Diet Drugs

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Laws regulating Diet Drugs define the responsibility and / or liability of anyone with a responsibility for a diet product -- from the supplier or manufacturer to the seller -- if that product causes damage due to defect.  Physicians may also be found liable if the diet drug in question is a prescription product and the guidelines regulating its use and monitoring were not followed. These instances would generally be a failure to provide reasonable professional standards for the practice of medicine and would be considered medical negligence or malpractice.

Product liability laws allow liability claims based on negligence, strict liability, or breach of warranty of fitness for a particular purpose.  The United States Department of Commerce has promulgated a Model Uniform Products Liability Act (MUPLA) for voluntary use by the states.

There are no federal product's liability laws and yet most diet drugs are tested and released for prescription by American physicians under the Federal Food and Drug Agency (FDA).  Testing of diet drugs is commonly inadequate. 

Examples of product liabilities in diet drugs involve defective products such as drugs appearing on the market with improper labeling and lack of quality control in the producing of such drugs as well as products that do not live up to their respective guarantees or warranties. A product is legally considered defective if it was made poorly or sold with flaws. A diet drug may commonly fulfill its purpose as expected but normal use may cause discomfort, injury or even death. A diet drug may also be safe if used carefully, but it may be considered defective if the manufacturer 's information on proper dosage or proper monitoring is unclear, incomplete or incorrect. This misrepresentation concerning the product, if resulting in an injury, may entitle the plaintiff to damages.

Recent years have seen many recalls of hastily approved diet drugs. Scheduled to be prescribed for blood sugar control in patients with type 2 diabetes mellitus- (non-insulin dependent diabetes), these defective products are responsible for scarring, pain, suffering, disabilities, loss of income, debt due to medical and other bills and even death.  Unfortunately, the very patients who are receiving these prescriptions may be least likely to tolerate them.

• In July of 1997, the FDA requested that fen-phen, and derivations of fen-phen, also known as redux, be recalled after reports of neurological damage or heart failure.
• Ephedra or Ma Huang  is a diet supplement (not regulated by the FDA). The FDA is now calling for limits on recommended dosages and proposing new consumer notice (labeling) requirements due to reports of heart attack, seizure, stokes, hemorrhage, high blood pressure, rapid or irregular heart rate, or death.
• In March 2000, Rezulin®, also known as Actos, or Avandia, was recalled in the United States due to liver toxicity and reports of heart damage.
• PPA or Phenylpropanolamine is used in numerous diet pills, such as Dexatrim and Accutrim.  The FDA is investigating a ban on the use of PPA in prescription and nonprescription drugs. PPA may be responsible for several hundred hemorrhagic strokes suffered by people under the age of 50.
• On Tuesday, March 19, 2002, Public Citizen, a consumer group, petitioned the FDA to pull Meridia off the market in the United States. Meridia, also known  as Sibutramine or Reductil, was called "unacceptably dangerous" after reports began to be received of liver failure and deaths.  (Some European countries have suspended sales of Meridia.)

Many patients in need of weight reduction due to other serious and possibly life threatening medical conditions, have also been prescribed other drugs which interact with these diet drugs in dangerous ways.  A majority of patients with Type 2 Diabetes also have hypertension (high blood pressure) and other disorders.  Medications for hypertension, Parkinson's disease, depression - even medications over the counter for allergies and colds - have been shown to dangerously increase medical risks of cardiac problems (including heart failure), liver problems (including extensive damage requiring a transplant of the liver and liver failure), eye damage, inability of blood to clot, bruising, neurological complications and seizures.

Products' liability laws are designed primarily to prevent harm or to compensate a person or property for harm.  The harm or injury caused by diet drugs is most often a physical injury and/or financial injury.  These laws are generally grouped under the same category as Personal Injury Law, which is tort law. 

A civil wrong, known as a tort, is recognized by law as grounds for a lawsuit.  Sometimes these wrongs are considered crimes and punishable by imprisonment, but the primary aim of tort law is to provide relief through compensation to injured parties for the damages they have incurred.  Among the types of recoverable damages are: loss of earnings capacity, pain and suffering, and reasonable medical expenses.  They include both present and future expected losses. This means that a person who has been injured due to a defect in a product or a breach of an expressed or implied warranty may be able to bring a lawsuit against the manufacturer or the seller, or anyone else in between.

Wrongful Death is a very real possibility when diet drugs are taken improperly or not monitored properly and the end result is death.  In these instances the law provides for compensation to the victim's heirs or estate.

Torts occur through unreasonable negligence, malicious intention or strict liability.  Tort law is state law created through state courts and generally using the Restatement of Torts (2nd) as an influential guide.

Product Liability

American National Standards Institute (ANSI)

Consumer Information Center

Consumer Product Safety Commission

Injury Statistics Query and Reporting System

Injury Statistics Query and Reporting System

Kids In Danger

National Toxicology Program

Products Liability

Product Safety Research - Standards and Specifications

Tobacco Industry Documents

Toxic Torts

U.S. Consumer Gateway: Product Safety

Vehicle Recall Information from the Consumer Product Safety Commission

Product Liability Federal Statutes

Magnuson - Moss Warranty Act (Consumer Product Warranties), 15 U.S.C. §§ 2301 et seq.

Product Liability Federal Judicial Decisions

U.S. Supreme Court: Recent Products Liability Decisions

U.S. Circuit Courts of Appeals: Recent Products Liability Decisions

Product Liability State Statutes

• Uniform Commercial Code Article 2

• Article 2 of the U.C.C. as Adopted by Particular States

• N.Y. Court of Appeals:
  • Recent  Products Liability Decisions
  • Commentary from liibulletin-ny

• Appellate Decisions from Other States

Drugs / Pharmaceuticals

• Baycol (Cerivastatin) Information  - from the FDA.
• Baycol FDA.com  - informational news service helping those affected by Baycol and rhabdomyolysis.
• Bayer Voluntarily Withdraws Baycol  
• Biology of the Kidneys and Urinary Tract
• CNN.com - Bayer: Baycol anti-cholesterol drug linked to ...
• Kidney Failure
• DES
• DES Action USA
• The DES Cancer Network
• Diabetes
• Rezulin
• Avandia
• Enbrel
• Important Drug Warning - Enbrel
• Federal Health Agencies
• Fen-Phen
• The New England Journal of Medicine
• Fen-Phen, obesity, and fitness issues
• Fen-Phen Chat room
• Fighting for Victims of Fen-Phen
• Fen-Phen Frequently Asked Questions
• Public Citizen Press Release To Recall Meridia
• AP Wire | 03/19/2002 | Group Asks FDA to Pull Diet Drug
• U.S. Food and Drug Administration (FDA)
• FDA APPROVES SIBUTRAMINE TO TREAT OBESITY
• Phenylpropanolamine (PPA) Information Page
• Public Citizen | Drug Information Center - Drug Information
• Meridia home page
• Meridia FAQ: For Patients
• Medical Products Liability and Recalls
• Pharmapages
  By the publisher of Scrip World Pharmaceutical News. Covering internet and technology issues in the pharmaceutical industry, articles on regulatory affairs, research and development and technology developments listings of new pharmaceutical websites, virus news, conference listings, and a glossary of terms
• Propulsid Cisapride Information
• Prozac
• Prozac murder-suicide coming before a federal court judge
• Fighting for Victims of Prozac & Fen-Phen
• Kids, Drugs, Guns and Psychopolitics
• Propulsid Information  Cisapride
• Raxar
• Raxar - FDA
• Registration for Medscape
  First time users must register - free
• Researching Medical Literature on the Web
  Article providing medical research links and an explanation of what each site offers
• Rezulin
• Clinical Manifestations of Liver Disease
• Diagnostic Tests for Liver and Gallbladder Disorders
• FDA press release - withdrawing Rezulin
• Fatty Liver, Cirrhosis, and Related Disorders
• Lifeclinic Diabetes Center
• Signs and Symptoms of Liver Cancer
• Symptoms of Hepatitis
• Rezulin Information
• Avandia - Similar Diabetes Drug
• RxList-The Internet Drug Index

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