Wyeth Goes On A Preemption Offensive
12 CommentsBy Ed Silverman // October 20th, 2008 // 12:00 pm
As the November 3 hearing before the US Supreme Court nears, the drugmaker is trying to take its case directly to the public. For months, Wyeth has relied on various court briefs to stake it position, but has said very little publicly, other than a letter to the editor in The New York Times last week. Now, though, a press release has emerged in which the rationale for preemption is spelled out.
What is preemption? The legal notion that FDA approval of a drug supercedes state law claims challenging safety, efficacy, or labeling. Drugmakers and the FDA argue preemption exists by maintaining the agency’s actions are the final word on safety and effectiveness. The court’s decision, therefore, is being closely watched because its ruling will determine whether patients can sue a drugmaker through state law when a product has already been approved by the FDA.
In its release, Wyeth argues that preemption protects everyone; the Constitutional principle of preemption is not new; patients and physicians need to be able to rely on a single federal standard and guidelines for the risks, benefits, and use of medicines - the FDA-approved labeling, and upholding preemption will still leave America’s courthouse doors open to injured patients.
“The public health is better served by having a single expert regulatory body making decisions about risks, benefits, and warnings - rather than an ad hoc system that could produce hundreds of conflicting results that would be impossible for manufacturers, physicians, and patients to reconcile or interpret. Such a system would undermine the careful balance struck by the FDA when making approval decisions,” the drugmaker maintains. “If Wyeth prevails here, it will only reinforce the principle that doctors are entitled to rely on FDA-approved professional labeling.”
What’s the issue? Vermont musician Diana Levine was given a Wyeth nausea med called Phenergan during a visit a hospital emergency room. However, the drug was administered improperly, causing her to lose her right arm below the elbow. She successfully argued that, even though labeling complied with FDA requirements, the adequacy of the warning still wasn’t established for a particular method of administering the drug.
And she contended Wyeth wasn’t prevented from adding or strengthening the warning on the label, even though the FDA rejected a proposed change. Levine was awarded more than $6 million and, despite appeals, the Vermont Supreme Court sided with her. But Wyeth appealed again (Read our interview with Levine here and look here to learn why one legal expert thinks this is the wrong case to decide preemption).
Justice in MI
Wyeth may not have been deliberately misleading in their labeling of Phenergan, but they are certainly misleading in their release about the Levine case. I am very glad they are going public, however. Their arguments dissolve like the mist.
For starters:
- How and whether FDA reviewed IV push, and whether “careful consideration” was given to the phenergan label, is a matter of debate. FDA itself has yet to document a review process anything like what Wyeth suggests. See Catherine Sharkey on this.
- As we all know from CBE discussions, Wyeth certainly _could_ have unilaterally changed the warnings had they been inclined to do so. The so-called “violation of federal law” is all smoke. If FDA disagreed with any such change, the label would have been changed back. End of story.
- Preemption of the sort being sought currently _is_ entirely new for FDA. Appeals to the Supremacy Clause are more distraction from that reality, which FDA itself acknowledges.
- The ‘chaos theory’ of multiple standards has always been airy fairy. As has been noted, for example, when Medicaid in Washington and Oregon opted in 2002 not to include Vioxx because of safety/effecacy, no one in Idaho got confused. We have lived very well for yours with civil liability and FDA regulation as complementary systems, just as we have complementary and parallel state and federal requirements in many areas. Unless the preemptors are ready to abolish the states entirely, there is no substance to this argument.
- The final paragraph of Wyeth’s release shows lawyerly shenanigans at their most obvious. It is one non sequitur after the other, all deliberately aimed to suggest what Wyeth knows is not true. Core issue - the vast number of cases in which companies committed everything from negligence to felony fraud could be preempted as a result of Levine. Wyeth tries to side-step this by suggested there are only cases like Levine and those that involve “manufacturing defects.” The very way this is phrased reveals that Wyeth, like preemptors in general, want preemption to be upheld as broadly as possible - including all failure-to-warn cases even when negligence/fraud are involved.
Doug Bremner MD
These are just a FEW of the reasons I think this argument is ludicrous.
How can you say that the FDA’s viewpoints are carefully balanced, when they are guided by advisory panels of physician “key opinion leaders” that are usually on their payrolls as consultants, speakers, and/or advisory board members? And the fact that this advice is skewed can be shown by numerous examples, e.g. the fact that “expert guidelines” recommend the use of statins for the prevention of heart disease in women, when the evidence in the literature clearly shows that there is no benefit, only the risk of harm in the way of side effects?
Preemption would effectively yank the protection that Americans get from the judicial branch of government and leave the executive and legislative branches in charge of protecting them. And what do they know about drug safety? Since the FDA’s leadership is politically appointed, this would put the responsibility for guarding Americans in the hands of a small group of politicians who frequently benefit from donations from pharmaceutical companies. Witness how Dan Troy went from representing pharma to a job as chief counsel at the FDA, where he filed friends of the court briefs on behalf of FDA on the side of pharmaceutical companies whose medications had caused serious injury or death, on the rationale that since the FDA had approved the medications that they had a stake in the outcome. After this little jaunt he then tripped back to a cushy job in pharma.
Or here is another example. George Bush was so concerned about protecting us from potential dangers with prescription medications, that he appointed a veterinarian, Lester Crawford, to run our nation’s drug regulatory body, the FDA. I’m not sure if I feel comfortable having an expert on cows deciding which drugs end up in my medicine cabinet.
Lately we have had to watch senators shouting at the FDA to tell him how much money they needed to keep America safe from Chinese milk or pet food or the latest drug disaster. The Director couldn’t tell him, or more likely wouldn’t, since his marching orders were to keep the budget small.
With the Prescription Drug User Fee Act” (PDUFA) resulting in pharmaceutical companies paying more and more of the budget of the FDA, with PDUFA mandating that less goes to drug surveillance (watching drugs already FDA approved), it is not innappropriate for pharma to think it will be a good idea to have a “single regulatory body”, since the FDA is essentially working for them. And outside reviews of the FDA have said they are putting Americans at risk through regulation of prescription medications.
Another argument against preemption is that taking the issue out of the courts removes a potential way to uncover previously undisclosed information related to clinical trials, something that has come up not just once, but repeatedly, through the discovery process of ongoing trials.
And what is the argument about the law being “impossible to interpret.” If a prescription medication is found to have an adverse outcome, warn doctors and the public, and if is too dangerous, take it off the market. That is what you are paying your doctors and scientists to do, analyze your data and evaluate risk/benefit ratios.
How about
“…reinforce the principle that doctors are entitled to rely on FDA-approved professional labeling.”
Let me translate that one for you:
Physicians, support this proposed ruling, because then you won’t have to worry about covering your asses for prescription medication disasters. How about the idea that physicians actually CARE about whether we are doing harm or good for our patients.
>>Answering Weyth resend.
Sorry some of Weyth’s letter in the above was deleted.
They begin:
Preemption Protects Everyone
– The fact is this is simply unsubstantiated and unsupported in the arguments below.–
Wyeth:
The Constitutional principle of preemption is not new. Preemption arises from the U.S. Constitution, which under the Supremacy Clause invalidates all state laws that conflict or interfere with federal law.
–The Supremacy Clause was meant for issues such as declaration of war or treaties that might be initiated by States, not in reference to public safety unless specifically stated by law initiated by Congress. Law initiated by any branch of government other than the Congress should be suspect from the start. This is the circuitous route preemption has taken.
The laws of the land, as with any governing rules, should not contradict themselves. Preemption itself causes such contradiction with the Federal Constitution. On the one hand, our Constitution states that the citizens shall have the right to be heard in a court of law when its citizens feel they have been harmed. Preemption repeals that right by absolving certain corporations from challenge in a court of law.
Furthermore States are given the responsibility, by the Federal Constitution, for the safety of its citizens. State law is one means to accomplish that. Again preemption causes conflict with this mandate.
It seems that preemption causes more conflict than it remedies. Unfortunately the harm that the conflict causes is taken from the corporation and thrust upon the backs of the public.–
Wyeth:
In Wyeth v. Levine, the Vermont’s jury verdict was in direct conflict with the FDA’s considered scientific judgment.
–This brings into question the judgment of the FDA. Two points can be made here.
1. What is the capability of the FDA’s judgment?
The FDA itself admits that its capability is such that the American public is in danger.
2. Who is the FDA is judging for. If the FDA is judging for the public, that’s fine. Is this the case? In these times, sadly this point is being debated. Does the FDA cater more to the corporation or the American citizen? The fact that there even IS a debate about this should cause one to shudder. If there is any doubt about who the FDA serves, preemption should be shelved until such time as this issue is unquestionably resolved.–
Wyeth:
Patients and physicians need to be able to rely on a single federal standard and guidelines for the risks, benefits, and use of medicines — the FDA-approved labeling.
– What patients need is a sense of confidence in their drugs, devices and doctors. The current clear lack of confidence (which is getting worse by the day) warrants an increase in protection not a decrease in recourse from harm. Preemption is calling for the public to lay down the one means of personal protection that they can grasp with their own two hands (If they still have them) and put total trust in the Pharmaceuticals companies and the FDA, both shown to be untrustworthy. –
Wyeth:
The public health is better served by having a single expert regulatory body making decisions about risks, benefits, and warnings — rather than an ad hoc system that could produce hundreds of conflicting results that would be impossible for manufacturers, physicians, and patients to reconcile or interpret.
– Please provide evidence of this.–
Wyeth:
Such a system would undermine the careful balance struck by the FDA when making approval decisions.
– This so called “careful balance” would suffer a seismic shift from the public that consumes the product in favor of the manufacturer that produces the product. This careful balance of safety would be destroyed.
Again please provide the evidence that the current system is out of “balance”? How has the past 70 year of no preemption caused such harm?–
Wyeth:
Upholding preemption will still leave America’s courthouse doors open to injured patients. The only claims that will be decided are those where the jury’s verdict conflicts with the FDA’s considered scientific judgment.
–See above comments about considered judgment.–
Wyeth:
Any consumer who is injured as a result of a manufacturing defect may still seek redress in court and manufacturers will remain subject to strict FDA-imposed penalties for concealing information from the FDA.
–Maybe you can fool some of the people some of the time… this statement reeks of duplicity.
The evidence is – Some Pharmaceutical companies (probably more than we know about) habitually conceal information from the public and from the FDA. How would you propose that we find out about that aside for the state torte? No, preemption slams the courthouse door, locks it and throws away the keys that have for so long been the property of the American citizen.–
Justice in MI
Just one further note. Pointing to all the deficits of the FDA, its politicization, regulatory capture, etc. is important.
But it is also important to remember that even if we had a utopian FDA (dream on), preemption would still be irrational policy. One reason is the host of potential delinquencies that may become relevant in civil liability that are entirely _outside_ FDA’s jurisdiction. These include;
- attempts to bribe scientific researchers.
- attempts to intimidate researchers.
- deliberately mispresenting reality in medical journal articles
And so on.
Dianne
Shame on Wyeth. They have sunk to the lowest of the low.
FDA preemption protects no one except pharma. Business friendly politicians on the state and federal level are trying to disguise the assault on civil rights as tort reform.
If this policy is upheld, victims injured by dangerous drugs will go uncompensated, the regulatory powers of the states will end, and the drug companies will only be answerable to the FDA. Beyond losing a precious right, the health and safety of all Americans will be at risk.
Doug Bremner MD
I can’t see that anyone who doesn’t work for pharma is in support of preemption. The fact that they don’t want to argue about it on forums like this indicates that they would rather just stuff a suitcase full of cash and seek out their key supporters rather than have a rational discussion. The biggest problem is that the average person sees the word ‘preemption’ and draws a blank stare, and doesn’t see how it pertains to them. I don’t think that the courts should be allowed to take away our constitutional rights. Perhaps legislation is what is required.
Jaynesday
Doug,
Agreed. The stealth bomber has opened the bomb doors and the target (the American Public)is in sight.
Jim
I have kept up on Wyeth v Levine, mostly through this Blog; it’s unfortunate that the Party that represents itself as the champion of States Rights has proven that States Rights are subordinate to the protection of money interests.
While I believe Wyeth v Levine was primarily a malpractiice lawsuit the real issue, as I understand it, is the original Congressional intent of the laws which grants the FDA its regulatory authority. According to the Levine Brief the original intent of the law granted manufacturers the right to strengthen label warnings without FDA approval so as best to protect the public.
I am looking forward to reading the majority opinion, which most expect will favor Wyeth, and would appreciate very much how the strict Constructionists will explain how their decision should not be construed as Judicial Activism.
Justice in MI
Jim - You have it right. All the discussion here about the “CBE” labeling concerned FDA’s changing the criteria at which companies can unilaterally report. This obviously part of barn-door closing, along with similar initiatives that are supplemental to the main course, preemption. They were all drafted by the same folks.
I do have this caveat re: Doug’s comment. I know plenty of people who work for pharma who are solidly against preemption. They recognize that, while there are certainly exploitative lawsuits, civil litigation in general is not the demon painted (any more than pharma’s own transgressions don’t represent the entire industry).
Some also believe as I do that preemption, if broad, is more likely to hurt the industry - potentially, very badly - than help it. So it is a lose, lose, lose situation - for the industry, for justice, and for everyone/everything else.
It is too bad that those who do support preemption have seemed to lose interest in engaging here. There are good middle ways - including genuine tort reform, narrower definitions, and so on. It remains possible Levine will be decided narrowly, but Wyeth’s statement makes it clear that it hopes not.
Justice in MI
p.s. Re: responses, there is already legislation that would reverse Riegel, and that is certainly likely to be upheld in a Dem Congress. So the device arena is relatively easy.
As DDL has often reiterated, the drug arena is more complicated because there is not a specific law which either grants, or denies, tort remediation over FDA approved products. So the Court must take a broad, largely conjectural reading of Congressional intent and regulation - as much in theory as in actuality. This is where ideology, and the capacity to suspend it, enters in.
I have not been convinced, however, by the arguments that, in essence, the country would have to be dismantled and begin again at Jamestown to reverse a braod preemption decision in Levine.
John S. Campana
Phenergan has been out for years. The fault in this case is with the person that gave the drug improperly. Case closed. John Campana
Justice in MI
John - What the Supreme Court will decide is not the merits of the Levine case (unless they remand it back to Vermont) but the merits of preemption as a doctrine. That is what the Court decided to hear, and what Wyeth and its allies wanted them to hear.
Based on off-board communications, the following needs clarification. It is a good lesson for those who have a congenital distrust for lawyer-speak. That is, it will confirm your prejudice.
Wyeth concludes its statement with the assertion: “Upholding preemption will still leave America’s courthouse doors open to injured patients. The only claims that will be decided are those where the jury’s verdict conflcits with the FDA’s considered scientific judgment. Any consumer who is injured as a result of a manufacturing defects may still seek redress in court and manufacturers will remain subject to strict FDA-imposed penalties for concealing information from the FDA.”
Here are four non sequiturs in a row. It is certainly “crafty,” to put the best face on it.
Initially, it is written to _sound_ like a Catherine Sharkey position. FDA will have to demonstrate “considered scientific judgement” on the risk in question. That could lend itself to very narrow preemption if FDA was compelled to demonstrate its assessment process, as in Sharkey’s model. But that is not the argument here. “Considered scientific judgment” - in this statement - means anything the FDA has decided re: labeling preempts all civil claims. Period. End of story.
The “manfacturing defect” is an old canard in preemption speak. It rarely applies in the drug arena; more often in devices, but is extremely difficult to prove. So the courthourse door that is supposedly “left open” by it remains, in fact, bolted if not barred.
The reference to “strict FDA imposed penalties for concealing information’ has been exposed many times here for the farce that it is.” Such penalties are very rare, and even more rarely strict. What we’re talking about are occasional warning letters, remedial plans, occasional small fines (in the scheme of things), and in very rare cases larger fines and a misdemeanor charge. So much for policing fraud.
As I said up thread, Wyeth may have been honest about phenergan. It is not being honest about this case.