FindLaw | Legal News & Information

Driver's Insulin Pump Blamed for Fatal Crash

A Warren County, Ky., man was killed in a motor vehicle collision after his insulin pump failed to deliver sufficient medication and he lost consciousness behind the wheel, according to a lawsuit filed in a Kentucky federal court.

Plaintiff Paula Kennedy, the administrator of Jeffrey T. Kennedy's estate, alleges her husband was killed Feb. 17, 2004, when his Paradigm Sof-set Ultimate QR Infusion Set malfunctioned. The pump was attached to his abdomen and sent the insulin into his system subcutaneously.

The plaintiff says manufacturer Medtronic Inc. was preparing to issue a recall of a similar infusion set yet failed to advise or warn consumers, including Kennedy, of the impending recall. Medtronic had not filed an answer to the complaint at press time.

Medtronic recalled more than 160,000 Paradigm Quick-set Plus insulin pumps in June 2004 because the tube that delivers insulin to the body could become dislodged or disconnected, causing an interruption of the insulin flow.

The problem caused some 200 diabetics across the country to be hospitalized for elevated blood sugar levels, according an Associated Press report at the time.

The complaint, filed in the U.S. District Court for the Western District of Kentucky, names Medtronic and subsidiary Minimed Distribution Corp. as defendants.

It alleges the same design and manufacturing flaws that prompted the recall of the Quick-set Plus pumps also affected Kennedy's Paradigm Sof-set model and that Medtronic and Minimed knew or should have known of the dangers posed by the pump.

On the negligence count, Paula Kennedy says Medtronic failed to provide proper and adequate adhesive to attach the tubing to the infusion set, failed to manufacture the pump so as to avoid interruption of insulin flow, and failed to equip the pump with an adequate alarm system.

The plaintiff also claims Medtronic failed to provide all of the data on potential risks of using the pump to the Food and Drug Administration and failed to study the adverse reactions that users were experiencing.

The complaint alleges negligence, strict liability and breach of warranty.

The lawsuit seeks economic damages for medical and funeral expenses and loss of earning capacity, damages for loss of consortium for Paula Kennedy and her minor son, and punitive damages.