No matter that drugs and medical devices are FDA approved, they still may be defective and dangerous. The FDA approval process is not a rigorous as many people believe There are various causes of drug and defective medical device injuries.
Contamination can become a major issue when dealing with drugs or defective medical devices. This does not happen often, but when it does, the injuries to patients can be devastating. Injuries include infections, intense pain, issues with vision, hearing loss, and sometimes even death.
If drugs become contaminated, specifically with fungal mold, patients who take the drugs can become ill. In a recent outbreak, steroid users were infected with bacterial meningitis due to fungal mold, which resulted in serious injuries and some deaths.
Medical devices can be contaminated if they are not sterilized properly or sterilized before they are implanted into a patient. For example, many tools used by a doctor are not thrown away. They are reused multiple times after being sterilized. If they are not sterilized properly, patients could be subject to infections.
Errors in Manufacturing
It is all too common for manufacturing errors to occur during the production of drugs and medical devices.
At times, drugs can be mixed with the incorrect amount of an ingredient or with the wrong ingredient completely. When it comes to medical devices, a mistake might have been missed in the manufacturing process that leads to injuries or the wrongful death of patients.
For example, thousands of patients were injured when their Stryker metal on metal hip implants malfunctioned. The design of metal on metal hips released particles of heavy metals into the blood that caused intense pain chronic inflammation and degradation of bone.
Safety Testing Not up to Par
Another common cause of drug and defective medical device injuries is that of inadequate safety testing. The laws in the United States allow drugs and medical devices to skip the safety testing process if it can be proven that they are similar to drugs and medical devices that are already approved for the market. When this happens, the items that find their way onto the market without safety testing could be harmful to users.
In some instances, inadequate instructions can lead to drug and medical device injuries. Sometimes, the manufacturer of the drug or medical device does not provide the correct instructions or warnings so that the public will know how to properly use the items.
When medical devices are being designed, it is possible that a flaw could be missed by the manufacturer. If this occurs, the public can be hurt by the design flaw. It is the responsibility of the manufacturer to ensure the safety of users.
If you or a loved one has been injured due to a defective drug or medical device, contact the law offices of Carey, Danis & Lowe by filling out our contact form or by calling 877-678-3400 and we will be in touch within 24 hours.