Gale Encyclopedia Of American Law 3Rd Edition Volume 4 P50 potx

CONSUMER PROTECTION agencies, the Food and Drug Administration FDA protects the public from unsafe foods, drugs, medical devices, cosmetics, and other potential hazards.. It also protect

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the bill, Grove L Johnson, switched his aye vote

to nay in order to move for reconsideration of

the defeated bill After a heated debate at the

very end of the legislative session, the Woman

Lawyer’s Bill passed the assembly The bill

nearly died until Foltz managed a last-minute

audience with Governor William Irwin In the

waning hours of the session, on the last possible

day, March 29, 1878, the governor signed

the bill

Foltz and Gordon divided their

responsibil-ities the summer of 1878 Foltz studied and

was the first woman to take advantage of

their recent legislative success, taking the BAR

EXAMINATION Gordon, although she was not a

delegate, attended the first California

constitu-tional convention as a member of the press, and

successfully lobbied for the inclusion of two

clauses that she and Foltz had a hand in

drafting The first clause prohibited restrictions

to any business, vocation, or profession based

on sex; the second prohibitedSEX DISCRIMINATION

in college faculty hiring Foltz passed the bar

examination and became California’s first

female lawyer on September 5, 1878

In January 1879, Foltz and Gordon registered

for classes at Hastings, California’s first law

school However, after only a few days of classes,

Foltz received a letter from the Hastings Law

School Board, informing her that the directors

had resolved not to admit women Foltz and

Gordon filed suit to compel the college, as a state

institution, to admit women The district court

judge, who reportedly did not believe in women

lawyers, nevertheless found these women lawyers

to be correct in the law, and ordered Hastings to

admit them Hastings appealed, and the case went

to the California Supreme Court (Foltz v Hoge, 54

Cal 28[1879]) Although Foltz and Gordon were

victorious again, the time for Foltz to attend law

school had passed She went to Sacramento to

serve as clerk, or counsel, to the judiciary

committee of the state assembly Foltz

neverthe-less considered the Hastings victory to be her

finest moment

Foltz had a long and successful career as an

attorney, first in San Francisco and then in Los

Angeles She practiced probate, criminal, family,

and corporate law Some of her very first cases,

in 1878, heard in justice court, involved

reclaiming the property of young women put

in vulnerable circumstances by desertion,

ill-ness, or an ex-employer

Throughout her career, in addition to conducting a thriving practice, she worked for suffrage and women’s rights She actively encouraged the participation of women in the legal profession In 1893, she organized the Portia Law Club in San Francisco She taught women the law at her offices in San Francisco and in Los Angeles, where she relocated in 1906

In 1918, she helped found the Women Lawyers’ Club in Los Angeles She was responsible for California laws allowing qualified women to act

as administrators, executors, and notaries public

Foltz was a primary force behind improving the criminal defense system In 1893 she represented the California bar at the National Congress of Jurisprudence and Law Reform, held in conjunction with the Chicago World’s Fair It was there that she first introduced the Foltz Public Defender Bill This proposal was subsequently adopted, owing in large part to her lobbying, in over thirty states

The Foltz Public Defender Bill proposed a defender system in which salaried lawyers would devote all or a substantial part of their time to the specialized practice of representing indigent defendants, as opposed to the existing system, in which the court appointed lawyers

on an ad hoc basis from the bar at large The model bill proposed that public defenders meet certain qualifications, receive a salary, have clearly defined job responsibilities, and serve for a term of office A public defender would be a county officer who would defend, without expense to them, all persons who were not financially able to employ counsel and who were charged with the commission of any contempt, MISDEMEANOR, felony, or other offense

Nearly two decades passed before the first public defender office was actually established

in Los Angeles County in 1914, where Foltz was then living In fact, she had already served as the first woman deputy district attorney, in 1911 It was 1921 before California passed a statewide public defender bill

Foltz was also an active writer and

publish-er She founded the weekly newspaper The San Diego Bee She also published a feminist weekly, The Mecca, during a brief stay in Colorado, and

a magazine, The New American Woman She also contributed articles to other papers and magazines throughout her life

THEY CALLED ME THE LADY LAWYER A DAINTY SOBRIQUET THAT ENABLED ME TO MAINTAIN A DAINTY

BROWBEAT MY WAY THROUGH THE MARSHES OF IGNORANCE AND PREJUDICE

—C LARA F OLTZ

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Foltz died in Los Angeles on September 4,

1934 The pallbearers for her funeral included the governor and several prominent federal and state judges

FURTHER READINGS Akers, Virginia Elwood 1984 “Clara Shortridge Foltz, California ’s First Woman Lawyer.” Pacific Historian 28.

Babcock, Barbara Allen 1991 “Clara Shortridge Foltz:

Constitution Maker ” Indiana Law Journal 66.

——— 1994 “Clara Shortridge Foltz: ‘First Woman’.”

Valparaiso Univ Law Review 28.

——— 1993 “A Place in the Palladium: Women’s Rights and Jury Service ” Cincinnati Law Review 61.

Foltz, Clara Shortridge 1897 “Public Defenders.” American Law Review 31.

Polos, Nicolas C 1980 “San Diego’s ‘Portia of the Pacific’:

California ’s First Woman Lawyer.” The Journal of San Diego History 26, no 3 Available onlinei at https://www.

sandiegohistory.org/journal/80summer/portia.htm; web-site home page: https://www.sandiegohistory.org (accessed July 24, 2009).

Schwartz, Mortimer D., Susan L Brandt, and Patience Milrod 1976 “Clara Shortridge Foltz: Pioneer in the Law.” Hastings Law Journal 27 Available online at http://

www.countyofsb.org/defender/Docs/HastingsFoltz.html;

website home page: http://www.countyofsb.org (accessed July 24, 2009).

FOOD AND DRUG ADMINISTRATION One of the oldest U.S CONSUMER PROTECTION agencies, the Food and Drug Administration (FDA) protects the public from unsafe foods, drugs, medical devices, cosmetics, and other potential hazards As part of theDEPARTMENT OF HEALTH AND HUMAN SERVICES, the FDA annually regulates over $1 trillion worth of products, which account for one-fourth of all consumer spending in the United States It also protects the rights and safety of patients in clinical trials of new medical products, monitors the promotional activities of drug and device manufacturers, regulates the labeling of all packaged foods, and monitors the safety of the nation’s blood supply

To ensure compliance with its regulations, the FDA employs more than 1,000 investigators and inspectors who visit more than 15,000 food-processing, drug-manufacturing, and other facili-ties each year If it finds violations of law, the FDA first encourages an offending company to volun-tarily correct the problem or to recall a faulty product from the market If the firm does not voluntarily comply with the law, the FDA may take

it to court and seek criminal penalties against it

The FDA may also seize faulty products, order product recalls, seek injunctive relief, impose fines, and take other types of enforcement action

Each year, the FDA declares about 3,000 products and 30,000 import shipments to be unacceptable

in various ways

The FDA employs more than 2,000 scientists—including 900 chemists and 300 microbiologists—who provide the SCIENTIFIC EVIDENCE to back up its regulatory and inspec-tion duties These scientists analyze samples of products for purity and review test results of new products The FDA itself does not do research for a new medical product Instead, it evaluates the results of studies undertaken by the manufacturer

History

Food production in the United States has been regulated since the late eighteenth century Colonies and, later, states passed laws banning impurities from selected foods In 1848 the United States began regulating imported drugs, under the Drug Importation Act (Ch LXX, 9 Stat 237) The enforcement of food and drug laws was first assigned to the Chemical Division

of the new U.S DEPARTMENT OF AGRICULTURE (USDA) in 1862 (12 Stat 387)

The need for laws to regulate food and drug purity became increasingly urgent in the late nineteenth century, when substances such as opium, cocaine, and heroin were commonly added to medicinal elixirs and tonics The need for government regulation was also made evident in Upton Sinclair’s book, The Jungle, which exposed the unsanitary conditions of Chicago’s meatpacking industry and shocked the nation On June 30, 1906, Congress, with the support of President THEODORE ROOSEVELT, passed two landmark pieces of Progressive Era legislation that strengthened the government’s ability to protect consumers: the Food and Drug Act (34 Stat 768[21 U.S.C.A § 1–15]) and the Meat Inspection Act (21 U.S.C.A § 601 et seq.) The former prohibited interstate commerce in misbranded and adulterated foods, drinks, and drugs, and the latter addressed the unsanitary conditions and use of poisonous preservatives and dyes in the meatpacking industry

In 1927 Congress authorized the creation of the Food, Drug, and Insecticide Administration within the U.S Department of Agriculture In

1930, the agency’s name was changed to the current one, Food and Drug Administration (Agriculture Appropriation Act, 46 Stat 976)

In 1937, 107 people died after taking the elixir sulfanilamide, a supposedly healing tonic

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This tragedy prompted the passage of the next

major reform of food and drug law, the Federal

Food, Drug, and Cosmetic Act of 1938 (21 U.S

C.A § 301 et seq.) The FDA was then entrusted

with the regulation of cosmetics and therapeutic

devices and was authorized to do factory

inspections Even more importantly, the act

required new drugs to be tested on animals and

humans for safety before being marketed In

1957, the Food Additives Amendment (Pub

L 85-250, Aug 31, 1957, Stat 567) required the

evaluation of food additives to establish safety,

and in the following year, the Delaney Clause

(Pub L 85-929, Sept 6, 1958, 72 Stat 1784)

forbade the use in food of substances found to

cause cancer in laboratory animals

In 1962 the Kefauver-Harris Drug

Amend-ments (Pub L 87-781, Oct 10, 1962, 76 Stat

780) were passed These laws required drug

manufacturers not only to show that their

drugs were safe but also to prove that their

drugs achieved the effects claimed That same

year, FDA regulations were shown to be

effective after the drug thalidomide, for which

the FDA had delayed approval, caused

thou-sands of birth defects in western Europe

In 1979 the FDA was made part of the

Department of Health and Human Services (96

Stat 668, 695) Other laws with major

implica-tions for the FDA’s activities include the 1990

Nutrition Labeling and Education Act (Pub L

101-535, Nov 8, 1990, 104 Stat 2353), which

requires all packaged foods to carry labels with

nutrition information, and the Prescription Drug

User Fee Act of 1992 (Pub L 102-571, Title 1, Oct

29, 1992, 106 Stat 4491 to 4500), which requires

drug and biologics manufacturers to pay fees that

support FDA assessment of their products

Effective October 2002, the FDA

implemen-ted its National Organic Program (NOP) under

the Organic Foods Production Act of 1990

(OFPA), 7 U.S.C 6501 et seq The NOP sets

the first national standards for the use of the

label term organic on food items and products

Products that qualify as “100 percent organic”

under NOP rules may use the“USDA Organic”

seal on their principal display panel The rules

specifically prohibit the use ofGENETIC

ENGINEER-ING methods, ionizing radiation (irradiation),

and sewage sludge for fertilization In addition,

all agricultural products that are labeled organic

must originate from farms or handling

opera-tions that have been certified by a state or

private agency accredited by the USDA

Organization

The FDA carries out its activities through a number of subdivisions The Center for Drug Evaluation and Research regulates the safety, effectiveness, and labeling of all prescription and over-the-counter drugs intended for hu-man use It also monitors drug advertising for accuracy, ensures the safety and rights of patients in drug studies, and distributes infor-mation on drug products to the medical community and the public

The Center for Biologics Evaluation and Research regulates biological products, which include blood, vaccines, human tissues, and drugs derived from living organisms It coordi-nates an AIDS program, which works to develop

an AIDS vaccine and AIDS diagnostic tests It also conducts research on the safety of blood and blood products and inspects manufacturing plants to ensure compliance with FDA standards

The Center for Food Safety and Applied Nutrition develops regulations related to food, food additives and colorings, and cosmetics The Center for Devices and Radiological Health seeks

to ensure the safe use of potentially hazardous radiation such as that produced by X rays It conducts research into the effects of exposure to radiation-producing medical devices and devel-ops manufacturing standards for such devices

The Center for Veterinary Medicine evalu-ates the safety of drugs and devices used on animals The National Center for Toxicological Research assesses the biological effects of toxic chemical substances

Other offices of the FDA include the Office of Policy, the Office of External Affairs, the Office of Management and Systems, the Office of AIDS Coordination, the Office of Orphan Products Development, and the Office of Biotechnology

The administration operates six field offices, 21 district offices, and 135 resident inspection posts throughout the United States and Puerto Rico

FURTHER READINGS Branding, Frederick H 2002 “Preparing for and Surviving FDA Inspections.” Update 1 (January/February).

Washington, D.C.: The Food and Drug Law Institute.

Burkholz, Herbert 1995 The FDA Follies New York: Basic.

“Center for Drug Evaluation and Research.” 2009 U.S Food and Drug Administration Available online at http://

www.fda.gov/AboutFDA/CentersOffices/CDER/default.

htm; website home page: http://www.fda.gov (accessed July 24, 2009).

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“FDA Mission Statement.” 2009 U.S Food and Drug Administration Available online at http://www.fda.govt (accessed July 24, 2009).

Harmon, Daniel E., and Arthur Meier Schlesigner 2002 The Food and Drug Administration New York: Chelsea House.

Parver, Deborah G 1999 “Expediting the Drug Approval Process: An Analysis of the FDA Modernization Act of 1997.” Administrative Law Review 51 (fall) Available

online at http://www.wcl.american.edu/journal/alr/51/ 51-4parver.pdf?rd=; website home page: http://www wcl.american.edu (accessed July 24, 2009).

“Reinventing Drug and Medical Device Regulations.” National Performance Review (April 1995) Washington, D.C.: U.S Government Printing Office Available online at http://govinfo.library.unt.edu/npr/library/ reinvent-fda.htm; website home page: http://govinfo library.unt.edu (accessed July 24, 2009).

How the FDA Approves New Drugs

The process by which the Food

and Drug Administration (FDA)

approves drugs as safe and effective is

generally long and complicated, though

it may vary according to the type of drug

and the nature of the illness for which it

is being developed The FDA refers to

drugs under development as

investiga-tional new drugs, or INDs

The evaluation of new drugs requires

the skills of many different FDA scientists

and professionals performing a wide

variety of tasks Biochemists and

molecu-lar biologists evaluate the basic chemistry

and biology of new chemical compounds

and molecular structures Toxicologists

assess the potential harm of proposed

drugs, and pharmacologists study how

these drugs affect the body and are broken

down and absorbed by it Computer

scientists create electronic models that

aid in the understanding of new chemicals

Physicians evaluate the results of clinical

trials, assessing both the beneficial and

adverse effects of the drugs Plus,

statisti-cians evaluate the design and results of

controlled studies

Complete evaluation is an

expen-sive and time consuming process,

particularly for the company developing

the drug, called a drug sponsor A

sponsor spends an average of $802

million for each new drug brought to

market Typically, the process takes up

to eight years and may be divided into

roughly three stages: preclinical trials,

involving animal and other laboratory

tests (lasting one and a half years on

average); clinical trials, involving tests

on humans (five years); and FDA review (two years)

Preclinical Trials Once a sponsor has developed a drug, it must test the drug on animals in the laboratory In doing so, the drug sponsor must follow FDA guidelines and regulations These tests, also called preclinical trials, are usually done on more than one species of animals FDA guide-lines call for the inspection of animal laboratories every two years to ensure that they are being operated according to the administration’s regulations

After short-term lab testing has been performed and the sponsor has deemed its results adequate, the sponsor submits test data and plans for future clinical trials

to the FDA FDA scientists, together with

a local institutional review board com-posed of scientists, ethicists, and non-scientists, then conduct a thirty-day safety review to decide whether to allow testing

on humans The vast majority of new drugs tested in the laboratory are rejected

by either the sponsor or the FDA because they are unsafe or ineffective

If the FDA indicates approval, the drug sponsor may begin clinical testing on humans Even if a drug is approved for clinical trials, the sponsor continues ani-mal testing of the drug in order to better understand the drug’s long-term effects

Clinical Trials Clinical trials are sci-entifically controlled studies in which the drug being tested is given to one group of patients, while another treatment, often a placebo (an inactive substance that looks

like the drug being tested), is given to another group Ideally, neither group of patients knows which is receiving the new drug and which is receiving the placebo The clinical trials, like the animal tests, examine what happens to the drug in the body, including whether it is changed, or metabolized, in the body; how much of it

is absorbed into the blood; and how long it remains in the body If human tests produce unexpected results, researchers may conduct further animal tests to better understand the drug

Clinical trials proceed in three phases: Phase 1 involves testing primarily for safety and dosage level Twenty to one hundred healthy patients are assessed over several months If the results are within FDA safety guidelines, the trials proceed

to phase 2

Phase 2 involves a greater number of patients—up to several hundred—who have the condition that the drug is intended to treat During this stage, which lasts from several months to two years, researchers attempt to determine the drug’s effectiveness in achieving its stated purpose, as well as its safety At the end of this phase, sponsors meet with FDA officials to discuss the best way to conduct the next phase of testing

In phase 3, the most crucial stage of testing, the number of patients is expanded

to several hundred to several thousand, and the length of the study is increased to one

to four years This phase establishes the correct dosage of the drug and how it will

be labeled and provides additional evidence regarding its safety and effectiveness

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“Reinventing the Regulation of Drugs Made from

Biotech-nology ” 1995 Washington, D.C.: U.S Government

Printing Office Available online at http://govinfo.

library.unt.edu/npr/library/951109.html; website home

page: http://govinfo.library.unt.edu (accessed July 24,

2009).

“Significant Dates in U.S Food and Drug Law History.”

2009 U.S Food and Drug Administration Available

online at http://www.fda.gov/AboutFDA/WhatWeDo/

History/Milestones/ucm128305.htm; web site home page: http://www.fda.gov (accessed July 24, 2009).

U.S Food and Drug Administration Web site Available online at http://www.fda.gov (accessed July 24, 2009).

U.S Government Manual Web site Available online

at http://www.gpoaccess.gov/gmanual/index (accessed July 21, 2009).

Of 100 drugs submitted for testing

in humans, an average of 70 will pass

phase 1 Of these 70, on average, only

33 will remain after phase 2 testing, and

25 to 30 after phase 3 Finally, an average

of only 20 will actually receive FDA

approval

Once the drug sponsor has

complet-ed clinical trials, it submits a new

drug application (NDA) to the FDA,

requesting approval to market the

drug This application consists of

docu-mentation detailing the chemical

compo-sition of the drug, the design of the trials,

the results of the trials, and the means by

which the drug is made and packaged

FDA Review In assessing an NDA, the

FDA undertakes its closest scrutiny of all

during the drug approval process Its

principal goal during review is to

deter-mine whether the benefits of the new drug

outweigh the risks To reach this

determi-nation, the FDA examines the

documen-tation provided by the sponsor and looks

at samples of the drug

If inadequacies are discovered in

the NDA, the FDA may require

addi-tional information, further testing, or

modified labeling In cases where it is

difficult to establish clearly whether the

benefits of the drug outweigh the risks, a

panel of outside experts is often

con-sulted

If the FDA approves the drug, the

sponsor may begin manufacturing and

marketing the drug immediately

The FDA does not stop monitoring a

drug once it has been marketed It

continues to evaluate the drug’s safety

and effectiveness through its program of

postmarket surveillance This program

consists of surveys, the testing of product

samples, and the analysis of reported

adverse reactions

Speeding Drugs to Those Who Need Them The FDA has longstand-ing policies allowlongstand-ing what it calls the compassionate use of new drugs for those

in desperate need Innovative cancer treatments, for example, have been made available to patients since the 1970s through the National Cancer Institute

However, during the 1980s, the FDA came under increasing fire for its slow approval of new drugs Particularly with the emergence of AIDS during the 1980s, the public outcry for fast delivery of innovative new drugs strengthened As science pro-duces ever more pharmaceuticals, the FDA

is called on to review drug applications as quickly as is reasonably possible

In response to the growing demand for speedy drug evaluation, the FDA has made significant changes in its review protocols

In 1987, for example, the agency adopted

“expanded access” regulations, which per-mit certain drugs to be designated as investigational new drugs for treatment,

or INDs A treatment IND may be administered to patients even while it is still undergoing clinical trials This pro-gram allows patients with no other alter-natives to undergo a treatment that may benefit their health By 1999, 39 agents had been designated treatment INDs Between

1997 and 2005, an average of 659 patients received INDs A 2009 FDA rule was designed to expand patient access to INDS

The FDA estimates a 50 percent increase in patients using these drugs By 1995, more than 75,000 patients had received access to new therapies through this program New drugs used to treat patients with AIDS are made available through a similar process known as the parallel track approach

Identifying priorities is another method the FDA uses to provide more rapid access to promising new treat-ments AIDS drugs, drugs that treat

life-threatening or severely debilitating illnesses, and drugs that appear to offer significant improvements over existing therapies are classified as priority drugs and receive faster review than those classified as standard drugs With

priori-ty drugs, the FDA priori-typically becomes involved earlier in the development process and is thereby able to more quickly review the relevant applications Drugs are also classified as to chemical type, so that those closely similar in structure to existing drugs will receive less intensive review than those with a molecular structure that has never been marketed before

Accelerated approval is another mechanism for faster review of promis-ing new drugs Under this program, created in 1991, a product may be approved for limited use if it has been shown in trials to achieve particular results such as lowering blood pressure

or cholesterol Drugs approved under this program include didanosine for AIDS, interferon beta-1B for multiple sclerosis, and DNase for cystic fibrosis The Prescription Drug User Fee Act of

1992 (Pub L 102-571, Title 1, Oct 29,

1992, 106 Stat 4491 to 4500) has also enabled the FDA to speed drug review Under this law, fees paid by drug manu-facturers are used by the agency to hire hundreds of additional review staff and buy improved equipment, including compu-ters that make review more efficient Efforts that began in the mid-1990s

to streamline the drug approval process have proved successful In 1994 a new drug was approved by the FDA in a median time of 19 months, and priority drugs with important therapeutic uses were approved in an average of 10.4 months By 2009 the FDA approved priority drugs within six months and standard drugs within ten months

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FOOTNOTE 4 Footnote 4 is a footnote to United States v

Carolene Products Co., 304 U.S 144, 58 S Ct

778, 82 L Ed 1234 (1938), in which the U.S

Supreme Court upheld the constitutionality of the Filled Milk Act, 42 Stat 1486, which Congress passed in 1923 to regulate certain dairy products Written by Justice HARLAN F STONE, footnote 4 symbolizes the end of one era

of constitutional jurisprudence and the dawning

of another

In upholding the constitutionality of the Filled Milk Act, the Supreme Court drew a distinction between legislation that regulates ordinary economic activities and legislation that curtails important personal liberties The con-stitutional authority of state and federal legis-latures over economic matters is plenary, the Court said, and laws passed to regulate such matters are entitled to a presumption of

constitutionality when reviewed by the judicial branch of government

Courts must pay great deference to legisla-tion that is principally aimed at economic affairs, the Court continued, and judges should refrain from questioning the wisdom or policy judgments underlying such legislation Al-though some commercial laws may seem undesirable or unnecessary to a particular judge, the Court cautioned, the judicial branch may not overturn them unless they fail to serve a rational or legitimate purpose

This deferential posture toward the legisla-tive branch represents the crux of judicial self-restraint, a judicial philosophy that advocates a narrow role for courts in U.S constitutional democracy Because state and federal legislatures are constitutionally authorized to make the law, proponents of judicial self-restraint argue, courts must limit their role to interpreting and applying

AZT: An Agent of Change for the FDA

A

B

zidothymidine (AZT) is a celebrated example

of speedy FDA approval of a new drug The

unusually swift approval of AZT during the early

years of the AIDS (acquired immune deficiency

syndrome) epidemic led to the creation of a new

FDA category, treatment investigational new drug

(treatment IND), that established new procedures

for more rapid and flexible drug approval

The pharmaceutical company Burroughs

Well-come first presented AZT as a new drug to the FDA

in June 1985 Public fear of AIDS had increased

dramatically during the previous few years, as had

protests by AIDS activists who complained of slow

FDA movement with regard to promising new

treatments Keenly aware of the need for swift

decision making in the face of the deadly AIDS

disease, the FDA approved phase 1 clinical trials of

the drug within one week of the initial application

Phase 1 testing of AZT, between July and

December 1985, was promising, and phase 2,

involving 300 patients in placebo-controlled trials,

began in February 1986 After six months, 19 of the

137 patients in the group taking the placebo had

died, whereas only 1 of 145 in the group taking AZT

had died The results were encouraging enough for the FDA to forgo further testing The group taking the placebo was switched to AZT, and phase 3 testing, traditionally the most important step in clinical trials, was deemed unnecessary

In September 1986 the FDA authorized the treatment of patients who wanted access to AZT, even before it had given approval to the drug By the time approval for general public use came in March

1987, some 4,000 patients had already been treated with AZT, and thus the drug was already potentially extending the lives of hundreds of people

Taking an example from its handling of AZT, the FDA in May 1987 created the treatment IND classification to facilitate faster approval and wider distribution of promising new therapies for life-threatening diseases The rapid approval of AZT also proved greatly encouraging to the pharmaceu-tical industry, which has since used the accelerated process to bring new, more effective AIDS drugs to market much more rapidly and at lower cost

CROSS REFERENCE Acquired Immune Deficiency Syndrome.

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the law, except in the rare instance where a piece

of legislation clearly and unequivocally violates a

constitutional provision, in which case they may

strike it down

In footnote 4 the Supreme Court indicated

that this presumption of constitutionality might

not apply to certain categories of noneconomic

legislation Legislation that restricts political

processes, discriminates against minorities, or

contravenes a specifically enumerated

constitu-tional liberty, the Court said, may be subject to

“more searching judicial scrutiny.”

Legislation that limits the right to assemble

peaceably, the freedom to associate, or the liberty

to express dissenting viewpoints, the Court

suggested, tends to obstruct ordinary political

channels that average citizens traditionally rely on

to participate in the democratic process By the

same token, the Court suggested that legislation

discriminating against racial, religious, and

ethnic minorities tends to marginalize groups

that are already politically weak and vulnerable

The Court also reasoned that legislation

contravening a specifically enumerated

consti-tutional right should be given less deference by

the judiciary than legislation that purportedly

contravenes an unenumerated right This

pas-sage in the Court’s opinion alluded to its

decision in an earlier case,LOCHNER V.NEW YORK,

198 U.S 45, 25 S Ct 539, 49 L Ed 937 (1905),

which has been maligned throughout the

twentieth century

In Lochner the Supreme Court recognized an

unenumerated freedom of contract that is loosely

derived from the Fifth and Fourteenth

Amend-ments to the U.S Constitution Based on this

freedom, the Court struck down a New York law

(N.Y Laws 1897, chap 415, art 8, § 110) that

regulated the number of hours employees could

work each week in the baking industry The Court

said employers and employees enjoy an

unwrit-ten constitutional right to determine their wages,

hours, and working conditions without

govern-ment interference

Over the next 32 years, state and federal

courts relied on Lochner to invalidate scores of

statutes that attempted to regulate

employ-ment relations, business affairs, and various

property interests At the same time, the

Supreme Court was upholding legislation that

restricted specifically enumerated

constitu-tional liberties, such as theFREEDOM OF SPEECH

For example, inSCHENCK V UNITED STATES, 249

U.S 47, 39 S Ct 247, 63 L Ed 470 (1919), the Supreme Court upheld the ESPIONAGE ACT OF

1917, 40 Stat 217, which prohibited the circulation of printed material that encouraged resistance to the military draft during WORLD WAR I

The reasoning of footnote 4 helped bring an end to the Lochner era and a reversal of the judicial standards of review for economic and noneconomic legislation Before Carolene Pro-ducts, legislation that in any way touched upon

an economic interest was subject to judicial scrutiny During the same period, state and federal courts gave leeway to legislation touch-ing upon noneconomic freedoms, even the personal freedoms expressly contained in the BILL OF RIGHTS

Since Carolene Products, state and federal legislatures have been given wide latitude to regulate the workplace, commercial interests, and other economic matters Conversely, laws that have hindered access to political processes, discriminated against minorities, or impinged

on fundamental freedoms contained in the Bill

of Rights, as made applicable to the states through the FOURTEENTH AMENDMENT, have been deemed suspect, and subject to strict judicial scrutiny Such laws are typically invalidated by the judiciary unless the government can dem-onstrate that they serve a compelling interest

The legacy of footnote 4 can be observed in cases where the Supreme Court has expanded the class of minorities who are protected by heightened judicial scrutiny In addition to the racial, ethnic, and religious minorities refer-enced in footnote 4, women, illegitimate children, and other “discrete and insular”

minorities have received increased

constitution-al protection by the Supreme Court since 1938

FURTHER READINGS Ackerman, Bruce A 1985 “Beyond Carolene Products.”

Harvard Law Review 98 (February).

Linzer, Peter 1995 “The Carolene Products Footnote and the Preferred Position of Individual Rights: Louis Lusky and John Hart Ely vs Harlan Fiske Stone ” Constitu-tional Commentary 12 (summer).

Perry, Matthew 1996 “Justice Stone and Footnote 4.”

George Mason Univ Civil Rights Law Journal 6 (fall).

Robinson, John H 1998 “The Compromise of ‘38 and the Federal Courts Today ” Notre Dame Law Review 73 (May).

CROSS REFERENCES Judicial Review; Strict Scrutiny.

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FORBEARANCE Refraining from doing something that one has a legal right to do Giving of further time for repayment of an obligation or agreement; not to enforce claim at its due date A delay in enforcing a legal right Act by which creditor waits for payment

of debt due by a debtor after it becomes due

Within usury law, the contractual obligation

of a lender or creditor to refrain, during a given period of time, from requiring the borrower or debtor to repay the loan or debt then due and payable

FORCE Power, violence, compulsion, or constraint exerted upon or against a person or thing Power dynamically considered, that is, in motion or in action; constraining power, compulsion; strength directed to an end Commonly the word occurs in such connections as to show that unlawful or wrongful action is meant, e.g., forcible entry

Power statically considered, that is, at rest, or latent, but capable of being called into activity upon occasion for its exercise Efficacy; legal validity This is the meaning when we say that a statute or a contract is in force

Reasonable force is that degree of force that is appropriate and not inordinate in defending one’s person or property A person who employs such force is justified in doing so and

is neither criminally liable nor civilly liable in tort for the conduct

DEADLY FORCE is utilized when a person intends to cause death or serious bodily harm

or when he or she recognizes personal

involvement in the creation of a substantial risk that death or bodily harm will occur

FORCE MAJEURE [French, A superior or irresistible power.] An event that is a result of the elements of nature, as opposed to one caused by human behavior The term force majeure relates to the law of insurance and is frequently used in construction contracts to protect the parties in the event that

a segment of the contract cannot be performed due to causes that are outside the control of the parties, such as natural disasters, that could not

be evaded through the exercise of due care

FORCED SALE

An involuntary transaction that occurs in the form and at the time specified by law for the purpose of applying the proceeds to satisfy debts, such as a mortgage or a tax lien, incurred

by the owner of the property

A forced sale results from the execution of a judgment previously rendered by a court

FORCIBLE DETAINER

A summary and expeditious statutory remedy used

by a party entitled to actual possession of premises

to secure its possession, where the occupant initially

in lawful possession of it refuses to relinquish it when his or her right to possession ends

CROSS REFERENCE Forcible Entry and Detainer.

FORCIBLE ENTRY AND DETAINER

A summary proceeding to recover possession of land that is instituted by one who has been wrongfully ousted from, or deprived of, possession Forcible entry and detainer, one aspect of which is known asUNLAWFUL DETAINER, alludes to two separate misdeeds and two divergent remedies of statutory origin

The forcible intrusion into another person’s peaceable possession constitutes one type of infraction Even if it is unlawful, peaceable possession cannot be terminated by violence In many jurisdictions, even the rightful owner is held liable for damages, which as provided by statutes are often multiple in nature, if he or she employs excessive force in ousting one in peaceful possession In such instances, the offense involved is the force itself and not the actual dispossession

Hurricanes such as

Hurricane Ike, which

hit Texas in 2008, are

examples of force

majeure, as they are

natural events that

cannot be controlled.

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The second form of misdeed entails the

initiation of LEGAL PROCEEDINGS by the rightful

owner against a squatter without title or a tenant

who declines to depart Force in such instances

might be inconsequential, figurative, or

nonexis-tent Damages are avoidable, but the restoration

of the lawful owner to possession of the property

by eviction of the defendant is also within the

purview of the remedy This remedy, which

awards both damages and possession, resembles

ejectment, which also entails theRECOUPMENT of

possession of property by the person entitled to

it, but significant differences exist

In addition to historical dissimilarities, the

summary nature of the forcible entry and

detainer action is unlike the nature of an

ejectment action The trial and eviction can be

accomplished within a few days afterSERVICE OF

PROCESS Statutes frequently provide, however,

that the decision in forcible entry or unlawful

detainer is not binding as to title If title is

seriously disputed, a second and more

compre-hensive suit in ejectment orTRESPASSis warranted

The forcible entry or unlawful detainer action

is restricted to cases in which the plaintiff’s right

to possession is unequivocal, because SUMMARY

PROCEEDINGS would not be justified under any

other circumstances A minority of jurisdictions,

however, limit the action to the eviction of those

who have actually entered by force

A forcible entry suit, although burdensome

in nature, functions not merely as a method of

prompt relief but also affects a subsequent

ejectment action Because theBURDEN OF PROOFis

imposed upon the PLAINTIFF who has been

dispossessed in the ejectment suit, in regard to

his or her own PARAMOUNT TITLE, the issue of

possession determined in the forcible entry suit

affects the ultimate burden of proof It would be

inequitable to permit this to be manipulated by

those who forcibly enter, or perhaps even by

holdover tenants The forcible entry action, in

dispossessing the occupant where his or her title

is patently invalid, influences the ejectment

action by its principle that the plaintiff never

prevails on the basis of the possessor’s defective

title, but must instead recover on the validity of

his or her own title

The supposition that unlawful detainer

involves possession and not title, whereas

ejectment entails title, is somewhat inaccurate

Both ejectment and unlawful detainer actions are

possessory in nature, and title is nearly always the

basis of possessory rights The differences in the

two actions reside in the summary character of

forcible entry, the restricted class of person against whom it can be instituted, and its lack of RES JUDICATAeffect on title issues

These forcible entry and detainer, or summary eviction, statutes are primarily utilized

by landlords attempting to regain possession

of premises from recalcitrant tenants The Supreme Court has upheld the validity of such statutes, regardless of the limited number of issues triable and the brief period between summons and trial

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