If you or a family member was implanted with a recalled St. Jude defibrillator, a St. Jude defibrillator lawsuit is possible but not straightforward. Patients have already recovered through a $27 million federal whistleblower settlement, a roughly $14.25 million product-liability settlement covering Riata lead injuries, and a $5 million CAD Canadian class action. Individual injury claims still get filed, but federal preemption blocks many of them unless the complaint pins the injury to a specific violation of FDA rules.
Which St. Jude Devices Are at the Center of the Lawsuits
Two separate defects drive the litigation. The first is a battery flaw in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured between January 2010 and May 2015. The affected models are Fortify, Fortify Assura, Unify, Unify Assura, Unify Quadra, Quadra Assura, and Quadra Assura MP. The FDA classified the October 10, 2016 action as a Class I recall, its most serious category. It covered 398,740 devices worldwide, about 350,000 still implanted, roughly 251,000 in the United States.
The second is the Riata and Riata ST defibrillator leads, the wires that carry the shock from the device to the heart. St. Jude pulled them from the market in December 2010, and in November 2011 the FDA classified the action as a Class I recall covering 128,000 units.
What Went Wrong Inside the Devices
In the recalled defibrillators, lithium clusters formed inside the battery and could short-circuit it. Patients are supposed to get months of warning through an Elective Replacement Indicator alert before a battery dies. With these units, some batteries drained completely within 24 hours of the alert, leaving no protection against a dangerous heart rhythm. By the time of the recall, two deaths had been linked to the defect, along with ten reports of fainting and 37 reports of dizziness. By August 2016, St. Jude reported 729 premature-depletion events to the FDA, including two deaths and 29 incidents involving loss of pacing.
The Riata leads used silicone insulation that could wear through, letting internal conductors poke outside the insulation. That “externalized conductor” defect could trigger malfunctions such as inappropriate shocks.
What St. Jude Knew and When
The company’s internal knowledge is central to the litigation, because it is what lets plaintiffs get past preemption. According to the U.S. Department of Justice, St. Jude was aware of the lithium cluster problem by 2013. In late 2014, while asking the FDA to clear a design change to fix it, the company told the agency that “no serious injury, permanent harm or deaths have been reported” in connection with the battery flaw. The government alleged the company already knew about two serious injuries and one death. St. Jude then allegedly continued selling thousands of the original, unmodified devices between November 2014 and October 2016.
An April 12, 2017 FDA warning letter added that St. Jude’s Medical Advisory Board was not given complete information about premature battery depletion, that the company had underestimated the risk of lithium bridging, and that after the October 2016 recall began, ten recalled devices were shipped to field representatives and seven were implanted in patients between October 14 and October 26, 2016.
Settlements and Recoveries Already Reached
The $27 Million Federal Whistleblower Settlement
Debbie Burke, a patient who received one of the recalled devices, filed a qui tam whistleblower suit alleging that St. Jude sold defective defibrillators to hospitals that then billed Medicare, TRICARE, and other federal programs. On July 8, 2021, the DOJ announced that St. Jude (by then an Abbott subsidiary) would pay $27 million to resolve the claims. The case, United States ex rel. Debbie Burke v. St. Jude Medical, Inc., was filed in the U.S. District Court for the District of Maryland. The company denied the allegations and the settlement included no determination of liability.
The Riata Lead Settlement
Roughly 950 Riata product-liability lawsuits and claims were filed across the country. In December 2014, St. Jude agreed to settle the bulk of them for an estimated $14.25 million, including legal fees and administrative costs, with a March 2015 deadline to join. The company admitted no liability. Three U.S. cases were carved out, and the Canadian class action continued separately. One firm has since confirmed it no longer accepts new Durata lead cases, and the Riata litigation has largely wound down.
The Canadian Class Action
An Ontario Superior Court of Justice class action covering the same battery-defect models settled for $5 million CAD, approved by Justice Perell on August 1, 2019. After legal costs, patients who kept their device received up to $100 CAD (implanted before December 1, 2013) or $500 CAD (implanted on or after). Patients who had the device surgically removed received an estimated $1,652 CAD from a separate pool. Extraordinary injuries qualified for more: $100 to $500 CAD for out-of-pocket expenses, $1,000 to $12,500 CAD for surgical complications, and $20,000 to $60,000 CAD in death benefits to close family members. The claim deadline was January 10, 2020, payments went out by June 2021, and the settlement is closed.
Can You Still Sue as an Individual Patient?
Battery-defect claims continued to be filed into the mid-2020s, but the biggest obstacle is federal preemption. Because the FDA approved these devices through its premarket approval (PMA) process, the Supreme Court’s 2008 decision in Riegel v. Medtronic blocks state-law claims that would impose requirements “different from, or in addition to” what the FDA required. Abbott and St. Jude lean on this defense heavily.
It works often. In January 2019, a federal judge in Minnesota dismissed a proposed class action by health insurance payors (the ASEA/AFSCME Local 52 Health Benefits Trust) seeking to recover costs tied to the recalled devices. In September 2024, Judge Rebecca Grady Jennings of the Western District of Kentucky dismissed Nathan Jackson’s suit over an allegedly malfunctioning Gallant ICD on the same grounds.
The path that has worked is the “parallel claim” exception: a plaintiff can sue under state law when the claim is based on the manufacturer allegedly violating the same federal rules the FDA imposed. In Sharp v. St. Jude Medical (2020), the Eleventh Circuit reversed a dismissal and let a manufacturing-defect claim over a Riata lead go forward under this narrow exception. In Kaemmlein v. Abbott Laboratories (E.D.N.Y., 2021), the court refused to dismiss claims over a Unify Assura device, finding the plaintiff had adequately alleged that concealing defects and failing to report adverse events violated federal requirements. In Bull v. St. Jude Medical, where a patient said her device fired six times because of insulation failures, Judge Michael Baylson of the Eastern District of Pennsylvania ruled in July 2018 that her failure-to-warn claim was not preempted because it paralleled the company’s federal duty to report device problems to the FDA.
The pattern is consistent. A general product-liability complaint tends to be dismissed. A complaint that identifies a specific federal violation, such as concealing safety data, failing to file required adverse-event reports, or shipping devices that deviated from the FDA-approved design, has a real chance of surviving.
What Abbott Offers Outside of Litigation
Separate from any lawsuit, Abbott has offered replacement device credits and reimbursement of up to $2,500 in unreimbursed medical expenses for patients who needed replacement surgery on a recalled battery-defect device. Abbott also issued firmware updates and a battery performance alert algorithm in 2017 and 2018 to give patients earlier warning of abnormal battery behavior. Accepting this reimbursement is not the same as bringing a personal-injury claim, and the company’s compensation program is limited to specific out-of-pocket costs.