Medical device lawsuit deadlines and FDA preemption

Statute of limitations: the deadline to sue

A statute of limitations is a deadline to file a lawsuit. If you miss it, a court can dismiss your case, no matter how strong it is. Each state sets its own deadlines. Which state’s deadline applies can itself be a legal question, so ask a lawyer.

Here are four examples for personal injury claims. They show how much the rules differ.

State	Deadline	Notes	Law
California	2 years	Covers injury caused by a wrongful act or neglect	Code Civ. Proc. § 335.1
Texas	2 years	Runs from the day the claim accrues	Civ. Prac. & Rem. Code § 16.003(a)
New York	3 years	For latent effects of exposure to a substance, the 3 years run from discovery of the injury	CPLR 214(5) and 214-c
Tennessee	1 year	Runs from the date of injury; applied to product liability injury claims	Tenn. Code § 28-3-104

These are examples, not a full list. Other states have their own rules. Ask a lawyer which filing deadline applies in your state.

The discovery rule

Some device injuries are not obvious right away. A catheter can fracture inside the body. An implant can migrate. You may not learn of the problem until a scan or a later surgery.

The discovery rule addresses this. Under it, the clock starts when you discover the injury, not when it first happened. New York applies this to latent effects of exposure to a substance under CPLR 214-c. The three years run from discovery.

Not every state works this way. Tennessee’s 1-year period for product injury claims runs from the date of injury. States also set statutes of repose, which are outer limits on some claims. Discovery-rule and repose rules vary from state to state.

What this means for you:

1. Write down key dates. Note when the device went in, when symptoms began and when a doctor linked them to the device.
2. Keep the paperwork. Scan reports and surgery notes often show when a problem was first found.
3. Do not wait for a recall or a settlement. Act when you first suspect the device caused harm.
4. Ask a lawyer which filing deadline applies in your state. Only a lawyer can tell you which deadline applies to you.

Other deadlines in device cases

State law is not the only clock. Court cases and settlements set their own dates, and they can close for good.

Deadline	Date	What it means
Philips CPAP economic-loss claims period	Closed Aug. 9, 2024	Money-loss claims under the class settlement ended
Philips CPAP personal-injury registration	Jan. 31, 2025	Registration for the $1.075 billion injury program ended
Bard IVC filter MDL closed to new cases	May 31, 2019	New cases could no longer join that MDL

Courts also set deadlines inside a case. In the Philips MDL, plaintiffs outside the settlement had to meet court-ordered discovery steps. Some MDLs allow direct filing. The Boston Scientific spinal cord stimulator MDL began allowing it in August 2026. See MDL vs class action for more.

FDA approval vs FDA clearance

The FDA reviews many medical devices before they are sold. It uses two main paths. The path matters in court.

	Premarket approval (PMA)	510(k) clearance
Which devices	Class III: devices that support or sustain life, or present a potential unreasonable risk	Devices shown to be “substantially equivalent” to a legally marketed device
What the FDA reviews	Scientific and regulatory review of safety and effectiveness	Whether the device is as safe and effective as a “predicate” device
FDA’s word	Approved	Cleared
Strictness	The most stringent device marketing application	A comparison to an existing device
Effect on state claims	Strong preemption defense under Riegel	Fewer preemption limits

A 510(k) device is “cleared,” not “approved.” The difference can decide which claims a court allows. Your lawyer can check which path your device took.

Riegel v. Medtronic and preemption

Preemption means federal law overrides state law. The Medical Device Amendments include a preemption clause at 21 U.S.C. § 360k(a).

In Riegel v. Medtronic, Inc., 552 U.S. 312, the Supreme Court applied that clause. It decided the case on Feb. 20, 2008. Justice Scalia wrote the opinion. Justice Ginsburg dissented.

The Court held that the clause bars state common-law claims that challenge the safety or effectiveness of a device with FDA premarket approval. In plain terms, state-law claims that a PMA device was unsafe or did not work are generally barred.

The Court left one door open. It declined to address “parallel” claims. These are state claims based on a maker’s violation of FDA requirements.

Preemption in a current case: spinal cord stimulators

Most spinal cord stimulators are PMA devices. That gives their makers a strong preemption defense. Plaintiffs have built their claims around it.

In the Boston Scientific MDL (MDL 3181), plaintiffs say the company won PMA using published studies of other makers’ devices, not its own clinical studies. They also say it “abus[ed]” the PMA supplement process to add significantly changed devices. A group of plaintiffs also brought a suit against the FDA itself under the Administrative Procedure Act.

This shows how preemption shapes a case. Lawyers do not just argue that a device hurt someone. They examine how the device reached the market.

Steps to protect your claim

1. Find your device’s maker and model. Check your operative report or implant card.
2. Note your key dates. Write down when you were implanted, when symptoms began and when you learned the cause.
3. Read about eligibility. Our Do I qualify? page covers each device.
4. Ask a lawyer which filing deadline applies in your state. The guide homepage lists five firms that take device cases. Our settlements page explains what recoveries look like.