Serving Marin County and the greater San Francisco Bay Area from our San Rafael office. Synergist Law, P.C. is a boutique California personal injury firm led by Sami Sedghani, Pharm.D., J.D. — an accomplished trial attorney with clinical training. We represent people throughout California who were harmed by a prescription drug, an over-the-counter medication, or an implanted medical device.
What is a pharmaceutical or medical device injury case?
A pharmaceutical or medical device case is a civil claim against the maker (and sometimes the seller, distributor, prescriber, or implanting surgeon) of a drug or device that caused injury — because it was defectively designed, defectively manufactured, inadequately labeled, or marketed without honest disclosure of its risks. These cases sit at the intersection of product liability, medical science, FDA regulation, and California tort law. They are among the hardest personal-injury cases to try well, which is why they are often referred to firms with real clinical and regulatory fluency.
Types of drug injury claims
- Prescription drug injuries. Serious adverse events from a prescribed medication — cardiovascular events, strokes, kidney or liver failure, aplastic anemia, severe skin reactions (Stevens–Johnson Syndrome / toxic epidermal necrolysis), tendon ruptures, pregnancy-related harms, and others.
- Over-the-counter drug injuries — harms from drugs sold without a prescription, often involving inadequate warnings about dosing, interactions, or special populations.
- Opioid-related harms and inadequate opioid risk disclosures.
- Birth-defect / teratogen claims involving drugs taken during pregnancy.
- Vaccine injuries (handled through the federal Vaccine Injury Compensation Program when applicable; traditional tort pathway where VICP does not apply).
- Compounding pharmacy errors — sterility failures, dosage errors, wrong-drug dispensing.
- Pharmacy dispensing errors — wrong drug, wrong strength, wrong patient, wrong directions.
- Drug-interaction injuries that a prescriber or pharmacist should have caught.
Types of medical device injury claims
- Hip, knee, and shoulder implants — failed replacements, metal-on-metal reactions (metallosis), fractured components, and revision-surgery cases.
- Spinal implants — including cervical artificial discs. Cervical disc replacement (CDR) cases, including the Mobi-C — see our dedicated Mobi-C pillar page and the summary section below.
- Hernia mesh — migration, adhesion, contraction, infection, and chronic pain.
- Transvaginal mesh and pelvic floor devices.
- IVC filters — fracture, migration, perforation.
- Pacemakers, defibrillators, and cardiac leads.
- Insulin pumps, infusion pumps, and continuous glucose monitors with dosing or delivery failures.
- Surgical staplers, powered surgical devices, and robotic surgical systems that malfunctioned intraoperatively.
- Breast implants — rupture, BIA-ALCL, and systemic illness claims where supported by the evidence.
- Dental and orthodontic implants, catheters, and other implanted devices.
Mobi-C cervical artificial disc cases
The Mobi-C is a cervical artificial disc originally developed by LDR Spine (now Zimmer Biomet). It received FDA Premarket Approval (PMA) in 2013 for single-level cervical disc replacement, with two-level approval following in 2015 — marketed as an alternative to anterior cervical discectomy and fusion (ACDF) for patients with symptomatic cervical degenerative disc disease. It is one of the most-implanted cervical disc replacement (CDR) devices in the United States, and one we actively handle at Synergist Law.
Failure patterns we see in Mobi-C and comparable CDR cases include:
- Subsidence — the implant settles into the adjacent vertebral endplate, collapsing disc height and loading the adjacent levels.
- Migration or extrusion — the device shifts from its implanted position, sometimes requiring urgent revision surgery.
- Heterotopic ossification — abnormal bone formation around the implant that eliminates the intended motion-preserving function and effectively converts the segment into a fusion.
- Adjacent-segment disease presenting earlier or more severely than disclosed in the IDE trial data or in the physician-facing labeling.
- Component fracture or wear-related failures.
- Revision surgeries that are more technically difficult than disclosed, with higher complication rates than labeled.
Because the Mobi-C is a PMA Class III device, state-law claims face preemption under Riegel v. Medtronic (2008) 552 U.S. 312. That does not end the inquiry — parallel claims alleging a specific violation of an FDA requirement (CGMP violations, mislabeling against the approved labeling, failure to submit required Medical Device Reports, off-label marketing) survive. Pulling the device’s MAUDE record, tracing warning-letter history, and comparing the clinical experience to the IDE trial representations are the technical work that distinguishes a viable Mobi-C case from one that gets dismissed on preemption at the pleading stage.
If you were implanted with a Mobi-C and have experienced subsidence, migration, revision surgery, or symptoms that your surgeon connects to the device, we would like to review the records.
The four kinds of defects that drive these cases
- Design defect. The product’s design is unsafe for its intended use even when manufactured correctly. In California, design defect is tested under the Barker v. Lull consumer-expectation and risk-benefit tests ((1978) 20 Cal.3d 413). Pharmaceutical design-defect claims are limited by Brown v. Superior Court ((1988) 44 Cal.3d 1049), which generally bars strict-liability design-defect against prescription drugs — but medical devices are treated differently, and warning and manufacturing claims against drugs remain available.
- Manufacturing defect. This specific unit deviated from the manufacturer’s own specifications — a contaminated batch, a compounding error, a cracked implant.
- Warning defect / failure to warn. The maker knew or should have known about a risk and did not adequately warn — through the labeling, the package insert, the Dear Doctor letter, or (in California) the physician under the learned-intermediary doctrine.
- Negligent marketing / off-label promotion. Marketing the product for uses not supported by the evidence, or minimizing risks in direct-to-consumer or physician-facing promotion.
FDA pathways, MDRs, and why they matter in your case
Not every FDA-cleared product carries the same legal exposure. The regulatory pathway often decides the shape — and even the viability — of a device claim:
- Premarket Approval (PMA) — Class III devices. The most rigorous pathway. State-law claims against PMA devices that would impose requirements “different from, or in addition to” FDA requirements are generally preempted under Riegel v. Medtronic (2008) 552 U.S. 312. Parallel claims (alleging a violation of a specific FDA requirement) survive. Preemption analysis is case-dispositive and requires early workup.
- 510(k) clearance. A clearance pathway based on substantial equivalence to a predicate device. State-law claims against 510(k) devices are generally not preempted under Medtronic v. Lohr (1996) 518 U.S. 470. Many of the most-litigated devices (hernia mesh, metal-on-metal hips, surgical staplers) came through 510(k).
- HDE and De Novo pathways have their own preemption contours.
- Prescription drugs. Brand-name failure-to-warn claims generally survive preemption after Wyeth v. Levine (2009) 555 U.S. 555. Generic drug failure-to-warn claims face steep preemption under PLIVA v. Mensing (2011) 564 U.S. 604 and Mutual Pharmaceutical v. Bartlett (2013) 570 U.S. 472 — a critical distinction for case screening.
The FDA’s MAUDE database (Manufacturer and User Facility Device Experience) collects Medical Device Reports (MDRs). A pattern of MDRs documenting the same failure mode predating the client’s injury is often the single most powerful piece of pre-filing evidence in a device case. Pulling MAUDE early is standard practice at this firm.
The learned-intermediary doctrine — and how it is argued
California applies the learned-intermediary doctrine: the manufacturer’s duty to warn runs to the prescribing physician, not directly to the patient (Carlin v. Superior Court (1996) 13 Cal.4th 1104). Defense counsel in pharma and device cases use this doctrine as the centerpiece of causation defense — arguing that even an inadequate warning would not have changed the prescriber’s decision, or that the prescriber was aware of the risk from other sources.
Beating that argument requires preparing the treating prescriber for deposition on what they knew, what they would have done differently, and reconstructing the actual information environment at the time of the prescription. It is slow, methodical work — and it is where a Pharm.D.-trained lawyer earns the fee.
What is a drug or device injury case worth?
There is no bracket. Value depends on severity of injury, strength of causation (did the drug or device actually cause the harm, and can you prove it), the regulatory and warning record, available defendants and insurance (manufacturer, distributor, prescriber, hospital), MDL/mass-tort venue versus single-plaintiff California venue, and the quality of the life-care plan and economic analysis. Categories of damages routinely in play:
- Past and future medical expenses, including revision surgeries, device explantation, and lifetime follow-up.
- Lost wages and lost earning capacity.
- Pain and suffering, loss of enjoyment of life, emotional distress.
- Loss of consortium for a spouse.
- Punitive damages where the manufacturer’s conduct meets the fraud, malice, or conscious-disregard standard of California Civil Code § 3294.
- Wrongful-death damages in fatal cases.
California law that potentially impacts your drug or device case
- Statute of limitations. Personal injury claims generally run on a two-year clock under CCP § 335.1. The discovery rule often applies in pharma and device cases, delaying accrual until the plaintiff knew or reasonably should have known the drug or device caused the injury.
- Medical malpractice overlay. Where a prescriber’s or implanter’s negligence is also at issue, MICRA applies under CCP § 340.5 — one year from discovery, three-year outer limit.
- Preemption — federal law preempts certain state-law claims against PMA Class III devices and generic drugs. Early preemption analysis is case-dispositive.
- Product liability. California applies strict products liability under Greenman v. Yuba Power Products (1963) 59 Cal.2d 57, with design-defect tested under Barker v. Lull. Prescription-drug design-defect claims are limited by Brown v. Superior Court, but warning and manufacturing claims survive.
- Learned-intermediary doctrine — the duty to warn runs to the prescribing physician, not directly to the patient (Carlin v. Superior Court).
- Comparative fault. California applies pure comparative negligence under Li v. Yellow Cab Co. (1975) 13 Cal.3d 804.
- Prop 51 apportionment of non-economic damages (Civ. Code § 1431.2).
- MDL & mass tort coordination. Many drug and device cases are part of a federal MDL or a California JCCP (Judicial Council Coordinated Proceedings) coordination. The decision whether to join a coordinated proceeding, or pursue a standalone California case, is strategic and consequential.
- Medi-Cal, Medicare, and ERISA liens are near-universal and often negotiable. Lien planning starts at the beginning of the case.
Why choose Synergist Law for your drug or device case
- Clinical and regulatory fluency. Sami Sedghani holds a Doctor of Pharmacy in addition to his law degree. Reading an FDA label, a package insert, a Dear Doctor letter, a MAUDE pull, or an adverse-event report is first-chair work.
- Boutique attention. You will not be handed off to a case manager, intake nurse, or junior associate.
- Local trial experience. We try cases in Marin, San Francisco, Alameda, Contra Costa, and Sonoma courts, and participate in California JCCP and federal MDL coordinated proceedings where appropriate.
- Bilingual service. Fluent Spanish-language representation at every step.
- No attorney’s fee unless we recover. You may be responsible for advanced costs depending on your written fee agreement. Standard contingency representation with case costs advanced by the firm.
California drug & medical device injury FAQ
The FDA cleared the drug or device. Doesn’t that mean it’s safe?
No. FDA approval or clearance is a floor, not a ceiling. Many of the most consequential pharma and device cases involve FDA-cleared products that caused real harm. What approval does affect is preemption — whether federal law bars certain state-law claims. PMA Class III device claims face stiff preemption; 510(k) clearances generally do not. Prescription drug warning claims generally survive; generic drug warning claims face steep preemption. The pathway matters.
What is MAUDE and why do you ask about it on intake?
MAUDE is the FDA’s Manufacturer and User Facility Device Experience database — the public repository of Medical Device Reports (MDRs). A pattern of similar failure reports before your injury is often the strongest pre-filing evidence that a device is defective. We pull MAUDE early on every device matter.
My drug was generic. Can I still sue the manufacturer?
Possibly, but the path is narrower. Under PLIVA v. Mensing (2011) and Mutual Pharmaceutical v. Bartlett (2013), failure-to-warn and design-defect claims against generic drug manufacturers are largely preempted, because federal law requires generics to carry the same label as the brand. Manufacturing-defect and some narrow parallel claims may survive. We screen generic-drug cases carefully.
Should I join an MDL or multidistrict litigation?
Sometimes yes, sometimes no. MDLs offer economies of scale, consolidated discovery, and coordinated expert work, but settlement grids may not reflect the severity of a specific client’s injury. Standalone California cases can produce stronger outcomes for severely-injured plaintiffs in favorable venues. The decision is strategic, not reflexive.
How long do I have to file a drug or device case in California?
Generally two years from the date of injury under CCP § 335.1, with the discovery rule often delaying accrual until the plaintiff knew or should have known the drug or device caused the injury. Where a prescriber’s or implanter’s negligence is also at issue, MICRA deadlines (CCP § 340.5) apply. Because the deadline depends on the facts, it is better to have a licensed California attorney determine the deadline that applies than to calculate it yourself.
What is the learned-intermediary doctrine and why does it matter?
Under Carlin v. Superior Court, the manufacturer’s duty to warn runs to the prescribing physician, not directly to the patient. Defense counsel will argue the warning, even if inadequate, would not have changed the prescriber’s decision. Overcoming that argument requires preparing the treating physician for deposition on exactly what they knew, when, and what they would have done with a complete warning.
What is a drug or device case worth?
There is no bracket. Value depends on severity of injury, strength of causation, the warning and regulatory record, available defendants, venue, and quality of the life-care plan and economic analysis. We do not quote numbers before reviewing the file.
How does Sami’s Pharm.D. help a drug or device case?
Drug and device cases turn on reading the medicine and the regulatory record in detail — the FDA label, the package insert, Dear Doctor letters, MAUDE reports, adverse-event reports, pharmacokinetics, drug-drug interactions, and the standard of care for prescribing and implanting physicians. A Pharm.D.-trained lawyer reads those documents natively, prepares treating physicians and retained experts to meet defense cross-examination, and builds a causation case that most plaintiff lawyers refer out.
Talk to a Marin County drug & medical device lawyer today
If you or a loved one was harmed by a prescription drug, an over-the-counter medication, or an implanted medical device, Synergist Law, P.C. offers a free, confidential consultation. Call (415) 835-4448 or contact us online. Serving Marin County, the Bay Area, and all of California.
Attorney Advertising. The information on this page is for general informational purposes only and does not constitute legal or medical advice. Reading this page, contacting the firm, or submitting a case inquiry does not create an attorney–client relationship. Past results do not guarantee a similar outcome. Every case is different; prognosis, treatment, and settlement value depend on facts specific to the individual client. For advice about your situation, consult a licensed California attorney.