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The Case of Patients v. Big PharmaOn November 3rd the Supreme Court will hear the case of Wyeth v. Levine, which has been called the “business case of the centuryâ€â€”and with good reason. In essence, Monday’s ruling will decide if patients have the right to sue pharmaceutical companies for personal injuries stemming from prescription drugs approved by the Food and Drug Administration (FDA). This is the big one, folks. First, the details of the case: In the spring of 2000, Levine of Vermont received treatment for migraines which consisted of the painkiller Demerol and Phenergan, an antihistamine manufactured by Wyeth Pharmaceuticals. Phenergan is typically injected directly into the muscle or dripped into the vein through steady doses (a procedure called an “IV dripâ€). When administering the drug, clinicians must be careful not to expose it to blood in the arteries; doing so causes “swift and irreversible gangrene,†to use an evocative phrase from a September New York Times article on Levine’s case. Unfortunately, the physician assistant who attended to Levine administered Phenergan neither through muscular injection nor IV drip, but through a process called “IV pushâ€â€”a direct intravenous shot in the arm. The assistant missed and hit an artery. Over the next few weeks, Levine, who was an avid guitarist, saw her right hand and forearm turn purple and then black—until both were finally amputated. The court battle is over whether or not Wyeth Pharmaceuticals sufficiently warned against the dangers of IV push on its packaging for Phenergan—packaging that had been approved by the FDA. The drug’s labeling did warn that it was preferable to give Phenergan through IV drip, and warned that “inadvertent intra-arterial injectionâ€â€”accidentally injecting the drug into an artery—could cause “gangrene requiring amputation.†But nowhere on the Phenergan label was there an express warning that the method of IV push is extremely risky for this very reason. In 2006, the Vermont Supreme Court upheld a jury decision in state court to grant Levine $6.7 million from Wyeth on grounds that the company should have more expressly prohibited IV pushing on the drug’s labeling. Wyeth appealed, arguing that, because the packaging was FDA approved, patients had no right to question it through state laws. In effect, Wyeth claims that federal approval preempts state-based challenges to regulatory standards. The Preemption Wars This principle of preemption makes for one of the most heated and important Court cases in a very long time. Levine is really about more than just drug labeling: it’s about whether or not the FDA can be second-guessed, even after a patient has been harmed by a product that the agency has approved. Earlier this year, the U.S. Supreme Court upheld this principle in deciding that preemption applied to medical devices in the case of Riegel v. Medtronic. New Yorker Riegel and his wife, Donna, brought suit against Medtronic Inc. after a catheter it had manufactured burst inside Riegel’s coronary artery during heart surgery. In February, the High Court ruled against Riegel in an 8-1 decision. When the Court announced its decision, I lamented Medtronic's victory as a “blank check†for medical device makers in that it effectively shields them from law suits once they manage to get FDA approval for their products. But the stakes around Levine are even higher—in the words of the Times, Monday’s case is the “next frontier†in preemption. That’s because, at its heart, Riegel was a question of statutory interpretation. In 1976, Congress passed a Medical Device Amendment to the Food, Drug, and Cosmetic Act (FDCA), the law that effectively created the FDA. This amendment expressly calls for preemption in the regulation of medical devices. As such, the Court’s decision was relatively simple, albeit ultimately dangerous. In that case, the Justices pretty much just read the letter of the law. But Levine isn’t so cut-and-dried. There’s nothing in the broader Food, Drug and Cosmetic Act that constitutes an express intent to preemption. There is no preemption clause. Thus, as NYU law professor Sharkey put it to the Times, Levine “challenges the court to define the parameters of preemption outside the safe confines of the legislators’ text.†In other words, Monday’s decision will decide if preemption is valid even when legislation doesn’t explicitly call for it—if, in effect, the way we regulate drugs in the United States of America prevents injured patients from bringing suits against drug companies that have FDA approval for their products. Taking SidesThis case will make law. If the Court rules in favor of Wyeth, patients effectively lose their right to sue a drug company, even if its product harms them in an unexpected way. An FDA stamp of approval would essentially function as a shield from law suits. To the pro-business crowd, this sounds just peachy. In June, the Bush Administration, a long-time proponent of preemption, filed an amicus brief with the Court on behalf of Wyeth. The administration argued that the FDA’s “thorough evaluation†of new drugs should not be questioned. The Bushies specifically note that, in approving a drug, the FDA strikes a particular balance between risks and benefits. “tate laws that strike a different balance†necessarily “conflict with the FDA’s determination,†they say, and in such a conflict the federal government’s assessment should come out on top. Hence there’s an “implied preemption†to all of the FDA’s decisions. The Chamber of Commerce also filed a brief urging the Court to rule against Levine, as did PhRMA, the pharmaceutical manufacturers association. PhRMA insists that the state tort laws that allow patients to sue drug companies pose “significant risks to public health and to FDA’s ability to accomplish its mission.†In PhRMA’s view, a win for Levine would force “pharmaceutical companies to inundate the FDA with requests for labeling changes to ensure that federal regulators have been presented with every potential labeling permutation.†In turn, this will supposedly “distract agency scientists from their core mission of reviewing the safety and effectiveness of prescription medications.†When the Bush Administration, the largest business lobby in the country and the drug industry are all arguing that we should respect the authority and integrity of federal regulators, you know something’s up. And indeed it is: conservative forces know that the FDA is one of the most impotent federal regulatory agencies we have. Earlier this year, a former legal counsel to the FDA estimated that the agency needed to double its budget and expand its staff by 50 percent in order to effectively regulate the $1.5 trillion worth of goods that falls under its purview. Strapped for resources, in recent years the FDA has instituted a “user fees†program through which drug companies pay extra to speed up approval of their products. Every year the agency hauls in close to $400 million—or almost 20 percent of its total budget—from this program. That’s right: about one-fifth of the FDA is directly bankrolled by the prescription drug industry.Most drug companies pay the fees for expedited approval, which means that the under-staffed, under-funded FDA is often scrambling to get approvals out the door. Last year an FDA insider told Health Beat that the mad rush for approval compromises the quality of the agency’s oversight. According to the source, drug companies are “betting that, because [the FDA wants] to make the [expedited] deadline [for reviewing and approving new drugs], we won’t send the application [for approval] back. If you find a problem or there is something missing [from the application] and it doesn’t seem terribly material, there is a tendency to overlook it. Because if you don’t it will just delay the whole process.†Time pressures mean that FDA regulators “send [a drug submission] back [only] if it’s really crappy.â€It’s no wonder that the drug industry is so eager to give the FDA the final word in drug safety: the agency is gradually becoming a rubber stamp factory that survives on corporate pharmaceutical money to operate. There’s no easier regulatory process to navigate than the one you control. As Dr. Marcia Angell, a former editor of the New England Journal of Medicine (NEJM), recently told the Wall Street Journal: “the FDA has been given over to the industry it regulates.â€An Inexact ScienceEven if the FDA were operating efficiently and effectively, it would still be unreasonable to insist that its decisions preclude any future legal challenges to drug safety. In a commentary published earlier this month in support of Levine, the Journal of the American Medical Association (JAMA) noted that “the drug and device regulation process is at best an inexact and incomplete science.†Indeed, no matter how honest FDA regulators may be, “the current approach of basing drug approval decisions on clinical trials of efficacy that include relatively small numbers of patients virtually guarantees that the full risks and complete safety profile of these drugs will not be identified at the time of approval.†You can’t really know what will happen when millions of people take a drug for years if you’ve only tested it on dozens of people over a few months. The FDA is a regulatory body, but it’s not omniscient. Moreover, because the Agency has been pushed to approve drugs as quickly as possible, many are “fast-tracked†through the agency. This means that they are rushed to market before there is time to know how patients who take it will fare over the long-term. In theory, manufacturers are supposed to continue long-term trials, and report the results to the Agency. But in practice many ignore this regulation, and the FDA doesn’t have the funding to enforce post-market surveillance. So much for what the Bush administration calls the FDA’s “thorough evaluation†of new drugs.Drug companies are betting on the FDA’s limited knowledge—and are eager to limit it further. As the NEJM noted in a brief filed in support of Levine—the first such document to have the full support of the publication’s full roster of past and present editors—“pharmaceutical companies…[often] learn about dangers caused by their drugs long before the FDA does…[and do not] disclose this information to the FDA.†Consider the case of Trasylol, a clotting drug used during heart surgery to prevent bleeding that was linked to increased probability of kidney damage and death. Bayer pharmaceuticals, the drug’s manufacturer, knew that it was associated with severe kidney damage since the 1980s, but the company ignored this evidence and a steady stream of similar studies over the next decade. In 1993, the drug was brought to market and wasn’t pulled from the shelves until November of last year, after the Canadian government had to stop large clinical trials of the drug because too many patients in the study group were dying. Researchers estimate that 22,000 lives could have been saved had the drug been recalled sooner. There’s also Vioxx, Merck’s blockbuster $2.5 billion painkiller. In 2001, company scientists discovered that patients who took their drug were at a threefold risk of death due to heart problems relative to placebo patients. They withheld this information from the FDA for two years before law suits began popping up around the nation and the drug was pulled from shelves in 2004. Other examples: internal documents show that drug maker Eli Lilly consciously played down the risks of Zyprexa, a drug for schizophrenia that causes major weight gain in many patients, for years. In the late 1990s, court investigators found that Wyeth had known that its weight-loss drug cocktail of Pondimin and Redux was causing a rare heart valve disease on a much wider scale than had been reported to federal regulators. These are just a few examples of how the drug industry conceal risks. As the Medicare Payment Advisory Commission noted in its June 2008 report to Congress, "researchers have shown that bias in industry-sponsored trials is common.†The problem is that the manufacturers control the trials of their own products. Big Pharma is virtually the only industry that is not subject to third-party evaluation of the safety of its products. Imagine if we let automakers oversee crash tests on new models, allowing the industry report results, as it sees fits, to the government and consumers. This would never happen: we have the U.S. the National Highway Traffic Safety Administration (funded by taxpayers) and the Insurance Institute for Highway Safety (funded by insurers) to run safety trials. But in the case of drugs that have the power to kill or maim patients, drug makers themselves monitor the trials. Thus, when it comes to protecting patients, law suits and court orders have played a unique role in bringing the true dealings of drug companies into the light. Often, transparency and accountability must be forced on these companies through legal proceedings. As the JAMA commentary puts it, “tort law serves in effect as a way to close regulatory gaps in the FDA premarketing approval process and to provide a mechanism for postmarketing surveillance.†But if the Supreme Court decides in favor of Wyeth, we’re less likely to ever see internal documents that show what drug companies know and don’t know at any given moment, because we’d see fewer court orders and fewer law suits. It’s hard to pinpoint how many personal injury law suits would be thrown out should the Court decide that FDA approval preempts any other claims that drugs are unsafe. The L.A. Times puts the number in the “tens of thousands†and JAMA says that such a “decision would likely result in thousands of lawyers defending drug manufacturers to file motions in state courts to dismiss plaintiffs' claims under preemption.†Thousands of people like Levine would lose their only recourse for redress. This, of course, would be great news for Big Pharma, which spends billions on law suits every year. In 2005, Eli Lilly spent $700 million to settle 8,000 lawsuits over Zyprexa, Between 1998 and 2006, Wyeth spent $15 billion to resolve lawsuits over Pondimin/Redux. In November, Merck offered a $4.85 billion settlement to cover some 27,000 lawsuits over Vioxx, but only after spending $1.2 billion in order to get to the settlement stage. Some analysts expect the Vioxx debacle will ultimately cost the drug giant somewhere around $30 billion. This year Bayer announced that it faced 78 law suits in the U.S. over Trasylol. Do we really need all of these law suits to keep the prescription drug industry in check? Surely, even if the Supreme Court were to uphold preemption, medical research into prescription drugs would continue, and we’d find out what's safe and what isn’t, right? Wrong. As we’ve seen, if you leave truth-seeking only to company researchers, the drug companies will do all they can to ignore or suppress unpleasant results. And without the threat of legal action to serve as a deterrent to misconduct, poor clinical trials becomes little more than bad press. Drug companies are well-equipped to deal with the press: they spend about $57 billion a year on marketing—almost twice what they spend on R & D. The Blank CheckWhen the Supreme Court decides Wyeth v. Levine on Monday, it will effectively be deciding whether or not prescription drug companies get a blank check from the government. A victory for preemption will mean that, so long as a company can manipulate the FDA—or cover-up the risks of its product—it will never be held accountable for the harm its products and decisions cause patients around the country. An industry forecasted to hit $842 billion in sales in 2010 would be told that its only public safety hurdle is the FDA—an toothless agency that operates on industry dollars. Levine’s case is about much more than the wording of a drug label. It’s about transparency and accountability, about industry’s hold on the federal government, and about patients’ right to protect themselves. Let’s hope the Supreme Court makes the right decision.Posted by Niko Karvounis on October 29, 2008 | Email this postTrackBackTrackBack URL for this entry:http://www.typepad.com/t/trackback/856730/35109503Listed below are links to weblogs that reference The Case of Patients v. Big Pharma:CommentsTo Tom Lamb:I don't disagree that there need to be accurate labels. Do you disagree that a practitioner should not be familiar with common drugs, and especially with injection techniques that have nothing to do with the manufacturer?Again, unless there is a massive lack of information on what seems a very straighforward clinical screwup, how did this case wind up as the poster child for drug labeling?We don't know if the patient had a true migraine, but, if so, opioids are not the first choice. If opioids are indicated, more and more clinicians are treating meperidine as a deprecated drug except in cases of morphine (but not meperidine) allergy.IV push gives drug abusers more of a rush, but I fail to see an indication here. Now, promethazine, as well as meperidine, is not a first line drug; the best reason to use it is that it's desirable to maximize sedation, not pain relief.These are old, generic drugs. I could easily name many, many questionable drugs on patent, and don't start me on direct-to-consumer advertising.Does it occur to any of the lawyers involved that this is a terrible test case?Posted by: HCBerkowitz | November 01, 2008 at 05:30 PMThanks for your excellent presentation on the real meaning of this very important legal and public policy issue.As an attorney, it is my position that any application of the federal preemption doctrine to drug injury lawsuits would effectively eliminate a significant incentive for the drug company to ensure that its drug labels reflect accurate and up-to-date safety information, i.e., the possibility of failure-to-warn product liability litigation.We have some background information as well as an assortment of commentary on our Federal Preemption information page: http://www.druginjurylaw.com/FederalPreemption.phpTogether with you, I hope that patient safety continues to take priority over the interests of Big Pharma.Posted by: Tom Lamb | November 01, 2008 at 09:37 AMI agree with Dr. Val. This whole argument is really about a balance. The balance between pharm companies being able to produce and sell whatever they want with little or no regard to adverse effects vs. stifling drug development and research by requiring exorbitant product information describing the thousands of possible effects. In terms of finding a reasonable place in this balance, I think you are wrong on this one. This is clearly a case of error on the part of the provider and a ruling against the company would do much more harm than the good it might accomplish in terms of transparency and information. Posted by: ksmedstudent | November 01, 2008 at 08:09 AMMaggie - you're a terrific writer and explained things really well here. I have to disagree about something, though. I don't think this case is about patients being allowed to sue drug companies for damaging outcomes... I think it's about allowing patients to sue drug companies for known risks of drugs. As a physician - reading the current Phenergan warning label it is pretty darn clear to me that the drug should NEVER come into contact with arterial blood. Neither via IV, nor direct contact with a wound, nor any other mechanism. In my opinion Wyeth made that clear and I don't think they should be held liable for some permutation of language that "should have" been on the label. It's not as if they hid a risk from us. The provider who administered the drug took a risk in full knowledge of potential consequences.To me, if Wyeth loses, this could open up the court system to countless hearings about patient complaints of known risks. Can you imagine people having the right to sue for side effects just because the side effect wasn't described in exact terms of how they experienced it?I agree that the FDA can't possibly figure out all the potential risks of all new drugs. Maybe in those cases patients should be able to sue. But when risks ARE known, we have to draw the line. Wyeth's loss would be a loss for all of us taxpayers.Posted by: Dr. Val | November 01, 2008 at 05:12 AM,But how is Wyeth v. Levine becoming the test case for something that appears to be professional negligence? I'm not wild about using the courts to solve things that may be bad outcomes that could be handled in a no-fault manner. The right to sue practitioners is also driving up defensive medicine, and, in my personal experience, preventing deployment of quality improvement that might produce discoverable information.When a manufacturer suppresses knowledge of a risk factor, I could live with the responsible executive getting regular doses of the risky drug.Is there any other clinical data that suggests there was a reason to do IV push? I just looked up promethazine injection on Medscape Drug Reference, and see three generic manufacturers. I don't know when Phenergan went off Wyeth patent, but I doubt it was recent.Posted by: HCBerkowitz | October 30, 2008 at 02:59 PMThe right to sue is the ultimate safeguard for a free society that promotes free enterprise. Preemption would remove that right in far too many situations. My wife followed her doctors advice and took Premarin for 10 yrs for hot flashes. Like thousands of others, she developed breast cancer and her physician stated the drug, at a minimum, fed and advanced the disease if not caused it. Will a finding of Preemption via Levine preclude our suite? Tell me, please, that evidence of a Pharma suppressing knowledge of a dangerous side effect will still permit litigation. This is Caveat Emptor gone too far. Posted by: gary r | October 30, 2008 at 01:55 PMThere are unquestioned examples of pharma misconduct. Wyeth v. Levine is a bad test case. Meperidine and promethazine are not exactly things whose real behavior are in concealed clinical trials. The oldest text I could readily find is 1968, and they are both in it. These are prescription drugs. One is a Schedule II controlled substance. Is there no reasonable expectation that someone administering such drugs has a basic competence? Neither was a first-line drug for the indication as described. Both are old drugs, for which the basic doses, routes of administrations, common side effects, should long ago have been memorized by anyone who administers them by injection. Basic how-to-inject 101 says that IV push is an advanced and risky technique. So far, I see malpractice by a PA or, if the physician ordered it, both. Posted by: HCBerkowitz | October 30, 2008 at 10:38 AMThanks Niko,There are complex legal questions posed by the case and others like it.But it is high time that we start to rigorously apply self or externally imposed ethical standards to both Big PhRMA and the FDA. A good start would be "primum non nocerum"= "first do no harm"I will not rest until especially Big PhRMA executives do jail time. Fines and lawsuits have not been enough to stop the greed driven corruption and excess.The understaffed and underfunded FDA,like many other federal agencies,cannot properly regulate in a political environment where "regulation" is a dirty wordDr. Rick LippinSouthampton,Paralippin@... Posted by: Dr. Rick Lippin | October 30, 2008 at 06:53 AMThis wouldn't be important if the FDA was doing its job properly. From a legal point of view a ruling should be based upon the law and not the desired outcome. It is fairly well established that the court can decide where the balance between state's rights and the federal preemption lies.So the proper solution to this issue is really legislative. This is also the result of the legislature not doing its job properly. It has become the handmaiden of industry regardless of which party has the majority. It's just that under the GOP the giveaways to business are more blatant.If it wants to the legislature can set the dividing line between the states and the federal government in as detailed a way as it wishes; take the voting rights act as an example.The real problem is that progressives keep looking for administrative or legislative or judicial solutions to what is really a problem with our democracy.This problem is that it takes a lot of money to get elected and only those with access to such funds win. In the US this means the wealthy and the firms that they control.If we want to see the rights of the people defended the place to start is with electoral reform. The cure for broken democracy is more democracy, not an end run around the problem.Posted by: robertdfeinman | October 29, 2008 at 07:18 PMI'd like to know more of the facts of this case. IV push is an inherently riskier method than drip. There are times where it is absolutely appropriate. I see no reason for it to be needed with these drugs, which are old, off-patent, and whose dose, means of administration and risks should be in the memory of anyone who uses them. It would not be inappropriate to refer to meperidine and promethazine, since Demerol and Phenergan are old drugs long on generic.While Mc's has decided to label coffee "hot", my prescription sleeping pills say "may cause drowsiness", and the hair drier is marked "do not use in shower," these are old, well-known drugs, long off patent. I don't even have to get a textbook to know the dose, route, and precautions, and I don't administer it. If it is a classic migraine, a triptan, specific against migraine, might be as or more effective than a Schedule II opioid. Did the patient already have an IV running? If not, most clinicians would probably give an IM. An opioid will still work fairly quickly; this isn't sitution where seconds, or short minutes, make a life-critical difference. Even IV drip involves a risk of more serious infection than IM. If there was no IV line, I see no reason to do an IV push. If there was a line running, injecting it into the drip should start taking effect in 3-5 minutes or so.Sorry, while I'm not an apologist for pharma, this could have happened with generic meperidine and promethazine. Meperidine itself is used less than it once was; it is not safer than morphine or fentanyl. I'm hearing incompetence on the part of the PA. On the other hand, I've never understood why someone would use a hair drier in the shower. Wouldn't it be simpler to get out of the water?Posted by: C. Berkowitz | October 29, 2008 at 03:06 PMWhat an excellent primer, Niko! Thank you for paying this out so clearly.From a nursing perspective, I'm worried about the ability to ascertain the objective and dispassionate research and patient safety information. Since pharma is not a disinterested party, and there are profit motives from insurers, healthcare institutions, drug manufacturers and distributors, it's critically important that government regulation and oversight is robust enough to assure that needed testing, accurate analysis and full publication of drug administration instructions, warnings and caveats are available to prescribers, professionals who administer medications and all patients.This court case shouldn't even be necessary if healthcare was a not for profit venture and was driven by ethics and professionals instead of by investors and commercial corporations.That safety around health care goods, services, infrastructure, delivery and providers isn't connected to government scrutiny and adequate oversight is very scary - and preventable.If we are really serious about addressing preventable patient errors, harm and patient deaths, we must have the ability to hold every entity accountable.If SCOTUS finds for Wyeth, you can kiss that idea goodbye. epiousian = the expression of agapequite a bit more than enough

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Begin forwarded message:

From: Francine

Date: November 2, 2008 8:59:03 AM EST

To: jgenet@...,

Subject: the Supreme Court case affecting parents/autism tomorrow

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October 29, 2008

The Case of Patients v. Big Pharma

On November 3rd the Supreme Court will hear the case of Wyeth v.

Levine, which has been called the “business case of the century”—and

with good reason. In essence, Monday’s ruling will decide if patients

have the right to sue pharmaceutical companies for personal injuries

stemming from prescription drugs approved by the Food and Drug

Administration (FDA). This is the big one, folks.

First, the details of the case: In the spring of 2000, Levine of

Vermont received treatment for migraines which consisted of the

painkiller Demerol and Phenergan, an antihistamine manufactured by

Wyeth Pharmaceuticals. Phenergan is typically injected directly into

the muscle or dripped into the vein through steady doses (a procedure

called an “IV drip”). When administering the drug, clinicians must be

careful not to expose it to blood in the arteries; doing so causes

“swift and irreversible gangrene,” to use an evocative phrase from a

September New York Times article on Levine’s case.

Unfortunately, the physician assistant who attended to Levine

administered Phenergan neither through muscular injection nor IV drip,

but through a process called “IV push”—a direct intravenous shot in the

arm. The assistant missed and hit an artery. Over the next few weeks,

Levine, who was an avid guitarist, saw her right hand and forearm turn

purple and then black—until both were finally amputated.

The court battle is over whether or not Wyeth Pharmaceuticals

sufficiently warned against the dangers of IV push on its packaging for

Phenergan—packaging that had been approved by the FDA. The drug’s

labeling did warn that it was preferable to give Phenergan through IV

drip, and warned that “inadvertent intra-arterial

injection”—accidentally injecting the drug into an artery—could cause

“gangrene requiring amputation.” But nowhere on the Phenergan label was

there an express warning that the method of IV push is extremely risky

for this very reason.   

In 2006, the Vermont Supreme Court upheld a jury decision in state

court to grant Levine $6.7 million from Wyeth on grounds that the

company should have more expressly prohibited IV pushing on the drug’s

labeling. Wyeth appealed, arguing that, because the packaging was FDA

approved, patients had no right to question it through state laws. In

effect, Wyeth claims that federal approval preempts state-based

challenges to regulatory standards.

The Preemption Wars

This principle of preemption makes for one of the most heated and

important Court cases in a very long time. Levine is really about more

than just drug labeling: it’s about whether or not the FDA can be

second-guessed, even after a patient has been harmed by a product that

the agency has approved.

Earlier this year, the U.S. Supreme Court upheld this principle in

deciding that preemption applied to medical devices in the case of

Riegel v. Medtronic. New Yorker Riegel and his wife, Donna,

brought suit against Medtronic Inc. after a catheter it had

manufactured burst inside Riegel’s coronary artery during heart

surgery. In February, the High Court ruled against Riegel in an 8-1

decision.

When the Court announced its decision, I lamented Medtronic's victory

as a “blank check” for medical device makers in that it effectively

shields them from law suits once they manage to get FDA approval for

their products. But the stakes around Levine are even higher—in the

words of the Times, Monday’s case is the “next frontier” in preemption.

That’s because, at its heart, Riegel was a question of statutory

interpretation. In 1976, Congress passed a Medical Device Amendment to

the Food, Drug, and Cosmetic Act (FDCA), the law that effectively

created the FDA. This amendment expressly calls for preemption in the

regulation of medical devices. As such, the Court’s decision was

relatively simple, albeit ultimately dangerous. In that case, the

Justices pretty much just read the letter of the law.

But Levine isn’t so cut-and-dried. There’s nothing in the broader

Food, Drug and Cosmetic Act that constitutes an express intent to

preemption. There is no preemption clause. Thus, as NYU law professor

Sharkey put it to the Times, Levine “challenges the court to

define the parameters of preemption outside the safe confines of the

legislators’ text.”

In other words, Monday’s decision will decide if preemption is valid

even when legislation doesn’t explicitly call for it—if, in effect, the

way we regulate drugs in the United States of America prevents injured

patients from bringing suits against drug companies that have FDA

approval for their products.

Taking Sides

This case will make law. If the Court rules in favor of Wyeth, patients

effectively lose their right to sue a drug company, even if its product

harms them in an unexpected way. An FDA stamp of approval would

essentially function as a shield from law suits. 

To the pro-business crowd, this sounds just peachy. In June, the Bush

Administration, a long-time proponent of preemption, filed an amicus

brief with the Court on behalf of Wyeth. The administration argued that

the FDA’s “thorough evaluation” of new drugs should not be questioned.

The Bushies specifically note that, in approving a drug, the FDA

strikes a particular balance between risks and benefits.  “tate laws

that strike a different balance” necessarily “conflict with the FDA’s

determination,” they say, and in such a conflict the federal

government’s assessment should come out on top. Hence there’s an

“implied preemption” to all of the FDA’s decisions.

The Chamber of Commerce also filed a brief urging the Court to rule

against Levine, as did PhRMA, the pharmaceutical manufacturers

association. PhRMA insists that the state tort laws that allow patients

to sue drug companies pose “significant risks to public health and to

FDA’s ability to accomplish its mission.” In PhRMA’s view, a win for

Levine would force “pharmaceutical companies to inundate the FDA with

requests for labeling changes to ensure that federal regulators have

been presented with every potential labeling permutation.” In turn,

this will supposedly “distract agency scientists from their core

mission of reviewing the safety and effectiveness of prescription

medications.”

When the Bush Administration, the largest business lobby in the

country and the drug industry are all arguing that we should respect

the authority and integrity of federal regulators, you know something’s

up. And indeed it is: conservative forces know that the FDA is one of

the most impotent federal regulatory agencies we have.

Earlier this year, a former legal counsel to the FDA estimated that

the agency needed to double its budget and expand its staff by 50

percent in order to effectively regulate the $1.5 trillion worth of

goods that falls under its purview. Strapped for resources, in recent

years the FDA has instituted a “user fees” program through which drug

companies pay extra to speed up approval of their products. Every year

the agency hauls in close to $400 million—or almost 20 percent of its

total budget—from this program. That’s right: about one-fifth of the

FDA is directly bankrolled by the prescription drug industry.

Most drug companies pay the fees for expedited approval, which means

that the under-staffed, under-funded FDA is often scrambling to get

approvals out the door. Last year an FDA insider told Health Beat that

the mad rush for approval compromises the quality of the agency’s

oversight. According to the source, drug companies are “betting that,

because [the FDA wants] to make the [expedited] deadline [for reviewing

and approving new drugs], we won’t send the application [for approval]

back. If you find a problem or there is something missing [from the

application] and it doesn’t seem terribly material, there is a tendency

to overlook it. Because if you don’t it will just delay the whole

process.” Time pressures mean that FDA regulators “send [a drug

submission] back [only] if it’s really crappy.”

It’s no wonder that the drug industry is so eager to give the FDA the

final word in drug safety: the agency is gradually becoming a rubber

stamp factory that survives on corporate pharmaceutical money to

operate. There’s no easier regulatory process to navigate than the one

you control. As Dr. Marcia Angell, a former editor of the New England

Journal of Medicine (NEJM), recently told the Wall Street Journal: “the

FDA has been given over to the industry it regulates.”

An Inexact Science

Even if the FDA were operating efficiently and effectively, it would

still be unreasonable to insist that its decisions preclude any future

legal challenges to drug safety. In a commentary published earlier this

month in support of Levine, the Journal of the American Medical

Association (JAMA) noted that “the drug and device regulation process

is at best an inexact and incomplete science.”

Indeed, no matter how honest FDA regulators may be, “the current

approach of basing drug approval decisions on clinical trials of

efficacy that include relatively small numbers of patients virtually

guarantees that the full risks and complete safety profile of these

drugs will not be identified at the time of approval.” You can’t really

know what will happen when millions of people take a drug for years if

you’ve only tested it on dozens of people over a few months. The FDA is

a regulatory body, but it’s not omniscient.

Moreover, because the Agency has been pushed to approve drugs as

quickly as possible, many are “fast-tracked” through the agency. This

means that they are rushed to market before there is time to know how

patients who take it will fare over the long-term. In theory,

manufacturers are supposed to continue long-term trials, and report the

results to the Agency. But in practice many ignore this regulation, and

the FDA doesn’t have the funding to enforce post-market surveillance.

So much for what the Bush administration calls the FDA’s “thorough

evaluation” of new drugs.

Drug companies are betting on the FDA’s limited knowledge—and are eager

to limit it further. As the NEJM noted in a brief filed in support of

Levine—the first such document to have the full support of the

publication’s full roster of past and present editors—“pharmaceutical

companies…[often] learn about dangers caused by their drugs long before

the FDA does…[and do not] disclose this information to the FDA.”

Consider the case of Trasylol, a clotting drug used during heart

surgery to prevent bleeding that was linked to increased probability of

kidney damage and death. Bayer pharmaceuticals, the drug’s

manufacturer, knew that it was associated with severe kidney damage

since the 1980s, but the company ignored this evidence and a steady

stream of similar studies over the next decade. In 1993, the drug was

brought to market and wasn’t pulled from the shelves until November of

last year, after the Canadian government had to stop large clinical

trials of the drug because too many patients in the study group were

dying.  Researchers estimate that 22,000 lives could have been saved

had the drug been recalled sooner.

There’s also Vioxx, Merck’s blockbuster $2.5 billion painkiller. In

2001, company scientists discovered that patients who took their drug

were at a threefold risk of death due to heart problems relative to

placebo patients. They withheld this information from the FDA for two

years before law suits began popping up around the nation and the drug

was pulled from shelves in 2004.

Other examples: internal documents show that drug maker Eli Lilly

consciously played down the risks of Zyprexa, a drug for schizophrenia

that causes major weight gain in many patients, for years. In the late

1990s, court investigators found that Wyeth had known that its

weight-loss drug cocktail of Pondimin and Redux was causing a rare

heart valve disease on a much wider scale than had been reported to

federal regulators.

These are just a few examples of how the drug industry conceal risks.

As the Medicare Payment Advisory Commission noted in its June 2008

report to Congress, " researchers have shown that bias in

industry-sponsored trials is common.”

The problem is that the manufacturers control the trials of their own

products. Big Pharma is virtually the only industry that is not subject

to third-party evaluation of the safety of its products. Imagine if we

let automakers oversee crash tests on new models, allowing the industry

report results, as it sees fits, to the government and consumers. This

would  never happen: we have the U.S. the National Highway Traffic

Safety Administration (funded by taxpayers) and  the Insurance

Institute for Highway Safety (funded by insurers) to run safety trials.

But in the case of drugs that have the power to kill or maim patients,

drug makers themselves monitor the trials. Thus, when it comes to

protecting patients, law suits and court orders have played a unique

role in bringing the true dealings of drug companies into the light.

Often, transparency and accountability must be forced on these

companies through legal proceedings. As the JAMA commentary puts it,

“tort law serves in effect as a way to close regulatory gaps in the FDA

premarketing approval process and to provide a mechanism for

postmarketing surveillance.” But if the Supreme Court decides in favor

of Wyeth, we’re less likely to ever see internal documents that show

what drug companies know and don’t know at any given moment, because

we’d see fewer court orders and fewer law suits.

It’s hard to pinpoint how many personal injury law suits would be

thrown out should the Court decide that FDA approval preempts any other

claims that drugs are unsafe. The L.A. Times puts the number in the

“tens of thousands” and JAMA says that such a “decision would likely

result in thousands of lawyers defending drug manufacturers to file

motions in state courts to dismiss plaintiffs' claims under

preemption.” Thousands of people like Levine would lose their

only recourse for redress.

This, of course, would be great news for Big Pharma, which spends

billions on law suits every year. In 2005, Eli Lilly spent $700 million

to settle 8,000 lawsuits over Zyprexa, Between 1998 and 2006, Wyeth

spent $15 billion to resolve lawsuits over Pondimin/Redux. In November,

Merck offered a $4.85 billion settlement to cover some 27,000 lawsuits

over Vioxx, but only after spending $1.2 billion in order to get to the

settlement stage. Some analysts expect the Vioxx debacle will

ultimately cost the drug giant somewhere around $30 billion. This year

Bayer announced that it faced 78 law suits in the U.S. over Trasylol. 

Do we really need all of these law suits to keep the prescription drug

industry in check? Surely, even if the Supreme Court were to uphold

preemption, medical research into prescription drugs would continue,

and we’d find out what's safe and what isn’t, right?

Wrong. As we’ve seen, if you leave truth-seeking only to company

researchers, the drug companies will do all they can to ignore or

suppress unpleasant results. And without the threat of legal action to

serve as a deterrent to misconduct, poor clinical trials becomes little

more than bad press. Drug companies are well-equipped to deal with the

press: they spend about $57 billion a year on marketing—almost twice

what they spend on R & D.

The Blank Check

When the Supreme Court decides Wyeth v. Levine on Monday, it will

effectively be deciding whether or not prescription drug companies get

a blank check from the government. A victory for preemption will mean

that, so long as a company can manipulate the FDA—or cover-up the risks

of its product—it will never be held accountable for the harm its

products and decisions cause patients around the country. An industry

forecasted to hit $842 billion in sales in 2010 would be told that its

only public safety hurdle is the FDA—an toothless agency that operates

on industry dollars.

Levine’s case is about much more than the wording of a drug

label. It’s about transparency and accountability, about industry’s

hold on the federal government, and about patients’ right to protect

themselves. Let’s hope the Supreme Court makes the right decision.

Posted by Niko Karvounis on October 29, 2008 | Email this post

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Comments

To Tom Lamb:

I don't disagree that there need to be accurate labels. Do you disagree

that a practitioner should not be familiar with common drugs, and

especially with injection techniques that have nothing to do with the

manufacturer?

Again, unless there is a massive lack of information on what seems a

very straighforward clinical screwup, how did this case wind up as the

poster child for drug labeling?

We don't know if the patient had a true migraine, but, if so, opioids

are not the first choice. If opioids are indicated, more and more

clinicians are treating meperidine as a deprecated drug except in cases

of morphine (but not meperidine) allergy.

IV push gives drug abusers more of a rush, but I fail to see an

indication here. Now, promethazine, as well as meperidine, is not a

first line drug; the best reason to use it is that it's desirable to

maximize sedation, not pain relief.

These are old, generic drugs. I could easily name many, many

questionable drugs on patent, and don't start me on direct-to-consumer

advertising.

Does it occur to any of the lawyers involved that this is a terrible

test case?

Posted by: HCBerkowitz | November 01, 2008 at 05:30 PM

Thanks for your excellent presentation on the real meaning of this very

important legal and public policy issue.

As an attorney, it is my position that any application of the federal

preemption doctrine to drug injury lawsuits would effectively eliminate

a significant incentive for the drug company to ensure that its drug

labels reflect accurate and up-to-date safety information, i.e., the

possibility of failure-to-warn product liability litigation.

We have some background information as well as an assortment of

commentary on our Federal Preemption information page:

http://www.druginjurylaw.com/FederalPreemption.php

Together with you, I hope that patient safety continues to take

priority over the interests of Big Pharma.

Posted by: Tom Lamb | November 01, 2008 at 09:37 AM

I agree with Dr. Val. This whole argument is really about a balance.

The balance between pharm companies being able to produce and sell

whatever they want with little or no regard to adverse effects vs.

stifling drug development and research by requiring exorbitant product

information describing the thousands of possible effects.

In terms of finding a reasonable place in this balance, I think you

are wrong on this one. This is clearly a case of error on the part of

the provider and a ruling against the company would do much more harm

than the good it might accomplish in terms of transparency and

information.

Posted by: ksmedstudent | November 01, 2008 at 08:09 AM

Maggie - you're a terrific writer and explained things really well

here. I have to disagree about something, though. I don't think this

case is about patients being allowed to sue drug companies for damaging

outcomes... I think it's about allowing patients to sue drug companies

for known risks of drugs. As a physician - reading the current

Phenergan warning label it is pretty darn clear to me that the drug

should NEVER come into contact with arterial blood. Neither via IV, nor

direct contact with a wound, nor any other mechanism. In my opinion

Wyeth made that clear and I don't think they should be held liable for

some permutation of language that " should have " been on the label. It's

not as if they hid a risk from us. The provider who administered the

drug took a risk in full knowledge of potential consequences.

To me, if Wyeth loses, this could open up the court system to countless

hearings about patient complaints of known risks. Can you imagine

people having the right to sue for side effects just because the side

effect wasn't described in exact terms of how they experienced it?

I agree that the FDA can't possibly figure out all the potential risks

of all new drugs. Maybe in those cases patients should be able to sue.

But when risks ARE known, we have to draw the line.

Wyeth's loss would be a loss for all of us taxpayers.

Posted by: Dr. Val | November 01, 2008 at 05:12 AM

,

But how is Wyeth v. Levine becoming the test case for something that

appears to be professional negligence? I'm not wild about using the

courts to solve things that may be bad outcomes that could be handled

in a no-fault manner. The right to sue practitioners is also driving up

defensive medicine, and, in my personal experience, preventing

deployment of quality improvement that might produce discoverable

information.

When a manufacturer suppresses knowledge of a risk factor, I could live

with the responsible executive getting regular doses of the risky drug.

Is there any other clinical data that suggests there was a reason to do

IV push? I just looked up promethazine injection on Medscape Drug

Reference, and see three generic manufacturers. I don't know when

Phenergan went off Wyeth patent, but I doubt it was recent.

Posted by: HCBerkowitz | October 30, 2008 at 02:59 PM

The right to sue is the ultimate safeguard for a free society that

promotes free enterprise. Preemption would remove that right in far too

many situations. My wife followed her doctors advice and took Premarin

for 10 yrs for hot flashes. Like thousands of others, she developed

breast cancer and her physician stated the drug, at a minimum, fed and

advanced the disease if not caused it. Will a finding of Preemption via

Levine preclude our suite? Tell me, please, that evidence of a Pharma

suppressing knowledge of a dangerous side effect will still permit

litigation. This is Caveat Emptor gone too far.

Posted by: gary r | October 30, 2008 at 01:55 PM

There are unquestioned examples of pharma misconduct. Wyeth v. Levine

is a bad test case.

Meperidine and promethazine are not exactly things whose real behavior

are in concealed clinical trials. The oldest text I could readily find

is 1968, and they are both in it. These are prescription drugs. One is

a Schedule II controlled substance. Is there no reasonable expectation

that someone administering such drugs has a basic competence?

Neither was a first-line drug for the indication as described. Both

are old drugs, for which the basic doses, routes of administrations,

common side effects, should long ago have been memorized by anyone who

administers them by injection. Basic how-to-inject 101 says that IV

push is an advanced and risky technique. So far, I see malpractice by a

PA or, if the physician ordered it, both.

Posted by: HCBerkowitz | October 30, 2008 at 10:38 AM

Thanks Niko,

There are complex legal questions posed by the case and others like it.

But it is high time that we start to rigorously apply self or

externally imposed ethical standards to both Big PhRMA and the FDA. A

good start would be " primum non nocerum " = " first do no harm "

I will not rest until especially Big PhRMA executives do jail time.

Fines and lawsuits have not been enough to stop the greed driven

corruption and excess.

The understaffed and underfunded FDA,like many other federal

agencies,cannot properly regulate in a political environment where

" regulation " is a dirty word

Dr. Rick Lippin

Southampton,Pa

ralippin@...

Posted by: Dr. Rick Lippin | October 30, 2008 at 06:53 AM

This wouldn't be important if the FDA was doing its job properly.

From a legal point of view a ruling should be based upon the law and

not the desired outcome. It is fairly well established that the court

can decide where the balance between state's rights and the federal

preemption lies.

So the proper solution to this issue is really legislative. This is

also the result of the legislature not doing its job properly. It has

become the handmaiden of industry regardless of which party has the

majority. It's just that under the GOP the giveaways to business are

more blatant.

If it wants to the legislature can set the dividing line between the

states and the federal government in as detailed a way as it wishes;

take the voting rights act as an example.

The real problem is that progressives keep looking for administrative

or legislative or judicial solutions to what is really a problem with

our democracy.

This problem is that it takes a lot of money to get elected and only

those with access to such funds win. In the US this means the wealthy

and the firms that they control.

If we want to see the rights of the people defended the place to start

is with electoral reform. The cure for broken democracy is more

democracy, not an end run around the problem.

Posted by: robertdfeinman | October 29, 2008 at 07:18 PM

I'd like to know more of the facts of this case. IV push is an

inherently riskier method than drip. There are times where it is

absolutely appropriate. I see no reason for it to be needed with these

drugs, which are old, off-patent, and whose dose, means of

administration and risks should be in the memory of anyone who uses

them. It would not be inappropriate to refer to meperidine and

promethazine, since Demerol and Phenergan are old drugs long on

generic.

While Mc's has decided to label coffee " hot " , my prescription

sleeping pills say " may cause drowsiness " , and the hair drier is marked

" do not use in shower, " these are old, well-known drugs, long off

patent. I don't even have to get a textbook to know the dose, route,

and precautions, and I don't administer it.

If it is a classic migraine, a triptan, specific against migraine,

might be as or more effective than a Schedule II opioid. Did the

patient already have an IV running? If not, most clinicians would

probably give an IM. An opioid will still work fairly quickly; this

isn't sitution where seconds, or short minutes, make a life-critical

difference. Even IV drip involves a risk of more serious infection than

IM. If there was no IV line, I see no reason to do an IV push. If there

was a line running, injecting it into the drip should start taking

effect in 3-5 minutes or so.

Sorry, while I'm not an apologist for pharma, this could have happened

with generic meperidine and promethazine. Meperidine itself is used

less than it once was; it is not safer than morphine or fentanyl.

I'm hearing incompetence on the part of the PA. On the other hand,

I've never understood why someone would use a hair drier in the shower.

Wouldn't it be simpler to get out of the water?

Posted by: C. Berkowitz | October 29, 2008 at 03:06 PM

What an excellent primer, Niko! Thank you for paying this out so

clearly.

From a nursing perspective, I'm worried about the ability to ascertain

the objective and dispassionate research and patient safety

information. Since pharma is not a disinterested party, and there are

profit motives from insurers, healthcare institutions, drug

manufacturers and distributors, it's critically important that

government regulation and oversight is robust enough to assure that

needed testing, accurate analysis and full publication of drug

administration instructions, warnings and caveats are available to

prescribers, professionals who administer medications and all patients.

This court case shouldn't even be necessary if healthcare was a not for

profit venture and was driven by ethics and professionals instead of by

investors and commercial corporations.

That safety around health care goods, services, infrastructure,

delivery and providers isn't connected to government scrutiny and

adequate oversight is very scary - and preventable.

If we are really serious about addressing preventable patient errors,

harm and patient deaths, we must have the ability to hold every entity

accountable.

If SCOTUS finds for Wyeth, you can kiss that idea goodbye.

 

epiousian = the expression of agape

quite a bit more than enough

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