In a Shift, Bush Moves to Block Medical Suits

why not hold the fda responsible instead.

why bankrupt a poor pharmacetuical company (many are quite poor) when they had no reason to believe their product was faulty in the first place.

it's the fda's job to make sure a product is safe. it's their responsibility. they are the ones that do all the testing and what not on it and decide if it's safe for people to use. they should be the one's held responsible.

it sure beats bankrupting companies and putting thousands upon thousands of people out of jobs.

Poor Pharmaceutical companies. You got to be kidding!

Well, what does a consumer do when a drug manufacturer possibly willfully withholds information about a drug and it's potential side effects?

Consider the case of Zoloft, a widely prescribed anti-depressant:

Posted on Sat, Jul. 24, 2004
Lawsuit charges Pfizer misled public about anti-depressant Zoloft

ALEX VEIGA
Associated Press

LOS ANGELES - A California woman is suing Pfizer Inc., claiming the drug maker misled physicians and patients about the safety, effectiveness and side effects of the anti-depressant drug Zoloft.
The 19-page complaint, filed Friday in Los Angeles Superior Court, contends that Pfizer buried evidence showing the drug was no more effective than a placebo and its users tended to develop an array of side effects, including withdrawal symptoms, dependency, convulsions and psychosis.
The lawsuit also accused the New York-based drug maker of suppressing data indicating the drug increased the risk of suicidal and violent impulses in users.
"Pfizer has engaged in repeated and persistent false and misleading conduct by misrepresenting, concealing and otherwise failing to disclose to physicians and other prescribing health care providers information in its possession ... concerning the safety and effectiveness of Zoloft," the lawsuit claims.
The woman, Roberta Madison, was identified as a nurse and doctor of Public Health who lives in Los Angeles.
Madison's claim does not stem from personal injury, the suit states. Instead she decided to sue on behalf of all Californians who "have been misled about Zoloft," the law firm representing her said in a statement.
The suit asked the court to order Pfizer to pay an undetermined amount of money in restitution, including proceeds from Zoloft sales, to users of the drug in California. It also seeks a court order forcing Pfizer to give access to Zoloft research studies.
The lawsuit asserts that while Pfizer has been known to publicize positive information about Zoloft, the company has "intentionally withheld and concealed" negative information on the drug, ultimately hampering physicians' ability to determine whether to prescribe the drug.
The suit also claims early Pfizer studies of the drug's effectiveness were negative, failed or were neutral, and the majority of the studies showed there were no clinically or statistically significant differences between the drug and placebo, but the drug maker concealed the results.
"Many Pfizer studies not only failed to demonstrate that Zoloft is efficacious, they clearly demonstrated that Zoloft is associated with serious, severe and sometimes fatal side effects," the suit claimed.
A message left after hours with a Pfizer spokesman was not immediately returned Friday.

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And, consider the case of Zyprexa...where serious symptoms of hypergylcemia and diabetes were reported outside the U.S., for a few years, before the FDA bothered to require warnings about links to hyperglycemia and diabetes in the Zyprexa prescribing information.

Zyprexa Has Been Linked to Diabetes & Hyperglycemia


The FDA is now requiring a warning on Zyprexa saying that is linked with diabetes, hyperglycemia and other blood sugar disorders.
Zyprexa's link with diabetes was first exposed on May 3, 2002, when Britain's Medicines Control Agency warned that several patients taking Eli Lilly's top selling drug Zyprexa (used to treat schizophrenia) had developed diabetes-related complications. In the Medicine Control Agency's Current Problems newsletter, the regulatory body said that the antipsychotic drug "can adversely affect blood glucose."
Forty reports "of hyperglycemia (elevated blood sugar), diabetes mellitus, or exacerbation of diabetes have been received in the UK. Four were associated with ketoacidosis and/or coma including one with a fatal outcome," according to the newsletter. "The precise mechanism of this suspected adverse drug reaction has not yet been elucidated and is currently being investigated further.
This follows an emergency report issued in April 2002 by the Japanese Health and Welfare Ministry to Eli Lilly Japan KK concerning side effects of Zyprexa after the deaths of two diabetic users of the drug. It said seven other patients had lost consciousness or become comatose after taking the drugs in the last 10 months. The Japanese Ministry said no new diabetes patients should be treated with the drug and ordered Eli Lilly to warn doctors to closely monitor diabetics already on the medication.

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So why did it take the FDA so long to require new warnings in the prescribing information for Zyprexa in the U.S.?

The FDA may not do it's job properly, and pharmaceutical manufacturers may hold back information which might adversely affect sales of a drug. Consumers have a right to sue when damages occur as the result of such negligence, or attempts to defraud.

It is ridiculous to have such blind faith in the FDA's operations that you would move to block a consumer's right to sue. This is all about protecting the drug companies, and the government, when they fail to discharge their duties responsibly.

If you can prove that a drug company willfully or purposefully withheld damaging research or information, that's a different suit altogether.

I believe such an act is criminal and if not there are a wide array of different categories the law suit could be carried out under.

What I oppose is when a drug company is forced to bankrupcy because of something they were not aware of and couldn't have predicted.

It's the fda's job more than the drug companies to make sure a drug is safe.

But many drug companies are forced to bankrupcy by lawsuits and tens of thousands of people are unefmployed as a result each year.

I think that it such cases, it's the FDA that should be sued.

I find it ridiculous that we can't ever sue the govt. when they screw up.

In a famous supreme court case, it ruled that this person, who had his home destroyed by police officers who screwed up the adress and mistook this to be the home that was the crack house, had no right to ask the state government for the cost of the damages incurred.

If a private company screws up even a tiny bit with no prior knowledge of their own, they get sued for billions. They go bankrupt and tens of thousands get unemployed as a result. If the government screws up, it doesn't even have to pay back the damages. That's just ridiculous and idiotic.

Here is another example of a drug manufacturer making misleading claims, and downplaying serious side-effects:

Schizophrenia Drug Maker Clarifies Risks
By THE ASSOCIATED PRESS

Filed at 7:16 a.m. ET

TRENTON, N.J. (AP) -- The maker of a popular medicine for schizophrenia has notified doctors that it minimized potentially fatal safety risks and made misleading claims about the drug in promotional materials.

Janssen Pharmaceutica Products sent a two-page letter to the health care community this past week to clarify the risks of Risperdal, Carol Goodrich, a spokeswoman for the Johnson & Johnson subsidiary, said Saturday.

The letter stems from a directive issued last year by the Food and Drug Administration, which told several makers of anti-psychotic drugs to update their product labels.

Janssen complied in November 2003, but the FDA determined that the company's promotional materials still minimized the risk of strokes, diabetes and other potentially fatal complications. The agency also said Janssen made misleading claims that the medication was safer in treating mental illness than similar drugs.

The Miami Herald reported Saturday that a handful of boys in Florida developed lactating breasts after taking Risperdal.

The drug, which is prescribed to more than 10 million people worldwide, was cited in a federal lawsuit filed earlier this month by a doctor who claims children have been harmed and even killed by the misuse of drugs he blames on aggressive marketing by drug manufacturers.

``The FDA did not think we had (initially) provided enough information, so that is why further notification was done,'' Goodrich said.

Risperdal is the leading drug used to combat schizophrenia and other types of psychotic disorders, earning Janssen about $2.1 billion in annual sales. The drug was first marketed about eight years ago.


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If anyone developed diabetes, or suffered a stroke while taking Risperdal, shouldn't they have a right to sue Janssen for withholding information? If Janssen makes $2.1 billion a year from this drug, they can certainly afford to pay damages to those who might have been harmed by their negligence. And people should have the right to sue them.

I find it hard to work up any sympathy for the drug manufacturers.

Law suits are one way of making sure the drug companies act responsibly in the future.

Actually, that last is a good point, centroles. You mean to tell me that those people have no recourse?

That's right suzy. The supreme court ruled that if cops screw up and damage your house breaking into it, or damage your car, you don't have the right to recoup damages from the state.

I have nothing against law suits for drug companies for purposefuly withholding information etc.

I do sympathesize with some of the smaller ones that did everything by the book, reported their tests and results, were approved by the fda after it did it's own tests etc, and then later on found out that the drug can cause some random side effect that no one could have predicted and get bankrupted by lawsuits as a result. Its not just the company that's hurt. It's the tens of thousands that hte company employs. In such instances, I think the FDA is just as accountable for missing the side effect as the drug company.

Well, but why should the FDA (us) have to pay for all that testing? They should be able to trust, to at least some extent, that the company has done their homework. For things that come up later, when the drug is widely used, well, someone has to pay damages, and why should it be us? And if the drug is widely used, you can bet the company is not poor.
What drug comapnies have gone bankrupt in these situations?

This is a famous supreme court case? Funny, I've never heard of it. But if it's so famous, surely you'll have no trouble providing a link to the opinion, right Centroles?

Centroles
The City of NY is constantly being sued for the actions of their civil servants. In fact it just got tapped for $500,000 because the police did not protect woman from the drunken sexual harassment during a Puerto Rican day parade several years ago. Governments do indeed pay for their civil servants negligence.

Well, consider other forms of product liability, say, from an auto manufacturer. Who can be sued if a Pinto's gas tank explodes (I'm not talking about the actual Pinto lawsuits; this is a hypothetical new lawsuit)?

Ford Motor Company
The dealer
the manufacturer of the gas tank
the manufacturer of anything else that might have been involved in the explosion (e. g. if the gas tank was hit by the drive shaft, the drive shaft's manufacturer is also brought in)
the distributor of the faulty part
possibly the supplier of the materials used to manufacture the faulty part, even the steel mill
anyone else in the chain of manufacture and distribution who I may have forgotten, like a trucking company that moved the gas tank from one place to another (after all, parts can be jostled in shipping and sometimes that's the cause of a defect)
anyone else? I don't think so (joefromshytown can add if I've forgotten anyone)

The liability is divided (usually prorated, this depends on the state the suit was brought in) and it all depends upon testing to determine where the defect is. So the steel mill might be able to get out of the case. And perhaps the manufacturer of the gas tank and even the distributor. Ford is probably on the hook, whether they knew about the defect or not. After all, they are under an obligation to test their vehicles as they come off the assembly line and they are under an obligation to not release defective products (in practice, Ford and other large manufactures test far less than 100% of all of the items that they sell. They test a reasonable sample. It would be prohibitively costly for them to test every single car, so they trust that their manufacturing methods are consistent enough that testing a sample will suffice to cover the entirety).

Anyway, to make a long story only slightly longer, product liability is generally, these days, seen as a strict liability matter. That is, fault is not at issue and is not an element of the tort. Rather, if it can be proven that a company was involved in the manufacture, sale or distribution of a defective product, and the defect is proven, then liability is proven. Then everyone in the chain just points fingers to see who pays what.

If this law goes through, it will turn current product liability law on its head, by according 100% immunity from suits for drugs that have passed FDA scrutiny. Since it doesn't appear that the level of FDA scrutiny is being raised, that raises a lot of questions in my mind. Does this now mean that the FDA's findings can never be questioned? That gives an awful lot of power to someone who I believe is appointed through the political process (President chooses the appointee and Congree approves him or her, or not). Hmmm.

Joe, I am familiar with that one, as I think it was in Boston just a few years back. I'll see if I can find anything on it.
Oh, no. Never mind. Actually, I am thinking of the case where an elderly man died of a heart attack when police busted down the door in a drug raid. (wrong house). I don't recall where that went.