After undergoing major surgery, including heart surgery, surgical implants, or joint replacement, it is a great relief to be healed up enough to leave the hospital and go home. After a few weeks or months, everything may be looking positive. However, months or years later, you may find out that the medical device implanted in your body was defective. It may cause infection or break down over time.
Many patients who were involved in a medical equipment defect surgery feel helpless as they try and navigate their options. They may need further surgery, additional medical care, and may have difficulty getting answers from their doctors, insurance company, or the medical equipment manufacturer.
If the medical equipment manufacturer puts out a defective device, they may be liable for any damages caused by the defective equipment. Talk to a medical malpractice attorney about your legal options. Your experienced medical malpractice lawyer can sue the medical equipment company to help you recover damages for your injuries and losses.
Medical Equipment Injuries
Medical devices include any device used in medical care. This could include anything from a scalpel to an artificial heart valve. Medical equipment needs to be held to a higher standard because it is involved in treating medical patients, including contact and use inside the patient’s body. This means this equipment has to be sterilized and disinfected before being used on a patient.
There are a few ways that medical equipment could cause injuries to a patient, including infection, product defect, or equipment left behind in the patient. When medical material is left behind inside the patient, that is generally caused by negligence of the surgeon, doctors, hospital, or medical team.
When medical equipment is defective or not sterile, that may be because of the negligence of the medical equipment company. Medical equipment companies can be strictly liable for any injuries caused by defective equipment. Unfortunately for many patients, these defects are not discovered until weeks, months, or even years after the defective products were used or implanted into the patient.
Injuries caused by medical equipment defects can include pain, infection, replacement surgery, tissue damage, heart attack, or stroke. If defective equipment is discovered, the patient may need to contact their doctor as soon as possible to treat the defect or surgically remove or replace the damaged equipment. Unfortunately, some patients do not find out about medical equipment injuries until too late, and these injuries can be fatal.
Who Is Responsible for Defective Medical Equipment?
Finding out who is responsible for a medical equipment injury is important because it determines liability. In a medical malpractice lawsuit (or personal injury claim), the party liable for the injury has to pay the costs of damages. There may be more than one party liable for the injury and the injury victim may be able to claim damages from either or multiple parties, depending on the state.
In a product liability claim, where the equipment was defective when it was put out to the consumer, the party liable for the defect may include:
- Product designer
- Product manufacturer
- Product distributor
It is not necessarily up to the injury victim to decide who was responsible. If the product was defective and caused the injury, the injury victim may be able to file a claim against any or all of the parties involved. This is intended to make it easier for the victim to recover compensation when they are not in the best position to know at what point the defect occurred.
However, in some cases, the doctor or hospital may also be responsible for a medical equipment injury. For example, if the doctor used some medical equipment in an improper way or against warnings by the product manufacturer, if the doctor’s improper use caused the injury, the doctor may be responsible.
The hospital could also be responsible for a medical equipment injury. For example, if the hospital did not properly maintain, store, or sterilize the medical equipment, the hospital may be liable for damages. Similarly, if the medical equipment was expired or subject to a recall and the hospital continued using the equipment, knowing it should not be used, the hospital could be responsible for damages.
It can be difficult for the injury victim or patient’s family to know who is responsible for the defective medical equipment. This information may come out during the “discovery” phase of litigation, where your attorney can review all the records and testimony from the parties involved to determine which parties are going to be held liable for damages. Talk to your medical malpractice attorney about who might be responsible for a medical injury in your case.
Types of Medical Equipment Defect Injuries
There are thousands of types of medical equipment used every day in surgery and medical treatment. However, some types of medical equipment may be more prone to serious injuries caused by defects in the equipment, design, or marketing of the equipment. Some of the more common and serious medical equipment injury accidents involve:
- Defective hip implants
- Defective joint implants
- Contaminated implant devices
- Pelvic mesh
- Defective stents
- Defective pacemakers
- IVC blood clot filters
- Dialysis filter defects
- Defective pain pumps
Defective Hip and Joint Implants
Over time, wear and tear on the hips, knees, and other joints can cause the tissue, cartilage, and bone to break down. Many older people have difficulty walking or moving because of mobility issues and joint pain. Hip or joint replacement surgery can increase mobility and decrease pain, giving patients a renewed quality of life.
A number of medical device manufacturers have issued a voluntary recall of their hip implant systems, based on possible problems with corrosion, releasing metal debris in the body, and damage to surrounding tissue. In 2010, DePuy recalled their ASR XL Hip Implant, based on poor implant results and the number of patients who had to return to the hospital for revision surgery. According to a New York Times investigation, DePuy likely knew of the poor results long before then but did not disclose the problems to preserve profits.
Contaminated Implant Devices
According to the FDA, “medical implants are devices or tissues that are placed inside or on the surface of the body.” One of the risks of medical implants is infection. Infections are not uncommon, and many infections are caused by outside contamination at the time of surgery. However, some implants may be contaminated before they ever get to the hospital.
Medical devices and medications are supposed to be manufactured under certain sterile conditions, to prevent contamination by bacteria, fungus, or viruses. However, when manufacturing quality control is not ensured, infections can be caused by leaking pipes, faulty ventilation, pests and vermin, or improper handling and packaging.
Implanting contaminated medical devices, or using contaminated medical equipment during surgery can increase the risk of infection. In some patients, even minor infections can be difficult to bring under control and could spread throughout the patient’s body, causing pneumonia, tissue damage, or septic shock.
Defective Pelvic Mesh
Pelvic mesh is a net-like medical implant that is used in pelvic surgery, including treatment for stress urinary incontinence and pelvic organ prolapse. Also known as transvaginal mesh, it provided a lot of promise to patients suffering various pelvic medical conditions. However, a number of problems developed showing the problems with transvaginal mesh. The material the mesh was made from could break down, cause tissue damage, internal bleeding, pain, and absorption into the body. Removal of the mesh was complicated and could involve multiple surgeries. Even after surgery, many patients were left with permanent pain, nerve damage, and organ damage.
Implantable defibrillators are electronic devices that are implanted in a patient to artificially stimulate the heart through electricity. Defibrillators and pacemakers can bring arrhythmia into a more regular rhythm or speed a slow beating heart. Defibrillators can help patients maintain a normal life and help them avoid the risks of a heart attack.
However, there have been some defective internal defibrillators that have been implanted in patients across the decades. Some of these defibrillator defects were fatal. Possible problems with defibrillators and pacemakers were shorts in the system which failed to detect abnormal heart beats or failed to deliver the proper level of electricity to the heart.
Defective Blood Clot Filters
An inferior vena cava filter (IVC filter) is a device implanted in the patient’s artery to prevent blood clots from getting to the heart and lungs. IVC filters can help patients with blood clotting conditions or those at risk of pulmonary embolism. However, there have been defects with a number of IVC filters that have caused injury or death to patients.
In some of the medical device defects, the filter would migrate to different parts of the body, causing damage or rendering them ineffective against stopping blood clots. Other complications included embolization from the device breaking loose, perforation of the filter, or filter fracture. To make the fatal events more tragic, the use of the filter is not always necessary. According to one study, “IVCFs are likely being over-utilized.”
Medical Device Recalls
Many problematic medical devices are recalled by the manufacturer or by the Food and Drug Administration (FDA) but there are other defective devices that are never recalled. In 2021, the FDA issued more than 50 recalls for medical devices. Just a few examples of the recalls from 2021 include:
- CardioSafe Hybrid/Rescue Intra-Aortic Balloon Pumps cardiac assist devices are used in patients undergoing cardiac surgery. Risks of fluid leaks causing pump shutdown or inability to initiate therapy.
- HeartWave Ventricular Assist Device (HVAD) Pump Implant Kit is used to help the heart pump blood to the rest of the body. Devices may fail to start, restart, or have a delay in restarting after the pump has stopped.
- EMBLEM S-ICD (Subcutaneous Implantable Cardioverter Defibrillator) provides electrical shock to stop dangerously fast heart rhythms and pacing. The manufacturing process may allow moisture to get inside the ICD and cause a short circuit.
- Valiant Navion Thoracic Stent Graft System is used to repair lesions on the thoracic aorta. The product is being recalled because of stent fractures and endoleak problems.
- Scalable Bradycardia Platform (SBP) Pacemakers are implantable pacemakers that send a signal to the heart to make it beat at the right pace when it is beating too slowly. Some of these pacemakers have had problems when moisture gets into the device, causing an electrical short.
Every year, there are dozens more device and medication recalls. An FDA recall can provide notice that a medical device may have serious problems but just because your medical device was never recalled does not mean it is safe. The FDA may wait until there are multiple reports of similar injuries before they even begin to investigate the defect claims.
Damages in a Medical Equipment Defect Claim
Damages are the amount of money an injury victim or their family can claim after a medical defect injury. Damages in a medical equipment defect can depend on a number of factors. Common damages in a medical malpractice case include:
- Medical bills
- Cost of additional surgery
- Future medical care
- Lost wages
- Loss of earning potential
- Pain and suffering
Get Started Today With a Lawsuit Against the Medical Equipment Company
Lawsuits involving medical equipment can seem complex, and they may end up taking years before they are resolved. However, you do not have to shoulder the burden by yourself. The benefit of talking to experienced medical malpractice lawyers, like the trial attorneys at Gilman & Bedigian, is that they will take care of most of the case for you. They have the experience to handle these complex claims so you can focus on recovery and getting your life back to normal.
It is important to hold the medical equipment companies responsible for their actions. A medical device defect claim can help other families avoid unnecessary injury in the future. Our attorneys have a lot of experience in medical malpractice claims because they focus on just these types of cases. With the right legal team on your side, you will have the resources to help you recover damages after a medical injury. Contact Gilman & Bedigian online or at 800-529-6162 for a free consultation.