## Facts

- Richard Davenport, a Parkinson’s patient, received an implanted deep brain stimulation system (the Medtronic Activa Tremor Control System).
- The device was a Class III medical device with FDA premarket approval (PMA) for unilateral use at the time of implantation.
- Davenport underwent an off-label bilateral implantation with informed consent; the FDA later approved bilateral use years after the surgery.
- Davenport initially reported symptom relief but later experienced recurring problems, including loss of tremor control, leading to evaluations and additional surgeries.
- During a follow-up, physicians observed fatty material in a device connector and suspected impaired electrical flow; later testing showed connectors functioning, and symptoms continued despite component replacement.
- Davenport sued Medtronic alleging a manufacturing defect, asserting the device did not comply with FDA/PMA requirements.
- Medtronic produced evidence that the implanted system and components complied with FDA specifications and PMA requirements and moved for summary judgment.
- Davenport relied primarily on device malfunction and the connector finding, offering general assertions that the device would not malfunction absent a defect.

## Issues

1. Whether state-law claims concerning an FDA PMA-approved Class III device were barred to the extent they imposed requirements different from, or in addition to, federal requirements, as opposed to truly parallel claims.
2. Whether Davenport produced sufficient evidence under Pennsylvania law to create a genuine dispute that the device deviated from FDA-approved/manufacturer specifications and that the deviation caused his injuries.

## Decision

- The court granted Medtronic’s motion for summary judgment and dismissed Davenport’s claims.
- Claims were barred to the extent they sought to impose obligations beyond or different from PMA requirements for the device.
- Even treated as a parallel manufacturing-defect theory, Davenport failed to produce evidence of a deviation from FDA-approved specifications or proof of causation.
- Malfunction evidence and the presence of fatty material in a connector, without competent technical support linking them to a manufacturing deviation and injury, did not create a triable issue.

## Legal Principles

- For PMA-approved Class III medical devices, state-law claims are preempted insofar as they impose requirements different from, or in addition to, FDA device-specific requirements; only claims paralleling federal requirements may proceed.
- Under Pennsylvania manufacturing-defect doctrine, a plaintiff must show the product deviated from applicable specifications (or from otherwise identical units) and that the deviation caused the injury.
- On summary judgment, once the movant negates an essential element, the nonmovant must present specific facts supported by admissible evidence; conclusory statements and speculation are insufficient, particularly for complex medical devices.
- A manufacturer generally has no state-law duty to control physicians’ off-label use of an approved medical device.

## Conclusion

The court entered summary judgment for the manufacturer because the plaintiff’s theories either attempted to add to federally imposed PMA requirements or lacked evidence that the implanted device deviated from FDA-approved specifications and caused the alleged injuries.


Davenport v. Medtronic, Inc., 302 F. Supp. 2d 419 (E.D. Pa. 2004)