St. Jude Hit by New Suits
St. Jude Medical Inc. is facing many suits in both Los Angeles Superior Court and in the Central District of California due to the manufacturing of the Riata defibrillator that has lead to injuring and killing more than 30 patients. The defibrillator is claimed to have faulty leads and deliver blasts of electricity and zap irregular heart rhythms. If these cases are successful, it can bring up the past cases where many people were injured due to medical devices, and lawyers who had earned a large amount of fees. In the past cases such as this one, would have to go through the Food and Drug Administration’s premarket approval process, where the companies had to follow the standards that included those for manufacturing, labeling and device monitoring. Companies would even be protected if their devices would be found defective later on. It is generally considered difficult for lawyers to find state laws that would address the FDA’s requirements.
It is important that the past cases will be brought up again and that there should be protections from the state law that will lead to a central standard for device safety. Since there are patients’ lives at risk, it is important that there is a standard made for the effectiveness, testing, labeling, and marketing of the devices used on them.
Written by: Samantha Chin
Source: The Wall Street Journal
Weaver, C., & Smith, J. (2013, April 4). St. Jude Hit by New Suits. Retrieved April 4, 2013, from The Wall Street Journal: http://online.wsj.com/article/SB10001424127887323916304578402930543579870.html?mod=WSJ_business_whatsNews