SUMMARY JUDGMENT UNDER THE FEDERAL RULES WHEN AN ISSUE OF FACT IS PRESENTED

Rule 56 of the Federal Rules of Civil Procedure introduced to federal practice the summary judgment procedure, which had been developed previously in England and several of the states. The scope of rule 56 is the broadest possible, since the rule provides that any party may move for a summary judgment in any type of civil action. Rule 56(c) provides that the court shall grant a motion for summary judgment if the pleadings, depositions, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law. It is clear from this provision that the movant in order to obtain a summary judgment must show: (1) that there is no genuine issue as to any material fact in the case, and (2) that he is entitled to a judgment in his favor as a matter of law. The second of these requirements has not caused much difficulty; here generally the courts have borrowed a test with which they are familiar, holding that the movant to obtain summary judgment must show that he would be entitled to a directed verdict at trial (if the case were tried to a jury) on the basis of the undisputed facts. It is rather the first of these two requirements which has caused conflict and uncertainty

Scope of Discovery Against the United States

In the interpretation and application of the discovery provisions of the Federal Rules of Civil Procedure, one of the most controversial problems is the extent to which discovery is available against the United States when it is a party to an action. Undeniably, the Government is entitled to use the discovery procedures, and it has not hesitated to do so; however, it has often fought vigorously the use of the same procedures against it. At one time the Government argued unsuccessfully that it was entirely exempt from the discovery provisions of the Rules. It has apparently abandoned this argument, but it continues to fight discovery by urging not only its well-recognized evidentiary privileges, but also an all inclusive privilege which, it contends, executive officers alone can apply. In answer to claims of this latter privilege, the courts have gone in all directions, often assuming or inventing such a privilege, and sometimes even applying it, but more frequently finding a way to avoid it. The purpose of this article is to discuss the unique problems arising as to discovery against the United States as a party litigant. The discussion does not cover the situation where discovery is sought against the United States although it is not a party. Nor does it cover the usual problems which are presented in seeking discovery against any private litigant and which are, of course, also present when the United States is involved. The subject to be discussed can be divided into three parts: (1) whether the United States is subject to discovery; (2) whether there are any special privileges available to it which are not available to an ordinary litigant; and (3) to the extent that there are such special privileges, who decides their application

Evacetrapib and Cardiovascular Outcomes in High-Risk Vascular Disease

BACKGROUND: The cholesteryl ester transfer protein inhibitor evacetrapib substantially raises the high-density lipoprotein (HDL) cholesterol level, reduces the low-density lipoprotein (LDL) cholesterol level, and enhances cellular cholesterol efflux capacity. We sought to determine the effect of evacetrapib on major adverse cardiovascular outcomes in patients with high-risk vascular disease. METHODS: In a multicenter, randomized, double-blind, placebo-controlled phase 3 trial, we enrolled 12,092 patients who had at least one of the following conditions: an acute coronary syndrome within the previous 30 to 365 days, cerebrovascular atherosclerotic disease, peripheral vascular arterial disease, or diabetes mellitus with coronary artery disease. Patients were randomly assigned to receive either evacetrapib at a dose of 130 mg or matching placebo, administered daily, in addition to standard medical therapy. The primary efficacy end point was the first occurrence of any component of the composite of death from cardiovascular causes, myocardial infarction, stroke, coronary revascularization, or hospitalization for unstable angina. RESULTS: At 3 months, a 31.1% decrease in the mean LDL cholesterol level was observed with evacetrapib versus a 6.0% increase with placebo, and a 133.2% increase in the mean HDL cholesterol level was seen with evacetrapib versus a 1.6% increase with placebo. After 1363 of the planned 1670 primary end-point events had occurred, the data and safety monitoring board recommended that the trial be terminated early because of a lack of efficacy. After a median of 26 months of evacetrapib or placebo, a primary end-point event occurred in 12.9% of the patients in the evacetrapib group and in 12.8% of those in the placebo group (hazard ratio, 1.01; 95% confidence interval, 0.91 to 1.11; P=0.91). CONCLUSIONS: Although the cholesteryl ester transfer protein inhibitor evacetrapib had favorable effects on established lipid biomarkers, treatment with evacetrapib did not result in a lower rate of cardiovascular events than placebo among patients with high-risk vascular disease. (Funded by Eli Lilly; ACCELERATE ClinicalTrials.gov number, NCT01687998 .)

Effects of Anacetrapib in Patients with Atherosclerotic Vascular Disease

BACKGROUND: Patients with atherosclerotic vascular disease remain at high risk for cardiovascular events despite effective statin-based treatment of low-density lipoprotein (LDL) cholesterol levels. The inhibition of cholesteryl ester transfer protein (CETP) by anacetrapib reduces LDL cholesterol levels and increases high-density lipoprotein (HDL) cholesterol levels. However, trials of other CETP inhibitors have shown neutral or adverse effects on cardiovascular outcomes. METHODS: We conducted a randomized, double-blind, placebo-controlled trial involving 30,449 adults with atherosclerotic vascular disease who were receiving intensive atorvastatin therapy and who had a mean LDL cholesterol level of 61 mg per deciliter (1.58 mmol per liter), a mean non-HDL cholesterol level of 92 mg per deciliter (2.38 mmol per liter), and a mean HDL cholesterol level of 40 mg per deciliter (1.03 mmol per liter). The patients were assigned to receive either 100 mg of anacetrapib once daily (15,225 patients) or matching placebo (15,224 patients). The primary outcome was the first major coronary event, a composite of coronary death, myocardial infarction, or coronary revascularization. RESULTS: During the median follow-up period of 4.1 years, the primary outcome occurred in significantly fewer patients in the anacetrapib group than in the placebo group (1640 of 15,225 patients [10.8%] vs. 1803 of 15,224 patients [11.8%]; rate ratio, 0.91; 95% confidence interval, 0.85 to 0.97; P=0.004). The relative difference in risk was similar across multiple prespecified subgroups. At the trial midpoint, the mean level of HDL cholesterol was higher by 43 mg per deciliter (1.12 mmol per liter) in the anacetrapib group than in the placebo group (a relative difference of 104%), and the mean level of non-HDL cholesterol was lower by 17 mg per deciliter (0.44 mmol per liter), a relative difference of -18%. There were no significant between-group differences in the risk of death, cancer, or other serious adverse events. CONCLUSIONS: Among patients with atherosclerotic vascular disease who were receiving intensive statin therapy, the use of anacetrapib resulted in a lower incidence of major coronary events than the use of placebo. (Funded by Merck and others; Current Controlled Trials number, ISRCTN48678192 ; ClinicalTrials.gov number, NCT01252953 ; and EudraCT number, 2010-023467-18 .)

SUMMARY JUDGMENT UNDER THE FEDERAL RULES WHEN AN ISSUE OF FACT IS PRESENTED

Rule 56 of the Federal Rules of Civil Procedure introduced to federal practice the summary judgment procedure, which had been developed previously in England and several of the states. The scope of rule 56 is the broadest possible, since the rule provides that any party may move for a summary judgment in any type of civil action. Rule 56(c) provides that the court shall grant a motion for summary judgment if the pleadings, depositions, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law. It is clear from this provision that the movant in order to obtain a summary judgment must show: (1) that there is no genuine issue as to any material fact in the case, and (2) that he is entitled to a judgment in his favor as a matter of law. The second of these requirements has not caused much difficulty; here generally the courts have borrowed a test with which they are familiar, holding that the movant to obtain summary judgment must show that he would be entitled to a directed verdict at trial (if the case were tried to a jury) on the basis of the undisputed facts. It is rather the first of these two requirements which has caused conflict and uncertainty