Is FDA approval enough?
July 25, 2004
In a Shift, Bush Moves to Block Medical Suits
The Bush administration has been going to court to block lawsuits by consumers who say they have been injured by prescription drugs and medical devices.
The administration contends that consumers cannot recover damages for such injuries if the products have been approved by the Food and Drug Administration. In court papers, the Justice Department acknowledges that this position reflects a “change in governmental policy,” and it has persuaded some judges to accept its arguments, most recently scoring a victory in the federal appeals court in Philadelphia.
Allowing consumers to sue manufacturers would “undermine public health” and interfere with federal regulation of drugs and devices, by encouraging “lay judges and juries to second-guess” experts at the F.D.A., the government said in siding with the maker of a heart pump sued by the widow of a Pennsylvania man. Moreover, it said, if such lawsuits succeed, some good products may be removed from the market, depriving patients of beneficial treatments.
This position raises an interesting philosophical and legal point. If we have a federal agency which certifies the safety of medical products, then how can one sue the manufacturer? One could make as good a case for suing the FDA as suing the manufacturer. And we cannot sue the FDA.
I have not yet developed a full opinion on this, and urge your comments to help me.
free viagra
buy viagra online
generic viagra
how does viagra work
cheap viagra
buy viagra
buy viagra online inurl
viagra 6 free samples
viagra online
viagra for women
viagra side effects
female viagra
natural viagra
online viagra
cheapest viagra prices
herbal viagra
alternative to viagra
buy generic viagra
purchase viagra online
free viagra without prescription
viagra attorneys
free viagra samples before buying
buy generic viagra cheap
viagra uk
generic viagra online
try viagra for free
generic viagra from india
fda approves viagra
free viagra sample
what is better viagra or levitra
discount generic viagra online
viagra cialis levitra
viagra dosage
viagra cheap
viagra on line
best price for viagra
free sample pack of viagra
viagra generic
viagra without prescription
discount viagra
gay viagra
mail order viagra
viagra inurl
generic viagra online paypal
generic viagra overnight
generic viagra online pharmacy
generic viagra uk
buy cheap viagra online uk
suppliers of viagra
how long does viagra last
viagra sex
generic viagra soft tabs
generic viagra 100mg
buy viagra onli
generic viagra online without prescription
viagra energy drink
cheapest uk supplier viagra
viagra cialis
generic viagra safe
viagra professional
viagra sales
viagra free trial pack
viagra lawyers
over the counter viagra
best price for generic viagra
viagra jokes
buying viagra
viagra samples
viagra sample
cialis
generic cialis
cheapest cialis
buy cialis online
buying generic cialis
cialis for order
what are the side effects of cialis
buy generic cialis
what is the generic name for cialis
cheap cialis
cialis online
buy cialis
cialis side effects
how long does cialis last
cialis forum
cialis lawyer ohio
cialis attorneys
cialis attorney columbus
cialis injury lawyer ohio
cialis injury attorney ohio
cialis injury lawyer columbus
prices cialis
cialis lawyers
viagra cialis levitra
cialis lawyer columbus
online generic cialis
daily cialis
cialis injury attorney columbus
cialis attorney ohio
cialis cost
cialis professional
cialis super active
how does cialis work
what does cialis look like
cialis drug
viagra cialis
cialis to buy new zealand
cialis without prescription
free cialis
cialis soft tabs
discount cialis
cialis generic
generic cialis from india
cheap cialis sale online
cialis daily
cialis reviews
cialis generico
how can i take cialis
cheap cialis si
cialis vs viagra
levitra
generic levitra
levitra attorneys
what is better viagra or levitra
viagra cialis levitra
levitra side effects
buy levitra
levitra online
levitra dangers
how does levitra work
levitra lawyers
what is the difference between levitra and viagra
levitra versus viagra
which works better viagra or levitra
buy levitra and overnight shipping
levitra vs viagra
canidan pharmacies levitra
how long does levitra last
viagra cialis levitra
levitra acheter
comprare levitra
levitra ohne rezept
levitra 20mg
levitra senza ricetta
cheapest generic levitra
levitra compra
cheap levitra
levitra overnight
levitra generika
levitra kaufen
Related Posts
No related posts.
Related posts brought to you by Yet Another Related Posts Plugin.
Posted in General
content rss
July 25th, 2004 at 6:25 pm
I have always thought that this is exactly what should have been ongoing policy. If a doc prescribes a drug or uses a device according to FDA indications, there should be presumed immunity from suits. Taking it a step further, this would encourage the companies to seek FDA approval for more indications to encourage docs to prescribe their product. This would eliminate “off-label” prescribing as we would seek to minimize our liability exposure. This would give the FDA a bigger role in policing what we do, which has certain disadvantages, but will be on balance worth it if it prevents lawsuits.
July 25th, 2004 at 7:35 pm
“I was only following orders” does not grant you immunity during wartime, nor should it grant Big Pharma immunity from lawsuits.
Let’s be honest. Everyone knows public policy is made at the behest of high paid lobbyists. Should Big Pharma, who pays these lobbyists to make public policy then turn around and claim immunity for the policy they influenced?
July 25th, 2004 at 8:25 pm
Sorry to burst your lefty bubble, Bernie, but “Big Pharma” spends hundreds of millions of dollars getting their drugs approved by the FDA. This money goes for very expensive 3 phase clinical testing and takes most of a decade to complete. “Everybody” does not know what you propose as truth. I’m not saying that their lobbying, which definitely exists, has no influence. I am saying that any prescription medication that makes it to the US market has very extensive data behind it supporting its efficacy and safety. Not a perfect system, as a small minority of approved drugs are subsequently withdrawn (Baycol, Trovan in recent years). How many useful agents never make it to market because of concern of lawsuits? We will never know the number, but you know that “Big Pharma” has a number in every new drug’s budget for lawsuit expenses. If that number is too large relative to the development expense, that drug never gets to market. It may have been the one that saves your kid’s life.
July 25th, 2004 at 9:42 pm
Is FDA apprvoval enough?
DB’s Medical Rants ? Is FDA approval enough? As a user of both drugs and medical devices, I believe that FDA approval is enough. I personally am appalled at the number of lawsuits and amount of money that has been…
July 25th, 2004 at 10:34 pm
FDA approval is hardly a guarantee of safety. Look at the number of drugs and devices pulled from the market after approval.
If manufacturers want to give the FDA the power to review their internal data on new products in much more of a real-time fashion, and if they will grant access to all data collected for products brought to market, then I think this could be reasonable, but FDA approval has hardly been a guarantee of safety historically.
July 26th, 2004 at 12:48 am
Quoting the words of the recently incarcerated Martha Stewart: “Its a Good Thing”
Considering the rigorous testing and review of products to gain the approval of the FDA, this is obviously a good move. The FDA is GLOBALLY respected as setting the standard for safe drugs and medical products. I know the steps necessary to gain approval (I am the son of a drug safety researcher), and if the FDA determines a product to be safe, I trust them. Anyone that is familiar with all the hassles of getting FDA approval will gladly support this. Many of the lawsuits levied against pharmaceutical companies are bogus and instigated by trial lawyers to turn a quick buck. Anyone familiar with the 16(i believe its up to 16 now) billion dollar lawsuit against Wyeth can attest to this.
Who knows, if this system works well, it could pave the way for malpractice reforms in the idea of medical courts. This could be setting an unheard-of precedent in that the experts and scientists are more knowledgeable than the lay-judges and juries!
July 26th, 2004 at 11:24 am
THE FDA AS A SHIELD
DB linked to this New York Times article today:
In a Shift, Bush Moves to Block Medical Suits
July 26th, 2004 at 12:44 pm
If I recall correctly, the FDA approved silicone breast implants and then withdrew that approval under pressure from feminist groups, amongst others. There was no scientific reason why the FDA’s approval of silicone breast impants should have been withdrawn. But it happened and trial lawyers made billions of dollard bankrupting Dow Corning and a host of other businesses. Little wonder the trial lawyers will be very upset if FDA approval shields drug and medical device manufacturers.
The threat of lawsuits has had a negative impact on vaccine manufacturing and on devices that use anything related to silicone.
July 26th, 2004 at 9:59 pm
It would be nice to have an agency that can pass judgments on drugs and medical devices without making any mistake. That is, unfortunately, impossible. Despite the volumes of data reviewed about drugs and devices, by the best experts available, there will be those occasional drugs that, with time and broader usage, may have side effects requiring withdrawal.
I cannot, at this time, think of any better way to assess drugs before the drug companies release them for public use. In the absence of such mechanism, it is indeed prudent to support the administration’s policy to grant immunity to pharmaceutical companies from lawsuits. Lawsuits will not make drugs in the future better; they will, however, make it harder for drug companies to spend the money needed for further research when that money can be siphoned off to the trial lawyers.
And as a general policy, I believe in the supremacy of federal laws over those of the states. Unless, of course, we want chaos, which trial lawyers would love to have.
July 27th, 2004 at 9:23 pm
I’m not saying that their lobbying, which definitely exists, has no influence. I am saying that any prescription medication that makes it to the US market has very extensive data behind it supporting its efficacy and safety.
How many FDA approved medicines are later withrawn from the market because of safety questions? How many are of dubious benefit to anyone?
July 27th, 2004 at 9:30 pm
I don’t know the answer, but I estimate that the released and then withdrawn percentage is well under 5% Anyone with real data out there? Even the ones that are withdrawn have been beneficial to the vast majority of people who have used them; they are withdrawn because of a higher than expaect number of ill effects, but that higher than expected number is still very small. Drugs that hurt more people than they help, or are of “dubious benefit,” do not make it thru the clinical trial process. Often, drugs that are withdrawn have helped thousands, hurt a small handful, but are withdrawn due to lawsuits.
April 13th, 2008 at 10:46 pm
Okay…so the FDA says we cannot sue device manufacturers when their products fail and cause harm. Wonder what their answer would be if asked “who foots the medical bills when it happens?” I am the parent of a 12 year old whose heart device failed back in October. It failed within three years of its original implantation and caused him to have to undergo an additional surgery to replace the failed device. HUGE medical bills, and the device manufacturer offers NO assistance with the bills. By the way, we discovered it had failed within one week of the FDA recall. Is it right for our medical insurance company to have to pay for the SAME surgery a second time because of an FDA recall/device failure? There is such a thing as Maximum Lifetime Coverage with insurance companies, and now, with the second surgery, our son has made a huge dent in his lifetime coverage. Good God…he’s only 12!!!! With the heart defect he has, HE NEEDS MEDICAL COVERAGE. Medical insurance keeps going up for all of us because of big device manufacturers whose products fail and they refuse to anti-up…just keep posting record profits. Shame on them, and shame on the Supreme Court for increasing our insurance costs as a result of the Reigel v. Medtronic ruling. I am not talking about personal gain or trying to sue in order to pocket big bucks…I am talking about paying a kid’s medical bills when his heart device failed within its warranty period. What ever happened to the idea of making the “cost causer” pay? Any thoughts or suggestions?