Each year, thousands of products are recalled due to bad quality, poor performance, faulty design or some other defect. When these failures involve medical devices, the risk of serious illness, injury or death is greatly amplified.
Dangerous or defective medical devices can include (but aren’t limited to):
- Surgical instruments
- Surgical robots
- Surgical mesh
At The Ansara Law Firm, our Fort Lauderdale product liability attorneys know that patients and consumers trust these devices are safe after being thoroughly vetted. Surely, they reason, medical devices wouldn’t be placed on the market unless there was rigorous independent testing, careful assessment of those results and meticulous corroboration of those benefits as compared to the risks – right?
Unfortunately, this is not true. In fact, the U.S. Food and Drug Administration (FDA), the federal agency responsible for regulating approval of medical devices since 1976, doesn’t actually test these products itself. The agency instead trusts manufacturers to fully test their products. As you might expect, some companies fail to conduct adequate research in the rush to get their product to market so they can start turning a profit.
The FDA’s regulatory oversight has not fully kept the pace with the increasing complexity of medical technology. What’s more, the agency allows “substantially similar” devices – which are deemed to be much the same as a product already on the market – to get a pass on the stringent testing they would otherwise need to undergo.
Even worse, as The New York Times has reported, there are a wide range of high-risk medical devices available today that received FDA approval on the basis of a single clinical trial (in contrast to most pharmaceutical products, which require two trials). Even in those studies, only a small sliver meet the gold standard for reliable medical testing, meaning they are:
That’s why it’s not surprising that in recent years there has been an uptick in warnings, recalls and outright withdrawals of medical devices for which the danger was only fully discovered once it hit the market. Essentially, the public – specifically, the ailing public – is being used as guinea pigs.
If you have been injured or suffered some other damages as a result of using a defective medical device, there may be grounds for a product liability claim. Our experienced injury lawyers can help.Proving Medical Device Injury Claims
Although medical devices can improve and even save lives, they may pose an unreasonable risk of injury when they are not properly tested before being released to consumers. It’s worth noting that a poor medical outcome alone is not necessarily enough to prevail on a defective product claim.
Plaintiffs in defective medical device lawsuits need to show:
- The device was defective;
- The company failed to warn of possible complications;
- Plaintiff’s injuries were legally caused by the defective device.
No person is guaranteed a positive outcome when undergoing surgery or using some type of medical device. The key in these cases is usually showing plaintiff was deprived of making an informed choice.Medical Device Recalls
When medical devices prove dangerous or fail to perform as expected, a recall may be in order. The goal of a recall is to inform patients of the risk and remove dangerous products from the market. In many cases, medical device recalls trigger legal action because they provide patients with a clear link between the medical device and the complications they are experiencing.
As the FDA notes in Subchapter 7.1 of its Investigators Operators Manual, recalls are classified in different ways, depending on whether the action was ordered by the FDA or voluntary on the part of the manufacturer. They may also be categorized based on risk to the public.
- Class I Recall: Ordered by the FDA when there is “reasonable probability” of serious negative health effects, up to and including death.
- Class II Recall: Ordered by the FDA when use or exposure to the device could cause negative health effects that are temporary and could be reversed with medical intervention. Could also be ordered when there is risk of severe injury, but the risk is remote.
- Class III Recall: Ordered by the FDA when the product violates industry standards, but isn’t likely to cause negative health effects.
If you have been injured by a defective medical device – whether it’s been recalled or not – we can help.
Contact Fort Lauderdale Defective Product Attorney Richard Ansara at The Ansara Law Firm by calling toll-free (888) 267-2728.