The Supreme Court ruled yesterday that if the FDA approves a drug, it doesn't mean you don't have to keep the labeling up to date if you should warn people. So that settles one question about FDA approval. The FDA put its stamp of approval on the drug Vioxx, too, but approved or not, Vioxx was not OK. Some unfortunate people traded their arthritis pain for a heart attack. Not a good trade. So the maker of Vioxx got sued. When the regulatory agencies don't do their job, that's about the only remedy left. More important, it is the only way to change the behavior of companies whose negligence causes damage and death. Big Pharma and medical device manufacturers don't like to be regulated so they employ armies of lobbyists to prevent that from happening. They don't like to get sued, either, so they employ armies of high priced lawyers to defend them in the event they do. Not anywhere near as many lawyers as they employ as lobbyists or to sue other companies over contracts and patent infringement, of course. But still a lot of lawyers, because they can lose big. And Merck is losing big on Vioxx. Better all around that FDA had done their job. But that's drugs.
Because of another Supreme Court decision last year, the medical device folks have the best of all possible worlds (for them, that is):.
On the same day last month that a federal judge in St. Paul threw out hundreds of lawsuits against the maker of a faulty heart device, a man entered a nearby hospital to have one of those flawed products surgically removed.
The risky operation went terribly wrong. As doctors extracted the device, a thin electronic cable, from the patient's heart, a vessel was punctured, causing extensive bleeding. The 33-year-old patient, Mark Turnidge, died two days later, leaving behind a wife and two young sons.
"They told me he had suffered massive brain damage," said his wife, Wendy Turnidge.
She is considering suing the doctors, as well as the device's maker, Medtronic, which she said bore blame for her husband's death. But a Supreme Court decision last year stands as a barrier against suing medical device companies ? an obstacle that some members of Congress want to remove.
At issue is a February 2008 court ruling that barred patients or their survivors from suing makers of complex medical devices ? like the Medtronic product ? if the Food and Drug Administration has approved their sale. Since that ruling judges nationwide, including the one in St. Paul, have cited it to dismiss cases against a wide range of manufacturers, including Medtronic. (Barry Meier, New York Times)
Big Pharma and the Chamber of Commerce folks have been remarkably successful in getting the public to buy the canard that courts are filled to overflowing with frivolous lawsuits promoted by ambulance chasing trial lawyers. The truth is that 90% of civil court cases are business cases (contract disputes, etc.) and the champion filers of frivolous lawsuits are the trade associations of the recording and movie industry (RIAA and MPAA). Are there frivolous or fraudulent personal injury suits? Of course, just as there are fraudulent and frivolous patent claims, contract disputes and stockholder claims. But little of the court's time is spent on personal injury claims compared to the total, and of those, the ones that get to court are more likely to be meritorious.
Juries aren't stupid, contrary to the distorted arguments of tort deformers who like to trot out old chestnuts like the McDonalds hot coffee case. You know that one, don't you? The lady who sued McDonalds because she was burned by a cup of McDonalds coffee and the jury awarded her an exorbitant amount? Did it occur to you that if a jury of ordinary people may have had a compelling reason? If you want to know what it is, you can read the actual facts of the case here and then ask yourself how you would have decided.
The new Congress will likely consider legislation to nullify the court decision on medical devices. Naturally the medical device companies don't like this and they have their usual knee-jerk anti-regulatory allies among political conservatives. The claim is that it would "undermine the FDA process." (Pause, for laughter). How well did the "FDA process work" for this device?
The Medtronic component involved was a slender electrical cable, or lead, that connects an implanted defibrillator to a patient's heart. The faulty model, known as the Sprint Fidelis lead, was a follow-up product based on a Medtronic lead that was originally approved a decade earlier.
But the Fidelis lead, approved in 2004, was much thinner than any of its predecessors and was never tested in humans before it went on the market. By the time Medtronic recalled it in 2007, after discovering a high rate of fractures, the Fidelis had been implanted in more than 235,000 patients.
The flaw caused some defibrillators to deliver unnecessary shocks to a patient's heart or to not fire when needed to send a life-saving jolt. When Medtronic recalled the Fidelis, it said it knew of five cases in which patients might have died because of the problem.
Earlier this year, Mr. Turnidge's doctors determined his lead was fractured and decided to remove it.
And when they decided it had to be removed, what did Medtronics offer? They said they'd pay up to $800 towards Mr. Turnidge's out of pocket costs. Like his $4000 insurance deductible.
Now his life insurance can help settle his posthumous debts
Medical device manufacturers can still be sued for negligence in production. That court ruling has to go though. You say court cases are the only way to affect producers when regulatory agencies don't do their job but really it is still a major way WHEN agencies do their job too. A regulatory agency can't look at all possible cases or even really understand anywhere near all the situations for any complex device or drug. They really can only in the best case check out big issues and a set of checklist items. Those are (vitally) important but not really enough. I do think it is likely that the device ruling will get overturned due to this latest ruling.
Let's be clear here that you're talking about IMPLANTABLE medical devices.
If you want to see a real lack of oversight on safety and efficacy I think you'd want to look at non-implantable devices.
The medical device companies must submit all of scientific document to FDA for approval. Even after FDA Approval, the FDA are still monitoring the product, if FDA are received any complaint, FDA have to conduct investigation. If he think that medical device is defected, just file the complaint with FDA.