The Supreme Court has ruled in favor of these companies due to FDA regulations. The Supreme Court feels that the companies should be granted immunity since these products are not on the market until they receive FDA approval. The manufacturers are only granted the immunity if they completely manufactured their devices to the requirements of the FDA. Patients who sustain injuries from such products would have a difficult if not impossible chance of fighting the manufacturer in a court of law even at the state level.
State court judges have been asking whether current cases of this nature should go any further due to the ruling. A Florida court judge questioned legal officials as to whether a case of alleged injury stemming from a Cypher heart stent needs to run its length. No decisions one way or the other have been made at this point.
A case has been affected by the recent U.S. Supreme court mandate. A New York widow whose spouse had heart problems underwent a procedure that utilized a balloon catheter. While undergoing the procedure, the balloon catheter exploded within a coronary artery. The ruling was that the manufacturer of the balloon catheter was immune since it was already approved by the FDA.
The Supreme Court is mulling over the idea of extending the same type of immunity to pharmaceutical manufacturers. This would protect pharmaceutical companies from the effects of lawsuits for producing defective drugs. If the Supreme Court rules in favor of pharmaceutical companies and grants immunity to them, people with claims of personal injury will not be able to bring litigation even in a state court.
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Many in Washington were shocked that there wasn't a split decision between liberals and conservatives regarding this issue in the Supreme Court. Some in Congress are baffled by the ruling and never thought they would see such immunity granted to the companies. During the 1970's the need for regulation for many medical devices became a concern with advances in medicine.
By Delsia Hartford