Medtronic Recalls Series of Medtronic Cardiac Resynchronization Therapy with Defibrillation (CRT-Ds) and Implantable Cardiovert-Defibrillators (ICDs)
According to the United States Food and Drug Administration, the medical device manufacturer Medtronic has issued a recall of some of its defibrillator products. Specifically, the recall lists Medtronic Cardiac Resynchronization Therapy with Defibrillation (CRT-Ds) and Implantable Cardiovert-Defibrillators (ICDs).
The devices were manufactured between July 13, 2013, and August 8, 2017. Thus far, 48 units have been recalled in the United States.
Implantable cardioverter defibrillators are inserted just under the skin on the chest. The device monitors the patient’s heart rate and helps regulate it with electrical pulses. The ICD monitors the heartbeat through wires that are actually attached to the heart. A cardiac resynchronization therapy implantable cardioverter defibrillator (CRT-D) is a special type of ICD that is used in treating heart failure. The CRT-D has an extra lead that is secured to the left ventricle of the heart. If the CRT-D senses an abnormal heartbeat, it corrects it by delivering an electrical shock to the heart.
Both of these devices can slow a heartbeat that is too fast or speed up a heartbeat that is too slow.
Both ICDs and CRT-Ds are used to treat a variety of heart conditions. They may treat tachycardia (a heart rhythm that is too fast), bradycardia (a heartbeat that is too slow), or heart failure.
Medtronic has issued the current recall because of a manufacturing defect in the ICDs and CRT-Ds. The defect may lead to an “out of specification gas mixture” inside the defibrillators, which could stop the devices from providing electrical current. A patient with a defective device could be at serious risk of death if the patient’s heart rate is not paced properly or if the patient is not revived while in cardiac arrest.
The recall is a Class 1 recall, which, according to FDA standards, is the most serious type of recall because using the recalled device could result in serious injury or death.
How do I know if my Medtronic defibrillator was affected by the recall?
In January of 2018, Medtronic sent out a notice to its list of customers who had received the faulty devices. The notice, called an Urgent Medical Device Recall, suggested that customers should:
- Contact their Medtronic representatives to discuss possible warranties
- Consider replacing their devices as soon as possible
- For medical professionals, staff should be made aware of the recalls
If you believe that your device is included in the Medtronic recall, you should make an appointment with your defibrillator physician as soon as possible to determine what steps you should take.
If I am injured by a faulty medical device, what happens?
The FDA issues recalls on medical devices, drugs, and other items regularly throughout the year. However, a recall does not have to be issued on a product for a consumer to recover damages if that product causes injuries.
If a product injures a consumer, that consumer may be able to file a products liability lawsuit. In a products liability lawsuit, the consumer must show:
- The consumer was using the product as directed or as anticipated by the manufacturer
- The product was defective
- The consumer was injured
- The device’s defect was the direct cause of the consumer’s injuries
Each of these elements must be proven for a consumer to prevail in a products liability claim. Without one of the elements, the Medtronic defibrillator claim will fail, and the consumer will be responsible for the damages he has suffered.
There are three principal types of product defects:
- Design defects
- Manufacturing defects
- Marketing defects
With design defects, the problem lies in how the product was designed. For example, the design of metal-on-metal hip implants was a problem because the metal would rub together and leach metal ions into the body.
If the defect is a manufacturing defect, an issue arose during the creation or distribution of the product. Manufacturing defects may occur at any point during production or as the product is being passed on to consumers. In the current Medtronic recall, a manufacturing defect is what is causing the devices to fail in some situations.
With marketing defects, the manufacturer has failed to provide proper instructions or warnings with a product. For example, if the manufacturer knows that a device is more likely to fail in certain patients, the manufacturer should ensure that this information is provided to medical professionals and in product packaging.
To prove that the product is defective, a products liability attorney should be consulted. Medtronic defibrillator lawsuit attorneys will request all necessary information from the manufacturer and from other sources. For example, they may study internal company records, clinical trial results, photographs, surgical reports, and other documents. Medical experts are often consulted in medical device products liability claims.
The consumer must also show that he or she was using the product as directed or as anticipated by the manufacturer. In many cases, the consumer cannot control what happens with the device, as in the case of surgically implanted devices. However, if the patient failed to follow-up as required with a medical professional, the manufacturer may use this fact to avoid some of the liability for the device failure. If the device is within the patient’s realm of control and the patient does not take care of the device as directed, the manufacturer again may attempt to avoid some liability for the device failure.
Proving that the product’s defective nature is what caused the injury may be challenging, depending on the nature of the claim. However, with the assistance of our Medtronic defibrillator lawsuit attorney, the consumer may rest assured that the strongest evidence is being presented to the court.
Evidence in a Medtronic defibrillator lawsuit may include:
- Medical records
- Medical bills
- Expert medical reports
- Eyewitness statements
- Internal company documents
- Clinical trial reports
- Pay stubs and/or tax returns (to show income if lost wages are sought)
Many other types of evidence may also be submitted, depending on the facts of the case.
As for damages, the amount a consumer may be entitled to vary depending on how severe his injuries are, as well as a number of other factors. Damages may include:
- Medical expenses incurred to treat the injuries associated with the faulty product
- Lost wages
- The estimated expense of future medical care
- Pain and suffering
- Emotional distress
- Loss of consortium
- If the manufacturer’s behavior was reckless or egregious (for example, misleading the public about the safety of a product), punitive damages might also be awarded. A court may order punitive damages to both punish a defendant and to deter other manufacturers from behaving in a similar manner.
Other damages may also be included, depending on the circumstances of the claim.
To maximize recovery in a Medtronic defibrillator lawsuit, a Medtronic lawsuit attorney from Parker Waichman LLP should be consulted as soon as possible. There are deadlines to file your Medtronic defibrillator lawsuit. If a consumer misses this deadline, the consumer will be responsible for the financial costs he has endured.
Call Parker Waichman LLP today to schedule a free consultation
At Parker Waichman LLP, we are experienced in all types of medical device products liability lawsuits. To schedule your free consultation with our team, call 1-800-YOURLAWYER (1-800-968-7529) 24 hours a day, 7 days a week.
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