Bridging the Gap Between Science and the Law

Using Proper Pharmacovigilance Techniques to Prevail in Drug and Device Cases

Posted by David Schwartz on Sun, Feb, 22, 2015

Dr. Steven Weisman, Ph.D. Head of Global Healthcare Products at Innovative Science Solutions (Morristown, NJ), will be speaking at the ABA’s 2015 Life Sciences Legal Summit being held on March 4, 2015 at Genentech in South San Francisco.

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4 Types of Science-Based Allegations in Dietary Supplement Litigation

Posted by David Schwartz on Tue, Feb, 17, 2015

In early February 2015, the New York State attorney general’s office launched an investigation into store-brand supplements by four national retailers: GNC, Target, Walgreens, and Wal-Mart (see recent news reports here and here). Not surprisingly, class action lawsuits have been filed alleging these retailers are selling misbranded or adulterated products. I provided some preliminary thoughts on this breaking news in an interview that I did for A2L Consulting on February 6th. I thought it might be helpful to expand on some of this thinking in a blog post.

 

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Litigators! Are you on Top of the Latest Endocrine Disruptor Science?

Posted by David Schwartz on Thu, Feb, 12, 2015

This article was authored by Daniel Linkie, Ph.D., a consultant for the pharmaceutical industry at ARRENDEE LLC. Dr. Linkie provides expertise in identifying the risks and the actions needed to lower the operational barriers impeding drug and device product development.

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E-cigarette Science is Hazy, and Tracking it is Critical!

Posted by Giovanni Ciavarra on Fri, Jan, 30, 2015

Electronic cigarettes (e-cigarettes or e-cigs) are considered nicotine delivery systems (ENDS), which are devices that can deliver nicotine in an aerosolized form. Not only is the e-cig industry booming, but as we have discussed previously (see here), the science related to e-cigarettes is also booming, with progressively more publications on health impacts, chemistry, technology, and policy initiatives. As a result, it is increasingly important for individuals and organizations interested in e-cigs to stay on top of the science, or risk missing important studies or findings related to their safety, effectiveness, or regulatory status.

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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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