Via CNN: Protection for vaccine makers debated
I think this is completely correct:
Legislation would require proof of willful misconduct
WASHINGTON (AP) — People injured by a vaccine against bird flu or anthrax would have to prove willful misconduct to bring a claim for damages against drug manufacturers or distributors, according to legislation being drafted behind the scenes by Republicans.A 10-page draft of the legislation obtained by The Associated Press says it would be up to the Health and Human Services secretary to declare that such misconduct occurred. If that declaration is made, the case must be heard in federal court.
The measure, which would be included in a spending bill, would bar any punitive damages and limit awards for physical and emotional pain and suffering and other noneconomic damages to a maximum of $250,000.
The government has done this before, with the Swine Flu scare (which ended pretty badly for all concerned), and the vaccine manufacturers were very happy they had the legal protection they did.
The draft legislation was provided to the AP separately by two parties opposed to its provisions, who did not want to be identified.
The courage of their convictions is remarkable. It must be incredibly frustrating to work in an environment where trust is just a word on your money.
An aide to Sen. Bill Frist, R-Tennessee, confirmed the majority leader was looking to add the liability protections to a spending bill.
Amy Call said the legislation is important because “it would be a pity to appropriate $7.1 billion to purchase vaccines and antivirals but have no capacity to produce them.”
She said Frist is seeking clearly defined standards for an industry that is already heavily regulated.
“We would only provide liability protection in a serious situation and for a set period of time and for a specific purpose,” Call said. “The protection would only go into effect if the secretary makes a declaration that we are grave danger and the public is advised to take the product.”
President Bush’s plan for dealing with a flu pandemic called on Congress to give drug manufacturers sweeping immunity against lawsuits. “In the past three decades, the number of vaccine manufacturers in America has plummeted, as the industry has been flooded with lawsuits,” Bush said last month. “Today, there is only one manufacturer in the United States that can produce influenza vaccine.”
Let’s repeat that: there’s only one influenza vaccine manufacturer in the US. Hug a plaintiff’s lawyer if that makes you feel all warm inside.
Lawmakers from both political parties also have cited a need to grant the industry some protections. However, the protections described in the draft are quite broad, and some say they would make it extremely difficult for those harmed by a medicine to get any financial compensation.
Nice little editorialization thrown in pretending to be news, and who is ‘some’? The same ‘some’ who leaked a draft, ‘some’ already defined by their opposition to this legislation? Or the reporter and the mouse in his pocket?
“The Republican leadership in Congress is trying to do another special favor for the drug companies by slipping a provision into a massive spending bill to absolve the pharmaceutical industry of any responsibility to patients injured by dangerous drugs or vaccines, with no compensation for those who are harmed,” Sen. Edward M. Kennedy, D-Massachusetts, said in a statement.
He called for an open debate on the issue.
Dang Republicans, wanting to “do a special favor for the drug companies” like not see them sued out of existence for making a life-saving vaccine at government request. I am all for an open debate on the subject, and a roll-call vote. In two years if there isn’t vaccine and there is a pandemic, let’s have a full record so the survivors know who was responsible.
And, the vultures are unhappy:
Trial lawyers said they oppose having to prove “willful misconduct” to get financial compensation from an injury.
Yeah, shouldn’t emotion be the determining factor? It doesn’t matter that the vaccine company worked their tails off to produce a vaccine for a deadly disease on a tight deadline, if there is an adverse event, let’s sue!
“Basically, as an average person, I would have to prove some scientist at Merck or some CEO somewhere had made a determination to hurt me,” said Chris Mather, a spokeswoman for the Association of Trial Lawyers for America.
Willful misconduct, according to the draft legislation, would occur if manufacturers or distributors of a particular product knew that it presented “a significant or unreasonable risk to human health” and there was a “conscious failure to act” to avoid that risk.
If the HHS secretary rules against the petition, then those claiming to be harmed could seek judicial review from the U.S. Court of Appeals.
Unless there are legal protections, there won’t be a product to worry about, so all that is moot.
Rep. Dave Weldon, R-Florida, a doctor who said he is involved peripherally in the talks, said he doesn’t want protections so broad that people might be unwilling to take medicine in the event of a flu pandemic.
“The way it’s being discussed is lacking,” Weldon said.
I have to assume the reporter nodded off there, and didn’t write down the rest of Dr. Weldon’s sentence, as what is there doesn’t make much sense.
Unfortunately, this is the wave of the future, getting legislation passed to protect us from the legal wolves who would gladly devour us all.
some say they would make it extremely difficult for those harmed by a medicine to get any financial compensation
Generally you can replace the words “some say” in an article with the words “this reporter thinks”. The reporter could have used a direct quote with a little effort.
Isn’t this entire point rather moot as we already have a system in place for compensating victims of vaccine injuries:
On October 1, 1988, the National Vaccine Injury Compensation Program (VICP) was established to ensure an adequate supply of vaccines, stabilize vaccine costs, and establish and maintain an accessible and efficient forum for individuals thought to be injured by childhood vaccines.
The VICP is a no-fault alternative to the traditional tort system for resolving vaccine injury claims. The VICP covers all vaccines recommended by the Centers for Disease Control and Prevention for routine administration to children.
Here’s the website: http://www.hrsa.gov/osp/vicp/INDEX.HTM
Don’t get me wrong, I’m all for anything to make life harder for the trial lawyers, but doesn’t the proposed system just add redundancy to the system already in place? Why not instead of tacking on a good program to a spending bill that includes money for who knows what, do we not just expand a program that has been in existence for nearly 20 years and done a good job?
Oh, and Ted Kennedy is an idiot.
How far away are we from a similar bill that will provide the same protection against automobiles, trucks, ATVs, garden hoses and hair brushes? We desperately need to reform tort laws so that people who file frivolous law suits aren’t exempt from damages when they lose.
It’s all about the money and the knowledge that they might have to pay out if they lose will surely dampen the ardor of many potential litigants.
As far as the VCIP goes, I think these two statements are why they’re trying to make a specific bird-flu exception:
and
(I had no idea blockquotes would work in the comments. Cool.)
Whether just including the new vaccine under these rules would suffice would be for someone in the legal side of the vaccine community to say.
But I see nothing wrong with the proposed, new protections.
Remind me. Why is it that people who are injured through the negligence of vaccine makers (or doctors, for that matter, which I believe is the subtext here to explain the rancor against lawyers who represent victims) ought to just lump it? Negligence has to be proved through a rigorous and fair process, right? The reason pharmaceutical companies have gotten out of the vaccine business — along with developing drugs for the ho-hum diseases that mostly just kill the poor of the world — is that there’s no big profit in it. Then they all wail for legislative immunization from the adverse verdicts of juries of ordinary Americans who know what it means to face the loss of a loved one or a lifetime of ruinous medical bills because “this is no time to play the blame game.” Uh… remind me. What’s the alternative?
Dow, you must be kidding (or you’re a plantiffs attorney, and being deliberately disengenious).
The ‘rigorous and fair process’ is not fair at all, nor is it based on scientific data or fact. Just jury feelings, and attorneys are paid their 30 pieces of silver to dissimulate, prevaricate or just flat out lie to get the verdict they want. After all, thats how they make their 33%+ fees.
The alternative is either a runiously expensive, arbitrary and capricous legal ordeal for every single alleged case, resulting in no vaccine companies (or vaccines) and death by preventable infectious disease
or,
telling the trial bar to put a sock in it unless they can prove an intent to harm.
I know which one I’d want. It’s not even close.
And, for those who say ‘there’s no vaccine manufacturers because profit margins are small’, think about the economics of that statement. Think gas would be cheap with one refinery? It’s only through the persistent victimization of the vaccine manufacturers we’re at this point.
I’m not an attorney, so I’m being disingenuous on my own tab. Or not — I’m bending over backwards to avoid ad hominems. Again, what’s the alternative? Is there really something fundamentally broken about the American jurisprudential system? Would you do away with juries? Would you let them decide on the life, imprisonment or death of alleged criminals but declare that deciding civil matters — specifically when they turn on medical error — is beyond them? Just as an afterthought, I Googled the median salary of ER physicians in the US. According to salary.com, it’s $198,484. The lower quintile make $172,787. I don’t begrudge or envy a penny of that — you all (on this blog) more than earn it. But think: the proposal is to “bar any punitive damages and limit awards for physical and emotional pain and suffering and other noneconomic damages [for those injured by vaccines] to a maximum of $250,000.” A little over an ER doc’s pay for one year. I’m afraid I just don’t see that as reasonable or just — at least until such time as this country agrees to some more rational safety net. Interestingly, I also found that, according to the U.S. Labor Department, “in 2002, the median annual earnings of all lawyers was $90,290. The middle half of the occupation earned between $61,060 and $136,810…. [Only about] 10 percent earned more than $145,600.” It costs a lot to bring a case to trial, which is why contingency fees sound high. If you lose, you’re out the costs you fronted. I know lots of docs hate lawyers; I also happen to know a lot of docs who realize lawyers are not the enemy. Now, as to politicians and insurance companies….
DOW’s Straw men:
1. Juries are bad, and should never have anything to do with real trials (but I’ll give you the 1st Vioxx verdict or OJ before you decide)
2. The relative incomes of one groups vs. another. Taken as argued, docs should lose against everyone except Fortune 500 execs. Nonstarter.
Not necessarily a straw man, but one that’s already been voted on: jury caps. Texas’ Prop 12, for recent instance, or California’s’ MICRA. Google it, or search this blog. Because you don’t like it doesn’t mean it hasn’t been voted on, and approved by the same people that make up juries.
Basically, you want to change the subject and make it about incomes.
Answer the economics question: how is it that ONE US vaccine manufacturer of the Flu vaccine isn’t making money by the traincar load? A hint: It’s not supply, which is low, or demand, which is high.
Thanks for making me realize there are things marginally worse than lawyers and insurance companies.
Suggested background reading:
“Limiting Tort Liability for Medical Malpractice,” Congressional Budget Office, January 8, 2004 http://www.cbo.gov/showdoc.cfm?index=4968&sequence=0). Money quote: “In short, the evidence available to date does not make a strong case that restricting malpractice liability would have a significant effect, either positive or negative, on economic efficiency. Thus, choices about specific proposals may hinge more on their implications for equity–in particular, on their effects on health care providers, patients injured through malpractice, and users of the health care system in general.”
“The Malpractice Mess,” Atul Gawande, MD, The New Yorker, Nov. 14, 2005. (Up close and personal, but no longer online, unfortunately). Money quote: “Whether a cap is enacted or not, I will pay at least half a million dollars in premiums in the next ten years. I would much rather see that money placed in an insurance fund for my patients who suffer complications from my care, even if the fund cannot be as generous as we’d like it to be. There’s no real chance of this happening, though. Instead, we’re forced to make do with what we have.”
“The Fragility of the U.S. Vaccine Supply,” Frank A. Sloan, Ph.D., Stephen Berman, M.D., Sara Rosenbaum, J.D., Rosemary A. Chalk, B.A., and Robert B. Giffin, Ph.D., NEJM, Dec. 2,2004 (http://content.nejm.org/cgi/content/full/351/23/2443 — but you’ve gotta have a subscription, I believe). Money quote: “Pharmaceutical companies cannot justify investment in vaccines if their risk-adjusted returns on investment are low, and vaccine profitability appears to be relatively low. The prices of childhood vaccines have remained flat for two decades, the result of federal price caps and the federal government’s exercise of its considerable purchasing power…. Potential market entrants face additional barriers. As with drugs, the FDA does not accept data from foreign clinical trials for licensure of a vaccine in the United States. Therefore, the supplier must repeat comprehensive clinical trials in the United States.”
As you’ve noted, the National Vaccine Injury Compensation Program (VICP) already protects manufacturers from liability claims, and it covers flu vaccines (but not, as you’ve also pointed out, an Avian-flu vaccine), which are being made by four companies of which one – Medimmune – is American. Another, Chiron, just merged with Novartis, a British company. A big reason there is only one U.S. vaccine producer is the wonderful Global Market, which now makes it hard to distinguish what flag a multinational really flies.
Talk about straw-men: Lawyers and plaintiffs. To be sure, sleazeballs and greedheads are out there, and they wreak a lot of damage. But it would suit you to be less sweeping and more nuanced in your venom.
Sorry, my venom is based on experience. To date, I’ve dealt with only one pleasant plaintiff’s attorney, whose enormous laceration I was closing after his (I found out later) latest DWI. That one was pleasant.
The others I’ve dealt with ranged from nice-shark to worse, and there’s going to be a special spot in hell for them if I have anything to say about it. (I won’t but it’s good to have a plan, just in case).
On the plaintiff-atty as drag on medicine and society, this is a no-nuance zone.
“Answer the economics question: how is it that ONE US vaccine manufacturer of the Flu vaccine isn’t making money by the traincar load? A hint: It’s not supply, which is low, or demand, which is high.”
You’re half right, which isn’t bad. The problem is who is that the only one demanding it is government, and they don’t pay very well. The other problem is that a new vaccine has to be produced every year because the virus mutates, so any unsold vaccines are worthless.
So, if you’re a drug manufacturer, how much money and time are you going to spend chasing such a low profit drug, whose TOTAL market is about $6 billion, when the whole pharmaceutical market is about $250 billion?
Liability concerns have little, if anything to do with it.
“arbitrary and capricous legal ordeal for every single alleged case,”
This statement is completely lacking in any factual basis.
I’ll stick with arbritrary and capricious, thanks.
As well you should. A statement completely lacking in fact can certainly be described as such.
Oh. This suit didn’t happen:
http://www.mercola.com/2003/jun/18/alexander1.htm
Nor this one:
http://briandeer.com/mmr/lancet-lsc.htm (in Britan, but their lawsuits are free)
Fact: meritless lawsuits happen. Fact: they cost money. And, to get back to the original article, if the Govt. is going to commission a vaccine and set the price, then the manufacturer should be immunized against suits not arising from gross negligence or bad faith.
Meritless suits happen and malpractice happens. No human system is perfect, nor does the existence of a few cases of either indicate that the the whole legal system is flawed or all the services performed by physicians are flawed. You don’t throw the baby out with the bathwater. PS – English cases, involving different laws, different evidentiary rules, etc. mean nothing in this discussion, and I have no clue what you’re trying to say with your first link.
So your argument is that if your child is given a vaccine that causes lifelong damage and millions in medical care, and the reason for the problem with the vaccine is that the PRIVATE producer allowed the facility to become contaminated with a foreign substance (not intentionally, but negligently), they should be immune? Despite clear, but not gross, negligence on their part? Because we wouldn’t want a vaccine producer to lose money?
You must have a lot of pharmaceutical stocks.
Aah. CuriousJD. I had to look in the emails, but it’s you. Welcome back.
As I’d rather have a public rash than get into yet another discussion with an under-employed plaintiffs’ attorney, here’s my current policy on pointless dialouges in the comments:
http://www.gruntdoc.com/2005/10/how_i_feel_about_my_blog_and_c.html
You have a blog (or you used to), feel free to voice your opinions there.
Love that crack about the pharmaceutical stocks, and I’m sure an under-employed plaintiff’s attorney has absolutely no financial interest in encouraging lawsuits, right?
Silly cynical me; it must all be for the good of the victims.
Why does it always turn personal with you guys? Is this what happens when the facts don’t support your claims? How sad.
It turned personal when YOU turned it personal, Matt.
You take a backhanded parting shot about what stocks GruntDoc purportedly owns, while simultaneously playing the wounded gentlemen when the attorneys’ financial conflict of interest is highlighted?
What would you call that?
I guess I didn’t realize that was that personal. But if so, I apologize. I’m glad to keep it on a purely factual basis, because the facts favor my position. I never denied a financial interest, although I’ve never had a vaccine case and don’t imagine I ever will. My financial interest in these issues is no different than your financial interest in “tort reform” of any kind.
Besides, would you really want me OVER-employed, if all you believe about lawyers is true?
By the way Grunt, if you truly believe what I’m posting is incorrect, then by all means ban me, delete my comments, whatever you have to do. I don’t believe giving the whole story on any issue is “pointless”, but you may, so go ahead.
I’m not delicate. Some people don’t like dissent, I understand.
I don’t think GruntDoc has a problem with dissent… but it rings pretty hollow coming from some of you guys.
You’ll pardon us docs if we snicker when plaintiff’s attorneys argue the purity of their motives (“we’re just helping the victims get just compensation… for a fee”). When trial lawyers (who have a clear financial stake in their position) claim that there’s no malpractice crisis, that the greedy/negligent doctors just want a license to kill, and greedy insurance companies just want to make outrageous sums of money, while attorneys are the beneficient ones looking out for the “little guy,” you’ll excuse us if we guffaw a bit. Really… I’m serious… that’s how sanctimonious some of you come across.
I practice in Florida, where the PI attorneys are killing us. Physicians have left the state, our group is having a hell of a time recruiting, and a lot of it is the med-mal situation here. I can’t remember the last suit against one of my colleagues that had real, actual merit, yet we spend blood/sweat/tears defending every single one, since we have a brand-new 3-suits-and-you-lose-your-medical-license law in this state now.
Don’t tell me there’s no problem, when what you really mean is that there’s no problem for YOU. Do you really think us docs are bitching just to hear ourselves talk?
“You’ll pardon us docs if we snicker when plaintiff’s attorneys argue the purity of their motives ”
Which is why I don’t. Pardon me if I snicker when physicians argue caps are necessary for the patients, as well. There’s plenty of hypocrisy on both sides. Let’s both agree that both sides have a financial stake in the outcome.
But let’s be clear on one other thing. There is not a “malpractice crisis”. In most states the number of claims and payouts remain flat or track with medical inflation. What we have is an insurance crisis. Malpractice carriers lost money, for a variety of reasons, and they raised their rates on doctors until doctors squawked. It’s happened twice before in economic downturns.
For an excellent summary of this issue, try this article from Medical Economics:
http://www.memag.com/memag/article/articleDetail.jsp?id=141338
For a good summary of how insurance works, read Warren Buffett’s February ’04 letter to Berkshire shareholders, available at Berkshire’s website. It’s very readable and brief, and will explain the economics behind insurance. Berkshire just bought Medical Protective, the nation’s largest malpractice insurer, from GE by the way.
By the way, why do you have insurance if not to defend you and pay claims? Do you just pay it because it gives you a warm fuzzy feeling? Why is it so bad when you have to use it?
As for Florida’s 3 strikes and you’re out law, what did you think would happen when you cap damages? Considering your medical board rarely disciplines physicians despite multiple malpractice claims paid, the public ought to get something for giving up it’s right to recover. You routinely talk about the “climate” but that climate of fear physicians feel is not based in facts.
There is a problem, but your cure doesn’t address the cause. Here’s a couple of quotes from Florida insurers during the last “crisis” which are illuminating. These are typically what you see AFTER “reform” is enacted, and they come back for a rate increase:
Aetna Casualty and Surety Co. (Florida):
After Florida enacted what Aetna Casualty and Surety Co. characterized as “full-fledged tort reform,” including a $450,000 cap on non-economic damages, Aetna did a study of cases it had
recently closed and concluded that Florida’s tort reforms would not effect Aetna’s rates. Aetna explained that “the review of the actual data submitted on these cases indicated no reduction of
cost.” (Aetna Casualty & Sur. Co., Commercial Ins. Div., Bodily Injury Claim Cost Impact of Florida Tort Law Change, at 2 (Aug. 8, 1986))
St. Paul (Florida):
St. Paul’s found “a total effect of about 1% savings” from Florida’s 1986 tort reforms, but that even this 1% might be inflated. St. Paul concluded that “the noneconomic cap of $450,000, joint and several liability on the noneconomic damages, and mandatory structured settlements on losses above $250,000 will produce little or no savings to the tort system as it pertains to medical malpractice.” (St. Paul Fire & Marine Ins. Co., Medical Professional Liability, State of Florida–Addendum at 1 (1986))
What bothers me in this debate is that so many physicians seem unwilling to credit any evidence that contradicts their closely held prejudices. Yet their profession is so grounded, at least in theory, in “evidence-based” practice. I’m reminded of all those contemporaries of Semmelweis who dismissed the notion that failure to wash their hands might be causing infections – they just knew better. The argument that one has never met a trial lawyer he liked – oh yeah, except one, a chronic drunk driver – only sharpens the point. My father, a some time plaintiff’s attorney who ended his career representing Blue Cross – and a Republican of a stripe that no longer seems to exist – despised doctors because of their clannish refusal to discipline or testify against clearly inept colleagues. I guess “anecdotal” is a good enough type of evidence for a lot of people.
As in your anecdote. Thanks for clearing that up.
In case it isn’t clear, the point of my anecdote is that my father had no more logical basis for his generalized prejudice, based on limited, personal and highly partisan experience, than do you. The fallacy can cut both ways. And, alas, seems to.
Why do I have insurance? I have med-mal insurance because I’m required to have it; I can’t work at my facility without it. Why? Because the hospital doesn’t want to be the only deep pocket. Do you have life insurance because you’re planning on dying soon?
I don’t hear too many docs arguing that caps alone are the be-all-end-all for patients, rather they argue that a whole tort reform package is good for patients. If it increases physician supply (which gives patients more choice), and encourages physicians to take on typically higher-liability (yet necessary) cases like ER call, then everyone benefits. We may dicker about the incarnation/definition of “reform,” but I certainly don’t expect attorneys to be thrilled with the idea… there’s a lot of money in the status quo.
I also question the blaming of the 3-strikes law on the physicians for daring to ask for caps. That “blaming the victim” is something I’d expect from a criminal defense attorney, not a PI attorney. The trial lawyers pushed for the 3-strikes law after the FMA proposed giving a bigger percentage of any malpractice settlement to the victims… it was pure political payback.
Our medical board in Florida is actually fairly activist, at least from the physician perspective. They rake people over the coals with gusto, and generate a lot of money in fines. Even so, I suppose you could view them as ineffective if you define “discipline” as simply revoking licenses. How would the PI bar feel if we automatically disbarred attorneys who consistently lost cases, or brought 3 meritless cases?
Also, multiple suits are not themselves evidence of a dangerous physician. High-risk specialties encounter more suits simply by the nature of their practice. Neurosurgeons, for instance, practice a high-stakes, high-risk specialty, and encounter far more bad outcomes than other specialties… you’d expect more suits than a Dermatologist. Slagging on docs for their purported reliance on anecdote, while simultaneously claiming that a lawsuit or two (hardly a large dataset) represents a pattern of incompetence worthy of stripping licenses is a little incongruous.
I realize I’m coming down pretty hard on you PI guys, but you don’t operate in a vacuum. If there weren’t litigious people, you guys would be out of a job.
But let me turn this question around: Some of you seem to agree that frivolous cases and “greedheads” are a problem… how would you propose we winnow out the meritless cases? What sort of tort reform would you support?
I have life insurance to provide for my family in the event I am unexpectedly killed. If I had enough net worth, I probably wouldn’t. I carry legal malpractice insurance to protect my assets in the event I make a mistake unintentionally that falls below the standard of care. This prevents me from having to pay the whole amount out of my pocket.
You may not hear docs talking about caps, but literally every proposal that makes it to the legislature contains caps. Actions speak louder than words.
“there’s a lot of money in the status quo.”
There’s probably not as much as you’d think, certainly not compared to the risk involved. Med mal is a specialty, and practiced by very few attorneys because of the cost and the complexity of the issues. The good ones are very good, but could probably make a lot of money trying any kind of case.
I wasn’t “blaming” anyone for the 3 strikes. But again, what did you expect? You convince people the good doctors deserve protection, pretty soon they realize they can’t all be good and can’t think of any better way to tell the difference than malpractice payments. Can you tell a good plumber from a bad one just by talking to them?
I wasn’t referring to the number of suits filed, I was referring to payouts. Your claims of activism though are not supported. Of the 24 doctors who have paid 10 or more claims, only 12 have been disciplined. And that wasn’t me talking about the reliance on anecdotal evidence.
Did it ever occur to you that litigious people don’t necessarily want to be litigious? That sometimes insurers flat deny meritorious claims that should be paid leaving people with no recourse? Or lowball offers knowing the claimant probably can’t afford to hold out? By the way, one can lose a case and it doesn’t mean it lacks merit.
As for what tort reform I would propose, it would be to strengthen Rule 11 sanctions which would allow judges to be harsher on those bringing meritless claims. One thing to note though, in medical malpractice, because of the short statute of limitations, it’s often necessary to file suit against all physicians involved to sort out who was responsible for what. If physicians would give depositions pre-suit, this would probably not be necessary, but I don’t see this happening soon.
You can’t really stop people from FILING claims, though. Because you can’t judge something meritorious or not until you see the evidence.
You shouldn’t come down that hard on us, for you’re only a drunk driver, or even someone trying to get through a red light, away from needing us. Do you think insurance defense lawyers represent personal injury plaintiffs? How about those big national and international firms with rosters of Fortune 500 companies as clients?