Heart defibrillator lawsuits are product liability claims brought by patients and families against the makers of implantable cardioverter defibrillators (ICDs), cardiac resynchronization therapy defibrillators (CRT-Ds), and automated external defibrillators (AEDs), typically alleging that a device failed to deliver a life-saving shock, that batteries or leads malfunctioned, or that the manufacturer hid safety problems from the FDA. Over the past two decades these cases have produced settlements ranging from roughly $15 million to $268 million, a criminal guilty plea from one manufacturer, and a Supreme Court decision that now blocks most state-law claims against FDA-approved devices.
What Claims These Lawsuits Bring
Defibrillator cases generally rest on three product liability theories. A manufacturing defect claim alleges that a specific device came off the line differently from its intended design; under strict liability the plaintiff needs to show only that the defect existed and caused harm. A design defect claim targets the entire product line and argues that a safer alternative design was feasible. A failure-to-warn claim alleges the manufacturer did not adequately disclose known risks to patients or physicians.1Justia. Medical Devices
Expert testimony is almost always required to identify the defect, prove causation, and explain the device’s engineering to a jury. Depending on the facts, lawsuits may also name distributors, component suppliers, or sales representatives who allegedly minimized risks. When the claim is that a physician improperly recommended or implanted a device, it typically proceeds as a medical malpractice case rather than a product liability action.1Justia. Medical Devices
A separate track of litigation involves AEDs and turns on whether a business had one available, kept it working, or used it properly. Those cases are discussed further below.
Medtronic: Sprint Fidelis, Marquis, and the 2023 Recall
The Sprint Fidelis defibrillator leads (models 6930, 6931, 6948, and 6949) — the thin wires connecting an ICD to the heart — were prone to fracturing, which could cause inappropriate shocks or a failure to deliver therapy. Over 8,100 individual complaints were consolidated in MDL No. 1905 before Judge Richard H. Kyle in the District of Minnesota.2CourtListener. In Re Medtronic, Inc., Sprint Fidelis Leads Products Liability Litigation3FindLaw. In Re Medtronic, Inc., Sprint Fidelis Leads Products Liability Litigation4Medtronic. Medtronic Settles U.S. Lawsuits on Sprint Fidelis Family of Defibrillation Leads5Medscape. Medtronic Agrees to Pay $268 Million to Settle Sprint Fidelis Lawsuits
An earlier round of Medtronic litigation involved the Marquis line of ICDs, subject to a February 2005 field action for battery problems that could cause the devices to fail. The MDL resolved 2,682 cases for $95.6 million plus $18.5 million in attorneys’ fees, again with no admission of liability.6DICA Cardiology. Medtronic Settles Marquis Defibrillator Lawsuits
More recent Medtronic litigation has not fared as well for plaintiffs. In May 2023, the FDA classified as Class I — its most serious category — a Medtronic recall of nearly 350,000 ICDs and CRT-Ds distributed between October 2017 and June 2023, tied to a “glassed feedthrough” component that could inappropriately trigger a short-circuit protection feature and reduce or eliminate the delivered shock. Medtronic reported 28 incidents and 22 injuries, with no deaths, and both the FDA and Medtronic instructed doctors to reprogram the devices rather than remove them.7FDA. Medtronic Recalls Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds)8Cardiovascular Business. Medtronic FDA Recall of Implantable Heart Devices Linked to 22 Injuries A class action filed in the District of Minnesota was dismissed in August 2023 after the court found no plausible federal claim, and in March 2025 the District of Massachusetts dismissed Summers v. Medtronic, Inc., a negligence and breach-of-warranty case involving three implanted Medtronic devices, on preemption grounds with leave to amend.9FindLaw. Medtronic Defibrillator Recent News10Drug and Device Law Blog. No Shock Here: D. Mass. Holds Complaint Regarding Class III Medical Device Preempted
Guidant: Criminal Guilty Plea and Civil Settlements
The Guidant case is one of the few times a medical device company has faced criminal prosecution. Guidant’s Ventak Prizm 2 DR (Model 1861) and Contak Renewal (Models H135 and H155) defibrillators suffered from faulty wiring and short-circuiting. The company discovered the problems and modified its manufacturing process in 2002, but continued selling unmodified units through 2003 and did not notify patients or doctors until 2005, by which time three patient deaths had occurred.11U.S. Department of Justice. Medical Device Manufacturer Guidant Sentenced for Failure to Report Defibrillator Safety Problems
Civil claims were consolidated in MDL No. 05-1708 before Judge Donovan W. Frank in the District of Minnesota, where over 8,100 claims were eventually resolved, mostly by settlement.12George Washington University Law School. Show Cause Order, In Re Guidant Corp. Implantable Defibrillators Products Liability Litigation A separate multistate settlement announced in August 2007 by Washington Attorney General Rob McKenna required Guidant to pay $16.75 million, extend device warranties, provide replacement devices, reimburse patients’ out-of-pocket medical expenses, and establish a patient safety advisory board with quarterly public failure-data reporting.13Washington Attorney General. McKenna Announces $17 Million Settlement With Heart Defibrillator Manufacturer
On the criminal side, the Justice Department charged Guidant LLC (by then a Boston Scientific subsidiary, following Boston Scientific’s 2006 acquisition) in February 2010 with misdemeanor counts of withholding safety information from the FDA. Guidant pleaded guilty in April 2010, admitting it had lied to the FDA about the Ventak Prizm 2 DR and failed to report a correction to the Contak Renewal devices.14Health Leaders Media. Guidant Pleads Guilty to Hiding Defibrillator Problems Judge Frank initially rejected the proposed plea deal as insufficient but in January 2011 sentenced Guidant to pay more than $296 million in criminal fines and forfeiture and to serve three years of supervised corporate probation, including unannounced inspections and employee notification requirements. It was the largest criminal penalty ever imposed on a device manufacturer under the Food, Drug, and Cosmetic Act at that time.11U.S. Department of Justice. Medical Device Manufacturer Guidant Sentenced for Failure to Report Defibrillator Safety Problems
St. Jude Medical and Abbott: Riata Leads and Battery Depletion
St. Jude Medical’s Riata and Riata ST defibrillator leads were subject to a 2011 FDA Class I recall after reports that the silicone insulation was eroding, allowing internal conductors to break through. About 79,000 Americans had been implanted with the affected leads.15AboutLawsuits.com. St. Jude Riata16MPR News. St. Jude Medical Settles17Cardiovascular Business. St. Jude Sets Aside $15M to Settle Riata Cases
A separate defect involved premature battery depletion caused by lithium clusters in St. Jude’s Fortify, Fortify Assura, Quadra, and Unify defibrillators. In October 2016, St. Jude and the FDA issued a Class I recall after finding the batteries could drain within 24 hours of triggering an elective replacement alert, far faster than the standard three-month window. Nearly 350,000 affected devices were implanted worldwide at the time.18Medscape. Lawsuit Filed Over St. Jude Battery-Depletion Defect
In July 2021, St. Jude (by then owned by Abbott, which acquired the company in 2017) agreed to pay $27 million to resolve a False Claims Act suit brought by the U.S. Justice Department. The government alleged that St. Jude knowingly sold defective devices and failed to disclose reports of serious injuries and one death to the FDA while seeking approval for a design change in 2014. The case, United States ex rel. Debbie Burke v. St. Jude Medical, Inc. (No. 16-cv-3611, D. Md.), resolved without a formal determination of liability.19DICA Cardiology. St. Jude Medical Pays $27 Million for Allegedly Selling Defective Heart Devices
Boston Scientific Defibrillator Recalls
Beyond the legacy Guidant litigation, Boston Scientific has faced its own recalls. In February 2021, the FDA recalled the Emblem S-ICD subcutaneous defibrillator over electrode fractures linked to 26 injuries and one death. A second recall followed in July 2023 for a software glitch affecting sensing in certain S-ICD models.20Foster & James. Boston Scientific Lawsuit
In July 2025, the FDA classified as Class I a recall of Boston Scientific’s Endotak Reliance and Reliance 4-Site/4-Front defibrillation leads. Calcification can develop on the coated coils, raising electrical impedance and potentially preventing full shock delivery. As of the July 24, 2025 notification, Boston Scientific had reported 386 serious injuries and 16 patient deaths associated with the issue. Leads with impedance readings above 150 ohms carry roughly a one-in-ten risk of shock failure and should be considered for replacement, according to the company’s guidance.21FDA. Update Alert: Defibrillation Lead Issue, Boston Scientific
The Preemption Barrier That Blocks Most Claims
The single largest obstacle in defibrillator litigation is the Supreme Court’s 2008 decision in Riegel v. Medtronic, Inc. (552 U.S. 312). In an 8-1 ruling, the Court held that the Medical Device Amendments of 1976 preempt state tort claims that would impose safety or design requirements “different from, or in addition to” those established through the FDA’s premarket approval (PMA) process.22Justia. Riegel v. Medtronic, Inc., 552 U.S. 312
Because ICDs and CRT-Ds are Class III devices that undergo the FDA’s most rigorous review, a plaintiff generally cannot argue under state law that an FDA-approved defibrillator was defectively designed or inadequately labeled. Such a claim would, in the Court’s view, ask a jury to second-guess the FDA’s risk-benefit analysis.23SCOTUSblog. More on the Decision in Riegel v. Medtronic
The Court left one door open: “parallel” claims, where a plaintiff alleges that the manufacturer violated an FDA requirement and the state-law claim mirrors that same requirement rather than adding new ones. Lower courts disagree about how narrow that exception is. The Eighth Circuit, in the Sprint Fidelis litigation, took a restrictive view, holding that generic allegations of violating manufacturing standards were too vague to qualify.3FindLaw. In Re Medtronic, Inc., Sprint Fidelis Leads Products Liability Litigation The Fifth and Seventh Circuits have been more willing to let claims proceed when based on violations of FDA regulations like manufacturing practice standards or adverse-event reporting duties.24NYU Law Review. The Federal Preemption of Medical Device Product Liability Claims A patient’s ability to sue can turn on where the case is filed. Legislation to overturn Riegel has been introduced in Congress but not enacted.25Every CRS Report. Medical Device Preemption After Riegel v. Medtronic
When a Business Can Be Sued Over an AED
A distinct category of litigation involves not the device itself but the failure to have an AED available or to use it properly. Survival rates from sudden cardiac arrest fall roughly 7 to 10 percent for every minute without defibrillation. Without an AED within the first five minutes, survival is around 5 percent; with one, it can exceed 90 percent.26Advocate Magazine. Liability of Health Clubs for Failure to Use an Automated External Defibrillator
Whether a business must maintain an AED depends on the state. The California Supreme Court in Verdugo v. Target Corp. (2014) held that businesses have no common-law duty to acquire one. Statutes can change that. California and New York require health clubs to keep AEDs on-site and train staff to use them, and a New York court in Diniro v. Aspen Athletic Club, LLC (2019) held that a health club had an affirmative statutory duty to maintain a working AED.27Collins & Lacy. Claims Involving Automated External Defibrillators Good Samaritan laws in most states protect bystanders who use an AED in good faith, but that protection typically does not extend to gross negligence, and signed liability waivers do not shield a business from gross negligence claims either.26Advocate Magazine. Liability of Health Clubs for Failure to Use an Automated External Defibrillator
Failure-to-maintain claims arise as well. The family of a man who died of a heart attack in Chicago recovered a $3.2 million settlement after paramedics could not resuscitate him because a defibrillator’s batteries had not been replaced on the standard two-year schedule.28Corboy & Demetrio. $3.2 Million Wrongful Death Settlement