Preemption and Medical Devices: The Courts Run Amok

Perhaps the most dramatic indication that the courts have shifted attitudes on health and safety matters comes from recent cases relating to medical devices and preemption. In this Article, we review the law relating to preemption, the Cipollone decision, the preemption provisions of the MDA, the regulations issued by the Food and Drug Administration ( FDA ) relating to preemption, and the impact of Cipollone on court interpretations of the MDA. Based on our review of the intended preemptive effect of the MDA, we conclude that it is unlikely that either Congress or the FDA intended for the MDA to preempt state tort claims. Moreover, even if preemption were justified for some tort claims-a proposition we reject-the courts have extended the rationale in Cipollone far beyond anything that the Supreme Court intended in its ruling. In short, we maintain that the courts have run amok in their rulings on preemption

Good Faith: A New Look At An Old Doctrine

In this article we sketch the basic contours of the contractual policing devices that apply to special relationships and to arm\u27s length transactions. We then explicate in greater detail the duty of good faith under general contract law and the Uniform Commercial Code. Finally, we explore some strategies for shortening arm\u27s length transactions through consensual extensions of the duty of good faith

Clinical utility of denosumab for treatment of bone loss in men and women

While most older patients with osteoporosis are treated with antiresorptive bisphosphonates such as alendronate, risedronate, ibandronate, and zoledronic acid, such drugs have side effects, remain in bone for extended periods, and lead to poor adherence to chronic treatment. Denosumab is a humanized monoclonal antibody and antiresorptive agent that works by decreasing the activity of the receptor activator of nuclear factor kappa B ligand. In major trials in postmenopausal women, denosumab increased bone mineral density by dual energy x-ray absorptiometry in the spine, hip, and distal third of the radius and decreased vertebral, nonvertebral, and hip fractures. Denosumab is administered by subcutaneous injection every six months, suggesting that adherence may be improved with such therapy. In addition, pharmacokinetic studies measuring bone turnover markers imply that the antiresorptive effect diminishes more quickly over time. Whether these properties will lead to fewer long-term side effects needs to be proven. Denosumab has also been studied in men with prostate cancer treated with androgen deprivation therapy. These men, at high risk for fracture, also have increases in spine, hip, and forearm dual energy x-ray absorptiometry, as well as fewer morphologic vertebral fractures on x-ray. Denosumab is approved for postmenopausal women with osteoporosis in the US and Europe and for men on androgen deprivation therapy in Europe

Non Gaussian extrema counts for CMB maps

In the context of the geometrical analysis of weakly non Gaussian CMB maps, the 2D differential extrema counts as functions of the excursion set threshold is derived from the full moments expansion of the joint probability distribution of an isotropic random field, its gradient and invariants of the Hessian. Analytic expressions for these counts are given to second order in the non Gaussian correction, while a Monte Carlo method to compute them to arbitrary order is presented. Matching count statistics to these estimators is illustrated on fiducial non-Gaussian "Planck" data.Comment: 4 pages, 1 figur

A Strategic Conceptualization Of The IT Outsourcing Decision And The Role Of Teams

We examine how organizational, individual, and team factors affect team-based judgment of value for outsourcing information technology (IT) services.  The study of team-based judgment of value is important because team designs are growing in popularity to support the customization of IT services to meet larger, organizational objectives.  A strategic reconceptualization of how IT outsourcing decisions are operationalized through team-based judgments of value is fundamental for understanding how organizational objectives, work requirements, and contractual conditions are framed and executed.

Patterns of Dynamical Gauge Symmetry Breaking

We construct and analyze theories with a gauge symmetry in the ultraviolet of the form $G \otimes G_b$, in which the vectorial, asymptotically free $G_b$ gauge interaction becomes strongly coupled at a scale where the $G$ interaction is weakly coupled and produces bilinear fermion condensates that dynamically break the $G$ symmetry. Comparisons are given between Higgs and dynamical symmetry breaking mechanisms for various models.Comment: 14 pages, late

Lack of autoantibody production associated with cytomegalovirus infection

To confirm an association between cytomegalovirus (CMV) infection and the presence of antibodies to Smith (Sm), to ribonucleoprotein (RNP), and to a component of the U1 ribonucleoproteins (U1-70 kD), we measured antibodies to these protein antigens using an enzyme immunoassay and an immunoblot. The antibodies were measured in the sera of 80 healthy subjects, one-half of whom were naturally CMV seropositive and one-half were CMV seronegative, and in eight subjects immunized with a live attenuated strain of CMV. None of the vaccinees developed antibodies to Sm, to RNP, or to U1-70 kD at either 4 or 12 months after immunization. Additionally, there was no statistically significant association between levels of antibodies to Sm or to RNP and between sera obtained from vaccinees, natural CMV seropositive individuals, and CMV seronegative individuals. One CMV seropositive serum and one CMV seronegative serum tested positive for antibodies to U1-70 kD. These data indicate that neither wild-type infection nor the live-attenuated Towne vaccine frequently induce autoantibody production

Types of quantum information

Quantum, in contrast to classical, information theory, allows for different incompatible types (or species) of information which cannot be combined with each other. Distinguishing these incompatible types is useful in understanding the role of the two classical bits in teleportation (or one bit in one-bit teleportation), for discussing decoherence in information-theoretic terms, and for giving a proper definition, in quantum terms, of ``classical information.'' Various examples (some updating earlier work) are given of theorems which relate different incompatible kinds of information, and thus have no counterparts in classical information theory.Comment: Minor changes so as to agree with published versio

HE AMOT FAMILY OF PROTEINS BINDS AND ACTIVATES NEDD4 FAMILY LIGASES TO PROMOTE THE UBIQUITINATION OF LATS AND YAP

poster abstractAmot adaptor proteins bind and integrate signaling that controls cell po-larity and growth. All three Amot family members (Amot, AmotL1 and AmotL2) directly bind YAP; a transcriptional co-activator that controls the expression of genes involved in organ homeostasis and cell growth. Preven-tion of nuclear accumulation of YAP by either sequestration or degradation in the cytosol abolishes its transcriptional functions and is a major mechanism for growth arrest in response to cellular differentiation. This is mainly thought to be regulated by phosphorylation of YAP by the Hippo kinases LATS1/2. Recently, binding by the Amot proteins was also found to inhibit YAP by sequestering it in the cytosol through both LATS dependent and in-dependent mechanisms. This study identifies a novel mechanism whereby Amot proteins control YAP activation in a Hippo independent mechanism by coupling it to ubiquitination by Nedd4 family ligases. Amot proteins mediate the coupling of Nedd4 ligases with YAP by simultaneously binding both pro-teins via multiple PY motifs that are recognized by WW domains in both YAP and Nedd4. Binding of Nedd4 by Amot is also shown to relieve the auto-inhibition of its ligase activity. This may be a direct consequence of binding Amot or from being re-targeted in cells by Amot proteins to endosomes. Im-portantly, Amot induced ubiquitination of YAP by Nedd4 proteins is shown to enhance the residence of YAP in the nucleus and in YAP activated transcrip-tion. Taken together our data suggest that Amot couples Nedd4 family ubiq-uitin ligases with the transcriptional co-activator YAP to drive the ubiquitination and activation of YAP

Variability in EIT Images of Lung Ventilation as a Function of Electrode Planes and Body Positions

This study is aimed at investigating the variability in resistivity changes in the lung region as a function of air volume, electrode plane and body position. Six normal subjects (33.8 ± 4.7 years, range from 26 to 37 years) were studied using the Sheffield Electrical Impedance Tomography (EIT) portable system. Three transverse planes at the level of second intercostal space, the level of the xiphisternal joint, and midway between upper and lower locations were chosen for measurements. For each plane, sixteen electrodes were uniformly positioned around the thorax. Data were collected with the breath held at end expiration and after inspiring 0.5, 1.0, or 1.5 liters of air from end expiration, with the subject in both the supine and sitting position. The average resistivity change in five regions, two 8x8 pixel local regions in the right lung, entire right, entire left and total lung regions, were calculated. The results show the resistivity change averaged over electrode positions and subject positions was 7-9% per liter of air, with a slightly larger resistivity change of 10 % per liter air in the lower electrode plane. There was no significant difference (p\u3e0.05) between supine and sitting. The two 8x8 regions show a larger inter individual variability (coefficient of variation, CV, is from 30% to 382%) compared to the entire left, entire right and total lung (CV is from 11% to 51%). The results for the global regions are more consistent. The large inter individual variability appears to be a problem for clinical applications of EIT, such as regional ventilation. The variability may be mitigated by choosing appropriate electrode plane, body position and region of interest for the analysis