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Sam, Attorney at Law
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How can I argument a valididity of an administrative law by

Resolved Question:

How can I argument a valididity of an administrative law by the fda?
Submitted: 6 years ago.
Category: Legal
Expert:  Sam replied 6 years ago.



Please elaborate somewhat? What are the circumstances; which law are you referring to?

Customer: replied 6 years ago.

I got that one I just need your help regarding some other questions. I will pay you what you want just verify my answers please.

Expert:  Sam replied 6 years ago.



Alright. Please post it here and I will see what I can do

Customer: replied 6 years ago.

This is the question

TCO E and H. A private high school hires a new Superintendent, George Forester. The school is owned by a local Lutheran Church and is run by a board of directors chosen by church members. Supt. Forester shows up for his first day of work, and sends a memo via intercompany mail to all teachers:

Dear Staff:

There is a new Sheriff in town - and it is me. As your new leader, I am implementing a dress code that includes no slacks or shorts for women and no earrings for male teachers. Men shall all be clean shaven. Violators will be docked one week's pay; 2nd offenses will result in a one week suspension without pay and 3rd offenses, dismissal. All teachers will address me as "Pastor Forester" or "Amen, Pastor Forester." Teachers who fail to abide by these dictates will be docked two points on their annual evaluations. Amen, Pastor Forester."

That day, one teacher, Anna Seenandfeld had a birthday party at the school, having just turned 40. Her frown at the party showed everyone she was not happy about her party. Pastor Forestor had bought black balloons for her and joked with the other teachers about the "over the hill" teacher. The next day, Pastor Forester goes into the teacher's lounge and calls all non-tenured teachers into his office. He tells them that he has assigned himself to be their mentoring teacher and that effectively immediately they will be evaluated weekly. One teacher, Anna Seenandfelt, begins to cry. Another teacher, Andy DuFrane, rolls his eyes and says, "God! These menopausal women should not be allowed around our students." Pastor Forester goes to Anna and hugs her, offering her a tissue. He pats her gently on the behind and whispers, "Act your age, please." When she pulls forcefully away from him, Pastor Forester assigns her to work Saturday detention for the next three weeks to "toughen her up."

A pregnant P.E. teacher, Lisa Ready, is reassigned by Pastor Forester to a math position (even though she has only three credits in math) because Pastor Forester says this position is "less strenuous for a pregnant lady."

On the 3rd week of detention duty, a student stabs Anna, wounding her severely. Although she survives and recovers, she loses one kidney as a result of the injury. The school doesn't offer health insurance, and Anna incurs over $55,000 for her hospital bills; the student (and his family) is insolvent.

One month later, a parent complains about his student being unable to succeed in his math course due to the teacher's (Lisa's) incompetence, Pastor Forester fires Lisa Ready for her inability to perform her job. Pastor Forester tells Lisa in front of her class of students, and then walks her out of the building; 2 hours later, Lisa goes into premature labor and delivers her first son, who has severe health issues as a result of being premature. The baby's doctor states the cause of early labor as being from "intense duress and undue stress." Lisa's husband's health insurance covers all of the costs of the birth and the baby's care.

Pastor Forester is really not a Pastor. His real name isXXXXX who is a parolee with convictions for child molestation. His parole agreement prohibits him being closer than 1000 feet to any school. In order to cut costs, the school had stopped doing background checks on new employees, and this slipped through the cracks. This comes to the attention of the school board, and the President of the Board of Directors immediately fires Pastor "XXXXX XXXXXes" Forester and notifies his parole officer of the violations. Pastor Forester claims the board knew about his background, because one member of the board (his aunt Theresa) knew the truth.


Time Remaining:

TCO E. Pastor Forester claims his firing was illegal because it was based on his being a convicted felon. His contract with the school provides him with defense coverage for any acts he takes while working for the school. Anna and Lisa sue Pastor Forester and the school for sexual harassment and discrimination and Pastor Forester requests the school pay for his defense. Discuss whether Anna and Lisa will be successful in their claim of sexual harassment and discrimination against the school and Pastor Forester. Discuss whether the school illegally fired Pastor Forester. Will the school have to pay for the Pastor's defense? Analyze and defend your answer.

This is my answer


From the examination of facts, Pastor Forrester has committed illegal and discriminatory acts these acts can bring liability to school. The school can be held liable for the acts of Pastor Forrester and may have to pay damages.
Pastor Forrester has committed illegal and discriminatory practices when he addressed Anna Seenandfeld as "over the hill" teacher. He created such an atmosphere in the school that Andy DuFrane called her "God! These menopausal women should not be allowed around our students". Title VII has described "hostile environment" and this was created on the basis of age for Anna.
Further, Pastor Forrester was required to treat a pregnant lady Lisa Ready in the same way as he would treat temporary illness. Instead of assigning light work to her, he assigned especially hard and dangerous work to her. This is Pregnancy Based Discrimination under Title VII.
Under the common law the school can be held liable for damages for pain and suffering inflicted on both the victims. The school can be held liable for medical expenses, future economic loss, past and future domestic care. In case of Lisa Ready, the school will be liable to her for her son's medical and other expenses because of premature delivery. From the perspective of labor laws, the school will be liable under the Work Injury Compensation ACT.
The defenses available to the school are that the board did not know of the antecedents of Pastor Forrester and that the school is a religious private school. The plea that the school did not carry out a background check will not hold in the court of law. And to get protection as a religious school, the school must establish that Anna and Lisa were performing religious duties. This defense will not stand as both Anna and Lisa will be able to establish that they were performing secular duties.



SEcond question


TCO H and E. In the discovery portion of the case, it is determined that Pastor Forester is really not a Pastor. His real name isXXXXX who is a parolee with convictions for child molestation. His parole agreement prohibits him being closer than 1000 feet to any school. In order to cut costs, the school had stopped doing background checks on new employees, and this slipped through the cracks. The President of the Board of Directors immediately fires Pastor "XXXXX XXXXXes" Forester and notifies his parole officer of the violations. Pastor Forester claims the board knew about his background, because one member of the board (his aunt Theresa) knew the truth. He claims her knowledge should be imputed to the entire board of directors. He then sues the school for firing him for being a convicted felon. He claims that is illegal, and he publicly attacks the church for their "less than Christian" behavior in firing him.

The board immediately convenes to discuss "damage control." They know you took a Law and Ethics course recently and ask you to write a news release to the local newspaper, explaining the situation. Using ethical and legal considerations (including the fact you are in the middle of multiple lawsuits), write the brief news release. Then, explain why you wrote it the way you did.


My answer

I regret to inform you that the appointment of Pastor Forrester was a fraud on the school. He was an imposter. Unethical and fraudulent means had been used by him to secure appointment.

The appointment of Pastor Forrester as the superintendent of the school had been done by deception. He had presented himself as Pastor Forrester, even though his real name was XXXXX XXXXXes. He was a parolee with convictions for child molestation. His parolee agreement disallowed him from being closer than 1000 feet to any school. He never disclosed his real name or his status as a parolee to the school and instead impersonated as a pastor. His was not an act of good character and the consequences of his continuing in the school could have been disastrous to both the school and the children who study here. Fortunately, his background came to the light of the board and he was immediately dismissed from service. In addition, the board is initiating legal actions against XXXXX XXXXXes and will seek justice in the court of law. Pastor Forrester is wrongly claiming that the board knew of his antecedents because one member Theresa was his aunt knew him and his background. The fact is that the member, Theresa, never disclosed this information during any board meeting.

Please be reassured that Pastor Forrester has been removed from the post of superintendent and your children are safe at school.



My sources - - › Programs › Legal Legislative Serv




Please help I don`t have a lot of time left

Expert:  Sam replied 6 years ago.



Excellent. You hit it all and articulated it excellent.


Customer: replied 6 years ago.

Please look at the 3rd question its not answered yet

1. TCO D Short Answer Question and Facts for Page 1 Questions:

A well known pharmaceutical company, Robins & Robins, is working through a public scandal. Three popular medications that they sell over the counter have been determined to be tainted with small particles of plastic explosive. The plastic explosives came from a Robins & Robins supplier named Casings, Inc., that supplies the capsule casings for the medication pills. Casings, Inc., also sells shell casings for ammunition. Over $8 million in inventory is impacted. The inventory is located throughout the Western United States, and it is possible that it has also made its way into parts of Canada.

Last fall, the FDA had promulgated an administrative proposed rule that would have required all pharmaceutical companies that sold over-the-counter medications to incorporate a special tracking bar code (i.e., UPC bars) on their packaging to ensure that recalls could be done with very little trouble. The bar codes cost about 35 cents per package.

Robins & Robins lobbied hard against this rule and managed to get it stopped in the public comments period. They utilized multiple arguments, including the cost (which would be passed on to consumers). They also raised "privacy" concerns, which they discussed simply to get public interest groups upset. (One of the drugs impacted is used for assisting with alcoholism treatment - specifically for withdrawal symptoms - and many alcoholics were afraid their use of the drug could be tracked back to them.) Robins & Robins argued that people would be concerned about purchasing the medication with a tracking mechanism included with the packaging and managed to get enough public interest groups against the rule. The FDA decided not to impose the rule.

Robins & Robins' contract with Casings, Inc., states, in section 14 B.2.a., "The remedy for defects in supplies shall be limited to the cost of the parts supplied." Casings, Inc., had negotiated that clause into the contract after a lawsuit from a person who was shot by a gun resulted in a partial judgment against Casings for contributory negligence.

List any bases Robins & Robins could sue Casings, Inc., under contract theory ONLY for the damages caused by the explosives in their drugs, over and above the cost of the capsule shells. (short answer question)


My answer

A contract is a legally enforceable agreement between two or more parties with mutual obligations. The remedy at law for breach of contract is "damages" or monetary compensation. In equity, the remedy can be specific performance of the contract or an injunction. Both remedies award the damaged party the "benefit of the bargain" or expectation damages, which are greater than mere reliance damages, as in promissory estoppels.

We have the fact that when Robins & Robins' contracted with Casings, Inc., They made sure to state in the section 14 B 2a that "The remedy for defects in supplies shall be limited to the cost of the parts supplied."
Vitiating factors constituting defenses to purported contract formation include:
Unconscionability and duress. The fact that Casting products are damaged makes the contract's lopsidedness unconscionable. Robins has a right to mitigate his damages, , if for no other reason. The price increase in the value of the clams is immaterial to the case, mistake;
Also we can consider.
undue influence;
misrepresentation/fraud; and
frustration of purpose.



question 2

. TCO B. The FDA discovers that, during the public comment process, Robins & Robins bribed one of the members of the administrative panel that decided to pull the rule from consideration. The member of the panel was removed and is being charged criminally. As a result, the FDA immediately implements an emergency order that puts into effect the "tracking bar" requirement and makes the rule retroactive, but only to Robins & Robins. Provide two arguments Robins & Robins can make to have the rule determined to be invalid under the Administrative Procedures Act. Explain your answer. (Points: 30)

The validity of any rule may be determined upon petition for a declaratory judgment addressed to the Court when it is alleged that the rule, or its threatened application, interferes with or impairs or immediately threatens to interfere with or impair, the legal rights or privileges of the petitioner. The FDA shall be made a party to the proceeding; provided, that the court shall not have jurisdiction to hear any such petition for declaratory judgment, and no declaratory judgment may be rendered, unless the petitioner has first requested in writing that the sponsoring department pass upon the validity of the rule in question. Upon its receipt of any such petition the sponsoring department may elect to take no action other than to immediately refer the matter to the appropriate administrative appellate body with jurisdiction over the matter in question and request that such administrative appellate body respond to the petition on the department's behalf. In such a case, the administrative appellate body shall first determine whether it has jurisdiction over the referred matter and if so finding the administrative appellate body shall then pass upon the validity of the rule in question.
Robins can also argument the invalidity and have the regulation declared invalid and overturned would be if additional research were performed that presented a challenge or proved that there were flaws in the original research and results.
1/-The first ground on which to challenge an agency rule is that it is arbitrary, capricious, and abuse of discretion, or in violation of some other laws. This standard is generally applied to informal rulemaking and simply requires the agency to show evidence to support the proposed rule. Without such evidence, the rule can be held arbitrary and capricious.
2/-A second theory for challenging an agency`s regulation is that the regulation is unsupported by substantial evidence. This substantial evidence test is applied in the review of formal and hybrid rulemaking. Where the arbitrary and capricious standard simply requires some proof or basis for the regulation, substantial evidence requires that more convincing evidence exist in support of the regulation than against it.
3/- A third ground on which to challenge an agency`s regulation involves the rule that a regulation can beset aside if the agency did not apply with the APA requirements of notice, publication, and public comment or input. The procedures for rule making must be followed in order for the regulatory process and resulting rules to be valid. An agency that seeks public comment for the purpose of drafting legislation cannot then turn the legislation into rules after the comment period.
4/-Another basis for challenging a regulation is that the regulation is unconstitutional. Many challenges based on constitutional grounds deal with regulations that give an agency to search records or that impose discriminatory requirements for licensed professionals.
5/-Another theory for the challenging a regulation in court is ultra vires, a Latin meaning" Beyond it`s powers" An ultra vires regulation is one that goes beyond the authority given to the agency in its enabling act. Although most agencies stay clearly within their authority, if an agency tries to change the substance and purpose of the enabling through regulation, the regulations would be ultra vires.


3rd question

3. TCO C. Robins & Robins immediately issued a massive recall for the tainted medication upon learning of the situation. Despite the recall, 1,400 children and 350 adults have been hospitalized after becoming very ill upon taking the tainted medication. Each of them had failed to note the recall after having already purchased the medication. It is quickly determined that they will need liver transplants and many of them are on a waiting list. During the wait, to date, 12 children have died. Their families are considering suing for both 402A and negligence. The attorneys stated that but for the lobbying efforts, the recall process would have been automated and the people would not have gotten sick or died.

You are the attorney for one of the dead children's family. List the causes of action (if any) you would file against Robins & Robins, the FDA, and the bribed FDA member. List the elements of the causes of action, and set forth the facts that you have that would support a lawsuit against each of the three named defendants. State any defenses any of the three would have. Analyze the success of the defenses



I don`t know how to answer it

Expert:  Sam replied 6 years ago.




You will be suing for product liability, defective drugs and wrongful death.


Not even FDA approval relieves a company of its responsibility to the consumer, nor does it protect the company from liability



Sam and 5 other Legal Specialists are ready to help you
Customer: replied 6 years ago.
How about the other answers?