US Supreme Court Says Law Bars Suits on Medical Devices
Let me get this straight. The FDA has the final say in whether a medical related device is safe enough to be released to the public. This information is almost always provided by the manufacturer wishing to market the item. Bias in the info provided and financial ties with the FDA are well known and even documented in some cases. Now, the Supreme Court basically says it’s okay for the manufacturer to provide fraudulent info to the FDA to get their item approved???? And yet the safety of supplements is frequently called into question?? People in glass houses…
(article) The US Supreme Court on Wednesday ruled that individuals cannot sue manufacturers of medical devices for allegedly defrauding the US Food and Drug Administration (FDA) in order to win marketing approval. The case involved a lawsuit in which more than 5,000 individuals accused a company of fraudulently winning federal approval for marketing bone screws used in spinal surgery. The lawsuit alleged that the Buckman Co., a consulting firm for medical device manufacturers, used misrepresentations to get FDA approval in 1986 for marketing a device known as the Variable Screw Placement Spinal Plate Fixation System. The ruling also was a victory for the company. Chief Justice William Rehnquist said for the court that a US appeals court had been wrong in reinstating the claims against the company and allowing the lawsuit to go forward. Allowing such lawsuits might expose manufacturers of medical devices to “unpredictable civil liability,” he said. Rehnquist said the federal regulatory scheme amply empowered the FDA to punish and deter fraud against the agency, and that the FDA used its authority to achieve a delicate balance of objectives that can be skewed by allowing such lawsuits. “The FDA…has at its disposal a variety of enforcement options that allow it to make a measured response to suspected fraud upon the agency,” Rehnquist said in the opinion. He said this flexibility was a critical component of the framework under which the FDA pursues its objective of regulating marketing and distribution of medical devices. Rehnquist said state law fraud claims inevitably conflict with the FDA’s responsibility to police fraud. He said companies complying with the FDA’s detailed regulatory regime, but then facing possible lawsuits under the laws of 50 states, might be deterred from seeking approval of devices with potentially beneficial uses. In the case at issue, the FDA had rejected Buckman’s two previous applications, made on behalf of AcroMed Corp., for marketing the device. But a third application, which separated the device into its component parts and which said the screws were intended to be used in the arm and leg bones, won FDA approval. The plaintiffs claimed they were injured when their doctors implanted the device into their spines and alleged that Buckman had perpetrated a fraud on the FDA. The individual claims seeking monetary damages were consolidated into one lawsuit. The lawsuit said that Buckman won FDA approval under a pretext because the intention all along had been to market the bone screws for use in spinal surgery. The FDA did not approve the marketing of bone screws for spinal surgery until 1995.