Supreme Court Backs Amputee In Drug Suit

Woman Lost Arm After Botched Injection; $6.7 Million Award Upheld

(CBS/AP)  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 that it limit 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," Levine said. "I'm just ecstatic. I'm going to have to sit down."

The decision is the second this term to reject business groups' arguments that federal regulation effectively pre-empts consumer complaints under state law.

"In the short term, it’s likely that the ruling will increase the number of lawsuits against drug companies. Some of these cases will be legitimate. Some will not be. In the longer term, the ruling is likely to push companies like Wyeth into enhancing their labels - into making them safer before litigation - and perhaps as well push FDA regulators as well to be less beholden to the industry they regulate," writes CBS News legal analyst Andrew Cohen.

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. Gangrene is likely if the injection accidentally hits an artery - precisely what happened to Levine.

In fact, the injection method, known as IV-push, had been linked to 20 cases of gangrene and amputation before Levine's, reports CBS News correspondent Wyatt Andrews.

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.

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Click here to read the complete Supreme Court decision

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This was a high stakes case because, if the drug industry had prevailed, future drug safety cases-the next Vioxx or Fen-Phen-would have been barred from state court. Now not only can drug cases move forward but so will other consumer claims where federal regulation is also involved, Andrews reports.

"The real attempt here was to close the courthouse door to lawsuits and cut off any compensation for people who are harmed by defective or mislabeled drugs," Brian Wolfman of Public Citizen told Andrews.

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.

[Phxfire]

So what some of you are saying, if a drug company fails to adequately warn or advise on the use of their drug its to bad for the victim? What exactly is the limit for your acceptable loses? The victim can die, but doesn't impact you, the victim loses ability to work and provide for themselves or their family, doesn't impact you...until it is you or your family member. And it does hit you in the pocketbook. Kids who need financial aid after the lose of a parent, public assistance for the disabled. Drug companies will NEVER stop research and development,. Even with the high costs of bringing a new drug to the consumer, the money to be made after approval is astronomincal while they have the patent. People really need to do their homework before making blanket generalizations based on rumor.

[barbaram99]

i am so glad she won . It is so sad her lost her arm and her carreer over a drug. Glad ye won. I had hoped she wopuld,

[mrzerato]

I think it is time to pack the court. FDR had a hard time with the court undoing his programs until he suggested court packing. It will minimize the influence of the radical right on the coming court cases

[toolmangler-2009]

we won and the other party had to pay everything.
Posted by dmw1167 at 12:23 PM : Mar 4, 2009



So, If the other party is a crippled victim of bad drugs, and the Drug company has 40 lawyers to the victims one lawyer (pro bono) sshhheeeeesssshhhh I will take Americas way of doing things...

[mdalerwill]

Hmm, looks like for 2007 pharma was only the 3rd most profitable industry in the US. Definitely bailout material after this lawsuit.

[rhs648]

There are many people here who falsely believe that these lawsuits cause drug prices to go up. 6 million is nothing to these companies. If the fine was a billion or more you would see an increase in costs. 'Tort reform' as it's been labeled does nothing to lower cost to the consumer. All it does is protect shareholders from fluctuations in stock value. The Bush family is a major holder of stock in Wyath and several other pharm companies. George H.W. Bush was on the board at Lily Pharmaceuticals for a long time. It's more inside manipulation of margins at the expense of average Americans.
Posted by at 12:23

You are probably correct. Many lawsuits often carry the threat of very large judgements. In many cases, insurance companies and their clients often offer settlements even if they feel they are right to avoid the risk of large judgements, becuae some cases are nuisance cases, or the legal fees don't warrant a prolonged battle in the courts.

[credibility2]

Most law suits provide for recovery of the successful litigant's legal fees. I believe, however, that this must be clearly stipulated in the lawsuit; normally this is also a reciprocal arrangement for either the plaintiff or the defendant. If this woman's lawyers didn't insert this verbiage in her filing, then she'll probably have to pursue suing the drug company.

[rhs648]

The best way to stop unwarranted lawsuits is to adopt the law of most European countries and that is, the loser of a case has to pay all cost including the winners lawyers. My company was involved in a multi-million dollar lawsuit in Germany, we won and the other party had to pay everything.
Posted by dmw1167

This could be accomplished with the stroke of a pen if it weren't for lawyers and other powerful interest groups who would oppose such an action. If we look at Congress, there are many lawyers among its members who would oppose an improvement like the one you are suggesting.

[dahizzle]

There are many people here who falsely believe that these lawsuits cause drug prices to go up. 6 million is nothing to these companies. If the fine was a billion or more you would see an increase in costs. 'Tort reform' as it's been labeled does nothing to lower cost to the consumer. All it does is protect shareholders from fluctuations in stock value. The Bush family is a major holder of stock in Wyath and several other pharm companies. George H.W. Bush was on the board at Lily Pharmaceuticals for a long time. It's more inside manipulation of margins at the expense of average Americans.

[rhs648]

A drug company might be wise to eliminate research and development and simply milk the drugs already in its inventory.
Posted by rhs648 at 11:46 AM : Mar 4, 2009

They won't do that because their profits dwindle as their patents run out and generics cut into their business.
Posted by mdalerwil

You are correct. That is where diversification could help a drug company. Drug companies could invest in other areas such as food, high tech, and things that take up the slack as their drug sales decline. Cigarette companies may already have done that.

[mdalerwill]

A drug company might be wise to eliminate research and development and simply milk the drugs already in its inventory.
Posted by rhs648 at 11:46 AM : Mar 4, 2009

They won't do that because their profits dwindle as their patents run out and generics cut into their business.

[rhs648]

correction

Well, good for her!

Nothing like a giant cash settlement to drive up the cost of drugs for the rest of us hard-working dolts.
Posted by davicar2

If I were a drug manufacturer, I would rethink whether research and development of new drugs is worthwhile. It takes millions of dollars and 10 to 15 years to bring a new drug to the market. Even after a manufacturer jumps all of the hoops for approval and states the possible side effects and warnings of possible death, they are sued when there is a side effect or death. Furthermore, drug companies can not control how doctors and hospitals use the drugs. A drug company might be wise to eliminate research and development and simply milk the drugs already in its inventory. Then we will complain that future drugs to prolong life and fight disease aren't being produced.
Posted by rhs648

[rhs648]

Well, good for her!

Nothing like a giant cash settlement to drive up the cost of drugs for the rest of us hard-working dolts.
Posted by davicar2

If I were a drig manufacturer, I would rethink whether research and development of new drugs is worthwhile. It takes millions of dollars and 10 to 15 years to bring a new drug to the market. Even after a manufacturer jumps all of the hoops for approval and states the possible side effects and warnings of possible death, they are sued when there is a side effect or death. Furthermore, drug companies can not control how doctors and hospitals use the drugs. A drug company might be wise to eliminate research and development and simply milk the drugs already in its inventory. Then we will complain that future drugs to prolong life and fight disease aren't being produced.

[mdalerwill]

Nothing like a giant cash settlement to drive up the cost of drugs for the rest of us hard-working dolts.
Posted by davicar2 at 10:42 AM : Mar 4, 2009

Please, Vic, it's not like the woman broke a nail. First, being a musician, this was her whole livelihood. Second, I can tell you as an artist myself (though only semi-pro), losing the ability to pursue your art goes waaaaaay beyond lost wages. Think about losing the thing in the world that means most to you, aside from actual people like a spouse or children, and you might come close to knowing what this feels like. Some artists will even sacrifice their health if it comes to a choice between that and their art.

And I would be really really surprised if this drives the pharmaceutical company into bankruptcy. Or are the pharmacuetical companies lining up for bailouts now?

[gramto8]

I think you are all forgetting that the medication was supposed to be given intravenously... It was, instead, erroneously given intra-arterially. This is what caused the gangrene that caused her to lose her arm. There was NO warning on the label that mentioned that this could happen though it was known. That is why Wyeth is being held liable, as they should be.

[mgkonyx]

Here's to hoping something like this happens to me so my family can be set for life and I can still travel, play guitar, and enjoy a productive life.

~~~scoobydob

It might interest you to know that this woman was a musician - that is how she made her living before her arm was amputated. She played guitar and piano.

Wyeth and the FDA knew that injection into an artery could cause this kind of reaction, yet did nothing to prohibit its use in such a fashion. The general public shouldn't have to give their physicians the third degree before a drug is given to them on an emergency basis (this woman went to the ER because she had a migraine). The FDA rarely goes against Big Pharma - the FDA doesn't test the drugs it approves, it accepts the findings of the drug companies. Which is why drugs are continually being recalled or re-labeled when there are adverse reactions to their use. Big Pharma basically uses the general citizenry as a laboratory more often than the FDA cares to admit.

[lawyertom1]

The arguments of Wyeth were based on some language thrown into a Federal Register notice, probably as the result of some heavy-handed lobbying of the Bush Administration. There is nothing in the FD&CA that justifies a preemption argument. The Court made the correct decision. Some commentators, reflecting BigPharma, complain about 50 different standards. Well, that is what happens when the law is not in your favor and you have a completely corrupted FDA. If the last 8 years have demonstrated anything it is the need for checks-and-balances, whether it is drug safety, the environment, kids' toys, or whistleblowers. The Bush Administration would make the Grant Administration proud in terms of its level of corruption and back-channel influence.

[scoobydob]

Forget fines and monetary judgments send these souless profiteers to prison for a long, long time and then let the other greedy corporate types decide if it's worth it to recklessly endanger others for profit.

[blazercoach1]

This is a good thing, drug makers need to realize the general public is not taking their garbage anymore without actually knowing what it is they are taking.
Posted by hologram5

Why would YOU take anything without knowing what is in it?

These supreme court throwbacks believe the government and corporations are always right.
Posted by DefendLiberty

And which whackos decided that McDonalds was at fault because that lady spilled hot coffee on herself?

The problem is that the FDA didn't do its job. That's what lawsuits are for.
Posted by hatesthecolt

Then why is the lawsuit against WYETH??

Honestly....I WOULD give my right arm to have enough money to send my kids to college and retire for the rest of my life. While I'm sure it's disturbing and upsetting to have an arm "taken" from you.....there are worse things in life. Here's to hoping something like this happens to me so my family can be set for life and I can still travel, play guitar, and enjoy a productive life.

[888irish]

Something needs to be done about the MASSIVE corruption. I just can't understand how things have gotten so out of control.