The Ballad of Diana v. Goliath
By Rickey Gard Diamond
Eight years ago, my good friend Diana Winn Levine, a musician from Marshfield, Vermont lost her right hand to an amputation because of a medical foul-up. If international drug corporations get their way in the U.S. Supreme Court case Wyeth v. Levine this month, you may find yourself more severed from justice than she.
Diana had long suffered from migraines, but under the care of her local doctor managed her pain throughout a busy musical life, motherhood, and even the untimely death of her musician husband. Seeking relief from a headache one April night in 2000, she went to a local clinic and was given drugs she had been treated with previously without problem: Demerol for the pain and Wyeth’s drug Phenergan for nausea.
Over the next seven weeks her injected arm swelled to twice its size. Her hand and forearm began to throb and turn purple, then black. Her doctor at first gave her morphine, then checked her into the Central Vermont Hospital; from there she was taken to Dartmouth Hitchcock Medical Center, where the unimaginable was pronounced. Her right hand was literally dying.
Diana spent over a month in hospital care, reeling from pain and shock, along with her family and friends. How had this happened, we all asked? Phenergan is used safely when administered by intramuscular injection or intravenous drip. The drug’s label, approved by the Food and Drug Administration (FDA), had warned “inadvertent intra-arterial injection” can result in “gangrene requiring amputation,” but did not rule out a method called IV push. The clinic’s physician’s assistant used this method on Diana that spring night – apparently missing the vein and hitting an artery. Surgeons ultimately amputated Diana’s hand, and later her right forearm halfway to the elbow.
Diana had been putting her musical career back together after losing her partner. What would she do now that she could never play her bass guitar or piano again? At home, trying to fathom Diana’s loss, I spent an afternoon with my right hand held behind my back. At the hospital, I watched her courage every time she was injected with more drugs, or had blood drawn for constant testing. Needle-procedures now carried a dread weight of fear, but like anyone ill, she had little choice but to trust. Health care depends upon such trust.
“My livelihood came to a screeching halt,” she says now, adding it was “a long haul” getting fitted for prosthesis, doing physical and occupational therapy, and relearning how to dress, cook, and take care of herself and her daughter with only one hand. “I knew the first thing I had to do for my emotional survival was finish the album I’d started.” Ironically, the songs she’d been working on were about grief; they held a deeper meaning.
Traumatized, Diana soon found herself in the middle of a legal war.
An Unlikely Path
Diana is not a person you’d call hot-headed. She’s more apt to cry or laugh than get angry. But when she learned that the Wyeth pharmaceutical company knew about the arterial damage its drug could do because it had happened before, she got mad. Phenergan can be used safely in a drip IV bag. Wyeth’s label did not warn against the drug’s known dangers when a direct or push-IV is used. Eight years after Diana’s loss, Wyeth still refuses to include the warning for physicians.
In our states’ civil courts, tort law allows individuals to sue when hurt, or when something is being ignored and might hurt others. In 2004, a jury of the Vermont Superior Court found Wyeth liable for failing to change their labels, based on what the drug company knew before Diana was treated. The jury ordered Wyeth to pay for Diana’s medical bills, her prosthesis, and physical therapy treatment as well as her business losses and other damages, a total of $6.7 million.
Diana couldn’t anticipate how much interest her case would generate in the debate about tort reform in Washington, D.C. Tort reformers supporting a shift from the current parallel systems of federal regulation and access to civil courts for redress hailed back to those bad old days when a flood of cases bankrupted Dow-Corning (for its leaky and toxic breast implants) and A.H. Robins (for its deadly intrauterine device, the Dalkon Shield). Their argument goes like this: If only those women had kept their mouths shut, those companies would still be in business. (They still are, of course, only under other corporate names.)
With few large corporations in Vermont, tort reform talk didn’t catch much attention here. In a case like Diana’s, abstract legal principles got outweighed by the concreteness of Diana’s lost hand and lost livelihood. A year after the first Vermont verdict in Levine’s favor, the U.S. Congress passed the Class Action Fairness Act of 2005. It turned over to federal courts the jurisdiction of civil cases totaling more than $5 million dollars.
Wyeth appealed to the Vermont Supreme Court, compelling Diana to relive her loss, and necessitating more legal fees. In 2006, Vermont’s Supreme Court supported the previous court’s decision, and Diana hoped finally to get on with her life. Then Wyeth announced they would appeal the case to the U.S. Supreme Court. They claimed the FDA’s release of the drug as safe “pre-empted” her – or anyone’s – complaint.
Pre-Emption: Do Unto Others Before They Can Do Anything
Four years after those two Vermont court decisions, and a year after the U.S. Supreme Court agreed to hear Wyeth’s case, Diana still has not seen a dime of her settlement award. Meanwhile, she’s been taken up as the poster girl for The American Association for Justice, or the trial lawyers lobby. Drawing attention to Wyeth’s use of this legal term, “pre-emption,” which is also being used more broadly by the FDA and other federal agencies, the AAJ says a dangerous precedent is being set.
Pre-emption isn’t a catchy phrase. Mild-sounding, the word is reminiscent of George Orwell’s essay, “Politics and the English Language,” wherein he warns us of one of the common swindles of modern language: the multi-syllabic word with a Latin root, “used to dress up simple statements and give an air of scientific impartiality.” Pre-emption sounds nicer than “gotcha.”
In November, not only will Wyeth argue that the FDA’s original safety determination for Phenergan pre-empts Diana’s case, but our nation’s Justice Department will stand at the side of the FDA – and against Diana – to see to it that Wyeth Corporation isn’t victimized.
Phenergan is not the real stake in this. Setting precedent for pre-emption is. If Wyeth wins, it could mean a great deal more to, say, Baxter Corporation, the manufacturer of the commonly used blood thinner heparin. Actor Dennis Quaid brought heparin’s label to the public’s attention last year after his newborn baby twins nearly died of an overdose.
Like Diana, Quaid testified before a U.S. House Committee hearing in May of this year on the question of pre-emption: “Like many Americans, I have always believed that a big problem in this country has been frivolous lawsuits,” he said. “But now I know that the courts are often the only path that families have [who] are harmed by drug companies’ negligence.”
Vioxx is another drug in recent headlines, with patients in many states claiming heart damage in multiple civil suits. With a ruling in Wyeth’s favor instituting “pre-emption,” any drug manufacturer, whether making Vioxx or an even bigger-selling drug in the future, will no longer have to worry about pesky lawsuits and whiney patients. Wyeth, for instance, previously brought us that wonderful diet drug, Phen-fen, never mind those accompanying heart-failures. Judges have already put three cases on hold, involving GlaxoSmithKline’s Paxil, an anti-depressive drug that allegedly increased suicide attempts, pending the Supreme Court’s ruling on Wyeth v. Levine.
In Whom Do We Trust?
When you’re sick, you put your confidence in those who charge you for taking care of you. You trust, and most often things go well. Our states’ civil tort system has given Americans some recourse on those rare occasions when they end up paying for a disaster; Diana and other Davids have faced off against Goliaths with slingshots and stones. The resources of a Diana Winn Levine and the Wyeth Corporation remain starkly mismatched, but the tort-law safety-net makes it possible to take that leap, or that pill, or that shot, and entrust yourself to your doctor’s prescriptions. Without the intangible commodity of trust, Americans can hardly claim to have a health care system.
We cannot divorce our malpractice suits and drug cases from the overall health of our health care system. In Britain, for instance, the loser of any contested case must always pay the legal costs of the winner, and few such cases are brought forward. On the other hand, Britain’s social insurance system, along with that of other European and Asian nations, provide victims with much more comprehensive medical and financial benefits than is true here in the U.S. Other countries may fight less often over who pays the bills when things go wrong, but they’ve placed a priority on care and have balanced out powers in ways worth studying.
We will all suffer if health care and the business of its suppliers is no longer affordable. But the last time I looked, American drug companies appeared to be prospering more than American patients – including those with health insurance. How many other damaged patients lacked Diana’s resources and will to run an eight-year legal marathon?
It’s why Diana has felt responsible to carry on this legal fight. “Wyeth may have taken this away,” she told me recently, holding up her arm’s stump, “but they can’t take this away,” and she patted her throat. “My voice! I can still use my voice and I will.”
Who’s Embedded with Whom?
A Republican all his life, Diana’s father had been certain “states’ rights” and state tort law would trump the FDA pre-emption argument, particularly since safety knowledge evolves with use. Why would the U.S. Supreme Court stoop to hear such a case? A Wall Street Journal story late in July 2008 asked similar questions of the FDA’s commissioner, who claimed “the agency is independent of industry influence.”
FDA resources are limited; the people’s legal access is limited. Who then will be left in charge of our global health system henhouse? According to The New England Journal of Medicine in a July editorial on pre-emption: “In stripping patients of their right to seek redress through due process of law, pre-emption of common-law tort actions is not only unjust but will also result in the reduced safety of drugs and medical devices for the American people. Pre-emption will undermine the confidence that doctors and patients have in the safety of drugs and devices.”
Vermont’s senior Senator Patrick Leahy (D), chair of the Senate’s Judiciary Committee, filed an amicus brief on Diana’s behalf stating that Congressional preservation of state-law damages claims was “deliberate,” both in FDA legislation and in settled practice, providing two layers of protection. The brief, filed with the support of Vermont’s Representative Peter Welch, Senator Bernie Sanders, and 15 other Congressional members, calls this FDA move to pre-empt legal access to state law “radical.” The brief argues:
“An agency cannot supplant Congress ... The FDA’s attempt to expand the pre-emptive scope of the regulatory scheme is nothing short of an illegitimate power grab. The FDA’s position poses a threat not merely to injured consumers and the States, but also to the separation of powers and the constitutionally assigned role of Congress in our system of government.” Forty-seven Attorneys General, including Vermont’s, likewise understand these Constitutional issues, having also filed a supporting brief for Diana.
Meanwhile, The Federal Register (a daily compilation of Federal regulations and other Federal agency documents of public interest, prepared by the National Archives) records an imperial trend since 2002 in federal agency rules publication. Seen at the FDA, but also in standards of the Consumer Product Safety Commission, the National Highway Traffic Safety Administration, the Federal Railroad Administration, and the Department of Homeland Security (DHS), federal agencies have begun to include regulation language that seeks to pre-empt state tort law. Like Bush’s “signing statements” on Congressional legislation, these agency “preambles” declare pre-emption by fiat, rather than taking the time to respond to public comment or debate with those most affected.
Homeland Security’s rule is particularly noteworthy for its proposal of chemical-facility anti-terrorism regulations. DHS misplaced its priorities, framing the security of chemical plants in terms of limiting its neighbors’ liability claims. When our government stands at the side of a powerful corporation in a fight against a one-armed woman, I have to wonder what’s gone wrong. But when it wants to protect chemical corporations from being sued by their neighbors in future, I worry that things are much worse than we know.
Too cozy a relationship between government and multinational business is no better for small businesses, like the hardware stores down the street from the chemical plant, than it is for music-loving moms like Diana. I’m rather taken by the ideas of The Committee for Economic Development (www.ced.org), which proposes corporations come forward quickly to redress people’s honest grievances in another kind of pre-emption, called “Early Offers.” Taking initiative might allow corporations more humane interactions than the present dynamic that admits to no mistakes, but where are those brave-hearted businesses that will take the first step?
Ultimately, a less embattled approach might be cheaper for business and far less hurtful for victims like Diana. New Zealand and Switzerland have abolished their tort law system, adopting in its place comprehensive “accident” programs to compensate all injured persons. (Both countries also have national health care programs.) But if legal fights are the best we Americans can manage in our present political climate, my hope is Diana’s upcoming pre-emption case will convince Americans that trust is much more than just a nice feeling. Trust is essential for any just democracy, any healthy economy, and surely for any health care system that dares call itself that.
Rickey Gard Diamond of Montpelier is a contributing editor, a patient who trusts her doctors, and one of Diana’s many groupies.
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