Implantable cardiac devices including pacemakers and implantable cardioverter-defibrillators (ICDs) save lives by regulating heart rhythm and delivering life-saving shocks when needed. However, defective cardiac devices have caused serious injuries and deaths when they malfunction, deliver inappropriate shocks, or fail to function when needed.
Types of Cardiac Device Defects
Implantable cardiac device failures fall into several categories, each presenting different risks and requiring different legal approaches:
Battery depletion failures occur when device batteries drain faster than predicted, potentially leaving patients without protection from dangerous arrhythmias. Premature battery failure may require emergency replacement surgery.
Lead failures affect the wires connecting the device to the heart. Leads may fracture, develop insulation breaches, or fail to properly sense cardiac activity. Lead failures can cause inappropriate shocks, failure to deliver needed therapy, or dangerous electrical malfunctions.
Software and firmware defects can cause devices to malfunction, fail to detect dangerous rhythms, or deliver inappropriate therapy. These defects may affect entire product lines and often result in recalls or urgent software updates.
Inappropriate shocks occur when ICDs misinterpret normal heart activity as dangerous arrhythmia and deliver painful, unnecessary shocks. Patients may experience multiple inappropriate shocks, causing psychological trauma and physical harm.
Failure to deliver therapy represents the most dangerous malfunction—when a device fails to recognize or treat a life-threatening arrhythmia, potentially resulting in sudden cardiac death.
Major Cardiac Device Recalls and Litigation
Several high-profile recalls have resulted in significant litigation:
St. Jude Medical (now Abbott) faced extensive litigation over its Riata and Riata ST leads, which experienced insulation failures at high rates. The company also faced claims over its defibrillators following cybersecurity vulnerabilities and premature battery depletion issues.
Medtronic has faced lawsuits over various lead failures, including its Sprint Fidelis leads that were recalled due to fracture risks.
Boston Scientific has faced litigation over its Guidant devices and lead products.
When the FDA issues safety alerts or manufacturers announce recalls, patients with affected devices face difficult decisions about whether to undergo risky extraction surgery or continue living with potentially defective devices.
Legal Claims for Cardiac Device Injuries
Cardiac device lawsuits typically proceed under theories of:
Design defect when the device's design makes it unreasonably prone to failure, such as leads designed with inadequate insulation or batteries that deplete faster than specifications.
Manufacturing defect when specific devices or lots were improperly manufactured, failing to meet design specifications.
Failure to warn when manufacturers knew about defect risks but did not adequately communicate them to physicians and patients, or delayed issuing recalls after learning of problems.
Compensation for Cardiac Device Injuries
Patients injured by defective cardiac devices may recover:
Medical expenses for device replacement surgery, lead extraction procedures, treatment of injuries from inappropriate shocks, and ongoing cardiac monitoring.
Pain and suffering for physical injuries, psychological trauma from inappropriate shocks or living with a known defective device, and anxiety about future device performance.
Lost wages during treatment and recovery periods.
Wrongful death damages when device failures cause or contribute to patient death, allowing surviving family members to pursue claims.
Taking Action on Cardiac Device Claims
Patients with potentially defective cardiac devices should remain in close contact with their cardiologists regarding any recalls or safety alerts. Those who have experienced device malfunctions, inappropriate shocks, or required premature device replacement should preserve all medical records and consult with an attorney experienced in medical device litigation to evaluate potential claims.