Michigan Dangerous Drug Attorney

When Drugs Become Dangerous

A defective drug is any medication that causes psychological, physical or emotional injury. However, the drug does not have to be inherently dangerous for it to harm those who take it. This is because injuries can also occur due to insufficient warnings or incomplete labeling.

For example, according to ABC News, two different types of children’s cough syrup were released with dosing cups that had incorrect markings on them. Since accidental overdose is one of the potential consequences of this error, both medicines were recalled. Although no reports of an accidental overdose have been reported, some of the possible side effects of a child taking the wrong dose of this cough medicine include dystonia, stupor, coma, hallucinations, rapid eye movements and changes in muscle reflexes. Other possible side effects include irregular heartbeat, respiratory depression, nausea, vomiting and in severe cases, death.

Dangerous Drug Recalls

According to the Cleveland Clinic, drug recalls, like the one involving the children’s cough syrup, are becoming more and more frequent. The U.S. Food and Drug Administration (FDA) reported 1,742 drug recalls in 2009 and 426 recalls in 2008, which is a 309 percent increase in the number of recalls issued. Despite this significant increase in the number of medication recalls issued by the FDA, it is projected that this trend for an increasing number of drug recalls will continue.

There are many different reasons why drug recalls could have increased heavily over the past few years. For example, many of these drug recalls are initiated due to a problem that occurs during the distribution or manufacturing process. However, others believe that quality assurance issues have impacted the number of recalls occurring because many generic companies feel pressure to manufacture the first approved generic drug for brand-name products already on the market.

Classes of Recalls

When the safety of a medication is called into question and a drug recall is issued, the FDA states that the recall is classified into one of three categories. These include the following:

• Class I recall—This type of recall is the most serious. When a Class I recall is issued, a situation exists where a medication is likely to cause adverse health consequences or death if it is used.
• Class II recall—When a Class II recall is issued, a drug may cause irreversible or temporary health consequences. Although serious side effects are still a possibility, the risk of them occurring is remote.
• Class III recall—The least serious of the three recall classes, Class III recalls are issued when a medication is not likely to cause adverse health effects.

Just like there are three different classes of drug recalls, according to the Cleveland Clinic, there are also three steps that occur when a drug recall is initiated. First, the manufacturer of the drug notifies the FDA that there is a problem with their medication. However, if the manufacturer does not initiate the recall process, the FDA will move the recall process forward instead. Second, the public is notified and warned about how the drug might cause adverse health consequences. Finally, the recall process is evaluated and steps are taken to either make the drug safe to use or to withdraw it from the market altogether.

Attorneys are alleging serious injuries and other complications in Michigan dangerous drug lawsuits being filed on behalf of affected patients.