04 March 2009


On November 3, 2008 I wrote A SUPREME TEST OF PATIENTS' RIGHTS about the case of Diana Levine, who lost her arm because of a botched injection of an anti-nausea medication. She sued Wyeth Pharmaceuticals, who claimed that since their drug was approved by federal regulators at the FDA, that Wyeth should bear no financial responsibility for Ms. Levine's tragic loss.

"For the nation," I wrote then, "Wyeth's appeal of a $6.7 million verdict Levine won from a Vermont state jury has far reaching consequences. Backed by the Bush administration, Wyeth argued that "once a drug's warning label gets FDA approval, consumers cannot pursue state law claims that they were harmed.”

Today comes the breaking news that Wyeth's appeal to the Supreme Court has been rejected. Thus, health freedom has been preserved for another day, thanks to Diana Levine.


By MARK SHERMAN, Associated Press Writer

WASHINGTON – The Supreme Court on Wednesday upheld a $6.7 million jury award to a musician who lost her arm because of a botched injection of an anti-nausea medication. The court brushed away a plea for limiting lawsuits against drug makers.
In a 6-3 decision, the court rejected Wyeth Pharmaceuticals' claim that federal approval of its Phenergan anti-nausea drug should have shielded the company from lawsuits like the one filed by Diana Levine of Vermont.

Levine, 63, struggled with her emotions when told of the ruling in a phone call from an Associated Press reporter Wednesday: "Oh, my God. I'm so, so happy. I can't believe this phone call," she said.

"I've been waiting for so long, and I had no idea of what the chances were. I'm just ecstatic. I'm going to have to sit down," said Levine, once a professional guitar and piano player. She now plays with one hand, and sings.

Levine's lawsuit said she wasn't sufficiently warned of the risks of using Phenergan. But Bert Rein, a Washington lawyer who represents Wyeth, said the company's label complied with federal law.

"The medical and scientific experts at FDA are in the best position to weigh the risks and benefits of a medicine and to assess how those risks and benefits should be described in the product's label," Rein said in a statement.

Wyeth is in the process of being bought by rival Pfizer, Inc., in a $68 billion deal that is expected to close later this year.
The decision is the second this term to reject business groups' arguments that federal regulation effectively pre-empts consumer complaints under state law.

A Vermont jury agreed with Levine's claim that Wyeth failed to provide a strong and clear warning about the risks of quickly injecting the drug into a vein, a method called IV push. Gangrene is likely if the injection accidentally hits an artery — precisely what happened to Levine.

The company appealed and, backed by the Bush administration, argued that once a drug's warning label gets approval from the Food and Drug Administration, the label can't be changed without further FDA approval and consumers cannot pursue state law claims that they were harmed.

Justice John Paul Stevens, writing the majority opinion, said Wyeth could "unilaterally strengthen its warning."
Stevens said he was persuaded that until a recent change by the FDA, the agency "traditionally regarded state law as a complementary form of drug regulation" because it monitors 11,000 drugs.

Justice Clarence Thomas agreed with the outcome of the case, but did not join Stevens' opinion.

Justice Samuel Alito wrote a dissent that was joined by Chief Justice John Roberts and Justice Antonin Scalia.
"This case illustrates that tragic facts make bad law," Alito said. "The court holds that a state tort jury, rather than the Food and Drug Administration, is ultimately responsible for regulating warning labels for prescription drugs."

The FDA has approved the use of Phenergan by injection, including the method at issue in Levine's case. The drug has been available for decades to treat nausea and when used properly, both sides agree it is safe and effective.

The Bush administration and business groups aggressively pushed limits on lawsuits through the doctrine of pre-emption — asserting the primacy of federal regulation over rules that might differ from state to state.

The Supreme Court had largely agreed, ruling last term that FDA approval shields medical devices from most lawsuits. That case turned on a provision of federal law prohibiting states from imposing their own requirements on the devices.
The Levine case drew a lot of attention because the administration and Wyeth contended that, although the federal Food, Drug and Cosmetic Act lacks a similar provision, drug manufacturers also are protected from most suits over federally approved drugs.

Stevens said there could be circumstances where consumer lawsuits would not be allowed, including if the FDA had considered and rejected a stronger warning label.

But that was not the case with Phenergan, he said. "As we have discussed, the FDA did not consider and reject a stronger warning against IV-push injection of Phenergan," Stevens said.

Justice Stephen Breyer agreed in a brief, separate opinion. "It is also possible that state tort law will sometimes interfere with the FDA's desire to create a drug label containing a specific set of cautions and instructions," Breyer said.
The case is Wyeth v. Levine, 06-1249.
Associated Press writer John Curran contributed reporting from Montpelier, Vt.


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Anonymous Dr. JA said...

The recent Supreme Court decision is a miscarriage of justice, in my opinion. There certainly was a tort, but it was due to malpractice rather than a weak package insert warning. When a clinic allows a PA to insert and IV, and when the PA is not well enough trained to tell an arterial puncture from a venepuncture, the fault for the injury is clearly due to a practice error, not to the drug. Many drugs which are given IV every day might cause vasosopasm when injected into an artery. Even normal saline might cause gangrene if injected into the arterial wall in high enough volume to cause arterial occlusion.

Intra-arterial injection by a poorly trained PA is the obvious cause of this tragic injury.

It is difficult to see how we can get health care costs under control when such legal witch hunts are permitted.

4:50 PM EST  
Blogger Kevin P. Miller said...

Dr JA:

Thank you for your comments. I think you've missed the point — by a country mile. The recent Supreme Court decision is ANYTHING but a miscarriage of justice. While it could well be that IV's might cause vasosopasm when injected into an artery, Wyeth did not argue that point.

Instead Wyeth made this case about hiding behind the skirts of the FDA, which is among the most corrupt of government agencies. Since Wyeth pursued the claim that they should not be punished "because the drug was approved by the FDA," they forced the Supreme Court to address this issue once and for all.

And so they did...and protected consumers not only from accidents like Ms. Levine's, but from drugs that often have no proven scientific efficacy but DO carry deadly side effects.

As far as your claim, "It is difficult to see how we can get health care costs under control when such legal witch hunts are permitted," it seems quite convenient that you would use this line of logic. Every honest doctor, nurse, and practitioner I know (and there are dozens) insist that the high cost of healthcare has more to do with padding the books and outright corruption than "legal witch hunts," as you call them.

You forget that TAXPAYERS pay for approximately 50% of drug development costs, only to have the drug companies turn back around and charge $100, $200 or more per pill. Somewhere along the line, many doctors have also changed the ethos of their profession from caring to cashing in. You don't think that marching out hundreds of thousands of "freshly minted" surgeons to perform too-many worthless bypass procedures have spiked the cost of healthcare and diminished the profession?

No, sir, doc, waste is spreading like a plague throughout western medicine. Mark my words: if we ever truly export this system to China, with it's 1.5 billion people, we will bankrupt the world economy — for good.

Blaming waste on Diana Levine, who lost her arm is like blaming President Obama for the sins of the past eight years. It might feel good if you're a Republican...but it's simply not rooted in fact.

I appreciate you taking the time to write.


7:35 PM EST  
Anonymous Ben Rall said...

I love your TRUTH Kevin! Good Luck in Lincoln

10:33 PM EST  

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