California Personal Injury: Fight Dangerous Drugs and Medical Devices

Who can bring a dangerous drug or device claim?

If you were injured by a prescription or over-the-counter drug, or by a medical device used or implanted in your care, you may have a claim. Families may also bring wrongful death claims. Health insurers and government programs may assert reimbursement or lien rights that must be addressed in any settlement.

Common legal theories in California

• Strict product liability: California recognizes strict liability for product defects in many contexts, including manufacturing defects, design defects, and failure to warn. See, for example, Greenman v. Yuba Power Products, Barker v. Lull Engineering, Anderson v. Owens-Corning, and Vandermark v. Ford.
• Important limits for prescription products: California generally does not allow strict liability design-defect claims against prescription drug manufacturers under comment k, but failure-to-warn and manufacturing-defect claims may still be available. See Brown v. Superior Court and Carlin v. Superior Court. Some California courts have extended comment k to certain medical devices.
• Negligence: Claims may allege careless design, testing, manufacturing, labeling, post-market surveillance, or failure to update warnings.
• Breach of warranty: Express and implied warranties can be implicated when a product is not fit for its ordinary or intended use. See California Commercial Code provisions on merchantability and fitness; limitations periods may apply (e.g., Com. Code § 2725).
• Fraud or misrepresentation: In limited circumstances, misleading marketing or concealment of known risks may give rise to additional claims; claims premised solely on alleged fraud on the FDA are generally preempted. See Buckman Co. v. Plaintiffs’ Legal Comm..
• Medical negligence: Separate from product claims, a healthcare provider’s deviation from the standard of care (e.g., contraindicated prescribing or improper implantation) can create a malpractice claim.

What makes a drug or device legally “defective”?

• Manufacturing defect: A departure from intended specifications renders an individual unit unreasonably dangerous. See Greenman.
• Design defect: The design poses unreasonable risks, often assessed under the consumer-expectation or risk–benefit tests. See Barker. Note: California generally bars strict design-defect claims for prescription drugs (see Brown).
• Failure to warn: Inadequate warnings or instructions given known or knowable risks at the time of distribution. California applies the learned intermediary doctrine for prescription products; the duty to warn typically runs to the prescribing physician. See Anderson and Carlin.

How federal preemption can affect your claim

• Brand-name drugs: FDA approval does not automatically preempt state-law failure-to-warn claims. See Wyeth v. Levine. California also recognizes certain warning-based claims against brand manufacturers even when the patient took a generic equivalent in limited circumstances. See T.H. v. Novartis.
• Generic drugs: Many failure-to-warn and design-defect claims are preempted because generic manufacturers must match brand labeling and design. See PLIVA, Inc. v. Mensing and Mutual Pharmaceutical v. Bartlett.
• Medical devices: State-law claims about FDA premarket-approved (PMA) Class III devices are often preempted. See Riegel v. Medtronic. Some claims involving devices cleared via 510(k) may proceed. See Medtronic v. Lohr.

Key evidence to preserve

• Medical and pharmacy records, implant records, device stickers/cards, and medication guides (including lot numbers and model/serial numbers).
• Product packaging, labeling, and instructions for use.
• A timeline of use and symptoms: start/stop dates, onset of issues, hospitalizations, and follow-ups.
• Communications with your providers and insurers.
• Photos of the device (if available), surgical sites, or visible injuries.
• If a device is removed, request that the hospital preserve the explanted device for potential inspection and testing.

How these cases are organized

• Individual lawsuits: Your case proceeds on its own facts and damages.
• Coordinated proceedings: Similar California state cases may be coordinated for efficiency. See the Judicial Council’s materials on coordination and complex litigation (overview).
• Federal multidistrict litigation (MDL): Federal cases may be centralized for pretrial proceedings. See 28 U.S.C. § 1407. MDL coordination does not by itself determine the value of your individual claim.

Potential damages

• Medical expenses (past and future), lost wages, diminished earning capacity.
• Pain and suffering and, where applicable, loss of consortium.
• Punitive damages in appropriate cases, subject to clear and convincing proof under Civ. Code § 3294.
• Resolution of liens or subrogation claims from insurers or government programs may be required from any recovery.

Deadlines and timing

California’s deadlines vary by claim and facts, and they are strictly enforced. For example, personal injury claims are often subject to a two-year statute of limitations (CCP § 335.1), medical malpractice claims have special time limits (CCP § 340.5), warranty claims have their own periods (see Com. Code § 2725), and claims against public entities generally require a government claim within six months (Gov. Code § 911.2). Because accrual and discovery rules can be complex, consult a California attorney immediately to protect your rights.

What to do if you suspect harm

• Do not stop using a prescribed drug or device without consulting your physician—medical judgment comes first.
• Document symptoms, key dates, and changes in medications or device settings.
• Request and save complete medical and pharmacy records.
• Report adverse events to your healthcare provider and consider submitting a report to FDA MedWatch (FDA MedWatch).
• Contact a California personal injury attorney experienced in drug and device litigation to evaluate your options. We can help.

Practical tips

How a California attorney can help

• Analyze product labeling, scientific literature, and regulatory history.
• Preserve and evaluate your medical evidence and, where possible, the product itself.
• Identify responsible parties across the supply chain.
• Navigate coordinated proceedings or MDLs while keeping your claim individualized.
• Engage experts in pharmacology, toxicology, biomedical engineering, and warnings.
• Negotiate with insurers and lienholders to maximize your net recovery.
• Litigate through trial when a fair settlement is not offered.

Frequently asked questions

Do I need the exact drug lot number or device model?

It helps. Pharmacy and implant records often include lot, model, or serial numbers that can be critical for proving manufacture, warnings, and recalls.

What if the drug or device was FDA-approved or cleared?

FDA approval or clearance does not automatically bar California product liability claims, but federal preemption may limit certain claims—especially for generic drugs and PMA Class III devices. See Wyeth v. Levine, PLIVA v. Mensing, Bartlett, and Riegel.

What if there was a recall?

A recall can support notice and defect arguments, but you may still have a claim without a recall if the product was defective or inadequately warned.

Can I sue both my doctor and the manufacturer?

Potentially, but the legal standards differ. Product liability focuses on the product and warnings; medical negligence focuses on a provider’s care. Your attorney will assess which claims fit your facts.

Ready to talk? Contact our California injury team.