The U.S. Food and Drug Administration (FDA) is the federal agency tasked with approving drugs and medical devices. Once something has been approved for use, there may be reasons why the item is recalled later on. Usually it is because some users have discovered that in the case of a drug that it is causing some harm or in the case of a medical device that it is faulty or potentially faulty and that this fault can cause harm.
When the FDA receives significant notice that something it has approved could cause “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death” it issues a Class I recall.
Unfortunately, manufacturers of drugs and medical devices do not always spend enough time trialing a newly designed product before wanting to put it on the market. The fact that the FDA approves a particular product is not always a guarantee that the product is entirely safe. The FDA works on the basis that in their professional opinion the benefits of a particular product appear to be greater than the potential risks.
Manufacturers are often under considerable commercial pressure to release a product on the market and recoup profits from its sale before a competitor does. The current Covid-19 vaccine trials are a case in point. Vaccine research is under huge pressure to make an effective coronavirus vaccine available as fast as possible. There is a combination of public health, economic, commercial and, in some cases, political pressure to speed up vaccine trials. The FDA has to strike a balance between approving a vaccine once ready for submission and being cautious in case there are serious side effects down the track.
A case study: The FDA’s Class I recall of Medtronic’s HeartWare heart pumps
Earlier this year, the FDA issued a Class I recall of a medical device manufactured by Medtronic called a heart pump. The heart pump is an electrical device that helps someone with a weak or damaged heart pump blood through their left ventricle. The left ventricle is the largest of the human heart’s four chambers and its job is to pump oxygenated blood around the body. Some types of heart failure involve weak ventricles that cannot pump quite enough blood fast enough around the body.
In the case of this particular heart pump, it is battery operated and the battery is kept charged with a d.c. or a.c. adaptor. If the battery charging device fails, the battery goes flat and that means that the device controller stops working. This is what has happened to the Medtronic device. There was a fault in the design of the battery adaptor, causing occasional breaks in the charging capacity.
It took 36 complaints and a death before Medtronic initiated a recall of all its HeartWare heart pumps. The FDA followed this with a Class I recall. The recall is important because the fault could interfere with someone’s heart function while asleep at home or when being transported to or from a hospital.
Other problems with Medtronic devices
Medtronic has had to issue recalls for its other medical products before. The most serious followed the manufacture of a bone graft. People who underwent surgery with Medtronic’s Infuse bone graft system suffered from numerous symptoms including dizziness, paralysis, problems breathing and swallowing ad nerve damage. It was alleged that Medtronic did not provide sufficient information about potential risks before its release. Over 100 defective product lawsuits followed and around 500,000 complaints from patients.
In 2012, Medtronic was alleged to have stolen a heart valve patent from a competitor.
In November 2019, the FDA issued another Class I recall for more than 160,000 catheters manufactured by Medtronic. These defective catheters would break up in use, potentially causing serious injury. Luckily, although there were many complaints before the device was recalled, no one was permanently injured or killed.
Defective medical device claims
If you have been prescribed a drug , had a medical device fitted, or one used, that turns out to be a failure, you may be able to claim compensation, whether there has been a recall issued or not. To make a claim for negligence, you will need to be able to prove to a court that the drug or device was dangerous to your health, and that the company manufacturing it or marketing it was either aware that there was a defect, had not sufficiently informed users of the product of potential risks or had circumvented proper protocols and not done sufficient safety checks before release of the product.
Defective medical devices can cause serious injury, illness or even death. If the use of a defective device has happened to you, you will need legal advice before proceeding with a lawsuit against the manufacturer or distributor or both.
Contact a defective product attorney at the Keith Williams Law Group in Nashville for aggressive representation in the event of an unexpected injury. The office can be contacted at (615) 313-3999.