It’s an interesting week for thinking about risk. As it happens, I’m presenting on lethal diseases and “real world evidence” at the annual meeting of the Society for Risk Analysis. Meanwhile, the General Counsel of Praedicat recently published an interesting article on:  “What’s the risk in learning about risks?” It’s well worth reading. The article starts out as follows:

“In talking with product stewardship and risk management professionals, we occasionally see a fear of too much knowledge.  You may believe that knowing about a specific risk means being held legally responsible if the risk manifests.  Unfortunately, that’s true.

Proving liability when a harm results requires showing that the risk was reasonably foreseeable.  And known risks are by definition reasonably foreseeable.  In product liability cases in particular, a manufacturer has a duty to warn consumers of any risks that it knows about or reasonably should know about.”

 

 

The latest global failure of cyber security is covered in detail in a November 30, 2018 post at Krebs on Security, and is headline news around the world. Initial data shows a massive, global scale to the failure. This breach also is only one of many at international and national hotel chains, as explained by Krebs.

Market failures often lead to regulation. And, the pressure to block cyber failure is growing issue for corporate boards because so much corporate value lies in corporate reputation, data and intangibles, rather than tangible things, according to a 2015  article at the World Economic Forum.  One wonders how all of this will evolve vis a vis state based immunity and/or regulation at state, national and global levels.  And, if a global immunity/regulation process is built for cyber security, will that process then lead to more global regulation in other substantive areas? Global class actions? Or, will soft law provide alternative answers and outcomes? Interesting times ahead.

As explained by Krebs:

“Marriott said the breach involved unauthorized access to a database containing guest information tied to reservations made at Starwood properties on or before Sept. 10, 2018, and that its ongoing investigation suggests the perpetrators had been inside the company’s networks since 2014.

Marriott said the intruders encrypted information from the hacked database (likely to avoid detection by any data-loss prevention tools when removing the stolen information from the company’s network), and that its efforts to decrypt that data set was not yet complete. But so far the hotel network believes that the encrypted data cache includes information on up to approximately 500 million guests who made a reservation at a Starwood property.

“For approximately 327 million of these guests, the information includes some combination of name, mailing address, phone number, email address, passport number, Starwood Preferred Guest account information, date of birth, gender, arrival and departure information, reservation date and communication preferences,” Marriott said in a statement released early Friday morning.

A press release yesterday brought news of an interesting next step in the process of increasing the intersections between law and molecular science. In short, liability insurance clients of Allianz will receive access to the ChemMeta analytic system developed by Praedicat. The ChemMeta system evaluates scientific literature regarding a selected set of chemicals that are or alleged to be “toxic” to some degree or another. I’ve been publicly pointing out Praedicat since 2014. See Praedicat – Foretelling the Future of Toxic Tort Litigation.  Their work ties well to our work at ToxicoGenomica. Their latest action is further proof that the future is arriving more quickly than many anticipated. The press release is pasted below, and well worth reading.

“PRESS RELEASE. London/New York/Munich/Paris/Singapore – November 27, 2018.

Allianz Global Corporate & Specialty (AGCS), the Allianz corporate insurance carrier, together with Praedicat, an InsurTech analytics company based in Los Angeles, are expanding their partnership to provide a unique analytic resource to policyholders. Specifically, clients will benefit from access to ChemMeta®, Praedicat’s software solution delivering science and regulatory risk analytics for industrial companies. ChemMeta helps both chemical manufacturers and those who incorporate chemicals downstream minimize their product safety risks. Based on the latest peer-reviewed scientific literature and risk analysis, ChemMeta provides companies customized intelligence on thousands of chemicals and materials to help make better decisions across critical functions, including product stewardship, R&D, enterprise risk management, EHS and regulatory affairs.

“By offering access to ChemMeta with our product liability policies, we help clients maximize the overall safety of their products and production processes, striking the right balance between innovation and risk,” explains Hartmut Mai, Chief Underwriting Officer, AGCS. “Those opting to use ChemMeta will better understand which substances are more likely to cause negative impact on human health and wellbeing or trigger regulatory action in the future, helping them to look around the corner. This is another example of enriching our product offering with strategic risk management services that can prevent or mitigate potential losses.”

“Today’s science is tomorrow’s regulatory action and ChemMeta uses both AI and machine learning to scan, analyze and synthesize data from millions of peer-reviewed scientific journals to identify product risk,” says Robert Reville, CEO of Praedicat. “The early warning provided by mining technical literature at scale allows companies to make proactive product decisions.”

Understanding emerging risks inherent in any manufacturing process is particularly relevant in the chemical, pharmaceutical and food & beverage industries. In the end, it is relevant to any corporation which produces or uses chemicals within their own value chain.

Large companies from the mentioned sectors might employ teams of up to 100 scientists to monitor scientific publications and track relevant findings. However, the scope of their activity is often limited due to manual analysis and, as a result, only a certain number of production elements can be thoroughly investigated. For small and medium companies, resources are even scarcer. At the same time, there is exponential growth of data and information as a result of digitalization. To comprehensively evaluate chemical products or ingredients at a company, a scalable approach is required.

“Take DEHP, one of the most widely used phthalates, a plastics additive. More than 3,500 scientific papers are currently published on DEHP globally – with more than 200 articles having been released this past year alone,” explains Jessica Schuler, VP of Strategic Initiatives at Praedicat. “ChemMeta, when coupled with the expertise of the in-house teams, allows clients to significantly expand the scale of their research activities. As a result, they can track all relevant chemicals in their company’s portfolio throughout the product lifecycle, prioritize critical ingredients and more easily identify substances which can be replaced, if and when needed.”

“One of the exciting developments of InsurTech is the ability to bundle insurance with risk insights at scale,” says Nina Everding, Head of Business Analysis at AGCS Liability. “The Praedicat partnership allows us to bring product stewardship risk insights to our product liability clients. AGCS is committed to bringing the benefits of InsurTech directly to our clients.”

“With this partnership, product liability insurance instead becomes product stewardship insurance,” says Dr. Reville.

AGCS liability insurance policyholders may receive access to ChemMeta for a defined period. After this period, they can opt for their own subscription to the analytics.

AGCS and Praedicat began their partnership in 2014 to better predict key catastrophe liability risks of the future. By combining Praedicat’s forward-looking predictive modelling approach with its own underwriting expertise and extensive liability risk portfolio analysis, AGCS aims to accelerate its risk analytic capabilities to identify next generation catastrophe liability risks far earlier than currently possible. AGCS and Praedicat regularly publish white papers on emerging liability risks; the most recent risk bulletin “The Toxic Trio” investigates the potential impact of hazardous chemicals in personal care products.”

Over the years ahead, the term “somatic recombination” may make its way into the lexicon of more lawyers. Why? Because a new, high quality study (published in Nature) shows that brain neurons appear to include mechanisms that intentionally induce somatic changes in brain cells.  Some are calling it a “landmark” study. That said, it is an “early days” results that will need confirmatory studies and much more work. That said, it raises interesting questions, including whether a mechanism of that sort could be part of Parkinson’s or other diseases/conditions.

A November 21, 2018 news article in Science provides a summary of some of the findings and possible implications:

“Rather than having one constant blueprint that stays with us throughout life, neurons have the ability to change that blueprint,” Chun proposes. That capability may benefit neurons by enabling them to generate a medley of APP versions that enhance learning, memory, or other brain functions. On the other hand, somatic recombination may promote Alzheimer’s disease in some people by producing harmful versions of the protein or by damaging brain cells in other ways, the scientists conclude.

Where do all these gene variants come from? Chun and his team think gene reshuffling depends on an enzyme called reverse transcriptase that makes DNA copies of RNA molecules. A new variant could arise when a neuron produces an RNA copy of the APP gene—this step is part of the cell’s normal procedure to produce proteins. However, reverse transcriptase may then recopy the RNA molecule to make a DNA duplicate of the APP gene that slips back into the genome. But because reverse transcriptase is “a sloppy copier,” Chun says, this new version may not match the original gene, and it may code for a different variant of APP. Drugs that block reverse transcriptase are part of the standard treatment cocktail for HIV infection, and they might also work against Alzheimer’s disease, Chun suggests.”

Age of exposure to toxins is receiving increasing attention from researchers. Below, the abstract from an interesting study of arsenic drinking water exposures in Chile.

https://academic.oup.com/aje/article-abstract/187/11/2297/5063615#.W98xc7qmSq8.email

“Abstract

Arsenic in drinking water is known to cause cancer and noncancer diseases, but little is known about its association with age at exposure. Here, we investigated age at arsenic exposure and mortality in Antofagasta, Chile, 30螔years after a distinct period of very high water arsenic concentrations (1958). We calculated standardized mortality ratios (SMRs) comparing Antofagasta with the rest of Chile for 2001by sex and age at potential first exposure. A remarkable relationship with age at first exposure was found for bronchiectasis, with increased risk in adults 30螔years after exposure being confined to those who were in utero (SMR = 11.7, 95% confidence interval (CI): 4.3, 25.4) or aged 1蝶years (SMR = 5.4, 95% CI: 1.1, 15.8) during the high-exposure period. Increased SMRs for lung, bladder, and laryngeal cancer were evident for exposures starting at all ages, but the highest SMRs were for exposures beginning at birth (for bladder cancer, SMR = 16.0 (95% CI: 10.3, 23.8); for laryngeal cancer, SMR = 6.8 (95% CI: 2.2, 15.8); for lung cancer, SMR = 3.8 (95% CI: 2.9, 4.9)). These findings suggest that interventions targeting early-life arsenic exposure could have major impacts in reducing long-term mortality due to arsenic 30螔years after exposure ends.” 

As pointed out in Tuesday’s post (September 18, 2018),  Praedicat and Allianz recently published facts and assessments on a “toxic” trio associated with some cosmetics. Again, this is an innovative effort, and deserves careful consideration. The third member of the “toxic trio” substances is formaldehyde. The facts and assessment of the future are – again – notable:

“Formaldehyde is listed as a known carcinogen by the US National Toxicology Program and the International Agency for Research on Cancer (IARC)…. However, formaldehyde is most commonly used to make resins – precursors to many plastic and adhesive chemicals – that are used in dozens of industrial processes that eventually produce hundreds of consumer products: pressed wood, disinfectants, clothing, adhesives, laminates, insulation, paper products, and personal care products. Formaldehyde is often a component of hair straighteners used both in salons and at home.

***

Using Praedicat’s model to evaluate the current consensus and projected evolution of the peer-reviewed scientific literature, we summarize the hypothesised bodily injuries linked to formaldehyde exposure in the table.”

 

As pointed out in Tuesday’s post (September 18, 2018),  Praedicat and Allianz recently published facts and assessments on a “toxic” trio associated with some cosmetics. This is an innovative effort, and one that deserves careful consideration. One of the “toxic trio” substances is toluene. The report includes the following data, and Praedicat’s assessment of where the science likely will go. The report includes the following:

“Toluene is … a solvent commonly found in paints, inks, adhesives, paint thinner, stain removers, fragrances, hand and nail care products, and a wide variety of personal care products. The value of the toluene market was $16.6bn in 2016 and significant growth is projected over the coming years. The wide-ranging use of toluene as a solvent in the personal care product applications listed above presents two potential exposure routes: dermal and inhalation.

***

With exposure to toluene common from solvent-containing products, including personal care products, the potential for bodily injury is important to understand. Scientists have studied toluene fairly extensively, publishing 180 studies investigating its ability to cause bodily injury. As before, in the adjacent table we summarizes the consensus and projected evolution of the peer-reviewed scientific literature using Praedicat’s models.

The most innovative part of Praedicat’s work is assessing the current state of the science as to disease causation, and where it will go. From the 180 studies (and more factors), Praedicat assessed the science as follows:

A few far sighted liability insurers are paying attention to molecular science as to alleged or actual toxins, often aided by the ground-breaking work at Praedicat to assess the medical and scientific literature as to various actual or alleged toxins. See this February 7, 2014  post regarding Praedicat’s work and vision.

Some also are taking their concerns public. Thus, Allianz and Praedicat just issued a trio of publications reporting on concerns related to a so-called “toxic trio” as related to cosmetics and “personal care” products.  See:

https://www.businesswire.com/news/home/20180912005640/en/%E2%80%9CToxic-Trio%E2%80%9D-Cosmetics-Creates-Emerging-Liability-Risks

https://www.agcs.allianz.com/insights/white-papers-and-case-studies/emerging-liability-risks-toxic-trio/

https://www.agcs.allianz.com/assets/PDFs/risk%20bulletins/AGCS_Praedicat_Toxic_Trio_Risk_Bulletin.pdf

What’s the gist? The following:

“CHEMICAL DANGERS IN PERSONAL CARE PRODUCTS ALLIANZ GLOBAL CORPORATE & SPECIALTY®Increasing scientific, regulatory, and consumer concerns means increasing risk for manufacturers and suppliers of various personal care products. The potential for synergistic effects of a so-called “toxic trio”of hazardous chemicals used in these products threatens to expose them to latent liabilities. This risk bulletin by Allianz Global Corporate & Specialty and Praedicat, a leading science-based risk analytics company, reviews possible risk exposures and potential impacts of this trio of chemicals to businesses and the insurance industry.

Among the widely-used chemicals today, three have gained some notoriety, primarily for their use in nail varnish: dibutyl phthalate (DBP), toluene, and formaldehyde –or the so-called “toxic trio”which are prevalent in the personal care industry.”

As to DBP, they said, among other things:

“As a result, body lotions, perfumes, and nail varnishes containing DBP, because they are applied directly to the skin, have a clear dermal exposure route that theoretically allows DBP to enter the bloodstream, although until recently it was unclear whether it actually did so. Three separate peer-reviewed studies in the last decade have shown that it does [Janjua, N.R. 2008; Pan, T.L. 2014; Sugino, M. 2017]. Collectively, this research demonstrates that DBP can cross the skin but that the transport rate is likely to depend on the activity of certain enzymes that start the process of metabolizing DBP into its breakdown products.”

As to DBP, as shown by the chart below, Praedicat sees the science worsening for defendants as to causation as to “endocrine” system diseases and conditions. To me, the most innovative part of Praedicat’s work is assessing the current state of the science as to disease causation, and where it will go.