Drug Recalls at Record High
According to a recent article from Becker’s Hospital Review, 2014 may prove the worst year for drug recalls on record. Dangerous drugs and defective medical devices can lead to serious and even fatal injuries, and it is important to keep an eye on consumer safety trends.
Based on a report by the Regulatory Affairs Professionals Society (RAPS), pharmaceutical companies initiated a total of 836 drug recalls between January 1, 2014 and August 11, 2014. This number is very high when compared to the total number of recalls in 2013. In fact, a total of 1,225 recalls occurred in 2013, a significant jump from the 499 recalls in 2012.
According to RAPS, most of the recalls were considered Class II. The U.S. Food and Drug (FDA) administration describes a Class II recall as “a situation in which use of or exposure to a volatile product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.” RAPS emphasizes the importance of taking drug recalls very seriously, no matter the class. Commentators suspect the FDA is heightening its scrutiny in response to a 2012 fungal meningitis outbreak caused by drugs that originated from compounding pharmacies.
FDA Recalls: How Do They Work?
According to the FDA’s informational page on drug safety and availability, recalls are actions taken by a company to remove a product from market when that product poses a possible hazard to consumers.
Recalls can be conducted in any of the following ways:
- On the firm or company’s own initiative;
- By FDA request;
- By FDA order under statutory authority.
Recalls are categorized differently depending on the level of danger they pose to consumers. The following are the different types of recalls:
- Class I: There is a reasonable probability the product “will cause serious adverse health consequences or death;”
- Class II: Exposure to a product may cause “temporary or medically reversible adverse health consequences,” or the probability of serious consequences is “remote;”
- Class III: Exposure is “not likely to cause adverse health consequences;”
- Market withdrawal: The product has “a minor violation that would not be subject to FDA legal action.” Typically, market withdrawals occur when there is no evidence of a problem with manufacture or distribution;
- Medical device safety alert: These are issued in “situations where a medical device may present an unreasonable risk of substantial harm.”
The number of drug and defective medical device recalls is growing every year. It is important to research the side effects of every medication or device you use. In the event that you have been seriously injured by a dangerous drug, contact a product liability lawyer to discuss your options.