High Court May Immunize Big Pharma

[Purveyor]

The FDA’s new “preemption” doctrine jeopardizes consumers’ right to sue for drug-caused injuries

By Terry J. Allen

Struck by a blinding migraine, Vermont musician Diana Levine went to a clinic where she was injected with the anti-nausea drug Phenergan, produced by Wyeth Pharmaceuticals. Within weeks, the hand that had fingered her guitar was black with gangrene. Doctors amputated below the wrist and, when that failed to stop the necrosis, removed her forearm.

Wyeth’s label had warned that hitting an artery could cause irreversible damage, but it did not specifically direct physicians to avoid delivering the drug with intravenous (IV) push injection — rather than free-flowing IV drip or intramuscular shot.

Levine sued in Vermont court, charging that, because Wyeth had known for decades that using IV push to inject Phenergan directly into a vein creates avoidable risk, it should have added specific instructions on its label barring the practice.

Wyeth argued that Food and Drug Administration (FDA) approval of Phenergan and its label immunized it from state-level lawsuits. The Vermont court disagreed and awarded Levine $6.8 million.

The U.S. Supreme Court will hear Wyeth’s appeal on Nov. 3, the day before the presidential election, when few people will be paying attention. They should be.

If Wyeth’s legal defense wins, Rep. Henry Waxman (D-Calif.) said at a hearing in May, “Patients hurt by defective drugs … would no longer have the ability to seek compensation for their injuries.”

MORE...

http://www.inthesetimes.com/article/3894/high_court_may_immunize_big_pharma/

[Joanne98]

1. Dammit!

[Purveyor]

5. This is currently the way it is in Michigan. You can't sue any Pharma for defective drugs. Period.

With all the class-action claims and settlements against the drug companies, Michigan residents can only sit on the sidelines and watch. No relief for us...

[endthewar]

6. Sorry, but the drug wasn't defective

She should sue her doctor for malpractice.

[annabanana]

2. This is unconscionable.

The last remaining recourse against an industry that will ALWAYS cut corners, scrimp on research and try to minimize or HIDE problems and contra-indications.....

And this Court, if we're lucky, MIGHT save it 5 - 4. . But I wouldn't take any bets on it.

[antigop]

3. So where are the Big Pharma defenders? n/t

[barbtries]

4. if there is justice

she will win.

[unblock]

7. this would be fine if the fda stood behind big pharma like they stood behind fnma/fhlmc

well even there it would create nightmarish moral hazard, but at least there'd be compensation for the victims....

[Turner Ashby]

11. I don't think the drug itself was defective.

But the delivery was. So, the hospital or doctor was more likely at fault. So, I am confused by the lawsuit. I had a similar reaction to vistareal, which has a known necrosis factor. I was lucky. I only have a huge scar on my leg, because I got to a hospital fast, and actually threatened them with a lawsuit to react quickly to the dead tissue. (They were trying to ignore the big black patch on my leg that was growing that they had caused).

[OneBlueSky]

8. the biggest challenge facing this nation is how to . . .

restore citizen authority over corporations . . . and the biggest question facing an Obama administration (assuming there is one) is "will you aggressively work toward this end?" . . .

Reclaim Democracy!
http://www.reclaimdemocracy.org/

[kurth_]

9. The drug companies bought their justices when they bought BushCo

No surprise there.

[sui generis]

10. well there are sharks in the ocean

if we don't want big pharma to eat another surfer, we had better do something about the law that makes surfers available as snacks.

Given complete deregulation pharma would REQUIRE that we take their most expensive drugs until several years after being dead and charge your children for breathing air, unless it didn't benefit them economically. That's the key. They are driven, like sharks by hunger, by profit.

go after the lawmakers - sharks aren't evil. People who feed the sharks are evil.