Originally posted under the title: "Peanut Crimes The FDA and You"
When the FDA Fails, Have Your Day In Court?
FDA Scientists are desperate to get the word out that the medical devices section of the FDA is dysfunctional. A couple of weeks ago 9 FDA scientists who work in the device division wrote a letter to Barack Obama in an effort to bring problems with device testing to his attention. The scientists had first written to former FDA Commisioner von Eschenbach, then to members of the House and Senate, then to the president's transition team before addressing Obama in an effort to get their complaints heard.
The scientists maintain that the FDA has put them under criminal investigation as retribution for their public demands that the agency change how it regulates devices. The current methods for testing Class III devices are outdated, so devices like pacemakers and replacement heart valves can enter the market without adequate testing. An urgent report from the Government Accountability Office (GAO) also found device testing inadequate in an investigation it published this January.
The Minneapolis Star Tribune reported last year on a case where several hundred patients filed a suit against Medtronic for injuries suffered from faulty implanted heart valve replacement devices. A cracked lead in certain Sprint Fidelis models caused strong intermittent shocks to the heart, which apparently felt to the patient like getting kicked in the chest by a horse. One 68 year old woman interviewed by the Tribune said in one hour she was shocked 54 times. The Medtronic device received FDA approval as a Class III device.
The suit brought by the hundreds of patients with faulty Medtronic valve replacement with cracked leads was dismissed by a US District Court in St. Paul Minneapolis, who based his decision on a Supreme Court case that protected medical device makers from product liability cases after the products had been through FDA review. The Supreme Court ruling was for a different Medtronic product, the balloon catheter.
FDA Meets With Industry: 113, FDA Meets With Consumers: 5 -- Who Wins?
While regulation can hamper markets, inadequate regulation leads to dangers for citizens that also, in the end, hamper markets. Baseball with no rules would no longer a fun game that millions of fans pay exorbitant amounts of money to watch. From the Harper's Index, January, 2009:
"Number of times FDA officials met with consumer and patient groups as they revised drug-review policy in 2006: 5. Number of times FDA officials met with industry representatives: 113." (Source: FDA)
Perhaps the FDA met with business because of logistics, or because they were there, or perhaps because companies have more money than a 68 year old women with heart problems. Many would probably like to get rid of government so that companies (or as PJ O'Rourke would have it, community organizations) could save their lobby money and put it right back into shareholder's pockets the economy.
But we too will grow old and just might need such a device to continue on with our lives (in order to continue contributing to the economic well-being of our country). Then who should we trust so as not to get kicked in the chest by a horse 50 times an hour? The system that will revamp the FDA? Or the system that advocates handing all oversight to "independent" contractors hired by the companies selling the products? Your choice.
