Supreme Court: Mock vs. G.W.Bush/Levine vs. Wyeth

[watermock]

This is going to take a long time to resolve,or might be one of the last things Bush does before leaving office...whuch to effectively prevent legal action against negliegence by drug companies, particulirly regarding their lableing.

I am severely crippled from an injection of Phehegen, a nausa drug often given for migranes or morning sickness. Wymen has discontinued it's use in an IV push. It is usually given by tablet or suppositiry..

My story is long but somehow, I think I have arrived at the truth regarding what actually happenned to me..

I am going to use this as a temporary reference point.. The case will decide MY fate is due to be heard in October.

If your interested in following this or commenting, please do, but this is a deadly serious topic.

I'll be adding more as I put this altogether as I'm still regaining my cognative abilties.




Edit:

I originally got an allergic reaction from eating peanut butter after taking Lisinopril. I went to emergency, and would of been fine but I wrote down I was nauseous...it's complicated, but that's how I got injected with Phenegen.

[watermock]

€€[{Patient Lawsuits Against Pharmaceutical Companies For Drug Injuries Might Be Prohibited In U.S.
Our Tort System Provides A Needed Means Of Accountability; Law Professor: "A lot is lost without these lawsuits."

(Posted by Tom Lamb at DrugInjuryWatch.com)

On March 3, 2008 the U.S. Supreme Court issued its ruling in the Warner-Lambert v. Kent case and, in so doing, declined the invitation of pharmaceutical companies -- and the Bush administration -- to prohibit drug injury lawsuits from being filed by patients who have suffered serious side effects caused by unsafe prescription drugs.

The tie vote by which the Supreme Court arrived at its decision in Warner-Lambert v. Kent, however, means that this ruling does not set any precedent on the federal preemption issue that is the increasing focus of products liability lawsuits that involve FDA-approved prescription drugs and medical devices.

From the March 4, 2008 article, "Court Allows Suit Against Drug Maker", by New York Times reporter Linda Greenhouse:

This case, Warner-Lambert Co. v. Kent, presented a narrow slice of the broad pre-emption issue that the court will take up in its next term. In that new case, Wyeth v. Levine, the question is whether the Food and Drug Administration’s approval of a drug’s label precludes individual damage suits based on the claim that the label failed to include sufficient information or adequate warnings.

In essence, if the answer is yes, most individual lawsuits for damages caused by approved drugs would be pre-empted. Last month, in Riegel v. Medtronic Inc., the court interpreted a federal law, the Medical Device Amendments, as barring most individual lawsuits against manufacturers of approved medical devices....

The Bush administration, which has embraced a broad theory of federal pre-emption of individual tort suits, entered the case on the manufacturer’s behalf. It argued that “permitting lay juries to second-guess” the adequacy of a drug application would interfere with the agency’s “exercise of its expert judgment.”

In more detail, the Bush administration will be arguing in Wyeth v. Levine (No. 06-1294) that the Food, Drug and Cosmetic Act of 1938 -- under which the FDA regulates prescription drugs -- has "implied preemption" due to the structure of this statute, i.e., the law's text does not include any preemption clause.

The Levine case involves a Vermont woman who lost a hand and forearm to gangrene after being improperly injected with the drug Phenergan. At the trial of this lawsuit, Wyeth argued that its drug had met FDA labeling requirements and, accordingly, the drug company should face no liability under state law. The trial court judge disagreed, and the jury in that case awarded $6.8 million in legal compensation to Levine for her injury.

According to some critics, federal preemption of drug injury cases may have some merit in an ideal world where the FDA was performing its drug-safety regulatory functions at 100%. But that has not been the situation in the; past, nor is it the case today.

In his March 3, 2008 article, "Patients' ability to sue at risk", Los Angeles Times reporter Daniel Costello presented these facts which tend to show why federal preemption of drug injury cases is a bad idea:

The FDA "doesn't have the ability at this time to oversee in a comprehensive fashion everything it regulates," said David A. Kessler, a former FDA chief and a professor at UC San Francisco.

A trio of recent reports, including one by the FDA's own advisory committee, has raised serious questions about the agency's recent performance.

[b]Last fall a yearlong study by the FDA's advisory committee found "the agency is so underfunded and understaffed that it's putting U.S. consumers at risk in terms of food and drug safety." [b/]

[b]In an unusual public departure from the view of the Bush administration, the current FDA commissioner, Andrew C. von Eschenbach, said in an interview last week that the agency needed a systemic overhaul that could take years....[b/]

Some legal experts and attorneys are concerned that without such lawsuits, regulators and the public may never hear of evidence that manufacturers knowingly marketed products they knew were unsafe.

In recent years, documents and e-mails uncovered in court cases have shown that some companies kept safety issues involving their products from the FDA.

"Without the tort system, what reasonable assurance do we have we will learn about the bad actors?" asked David Vladek [sic], a law professor at Georgetown University.

"A lot is lost without these lawsuits."

Oral arguments in the Levine case are scheduled for October 2008. Sometime thereafter the Supreme Court will decide whether FDA approval of a prescription drug prohibits the filing of personal injury and wrongful death lawsuits against drug companies.

No doubt we will continue to hear a lot about this important policy issue in the months to come.

[watermock]

http://blogs.wsj.com/health/2008/01/...on-amputation/.

Even tho both the FDA AND Wyeth are grossly negligent, I may not be able to sue...I can show lost icome for my L.L.C. and more for pain and sufferring I'm crippled and am 100% disabled with extensive neurological damage.

For now...I wait till the Top court rules, and the President himself is against me!

[Rohirrim]

Damn, Mock. I hope this comes out in your favor. The idea that pharmas could get immunity is criminal. I don't see any thread of reasoning that could allow the SCOTUS to simply toss out the rights of citizens to seek redress for damages in a court of law.

[Odysseus]

I'm sorry to hear you going through this. A friends was misdiagnosed for having a problem with her digestion but when she went to her family physician they discovered a tumor the size of a bucket inside of her. A very big difference between THAT and the purple pill. The doctor defended the doctor that misdiagnosed saying that the first doctor was correct except he neglected to ask ONE question in order to complete his diagnosis.

If the Pharmaceutical companies are not responsible and the doctors are not responsible than WHO is responsible when horrible mistakes are made? The patient? I need to carry a Physicain Desk Reference to the emergency room for it's "buyer beware" healthcare?

Keep us posted Mock. It's good to see you fighting through this.

[theAPAOps5]

Mock I wish you all the best. I hope something positive comes out of this whole ordeal for you. Fight the good fight and stay positive.

[watermock]

Who's responsible?

The FDA!!! Their own ex;chief says their incompetent!

You cant sue the FDA or the drug company...and Wyeth has changed it administration of the drug so that it shouldn't be given in IV push.

I can sue the doctor but he will say he just folled directions...but to give such an inherently dangerous IV push when I was allready recovering from an acute allergic reaction to peanut butter was negligent too...

But that doctor also saved my life...it was super dramatic...I havent told the story yet...

I want to sue the drug company which knew about these side effocts...Levine was treated in 2000...and upheld Supreme Court in Vermont...so Wyeth had plenty of time addressrthe label before me me!

[watermock]

http://blogs.wsj.com/health/2008/01/...a/?mod=WSJBlog