Alarming Surge of Medical Device and Pharmaceutical Recalls in First Quarter of 2018

Medical devices help millions of people. However, many of the devices that are created to help individuals achieve a better quality of life are plagued with poor design issues and manufacturer defects. One of the major problems is manufacturing companies failing to perform or allow the proper testing necessary, to ensure their devices and drugs are safe and dependable for patients to use.

The problems are only increasing. Recent statistics that show a marked increase in medical device recalls. During the first three months of 2018, product recalls increased significantly in the medical device and pharmaceutical industry sectors, according to the U.S. Recall Index published by Stericycle Expert Solutions. Stericycle Expert Solutions provides recall data for a number of different industries including medical device, pharmaceutical, food, consumer product, and automotive.

Medical device recalls

In the first quarter (Q1) of 2018, medical device recalls increased by 126 percent. This represents the highest quantity of recalls in a single quarter since 2005. The major culprit was software problems, as it had been for the seven previous quarters. It accounted for nearly 23 percent of device recalls. Recalls of medical devices increased to 343 in Q1, a higher tally than all medical device recalls in 2017. Software issues, quality issues, mislabeling issues, and outside of specification issues are the leading causes of these recalls. Nearly 187 million average Class I devices were recalled in Q1. A little more than half of all medical device recalls covered the entire nation.

Per Medical Design & Outsourcing:

“The healthcare sector in Q1, both medical device companies and pharmaceutical manufacturers, saw significant increases in recall events,” Mike Good, VP of marketing and sales operations at Stericycle Expert Solutions, said. “Issues ranging from software to mislabeling in med device, to failed specs and foreign materials in pharmaceuticals caused pretty dramatic spikes and show that you have to be vigilant and act on recalls when they happen, especially when your health is on the line.”

Pharmaceutical recalls

Q1 2018 also saw pharmaceutical recalls rise by 52 percent, resulting in the largest number since 2013. Failed specifications were the reason for 22 percent of pharmaceutical recalls, and the top reason for the eighth consecutive quarter. The total number of pharmaceutical recalls rose to 105, with approximately 332.5 million recalled units. This quantity represents the largest number since Q2 of 2007. The breakdown of dangerous drug recalls was as follows:

• 9% – failed specs
• 2% – sterility issues
• 3% – mislabeling
• 4% – foreign materials found in the drug, its packaging, etc.
• 5% – subpotency of the drug

The Recall Index says 79 percent – nearly 4 out of 5 recalls – affected the entire country.

At McGowan, Hood, Felder & Phillips, LLC, our team of defective medical device lawyers offer comprehensive and aggressive representation for individuals who have incurred injury, pain, and suffering due to the effects of a dangerous medical device or drug. We can review your case and discuss your options for filing a possible lawsuit to obtain the financial recovery you deserve. Find out how we can help you. To arrange a free, initial case evaluation, call us today at 803-327-7800 or send us a message through our convenient contact form.