Due in part to increased federal oversight, this year has already seen record numbers in pharmaceutical recalls. The most common causes of drug recalls include contamination, packaging defects, safety problems and improper testing. Drug recall lawyers at Pintas & Mullins Law Firm have seen too many patients seriously injured and killed by recalled products.
Every recall is classified according to a three-tiered system, with Class I being the most serious and Class III being the least. Classifications are made by the FDA, and Class I recalls may only be made if the product or drug could reasonably cause serious injury or death.
An example of a Class I recall was the recent announcement from Cubist Pharmaceuticals concerning its Cubicin (daptomycin) injectable drug. According to the company, several lots of Cubicin may be contaminated with foreign particulate matter, such as shards of glass or plastic. Any presence of foreign particles in a drug that is meant to be injected is incredibly dangerous, with potential to cause life-threatening pulmonary embolism.
Other serious health consequences of injected a contaminated drug include blockage of the capillaries or arteries, activation of platelet, or skin-surface blood clots.
Cubicin is prescribed to patients with skin infections and certain types of blood infections. Patients who have received injections of Cubicin that may have been contaminated will receive notification by letter of phone. The drug manufacturer is also arranging for returns to be made of the recalled product from hospitals and pharmacies. Any questions regarding this recall should be directed to Cubist Pharmaceuticals at 877-534-8309.
The FDA has been in charge of managing drug recalls for several decades; however, only recently has it overseen an unprecedented surge. For example, ten years ago, 166 recalls were reported to the FDA. Just over halfway into 2014, and there have already been 836 recalls reported – last year, there were 1,225.
These numbers are raising many questions among experts about what exactly is driving this surge. According to the Regulatory Affairs Professionals Society (RAPS), most of the increase in recalls is in Class II. These drugs classified as this type are likely to cause temporary or reversible adverse health complications – but are often nonetheless serious. Of the 1,225 recalls last year, more than 1,000 were considered Class II.
Many health officials believe that this surge is also caused by a new FDA
rule implemented in 2012. In that year, a compounding pharmacy caused
a national outbreak of fungal meningitis, which killed dozens of patients
and injured hundreds more – nearly 500. Compounding pharmacies (which
are facilities that make specialized medicines for individual patients)
were previously regulated by state health departments, which are notoriously
After the fatal outbreak, the FDA announced it was taking control of compounding pharmacy oversight, inspecting all facilities in the country. As a result of these inspections, a sizeable amount of Class II recalls were issued due to possible contamination. Class II recalls are also often the result of poor manufacturing practices and other similar deficiencies.
Our team of drug recall lawyers is currently investigating cases of serious injury and death from dangerous or recalled drugs. If you have any questions regarding lawsuits against drug makers, contact our firm immediately. Our legal consultations are always free, confidential, and available to concerned families nationwide.