Manufacturer Role in Medical Device Malfunction
November 03, 2015 | Finz & Finz, P.C.
Blood thinners are the go-to treatment option for many people with blood clots, as the risk profile of these medications is frequently lower than other treatments. But for those who can’t tolerate blood thinners for a variety of reasons, there are other options. One of the more common treatments is a device called a blood clot filter.
The functioning of the filter is fairly simple. The filter is shaped like a spider, with metal legs coming off a body. The legs are designed to catch and hold clots, allowing the body to break them down slowly rather than have them traveling to the heart or brain and causing heart attack or stroke.
Many manufacturers produce these filters, but one company in particular has drawn attention for the negative outcomes associated with their device. Investigators noted that a larger percentage of people with the C.R. Bard produced filter had negative outcomes, including dozens of deaths. Though all the filters had some amount of negative outcomes, the C.R. Bard filters had large amounts of severe difficulties.
As regulators began to ask questions, it became more and more clear that C.R. Bard had woven a web of deceit to even get their product approved by the FDA. Allegations include:
- Suppressing evidence that the device had a high rate of malfunction
- Forging signatures when experts wouldn’t sign off on the device
- Collusion of company executives to lie about the rate of injury and death associated with the product
The device has malfunctioned in a variety of ways, including at least one incident where the filter came loose from the blood vessel and caused full occlusion of the heart. The danger level when a product like this fails or malfunctions is extreme, with the likelihood of death or serious debilitation extremely high.
If you or someone you love has suffered due to medical device malfunction, determining whether or not the malfunction was caused by faulty design, faulty manufacturing, or some other cause is extremely important. There are many products on the market produced by dishonest companies, and it is important to make sure others are aware of the risk. Please contact an attorney who can guide you through the proper steps of getting the device off the market.
Additional Info: Medical Devices
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