A drug or piece of equipment that causes serious harm was made available to you by someone who had a duty to warn you.

More Defective Medical Device Questions

• Does FDA approval mean I cannot sue the manufacturer?

  Not necessarily. While FDA premarket approval of Class III devices may preempt some state law claims under Riegel v. Medtronic, manufacturing defect claims based on deviation from the approved design are generally not preempted. Devices cleared through the 510(k) process have significantly less preemption protection. And where the manufacturer violated its own FDA-approved specifications or concealed information from the FDA, additional claims may survive. The preemption analysis is device-specific and requires careful legal and scientific assessment.

• How do I know if my drug injury was caused by a product defect versus a known side effect?

  All drugs carry known risks, and not every adverse reaction gives rise to a product liability claim. A failure to warn claim requires evidence that the specific risk that caused your injury was known to the manufacturer and not adequately disclosed in the labeling. A manufacturing defect claim requires evidence that the specific lot or batch of drug you received was improperly produced.

• What if the drug or equipment met all regulatory standards?

  Meeting minimum regulatory standards is not an absolute defense to a product liability claim in Kentucky. A product can be manufactured to specification and still be defectively designed if a safer alternative was feasible. A drug can meet FDA labeling requirements and still give rise to a failure to warn claim if the label did not adequately disclose a known risk. Regulatory compliance is relevant but not conclusive.

• Can I sue my employer if I was injured by defective equipment at work?

  Workers’ compensation is typically the exclusive remedy against an employer for workplace injuries in Kentucky. However, a separate product liability claim against the manufacturer of the defective equipment is not barred by workers’ compensation. These are independent claims against different defendants. If defective equipment caused your workplace injury, you may be able to pursue both workers’ compensation benefits from your employer and a product liability claim against the manufacturer simultaneously.

• What if the product or drug is no longer on the market?

  The product’s removal from the market, whether through recall, voluntary withdrawal, or regulatory action, does not bar a product liability claim. In many cases, removal from the market is itself evidence relevant to the defect. The applicable statute of limitations and any KRS 411.310 presumptions depend on when the product was sold and when the injury occurred, not on its current market status.

• What compensation can I recover?

  You may recover medical expenses past and future including treatment of the injury and any corrective care required, lost wages, reduced earning capacity, pain and suffering, and property damage where applicable. Kentucky permits punitive damages in product liability cases under KRS 411.184 where the defendant’s conduct constitutes oppression, fraud, or malice. In cases where a manufacturer knew of a defect and continued to sell the product anyway, or concealed the defect from regulators and the public, a punitive damages claim may be viable.