"Now that the key parties have filed their briefs with the US Supreme Court, which will review a case involving Wyeth on November 3, a host of interested parties — including 47 state attorneys general, former FDA commissioners, members of Congress, constitutional experts and editors of The New England Journal of Medicine — have just filed their own briefs arguing against preemption....See the whole article here, with links to lots of related information and briefs.The background: During an emergency room hospital visit, Diana Levine was given a Wyeth nausea med called Phenergan, which was administered improperly and caused the Vermont musician to lose her right arm below the elbow. She successfully argued that, even though labeling complied with FDA requirements, the adequacy of the warning still wasn’t established for a particular method of administering the drug.
And she contended Wyeth wasn’t prevented from adding or strengthening the warning on the label, even though the FDA rejected a proposed change. Levine was awarded more than $6 million and, despite appeals, the Vermont Supreme Court sided with her. But Wyeth has appealed again and now the US Supreme Court will review the case.
Wyeth’s defense hinges on preemption — the legal notion that FDA approval of a drug supercedes state law claims challenging safety, efficacy, or labeling."
Sunday, August 17, 2008
Wyeth v. Levine and the Right To Sue
There has been a lot of press related to the case before the Supreme Court, Wyeth v. Levine, being watched as a potential landmark ruling that would make it easier for pharmaceutical companies to protect themselves from product liability lawsuits. This article on Pharmalot does a good job of wrapping up the loose ends with links to original material. See: The Right To Sue: A Case Against Preemption.
Labels:
pharmaceutical,
preemption,
product liability
Friday, August 15, 2008
What is a medical error? Here's a list of 28 things that should never happen in a hospital
This list of 28 errors that should never happen is part of an article on MSNBC: More states shred bills for awful medical errors. The list is created by the National Quality Forum, a nonprofit health care safety agency, it includes:
See full article here, which includes a nice interactive graphic to view medical error billing policies/laws by state.
1. Surgery on the wrong body part.Currently, according to the report, hospitals in 23 states don't charge patients for these errors. Gee, that's nice of them, huh?
2. Surgery on the wrong patient.
3. Wrong surgical procedure performed on a patient.
4. Object left in patient after surgery.
5. Death of patient who had been generally healthy during or immediately after surgery for a localized problem.
6. Patient death or serious disability associated with the use of contaminated drugs, devices or biologics.
7. Patient death or serious disability associated with the misuse or malfunction of a device.
8. Patient death or serious disability associated with intravascular air embolism.
9. Infant discharged to wrong person.
10. Patient death or serious disability associated with patient disappearing for more than four hours.
11. Patient suicide or attempted suicide resulting in serious disability.
12. Patient death or serious disability associated with a medication error.
13. Patient death or serious disability associated with transfusion of blood or blood product of the wrong type.
14. Maternal death or serious disability associated with labor or delivery in a low-risk pregnancy.
15. Patient death or serious disability associated with the onset of hypoglycemia, a drop in blood sugar.
16. Death or serious disability associated with failure to identify and treat hyperbilirubinemia, a blood abnormality, in newborns.
17. Severe pressure ulcers acquired in the hospital.
18. Patient death or serious disability due to spinal manipulative therapy.
19. Patient death or serious disability associated with an electric shock.
20. Any incident in which a line designated for oxygen or other gas to be delivered to a patient contains the wrong gas or is contaminated by toxic substances.
21. Patient death or serious disability associated with a burn in the hospital.
22. Patient death associated with a fall suffered in the hospital.
23. Patient death or serious disability associated with the use of restraints or bedrails.
24. Any instance of care ordered by or provided by someone impersonating a physician, nurse, pharmacist or other licensed healthcare provider.
25. Abduction of a patient.
26. Sexual assault on a patient.
27. Death or significant injury of a patient or staff member resulting from a physical assault in the hospital.
28. Artificial insemination with the wrong donor sperm or donor egg.
See full article here, which includes a nice interactive graphic to view medical error billing policies/laws by state.
Monday, August 11, 2008
California Jury Awards $8.5 Million But Medical Malpractice Limits Reduce Award
The San Jose Mercury News reports from Modesto, CA that:
"A jury has awarded $8.5 million to the widow of a man who died on the day a surgeon was going to discharge him from the hospital.See news account here.Because of medical malpractice limits, 38-year-old Holly Stinnett likely will receive only $1.6 million of that amount."
Labels:
california,
jury award,
medical malpractice caps
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