Litigation in the Pipeline for Liquid Filled Intragastric Balloon Systems?

Posted by on July 2, 2018

This post was authored by Sai Gandhe and Giovanni Ciavarra, PhD. Sai is a summer intern at Innovative Science Solutions and a senior at Case Western Reserve University studying systems biology and business management. Obesity has been associated with numerous health problems such as increased risk for heart disease, stroke, diabetes, high blood pressure, sleep
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Genomics as an Insurance Claims Management Tool

Posted by on June 25, 2018

This article was co-written with William Wilt, President of Assured Research, a research and advisory firm dedicated to delivering highly customized, actionable research and analysis to insurance and investment professionals. It was adapted from their February 2018 briefing. Since the human genome was mapped more than a decade ago, and with the exponential increases in
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All Mesothelioma Cases Are Not Caused by Asbestos

Posted by on June 5, 2018

Ask any seasoned lawyer how he or she plans to defend their next asbestos mesothelioma case and you are very unlikely to hear that general causation will be at the heart of their strategy. In other words, there seems to be a tacit acceptance that asbestos exposure in some form was a cause of the
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The Meso Gene

Posted by on May 29, 2018

The ongoing revolution in genomic science is having an impact on many facets of modern life, including toxic tort litigation. This point was apparent at the recently held American Conference Institute’s 23rd National Forum on Asbestos Claims & Litigation (May 21-23, 2018) in Chicago, where I presented with my colleague Kirk Hartley (also of ToxicoGenomica)
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Biosimilar Patent Litigators Can Benefit from the Right Consulting and Testifying Experts

Posted by and on May 29, 2018

The commercialization of biosimilars was enabled by the Biologics Price Competition and Innovation Act (BPCIA) of 2009 which was signed into law on March 22, 2010 as part of the Patient Protection and Affordable Care Act. Biologics are produced using living organisms, and thus, are usually much more complex than most small molecule drugs. Biosimilars
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Opioid Litigation – The Defense Perspective [Download Conference Presentation Slides]

Posted by on April 23, 2018

The opioid litigation landscape continues to evolve, with over 200 lawsuits currently consolidated in the multidistrict litigation (MDL), In re: National Prescription Opiate Litiga­tion, MDL No. 2804, in the Northern Dis­trict of Ohio and being overseen by U.S. District Court Judge Dan Polster. New opioid cases continue to be filed (inside and outside of the
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Unverified Science-Based Claims in the Media – Another Example Why the “Ingelfinger Rule” is so Important

Posted by on March 19, 2018

It’s likely that most readers of this blog, let alone most members of the public, have little idea of what the Ingelfinger Rule is and less about why it is so important. First promulgated in-house by the New England Journal of Medicine in 1969, the rule stipulated that the editors would not accept findings that
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How to Find the Right Regulatory Experts for Your Case or Controversy

Posted by , and on March 13, 2018

Whether you are outside counsel retained in a pharmaceutical product liability case or in-house counsel responsible for a chemical manufacturer in a high-profile government investigation, having the right regulatory expert can be the difference between remarkable success and high stakes failure. What should you look for in an expert? In selecting the best regulatory expert,
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The Importance of Genetics Experts in Pharmaceutical Litigation

Posted by on March 6, 2018

A Case Study from the Testosterone Litigation A recent defense verdict in the testosterone litigation highlights the importance of genetics in pharmaceutical litigation. In this case, neither the plaintiffs nor the defense called a geneticist as an expert, yet both sides tried to use genetic arguments in their case. In this post we summarize the
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Protein-based adverse drug reactions (ADRs): Using proteomics to assess drug safety

Posted by on February 20, 2018

Each year, adverse drug events cost millions of dollars in hospital admissions, injuries to patients, and malpractice. And companies spend billions of dollars on litigation involving allegations that their drugs caused adverse drug reactions (ADRs). What if there was a better way to determine individualized drug adverse events? Welcome to the Age of Proteomics The
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