The world of pharmaceutical development, testing, and approval can be very confusing. In some cases, lawmakers and drug manufacturers complain about the long and arduous process of getting Food and Drug Administration (FDA) approval for new drugs that could start helping people right now. However, even after this long testing process, years go by before the public begins to realize that they have been taking a harmful or even deadly drug without any warning.
When there is a problem with a pharmaceutical or even an over-the-counter drug, the results can be catastrophic. Unfortunately, many people never learn that a drug was harmful, even after a loved one died as a result of the defective drug. If you have any suspicion that a defective drug was responsible for an injury, ailment, or death of a loved one, contact experienced Philadelphia personal injury attorneys for an evaluation of your case.
Common Drug Defects
Every year, new drugs are taken off the market or recalled after they have been linked to dangerous reactions. The FDA maintains a website listing drug recalls, categorized based on the perceived danger of the defect. Recalls may come at the recommendation of the drug manufacturing company, through an FDA request, or by an order from the FDA.
A Class I recall involves a situation where there is a “reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.” Class II recalls may involve temporary or medically reversible adverse health consequences and Class III recalls involve products that are not likely to cause adverse health consequences.
In 2016 alone, the FDA issued more than 1,000 Class I and Class II enforcement reports for FDA drug recalls. This included a wide variety of prescription and over the counter drugs, including a number of diet pills, pain relievers, opioid pain medications, epi-pens, vitamin supplements, and cough medicine.
These drugs have been deemed defective based on failure to obtain FDA approval while containing regulated drugs, undisclosed ingredients, contamination of particulate matter, bacterial contamination, or having too low or high of a potency.
Drug defects may be a result of the manufacturing process or from a product defect. In a manufacturing defect, the drug may have been contaminated with bacteria or some other substance. A manufacturing defect could also lead to potency variation that could cause patients problems when they require a regulated measure of drug's active ingredient. A design defect with drugs usually involves some danger that is inherent in the drug itself or the way it is delivered to the individual. Some drugs are dangerous no matter how cautiously they are used. However, these dangers may not become clear until the product has been on the market for years.
Many so-called dietary supplements do not have to go through the same type of testing as pharmaceuticals. As a result, a number of diet, weight loss, or energy pills may contain dangerous drugs that may lead to heart attacks, strokes, or seizures. Others may contain no active ingredients at all, leaving individuals to rely on the promises made by the company selling the product. Other supplements may be contaminated with dangerous substances or bacteria.
Even pharmaceutical drugs can be defective as a result of the manufacturing process or through discovering unintended side-effect of the drug. Prescription drugs including morphine sulfate, amikacin sulfate injections, Avastin, fentanyl citrate, and others have been recalled for sub-potency, microbial contamination, the presence of particulate matter including glass or insects, fungal contamination, and bacterial contamination.
Some of the most widespread cases of defective drugs include medications that were prescribed by doctors to thousands of patients for years. It was only after a number of people began to experience side-effects, pain, injuries, or death that the drugs were identified as defective. This included drugs like Celebrex, Paxil, Chantix, Yasmin or Yaz, Actos, and Risperdal.
Defective Drug Injuries
Injuries can vary depending on the type of drug, the length of use, individual patient, and if they the use of other pharmaceuticals at the time. Common injuries include increased risk of cancer, kidney damage, heart problems, the risk of stroke, increased risk of suicide, blood clots, and internal bleeding. In the worst cases, taking a defective drug can lead to death.
The defects could be caused by a manufacturer who is looking to cut costs and does not maintain a sterile environment for manufacturing and packaging drugs. In other cases, even after patients and doctors express concern over side-effects, the drug companies may try and deny that there is anything wrong with their drug while allowing thousands of other patients to be put at risk of injury or death.
Philadelphia Defective Drug Lawyers
If you were injured by after taking a defective drug, you may have a legal claim for medical bills, lost wages, and other damages. If a loved one died as the result of taking defective medications, you should talk to an experienced Philadelphia personal injury attorney to help you determine if you have a claim. They will fight to make sure you get the compensation you deserve. You should not have to suffer due to the drug company's negligence. Do not hesitate to contact Gilman & Bedigian today for a free consultation.