Lawsuits help guarantee drug safety, doctors say

[Celebration]

Source: Associated Press

(AP) -- Top doctors at the helm of one of the nation's most influential medical journals are giving the Supreme Court some unsolicited legal advice about a major case.

The Food and Drug Administration "is in no position" to guarantee drug safety, the editors of the New England Journal of Medicine said in a friend-of-the-court brief. Lawsuits can serve as "a vital deterrent" and protect consumers if drug companies don't disclose risks.

........................

Diana Levine, a Vermont guitarist, lost her right arm below the elbow after she was injected with Phenergan, a medicine for nausea, and developed gangrene. She sued the manufacturer, Wyeth, arguing that the company had a duty to warn consumers that such injections could have devastating consequences. The courts in her state agreed, awarding her nearly $7 million.

But Wyeth appealed, countering that it was protected from such lawsuits. It argued that the FDA's judgment could not, in effect, be overruled by a state court. FDA scientists had weighed the risks and benefits of Phenergan in approving the drug's prescribing literature, or label, as a guide for doctors. The FDA was aware of risks associated with injecting some forms of Phenergan, but the label did not specifically warn about the technique used with Levine.



Read more: http://www.physorg.com/news138072010.html

[bertman]

1. This is good news for all Americans. More and more doctors are lining up in favor of healthcare

reform and sensible laws to protect the public.

Bless them for taking that stand.

[DissedByBush]

8. Off-label use

"but the label did not specifically warn about the technique used with Levine"

This sounds like the doctor gave an off-label use of the drug. If that is the case, sue the doctor, but the drug company can't be held responsible. If it was an on-label use, then the drug company got off light.

[merwin]

2. Isn't this obvious?

Since the corporations aren't taxed worth a shit, don't answer to anyone but stockholders, and generally have a lack of morals, what's to stop them from lowering quality? Nothing! ... except the fear of people suing them.

However, this only keeps them just a tiny bit above getting sued, which isn't a good thing either.

[gristy]

3. Lawsuits may contribute to drug safety

I would not say they help guarantee it.

[baldguy]

9. An expensive & troublesome way to do it too.

Regulation & oversight by the GOVERNMENT is better & more efficient.

[Karl_Bonner_1982]

12. That's what Repubbies hate the most

Their ideal goal is no regulations and no way to sue for unsafe products, but they lost the latter battle and now it looks like they're losing the former.

[truedelphi]

4. Something the article leaves out: the revolving door between industry and FDA

Although I am pleased that physorg.com wants to report on this, their report is a tad misleading. Nowhere do they bring up the concept, an important one, that the pharmaceutical companies and the FDA are one and the same, and have been since the days of Reagan.

Promise industry you'll do what they want, and industry will get you into a slot at the FDA.

Or even worse, operate as an executive for Searle or Monsanto or whoever for a few years, then work for the FDA, then come out and get an even better position. (If you want to know what I mean, google "Monsanto" + aspartame + "Reagan" + FDA.)


I have several "liberal" friends who started bombarding me with Ron Paul emails six months ago. At first I was amazed, but their thinking is this: since our agencies are now nothing but the corporate-controlled arm of industry, offering industry and Federal agency approval to the corporations, perhaps we shouldn't bother spending the resources on having agencies. (I am not saying I agree with this ide aof voting for Ron Paul, rather I am just pointing out how frustrating the situation has become!)

[Nikki Stone1]

5. The other thing the article leaves out: the fight against "frivolous" lawsuits

Neocons talk out of both sides of their mouth with this one. On one hand, they argue that we don't need an FDA: people can sue to keep companies in line. Then, on the other hand, they try to take away that right to sue by calling many lawsuits against companies "frivolous." In the end, they are squeezing from both ends.

[truedelphi]

6. That's avery good point - I hadn't thought of that n/t

[Nikki Stone1]

13. It's a squeeze play.

And a threat to the consumer.

[pnwmom]

7. Absolutely. It was a handful of lawsuits here that got Thalidomide off the market.

There were many cases in Europe, but the drug remained on the market there because the awards were so low. Then a few U. S. babies (whose mothers were prescribed the drug while out of the country) received millions in damages here and the drug was pulled.

Luckily, Thalidomide had never been released in the U.S. because of a cautious head of the FDA.

[Clear Blue Sky]

10. Actually no one can guarantee drug safety.

Rare side effects occur rarely, but still occur.

[truedelphi]

14. I think people somewhat understand that.

And there will always be people that want to maximize their profits from some minor tragedy.

SIDEBAR: A friend worked as an underwriter at an insurance firm. Across her desk would come dozens of notices of lawsuits pending against those grocery stores her firm insured.

one of them read: "I went into 'Grocery Store X' and walked by the cheese display. I looked at it for a minute, and it made me sick. I became ill and..." I forget how many thousands of dollars that person wanted.

There were other similarly hilarious lawsuits, one about bulk cherries and acne, that I don't remember. But people will go after the gold in as many ways as they can. As shamelessly as they can.

In terms of drug safety, I think Consumer Organizations are simply trying to make sure that we the public are not the guinea pigs here. And that the risk to benefit aaspect of any drug, vaccine or medical device is carefully considered.

Sadly sometimes due to industry over-inviolvement with the FDA - we, or our children, are the guinea pigs. Here's one blot on the FDA's record: I remember when the first Rotavirus vaccine (RotaShield) was recalled in 1999, it had been designed to make sure that infants would avoid illness or death from diarrhea, but about 135 infants died from the vaccine. Some researchers believe only 40 babies a year die from diarrhea - so we REALLY need to make sure that we have figured out the risk-benefit before we go plunging forward with the release of this or tha product.

And at least one medical device for the heart has been approved by the FDA, and then determined to kill outright far more people than made the benefits of the devices worthwhile. The company knew this device wasn't a good idea, but felt that they woul dmake more money from the device than they would lsoe to lawsuits.

[question everything]

11. See also

http://www.democraticunderground.com/discuss/duboard.php?az=view_all&address=389x3793911

and

http://www.democraticunderground.com/discuss/duboard.php?az=view_all&address=222x40531