Musician Who Lost Forearm to a Drug Reaction Wins Right to Sue Manufacturer

March 9, 2009 at 12:58 AM ·

Diane Levine, a musician, lost her lower right arm to gangrene after a botched injection of the antinausea medicine Phenergan nine years ago.  She now plays the guitar with an artificial right arm, hand, and fingers.  After years of litigation, the Supreme Court ruled on March 4, 2009, that Wyeth, the company that makes Phenergan, must pay for her loss.  Many consumer groups are pleased because the Court's ruling opens the door for other consumers to sue drug companies.  However, drug companies are alarmed at the prospects. She speaks about her devastation as a professional musician in http://www.reboprecords.com/Armed_with_a_Voice/index.

Replies (35)

March 9, 2009 at 02:31 AM ·

Who botched the injection? Did the doctor make the mistake? I'm confused, the drug had a warning lable on it. It's no wonder that drug costs are so freakin high!

March 9, 2009 at 04:04 AM ·

There were five or six warning labels that said that the drug must not be injected in an artery but a negligent nurse didn't read the labels. So we must sue the drug company for the nurses negligence. There should have been ten warning labels. Sort of like don't trim your hedges with a lawn mower. . I think that drug companies will quit making new drugs because no one will accept any risk. 

Of course these mad scientists at drug companies work night and day to find devious ways to grab money from consumers. They are truly wicked and evil people. Aren't they?

March 9, 2009 at 07:13 AM ·

Not that this a thread likely to get much attention (after all the topic is pretty far from violins, and the injured person in question was a rock guitarist), but both the two prior comments give a misimpression, and to a small extent so does the original post (though reading the link posted by Pauline Lerner - thanks - would clear some of this up).

First, though, a general comment: in 30 years of teaching a variety of courses that dealt directly with legal issues (including criminology), plus 6 years of direct involvement in the judicial system (field of judicial ethics), it's been clear that relying on first impressions or a news report about a legal decision can lead to a grossly erroneous conclusion. A good bit of the time court decisions, and especially those of appellate courts (which includes the Supreme Court), turn on precise legal issues, typically not well covered or explained in the press, and that was the case here.

Now a few of the facts: the woman in question had already settled out of court with the clinic and medical personnel who botched the injection (briefly, the p.a. aimed for a vein and hit an artery instead, and there was more than that). She also sued Wyeth (the drug manufacturer) under State of Vermont law; a NY Times editorial on the subject 11/7/08, available on-line, summarizes the issues. She was awarded a $6.7 million judgment by a trial court jury, which was upheld by the Vermont Supreme Court on appeal. Wyeth then played its only remaining legal card, which was to argue that because the FDA had approved the drug, they could not be held responsible under state law. That was the issue that the Supreme Court decided; it had only incidentally to do with the woman's injuries (which weren't casual). Since the court ruled against Wyeth's argument, presumably the injuried guitarist can now collect her award.

So if you want to second-guess anyone substantively in this case, it isn't the Supreme Court; you'd have to go after the jurors who made the award, the Vermont Supreme Court which upheld it, and the legislators in Vermont who passed the laws making the suit possible. Was the award excessive? Perhaps, but we don't know the facts that jurors heard, or the precise legal standards about responsibility. An award of this size is big, but I just did some quick fact checking on-line (imprecise, I don't want to spend much time on this) about Wyeth: the company has recently made profits of over $1billion/quarter, on annual sales of about $24 billion. Their CEOs earned in 2006-2008 (respectively all in millions) $32, $24, and $12 million. And Pfizer bought Wyeth for $68 billion in January with this decision pending, so in this perspective the Supreme Court decision may not have the chilling effect on medical innovation that some have foreseen. Whether big jury awards in product liability cases contribute to high consumer prices is quite another matter.

As you can see, the issues here are more complex than the previous 3 posts on the matter suggest. And I haven't even mentioned some biggies, but this is a violin site. So let's get back to more pleasant matters, shall we?

March 9, 2009 at 03:24 PM ·

I disagree entirely. You can't wave your arm so quickly over this and make it go away. Payouts of this size mean that I will have less access to the drugs that I may need in the future to save my life. 

Samuel Alito, in  his dissenting opinion, pointed to the large number of warning labels and asked rhetorically did they need just one more? 

The profits of the drug companies are not free cash used for splurging and partying. They are the principal way a company finances new  research. If they don't make healthy profits where will the new drugs come from? The salaries of the executives are mostly irrelevant. 

The readers of this forum are intelligent people and they deserve to consider these serious issues of how an economy works and how free markets make our way of life better. Sticking our heads in our violins is no way to deal with the realities of living. 

Thank goodness for smart people who work hard so that they can enjoy lives of comfort and the arts and have the wherewithal to raise children who can play the violin. 

March 9, 2009 at 08:00 PM ·

 

ever read the labels now on a wooden step ladder? Don't stand on the fold-down paint can shelf

yup, someone did, sued and won

What a country

March 9, 2009 at 08:42 PM ·

And someone really did get badly injured trimming their hedge by holding a power lawnmower up to the hedge with predictable results. They won mega money because there was no warning on the lawnmower saying don't do that. I guess we're not responsible for our own actions anymore.

March 10, 2009 at 01:37 AM ·

"Payouts of this size mean that I will have less access to the drugs that I may need in the future to save my life. "

Ha!  Or it might instead mean that you don't get your arm blown off by the next cockeyed nurse.

Ralph Nader was on one of the Sunday morning shows and gave a totally convincing argument for the value of consumer lawsuits.  Termed it the "American Way" in fact.  Mostly our malpracticing media only lets us know about the ridiculous therefore "news"worthy ones, explaining our knee jerk negative reaction in large part.  The mirror side of this is the national insurance scam, but that's for another day.

March 10, 2009 at 03:54 AM ·

Corwin said, "There were five or six warning labels that said that the drug must not be injected in an artery but a negligent nurse didn't read the labels. So we must sue the drug company for the nurses negligence." I agree that the drug company is not at fault. The nurse is.

I suggest that people read the victim's own account of how it feels for a professional musician to lose the ability to make music.  It is very moving.

March 10, 2009 at 04:17 AM ·

There are hundreds of lawsuits pending every year against drug manufacturers that the general public never hears about.  However, it doesn't make them any less important.  People sue drug companies because they can.  Because they know a good attorney will have the jury eating out of their hand and bawling their eyes out.  Peer juries are not capable of separating their emotion's from the facts of the case.  As in this one, the person responsible for the catastrophie was the medical personnel who administered the drug.  It was their botched technique...or more correctly their lack of good technique...that caused this woman to lose her arm.

However, you can't get blood from a turnip.  So, her attorney goes after the drug company instead because there are lots of dollars there and juries love to award big settlements in personal injury cases. 

 

March 10, 2009 at 12:01 PM ·

I think we live in a very litiginous society.  I know of a case where a physician stopped to help at a terrible accident.  He pulled the driver away from the area after smelling gas, and indeed the car caught fire.  The physician was unable to stabilize his spine first, as EMT's hadn't arrived.  The driver had a spine injury, but would have died in the fire if not moved.

The driver sued the physician for moving him without stabilizing his spine, despite the fact that the physician saved him from the fire.  He won.  The physician's malpractice insurance wouldn't cover him because he wasn't at work, and he was financially ruined for being a good samaritan.

I still stop and help at accident scenes.  I never tell anyone I'm a doctor.  I'm calm and know what to do, and people just seem to follow my lead.  I never give my name, and leave right after giving EMT's my report.  Call me paranoid.  It is my ethical duty to help but I won't be in the same type of situation as that poor physican, who only did his best to give assistance.

March 10, 2009 at 12:24 PM ·

i know of a pi lawyer and he is pretty candid.  he would tell his clients that he can't make them whole again,,,or even get justice. the only thing he can do is to try to get them money.  shaking down o'reilly for having the affair, going after morgan stanley for racial discrimination,,,money in the name of justice. that is the stage of our evolution:) and for people outside usa looking in, it is odd at times because essentially this country is made by lawyers, for lawyers.

no matter how touching the story is for the lady musician to lose her arm, it boils down to money.  she already got 6 mil.  you think for the drug maker to settle for another 20 min will necessarily stop another nurse to accidentally push the drug into another person's artery despite, say,  100 labels on the bottle warning against it?  i don't think so.   

by the way, i like violin music.

March 10, 2009 at 12:44 PM ·

I used to work for one of those "evil" drug companies, and my experience is that their arguments, tough as they can be to swallow, are compelling.  It is very hard, and very expensive, to innovate and develop new drugs.  The vast majority of new drugs fail, and so the few successes are the only revenue stream the companies have to put into research and development.  Big pharma companies have also been at the forefront of workplace innovations like flex-time, job sharing, generous parental leave, and health benefits for their workers.  They regularly make lists of "top 50 best places to work in the US."

All that said, people like this woman need help.  According to the articles I've read on the subject, she isn't getting rich off this award, she has many outstanding medical bills to be paid with it, she has lost her livelihood, and no amount of money can replace that. 

I don't often find myself in agreement with the Washington Times, but they published an interesting editorial yesterday, suggesting that a government-run fund be set up to compensate victims of accidents involving pharmaceuticals, analogous to the national vaccine injury compensation program.  I think this is an idea worth looking into:

http://washingtontimes.com/news/2009/mar/09/a-cure-worse-than-gangrene/

March 10, 2009 at 01:33 PM ·

Karen said: It is very hard, and very expensive, to innovate and develop new drugs. 

I have a cousin who heads a department of drug research and development. I remember him saying 90-95% of all drugs that are made do not get put on the market. That's a pretty tough ratio to live with. Imagine if we played 90-95% of our notes out of tune no matter what we did O_O. I think the most fault here is with the FDA. It is a given that companies are profit-driven - that's the whole point of capitalism. But of course this would be bad as we have discovered in the last 120 years. So we need some type of regulation. I remember from the original article that the chance of this happenign to the woman was 1 out of 1-2 million. If I'm the head of a company and the drug is going to be used by tens and tens of millions of people, I think I would be ok with that considering 95% of my other drugs fail. The FDA is supposed to say No. In a way this was like asking a child to come up with his own rules and then severely punishing him when they don't meet your expectations. That doesn't make any sense. Why wasn't the parent there in the first place.

March 10, 2009 at 02:13 PM ·

"I think the most fault here is with the FDA."

heaven forbids, but if e string breaks and impairs someone's vision,  what to do then?   sue the e string maker?  sue the e string retailer?  sue the luthier that made the bridge,  sue the violin teacher that recommends that brand?  should e string maker put out warning labels about potential break and encourage the use of goggles?

until an 100% fail proof, unbreakable e string is made, e string should be banned in the usa?

 ------

tens of thousands lose arms and legs each year in the usa.  possibly millions in the world.  some must be just dumb farmers and factory workers with stories not sad enough to sue. 

 

March 10, 2009 at 02:25 PM ·

Al, the right legal team would successfully sue all of the above and the jury of peers would award millions for that eye.

I would like to add to the comments on drug manufacturing that the actual cost of developing, testing, and getting approval of a new biological or pharmaceutical is staggering.  So indeed, when a company does get a new drug on the market, they are depending on it to help fund further research & development, continue quality control, pay for employee benefits and salaries. 

A new cancer drug is priced at $3000 per dose.  People can't afford it so they have to choose less expensive, less effective routes of treatment.   In the end...who is really paying the price for all of these huge settlements?

The tobacco industry is no different.  We make a choice to smoke or not.  We all know the risks involved yet how many millions in settlements has tobacco paid out?  People sue them because the money is there.  They aren't dragging their meth dealer into court to sue him for ruining their health, rotting their teeth out of their heads.  No one sues Jack Daniels when they get into a car drunk and then kill someone.

At some point, common sense has to enter into the equation.  But it hasn't yet.

March 10, 2009 at 03:22 PM ·

tess, it is probably fair to say that regardless of the cost of drug developments and the resultant high cost of patented medications, the key issue here is that   if we live in the usa, fda has the last say on a drug's approval.    there are a lot of concerns and issues to be resolved by fda, which consults the top clinicians in the country,  in terms of public health before a high risk med is approved.  if the chance of saving 20000 lives without any complication does not exist, do we accept the odds that 2 lives will be lost but 19998 saved?   

yet, just because fda has approved a drug with listed potential side effects and complications does not mean there are no unforeseen circumstances, some of which can be personal and "sad".  imo, many frivolous lawsuits take advantage of this gray area because physicians and hospitals tend to settle for fear of a big verdict.  in new york metro areas, lawyers file their cases from richer surburbs in "poorer" boroughs knowing that the jury will be more sympathetic toward victims:)   big money,,,big money!

several prominent hospitals in the northeast essentially created their own insurance company (harvard system, sloan and rochester in ny) and take a hard stand against this trend.  they try to defend every case in court instead of settling.  because it takes about 1/2 mil for a claimant  lawyer to prepare and go through a trial, many frivolous lawsuits are dropped as a result because there is no money to make in the end. bad, unfortunate outcome does not necessarily mean malpractice.   many kids work hard but fail to play well in recitals.  let the kids and their teachers live:)

 

tess, do you mean common sense or $en$e?:):):)

March 10, 2009 at 04:10 PM ·

Al, there is no government agency that is responsible for overseeing and protecting violinists from mishaps on their violins.

There is a big difference with medicine. The FDA is supposed to oversee the dangers of drugs. An average person can deduce that broken strings happen and have the remote probably of causing harm. The average person however can not deduce for him/herself the extemely complex chemical interactions of drugs with the body. The people who make the drugs sometimes don't even know how the drugs work. That is why the FDA is in place: to make sure the risk never outweighs the benefit. If poisonous food or a drug with malicious side-effects gets through, the FDA, our security guard, was the one who allowed that to pass.

Suing the companies for what is the FDA's responsibilty and purpose is a huge double standard. It says "Yes, you can develop drugs, and don't worry about it, we'll determine their safety for the market", and then turning around and saying "What were you thinking selling that drug!" That's a terribly awkward circumstance to be in.

March 10, 2009 at 04:18 PM ·

i have no idea what you are talking about, christopher.

March 10, 2009 at 04:23 PM ·

Chemotherapy drugs and radiation treatments are toxic.  Cancer patients are made aware of the possible side effects.  They make a choice to receive the treatment or not.  Just as the woman who lost her arm made the choice to take the risk and hope that she wasn't that 1% out of a million.  Of course her situation was aided by an incompetant nurse.

 

March 10, 2009 at 06:59 PM ·

Christopher makes an excellent point about the FDA.  Like the SEC, they don't do their job as well as a private oversight company would.

As to juries:  "juries love to award big settlements in personal injury cases. "  That is actually not true.  Generally speaking, attorneys are having a tougher and tougher time winning these lawsuits.  For every crazy-sounding unreasonable award there are 10s if not 100s of situations in which someone didn't get what they actually, really deserved, from the party who was actually responsible.  The problem is so widely recognized that seminars are given on how to deal with juries prejudiced against lawsuits.

The fact that juries are gullible and manipulable in WHATEVER direction is a sign that we desperately need to get reason, logic, and real 'critical thinking' (not the politically correct indoctrination currently pretending to the title) back into our schools.

March 10, 2009 at 10:44 PM ·

"The fact that juries are gullible and manipulable in WHATEVER direction is a sign that we desperately need to get reason, logic, and real 'critical thinking' (not the politically correct indoctrination currently pretending to the title) back into our schools." - Andres

And here we come to, I think, the root of the problem, and the root of many other problems as well. Thanks Andres :D 

March 10, 2009 at 11:27 PM ·

andres,  this is the first time ever i have seen someone comparing fda with sec. but if the central theme is bureaucracy, i guess i will have to agree. 

with private oversight company, is that an idea of yours, a direction that you think we should be heading to, or is it in existence already in another field or similar capacity, on a national scale?  you will stop short privatizing the entire usa govt, right ? :)

"The fact that juries are gullible and manipulable in WHATEVER direction".  i have followed many court cases and do not find that to be the case, generally speaking.   you said that it is getting harder to get big verdicts which, if factual,  i think speaks to the quality of the jury pool to some degree.

March 11, 2009 at 12:45 AM ·

Elizabeth--my pleasure.

Al--The SEC's failings have been well documented lately.  Private due diligence firms are used by investors to evaluate companies offering financial services, particularly those relating to less-regulated products.  One such firm protected its subscribing investors from getting into Madoff's scam in the middle of 2007, just by paying attention to the facts.

I think I'll stop short of discussing where I would stop short as far as privatization.  ;-)   I'll just say that human cultures inevitably run into trouble the more responsibility and consequences are diffused away from the parties making the decisions, which is possibly a slightly more fundamental way of looking at the fact that 'power corrupts'.

As to juries, I think that if you read a random sampling of cases from all over the country, taken directly from court records rather than published for the purpose of making interesting reading, you will find that it is in fact getting harder to get monetary damages of all sizes.  I don't think this is a sign of 'improved juries'.  I think it is due to widespread propaganda against litigation.  I say 'propaganda' because the actual, difficult, thought-provoking legal and philosophoical issues are rarely spelled out in a reasoned way.  I see cases that disturb me going both directions:  parties required to pay who are not actually responsible by any rational standard, AND genuinely injured people who don't get compensated because a defense attorney is very good at blowing smoke.

March 11, 2009 at 01:57 AM ·

Karen, thanks for citing that article in the Washington Times.  It was very interesting.

I used to work for the FDA, although not in the area of new drugs.  I heard that of every 10,000 drugs initially screened, only one drug makes it to market.  The decisions in the drug approval process are very difficult and subject to bad press, so the FDA is increasingly relying on the advice of groups of outside esperts.  The issue of risks vs benefits is important.  For example, a high degree of risk may be acceptable for a cancer drug when the alternative is death.  At the other extreme, very little risk is acceptable for oral contraceptives, which can be taken for years by healthy women.  In the case discussed in this news article, the drug company had given warnings on the label which said that there is a big risk if the product is misused.  If it is injected into an artery, gangrene may result, so don't administer the drug this way.  The jury pre-empted the FDA in making this decision.  The jury said, in effect, that the drug is so risky for this manner of administration that it should never be used.  For the one woman who was seriously injured by someone who didn't administer the drug properly in spite of several label warnings, there are probably many people who benefited from the use of this drug.  I believe that the drug company did all they could to prevent misuse leading to gangrene.  Warnings can protect us from fools but not from damn fools. 

As for the idea that private auditors would solve problems, it has been recently reported that private auditors paid by food manufacturers miss many flaws in the food manufacturing process, even though these auditors were doing their audits perfectly well, following the directions of the food companies, which were consistent with FDA rules and policies.

 

March 11, 2009 at 01:58 AM ·

Part of the function of the FDA is to make sure that risks are properly evaluated and disclosed. Companies that do this expect that their good faith efforts to comply with the regulatory process will justify a degree of legal protection. If they deceived the FDA none of us would feel justified in protecting a drug company from liability. 

A life without risks isn't a life.

March 11, 2009 at 03:05 AM ·

HI Everyone,

It is heartening to read in this thread that not everyone is just jumping to condemn the big bad drug company.  It is also fascinating to see so many scientific and medical people participating in violinist.com!

Full disclosure:  I am a scientist in a drug company. I do drug development and evaluate potential new drugs for the pipeline.  

For what it's worth, I'd like to add that drug labels are negotiated with the FDA.  A company might propose wording. FDA will then request changes. Then the company will either accept or propose alternative changes using actual data to make their case. If a company can't make that case to FDA's satisfaction, then the FDA's wording will stand.  Therefore it is fair to say that the FDA basically establishes the minimum necessary level of safety warning.  It is also fair to say that a company can always issue a stronger wording, but the final package insert must be approved by FDA.

March 11, 2009 at 05:06 AM ·

I have one small quibble, off the mainstream, then I will add my comments to the mainstream.

I can't look at the fact that 95% of drugs don't make it to market. To do so is blatantly wrong.
How many little swimming tadpoles died in vain in the process of each of us being conceived? Development always has been a process of discarding much more than you keep. Get used to the concept. If it was a manufacture process with that ratio, it would be bad management. If that percentage is an important percentage, call it bad management, instead of high risk.

Now, the fact that society litigates is in part based on the fact that we allow ourselves the comforting thought that we can legislate safety. Part of the reason cars cost so much more than they did 40 years ago is the cost of safety additions. Many of them are sane, like seat belts and airbags. Some of them are not. Did you know your car has a sensor to see if the camshaft is turning; if it is not turning, fuel will not flow to the engine. Nice idea, yes, but the part does exactly what a tachometer does (cost less than $50.00), but this part costs well over $500. to be installed in most cars (some, over $1000). Litigation is only one part of the problem in society; we want to be padded and protected, so there is a normal tendency to think that when something bad happens, it is someone's fault. Then we have just enough ego to not admit that someone may be ourselves.

Aside from that, I think that drug companies pull some really dirty tricks to protect their profits, and that makes them easier targets; it is easier to vilify the bad guy. In this case, I do not think they should be forced to pay; it was a procedure error, not a defective product.

March 11, 2009 at 05:17 AM ·

Pauline--your example doesn't really strike me as a good example of the failure of the private sector.  Sounds more like another strike against the FDAs reputation, and an unecessary confirmation of the fact that auditors should not be beholden to auditees.

March 11, 2009 at 08:21 AM ·

Andres, I will give you a more detailed explanation.  Dishonesty or incompetence is not necessarily the problem.  Food manufacturers are required to sell only products which are safe to consume.  Until a few years ago, the determination of safety was made by testing the finished product as it was about to go to market.  Sounds sensible, right?  Then the FDA and many other organizations worldwide adopted a different approach.  Now the manufacturer is only required to determine the critical points in their manufacturing process where problems might occur and keep those points running properly.  For example, heat treatment may be used to kill off bacteria, so the manufacturer is only required to monitor the heating process.  The manufacturer writes a plan which designates the critical points and how they should be monitored.  The manufacturer usually hires an outside auditor to do the specified monitoring so that the manufacturer is not policing itself.  The auditor may do a flawless job of monitoring the parts of the process chosen as critical by the manufacturer and using the test method described by the manufacturer.  In the example I discussed above, the auditor may need to check the calibration and functioning of the thermometer as described by the manufacturer.  This check may be valid, but if the container of the product or one of its ingredients springs a small leak farther down the production line, live bacteria can invade.  This problem would not be detected by the manufacturer's plan.  It's not necessary to have corrupt or incompetent auditors for a product which has been tested legally for safety to be completely unsafe.

March 11, 2009 at 04:24 PM ·

andres, i think pauline has provided a very clear view on how fda works in the areas that she is familiar with. it seems to me that we should be appreciative of her insight instead of saying that well, that still does not show that private sector is failing.  it does not but at the same time, i am not sure you have shown that the private oversight company is not failing since it does not exist.  it is an idea that needs to be looked into, if i am not mistaken.

with your explanation, i am still not convinced by your putting sec and fda together (except that both are govt agencies.  why not put irs and dmv together because both have lots of forms?)

it is not really true that an oversight private company has uncovered the madoff scam.  that person is from a competitor hedgie who was trying to copy madoff and then realized the mathematical impossibility.   and i am sure there are similar personalities that take on certain medical or food issues as their calling and communicate with fda with their concerns.  i am all for that, but to me that is not private oversight company.   it is like people here calling out ebay scammers.

garrison, you have indicated that you are not pleased that 90-95% of drugs in development do not make to the marketplace.  i have noticed that at least 90-95% of people trying to be violin soloists do not make it.  the same probably applies to top luthiers, top sportsmen/women, top surgeons, top garbage disposal/recycle companies.

since the sentiment on this thread is that lets not harm people if we are not going to help them,  it is gratifying to know that fda has to evaluate each product very very carefully.  that is why american developed and made drugs are desired all over the globe because of this high standard, in efficacy and risk management.  problem with under and over regulation?  sure, why not? we are human and hindsight is always 20/20. 

it can take hundreds of millions to billions to go through the process because this thou-shall-do-no-harm is very important to consumers and fda.  i will give you couple situations to look over:

1.  say you have spent 400 mil to develop a drug and looking for one extra dollar to finish the process and you cannot find that dollar.  the drug passed every test, but lacking funding and therefore your product will not make to the market.  ok?

2. two giant makers merge,  similar, competing  products are stopped in their tracks.  ok?

3. drugs doing well in phase 1 and 2 finally hit a wall in phase 3 with unacceptable human side effect (a third ear grows out of forehead).  200 mil already down the drain.  stop or continue?

4. drugs just got fda approval.  at the same time, a competing drug also got approval, with better efficacy and risk profile and pricing.  to compete or get out?

5. say you have a very promising product in early development and it takes about 500 mil to bring to market.  but studies show  that even if the drug gets approved, the yearly revenue is 30 mil since not many people suffer this rare disease.  on top of that, 15 years later, your patent runs out.   do the math, debate the ethics.

so as you see, this list of how not to make it can goes on and on, for various reasons and once we learn to appreciate them, it becomes rather intuitive.

March 11, 2009 at 04:11 PM ·

I'm not sure I understand your point, Roland.  It's not that the 95% failure rate arises because of human decision-making, by the FDA or anyone else.  Most of the failure rate of new drugs comes from science, from basic facts.  That is, the drug candidates don't work as hypothesized, or they have unacceptable side effects that are uncovered in cell culture or animal studies ("preclinical" studies--they are also time-consuming and expensive, although not anywhere near as expensive as clinical trials). Most don't even make it as far as being evaluated by the FDA.  So whether any of us "like" that failure rate or find it acceptable is really beside the point.  It's like complaining about the weather. 

March 14, 2009 at 07:15 PM ·

It's like complaining about the weather.

After reading the above comments, I am of a feeling that some could only be made by those whom have never had to go through the devastation, and often the very humbling, effects of a medication that has gone wrong. I have personal experiences in this, so I can understand, to a degree, why the victim should be well compensated in this case. I both lost and gained a great deal in the whole affair, but I can safely say the loss/gain is equal in proportion, and the my faith was the only real strength  I could really rely upon. Of course, no amount of money can make up for what she has lost, and  each individual will ultimately handle their unique situation as their psychological makeup will allow them to.

I am afraid this is the price of progress, and we have all ( whether we know it or not) are all unwittingly the final hosts of the experiment. The drug compaines are so huge (and insanely rich) that they forsee disaster on a regular time scale, and and amazing prediction success, that you would think they have Nostradamus himself working for them. Perhaps they do, else they would have successfully predicted the prediciment they are facing now.

I have to lend a positive note in this discussion. Although one may have had a terrible side-effect, even to the point of certain disabilities, it remains that such occurences can happen in life itself, drug induced or not. One may comtemplate many tragedies that can happen in life, and in doing so, will only increase the potential for fear. This is not progressive. Instead, the victim of any tragedy should look on the bright side of the street, and consider that it could have been worse, not including death, as that is our ultimate life goal anyway.

I would hope that the individual will utilize the awards to the best of others advantage, and hopefully use whatever talents/faculties they may have available. Foremost, I pray that the woman that it happened to will have the strength and faith needed to handle such a situation and move on to other productive endevours. One would be suprised at the many blessings that can come out of a single tragedy.

March 15, 2009 at 01:00 AM ·

The mistake in question was almost certainly made by the  person who administered  the  medication. It is well-known in the medical community that Phenergan can cause gangrene if administered into arteries or fatty tissue. The correct route of parenteral administration is  either  intramuscular or  injection  into a vein, and it is safe if it is administered in either of these two ways. The clinician apparently failed to distinguish between a vein and an artery.

March 15, 2009 at 01:01 PM ·

Jerald,

The comment "it's like complaining about the weather" was not directed at the woman who suffered the terrible tragedy and was not meant to trivialize her suffering. What I meant by that comment was that the failure and risk of drugs is something ultimately beyond complete human control, the way the weather is.  Weather is usually benign and is something that people just grouse about, but it too, in extreme cases like hurricane Katrina, can occasionally cause terrible suffering and tragedy to individuals. 

I think there's a natural human tendency to find a human or a human institution to hold responsible.  That also happens after weather-induced tragedies.  But even if humans and human institutions were much better than they are now, even if the FDA did its job perfectly, even if FEMA did its job perfectly, we still wouldn't be rid of all of these risks or potential for tragedy.  In that light, I agree with what I think you are saying--that a compassionate response in a decent society would require that people like this woman, and hurricane victims, receive adequate compensation and help.  I think there's something very wrong when lawsuits are their only recourse.

March 15, 2009 at 10:11 PM ·

Karen,

I apologize for any misunderstanding that you have aquired in regards to the use of your comment regarding the analogy between the weather and the situation under discussion. I was actually agreeing with your comment in the sense of the vain actions one can take against a controlling force such as a giant drug company, and expect to come out ahead , not that you are making trivial the unfortunate woman's situation. Once again I apologize to you for the misunderstanding.

Jerald Franklin Archer

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