Why Are Medical Device Recalls on the Rise?

Most patients are willing to put their trust in the medical professionals around them. While these trained professionals have spent years learning how to properly care for patients in different ways, things can still go wrong because of defective or dangerous medical devices and drugs.

Over the past few years, we have noticed an increased number of recalls of defective devices and dangerous medications. The cause of these recalls varies. For example:

• Medtronic recently recalled a number of its MiniMed insulin pumps because there is a chance that these pumps can be hacked.
• Teleflex has put out a list of recalled endotracheal tubes that have failed to work properly due to a disconnection issue. Four people have died from the use of these tubes, and others have been injured by them.
• Lupin Pharmaceuticals Inc recalled more than 18,000 bottles of the antibiotic Cefdinir because of “complaint received of metal piece identified in the product bottle prior to the reconstitution.”

According to Becker’s Hospital Review, additional recalls have been made for microbial growth found in medications, defects leading to inaccurate test results, contamination concerns, and expired dates for medication.

Why is the FDA failing to do more?

The Food and Drug Administration (FDA) is responsible for sending out recall notices when products in the medical industry are potentially contaminated, or dangerous to use and consume. (Companies often send out voluntary recall notices on their own, in conjunction with the FDA warnings.) The questions remains, though: why isn’t the FDA stopping these defective products from reaching the market before a recall is required?

In some cases, it is because the compounding facilities are located outside of the United States. Drugs manufactured overseas are supposed to be made in facilities that meet U.S. standards, but that is not always the case. This is what happened with the Valsartan recall.

Some of these recalls are related to the 510(k) testing that allows manufacturers to fast-track products that are based on other medical devices. This allows the manufacturers to skip some important steps, especially when it comes to testing a product. This is what happened with DePuy’s cobalt-based joint replacement systems, and with the transvaginal mesh manufacturers by Ethicon, a subsidiary of Johnson & Johnson.

What is most troubling, however – and what the FDA needs to be held accountable for – is the number of inspections it is actually performing. Between October 2018 and December 2018, there were 29 completed inspections for human medications, and 3 completed inspections for medical devices. Out of the 17,468 full-time FDA employees, more than 7,000 work in the areas of medication and medical device research. One would be forgiven for wondering why so few inspections are performed each month, given the number of employees.

If you were injured by a defective medical device or dangerous drug, Harris Lowry Manton LLP can help you decide which stops to take next. Our experienced medical product liability lawyers in Atlanta and Savannah have obtained millions of dollars on behalf of clients. To discuss your options in a free consultation, please call our Atlanta lawyers at 404-961-7650, our Savannah attorneys at 912-651-9967, or fill out our contact form.