US Legislative Process

Legislative Process - Federal Level

• Congress passes legislation at the federal level.
• Congress consists of the Senate and the House of Representatives.

The Senate

• The Senate has 100 members, with two senators from each state, regardless of population size.
• Wyoming (less than a million citizens) and California (40 million citizens) each have two senators.

The House of Representatives

• The House of Representatives has 435 members.
• The number of House members per state is proportional to the state's population.
• States can gain or lose House members if population changes occur.

Bill Sponsorship

• Legislation requires sponsorship by one or more legislators.
• Bipartisan support may be sought by having both a Democrat and a Republican sponsor a bill.

Congressional Committees

• Bills are sent to relevant Congressional committees after sponsorship.
• Committees hold hearings, conduct investigations, and may rewrite (mark up) the bill.
• Experts may be consulted to discuss the bill's strengths and weaknesses.
• Committees vote on whether to send the bill to the House or Senate floor for a vote.
• Bills can be blocked in committee if a majority opposes it.

Importance of Committee Hearings - Legislative Intent

• Committee hearings are an important resource for determining legislative intent.
• Courts review committee hearings to understand the intent behind a law when interpreting it in legal cases.
• Legislative intent derived from committee meetings can significantly influence court decisions.

Floor Consideration and Voting

• The majority party leadership decides if and when a bill is debated and voted on.
• A bill must be debated and passed in one chamber before being sent to the other.
• A bill can be voted down and not proceed to the other chamber.

Conference Committee

• Conference committees reconcile differences between versions of a bill passed in the House and Senate.
• Members from both houses work to compromise on a final version.

Presidential Action

• The President can sign a bill into law or veto it.
• Congress can override a presidential veto with a two-thirds vote in both houses.
• Overriding a veto is difficult but possible.

Terminology

• Federal/State legislatures (Congress or state legislatures) enact statutes (e.g., Food, Drug, and Cosmetic Act).
• Regulations are based on authority granted by a legislative body to an agency.
• Federal/State administrative agencies (e.g., FDA, state Boards of Pharmacy) promulgate regulations based on statutory authority.
• Local entities (cities/counties) pass ordinances (e.g., local pharmacy zoning laws).
• Regulations cannot exceed the authority delegated by the legislative body.
• Agencies create specific rules to implement the statute's intent and authority.

State Level Legislative Process

• Most state legislatures are bicameral, modeled after Congress with a Senate and a House of Representatives.
• Some states have a unicameral legislature with only one house.
• Legislative history for determining legislative intent is often harder to find at the state level.
• Some states don't keep records of legislative hearings, making it difficult to ascertain legislative intent.

Distinguishing Legal Case Types

• It's important to distinguish between criminal cases, civil cases, and administrative actions, because pharmacists can be subject to all three.

Criminal Cases

• Criminal case headings typically indicate "the government v. a private party" (e.g., FDA v. Merck, US Justice Department v. [Individual/Company]).
• State-level cases may say "the Department of Health or the Florida Board of Medicine versus" the private party.
• Charges are based on statute and penalties are specified by statute.
• The defendant is either acquitted or found guilty.
• The term "guilty" is only applicable to criminal cases.

Civil Cases

• Civil case headings show one private party against another (e.g., Joe Blow v. CVS).
• Civil cases can be based on statute or common law legal rights.
• The duty to exhibit due care is a common law obligation to protect people from unreasonable harm.
• A defendant is found liable or not liable for damages; there are no prison terms.

Administrative Actions

• Administrative actions involve an administrative agency (e.g., Board of Medicine or Board of Pharmacy) versus a private party.
• The agency makes a disciplinary determination.
• Disciplinary actions can include a warning, letter of censure, fines, temporary or permanent licensure revocation/suspension, probationary status, or continuing education obligations.
• Reinstatement is more difficult after revocation than suspension.

Judicial Process - Federal Court System

• The federal court system is hierarchical, with the US Supreme Court at the top, consisting of nine justices with lifetime appointments.
• Cases usually come up to the Supreme Court through appeals.
• Cases of original jurisdiction go directly to the Supreme Court, such as those involving ambassadors or disputes between states.
• Most cases start at a federal circuit court (trial court), then go to a court of appeal (one of 11 numbered circuits or the DC circuit) before potentially reaching the Supreme Court.

Jurisdiction - Getting into Federal Court

• A basis is required to enter federal court (e.g., federal law or a constitutional issue).
• Litigating DEA or FDA cases involves federal agencies and federal laws.
• US constitutional issues can also provide grounds for federal jurisdiction.
• State Supreme Courts are the final arbiters of their state's constitution, unless it conflicts with the federal constitution.
• The Supreme Court can overrule a State Supreme Court if a state constitution disagrees with the federal constitution.
• Other ways to get into federal court include diversity of citizenship (citizens of different states suing each other) and cases where a state or the US government is a party.

Specialty Courts

• Specialty courts exist for specific issues (e.g., the US Patent Court hears all patent claims).
• Specialty court cases can ultimately be appealed to the US Supreme Court.
• Patent court is one specialty court relevant to pharmacy.

Binding Precedent

• Rulings by a State Supreme Court or the US Supreme Court are binding on all lower courts within that system.
• US Supreme Court rulings are binding in every jurisdiction.
• An 11th Circuit Court of Appeals ruling (Florida, Georgia, and Alabama) is binding only in those three states.
• Rulings in one federal district are not binding on other federal district courts, but may be influential.

Resolution of Circuit Disagreements

• Disagreements between federal circuits often go to the US Supreme Court to resolve.
• The Supreme Court may not always accept these cases, leading to different laws in different circuits for extended periods.
• In important areas, the Supreme Court will usually find a case to rule on, potentially favoring one circuit, opposing another, or combining aspects of both.

State Court System (Florida Example)

• The state court system parallels the federal system.
• Florida has five intermediate appellate court districts, not 12.
• Appeals from the local trial court goes up to those divisions.
• Trial courts have various names: county courts, superior courts, district courts, or circuit courts.
• Florida trial courts are called circuit courts, which have nearly unlimited jurisdiction.
• Specialty, limited jurisdiction courts include probate court, family courts, juvenile courts, traffic court, and small claims court.

Civil Court Procedures

• There is some degree of court selection, but you can't just choose federal court arbitrarily.
• State court is mandatory unless a federal issue, the state or US government is a party, or there is diversity of citizenship.

Parties to a Lawsuit

• The plaintiff brings the action, their name appears first.
• In an administrative action, the state agency's name comes first.
• The defendant is the person the action is brought against.
• There may be multiple plaintiffs or defendants.

Standing

• The plaintiff must prove standing, showing they were directly injured and have a legally protectable interest.
• Exceptions include a parent suing for an injured child or a guardian for their ward.

Statutes of Limitations

• Cases must be brought within a certain timeframe, as defined by statutes of limitations.
• In Florida, the statute of limitations for medical malpractice (including pharmacy malpractice) is generally two years from the injury date, but may be two years from when the injury became manifest.

Filing a Complaint and Summons

• A complaint must be submitted, including all material facts and the requested remedy.
• The amount of damages being requested must be stated.
• The court issues a summons to the defendant, notifying them of the lawsuit.

Filing an Answer

• The defendant must file an answer admitting or denying the plaintiff's allegations.
• Failure to answer results in a default judgment for the plaintiff.

Discovery

• Most cases settle before trial.
• Discovery is the process of exchanging all known facts and evidence between both sides.
• Witness lists must be submitted.

Depositions

• Witnesses are deposed under oath, answering questions from both sides' attorneys.
• Depositions reveal facts and help assess the strengths/weaknesses of the case, forming the basis for settlement negotiations.
• Depositions are out-of-court testimonies by witnesses.

Jury Selection (Voir Dire)

• Lawyers select a jury from the jury pool during voir dire.
• Potential jurors are questioned and may be eliminated if biased.
• Each side gets three peremptory rejections and additional rejections "for cause" (requiring judge approval).

Role of the Jury and Judge

• The jury determines questions of fact, not the law.
• The judge decides questions of law and whether evidence is admissible.
• The judge instructs the jury on the law and how to apply it.
• The jury then delivers a verdict.

Witnesses and Subpoenas

• Witnesses may be subject to a subpoena (court order to appear), with failure to appear resulting in contempt of court.
• Expert witnesses are called when the subject matter is beyond jurors' scope of knowledge.
• Plaintiff experts argue the standard of care was not met, while defense experts argue it was.

Motions

• Motion for summary judgment: Filed before trial, arguing that there is NO case because no law was violated, even if facts are agreed upon. Either side can file.
• Motion for a directed verdict: Filed after the plaintiff's case, arguing that the plaintiff failed to prove their case and no reasonable jury could rule in their favor.

Objections

• Objections are based on irrelevance, immateriality, prejudice, or hearsay.
• Objections must be made at the time of the event to preserve the right to appeal on that basis.

Jury Instructions and Verdict

• The judge instructs the jury on the applicable law, and the jury then deliberates and reaches a verdict.

Judgment Notwithstanding the Verdict (JNOV)

• Judges rarely overrule a jury's decision, only doing so if the verdict was clearly based on bias or disregard of evidence.

Mistrial

• A mistrial can be granted for major errors or violations of law.
• The case can usually be retried.

Appeals

• Either party can appeal the final verdict based on errors of law.
• Appeals are not based on the jury's determination of facts.
• Appellate courts review the judge's legal rulings and jury instructions, potentially sending the case back for retrial.
• Appeals are based on challenges to what the judge did regarding the law, not the facts.
• Attorneys submit briefs to the appellate court.
• Oral arguments clarify points, but decisions are mainly based on written briefs.

Criminal Court Procedures

• A defendant can be indicted or arrested.
• Indictments are issued by a grand jury if sufficient evidence exists for a trial.
• A grand jury does not decide guilt or innocence.
• At the preliminary hearing, the judge must determine if there is enough probable cause for the arrest.
• The defendant enters a plea of guilty, not guilty, or nolo contendere at the preliminary arraignment.
• A plea bargain may be agreed upon.
• The burden of proof is beyond a reasonable doubt (like 99%).
• The standard is so high because it's preferred to let a guilty person go free than to convict an innocent person.

Case Citations

• Case citations provide information on how to find a specific court case.
• Example: Brown v. Board of Education, 347 U.S. 483 (1954).
  • Brown v. Board of Education = The name of the case, with Brown being the plaintiff.
  • 347: The volume number of the reporter.
  • U.S.: Indicates it's a reporter of US Federal cases.
  • 483: The page number where the case begins.
  • (1954): The year the case was decided.
• Citations reveal where to find the case and who was involved.

Federal Versus State Law

• The Supremacy Clause of the US Constitution states that federal law preempts state law when they conflict.
• Conflicts arise when state law is less strict (less protective of rights or less harsh on crime) than federal law.
• Stricter state laws do not conflict with federal law; the stricter law applies.
• Federal law to regulate drugs generally comes from the Interstate Commerce Clause.
• State authority to regulate generally derives from the 10th Amendment.
• State laws must bear a reasonable relationship to the public health, safety, and welfare (within the state's police powers).