WEST VIRGINIA RECORD

CHARLESTON -- A man is suing Medtronic Inc. after he claims it is responsible for his wife's death.

Unomedical, Inc. f/k/a Maersk Medical, Inc.; Convatec, Inc.; and John Doe, Inc., were also named as defendants in the suit.

On April 18, 2009, Susan Sawyers was using a Medtronic insulin pump when she received an inappropriate and incorrect amount of insulin that resulted in her passing out and falling and string her head with sufficient force to cause her death, according to a complaint filed April 15 in Kanawha Circuit Court.

James Sawyers claims the defendants' product was defective and dangerous.

On June 1, 2009, the United States Food and Drug Administration cited Medtronic for failure to report to FDA the no later than 30 calendar days after the day it became aware that one of its devices may have caused or contributed to a death or serious injury or had malfunctioned, according to the suit.

James Sawyers claims the FDA also cited Medtronic for "failure to have a person who is qualified to make a medical judgment reasonably conclude that a device did not cause or contribute to a death or serious injury ..."

The FDA's investigation revealed that Medtronic's employee entrusted with making the "critical determination 'only had a high school diploma with some additional in-house training,'" according to the suit.

James Sawyers claims the defendants were negligent in failing to adequately test the insulin pump and its component parts.

James Sawyers is seeking compensatory and punitive damages with pre- and post-judgment interest. He is being represented by Paul M. Stroebel.

The case has been assigned to Circuit Judge Jennifer Bailey.

Kanawha Circuit Court case number: 11-C-619