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Nick Avgerinos
Nick Avgerinos
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Does Congress Afford too many Protections to Makers of Medical Devices?

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Technological advancements add lifesaving and revolutionary products that enhance the practice of medicine. Doctors can save lives with devices such as artificial pacemakers and dialysis machines, or improve one’s quality of life with a joint replacement procedure. However, there can be problems with these medical devices that may cause harmful injury or death to the patient when they are either defective or malfunctioning.

The major problems with medical devices come through a defective product, incorrect use of the device, or medical incompatibility. According to the Institute of Medicine , about 1.3 million Americans are seriously injured each year by adverse events involving medical products.

In order to regulate these potential dangers, the FDA has regulations with which these medical devices must comply. To use the device should be logical and not confusing, with a minimal dependence on the memory or mental calculations of the patient. There should be appropriate warnings, labels, and alerts, and the devices should be well tested and re-checked regularly. If these regulations are not followed, a patient typically has the right to sue the manufacturer to recover for their injuries.

In February, the Supreme Court decided 8-1 that makers of medical devices that have passed the most rigorous review standards and approved by the FDA are protected from lawsuit. Justice Scalia wrote the opinion of the majority based on the principle that federal law preempts imposition of liability for such manufacturers under state law. Those who support this decision see the protection of the companies as crucial in furthering more medical advancements. Also, in a lawsuit, a jury is not confronted with the benefits a device may have for millions of people, not just how a malfunction harmed one person.

While the decision is narrowly tailored for devices that have passed the highest level of scrutiny, it can be potentially dangerous for those who have been wrongly injured. Such protections could encourage a greater sense of carelessness on the part of the manufacturers. Traditionally, lawsuits have acted as a check to ensure that quality standards are kept high when human lives are at stake. Furthermore, even the FDA admits that in many areas they are understaffed and under-funded . If this is the case, defective devices might gain FDA approval, harm someone, and the manufacturer would be immune from liability, leaving victims with no means to seek justice in the courts.

In the past few months, highly publicized petitions to Congress have been made to reform laws to make sure negligent companies are held liable for medical devices that are either defective or not properly labeled to ensure that patients can easily use them. Many members of Congress , such as the chairman of the House Committee on Oversight and Governmental Reform , want to pass legislation to protect the rights of the wrongly injured.

In the meantime, doctors and patients should continue to do everything they can to avoid tragic accidents. Patients should research medical devices on which they rely, and be sure to report any malfunctions, so they can hopefully be improved. They should also be sure to read and understand any warning labels and instructions, and treat even a simple device with the utmost care.