The ISS Blog

Providing Scientific Stewardship to the Healthcare Industry and Counsel.

Pretomanid NDA for Drug-Resistant TB reviewed by FDA’s Antimicrobial Drugs Advisory Committee
07 June 2019
Pretomanid NDA for Drug-Resistant TB reviewed by FDA’s Antimicrobial Drugs Advisory Committee

On June 6th, 2019, the Antimicrobial Drugs Advisory Committee convened to discuss the new drug application. Read more

Welcome To The FDA Blog At ISS!
07 June 2019
Welcome To The FDA Blog At ISS!

Innovative Science Solutions (ISS) is a consulting firm with over two decades of experience in the regulatory industry. Read more

E-Cigarette Litigation is Heating Up and The Science is Too
06 June 2019
E-Cigarette Litigation is Heating Up and The Science is Too

Manufacturers, retailers, and distributors of e-cigarettes are likely to be defending themselves in against a variety of claims involving these products. Read more

New PFAS Legislation Will Have Big Impact on Litigation
03 June 2019
New PFAS Legislation Will Have Big Impact on Litigation

Recently, both the U.S. House of Representatives and Senate held separate legislative hearings to address potential health and environmental impacts of pre-/polyfluorinated substances (PFAS). Read more

Can Smoking Cause Mesothelioma?
16 May 2019
Can Smoking Cause Mesothelioma?

The causal relationship between smoking and lung cancer is one of the strongest and most well established in all the health sciences. Read more

PFAS Inspired Litigation: An Increasing Number of Entities are at Risk
08 May 2019
PFAS Inspired Litigation: An Increasing Number of Entities are at Risk

Poly- and per-fluorinated alkyl substances (PFAS) are a group of synthesized chemicals that have been used for more than 50 years across many types of industries. Read more

Signature Mutations Might be the Best Alternative Cause Defense You Never Heard Of
29 April 2019
Signature Mutations Might be the Best Alternative Cause Defense You Never Heard Of

Genetic knowledge continues to increase at a rapid pace, transforming not only the practice of medicine but also toxic tort litigation. Read more

New Study Identifies Potential Genetic Biomarker of Malignant Pleural Mesothelioma
21 January 2019
New Study Identifies Potential Genetic Biomarker of Malignant Pleural Mesothelioma

In a recently published article, Guarrera and colleagues report differential DNA methylation between malignant pleural mesothelioma (MPM) patients and cancer-free controls. Read more

Wasting too much time searching for scientific articles and not enough time reading them?
15 January 2019
Wasting too much time searching for scientific articles and not enough time reading them?

The volume of newly published scientific literature continues to grow at a staggering pace. Read more

Malignant Mesothelioma in Women: Non-Occupational Asbestos Exposure or Genetics?
09 January 2019
Malignant Mesothelioma in Women: Non-Occupational Asbestos Exposure or Genetics?

A recent article by Marinaccio and colleagues examined gender differences and modalities of asbestos exposure in malignant mesothelioma (MM). Read more

Malic Acid Under Fire in a Growing Number of Lawsuits and the Right Experts will be Key to Defending These Cases
16 December 2018
Malic Acid Under Fire in a Growing Number of Lawsuits and the Right Experts will be Key to Defending These Cases

Malic acid is a versatile ingredient that is commonly found in food and dietary supplement products. Lately, malic acid has become the target of a growing number of lawsuits. Read more

Message to P/C Insurers: The Scientific Revolution is Here
22 November 2018
Message to P/C Insurers: The Scientific Revolution is Here

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. Read more

New Evidence Of Genetic Drivers For Mesothelioma In Persons With No Known Asbestos Exposure
15 November 2018
New Evidence Of Genetic Drivers For Mesothelioma In Persons With No Known Asbestos Exposure

A recently published article authored by Drs. Michele Carbone, Haining Yang, and Harvey Pass (among others) is relevant to asbestos and talc defendants because it provides additional data supporting the conclusion that inherited genetic variations cause mesothelioma in some persons without any known exposure to asbestos. Read more

New Paper Explores Heritable Genetic Factors Related To Mesothelioma
11 October 2018
New Paper Explores Heritable Genetic Factors Related To Mesothelioma

A new paper by Kharazmi and colleagues present important data regarding the heritable nature of mesothelioma using epidemiological techniques to analyze the population-based Swedish Cancer Registry. Read more

Advances in Interpreting Findings from BRCA1 Mutations
20 September 2018
Advances in Interpreting Findings from BRCA1 Mutations

An interesting new paper about the BRCA1 gene was published in the journal Nature last week (see here for a summary of the findings). Read more

Courtroom Implications of New Paper On Germline (Inherited) Mutations Associated with Mesotheliomas (and Perhaps Ovarian Cancers)
17 September 2018
Courtroom Implications of New Paper On Germline (Inherited) Mutations Associated with Mesotheliomas (and Perhaps Ovarian Cancers)

This is our second comment on a very recent paper (Panou 2018) reporting findings from a study looking for germline (inherited) variants (mutations) in persons afflicted by mesotheliomas. Read more

Two Recent Toxic Tort Verdicts (Totaling Nearly $5 Billion) Demonstrate the Importance of Genomics in the Courtroom
10 September 2018
Two Recent Toxic Tort Verdicts (Totaling Nearly $5 Billion) Demonstrate the Importance of Genomics in the Courtroom

As many of our readers know, there have been two recent, large toxic tort verdicts:  (1) $4.6 billion talc verdict against J&J (22 ovarian cancer cases); and (2) $300 million glyphosate verdict against Monsanto. Read more

New Paper Identifies Several New Inherited Genetic Mutations in Mesothelioma Patients, Creating New Opportunities and Risks for Litigants
06 September 2018
New Paper Identifies Several New Inherited Genetic Mutations in Mesothelioma Patients, Creating New Opportunities and Risks for Litigants

Some scientific findings provide both opportunities and risks for litigants in mass tort cases. Read more