As healthcare consumers, we expect medical devices to enhance our well-being. Although they play an outstanding role in supporting our health and allowing doctors to manage or even cure diseases, medical gadgets are produced for profit.
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.
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.
Many patients would be shocked to learn that only a relatively small portion of medical devices undergo rigorous regulatory review. Although the federal Food and Drug Administration (FDA) approves medical devices for sale in the United States, the FDA clears most applications without substantial investigation.
The majority of medical devices enter the market through the 510k program, which 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 percent 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, indicating that both processes are ineffective to properly protecting patients.
The term “medical device” encompasses a broad range of products, from bandages to dialysis machines, to surgical staples and artificial joints. 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, and sometimes the FDA attempts to force a removal, particularly when the item appears to pose 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 be taken off the market. A defective medical device attorney 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 company that made it should be responsible to anyone who consequently suffers 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 mass torts 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 for all your losses in an effective mass tort claim. The manufacturer has a legal responsibility to pay damages to patients who suffered harm because of 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.