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Drugs and medical devices are regulated by a combination of federal, state, and local law. At the federal level, the U.S. Food and Drug Administration (FDA) has primary authority over the approval, labeling, manufacturing, distribution, post-market surveillance, and recalls of pharmaceuticals and medical devices. In California, state laws and agencies add additional requirements for licensing, controlled-substance regulation, patient privacy, and public-health enforcement. Local authorities in Orange County and the City of Irvine enforce public-safety rules and coordinate with state and federal agencies in investigations and emergency responses.
Legal issues in this area commonly involve regulatory compliance, product-liability claims, adverse-event reporting, clinical-trial disputes, marketing and promotion restrictions, reimbursement and coverage disputes, controlled-substance enforcement, and privacy concerns for health data. Because the field combines complex science with technical regulations and strict timelines, people affected by drugs or devices often need specialized legal help to protect their rights and navigate enforcement or litigation.
There are many situations where a lawyer can be essential when a drug or medical device is involved. Examples include:
- You or a loved one was injured by a prescription drug, over-the-counter medicine, implant, or other medical device and you want to pursue compensation.
- You received a recall notice or were told to stop using an implanted device and you need advice about monitoring, treatment, or potential claims.
- You are a clinician, manufacturer, distributor, or clinical investigator facing an FDA inspection, warning letter, or enforcement action.
- You are a whistleblower with information about off-label promotion, false claims, manufacturing problems, or safety violations and are considering a qui tam or False Claims Act claim.
- You are involved in or planning a clinical trial and need help with informed consent, regulatory compliance, institutional review board issues, or sponsor agreements.
- You face criminal investigation or charges related to controlled substances, diversion, prescription fraud, or other drug-related offenses.
- You need help protecting or challenging intellectual property, regulatory approvals, or market access for a drug or device.
Irvine is in Orange County, California, and local rules operate alongside state and federal law. Important legal frameworks to know about include:
- Federal regulation. The FDA governs premarket approval processes for drugs and devices, post-market surveillance, labeling, adverse-event reporting, recalls, and manufacturing standards such as quality-system requirements. Federal criminal statutes and the Drug Enforcement Administration - DEA - regulate controlled substances.
- California regulation. California enforces state health and safety codes that address controlled substances, pharmacy practice, clinic and hospital licensing, and medical-device requirements. The California Department of Public Health and the California Board of Pharmacy are key state agencies. State privacy law such as the Confidentiality of Medical Information Act applies to medical records and certain device data.
- Local agencies. The Orange County Health Care Agency and local law enforcement handle public-health investigations, infectious-disease control, and local enforcement of public-safety rules. Local hospitals and health systems follow state licensing rules and may have institution-specific reporting and review procedures for adverse events.
- Civil liability and consumer protection. California civil law governs personal-injury and product-liability lawsuits that may be brought in state or federal court. Consumer-protection statutes and the California False Claims Act may also apply to wrongful marketing, reimbursement fraud, or deceptive practices.
- Practical local considerations. Irvine itself does not have a separate set of drug- or device-specific regulations that override state or federal law, but local hospitals, clinics, and employers may have policies that affect reporting, treatment, and employment matters.
Get prompt medical care and keep thorough medical records. Preserve the device if possible and the packaging, labeling, prescription information, and any instructions. Write down what happened, dates, symptoms, and names of treating providers. Avoid disposing of evidence and limit public discussion about the incident. Contact a lawyer who handles product-liability and regulatory cases to evaluate your situation.
Adverse events involving drugs or devices can be reported to the FDA through its adverse-event reporting system and to the drug manufacturer. California providers and institutions report to state public-health authorities as required. If you are in Irvine, you can also notify your treating facility and the Orange County Health Care Agency if there is a local public-health concern. Reporting helps regulators identify safety trends and can preserve documentation for legal claims.
Yes, you may be able to bring a product-liability claim in state or federal court if you can show the drug or device was defective, improperly labeled, or that the manufacturer failed to warn about known risks and that the defect caused your injury. Manufacturers have specific defenses and regulatory preemption issues may arise in certain device cases, so you should consult a lawyer experienced in this area promptly.
A recall is an action taken by a manufacturer or requested by the FDA to address a product that may be unsafe or mislabeled. A recall does not automatically create a legal claim, but it is evidence that the product had a safety issue. Whether you have a lawsuit depends on causation, damages, and other legal elements. You should preserve records of the recall notice and seek legal advice about your options.
Controlled-substance enforcement can involve multiple agencies. The DEA enforces federal controlled-substances laws, and California agencies including the California Department of Justice and local law enforcement handle state crimes. Healthcare licensing boards may pursue administrative discipline against practitioners for diversion or improper prescribing. Criminal cases carry different procedures and standards than civil claims, so consider criminal defense counsel if you face investigation.
Potentially yes. Medical malpractice claims can be available if a healthcare provider failed to adhere to the standard of care in implanting, using, or monitoring a device and that failure caused harm. Separately, the manufacturer can be sued for product defects or inadequate warnings. These are distinct legal theories and may be pursued together. Medical-malpractice claims have special notice and filing requirements in California, so act quickly.
There are strict time limits for filing lawsuits, called statutes of limitations and sometimes statutes of repose. These deadlines vary by the type of claim and circumstances and can begin at the time of injury or discovery of the injury. Because deadlines can expire quickly, contact an attorney as soon as possible to preserve your rights.
The FDA regulates safety, approval, and post-market surveillance, but it does not award compensation to injured individuals. However, FDA findings and enforcement actions can be important evidence in civil litigation. State courts and federal courts decide liability and damages in private lawsuits.
You may have options to report internally, to government agencies, or to bring a whistleblower action under the federal False Claims Act or California False Claims Act. Whistleblower cases can be complex and have special procedural requirements and protections against retaliation. Consult an attorney experienced in qui tam and whistleblower law before disclosing sensitive information to ensure you preserve legal protections.
Look for attorneys or firms with experience in FDA law, product liability, healthcare law, or criminal defense depending on your situation. Ask about their track record in similar cases, trial experience, regulatory knowledge, fee structure, and whether they work on contingency for injury claims. Initial consultations are often available to assess your case and next steps.
The following types of organizations and agencies can be helpful when you need information or want to report concerns:
- U.S. Food and Drug Administration - oversees premarket approvals, adverse-event reporting, recalls, and manufacturing standards.
- U.S. Drug Enforcement Administration - enforces federal controlled-substance laws and handles diversion investigations.
- California Department of Public Health - state-level public-health oversight and reporting requirements.
- California Board of Pharmacy - regulates pharmacists, pharmacies, and some controlled-substance issues.
- California Attorney General - enforces certain consumer-protection laws and may investigate healthcare fraud.
- Orange County Health Care Agency - local public-health authority that can advise on community health and reporting.
- Professional organizations such as Regulatory Affairs Professionals and medical-device or pharmaceutical trade associations - for background on regulatory standards and best practices.
- Medical and legal libraries, law school clinics, and local bar referral services - for help finding experienced counsel and learning more about your rights.
If you need legal assistance in Irvine for a drug or medical-device matter, take these practical steps:
- Seek medical attention immediately for any health concerns and keep all medical records, imaging, prescriptions, and billing statements.
- Preserve physical evidence, including packaging, labels, device components, and any device serial numbers or implant records.
- Document the facts in writing - dates, locations, people involved, and the sequence of events. Take photos where appropriate.
- Report the event to your healthcare provider, the manufacturer if advised, and to the FDA or state public-health authorities if there is a safety issue.
- Avoid posting detailed descriptions of the incident on social media and limit conversations about the matter to trusted individuals and your attorney.
- Contact an attorney experienced in drugs and medical-devices law for an initial consultation to review your situation and explain your legal options, deadlines, and likely costs. Ask about fee arrangements, including contingency fees for injury claims and hourly rates for counseling or defense matters.
- If you are a clinician, manufacturer, or investigator facing regulatory scrutiny, assemble documentation, compliance records, and communications, and retain counsel quickly to coordinate responses to inspections or enforcement inquiries.
Beginning these steps promptly preserves evidence and legal options. A qualified lawyer can help you evaluate claims, interact with regulators, protect your rights, and pursue the best outcome for your situation.
