A lawsuit that has bounced around the federal court system for more than two years is back in Huntington federal court.

Back in February 2006, the family of James A. LoFiego filed a medical malpractice lawsuit in federal court against Medtronic Inc., alleging the company's equipment made caused LoFiego's death.

At the time the LoFiego case was filed, a handful of other suits against Medtronic were filed in West Virginia, and thousands were filed nationally.

In an attempt to get all of the suits handled in a timely manner, the federal court system consolidated them into a multidistrict case, and in May 2006 the LoFiego case was combined with other, similar cases and transferred to a federal court in Minnesota, the state where Medtronic is based.

The case, for all intents, was closed in West Virginia until this month when the LoFiego case was shipped back to the U.S. District Court in Huntington.

An attorney familiar with the case said while most of the lawsuits against Medtronic settled, a few, including the one filed by the LoFiego family, did not. And so it was sent back. Attorneys representing Medtronic and the LoFiego family could not be reached for comment.

According to court records, the LoFiego case was filed on behalf of LoFiego's widow, Doris, by Teresa Toriseva, a Wheeling-based attorney with Wexler, Toriseva, Wallace LLP, and several other attorneys.

It claims the company's devices failed to detect, control and treat rapid and irregular heartbeats as they should have and accuses Medtronic of negligence/wrongful death, liability due to design and manufacturing defects, failure to warn and breaches of implied and express warranty. In addition, it alleges that Medtronic violated the West Virginia Consumer Protection Act by "engag(ing) in unfair competition or unfair, unconscionable, deceptive or fraudulent acts or practices ... when it failed to adequately warn consumers and the medical community of the safety risks associated with the Medtronic devices."

LoFiego's lawsuit, which requests a jury trial, also accuses the company of "unjust enrichment" for accepting money and payment from LoFiego, other patients, doctors, hospitals and insurance companies for defective equipment.

The lawsuit stems from the Feb. 29, 2004, death of James A. LoFiego, who had two Medtronic devices implanted in September 2003. According to court records, LoFiego underwent surgery at St. Mary's Medical Center in Huntington to receive an implantable cardiac defibrillator and a cardiac resynchronization therapy device.

Implantable cardiac defibrillators, or ICDs, are designed to detect, control and treat rapid or irregular heart beats, including abnormally fast heart beats (tachycardia) and sudden heart failure by shocking the heart with an electric pulse to restore a normal rhythm. Cardiac resynchronization therapy devices, or CRT-Ds, are designed to provide a mild electrical impulse to the lower chambers of the heart to remedy heart failure symptoms and allow the heart to beat in a normal sequence.

The lawsuit alleges that Medtronic is negligent and under strict liability because "the manufacturing process for the defibrillators and certain ... components did not satisfy the (Food and Drug Administration's) pre-market approval standards" and that failure to satisfy the (FDA's) standards resulted in the devices having "unreasonably dangerous manufacturing defects." The lawsuit also accuses the company of failing to warn doctors and patients of the potential risks "created by these ... defects."

Lawyers representing Doris LoFiego allege that failures of those devices caused her husband's death.

"Mr. LoFiego ultimately died as a result of failure of the device," the suit reads.

Less than two months after LoFiego's death, the FDA announced April 4, 2004, that it was recalling two models of cardiac devices made by Medtronic, the same company that manufactured the cardiac devices in LoFiego. The FDA's recall was due to defective high-voltage capacitators, which resulted in problems with the devices' batteries charging. At the time, Medtronic said that problem was related to "one serious injury and four deaths," according to court documents.

But the recalls didn't end there. In February 2005, Medtronic issued a worldwide advisory/recall on four additional types of ICDs and four models of the company's CRT-Ds. The reason for the recall? According to court documents, both the FDA and Medtronic said the models had "potential battery shorting mechanisms."

The lawsuit also states that Medtronic was aware of potential battery problems early on in the development of the devices and did not do anything to warn physicians of the possibility that the batteries could fail.

"Between January 2003 and February 9, 2005, Medtronic took no action to prevent the implantation of ICDs and CRT-Ds powered by the (battery mechanism)," the lawsuit reads.

The recall affected not just the LoFiego family but millions of others.

According to court records, Medtronic's cardiac devices were implanted in approximately 2 million people worldwide and about 200,000 patients just in 2005.

"ICDs have been Medtronic's fastest growing product for the past three years: between 2002 and 2005, Medtronic's revenues from sales of the devices rose by nearly 63 percent from $2.944 billion to $4.615 billion," according to the LoFiego lawsuit.

The lawsuit alleges "Medtronic knew or should have known that the devices were not safe for patients who received them because of failure/short-circuiting of the batteries and/or high-voltage capacitors and the resultant effect on the units, rendering the devices unsafe and unreliable."

"The devices were defective, unreasonably dangerous and unfit for their intended uses," the lawsuit continues. "Medtronic placed tens of thousands of patients unnecessarily at risk of serious injury and/or death."