Fla. 1996), aff’d, 158 F. 3d 588 (11th Cir. 1998); In re Accutane Products Liability Litig., 511 F. Supp.2d 1288, 1298-1303 (M.D. Fla. 2007); Benkwith v. Matrixx Initiatives, Inc., 467 F. Supp. 2d 1316, 1327 (M.D. Ala. 2006); Leathers v. Pfizer, Inc., 233 F.R.D. 687, 694 (N.D. Ga. 2006). See also Glastetter v. Novartis Pharmaceuticals Corp., 252 F. 3d 986, 990-91 (8th Cir. 2001) (“Case reports make little attempt to screen out alternative causes for a patient’s condition. They frequently lack analysis. And they often omit relevant facts about the patient’s condition.”); Dunn v. Sandoz Pharmaceutical Corp., 275 F. Supp.2d 672, 682 (M.D.N.C. 2003) (“Case reports are not scientific proof of causation.”); Caraker v. Sandoz Pharmaceuticals Corp., 172 F. Supp. 2d 1046, 1050 (S.D. Ill. 2001) (rejecting expert opinions insofar as they relied upon case reports); Nelson v. American Home Products Corp., 92 F. Supp. 2d 954, 969 (W.D. Mo. 2000) (“At most, these case reports relay a basis for scientific hypotheses; they do not demonstrate a causal link sufficient for admission to a finder of fact in court.”); DeLuca v. Merrell Dow Pharmaceuticals, Inc., 791 F. Supp. 1042, 1051 (D. N.J. 1992), aff’d, 6 F. 3d 778 (3d Cir. 1993), cert. denied, 510 U.S. 1044 (1994) (ADEs “are not of a type of data that are reasonably relied upon by experts in the fields of epidemiology and public health.”); Siharath v. Sandoz Pharmaceuticals Corp., 131 F. Supp. 2d 1347, 1359-63 (N.D. Ga. 2001); Cartwright v. Home Depot USA, Inc., 936 F. Supp. 900, 905 (M.D. Fla. 1996).
 

Eighth Circuit Affirms Exclusion Of Causation Expert In Toxic Tort Case

The 8th Circuit has upheld the trial court’s decision that a plaintiff who alleged she was injured by drinking water from a bottle filled with freon did not have adequate and valid expert evidence of causation. Bland v. Verizon Wireless, 2008 WL 3474178 (8th Cir. August 14, 2008).

Plaintiff alleged that she inadvertently left her water bottle behind in a store, and an employee of defendant sprayed compressed air into her water bottle “as a joke,” believing the water bottle belonged to a fellow employee. At home, plaintiff opened the bottle which “made a-kind of pressurized noise.” She took a drink, then decided to smell the contents, taking a big whiff which made her cough. She then allegedly took another drink.

Plaintiff later reported to her doctor that after drinking from the bottle she coughed, which persisted for nearly an hour. She also described a “sore sensation in her throat” and for the next few days a “raspy sensation in her lungs.” Plaintiff alleged she developed a headache which persisted for about two weeks. Later testing at the University of Iowa Lab determined the bottle contained 820 parts per million (ppm) (.08%) of difluoroethane, a freon compound.

Plaintiff was later seen by a Dr. Sprince, complaining of shortness of breath when running. Her lung function test results were basically normal. Dr. Sprince eventually diagnosed her as having “exercise-induced asthma.” Dr. Sprince later theorized that “[b]ased on the initial clinical findings, [a] strong temporal relationship between the inhalation of freon and the occurrence of respiratory symptoms, and the subsequent response to pre-exercise treatment with inhaled bronchodilator” that plaintiff's exercise-induced asthma was caused by the inhalation of freon.

Plaintiff sought to use the testimony of this treating physician, Dr. Sprince, to establish a causal link between inhalation of freon and the alleged exercise-induced asthma. The district court excluded Dr. Sprince's testimony because Dr. Sprince's proffered testimony as to causation did not satisfy the standards for admission of expert scientific testimony under Daubert.

The 8th Circuit affirmed, noting first that a treating physician's expert opinion on causation is subject to the same standards of scientific reliability that govern the expert opinions of physicians hired solely for purposes of litigation.

The first problem with Dr. Sprince's causation testimony was that she failed scientifically to eliminate other possible causes as part of her differential diagnosis. In particular, her own testimony acknowledged the cause of exercise-induced asthma in the majority of cases is unknown. Where the cause of the condition is unknown in the majority of cases, an expert cannot properly conclude, based upon a simple differential diagnosis, that exposure, here to freon, was the most probable cause of the injury. As a practical matter, Dr. Sprince's causation opinion could not possibly be based upon a reasonable degree of medical certainty. Where the majority of cases of exercise-induced asthma have no known cause, and where Dr. Sprince failed to do an investigation and analysis of plaintiff's home or other environments in search of other possible causes, the district court did not abuse its discretion in determining Dr. Sprince's differential diagnosis did not satisfy Daubert.

Second, plaintiff’s expert did not know what amount of exposure to freon causes, or involves an appreciable risk of causing, asthma, and had no good grounds for determining whether plaintiff  was exposed to a sufficient dose to have caused her asthma. Dr. Sprince could not determine or estimate the amount of freon plaintiff was actually or probably exposed to. The expert could not extrapolate from the existing data because the gap between the data identified (exposure facts) and Dr. Sprince's proffered opinion was simply too great an analytical gap to support admissibility. Critical to a determination of causation is characterizing exposure. In a toxic tort case, the magnitude or concentration of an exposure should be estimated and the temporal aspects of the exposure should be determined --whether the exposure was short-term and lasted a few minutes, days, weeks, or months, or was long-term and lasted for years. Dr. Sprince lacked knowledge regarding what level of exposure to freon constitutes an appreciable risk of causing asthma and the specific concentration and degree of exposure to the freon. Similarly, plaintiff’s expert did not offer as evidence any personal experience with treating other patients following a similar exposure, admitting she had no such experience.

Finally, the expert’s heavy reliance on temporal proximity, without more, was insufficient to establish causation. In the absence of an established scientific connection between exposure and illness, or compelling circumstances, the temporal connection between exposure to chemicals and an onset of symptoms, standing alone, is entitled to little weight in determining causation. See Moore v. Ashland Chem., Inc., 151 F.3d 269, 278 (5th Cir.1998). It is not always irrelevant, said the court. The temporal relationship often will be one of several factors, and the weight to be given to the temporal relationship will differ depending on the strength of that relationship. But in this case, the district court properly discounted all the other factors supporting Dr. Sprince's opinion leaving only temporal proximity to support Dr. Sprince's causation opinion. And that was not enough, especially when plaintiff did not make an appointment with a doctor until two to three weeks after the incident.
 

FDA To Hold Meeting On BPA Issues

For those readers of MassTortDefense interested in the issues surrounding BPA, the FDA has announced a meeting of its Bisphenol A (BPA) Subcommittee of the Science Board.

The topic to be discussed is the draft assessment of BPA for use in food contact applications. The Subcommittee will hear and discuss the draft assessment of BPA for use in food contact applications, including oral presentations from the public. The meeting will be held on September 16, 2008.

The FDA draft assessment report finds that the chemical does not pose a serious health risk under current uses. The new 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.
 

D.C. Circuit Upholds USDA Ban On Additional "Mad Cow" Testing-- So Far

The U.S. Court of Appeals for the District of Columbia Circuit has overturned the ruling of a trial court, and has held that the federal government can prohibit meatpackers from doing additional testing of their animals for "mad cow" disease. Creekstone Farms Premium Beef, L.L.C. v. Department of Agriculture, 2008 WL 3980533 (D.C. Cir. 2008).

The dispute arose between the Agriculture Department, which tests a statistical sample of cows for the potentially deadly disease, and a Kansas meatpacker, Creekstone Farms Premium Beef, which wants to test all of its animals.

Background
Bovine Spongiform Encephalopathy (BSE) is an invariably fatal neurological disease that causes degeneration of the cow's central nervous system. BSE occurs when healthy cattle are fed the remains of an animal infected with abnormally formed prions. As abnormal prions accumulate within the brain cells, they cause the cells to rupture, resulting in a loss of coordination and ultimately the death of the animal. Prions that cause BSE in cattle can cause a similar disease in humans known as variant Cruetzfeldt-Jakob Disease (vCJD). Since 1986, approximately 190 people - 95% of whom resided in the United Kingdom - have died as a result of confirmed cases of vCJD. Some scientists believe humans can contract vCJD by consuming BSE-contaminated beef or beef products.

BSE was first diagnosed in the United Kingdom in 1986. Since then, more than 189,000 confirmed cases of BSE in cattle worldwide have been reported. While almost all of the cases (95%) have occurred in the United Kingdom, BSE has been found in cattle raised in at least twenty-five other countries. In 1989, USDA banned the importation of animal remains from countries with known BSE-infected cattle. Only three BSE-infected cows have been found in the United States. The first was reported in December, 2003 in a Canadian-born cow in Washington State. Two more BSE-infected cattle were found after that, one in Texas in June, 2005, and one in Alabama in March, 2006. In July, 2006, USDA announced that in light of “the extremely low prevalence of the disease” in the U.S ., it intended to test a sampling of approximately 40,000 per year, about 1% of the total number of cattle slaughtered in the United States.

The Dispute

In December, 2003, many countries began to ban or severely limit importation of U.S. beef because bovine spongiform encephalopathy (BSE) -mad cow disease- had been found in that one cow in Washington State. To counter the fears of beef importers as well as domestic consumers, plaintiff Creekstone developed a plan, it asserted, to test for BSE each of the approximately 300,000 cattle it slaughters each year. The United States Department of Agriculture (USDA), however, asserting authority under the Virus-Serum-Toxin Act, denied Creekstone's request to purchase or use BSE test kits. Specifically, Creekstone sought to purchase rapid BSE test kits but the importer informed Creekstone that it could not sell Creekstone the kits without USDA authorization. USDA denied Creekstone's requests for permission.

Plaintiff sued, and the trial the court concluded that USDA cannot regulate BSE testing because, while the regulations allow USDA control of the diagnosis and treatment of cows, the test kit cannot be used in the treatment of domestic animals. The court reasoned that, because there is no known cure for BSE and because testing can be done only post-mortem, rapid BSE test kits are not used for “treatment.”

The Court of Appeals disagreed. The regulations define “treatment” as including the prevention, diagnosis, management, and cure of diseases of animals. The rapid BSE test kit need fulfill only one of the functions. Plainly, rapid BSE testing is used to diagnose the disease. Moreover, rapid BSE testing plays a valuable role in preventing and managing the spread of BSE. It allows USDA to identify and destroy the remains of an infected cow, trace the spread of the disease, and evaluate the success of its disease management measures. Thus, while there is no way to “treat” or cure the dead cow if the test is positive, the test kit nonetheless plays an important diagnostic role. Moreover, the USDA explained that universal testing is not meaningful because, given BSE's long incubation period and the relatively young age of most cattle at slaughter, it would not produce meaningful results. In contrast, the agency found efficacy of BSE testing when used on high-risk cattle as part of a statistically and epidemiologically valid surveillance plan.

The concurring opinion stressed that the Department's interpretation allowing it to restrict import permits based on intended use of a biological product is entitled to deference under Chevron U.S.A., Inc. v. Natural Res. Def. Council, Inc., 467 U.S. 837 (1984). 

Summary judgment vacated, and plaintiff to have an opportunity to go forward with its case on remand, subject to the ruling.
 

Daubert Ruling And Summary Judgment Updheld In Accutane Cases

A federal appeals court last week affirmed a district court's grant of summary judgment against plaintiffs who alleged the acne drug Accutane caused inflammatory bowel disease (IBD). Rand v. Hoffmann-LaRoche Inc., 2008 WL 3977611 (11th Cir., 8/26/08). After considering the briefs, the relevant parts of the record, and the opinion by the district court, In re Accutane Prods. Liab., 511 F.Supp.2d 1288 (M.D.Fla .2007), the appeals court concluded that the district court did not abuse its discretion by excluding the plaintiffs’ expert causation evidence and had properly granted summary judgment.

This trial court order dealt with the general causation issue of the IBD cases. General causation is concerned with whether an agent is capable of causing a disease and not whether the agent caused any given individual's disease. In this case, plaintiffs’ expert, Dr. Fogel, opined that Accutane is a cause of IBD. The issue before the trial court was whether the methodology Dr. Fogel employed in reaching this opinion met the legal standard of reliability set forth in Daubert v. Merrell Dow Pharmaceuticals.

Dr. Fogel pointed to several data sources to support his opinion. First was an alleged analogy to animal and cell culture studies. The court found that Dr. Fogel relied on certain studies of dogs, rats and cell cultures, but had simply ignored the parts of those studies that do not support his opinion, particularly the dose-response relationship. He further drew conclusions not supported by the authors of those studies, said the court. Furthermore, there were other studies, both of dogs and humans, that were contrary to Dr. Fogel's opinions, but he failed to explain why these other studies have no significance or to otherwise somehow differentiate them from the ones upon which he relied.

On the important issue of dose, the court noted that dose is critical to any evaluation of toxicity of a drug. In fact, dose may be the single most important factor to consider in evaluating whether an alleged exposure caused a specific adverse effect. Indeed, the basic dictum of toxicology as stated by the 16th century physician/philosopher, Paracelsus, was “All substances are poisonous-there is none which is not; the dose differentiates a poison from a remedy.”  An expert who ignores the dose-response relationship casts suspicion on the reliability of his entire methodology. Often low dose exposures -even for many years- will have no consequence at all, since the body is often able to completely detoxify low doses before they do any damage. Furthermore, for most types of dose-response relationships following chronic (repeated) exposure, certain thresholds exist, such that there is some dose below which even repeated, long-term exposure would not cause an effect in any individual.

The expert also tried to rely on defendants' own internal documents purportedly expressing conclusions on causation. But contrary to Dr. Fogel's conclusion about these “admissions,” the court determined that the causality assessments referred to by Dr. Fogel did not evidence any conclusion that the adverse events reported were caused by Accutane. Instead, they constituted a synopsis of complaints received by the defendant from various reporters (patient, parent, doctor, or even attorney) regarding their subjective beliefs as to the causes of particular ailments. That is, they reflect the reporter's opinion as to causality, not the company’s. And they do not necessarily contain information regarding the patient's medical history, family medical history, or information concerning other risk factors of IBD that would even allow the company to make any legitimate conclusions. While a review of the assessments may possibly support a conclusion that there was an association between Accutane and IBD, an association is not equivalent to causation. This review may serve as a basis for forming an hypothesis, but certainly did not equate with causation.

Lastly, Dr. Fogel relied on anecdotal consumer complaints themselves (“adverse event reports” or “case reports”) reported to the company or the FDA, or published to the medical community. However, these reports concerned events that occurred without any medical controls or scientific assessment. Uncontrolled anecdotal information offers one of the least reliable sources to justify opinions about both general and individual causation, said the court. The reports were unreliable as proof of causation because, in general, the events were not observed in such a way as to rule out coincidence or other potential causes.
 

FDA Considering Revised Rule For Pediatric Cough and Cold Medications

The Food and Drug Administration has announced 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. 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. At this public hearing, FDA is interested in obtaining public comment about certain scientific, regulatory, and product use issues as it proceeds with the rule-making and reviews new drug applications (NDAs) for these ingredients.

MassTortDefense notes that there has been significant litigation in the past concerning ingredients used in many over-the-counter and prescription cough and cold medications as a decongestant to relieve stuffy nose or sinus congestion. At one point, Americans took 6 billion doses of the ingredient PPA each year from as many as 400 over-the-counter products containing PPA. A Yale Univ. study suggesting possible increased hemorrhagic stroke risks led manufacturers to remove PPA from their products. This in turn led to a mass tort, MDL and all. The epidemiology of the Yale study, according to plaintiffs, indicated that there were about 10,000 PPA-related strokes in the ten years preceding the FDA withdrawal. As it turned out, of nine PPA verdicts 2000-2006, only one was a plaintiff victory. As a result, PPA defendants were reportedly able to settle hundreds of the plaintiffs' best PPA cases for relatively modest amounts. Multiple PPA cases have been dismissed, either by plaintiffs lawyers or by the MDL court.

Today, FDA estimates that there are approximately 10,000 products being marketed for cold, cough, or combined indications under the OTC Drug Review. Depending on the dosage form and strength of these products, many of them are labeled for pediatric use, including some that are labeled for use in both adults and children. There are approximately 38 active ingredients in the final Monograph. Some combination cough and cold products contain as many as four of these active ingredients in a single dosage form, meaning that patients may be exposed to four different active ingredients when using a single product. From 2002 to 2006, there were approximately 36 billion units of combination cough and cold products sold each year in the United States. For liquid formulations used for the youngest children, there were approximately 190 million units sold each year in the combined cough and cold categories during this period. Cough and cold products are commonly used in children. A recent report suggested that 1 in 10 children uses one or more cough and cold products during a given week with exposure being highest among 2 to 5 year-olds.

FDA is interested in obtaining public comment on several issues, including:
1. What types of studies should be conducted to assess effectiveness and/or safety, and determine appropriate dosing of cough and cold ingredients in the pediatric population?
2. Should cough and cold products for the pediatric population continue to be available OTC, or should they be made available only by prescription?
3. If the pediatric indications and dosing for cough and cold products were no longer available OTC, would the public use the adult formulations of the products for children, and thus create a greater potential risk of misuse or overdose?
4. Current standards permit extrapolation of pediatric efficacy  -- but not safety-- based upon sufficient adult data. Does it remain appropriate to recommend in the cough and cold monograph that children 12 and over should receive the same dose of medication as adults, without requiring any additional studies in children in this age group?
 

FDA Finalizes CBE Rule, Reinforcing Preemption

The Food and Drug Administration has finalized the updated rule on using supplemental applications for changes to prescription drug, biologics, and medical device labels. The final rule, 73 Fed. Reg. 49603, allows manufacturers to submit a supplemental application to amend the labeling for an approved product to reflect newly acquired information. These supplements are commonly referred to as "changes being effected supplements" or "CBE supplements." The final rule becomes effective on Sept. 22, 2008. The final rule modifies 21 C.F.R. Sections 314, 601 and 814.

MassTortDefense would disagree with the media reports describing this as a “new” rule. In fact, the final rule affirms FDA’s longstanding position that a CBE supplement is appropriate to amend the labeling for an approved product only to reflect newly acquired information. But even though when it originally adopted this regulation FDA intended it as a limited, narrow, emergency exception to the general rule of Agency pre-approval of changes to prescription drug labeling, after preemption became a huge issue in prescription drug product liability litigation the regulation has been at times cited by courts as applying far more broadly than the FDA intended.

Plaintiffs argued that, since manufacturers are supposedly free to change their labels without prior FDA approval, there can be no conflict with state law holding them liable for not doing what the regulation supposedly allows. The plaintiffs thus have argued that the narrow exception swallows the rule that drug labeling changes are subject FDA pre-approval. Some courts have accepted this argument, and for example ruled that pharmaceutical defendants should have unilaterally strengthened suicide warnings for antidepressants – despite the FDA having evaluated the evidence of this alleged risk multiple times, concluding that there is no sufficient scientific basis for including a suicide warning. Compare McNellis v. Pfizer, Inc., 2006 WL 2819046 (D.N.J. Sept. 29, 2006) with Colacicco v. Apotex, Inc., 432 F. Supp.2d 514, 523, 527-28 (E.D. Pa. 2006). The Third Circuit's  take on this split is at Colacicco v. Apotex, 521 F.3d 253 (3d Cir. 2008).

FDA proposed the CBE procedure in 1982, making clear at the time that CBE supplements were intended to apply only if the sponsor became aware of newly discovered safety information that was appropriate for inclusion in the labeling for the product. Since then, the FDA has repeatedly tried, through amicus briefs, and in the 2006 preemption preamble, to inform courts of the limited scope of the regulation, with arguably mixed success. In briefs recently filed in the Supreme Court and in testimony before Congress, FDA has also stated a more generally applicable rule that is consistent with the examples of  cases finding preemption, and the principles set forth in the preamble to the 2006 Physician Labeling Rule,  that: (1) The labeling requirements are not a mere minimum safety standard, but rather strike a balance between risks and benefits, and (2) FDA's regulations permit changes in labeling without prior approval only in narrow circumstances. Specifically, FDA has explained that State law claims that "challenge labeling that FDA approved after being informed of the relevant risk" are preempted.

So now, the agency decided to change the regulation to say precisely what the agency has said it meant all along, with the hope that the lawyers and judges who have been ignoring it can’t do so any longer.

In January, several liberal Democrats in Congress wrote a letter to FDA questioning the basis for the proposed CBE rule, saying it appeared to be designed to shield pharmaceutical and medical device companies from liability sustained by consumers. But the rule does not alter the agency's current practices with respect to accepting or rejecting labeling changes proposed by a CBE supplement, reiterating the agency's longstanding view that the changes-being-effected mechanism is a narrow exception to the FDA's requirement of prior approval for labeling changes to approved products.

Under the rule, newly acquired information means data, analyses, or other information not previously submitted to the agency, which may include (but are not limited to) data derived from new clinical studies, reports of adverse events, or new analyses of previously submitted data (e.g., meta-analyses) -- if the studies, events or analyses reveal risks of a different type or greater severity or frequency than previously included in submissions to FDA. The final rule thus clarifies the meaning of "newly acquired information," such that the data, whether derived from new clinical studies, reports of adverse events, etc., needs to be new and different -- of a different type or greater severity or frequency than previously submitted to FDA. This limitation applies to data derived from new clinical studies, reports of adverse events, and new analyses of previously submitted data, alike. The final rule notes thus that there must be reasonable evidence of a causal association before a CBE supplement may be used to add or strengthen a contraindication, warning, precaution, or adverse reaction language.

The FDA rejected comments suggesting that a lower standard should be used under CBE for when a sponsor may warn, reiterating that it "interprets the Act to establish both a 'floor' and a 'ceiling', such that additional disclosures of risk information can expose a manufacturer to liability under the act if the additional statement is unsubstantiated or otherwise false or misleading." 

The new rule may be of some assistance in dealing with those courts that seem reluctant to recognize the longstanding view of the narrow scope of the CBE rule.  The rule limits the scenarios in which manufacturers of drugs, biologics, or medical devices can change a previously approved label in advance of the FDA’s formal review and approval mechanism. And the smaller the scope of things permitted in a CBE change, the greater the scope of conflict between FDA-approved labels and state court second-guessing of the warnings.  

District Court Certifies Nationwide Consumer Fraud Act Class Action

MassTortDefense has posted about the dangers lurking in consumer fraud class actions before. The threat is no more evident than in the recent decision in Nafar v. Hollywood Tanning Systems, Inc., 2008 WL 3821776 (D.N.J., August 11, 2008), where the district court certified a nationwide class of tanning customers.

Plaintiff alleged she purchased monthly tanning memberships from defendant Hollywood Tanning Systems, in New Jersey. Plaintiff alleged that defendant fraudulently failed to disclose the fact that any exposure to ultraviolet rays (UV rays) increases the risk of cancer and allegedly deceptively failed to warn consumers about the dangers of indoor tanning. While plaintiff acknowledged that defendant's machines may block out most UVB rays, she contended that defendant failed to inform consumers that UVA rays, also emitted by its machines, are allegedly linked to skin cancer. Plaintiff instituted suit alleging: (1) violation of the New Jersey Consumer Fraud Act (“NJCFA”), (2) fraud, (3) unjust enrichment, and (4) breach of warranty. Plaintiff disclaimed any remedy for personal injuries suffered, but proceeded on her fraud-based causes of action, seeking return of her membership fees, treble damages, punitive damages, and attorney's fees.

Plaintiff sought a nationwide class of consumers who had purchased tanning memberships. The court’s analysis of the Rule 23(b) requirements for class certification was, unfortunately, devoid of substance. For the all-important predominance inquiry, the court first stated that common issues of law predominated: “Common questions of law predominate because New Jersey law is central to this litigation. The NJCFA [consumer fraud act] will apply to all class members because this particular law governs Defendant's behavior and uniform policies. New Jersey has a strong interest in this litigation because the case's outcome will likely affect Defendant's nationwide behavior…. Indeed, the NJCFA is one of this nation's strongest consumer protection laws and its application will not frustrate other states' consumer protection laws. ” That conclusion was not based on an analysis of the choice of law rules of the forum state; cited no state court cases suggesting that NJ law should apply to the claims of consumer from other states; failed to analyze the differences among the consumer protection laws of the various states; and failed to analyze the interests other states may have in applying their laws by simply assuming every state would rather apply NJ’s law.

The court then stated that common fact issues predominated as well because the alleged misrepresentations and omissions concerning the negative consequences related to indoor tanning are alleged to be uniform. However, the court failed to conduct any analysis of the elements of the claims upon which the class was certified, and whether any of the elements might raise individual questions. Nor did it discuss any of the defenses. For example, the defendant apparently submitted surveys showing that the risks of tanning are common knowledge, and many consumers understood the cancer risks involved. Even if plaintiffs were not required to present any direct proof of individual reliance – which they would be under some state laws – this would not prevent a defendant from presenting direct evidence that an individual plaintiff did not rely on any representations from the company. Defendants have a right to present evidence negating a plaintiff's direct or circumstantial showing of causation and/or reliance. The "predominance" inquiry here thus resembled a mere commonality test.

Similarly, the cursory superiority analysis reads as a mere recitation of the elements of the inquiry rather than as an application of the elements. It also fails to cite a single federal appellate decision supporting the conclusion reached. To determine if these requirements have been met, a trial court must envision how a class action trial would proceed. (MassTortDefense has frequently urged trial judges to "look down the road" and not blindly accept plaintiffs' bold assertions about trial procedures.) Under this analysis, the trial court must determine whether the purported class representatives can prove their own individual cases and, by so doing, necessarily prove the cases for each one of the thousands of other members of the class. If they cannot, a class should not be certified.

Clearly, this certification decision ought to be reviewed by the Third Circuit.
 

British Advisory Panel Recommends Expanded Class Actions In English Courts

The possible transplantation of U.S.-style class actions to other countries has been a subject of much concern and study by those defending companies that market and sell their products internationally. Some have expressed skepticism that other nations, particularly those in Europe, will ever adopt true class actions because of general cultural differences, or specific factors, such as the absence of contingency fees. Others, pointing to examples like Canada, predict that the spread, while slow, may be inexorable.

Now comes a report issued by the advisory body responsible for overseeing the modernization of the English civil justice system recommending an expansion of class-like procedures in England. Entitled “Improving Access to Justice Through Collective Actions,” the Civil Justice Council proposes that the English civil justice system should add an “opt-out” class action to the existing range of procedural options available for civil claims. (The CJC is an Advisory Public Body, established under the Civil Procedure Act 1997 with responsibility for overseeing and coordinating the modernization of the civil justice system. The group provides advice to the Secretary of State for Constitutional Affairs on the effectiveness of aspects of the civil justice system, and makes recommendations to test, review or conduct research into specific areas. The Council includes members of the judiciary, members of the legal profession, civil servants concerned with the administration of the courts, persons with experience in and knowledge of consumer affairs, and persons able to represent the interests of particular kinds of litigants (for example business or employees)).

The Council report made several key findings:
-Existing English procedure does not provide sufficient or effective access to justice for consumers, small businesses, and employees;

-Existing collective actions could be improved considerably to promote better enforcement of citizens’ rights, while also protecting defendants from non-meritorious litigation;

-There are meritorious claims that could fairly be brought with greater efficiency and
effectiveness on a collective rather than unitary basis;

-Collective claims can benefit defendants in resolving disputes more economically and
efficiently, with greater conclusive certainty than can arise through unitary claims.

-The Courts are the most appropriate body to ensure that any new collective procedure is
fairly balanced as between claimants and defendants, the latter of which should be properly protected from unmeritorious, vexatious or spurious claims as well as from “blackmail” claims.

In turn, the CJC made several major recommendations:

-A generic collective action should be introduced.

-Collective claims should be brought by a wide range of representative parties: individual
representative claimants or defendants, designated bodies, and ad hoc bodies.

-Where an action is brought on an opt-out basis the statute of limitation period for class members should be suspended pending a defined change of circumstance.

-Certification of class status should be subject to a strict certification procedure.

-Appeals from either positive certification or a refusal to certify a claim should be subject
to the current rules on permission to appeal from case management decisions.

-Collective claims should be subject to an enhanced form of case management by
specialist judges.

-To protect the interests of the represented class of claimants any settlement agreed by the
representative claimant and the defendant(s) must be approved by the court within a
‘Fairness Hearing’ before it can bind the represented class of claimants.

While the CJC claimed to be wary of adopting the exact same model utilized by the U.S. justice system, and said it studied the pros and cons of the U.S. class action system, the report also suggests changes to the English court system that ought to be a cause for concern. These include aggregate damages, and the ability to have unallocated damages from an aggregate award distributed by a trustee of the award according cy-près.

The report invites a formal response from the lord chancellor, who is responsible for government policy on the legal system.
 

Mass Tort Litigation Screenings Exposed

Professor Lester Brickman, of Cardozo School of Law, has published a fascinating article entitled, "The Use of Litigation Screenings in Mass Torts: A Formula for Fraud?"

At MassTortDefense, we would simply remove the question mark.

Plaintiff lawyers obtain the "mass" for some mass tort litigation by conducting screenings to sign-up potential litigants. These "litigation screenings" have no intended medical benefit, and thus this entrepreneurial response to highly profitable opportunities that arise in certain mass tort litigation should not be confused with true medical screening. In a litigation screening, potential litigants are solicited by lawyers or their agents by use of mass mailings, television and newspaper advertisements providing “800” telephone numbers, and by use of web sites purporting to provide medical information about toxic exposures, drugs, devices, or specific diseases but which are, in fact, “fronts” for law firms to whom the web site visitor is referred.

Screenings can be held in motels, shopping center parking lots, local union offices, and even lawyers' offices. There, an occupational history is taken by persons typically with no medical training, a doctor may do a cursory physical exam, and non-doctor technicians administer tests, such as X-rays, pulmonary function tests, echocardiograms and blood tests. The sole purpose of screenings is to generate "medical" evidence of the existence of an injury to be attributed to exposure to or ingestion of defendants' products – all pre-planned. Usually a handful of doctors ("litigation doctors") provide the vast majority of the thousands of medical reports prepared for that litigation.

By the good professor’s count, at least 1,500,000 potential litigants have been screened in the asbestos, silica, fen-phen (diet drugs), silicone breast implant, and welding fume litigation. Litigation doctors found that approximately 1,000,000 of those screened had the requisite condition that could qualify for compensation under plaintiffs’ legal theory, such as asbestosis, silicosis, moderate mitral or mild aortic value regurgitation or a neurological disorder. He further estimates that litigation doctors and screening companies have been paid well in excess of $250 million – huge number, but a tiny fraction of the contingency fees earned well in excess of $13 billion by his estimates.

The professor concludes that approximately 90% claims generated from the screenings were based on "diagnoses" of the type that U.S. District Court Judge Janis Jack, in the silica MDL, found were "manufactured for money."

He also presents the case that bankruptcy courts adjudicating asbestos related bankruptcies have effectively legitimized the use of these litigation screenings.

Professor Brickman's areas of expertise include legal ethics, contingency fees, mass torts, and asbestos litigation. He notes the significant volume of literature about the use of junk science in the court, even today, especially to try to prove general causation in mass torts. But his analysis is particularly valuable because it turns an empirical light on the use of litigation screenings to try to prove specific causation.