The False Claims Act\u27s First-to-File Bar: Jurisdictional or Not?

While the general theory behind the First-to-File bar may appear relatively simple, properly and practically applying it is a difficult task. Though there are many complexities involved with First-to-File litigation, this Article focuses on the current disagreement among the various circuit courts of appeals as to whether the First-to-File bar is a jurisdictional bar to litigation. This Article is not intended to offer an exhaustive analysis or resolution to this issue, but rather, will simply introduce the current debate and offer initial thoughts on why the authors believe the First-to-File bar is a non-jurisdictional provision

Considerations for the Next Administration: Criminal Justice Reform and Prisoner ReEntry

This Article explains the concept of prisoner reentry, which are Reentry programs that are designed to assist incarcerated individuals to successfully transition back into society after being released from prison. One critical component for reforming our system is through enhanced reentry programming and support: ensuring that offenders are provided adequate support and guidance post-incarceration, so that they may re-enter society as a contributing member of the global community. For the next administration, criminal justice reform will present an opportunity to implement rehabilitative justice through an investment of resources. The benefits of doing so appear clear\u27the community is safer when people are successfully reintegrated and precious resources are saved by not having to incarcerate those who don\u27t successfully reintegrate

Automated balloon control in resuscitative endovascular balloon occlusion of the aorta (REBOA)

Objective: The goal of this work was to demonstrate technical feasibility of automated balloon pressure management during REBOA in the pre-clinical setting. Methods: This paper presents an intelligent balloon management device which automates the balloon inflation process, preventing the possibility of balloon over or under inflation, optimizes inflation pressure and if indicated, deflates automating partial REBOA to allow distal organ perfusion. Edwards TruWave pressure transducers are used to monitor the blood pressure proximal and distal to the balloon, as well as the internal balloon pressure. A faux PID controller, implemented on an Arduino platform, is used in a feedback control loop to allow a user defined mean arterial pressure setpoint to be reached, via a syringe driver which allows intelligent inflation and deflation of the catheter balloon. Results: Ex vivo testing on a vascular perfusion simulator provided the characteristic behavior of a fully occluded aorta, namely the decrease of distal pressure to zero. In vivo testing on live porcine models indicated that automated partial REBOA is achievable and by enabling partial occlusion may offer improved medical outcomes compared to manual control. Conclusion: Automated balloon pressure management of endovascular occlusion is feasible and can be successfully implemented without changes on current clinical workflows. Significance: With further development, automated balloon management may significantly improve clinical outcomes in REBOA

Immune-mediated mechanisms influencing the efficacy of anticancer therapies

Conventional anticancer therapies, such as chemotherapy, radiotherapy, and targeted therapy, are designed to kill cancer cells. However, the efficacy of anticancer therapies is not only determined by their direct effects on cancer cells but also by off-target effects within the host immune system. Cytotoxic treatment regimens elicit several changes in immune-related parameters including the composition, phenotype, and function of immune cells. Here we discuss the impact of innate and adaptive immune cells on the success of anticancer therapy. In this context we examine the opportunities to exploit host immune responses to boost tumor clearing, and highlight the challenges facing the treatment of advanced metastatic disease

Immunobiological effects of gemcitabine and capecitabine combination chemotherapy in advanced pancreatic ductal adenocarcinoma

Background: Preclinical studies suggest that chemotherapy may enhance the immune response against pancreatic cancer. Methods: The levels of granulocyte macrophage-colony-stimulating factor (GM-CSF) and interleukin-6 (IL-6) and the associated inflammatory marker C-reactive protein (CRP) were assessed in 38 patients receiving gemcitabine and capecitabine combination chemotherapy for advanced pancreatic cancer within the TeloVac trial. Apoptosis (M30) and total immune response (delayed-type hypersensitivity and/or T-cell response) were also assessed and levels of apoptosis induction correlated with immune response. The telomerase GV1001 vaccine was given either sequentially (n=18) or concomitantly (n=24) with the combination chemotherapy. Results: There were no differences between baseline and post-treatment levels of CRP (P=0.19), IL-6 (P=0.19) and GM-CSF (P=0.71). There was a positive correlation between post-chemotherapy CRP and IL-6 levels (r=0.45, P=0.005) and between CRP with carbohydrate antigen-19-9 (CA19-9) levels at baseline (r=0.45, P=0.015) and post treatment (r=0.40, P=0.015). The change in CRP and IL-6 levels was positively correlated (r=0.40, P=0.012). Hazard ratios (95% CI) for baseline CA19-9 (1.30 (1.07–1.59), P=0.009) and CRP (1.55 (1.00–2.39), P=0.049) levels were each independently predictive of survival. The M30 mean matched differences between pre- and post-chemotherapy showed evidence of apoptosis in both the sequential (P=0.058) and concurrent (P=0.0018) chemoimmunotherapy arms. Respectively, 5 of 10 and 9 of 20 patients had a positive immune response but there was no association with apoptosis. Conclusions: Combination gemcitabine and capecitabine chemotherapy did not affect circulating levels of GM-CSF, IL-6 and CRP. Chemotherapy-induced apoptosis was not associated with the immunogenicity induced by the GV1001 vaccine in advanced pancreatic cancer

The False Claims Act\u27s First-to-File Bar: Jurisdictional or Not?

While the general theory behind the First-to-File bar may appear relatively simple, properly and practically applying it is a difficult task. Though there are many complexities involved with First-to-File litigation, this Article focuses on the current disagreement among the various circuit courts of appeals as to whether the First-to-File bar is a jurisdictional bar to litigation. This Article is not intended to offer an exhaustive analysis or resolution to this issue, but rather, will simply introduce the current debate and offer initial thoughts on why the authors believe the First-to-File bar is a non-jurisdictional provision