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a court’s establishment of a certain rule of law based on a particular set of facts becomes a precedent that all lower courts in that jurisdiction must follow
stare decisis
-
order of court power
Supreme Court > appellate > district
-
4 factors courts commonly apply in reaching decisions
- 1) fundamental notions of fairness
- 2) custom/history involved
- 3) command of a political entity
- 4) best balance between conflicting societal interests
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role of law in pharmacy practice
create parameters/general guidelines for professionals to work in to keep patients safe
-
NOT the role of law to dictate:
- practice strategy
- professional judgement
-
limits of the law
- certain human relationships
- de minimis violations with overly harsh punishments
-
violations having no real impact on the quality of drug therapy
de minimis violation
-
branches of the tripartite system
legislative, executive, judicial
-
supreme law of US
Constitution
-
gives Congress the power to make all laws "necessary and proper" for carrying out its responsibilities
article 1, section 8 of the Constitution
-
allows states to legislate in all areas except those prohibited or given to Congress by the US Constitution
10th Amendment
-
- states that State Legislatures have extremely broad "police" powers to pass laws to protect the "health, safety, and welfare" of the public
- the State can make federal laws more stringent, as long as constitutional rights are not impinged upon
10th Amendment
-
an elected body of persons with the primary responsibility to enact laws, also called statutes
legislature
-
hierarchical order of statutes
federal laws > state constitutions > state legislation > political subdivisions (ordinances)
-
"4th branch" of government
administrative agencies
-
2 ways admin agencies create "law"
- 1) enacting policies, rules, procedures, and regulations
- 2) rendering decisions at hearings
-
implement desired changes in policies, and administer a body of substantive law
administrative agencies
-
This process ensures that constituents
whose interests are affected by the actions of the agency receive notice of any proposed regulation. Constituents then have an opportunity to comment on the proposed
regulation. The agency considers all comments and may incorporate them into the regulation before its final promulgation.
notice-and-comment rulemaking
-
interpret, define, and add detail to statutes
regulations
-
how regulations are enacted
via notice-and-comment rulemaking
-
legislative function
promulgate regulations
-
3 validity tests of a regulation
- 1) within the scope of the agency's authority
- 2) based upon statutory authority
- 3) reasonable relationship to public health, safety, & welfare
-
laws made by administrative agencies
regulations
-
Are regulations considered statutory law?
NO, they just have the effect of law
-
daily publication of proposed and final regulations and notices
Federal Register (Fed. Reg)
-
compilation of final regulations divided and indexed by subject matter
Code of Federal Regulations (CFR)
-
where to find proposed/final regulations that affect the Pharmacy Practice
- 1) Fed Reg
- 2) CFR
- 3) Board website
-
law developed from judicial opinions
common law
-
- analogous to administrative law, but not created by an administrative agency
- enforceable
judicial opinion
-
opinions are binding on lower courts in the same jurisdiction and serve as precedent
stare decisis
-
reasons for deviating from stare decisis
- factual distinctions
- changing times/circumstances
-
principles of interpretation
- 1) legislative intent ("what is the law attempting to accomplish?")
- 2) give the ordinary meaning of the words
- 3) support the best fit with current social policy
- 4) heed is an individual’s constitutional due process rights
-
3 types of action that can be imposed on an offender
- 1) criminal
- 2) civil
- 3) administrative
-
government vs. private party
criminal action
-
objectives of this action: deter, punish, rehabilitate
criminal action
-
private party vs private party
civil action
-
objective of this action: compensation to injured party
civil action
-
agency vs private party
administrative action
-
action that may be based on statute or common law
civil action
-
charged with a crime as prohibited by a statute and subject to fines/prison specified by statute
criminal action
-
disciplinary determination which may include warning, fines, licensure revocation/suspension/probation
administrative action
-
like criminal action, but can't impose jail time/revocation of civil liberties
administrative action
-
part of the Federal court system
created by Congress via Article III
12 judicial circuits and courts
primarily hears appeals
Court of Appeals
-
If an act requires legal authority and it is done withOUT such authority
ultra vires
-
Federal Court System order of power
Supreme Court > Court of Appeals > District Courts > Specialty Courts
-
composed of: tax courts, customs & patent courts, court of claims
specialty courts
-
the court where you sue the U.S.
court of claims
-
person bringing the action
plaintiff
-
person action is brought against
defendant
-
plaintiff must prove "standing"
the challenged conduct has caused the plaintiff actual injury and there is a legally protectable interest
-
Civil Court Procedure
- 1) complaint
- 2) summons
- 3) answer
-
"complaint" in civil court
all material facts of case and remedy requested
-
"summons" of civil court
issued by court notifying defendant of suit and commanding defendant to file an answer
-
"answer" of civil court
admitting to or denying ALL allegations in the complaint
-
if answer not filed in civil court
default judgement
-
civil court discovery
- 1) pretrial
- 2) deposition
- 3) interrogatory
-
civil court procedure where each side must give the other side all the facts, evidence, and names of witnesses upon which it will rely to present its case (evidence discovery)
pretrial
-
civil court procedure involving out of court testimony by a witness under oath
deposition
-
civil court procedure consisting of a list of written questions that witness must respond to under oath
interrogatory
-
the questioning by each side of the potential jurors
voir dire examination
-
whose role is it to determine questions of fact?
jury's
-
whose role is it to determine questions of law?
judge
-
level of legal proof required
burden of proof
-
% needed to be considered "probable cause"
51%
-
% needed to be considered "reasonable doubt"
99.9%
-
level of proof criminal cases require
reasonable doubt
-
level of proof civil cases require
probable cause
-
states that federal law always prevails over state law
Supremacy Clause
-
authorizes Federal law to regulate drugs
Interstate Commerce Clause (of US Constitution)
-
authorizes State law to regulate drugs
10th Amendment
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