The Supreme Court, the Election and the Sad Story of Diana Levine

It is fitting that Monday, the day before the presidential election, the Supreme Court will hear argument in Wyeth v. Levine, a case that illustrates both the importance of Supreme Court rulings to ordinary Americans and the aggressive efforts of the outgoing Administration to use the Court and its own regulatory authority to protect corporations from being held accountable for the harms caused by their products.

Diane Levine is a Vermont musician who went to the hospital for treatment of a migraine headache and left with her arm amputated and career in ruins. Ms. Levine sued the pharmaceutical company, Wyeth, which manufactured the anti-nausea drug that caused gangrene to develop after being injected into her arm. A Vermont trial court awarded Levine $6.7 million for her injuries and Wyeth has asked the Supreme Court to overrule this verdict, asserting that a federal drug labeling law "preempts" Levine's state law personal injury action. Breaking with the position taken by past Democratic and Republican administrations, the Bush Administration filed a brief supporting Wyeth.

This is a critical case. For decades, drug manufacturers have known that they will be held accountable in state court when their products harm patients instead of healing them. This accountability protects Americans against unsafe products and Congress never intended to strip drug consumers of this important form of protection. In this brief filed before the Supreme Court, we have asked the Supreme Court to jettison a form of preemption known as "implied obstacle" preemption, which promotes a freewheeling analysis by judges into the "purposes," rather than the textual provisions, of federal statutes.

Hopefully the Court will use the Wyeth case to get its own preemption act together. But the case is just as important as an illustration of the power of the next President and the incoming Congress to undo the Bush Administration's aggressive use of preemption as a tool for corporate deregulation.
In the 70 years since the Federal Food, Drug & Cosmetic Act (FDCA) was enacted, state-law remedies for a drug company's failure to adequately warn consumers of the dangers of their products have existed in harmony with the statute, which governs drug-labeling and is the relevant federal law in Wyeth. Congress has amended the FDCA several times, but has never expressly preempted state law claims against drug manufacturers--even though it chose to include an express preemption clause regarding medical devices (as discussed in last term's case, Riegel v. Medtronic).

The Bush Administration, however, favored insulating drug manufacturers from liability under state law, and so, in an introductory statement or "preamble" to its most recent prescription drug labeling rule (effective June 2006), the FDA made clear its belief that "FDA approval of labeling under the act . . . preempts conflicting or contrary State law." This revision of long-standing FDA policy on preemption in the drug labeling context was made over the objection of career agency officials, including the highest official in the drug review process, who warned that "much of the argument for why we are proposing to invoke preemption seems to be based on a false assumption that the FDA approved labeling is fully accurate and up-to-date in a real time basis. We know that such an assumption is false." According to a report released today by the House Committee on Oversight and Government Reform, "the White House played a significant role in the preemption provisions and pressured the agency to reject the concerns of career experts."

This attempt to achieve "preemption by preamble" not only places Americans' health and safety at risk, but it also circumvents Congress and the Constitution--the Supremacy Clause, after all, states that the laws of the United States are supreme, not federal agency preambles. This is akin to the President Bush's use of signing statements as a way of trying to limit the meaning of the bills (such as the Congressional ban on torture) it is signing into law, and it is indicative of the abuse of executive power that has come to characterize this administration.

The good news is that the Bush Administration's use of "preemption by preamble" may be undone even without the help of the Supreme Court in Wyeth. A top priority of the new administration should be to review the preemption decisions by the Bush Administration and reverse them unless Congress has declared clearly in federal law its intent to displace state law. And Congress can overturn any holding by the Court in Wyeth, as well as a long-list of other bad preemption decisions by the courts in recent years, by amending the laws in question and clarifying that the states should not be inappropriately displaced by federal law.

The Court needs to do its job and rule for Diana Levine in Wyeth. But the results of the election held the day after the Wyeth argument should have an equally great impact on the ability of states to serve as laboratories of democracy and the availability of remedies for individuals who are harmed by corporate wrongdoing.

(This post was written by Doug Kendall and Elizabeth Wydra, Constiutional Accountability Center's Chief Counsel. For more analysis of how the Constitution favors progressives, visit Constitutional Accountability Center's blog, Text and History.)

Comments

[MossyOak]

One of the biggest Catch 22's in the pharm industry is that they are constrained from testing on humans. Instead, they test a drug on animals to make sure it doesn't outright kill them on a regular basis, then throw it out on the market with a big ad campaign: "Let the testing begin!"

Only instead of getting paid to be guinea pigs, consumers pay to be guinea pigs. After enough time passes, the results of the testing are measured by the amount paid out in lawsuits, which determines whether or not a drug is "safe," that is, safe for the manufacturer to continue making, not the people taking it.

The only solution to this problem is for the consumer to say no to drugs and seek alternative remedies, of which there are many. Until people take total responsibility for their own health, the government will continue to aide and abet the pharm and healthcare industries. After all, when you're talking millions of consumers, it's not a big deal to lose a few....

[rwt1138]

Well, since one of the litigants is a corporation and one an individual, we already know four votes on the court: Scalia, Alito, Thomas and Roberts all believe a variation of the Dred Scot ruling, namely that "an individual has no rights that a corporation is bound to respect."

[Jaynesday]

Preemption makes sense to the drug company finance departments but is nonsense to everyone else. The following people/groups are opposed to preemption (among others). Google them
1. The New England Journal of Medicine – Why Doctors Should Worry about Preemption
2. The Journal of American Medical Association – Prescription Drugs, Products Liability and Preemption of Tort Litigation
3. The FDA itself – see Report of the Subcommittee on Science and Technology, FDA Docket November 2007
4. Amicus brief by 47 States Attorneys General in the Levine case
5. Past FDA Commissioner – Dr. David Kessler – A Critical Examination of the FDA’s Efforts to Preempt Failure-To-Warn Claims
6. AARP – Amicus brief in the Levine case
7. California Medical Association – Amicus brief in the Levine case
8. National Conference of State Legislatures – Amicus brief in the Levine case
9. Members of Congress – Amicus brief in the Levine case
10. Senior Citizens Legue – Amicus brief in the Levine case
11. Dr David Graham – Vioxx Whistleblower inside the FDA
12. New York Times – The Dangers of Preemption
13. Boston Globe – No Haven for Dangerous Drugs

Also preemption violates Amendment 7 (“..the right of a trial by jury shall be preserved”) and Amendment 14 of the Constitution. (“…nor shall any State deprive any person of life, liberty, or property without due process of law; nor deny to any person within its jurisdiction the equal protection of the laws.”)

[GrainOSand]

I realized before typing this comment that the subject of law is a serious and complex subject. Forgive me any error of oversimplification in this retort.

If I lose my arm due to corporate malfeasance that can be proved -- the case is over. If I am the corporation, I cannot find a six million dollar award by a jury or judge objectionable. If I am the plaintiff, six million, seven hundred thousand dollars is a pittance compared to loss of limb and even more so when that limb was utilized in my profession and my life’s passion.

Contracts and tort reform are all symptoms of a disease. The collective heart of people kind contains an element that is towards evil, greed, deception, victimization, and criminality; therefore, societies must erect complex systems to adjudicate legal transgressions, or breaks with laws erected to dissuade from such manifestations of black hearted activity.

In the ideal world, there would be no need for contract law or consumer law for each party to the agreement would give their word and live up to their word in execution of the agreed upon action and further assume accountabi­lity/respo­nsibility in morality and quality of execution, and quality and satisfaction of outcome. The corporation would be driven, not by shielding of profits in all questionable outcomes, but by desire to do the right thing. The same would hold for the plaintiff.

Now back to the real world of cancerous greed and corruption that consumes courts.

[dukeitout]

Let's hear the other side of the argument. Cars cause death if not driven correctly but the manufacturers aren't normally held liable for an absence of labeling. Let's hear both sides. Part of the problem with exorbitant medical costs is due to humongous insurance premiums. Insurance premiums are significantly influenced by court decisions.

[BigGuy]

FALSE.

The biggest expense in the health care system is the administration of health insurance, especially the underwriting of insureds -- not medical malpractice insurance. Health insurance firms make more if they pay out less, so their overall administrative costs are 15% versus less than 2% for our Social Security Administration. SS does not weed out those who are most likely to need SS and everybody who works pays into SS as a universal system; that's why it costs much less to administer. To make money, insurers have to spend more to avoid insuring sick and accident prone people and to avoid paying claims.

[dukeitout]

Read the comment again. It says medical malpractice insurance costs are a "part" of the problem. It is probably true that the biggest expense is the administration factor as you point out. Neither should be abused.

[proreality]

It is called a corporatist agenda. "Fascism would be better served if it were called corporatism" Mussolini It is about citizens being subjugated on behalf of corporations by the Government. It is a twisted disgraceful and poisoness ideal, as with everything else that has come out of this administration and the right wing. Exxon being let off the hook, Enron being let of the hook. Corporations being constantly unaccountable, finance company's, drug companies, health care company's etc. etc. etc.

[NationalTreasure]

the ultra conservative right wing court will not rule against a pharmaceutical company

[polyfoamworkshop]

Hopefully the Supreme Court will be fair and impartial. I am sometimes perplex by their rulings. Thank you for a thought provoking read.

[RightWingMarine]

Our society is too litigious as it is. Every drug isn't safe for every person. Sometimes no one can make a mistake and someone still gets hurt. It's tragic what happened to Ms. Levine but I don't see how the drug manufacturer is at fault. If she wins all this will do is make fewer drugs available and the ones that we do have more expensive. There are incredible drugs out there now that are ready for use in humans but we don't have because the risk of lawsuit is too great. The fact that millions would be spared pain or even live longer is thrown to the wayside because some would seek to get rich quick.

[bakingmom]

I am very left wing but I completely agree with you, RightWingMarine. Ms. Levine's story is tragic and absolutely heart-breaking but, unfortunately, there are always incidents of "rare" or "unexpected" tragic effects with treatments (through absolutely no real fault of the patient or the provider or the drug manufacturer, for that matter) that do not adversely affect the majority of people receiving those treatments.

If we had reliable crystal balls, everyone would be spared pain and suffering. Without a crystal ball, we do what we can to help those who need help. Our litigious society runs the risk of being "entitled" to mistake-free, risk-free treatment which really dampens the medical/ph­armaceutic­al industry's involvement in research and extension of treatment.

[Gidster]

Wyeth already lost this case in state court, what they are attempting is to have their punitive damages waived.

This will set a dangerous precedent that put pharmaceutical companies out of reach of the consumers hurt by their products.

This is different than a rash, she lost her arm and her ability to engage in her profession.

[MossyOak]

You would hold a totally different opinion it it was your arm.

[convictbush]

I do not agree when it comes to the drug companies. Reagan began the deregulation of the FDA and in so doing not only opened the flood gates for drugs that are not sufficiently tested but also all but eliminated the inspection programs that ensured honesty in what little testing is done. Now comes along Bush and completes the perfect crime by declaring that the drug companies can not be held liable. Lack of testing, no inspections, no liability... that is our current drug development environment!

I don't care how good intentioned the people in a corporation are, when there are no consequences for bad decisions, there is no incentive to spend money on the right decisions. Corporate rule demands least cost and max profit. Where no regulations exists to justify cost, and no liability exists either, the cost of proper testing will never be justified.

[RoloTomassi]

Spit out the nonsensical Corporatist Kool-Aid you've drinking.

[Kindheart]

I hope the Supreme Court does the right thing for Diana Levine. George Bush can't get out of office too soon for me. I just wish he and his posse would get out of town now.