State and federal lawsuits filed last week in California are seeking to change current legal thinking and make it harder for medical device makers to avoid responsibility for defective products. According to an analysis published in the Wall Street Journal the suits “could challenge the broad liability protection that medical device makers have enjoyed since a key Supreme Court ruling in 2008.”
The target of the suits is St. Jude Medical, the maker of the Riata line of defibrillators. According to the Journal, the plaintiffs in the suit claim “that problems with the manufacturing and oversight of Riata defibrillator ‘leads’ injured or killed more than 30 patients. Faulty leads, which connect the heart to defibrillators that zap irregular heart rhythms back to normal, caused the devices to fail or needlessly deliver blasts of electricity, the suits allege.”
It might seem obvious that here in Oregon, in Washington or anywhere else in the country companies have an obligation to ensure that the products they sell are safe and function properly, but manufacturers of unsafe medical devices gained unprecedented liability protection via the Supreme Court’s 2008 Riegel v Medtronic case. That ruling, as the Journal reports, granted medical device makers immunity from state unsafe product liability laws on the grounds that medical device safety is a federal issue.
Medical device makers argue both that federal standards trump state ones and that a single national standard is necessary for them to be able to market their products. This, of course, ignores the fact that there are separate federal and (often higher) state standards for many other products and that the manufacturers of those products still manage to find buyers from Florida to Oregon, Washington and the rest of the Pacific Northwest. Cars, for example are subject to different, stricter, emissions standards in California than they are elsewhere in the country.
As the Journal notes, the belief that the Riegel case has been read too broadly and that it does not give medical device manufacturers a free pass where state unsafe product laws are concerned has many backers. The broad interpretation of unsafe product liability immunity has been successfully challenged in some other courts. The fact that in this instance St. Jude is alleged to have broken federal rules by failing to report flaws in its products to the FDA in a timely manner gives the case added strength. As an Oregon and Washington consumer safety advocate I’ll be watching both the federal and state suits closely in the weeks and months to come. Regulatory approval at the federal level for complex products like medical devices was never intended to provide the makers of those devices with a license to sell defective and unsafe products here in Oregon or anywhere else.
Wall Street Journal: Cases Challenge Liability Protection Enjoyed by Device Makers (requires subscription)