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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_

(http://online.wsj.com/article/SB122506300017470355.html)

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_

(http://www.nytimes.com/2008/09/19/us/19scotus.html?pagewanted=1) 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_

(http://www.healthbeatblog.org/2008/05/is-dennis-quaid.html) Medtronic's

victory as a “blank checkâ€

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._ (http://www.healthbeatblog.org/2008/02/the-supreme-cou.html) 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.â€

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._

(http://www.abanet.org/publiced/preview/briefs/nov08.shtml) In June, the Bush

Administration, a

long-time proponent of preemption, filed an _amicus brief_

(http://www.fileden.com/files/2007/7/10/1254845/Levine%20FDA%20Merits%20Amicus%2\

0Brief.pdf) 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 balanceâ€

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 _

(http://www.uschamber.com/nclc/wyeth_amicus_pr.htm) urging the Court to rule

against Levine, as did PhRMA,

the pharmaceutical manufacturers association. PhRMA _insists_

(http://www.abanet.org/publiced/preview/briefs/pdfs/07-08/06-1249_PetitionerAmCu\

PhRMABIO.pdf)

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.â€

In turn, this will supposedly “distract agency scientists from their core

mission of reviewing the safety and effectiveness of prescription

medications.â€

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_

(http://www.healthbeatblog.org/2008/02/update-on-fda-s.html) 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_ (http://www.healthbeatblog.org/2007/12/the-fda-what-ha.html) 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_

(http://www.medicalnewstoday.com/articles/60768.php) to $400 million—or

almost 20 percent of its total _budget_

(http://www.usatoday.com/money/industries/food/2008-02-04-fda-budget-food-safety\

_N.htm) —

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_

(http://www.healthbeatblog.org/2007/10/inside-the-fda.html) 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.â€

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_

(http://blogs.wsj.com/health/2008/08/15/nejm-editors-enter-supreme-court-fray-ov\

er-drug-risks/) the Wall Street Journal: “the FDA has been given over

to the industry it regulates.â€

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_

(http://jama.ama-assn.org/cgi/content/full/300/16/1939) 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.â€

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_

(http://online.wsj.com/public/resources/documents/NEJM_Editors_Amicus.pdf)

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.â€

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_

(http://www.cbsnews.com/stories/2008/02/14/60minutes/main3831900.shtml#ccmm)

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_

(http://www.cbsnews.com/stories/2008/04/15/health/webmd/main4018030.shtml)

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_

(http://www.nytimes.com/2006/12/20/business/20lilly.html?scp=8 & sq=alaska,+zyprex\

a,+ & st=nyt) 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_

(http://query.nytimes.com/gst/fullpage.html?res=9B03E6DF123DF933A2575AC0A96F9582\

60 & sec=health & spon= & pagewanted=all) 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_

(http://www.medpac.gov/documents/Jun08_EntireReport.pdf) to Congress,

" researchers

have shown that bias in industry-sponsored trials is common.â€

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

products. Big Pharma is virtually the _only industry_

(http://www.healthbeatblog.org/2008/03/obstacles-to-he.html) 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_

(http://www.latimes.com/news/nationworld/washingtondc/la-na-scotus7-2008sep07,0,\

3541470,full.story) 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_

(http://www.reuters.com/article/healthNews/idUSL2582136820080425) 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_

(http://www.healthbeatblog.org/2008/01/shocking-shocki.html) 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_

(http://www.sciencedaily.com/releases/2008/01/080105140107.htm) 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_

(mailto:?subject=Read The Case of Patients v. Big Pharma & body=Go to

http://www.healthbeatblog.org/2008/10/the-case-of-pat.html)

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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_ (http://profile.typekey.com/HCBerkowitz/) |

_November 01, 2008 at 05:30 PM_

(http://www.healthbeatblog.org/2008/10/the-case-of-pat.html#comment-137327901)

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_

(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_

(http://www.typepad.com/t/comments?__mode=red & user_id=856730 & id=137285463) |

_November 01, 2008 at 09:37 AM_

(http://www.healthbeatblog.org/2008/10/the-case-of-pat.html#comment-137285463)

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_

(http://www.healthbeatblog.org/2008/10/the-case-of-pat.html#comment-137278311)

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_

(http://www.typepad.com/t/comments?__mode=red & user_id=856730 & id=137267515) |

_November 01, 2008 at 05:12 AM_

(http://www.healthbeatblog.org/2008/10/the-case-of-pat.html#comment-137267515)

,

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_ (http://profile.typekey.com/HCBerkowitz/) |

_October 30, 2008 at 02:59 PM_

(http://www.healthbeatblog.org/2008/10/the-case-of-pat.html#comment-137089073)

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_

(http://www.healthbeatblog.org/2008/10/the-case-of-pat.html#comment-137081111)

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_ (http://profile.typekey.com/HCBerkowitz/) |

_October 30, 2008 at 10:38 AM_

(http://www.healthbeatblog.org/2008/10/the-case-of-pat.html#comment-137053461)

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_

(http://www.healthbeatblog.org/2008/10/the-case-of-pat.html#comment-137018053)

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_

(http://www.typepad.com/t/comments?__mode=red & user_id=856730 & id=136968831) |

_October 29, 2008 at 07:18 PM_

(http://www.healthbeatblog.org/2008/10/the-case-of-pat.html#comment-136968831)

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_

(http://www.healthbeatblog.org/2008/10/the-case-of-pat.html#comment-136936221)

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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