The ISS Blog

Providing Scientific Stewardship to the Healthcare Industry and Counsel.

DEFENDING CAFFEINE, ALCOHOL, AND ENERGY DRINKS
03 January 2013
DEFENDING CAFFEINE, ALCOHOL, AND ENERGY DRINKS

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 more recent science. Read more

Establishing Causation in the Courtroom – A Basic Introduction
27 December 2012
Establishing Causation in the Courtroom – A Basic Introduction

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. Read more

Good Scientific Monitoring: Key to Winning Pharmaceutical Litigation
29 November 2012
Good Scientific Monitoring: Key to Winning Pharmaceutical Litigation

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. Read more

Biologics and Biosimilars: Focus of Future Litigation – Dr. Steven Weisman of ISS presents at ABA Litigation Meeting
27 November 2012
Biologics and Biosimilars: Focus of Future Litigation – Dr. Steven Weisman of ISS presents at ABA Litigation Meeting

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. Read more

Why Did You File The Daubert?
21 November 2012
Why Did You File The Daubert?

Over the years, Innovative Science Solutions has provided our fair share of scientific support on litigation matters involving Daubert hearings. Read more

FDA Crashing 5-hour Energy Dietary Supplement?
16 November 2012
FDA Crashing 5-hour Energy Dietary Supplement?

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. Read more

Meningitis Product Liability Litigation: Definition of Injection?
13 November 2012
Meningitis Product Liability Litigation: Definition of Injection?

The CDC reports that the multi-state meningitis outbreak linked to tainted steroid injections have left over 30 dead and over 400 infected. Read more

What do scientific organizations consider as valid evidence?
19 October 2012
What do scientific organizations consider as valid evidence?

The Institute of Medicine (IOM) has taken a critical stance on epidemiologic methods and systems for determining the value of study evidence. Read more

The FDA Sentinel Initiative:  Holy Grail of Safety Signal Data
01 October 2012
The FDA Sentinel Initiative: Holy Grail of Safety Signal Data

This initiative could have implications for both the Plaintiff and the Defense bar in drug and device litigation. For example, defendants may be in a position to make a case that this adds another layer of oversight and product stewardship into the process. Read more

Prioritizing FDA Adverse Event Reporting
22 March 2012
Prioritizing FDA Adverse Event Reporting

FDA has recently issued a series of guidance documents related to prioritizing and classifying significant post market drug safety issues. Read more

Should you stop taking your vitamins?
15 December 2011
Should you stop taking your vitamins?

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. Read more

Are you making the GRADE?
05 December 2011
Are you making the GRADE?

Making proper judgments about the quality of scientific evidence and recommendations can be complex for scientists, let alone lawyers litigating drug and medical device litigation. Nevertheless, if you are an attorney wading through published scientific papers, it is your job to effectively grapple with these complexities. Read more

Dietary Supplements: Are they still good for consumers?
05 December 2010
Dietary Supplements: Are they still good for consumers?

Consumers who use dietary supplements take comfort in the fact that they are taking a safe, natural and non-medical alternative to some prescription or over the counter (OTC) drugs to boost their health. However, the regulatory landscape for dietary supplements is changing and may seriously alter our perception of dietary supplements. Read more

Zohydro ER Set to Hit Market This Month, Against Recommendation of FDA Advisory Committee
01 January 1970
Zohydro ER Set to Hit Market This Month, Against Recommendation of FDA Advisory Committee

Given the green light in October, and set to hit the market this month, new opioid painkiller Zohydro ER (manufactured by Zogenix Inc) has been causing quite a controversy. Zohydro ER, a Schedule II controlled substance under the Controlled Substances... Read more