Laws and Liability for Prescription Drugs

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People take pharmaceutical drugs to achieve a health benefit.  They may be trying to reduce the side effects of a medical condition or to reduce pain, for example.  While many drugs have known side effects, patients take a specific drug with the belief that the benefits of taking the drug will outweigh the known side effects.  However, sometimes the potentially harmful effects of the drug are not known to the patient and dangerous, even fatal, consequences result. In these cases, the law may find the manufacturers of the drug legally responsible for the harm done to the patient.

Liability for Prescribed Drugs

Generally, drug manufacturers are found liable for defective pharmaceutical drugs pursuant to a product liability lawsuit.  A manufacturer is liable for a products liability claim if there was:

  • A defective design of the drug: drugs must be properly designed and tested for side effects prior to being made available to consumers;
  • A defective manufacturing of the drug: drugs must be properly manufactured according to the design specifications. If the manufacturing process is contaminated or all of the steps are not followed and an injury results then the drug manufacturer may be liable.
  • Inadequate warning provided about the drug’s dangers: many drug product liability claims come under this theory of products liability.  If drug manufacturers knew or should have known about potential side effects and failed to warn physicians, pharmacists and consumers about the known dangers then a patient who is injured by the drug may have a legal claim.

Dangerous Pharmaceutical Drugs and Lawsuits

The Federal Drug Administration (FDA) is responsible for approving drugs and for recalling drugs that are later found to be dangerous.  A chronological list of recalled drugs can be found on the FDA’s website.  Some examples of drugs that were once commonly used and later found to be dangerous include:

Name of Drug Drug Type Treatment Side Effects Recalled?
Acetaminophen Analgesic Acetaminophen is a commonly sold over the counter drug for pain relief and reduction of fever. Overdose could cause nausea, vomiting, appetite loss, diarrhea, abdominal pain, yellow eyes and skin, liver failure, kidney failure, coma, seizures and death.  
Aredia Biphosphonate Aredia is used to address cancer-related hypocalcaemia, which are inordinate amounts of calcium in the blood. Problem with drug includes developing osteonecrosis of the jawbone.  
Avandia Anti-Diabetic Avandia is an oral medication that increases the sensitivity of insulin receptors and helps control blood sugar levels Dangers include breathing difficulties, chest pain, fluid retention, frequent urination, rapid weight gain, stomach pain, and nausea. x
Baycol Lipid Modifying - Synthetic Statins Baycol works in lowering cholesterol through blocking specific enzymes needed for the creation of cholesterol. Side effects include rhabdomyolysis, which is a breakdown of muscle cells. x
Bextra Anti-Inflammatory - COX-2 inhibitor Bextra is prescribed primarily for arthritis relief, menstruation relief, and any type of anti-inflammatory use. Some risks include heart attack, stroke, blood clots, nonbacterial meningitis, kidney damage/failure, death, etc. x
Celebrex NSAID - Non-steroidal anti-inflammatory drug Celebrex is designed primarily for the relief of arthritis pain, both osteoarthritis and rheumatod arthritis. Side effects include headache, diarrhea, stomach pain, indigestion, nausea, upper respiratory tract infection, and sinus inflammation.  
Celexa SSRI - Antidepressant Celexa, also known as citalopram, is used to treat depression. Side effects include dry mouth, nausea, sleepiness, sucidal thoughts, bleeding, mania and seizures.  
Chantix Nicotine Receptor Partial Agonist Chantix, known as Champix abroad, is used in the treatment of stopping nicotine and smoking addition. Side effects include diabetes, low glycemic levels, irregular heart rhythm, vision problems, seizures, and motor skill disorders  
Crestor Lipid Modifying - Synthetic Statins Crestor is used to lower bad cholesterol and raise good cholesterol. High dosages can lead to serious muscular problems like rhabdomyolysis.  
Depo Provera Hormonal Birth Control Depo Provera is an injectable contraceptive used in hormonal birth control for women. This drug may lead to undue amounts of bone density loss.  
Dexatrim Dietary supplement Dexatrim is designed to help with weight loss and may include phenylpropanolamine. Phenylpropanolamine may increase risk of heart attack and stroke, also known as Primary Pulmonary Hypertension.  
diclofenac NSAID - Non-steroidal anti-inflammatory drug Diclofenac is a generic prescription drug used as an anti-inflammatory to manage pain. Short term use of Diclofenac may cause hepatic toxicity, liver damage, and higher risk of heart attack and stroke.  
Yaz (Drospirenone) Hormonal Birth Control Yasmin, Yaz, and Ocella birth control pills, also known as Drospirenone can cause gallbladder disease and kidney stones. Drospirenone can cause gallbladder disease, kidney stones, blood clots, heart attacks, stokes, deep vein thrombosis and pulmonary embolism.  
Effexor SNRI - serotonin-norepinephrine reuptake inhibitor Effexor, also known as Venlafaxine, is used to treat major depressive disorder. It has been shown to cause substantial weight loss, as well as generalized anxiety diorders, and social phobias.  
Ephedra Dietary supplement Ephedra is an amphetamine-like compound with potentially powerful stimulant effects on the nervous system and heart. Side effects include heart attack, tachycardia, paranoid psychosis, depression, coma, fever, palpitations, hypertension, seizures and death.  
Evista SERM - Selective Estrogen Receptor Modulator Evista reduces instances of breast cancer and osteoporosis. Side effect include an increased risk of strokes and blood clots.  
Fen phen Antiobesity Stimulants - Anorectic Fen Phen is a weight-loss drug in a fenfluarmine and phentermine combination. Side effects include heart problems in women. x
Fluvoxamine SSRI - Antidepressant Fluvoxamine is used to treat OCD, or obessive-compulsive diorder. The risk of this drug include suicidal behavior and thoughts.  
Fosamax Biphosphonate Fosamax blocks bone resorption and promotes natural bone development when taken with vitamin D and calcium. Side effects include loss of jaw function, pain, tooth loss, exposed bone, and disfigurement.  
Gleevec Chemotherapeutic - Mesylate Salt Gleevec, known as imatinib, inhibits the enzyme that is found in some cancer cells, specifically in Chronic Myeloid Leukemia (CML) and Gastrointestional Stromal Tumors (GIST). Side effects include kidney problems and possible congenital heart failure.  
Hydroxycut Nutritional Supplement Hydroxycut is a weight loss drug by quelling hunger cravings Side effets include rhabdomyolysis which causes kidney failure, cardivascular disease and severe liver damage. x
Ketek Antibacterial Protein Synthesis Inhibitors Ketek, known as telithromycin, is used to treat bacterial infections in the respiratory system, such as pneumonia and bronchitis. Ketek will cause severe liver disease, liver damage, and hepatitis.  
Lotronex Serotonergic Lotronex, also known as Alosetron, is intended for use by women only in the control of chronic diarrhea related to irritable bowel syndrome. Side effects include serious gastrointestinal conditions. x
Meridia SNRI - serotonin-norepinephrine reuptake inhibitor Meridia, known as sibutramine, is an orally administered treatment for obesity. Meridia may increase blood pressure and pulse rate.  
Miraplex SSRI - Antidepressant Mirapex is a dopamine agonist used to treat Parkinson's disease and restless leg syndrome. Dangers include nausea, dizziness and drowsiness. Side effects include nausea, drowsiness, hallucinations, and serious lung, chest and heart problems.  
Neurontin GABA Analgesic Neurontin, or gabapentin, is used to treat epilepsy and relieve neuropathic pain. It is also used to treat panic and anxiety disorders in psychatric situations. Taking this drug may cause withdrawal and cause of seizures.  
Ortho evra patch Hormonal Birth Control The Ortho Evra Patch is a skin patch used as a contraceptive device in women. Dangerous side effects include high levels of estrogen causing blood clots and heart vessel complications.  
Paxil SSRI - Antidepressant Paxil is used in treatment of depression, anxiety, panic, PTSD, generalized anxiet disorder, and obessive-compulsive behavior. The main risk of the drug is an incrase in risk of sucide while taking the drug.  
Perchlorate Antithyroid - Sodium-iodide symporter inhibitor Potassium Perchlorate is a salt that occurs naturally and is used to treat hyperthyroidism. However, usage of this salt included side effects such as the development of aplastic anemia.  
Pondimin Antiobesity Serotonergics Pondimim, known as Fenfluramine, is a key component of several anorectic drugs. It is used for long term-cosmetic weight loss and fat burning. Dangers included damage to the aortic heart valve, and possibility of causing cardiac fibrosis and pulmonary hypertension.  
Prempro Sex hormone Prempro is a hormone replacement therapy (HRT) drug used to treat menopause. Dangers include higher chance of strokes, heart attacks, blood clots, and breast cancer.  
Propulsid Serotonergic Propulsid, known as Prepulsid and Cisapride, is used to treat chronic gastroesophageal reflux disease, and other gastrointestinal condions such as constipation. This drug causes Long QT Syndrome which causes life-threatening heartbeat arrhythmias. x
Prozac SSRI - Antidepressant Prozac, known as fluoxetine, is used to treat depression, obsessive-compulsive disorder, bulimia, anorexia, panic disorder and premenstrual dysphoric disorder. The drug causes an imbalance of brain chemicals which lead to restlessness and sucide impulses.  
Redux SSRI - antiobesity Redux, known as Dexfenfluramine, was used to treat obesity. Hazards included increase in risk of heart problems by hardening the lining of heart valves.  
Reglan Dopaminergic, Serotonergic Reglan is used to treat diabetic gastroparesis. Side effects include Tardive Dyskinesia when using Reglan for over a year.  
Rezulin Anti-diabetic, Anti-inflammatory Rezulin was developed to treat type 2 diabetes. Side effects include headche, dizziness, back pain, nausea, liver damage, and death. x
Risperdal Atypical Antipsychotic Risperdal, known as Risperidone, is intended to treat the symptoms of schizophrenia, psychotic bipolar disorder and other mental illnesses. It has an extremely serious side effect include strokes, and stroke-like events such as blood clots and hemorrhages.  
Vioxx NSAID - Non-steroidal anti-inflammatory drug Vioxx was designed to treat osteoarthritis and acute pain conditions. Side effects include serious cardiovascular conditions such as heart attack. x
Zicam Anti-histamine, Anti-cold drug Zicam is a series of cold and allergy drugs using zinc to help users rid themselves of cold or allergy symptoms Side effects include anosmia, or loss in sense of smell, and loss in sense of taste x
Zyprexa Atypical Antipsychotic Zyprexa, known as Olanzapine, is used to treat mental disorders including: bi-polar, schizophrenia, depressive, obessive-compulsive, and generalize anxiety. Harmful side effects include rapid weight gain, lack of appetite control, increased blood sugar, diabetes, and obesity.

Getting Legal Help

You can be confident that drug manufacturers are well represented by attorneys.  You deserve the same advantage.  If you have been hurt, or a loved one has been killed, by a dangerous pharmaceutical drug then you may have the legal right to recover damages for your medical costs, rehabilitation costs, out of pocket expenses, and pain and suffering.  You may also be entitled to punitive damages. In most cases it is necessary to file a products liability lawsuit, with the assistance of experienced defective pharmaceutical attorneys, in order to recover damages.

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