ENFORCEMENT OF ETHICAL STANDARDS IN CONGRESS … or what used to be settled practice under US constitution


“The aim of every political constitution is, or ought to be, first to obtain for rulers men who possess most wisdom to discern, and most virtue to pursue, the common good of society; and in the next place, to take the most effectual precautions for keeping them virtuous whilst they continue to hold their public trust . . . .”
James Madison, The Federalist Papers, No. 57.

Members of Congress, like other citizens in the United States, are subject to investigation and prosecution for criminal misconduct and other statutory violations through the criminal justice system, initiated by Federal, State, or local public prosecutors, and conducted through the courts. Violations of “ethical norms” and principles of ethical behavior by a Member, however, are enforced, principally, at the ballot box by the Member’s constituents who choose their representatives in Congress, but are also enforced internally in each House of Congress by other Members of the House or the Senate.

The enforcement of Federal statutory laws, including criminal statutes, is vested in the President of the United States by the United States Constitution at Article I, Section 1. Criminal prosecutions for Federal crimes are under the authority of the Attorney General, appointed by the President as head of the Justice Department in the executive branch.1 Members of Congress have no general immunity from criminal prosecutions,2 and are subject to prosecution for violations of Federal criminal laws by the United States Attorneys of the Department of Justice.3

Unlike criminal laws or other Federal statutory provisions, however, there exist broad ethical standards, codes of conduct or behavior, and general principles of morality, written or unwritten, by which a Member of Congress may also be judged. This chapter explores these ethical standards and their enforcement in the Congress.

SOURCES OF AUTHORITY AND POWER OF SELF-DISCIPLINE
Each House of Congress has been given in the United States Constitution express authority and responsibility for decisions about the qualifications, elections, and the conduct of its own Members. The Constitution expressly instructs that each House of Congress “shall be the Judge of the Elections, Returns, and Qualifications of its own Members;”4 and further provides that each House of Congress may determine its own rules of proceedings, may “punish its Members for disorderly Behavior,” and may, “with the Concurrence of two-thirds, expel a Member.”5

The direction to discipline or “punish” its own Members, and the authority to expel, relate directly to and inform the right “recognized by common parliamentary law” of self-preservation of the institutional integrity of the legislature and its proceedings.6 Even if not granted expressly within a constitution or similar document, authorities have contended that the right to expel and to discipline members of a legislative body is an inherent right of that institution. This disciplinary authority has been described as one “naturally and even necessarily incidental to . . . legislative bodies; which, without such power, could not exist honorably, and fulfill the object of their creation.”7

The power and practice of congressional self-discipline for legislative misconduct is one which is, to some extent, compelled by the structure of our Federal government. In formulating the new Federal government, the Framers of the Constitution were determined, for reasons of the balance of powers and of “checks and balances” within the governmental system, to have three independent and co-equal branches of government.8 As part of the assurance of an independent legislature, one not fettered nor intimidated by a powerful law-enforcing executive, the Constitution expressly granted a limited immunity to Members of Congress from prosecution when the conduct involved official legislative activities.9 The so-called “speech or debate” clause immunity provides that a Member “shall not be questioned in any other place” concerning official legislative conduct.10 Since a Member may not be questioned “in any other place” regarding certain conduct in the legislative process, this speech or debate immunity provides a cogent and practical reason for the countervailing authority and responsibility within the Constitution for congressional self-discipline and the necessity for internal enforcement of legislative standards of conduct.

CONSTITUTIONAL HISTORY
The practice of internal discipline within our national legislature reflected British parliamentary experience, as did the recognition by the Framers of the need to protect the independence and privileges of the legislature from undue influence or intimidation from the executive. In parliamentary practice, the House of Commons has had the right to discipline or “punish its own Members for disorderly conduct” and for other contempts or breaches of the privileges of the House.11 This authority was concurrent with that of punishing contempt by those who are not Members, and sought to protect the integrity of the legislative institution, and its privileges and functions.12

The constitutional authority for the legislative bodies in Congress to discipline their own Members did not appear to be accompanied by any significant debate in the Constitutional Convention, save for the amendment by James Madison to require a two-thirds majority to expel a Member so that such “an important right” could not be exercised “by a bare majority” and thus could be a power which majority factions might dangerously abuse.13 Madison and Hamilton had earlier expressed concern, with respect to the issue of “qualifications” of Members, that if the institution of Congress itself could limit membership to those that it deemed to be “fit” to serve in the legislature, the institution might usurp from the people the power to choose whom they wished to represent them in Congress.14 The authority to expel stated in the Constitution was not, however, couched with any additional limitations other than the requirement for a super-majority of two-thirds.

In punishing Members by means other than expulsion, the constitutional provision originally drafted in the Committee on Detail provided simply the authority for each House to “punish,” but as finally reported added the modifier phrase that each House may punish for “disorderly behavior.” There had in the past been questions raised about whether the power to punish for “disorderly behavior” was restricted only to conduct in Congress, that is, behavior which directly disrupted the proceedings and functions of the institution itself. But early precedents and discussions indicated clearly that of Congress the power to discipline was not narrowly focused on merely internal conduct within the institution, nor was congressional authority limited merely to addressing misconduct or disorderly behavior which was not otherwise considered as a criminal or civil offense.15 In his historic work on the Constitution, Justice Joseph Story noted in 1833 that congressional disciplinary authority under this clause of the Constitution is apparently unqualified as to “the time, place or nature of the offense” for which one is to be punished, similar to the British parliamentary practice.16

Later cases and precedents within the House and Senate have affirmed the broad application of each House’s authority to “punish” misconduct by means other than expulsion. In the censure of Senator Joseph McCarthy of Wisconsin, the Select Committee to Study the Censure Charges in the 83d Congress reported to the Senate: “It seems clear that if a Senator should be guilty of reprehensible conduct unconnected with his official duties and position, but which conduct brings the Senate into disrepute, the Senate has the power to censure.”17 The House of Representatives has held a similar view. In the report on Representative Adam Clayton Powell from the House Judiciary Committee, the Committee noted that: “Nor is the conduct for which punishment may be imposed limited to acts relating to the Member’s official duties.”18

INTERNAL ETHICS ENFORCEMENT GENERALLY
Unlike the enforcement of criminal laws, or even civil litigation to resolve competing legal claims, ethics procedures and the enforcement of general standards of ethical conduct or professional responsibilities are, by their nature, generally collegial exercises, where peers must judge the conduct of those within their own group, profession, or own organization. Professional boards of review and panels for professional responsibility, discipline, and review are somewhat common for many occupations and professions in the private sector.

In the public sector, ethics enforcement is, to a large extent, similarly an internal, in-house procedure. The executive agencies of the Federal Government, for example, are instructed to appoint an official of the agency as the Designated Agency Ethics Officer to provide the front-line interpretations and instructions to officers and employees of the agency concerning standards of ethical conduct. Although there is now a centralized agency which provides coordination of ethics interpretations and standards, that agency, the Office of Government Ethics, does not generally involve itself in day-to-day enforcement of ethics of individual employees within an agency. Rather, the regulations on standards of conduct, promulgated by each executive agency in line with presidential executive orders and regulations of the Office of Government Ethics, are enforced internally by the respective agency.19 The courts have recognized that enforcement of ethical standards of conduct in the Federal Government is an exercise of discretion, applying often subjective terms and general ethical principles and concepts, and is an area where the organization or institution itself has the experience, expertise, and familiarity with the acceptable standards of conduct, mores, and nature of the responsibilities of the official.20

In the judicial branch of the Federal Government, a judicial review panel or committee, made up of sitting Federal judges, reviews conduct and disciplinary complaints concerning members of the Federal judiciary.21 The review committee may forward a report on a particular matter to the judicial council in that circuit for appropriate action, including censure, reprimand, temporary suspension of assigning cases to that judge, request to the judge to retire, and/or referral of a matter to the House of Representatives for possible impeachment proceedings.22

INTERNAL ETHICS ENFORCEMENT IN CONGRESS
Somewhat similar to officials and officers in the executive and judicial branches of government, Members of Congress are subject to an ethics review and possible disciplinary proceedings by their peers in their respective House of Congress. As noted, the authority for internal discipline of misconduct in Congress derives directly from the Constitution, in Article I, Section 5, which gives each House of Congress the authority to “punish its Members” for misconduct and to expel a Member by a two-thirds vote.

Prior to the 1960s there was no full-time or standing ethics committee in either the House or the Senate. Complaints of misconduct or behavior abusive to or disruptive of the proceedings and privileges of either House of Congress were generally referred to an ad hoc special or select committee in the House or Senate for investigations, determinations, and recommendations. A matter concerning misconduct could also have been referred to a standing committee which normally had jurisdiction in other areas, such as the committees on the judiciary, or the rules or administration committees. There was no specific set of rules for proceedings in disciplinary matters, nor was there a written code of conduct or a written set of ethics rules.

The Senate in 1964, and the House in 1967, established for the first time standing committees on ethics to which complaints of misconduct and resolutions for disciplinary action would be referred, and where Members and employees might also seek advice and opinions on matters of ethical standards. The permanent Senate ethics committee, then known as the Select Committee on Standards and Conduct, was created by S. Res. 338, in the 88th Congress, by the adoption of a substitute proposal of Senator John Sherman Cooper of Kentucky, on July 24, 1964. Events arising out of the Bobby Baker investigation in the Senate by the Senate Rules Committee had propelled the matter of a standing committee for ethics in the Senate to full Senate consideration. In 1977 the Senate Select Committee on Ethics was established to replace the former Standards and Conduct Committee.

The House Committee on Standards of Official Conduct was created when the House adopted H. Res. 418, 90th Congress, on April 13, 1967. During hearings before the Joint Committee on the Organization of Congress in 1965, and in its final report, a recommendation was made to establish a permanent House committee for standards and conduct, similar to the one established in the Senate in 1964.23 Shortly after the Joint Committee’s report, and following highly publicized allegations of official misconduct by Representative Adam Clayton Powell, a House Select Committee on Standards and Conduct was established during the final days of the 89th Congress.24 In the 90th Congress, H. Res. 418 established a new Committee on Standards of Official Conduct. That Committee recommended changes in the House rules dealing with standards of ethical conduct and recommended its continuance as a permanent standing committee.25 Based on that report, H. Res. 1099 was reported from the House Rules Committee containing much of the substance of the Standards Committee report, including making permanent the House Committee on Standards of Official Conduct, and was adopted by the House on April 3, 1968.

In 1968 a written code of ethical conduct was for the first time adopted in the House and in the Senate. Prior to that time Members were judged almost exclusively on unwritten ethical norms and standards of conduct and behavior.26 The ethics codes in the House and Senate have been amended, updated, and tightened on several occasions since 1968, most notably in 1977, and again in the Ethics Reform Act of 1989.

The standing committees on ethics in the House and the Senate were intended to be permanent committees to develop expertise and precedents in the area of legislative ethics, conduct, and disciplinary actions. Unlike other legislative committees in the House and Senate, the membership of the House Standards and Senate Ethics committees are equally divided between majority and minority party members to require and assure at least some bipartisanship in the consideration of issues relating to ethics and standards of conduct.

Disciplinary proceedings in the committees now follow detailed procedural rules, and if warranted, evidence is eventually taken in formal hearings presided over by a panel of Members of the Committee who are sitting Members of the House or the Senate, respectively. Any formal disciplinary action by the institution, such as a censure or expulsion and, in the House of Representatives, a reprimand, is recommended by the House or Senate ethics committee to the respective body, and there voted upon by the full House or Senate. Both the House and Senate Committees have also issued letters of reproval or reprimand on their own accord to Members, but this is not considered a formal disciplinary action by the entire institution such as a censure.
In the House the disciplinary procedure since 1990 has been “bifurcated,” wherein a subcommittee of Members of the standing committee will review the initial charges and will conduct the preliminary investigations. If more formal ethics charges are to be heard (upon the issuance of a “Statement of Alleged Violations’), then another subcommittee made of the remaining Members of the House Committee on Standards of Official Conduct hears the evidence and determines whether the charges are proven. The full Committee then may make disciplinary recommendations to the membership of the House.

DISCIPLINARY ACTIONS AND INTERNAL ETHICS ENFORCEMENT
Actual disciplinary actions by the full Senate or House have, in fact, been relatively rare. The Senate has adopted censure motions only eight times, censuring nine Senators, in its history, and has not expelled a Member of the Senate since the Civil War. (Fourteen Senators were expelled during the Civil War for disloyalty to the Union, and one other Senator expelled in 1797, also for disloyal conduct). The House has censured 22 Members (21 Representatives and one Delegate), and “reprimanded” seven others, while expelling only four of its Members in its history, three during the Civil War for disloyalty to the Union, and the most recent expulsion in 1980 after conviction for bribery in congressional office.

The low number of actual disciplinary actions may be attributable to some degree to the fact that many Members, facing such disciplinary action, prefer to resign from Congress rather than to pursue the matter. In other instances, the voters have either not renominated the Member in a primary, or voted the individual out of office in the general election before disciplinary action is completed.

The regular electoral review of a Member of Congress is a significant factor in the theory and practice of congressional discipline. It also distinguishes disciplinary procedures in the House and Senate from disciplinary procedures of government officials who are appointed with indefinite tenure, such as those in the judicial and executive branches who never have to face the judgment of the public by standing for regular election or reelection to office. In framing the Constitution, as was discussed above, great deference was paid to the sanctity of the choice of the electorate as to whom the people wished to send to Washington to represent them in Congress,27 and great weight was given to keeping the Members of the legislature “virtuous” by short terms of office and the “restraint of frequent elections.”28

On the other hand, however, it is recognized that discipline cannot be left entirely to the public through the electoral process, since the institution of Congress itself, like all legislatures, has a vital interest in self-preservation and in the integrity of the institution and its proceedings.29 Thus, each House of Congress was given the express authority in the Constitution for such self-discipline.

The balance between controlling the conduct of individual Members through the electoral process and honoring the sanctity of the expression of the will of the people, on the one hand, and the institutional needs of the House or the Senate itself to preserve the integrity of the institution and its proceedings, on the other, is one which must be carefully maintained in internal ethics enforcement.30

Many observers argue, however, that it is not the reverence for and the sanctity of the electoral process that has principally restrained Congress in self-enforcement of conduct standards and ethical principles. It has been noted on many occasions that the enforcement of ethical standards against one’s peers, and disciplining individuals that one must work with, is a difficult and uncomfortable task. Some critics of congressional ethics procedures have argued that the inherent and structural “conflicts” in congressional self-discipline are the causes of what is seen to be an apparent reticence of Congress to enforce ethical standards against its own Members. Members must cooperate to a large extent with one another in the legislative process, and thus there is a natural reticence for Members to do something detrimental to one another. Many Members are now reluctant to serve on an ethics committee, where the proceedings may take a great amount of one’s time, and where the Member may be subject to criticisms from the public if perceived as being too lenient, or from congressional colleagues if perceived as being too harsh.

Several reforms have thus been suggested to mitigate the inherent conflict in ethics enforcement. The proposals include a citizen advisory committee to advise the committees of Congress on citizen reaction to ethical complaints, as well as an “independent” ethics panel, made up of non-Members, which would actually be empowered to receive and subpoena evidence, take testimony under oath, and make disciplinary recommendations concerning complaints of ethical conduct of Members of the House or the Senate.

SUMMARY OF HEARINGS ON ETHICS
The Joint Committee on the Organization of Congress held two hearings on the ethics process on February 23 and 25, 1993. The committee received testimony from the former leadership of the House Committee on Standards of Official Conduct, a former Chairman of the Senate Ethics Committee, four other Members of Congress, and four academic experts.

Most witnesses who testified believed that ethics reform should be a priority for the committee, but there were differing opinions of what constituted reform. The most discussed reform was including non-Members as a part of the process. Other changes proposed ranged from updating the Senate ethics manual, mandating ethics training for Members and staff, utilizing the same set of ethical standards in both Chambers, and streamlining the steps of an ethics investigation.

The House of Representatives has a bifurcated ethics process, in which the Committee on Standards of Official Conduct divides into two subcommittees to handle the preliminary inquiry and adjudicative functions, and the whole committee reassembles to recommend punishment.   (1)The first step in this process is determining whether the complaint merits further inquiry.   (2)The following step is a preliminary inquiry to see if there is reason to believe a violation has occurred. If this violation was determined to have occurred,    (3)then the next step is proving these charges, and (Final) the final step is recommending punishment. This system is supposed to promote fairness to the accused by not having the same group act as grand jury, jury, and judge. A case has not yet been brought under the new House system.

The Senate follows a similar process, but the significant difference is that its system is not bifurcated.  (1)The first step is a preliminary inquiry to see whether there is enough evidence to merit an investigation. If there is sufficient evidence, (2) the second step is an initial inquiry — investigating the charges.  (3)The third step is the investigation, which includes hearings. The final two steps are proving the charges and recommending punishment, if necessary. Some witnesses wanted the Senate to move to a bifurcated process. Former Senator Warren Rudman stated, “. . . It is probably unfair to Members of the committee as well as to Members who are accused to have the matters investigated and then heard by the same Senators.”31

The Constitution gives Members of Congress the responsibility for disciplining their colleagues. While no witnesses advocated giving the entire responsibility to a group of outsiders, some wanted non-Members to be able to investigate charges and recommend punishment. Representative Robert Andrews, when testifying in favor of an external ethics commission, said, “Our system purports to conduct review of ethics by our peers, but I think we misdefine what it means to be a peer. Ultimately, our peers are not fellow Representatives or Senators, ultimately our peers are ordinary citizens.”32 Conversely, other witnesses wanted ethics proceedings to be conducted only by Members. As former Senator Warren Rudman testified, “I believe that the Constitution, when it says that we ought to be the judge of our own Members, means precisely what it says.”33 A former Chairman of the Standards of Official Conduct Committee, Representative Louis Stokes was “troubled by calls for further procedural reforms, which are based on the notion that the Ethics Committee has not done its job or has not done it properly.”34

The main reason for bringing in non-Members to the ethics process was summarized by Rutgers University professor Alan Rosenthal when he stated, “. . . . Members are reluctant to serve on such bodies, and have little incentive to pursue any type of ethics agenda. Second, Members who are pressed into service naturally are reluctant to punish colleagues with whom they have empathy and whose support they undoubtedly will need on one matter or another.”35 Numerous witnesses said that using outsiders would solve the problem of Members not having sufficient time to serve on the Ethics Committee.

One of the concerns of bringing in outsiders was typified when Representative Louis Stokes said, “Why would an outside group not accountable to other Members or to the voters do a better job of deciding hard cases or of convincing the public of the wisdom of their decisions?”36 Another concern is that outsiders may not understand the norms of Congress; there are “competing and often conflicting duties and obligations and roles that [m]Members play,”37 as former Counsel to the Senate Ethics Committee, John Saxon, noted. While some proposals for outside commissions call for using former Members who would understand the role of a Member, witnesses pointed out that they might be perceived as unable to objectively judge a former colleague.

Many of the witnesses wanted ethical standards to be detailed in an ethics manual. Senator Howell Heflin, former chairman of the Senate Ethics Committee, suggested having “. . . . a continuing updating of the code of ethical conduct and that each one of the codes be annotated to the interpretative rulings that have been issued by the Ethics Committee”38 and Senator Trent Lott wanted “. . . . guidelines as to, ‘if you do this, or you don’t do this,’ then you may reach this standard of discredit or reflecting on the Senate.”39 While the House has the Office of Education and Advisory, which answers Members’ ethical questions, “one of the best things that we have come up with on the committee,”40 according to Representative James Hansen, former ranking Member of the House Standards Committee, there is not an equivalent body in the Senate. Although the staff of the Ethics Committee does answer questions of Senators and staff, it is not a formalized responsibility as it is in the House. Senator Heflin wanted “uniformity of rules and interpretation of those rules between the House and Senate.”41 There was agreement that there should be mandatory ethics training for both House and Senate Members and staff. Senator Trent Lott echoed many other witnesses’ concerns when he asked, “Shouldn’t we at least make sure that we know what the rules are and that our staff knows what the rules are?”42

Finally, there was a discussion of the length of the ethics process. While witnesses said that the rights of the accused must be protected by having a complete investigation, there was concern that the investigations take so long, and the accused has their “trial” in the media. Senator Richard Lugar said that in Senate proceedings, “. . . . the preliminary steps are so arduous and time consuming and expensive in terms of legal costs, as well as the press coverage of each of these” that the proceedings take the trappings of a trial.43There was discussion of streamlining steps in the Senate; in former Senator Warren Rudman’s view, it takes “two to three times as long as it should.”44 Representatives Stokes and Hansen argued that the procedures followed in the House were sound and the best possible for the accused; they did not think the process could be shortened.

FOOTNOTES
1 See now 28 U.S. Code 501 et seq.
2 Note limited immunity for “Speech or Debate,” Article I, Section 6, discussed below, and footnote 9, infra.
3 Under the “independent counsel” provisions of the Ethics in Government Act of 1978, 28 U.S. Code 591 et seq., which were allowed to expire on December 15, 1992, the Attorney General was authorized to request from a special three-judge panel the appointment of an “independent counsel” to investigate and prosecute allegations of criminal misconduct against specified government personnel, and against “any person,” including a Member of Congress, if there presented in the Attorney General’s opinion a “personal, financial or political conflict of interest” for Department of Justice personnel to prosecute the matter. 28 U.S. Code 592(c). In private disputes, Members may also be subject to private civil actions, litigated in Federal or State courts, for such private and personal conduct as breaches of contracts, torts, or the like.
4 Article I, Section 5, clause 1.
5 Article I, Section 5, clause 2.
6 Cushing, The Law and Practice of Legislative Assemblies, Section 684, at 269 (Boston 1874).
7 Cushing, supra at Section 625, pp. 250-251. See Hiss v. Bartlett, 68 Mass. 468 (1855).
8 Note James Madison, The Federalist, at Nos. 47, 48, 51. See discussion in United States v. Brewster, 408 U.S. 501, 508 (1971).
9 United States v. Johnson, 383 U.S. 169, 178 (1966): “Behind these simple phrases lies a history of conflict between the Commons and the Tudor and Stuart monarchs during which successive monarchs utilized the criminal and civil law to suppress and intimidate critical legislators. Since the Glorious Revolution in Britain, and throughout United States history, the privilege has been recognized as an important protection of the independence and integrity of the legislature.” United States v. Brewster, 408 U.S. 501, 507: “The immunities of the Speech or Debate clause were not written into the Constitution simply for the personal or private benefit of Members of Congress, but to protect the integrity of the legislative process by insuring the independence of individual legislators.”
10 United States Constitution Article I, Section 6.
11 T. Erskine May, The Law, Privileges, Proceedings and Usage of Parliament, 89, 102-108 (17th Edition 1964).
12 May, supra at 109-149; note May, supra at 103: “Where the offense is not so grave as to warrant the committal of the offender he is generally directed to be reprimanded or admonished by . . . . the Speaker.”
13 M. Ferrand, Records of the Federal Convention of 1787, Volume 2, at 254.
14 Ibid. at 249-250; note Hamilton, The Federalist No. 60; see discussion in Powell v. McCormack, 395 U.S. 486, 535 (1969).
15 Note In re Chapman, 166 U.S. 661, 669-670 (1987), which supported the constitutional authority of either House of Congress to punish a Member for conduct which in the judgment of the body “is inconsistent with the trust and duty of a member” even if such conduct was “not a statutable offense nor was it committed in his official character, nor was it committed during the session of Congress, nor at the seat of government.”
16 “It may be thought difficult to draw a clear line of distinction between the right to inflict the punishment of expulsion, and any other punishment upon a Member, founded on the time, place, or nature of the offense. The power to expel a Member is not in the British House of Commons confined to offenses committed by a party as a member, or during the session of parliament; but it extends to all cases, where the offense is such, in the judgment of the house, unfits him for parliamentary duties.” Story, Commentaries on the Constitution of the United States, Volume II, 836, Boston 1833 (De Capo Press Reprint Edition, 1970). Emphasis added.
17 S. Rpt. 2508, 83d Cong., 2d Sess. 20-21, 22 (1954), “Report of the Select Committee to Study Censure Charges”, pursuant to S. Res. 301 and amendments, a resolution to censure the Senator from Wisconsin, Mr. McCarthy.
18 H.R. Rpt. No. 27, 90th Congress, 1st Sess. 24 (1969). The Committee explained further: “Censure of a Member has been deemed appropriate in cases of the a breach of the privileges of the House. There are two classes of privilege, the one, affecting the rights of the House collectively, its safety, dignity, and the integrity of its proceedings; and the other, affecting the rights, reputation, and conduct of Members individually, in their representative capacity . . . . .” H.R. Rpt. 27, supra at 25.
19 See Executive order No. 12674, Part III, April 12, 1989; 5 CFR 2638.201 et seq. Note 5 U.S. Code 7513 for requirements of “adverse action” proceedings against covered civil service employees, including right to hearing and appeal.
20 Note Wathen v. United States, 527 F.2d 1191 (Ct. Claims 1975), rehearing den., January 30, 1976; Wild v. HUD, 692 F.2d 1129 (7th Cir. 1982), rehearing and rehearing en banc denied, January 26, 1983; see also discussions in Center for Auto Safety v. F.T.C., 586 F. Supp. 1254 (D.D.C. 1984); Grassetti v. Weinberger, 408 F. Supp. 142 (N.D.Cal. 1976); and CACI Inc.-Federal v. United States, 719 F.2d 1567 (Fed. Cir. 1983).
21 U.S. Code 372 (c).
22 Federal judges, like other “civil officers” of the United States Government are subject to removal by “impeachment” by the House and conviction by the Senate for “Treason, Bribery, or other high Crimes and Misdemeanors.” United States Constitution, Article II, Section 4.
23 S. Rpt. No. 89-1414, 89th Cong. 2d Sess. 48 (1966), Joint Committee on the Organization of Congress. Organization of Congress. Final report pursuant to S. Con. Res. 2.
24 H. Res. 1013, 89th Congress, October 19, 1966.
25 H.R. Rpt. No. 90-1176, 90th Cong., 2d Sess (1968).
26 Note Baker, Richard. The History of Congressional Ethics, in Representation and Responsibility, Exploring Legislative Ethics, at 4 (New York 1985): “For nearly two centuries, a simple and informal code of behavior existed. Prevailing norms of general decency served as the chief determinants of proper legislative conduct.”
27 See Powell v. McCormack, supra at 508, 509; note Judiciary Committee Report, H.R. Rpt. No. 77, 42d Congress, 3d Session; II Hinds Precedents 1283 and 1285. As expressed by Alexander Hamilton, a fundamental principle of our representative democracy is “that the people should choose whom they please to govern them.” 2 Eliot’s Debates 257; Powell v. McCormack supra at 531.
28 Madison, The Federalist Papers, No. 57, supra at p. 350-351, 352: “The aim of every political constitution is, or ought to be, first to obtain for rulers men who posses most wisdom to discern, and most virtue to pursue, the common good of society; and in the next place, to take the most effectual precautions for keeping them virtuous whilst they continue to hold their public trust . . . . The means relied on in this form of government for preventing their degeneracy are numerous and various. The most effectual one is such a limitation on the term of appointments as will maintain a proper responsibility to the people . . . . All these securities, however, would be found very insufficient without the restraint of frequent elections. Hence, in the fourth place, the House of Representatives is so constituted as to support in the members an habitual recollection of their dependence on the people.”
29 Cushing, The Law and Practice of Legislative Assemblies, supra at p. 269; Section 625, pp. 250-251. In a report to the Senate in 1807, reproduced at II Hinds’ Precedents of the House of Representatives of the United States, 1264, p. 814 (1907), Senator John Quincy Adams unsuccessfully pressed for the expulsion of Senator John Smith, who was accused of complicity in the Aaron Burr conspiracy. Adams argued that since the Framers of the Constitution did not opt to include a “recall” provision in the Constitution, that the Senate itself must be ready to exercise its constitutional authority to cleanse itself, for its own institutional protection and for the protection of the nation. Adams argued that: “[D]efective indeed would be the institution which would be impotent to discard” an individual who, after election “on the pledge of a spotless reputation, has degraded himself by commission of infamous crimes, which become suddenly and unexpectedly revealed to the world.”
30 Bowman and Bowman, “article I, Section 5: Congress’ Power to Expel — An Exercise in Self Restraint,” 29 Syracuse Law Review 1071, 1101 (1978). The authors note that “Congress has demonstrated a clear reluctance to expel when to do so would impinge . . . . upon the electoral process.”
31 Joint Committee on the Organization of Congress. Operations of the Congress Hearing. Jan. 28, 1993. p. 5.
32 Joint Committee. Ethics Process Hearing. Feb. 23, 1993. p. 33.
33 Joint Committee. Operations of the Congress Hearing. Jan. 28, 1993. p. 6.
34 Joint Committee. Ethics Process Hearing. Feb. 25, 1993. pp. 3-4.
35 Ibid. Feb. 25, 1993. p. 26.
36 Ibid. Feb. 25, 1993. p. 4.
37 Ibid. Feb. 25, 1993. p. 36.
38 Ibid. Feb. 23, 1993. p. 6.
39 Ibid. Feb. 23, 1993. p. 17.
40 Ibid. Feb. 25, 1993. p. 6.
41 Ibid. Feb. 23, 1993. p. 4.
42 Ibid. Feb. 25, 1993. p. 19.
43 Ibid. Feb. 25, 1993. p. 13.
44 Joint Committee. Operations of the Congress Hearing. Jan. 28, 1993. pp. 4-5.

Table of Contents

Advertisements

FDA/USDA~May ~2019~ Alerts & Safety


 

 

 

  • MedWatch Safety Alert was just added to the FDA Medical Device Safety, Letters to Health Care Providers web page.TOPIC: UPDATE On Risk of Cross-Contamination From 24-Hour Multi-Patient Use Endoscope Connectors – Letter to Health Care Providers and Staff at Health Care Facilities Performing Gastrointestinal Endoscopy Procedures

    AUDIENCE: Gastroenterology, Health Professional, Risk Manager

    ISSUE: The FDA is issuing this letter to announce the FDA clearance of a modified Erbe USA Inc. (Erbe) ERBEFLO port connector designed to help reduce the risk of cross-contamination that was identified in FDA’s

  • MedWatch Safety Alert was just added to the FDA Medical Device Recalls web page.TOPIC: DxH 800, DxH 600 and DxH 900 Hematology Analyzers by Beckman Coulter Life Sciences: Class I Recall – Due to Sporadic Erroneously Elevated Platelet Count Results Without Flags or System MessagesAUDIENCE: Health Professional, Patient, Risk Manager

    ISSUE: Beckman Coulter is recalling the DxH 800, DxH 600, and DxH 900 Hematology Analyzers due to sporadic erroneously elevated platelet count results without flags or system messages, meaning there is no way for the laboratory operator of the test to recognize the error. Inaccurate platelet counts may cause serious adverse health consequences such as increased risk for life-threatening bleeding associated with withholding platelet transfusion or inappropriate decisions for surgeries or invasive procedures; delayed or missed diagnosis of serious medical conditions, including thrombotic microangiopathy and heparin induced thrombocytopenia.   http://s2027422842.t.en25.com/e/er?utm_campaign=FDA%20MedWatch%20-%20UPDATE%20On%20Risk%20of%20Cross-Contamination%20from%20Multi-Patient%20Use%20Endoscope%20Connectors&utm_medium=email&utm_source=Eloqua&s=2027422842&lid=8067&elqTrackId=284856C243E893A822E84304FBECCA6C&elq=ea810948becd436ba374765fe8711c53&elqaid=8160&elqat=1

  • Aurora Packing Company, Inc., a North Aurora, Ill. establishment, is recalling approximately 62,112 pounds of raw beef products that may be contaminated with E. coli O157:H7, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
    The raw beef products were packaged on April 19, 2019. This spreadsheet contains a list of the products subject to recall.[View Labels(PDF only)]
    The products subject to recall bear establishment number “EST. 788” inside the USDA mark of inspection. These items were shipped nationwide for further distribution and processing.
    The problem was discovered during traceback activities in response to random sample testing by FSIS. There have been no confirmed reports of adverse reactions due to consumption of these products.
    Anyone concerned about an injury or illness should contact a healthcare provider. E. coli O157:H7 is a potentially deadly bacterium that can cause dehydration, bloody diarrhea and abdominal cramps 2–8 days (3–4 days, on average) after exposure the organism. While most people recover within a week, some develop a type of kidney failure called hemolytic uremic syndrome (HUS). This condition can occur among persons of any age but is most common in children under 5-years old and older adults. It is marked by easy bruising, pallor and decreased urine output. Persons who experience these symptoms should seek emergency medical care immediately.
    FSIS is concerned that some product may be in institutional facility freezers. Institutions who have purchased these products are urged not to use them. These products should be thrown away or returned to the place of purchase.
    FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers. When available, the retail distribution list(s) will be posted on the FSIS website at http://www.fsis.usda.gov/recalls.
    FSIS advises all consumers to safely prepare their raw meat products, including fresh and frozen, and only consume product that has been cooked to a temperature of 165°F. The only way to confirm that beef is cooked to a temperature high enough to kill harmful bacteria is to use a food thermometer that measures internal temperature, https://www.fsis.usda.gov/safetempchart.
    Consumers and members of the media with questions about the recall can contact David Stewart, Director of Sales and Marketing for Aurora Packing Company, Inc., at (630) 897-0551.
  • Caito Foods LLC., an Indianapolis, Ind. establishment, is recalling approximately 1,767 pounds of salad with chicken products due to misbranding and undeclared allergens, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The products contain soy, a known allergen, which is not declared on the product label.
    The ready-to-eat salads with chicken items were produced on May 12 through May 15, 2019. The following products are subject to recall: [View Labels (PDF only)]
    13.5-oz. plastic square bowl packages containing “Greek Salad with Chicken with Chicken Breast & Red Wine Olive Oil Vinaigrette Dressing” and Sell By dates ranging from 05/18/19 through 05/21/19 represented on the label.
    11.25-oz. plastic square bowl packages containing “Tuscan Style Caesar Salad with Grilled Chicken With Grilled White Chicken Tossed In Pesto” and Sell By dates ranging from 05/18/19 through 05/21/19 represented on the label.
    The products subject to recall bear establishment number “P-39985” inside the USDA mark of inspection. These items were shipped to Kroger retail locations in Illinois, Indiana, Kentucky, Michigan, and Ohio.
    The problem was discovered by the recalling firm during label verification activities.
    There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.Consumers with questions about the recall can contact Caito Foods LLC.’s Consumer Feedback Line at (844) 467-7278. Members of the media with questions about the recall can contact Meredith Gremel, Organizational Communications, Spartan Nash, at (616) 878-2830.
  • Vienna Beef Ltd., a Chicago, Ill. establishment, is recalling approximately 2,030 pounds of beef frank links products that may be contaminated with extraneous materials, specifically metal, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
    The beef frank links items were produced on May 2, 2019. The following products are subject to recall: [View Labels (PDF only)]
    10-lb. cases containing “SKINLESS BEEF FRANKFURTERS 6” 8’s 10#” with case code 013180 and package code 9122 represented on the label.
    10-lb. cases containing “SKINLESS BEEF FRANKFURTERS 6” 11’s 10#” with case code 013312 and package code 9122 or 9123 represented on the label.
    10-lb. cases containing “SKINLESS BEEF FRANKFURTERS 7” 9’s 10#” with case code 013490 and package code 9122 or 9123 represented on the label.
    The products subject to recall bear establishment number “EST. 1” inside the USDA mark of inspection. These items were shipped to food service locations in Illinois, Indiana, and Wisconsin.
    The problem was discovered by the establishment and reported to FSIS.
    There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider. Consumers and members of the media with questions about the recall can contact Tom McGlade, VP of Marketing, Vienna Beef Ltd., at (773) 435-2204.
  • Seven Seas International USA, LLC of St. Petersburg, Florida is recalling its 4 oz. Biltmore Smoked Sockeye Salmon, because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
    The 4 oz. Biltmore Smoked Sockeye Salmon was distributed only in Florida by Publix Grocery stores. The product can be identified by its production code, which is a four digit code printed on the clear vacuum bag that contains the product. The Biltmore Smoked Sockeye product is sold in 4 oz. black printed carton sleeves with the Brand name “Biltmore” printed on the front, containing the smoked sockeye product in a clear vacuum bag, the product is displayed on a gold plate. Only products with Production Code 41CM and a sell by date of 23rd May 2019 are subject to this recall, all other production codes are not part of this recall. The product carries the following UPC code: 007-36211-88774
    No illnesses have been reported to date.
    The recall was the result of a routine sampling program by the Florida Department of Agriculture, which revealed that some of the finished product samples tested positive for the bacteria. Seven Seas and Publix out of an abundance of caution have decided to voluntarily remove all of the Biltmore Smoked Salmon of this particular production code. All subsequent production codes were tested and found not to contain the bacteria. The FDA and Seven Seas International USA, LLC continue their investigation as to what caused the problem.
    Publix Customers who have purchased this product are being advised not to consume it and return it to the store where it was originally purchased for a full refund.
    Customers who have additional questions or concerns may contact Seven Seas International USA, LLC from 6 AM EST to 6 PM EST at 1(888) 627-5668 or visit their website at http://www.7siusa.com
  • Crab House Trading Corp., a Los Angeles, Calif. establishment, is recalling approximately 36,040 pounds of frozen Siluriformes products, specifically yellow walking fish, that were produced without the benefit of federal inspection, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
    The following products are subject to recall: [View Labels (PDF only)]
    Various weight vacuum-sealed packages containing frozen “TRIPLE PEARL HEADLESS-CLEANED YELLOW WALKING FISH CA TRE VANG LAM SACH – CAT DAU” and may have best before dates of 20210203 or 20201225 or no date at all represented on the label.
    These items were shipped to retail and wholesale locations in California.
    The problem was discovered by FSIS during follow-up surveillance activities.
    There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about a reaction should contact a healthcare provider. Consumers and members of the media with questions about the recall can contact Jose Benitez, Office Manager, Crab House Trading Corp., at (213) 627-6398.
  • Seven Seas International USA, LLC of St. Petersburg, Florida is recalling its 4 oz. Biltmore Smoked Sockeye Salmon, because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
    The 4 oz. Biltmore Smoked Sockeye Salmon was distributed only in Florida by Publix Grocery stores. The product can be identified by its production code, which is a four digit code printed on the clear vacuum bag that contains the product. The Biltmore Smoked Sockeye product is sold in 4 oz. black printed carton sleeves with the Brand name “Biltmore” printed on the front, containing the smoked sockeye product in a clear vacuum bag, the product is displayed on a gold plate. Only products with Production Code 41CM and a sell by date of 23rd May 2019 are subject to this recall, all other production codes are not part of this recall. The product carries the following UPC code: 007-36211-88774
    No illnesses have been reported to date.
    The recall was the result of a routine sampling program by the Florida Department of Agriculture, which revealed that some of the finished product samples tested positive for the bacteria. Seven Seas and Publix out of an abundance of caution have decided to voluntarily remove all of the Biltmore Smoked Salmon of this particular production code. All subsequent production codes were tested and found not to contain the bacteria. The FDA and Seven Seas International USA, LLC continue their investigation as to what caused the problem.
    Publix Customers who have purchased this product are being advised not to consume it and return it to the store where it was originally purchased for a full refund.
    Customers who have additional questions or concerns may contact Seven Seas International USA, LLC from 6 AM EST to 6 PM EST at 1(888) 627-5668 or visit their website at http://www.7siusa.com
    External Link Disclaimer
    .
  • MIBO Fresh Foods LLC, a Fort Worth, Texas establishment, is recalling approximately 1,460 pounds of salad with meat products due to misbranding and undeclared allergens, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The product contains anchovies, a known allergen, which is not declared on the product label.
    The ready-to-eat Chef salad with ham and turkey items was produced on May 10 and May 13, 2019. The following products are subject to recall: [View Label (PDF only)]
    9.65 oz. clear plastic packages containing “H.E.B. MEAL SIMPLE CHEF SALAD with Homestyle Ranch Dressing” and “Best By” dates of 05-18-19 and 05-20-19 represented on the label.
    The products subject to recall bear establishment number “EST. P-27399” inside the USDA mark of inspection. These items were shipped to retail stores in Texas. ­
    The problem was discovered by a retail store when the mislabeled products were being unboxed to be placed on the retail store shelves.
    There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.onsumers with questions about the recall can contact Debbie Patterson, Business Development, MIBO Fresh Foods LLC, at (817) 882-9600. Members of the media with questions about the recall can contact Uzor Nwoko, President, MIBO Fresh Foods LLC, at (817) 882-9600.
  • Deshi Distributors LLC. of Jamaica, NY, is recalling its 3.5 oz, 7 oz and 14 oz packages of Deshi “Golden Raisins” because they contained undeclared sulfites. Consumers who have severe sensitivity to sulfites run the risk of serious or life-threatening allergic reactions if they consume this product.
    The Golden Raisin with “undeclared sulphite” was distributed in New York, New Jersey, Pennsylvania, and Michigan and through delivery to retail stores.
    The product comes in a 3.5 oz, 7 oz. and 14 oz. clear plastic package. UPC codes of Deshi Golden Raisin products are as follows: 3.5 oz is 691035359586; 7 oz. is 691035360179; and 14 oz. is 691035360483.
    No illness or allergic reactions involving this product have been reported to date.
    The recall was initiated after routine sampling by New York State Department of Agriculture and Markets Food Inspector and subsequent analysis by Food Laboratory personnel revealed the presence of sulfites in the 7 oz. packages of Deshi “Golden Raisin” which were not declared on the label. The same raisins were packaged in 3.5 oz and 14 oz packages and are included in this recall.
    Consumers who have purchased 3.5 oz, 7 oz and 14 oz packages of Deshi “Golden Raisins” are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company at 718-291-1205 from 9 am to 5 pm Eastern Time.
  • Novartis today announced a voluntary recall of three lots of Promacta (eltrombopag) 12.5 mg for oral suspension to the consumer level. The oral suspension lots are being recalled because of a risk of potential peanut flour contamination that occurred at a third-party contract manufacturing site.
    Promacta tablets in 12.5 mg, 25 mg, 50 mg and 75 mg strengths are not impacted by this recall and are not manufactured in the same facility.Product Description
    NDC Number on Carton
    NDC Number on Packet
    Lot Number
    Expiration Date
    Distribution Dates
    Promacta for Oral Suspension
    0078-0972-61
    0078-0972-19
    8H57901589
    09/2020
    1/2/19 – 2/11/19
    Promacta for Oral Suspension
    0078-0972-61
    0078-0972-19
    9H57900189
    12/2020
    2/11/19 – 4/17/19
    Promacta for Oral Suspension
    0078-0972-61
    0078-0972-19
    9H57900289
    12/2020
    3/6/19 – 4/2/19
    Consumers who have impacted product with these lot numbers and NDC numbers in their homes should contact 1-866-918-8772 (8:00 AM – 5:00 PM EST, Monday through Friday) for instructions on how to return recalled product. For all additional questions, please contact Novartis at 1-888-NOW NOVA (8:30 AM – 5:00 PM EST, Monday through Friday).
  • Edwards Lifesciences is recalling the Miller Balloon Atrioseptostomy Catheter and Fogarty Dilation Atrioseptostomy Catheter because of the possibility of difficulty in balloon deflation after deployment, which may lead to balloon fragmentation or detachment upon attempted retrieval. The firm has received reports of balloon fragmentation or detachment, which may cause serious adverse health consequences including: damage to the heart, the inferior vena cava, and/or the femoral and iliac veins; additional procedures to retrieve the fragments; permanent patient disability; pulmonary embolism; stroke; damage to other organs; or death. One serious injury was reported in which an infant underwent an invasive, but successful surgical procedure to retrieve a detached balloon. There were no deaths Recalled Product(s): Miller Balloon Atrioseptostomy Catheter and Fogarty Dilation Atrioseptostomy Catheter
    Model Numbers: 830515F and 830705F
    Lot Numbers: All lots expiring within 15 months. Lot numbers include: 59971507, 61068488, 61135027, 61176259, 61176335, 61209914, 61230764, 61245298, 61252231, 61252473, 61288724, 61332460, 61339380, 61350747, 61371827, 61393284, 61408923, 61415949, 61427629, 61453869, 61478583, 61481224, 61491734, 61516358, 61524807, 61532783, 61542460, 61552718, 61561749, 61569309, 61579845, 61719588, 61825706, 61846022, 61135026, 61046484, 61146229, 61176182, 61230763, 61252229, 61252230, 61252471, 61270367, 61321210, 61329796, 61350746, 61361008, 61369040, 61435190, 61444420, 61491732, 61516362, 61532782, 61542459, 61561748, 61569308, 61687687, 61697835, 61731942, 61809420.
    Manufacturing Dates: December 22, 2017 to January 18, 2019
    Distribution Dates: January 9, 2018 to February 25, 2019
    Devices Recalled in the U.S.:reported.If you have unused product to return, contact Edwards Customer Service at 1-800-424-3278 option 1, to obtain a Returned Good Authorization (RGA) number.
    Complete the acknowledgement form and fax to Edwards Customer Service at 1-800-422-9329 or 949-809-5467 within 10 days from receipt of the notification. 
  • Life Rising Corporation of Willowbrook, IL is recalling Life Rising Holder-W Holder Warmer capsules, Life Rising NECK-ND Neck Clear capsules, and HoliCare Metabolism Cleansing (MET-CLS) tablets because the products have the potential to contain excessive levels of lead. According to FDA instruction, lead can accumulate in the body over time and too much of it can cause serious and sometimes permanent adverse health consequences. People with high blood levels of lead may show no symptoms, but the condition may cause damage to the nervous system and internal organs. Acute lead poisoning may cause a wide range of symptoms, including abdominal pain, muscle weakness, nausea, vomiting, diarrhea, weight loss, and bloody or decreased urinary output. Children are particularly vulnerable to lead poisoning. Lead poisoning can be diagnosed through clinical testing.
    The recalled products were mostly sold locally in Chicago area at HoliCare clinics and a limited quantity were also distributed through mail orders.
    The recall includes all products purchased before May 2, 2019 of the Life Rising Holder-W Holder Warmer capsules and Life Rising NECK-ND Neck Clear capsules and lot number T81171040 of the HoliCare Metabolism Cleansing (MET-CLS) tablets. The Life Rising Holder-W Holder Warmer capsules are sold in a bottle with 54 capsules, the Life Rising NECK-ND Neck Clear capsules are sold in a bottle with 54 capsules, and the HoliCare Metabolism Cleansing (MET-CLS) tablets are sold in a bottle with 60 tablets, marked with lot # T81171040 on the bottom.
    No illnesses have been reported to date.
    The recall was initiated after it was discovered based on sampling by U.S. Food and Drug Administration that the products contained high levels of lead which exceeded the new daily limit guidelines of 3 µg per day for children, the 12.5 µg per day for adults which we were informed by FDA on May 1, 2019.
    The sale of these products has been suspended and inventory put on hold while FDA and the company continue to investigate the source of the problem. Consumers who have purchased these products should not consume them and are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company at 1-630-654-0617 central standard time, Monday to Friday, from 9:00AM to 4:30PM.
  • Vivimed Life Sciences Pvt Ltd (Vivimed) is recalling 19 lots of Losartan Potassium Tablets USP 25 mg, 50 mg, and 100 mg to consumer level. Due to the detection of an impurity – N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) – that is above the US Food & Drug Administration’s interim acceptable exposure limit of 9.82 ppm. Based on the available information, the risk of developing cancer in a few patients following long-term use of the product containing high levels of the impurity NMBA cannot be ruled out.This product is made by Vivimed at its Plant in Alathur, Chennai, India and Distributed by Heritage Pharmaceuticals Inc, East Brunswick NJ (Heritage). To date, neither Vivimed nor Heritage has received any reports of adverse events related to this recall.Losartan Potassium is indicated for the treatment of hypertension, hypertensive patients with left ventricular hypertrophy, nephropathy in Type 2 diabetic patients and is packaged in 90-count and 1000-count bottles. The lots were manufactured by Vivimed at its Plant in Alathur, Chennai, India and Distributed by Heritage Pharmaceuticals Inc, East Brunswick NJ (Heritage) .
  • Santa Fe Importers, Inc., a Long Beach, Calif. establishment, is recalling approximately 1,589 pounds of ready-to-eat (RTE) chicken meatball products due to misbranding and an undeclared allergen, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The products contain soy, a known allergen, which is not declared on the products label.
    The frozen, RTE chicken Thai-style meatballs were produced and packaged on April 24, 2019 There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.
    226 cases containing “lemonade CHICKEN THAI STYLE MEATBALL” with packaging date “04/24/2019” and case code “114-102130” on the labels.Consumers and members of the media with questions about the recall can contact Jorge Endara, General Manager of Santa Fe Importers, Inc., at (562) 437-7775 or at Jorge@SanteFeImporters.com.
    The products subject to recall bear establishment number “EST. P-4118” inside the USDA mark of inspection. These items were shipped to a distribution center in California and packed for Lemonade restaurants as indicated on the label.

Medtronic Pacemakers: Safety Communication

  • Affected Medtronic implantable pacemaker and CRT-P device models include:• Azure models: W1DR01, W2DR01, W3DR01, W1SR01, W2SR01, W3SR01
    • Astra models: X1DR01, X2DR01, X3DR01, X1SR01, X2SR01, X3SR01
    • Percepta models: W1TR01, W1TR04, W4TR01, W4TR04
    • Serena models: W1TR02, W1TR05, W4TR02, W4TR05
    • Solara models: W1TR03, W1TR06, W4TR03, W4TR06
  • Cargill’s animal nutrition business is conducting a voluntary recall of select Southern States® feed due to aflatoxin levels that exceed FDA’s action levels. The affected products, which were manufactured and sold in the eastern United States, were removed from retail shelves throughout February, March, and April 2019. Livestock, horses, and poultry exposed to aflatoxin are at risk of exposure to several health hazards.Aflatoxicosis has the same acute and chronic adverse effects and health consequences across all species and age classes (immature and mature). Immature animals are more sensitive to aflatoxins. Acute aflatoxicosis may result in generalized hemorrhage, bloody diarrhea and death in 1-3 days. In addition, aflatoxin toxicity can cause reduced feed intake, reduced weight gain, liver damage, jaundice, and eventually death.No adverse health effects to animals have been reported to date. Nonetheless, Cargill is taking this voluntary step out of an abundance of caution. The affected products were manufactured at Cargill’s Cleveland, North Carolina, facility. Cargill first learned of the issue when it received a notification from the North Carolina Department of Agriculture of test results showing that a single lot of a specific Southern States product contained elevated levels of aflatoxin. Cargill has identified and corrected the root cause.
  • Out of an abundance of caution, Mecox Bay Dairy, LLC, is recalling their Mecox Sunrise washed-rind Tomme style cheese because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria monocytogenes infection can cause miscarriages and stillbirths among pregnant women.
    This cheese was distributed and sold at seven retail locations and one restaurant on Eastern Long Island, NY, and served at one restaurant in Chicago, IL. The product comes in a clear plastic package marked with “Mecox Sunrise” cheese label. As of the date of this release, all affected Mecox Sunrise has been removed from all stores and restaurants.
    No illnesses have been reported to date in connection with this problem. The potential for contamination was noted after routine testing by New York State Agriculture and Markets Division of Milk Control revealed the presence of Listeria monocytogenes in a sample of Mecox Sunrise cheese.
    The production of the product has been suspended while FDA, New York State Agriculture and Markets, and Mecox Bay Dairy continue to investigate the source of the problem. Consumers who have purchased any “Mecox Sunrise” cheese are urged to return it to the place of purchase for a full refund. Consumers with questions may contact the company between 8:00am and 6:00pm EST at 631-537-0335.
  • Vivimed Life Sciences Pvt Ltd (Vivimed) is recalling 19 lots of Losartan Potassium Tablets USP 25 mg, 50 mg, and 100 mg to consumer level. Due to the detection of an impurity – N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) – that is above the US Food & Drug Administration’s interim acceptable exposure limit of 9.82 ppm. Based on the available information, the risk of developing cancer in a few patients following long-term use of the product containing high levels of the impurity NMBA cannot be ruled out.This product is made by Vivimed at its Plant in Alathur, Chennai, India and Distributed by Heritage Pharmaceuticals Inc, East Brunswick NJ (Heritage). To date, neither Vivimed nor Heritage has received any reports of adverse events related to this recall. Losartan Potassium is indicated for the treatment of hypertension, hypertensive patients with left ventricular hypertrophy, nephropathy in Type 2 diabetic patients and is packaged in 90-count and 1000-count bottles. The lots were manufactured by Vivimed at its Plant in Alathur, Chennai, India and Distributed by Heritage Pharmaceuticals Inc, East Brunswick NJ (Heritage) .
  • A MedWatch Safety Alert was added to the FDA Recalls webpage.TOPIC: Mycophenolate Mofetil for Injection by Par Pharmaceutical: Recall – Due to the Presence of a Glass Fragment Observed in One Vial of Reconstituted ProductAUDIENCE: Patient, Health Professional, Risk Manager, PharmacyISSUE: Endo International, announced on May 1, 2019, that one of its operating companies, Par Pharmaceutical, Inc., is voluntarily recalling Lot# AD812 (expiry 09/2020) of Mycophenolate Mofetil for Injection, to the hospital and retail pharmacy level. One vial of product was observed containing a glass fragment after reconstitution.
  • Tyson Foods, Inc., a Rogers, Ark. establishment, is recalling approximately 11,829,517 million pounds of frozen, ready-to-eat chicken strip products that may be contaminated with extraneous materials, specifically pieces of metal, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
    The problem was discovered when FSIS received two consumer complaints of extraneous material in the chicken strip products. FSIS is now aware of six complaints during this time frame involving similar pieces of metal with three alleging oral injury.
    The frozen, ready-to-eat chicken strip items were produced on various dates from Oct. 1, 2018 through March 8, 2019 and have “Use By Dates” of Oct. 1, 2019 through March 7, 2020. The chart contains a list of the products subject to recall.[View Labels (PDF only)]
    The products subject to recall bear establishment number “P-7221” on the back of the product package. These items were shipped to retail and Department of Defense locations nationwide, for institutional use nationwide and to the U.S. Virgin IslandsConsumers with questions about the recall can contact Tyson Foods Consumer Relations at 1-866-886-8456. Members of the media with questions about the recall can contact Worth Sparkman, Public Relations Manager, Tyson Foods, Inc., at Worth.Sparkman@Tyson.com (479) 290-6358.
  • Sagent Pharmaceuticals, Inc. today announced the voluntary nationwide recall of one lot of Ketorolac Tromethamine Injection, USP, 60mg/2mL (30mg per mL). This product was manufactured by Zydus (Cadila Healthcare Limited) and distributed by Sagent Pharmaceuticals, Inc. Sagent has initiated this voluntary recall of Ketorolac Tromethamine Injection, USP to the to the user level due to microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the products.Adult patients administered the product intravenously are at most risk of a serious bloodstream infection of sepsis (serious condition resulting from the presence of harmful microorganisms in the blood and the body’s response to their presence, potentially leading to shock and death).
  • MedWatch Safety Alert was just added to the FDA Recall webpage. TOPIC: Bevacizumab 1.25mg/0.05mL 31G Injectable by AmEx Pharmacy: Recall – Due to Reported Defective Delivery System

AUDIENCE: Patient, Health Professional, Pharmacy, Risk Manager

ISSUE: The Monoject Syringe of this product may become difficult to express, and when additional force is applied, while the needle is in the eye, may cause injury to the patient.
The additional force needed to express the drug product could potentially result in damage to the eye while the needle is in the eye. To date, AmEx Pharmacy has received three reports associated with the Lot being recalled as either being difficult to express, two of which, resulted in an Adverse Drug Event.

  • Teva Pharmaceuticals USA, Inc. has initiated a voluntary recall in the United States, to the patient level, of 35 lots of bulk Losartan Potassium USP Tablets (6 lots of 25 mg strength and 29 lots of 100 mg strength). This recall is due to the detection of an impurity – N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) – found in six lots of active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited that is above the US Food & Drug Administration’s interim acceptable exposure limit of 9.82 ppm. Based on the available information, the risk of developing cancer in a few patients following long-term use of the product cannot be ruled out.Losartan Potassium is indicated for the treatment of hypertension, hypertensive patients with left ventricular hypertrophy, and nephropathy in Type 2 diabetic patients.

1925 – John Scopes was indicted for teaching the Darwinian theory in school.


John Scopes

John Scopes is best known as the Tennessee educator found guilty of breaking the law for teaching evolution in his class room.

Synopsis
Born in Kentucky in 1900, John Scopes was a teacher in Tennessee who became famous for going on trial for teaching evolution. Scopes was part of an American Civil Liberties Union attempt to challenge a state law prohibiting the teaching of evolution. Scopes’s trial became a national sensation, with celebrity lawyers like Clarence Darrow and William Jennings Bryan involved in the case. Scopes was found guilty, but his story remains famous as the Scopes “Monkey Trial,” dramatized in the 1960 film Inherit the Wind starring Spencer Tracy.

Early Life
A high school science teacher, John Scopes found himself at the center of one of the 20th century’s most famous court battles. He served as the defendant in a case meant to challenge a state law against teaching Charles Darwin’s theories of evolution in public schools.

Born on August 3, 1900, in Paducah, Kentucky, Scopes was the youngest of five children born to railroad worker Thomas Scopes and his wife, Mary. The couple’s only son, he spent his early years in Kentucky before moving to Illinois as a teenager. There, he graduated from high school in 1919. After one year at the University of Illinois, Scopes transferred to the University of Kentucky. He had to drop out for a time for medical reasons, but he eventually earned a degree in law.

Evolution on Trial

In the fall of 1924, Scopes joined the faculty of Rhea County Central High School in Dayton, Tennessee, where he taught algebra, chemistry and physics. At the time, there was a national debate about whether evolution should be taught in schools. British naturalist Charles Darwin championed the theories of evolution, espousing that all modern animal and plant life had descended from a common ancestor. Darwin’s theories, however, directly contradicted the Bible’s teachings on the beginning of life. Across the United States, Christian fundamentalists moved to bar any discussion of evolution from the nation’s classrooms.

Tennessee passed their own law against the teaching of evolution in March 1925. The Butler Act made it illegal for any teacher in a publicly funded school “to teach any theory that denies the story of the Divine Creation of man as taught in the Bible, and to teach instead that man has descended from a lower order of animals.” The American Civil Liberties Union (ACLU) wanted to challenge the Butler Act in court. While he was not a biology teacher, Scopes volunteered to be tried under the new law. He admitted he had used a textbook that supported evolution while serving as a substitute biology teacher. That was enough to get him charged under the new law.

biography.com

1787 – Delegates began gathering in Philadelphia for a convention to draw up the U.S. Constitution.


Constitutional Convention delegates begin to assemble. On this day in 1787, delegates to the Constitutional Convention begin to assemble in Philadelphia to confront a daunting task: the peaceful overthrow of the new American government as defined by the Article of Confederation. Although the convention was originally supposed to begin on May 14 James Madison reported that a small number only had assembled. Meetings had to be pushed back until May 25, when a sufficient quorum of the participating states—Massachusetts, New York, New Jersey, Pennsylvania, Delaware, Virginia, North Carolina, South Carolina and Georgia—had arrived.

As the new United States descended into economic crisis and inter-state quarrels, the new nation’s leaders had become increasingly frustrated with their limited power. When in 1785, Maryland and Virginia could not agree on their rights to the Potomac River, George Washington called a conference to settle the matter at Mt. Vernon. James Madison then convinced the Virginia legislature to call a convention of all the states to discuss such sticky trade-related issues at Annapolis, Maryland. The Annapolis Convention of September 1786 in turn called the Philadelphia Convention, to devise such further provisions as shall appear to them necessary to render the constitution of the Federal Government adequate to the exigencies of the Union.

Between Madison’s initial call for the states to send delegates to Annapolis and the presentation of Madison’s Virginia plan for a new government to the convention in Philadelphia, a fundamental shift in the aims of the convention process had taken place. No longer were the delegates gathered with the aim of tweaking trade agreements. A significant number of the men present were now determined to overhaul the new American government as a whole, without a single ballot being cast by the voting public.

Ending DACA costs states billions in GDP ~ reminder


While several groups on both sides of the political aisle have posted how much they believe ending DACA will cost, the trump admin doesn’t seem to care.  As Americans, some of us believe in the lower case c for capitalism so the idea that it would cost approx $290 billion to not only end DACA but Deport the Dreamers as well seems like an obvious wtf moment. The logical response would seem to be Nah we can’t afford to do this so work this ish out in a bipartisan reasonable way seems much saner… right? but Noooooo the chip on this admin’s shoulder is beyond the greater good for Americans

~Nativegrl77

politics,pollution,petitions,pop culture & purses

%d bloggers like this: