Posted by on January 22, 2013

Late last week, three lawmakers (Senator Durbin, Senator Blumenthal, and Congressman Markey) sent letters to more than a dozen manufacturers of caffeinated energy drinks, as a follow up to letters sent by the lawmakers to the FTC, and FDA. The letters  pose a series of questions requesting information on a variety of issues including:
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Vinyl Chloride Train Wreck Safety Assessment

Posted by on January 18, 2013

This article was authored by Peter Harnett, a certified industrial hygienist (CIH) who provides expertise in evaluation of environmental exposure assessments, consumer product health-based risk assessments, health and safety program development, toxicology assessments, occupational safety training programs, biosafety evaluations, compliance audits for laboratories and other workplace settings. Peter is the founding member of Counsel in
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Adverse Drug Reactions in Pharmaceutical Litigation

Posted by on January 17, 2013

Pharmaceutical litigation is characterized by complex scientific studies of various types, including randomized controlled clinical trials and analytical epidemiological studies of varying levels of rigor (usually cohort or case control study designs). These studies evaluate relationships between a drug exposure and adverse event outcomes as a function of a number of conditions. A rigorous assessment
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Top 5 Reasons You Need a Scientific Consulting Expert

Posted by on January 10, 2013

Every lawyer trying a complex product liability (pharmaceutical, medical device, or consumer product) or toxic tort (chemical exposure) case knows that one of his/her greatest needs is a top-rate testifying expert witness.  Most lawyers instinctively believe that this expert will provide him with all the answers: education for an effective direct examination; tips for a
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Posted by on January 3, 2013

As the fastest-growing segment of the beverage industry, it is no surprise that energy drinks have come under increased scrutiny over the past year including the recent 5-hour Energy drink issue. This post provides a brief overview of the recent FDA regulatory history of the issue as well as a summary of some of the
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Establishing Causation in the Courtroom – A Basic Introduction

Posted by on December 27, 2012

As every lawyer working on personal injury cases involving an exposure and an adverse event is aware, there are two hurdles that plaintiffs should be forced to overcome: general causation and specific causation. While each of these hurdles should have its own burden of proof, the specific nature of that burden has been hotly debated
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Good Scientific Monitoring: Key to Winning Pharmaceutical Litigation

Posted by on November 29, 2012

Complex scientific and medical data play an integral role in pharmaceutical litigation. Understanding and a keen awareness of the exact nature of the science is key to winning cases.
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Biologics and Biosimilars: Focus of Future Litigation – Dr. Steven Weisman of ISS presents at ABA Litigation Meeting

Posted by on November 27, 2012

I was recently invited to be part of a panel on the role of biopharmaceuticals in product liability litigation as part of ABA’s section on Litigation held in Boston: Current Issues in Pharmaceutical and Medical Device Litigation. The panel was moderated by Debra Perry of McCarter and English and my co-presenters were Krista Cosner of
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Why Did You File The Daubert?

Posted by on November 21, 2012

Over the years, Innovative Science Solutions has provided our fair share of scientific support on litigation matters involving Daubert hearings. Specifically, we have worked on cases involving the following types of claims that have been evaluated in the context of Daubert rulings:
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FDA Crashing 5-hour Energy Dietary Supplement?

Posted by on November 16, 2012

This week the New York Times reported they learned in an interview with an FDA official that FDA has been investigating the “possible” involvement of the dietary supplement 5-hour ENERGY in the deaths of 13 individuals over the last four years.
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