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Supreme Court to rule on drug warning labels

November 6, 2008 by  

Drug warning labels are under legal scrutinyOn Monday, attorneys for the Bush administration argued in front of the Supreme Court that drug companies should be shielded from consumer lawsuits even if they fail to warn patients about risks which could have long reaching effects on their health.

The case involves Diana Levine, a Vermont woman who had her arm amputated after an IV push of the anti-nausea medication Phenergan struck an artery, causing gangrene.

A jury awarded Levine $6.7 million in her suit against Wyeth, the drug’s maker, which the company appealed claiming the federal Food, Drug and Cosmetic Act prevents state lawsuits that conflict with federal drug regulations like warning labels approved by the U.S. Food and Drug Administration.

Levine’s lawyer, David Frederick, argued that Wyeth didn’t do everything in its power to warn of the potential dangers.

"The manufacturer has a duty of due care, a duty to analyze new information on risk and to make appropriate change in the warning to reflect that," said Frederick. "It didn’t live up to that duty."

According to Wyeth’s website, Phenergan has been on the market since 1951 and is typically used to treat the effects of inhaled allergens or food allergies.

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  • http://Yahoo Mary Brown

    I think the ones who make the drugs should be held accountable.  However at the price of drugs people can’t afford to buy their medication anyway, whats up with this. You know what it is GREED and the almighty DOLLAR – it’s shameful.   As far as the safty of the drugs I guess the individuals should ask themselves, what if this were someone in my family.

  • Trinity

    The insurance and drug companies will not be happy until they are able to limit all individual access to the courts. It is absolutely shameful that judges are so in the pocket of the lobbyists.  They want to clear their dockets so they can play golf, paid for by the lobbyists.

  • Jack Adams, RPh.

    This story sounds much more like a problem with drug administration technique than the drug itself.  Phenergan should not have been injected into an artery in the first place. It should have been injected either intramuscularly or via slow intravascular push. How the drug “struck and artery” via IV push is a mystery to me. The medical professional administering the drug may deserve some blame here and not the drug manufacturer. Those of us in the medical profession whether pharmacists like me, physicians, or nurses are responsible for the proper administration of drugs, and we are supposed to knoe the consequences of improper drug delivery as well. This is a very sad and unfortunate event that the drug manufacturer had absolutely no involvement, based on the story I just read.

    While some lawsuits are quite justified, many are not. Wyeth can not be held responsible for improper injection technique when proper technique is common knowledge among medical professionals. Also, the literature from the manufacture informs the professional of the proper way to deliver the medication.

    Jack Adams, RPh

  • Bob Livingston

    I agree with Jack that the person administering the drug apparantly had some blame in this case.  However, the theme of the article that drug companies should have limited liability is shameful, but the way it’s going with drug companies today.  They are fighting in all directions for limited liability.
    Don’t get me wrong, here… I think litigation is way out of control in America.  However, when the facts are covered up in the interest of profits, they should be held liable. –Bob.

  • http://www.roseandearl.com Earl Taylor

    Drug companies have far too long had “immunity” it seems on the side effects of drugs. Sure, you can find many sources of information on the Internet, but most people will “pop that Pill” without reading past the information given when the druggist fills the prescription.Do many people ever do research on the medicine they take BEFORE they take it? I would venture a quick NO, they don’t. Just because a Doctor prescribes it doesn’t mean it is safe to take. The handouts some drug stores give don’t really tell the whole story either. Clinical studies that you can research tell a WHOLE LOT more. But, we have become too trusting on what we put in our bodies as our physician wouldn’t do us harm now would they? Face it, there’s tremendous pressure from Drug manufacturers to get Doctoors to prescribe their drugs. Look at the Notepads, the Pens, other stuff that these drug Reps give out (even loads of Free Samples that Doctors can give to Patients). Having a medical condition that requires fairly regular doctor visits, I can see Drug Reps waiting to speak to the doctor on a constant basis. I’m not saying that Doctors are strong-armed, but face it, after a deluge of “hype” and smooth talk (sound familiar from our past election?), they “go for it.” Drug companies are in it for the money as any other “for profit” company. BUT, their accountability and liability is not in line with the harm that a lot of drugs do. Now, this country will soon see a whole new ball game if this national health plan takes off. This whole thing is going to get scary. Lord, help us all.

  • Skipper

    I worked in an ICU unit for 6 years and Phenergan was used. I have never heard of an IV push med being the cause of anything like what was described in this report. Most of the meds given in a unit like that are given via IV which is put in when the patient is brought to the unit, or in an ER or other unit. How did they ascertain that it was the Phenergan? Patients get all kinds of meds via their IV’s in a unit like that and even on a regular floor.
    As already stated, the person administrating the med would have been at fault not the med given. The greed is people suing the drug company who has more money than any hospital personnel. Drugs are very expensive to research and when the drug is on the market a certain length of time, it can be manufactured as a generic drug, which is a fraction of what the original
    drug costs but is just as effective. The staff at the hospital surely would have noticed if there was inflamation at the IV site and corrected it before anything as drastic as an amputation would have to be done. Something does not seem right with this case.

  • tivka

    I too am an RPh.  I agree with Jack Adams 100%.  The warning about not giving Phenergan IV push is on the vial or ampule and in the drug insert.  It is totally the responsibility of the person who administered the medication.  Where were Wyeth’s lawyers? This case ruins the possibility for someone to sue a drug company when it really is necessary.

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