Hurt by a medication or medical device? What to do and when you can sue
Do not stop a prescribed medicine without calling your doctor, since stopping can be more harmful. Keep the packaging and lot number and report the problem to FDA MedWatch. A recall alone does not prove your claim. Federal law can block some cases, especially for generic drugs and premarket-approved devices.
Last checked November 9, 2026 · Official sources (34)
How do I know if a drug or medical device hurt me?
The hard part of these cases is cause. You may have felt worse after starting a new pill, but a claim needs medical proof that the product caused the harm, not just that the harm came after it. A doctor's note that connects the two is a strong start.
Reports sent to the FDA can show a pattern, but the agency says the cause of an event cannot be determined from those reports alone. Other questions matter too: were you taking it the right way, and did the warning say anything about what happened to you?
What should I do if a medication or device hurt me?
- Call your doctor or pharmacist before you stop a prescribed drug. For a severe reaction, call 911.
- Keep the bottle, box, lot number and any leftover pills. Compare the lot number to any recall notice.
- Tell every doctor exactly what you took and when. Ask them to write down the link they suspect.
- If a device is being removed, ask in writing before surgery that it be saved and not thrown away.
- Report the problem to FDA MedWatch. Your doctor does not have to report, but you can do it yourself online.
- Get your pharmacy history. It proves what you were given, the maker, and the dates.
- Do not assume a TV ad or a class action covers you. Talk to a lawyer about your own facts and deadline.
Was my medication or device recalled, and does that matter?
A recall is an action by a company to take a product off the market, either on its own or at the FDA's request or order. It can help show there was a problem. It does not prove the product harmed you, and many injuries happen with products that were never recalled. Not all recalls are announced on FDA.gov or in the news.
| FDA class | What it means |
|---|---|
| Class I | A reasonable probability of serious harm or death |
| Class II | Temporary or reversible harm, or a remote chance of serious harm |
Device makers and hospitals must file certain reports with the FDA. Look up your device in the FDA's public report database, but remember those reports are not proof of what happened to you.
Can federal law stop me from suing a drug or device company?
Yes, sometimes. This is the trap in this area of law, and the answer depends on the kind of product you were given.
| Product | Basic rule | What it means for you |
|---|---|---|
| Brand-name drug | The maker is responsible for its label at all times | A claim that the warning was too weak is usually possible |
| Generic drug | Generic labels must match the brand name | Many warning claims against the generic maker are blocked. Design claims that turn on warnings are blocked too |
| Device with FDA premarket approval | Common-law safety claims are barred | Narrow claims may remain if the maker broke federal rules. Get a lawyer's opinion early |
| Device cleared through a 510(k) | A process about equivalence, not safety | More claims can usually go forward |
| Vaccine | A no-fault federal program, not a regular lawsuit | COVID-19 vaccine claims go to a different federal program |
Claims that a company lied to the FDA are treated as a matter for the FDA, not for state court. Your pharmacy records tell you if you took a generic. That one detail can decide whether you have a claim against the maker at all.
Who can pay in a dangerous drug or device case?
Usually the maker, and sometimes others in the supply chain or the medical team. If a pharmacy filled the wrong drug or a doctor missed a clear warning, that may be a separate malpractice claim with its own expert rules.
If the product has caused many injuries, federal cases may be gathered before one judge. That is not the same as a class action, and each person's injuries still count. If Medicare paid for your care, it must be repaid from a settlement. Medicaid and private health plans may ask too.
How do drug and device claims differ in Arizona and Texas?
| Rule | Arizona | Texas |
|---|---|---|
| Time to sue | Two years under the injury statute | Two years after the claim accrues |
| Outer cutoff | A 12-year cutoff still appears in the statute, but the Arizona Supreme Court said it was struck down | 15 years after sale, except certain slow-developing diseases |
| FDA-approved label | Limits punitive damages against the maker, unless it knowingly withheld information from the FDA | Rebuttable presumption of no liability on warning claims |
| Getting around the presumption | Not applicable | Includes withholding from the FDA and promoting unapproved uses |
| Design defect test | No drug or device exclusion in the statutes reviewed here | The state design defect statute does not apply to drugs or devices |
| Limits on damages | None | No general cap on compensatory damages in product cases, but a health care claim against a provider has its own limits |
One Texas point is unsettled. A federal appeals court held that federal law can preempt the Texas exception for withholding information from the FDA. Texas state courts could read this differently, so ask a lawyer how it applies to your case.
What evidence should I save, and how fast does it disappear?
- Removed implants and devices. Hospitals often discard them unless someone asks first.
- Lot numbers and packaging, which are often all that links you to a batch.
- Pharmacy records and insurance claims showing the manufacturer.
- The label and patient leaflet that came with your medicine at that time. Labels change.
- Your doctor's reasons for choosing the drug or device, which are usually in your chart.
What can a claim cover, and how long does it take?
A claim can include medical care, revision surgery, lost pay and pain and suffering. These cases are often slower than other injury claims. Expect the review of your records to take months, and a claim gathered with others may take years. No official source publishes a typical amount, so do not trust a number from an ad.
What mistakes hurt drug and device claims?
- Stopping a medicine without medical advice.
- Throwing out the bottle or allowing a device to be discarded.
- Waiting for a recall before calling a lawyer.
- Assuming a generic drug claim works the same way as a brand-name claim.
- Calling a claim-signup number from an ad without checking your state deadline.
Questions
How long do I have to sue for a dangerous drug?
Generally two years in both Texas and Arizona, and the Texas cutoff is 15 years after sale with some exceptions.
Can I sue if I took a generic drug?
Often not for the warning itself. The Supreme Court held that generic labels must match the brand name label.
Can I sue over a device the FDA approved?
It depends on how it reached the market. Devices with premarket approval are heavily protected, and 510(k) devices much less so.
What is MedWatch?
It is the FDA's program for reporting serious reactions and product problems, and you can file a report yourself.
Does a recall prove my case?
No. It can help show a problem, but you still need proof the product harmed you.
Dangerous drug or medical device? See if you are owed money.
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See if I’m owed moneySources (34)
- FDA, checked 2026-11-09. “stopping your medicine may be more harmful to your health than continuing to take the recalled medicine”
- FDA MedWatch, checked 2026-11-09. “program for reporting serious reactions, product quality problems”
- Supreme Court, PLIVA v. Mensing (2011), checked 2026-11-09. “violated the federal requirement that generic drug labels be the same as the corresponding brand-name drug labels”
- Supreme Court, Riegel v. Medtronic (2008), checked 2026-11-09. “bars common-law claims challenging the safety or effectiveness of a medical device marketed in a form that received premarket approval from the FDA”
- FDA MedWatch, checked 2026-11-09. “you may complete the Online Reporting Form yourself”
- FDA MedWatch, checked 2026-11-09. “Your health care provider is NOT required to report to the FDA.”
- Supreme Court, Medtronic v. Lohr (1996), checked 2026-11-09. “process is focused on equivalence, not safety”
- Texas Civ. Prac. & Rem. Code 82.007, checked 2026-11-09. “there is a rebuttable presumption that the defendant or defendants, including a health care provider, manufacturer, distributor, and prescriber, are not liable”
- FDA MAUDE, checked 2026-11-09. “cannot be determined from this reporting system alone”
- FDA, checked 2026-11-09. “check the lot number on the label of your medicine”
- FDA, checked 2026-11-09. “Recalls are actions taken by a firm to remove a product from the market.”
- FDA, checked 2026-11-09. “not all recalls are announced on FDA.gov or in the news media”
- FDA, checked 2026-11-09. “Class I recall: a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”
- FDA, checked 2026-11-09. “Class II recall: a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences”
- FDA, checked 2026-11-09. “manufacturers, device user facilities, and importers) are required to submit to the FDA”
- Supreme Court, Wyeth v. Levine (2009), checked 2026-11-09. “the manufacturer bears responsibility for the content of its label at all times”
- Supreme Court, Mutual Pharmaceutical v. Bartlett (2013), checked 2026-11-09. “State-law design-defect claims that turn on the adequacy of a drug's warnings are pre-empted by federal law under PLIVA.”
- FDA, checked 2026-11-09. “A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective”
- HRSA, checked 2026-11-09. “is a no-fault alternative to the traditional legal system for resolving vaccine injury petitions”
- HRSA, checked 2026-11-09. “please file your Request for Benefits with the Countermeasures Injury Compensation Program”
- Supreme Court, Buckman v. Plaintiffs' Legal Committee (2001), checked 2026-11-09. “claims conflict with, and are therefore impliedly pre-empted by”
- CMS, checked 2026-11-09. “it must be repaid to Medicare when a settlement, judgment, award, or other payment is made”
- A.R.S. 12-551, checked 2026-11-09. “shall be commenced and prosecuted within the period prescribed in section 12-542”
- Texas Civ. Prac. & Rem. Code 16.003, checked 2026-11-09. “not later than two years after the day the cause of action accrues”
- Arizona Supreme Court, Cronin v. Sheldon (1999), checked 2026-11-09. “Hazine declared unconstitutional the same statute of repose that Bryant upheld”
- Texas Civ. Prac. & Rem. Code 16.012, checked 2026-11-09. “before the end of 15 years after the date of the sale of the product by the defendant”
- Texas Civ. Prac. & Rem. Code 16.012, checked 2026-11-09. “the symptoms of the claimant's disease did not, before the end of 15 years”
- A.R.S. 12-701, checked 2026-11-09. “is not liable for exemplary or punitive damages if the drug alleged to cause the harm”
- A.R.S. 12-701, checked 2026-11-09. “knowingly, in violation of applicable federal food and drug administration regulations, withheld from or misrepresented”
- Texas Civ. Prac. & Rem. Code 82.007, checked 2026-11-09. “withheld from or misrepresented to the United States Food and Drug Administration required information”
- Texas Civ. Prac. & Rem. Code 82.007, checked 2026-11-09. “the defendant recommended, promoted, or advertised the pharmaceutical product for an indication not approved”
- Texas Civ. Prac. & Rem. Code 82.005, checked 2026-11-09. “a drug or device, as those terms are defined in the federal Food, Drug, and Cosmetic Act”
- Arizona Constitution, art. 18, sec. 6, checked 2026-11-09. “the amount recovered shall not be subject to any statutory limitation”
- Fifth Circuit, Lofton v. McNeil (2012), checked 2026-11-09. “the district court correctly found that federal law preempts a Texas tort reform law”