SUPREME COURT REJECTS LIMITS ON DRUG LAWSUITS

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.


SUPREME COURT REJECTS LIMITS ON DRUG LAWSUITS

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.
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Associated Press writer John Curran contributed reporting from Montpelier, Vt.


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A SUPREME TEST OF PATIENTS' RIGHTS

TOMORROW IS ELECTION DAY IN AMERICA, but the truth is that the shadow of the Bush legacy could resonate for years, if not decades. This is particularly evident in healthcare policy, where President Bush has aggressively sided with big business over patient’s rights time and again.

When the President battled John Kerry in 2004, one of the battle cries repeatedly espoused throughout the campaign was that “trial lawyers” were the marquee offenders in what had become an overly litigious society. Opportunistic Trial Lawyers, they opined, were the reason why healthcare costs were out of control. As the President decried “junk lawsuits,” however, his real aim was to insulate major pharmaceutical companies from lawsuits — and to distance consumers from their day in court — if an approved drug harmed them.

President Bush proposed setting, in his words, "a hard cap of $250,000" on physical and emotional pain and suffering. Then he went one step further — and pushed legislation designed to exonerate drug companies from ANY liability whatsoever for drugs which harmed Americans. “Since the Food and Drug Administration already approved the drugs as “safe and effective,” he reasoned, "they should be immune from lawsuits."

Journalist Jane Akre, a veteran of radio, local TV news and even CNN, has seen all of this before, and now she is reporting on some of the blowback from the Bush policies. Akre has earned kudos as one of the nation’s most admired journalists for her expose’ on Monsanto’s rBgh — the synthetic growth hormones used in cows — and for her refusal to change the facts of her investigative series that were unfavorable to Monsanto. She was summarily fired by Fox because of her journalistic integrity and has endured a series of expensive and career threatening lawsuits (see my blog entry “Is Media Your Servant?” for the details of that dramatic story).

Ah, but you can’t keep a good woman down, as the saying goes.

Akre is again in the midst of some sterling reporting about corporate protectionism and how it has afftected the lives of real people. As News Editor of the National News Desk, Jane featured an interview with musician Diana Levine, a woman whose case appears before the U.S. Supreme Court today. The case, brought forth by pharmaceutical giant Wyeth, “will test whether corporations have blanket immunity from lawsuits when their product is approved by the government,” including the FDA, according to Akre.

In April 2000, Ms. Levine went the emergency room of a local hospital for treatment of a migraine. “In addition to a medication to treat the migraine she was given another medication called Phenergan made by Wyeth to stop the nausea,” reports Akre. Today, Akre writes, “she wishes she had stuck with the nausea.” Tragically, Levine acquired gangrene as a side effect of the way the drug was administered and while in the hospital, doctors removed her hand. “In a second procedure,” Akre continues, “they took the right arm up to below the elbow. She has a prosthetic arm now, but making music became difficult if not impossible.”

According to Dr. Carolyn Dean, an MD who appeared in my film WE BECOME SILENT, over two million patients suffer adverse reactions to pharmaceutical medicines in hospital-based settings annually — and often suffer serious consequences like Ms. Levine’s. In Dr. Dean’s stellar book, DEATH BY MODERN MEDICINE, she exposed the fact that over 780,000 Americans die each year from iatrogenic — or “doctor-caused” treatments. This is, incidentally, a far greater number than has been reported on by the mainstream media, which repeatedly insists that the number is between “40,000 – 100,000 iatrogenic deaths annually.”

So today, the Supreme Court is set to decide whether Wyeth has any culpability in the wake of Diana Levine’s tragic circumstances, even though it is widely agreed that the anti-nausea drug Phenergan, which she was given intravenously, was indeed responsible for Levine losing her hand and half of her arm.

According to the Associated Press, several justices indicated that if the FDA “had clear information about the risks of Wyeth Pharmaceuticals' anti-nausea drug Phenergan” — and approved its warning label anyway — then Wyeth “would probably prevail in its court fight against Diana Levine.”

For the nation, 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.”

For those of us who know how endemic corruption at the FDA has become, the prospect of a Supreme Court victory for Wyeth is a chilling one indeed.

Thus, on the eve of one of the most important elections in U.S. history, an equally monumental decision regarding patients' rights will be made in the next 24 hours in the highest court in the land. And President Bush, arguably the most unpopular President in history, may well secure what he wanted all along: to insulate the petrochemical companies from consumer lawsuits and leave more Americans to wonder what his legacy has wrought.