Bridging the Gap Between Science and the Law

Statistical Significance Testing in Mass Tort Litigation

Posted by David Schwartz on Sun, Jan, 11, 2015

Statistical significance testing is a fundamental principle relevant to mass tort cases involving complex scientific information (e.g., pharmaceutical and medical device cases as well as toxic torts and consumer fraud cases). Simply stated, if a scientist wants to show that one factor causes changes in another factor (e.g., a drug treatment, a chemical exposure, a source of radiation), conventionally he must rely upon statistical significance testing to demonstrate that difference. Demonstrating that a factor does not cause changes in another factor is a more nuanced and complex issue, but statistical significance testing also becomes a critical factor.

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Topics: statistical significance testing

8 Examples of Causal Inference Without Data from Controlled Studies

Posted by David Schwartz on Sun, Dec, 14, 2014

Every pharmaceutical and medical device lawyer knows that the heart of the general causation defense lies in insisting on the need for controlled scientific studies linking the exposure to the disease entity. Indeed, controlled epidemiological studies are the tools required to meet many of the Hill criteria (e.g., strength and consistency of association must be demonstrated using these types of studies). In a perfect world, the evidence goes beyond the observational realm and the relationship is established using the gold standard: randomized controlled trials (RCTs).

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Topics: causation assessment

E-Cigs are Heating Up! And Science Will Have an Impact on the Legal Landscape

Posted by Giovanni Ciavarra on Fri, Dec, 05, 2014

Since entering the U.S. market in 2007, the science related to electronic cigarettes, or e-cigarettes, has been emerging on a number of fronts including their potential health effects, and effectiveness as potential smoking cessation instruments. As a testament to their prominence in mainstream culture, the verb vape (i.e. related to inhaling/exhaling the vapor produced by an e-cigarette) was named as Oxford English Dictionary's 2014 Word of the Year.

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The Burden of Proof in Science

Posted by David Schwartz on Tue, Nov, 25, 2014

I recently published a letter to the editor in the journal Environmental Health Perspectives in response to a commentary that got my attention. The commentary raised a provocative and fundamental question that has come up from time to time since I began consulting for the legal profession:

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Keeping Up with Asbestos Science is Hard!

Posted by Giovanni Ciavarra on Thu, Nov, 06, 2014

The science related to asbestos health effects is emerging at break-neck speed.

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Four Common Mistakes in Making Science-Based Policy

Posted by David Schwartz on Fri, Oct, 31, 2014

Check Out Our Letter to the Editor in Environmental Health Perspectives

Back in July, I read with interest a commentary in Environmental Health Perspectives by Kevin Elliott and and David Resnick discussing an important topic related to litigation involving complex scientific topics: the role of science in setting policy. It was both interesting and disheartening to see the following three common mistakes in using science to set policy.

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Effective Use of Science and Regulations in Pharmaceutical Litigation

Posted by David Schwartz on Sun, Oct, 26, 2014

On October 14th, Innovative Science Solutions organized a webinar with Momentum Events, entitled:

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Is Your Adversary Navigating Toxic Tort Litigation Systematically?

Posted by David Schwartz on Tue, Oct, 21, 2014

The Navigation Guide Systematic Review Methodology is an approach developed by a group of scientists to objectively and transparently evaluate a set of data related to environmental and chemical exposures. 

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Topics: toxic tort

Importance of Safety Signaling in Drug and Device Litigation

Posted by David Schwartz on Fri, Oct, 17, 2014

Safety signaling is a key scientific disipline that often gets overlooked in personal injury case involving pharmacetutical or medical device products. John Clark and I recently published an article on this topic in the Defense Research Institute's (DRI's) quarterly publication, Rx For the Defense.

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5 Things Your Consulting Expert Can Help You Do

Posted by David Schwartz on Tue, Aug, 05, 2014

Every lawyer knows the importance of finding the perfect testifying expert in complex litigation, such as toxic torts, product liability, or patent disputes. Your testifying expert is the star of the case. You retain him or her to be the face of your case to the court.  This testifying expert must be knowledgeable, credible, persuasive, and personable. Indeed, that perfect testifier can make all the difference and the critical nature of that role cannot be overemphasized.

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