Kevin, M.D. - Medical Weblog

Mark Herrmann: Regulation by lightning bolt

The following is a reader take by Mark Herrmann.

Last month, the Supreme Court held that manufacturers of medical devices approved for marketing by the FDA through the "pre-market approval" process generally cannot be sued by private plaintiffs. The medical device industry hailed that decision. At long last, companies that ran the regulatory gauntlet of FDA approval would no longer have the FDA's decisions about appropriate product design and warnings second-guessed by lay juries sitting in the presence of an injured plaintiff.

The New York Times reports on a different subject, but it's all of a piece. American courts permit juries to award punitive damages in some cases, but foreign courts are increasingly refusing to enforce those punitive damage awards. "Punishments," those foreign courts say, "should be meted out by the criminal justice system, with its elaborate due process protections and disinterested prosecutors." Lay juries should not be the gatekeepers of damage awards intended to punish wrongdoers.

These two recent developments grow out of different areas of law, but they point to the same underlying concern. Neutral government experts - either scientific experts at the FDA or legal experts in prosecutors' offices - are the appropriate people to set public policy. Lay juries are not.

Juries serve important purposes. At the founding of the republic, criminal cases might ask whether the inhabitant of a log cabin had the right to shoot an intruder in self-defense or whether the owner's response went beyond societal norms. A jury is the perfect decision-maker in that situation - who better knows societal norms than a small cross-section of local society itself?

And juries' capabilities extend far beyond criminal cases. In many civil matters, a jury's collective wisdom will resolve disputes more intelligently than many possible alternatives.

But juries are far less suited to decide whether complex medical devices have been designed appropriately, so society is right to limit a jury's power to second-guess the FDA's decisions on that score. Even if capable of making those decisions, jurors are sitting in the presence of an injured plaintiff and so are naturally sympathetic to that person's plight. Juries are not weighing the risks and benefits of a product's design in a neutral, dispassionate setting.

Juries' decisions to award punitive damages suffer similar flaws. Juries rarely award punitive damages - but when they do, they occasionally do so in breathtaking amounts. Randomly imposing breathtaking damages is regulation by lightning bolt, not a carefully calibrated regulatory policy. If misconduct is to be deterred, people must know that it is likely to be uncovered and punished. Misconduct will not be deterred by rules that make it unlikely that the misconduct will be found, but, if it is, might be punished disproportionately.

Physicians, no less than other participants in the legal system, should work in an environment that deters negligence and compensates injured victims. But that system must be calibrated so that its results are predictable and layman are not forced to second-guess the decisions of neutral experts. In the field of medical malpractice, as in the fields of product liability and punitive damages, society is right to search for a system that regulates predictably, not erratically.

Zeus should dispense justice only in ancient Greek myths, not in modern American courts.

Mark Herrmann is the author of The Curmudgeon's Guide to Practicing Law and blogs at the Drug and Device Law Blog.

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Fear and "condition branding"

Shannon Brownlee: "By constantly reminding us to be on the lookout for illness, doctors and the media have made many Americans feel more anxious. I'm not so sure their warnings have made us any healthier, but they have decidedly eroded our sense of well-being. We worry about every ache and pain; we fret that the least little sign of sadness in a teenager is a symptom of clinical depression. But in viewing so many aspects of ordinary human experience as treatable diseases, we may have granted medicine more power than it deserves -- or is good for us."

(via a reader tip)

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Dosing infants

Can be tantamount to guesswork.

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Tanning industry

The new Big Tobacco?

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What do Schering-Plough and Spitzer have in common?"

"Both had high-priced whores who turned on them in the end."

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Search for a defibrillator magnet

Shadowfax: "Long after the patient had basically expired, long after his heart had lost the ability to beat in any sort of functional pattern, the silly thing kept pacing away and periodically issued a shock, which caused the patient's body to twitch in a manner most distressing to the family."

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The fallacy of "more medicine"

Unnecessary tests for no reason simply leads to more invasive diagnostic studies.

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Anal retentive . . .

. . . or simply a good surgeon?

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MedBlog Power 8

03/26/2008 - 04/03/2008
Next revision: 04/03/2008



(Key: Rank, Blog name, Last week's rank, Post of note)

1) Surgeonsblog (4), Spendtacular Surgery

2) The Happy Hospitalist (2), Only In America

3) over my med body! (1), Health Care’s Broke: Drug Access

4) Health Beat (5), Newsflash: Doctors Are Human Too

5) Musings of a Distractible Mind (-), When a System is not a System

6) ER Stories (3), Just one day….

7) Panda Bear, MD (7), Defending the Pie

8) GoozNews (-), Big Tobacco Behind Lung Cancer Screening Study

The MedBlog Power 8 is a list of medical blogs that have had an exceptional week of blogging, based purely on my subjective measures. Factors I consider are how provocative the posts are, the amount of discussion it generates, and posting frequency.

The list is revised mid-week and will be published every 1-2 days on Kevin, M.D. If you want me to consider your exceptional week of blogging, you can contact me.

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EMR Experts

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Part-time doctors and the physician shortage

An increasing number of part-time physicians are leading to access problems. Is this shades of what's happening in Canada?

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Rural medicine

Even loan forgiveness may not be enough to lure doctors.

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Hospitalists and referrals

The Happy Hospitalist: "Hospitalist medicine has changed the landscape. New relationships are being formed. Based on respect instead of fear and ass kissing. Some will survive. Those that don't accommodate will die the way of the dinosaur. You could, in fact, say that these are market forces creating respect where none previously existed."

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Vytorin: "No added benefit"

Ouch. (via Peter Rost)

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Cardiologists doing primary care: "You're not very good at it"

#1 Dinosaur: "Don't go ordering lipids (which I just did a month ago) and prescribing Chantix (which I've already given him twice) and basically trying to do Primary Care. You don't know what you're doing, and you don't even realize it."

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Customer satisfaction

Associating it with job security is simply wrong:

Just telling someone off when they deserved it and not dispensing dilaudid like a dealer should not be grounds for termination in my book.

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Surrogate mothers

Newsweek: "Surrogates challenge our most basic ideas about motherhood, and call into question what we've always thought of as an unbreakable bond between mother and child. It's no wonder many conservative Christians decry the practice as tampering with the miracle of life, while far-left feminists liken gestational carriers to prostitutes who degrade themselves by renting out their bodies."

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Reader Takes

Reader Takes is a regular feature where selected op-ed style pieces from the audience at Kevin, M.D. will be published on the blog.

Posts are between 500 and 600 words in length, and can argue any opinion related to medicine and health care.

Original articles that are provocative, well-written, free of grammatical or spelling errors, and generally follow these guidelines are preferred.

Once a reader take is published, it will remain at the top of the blog above the fold for one day. A link to the author's book, blog, or website will be included.

Kevin, M.D. receives in excess of 10,000 visits daily, and is regularly read by major media outlets.

The piece will remain exclusive to Kevin, M.D. and may not be republished elsewhere.

If you are interested in submitting a take for consideration, please contact me.

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Unnecessary ambulance calls

Washington Post: "The ambulances come screaming down city streets, rushing on calls to burst boils, clip hangnails and check on smelly body parts. At the cost of $700 a visit . . .

. . . Thirty people accounted for 2,400 emergency transports last year."

(via a reader tip)

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"The primary care physician has become a classic immigrant position"

David Williams: "A low-paid, unattractive job that Americans won’t fill." (via DrRich)

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Alternative medicine

Panda Bear: "Expensive, carefully constructed placebo."

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Disband the RUC

Jay Parkinson: "If the total number of healthcare visits in the US are 75% primary care visits, 75% of the docs on the RUC should be primary care docs."

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Divided America

Why health care reform can never be enacted:

We’ve circled back to the notion that "the U.S. is different." And once again, that "difference" is not to our credit. Reinhardt is predicting that we cannot—and will not—pull together to create and finance a high-quality healthcare system for all Americans because we don’t identify with each other. Instead, we live in our separate pods, defined, to a large degree, by how much we earn, and what we can afford to buy.

Maggie Mahar is right on the money. I happen to agree with her assessment, but I'm much less hopeful than she is.

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Patient's son kills ICU nurse

AP: "Armed with a three-year grudge and more guns than he could hold, a former substitute teacher stormed a west Georgia hospital looking to punish the nurse he blamed for his mother's death." (via ER Stories)

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Lortab on the street

When was the last time you saw narcotics just laying around?

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Why the best and the brightest need to be in primary care

Robert Centor: "We need the best and brightest to understand why you are short of breath, or why your abdomen hurts, or why you feel weak. If you start with a subspecialist you likely will fall victim to Maslow’s admonition - 'If you only have a hammer, you tend to see every problem as a nail.'"

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United, gynecologists stand

A patient in Florida finds that all OBs require signing away their right to sue. Again, patients lose in today's malpractice climate:

The gynecologist I’ve seen for seven years has begun requiring patients to waive their right to a day in court and to accept binding arbitration to settle any potential disputes, or she will not treat them. I sought care elsewhere but discovered that nearly all ob-gyn practices in the area make the same demand.

Posted by Kevin | link | Comments (27) |

MedBlog Power 8

03/26/2008 - 04/03/2008
Next revision: 04/03/2008



(Key: Rank, Blog name, Last week's rank, Post of note)

1) Surgeonsblog (4), Spendtacular Surgery

2) The Happy Hospitalist (2), Only In America

3) over my med body! (1), Health Care’s Broke: Drug Access

4) Health Beat (5), Newsflash: Doctors Are Human Too

5) Musings of a Distractible Mind (-), When a System is not a System

6) ER Stories (3), Just one day….

7) Panda Bear, MD (7), Defending the Pie

8) GoozNews (-), Big Tobacco Behind Lung Cancer Screening Study

The MedBlog Power 8 is a list of medical blogs that have had an exceptional week of blogging, based purely on my subjective measures. Factors I consider are how provocative the posts are, the amount of discussion it generates, and posting frequency.

The list is revised mid-week and will be published every 1-2 days on Kevin, M.D. If you want me to consider your exceptional week of blogging, you can contact me.

Posted by Kevin | link | Comments (0) |

My take: Henschke, insolvency, MIs, specificity

1) Claudia Henschke has been coming under fire after the NY Times connected her research to tobacco companies.

My take: She has been the most zealous proponent of CT scans for lung cancer screening. Unreasonably at times, ignoring basic evidence-based medicine principles. Perhaps in the future its time will come. Today, the data is too inconclusive to make a firm recommendation.

Now that we hear that she stands to benefit financially (through the patents she held on the technology), and that Big Tobacco financed her research.

It is unfortunate that the media took her message and ran with it. Hopefully they will report the questions surrounding her research with the same vigor.

2) Medicare is on the road to insolvency.

My take: Dr. Wes alluded to this today.

Physicians are being killed slowly with payments not keeping up with practice costs, patients face rising health premiums, and the number of uninsured continue to grow.

Maybe we should let Medicare die, so some real change can happen.

3) Only half of all patients with heart attacks arrive to the hospital via ambulance.

My take: In cases of acute MI, seconds count. It is foolish to discount chest pain unless proven otherwise. Don't "tough it out" and drive yourself to the hospital when chest pain occurs.

4) The BBC reported that breast MRIs are having problems with specificity.

My take: Specificity is defined as the frequency of a positive test in the absence of disease. As advanced imaging studies continue to be promoted by the media as "better", more patients will believe that.

The problem is that CTs, MRIs or PET scans increasingly detect findings that are benign, leading to more invasive tests. Unnecessarily ordering these studies exposes the patient to potential biopsies, which can have serious complications.

Posted by Kevin | link | Comments (7) |

Reader Takes

Reader Takes is a regular feature where selected op-ed style pieces from the audience at Kevin, M.D. will be published on the blog.

Posts are between 500 and 600 words in length, and can argue any opinion related to medicine and health care.

Original articles that are provocative, well-written, free of grammatical or spelling errors, and generally follow these guidelines are preferred.

Once a reader take is published, it will remain at the top of the blog above the fold for one day. A link to the author's book, blog, or website will be included.

Kevin, M.D. receives in excess of 10,000 visits daily, and is regularly read by major media outlets.

The piece will remain exclusive to Kevin, M.D. and may not be republished elsewhere.

If you are interested in submitting a take for consideration, please contact me.

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Medical malpractice, lawnmowers and bicycles

Dr. Sam: "Regardless of all the propaganda being spewed by the disciples of John Edwards, the ridiculous lawsuit culture absolutely has a tremendously damaging effect on the cost and efficiency of, and access to, needed medical care in the United States.

Just as the makers of my lawnmower and my bicycle have altered their products to cover their asses legally, every physician in the U.S. with half a wit, alters their products (medical practice) to cover their asses legally.

Unfortunately, in medicine CYA doesn’t mean just slapping on a sticker or putting inconvenient little blobs of metal on a bicycle fork."

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Operating on family and friends

Is it really a close call?

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"There is no free lunch"

retired doc: "The medical utopia of which [Michael] Moore talks about doesn't exist anywhere. Many countries are finding that some system of co-payments and deductibles need to be in place to mitigate the escalating costs that are occurring everywhere-rising costs are not unique to the U.S."

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"I'm reluctant to pump more money into a broken system"

Jay Parkinson: "So Hillary, what do you think mandatory insurance for everyone does?"

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Claudia Henschke and "blood money"

Roy Poses investigates the controversy surrounding her CT scan for lung cancer screening research.

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More drug rep confessions

Shahram Ahari, former drug rep: "Gift giving is the key. You are programmed as a human to reciprocate. You feel obliged to return the favor. As a matter of fact, the smaller the gift, the greater the sense of obligation."

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Don't try to kill yourself this way

Using a screwdriver for suicide can get messy.

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Maybe we need Medicare to go bankrupt

Dr. Wes: "Additional pressure would also be applied to limit unnecessary and costly testing in a non-Medicare era. Pressure to establish meaningful nation-wide tort-reform will simultaneously take place. Since medical errors in any healthcare system are inevitable, peer-directed health courts or a no-fault payment policy would have to be implemented."

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"I kill you"

Not. (via Dr. Val)

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A blogger's worst nightmare

Fat Doctor accidentally erased her blog. Any way to help her out?

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"Self-propelled" colonoscopies

Wave of the future?

Instead of pushing an endoscope through the colon, researchers now are developing endoscopes that can pull themselves . . .

. . . The main challenge to building such devices involves clutching onto the slippery walls of the colon in a way that does not damage them.

Dodou and her colleagues have found sticky films called mucoadhesives that could help such devices find the traction they need by sticking onto the mucus lining colon walls. These adhesives already find use in techniques for delivering medicines into the body.

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Prayer doesn't cure diabetes

AP: "Police are investigating an 11-year-old girl's death from an undiagnosed, treatable form of diabetes after her parents chose to pray for her rather than take her to a doctor."

Posted by Kevin | link | Comments (2) |

If you think you're having a heart attack . . .

. . . please call 911.

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Insidermedicine: In the Clinic - Several Common Endocrine Disorders

In the Clinic - Dr. Robyn Houlden, MD, Studies Several Common Endocrine Disorders

Thanks to Insidermedicine for their continuing sponsorship at Kevin, M.D.

Insidermedicine (www.insidermedicine.com) is a physician-led news organization that brings daily evidence-based updates to patients, doctors and medical students. Also available in Chinese and Spanish.

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MerckMedicus

I would like to introduce MerckMedicus as the latest sponsor at Kevin, M.D.

MerckMedicus is one of the most innovative and comprehensive medical resources on the Internet. This advertising-free medical portal for today's healthcare professional combines breaking medical news, a wide variety of online learning resources, cutting-edge diagnostic tools, and even the patient's perspective on the world of medicine. MerckMedicus is the convenient solution for professionals who don't have time to log on to numerous medical websites.

Sponsorship opportunities continue to be available. This can be via a Standard Blogad or a customized package. Please visit the advertising information page for further details.

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How to get into dermatology

Sure to be a popular post amongst medical students. Dermatologist Jeffery Benabio shares some tips.

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Reader Takes

I'm happy to introduce Reader Takes, a new regular feature.

Reader Takes will feature selected op-ed style pieces from the audience at Kevin, M.D.

Posts are between 500 and 600 words in length, and can argue any opinion related to medicine and health care.

Articles that are provocative, well-written, free of grammatical or spelling errors, and generally follow these guidelines are preferred.

Once a reader take is published, it will remain at the top of the blog above the fold for one day. A link to the author's book, blog, or website will be included.

Kevin, M.D. receives in excess of 10,000 visits daily, and is regularly read by major media outlets.

The piece will remain exclusive to Kevin, M.D. and may not be republished elsewhere.

If you are interested in submitting a take for consideration, please contact me.

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The state of EHRs today

A nice overview of the plight of electronic records.

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How to piss off a pediatrician . . .

. . . or what not to say.

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Limits

DrRich: "If we fail to limit our appetite for healthcare expenditures that benefit only ourselves, we will be revealed in a decade or two to our own children and grandchildren (not to mention to future historians) as among the most morally repugnant generations in history."

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Dr. Crippen changes a BBC headline

His criticism of a recent headline garners an apology from the BBC. (via TBTAM)

Posted by Kevin |