Medical Devices Sometimes Hurt More Than They Help
Every month the FDA recalls a new handful of defective medical devices after it becomes aware of a danger to the public. Unfortunately, it often takes many months before these problems come to the attention of the FDA, and many more before a recall is actually implemented.
By that time, many people may have already been seriously harmed. It is the job of medical device manufacturers to thoroughly test their products and ensure they are safe before shipping them out to doctors’ offices and hospitals, where they have the potential to create serious or deadly harm if they were not designed or manufactured correctly.
The attorneys at the Slechter Law Firm in Louisville help people in Kentucky, Indiana and Tennessee who have been harmed by defective medical devices get compensation for their injuries and get those dangerous products off the market.
Kentucky Law Imposes Strict Liability On Medical Device Manufacturers For Defective Products
Product makers can be held strictly liable for product defects that cause injury. This means that an injured plaintiff does not have to prove that the manufacturer was negligent or knew about the defect; the plaintiff need only show that the product was unreasonably dangerous when it left the manufacturer’s control, and the defective device caused an injury.
Typical defects in medical devices include the following:
- Devices inserted or implanted in the body which break off or detach and migrate to other areas of the body, causing obstructions or perforations
- Foreign particulate matter in saline and other solutions intended for internal use
- Equipment that is improperly sterilized and harbors bacteria, viruses, mold and harmful microbes
- Monitors and meters which report false results or deliver too much or too little medication
- Electrical equipment that loses power or software that fails during surgery or in post-op recovery rooms
Do You Have Injuries From A Medical Device Defect?
Medical products should be approved by the U.S. Food and Drug Administration (FDA) before they make it to the doctor’s office or the drugstore shelf. In its approval process, the FDA classifies medical devices into one of three different categories:
- Class I – There is a reasonable probability that use of or exposure to the device will cause serious negative consequences or death (e.g. automated external defibrillators, metal-on-metal hip implants, pacemakers, breast implants)
- Class II – Use of the device may cause temporary or reversible consequences (e.g. drug infusion pumps, surgical drapes, powered wheelchairs, pregnancy tests)
- Class III – The device is not likely to cause adverse health consequences (e.g. bandages, dressings, enema kits)
In recent years, recalls of fairly harmless Class III devices have decreased, while recalls for the more dangerous Class I and Class II devices have gone through the roof. Although these devices are supposed to be tested and approved by the FDA as safe and effective before they are ever brought to market, product makers have found many ways to get around the premarket approval process.
For instance, they may claim their device is similar to another device which has been previously approved, but they do not account for significant changes in design or the manufacturing process that may make the product unsafe.
Product makers have also been known to mislabel a Class I or Class II device as a Class III device in their application for approval, knowing that these devices receive much less scrutiny from the FDA.
Call Slechter Law Firm For Complete Medical Device Litigation
If you have been harmed during a medical procedure and believe a defective medical device may be to blame, call the Slechter Law Firm in Louisville at 502-694-5407. We help clients throughout Kentucky, Indiana and Tennessee, offering a no-cost, no-obligation evaluation of your potential claims. We are proud to work on a contingency fee basis, where you do not pay us unless we obtain a recovery for you. Please reach out to us online if it is more convenient for you.