Mass Torts: State of the Art : Mass Torts Lawyer & Attorney : Vorys, Sater, Seymour & Pease Law Firm : Toxic Torts & Wrongful Death

Yesterday the U.S. Supreme Court granted a petition for writ of certiorari in Bruesewitz v. Wyeth, Inc. and will review the Third Circuit’s holding that a plaintiffs’ design defect claims against the manufacturer of a vaccination were expressly preempted by the 1986 National Childhood Vaccination Injury Act (“NCVIA”) and that plaintiffs failed to establish a manufacturing defect or a warning defect claim under the Act.

In a footnote in the Bruesewitz opinion the Third Circuit had distinguished the Supreme Court’s opinion in Wyeth v. Levine in which the Court held that federal law did not preempt state tort claims that alleged that a drug manufacturer failed to adequately warn of the dangers associated with a drug on the basis that unlike the NCVIA, there was no express preemption provision in the Food, Drug, and Cosmetic Act (“FDCA”). Another distinguishing factor was Congress’ silence on the issue of preemption in the FDCA “coupled with its certain awareness of the prevalence of state tort litigation” which was “powerful evidence that Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness” as the Court stated in Levine. In addition, the Third Circuit noted that Levine recognized that under federal law, a drug manufacturer could strengthen a drug’s label without preapproval from the FDA, which “stands in contrast to the FDA’s far-more extensive control and oversight of the drug’s design and alternation.”

Also the Third Circuit had disagreed with the interpretation of the Georgia Supreme Court on this issue. In American Home Products Corp. v. Ferrari (in which a petition for writ of certiorari is pending), the Georgia high court had ruled that the Vaccine Act “clearly did not preempt all design defect claims against vaccine manufacturers, but rather provides that such a manufacturer cannot be held liable for defective design, if it is determined, on a case-by-case basis, that a particular vaccine was unavoidably unsafe.” The Third Circuit noted in Bruesewitz that if the NCVIA was interpreted to permit a case-by-case analysis of whether “particular vaccine side effects are avoidable, every design defect claim is subject to evaluation by a court.”

It will be interesting to see how the Supreme Court resolves the split between the Third Circuit and the Georgia Supreme Court on this issue.

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Mitochondrial DNA, or mtDNA, is increasingly assayed for early evidence of a disease which will eventually become manifest. Take a sample, amplify the DNA, examine it and look for change - makes sense, right? Your genes are the ones you're born with, right? And if they've changed that can't be good, right?

Well, it turns out that you, or your mitochondria at least, evolve or mutate within the course of your lifetime - and it's perfectly normal. We may have started out with Mom's mitochondria but it looks like by the time we're adults mitochondria in different parts of the body don't just express different genes, they have different genes. That's the conclusion of "Heteroplasmic Mitochondrial DNA Mutations in Normal and Tumour Cells" just published in Nature.

There's a great write-up of the findings at TheScientist.com and it makes two very important points for those of us dealing with litigation involving mtDNA biomarkers.

1) "we have to keep in mind [that] some of the changes we see may not really be [disease-related] mutations." - quote from author Nickolas Papadopoulos

2) "there's a big question mark about how early this increase in mtDNA variation appears in the blood. If it's only apparent once the cancer is well established then it isn't much use as a biomarker." - email from molecular biologist Ian Holt to The Scientist

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The genes belong to bacteria living in your gut. They, along with their fellow microbes in and on "your" body outnumber human cells 10 to 1. But their genes collectively outnumber yours 150 to 1. These findings are just part of what you'll find in "A Human Gut Microbial Gene Catalogue Established by Metagenomic Sequencing"  published in Nature and free online.

The authors conclude that  this catalogue of bacterial genes found in the human gut "will lead to a much more complete understanding of human biology than the one we presently have." I think it's fair to say that the realization that the microbes we host have so much control over our lives will lead to a revolution in how we think of ourselves and how we prevent, diagnose and treat conditions like obesity, diabetes and cancer.

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Apparently it depends on where they fall along the powerful/powerless spectrum.

"In determining whether an act is right or wrong, the powerful focus on whether rules and principles are violated, whereas the powerless focus on the consequences." - from "How Power Influences Moral Thinking" published in the Journal of Personality and Social Psychology. Hat Tip: Barking Up the Wrong Tree.

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Score one for transparency and fairness in the Mountain State.

The West Virginia Record reported in this article on March 3 that Circuit Judge Ronald Wilson has now ordered that all asbestos plaintiffs in West Virginia must henceforth disclose which bankruptcy trusts they have communicated with and against which trusts they might have a claim. The purpose of the order is to ensure that defendants in asbestos cases receive proper credit when plaintiffs are paid by trusts of bankrupt defendants.
 

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The Chemical Safety Board (CSB) has developed recommendations following its investigation of a triple fatality accident that occurred when welding on a tank containing hydrogen, due to bacteria digesting organic matter within, sparked an explosion. The seven key lessons learned from CSB's recent hot work accidents are:

1. Use alternatives when possible

2. Analyze the hazards

3. Monitor the atmosphere even in areas where a flammable atmosphere is not anticipated

4. Test the area whenever work is done near other tanks containing flammable liquids or gases.

5. Use written permits (Editorial comment: there are places where Hot Work permits aren't used? In 2010?

6. Train thoroughly

7. Supervise contractors - Provide safety supervision for outside contractors conducting hot work. Inform contractors about site-specific hazards including the presence of flammable materials.

CSB notes that while OSHA does not explicitly require the use of a combustible gas detector it is good practice to do so. The American Petroleum Institute and FM Global both have long stressed the need for combustible gas detectors to prevent fires and explosions.

As an aside, your writer learned, shortly after being admitted to the practice of law in 1986, that the oil and chemical companies here in Southeast Texas were using such gas detectors by the 1960s. In fact, in the case of one of my clients, a major refiner, its very first recorded fatality occurred in the 1930s when a man was killed by a manhole cover thrown through the air as the result of an explosion caused by hot work near a sewer. After its investigation the company paid to have someone develop a gas detector and it instituted a hot work permitting system more than 60 years ago.

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This just in from the British journal, Occupational Medicine (2010 60(1):53): “The Strange Case of Irving Selikoff.” The author traces Selikoff’s 1941-45 educational odyssey from the U.S., to Scotland, to Australia, back to Scotland, and back to the U.S. He concludes, “it is apparent Selikoff had an early struggle to qualify, but qualify he did.” That, and many of the other conclusions and suggestions of this paper may find their way into the asbestos courtroom, if they have not already.

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You can read about a new vaccine based therapy for mesothelioma that is both safe and, in some at least, effective in "Consolidative Dendritic Cell-Based Immunotherapy Elicits Cytotoxicity Against Malignant Mesothelioma"

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According to the Houston Chronicle the American Cancer Society has finally come to grips with mounting evidence that indiscriminate screening for prostate cancer causes more harm than good thanks to (a) the inevitable morbidity resulting from needless biopsies and surgeries due to false positive tests; (b) the realization that an awful lot of people who consider themselves "cancer survivors" would never have known they had cancer but for the screening test as their cancers would have gone away on their own or would have grown so slowly that they'd have died of something else before the prostate cancer became threatening; and, (c) the unfortunate fact that early detection, despite what everybody has been led to believe, does not mean that aggressive cancers can be cured - it just means that we get to be treated for them, and worry about them, longer.

Here's a link to the new screening recommendations: "Revised Prostate Cancer Screening Guidelines: What Has -- and Hasn't -- Changed"

Also of interest may be the readers' comments over at the Chronicle and elsewhere. Predictably there are two dominant camps. One sees this change as a nefarious plot by Big Pharma and Big Medicine to prevent early detection so they can make more money by making people wait until they need more expensive medicines and surgeries. The other one sees the new guidelines as a nefarious plot by Big Government to save money by preventing early detection so it can save money on treatment and hasten the deaths of Americans thereby saving money on Social Security payments as the cherry on top. I've run across veniremen able to hold both views simultaneously. But that's a discussion for another day.

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