Read the following passage and analyze the facts in the contexts of IRAC and IDDR (see the referential outline for consideration that follows the passage 


Tinkerbelle Lily was thirteen years old when a practicing psychiatrist prescribed, Terasperndoz, a pharmaceutical drug characterized as an atypical antipsychotic, during her stay at an inpatient unit at Advez psychiatric institution to which she was confined, reportedly for treatment of disordered eating. Her disposition was then, as usual, relatively calm and quiet. She was a kind individual whom was organized and methodical in her habits and whom loved to learn. At the time that Tinkerbelle was admitted to the facility, she did not meet the diagnostic criteria for an eating disorder, unless it was the case that she met the criteria for a neurodevelopment disorder. Reportedly, no physician, at least prior to admission, informed Tinkerbelles mother of any information in relation to a suspected neurodevelopment disorder and while Tinkerbelle displayed what was relatively idiosyncratic behavior at times (e.g., lining items up, intolerance for changes in routine, and difficulty with social interaction and communicative skills), she was often thought to display signs of high intellect and excelled at sciences, math and music and historically performed notably well in these areas in academic settings and at extracurricular events.

Prior to admission to Advex, Tinkerbelle Lillys mother was seeking support from healthcare professionals. Tinkerbelles father was deceased since Tinkerbelle was about 8 years old and Tinkerbelle Lilly showed relative signs of depression. A community case worker and a pediatrician suggested inpatient psychiatric care due to the disordered eating and depression. The mother was amenable to the inpatient treatment for counseling services though expressed to Advez that she did not consent to the use of psychotropic medicative therapy.

     

Prior to the hospitalization, Tinkerbelle Lilly had been Subsequent to the administering of Terasperndotz, Tinkerbelle Lily immediately and rapidly gained over a 20% increase in body weight and BMI and developed signs and symptoms of fluctuating mood and emotionality, neurocognitive decline and a notable deterioration of physical condition (e.g., loss of muscle tone and motor skills), all of which were downplayed by the assigned healthcare professionals whom comprised a collective care team and advocates of the treatment protocol. To the contrary, the signs were expressly attributed to the worsening of and additional/other signs of disorder to the realized effects of continuation of an eating disorder and which then justified the ongoing treatment regime. Tinkerbelle Lilly developed a major depressive disorder and, resultantly, the dosage of Terasperndotz was increased in combination with another similar medication of its class.

Throughout a 5 year period, Tinkerbelle Lilly was routinely placed in intensive outpatient hospital programs and was often re-admitted for inpatient treatment. Throughout the same 5 year period, Tinkerbelle Lilly had experienced numerous fainting episodes, both at school and home. Tinkerbelle Lilly rarely attended classes and could no longer consistently see to read or interpret school related assignments. For years, even when she attended school, she was often excused from class to in-school and/or out-of-school suspension and bullying and mockery in the academic setting. She did have some very good friends and advocates during this time, however. During the fourth year of treatments, however, Tinkerbelle Lilly encountered a significant collapse, during an inpatient stay at a Forensic Psychiatric Hospital, and sustained a traumatic brain injury due to the excessive amount of antipsychotic medication that had been administered and the physical impact to her head. Within the 3 days following the collapse, Tinkerbelle Lilly displayed signs of disorientation, mild outbursts, and vomiting. The signs were seemingly misattributed to psychiatric disorder, including the vomiting as a sign of bulimia despite the fact that no food was consumed prior to episodes of vomiting.

It was later determined by a nearby healthcare facility that Tinkerbelle Lilly had suffered a brain injury and was exhibiting signs of a physical brain injury. Terasperndotz is contraindicated in persons whom have a traumatic brain injury as it can worsen a condition and cause numerous adverse effects including progressive brain dysfunction and death.

Sometime after the TBI episode, it was discovered that Tinkerbelle Lily had been treated for a major concussion at the age of 7 following an accident at a school playground. At the age of 5, Lilly had undergone surgery during which she experienced major complications including vomiting of blood. It was known that Tinkerbelle Lilly was a very picky eater and often fought to get up from the table prior to finishing meals. She was usually amenable to popsicles and sherbet, though otherwise disliked the smell and texture of most food. Tinkerbelle Lilly often had notable GI troubles following consumption of meals.

Sometime after 2001, Tinkerbelle Lilly was admitted to a medical facility following serious injuries and a brief death from which she was resuscitated. She had sustained major fractures and was treated with implantation of medical devices and equipment. She has since spent numerous years working to recover from a lifetime of a very confusing and traumatic lifestyle. During this time, it was discovered that Tinkerbelle Lilly may have in fact had an underlying condition often characterized as a neurodevelopment disorder and that Terasperndoz was not FDA approved as a treatment for disordered eating or other conditions associated with neurodevelopmental disorders. Terasperndoz had only been FDA approved for psychiatric disorders with specified characteristics such as psychiatric conditions accompanied with clinical psychosis. That said, it was also discovered 10 years thereafter that the timeframe of Tinkerbelle Lillys course of treatment was squarely aligned with the Pharmaceutical Companys, D.V. Aspredop, Inc., application for approval from the FDA for the treatment of specified conditions in relation to neurodevelopment disorders and the corresponding clinical studies. A limited approval was issued by the FDA.

Tinkerbelle Lilly aspired to work in a worldly multinational teaching hospital and has since continued that pathway. Her journey has been met with numerous frustrations due to medical impairments and complications that are significantly costly on all accounts. She successfully completed graduate school from a prestigious university though experiences significant inconsistence with abilities that result in significant employment and relationship challenges. Resultantly, she has experienced much difficulty affording the cost of living and currently has a multi-million dollar debt assigned to her name in relation to. Due to a domino effect of financial troubles and resultantly lack of sustainable housing, she was subject again to compulsory treatment despite repeated express refusal of the specified treatment. She was routinely bullied and mocked by healthcare ambulatory workers and other local professionals in safety and/or healthcare. She was grossly medicated against her will and held in locked facilities for a collective period of over 6 months. She was not allowed to go outside during her hospital stays and was most usually confined to 1:1 in a room with an assigned monitor. She has explained that she often cannot establish a reasonably foreseeable future as she faces complications that are in relation to. She currently works as a consultant in clinical and institutional healthcare in an effort to promote social responsibility, including safe and humane medical and research methodologies and practices.

A major health insurance company has sought the advice from professional student opinions in an effort to receive uncompromised or conflicting opinions given the broad scope of implications. A legal consultant has been retained in response to a committee that was formed in relation to the aforementioned facts as it has been deemed a matter of concern with regard to reform efforts in an ongoing effort to ensure integrity in clinical sciences. The team is seeking a comprehensive draft report in relation to respective legal and business implications with regard to the implications of various stakeholders. 

Please provide a written draft of the identified legal and ethical implications in relation to the scope of Business Law I considerations. Please include an analysis of the facts in the context of Torts both intentional and unintentional negligence

  • i.)  Primary: Tinkerbelle Lilly, Tinkerbelle Lillys parent, Tinkerbelle Lillys pediatrician or case worker, Advez Psychiatric Institute, Forensic Psychiatric Hospital Manufacturer of Terasperndoz,

  • ii.)  Secondary: Distributors including intermediaries of Terasperndoz, FDA, Tinkerbelles Healthcare Insurance Company, Tinkerbelles care teams malpractice insurance company, municipalities and municipal organizations,

  • iii.)  Other: Related communities and future states of respective communities, related friends and family, related professional and/or other relative organizations and trustees of organizations in light of professional responsibilities, places of employment and co-workers.

Referential Outline for Consideration1:

iv.) Legal Implications (IRAC) – retrospective/prospective implications

  • Actionable Torts Negligence 

    1. Liability what /whom
      1. What are the elements of legal actions and how do the facts
      relate
      2. ANALYSIS: What are the legal issues (claims), applicable
      rules, analysis, and conclusion as to liability of a particular
      claim?

Legal and/or Equitable Remedies
1. Civil liability with awarded damages and/or exemplary fees
2. Injunction action that orders equitable estoppel?


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