Defective Medical Device Lawsuits Each year in the U.S., thousands of people are injured by medical devices and suffer serious injury, permanent disability or even death. Seeger Weiss attorneys have helped people or loved ones of those injured by medical devices, obtain compensation for their injuries, pain and suffering or other damages. FREE CASE EVALUATION Menu ABOUT Lawsuits alleging that medical devices were defective are typically brought as product liability cases. Despite regulation by the United States Food and Drug Administration (“FDA”), some medical devices do not function properly for a variety of reasons, and as a result, individuals are injured. If you are injured by a medical device it is important to be aware of the most common defective medical devices, injuries, and the laws and regulations that apply to a potential claim. WHAT IS A MEDICAL DEVICE? FDA Definition – The FDA defines a medical device as an instrument, apparatus, machine, or implant that diagnoses, cures, mitigates, treats, or prevents a medical condition. Medical devices can also affect the structure or function of the body. Combination Products – Some medical devices include a combination of medical device and a drug. An example is a drug-eluting cardiac stent, which is a medical device that also contains a time-released drug that helps prevent blood clots. WHAT IS NOT A MEDICAL DEVICE? A Drug – Medical devices in general do not have a drug purpose. Software Products – These include data storage and electronic patient records. TYPES OF DEFECTIVE MEDICAL DEVICES CAUSING INJURIES Hip Replacement Devices or other Artificial Joint Products Pumps for Vital Medication such as Insulin or Pain Treatment Implanted Surgical Products like Surgical or Transvaginal Mesh Cardiac Defibrillators or Pacemakers Cardiac Surgical Intervention Devices like Stents and Filters COMMON INJURIES FROM DEFECTIVE MEDICAL DEVICES Permanent Disability Psychological Trauma Chronic Pain Additional Surgery Birth Defects Other Medical Complications Death LAWS AND REGULATIONS REGARDING DEFECTIVE MEDICAL DEVICES Product Liability Laws Medical devices are products, and as such, product liability claims apply if the devices are defective and injure individuals. State Laws Product liability claims are brought under the laws of each state. The state laws vary but in general, a plaintiff would proceed with a product liability claim based upon the theories of negligence, strict product liability or breach of warranty. Negligence – In a negligence claim concerning a defective medical device, the plaintiff must show that the manufacturer, seller, or supplier owed a duty of reasonable care to provide users with safe products. Strict Product Liability – Under this theory, a person injured by a defective medical device can sue without having to prove negligence. It is still necessary, however, to show that the medical device was defective and that it caused injury. Breach of Warranty – A warranty applies in a defective medical device claim because these products are generally warranted or claimed to meet specific quality, performance and safety standards. Federal Laws FDA Regulation of Medical Devices The FDA is responsible for regulating the approval and sale of medical devices in the United States, with approximately 6,500 different categories of medical devices currently approved. Within these categories there are approximately 200,000 different products. There are only a few defective medical devices that are ultimately responsible for almost all the injuries. The Federal Food, Drug and Cosmetic Act (“FD&C Act”) The FD&C Act is contained in Section 21 of the Code of Federal Regulations, and includes regulations that manufacturers and distributors must adhere to regarding the registration, classification, reporting, scientific evidence of safety, labeling, premarket approval, and quality regulation of medical devices. Registration – Companies that manufacture or distribute medical devices must register their organization and the medical devices with the FDA. Classification – Medical devices are classified as Class I, having the least potential risk, such as band aids and stethoscopes, Class II, intermediate risk, including medicine infusion pumps and CT scanners, and Class III, having the highest risk to patients, such as cardiac pacemakers, and stents. Reporting Requirements – If a medical device causes serious injury or death it must be reported to the FDA. Manufacturers must use a specific form for their reports, but healthcare providers and consumers can use the Medwatch form to report adverse events. https://www.accessdata.fda.gov/scripts/medwatch/? Scientific Evidence/Premarket Approval – Prior to marketing a Class III medical device, the FDA requires manufacturers to submit safety and effectiveness data that includes a plan of investigation or clinical study for the medical device. Labeling – Labels are required on all medical devices and must conform to FDA rules. Premarket Notification – Clinical studies are not required, under an exception in Section 510(k) of the FD&C Act, if manufacturers can demonstrate there is already a substantially similar product on the market. Manufacturers only need to submit a notification prior to marketing, indicating the device is safe, effective, and substantially equivalent to a legally marketed device. Quality System Regulation – The FDA has requirements that relate to the methods, facilities, and controls for medical devices. These rules specify the methods of purchase, design, manufacturing, packaging, storing, installing, and servicing of medical devices. WHO CAN SUE FOR A DEFECTIVE MEDICAL DEVICE? Any Individual Injured by a Defective Medical Device – You may sue if you had a medical device implanted in your body and suffered adverse effects. Family Members Eligible to Sue – Relatives of the injured party may also be part of the lawsuit if those family members suffered economic or emotional injury. WHO IS LIABLE FOR INJURY FROM A DEFECTIVE MEDICAL DEVICE? Manufacturer Retailer Healthcare Professionals Supplier of Materials and Components HOW CAN I PROVE MY MEDICAL DEVICE WAS DEFECTIVE? Product Liability Claim Injury – You must establish that you were injured by the defective medical device. Medical Device is Defective – You need to show that the medical device has a defect in the design, manufacturing, or marketing of the product. Causation – The defect must be the cause of your injury. HOW MUCH MONEY CAN I RECOVER FOR A DEFECTIVE MEDICAL DEVICE CLAIM? The amount of damages in defective medical device cases varies depending on the facts of the injury, but there are specific types of damages that you should be aware of when calculating your potential recovery. Types of Damages When seeking compensation for injuries or deaths caused by defective medical devices, victims or loved ones of those injured, may be eligible for a combination of economic and other compensatory damages, including: Medical costs Lost wages Pain and Suffering Loss of Consortium (Includes loss of family relationship, affection, and sexual relations) Wrongful death Punitive Damages In some cases, if it can be proven that a manufacturer knew that a device was defective but continued to sell it anyway, they may be forced to pay punitive damages as well. Punitive damages are intended to punish the company and may be much higher than other awards. SEEGER WEISS LLP DEFECTIVE MEDICAL DEVICE LAWSUITS AND INVESTIGATIONS ASR Hip Replacement Lawsuit What Happened? Seeger Weiss LLP, was a member of the Executive Committee and Negotiating Committee on behalf of thousands of victims who brought lawsuits against Johnson & Johnson and subsidiary Depuy Orthopaedics, alleging that their defective ASR hip replacement implants caused infections and other complications, requiring revision surgery. How Much Did Plaintiffs Receive? The firm ultimately negotiated an almost $3 billion settlement for the plaintiffs. MEDTRONIC DEFIBRILLATOR INVESTIGATION What Happened? Seeger Weiss LLP is investigating claims against Medtronic, Inc., a Minnesota based company, which is one of the largest medical technology companies in the world. Our firm is considering filing a class action lawsuit against Medtronic relating to its manufacturing and sales of approximately 87,000 implantable cardioverter defibrillators (“ICDs”) and cardiac resynchronization therapy defibrillators (“CRT-Ds”), that contain potentially life-threatening defects. What are ICDs and CRT-Ds? ICDs and CRT-Ds are surgically-implanted devices that are designed to monitor heart rhythm, and if necessary, shock or pace the heart into normal rhythm when patients suffer rapid, life-threatening heart rhythm disturbances that can lead to cardiac arrest. Medtronic Defects In February 2005, Medtronic notified doctors of a defect in approximately 87,000 ICDs and CRT-Ds that were manufactured between April 2001 and December 2003. This defect in the Medtronic devices may cause the defibrillators to short out or rapidly deplete the battery. What is the Potential lnjury? If the defibrillator shorts out or the battery is depleted the device will not work when it is needed, without any warning. If the devices fail when needed, the risk to the patient is potentially life-threatening. The batteries that operate ICDs and CRT-Ds are contained in the implanted device and, therefore, to eliminate the potential defect, the device must be surgically removed from the patient and replaced. The surgery necessary to remove the device has many risks. Medtronic Recalls Medtronic recalled numerous ICD and CRT-D models in 2004 and since Seeger Weiss LLP commenced its investigation, Medtronic has recalled additional models that were manufactured between 2013 and 2017. https://www.fda.gov/medical-devices/medical-device-recalls/medtronic-recalls-cardiac-resynchronization-therapy-and-implantable-cardioverter-defibrillators-due#list CONTACT SEEGER WEISS LLP REGARDING MEDTRONIC DEFIBRILLATORS If you or a family member is using or has used a Medtronic defibrillator and would like to discuss your rights, are interested in more information on Medtronic lawsuits, or if you have information about the cases that you would like to share with us, please fill out the free case evaluation form and a member of Seeger Weiss LLP’s experienced staff will call you to discuss your potential rights concerning Medtronic. Attorney consultations incur no obligation on your part and all initial consultations are free of charge and do not create an attorney-client relationship. Contact Seeger Weiss LLP Regarding Any Defective Medical Device Our firm has extensive experience representing victims of defective medical devices. If you or a family member was injured by a medical device, contact Seeger Weiss LLP for a free consultation to discuss your potential claim. For More Information See Our Medical Device Pages: Medtronic Defibrillators Stryker Hip Recall Transvaginal Surgical Mesh and Bladder Slings Sources: https://www.fda.gov/medical-devices https://www.einfochips.com/blog/an-overview-of-fda-regulations-for-medical-devices/ https://www.accessdata.fda.gov/scripts/medwatch/? https://www.fda.gov/medical-devices/premarket-submissions/premarket-notification-510k Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA. 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