Bridging the Gap Between Science and the Law
In a previous post, we talked about the importance of tracking the science related to electronic cigarettes (e-cigarettes or e-cigs). In this post, we turn to the regulatory framework and what issues we believe are likely to come under FDA scrutiny in the near future.Read More
The recent 2015 ABA Life Sciences Legal Summit was a great success!
Dr. Steve Weisman, Head of Global Healthcare Products at Innovative Science Solutions (Morristown, NJ), and Donald "Fritz" Zimmer of King & Spalding LLC, spoke on topics that were informative to both in-house and outside cousel. The panel covered the evaluation of evidence for signal detection for pharmacovigilance purposes (and possible label revisions) and for causation assessments in courts of law.
Most asbestos litigators understand the importance of the science to a solid representation of their clients. However, some fail to remain up-to-date with the science on a prospective basis. The latest science is important to both sides in a dispute and it is critical, whether you are plaintiff or defense, to not only be aware of the emerging scientific literature and research, but to also understand how it applies to your case. We recently posted about the difficulty of remaining up to date on the current science related to asbestos litigation. In this post, we describe the importance of some of this newly emerging science and try to provide you with some highlights.Read More
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.Read More
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.
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.Read More
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.
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.Read More
Topics: statistical significance testing
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).Read More
Topics: causation assessment