You trusted a medical device to improve your health, restore mobility, or even save your life. If that device fails, the consequences can reach far beyond another doctor’s appointment. You may face pain, another surgery, lost income, mounting medical costs, and serious questions about what went wrong.
A defective medical device claim may arise when an unsafe product causes injury because of its design, production, warnings, or another legally recognized defect. At Joumana Law, we represent people harmed by dangerous products and investigate who may be responsible. For Michigan patients, these cases can involve both state product liability law and federal medical device regulations.
What Is a Defective Medical Device?
Medical devices include far more than implants and sophisticated hospital equipment. The U.S. Food and Drug Administration regulates products ranging from simple medical supplies to pacemakers, prosthetics, surgical implants, and other complex technologies.
A medical device may become the subject of a product liability claim when a legally actionable defect causes injury. The exact legal theory depends on how the product failed and the law governing the claim.
What Can Make a Medical Device Defective?
Problems with a medical device can arise at several points in its life cycle. The issue may begin before the product ever reaches a patient. Potential problems can involve:
- Design: The device’s design may create an unreasonable safety risk.
- Production: A particular device may differ from how it should have been produced.
- Warnings or instructions: Important risks may not have been adequately communicated.
- Components: A part within a larger device may fail.
- Labeling: Instructions or safety information may not adequately address a known risk.
Determining what happened usually requires more than knowing that a device failed. Lawyers may need medical records, product information, regulatory history, and technical evidence.
Is a Recalled Medical Device Automatically Defective?
A recall is important, but it does not automatically establish a patient’s legal claim. The FDA uses recalls to address certain problems with devices that violate FDA law. A recall may involve removing a device from use. It can also involve inspecting, repairing, adjusting, relabeling, or monitoring the device. The FDA classifies recalls according to the relative degree of health risk.
An implanted device recall also does not automatically mean the device should be removed. The FDA advises patients to discuss the risks and benefits with their healthcare providers.
Does FDA Clearance or Approval Prevent a Lawsuit?
Not necessarily. FDA regulatory status and civil product liability are separate legal questions. Michigan law provides that certain regulatory compliance can create a rebuttable presumption against liability. Federal law can also affect some medical device claims. The result depends on the device, regulatory pathway, alleged defect, and legal theory.
That is one reason defective medical device cases require careful investigation. A broad statement about “FDA approval” cannot resolve every patient’s claim.
What Types of Medical Devices Can Cause Serious Injuries?
Implanted Medical Devices
An implant may remain inside a patient for years. Problems can therefore develop long after the original procedure. Potentially harmful implanted devices may include:
A patient may not immediately realize an implant is contributing to new symptoms. The connection sometimes becomes apparent only after imaging, testing, revision surgery, or a safety notice.
Surgical and Hospital Devices
Not every dangerous device remains inside the body. Equipment used during treatment can also cause serious harm if it fails. Examples can include:
A malfunction during a procedure can create immediate consequences. Other failures may not become apparent until complications develop later.
At-Home and Diagnostic Medical Devices
Modern healthcare increasingly depends on devices patients use outside hospitals. These products can also become important to diagnosis, treatment, and ongoing disease management. Examples may include glucose monitoring systems, testing equipment, and other home medical products. A malfunction could provide inaccurate information or fail when the patient needs the device.
How Can a Defective Medical Device Injure a Patient?
Mechanical Failure
A medical device can break, loosen, leak, migrate, or stop working as intended. An implanted component may move from its expected position. Mechanical failure can potentially result in:
The fact that a device failed does not automatically establish legal liability. Investigators still need to determine why it failed and whether that failure caused the injury.
Problems Involving Device Materials
Some investigations focus on the materials used to manufacture a device. Questions can arise about deterioration, contamination, wear, or interactions with surrounding tissue. Medical evaluation is especially important in these situations. Symptoms can have several possible causes, and legal claims require evidence connecting the alleged defect to the injury.
Additional Procedures and Revision Surgery
For many patients, one of the most difficult consequences is needing another procedure. Someone who believed treatment was finished may suddenly face surgery again. Additional care may involve:
Another procedure also means more time away from work and family. Recovery can affect independence, finances, and daily responsibilities.
Delayed Symptoms
Device-related problems are not always obvious immediately after treatment. Symptoms may appear months or even years later. That delay can make the situation confusing. A patient may first believe the pain or other symptoms are unrelated to an older procedure.
If you develop unexplained symptoms involving an implanted device, discuss them with a qualified medical professional. Your health should come first.
Who Could Be Responsible for a Defective Medical Device?
Medical Device Manufacturers
The manufacturer is often central to a defective medical device investigation. Depending on the circumstances, questions may involve design, production, testing, warnings, or other conduct. Important evidence may include:
- How the device was designed
- How the specific unit was produced
- What risks were known
- What warnings accompanied the product
- Whether safety concerns developed after distribution
- Whether the manufacturer issued corrective actions
- Whether the FDA announced a recall or safety communication
The applicable legal standards depend on the facts and jurisdiction.
Sellers and Other Companies
Other businesses may sometimes become relevant. Michigan law, however, places specific limits on claims against nonmanufacturing sellers. Under MCL 600.2947, a seller other than a manufacturer generally is not liable unless certain statutory conditions are satisfied. Those conditions can involve the seller’s own failure to exercise reasonable care or an express warranty.
This distinction matters. A product may pass through several hands, but that does not mean every company has the same legal responsibility.
What If a Doctor or Hospital Also Made a Mistake?
A product liability case and a medical malpractice case are not the same. Product liability generally focuses on the product and legally responsible companies. Medical malpractice focuses on whether a healthcare provider violated an applicable professional standard of care. In some situations, an investigation may reveal questions involving both the device and medical treatment.
That does not mean both claims exist in every case. The evidence must be evaluated separately.
How Does Michigan Law Apply to Defective Medical Devices?
Michigan product liability cases are governed by specific statutes. These rules can affect what a patient must prove and what evidence matters. Michigan’s product liability framework appears in MCL 600.2945 and related sections. The law addresses production defects, regulatory compliance, sellers, warnings, product alterations, misuse, and other issues.
Production Defect Claims in Michigan
Michigan law sets specific requirements for claims involving an alleged production defect. Under MCL 600.2946, a plaintiff generally must establish that the product was not reasonably safe when it left the defendant’s control. The statute also addresses whether a practical and technically feasible alternative production practice existed.
That inquiry can involve technical, scientific, and medical evidence. It can also require analysis of what technology and knowledge existed at the relevant time.
Regulatory Compliance Can Matter
Medical devices operate within an extensive regulatory system. Michigan law specifically addresses regulatory compliance in product liability actions. MCL 600.2946 provides a rebuttable presumption against liability in certain circumstances involving compliance with relevant government standards. That presumption is not the same as an automatic bar to every claim.
The details matter. Lawyers must examine the regulation, the alleged defect, the device, and the event that caused the injury.
Failure to Warn Under Michigan Law
Warnings can become a central issue in medical device cases. Michigan law addresses what manufacturers knew or should have known when the product left their control. Under MCL 600.2948, a failure-to-warn claim can require proof concerning the scientific, technical, or medical information reasonably available at that time.
That means a warning claim may involve questions such as:
- What risks were known?
- When did the manufacturer learn about them?
- What scientific information was reasonably available?
- What warnings or instructions accompanied the device?
- Was the alleged risk adequately communicated?
- Did later evidence reveal a previously unknown problem?
The timing of that information can be critical.
Product Alteration and Misuse
Michigan law also addresses product alterations and misuse. MCL 600.2947 provides rules concerning whether an alteration or misuse was reasonably foreseeable. These defenses can become highly fact-specific. Medical records, device records, instructions, and expert analysis may all become relevant.
What Should You Do If You Think a Medical Device Injured You?
Put Your Medical Care First
Speak with an appropriate healthcare professional about symptoms or concerns. Do not stop using a medical device solely because you saw a recall online. Likewise, do not assume a recalled implant needs immediate removal. The FDA explains that some recalls involve monitoring, adjustment, repair, or other corrective measures.
Your healthcare provider can discuss the medical risks of leaving or removing an implanted device. A lawyer should not replace that medical judgment.
Identify the Exact Device
The exact product can make an enormous difference. Two devices that sound similar may have different manufacturers, models, production histories, or recall statuses. Look for information such as:
If you do not have this information, medical and surgical records may help identify the device.
Preserve Your Medical Records
Medical records can establish a timeline between device use and later health problems. They can also document additional procedures and treatment. Useful records may include:
Keep copies of relevant recall notices and manufacturer communications too.
Preserve the Device When Possible
A removed device may become important evidence. Do not intentionally destroy or discard a device that could be relevant to a potential claim. Ask about what happened to the device if it was removed during surgery. Preservation issues can be complicated, so legal guidance may be useful.
Check FDA Recall and Safety Information
The FDA maintains information about medical device recalls and safety concerns. Its medical device recall database contains classified recalls and related information. A recall may involve a correction rather than complete removal. FDA actions can include inspection, repair, relabeling, patient notification, or monitoring.
Remember that a recall alone does not prove your individual case. Your injury and the reason for the device’s failure still require investigation.
Consider Reporting a Device Problem
Patients and consumers can voluntarily report medical device problems through the FDA’s MedWatch program. The FDA encourages voluntary reports involving significant adverse events and product problems. These reports can contribute to the agency’s broader safety monitoring.
Do not assume someone else already reported your experience. Reporting obligations vary for manufacturers, healthcare facilities, professionals, and patients.
What Compensation May Be Available?
Medical Expenses
A device failure may create substantial additional healthcare costs. A claim may seek qualifying past and future medical losses when supported by the evidence. Those costs can include:
Future medical damages generally require evidence establishing the anticipated need for care.
Lost Income and Earning Capacity
Recovery can take someone away from work for weeks or months. A serious injury can also affect the person’s ability to return to the same career. Depending on the case, economic losses may include lost wages and diminished earning capacity. Employment and financial documentation can become important evidence.
Pain and Other Noneconomic Losses
Physical injury can affect much more than medical bills. Pain, physical limitations, and changes to everyday life may also be relevant. Michigan law contains specific rules concerning noneconomic damages in product liability cases. The application of those rules depends on the facts and current law.
Wrongful Death
These cases require careful legal review. The available claims and damages depend on the circumstances and governing law.
How Is a Defective Medical Device Case Investigated?
Step One: Identify the Device
The investigation begins by identifying the exact product. That may require reviewing surgical records, implant records, labels, and device identification information. Once identified, attorneys can research the device’s regulatory and safety history.
Step Two: Build the Medical Timeline
Next comes the patient’s medical history. Investigators look at the condition before the device, the procedure, recovery, later symptoms, and additional treatment. Timing can help determine whether the alleged device problem is consistent with the claimed injury.
Step Three: Examine the Device’s Safety History
The investigation may review available FDA information, recalls, safety communications, and other relevant regulatory materials. A recall can be significant, but it is only part of the picture. The key question is how the evidence relates to the individual patient’s injury.
Step Four: Determine What May Have Failed
A lawyer may need to determine whether the evidence points toward production, warnings, design, device performance, or another issue. Technical and medical experts may be needed. Their role can include evaluating how the device worked and whether the alleged problem caused the injury.
Step Five: Identify Potentially Responsible Parties
The investigation then turns to responsibility. That can involve manufacturers and, in appropriate cases, other entities. This process should happen before conclusions are made. At Joumana Law, we believe injured people deserve careful case evaluation, not assumptions.
Why Injured Patients Turn to Joumana Law
Fighting for the Injured Is Personal to Joumana
Joumana Kayrouz’s commitment to advocacy grew from experiences that shaped her long before she became an attorney. She has built her career around fighting for people who have been hurt and need someone prepared to stand beside them.
That perspective matters in product liability cases. Behind every medical record is a person trying to recover, work, care for family, and rebuild a sense of normalcy.
Accountability Can Protect More Than One Patient
Compensation matters because an injury can change a person’s financial and physical future. Accountability can matter beyond one case too. Civil litigation can examine failures that might otherwise remain hidden. Holding responsible companies accountable can also create pressure for safer products and better safety practices.
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Legal Disclaimer
Every case is different. This page provides general educational information and is not legal advice. The existence, value and legal viability of any claim depend on the particular facts, applicable law, insurance coverage and jurisdiction. Listing a case type does not mean Joumana Law will accept or directly handle every matter. Depending on the circumstances, location and legal issues involved, the firm may work with qualified co-counsel or refer a matter to another attorney. Prior results do not guarantee a similar outcome. Speak with a lawyer about your individual rights and any deadlines that may apply.