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Failure to Remove Defective Medical Devices Medical Malpractice in Chicago
When a doctor implants a medical device in your body, they take on a responsibility that does not end when you leave the operating room. If that device is later found to be defective, recalled, or dangerous, your physician has a duty to act. Failing to remove or address a known defective medical device is a form of medical malpractice, and patients in Chicago who suffer harm as a result have legal rights under both Illinois and federal law. If you or someone you love has been harmed by a device that should have been removed, a Chicago personal injury lawyer at Briskman Briskman & Greenberg can review your case and help you understand your options.
Table of Contents
- What “Failure to Remove a Defective Medical Device” Means as a Malpractice Claim
- How Illinois Law Governs Medical Malpractice Claims Involving Defective Devices
- Common Devices Involved in Failure-to-Remove Malpractice Cases in Chicago
- What You Must Prove to Win a Failure-to-Remove Malpractice Case in Illinois
- The Statute of Limitations and Why Acting Quickly Matters in Chicago
- What Compensation Is Available and How Attorney Fees Work in Illinois
- FAQs About Failure to Remove Defective Medical Devices Medical Malpractice in Chicago
What “Failure to Remove a Defective Medical Device” Means as a Malpractice Claim
Failure to remove a defective medical device means a doctor or hospital knew, or should have known, that an implanted device was dangerous, recalled, or malfunctioning, and did nothing about it. This inaction is what gives rise to a medical malpractice claim. The failure is not in the device itself but in the physician’s response to a known problem.
Medical devices include a wide range of products, from pacemakers and hip implants to surgical mesh, spinal cord stimulators, and implantable defibrillators. When any of these devices is flagged as defective, the physician who implanted it or who manages the patient’s ongoing care has a duty to inform the patient and discuss options, which may include removal or replacement.
Under the Safe Medical Devices Act (SMDA), manufacturers are required to report device-related deaths, serious injuries, and malfunctions to the U.S. Food and Drug Administration (FDA). Once the FDA receives that information, it classifies the recall by severity. A Class I recall signals a reasonable probability of serious adverse health consequences or death. A Class II recall involves temporary or medically reversible harm. A Class III recall is unlikely to cause health consequences. When a Class I recall is issued, the urgency for a physician to act is at its highest.
The FDA’s recall process under 21 CFR Part 806 requires manufacturers and importers to report any correction or removal of a device initiated to reduce a risk to health. That notice goes to the physician community. If your doctor received that notice and did not act, that failure to respond may form the basis of a malpractice claim. Cases like this often overlap with the broader category of defective implant monitoring, where ongoing observation of a device’s performance is part of the standard of care.
How Illinois Law Governs Medical Malpractice Claims Involving Defective Devices
Illinois medical malpractice law governs claims where a physician’s failure to remove a defective device caused patient harm. The core legal standard is whether the doctor’s conduct fell below the accepted standard of care for a reasonably competent physician in the same specialty under similar circumstances.
Before you can even file a lawsuit in Illinois, you must meet a specific requirement under the Illinois Code of Civil Procedure. Under 735 ILCS 5/2-622, the Healing Art Malpractice statute, your attorney must attach a certificate of merit to the complaint. This certificate requires your attorney to confirm that a qualified health professional has reviewed the medical records and determined there is a reasonable and meritorious basis for the claim. That reviewing professional must have practiced or taught in the same area of medicine within the last six years. This requirement exists to screen out frivolous claims and ensure that every case has a legitimate medical foundation before it proceeds.
Illinois law also addresses how liability is shared among multiple defendants. Under 735 ILCS 5/2-1117, all defendants found liable are jointly and severally liable for a plaintiff’s past and future medical and medically related expenses. When a defendant’s share of fault is 25% or greater, they are jointly and severally liable for all other damages as well. This matters in device cases because multiple parties, including the manufacturer, the implanting surgeon, and the hospital, may each bear a share of responsibility.
Your claim may also involve product liability alongside malpractice. Under 735 ILCS 5/2-621, if you sue a seller or distributor rather than the manufacturer, that party must file an affidavit identifying the correct manufacturer. Once you have filed against the actual manufacturer and they have appeared in the case, the court can dismiss the non-manufacturer defendant, unless specific exceptions apply. Understanding how these claims work together is critical to pursuing full recovery.
Common Devices Involved in Failure-to-Remove Malpractice Cases in Chicago
Certain medical devices appear in failure-to-remove malpractice cases more often than others. These are devices that are either commonly implanted, subject to frequent recalls, or known to degrade over time in ways that create serious health risks.
Hip and knee replacement implants are among the most commonly litigated. Metal-on-metal hip implants, in particular, have been the subject of multiple FDA safety communications and recalls. When these devices shed metallic particles into surrounding tissue, a condition known as metallosis can develop, causing tissue death and bone loss. A physician who monitors a patient with a recalled hip implant and fails to recommend removal when symptoms appear may be liable for the resulting damage.
Surgical mesh implants, used in hernia repairs and pelvic floor procedures, have also generated significant litigation. When mesh erodes, migrates, or causes chronic infection, the standard of care requires the treating physician to evaluate the device and discuss removal with the patient. Ignoring those symptoms is a failure that can be actionable.
Pacemakers and implantable cardioverter-defibrillators (ICDs) carry their own risks when defective. A faulty pacemaker that delivers incorrect electrical impulses, or fails to deliver them at all, can cause cardiac arrest. Physicians managing these patients have a duty to respond to manufacturer recall notices and FDA safety communications. Failure to do so, particularly when the device is classified as a Class I recall, may constitute malpractice.
Spinal cord stimulators, neurostimulators, and drug infusion pumps are also implanted devices that can malfunction. When a device migrates, short-circuits, or delivers incorrect doses of medication, the physician overseeing the patient’s care must act. Patients who visit hospitals near the Loop, in Lincoln Park, or in the Near North Side neighborhoods of Chicago deserve to receive care that meets these standards.
What You Must Prove to Win a Failure-to-Remove Malpractice Case in Illinois
Winning a failure-to-remove malpractice case requires proving four specific elements. Each one must be supported by evidence, and the testimony of a qualified medical expert is almost always required.
First, you must establish that a doctor-patient relationship existed. This creates the legal duty of care. Second, you must show that the physician breached that duty by failing to act on known information about a defective device. This breach is measured against what a reasonably competent physician in the same specialty would have done under the same circumstances. For example, if an orthopedic surgeon in Chicago’s South Loop received an FDA Class I recall notice about a hip implant and took no steps to contact the patient or recommend evaluation, that inaction may constitute a breach.
Third, you must prove causation, meaning the physician’s failure to remove or address the device directly caused your injury. This is often the most contested element. The defense will argue that the injury would have occurred regardless of whether the device was removed. Your medical expert must counter that argument with specific clinical evidence tied to your case.
Fourth, you must show damages. These include medical bills for additional surgeries, lost wages, pain and suffering, and any permanent disability. Illinois law does not cap compensatory damages in medical malpractice cases following the Illinois Supreme Court’s ruling in Lebron v. Gottlieb Memorial Hospital, which struck down prior damage caps as unconstitutional. This means your full economic and non-economic losses are recoverable.
A skilled medical malpractice lawyer will work with qualified medical experts to build the evidence needed to satisfy each of these elements. The certificate of merit requirement under 735 ILCS 5/2-622 means this expert review happens before the complaint is even filed.
The Statute of Limitations and Why Acting Quickly Matters in Chicago
Illinois law sets strict time limits for filing a medical malpractice claim. Under the Illinois Code of Civil Procedure, you generally have two years from the date you knew, or reasonably should have known, of the injury caused by the malpractice. This is called the discovery rule, and it is especially important in device cases because patients often do not connect their symptoms to a defective implant right away.
However, Illinois also imposes a four-year statute of repose. This means that regardless of when you discovered the injury, no claim can be filed more than four years after the act or omission that caused the harm. For patients with implanted devices, this clock can be difficult to track, particularly when a recall is issued years after implantation.
There is a limited exception for minors. If the injured patient is under 18, the statute of limitations does not begin to run until their 18th birthday, though the four-year repose period still applies in most circumstances. If the malpractice involves a foreign object left in the body, a different rule may apply, extending the time limit up to 10 years from the date of the procedure under certain conditions.
Waiting to act has real consequences beyond missing the legal deadline. Evidence disappears. Medical records become harder to obtain. Witnesses’ memories fade. The device itself may be disposed of before it can be preserved as evidence. If you suspect your physician failed to respond to a recall or ignored signs that your implant was failing, contact a medical malpractice attorney as soon as possible. The attorneys at Briskman Briskman & Greenberg serve clients throughout the Chicago area, including those who receive care at hospitals near Millennium Park, in River North, and across Cook County.
What Compensation Is Available and How Attorney Fees Work in Illinois
Patients who are harmed by a physician’s failure to remove a defective medical device may recover several categories of damages. Economic damages cover financial losses you can document, including the cost of corrective surgery, hospitalization, rehabilitation, lost income, and future medical care. Non-economic damages cover pain and suffering, emotional distress, loss of enjoyment of life, and loss of consortium for a spouse or family member.
In cases where the physician’s conduct was particularly reckless or where a manufacturer knowingly concealed defect information, punitive damages may also be available. These are designed to punish extreme misconduct and deter similar behavior, not simply to compensate the victim.
Illinois law regulates how much your attorney can charge in a medical malpractice case. Under 735 ILCS 5/2-1114, the total contingent fee for a plaintiff’s attorney in a medical malpractice action cannot exceed 33 1/3% of all sums recovered. This means your attorney is paid a percentage of what you recover, and only if you recover. You do not pay attorney fees out of pocket. However, you should be aware that you may still be responsible for case costs and expenses, which are separate from attorney fees. Ask your attorney to explain the full fee arrangement before signing any agreement.
Working with a medical malpractice lawyer on a contingency basis means the firm has a direct financial interest in achieving the best possible result for you. At Briskman Briskman & Greenberg, located at 205 W Randolph St., Suite 925, Chicago, IL 60606, the firm handles medical malpractice cases on a contingency fee basis. You can reach the firm at (312) 222-0010 to schedule a free consultation. If you have been harmed by a physician’s failure to act on a known device defect, speaking with a medical malpractice attorney is the first step toward protecting your rights.
Liability in these cases can extend across multiple parties. Under 735 ILCS 5/2-1117, any defendant whose share of fault is 25% or greater is jointly and severally liable for all damages beyond medical expenses. This means that if both the implanting surgeon and the hospital share fault, both can be held responsible for your full losses. Having a medical malpractice lawyer who understands how to pursue all liable parties is essential to maximizing your recovery.
FAQs About Failure to Remove Defective Medical Devices Medical Malpractice in Chicago
How do I know if my doctor had a duty to remove my recalled implant?
Your doctor has a duty to act when a device recall or safety notice is issued and when you show symptoms consistent with device failure. The FDA classifies recalls by severity, and a Class I recall, which signals a reasonable probability of serious harm or death, creates the most urgent obligation. If your physician received notice of a Class I recall affecting your implant and did not contact you or recommend evaluation, that failure may meet the legal standard for a breach of the duty of care. A medical expert must review your specific records to confirm whether the standard of care was violated in your case.
Can I sue both the device manufacturer and my doctor?
Yes. You may have separate claims against the device manufacturer under product liability law and against your physician under medical malpractice law. These are distinct legal theories. The manufacturer may be liable for designing or producing a defective product. Your physician may be liable for failing to act on recall information or for not monitoring your device properly. Under 735 ILCS 5/2-1117, multiple defendants can be held jointly and severally liable for medical expenses, which means each party may be responsible for the full amount of those costs depending on their share of fault.
What if I did not know my device was recalled until years after it was implanted?
Illinois law’s discovery rule gives you two years from the date you knew or reasonably should have known about the injury caused by the malpractice. If you only recently learned that your device was recalled and that your symptoms are connected to that recall, your two-year clock may start from that date of discovery. However, the four-year statute of repose sets an outer limit regardless of discovery. Because these deadlines interact in complicated ways, you should speak with an attorney as soon as you suspect a problem. Waiting even a few months can affect your ability to file a valid claim.
Does my claim require a medical expert even if the recall is already public?
Yes. Under 735 ILCS 5/2-622, Illinois requires that a qualified health professional review your case and provide a written report confirming there is a reasonable and meritorious basis for the claim before your attorney can file the complaint. This requirement applies even when the device recall is publicly documented. The expert must be knowledgeable in the relevant area of medicine and must have practiced or taught in that field within the last six years. The purpose of this requirement is to ensure that every filed claim has a legitimate medical foundation, not just a documented recall.
What types of damages can I recover if my doctor failed to remove a defective implant?
You can recover economic damages, which cover documented financial losses such as the cost of corrective surgery, hospitalization, lost wages, and future medical care. You can also recover non-economic damages for pain and suffering, emotional distress, and loss of enjoyment of life. Illinois does not cap compensatory damages in medical malpractice cases. If the physician’s conduct was particularly reckless, punitive damages may also be available. The total value of your claim depends on the severity of your injuries, the extent of your financial losses, and the strength of the evidence supporting your case. Past results in other cases do not guarantee any particular outcome in your matter.
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