As healthcare consumers, we expect medical devices to enhance our well-being. Although they support our health and allow doctors to manage or even cure diseases, companies produce medical gadgets for profit. Every year defective medical devices injure thousands of individuals nationwide. When a medical device fails or malfunctions, patients may suffer irreparable harm. Even if they recover from their injuries, they might endure significant physical and mental suffering because of the faulty equipment. In these cases, people may enlist the assistance of a defective medical device lawyer to help them file a lawsuit against negligent manufacturers.
Device manufacturers are liable for the losses their defective products cause. If you know or suspect medical gear harmed you, allow the seasoned defective medical device lawyers at The Lake Law Firm to help you pursue compensation in a mass tort claim against the responsible parties.
The FDA logs hundreds of medical device reports annually. Medical device reports allow the FDA to monitor the safety of medical devices on the market to determine if the benefits of a product outweigh the risks. Hospitals, patients, and manufacturers include deaths, injuries, and device malfunctions in medical device reports to send to the FDA. Given the alarming amount of medical device reports, many patients would be shocked to learn that only a relatively small portion of medical devices undergo rigorous regulatory review. The federal Food and Drug Administration (FDA) approves medical devices for sale in the United States. However, the agency clears most applications without substantial investigation.
The majority of medical devices enter the market through the 510k program. This program allows for the fast-tracked approval of products that are substantially similar to other products which the FDA has already approved. If a medical product manufacturer submits evidence establishing similarity to an accessory that is legally on the market, the FDA will not review clinical testing or efficacy data before allowing the manufacturer to market it.
The Journal of the American Medical Association published a concerning study in 2021 about medical devices that entered the market between 2008 and 2017. The authors found that more than 97% of medical equipment recalled during that time went through the accelerated 510k approval process. Even more disturbing, the study indicated that the recalled devices which posed the most substantial danger went through the FDA’s intensive clinical review process. This revelation indicates that both processes are ineffective in properly protecting patients.
The term “medical device” encompasses a broad range of products. Bandages, dialysis machines, surgical staples, and artificial joints are all examples of medical devices. Many of these devices could be subject to recall in any given year. In 2021 alone, the FDA issued 56 medical device recalls.
The FDA issues recalls when products are not performing as expected. Sometimes manufacturers withdraw devices from the market on their own when they learn that there is a performance concern. Other times, the FDA forces a removal, particularly when the item presents a safety hazard to patients. The list of medical devices recalled due to safety concerns in recent years includes:
The above list represents only a fraction of medical devices that posed significant enough concerns to warrant market removal. Therefore, you can still reach out if you do not see your defective medical device on this list. A defective medical device lawyer could use a recall as evidence to support an injured plaintiff’s mass tort claim for damages.
All manufacturers must ensure that their products are safe for their intended uses. If a flaw in a medical device’s design, manufacturing, or labeling renders it unreasonably dangerous, the manufacturer is responsible for anyone who consequently suffers any injuries. This means the creator of a defective medical device is strictly liable for all ensuing damages.
It is also possible to bring a claim under the theory of negligence. A manufacturer may be considered negligent if they failed to use reasonable care to protect patients from foreseeable harm. A defective medical product lawyer could file a lawsuit against a manufacturer under applicable standards and fight for a positive case outcome on behalf of injured patients.
If a faulty product negatively impacted your health, you may be able to seek compensation. Manufacturers have a legal responsibility to pay damages to patients harmed by a defective medical device or instrument.
Let our team of diligent attorneys stand up for your rights against these large corporations. Contact a fearless defective medical device lawyer at our firm to take action against the companies that put their profits ahead of the public’s well-being.
The Lake Law Firm was founded by Edward J. Lake, Esq., a personal injury lawyer for over 25 years. Our dedicated team of attorneys is committed to seeking justice on behalf of those who have suffered injury or death due to the negligence of others. Our experienced attorneys handle many different types of pharmaceutical drugs, medical devices, and other defective products. The lawyers in our firm have helped collect millions of dollars for their clients. The Lake Law Firm will advocate for you and your rights. Please contact us for a free confidential case evaluation at (888) 274-0139 or submit an inquiry on this page to speak with a defective medical device lawyer.
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