Prescription for Harm: Recalled Pharmaceuticals Pose Serious Risks

While medications are required to undergo rigorous testing by the FDA, drug recalls occur each year, putting millions of lives in danger. Often, the problem lies in the fact that, while the FDA’s Center for Drug Evaluation and Research evaluates new drugs to ensure their effectiveness and that health benefits outweigh risks, the Center does not actually test the drugs itself.

Rather, it is the drug’s manufacturer that tests the drug on both human and animal subjects. Problems can also occur at the reporting stage, where manufacturers must review and report any problems associated with the drug once it enters the market. Delays or inaccuracies in these reports can result in health hazards for the public.

There are three types of recalls that consumers should be aware of. The FDA has classified these recalls based on levels of severity.

• Class I Recall: These are the most urgent and serious types of recalls that the FDA issues. In a Class I recall, there is significant and immediate danger of death or other serious injury from the use of the product being recalled. Though they are rare, these recalls should be addressed immediately.
• Class II Recall: A class II recall is issued when there is no immediate danger of death or other serious injury linked to a drug, but a risk is still present. These recalls are preventative and the FDA will work with the drug manufacturer to notify the public about the recall and formulate a plan to pull the drug from the maker.
• Class III Recall: While the use of a drug covered under a Class III recall is not likely to present adverse health effects, the drugs are in violation of FDA regulations such as being contaminated during the manufacturing process.

When a recall occurs, in most cases, the drug’s manufacturer will voluntarily pull the drug from the market and notify the FDA. However, in some cases, when the FDA makes a request that a manufacturer voluntarily recall the drug the manufacturer refuses to do so, the FDA can obtain the legal authority to seize the drug

Recently Recalled Drugs

From increasing the risks of heart attacks to causing uncontrollable bleeding in users, recalled drugs have made national headlines in recent years. After the drug manufacturer Merck decided not to conduct a study to determine the risks of heart attacks and strokes for users of Vioxx despite indications that the drug might pose a heart risk, hundreds of users began experiencing adverse health events. Yet, it was not until after Congressional inquiry and investigations by the FDA that the drug was finally removed from the market in 2004.

Similarly, the blood thinner Xaralto, use to prevent blood clots and strokes, has long been linked with reports of uncontrollable bleeding and stroke. Just this past year, however, thousands of units of the drug was also found to be contaminated due to the manufacturing process and was recalled by Johnson and Johnson.

If you or a loved one has suffered injuries due to a recalled drug, a lawsuit may help you hold the manufacturer accountable and enable you to compensation for medical expenses and lost earnings. For a free consultation with an attorney at The Pittman Firm, call us today.