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Search LawsuitsFrom antidepressants and blood pressure medications to drugs used for diabetes, millions of Americans take a prescription drug on a daily basis. According to researchers at the Mayo Clinic and Olmstead Medical Center, approximately 70 percent of people in the U.S. take at least one prescription medication daily. While prescription drugs are designed to alleviate the symptoms or effects of various medical conditions, many patients find themselves reaching out to a Maryland dangerous drug attorney after they experience unforeseen and serious complications caused by a medication.
The FDA’s Review Process
To prevent patients from experiencing negative and life-threatening side effects, new prescription drugs must go through a lengthy review process overseen by the U.S. Food and Drug Administration. The first step in this process involves testing the new drug on animals and explaining to the FDA how the drug manufacturer intends to conduct clinical studies on humans. This step is followed by phase one, two and three testing, a review meeting with the drug sponsor and the FDA and the filing of a New Drug Application.
Once an NDA is submitted, the FDA has 60 days to either file the application for review or deny it. If the application is filed for review, the drug begins the final part of its journey to the marketplace. Although the FDA’s drug review process is designed to be comprehensive, it is still possible for drugs that cause harmful side effects to be approved and prescribed to patients by medical providers.
When a Maryland Dangerous Drug Attorney Might be Needed
If the safety of a medication is called into question, it may be recalled either by the FDA or by its manufacturer. According to WebMD, there are four situations where a prescription drug might undergo the recall process:
- The medication was poorly manufactured: A drug may be recalled when its potency, quality or purity are called into question by patients, medical providers or another party.
- The medication does not match its packaging: If a medication is packaged in the wrong materials, it can be recalled. For example, if a pain reliever is packaged with the labelling meant for a blood pressure medication, a drug recall may be issued.
- The medication is potentially contaminated: A medication may be recalled if during the distribution process, it is contaminated by a non-harmful or harmful substance.
The medication is hazardous to those who take it: If a prescription drug has the potential to cause harmful side effects, it can be recalled and eventually pulled from the market. While the recall process, as well as the FDA’s review process, is designed to prevent patients from experiencing negative consequences, these health hazards are often not recognized until the medication is widely prescribed and used. For example, in 2010, it was determined that the weight loss drug Meridia could increase a person’s risk of having a stroke or a heart attack, and it was removed from the market.
When a drug recall occurs, it is put into one of three categories, which include Class I, Class II and Class III, depending on how much of a risk the medication poses to those who take it, states the FDA. If the recall is classified as Class I, the use of the medication is likely to cause serious health consequences and in certain situations, death. If the recall is considered a Class II recall, it is likely that the medication can cause side effects or consequences that are negative, but reversible. These effects are also not likely to be life-threatening or extremely serious. Finally, if the recall is categorized as Class III, the use of the medication is not likely to result in adverse health issues.
How a Maryland Dangerous Drug Attorney Can Help
Drug makers have a duty to provide safe products. If there are risks of harm associated with their products, they also must provide adequate warnings. If a drug maker fails to fulfill this duty, it could be held liable in lawsuits for injuries that may result.
People injured by bad drugs may be eligible to recover money for:
- Medical Expenses
- Lost Wages
- Pain and Suffering
The families of those who have died may be eligible to recover money for funeral expenses and the pain that comes with losing a loved one.