The FDA is on pace to recall more defective medical devices in 2016 than in any previous year. Eight factors are driving the number of recalls to increase each year.
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1. Poor Information
There are several layers between a medical device manufacturer and the patient. Without adequate information about the care and installation of the device, the manufacturer risks a lawsuit from a defective medical device lawyer in Reno, NV. The device must have clear instructions for cleaning and operation, as well as warning signs for improper use.
2. Rush To Test
A defective medical device lawyer like Matthew Sharp often cite manufacturers rushing through the testing process as a leading reason for device recalls. Companies invest millions of dollars into a new technology, and they are unable to recoup any of the investment until the product hits the market. Once the first clinical trials prove positive, the company hurries through the rest of the procedure, without giving enough time for long-term problems to become apparent. The FDA contributes to the problem by expediting approval for devices in high impact areas.
3. Minimizing Negative Information
In the rush to get the product to the market, companies sometimes ignore or minimize the negative information they receive. The company may blame abnormal results on an outlier in the patient pool or a bad batch of products. They may also claim the percentage of people injured by the product is an acceptable risk. A defective medical device lawyer such as Matthew Sharp can show the company minimized negative data, and consequently, may pursue substantial economic and non-economic damages.
4. Faulty Design
Poor device design is the primary reason for a device recall in approximately 17 percent of cases each year. In most instances, the design fails in one of two ways. The most common failure occurs when an internal device comes loose in the body. Another common design failure causes the product to leak into a patient. Lubrication in fabricated joints and overmedication through internal pumps are the leading causes of leakage. A defective medical device lawyer can hold the manufacturer responsible for either failing to instruct doctors on the proper method of installation or for designing the product in such a way that safe installation was impossible.
5. Software Hacking
The issue of device hacking rose to prominence in 2010 and 2011, when hackers were able to deliver fatal doses of insulin through a Medtronic insulin pump. With remote monitoring and access, an increasingly important feature for medical devices, the problem of software hacking will not end any time soon. Nearly 15 percent of all recalls involve some sort of software issue: either a security vulnerability or a poorly functioning code.
6. 510(k) Approval For Defective Products
Companies who can demonstrate their product is “substantially equivalent” to a product that already achieved FDA approval, may apply for expedited approval of their own product through the 510(k) premarket notification program at the FDA. The program allows consumers access to lower priced medical devices in the same way generic drugs lower the cost of prescriptions. In many cases, a defective medical device lawyer may reveal that the device initially granted approval was somewhat questionable or poorly functioning. Each device that then followed the original design deviated further and further from the approved product, increasing the potential for numerous unexpected and potentially life-threatening failures.
7. Insufficient Warning System
Even the best designed medical devices can develop problems over time, and companies incorporate warning systems to let doctors know when a problem is developing before serious injury occurs. A defective medical device lawyer can hold companies responsible for failure to include proper warning systems into their device or for not educating doctors and patients about how to interpret an existing warning system.
8. Off Label Use
The FDA approval process grants permission for a company to sell and market a device for a very specific purpose. Any use of the device outside of that purpose is considered “off label.” Both a doctor and the manufacturer may be held accountable for off label use. Unless the situation met several stringent criteria, a doctor is liable if he or she knowingly used the device for an off label purpose, even if the doctor received consent from the patient. A manufacturer can be held liable if the company marketed the product, directly or indirectly, for off label purposes.
As the number of medical devices continues to rise, patients will need the government and medical device attorneys like Matthew Sharp to protect the public from malfunctioning devices. These eight factors account for the majority of medical device recall cases, but the list of reasons for recalls will only grow as technology improves and more devices become available.
