A medical device implanted in your body or used in your care should not make you worse.

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.

• My device was recalled. Does that mean I automatically have a case?

  Not automatically. A recall, especially a Class I recall, is significant evidence that something was wrong with the device. However, establishing a viable claim still requires proving that the specific defect causing the recall is what caused your injury, and that the manufacturer’s conduct gives rise to liability under the applicable legal theory. The recall frames the investigation but does not complete it.

• What if the device is still inside my body?

  You do not need to have had the device removed to pursue a claim, but explantation may ultimately be necessary for your health.

• Can I join an existing lawsuit or class action against the manufacturer?

  Possibly. Where a defective device has injured many people, federal courts sometimes consolidate claims into multidistrict litigation. Whether joining consolidated litigation or pursuing an individual claim is the better strategy depends on the nature and severity of your injury, the status of the litigation, and the specific facts of your case. An attorney can assess which approach maximizes your recovery.

• What compensation can I recover?

  You may recover all medical expenses including corrective surgery and ongoing treatment, lost wages, reduced earning capacity, pain and suffering, and emotional distress. 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.

• What makes Hance & Srinivasan different in defective medical device cases?

  Chandrika Srinivasan’s Ph.D. in Pharmacology and Toxicology gives her the scientific foundation to engage with biomedical device evidence, FDA regulatory submissions, and clinical literature at a level most attorneys cannot. The preemption analysis that determines whether a device case is viable requires someone who understands the science of what the FDA approved and whether the manufacturer deviated from it. That is not a common skill set. Michael Hance brings over 40 years of trial experience. The firm takes cases selectively and handles them personally.