Dangerous Drug and Medical Device Claims (FDA Preemption)

Injury claims against makers of prescription drugs and medical devices, where whether federal FDA approval blocks the claim is often the deciding question.

Looking for a lawyer rather than a definition? Skip to the state-by-state list of Drugs & Medical Devices law firms.

What it means

A person injured by a prescription drug or a medical device, such as a hip implant, hernia mesh, a pacemaker lead or an insulin pump, may have a product liability claim against the manufacturer under state law: a manufacturing defect, a design defect, or a failure to warn of a risk. For prescription products, many states apply the learned intermediary rule, under which the maker's duty is to warn the prescribing doctor rather than the patient directly.

The federal question that decides many of these cases is preemption: whether FDA approval of the product bars a state-law claim. The answer depends on the kind of product.

• Devices with premarket approval, the FDA's most rigorous review, are protected from state claims that would impose requirements different from or additional to the federal ones (21 U.S.C. § 360k(a); Riegel v. Medtronic, Inc., 552 U.S. 312 (2008)). A claim that the maker violated the federal requirements themselves can survive.
• Devices cleared through the 510(k) process, as substantially equivalent to an existing device, generally do not get that protection (Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996)).
• Brand-name drugs: failure-to-warn claims are generally not preempted, because the maker can strengthen its label (Wyeth v. Levine, 555 U.S. 555 (2009)), unless there is clear evidence the FDA would have rejected the warning, a question decided by the judge (Merck Sharp & Dohme Corp. v. Albrecht, 587 U.S. 299 (2019)).
• Generic drugs must carry the same label as the brand, so failure-to-warn and most design-defect claims against generic makers are preempted (PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011); Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013)).

When many people are injured by the same product, federal cases are often transferred to one judge for coordinated pretrial proceedings in a multidistrict litigation (28 U.S.C. § 1407). Each case remains an individual claim, unlike a class action. Vaccine injuries are handled separately, through the National Vaccine Injury Compensation Program (42 U.S.C. § 300aa-10 et seq.).

Where this comes from

When people hire a lawyer for this

Keep the device if it is removed, or ask the surgeon in writing to preserve it, and keep the packaging, the prescription records and the pharmacy labels, which show the exact product and maker. A lawyer will first need to know whether the drug was brand-name or generic and how the device reached the market, because that can decide whether a claim exists at all. Adverse events can also be reported to the FDA through its MedWatch program.

Worried about the cost? A lawyer can be hired for one part of a case only (limited-scope representation), may be paid from what a claim recovers (contingency fee), or may be free through a pro bono program or legal aid; a court can also waive its own filing fees.

Find Drugs & Medical Devices law firms in your state

Choose your state to see Drugs & Medical Devices law firms in the city where we list the most; your city may be under “other cities”, A to Z. A state marked “Accidents & Injuries” has no Drugs & Medical Devices listing yet and opens the broader page.

• Alabama (Birmingham)
  +1 other city

  • Montgomery
• Alaska (Anchorage)
• Arizona (Chandler)
  +6 other cities

  • Gilbert
  • Glendale
  • Mesa
  • Phoenix
  • Scottsdale
  • Tucson
• Arkansas (Little Rock)
• California (Chula Vista)
  +19 other cities

  • Anaheim
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  • Fontana
  • Fremont
  • Irvine
  • Long Beach
  • Los Angeles
  • Oxnard
  • Riverside
  • San Bernardino
  • San Diego
  • Santa Ana
  • and 7 more with fewer listed firms
• Colorado (Aurora)
  +2 other cities

  • Colorado Springs
  • Denver
• Connecticut (Bridgeport)
• Delaware (Wilmington, Accidents & Injuries)
• District of Columbia (Washington)
• Florida (Hialeah)
  +5 other cities

  • Jacksonville
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  • Tampa
• Georgia (Atlanta)
• Hawaii (Honolulu, Accidents & Injuries)
• Idaho (Boise)
• Illinois (Chicago)
• Indiana (Fort Wayne)
  +1 other city

  • Indianapolis
• Iowa (Des Moines)
• Kansas (Kansas City, Accidents & Injuries)
  +1 other city

  • Wichita
• Kentucky (Lexington)
  +1 other city

  • Louisville
• Louisiana (Baton Rouge)
  +2 other cities

  • New Orleans
  • Shreveport
• Maine (Portland)
• Maryland (Baltimore)
• Massachusetts (Boston)
• Michigan (Detroit)
• Minnesota (Minneapolis)
  +1 other city

  • Saint Paul
• Mississippi (Jackson)
• Missouri (Kansas City)
  +1 other city

  • St. Louis
• Montana (Billings)
• Nebraska (Lincoln, Accidents & Injuries)
  +1 other city

  • Omaha
• Nevada (Henderson)
  +3 other cities

  • Las Vegas
  • North Las Vegas
  • Reno
• New Hampshire (Manchester)
• New Jersey (Jersey City)
  +1 other city

  • Newark
• New Mexico (Albuquerque)
• New York (Buffalo)
  +2 other cities

  • New York City
  • Rochester
• North Carolina (Charlotte)
  +5 other cities

  • Durham
  • Fayetteville
  • Greensboro
  • Raleigh
  • Winston-Salem
• North Dakota (Fargo, Accidents & Injuries)
• Ohio (Cleveland)
  +3 other cities

  • Cincinnati
  • Columbus
  • Toledo
• Oklahoma (Tulsa)
  +1 other city

  • Oklahoma City
• Oregon (Portland)
• Pennsylvania (Pittsburgh)
  +1 other city

  • Philadelphia
• Rhode Island (Providence)
• South Carolina (Columbia)
• South Dakota (Sioux Falls)
• Tennessee (Memphis)
  +1 other city

  • Nashville
• Texas (Austin)
  +12 other cities

  • Arlington
  • Corpus Christi
  • Dallas
  • El Paso
  • Fort Worth
  • Garland
  • Houston
  • Irving
  • Laredo
  • Lubbock
  • Plano
  • San Antonio
• Utah (Salt Lake City)
• Vermont (Burlington)
• Virginia (Chesapeake)
  +3 other cities

  • Norfolk
  • Richmond
  • Virginia Beach
• Washington (Seattle)
  +1 other city

  • Tacoma
• West Virginia (Charleston)
• Wisconsin (Madison)
  +1 other city

  • Milwaukee
• Wyoming (Cheyenne, Accidents & Injuries)

Related terms

Other entries in the same area of law, each written from the same primary sources.

• Asbestos and Mesothelioma ClaimsClaims for diseases caused by asbestos exposure, often diagnosed decades later, brought against solvent companies in court and against bankruptcy trusts set up by former manufacturers.
• Assumption of Risk and Liability WaiversThe defense that a person who knowingly took on a danger cannot complain of it - and the signed waiver that tries to make that agreement explicit before the gym, the ski slope or the trampoline park.
• Aviation Accident ClaimsInjury and death claims after a plane or helicopter crash, where the rules depend on whether the flight was a scheduled airline, a charter or a private aircraft, and whether it crossed a border.
• Birth Injury ClaimsMalpractice claims for injuries to a baby or mother during pregnancy, labor or delivery, with special rules in some states and for federally funded clinics.
• Bus Accident Claims (Common Carrier Liability)Injury claims against bus companies and transit agencies, which owe passengers a heightened duty of care, and whose public status can impose short claim deadlines.
• Car Accident ClaimsHow an injury claim after a car crash works: who pays first, how fault is decided, which insurance policies apply, and what a settlement has to account for.
• Comparative and Contributory NegligenceRules that decide what happens to a claim when the injured person was also partly careless - and they differ sharply from state to state.
• Construction Accident ClaimsInjury claims from construction sites, where workers' compensation, OSHA safety rules and claims against parties other than the employer interact.
• Contingency FeeA fee arrangement in which the lawyer is paid a percentage of what is recovered, and is paid no fee if nothing is recovered.
• Cruise Ship Passenger InjuryInjury claims by cruise passengers are governed by federal maritime law and the ticket contract, which can set where and how quickly a claim must be brought.
• Damages in a Personal Injury ClaimThe categories of loss an injured person can be compensated for - the bills and lost earnings, the pain and the lost enjoyment of life - plus the separate and rarer category meant to punish, and the state caps that limit some of them.
• Defamation (Libel and Slander)A false statement of fact about someone, communicated to others, that damages their reputation; libel is written or published, slander is spoken.
• Dog Bite LiabilityWho pays when a dog injures someone - the strict-liability statutes most states have and what they cover, the older "one-bite" rule that survives in the rest, negligence and leash-law claims that exist under either, the defenses of trespass and provocation, landlord and keeper liability, how homeowners' insurance responds, and the dangerous-dog proceedings that run alongside the civil claim.
• Dram Shop and Social Host LiabilityWhen a bar, restaurant, liquor store or private host can be held responsible for injuries caused by someone they served alcohol to - the statutes that create the claim in most states and the very different standards they set (visibly intoxicated, under the legal drinking age, or both), the states with no claim at all, social-host rules for minors, what must be proved, the notice requirements, and who can sue.
• Emotional Distress Claims (IIED and NIED)When the law compensates psychological harm on its own, without a physical injury - the intentional-infliction tort and its "outrageous conduct" threshold, the negligent-infliction claim and the limits states put on it (the impact, zone-of-danger and bystander rules), the proof a claim needs, and how these differ from the emotional-distress damages that ride on any ordinary injury claim.
• Independent Medical ExaminationAn examination by a doctor chosen and paid for by the other side - routine in injury, disability and workers' compensation claims, and not treatment.
• Insurance Bad FaithAn insurer's duty to deal fairly with its own policyholder - and the separate claim that arises when it does not.
• Joint and Several LiabilityWhat happens when more than one person is responsible for the same injury - the traditional rule that each is liable for the whole judgment, the modern rules in most states that limit it by share of fault or by type of damages, contribution between defendants, the effect of settling with one of them, and why the rule decides who actually pays when one defendant is uninsured or bankrupt.
• Loss of ConsortiumThe claim of a spouse - and in some states a child or parent - for what an injury to a family member took from the relationship itself: companionship, affection, household services and the marital relationship, what has to be proved, why it is derivative of the injured person's claim, and how it is pleaded, valued and settled.
• Maritime Injury Claims (Jones Act, LHWCA and General Maritime Law)The federal rules that replace ordinary workers' compensation and negligence law when someone is injured on a vessel, on the docks or on navigable water.
• Motorcycle Accident ClaimsInjury claims by motorcyclists, where helmet laws, insurance gaps and the other driver's failure to see the rider shape what can be recovered.
• NegligenceCarelessness that the law treats as a legal wrong because it fell below the level of care a reasonable person owed to someone else.
• Negligence Per SeThe rule that breaking a safety statute - running a red light, serving alcohol to a minor, violating a building code - can itself establish that the defendant was careless, without the jury deciding what a reasonable person would have done.
• Nursing Home Abuse and Neglect ClaimsInjury and wrongful death claims against a nursing home for abuse or neglect, such as pressure ulcers, falls, malnutrition or assault, and the arbitration clauses that often come with admission.
• Pedestrian Accident ClaimsInjury claims by people struck while walking, decided by right-of-way rules, comparative fault and which insurance policies cover a pedestrian.
• Personal Injury Claim (How the Process Works)The stages of an injury claim from the accident to a settlement or verdict: treatment and evidence, the insurance claim and demand, negotiation, suit, discovery, mediation, trial and payout, and what has to be proved at each.
• Premises LiabilityThe responsibility of whoever owns or controls property for injuries caused by its condition - the slip on the wet floor, the broken stair, the unlit car park - and the rules that make the visitor's reason for being there matter.
• Product LiabilityA claim against the maker or seller of a product that injured someone because of how it was designed, how it was made, or what it failed to warn about - and the federal rules that can shut some of those claims down.
• Res Ipsa LoquiturThe doctrine that lets an injured person prove negligence from the accident itself when the cause is unknown but the event is one that does not ordinarily happen without carelessness - its elements, the exclusive-control requirement and how it has loosened, what the doctrine does procedurally (an inference, or a presumption shifting the burden), and where it is and is not used.
• Rollover Accident ClaimsInjury claims after a vehicle rolls over, which often involve the vehicle's own design - roof strength, stability control, seat belts and window glazing - as well as the driver who caused the crash.
• Sexual Abuse Civil ClaimsA survivor's civil lawsuit for money damages against the abuser and against the institution that employed, supervised or failed to protect against them, separate from any criminal case.
• Slip and Fall Accident ClaimsHow an injury claim works after a fall on someone else's property, which turns on whether the owner knew or should have known about the hazard and what the injured person can prove about it.
• Strict LiabilityLiability for harm without any showing of carelessness - the rule for abnormally dangerous activities, for defective products in most states, and, under many state statutes, for the owner of a dog that bites.
• Subrogation and Medical Liens on a SettlementWhy an injured person does not keep the whole settlement - the right of health insurers, Medicare, Medicaid, ERISA plans, workers' compensation carriers and hospitals to be repaid from a recovery for the treatment they paid for, how each kind of lien is created and enforced, the rules that reduce them, and why the liens have to be resolved before the check is cashed.
• Suing the Government for an Injury (Tort Claims Acts)Why an injury caused by a government employee or a public property defect follows different rules - sovereign immunity and the statutes that waive it, the written claim that must be presented to the agency before any lawsuit and the short deadline for it, the exceptions that keep immunity (discretionary functions, most intentional torts, certain activities), damage caps, and the no-jury and no-punitive-damages rules.
• Toxic Exposure Claims (Toxic Torts)Injury claims from exposure to a harmful chemical, contaminant or substance in the air, water, soil, workplace or a product, where proving that the exposure caused the illness is the central fight.
• Traumatic Brain Injury (TBI) ClaimsInjury claims involving a brain injury, where proving an injury that may not show on a scan, and valuing a lifetime of care, are the central legal problems.
• Truck Accident Claims (Commercial Trucks)Injury claims involving tractor-trailers and other commercial trucks, which add federal safety rules, several possible defendants, higher insurance minimums and evidence that can disappear quickly.
• Vicarious Liability (Respondeat Superior)The rule that makes an employer liable for harm its employee causes while doing the job - the reason the trucking company, the hospital or the delivery firm is the defendant, and the reason "independent contractor" is fought over so hard.
• Workers' CompensationThe state no-fault system that pays medical care and part of lost wages for an injury at work without any proof of fault - and, in exchange, takes away the right to sue the employer, though not the right to sue anyone else who caused it.
• Wrongful Death ClaimA claim brought by surviving family members or an estate when someone dies because of another party's wrongful act.

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