Recalls are issued by the FDA and by drug manufacturers when a drug or medical device is determined to be harmful. Anyone affected by a recall could be eligible for compensation.
Drug Side Effects Can Trigger a Recall
Every year there are hundreds of drug recalls issued. As more and more drugs come to market, the number of recalls issued is expected to climb.
The FDA has programs in place that are supposed to protect consumers from dangerous drugs, but drug companies often circumvent the requirements. There might be too small a sample size used to test the drug, or no testing is done at all because a drug has similarities to something already on the market.
With approximately 60 percent of Americans using at least one prescription drug, the odds of being affected by a drug recall is high. All of these drugs have side effects, some serious, and sadly, some fatal.
Some of the most common side effects associated with prescription drugs include:
- Blood clots
- Birth defects
- Heart Attack
- Liver damage
- Kidney damage
There are even pharmaceutical drugs that have caused fatal consequences for users.
Drugs marketed and sold as completely safe for users often cause serious consequences. In response to dangerous drugs the FDA often requires drug companies to include “black box” warnings on its labels, and under the most severe circumstances, requires the drug be pulled from the market.
Sadly, these actions are not ordered until users have gotten sick or experienced life-changes side effects.
Drugs Prescribed for Off Label Use Can Be Harmful
Even drugs that are safe for their intended use can cause harm if they are given to people for other reasons. Doctors are allowed to prescribe medications for “off label” use, which means if the drug is able to treat an illness or condition, even if it has not officially been approved for that purpose, it can be prescribed by a doctor for that purpose.
This has led to a number of situations that have left prescription drug users at serious risk.
Types of Drug and Medical Device Recalls
There are three types of recalls, including:
- Class I: this is the most serious type of recall. It indicates there is a high probability a drug or medical device will cause severe health consequences which might be fatal.
- Class II: this is the most common type of recall and indicates a drug or medical device is likely to cause temporary harm or that there is a small chance it could cause serious harm.
- Class III: this is the least serious of the recalls and is issued if a drug is unlikely to cause harm, but there is information about the drug or device consumers need to know.
Drug manufacturers are responsible for notifying the public through proper media outlets that a recall has been issued. Doctors and pharmacists are also encouraged to be aware of and alert patients to recalls and potential dangers.
What Drugs are Associated with Recalls?
An acne drug that causes potentially life-threatening side effects, and has been linked to birth defects. Users have also suffered from muscle pain, hearing impairment, IBD, and decreased night vision.
A cholesterol drug linked to an increased risk for chest pains, heart attack, and stroke. It is also known to elevate blood sugar levels and increase users’ risk for type 2 diabetes.
Meridia is a weight loss drug that increases a user’s risk for cardiovascular events. There is also evidence the drug increases users’ risk for developing type 2 diabetes. Users also reported the drug to be less effective than expected or completely ineffective.
Prozac is an antidepressant medication that increases the risk of suicide in some users. There is also evidence the drug caused birth defects including cleft palate, clubfoot, and cranial defects in babies born to pregnant users.
What Medical Devices are Associated with Recalls?
Joint Replacement Devices
Hip and knee replacement devices, especially those featuring metal-on-metal components, have a high rate of failure. People who have joint implants have suffered loss of range of motion, pain, and metallosis, and have required risky follow-up procedures to correct the problems or remove their devices.
Mirena is a birth control device that was marketed as safe and convenient for women. Unfortunately, many Mirena users experienced neurological side effects, as well as device relocation and expulsion, ovarian cysts, and abdominal pain.
A power morcellator is a medical device used to pulverize and remove tissue during surgery. When used to perform hysterectomies or to treat uterine fibroids, there is a serious increase in risk for cancerous cells being spread throughout the body.
Many women who had previously undetected and early stage cancers were later diagnosed with advanced cancer after undergoing a procedure that involved a power morcellator. Several lawsuits have been filed and many hospitals have banned the use of morcellators.
Legal Help is Available
If you or a loved one has been injured or made ill by a recalled drug or medical device, or a recall has not yet occurred but you still suffered side effects, we can help.
Contact Seeger Weiss for help evaluating your case or to learn more about drug and device recalls.