Suit: Medtronic should pay for medical monitoring after leads failed

By Marilyn Tennissen | Oct 8, 2009

An East Texas man claims a cardiac defibrillator implanted in his chest could fail at any time, so he wants the company that made the device to pay for the continued monitoring of his condition.

Grayson County residents Norwood Koepsel and his wife, Peggy, filed a lawsuit against Medtronic Inc. and its subsidiaries on Oct. 6 in the Marshall Division of the Eastern District of Texas.

Koepsel uses an implantable cardiac defibrillator, or ICD, to maintain his heart rate.

According to the complaint, an ICD can correct slow heart rates, pace rapid heart rates and administer a shock to stop the heart and allow for it to return to an appropriate rhythm. As part of an ICD, a lead acts to conduct the electrical impulses between the heart and the device.

Typically, high voltage leads are inserted through a major cardiac vessel and attached directly to the heart muscle.

Koepsel was implanted with an ICD on Feb. 19, 2007, at Wilson N. Jones Medical Center in Sherman by Dr. Michael Isaac. The ICD was attached to his heart with a lead wire system called a Sprint Fidelis Lead, Model No. 6949, manufactured by Medtronic.

The suit states that the Sprint Fidelis Lead failed, and Koepsel underwent another surgery to have it replaced.

"Due to the failure/malfunction of Plaintiff's leads, Plaintiff Norwood Koepsel was implanted with a Medtronic 6076 right ventricular lead on Dec. 5, 2007, by Dr. Michael Isaac at Wilson N. Jones Medical Center," the complaint states.

Koepsel had to have his Sprint Fidelis Leads capped and left in his body, and he is now implanted with Medtronic leads, the Cap Sure Fix Novus Model 5076. Koepsel claims he fears there will also be problems with the Novus leads and that he will undergo more tests and treatment.

"Due to the failure of his Sprint Fidelis Leads and the fact that the Cap Sure Fix Novus leads may also subject him to terrifying and painful shocks or the complete failure of the leads, Plaintiffs are monitoring the leads through the CareLink monitoring system," the complaint states.

From any damages he may be awarded, Koepsel wants a treatment fund established to monitor his health and to pay for or reimburse for all monitoring and corrective medical expenses

The plaintiff alleges Medtronic marketed the Sprint Fidelis leads as being substantially similar to earlier lead products it made, when in fact it was aware that the new leads used completely new technology. The company relied on earlier test results, the suit states, and failed to test the Sprint Fidelis Leads in humans.

When the Sprint Fidelis Leads began to exhibit problems that would affect its effectiveness and longevity, Medtronic withheld the information from the U.S. Food and Drug Administration, the complaint alleges.

The suit claims Medtronic failed to report serious injuries or deaths that the Sprint Fidelis Leads may have caused or contributed to causing.

When doctors began to publish reports about the failure rate of the Sprint Fidelis Leads, Medtronic allegedly had its own medical experts publish criticisms of the doctors' data.

Due to Medtronics' wrongful conduct, "plaintiffs sustained and will continue to sustain severe physical injuries and/or death, severe emotional distress, mental anguish, economic losses and other damages for which they are entitled to compensatory and equitable damages and declaratory relief in an amount to be proven at trial," the complaint states.

The plaintiffs seek damages for claims of strict liability-failure to warn, strict liability-manufacturing defect, negligence, negligence per se, breach of implied and express warranties, negligent misrepresentation, fraud, constructive fraud, negligent infliction of emotional distress and unjust enrichment.

Peggy Koepsel is seeking damages for loss of consortium.

Shelly Sanford and Alex Barlow of Sanford Barlow LLP in Houston are representing the plaintiffs.

The case has been assigned to U.S. District Judge T. John Ward and referred to Magistrate Judge Charles Everingham for pretrial proceedings.

Case No. 2:09-cv-306-TJW-CE

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