Every year, the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) approves between 20 and 25 new drugs.
To have “FDA approval” means that this government division has determined, through rigorous testing, that the approved drug has more benefit than risk for the drug’s intended use.
While a vast majority of Americans depend on these new medications for their survival, sometimes an approved drug comes with extreme complications.
These complications can come about from:
There are three main categories of Class-Action Lawsuits against pharmaceutical companies:
“Improper Labeling” is when the directions for a medication are not clear resulting in unintentional mistreatment by the patient.
“Failure to warn” is when the potential side-effects are not clearly written to warn users of harm. (Especially if the patient is taking more than one medication.)
In other instances, some medications have been marketed for “off-label” treatments, such as the anti-depression drug, Cymbalta, being approved to treat chronic pain.
Drug design defects happen when the side-effects outweigh the benefits to the patient, and result in serious complications to the user’s health.
Drug Manufacturing Defects can happen a number of ways. Perhaps there was cross-contamination between two medications that altered the formula.
Perhaps the formula was mixed at improper levels that changed the strength of certain ingredients causing harm to the patient taking the tainted medication.
Class Actions Lawsuits as a result of a bad drug falls under Product Liability. Determining negligence can sometimes fall on many people and/or entities:
Since so many American take the same prescribed medication, many times a Class Action Lawsuit is pursued rather than 1000’s of individuals suing a manufacturer separately.
List of Class Action Lawsuits against Defective Drugs (while more lawsuits against defective drugs are opened and closed every year, these are some of the most common):
Was designed to regulate dopamine and serotonin levels in the brain to help patients struggling with psychiatric disorders and depression. Serious reactions have caused compulsive eating, shopping, gambling and sexual behavior.
Was developed to treat acne, and targets the oil glands within the skin causing them to shrink. It has since been linked to the development of Irritable Bowel Syndrome (IBS) including Crohn’s Disease and Ulcerative Colitis.
Was designed to help reduce chronic inflammation and damage caused by Rheumatoid arthritis. However, the drug’s labeling failed to warn users of an increased risk for heart attack, stroke, pancreatitis, lung disease and death.
Is often prescribed to treat insomnia. While the labeling does warn of the potential for memory-loss and sleep-walking, some patients have been seriously injured after driving their cars, or even committed crimes while under the influence of the drug.
Is prescribed to prevent osteoporosis in patients and other bone conditions. However, patients have reported osteonecrosis of the jaw (or “bone death”), as well as other bone diseases that have resulted in permanent disability or death.
Millions of patients with type II diabetes were prescribed Avandia to help control their blood-sugar levels. However, the manufacturer failed to report testing information that showed a significant risk of developing cardiovascular disease, including increased risk for heart attack.
Was developed to help control excess cholesterol that can lead heart disease. It was removed from the marketplace is 2001 when it was determined to cause kidney failure, muscle cell damage, and death in 100’s of patients.
There are many approved forms and brands of birth control for women which effectively prevent pregnancy. Brands such as: Nuvaring, Ocella, Yasmin, Yaz, and Ortho Evra.
These drugs have class-action lawsuits against them due to increased risk for blood clots, heart attack or stroke.
Is a commonly prescribed to patients with Type 2 diabetes to help control blood sugar levels. However, class actions lawsuits have been filed due to wrongful death claims and serious side such as thyroid cancer, pancreatic cancer and kidney failure.
Was released to help lower blood pressure in patients. While studies published suggested dizziness, swelling and difficulty breathing, they failed to publish a person’s increased chances of developing congestive heart failure was also increased.
Is an anti-inflammatory drug prescribed to reduce arthritis pain. The medication was recalled after it was connected to an increased risk of heart attack or stroke in patients.
Is a popular drug prescribed to help people who want to quit smoking by blocking nicotine’s pleasant effects on the brain. Between 2006 and 2011, the FDA discovered an increased risk for heart-related medical problems, and has since issued a warning.
Within 5 months of releasing Crestor to help lower a patient’s cholesterol, recalls were already being lobbied due to reports of muscle damage and kidney failure.
Patients who take anti-inflammatory drugs regularly, such as aspirin, have a greater chance of developing ulcers. Cyotec was designed to help reduce the risk of these ulcers. However, it was being prescribed “off-label” as a labor-inducing drug causing severe birth-related injuries to babies.
Zinc is a common ingredient used in Poligrip and Fixodent denture creams. While small doses of zinc can be beneficial, too much zinc can lead to copper deficiency in patients resulting in problems with the nervous system and spine.
A study revealed that almost 50 percent of pregnant women who were using Depakote to control symptoms of bipolar disorder or even migraines, gave birth to children who were developmentally disabled, had serious birth defects or died.
This anti-inflammatory drug was prescribed to treat short-term, acute pain and has been linked to 68 deaths.
Is a common ingredient in over-the-counter medications used to treat allergies and appetite suppressants and has been linked to patients having heart attacks, strokes, and a number of fatalities.
Was used primarily in appetite-suppressant and weight loss pills. In 1997, it was recalled after it was connected with causing heart-valve disease.
Found in the drugs Propecia and Proscar, which are prescribed to treat male pattern baldness, have been strongly linked to sexual side effects such as testicular lain, erectile dysfunction and decreased libido.
After receiving many reports of serious liver injury, jaundice and cardiovascular issues, The Food and Drug Administration (FDA) recalled many weight-loss supplement products produced under the Hydroxycut label.
Is prescribed to treat angina (chest pain), however the drug produced by Ethex Corporation is under recall due to a manufacturing error resulting in the potential for overdose due to the pills being made too large.
Johnson & Johnson’s talcum powder and Shower to Shower brand have been used by millions of women for decades as part of their daily hygiene routine.
Recent findings and court documents reveal that the company knew using these products regularly causes higher rates of ovarian cancer diagnoses and failed to warn consumers.
Is prescribed as an anti-convulsant for patients with epilepsy and bipolar disorder, however studies have shown an increased risk for birth defects, aseptic meningitis and suicidal thoughts.
Is an over-the-counter medication used to treat fungal infections, typically in feet. However, recent studies have linked its use to liver failure.
Is a commonly prescribed drug used to treat depression and anxiety disorders by increasing serotonin levels. However it has been reported pregnant women who take this drug see a 60% increase in risk of birth defects in their babies.
Is often prescribed to help reduce LDL cholesterol, or bad cholesterol, while designed to increase HDL cholesterol, or good cholesterol at the same time. However, long-term use has been linked to kidney failure, diabetes, and hepatitis.
Has been prescribed to patients to treat moderate to severe pain. It is classified as an opioid and is highly addictive.
Was designed to treat patients with depression, obsessive-compulsive disorder (OCD), a variety of anxiety disorders, and post-traumatic stress.
However, side effects include violent behavior, extreme agitation and suicidal thoughts.
Was approved to treat hypertension despite the conclusion of a congestive heart failure study showing it can disrupt heart rhythm when used with other drugs resulting in death.
Has been widely prescribed to patients suffering with severe depression, eating disorders and other sever anxiety disorders. Some patients have developed extreme side effects including violent behavior, such as either harming themselves or others.
Also called risperidone, is an antipsychotic drug used in the treatment of schizophrenia, bipolar disorder, and even autism. However, it has caused severe side effects in patients including irregular heartbeat, diabetes and pituitary gland tumors.
Is prescribed to children with Attention Deficit Hyperactivity Disorder (ADHD), but has also been known to trigger suicidal thoughts and seizures.
Was manufactured to prevent asthma attacks, yet has been linked to potentially life threatening asthma episodes in patients.
(Acitretin in its generic form) is used treat severe psoriasis in adults. Manufactured by Swiss company Roche, it has been connected with several side effects including birth defects, depression, and suicidal thoughts.
Is prescribed to treat myeloid leukemia. However, evidence has surfaced pointing to a connection between the drug and atherosclerosis, a plaque build-up inside the arteries.
Are often prescribed to reduce high blood pressure in patients. Side effects are shown to include increased rate of non-fatal stroke, renal problems and low blood pressure.
Was originally manufactured to treat seizures in patients. It is also one of the most prescribed drugs for migraine prevention.
It has since been marketed for many “off label” uses to help people with a variety of psychiatric disorders. However, the manufacturer failed to warn pregnant women about some serious risks connected with birth defects in their unborn babies.
A popular over-the-counter pain medication for decades has been linked to liver disease and liver failure.
Is a commonly prescribed drug used to treat erectile dysfunction. While the drug manufacturers warned of unexpected side effects such as sudden hearing or vision loss, they failed to warn patients about an increased risk of fatal skin cancer.
Is a new anticoagulant medication that is prescribed to help reduce the formation of blood clots in patients, however, it has since been shown to cause uncontrollable bleeding and increase the risk of blood clots.
Pregnant women, who were suffering with extreme nausea, were prescribed Zofran, however, the U.S. Food and Drug Administration did not approve this “off-label” use and as a result 30% of pregnancies have resulted in cleft-lip or heart conditions in babies.
Was prescribed for two uses, one use was to help patients quit smoking and the other as an antidepressant, however side effects include seizures, dangerous allergic reactions, severe nervousness and suicidal thoughts and behaviors.
Lawsuits against drug manufacturers are lengthy and difficult. There are many general laws in place to protect drug manufacturers and laboratories and it can be especially difficult to prove they knew their product would cause unintended harm to patients.
Before you can sue a drug manufacturer for injuries you feel were caused by a defective drug, ask yourself these questions?
Were you made aware of the risks and side-effects involved in using a particular drug and used the product anyway?
If your doctor or the pamphlet included with the medication clearly explained the risks for injury, you may be prevented from recovering financial compensation.
Did you change your dosage amount or modify the prescribed drug in any way that resulted in your injury?
If so, the manufacturer may be protected from lawsuit since your injuries were not a direct result of their negligence, but your own.
However, if it can be proven that the manufacturer should have been able to predict consumer modification of their product, then you may still have a case against them.
Depending on the state where you are filing a claim; you may have a time limit, or statute of limitations in which you can receive financial compensation for your injuries.
This can be difficult because some injuries can take several years to appear.
If you or a loved one has been injured and you believe it to be the result of a defective drug, then it is important you speak with a Bad Medicine Liability Lawyer who has experience working with defective drugs.
Having a lawyer who also speaks Spanish will be better able to explain your rights and if you have a case to sue a drug manufacturer or become a part of an existing class-action lawsuit.
Many times, a lawyer will offer a free initial consultation and will work on a contingency basis, meaning they do not receive payment unless they win money for your case.