The New Englad Journal of Medicine, one of the most widely read medical journals, had two interesting artilces 1 and 2 this week on heart device failures even after Food and Drug Administration (FDA) approval. The first article is particularly troubling as the Supreme Court ruled that a plaintiff may not sue under state law to challenge the safety or effectiveness of a medical device to which the FDA has given “premarket approval.” Riegel v. Medtronic, Inc., 2008 WL 440744 (Feb. 20, 2008). The premarket approval type of FDA approval–which reflects the agency’s determination that the product is reasonably safe and effective for human use–establishes certain federal requirements that preempt state law remedies, including common-law claims for strict products liability, breach of warranty, and negligent design. This decision, when it first came out in 2008, represented a significant victory for medical device manufacturers, protecting them from the risk of state court damage awards for devices that have been duly approved by the FDA. In the article, Riata and Riata ST implantable cardioverter-defibrillator (ICD) leads (St. Jude Medical), which are implanted in approximately 79,000 patients in the United States were discussed as having failure such that the leads came out of their protective coating and were only noticable upon x-ray or after study following an adverse event. The scary implication of the article is that the drug device manufactorer has little to no incentive to monitor the adverse effects post FDA approval. In fact, the postmarketing surveillance system put in effect by the FDA is without backbone or ability to fully protect patients. As the Medtronic Sprint Fidelis lead involving 268,000 patients who received leads that had the potential to fracture, have finally been resolved via litigation, it seems that once again only through litigation will the drug device manufacturer have to protect its patients who are the most vulnerable… only the Supreme Court in Riegel v. Medtronic has hampered the ability of the attorneys who can get justice from protecting those in need. Its time to recognize that our American system of government with the proper checks and balances, which includes an active judiciary, be given its proper due as the best system of government in the world and our Supreme Court should take into consideration that self regulation by an industry without proper judicial oversight is merely a pipedream.
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