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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Meningitis Product Liability Litigation: Definition of Injection?

Posted by on November 13, 2012

The CDC reports that the multi-state meningitis outbreak linked to tainted steroid injections have left over 30 dead and over 400 infected. Across the country, litigation is taking shape against not only New England Compounding Center, the drug-mixing pharmacy linked to the contaminated lots, but also against physicians and clinics.  However, the success of these latter suits
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What do scientific organizations consider as valid evidence?

Posted by on October 19, 2012

The Institute of Medicine (IOM) has taken a critical stance on epidemiologic methods and systems for determining the value of study evidence. This recently published report highlights the methods and criteria used by various reputable scientific organizations (e.g., International Agency for Research on Cancer and the American Institute for Cancer Research) and how these organizations
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The FDA Sentinel Initiative: Holy Grail of Safety Signal Data

Posted by on October 1, 2012

Back in 2008, FDA launched the Sentinel Initiative, the goal of which is to establish “… a national electronic system that will transform FDA’s ability to track the safety of drugs, biologics, and medical devices once they reach the market.” This fascinating initiative is designed to serve as a proactive alternative to retrospective “one-off” evaluations
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Prioritizing FDA Adverse Event Reporting

Posted by on March 22, 2012

FDA has recently issued a series of guidance documents related to prioritizing and classifying significant post market drug safety issues. One document, intended for regulatory professionals, describes the process that FDA will use to categorize adverse drug events as priority, standard, or emergency. This prioritization structure stems from FDA’s tracking of potential signals of a
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Should you stop taking your vitamins?

Posted by on December 15, 2011

Two vitamin-related studies have recently made a splash in the media. Both studies reported that taking extra doses of vitamins can do more harm than good.
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