Mass Tort Defense : Mass Tort Defense Lawyer & Attorney : Sean P. Wajert : Dechert Law Firm : Products Liability, Class Actions, Pharmaceutical Litigation

Readers of MassTortDefense involved in the defense of medical monitoring cases will want to follow the ongoing debate occasioned by the New York Times story this week, quoting Dr. Otis Brawley, chief medical officer of the American Cancer Society, admitting that American medicine has over-promised when it comes to medical screening and that the advantages of screening have been “exaggerated.”

Medical monitoring, whether a remedy or cause of action, is a claim for the cost of medical screening for a plaintiff exposed to a toxic substance allegedly because of the defendant’s wrongful conduct and who is accordingly at risk of future disease. Medical monitoring is designed to early detect the disease and thus maximize the chances of a cure or beneficial treatment.

As a an advocacy matter, medical monitoring is presented by plaintiffs with the seemingly unchallengeable notion that early detection saves lives. Plaintiff attorneys rely heavily on juror pre-loads about the importance and benefits of screening; virtually every juror has had a Pap smear, or mammogram, or prostrate test, and they have all been inundated with messages from the American Cancer Society that screening is highly efficacious-- messages that ignore the risks of screening. Defendants fight an uphill battle when they try to get the jury to keep an open mind about the risks and benefits of plaintiffs’ experts' proposed screening program.

Reportedly, the ACS is now working on a message, to put on its Web site early next year, to emphasize that screening for breast, prostate, and other cancers can come with a real risk. Those risks include not only the risks of the screening procedures themselves (such as radiation), but the risks of false positives, and the follow-on risks of over-treating a nodule that would never have developed into life-threatening disease. On the flip side, many researchers point out that the prostate cancer screening test has not been shown to prevent prostate cancer deaths. Similar lack of benefit has been noted with chest x-rays and CT scans for lung cancer. If cancer screening was really as effective as plaintiffs assert, the cancers that once were found late, when they were untreatable or incurable, would now be found earlier, when they could be treated and cured. Thus, a large increase in early cancers found would be accompanied by a decline in late-stage cancers, and an improvement in mortality. That just hasn’t happened for many types of screening.

Whether the issue is the screening tool or the screening itself, plaintiffs should no longer be allowed to base their medical monitoring claims on a widely accepted misconception that all screening is good, and all early detection saves lives.  Defense attorneys may have a juror pool more receptive to the evidence-based argument that plaintiffs must be held to their burden of proof to show that a monitoring procedure exists that makes early detection of the disease possible; the prescribed monitoring regime is different from that normally recommended in the absence of the exposure; and the prescribed monitoring regime is reasonably necessary according to contemporary scientific principles.
 

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The FDA is considering issuing guidelines on acrylamide content in food.  The agency has published a notice seeking comments from industry on the issue.

Acrylamide is a chemical formed primarily in baked and fried foods by a reaction between sugars and the amino acid asparagine. The reaction is partly responsible for the golden color and tasty flavor of baked, fried, and toasted foods. In 2002, some Swedish scientists reported unexpectedly high levels of acrylamide in carbohydrate-rich foods and also published a study associating the chemical to cancer in laboratory rats. Further research subsequently determined that acrylamide can form in some foods during certain types of high-temperature cooking.

FDA has not yet issued guidance for manufacturers on reducing acrylamide in food. However, it is anticipated by the agency that new information will soon be available about the toxicology of acrylamide, which may shed light on acrylamide's potential carcinogenicity in laboratory animals. Readers of MassTortDefense know how difficult it is to leap from animal studies to causation conclusions in human beings, because of the physiological and metabolism differences between species, the excessive dosages that are (and typically must be) given to experimental animals, and the varying biological defense mechanisms that species have to environmental insults.

International efforts to develop approaches to acrylamide mitigation are also beginning to prove successful. Moreover, FDA is aware that at least some manufacturers in the United States are seeking ways to reduce acrylamide in their products. In this context, FDA is considering issuing guidance for industry on reduction of acrylamide levels in food products.

Health Canada recently added acrylamide to that nation’s toxic substances list, as part of its ongoing review of over 200 chemical substances in commercial use. It stated that current consumption levels “may constitute a danger in Canada to human life or health,” but it also acknowledged that research into a possible carcinogenic link for humans has so far been inconclusive.

In fact, dietary intakes of acrylamide are not related to increased risks of brain cancer, according to a recently released study of 58,279 men and 62,573 women, published by Maastricht University in the Netherlands. J.G.F. Hogervorst, et al., “Dietary Acrylamide Intake and Brain Cancer Risk,” 18 Cancer Epidemiology, Biomarkers & Prevention (2009).  Researchers have also reported in the Journal of the National Cancer Institute that dietary acrylamide was not linked to lung cancer risk, and that the compounds may even reduce the risk in women. "Lung Cancer Risk in Relation to Dietary Acrylamide Intake," 101(9) JNCI 651-662 (2009).

In seeking comments, the FDA has asked food manufacturers to respond with details of any manufacturing changes they have made, the success and cost-effectiveness of those changes, methods for acrylamide reduction that could be appropriate for smaller manufacturers, and changes to on-pack instructions for consumers to mitigate acrylamide formation.

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

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

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

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

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

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

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

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

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The Agency for Toxic Substances and Disease Registry (ATSDR) issued a report on benzene a few months ago, and it has already begun to have an effect on the litigation.

ATSDR is an agency of HHS and is directed by congressional mandate to perform specific functions concerning the potential effect on public health of hazardous substances in the environment. These functions include public health assessments of waste sites, health consultations concerning specific hazardous substances, health surveillance and registries, response to emergency releases of hazardous substances, applied research in support of public health assessments, information development and dissemination, and education and training concerning hazardous substances.

A Toxicological Profile for Benzene, Draft for Public Comment was released in August 2005, and finalized in August, 2007. An ATSDR toxicological profile characterizes the toxicological and adverse health effects information for the hazardous substance at issue. They are peer-reviewed profiles, and each identifies and reviews the key literature that describes a hazardous substance's toxicological properties. Each profile is supposed to include the following:

(A) summary and interpretation of available toxicological information and epidemiological evaluations on a hazardous substance to ascertain the levels of significant human exposure for the substance and the associated acute and chronic health effects;

(B) determination whether adequate information on the health effects of each substance is available or in the process of development to determine levels of exposure that present a significant risk to human health; and

(C) identification of testing needed to identify the types or levels of exposure that may present significant risk of adverse health effects in humans.

The report notes that benzene, a colorless liquid with a sweet odor, evaporates into air very quickly and dissolves slightly in water. Benzene is found in air, water, and soil. Benzene comes from both industrial and natural sources. Benzene was first discovered and isolated from coal tar in the 1800’s. Today, benzene is made mostly from petroleum. Because of its wide use, benzene ranks in the top 20 in production volume for chemicals produced in the United States. Various industries use benzene to make other chemicals, used in plastics, resins, synthetic fibers. Benzene is also used in the manufacturing of some types of rubbers, lubricants, dyes, detergents, drugs, and pesticides. Natural sources of benzene include gas emissions from volcanoes and forest fires. Benzene is also present in crude oil and gasoline and cigarette smoke.

Everyone is exposed to a small amount of benzene every day, in the outdoor environment, in the workplace, and in the home. Exposure of the general population to benzene mainly occurs through breathing air that contains benzene. The major sources of benzene exposure are tobacco smoke, automobile service stations, exhaust from motor vehicles, and industrial emissions. Vapors (or gases) from products that contain benzene, such as glues, paints, furniture wax, and detergents, can also be a potential source of exposure. Auto exhaust and industrial emissions account for about 20% of the total national exposure to benzene. About half of the exposure to benzene in the United States results from smoking tobacco, according to the report. People living in cities or industrial areas are generally exposed to higher levels of benzene in air than those living in rural areas. Benzene levels in the home are usually higher than outdoor levels. For most people, the level of exposure to benzene through food, beverages, or drinking water is not as high as through air. Drinking water typically contains less than 0.1 ppb benzene. Benzene has been detected in some bottled water, liquor, and food.

Individuals employed in industries that make or use benzene may be exposed to higher levels of benzene. These industries include benzene production (petrochemicals, petroleum refining, and coke and coal chemical manufacturing), rubber tire manufacturing, and storage or transport of benzene and petroleum products containing benzene.

In an unpublished decision, the 5th Circuit relied on the ATSDR report to reverse the dismissal of a toxic tort case involving benzene. See Leblanc v. Chevron USA Inc., 2008 WL 1805448 (5th Cir. April 22, 2008).

Plaintiff alleged that after working as a tanker truck driver for over 30 years transporting products containing benzene, he was diagnosed with myelofibrosis with myeloid metaplasia-MMM, a rare disease. They tendered an expert who supported their claim that the exposure to benzene caused plaintiff's disease. Defendants challenged the expert testimony as unreliable under Daubert. The trial court excluded the testimony and, as is typically the case, because plaintiff had no other evidence on the critical causation issue, the case was dismissed.

At the time the district court issued its order, the ATSDR had issued the draft report on benzene. Because the report was still in draft form and the time for notice and comment had not expired when the district court issued its ruling, the trial court declined to consider it. During the pendency of the appeal, however, the draft received final approval. The Fifth Circuit noted that the ATSDR report on benzene was authored by a number of experts, was reviewed internally by the ATSDR, and peer reviewed by additional experts who collectively have knowledge of benzene's physical and chemical properties, toxicokinetics, key health end points, mechanisms of action, human and animal exposure, and quantification of risk to humans.

Moreover, in the report, the ATSDR concluded that benzene causes a life-threatening disorder called aplastic anemia in humans and animals. In describing a case report of a gasoline station attendant who had been exposed to benzene by inhalation, and probably also through dermal contact, the report calls myelofibrosis a form of aplastic anemia.

Because of this, and the “number and quality of the experts” who participated in the production of the final version of the ATSDR report, the 5th Circuit concluded that this report deserved the careful consideration of the district court before reaching a final conclusion on the reliability of plaintiffs’ expert testimony.

As readers of MassTortDefense interested in toxic torts will know, there is significant litigation surrounding benzene exposures. Some jurisdictions have consolidated cases for pre-trial coordination. E.g., In re: Benzene Litigation, No. 06C-BEN-1 (Del. Super. Ct., New Castle Cty.).

A week ago, a San Francisco jury reportedly awarded $8 million to a benzene plaintiff who claimed that his 17-year employment at SeaRiver Maritime Inc. exposed him to benzene, causing his kidney cancer. See Shelby v. Seariver Maritime Inc., f/k/a Exxon Shipping Co., No. CJC-06-449350 (Calif. Super. Ct., San Francisco Cty.). SeaRiver was the lone remaining defendant at the time of the trial.

Last month, several plaintiffs filed suit contending that they were wrongfully exposed to benzene while working at a Goodyear Tire Plant. Hauptmeier, et al., v. Barton Solvents Inc., et al., No. 08-187 (D. Neb.).

The litigation raises multiple important issues, including product identification, general and specific causation, and important procedural issues as well. In Anderson, et al. v. Crown Central LLC, et al., No. 08-0033 (Texas), plaintiffs are appealing the intermediate appellate court’s severance of their claims, Crown Central LLC v. Anderson, 239 S.W.3d 385 (Tex.App.-Beaumont,2007). Plaintiffs, as is common, prefer consolidated trials in their hand picked venue, with trial plans in which the best case (strongest plaintiff case) elevates the weaker plaintiff claims, despite the fact that often they cannot show their claims arose from the same transactions or occurrences.

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