The US Supreme Court hears arguments on Monday, November 3, in a closely watched case that could limit liability claims against drugmakers if one of their medicines causes harm.
http://www.bloomberg.com/apps/news?pid=20601109&sid=agDNyswitQ88&refer=home
Attorneys in Pre-Emption Case Seek To Add Documents Indicating Two FDA Officials Objected to Rules Aimed at Pre-Empting Lawsuits. See link below:
This is the Wyeth anti-nausea drug. Hope it goes in her favor.I hope it goes in Wyeth's favor. I don't agree that the drug company was at fault. The physician's assistant should have made sure he wasn't injecting into an artery.
Jan,
The case before the Supreme Court is Wyeth vs. Levine. Levine did win her lawsuit in Vermont's state court. Wyeth has appealed to the Supreme Court, because they claim since the FDA approved the label on this drug, they cannot be held liable.
The Supreme Court's ruling could have far more reaching ramifications than just Ms. Levine, it could affect any injured party's ability to bring a product liability lawsuit in a state court.
We'll have to agree to disagree. I shudder to think of what will happen if drugmakers have to shell out millions of dollars every time some brain-dead PA misuses their products.
[QUOTE=JasmineRain]We'll have to agree to disagree. I shudder to think of what will happen if drugmakers have to shell out millions of dollars every time some brain-dead PA misuses their products. [/QUOTE]
I agree...
The issue before the Supreme Court is "federal preemption," whether one is able to bring a product liability lawsuit in a "state court" when a federal agency, like the FDA, has, as in this case, approved the drug label. Federal rules/laws trump state's.
The FDA has been criticized for being understaffed and underfunded. Their decision to approve a drug is based on the clinical studies and information provided by the drug manufacturer. Sometimes problems with a drug become known after it has been on the market and a larger population has used it. Given that, should the FDA's initial approval of a drug be the last word on product safety and prohibit someone from bringing a lawsuit in a state court?
This case goes beyond the circumstances of Ms. Levine. There are several possibilities on how the Supreme Court may rule, we'll just have to watch and see.
"Although Phenergan's two-page packaging insert warned that
injection into an artery could cause gangrene, Levine says the IV
push method is so risky the company should have told doctors not
to use it."
This scares the hell out of me. They've told you it has the potential to cause gangrene if you f*ck up... but that's not good enough. Some people won't stop unless the CHOICE is taken away.
Perhaps all the lawsuit-happy people can all start their own country, and the drug companies can choose not to do business in that country.
Levine won her lawsuit in Vermont state court against the drug manufacturer Wyeth. From NPR:
" . . . .Wyeth appealed to the Supreme Court. Former Solicitor General Seth Waxman told the justices that the FDA had weighed the risks and benefits of the drug, had approved the label, and that the company could not on its own change the label to add additional warnings once the label was approved.
Justice Anthony Kennedy didn't seem to buy that argument.
Justice Kennedy: "You argue that it's impossible for Wyeth to comply with state law" on adequate warnings and "at the same time comply with the federal label" requirements. "I don't understand that. … I think I could design a label that meets both requirements."
Justice Samuel Alito: How could the IV push method "be safe and effective when, on the benefit side, this is not a lifesaving drug, this is a drug that relieves nausea; and on the other side, it poses the risk of gangrene?"
Justice Ruth Bader Ginsburg: "How could the benefit outweigh the substantial risk?"
Justice Souter: "Wyeth could have gone back to the FDA at any time" to change the label, "and it didn't."
Answer: In the absence of new information, we could not change the label.
Supporting Wyeth in the Supreme Court was the Bush administration, which in a sharp break with decades of FDA policy, is now siding with the pharmaceutical industry. Justice Ginsburg asked why the administration has changed positions, but got no answer from Deputy Solicitor General Edwin Kneedler.
Justice Ginsburg: "There are 11,000 drugs on the market. Is the FDA really monitoring all of them to see if there is new information that should be noted on a label?"
Justice Stephen Breyer: "Why isn't the fact that a certain number of people are getting gangrene — why isn't that new information" that justifies the manufacturer strengthening the warnings on the label? "If you read the regulation, it says the manufacturer can do that. End of case."
Answer: The risk of gangrene is not new information.
Levine's lawyer, David Frederick, rebutted that answer when he stood to argue. In the years since the label was approved by the FDA, he said, there have been more than 20 amputations in cases involving the IV push method. Wyeth knew about these, but did not connect the dots, he said, to warn that the IV push method should not be used.
Justice Antonin Scalia and Chief Justice John Roberts, with voices raised, went after Frederick.
Justice Scalia: "Excuse me, those risks were set forth on the labeling approved by the FDA"
Answer: The FDA never considered the relative risks of the IV push method and other methods of administering the drug.
Chief Justice Roberts: "People can say it's safe for you to walk down the sidewalk. That doesn't mean there is NO risk that you get hit by lightning or something else."
Justice Scalia: "If you're telling me that the FDA acted irresponsibly, then sue the FDA."
Answer: "The idea that the label is set in stone for all time misunderstands the way the process works. When the FDA approves a drug and its label," it does so based on small clinical trials, "one or two thousand people." When the drug is marketed and goes to lots and lots of people, and the adverse reactions start occurring in greater numbers, the regulations permit a drug maker to supplement the label with that information.
Chief Justice Roberts: "So your case depends on us finding that there was a new risk" here that the FDA did not consider?
Answer: "The question is what did the manufacturer know and when did it know it. … The manufacturer has a duty of due care, a duty to analyze new information on risk, and to make appropriate changes in the warning to reflect that. … It didn't live up to that duty."
[QUOTE=JasmineRain]" . . . . Perhaps all the lawsuit-happy people can all start their own country, and the drug companies can choose not to do business in that country.
[/QUOTE]
Well, I guess you should tell that to the people who had heart attacks after taking VIOXX, oh, but wait, some of them are dead.
From Houston Chronicle:
"This case (Wyeth vs. Levine) could well set a precedent for all future pharmaceutical-related litigation. If FDA approval means that drug companies are not liable, then there will be no recourse if someone experiences a serious or even deadly adverse reaction.
Take Vioxx, for example. At last count, tens of thousands of patients may have experienced heart attacks as a side effect of this arthritis medicine.
Questions about what the company knew about these potential problems and when it knew them have been raised. Many answers have been discovered only through the disclosure required in the process of lawsuits.
In recent years, the FDA has approved many medicines that have later been shown to carry serious risks. In some cases, the drugs have had to be removed from the market."
The issue before the Supreme Court is an issue of "federal preemption," did Levine even have the right to bring a lawsuit against Wyeth in a state court because a federal agency, FDA, had approved the label?
This is a big case. Alot of people are watching. Joie, glad you posted this.
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