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, Diana 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 Charles 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 Catherine 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. “[S]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 Diana 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.
Diana 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.
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.
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 McDonald’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?
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.
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@aol.com
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.
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.
Gary,
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.
Wyeth v. Levine
I don’t have much to add to the medical blogopshere’s discussion on the upcoming, landmark Supreme Court decision, so instead I’ll point to two reasoned posts, arguing the case from opposite sides.
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.
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.
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.
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?
To Howard Berkowitz:
You are correct in your observation that Wyeth v. Levine is far from the ideal case for the Supreme Court to decide the issue of whether the federal preemption legal doctrine should be applied to drug injury product liability cases.
Certainly, attorneys like me who represent patients and their families in drug injury lawsuits would liked to have seen some case other than Levine for this purpose.
To be clear, the appeal to the Supreme Court was made by the drug company, and thereafter the Court, in its discretion, decided to take up the Levine case.
Let’s hope for the best.
To Tom Lamb,
Thanks very much for the response. Again, while I obviously haven’t seen the detailed medical documents, then it sounds like there may have been some very interesting legal maneuvering to create a drug labeling case of what would appear to be medical malpractice. That, in and of itself, may be the real policy story for Maggie and other analysts.
As I understand the appellate theory, once something is at SCOTUS level, the concerns are procedural rather than with the facts of the case. Still, I seem to remember a case or so where justices essentially said “this is insane. Why are we doing this?” One can only hope.
Please understand that the amount of complaints here about pharma seem to ignore an apparently egregious breakdown in basic medical technique. It’s this sort of thing that frightens me when I think of the legal system as likely to improve the quality of health care. The scandal, then, would not be that these particular drugs were mislabeled — IV push simply makes no sense, for any number of reasons, and I wouldn’t assume the label of a surgical anesthetic to explain that it should not be used as an antibiotic. There might be a different standard in over-the-counter drugs.
There may be every reason to jump on Wyeth for creating a theory that would protect them, but it seems vary much a separate issue from the medical aspects of the case.
Annie, I disagree with you as well. The “deep pockets” theory about potentially holding every entity responsible, even when they may bear minimal responsiblility, makes for enormous defensive medicine problems. Your points about dispassionate research on new drugs are valid, but PROMETHAZINE AND MEPERIDINE ARE NOT NEW DRUGS. My oldest pharmacology textbook does not suggest using them in such a manner. If the labeling had had IV push in it, that would be another matter. I can’t find any indication of such indications on the generic labeling that I’ve read. Use a drug off-label; take additional responsibility.
To HC Berkowitz: regarding your question of competence on the part of the PA in this case. Perhaps the PA should have realized he cannulated an artery rather than a vein, though if the site were in the hand it makes me wonder if it really was in an artery and not a vein.
However, promethazine is known to cause the same sort of gangrene if it extravasates into soft tissues. The Journal of Emergency Nursing had an excellent article on the subject fairly recently:
Paparella, S. (2006) The Dangers of Intravenous Promethazine Administration
Journal of Emergency Nursing , Volume 33 , Issue 1 , Pages 53 – 56
I’ve known for years the problems with giving Phenergan IV push. I usually prefer to push it in a running IV. But often I end up giving it through a saline lock. For years I would look in the PDR, through the manufacturer’s information, and nursing drug books for guidance on diluting this drug. The drug books simply said not to push a greater concentration than 25mg/ml.
I dug out a 2000 edition of Mosby’s Nursing Drug Handbook, which says nothing about avoiding peripheral IV sites or arteries, and instructs 25mg/ml over 2 minutes.
I learned from other nurses as a new grad that it was best to dilute with 10cc NSS before pushing.
However, I realized the problems with phlebitis early on in my career, and doubled it to 20cc unless the patient was so fluid controlled that I asked the doc for something else.
I also know from experience that if you are giving meperidine IV, you really should give an antiemetic first. Meperidine often results in projectile vomiting otherwise. Fortunately, we don’t use it much anymore. But I would not want to have to give Phenergan via a drip before giving a narcotic like Demerol–fortunately, I’m seeing it ordered less often so I’m not in the conundrum of do I give the Phenergan first and prevent vomiting or do I give the Demerol and relieve pain?
I hope this case shakes out in favor of the plaintiff. This not only has implications for healthcare, it has implications for other consumer safety issues.
We are probably getting too sidetracked from the legal matters, but consider that neither meperidine or promethazine should be considered first-line for any pain control where an opioid is needed.
Maggie, there’s an issue not especially Big Pharma: when does the medical community withdraw or restrict a generic drug that offers little advantage? There are other such calls — I remember, in the sixties, the head of clinical chemistry being unable to get rid of a relatively ancient liver function test. I’ll never forget his saying “anyone who orders a thymol turbidity, as far as I’m concerned, is guilty of malpractice.”
Since they are both generic, there is a question of who continues their status, or at least strong warnings on questionable safety and efficacy. Meperidine used to be used for several assumptions that have been demonstrated incorrect: it was believed to cause less smooth muscle spasm than morphine, and somehow less abusable. More recently, it was demonstrated it builds up a toxic metabolite. Still, it probably does have applicability in morphine allergy.
Promethazine is not the preferred drug for any purpose. Assuming you want an antiemetic, one option is hydroxyzine, which, as opposed to promethazine, increases pain control without adding sedation.
One of my favorite TV crime show lines comes to mind: “Felony stupid”.
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Another 16 hours of double time. I ain’t mad at that. Especially w/ all the shopping imma be doing this next month or so