Medical Device Claims in Pennsylvania: Preemption and the FDA Question
How the device was approved determines whether you can sue at all.
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Whether a medical device claim can proceed depends heavily on the regulatory route the device took. Devices that went through full premarket approval attract strong federal preemption arguments, while those cleared through the less rigorous 510k pathway generally do not, and most litigated devices came through 510k.
The approval route decides a great deal
| Route | What it involved | Effect on claims |
|---|---|---|
| Premarket approval | Full safety and effectiveness review | Strong federal preemption arguments against many state law claims |
| 510k clearance | Shown substantially equivalent to an existing device | Generally does not carry the same preemption protection |
Most heavily litigated devices reached the market through 510k, which is a clearance rather than an approval and involves no independent demonstration of safety. Establishing the route is the first analytical step in any device case.
What these claims usually involve
- Surgical mesh, including hernia and pelvic mesh.
- Hip, knee and other joint implants, including metal wear and failure requiring revision.
- Cardiac devices and leads.
- Contraceptive implants and devices.
- Surgical staplers and clips.
- Infusion pumps and monitoring equipment.
Preserve the explanted device
If a device is removed during revision surgery, ask in writing beforehand that it be preserved and not discarded or returned to the manufacturer. Hospitals routinely dispose of explanted hardware or send it back to the maker, and once the manufacturer has it your access is at their discretion.
This request has to be made before the surgery, and it is the single most valuable practical step available in these cases.
Not the same as malpractice
A device claim is against the manufacturer for a defective product. A malpractice claim is against a clinician for substandard care. Both can arise from the same injury, and they run on different requirements: a malpractice claim needs a certificate of merit, a device claim needs the product.
Establishing which you have, or whether you have both, is part of the initial review.
Recalls and MDR reports
Manufacturers must report adverse events, and those reports are collected in public databases. A device with a substantial adverse event history before your injury supports an argument the manufacturer knew. Recalls are useful, and their absence is not an answer.
The attorneys who handle these cases
Every one of these bar numbers is searchable on the Pennsylvania Disciplinary Board register. The person who takes your call is the person at your hearing.
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Kenneth R. Schuster
Founding Member
Read Kenneth’s background -
Justin M. Bernstein
Associate
Read Justin’s background -
Christopher D. Gasda
Associate
Read Christopher’s background -
Anthony S. Pinnie
Of Counsel
Read Anthony’s background -
Joseph J. Jachetti
Associate
Read Joseph’s background -
Andrew Valentin
Associate
Read Andrew’s background
Questions people ask us about this
Can I sue a medical device manufacturer?
It depends significantly on how the device reached the market. Devices that went through full premarket approval attract strong federal preemption arguments against many state law claims. Devices cleared through the 510k pathway generally do not, and most heavily litigated devices came through 510k.
What is the difference between approval and clearance?
Premarket approval involves a full safety and effectiveness review. 510k clearance requires only showing substantial equivalence to an existing device, with no independent demonstration of safety. The distinction matters enormously to whether a claim can proceed.
They are removing my implant. What should I do?
Ask in writing, before the surgery, that the explanted device be preserved and not discarded or returned to the manufacturer. Hospitals routinely do one or the other, and once the manufacturer holds it your access is at their discretion. This is the most valuable practical step available.
Is this a malpractice claim or a device claim?
They are different. A device claim is against the manufacturer for a defective product. A malpractice claim is against a clinician for substandard care. Both can arise from one injury and they have different requirements, so establishing which you have is part of the initial review.
There was no recall.
Not an answer. Manufacturers must report adverse events and those reports are publicly collected, so a device with a substantial adverse event history before your injury supports an argument the manufacturer knew. Many defects are litigated without any recall ever issuing.
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