As a criminal lawyer can share, there are instances where a medical device recall triggers more than just civil litigation, it can lead to regulatory investigation and criminal charges. In the world of hip implant recalls, this becomes especially relevant when manufacturers are accused of concealing defects, delaying reports, or misleading federal regulators. The legal risks don’t stop at product liability. They may also fall under the enforcement umbrella of the Food and Drug Administration (FDA) and the Department of Justice (DOJ), both of which have authority under the Federal Food, Drug, and Cosmetic Act (FDCA) to pursue criminal sanctions.
What Can Turn A Recall Into A Criminal Matter
While recalls typically begin as civil or administrative processes, there are certain actions, or inactions, that escalate a case into the criminal realm. These include:
- Failing to report serious injuries or deaths linked to a device under the FDA’s Medical Device Reporting (MDR) requirements
- Distributing a misbranded or adulterated device, especially after becoming aware of a defect
- Making false statements or submitting forged documentation to the FDA
- Continuing to sell or delay recalling a device known to pose a risk of serious harm
These scenarios often surface in device categories with high regulatory scrutiny, such as class-III implants. As our friends at Rispoli & Borneo P.C. can share, failures in regulation resulting from high-risk products can result in direct risk to manufacturers, and even individual responsibility for company executives under the Park doctrine.
Why Oversight Matters In Hip Implant Cases
In the context of a recalled implant, a hip recall lawyer may focus on the civil case, typically involving pain, revision surgery, or long-term disability. However, when company records show a delayed response to device failures or internal communications reveal that known defects were ignored, criminal exposure becomes a real concern.
For instance, if a manufacturer continues to ship defective implants after identifying performance issues in internal testing, or if reports from surgeons are buried rather than forwarded to regulators, these actions may be seen as willful misconduct. That change from forgetful and/or negligent conduct is often what leads to regulatory action and potential involvement from agencies like the DOJ.
Parallel Civil And Criminal Tracks Are Increasingly Common
Once a recall begins, manufacturers are required to follow strict FDA protocols, submitting documentation, communicating with affected patients, and halting further distribution. If any of these steps are mishandled or delayed, regulatory authorities may initiate parallel proceedings.
This dual-track approach means companies may simultaneously defend civil lawsuits filed by injured patients and respond to regulatory investigations or criminal charges. The outcomes of one can influence the other. For example, a guilty plea in a regulatory case may bolster the plaintiff’s claims in civil court.
How Lawyers Manage Overlapping Legal Risks
When facing both civil liability and possible criminal scrutiny, manufacturers must carefully coordinate their legal defense. This often involves engaging different legal teams—one for the civil injury claims and another for regulatory compliance and criminal defense.
At the same time, plaintiffs may benefit from the release of internal reports, communications, and compliance audits that emerge during the course of government investigations. These materials can reveal the scope of misconduct and inform damage calculations in personal injury cases.
For clients and attorneys on both sides of a hip recall case, it’s important to recognize that the legal terrain may shift rapidly if regulators step in.
When a hip implant recall uncovers regulatory violations, the consequences may extend well beyond product liability. In those cases, it’s not just about compensating injured patients, it’s about addressing corporate conduct under federal law. If you or a loved one has experienced a similar situation, talk to a lawyer in your area today.