Supreme Court Rejects Limits on Drug-Injury Lawsuits

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VS71Y5

Fbdbllst of GA 8:10AM July 16, 2009

In these types of horrible events one has to look at where the problem really is. I haven't investigated the whole situation but based on what we have been told by media (which cannot always be trusted for giving a completely objective view of both sides, regardless of which paper you read), Phenergan was injected IV and hit an artery and this resulted in gangrene which was followed by amputation. based on what we know it sounds as though this could have occured with any drug so we cannot find fault in Wyeth. I am currently enrolled in Nursing clinicals and we are now learning injections. In the protocol it states to stick in the needle then draw back on the syringe, if you see blood, do NOT push the med., if you do not draw blood, then you push the drug in to the patient(there's more to the protocol but that's the important part). It would also be in the interests of the health professional to mention this to the doctor and keep an eye on the patient's arm for signs of infection. So basically, from the sound of it, the injection/occurence wasn't administered or monitored correctly. So, I'm confused as to how the pharmaceutical was tagged for this one.
I hate to call out a Fellow RN, but this needs to be investigated and safe injection protocols should be brought to the attention of the care givers in that hospital. Odds are RN's will ignore signs and emails, so the person who performed the injection should undergo some type of disciplinary action. Posters work as well as mandatory inservices
the hospital made out well in this case (relative to Wyeth) and Wyeth took the wrath...unfortunate

Rich of NY 10:24AM March 07, 2009

I thought it was a suppository. If so, perhaps using that method would have provided her treatment with less risk.

M Strauss of KS 2:50PM March 06, 2009

I sure hope that the pharma companies don't pull all their drugs off the US market. That's not what I would consider an increase in 'availability of health care'.
Naturally, if the pharmas perform fraudulent activities and lie about their products (fraud) they should be punished. And, if they hurt or maim people, they should be given the 'eye for an eye'; the company could even be shut down... so long as we freed up the patent laws so that others could take up the rightful manufacture of the beneficial products they produce. I'm not saying that we should just turn over their factories -- which belong to stockholders that were probably unaware of the fraud.. but those stockholders would probably be very willing to see their property brought back into use under a new company.
In the meantime, since the FDA doesn't really matter anymore, does this mean that we can get rid of them? This would speed up availability of alternative choices for all of us and reduce the cost of government as well.... I mean to say this -- we all know that the FDA dramatically increases the cost of producing new drugs and decreases their availability thru the regulatory process. Since this ruling gives the FDA the right to be absolutely irresponsible (no longer truly responsible for anything); this opens up the very dangerous situation that the people working at FDA can do anything they want without any repercussion. I think that we are going to have a lot of graft and corruption at the FDA in the future because of this...

Randy G of MD 9:57AM March 05, 2009

Drug companies like Pfizer and Wyeth can run but cannot hide. It is simply untrue that, as Wyeth attorney Rein asserts in a written statement:
"The medical and scientific experts at FDA are in the best position to weigh the risks and benefits of a medicine and to assess how those risks and benefits should be described in the product's label."
Drug companies 'negotiate' vigorously with the U.S. Food and Drug Administration (FDA) over the text of the warning label which accompanies each drug to the marketplace. Drug companies such as Pfizer and Wyeth hold the results of their clinical trials close, keeping from the public AND the FDA analysis of clinical data which link the use of their drugs to serious adverse events and deaths. Prescription drug makers routinely omit from regulators and the public any internal statistical analysis which point clearly to manufacturer causality of serious drug side-effects and death amongst children and adult 'consumers.'
Is it still true that potential tragedies for a 'few' American consumers become the 'cost of doing business' for Pfizer and others as they have practiced a strategy of lobbying to dilute FDA enforcement while also hiding behind it's 'expertise' as an insulation against litigation? Answer before today's supreme court ruling: Yes! Today's supreme court decision upholding a cash award for Ms. Levine may be an early warning signal to pharmaceutical companies such as Pfizer and Wyeth to take far more responsibility for what is contained in AND omitted from their warning labels. These drug companies have failed in their attempt to lead the public into believing that a chronically hog-tied Food and Drug Administration maintains ultimate legal and moral responsibility for the safety of the American public from harmful and deadly side-effects. How long did Pfizer think it could succeed with this strategy knowing how many deaths and other serious side-effects are suffered by its 'customers?'
To pharmaceutical companies everywhere: If your product maims and kills people, you will be exposed and will pay either in negative publicity or cash or both.

Jackie Wellbaum of CA 10:12PM March 04, 2009

So if I understand this correctly: A drug manufacture is now liable for any ill-effect of its product. Thier litigation costs will go up, along with insurance costs,and testing costs (including time to distribution).
I wonder who will have to pay for this? mmmmm could it be the consumer? YOU BETCHA!
So, the users cost will go up along with higher insurance costs, a longer time to get medications to fight diseases, and worse healthcare overall.
PS all those who think its great to get back at the greedy big pharma, check your 401Ks, IRAs, Mutual Funds, and other retirement accounts to see what your invested in. Much like those who complain that Exxon makes too much profit chances are its in one of these evil corps. because they make money for its investors.

Eric of CA 7:32PM March 04, 2009

As a physician with no love for pharma, one can see that the writing on the wall for its demise into insolvency, despite the impression people and trial lawyers my have that it is just another evil deep pocket.The entire country is in a perilous state with with both economic and healthcare disasters. To what extent does the Supreme Court decision have a positive impact on health reform, and not a negative one? How will it help the common good? What will happen to our society if pharma collapses? Who will make and distribute many of the drugs that tens of millions of people depend on for survival, or freedom from pain or nausea, to lower blood pressure, control blood sugar, prevent ulcers, relieve asthma, prevent migraines, regulate heart rhythm, or reverse erectile dysfunction.
The future of healthcare will depend heavily on innovation. Malpractice lawyers and judges have imposed on physicians the fear that should they innovate, they will run the risk of losing malpractice cases. Judge Ginsburg is probably unaware of a major innovation in cancer therapy, the subject of at least seventy published studies in the international medical literature. The quality and availability of healthcare for the Supreme Court Justices and their defendants may depend largely on innovation, as will everybody's. If pharma goes belly up within a few years, will the industry receive a bailout,or be nationalized? Has no one noticed how desperate pharma is, some having tied their futures to biotechnology or genomics,an industry now absorbing hits from FDA? Viewing pharma as all bad
overlooks the good it has done. Making it the unrelenting object of vitriol could so demoralize its excutives, that they will simply throw in the towel, as have many physicians.I have no love for the industry,but hurling venomous barbs at it is not in the interests of society.
When President Bush started out, he made tort reform a priority. Who talked hom out of it? Lawyers of all stripes, now is the time to come forward and let us know of the efforts you have made to prevent the healthcare collapse, and how you expect to make a tangible contribution to health reform. One sure way is to look into the the barriers that prevented the adoption of a paradigm shift for infectious disorders that emerged in the early nineteen eighties. If the Justices wish to tackle the suppression of medical paradigm shifts, they will make a valuable contribution to improving healthare for millions, while reducing it cost. .

Julian Lieb,M.D of VT 6:54PM March 04, 2009

As a physician with no love for pharma, one can see that the writing on the wall for its demise into insolvency, despite the impression people and trial lawyers my have that it is just another evil deep pocket.The entire country is in a perilous state with with both economic and healthcare disasters. To what extent does the Supreme Court decision have a positive impact on health reform, and not a negative one? How will it help the common good? What will happen to our society if pharma collapses? Who will make and distribute many of the drugs that tens of millions of people depend on for survival, or freedom from pain or nausea, to lower blood pressure, control blood sugar, prevent ulcers, relieve asthma, prevent migraines, regulate heart rhythm, or reverse erectile dysfunction.
The future of healthcare will depend heavily on innovation. Malpractice lawyers and judges have imposed on physicians the fear that should they innovate, they will run the risk of losing malpractice cases. Judge Ginsburg is probably unaware of a major innovation in cancer therapy, the subject of at least seventy published studies in the international medical literature. The quality and availability of healthcare for the Supreme Court Justices and their defendants may depend largely on innovation, as will everybody's. If pharma goes belly up within a few years, will the industry receive a bailout,or be nationalized? Has no one noticed how desperate pharma is, some having tied their futures to biotechnology or genomics,an industry now absorbing hits from FDA? Viewing pharma as all bad
overlooks the good it has done. Making it the unrelenting object of vitriol could so demoralize its excutives, that they will simply throw in the towel, as have many physicians.I have no love for the industry,but hurling venomous barbs at it is not in the interests of society.
When President Bush started out, he made tort reform a priority. Who talked hom out of it? Lawyers of all stripes, now is the time to come forward and let us know of the efforts you have made to prevent the healthcare collapse, and how you expect to make a tangible contribution to health reform. One sure way is to look into the the barriers that prevented the adoption of a paradigm shift for infectious disorders that emerged in the early nineteen eighties. If the Justices wish to tackle the suppression of medical paradigm shifts, they will make a valuable contribution to improving healthare for millions, while reducing it cost. .

Julian Lieb,M.D of VT 6:54PM March 04, 2009

It is so strange that folks find it hard to accept the fact that the law (yes, the actual federal code repeatedly cited in the opinion) holds the drug manufacturer ultimately responsible for its products. The FDA does not test drugs. There are no doctors or chemists in FDA labs examining drugs, conducting experiments, or performing trials. There are no labs, no beakers, no microscopes. The doctors at FDA (that tiny few responsible for "monitoring" drugs)review papers about the risks and benefits of drugs submitted by the drug company. The drug company also submits, indeed has the responsibiity, the proposed drug label. That's right, the FDA does not write the drug label. Through a give and take process, the FDA negotiates with the drug company to decide whether it can agree to approve the language of the label that is supposed to reflect the papers submitted.
Did you not see in the opinion that until 2007, the FDA lacked the authority to require the drug company to modify the label after approval. That is as incredible as it is shocking. So, an approved drug goes on the market in the 1980s and after its mass, long term use, adverse reports in the 1990s show it causes a certain cancer but the FDA was without authority = powerless = toothless to tell the drug company to change the warning on the label. What a crock! Big Pharma LOVES the FDA and wouldn't have it any other way.
The bottom line is that the drug company is responsible under FDA law to adequately warn of risks that it knows or should know. Afterall, there is no greater expert on the drug's risk than its manufacturer.
We will now see increased competition (that's good, right; market forces at work) among drug companies to adequately test drugs and inform doctors and patients of the risks instead of doing the minimum to get approval and then thumbing their nose at the FDA and putting profits over safety.
Thank God Justice Thomas stuck to core, conservative principles of states rights and federalism, and didn't legislate from the bench like the pro-business dissenters would have. This 6-3 decision is here to stay!

Steve in Houston of TX 6:21PM March 04, 2009

There is no drug that is 100% safe that is also going to be very effective. As a guitar player I feel very sorry for the woman who lost her arm, but I am not sure this is the best ruling.
For every drug there are going to be some side effects and possible risks. This should be discussed with the Doctor and if the risk is significantly less than the symptoms or effects of the disease then the drug is prescribed. Even so there will be those one in a million cases where the side effect is severe and we cannot simple expect the drug maker to pay for this, especially when the FDA has agreed that the efficacy of the drug is worth the risk of the possible side effects. This efficacy issue is something all drugs must prove for FDA approval.
If this ruling prevails then our choice of effective drugs will go down and treatments of health issues will be less because the pharma industry will only want to pursue manufacturing and marketing drugs that have 0% chance of creating an expensive law suit.
This will also mean more people will suffer because they won't have an effective treatment because of fear of a few people haveing side effect problems.

Stephen of CA 5:32PM March 04, 2009