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Constitutional Opinions
True Federalism or False?
Preemption and the states, in light of the recent Supreme Court ruling in Wyeth v. Levine.
Could the problem with Federalism be the States? As Milton Friedman observed, “The problem with capitalism is capitalists. The problem with socialism is socialism.” The problem with Federalism cannot be Federalism because the benefits of a federally structured government are easy to see; citizens can choose between high-tax, high-service, nanny States like Maryland, and low-tax, lower service options. One recent example of citizens’ ability to choose is Rush Limbaugh’s response to New York’s proposed increase in the taxation of high incomes, which was to think about moving out of New York.
So, the problem must be the States. For all of their ability to operate as laboratories of democracy, they are frequently prone to disappoint. One recent example of that disposition is their reluctance to limit their protection of local interests even where such limitation might serve the larger common good. That reluctance was expressed in a friend-of-the-court brief that 47 States joined in Wyeth v. Levine arguing that their juries, not the Food and Drug Administration, should be the final judges of the adequacy of a drug manufacturer’s warning of the potential dangers of its product.
Levine’s forearm was amputated after a physician’s assistant injected her with Phenergan, an effective anti-nausea drug. Levine received the injection after she returned to the hospital for the second time in a day complaining of a severe migraine headache. Unfortunately, as the result of the injection, the drug entered an artery, and gangrene resulted. Wyeth warned against the danger of gangrene if Phenergan were injected into or made its way into an artery, but did not specifically say that the drug should not be injected. Levine settled with the doctor and physician’s assistant, then sued Wyeth, and a Vermont jury awarded damages of $7.4 million, which were reduced to reflect the amount of the settlement.
In March 2009, the Supreme Court rejected Wyeth’s contention that federal law barred Levine’s claim. The FDA had approved Wyeth’s warning, but the Court said that the FDA’s action was not the final word. Federal law could have, but does not, expressly preempt state court lawsuits. The Court rejected the argument that it was impossible for Wyeth to comply with both federal and state law, noting that federal regulations permit Wyeth to “add or strengthen” its warning without getting prior FDA approval. The Court also gave short shrift to the preamble of a 2006 FDA regulation governing the content and format of prescription drug labels. In that preamble, the FDA declared that its action established “both a ‘floor’ and a ‘ceiling’” and operated to preempt certain state-law claims, like Levine’s failure-to-warn claim. The Court concluded that, for several reasons, that preamble was entitled to no weight.
In a concurring opinion, Justice Thomas objected to the whole idea of implied preemption, suggesting that, if Congress wants to preempt State lawsuits, it should say so expressly. That notion sounds appealing. But, as Michael Greve points out, the States have an incentive to circumvent Federal law, and there is no way that Congress can foresee the “myriad ways” in which they can do so. For example, in another case from last term, Altria Group v. Good, the Court said that, while state law claims “based on smoking and health … with respect to the advertising or promotion of any cigarettes the packages of which are labeled in conformity” with federal law and regulations are preempted, claims based on more general state law duties, like a duty not to deceive the buyers of products, are not. The result is to turn the lawyers loose to argue that the labeling of “light” and “low tar” cigarettes is deceptive to state court juries.
Wyethinvolves a warning, and warnings are generally easier to modify than products. Even so, if, as the Vermont Supreme Court put it, “federal labeling requirements create a floor, not a ceiling, for state regulation,” how does Wyeth know where the ceiling is? In his dissent, Justice Alito notes that, in the trial, Levine’s attorney told the jury that Wyeth’s warning should have said, “Do not use this drug intravenously,” and her expert witness said, “I think the drug should be labeled, ‘Not for IV use.”” Whatever ceiling Vermont established can be trumped by a jury in another State which concludes that an even more specific warning is needed. Thus, Wyeth’s warning and the use of Phenergan are at the mercy of juries and courts in the 50 States.
The effect will be to discourage the use of Phenergan, an effective anti-nausea drug, even though, when properly injected, Phenergan gets to work faster than it does when given in other ways. Remember that Levine needed relief quickly More generally, allowing state tort laws to second-guess FDA actions can discourage investment in the development of new drugs and, by forcing the removal of existing drugs from the market or some uses, make drugs less available. Those drugs that are available will be more expensive. Finally, drug warnings will become so detailed and lengthy that they warn of everything and nothing, discouraging some proper uses.
Instead of simply turning the issue over to juries, the States should consider a legislative solution. Michigan did precisely that in 1996 when it enacted an FDA Shield Law which provides that, with certain exceptions, drugs approved by the FDA that are approved by and in compliance with FDA requirements cannot be found to be “defective or unreasonably dangerous” in a state-law tort action. The Michigan law bars recovery of both compensatory and punitive damages. Other States have enacted other laws that limit liability for punitive damages for FDA-approved drugs, create a rebuttable presumption that an FDA-approved drug warning is adequate, or expressly call for the FDA approval to be considered in determining whether a manufacturer has acted reasonably. Significantly, the protection that these laws provide is conditioned on the manufacturer’s good faith.
If the States want to insist on an end to implied preemption, they should limit the effects of their tort systems. Rather than being part of the problem, they should be part of the solution.
About the Author
Jack Park is an attorney with the Atlanta law firm Strickland Brockington Lewis LLP.
Letter to the Editor View all comments (45) | Leave a comment
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Ryan | 7.31.09 @ 9:53AM
I can say with full confidence that the legal departments of research pharma companies know what the labeling rules are in all 50 states. While it would provide a shelter for research pharma, I'm not sure more federal government regulation is the answer. What I would like to ask is why the labeling is deficient? If there are problems with this drug entering arteries, the medical professional involved should take steps to make sure that doesn't happen or the patient should be given adequate information to assess the risks and make an informed decision about their own health-care. This seems to be a case of Failure to Read as all drugs have some side effects. Not every warning can be in giant bold red print or the labeling would be a sheet of bold red print and just as indistinguishable as if it were in regular type. The sad part is, blaming the labeling for not being glaring enough for a particular case and patient and the awards that follow greatly increase the already dizzyng cost of research pharma. These costs do factor into whether to take a drug to market and keep a lot of potentially useful drugs from being available to the public, especially for niche markets. If the risks are clearly disclosed to the decision maker then the burden should be on doctors and patients to read the information and use the drug correctly.
owyheewine| 7.31.09 @ 10:33AM
Another step in government for and by the lawyers.
Dr. Henry Greenspan| 7.31.09 @ 5:47PM
Jack Park's letter is misinforming on numerous counts:
1. There is no evidence whatsoever that civil liability has discouraged new drug development, made drugs less available, raised the cost of drugs, or led to labeling that is either more lengthy or complex. As often as we hear these assertions, they have no basis in fact.
2. As Michigan's law has been interpreted, there are in fact _no_ exceptions to companies being shielded, including fraud on the FDA. The exceptions that _appear_ to be part of the statute have not been met by any case in the past 25 years. The so-called "fraud exception" is itself fraudulent.
3. Regarding the Levine case, even the three Justices who decided with Wyeth rejected the kind of full preemption suggested in Jack Park's letter. Justice Alito, who wrote the dissent, concluded: "To be sure, state tort suits can peacefully coexist with FDA's labeling regime, and they have done so for decades. But this case is far from peaceful coexistence."
The operative phrase is "this case"--the very specific regulatory history of Phenergan. The fact that the drug and its label were FDA-approved is _ not_, in itself, enough to preempt lawsuits. That was the view of all nine Justices in the Levine case. They rejected the kinds of arguments that Jack Park makes unanimously.
Dr. Henry Greenspan| 7.31.09 @ 5:54PM
BTW, since Park begins by invoking Milton Friedman, he should recall that a critical part of the market forces that Friedman believed would regulate without federal intervention was precisely the possibility of being sued. The preemption doctrine is about as anti-Friedman as one can get.
History Jews don't want public| 8.1.09 @ 2:01PM
Jeschichte XVIII, 32)
The Jews revolted in Russia in 1917 and established bolshevism under the leadership of Trotsky, Sinojeff and other Jews, a total of 35 million Christians were shot, slayed, tortured, and starved to death. In Hungary, under the leadership of the Bolshevik Jew Bela Kuhn, a horrible massacre was prepared in which tens of thousands of Christians were murdered.
"'The Jewish Establishment": 'In the early 1930s, Walter Duranty of the New York Times was in Moscow, covering Joe Stalin the way Joe Stalin wanted to be covered. To maintain favor and access, he expressly denied that there was famine in Ukraine even while millions of Ukrainian Christians were being starved into submission. For his work Duranty won the Pulitzer Prize for journalism. To this day, the Times remains the most magisterial and respectable of American newspapers. How imagine that a major newspaper had had a correspondent in Berlin during roughly the same period who hobnobbed with Hitler, portrayed him in a flattering light, and denied that Jews were being mistreated, thereby not only concealing, but materially assisting the regime's persecution. Would that paper's respectability have been unimpaired several decades later? There you have an epitome of what is lamely called 'media bias.' The Western supporters of Stalin haven't just been excused; they have received the halo of victim hood for the campaign, in what liberals call 'the McCarthy era,' to get them out of the government, the education system, and respectable society itself. Not only persecution of Jews but any critical mention of Jewish power in the media and politics is roundly condemned as 'anti-Semitism.' But there isn't even a term of opprobrium for participation in the mass murders of Christians. Liberals still don't censure the Communist attempt to extirpate Christianity from Soviet Russia and its empire, and for good reason, liberals themselves, particularly Jewish liberals, are still trying to uproot Christianity from America. It's permissible to discuss the power of every other group, from the Black Muslims to the Christian Right, but the much greater power of the Jewish establishment is off-limits. That, in fact, is the chief measure of its power: its ability to impose its own taboos while tearing down the taboos of others, you might almost say its prerogative of offending. You can read articles in Jewish-controlled publications from the Times to Commentary blaming Christianity for the Holocaust or accusing Pope Pius XII of indifference to it, but don't look for articles in any major publication that wants to stay in business examining the Jewish role in Communism and liberalism, however temperately." (The Jewish Establishment, Joseph Sobran, September 1995 issue)
In Jewish-Bolshevik Soviet Russia mass murders are even now (1997) are being carried out. The executioners are mostly Jewish men and women. In inventing new methods of torture the Jews are past masters. To let Christians die under torture give them the greatest pleasure. English reporters write that the Chinese executioners frequently would not carry out their tortures and executions; they shouldered and could not continue. Therefore, Jews and Jewesses took their place.
"The Jews were now free to indulge in their most fervent fantasies of mass murder of helpless victims. Christians were dragged from their beds, tortured and killed. Some were actually sliced to pieces, bit by bit, while others were branded with hot irons, their eyes poked out to induce unbearable pain. Others were placed in boxes with only their heads, hands and legs sticking out. Then hungry rats were placed in the boxes to gnaw upon their bodies. Some were nailed to the ceiling by their fingers or by their feet, and left hanging until they died of exhaustion. Others were chained to the floor and left hanging until they died of exhaustion.
"Others were chained to the floor and hot lead poured into their mouths. Many were tied to horses and dragged through the streets of the city, while Jewish mobs attacked them with rocks and kicked them to death. Christian mothers were taken to the public square and their babies snatched from their arms. A red Jewish terrorist would take the baby, hold it by the feet, head downward and demand that the Christian mother deny Christ. If she would not, he would toss the baby into the air, and another member of the mob would rush forward and catch it on the tip of his bayonet.
"Pregnant Christian women were chained to trees and their babies cut out of their bodies. There were many places of public execution in Russia during the days of the revolution, one of which was described by the American Rohrbach Commission: 'The whole cement floor of the execution hall of the Jewish Cheka of Kiev was flooded with blood; it formed a level of several inches. It was a horrible mixture of blood, brains and pieces of skull. All the walls were bespattered with blood. Pieces of brains and of scalps were sticking to them. A gutter of 25 centimeters wide by 25 centimeters deep and about 10 meters long was along its length full to the top with blood. Some bodies were disemboweled, others had limbs chopped off, some were literally hacked to pieces. Some had their eyes put out, the head, face and neck and trunk were covered with deep wounds. Further on, we found a corpse with a wedge driven into its chest. Some had no tongues. In a corner we discovered a quantity of dismembered arms and legs belonging to no bodies that we could locate.'" (Defender Magazine, October 1933)
The history of the Jews is written in the blood of Christians.
jewish Hell on earth to come| 8.1.09 @ 2:35PM
Jewish Human Sacrifice
The ancient Khazar Jews along with other of that Near East era followed a common custom of human sacrifice. The practice was to burn a young person upon an altar called a Tophet. The Old Testament of the Bible mentions this practice and condemns it. Around the Tophet altar, drums would be beaten loudly to drown out the cries of the children being burned alive. In the days of Ancient Israel the Priests of Baal would blow trumpets to drown out their screams. The Carthaginians also were worshipers of Baal and sacrificed children on a massive scale. When faced with defeat in Syracuse in 310 B.C., they cast the sons of 500 nobles into a fiery pit, or Tophet, from a scaffold shaped in the likeness of the god Baal.
In Excavations at Gezer, the archeologist R.A.S. Macalister notes that the bodies of sacrificed young children are found in every strata of Jewish remains from the earliest times.
Photographs of the children's bodies are published in Macalister's book, although the book itself, like most works which attest to the criminal nature of the Jews, is now almost unobtainable. It is classified as a rare book, and most rare book dealers are Jews.
In the Bible, Isaiah 57:3-5 the prophet, talking of the Jews of his day says:
"But draw near hither, ye sons of the sorceress, the seed of the adulterer and the whore. Against whom do ye sport yourselves? against whom make ye a wide mouth, and draw out the tongue? are ye not children of transgression, a seed of falsehood, Enflaming yourselves with idols under every green tree, slaying the children in the valleys under the clefts of the rocks?"
By the phrase, "ye sons of the sorceress," Isaiah calls attention to the fact that Jewish ritual murder is a black magic rite. It is customary for the rabbi, as he drinks blood, to invoke the presence of Satan, who will then presumably carry out the wishes of the Jews. The drinkers of blood also swear eternal obedience to Satan during the blood rite.
Isaiah also calls attention to the fact that here the children are slain "under the cleft of the rocks." This refers to the Jewish ban against burying the slain gentile child, and to hiding the body in the rocks in the hopes that the gentiles will not discover their crime.
The Jewish Encyclopedia, Vol. VIII, page 653, published in 1904, says,
S.L. Toddard| 8.1.09 @ 6:19PM
To the person who keeps posting anti-semitic conspiracy theories and screeds: please stop. They are tiresome and lunatic, and to promote them is to immediately and irrevocably discredit oneself. You would be just as well off posting "Never - under any circumstances - listen to anything I have to say. Don't even notice me. I am insane."
Yikes| 8.1.09 @ 8:12PM
How typical is the psychotic stuff on American Spectator? Genuine question.
unseen| 8.1.09 @ 11:39PM
This article misses the point of federalism. What happens if the drug firms buy off the FDA? What happens if the FDA approves a drug for political reasons. What happens if the FDA is wrong should the entire nation be at the whim of a handful of individuals?
With 50 different departments testing drugs, 50 different governments voting on drug formulas then citizens enjoy more protection and safety.
Sure it costs more but the costs are worth the liberty and freedom and safety. What Jack thinks is a bug is really a feature of the system. Freedom is messy, its expensive yet it is still the best system devised.
If a drug company does not like the state's law there is no one as far as I know saying they have to do business within that state. If the laws get to complicated or anti-business those businesses will stop doing sales in those states and the people will rethink their laws and decide if it is worth the extra layer of protection.
But it will be the people of that state that decides that and not a handful of people in washington DC
Jack is saying that control from a central location is cheaper and thus better. Just because something is cheaper does not make it better
Dr. Henry Greenspan| 8.2.09 @ 4:25PM
The reality is that there are _not_ "50 different department testing drugs." There is no agency in any of the states which competes with FDA's mission--approving drugs, monitoring drug safety, overseeing maketing materials, withdrawing drugs, creating labels, changing labels, etc.. So the entire argument about competiting regulatory agencies is based on a false premise.
In the words of the FDA itself, state product liability and FDA regulation provide two generally complementary (but not identical) systems of consumer protection. That view is close to the general view expressed even by the minority in the Levine case--Scalia, Alito, and Roberts. The whole issue of FDA preemption comes down to whether it makes any sense to take one of those systems of consumer protection and throw it away.
Smidley| 8.2.09 @ 7:59PM
In fact the FDA has failed to protect citizens against harmful drugs.
Take the case of amiodarone. The manufacturers said this drug was not to be used for atrial fibrillation until safer agents were tried.
But amiodarone was introduced from abroad and not tested thoroughly for the dangers it posed. Pressure from doctors who had already been using it prevailed and they were allowed to continue prescribing it. Amiodarone has serious potential side effects: fibrosis in the lungs, liver disease, blindness, thyroid disease, and others. My thyroid was ruined by amiodarone before a doctor prescribed sotalol-- a much more benign treatment which has kept my heart in normal rhythm for six years.
Polemicscat| 8.2.09 @ 8:13PM
Jack should read Mark Steyn's and Thomas Dilorenzo's writing on Federalism and the reasons for rejecting statist intrusion into our lives.
States have been denied their constitutional powers for more than a hundred years. Those arguing for a strong central government will bring us expensive and ineffective healthcare, but worse, they will deny us the individual freedom that allows us to be in charge of our lives.
I recommend Steyn's America Alone and DiLorenzo's Hamilton's Curse.
name | 8.3.09 @ 7:45AM
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