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Medtronic Difibrillator Defective Leads Lawsuit News

Medtronic-induced 'pre-emption' concept takes another hit with ruling on depression suits

-MinnPost

03/04/2010 - Thirteen people died when the 35W bridge collapsed in August of 2007. Their families filed suits against the designers, inspectors and contractors working on the bridge at the time of the collapse, and have so far received settlements from the state of Minnesota and the contractor. Other suits are scheduled for trial in 2011.

Coincidentally, 13 deaths have been linked to a recalled heart device made by Medtronic. The next of kin for those deaths cannot sue the maker of that product, however, thanks to a Supreme Court ruling from 2008 that effectively prohibited lawsuits against the manufacturers of medical devices.

That ruling created a legal argument known as pre-emption, a tort-resistant force field which effectively stated that if the FDA approved a medical device for use, that approval "pre-empted" the rights of injured users to file suit against that manufacturer in state courts.

At the time of its issue, the ruling was termed "one of the more creative and far-reaching legal arguments of the business groups that litigate before the Supreme Court," and it sprang from a case involving a catheter made by Medtronic. As a result, according to a lengthy piece in the New York Times Magazine at the time by law professor Jeffery Rosen, Medtronic was "colloquially referred to in the business community as 'the pre-emption company.' " Since then, the FDA has taken steps to tighten the approval process for medical devices, but the Medical Device Safety Act of 2009, a bill that attempted to overwrite pre-emption in Congress, has stalled in committee. As a result, for most purposes, you still can't sue the maker of an FDA-approved medical device.

If you think it is inconsistent that you can sue the maker of a faulty bridge that killed 13 people but not the maker of a faulty pacemaker that may have killed 13 people — even though both are approved as safe by governmental authorities — you may be surprised to learn that the Supreme Court did not extend the protections afforded the makers of medical devices to the makers of drugs.

The court famously ruled last year in Wyeth vs. Levine that it had essentially taken leave of its senses when it placed pacemakers and stents into a special category of consumer product — goods unanswerable to those who would allege injury. The Medtronic ruling, Justice John Paul Stevens wrote in Levine, was "a dramatic change of position," and "entitled to no weight," ultimately casting it aside as an inexplicable protection that only Alito, Scalia and Roberts would have extended to the makers of drugs. They even lost Clarence Thomas.

In a test of the climate after Levine, now comes the news that a circuit court in Illinois has determined the makers of antidepressants can't use pre-emption to defend themselves from lawsuits alleging drug-induced suicide. Medtronic's pre-emption principle had been holding up antidepressant-induced suicide cases across the country for years, but with the latest ruling it appears that wall too has fallen.

For the time being, then, it would seem that the only products still protected by pre-emption are those whose Minnesota-based manufacturers first helped to establish the term. If the Medical Device Safety Act ever comes to pass, the concept of pre-emption may one day disappear altogether, a short-lived concept to be invoked by legal historians with a scratch of the head. Until then, or even afterwards, it will stand as a powerful legacy of the Minnesota device maker.

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