Record-Breaking Year for Medical Recalls

Clore Law · December 24 2014

According to the Regulatory Affairs Professionals Society (RAPS), 2014 has been a record-breaking year, but not in a good way. The US Food and Drug Administration (FDA) has been working at break-neck speeds to get dangerous drugs and unsafe medical devices off shelves. The number of faulty products is alarmingly high, which means consumers have been at a much greater risk for personal injury this year than in prior years. Recall Classification The FDA breaks their recalls into three classes.

• Class III recalls involve items which are not likely to cause someone harm. The FDA might issue one if the product's labeling is somehow incorrect or not in English.
• Class II recalls involve products which might cause a slight or temporary issue. For example, a medication which is not used to treat life-threatening illnesses, but is under-strength, could be classified as such.
• Class I recalls are the most urgent, and they include defective products that may be fatal or cause serious illness and injury.

Frequency of Recalls Typically, the FDA recalls somewhere between 13-75 hazardous devices on any given day, and they are generally not urgent. Of the products recalled over the past 10 years, approximately

• 86% have been Class II recalls
• 7% have been Class III recalls
• 6% have been Class I recalls

Largest Recall Ever Sadly, August 2014 broke the records. Rather than the typical 13-75 daily recalls, the FDA issued 233 in a single day, all for products belonging to one company. The items in question were sterile packs, which are commonly used in surgical procedures in hospital and outpatient settings. They were manufactured by a company called Customed and were defective due to an adhesion issue or packaging flaw which could then result in the contents losing their sterility. Though this design flaw appears small, it could also lead to doctors using contaminated instruments during procedures. To put the severity of this recall into perspective, the prior record-holder only involved 28 Class I recalls. It also occurred in 2014. Although the final numbers for 2014 have not yet been compiled, it may be the worst year on record for recalls. The year with the most recalls previously was 2013, and it included 1,225 products over all three classes. By August, 2014 was a mere 390 recalls away from taking the lead. Around the country, and in Charleston, personal injury claims are likely to increase along with this trend. Unfortunately, we live in a world where defective products are released, in which the FDA makes mistakes and approves drugs that should not be approved, and 90% of drug compounding facilities have "objectionable conditions,"as identified by FDA inspectors.

Charleston Medical Recall Attorney

The impact that these defective products and unsafe drugs can have is devastating. They can cause injury and cut lives short. If you have been injured or have lost a loved one due to a harmful medical product, you may be entitled to compensation. Moreover, bringing your case to light may help put an end to the release of hazardous products. If you'd like more information or a consultation at no charge, please use our online form or speak directly with one of our attorneys by calling 1(800)610-2546.