Comments on: Is FDA approval enough?

By: C C's Mom

C C's Mom — Mon, 14 Apr 2008 03:46:49 +0000

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?

By: jb

jb — Wed, 28 Jul 2004 01:30:57 +0000

I don’t know the answer, but I estimate that the released and then withdrawn percentage is well under 5% Anyone with real data out there? Even the ones that are withdrawn have been beneficial to the vast majority of people who have used them; they are withdrawn because of a higher than expaect number of ill effects, but that higher than expected number is still very small.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 Often, drugs that are withdrawn have helped thousands, hurt a small handful, but are withdrawn due to lawsuits.

By: Bernie Simon

Bernie Simon — Wed, 28 Jul 2004 01:23:19 +0000

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?

By: RGL

RGL — Tue, 27 Jul 2004 01:59:17 +0000

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.

By: pat

pat — Mon, 26 Jul 2004 16:44:29 +0000

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.

By: A Chance to Cut is a Chance to Cure

A Chance to Cut is a Chance to Cure — Mon, 26 Jul 2004 15:24:14 +0000

THE FDA AS A SHIELD
DB linked to this New York Times article today:
In a Shift, Bush Moves to Block Medical Suits

By: Chris

Chris — Mon, 26 Jul 2004 04:48:53 +0000

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!

By: Evan

Evan — Mon, 26 Jul 2004 02:34:20 +0000

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.

By: Living With Diabetes

Living With Diabetes — Mon, 26 Jul 2004 01:42:14 +0000

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…

By: jb

jb — Mon, 26 Jul 2004 00:25:27 +0000

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.