Bill shifts costs for faulty medical devices

The costs for replacing faulty medical devices would fall on the manufacturers instead of a patient's insurance company, under a bill in the Legislature's pipeline.

State Rep. Tony Cornish, RGood Thunder, introduced the bill Monday, calling it unfair for private insurers and Medicare to foot the bill for manufacturer mistakes.

Medical technology companies typically provide free replacement devices, but they don't routinely cover surgery and related costs.

There have been several recalls in the last year after safety alerts issued by the U.S. Food and Drug Administration, which oversees the industry.

Minnesota has a thriving medical device industry, but there have been recalls for devices made by three companies with facilities in the Twin Cities area, Medtronic Inc., Guidant Corp. and Boston Scientific Corp.

In a written statement, Medtronic said state and local proposals like Cornish's are unnecessary.

"We believe that any changes or new solutions should be developed at the federal level by private and public payers and industry," said spokesman Rob Clark.

Cornish would prefer to see a federal solution as well. But, he said, "If they don't go after it strongly enough, then it will be up to the states."

Before introducing the bill, Cornish said he consulted with Dr. Robert Hauser of the Minneapolis Heart Institute.

After one of his patients died after a Guidant defibrillator failed, Hauser and two other doctors went public claiming that Guidant failed to alert doctors about the potential for one of its devices to short-circuit.

The company faces an investigation by the U.S. Food and Drug Administration, two U.S. attorneys and New York Attorney General Eliot Spitzer. Several civil lawsuits have also been filed.

Hauser said he hopes Cornish's legislation would make device companies pay more attention to quality issues.

However, a representative from the industry trade group, Advanced Medical Technology Association, said Cornish's bill might conflict with the federal Food, Drug and Cosmetic Act which states that state governments can't enact requirements regarding devices intended for human use "which relates to the safety or effectiveness of the device."