You start a legal claim over a failed medical device by treating the injury, preserving proof, and getting a product-liability review. A product-liability claim is a lawsuit arguing a defective product caused your harm. The U.S.
Food and Drug Administration stresses prompt care and complete records. Tell your provider a device may be involved. Keep visit notes, imaging, implant records, and bills.
Table of Contents
- Save proof of failure and harm
- Check FDA records and report the problem
- Which legal claim fits your injury?
- What deadlines and limits could block you?
Save proof of failure and harm
Preserve the device exactly as removed. Injury firm Simmons and Fletcher advises saving the device, packaging, instructions, receipts, photos, and recall notices Simmons and Fletcher guidance on defective devices. It also advises requesting operative and implant logs.
Ask for your operative report and implant log early. Keep a dated photo log of symptoms and wound changes. Then ask a product-liability lawyer to review defect, causation, and filing venue.
- Keep the device, packaging, instructions, and receipts together
- Photograph labels, lot numbers, wounds, and swelling with dates
- Request operative, anesthesia, and implant logs in writing
- Save recall letters, bills, and missed-work records
Check FDA records and report the problem
Search the U.S. Food and Drug Administration MAUDE database for similar adverse events with your model FDA MAUDE search. MAUDE houses mandatory manufacturer, importer, and facility reports plus voluntary patient and clinician reports.
Use exact model and lot numbers. Check the FDA Medical Device Recalls database for recalls or corrections since November 2002. Patients, caregivers, and clinicians can voluntarily report serious problems to FDA MedWatch online or on Form 3500 or 3500B. Reporting does not file a lawsuit, but it creates a record.
Which legal claim fits your injury?
Most injury claims use product-liability theories, Cornell Law School Legal Information Institute explains, including manufacturing defect, design defect, inadequate warning, or breach of warranty Cornell Law School product-liability overview. Manufacturing defect means one unit went wrong. Design defect means the whole design is unsafe.
Strict liability does not always require proof of carelessness. It states a plaintiff must show the product left the defendant defective and caused injury. Courts judge defect by consumer expectation or risk-utility tests.
What deadlines and limits could block you?
Deadlines are short and state-specific. California generally allows two years for personal-injury actions under Code of Civil Procedure section 335.1, as shown in Casetext's text of the California limitations statute. Delay can bar an otherwise valid claim. Federal preemption is a second limit, as described in Medtronic's summary of the ruling.
Under Riegel v. Medtronic, 552 U.S. 312 (2008), state claims that add requirements beyond FDA premarket-approval rules for Class III devices are generally barred. Ask a lawyer early whether preemption applies to your model.