If you were harmed by a stent, a stent lawsuit generally takes one of three forms: a medical malpractice claim against the doctor or hospital, a product liability claim against the device manufacturer, or a civil claim tied to a fraud case in which a physician implanted a stent you did not need. Which path fits depends on what went wrong, and each has its own defendants, standards of proof, and obstacles.
Suing the Doctor or Hospital for Malpractice
A malpractice claim targets the provider, not the device. The question is whether the doctor deviated from the accepted standard of care and whether that deviation caused harm. In stent cases, common theories include performing the procedure when drug therapy or lifestyle changes would have been more appropriate, surgical errors during implantation such as puncturing a vein or artery, failure to monitor the patient afterward, and preventable infections from poor sterile technique.1Fronzuto Law Group. What Can Go Wrong With a Stent
A separate theory is lack of informed consent: the patient was not adequately told about the risks, benefits, and alternatives before agreeing to the procedure.2Gilman & Bedigian. Coronary Stent Implant Malpractice3Urology Times. Damage From Ureteral Stent Results in $8.5 Million Verdict4Medical Malpractice Lawyers. $8.5M Washington Medical Malpractice Verdict: Surgical Complication Leading to Injury
Technical errors during the procedure also support recovery. In April 2025, a Cook County, Illinois jury awarded $5.59 million to a 59-year-old man whose cardiologist at Norwegian-American Hospital (now Humboldt Park Health) implanted an undersized stent in his left coronary artery in June 2020. The undersized stent caused blood clotting that restricted blood flow, and the patient was left with permanent heart failure despite being transferred to another hospital.5Medical Malpractice Lawyers. Illinois Medical Malpractice Verdict: Negligent Stent Procedure Causes Heart Failure
Suing the Manufacturer for a Defective Stent
If the device itself malfunctioned, collapsed, migrated, or caused an allergic reaction to its metal or drug coating, the claim shifts to product liability against the manufacturer. A plaintiff does not have to prove the manufacturer was negligent, only that the device was defective when produced and that the defect caused the injury.2Gilman & Bedigian. Coronary Stent Implant Malpractice
The practical obstacle in these cases is federal preemption. In Riegel v. Medtronic, Inc. (2008), the Supreme Court ruled 8–1 that when the FDA grants premarket approval to a Class III medical device, state tort claims challenging the safety or effectiveness of that device are generally blocked.6EveryCRSReport.com. Medical Device Safety Stents are typically Class III high-risk devices, so Riegel shields manufacturers from many lawsuits alleging defective design, labeling failures, or inadequate testing.7AMA Journal of Ethics. Testing Manufacturer Liability for FDA-Approved Device Malfunction
The Court left open a narrow exception for “parallel” claims, meaning lawsuits premised on a violation of an existing FDA regulation rather than an attempt to impose a different or additional standard. Lower courts have split on which claims qualify, particularly manufacturing defect claims.6EveryCRSReport.com. Medical Device Safety Plaintiffs’ attorneys have also tried to work around preemption by arguing that drug-eluting stents are a drug-and-device combination or that the manufacturer promoted the stent for uses the FDA never approved. Legislative efforts to overturn Riegel were introduced in Congress but never enacted.
FDA recalls can create openings for parallel claims. In August 2025, the FDA announced a Class I recall of more than 26,000 units of the Boston Scientific Carotid Wallstent Monorail Endoprosthesis. A defect in the delivery system can cause resistance when the system is withdrawn, potentially injuring the vessel, damaging the stent, or releasing debris that could travel to the brain and cause a stroke. Boston Scientific had issued an Urgent Medical Device Removal Letter in early July 2025. Six cases requiring additional medical treatment were reported, with no deaths.8Cardiovascular Business. FDA Announces New Recall of Self-Expanding Stents Due to Risk of Serious Harm
In February 2026, the FDA posted a Class I recall of multiple configurations of the Boston Scientific AXIOS and HOT AXIOS Stent and Electrocautery-Enhanced Delivery Systems.9FDA. Stent Recall: Boston Scientific Removes Certain AXIOS Stents As of late December 2025, the company had reported 167 serious injuries and three deaths associated with the malfunctioning AXIOS devices.10FDA. 2Gilman & Bedigian. Coronary Stent Implant Malpractice These matters typically produce both federal criminal prosecutions and civil claims by the affected patients.
In the clearest example of patient recovery, Dr. Mark Midei at St. Joseph Medical Center in Towson, Maryland came under scrutiny after the hospital notified more than 500 patients in 2010 that they may have received unnecessary heart stents. Midei’s medical license was revoked in 2011.11WBAL-TV. $37M Settlement Reached in Unnecessary Stents Case In November 2010, the hospital agreed to pay $22 million to the U.S. government to resolve False Claims Act allegations covering both medically unnecessary stents implanted between 2008 and 2009 and a longer-running kickback scheme with the cardiology group MidAtlantic Cardiovascular Associates that violated the Anti-Kickback Act and the Stark Law. The case originated with a whistleblower suit by three physicians.12U.S. Department of Justice. St. Joseph Medical Center in Maryland to Pay U.S. $22 Million to Resolve False Claims Act Allegations A separate $37 million settlement in 2014 resolved two class-action lawsuits brought by patients. Catholic Health Initiatives, the former owner of the hospital, and Dr. Midei were parties but did not admit liability. Court documents indicated that up to 273 patients were expected to receive payments of at least $134,000 each.
Criminal convictions have followed similar fact patterns. On July 26, 2011, a federal jury convicted Dr. John R. McLean, a Salisbury, Maryland cardiologist, on six counts including health care fraud and false statements related to health care matters, after evidence that he performed unnecessary cardiac catheterizations and stent implantations on more than 100 patients between 2003 and 2007 and fabricated entries about blockage severity to justify the procedures and billing to Medicare, Medicaid, and private insurers.13U.S. Department of Justice. Salisbury Cardiologist Convicted of Implanting Unnecessary Cardiac Stents On November 10, 2011, he was sentenced to 97 months in federal prison and ordered to pay $579,070 in restitution.14U.S. Department of Justice. Salisbury Cardiologist Sentenced to Over 8 Years in Prison for Implanting Unnecessary Cardiac Stents
More recently, Brooklyn cardiologist Niranjan Mittal pleaded guilty in February 2025 to violating the Anti-Kickback Statute. From at least 2016 through 2023, Mittal paid other physicians for patient referrals, disguised the payments as rent, and instructed staff to falsify patient records to justify medically unnecessary vascular procedures. Insurance companies paid his practice more than $40 million during that period. He was sentenced on August 21, 2025 to 37 months in prison, two years of supervised release, and forfeiture of the proceeds.15U.S. Department of Justice. Brooklyn Cardiologist Sentenced to 37 Months in Prison in Connection With Health Care Fraud and Bribery Scheme16Cardiovascular Business. New York Cardiologist Headed to Prison, DOJ Says He Paid for Referrals and Performed Unneeded Procedures
If you were a patient of a cardiologist later charged or sanctioned for implanting unnecessary stents, a civil malpractice claim can proceed on its own track regardless of the criminal case’s outcome. The St. Joseph patient class action, for instance, settled without any admission of liability by the hospital’s former owner or the physician.
Deadlines and Pre-Suit Steps You Cannot Miss
Stent cases are governed by strict filing deadlines that vary by state and by claim type. Medical malpractice statutes of limitations are often shorter than those for other personal injury claims. California, for example, requires a malpractice suit to be filed within one year of discovering the injury or three years from the date the injury occurred, whichever comes first.17California Courts Self-Help. Medical Malpractice
Most states apply a discovery rule that pauses the clock until the patient knew or reasonably should have known about both the injury and its potential connection to medical negligence. Many states also set a statute of repose, an absolute outer deadline running from the date of the malpractice regardless of when the injury was discovered. Tolling exceptions may apply for fraudulent concealment, foreign objects left in the body, minors, or an ongoing course of treatment for the same condition.18Justia. Statutes of Limitations and the Discovery Rule
Before filing, many states require written notice to the healthcare provider, presentation of the claim to a medical review panel, or a certificate of merit, which is a sworn statement from a qualified medical expert attesting that the provider likely committed negligence.18Justia. Statutes of Limitations and the Discovery Rule In California, the notice must be sent at least 90 days before the lawsuit is filed.17California Courts Self-Help. Medical Malpractice A plaintiff’s lawyer in your state can confirm which deadline and which pre-suit steps apply, and the sooner that happens the better: on a stent injury discovered years after the procedure, the repose deadline can close the case before the discovery clock would have.