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The class certification of medical monitoring claims.

The tort claim of medical monitoring has produced a disarrayed set of state and federal court opinions. The procedural dimensions of this claim are as vexing as the related substantive issues with which courts and commentators have long been grappling. Ordinarily, mass tort actions, typically involving claims for money damages, are certified under Rule 23(b)(3), which class category requires the right to notice and to opt out of a proceeding, and the fulfillment of "predominance" and "superiority" requirements. Such features are absent in Rule 23's mandatory classes. Nevertheless, this Note argues that it is appropriate for claims exclusively for medical monitoring to be certified as a mandatory class action under Rule 23(b)(2) of the Federal Rules of Civil Procedure or its state law counterparts. Given that a medical monitoring fund is an equitable remedy, nonpreclusive of a future damages claim, and groupwide in nature, the (b)(2) class category adequately protects the due process rights of class plaintiffs.

Humans↗

US legal principles and confidentiality of the peer review process.

When drawn into other parties' litigation or investigations, journals often receive requests or subpoenas for confidential peer review documents. We describe reasons for such requests and reasons that journals resist producing confidential documents, ways that journals respond, and steps that journals can take to minimize third-party breaches of journals' confidential processes. We discuss legal principles on which resistance may be based in the United States, including the journalist's privilege, the scholar's privilege, the burdensomeness of response, and the Federal Rules of Civil Procedure, which protect against attempts to obtain expert opinion testimony without compensation. Illustrative cases are described in which courts affirmed the confidentiality of peer review conducted by journals.

Confidentiality↗

Payton v. Abbott Laboratories: an analysis of the Massachusetts DES class action suit.

In Payton v. Abbott Laboratories, U.S. District Court Judge Walter J. Skinner recently granted class certification to an action brought by twenty-seven Massachusetts women against major manufacturers of DES. This is the first case in which a judge has interpreted the requirements of Rule 23 of the Federal Rules of Civil Procedure to allow women exposed in utero to DES to sue as a class to determine liability for their injuries. This Note reviews the Payton certification in light of prior class action decisions involving DES and other types of claims, and of legal commentary on Rule 23. This Note contends that Judge Skinner's application of the Rule 23 requirements in Payton was procedurally correct, and recommends the class action device as an effective method for litigating such controversies. Finally, this Note analyzes the implication of this landmark ruling for plaintiffs seeking class certification in DES suits and in suits presenting analogous factual situations.

Diethylstilbestrol↗

Employment discrimination: procedures for handling complaints--Equal Employment Opportunity Commission. Proposed rule.

This proposed rule sets forth procedures for the handling of complaints of employment discrimination which are filed with Federal fund granting agencies under Title VI of the Civil Rights Act of 1964, Title IX of the Education Amendments of 1972 and other provisions of Federal law which prohibit discrimination on grounds of race, color, religion, age, sex or national origin in programs or activities receiving Federal financial assistance. The regulations allow the fund granting agency to refer complaints to the Equal Employment Opportunity Commission (EEOC). For complaints covered both by Title VII of the Civil Rights Act of 1964, as amended, or other statutes within EEOC's jurisdiction and by Title VI of the Civil Rights Act or Title IX, the regulations contemplate that most complaints of individual acts of discrimination will be referred to EEOC for investigation and conciliation, while most complaints of systemic discrimination will be retained by the fund granting agency. Employment discrimination complaints which are not covered by Title VI or Title IX will be transferred to EEOC. This proposed rule is not a "major rule" as defined by Section 1(b) of Executive Order 12291.

Civil Rights↗

Nondiscrimination on the basis of handicap relating to health care for handicapped infants--Office of the Secretary, HHS. Proposed rules.

The notice of proposed rulemaking proposes to modify existing regulations to meet the exigent needs that can arise when a handicapped infant is discriminatorily denied food or medically indicated treatment. Several current regulatory provisions are proposed to be modified to allow timely reporting of violations, expeditious investigation, and immediate enforcement action when necessary to protect a handicapped infant whose life is endangered by discrimination in a program or activity receiving federal financial assistance. Recipients that provide health care to infants would be required to post a conspicuous notice in locations that provide such care. The notice would describe the protections under federal law against discrimination toward the handicapped, and would provide a contact point in the Department of HHS for reporting violations immediately by telephone. Notice and complaint procedures have been effective instruments for deterrence and enforcement in a variety of civil rights contexts. The Secretary believes that the proposed rule provides the best means to ensure that violations can be reported in time to save the lives of handicapped infants who are denied food or are otherwise imperiled by discrimination in the provision of health care by federally assisted programs or activities.

Congenital Abnormalities↗

USMLE (United States medical licensing examination) step 1 examination. Legal vulnerability.

Since the passage of the Civil Rights Act of 1964, the courts have ruled that sponsors of job entry assessment procedures must demonstrate the absence of discrimination against minorities. If an assessment discriminates, the courts may prohibit the use of the assessment unless the assessment is linked to a job analysis and exhibits validity. In 1994, the Federation of State Medical Boards (FSMB) and the National Board of Medical Examiners (NBME) instituted a three-step USMLE examination program as a single pathway for medical licensure. The Step 1 examination is not linked to a physician job analysis, exhibits lower scores for minority groups, and lacks construct validity. To avoid the chaos and expense of a protracted legal challenge, the FSMB and the NBME may need to revise the Step 1 examination, or discontinue it as a requirement of medical licensure.

Civil Rights↗

Inmate fees for health care services. Final rule.

The Bureau of Prisons (Bureau) finalizes rules describing procedures we will follow for charging inmates fees for certain kinds of health services, as required under the Federal Prisoner Health Care Copayment Act of 2000 (Pub. L. 106-294, October 12, 2000, 114 Stat 1038, codified at 18 U.S.C. 4048).

Civil Rights↗

Clinical application of the new civil airman vision standards and certification procedures.

INTRODUCTION: The final rule revising the civil airman medical standards became effective September 16, 1996. The purpose of this study was to review changes in the vision standards and procedures and how they relate to the clinical optometrist. METHODS: Revision of Airman Medical Standards and Certification Procedures and Duration of Medical Certificates; Final Rule, (14 CFR, Parts 61 and 67) and the Guide for Aviation Medical Examiners, published by the Federal Aviation Administration's Office of Aviation Medicine, were reviewed, and those parts pertaining to the clinical optometrist were summarized. DISCUSSION: The uncorrected distance visual acuity standards for first- and second-class airmen have been deleted. New equivalent near-vision standards were established for all classes of airmen. A major change--for pilots > or = 50 years of age--was the addition of an intermediate vision requirement of 20/40 or better at 32 inches for both first- and second-class medical certificate holders. Although the third-class medical certificate is still valid for 24 months after the date of examination for those > or = 40 years of age, the certificate is now valid for 36 months for those < 40 years of age. CONCLUSION: The new vision standards primarily affect the elderly pilot. Ophthalmic considerations in the application of the new vision standards are reviewed.

Adult↗

Suits other than malpractice--loss of license.

Acts and negligence on the part of dentists which result in the revocation or suspension of the license to practice are discussed. The California Business and Professions Code and the California Rules and Regulations are used to present examples from the areas of inspection of books, records, and premises; conviction of a crime; and unprofessional conduct. The acts that provoke civil litigation and state and federal agency action, incompetence, gross and repeated negligence, unprofessional conduct, safety in the work place, sexual harassment, and fraud are also the acts that subject the licensee to discipline from the Board. Investigative and hearing procedures, penalties, appeal, and due process are also discussed.

California↗

Medicare program; withholding of payments to practitioners, providers, and suppliers of services--Health Care Financing Administration. Proposed rule.

This proposal would amend existing regulations to provide timely notice and administrative review when Medicare payments for services are withheld because there is evidence of fraud. This proposal would specify what constitutes evidence of fraud sufficient to support withholding: where a case is under criminal investigation, or a formal criminal charge has been issued, or a civil suit has been filed, or the procedures for exclusion from the Medicare program have been initiated because of fraud related to the Medicare program. The purpose of this proposal is to specify in regulations procedures to protect the interests of providers, practitioners, and suppliers of service without compromising pending actions or procedures or the ability of the Federal government to protect funds.

Crime↗

Child support enforcement program: paternity establishment and revision of child support enforcement program and audit regulations--Office of Child Support Enforcement. Final rule.

This final rule contains provisions regarding both paternity establishment and the audit. The paternity establishment provisions implement the requirements of section 13721 of the Omnibus Budget Reconciliation Act of 1993 (OBRA '93) signed by the President on August 10, 1993, which amends title IV-D of the Social Security Act (the Act). These provisions require States to adopt procedures for a simple civil process for the voluntary acknowledgement of paternity, including early paternity establishment programs in hospitals. For paternity cases that remain contested, the statutory provisions require States to adopt a variety of procedures designed to streamline the paternity establishment process. These include the use of default orders, a presumption of paternity based on genetic test results, conditions for admission of genetic test results as evidence, and expedited decision-making processes for paternity cases in which title IV-D services are being provided. In addition, this final regulation amends the Child Support Enforcement program regulations governing the audit of State Child Support Enforcement (IV-D) programs and the imposition of financial penalties for failure to substantially comply with the requirements of title IV-D of the Act. This regulation specifies how audits will evaluate State compliance with the requirements set forth in title IV-D of the Act and Federal regulations, including requirements resulting from the Family Support Act of 1988 and section 13721 of OBRA '93. This final regulation also redefines substantial compliance to place greater focus on performance and streamlines Part 305 by removing unnecessary sections.

Child Welfare↗

[Introduction of the DRG system from the point of view of private health insurers].

For the first time, there has been a worldwide attempt to fund all hospital services almost completely by a DRG system supplemented by additional charges, rebates, and procedural rates. In the interest of the efficiency and transparency of hospital services the introduction of a German DRG system settling the current implausible price differences would be welcome. The system selected by the medical self-governing bodies in Germany is based upon the Australian AR-DRG classification. In contrast to other systems, the latter provides the best medical plausibility, the highest transparency of the assignment algorithm and the highest potential for flexibility and adaptations to changing morbidity patterns and medical progress. The adaptation to the conditions of the German health care system requires considerable efforts on the part of hospitals as well as sickness funds and health insurers. Hospitals need to establish a cost unit accounting system satisfying the rules of Applied Economics to allow, among other things, the calculation of relative cost weights. The self-governing bodies will have to consent on a complex regulation system. The German Hospital Federation declared the break down of negotiations concerning a provisional DRG system to be optionally available to hospitals in 2003. The Federal Ministry of Health will now have to decide whether to implement the system through executive fiat. The comprehensive DRG system will introduce new risks. The economic risks of the individual hospital, though not the individual insurer's risks, will be partially compensated for in the introductory phase by revenue balance mechanisms, for example. In particular, both the privately insured and civil servants will face a rise in costs as they will no longer benefit from a shorter length of hospital stay. To end this discrimination against private health insurers, the double counting of the costs associated with medical treatment (included in the DRG price and additionally invoiced by the physician) must be avoided: Once the current reimbursement for costs of optional medical services--being mainly a subsidy borne by private patients--is discontinued, the fee reduction according to Sect. 6a GOAe (medical fee schedule) must be adjusted definitely. This new primacy of economics could pose a threat to the quality of medical treatment. Therefore, quality assurance directives find increasing relevance. Preferably, healthcare providers should rigorously adhere to their scientific standards. Only a strictly rule-based introduction and the system's annual adaptation can keep the risks calculable.

Diagnosis-Related Groups↗

The legislative and litigation history of special education.

Between the mid 1960s and 1975, state legislatures, the federal courts, and the U.S. Congress spelled out strong educational rights for children with disabilities. Forty-five state legislatures passed laws mandating, encouraging, and/or funding special education programs. Federal courts, interpreting the equal protection and due process guarantees of the Fourteenth Amendment to the U.S. Constitution, ruled that schools could not discriminate on the basis of disability and that parents had due process rights related to their children's schooling. Congress, in legislation now retitled the Individuals with Disabilities Education Act (IDEA), laid out detailed procedural protections regarding eligibility for special educational services, parental rights, individualized education programs (IEPs), the requirement that children be served in the least restrictive environment, and the need to provide related (noneducational) services. Decisions on instructional matters such as curricula and the elements of the IEP remain the province of local and state authorities. Advocates for students with disabilities have continually sought separate (categorical) funding for special education services. Current movements toward block grants rather than categorical programs and toward greater inclusion of special education students in general education classrooms raise concerns in some quarters about whether students with disabilities will continue to have full access to the special services they need. While the cost of special services may be an unexpressed criterion in many decisions made by school districts, nowhere does the IDEA explicitly allow cost to be considered. Where a service is necessary for an individual child, cost considerations would not allow a school district to escape its obligations to the child. However, in instances where more than one appropriate configuration of services is available to meet a child's needs, the school district may be allowed to consider the cost of different alternatives.

Adolescent↗