FDA-approved warning labels won't protect companies »
Posted By SenorCoconut 11 months, 1 week ago in Business & FinanceUS court says people harmed by drugs can still sue.
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SenorCoconut
"Every patient carries her or his own doctor inside" - Albert Schweitzer.
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nostalgia11 months, 1 week ago
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This is a case of medical malpractice
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FTA: The drug was mistakenly injected into an artery instead of a vein
Looks like the attorneys for Diana Levine were going after the drug manufacturer because of "deep pockets"
The FDA guidelines are very clear:
The IV route, along with inadvertent intra-arterial (injecting into an artery mistakenly) or subcutaneous administration is most likely to result in significant complications, ranging from burning and pain to paralysis, tissue necrosis, and gangrene. Sometimes surgical intervention such as fasciotomy, skin graft or even amputation is needed
the product labeling makes several recommendations to reduce the risk of these adverse events. They include giving the drug in concentrations no greater than 25 mg/mL, administering the drug at a rate no greater than 25 mg/minute, injecting the drug through the tubing of an infusion set that’s running and known to be working satisfactorily, and stopping the injection immediately if the patient reports burning in order to investigate whether there might be intra-arterial placement or perivascular extravasation.
Stock promethazine only in the 25 mg/mL concentration (not the 50 mg/ml) since this is the highest concentration of promethazine that can be given IV.
• Consider 6.25 to 12.5 mg of promethazine as the starting IV dose, especially for elderly patients.
• Give the medication only through a large-bore vein and check the patency of the access site before administering.
• Administer IV promethazine through a running IV line at the port furthest from the patient’s vein.
• Consider administering IV promethazine over 10-15 minutes.
• Before administering the drug, tell patients to let you know immediately if burning or pain occurs during or after the injection.
Someone in the hospital was not following protocol -
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StevieGee11 months, 1 week ago
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willottica11 months, 1 week ago
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I agree with the general ruling about the ability to sue drug makers if they are harmed by drugs. They should be responsible for ensuring that their product is safe when used as directed.
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However, I do not agree with the specific ruling in this case. The patient was not harmed by the drug, but by the medical practitioner who administered it incorrectly. The drug was used incorrectly.
This is like suing the makers of Advil when someone suffers kidney failure because of an overdose.-
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Endoscopy11 months, 1 week ago
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I totally disagree. If 100 people take a drug that a doctor prescribes for them a small number of them will have harmful side effects. The doctor is supposed to warn the patient about them so if they start having those symptoms they are to stop.. New ones still crop up and it is nobodies fault. The differences in people make giving a prescription an art and sometimes a patient might be allergic to that drug without knowing that fact. All this does is hang the drug companies out to dry and make the price of drugs go even higher.
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Endoscopy11 months, 1 week ago
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This is a disaster for the Drug companies and a boon for the suit happy lawyers. This will raise the cost of drugs. All of the lawyer fees and losses in court will have to be paid by the people buying the drugs. And people were bitching about the cost of drugs because of the costs of creating a mostly safe drug for different problems.
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Get a copy of the Physicians' Desk Reference and look at the voluminous information there about possible side effects, prescribing information, and much more. Several pages on each drug. Will they have to put that as a brochure attached to the medicine? This is stupid.
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