In another anti-consumer action, the drug and medical device makers have won the latest battle in the preemption war. The Wisconsin Supreme Court has thrown out a lawsuit against Medtronic, a manufacturer of defibrillators. The Wisconsin court followed a ruling by the U.S. Supreme Court, basically saying that if a manufacturer could slip a product past the Food & Drug Administration, it was home free, and consumers can’t sue for defects.
This has been a major offensive for manufacturers recently, especially throughout the Bush administration. The theory is for the government to starve the regulatory agencies by cutting budgets, make it easier for the agencies to miss defective products, and then have the courts agree that if a product has been approved by the government, a consumer has no legal right to sue the manufacturer. It’s a vicious cycle for consumers.
Here are excerpts from an article in the StarTribune about the most recent court decision:
Patients cannot sue the makers of potentially unsafe medical devices approved for sale by federal regulators, the Wisconsin Supreme Court ruled Tuesday. The court ruled against a Wisconsin man who had surgery to remove a defibrillator after the manufacturer, Medtronic, Inc., warned its battery had a chance of failing. The ruling is a victory for Minneapolis-based Medtronic and other manufacturers who want to limit product liability.
But two justices warned the decision leaves Wisconsin residents at the mercy of the U.S. Food and Drug Administration, which has a poor track record of ensuring the safety of medical devices.
At issue was whether patients could sue in state court over medical devices that received market approval from the U.S. Food and Drug Administration. Under a 1976 federal law, companies must prove the safety and effectiveness of such devices to the FDA before they can enter the marketplace.
The company knew of the problem more than two years earlier but kept selling the product. The FDA did not order a recall or withdraw its 2002 approval. In the meantime, Medtronic obtained approval from the FDA in 2003 to also sell an identical device with fixed batteries.
The U.S. Supreme Court ruled last year that state lawsuits were barred in a similar case involving a malfunctioning heart catheter sold by Medtronic.
Two concurring justices — Walsh Bradley and Chief Justice Shirley Abrahamson — criticized the U.S. Supreme Court decision but said they must follow it. The decision leaves Wisconsin residents’ safety in the hands of the flawed FDA, Walsh Braldey wrote.
She cited a letter from FDA scientists released last month that charged “the scientific review process for medical devices at FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at risk.”
“It is not at all apparent that the FDA approval process actually guarantees a minimum level of safety for medical devices,” Walsh Bradley wrote.
