Defective Medical Device Lawyers

How the FDA Approval Process Affects Your Claim

Many patients assume that because a device was allowed onto the market, it must have been rigorously tested and proven safe. In reality, the majority of medical devices never undergo the kind of testing most people imagine — and understanding why is often central to a claim.

The FDA reviews devices through two very different pathways:

• 510(k) clearance: The most common route. A manufacturer only has to show that its device is "substantially equivalent" to a product already on the market. This process generally does not require new clinical trials proving the device is safe and effective in patients. Many of the hip implants, surgical mesh products, and IVC filters at the center of major litigation reached the market this way.
• Premarket approval (PMA): A far more rigorous pathway reserved for high-risk devices, requiring clinical evidence of safety and effectiveness before approval.

This distinction matters because a device cleared through the 510(k) process was never independently proven safe — it was simply compared to an older product, which may itself have been flawed. Clearance or approval by the FDA does not shield a manufacturer from liability when a device causes harm, and it does not prevent an injured patient from filing suit. Our attorneys examine which pathway applied to your device, because it frequently shapes the legal strategy and the evidence a case requires.

Warning Signs of a Defective Medical Device Injury

Complications from a defective device are not always immediately obvious, and some develop months or even years after implantation. Recognizing the warning signs early can protect both your health and your legal rights. Patients who have been harmed by a defective device often report:

• Persistent or worsening pain at or near the site of an implant
• Swelling, inflammation, or fluid buildup that does not resolve
• Signs of infection, including fever, redness, or drainage
• Unexplained fatigue, cognitive changes, or symptoms of metal toxicity (associated with certain metal-on-metal hip systems)
• Device migration or the sensation that a component has shifted or broken
• The need for revision surgery or unexpected removal of the device

If you have experienced any of these after receiving an implant or undergoing a procedure involving a medical device, document your symptoms, seek medical evaluation promptly, and preserve any records related to the device — including the manufacturer, model, and lot number if available. These details can be critical to establishing a claim.

Understanding Medical Device Mass Torts and MDLs

When a single device injures many patients in similar ways, those claims are typically handled through a mass tort — often consolidated into federal multidistrict litigation (MDL) — rather than as individual, isolated lawsuits. This is how much of the litigation over hip implants, hernia mesh, and IVC filters has proceeded.

It helps to understand what this structure means for you:

• A mass tort is not a class action. In a class action, everyone shares a single combined outcome. In a mass tort or MDL, each patient's claim remains individual — your injuries, medical history, and damages are evaluated on their own facts, and any recovery reflects the specific harm you suffered.
• Consolidation creates efficiency and leverage. Shared pretrial work — gathering the manufacturer's internal documents, deposing its experts — is done once for all cases, rather than repeated in every lawsuit.
• Bellwether trials guide resolution. A handful of representative cases are tried first. Their outcomes often shape how the manufacturer approaches settlement for the remaining claims.

Because these cases are document-intensive and expert-driven, they reward firms with the resources to fund years of litigation. Our national mass tort experience allows us to give you the leverage of a large coordinated proceeding without sacrificing the individual attention your case deserves.