Judge Richard Kyle has dismissed thousands of lawsuits against Medtronic and has a son who works for a law firm tied to the company. Despite this, and criticism from lawyers for patients implanted with Medtronic's defective Sprint Fidelis defibrillator wires -- the Judge will not recuse himself from the case.

Lawyers have argued that Kyle failed to disclose an important conflict of interest that could have swayed his judgment: his son is a lawyer and shareholder at the Minneapolis-based law firm Fredrikson & Byron, whose clients include Medtronic.

Kyle rejected those concerns in an order handed down in the U.S. District Court of Minnesota, saying he was not obligated to disclose the relationship. Following the plantiffs' argument would require judges to "run conflict checks through the law firms employing their children, spouses, parents, aunts and uncles," said Kyle, adding that "that logic would cripple the bench."

In his Jan. 6 decision, Kyle ruled that Medtronic was shielded from thousands of patients' lawsuits because its device was deemed safe and effective by the Food and Drug Administration. The Minneapolis-based company, which is the largest device maker in the world, pulled its Sprint Fidelis defibrillator leads off the market in 2007 after identifying several patient deaths in which cracked wires may have played a role.

The wires, also called leads, connect patients' hearts to implanted defibrillators that sends an electrical shock if it senses a life-threatening abnormal heart rhythm. A fractured lead can prevent the device from sending a lifesaving shock.

Kyle based his ruling on a Supreme Court decision last year that state court cases involving devices are pre-empted by federal regulatory decisions. Since then, thousands of consumer lawsuits against Medtronic and other device makers have been dismissed by judges citing the ruling.

But last week Democrats in Congress said they would move to overturn the decision. Energy and Commerce Committee Chairman Henry Waxman, D-Calif., said that the FDA should not be considered the final arbiter of medical product safety, and that state courts help bolster federal regulation of devices. Hearings on the issue are expected in coming weeks.

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