Davenport v. Medtronic, Inc.

Richard Davenport (plaintiff), a Parkinson’s disease patient, had a prescription Activa device implanted to help relieve him of symptoms and achieve greater control over his bodily movements. The device, which was manufactured by Medtronic, Inc. (defendant), had Food and Drug approval for unilateral use; however, it was implanted in Davenport, with his consent, for off-label bilateral use, which received FDA approval five years later. Initially, Davenport received some relief until the device quit operating properly and he started experiencing problems within months. Despite numerous evaluations and two subsequent surgeries, a cause of the problems was never definitively discovered, though it was discovered that a strand of fatty material had grown in one of the device’s connectors and electricity was not flowing properly to the contacts in Davenport’s brain. But subsequent testing showed the connections were working and the problem persisted even after they were replaced, which Davenport later conceded. Davenport sued Medtronic for alleged manufacturing defects in the device. Medtronic, after producing evidence that the device and its components met all FDA standards, moved for summary judgment. Davenport responded with allegations that the mere presence of fatty material in one of the connectors where the FDA requirement mandated that there should be no such material constituted evidence that the device failed to meet FDA standards and broad conclusory statements suggesting that the device would not malfunction unless it was defective.