Supreme Court rejects limits on drug lawsuits

updated 5:48 p.m. ET, Wed., March. 4, 2009
WASHINGTON - The Supreme Court forcefully rejected calls Wednesday for limiting consumer lawsuits against drug makers, upholding a $6.7 million jury award to a musician who lost her arm to gangrene following an injection.

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

Diana Levine of Vermont once played the guitar and piano professionally. Her right arm was amputated after she was injected with Phenergan, an anti-nausea medicine made by Wyeth Pharmaceuticals, using a method that brings rapid relief, but with grievous risks if improperly administered.

In a 6-3 decision, the court turned away Wyeth’s claim that federal approval of Phenergan and its warning label should have shielded the company from lawsuits like Levine’s.

“Next to getting my hand back, it’s the best they could do and the least they could have done,” the 63-year-old Levine said. 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.

“Wyeth’s labeling of Phenergan provided clear instructions and warnings about its use, including clear warnings about the very risk at issue in this case,” Rein said.

He said the decision would affect how doctors treat patients. “The practical impact of this is going to be much greater caution” by doctors in deciding whether to use the most effective or least risky method of administering a drug, Rein said.

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 central issue in this case was the absence of language in the federal law setting out regulation of prescription drugs that forecloses consumer complaints in state courts. Congress has included such language in other areas.

“Unless Congress has spoken directly to the question, the court this term has said it is not going to favor broader arguments for pre-emption,” said David Frederick, who represented Levine and the cigarette smokers who won an earlier ruling this term allowing their lawsuits against tobacco companies to proceed.

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.

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,” especially after it learned of at least 20 incidents before Levine’s injury in which an injection led to gangrene and amputation.

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.

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.

Rein, the Wyeth lawyer, said he was pleased that the court recognized that some lawsuits could be blocked.

“There are such cases,” he said. “This is not one of them.”



The case is Wyeth v. Levine, 06-1249.

Not sure if the article mentions this, but Clarence Thomas actually voted in favor of this decision. Crazy, huh.

I couldn't believe it either. Although it should be noted that his rational for voting against preemption was significantly different than the majority.

How is this a great day for justice? You walk into a hospital fucked up and an accident happens. Obviously you deserve millions of dollars because of an accident. Jesus I love America. Rich people who work their entire lives to become rich don't deserve it. But you walk into a hospital and have a FUCKING ACCIDENT and somehow you should get millions of dollars. Accidents never happen. And lawyers are super.

Educate yourself before making ridiculous comments.

This is landmark. It should be discussed more.

We need a thread on healthcare, period. An all-encompassing one like the economy thread would be nice.

How much is a normal life worth?

Is this your argument? Let me ask you a question. How much is being alive worth? Doctors should blacklist this asshole and all other assholes like him. Oh yeah, and the lawyers that represent them.

Is this YOUR argument?

There was ONE major point in this decision: A drug company cannot hide from lawsuit for creating a dangerous product just because a governmental agency has given its approval.

Think of the alternatives. An FDA by run by a government like teh Bush Administration would just approve everything and protect their corporate overlords, since the FDA can't be sued under sovereign immunity. An FDA under a more responsible government would take FOREVER to approve anything because they would be even MORE cautious and slower in their approvals that they are today, and which a large number of people complain constantly about.

A dangerous product? Are you kidding me? So now drug makers have to be perfect? Doctors have to perfect? Or else? That's why these clowns should be blacklisted.

And I don't know if you actually read the article, but the drug had nothing to do with it, and it was properly labeled. It was the method with which it was administered that caused the complications. When my heart freaks out, I get an "IV push" myself. Lots of people get an "IV push" everyday and run the same risks as this woman did. An ER is not a free ticket to perfection. There are risks and side effects to everything. Nothing is perfect, and just because it's not and a fraction of a percent have side effects doesn't give them the right to sue people.

It was a fucking accident. A simple accident. People tried to help her. They did their best to help her. And when an accident occurred that nobody foresaw, and that nobody could prevent, she turned around and sued the people who tried to help her and maybe save her life. What a stellar individual. And somehow this precipitates a case that drug companies can't hide behind and FDA approved drug that had nothing to do with her infection? Totally awesome. This country is clearly on the right track.

I don't understand how fucking vile people can be. You go into a hospital feeling like crap, seeking a solution to how you're feeling. You go in there hoping people will save your life. And if something goes wrong by ACCIDENT you're gonna sue those same people for millions of dollars?

Scum of the mother fucking earth.

It'll be great now. The next time I go into a hospital needing an IV push of cardizem, the ER doctor is gonna be thinking, "Gosh, if I accidently hit his artery and he gets an infection, he might sue me. Maybe I shouldn't do an IV push." Great times.

Look, it's not my fault you don't know how to read a court opinion in order to discern what the actual legal questions decided were. The extraneous circumstances of the case are irrelevant. You know what, Miranda was guilty as hell, but his case has prevented countless bogus confessions over teh past 45 years.

I'd say "you can't see the forest for the trees," but you think you're looking at a rock.

approves.

I think if Obama is serious about getting health costs under control the first thing he'll have to do is limit the awards in malpractice suits. There's no reason for the person sueing to get any punitive damages, or give lawyers a cut of punitive damages. It's the punitive damages that makes winning a lawsuit into a lottery bonanza.

I wouldn't surprised if Obama capped malpractice punitive damages and put any and all punitive damages awards back into the healthcare system. If this were done I think you'd see a drastic decine in these suits.

I'd be in favor of a part (even the large majority) of punitive damages being paid into a national health insurance fund.

I've always wondered why the person sueing gets any punitive damages. Can you enlighten me as to why this is?

You underestimate the power of the trial lawyers association lobby and the plaintiff's bar in this country.

Who else would it go to? If you agree with the general idea of using punitive damages to deter bad acts, they have to be paid to someone, and I'd imagine that most people would find giving it to teh state in some way distasteful.

Punitive damages are awarded quite rarely, and when they are, there are knowingly bad acts involved, not just "mistakes" or "accidents". The exceedingly rare cases where punitive damages are awarded excessively become the model of the norm for those who seek litigation reform, but they are even worse than anecdotal, they are deliberately manipulative.

I actually think that if punitive damages went to teh state, or a healthcare fund in this case, the awards may actually INCREASE in frequency and/or amount.

For the record, everyone should learn from this. Don't inject anything for Nausea.

Geez. Scary.

Proud member.

I practice in Ohio and we already have a cap on non-economic damages for medical malpractice. The basic cap is the larger of $250,000 or three times economic damages, subject to a maximum of $350,000 per plaintiff and a maximum of $500,000 per occurrence. These maximum amounts increase to $500,000 per plaintiff and $1 million per occurrence if the plaintiff has suffered permanent and substantial physical deformity, loss of use of a limb, loss of a bodily organ system, or permanent physical injury that prevents self-care. The cap does not apply to cases brought under the wrongful death statute, but it does limit recovery by a decedent's estate for such non-economic damages as conscious pain and suffering experienced prior to death.

Additionally, many states make it very expensive and difficult to even file a med mal complaint. For example, Ohio requires that you hire an expert doctor to peel through every page of a patient's medical history and render an opinion as to whether the treating physician deviated from the requisite standard of care. The doctor must then put his opinion in writing in the form of a sworn affidavit. Costs associated with hiring the expert doctor can be around $10,000. These costs are fronted by the plaintiff's attorneys and are incurred before a formal complaint can even be filed. The system works because there are not many attorneys willing to throw $10K away to pursue a questionable case. As a result, it limits frivilous litigation.

Some states like Indiana even require that the attorney appear before a medical review board before filing suit. This allows the review board to review the case and make an initial judgment as to whether a complaint should even be filed.

Not to mention the fact that medical experts have the ability to set their own rate. If they want to charge $2,000/hour, they can. Figure in the amount of time they spend learning the case, testifying in depositions and testifying at trial. The money starts to add up VERY quickly. Moreover, you will likely need multiple experts to prove your case. So you're looking at a MINIMUM of around a $50K investment by plaintiffs attorney just to get the case to trial. And then there's that one thing...the possibility of losing everything including your client's confidence. Again, there are very few attorneys willing to make such a substantial investment on a frivilous case.

These processes act as screening tools and assist in limiting frivilous litigation. Even if a case does get filed it faces a 98% chance dieing somewhere along the path of litigation.


So, if a jury does return a favorable verdict for the plaintiff, you can be pretty damn sure that the doctor fucked up big time.