Separating the Rumors from the Science: Rivaroxaban

CoMeta™ Life Science adds pharmaceutical Litagion® agent profiles to CoMeta focusing on evaluating the liability that could arise from a manufacturer’s failure to warn physicians regarding the risk of specific bodily injuries. One pharmaceutical Litagion agent in CoMeta is rivaroxaban, widely known by its trade name Xarelto®. Rivaroxaban belongs to the new oral anticoagulants (NOACs) class of drugs which seek to replace warfarin as the primary blood thinner in the market. The advantage of NOACs over warfarin is their administration. Warfarin requires the establishment of a 2-4 week dosing regimen for every patient while NOACs have straightforward dosage directions. Rivaroxaban is currently the top seller among NOACs. However, it has been negatively portrayed in the news due to a faulty blood testing device, cover up accusations, and existing multi-district litigation (MDL) due to enter court trials this year.

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Perfluorinated Compounds Persist, As Do Concerns About Their Safety

In February 2017, Dupont and Chemours, a DuPont spin-off, settled over 3,000 pending lawsuits brought by Ohio and West Virginia residents who claimed they were sickened by contaminated drinking water[1]. The lawsuits had grown from a 1999 suit that claimed perfluorooctanoic acid (PFOA), a chemical ingredient in numerous consumer products including Teflon, seeped into the Ohio River from Dupont’s Washington Works plant. PFOA has been profiled in CoMeta™ since its inception, with PFOA’s profile demonstrating steadily growing scientific consensus around PFOA’s ability to cause bodily injury.

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Generic Drugs, Federal Preemption, and FDA Rulemaking

Praedicat’s new modeling capabilities in the pharmaceutical space present both opportunities for modeling and challenges arising in the ever-changing landscape of federal pharmaceutical law and regulation.  To illustrate how we approach such challenges, I will go through our approach to modeling the liability that could attach to the manufacturer of a generic drug when a plaintiff claims that the manufacturer failed to warn of the drug’s potential side effects.

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Does Fake Grass Mean Real Danger?

Many people who play touch football at their local high school or have taken their kids to youth soccer practice at the community park are familiar with artificial turf. Artificial turf is easier to maintain than grass, can be used year-round in cold climates, and is a go-to-choice in areas suffering from water scarcity. Modern artificial turf is made up of three components: artificial grass fibers, carpet backing, and infill (or “artificial dirt”). A high speed slide tackle or well-timed diving catch can leave an athlete covered in “black crumbs.” Artificial dirt is actually “crumb rubber,” which is chiefly composed of the shredded remains of discarded rubber tires. Many athletes, parents, and weekend warriors feel nervous when they see this crumb rubber inside their shoes, embedded in their hair, and (eventually) littered in their bath tub.

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What Happens to Liability Risk When Regulators Take Action? The Case of Silica.

Inhalation of crystalline silica can cause silicosis, a permanent scarring of the lungs leading to impaired lung functioning, and possibly death. Silicosis first garnered public attention in the early 1930s when nearly all the workers from a silica rock mining project in Hawk’s Nest, West Virginia, developed some form of the disease. The publicity from the tragedy, known today as the “Hawk’s Nest Tunnel Disaster,” greatly increased the use of respiratory protection in the mining industry. (more…)

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U.S. NTP Releases New Findings on Cell Phones and Cancer. Will Scientific Consensus Shift?

Do cell phones cause cancer? It’s a highly pertinent question considering that 5 billion people worldwide are expected to use mobile phones by 2017.1 The general causation risk scores on CoMeta™ for cell phones (“Radiofrequency Fields-Wireless Telephones”) indicate that there is not a consensus in the scientific literature that cell phone exposure causes cancer.

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Is All Fracking Created Equal?

In spite of all the controversy, not one study published before 2016 on hydraulic fracturing (fracking) finds evidence that the practice causes systemic groundwater contamination. Some instances of methane migration into or brine contamination of groundwater have occurred, but these are largely attributable to poor well design or failed cement or casings. In CoMeta, the negative general causation risk scores for methane migration and brine contamination hypotheses reflect the absence of science showing that fracking poses systemic risk to groundwater. This evidence points to the need to implement and enforce best practices in fracking rather than a need to reject it outright.
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