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Wednesday, January 29, 2020
The L-Tryptophan Recall Essay Example for Free
The L-Tryptophan Recall Essay What L-Tryptophan is? Amino acids are naturally occurring component of human body. They provide the monomer units from which large proteins are synthesized. Amino acids are described as the nitrogen-containing organic compounds forming the building blocks of proteins. â€Å"They are essential to human metabolism, and to making the human body function properly for good health†. (http://www.findarticles.com/p/articles/mi_g2603/is_0001/ai_2603000153)  Amino acids are classified as essential and non-essential amino acids. Essential amino acids are those which are required to be included in the diet as body is not capable of synthesizing it. â€Å"Of the 28 amino acids known to exist, eight of them are considered essential, defined as those that can be obtained only through food. These essential amino acids are tryptophan, lysine, methionine, phenylalaine, threonine, valine, leucine, and isoleucine. The non-essential amino acids include arginine, tyrosine, glycine, serine, glutmamic acid, aspartic acid, taurine, cycstine, histidine, proline, alanine, and creatine, which is a combination of arginine, glycine, and methionine.†(http://www.findarticles.com/p/search?qt=tryptophanqf=allqta=1tb=artx=0y=0) Tryptophan (L-Tryptophan) is one of the essential amino acid encoded by the genetic code as codon UG. Tryptophan is found in protein rich foods. Its sources includes â€Å"oats, bananas, dried dates, milk, yoghurt, cottage cheese, red meat, eggs, fish, poultry, sesame, chickpeas, sunflower seeds, pumpkin seeds, spirulina peanuts and turkey†. (http://en.wikipedia.org/wiki/Tryptophan) Tryptophan (L-Tryptophan) is used for treating Depression, Anxiety, Insomnia, Aggression, Pain and many other neurological disorders. It is helpful for neurological disorders because tryptophan is a precursor of serotonin. Serotonin is a neurotransmitters used at almost all nerve endings present in our body.            The metabolite of tryptophan, 5-HTP can be obtained in capsule or tablet form from any pharmacist without a prescription since it was included under the Dietary Supplement Act. What Products Contain It and What Their Uses Are? As already mentioned, L-Tryptophan is a precursor of serotonin. Serotonin works in the body as an anti-depressant, pain and anxiety suppressor, or a sleep inducer. Therefore,  L-Tryptophan is found in many anti-depressant drugs such as Paxil and Zolof and even Prozac and thus when taken, produces serotonin. Other pharmaceutical products containing L-Tryptophan includes names like Xanax, Valium, Halcion, Dalmane, Codeine, Anafranil. Xanax, or alprazolam, also belongs to the class of drugs benzodiazepines. Xanax is used to treat anxiety. It acts on the brain chemicals which causes anxiety. It should not be taken by pregnant or lactating women without prescription due to its harmful effects. Xanax can cause serious birth defects. Xanax overdose is fatal and should contact your doctor immediately. Halcion also belongs to the benzodiazepine class of drugs. Triazolam, the generic name for Halcion, is used for treating short-term insomnia. Dalmane, generic name Flurazepam hydrochloride, is used for treating insomnia. Insomnia is defined as difficulty in falling asleep or waking up frequently at night. Dalmane is usually used by people who have frequent insomnia or who have poor sleeping habits. It belongs to a class of drugs known as benzodiazepines. It is a prescription drug and taken as prescribed by your doctor. Side effects include dizziness, drowsiness, falling, lack of muscular coordination, light-headedness, staggering. The side effects increases if it is combined with the following:- â€Å"Antidepressants such as Elavil and Tofranil Antihistamines such as Benadryl and Tavist Antipsychotic drugs such as Mellaril and chlorpromazine Barbiturates such as Seconal and phenobarbital Narcotic painkillers such as Demerol and Tylenol with Codeine Sedatives such as Xanax and Halcion Tranquilizers such as Librium and Valium†(http://www.pdrhealth.com/drug_info/rxdrugprofiles/drugs/dal1113.shtml) Clomipramine, (brand name: Anafranil), is an anti-depressant used in treatment of depression and obsessive-compulsive disorder (OCD). It effects the serotonergic neuronal transmission by an unknown mechanism. Clomipramine should be avoided after myocardial infarction, liver damage, kidney damage, or glaucoma. The most noteworthy side effect of clomipramine known is seizures. Codeine is more commonly known as Empirin, Tylenol or Tylenol with Codeine Elixir. Codeine is an analgesic drug (narcotic pain reliever). It is used to treat all kinds of pain. â€Å"Codeine is frequently combined with Tylenol or aspirin for more effective pain relief.. EMPIRIN contains aspirin and is, therefore, not used in patients with a history of aspirin allergy†¦Ã¢â‚¬ ¦Tylenol with Codeine tablets contain a sulfite that can cause allergic asthma and even life-threatening anaphylaxis reactions in susceptible patients.† http://www.medicinenet.com/codeine/article.htm Other side effects are usually subtle including abdominal pain, constipation nausea, vomiting and sedation. Tryptophan was banned in the United States due to the endemic outbreak Eosinophilia- Myalgia Syndrome (EMS). â€Å"The ban is maintained till now and its availability is limited to the prescription drug (Tryptan), infant formulas, and enteral feeding products. Since 1994 tryptophan is available and marketed as a dietary supplement in the United States, while imported product remains limited by special regulations†. http://findarticles.com/p/articles/mi_m0FDN/is_1_11/ai_n16126569 EMS (The Disease Caused By These Products) L-tryptophan is popular among health conscious individuals for treating pain disorders and insomnia. Contrary to its popularity, tryptophan metabolism includes a lot of disorders. Some of the diseases/complications involved in tryptophan metabolism include Eosinophilia- Myalgia Syndrome (EMS), Pellagra, and Hartnup Disease, eosinophilic fasciitis, bronchiolitis obliterans with organizing pneumonia (BOOP), acute eosinophilic pulmonary disease, and Hypercapnic respiratory. â€Å"The name pellagra comes from the Italian pelle, skin + agra, rough = rough skin, referring to the skin problems in pellagra†. http://www.medicinenet.com/script/main/art.asp?articlekey=10366page=7 Pellagra is defined by a deficiency of niacin (B complex vitamin) or tryptophan (an amino acid). It is characterized by the 4 D’s: diarrhea, dermatitis, dementia, and death, usually appearing in this order. Other features are ulcerations within the mouth (glossitis), nausea, vomiting, seizures and balance disorder (ataxia). Niacin can prevent pellagra (and can cure it). Niacin is abundant in red meat, fish, poultry, and green leafy vegetables. Hartnup disease occurs when the essential amino acids such as, tryptophan, alanine, asparagine, glutamine, histidine, isoleucine, leucine, phenylalanine, serine, threonine, tyrosine and valine, are lost in the urine. â€Å"The clinical features of Hartnup disease are virtually identical to those of pellagra,†except the dermal findings are absent neuropsychiatric disturbances are more pronounced. â€Å"Cerebellar ataxia, psychiatric disturbances, and diarrhea are common†. (http://www.medstudents.com.br/nefro/nefro3.htm) Eosinophilic fasciitis is a syndrome effecting fascia. Fascia is a muscle tissue present underneath the skin. Fascia is inflamed and thickens. Rapid swelling occurs in the hands, arms, legs, and feet. The cause of eosinophilic fasciitis,however, is unknown. Eosinophils, a type of white blood cell, increases in the affected fascia and muscles. Eosinophils are associated with allergic-type reactions. Symptoms include tenderness and swelling of the arms and legs, thickened skin, muscle weakness and bone pain or tenderness. It is usually treated wit corticosteroid medications, which provides relief of the symptoms. Non-steroids anti-inflammatory (NSAIDs) may also help. â€Å"Bronchiolitis obliterans with organizing pneumonia (BOOP) is an inflammation of the bronchioles and surrounding tissue in the lungs. BOOP may affect small areas of the lungs or the entire lung†. The pneumonia isnt infectious, but it is due to inflammation of the lung tissue around the inflamed bronchioles. The causes of BOOP are still unknown but it is predicted that is caused by certain medications, radiation therapy, organ and tissue transplantation or some connective tissue disorders, such as lupus. â€Å"Chest radiographic findings [are also] suggestive of L-tryptophan.† â€Å"People with BOOP may or may not experience signs and symptoms. However, it can be detected on chest x-rays†. (http://lungdiseases.about.com/od/termsdefinitions/f/what_is_boop.htm) and (http://www.findarticles.com/p/articles/mi_m0984/is_n6_v104/ai_14707382) â€Å"A cluster of four patients has been identified with pulmonary infiltrates, pleural effusions, hypoxemia, peripheral eosinophilia, and histologic evidence of pneumonitis and pulmonary vasculitis. In addition, these patients report ingestion of L-tryptophan-containing products at a time when the public was made aware of an association between the ingestion of L-tryptophan-containing products and the development of an eosinophilia-myalgia syndrome.†(http://www.findarticles.com/p/articles/mi_m0984/is_n1_v99/ai_10489355) â€Å"Respiratory failure due to a disease of the muscles used for breathing (pump or ventilatory apparatus failure) is called hypercapnic respiratory failure. The lungs of these patients are normal. This type of respiratory failure occurs in patients with neuromuscular diseases such as myasthenia gravis, stroke, cerebral palsy, poliomyelitis, amyotrophic lateral sclerosis, muscular dystrophy, postoperative situations limiting ability to take deep breaths, and in depressant drug overdoses. Each of these disorders involves a loss or decrease in neuromuscular function, inefficient breathing and limitation to the flow of air into the lungs. Blood oxygen falls and the carbon dioxide increases because fresh air is not brought into the alveoli in needed amounts. In general, mechanical devices that help move the chest wall help these patients.†(http://www.healthnewsflash.com/conditions/respiratory_failure.php#6) â€Å"Pellagra is now rare in developed countries which enjoy balanced diets and fortified foods, but it was once a huge public health problem in the US. Three million Americans contracted pellagra and 100,000 died of it from 1906-40.†(http://www.medterms.com/script/main/art.asp?articlekey=4821) The most well-known disease of L-Tryptophan metabolism is of the Eosinophilia- Myalgia Syndrome (EMS). â€Å"Eosinophilia Myalgia Syndrome is an immune mediated disease that appeared in the United States as an epidemic in 1989. EMS resulted from ingestion of large amount of an amino acid, L-Tryptophan. Eosinophilia is an elevated level of a type of white blood cell called an eosinophil. Myalgia refers to muscle pain. Many Americans ingested the supplement regularly or occasionally during the 1980s, often upon the advice of a physician, for medical problems including insomnia, chronic pain, and depression†. http://eosinophilia-myalgia.swiftsite.com/) The overwhelming majority of persons who got sick with EMS had ingested contaminated L-Tryptophan eventually traced to one large petrochemical company, Showa Denko K.K., of Japan. Bottle labeling did not indicate the raw product originated in Japan, and nobody in this country, it seems, was told that genetic engineering had been used to manufacture the L-Tryptophan. â€Å"Evidence also shows that overloads of tryptophan supplements inhibit histamine degradation by increased formation of formate and indolyl metabolites, several of which inhibit the degradation of histamine, thereby potentiating its effects. Excessive histamine activity is known to induce blood eosinophilia and myalgia. Furthermore, patients with hypothalamic-pituitary-adrenal axis dysregulation who do not have EMS also manifest greatly increased sensitivity to incurred tryptophan and histamine. Histamine disequilibrium appears to be a final common pathway for syndromes characterized by eosinophilia with myalgia.†(http://www.emedicine.com/med/topic693.htm) EMS is characterized by flu-like symptoms. â€Å"Intense muscle pain with spasms and contractures, burning rashes, breathing difficulties and elevated eosinophil (a type of white blood cell) count are also present†. http://www.iffgd.org/GIDisorders/Other.html â€Å"The skin and other organs get infiltrated by inflammatory cells, including eosinophils, and the connective tissue is often inflamed and fibrotic. Other chronic features include neuromuscular disease and cardiac disease†. http://www5.geometry.net/detail/health_conditions/eosinophilia_page_no_5.html It â€Å"causes permanent scarring and fibrosis to nerve and muscle tissues, continuing inflammation, and provokes a permanent change in the bodys immune system.†The body systems affected by EMS includes â€Å"neuromuscular, cardiopulmonary, gastrointestinal, dermatologic and endocrine systems.†Over time, the cutaneous abnormalities tend to improve, but many EMS patients continue to experience muscle cramps, muscle pain, fatigue, and memory disturbances. There is, unfortunately, no cure for EMS. Research is being conducted to develop an animal model of EMS so that its pathophysiology can be studied and treatments can be developed. Actual Recall and What Happened When It Was Issued Eosinophilia Myalgia Syndrome appeared first in 1989 in Mexico. Three women were suffering from a mysterious, undiagnosable condition whose symptoms comprised of â€Å"muscle pain and a high Eosinophilia count (a type of white blood cell that is usually found when a toxin or parasitic infection is present). The one thing common among all of the women was L-tryptophan†. The product came from Showa Denko Inc, a Japanese company. Showa Denko Inc was reducing their manufacturing cost compromising in its purification procedures and quickens the production process through genetically engineered bacteria. Consequently, contaminated batches of L-tryptophan were placed on the market. Within months, 37 people killed and over 1500 were permanently disabled when they used this product. (http://www.nemsn.org/) â€Å"Food and Drug Administration (FDA), in 1990, banned the sale of all over the counter L-tryptophan dietary supplements as it was found to be the common link in the EMS cases. Research was conducted to discover the cause of this illness. An unidentified impurity, called peak X, was found. The products were traced back to one manufacturer, Showa Denko KK (SDKK), one of Japans largest petrochemical companies†. (http://www.nemsn.org/) Centers for Disease Control and Prevention (CDC) and the FDA agreed to that instituted a recall. â€Å"The Food and Drug Administration today expanded its recall of L-tryptophan to include even small dosages of the manufactured dietary supplements†¦.The recall applies to all L-tryptophan products in tablet, capsule, caplet, powdered or liquid form, along with multi-ingredient, non-protein supplements that also contain L-tryptophan. (http://www.fda.gov/bbs/topics/NEWS/NEW00064.html) Recall The Food and Drug Administration (FDA) is responsible for guaranteeing the safety of the people of United States from the use of a variety of products, including drugs, medical devices and foods. â€Å"The FDA provides important and timely clinical information about safety issues involving medical products, including prescription and over-the-counter drugs, biologics, medical devices, and special nutritional products, including medical foods and dietary supplements. The FDA issues and/or announces product safety alerts, recalls, withdrawals, and important labeling changes that may affect the health of all Americans.†(http://www.drugrecalls.com/drug_recalls.html) A Recall is defined as an action taken by the FDA to remove a product from the market. However, under the Federal, Food, Drug, and Cosmetic Act, FDA can only request and not impose a firm to recall a product.               FDA has no authority under the Federal Food, Drug, and Cosmetic Act to order a recall, although it can request a firm to Recall a product. Under FDA’s regulation, a firm usually proceeds with a recall of a product voluntarily. It is because if they don’t comply FDA can seek a court order under the Federal Government to confiscate the product.  â€Å"The recall of a defective or harmful drug or product is sometimes publicized in newspapers and in news broadcasts. The FDA publicizes a recall only when it believes the public needs to be alerted about a serious hazard. The FDA expects companies to take full responsibility for product recalls, including follow-up checks to assure that recalls are successful. After a recall is completed, the FDA makes sure that the product is destroyed or suitably reconditioned and investigates why the product was defective.†(http://www.drugrecalls.com/drug_recalls.html)               In 1989, an epidemic of a serious disorder called for eosinophilia-myalgia syndrome (EMS) spread in the United States. It was associated with ingestion of large amount of essential amino acid L-tryptophan. Over 1,500 EMS cases were reported which includes 38 deaths.               After this incident, FDA imposed a recall on â€Å"all marketed products to which manufacturers had added [been] L-tryptophan†. Some particular medical foods or infant product essential for nutrition is were left. FDA also put alerts on the import of raw material used in association of L-tryptophan. http://www.fda.gov/bbs/topics/CONSUMER/CON00259.html               EMS outbreak originated from a particular product coming from Japanese manufacturer. A lot of research has been done to know the exact cause of EMS; however, none of them has been successful. Yet, th e recall remains. Product Liability Laws Product liability comprises a number of laws and court rulings that apply to â€Å"manufacturers, wholesalers, distributors, suppliers, retailers [who] are held responsible for the injuries those products cause†. The phrase is used to describe situations in which a person or property is injured or damaged in some way due to a defective product or service. Negligence, Breach of warranty and strict tort liability are the claims associated with product liability laws. In the US, product liability laws are determined at the state level and they vary from state to state.  Different elements are needed to be proven for each type of claim. However, â€Å"in any jurisdiction one must prove that the product is defective. There are three types of product defects that incur liability in manufacturers and suppliers: design defects, manufacturing defects, and defects in marketing†. Design defects are present before the product is being manufactured; manufacturing defects occur during the manufacturing process; and, defects in marketing occurs during the marketing process of the product where false information is given to the consumers.  (http://www.law.cornell.edu/wex/index.php/Products_liability#products_liability_law:_an_overview) Negligence Negligence is defined as when the product manufacturer is unable to provide the legal standards protecting individuals against his/her product. In order to win a lawsuit against another person or company for products liability action under the theory of negligence, â€Å"a plaintiff must demonstrate that the injuries complained of were caused by a defective product whose defect existed at the time of injury and at the time in which the product left a manufacturers control†. A plaintiff must show that the goods were unreasonably dangerous either for the use to which they would ordinarily be put or for some other reasonably foreseeable purpose, and that the unreasonably dangerous condition existed when the goods left the manufacturer. (http://www.legal-definitions.com/personal-injury-law/product-liability/strict-liability-and-negligence-theories.htm) Elements Of Negligence Involved †¢ Duty:- According to the tort law, a Duty of Care is a legal obligation imposed on an individual or manufacturer requiring them to exercise a reasonable standard of care while performing any acts that could harm others. Duty of care in law should be identified for an action in negligence. Breach: Once the duty of care has been established, the plaintiff must prove that defendant failed to perform the necessary action. There will be a breach of the duty of care if defendant failed to do so. †¢ Causation: According to negligence, causation in defined as a situation when it has been proved that defendant has caused some kind of harm to the plaintiff. †¢ Damages/Harm:- â€Å"Damages are compensatory in nature and not penalizing. This means the amount awarded should aim to compensate for the pain and suffering suffered by the Plaintiff.†(http://en.wikipedia.org/wiki/Negligence) †¢ Manufacturer liabilities:- As previously mentioned, manufacturer liabilities occur during the manufacturing process of the product. Subsequent liabilities of the distributors:- Distributors are held responsible if they provide false information, regarding the product, to the consumers. Breach of Warranty            Breach of warranty is defined as the existence of defective goods at the time of sale. A warranty is violated and the seller may be held liable. Strict Tort Liability â€Å"Strict liability claims focus on the product itself. Under strict liability, the manufacturer is liable if the product is defective, even if the manufacturer was not negligent in making that product defective.†(http://en.wikipedia.org/wiki/Product_liability#Products_Liability_and_Strict_Liability) FDA regulations (briefly discuss FDA’s view)               On March 22, 1990, the FDA banned the public sale dietary of L-Tryptophan completely. This ban continues today. Even small dosage of manufactured dietary supplements and manufactured L-tryptophan products in tablet, capsule, caplet, powdered or liquid form, along with multi-ingredient, non-protein supplements that also contain L-tryptophan,†come under this recall. â€Å"HHS Secretary Louis W. Sullivan, M.D., said, We are confronted with a Major public health problem. He warned, EMS can cripple. It can cause great pain. It can kill. It has had long-term effects on some unfortunate individuals, and some patients are not responding to treatment. I urge everyone to stop taking these supplements immediately. FDAs Nov. 17 recall was base on evidence from the U.S. Centers for Disease Control in Atlanta and state public health agencies that EMS victims had intakes of L-tryptophan that ranged from 150 to 17, 000 milligrams a day.†(http://www.fda.gov/bbs/topics/NEWS/NEW00064.html)  Class Action Suits Brought On By People Affected By L-Tryptophan Recall              A tort is an unintentional violation of another persons rights, usually due to negligence. It is different than a crime, which generally is an intentional violation of anothers rights. A tort is subject to civil action and subsequent judgment for damages payable to the wronged party, whereas a crime is subject to criminal action and subsequent penalty. The Case: SHOWA DENKO K.K. v. PANGLE et al. (A91A1435)                 (1991)                 Product liability action. Catoosa Superior Court. Before Judge Tucker. Plaintiff: Juanita Louise Pangle Defendant: Showa Denko K.K. (Showa Denko), Natures Bounty, Inc., the Hudson Corporation, and Showa Denko America, Inc. (S.D.A.). In late 1989, the Plaintiff Juanita Louise Pangle, a resident of Georgia, suffered from eosinophilia myalgia syndrome. EMS resulted from ingesting a large dose of L-Tryptophan, an amino acid, in the over the counter food supplement. She and her husband filed a product liability case against: Nature’s Beauty, Inc., the pharmacy from where she purchased the food supplement; the Hudson Corporation, the manufacturers which produced and marketed the food supplement; â€Å"Showa Denko K.K. (Showa Denko), the Japanese company which allegedly produced the raw material used by the manufacturers of the tablets; and Showa Denko America, Inc. (S.D.A.), the New York subsidiary of Showa Denko which marketed and distributed the raw material to American pharmaceutical manufacturers. Showa Denko appeals the denial of its motion to dismiss on the ground that personal jurisdiction is lacking both under the Georgia Long-Arm Statute and pursuant to constitutional requirements of due process. The Georgia Long-Arm Statute requires that an out-of-state defendant must do certain acts within the State of Georgia before he can be subjected to personal jurisdiction.†(http://www.lawskills.com/case/ga/id/33636/) According to the evidence and investigations provided, S.D.A. distributes and markets L-Tryptophan and other products in the United States. S.D.A. works for Showa Denko. Georgia Long-Arm Statute states that since S.D.A is subjected to jurisdiction because it performed an act for Showa Denko, Showa Denko will also be subjected to jurisdictions. (S.D.A. filed no motion to dismiss)            Showa Denko is a diverse manufacturer who manufactures and sells many different products throughout the United States. Records show visits of employees of Showa Denko to Georgia for trade shows or business purposes. Most of the business is related to the marketing of the product. This evidence was provided to prove that Showa Denko is subjected to a jurisdiction under the Long-Arm Statute.            Showa Denko,according to records, have contact with the University of Georgia. Jointly they were testing feed-grade L-Tryptophan on laying hens. Showa Denko objected to this allegation and pointed out that this issue has no link to the jurisdiction. However, there were do records present that contradicted this point. L_tryptophan used for marketing is similar to testing of feed-grade L-tryptophan for animals. This animal search was not enough to confer jurisdiction because plaintiffs’ injuries were not due to this act. â€Å"Several other jurisdictions in which Showa Denko has been named as a defendant in a case alleging injury after ingesting L-tryptophan have found Showa Denko to be subject to personal jurisdiction.†(http://www.lawskills.com/case/ga/id/33636/) Liability Joint Liability: In the case SHOWA DENKO K.K. v. PANGLE et al., Joint Liability has been put forward. Joint Liability is defined when more than one person is held responsible for the negligence act. In this case, it was not only Showa Denko that suffered the jurisdiction. Instead it liability was confirmed on all its, manufacturers and its suppliers. Vicarious liability: â€Å"Vicarious liability as also observed. It is defined as when a person is held responsible for the tort of another person, even though the person being held responsible may not have done anything wrong†http://www.duhaime.org/dictionary/dict-uz.aspx .  Damages According to the tort law, damages are compensated in the form of monetary to the plaintiff. â€Å"Damages, in a legal sense, are the sum of money the law imposes for a breach of some duty or violation of some right.†The types of damages: Actual or Compensatory Damage: these kinds of damages are compensated with the injured plaintiff. Consequential: Consequential damages apply to â€Å"damages claimed and/or awarded in a lawsuit which were caused as a direct foreseeable result of wrongdoing.†General: In General damages, â€Å"there is no evidence of a specific dollar figure.†Liquidated:- Liquidated damages are â€Å"contractually established damages†Nominal: â€Å"a small amount of money awarded to a plaintiff in a lawsuit to show he/she was right but suffered no substantial harm.†Punitive: â€Å"Punitive damages are considered punishment and are awarded when the defendants behavior is found to be especially harmful, but are normally not awarded in the context of a breach of contract claim.†Special: â€Å"damages claimed and/or awarded in a lawsuit which were out-of-pocket costs directly as the result of the breach of contract, negligence or other wrongful act by the defendant. Special damages can include medical bills, repairs and replacement of property, loss of wages and other damages which are not speculative or subjective.†Treble: Treble damage is when the â€Å"successful parties should receive some multiple of their actual damages.†(http://www.law.cornell.edu/wex/index.php/Damages#definition) and (http://dictionary.law.com/) Actual Damages That Were Rewarded Expectations Damages: Expectation damages are a form of damages occurring when the defendant party fails to fulfill the contract. Showa Denko failed to provide the required amount of L-tryptophan in his product. General Damages: In general damages losses are not quantified in monetary terms. For example; it consists of the actual pain and suffering caused by the negligent act. Also, it covers the future losses including the continuing pain and suffering. The plaintiff suffered from Eosinophilia- Myalgia Syndrome (EMS). A disease that altered their lifestyles. Hedonic Damages; Hedonic Damages refers to loss of enjoyment of life damages or damages distinct from the human capital value. Treble Damages:- â€Å"Treble damages, in law, is a term that indicates that a statute permits a court to triple the amount of the actual/compensatory damages to be awarded to a prevailing plaintiff, generally in order to punish the losing party for willful conduct. Show Denko had to may a large sum of money to the plaintiff to compensate for the damage. (http://en.wikipedia.org/wiki/Treble_damages) Causes of Action â€Å"The cause of action according to the law is the ground on which the plaintiff files a lawsuit against the defendant. A Cause of action encompasses both the legal theory of what legal wrong the plaintiff claims to have suffered, and the remedy, which is the relief a court is asked to grant which is in the form of an Order of the Court instructing the defendant to do or not do something for the benefit of the plaintiff or an instruction in some cases to the plaintiff to do or not do something for the benefit of the defendant.†http://en.wikipedia.org/wiki/Cause_of_action In this case, Fraud on the U.S. Food and Drug Administration can not be considered in this case. The reason being that, fraud is defined as the intentional deceit. In contrast it was proved to be negligence. Strict liability in tort is also in effect. Strict liability in tort refers to the damages caused to the consumer by the manufacture, distributor, and wholesaler of the product. Thus, in this case, the plaintiff filed a lawsuit giving negligence and strict liability a cause of action against the defendant. The plaintiff, in return of the losses, filed financial compensation. (http://www.law.cornell.edu/wex/index.php/Category:Overview)  Conclusion      The paper is concerned with an amino acid, L-Tryptophan, and its effects on general society. L-Tryptophan is required in the diet but it spread an epidemic in 1989. Eosinophilia- Myalgia Syndrome (EMS) was caused due to overdose of tryptophan in the dietary supplement.  The product came from Showa Denko Inc, a Japanese company. Showa Denko Inc was reducing their manufacturing cost compromising in its purification procedures and quickens the production process through genetically engineered bacteria. Juanita Louise Pangle, a resident of Georgia, filed a case against Showa.  Due to the diverse and serious effects it produced, FDA banned tryptophan and placed a recall on all the products that contain it. All the over the counter food supplements had been removed. This recall is still in place, although, some changes has been made.  References John D Fernstrom (June 2000). Can nutrient supplements modify brain function?. American Journal of Clinical Nutrition.Vol. 71. No. 6. Richard Alexander. Contaminated L-Tryptophan and 5-Hydroxy-L-Tryptophan, Eosinophilia Myalgia Syndrome [EMS]: The 1989 Epidemic and the 1998 Warning. The Consumer Law Page U. S. Food and Drug Administration (February 2001). Information Paper on L-tryptophan and 5-hydroxy-L-tryptophan  Recall of L-Tryptophan http://www.fda.gov/bbs/topics/NEWS/NEW00064.html. Accessed Februaary 4,2007.  Tryptophan – Wikipedia,the free encyclopedia http://en.wikipedia.org/wiki/Tryptophan. Accessed February 4,2007 Sepp Hasslberger  (July 16 2004) Tryptophan, Niacin Protect Against Alzheimers http://www.newmediaexplorer.org/sepp/2004/07/16/tryptophan_niacin_protect_against_alzheimers.htm. Accessed on February 4,2007. Product Liability-Strict Liability -Negligence Liability http://www.legal-definitions.com/personal-injury-law/product-liability/strict-liability-and-negligence-theories.htm. Accessed February 4,2007. Law.com Law Dictionary http://dictionary.law.com/. Accessed on February 5, 2007. Category: Overview-Wex http://www.law.cornell.edu/wex/index.php/Category:Overview. Accessed February 5, 2007.  Vladimir Hegyi, MD, PhD, (December 4, 2006).Pellagra. http://www.emedicine.com/derm/topic621.htm. Accessed on February 3,2007. Sherif Nasef, MD, (November 7, 2006). Eosinophilic Fasciitis http://www.emedicine.com/med/topic686.htm. Accessed on February 3, 2007. Gary R. Epler, M.D. (January 22, 2001). Bronchiolitis Obliterans Organizing Pneumonia. Internal Medicine. Volume 161 (2). Pages 158-164. http://www.epler.com/boop1.html Ira Jeffry Strumpf,  Richard D. Drucker,  Karl H. Anders,  Sylvan Cohen,  Oluwole Fajolu. (January 1991).Acute eosinophilic pulmonary disease associated with the ingestion of L-tryptophan-containing products.CHEST. http://www.findarticles.com/p/articles/mi_m0984/is_n1_v99/ai_10489355. Accesses February 3. 2007. Robert K. Murray. Daryl K. Granner. Peter A. Mayes. Victor W. Rodwell.( 2003). HARPER’S ILLUSTRATED BIOCHEMISTRY. A Lange Medical Book. Anafranil, Clomipramine Pharmacology –Healthyplace.com http://www.healthyplace.com/medications/anafranil.asp#description. Accessed February 3, 2007. Codeine – Complete medical information regarding this narcotic pain reliever http://www.medicinenet.com/codeine/article.htm. Accessed February 3, 2007. Dalmane, Flurazepam hydrochloride, side effects, drug interactions, overdose, dosage http://www.pdrhealth.com/drug_info/rxdrugprofiles/drugs/dal1113.shtml. Accessed February 3, 2007. Xanax http://www.drugs.com/xanax.html. Accessed February 3, 2007. WHF Foods: Tryptophan http://www.whfoods.com/genpage.php?tname=nutrientdbid=103 Accessed on February 3rd, 2007 Dietary Supplements: Making Sure Hype Doesnt Overwhelm Science http://www.fda.gov/bbs/topics/CONSUMER/CON00259.html Accessed on February 3rd, 2007 FDA Recall Policies http://vm.cfsan.fda.gov/~lrd/recall2.txt Accessed on February 3rd, 2007 Drug Recalls – What is a Drug Recall? http://www.drugrecalls.com/drug_recalls.html Accessed on February 3rd, 2007
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