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The Sorry State of Medical Device Lawsuits

There has been an interesting proposal made in the House and Senate that things be made easier to sue makers of medical devices. The question is will this work if passed?

While it may be a good idea to have legislation in place that allows patients who have been harmed by defective medical devices to sue the device’s maker, the question becomes, will this work? Medical devices that have been in the news lately because they failed include artificial knees and heart valves.

The proposed Act, known as the Medical Device Safety Act (2009), if passed, would effectively overturn the ruling in a 2008 case (Riegel v. Medtronic) which dismissed a lawsuit based on a ruptured catheter. Medical device firms were overjoyed by that ruling and viewed it as something finally going right for “their” side. That bubble burst in early December 2009, when the Supreme Court handed down a ruling (Wyeth v. Levine) upholding a $6.7 million jury verdict for the amputation of a musician’s arm after he was injected with an anti-nausea drug.

Will the proposed legislation get enough votes to have it pass? This is more than just a good question and the reason for this is because the federal law pertaining to medical devices has a clause that specifically addresses the pre-empting of state laws/requirements. On the other hand, the federal law relating to pharmaceuticals does not.

The nugget that needs to be examined in this latest case decision and the possibility of new legislation being passed is this: if the legislation were successful it would in essence let state courts review medical devices. The result of this would not only be a major headache, but create a landscape of inconsistent and confusing guidance about using medical devices for patients and doctors. It may even ultimately limit their availability.

While there is something to be said for medical malpractice resulting from the use of defective medical devices, this isn’t to say that “all” medical devices are defective. Nor does this mean none of them should be used. Thus, limiting the availability of medical devices that on the “whole” tend to work well, may have even worse consequences than being able to access the devices even with their history of failures.

In the meantime, until something resolves, those filing lawsuits should expect that defendant’s attorneys will keep trying to have their suit booted out of state court by referencing the 2008 (Riegel v. Medtronic) decision.

On a more disturbing note, January 2009 was a dismal month in federal court when a judge in Minneapolis tossed out several class action lawsuits from patients who were implanted with heart defibrillators which had wires that fractured and delivered lethal shocks.

Where will this controversy end? Only time and further court cases will tell. As for the proposed legislation, if it is passed, it will become a matter of time before the provisions in the Act are tested in court.

Christopher Mellino is a Cleveland Malpractice Lawyer specializing in Cleveland Medical Malpractice cases in Ohio. To learn more, visit Christophermellino.com.

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