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America's Debate > Archive > Assorted Issues Archive > [A] Science and Technology > [A] Health and Medicine

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Cube Jockey

Jul 27 2004, 02:02 AM

From the SF Chronicle:

QUOTE

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 FDA, 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.

In 2002, the Bush administration outlined plans for "FDA involvement in product liability lawsuits," and it has been methodically pursuing that strategy.

The Bush administration has made it a point to paint this issue as reform against ambulance chasing trial lawyers. I guess it completely ignores the real need for lawsuits and protection like this -

Schizophrenia Drug Maker Admits to Making Misleading Claims:

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A major US drug maker that produces a popular medicine for schizophrenia is acknowledging that it minimized the risks and made misleading claims in promotional materials for the drug, according to reports.

Janssen Pharmaceutica Products LP, the maker of Risperdal, has sent a letter to health care providers to clarify the risks involved with the use of Risperdal, according to a Associated Press report.

So it appears that the FDA was wrong after all. Or maybe it was just because the maker of the drug lied and mislead the public about the risks of the drug.

Questions for Debate:
1. Should consumers be allowed legal recourse against drug companies, even if the drug has been approved by the FDA? Are most of these lawsuits genuine or frivolous?

2. Who is the Bush administration protecting here, the drug companies or the consumers?

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Victoria Silverwolf

Jul 27 2004, 10:03 AM

I'm astonished that anyone is suggesting that consumers should no longer be able to obtain some kind of recompense for adverse reactions to drugs and medical devices. In more than two decades as a pharmacist, I can tell you adverse drug reactions have become much more of a problem than they used to be. The reason is simple; new drugs are coming out at a much faster rate. This has advantages to consumers, of course, but it also increases the risk. Consider this report on a study published in The Journal of the American Medical Association:

Safety of New Drugs Cannot Be Known for Many Years

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The study, by researchers at Harvard Medical School and Public Citizen, a nonprofit consumer advocacy organization, found that half of these serious adverse effects are detected within seven years after a drug is first introduced onto the market. Damage to the liver, heart and bone marrow, as well as pregnancy risks, are the most common problems that arise after new drugs are introduced.

Sixteen drugs were withdrawn from the market over the 25-year study period; half of those withdrawals took place within two years of a drug’s introduction. The study also analyzed drug entries in the Physicians’ Desk Reference (PDR), the most common source of drug information for doctors. The authors examined 26 volumes of the PDR, from 1975-2000, to determine how many drugs were found to have new serious adverse effects that were not known when the drug was first released. The study authors found that the estimated probability of acquiring a new black box warning or being withdrawn from the market over 25 years was 20 percent

So, we have products which, although they can be very helpful, can also be very dangerous. These dangers are often unknown. There should be some way to compensate those who are harmed by drugs and medical devices.

I have no idea how many lawsuits against drugs and medical devices are "genuine." I certainly have no problem with reasonable reforms designed to weed out fradulent lawsuits. However, it seems clear that some lawsuits are well-founded, and I see no reason why the government should attempt to block these.

Amlord

Jul 27 2004, 01:39 PM

1. Should consumers be allowed legal recourse against drug companies, even if the drug has been approved by the FDA? Are most of these lawsuits genuine or frivolous?
Lawsuits against defective products and misleading (or false) advertising is a needed safeguard. The threat of a lawsuit may be the only thing that tips the "risk vs. reward" equation towards safety. Increase the cost of making a mistake (i.e. a defective product) and you will increase the safeguards against such a mistake.

2. Who is the Bush administration protecting here, the drug companies or the consumers?
A loaded question...

Here's the rub: let's say a device is approved by the FDA (such as the artificial heart example in the article):

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In the Pennsylvania ruling, issued Tuesday, the appeals court threw out a lawsuit filed by Barbara Horn, who said her husband had died because of defects in the design and manufacture of his heart pump. The Bush administration argued that federal law barred such claims because the device had been produced according to federal specifications. In its briefs, the administration conceded that "the views stated here differ from the views that the government advanced in 1997," in the U.S. Supreme Court.

At that time, the government said that FDA approval of a medical device set the minimum standard and that states could provide "additional protection to consumers." Now the Bush administration argues that the agency's approval of a device "sets a ceiling as well as a floor."

The administration said its position actually benefits consumers. The threat of lawsuits, it said, "can harm the public health" by encouraging manufacturers to withdraw products from the market or to issue new warnings that overemphasize the risks and lead to "underutilization of beneficial treatments."

The FDA approved the design and has decided it was safe. If a "safe" product harms someone, doesn't the FDA have some culpability? I think that is the question.

The administration seems to be arguing that emphasizing the negative will discourage use of the product, which is true to some extent. I don't really agree. Consumers need to make informed decisions, including possible side effects and interactions.

Cube Jockey

Jul 27 2004, 04:50 PM

QUOTE(Amlord @ Jul 27 2004, 06:39 AM)

The FDA approved the design and has decided it was safe. If a "safe" product harms someone, doesn't the FDA have some culpability? I think that is the question.

It depends on who you choose to hold responsible Amlord. Personally, I don't believe we can hold a government organzation responsible for the actions of drug and medical equipment companies. The FDA is not some omnipotent organization.

Drug companies ultimately need to bear responsibility for their actions. If they have mislead people or lied about the effectiveness or risk of their drug, they should be held at fault, because these things cannot always be determined in a clinical trial. Often the problems don't show up until much later.

QUOTE(amlord)

The administration seems to be arguing that emphasizing the negative will discourage use of the product, which is true to some extent.

And that is probably a good thing, until the product is fixed or can be re-evaluated. This most definitely doesn't hurt drug companies though, these companies make money hand over fist on new drugs or medical devices.

My point here is that by supporting drug companies the government is not supporting the American people. If there is a chance a product is dangerous it needs to be re-evaluated. If people really want to take the risk in using a product, they should have to sign a waiver or something, but they should also be adequately informed of the risks of the drug and/or device.

ralou

Sep 3 2004, 01:21 AM

1. Should consumers be allowed legal recourse against drug companies, even if the drug has been approved by the FDA? Are most of these lawsuits genuine or frivolous?

Yes they should have legal recourse, to either the drug company, the FDA, or both, but not just to the FDA. I think most of these lawsuits are genuine, and the reason I think that is that it's easier, if you want to make some cash, to fake a slip and fall in a store than to sue a drug manufacturer. It can take years for a court case to go through or settle. It's just not worth it to most people, in my opinion.

2. Who is the Bush administration protecting here, the drug companies or the consumers?

This question is loaded, but not in the way the previous poster stated. Clearly, the law would protect drug companies. Clearly it would hurt consumers in two ways:

1. It's harder to sue a government agency than to sue a drug manufacturer

2. Consumers are also tax payers. If we foot the bill when a drug company screws up and the FDA fails to catch it, then it hurts us.

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