Is a device recall required to pursue a defective medical device claim?

A recall is a regulatory action the FDA takes when a device violates applicable law, while a product liability claim is a separate civil matter with its own legal elements. A device can injure someone without ever being recalled, whether because the problem is still under review, affects only a particular unit, or simply has not been identified widely enough to trigger regulatory action. A device can be under investigation without any public recall ever being issued, since several sources can generate that history first.

• Complaint files manufacturers are required to maintain and investigate whenever a problem is reported

• FDA adverse event reports, which can exist independent of any recall and document malfunctions, infections, or injuries on their own
• Internal manufacturer investigations opened before any public announcement, sometimes prompted by reports from physicians or hospitals

These records show that the absence of a recall does not mean the absence of a documented problem, and it does not clear the manufacturer of responsibility.

Evidence, causation, and your specific device

A claim without a recall still needs to satisfy the standard elements of a product liability case, and the evidence has to fill in what a recall would otherwise suggest.

• Proof that the specific device departed from its intended design or manufacturing specifications
• Medical evidence linking the alleged defect to your particular diagnosis and treatment
• Testing or technical analysis of the device itself, when it is available for examination
• Documentation of the financial and physical impact the injury has had on your life

How The Law Offices of Sean M. Cleary can help with your defective medical device claim

The absence of a recall does not close the door on your defective medical device claim. Our office gathers the medical and device evidence needed to establish what happened, independent of whether a recall exists. Contact the Law Offices of Sean M. Cleary today for a free consultation, and our legal team will evaluate your case for free.