healthsignals new york

Dead from a nose job

The reporting's tabloid. But the story ...

The patient died after cosmetic surgery earlier this month. Yes, a nose job.

The doc then goes into hiding. The patient, Ms. Cregan was from Ireland leading the Irish Medical Council to express concern about the

lack of regulations governing the establishment and operation of cosmetic surgery clinics in Ireland.

So we wander over to New York's Physician Profiling System and we look up Dr. Michael Evan Sachs, license number 131958 (issued in 1977).

And we find one judgement from 2001 and 32 settlements from 1995 to 2003. All of the payments are "average" or "below average."

And in particular we look for any restrictions on this practice. Here's what we find, updated a mere five days before the surgery on Ms. Cregan:

Dr. Sachs shall be precluded from performing complex nasal procedures except when assisting, or assisted by, a surgeon who is either Board-Certified by the American Board of Plastic Surgery, Inc. or Board-Certified by the American Board of Otolaryngology and who has completed a fellowship in facial-plastic surgery, and who has at least ten years of experience and expertise in performing such complex procedures. For purposes of this limitation, the term "complex nasal procedures" shall mean those requiring multiple operations (more than two planned procedures) and serial reconstructive procedures, include those involving congenital malformations. This limitation shall not preclude him from performing, without such assistance, routine nasal-septal procedures, including but not limited to routine nasoplasties, open rhinoplasties, and cartilage or synthetic grafts for structural and functional purposes.

We find the same text at the State's Office of Professional Conduct and we find that he did not contest the charge of negligence in a prior case nor challenge three years of probation. We also find the legal Consent Agreement (PDF) stipulating the restrictions on his practice and indicating negligence on multiple treatments of a single patient. It's legalese and not revealing. You try to imagine what's between the lines.

Neither regulatory oversight, nor professional colleagues, nor the threat of lawsuits and high liability premiums (which probably were considered just a part of doing business), prevented this loss. Yes, there might have been a prior condition (though, if so, it would have been nice to know wouldn't it). But even if that's the case, doesn't it seem like  there might be a pattern here?

I can't help but be reminded of Ted, the co-pilot.

Frivolous?

Emotional reaction to the charges that medical lawsuites are frivolous. (Quicktime movie.) Thanks for the tip to Paul Waldman at Gadflyer.

Maybe it's not all due to trial lawyers

Several reports out the last couple of days describing investigations in New York and Connecticut regarding whether improper behavior by insurance companies has been a factor in the rapidly rising cost of malpractice insurance for lawyers and doctors. Read that again: ... for lawyers and doctors.

Behavior and organizations

After yesterday's rant about Merck and the potential effect on any reasonable prospect of tort reform, I had the following thought:

Why don't we differentiate between natural persons and artificial persons (namely corporations) in legal standards and disputes over liability, placing tighter constraints around artificial persons? Of course, there will be suggestions that this is primarily because corporations would tend to have more money, but that's not where the idea comes from.

Let's face it. People behave differently in corporate settings than they do outside of them.

First, the underlying purpose of the corporate form is to limit liability for individuals, i.e., reduce the personal risks associated with decisions. Reducing the risk reduces the price or probable price, thereby encouraging more risk-taking behavior. The corporate form, quite an innovation in its day, is but a few centuries old (I need to look that up). But the use of this form is so embedded in our economy and society that we don't typically give a second thought to the treatment of corporations as persons. OF course, corporations don't have the full rights as natural persons (such as the right to vote), but many discussions don't differentiate at all and I don't recall hearing any "tort reform" discussion or seeing a reform proposal that differentiated between the two. (If you're aware of any, send them my way.)

Second, all groups create pressure on all participants, encouraging behaviors that might not otherwise emerge. It's much easier to hold individuals to ethical standards, especially professionals, than it is to hold organizations to any standards at all.

So why don't we consider cutting individuals (natural persons) some more slack, but not corporations (artificial persons)?

In order to maintain the advantages of limiting liability, we might want to consider also differentiating between putting oneself or one's corporation at risk and putting those outside at risk (think environmental hazards, or hiding the results of drug trials). We might also want to re-consider the obligations and protections that adhere to an individual acting within a corporation.

We might also want to be more clear about the consequences for both corporations and corporate officers and employees of criminal behaviors. After all, we can put individuals in jail, but not corporations and we rarely dissolve them for criminal behavior.

Most medical practitioners have the sympathy of the public with respect to liability issues. But in getting lumped in with corporate miscreants under a general banner of "tort reform" and attacks on "trial lawyers" the opportunities for relief have been diminished.

Thoughts?

Is Merck the Richard Nixon of drug companies?

What did they know and when did they know it?

Anna Wilde Mathews and Barbara Martinez of the Wall Street Journal report that (subscription required) suggests that Merck knew about the cardio-vascular risks from Vioxx much earlier than the company had let on.

When Merck & Co. pulled its big-selling painkiller Vioxx off the market in September, Chief Executive Raymond Gilmartin said the company was "really putting patient safety first." He said the study findings prompting the withdrawal, which tied Vioxx to heart-attack and stroke risk, were "unexpected."

But internal Merck e-mails and marketing materials as well as interviews with outside scientists show that the company fought forcefully for years to keep safety concerns from destroying the drug's commercial prospects.

The Journal got hold of internal documents:

Merck's first worry, in the mid-to-late 1990s, was that its drug would show greater heart risk than cheaper painkillers that were harsh on the stomach but were believed to reduce the risk of heart attacks. Several company officials discussed in e-mails how to design a study that would minimize the unflattering comparison, even while admitting to themselves that it would be difficult to conceal.

By 2000, one e-mail suggests Merck recognized that Vioxx didn't merely lack the protective features of old painkillers but that something about the drug itself was linked to an increased heart risk.

Documents going back to 1996-97 anticipating blood clot related problems and these problems were revealed in a study completed in March of 2000. Nevertheless, Merck reported the next month:

Merck confirms favorable cardiovascular safety profile of Vioxx.

And then Merck funded researchers and consultants had a paper published in the November 23, 2000, New England Journal of Medicine, but:

The article, written by academics who received consulting contracts or research grants from Merck and by Merck employees, discussed Vioxx's benefits for the stomach and heart-attack rates. But it didn't include information that, in retrospect, was important. Among patients who weren't already at high risk for heart attacks, it said, Vioxx didn't show a significant rise in heart attacks. That implied it was all right for people with healthy hearts -- say, a jogger in his 30s with joint pain -- to take Vioxx. But the article didn't provide detailed information about other serious cardiovascular complications such as strokes or blood clots.

The Journal reports that sales rep training that suggests that the reps "dodge" when asked by physicians about the risks.

One training document is titled "Dodge Ball Vioxx" and consists of 16 pages. Each of the first 12 pages lists one "obstacle," apparently representing statements that might be made by a doctor. Among them are, "I am concerned about the cardiovascular effects of Vioxx" and "The competition has been in my office telling me that the incidence of heart attacks is greater with Vioxx than Celebrex." The final four pages each contain a single word in capital letters: "DODGE!"

Merck also reportedly tried to suppress or discourage reporting contradictory studies.

Merck denies all of this or says it is "out of context."

If even a fraction of this is true, then Merck will and should be toast. Financial fraud by companies like Enron or MCI is bad enough, but this kind of behavior is qualitatively worse. Sorry Doc, but it's a very good argument against "tort reform." Well maybe the remedy for this kind of misbehavior goes beyond civil redress. Maybe we'll see some criminal prosecutions.

Capping damages produces what savings?

Texas capped non-economic damages last year. Did it make a difference? ACSBlog reports according to one insurer, not much.

Be interesting to do some follow-up on this (along with a million other things).

And trial attorneys frighten you?

Remember what Moviemaker Michael Moore did to General Motors? Remember his bit on Charlton Heston and the NRA? And what about President Bush in Fahrenheit 9/11?

We may be next. Read the report of Moore's impending work on healthcare in the Chicago Tribune (requires registration). Thanks to the Health Law Blog for spotting this.

The scruffy movie producer/director, Michael Moore may be putting together a movie on healthcare! Rumor has it that the film will focus on pharaceutical and managed care firms. By I wouldn't count on anyone being safe until it's done and they've emerged unscathed. Nevermind the sober reports. This would really get to the public in ways that reports don't. I can already imagine the gnashing of teeth.

When it's not a system problem

I strongly suspect that most quality problems and most errors are the result of system or structural problems and require system re-configuration and process change to reduce and avoid. And I recognize that sometimes, even when a system is well structured, running smoothly and there are no errors, fate intervenes and the result is unfortunate. That's simply the laws of probability at work.

But sometimes, I'm not so sure that any of the above applies to a particular case or a particular practitioner. Let's face it. Sometimes, people know their stuff, but just can't apply it consistently correctly in the real world, especially under stress. This was the case when I read recently a news account of a physician whose license was suspended for "incompetence and negligence" by New York's Office of Professional Medical Conduct, initially for three years. The suspension was then reduced to three months with the proviso that he complete 125 hours of CME. This particular physician had failed to diagnose an ectopic pregnancy, had wrongly prescribed a drug for a patient "potentially deadly" in combination with another drug another the patient was taking, and had made other errors with other patients.

When I read about this case I thought back to a co-pilot I flew with on just one mission to Europe and the Middle East when I was in the Air Force. This particular co-pilot (we'll call him "Ted") was very experienced. He had lots of flight hours and was technically ready to upgrade to Aircraft Commander. He was quite smart, had graduated from a prestigious technical university, and knew the technical details of the plane we flew. But, sometimes, Ted just didn't seem to be fully present. First, when it was his turn to fly, he seemed sloppy and "disengaged." Then while I was flying into a short field in terrible weather, Ted failed to perform one of the most elemental checks he was responsible for during landing. And when I challenged him on it, he didn't seem to be particularly bothered. I finally lost it when we were just short of departing Turkey for the Middle East, an area politically sensitive even then. Despite the fact that I had reminded the entire crew at least three times, Ted didn't have the proper personal paperwork, and again didn't seem to be particularly concerned about it. Then he told me that he'd known that he didn't have it when we left the US and hadn't bothered to tell me even when I'd raised the issue.

Fortunately, I had a second co-pilot. So I left Ted in Turkey, telling him to find his own way back home and the rest of us continued with our mission. Yes, I threw him off the crew. I later learned that some of the crew celebrated because they already thought Ted was unsafe.

On the way home, I re-read, start-to-finish, Ted's complete flying record. The eight hours over the Atlantic gave me the opportunity to see the patterns that neither I nor anyone else had seen before. Before, it was just isolated incidents. Afterwards, we could see the pattern. Ted was incompetent. He wasn't a bad guy. His book learning was above average. But he just couldn't put it together in the real world in a consistent and safe manner. And no amount of re-training was going to solve the problem. I was greeted by the Squadron Commander and the head of Standarization and Evaluation (quality control) when I returned to the US. Needless to say, they wanted to know why I had tossed a crewmember off my crew. My response was to ask them to read Ted's flying record as I had. The next day, the head of Standardization called to tell me that, having read the record, they didn't need any more information from me. Ted never did become an Aircraft Commander.

This brings me back to where I started. Just as in all fields, some doctors are incompetent. I believe their percentages are much lower than in other fields, but I have no doubt that they're out there. And the solution isn't to suspend their licenses for three months because while they may know more at the end of that time, their ability to apply it will not have improved. A three month suspension strikes me as a political solution, but ultimately inadequate. Ted should never have become responsible for the lives of others. The same is true of some physicians. It's painful; it's unfortunate, even sad. But sometimes, it's just necessary.

It's not just the lawyers

Matthew Holt with a commentary on quality and the liability debate and what's really relevant.

Trial lawyer, trial lawyer, trial lawyer

So now that John Kerry has selected John Edwards to be his Vice-Presidential running mate we can expect to hear the Republican mantras about trial lawyers even more. A lot more. Yes, some of Edwards's cases were medical cases. But the "trial lawyer" attacks may work for politicians, but for the medical community they may backfire.

Expect Bush partisans to use the phrase "trial lawyer" repeatedly to attack Edwards. Of course, to do so unthinkingly exposes the assumption that representing an injured party in a civil action is a craven act.

For those of you who have reasoned concerns about medical liability issues, here's a cautionary note about joining in the "trial lawyer" attacks on Edwards. Those attacking Edwards and those pushing for Federal restrictions on tort actions are lumping medical malpractice with corporate misdeeds and negligence. A good example came tonight when Republican National Chairman Ed Gillespie attacked Edwards as a trial lawyer on MSNBC's Hardball with Chris Mathews. (I'll link to the transcript when it's available.) In Gillespie's words, the victim in the current tort system is physicians. But the tort "reform" he talks about doesn't just insulate physicians, it insulates corporations.

In Edwards world, the victim is the "little guy" seeking redress, not just from physicians, but from corporations. If this issue becomes a big one in the campaign and if this pattern continues, then physicians and other medical professionals are going to get lumped with Enron and the like.

Little guy injured. Big guy caused it. Who do you want to be associated with? There's a difference between medical professionals and corporations. But if this fight plays out wrong, the public will see medical professionals taking the side of "big corporations" against the little guy. In the classic American tale you lose that one Doc.

Lumping medical professionals and corporations may be OK for political operatives who want to wrap their argument in the sympathetic shroud of caring physicians and other professionals. But it will only cause pain for the professionals. This will be particularly easy trap to fall into with Edwards.

Josh Green writes of Edwards's Senate campaign against Lauch Faircloth:

Faircloth's campaign strategists considered making a commercial featuring a doctor whom Edwards had put out of business, but thought better of it when they realized Edwards would retaliate by putting forward the little girl who'd suffered at the doctor's hands.

Don't overestimate the public's distate for "trial lawyers." And definitely don't underestimate Edwards in tarring him with the stereotype. Edwards's signature cases attacked corporations and, in at least some of those cases, you don't want to be defending the companies he went after lest you wind up being tarred with their negligence. Indeed, the case I'm most familiar with, that of a young girl mauled by a swimming pool intake pump, would horrify the vast majority of medical people and must certainly have horrified those caring for the victim.

Edwards's campaign theme of "two Americas, one of work and one of wealth" had a Jacksonian ring to it and his family experience and his work as a trial attorney fits neatly with that outlook. It clearly resonated with a lot of people. This campaign is going to be really nasty. And even if Bush is re-elected, if doctors and other medical professionals allow themselves and their reputations to be used carelessly, they'll pay a terrible political price.