A patient was admitted to the hospital with chest pain and underwent a cardiac catheterization, The patient was found to have a partly blocked coronary artery that was opened with balloon angioplasty and stenting. The patient was started on aspirin and clopidogrel (Plavix) and discharged to home. The day after the discharge the patient returned to the hospital with recurrent chest pain and on repeat catherterization it was found that the stented artery had partly occluded with clotted blood and needed to be cleared.

Clotting or thrombosis within the stented part of the artery is an uncommon complication and can occur anytime following the procedure for up to a year or more. Within the first 30 days the most common cause of clotting is noncompliance with antiplatelet medication, i.e. the patient stops taking their clopidogrel.

In this case the patient was appropriately treated and discharged from the first admission after being given a prescription for clopidogrel. The patient then sued the cardiologist because . . (wait for it) . . he claims that he was NEVER TOLD TO FILL THE PRESCRIPTION AT THE TIME HE WAS DISCHARGED thus leading to the clotting. Never mind that:

1. Once-a-day medications like clopidogrel are usually given the same day as the discharge and that the antiplatelet effect lasts up to 3-6 days.
2. There is still a small chance of clotting despite treatment with clopidogrel.
3. A patient who does not follow simple directions for a scheduled once-a-day medication is either incompetent (thus requiring a guardian) or themselves negligent.

But despite the obvious frivolous nature of this lawsuit, our current system allows it to progress all the way to trial despite the low possibility of success all because a jury of individuals picked specifically for their ignorance of modern medical practice might find in favor of the plaintiff. As usual, a huge waste of time and money for all those involved.

Remember back in 1994 when seven CEOs representing the largest tobacco companies testified before the House Subcommittee on Health and the Environment and stated, quite clearly, their beliefs that nicotine is NOT addictive? Well, according to a new study, these same tobacco companies thought it important enough to increase the amount of this allegedly non-important, non-addictive substance in their products by 11% from 1998 to 2005.

Not too surprisingly the documented increase came on the heels of a massive $246 Billion 1998 “Master Settlement Agreement” (MSA) between 4 of the largest tobacco companies and 46 states (the total amount is being distributed to the states over 25 years on the pretext of reimbursing the states for the health costs of cigarette use). This latest news is more evidence that the MSA was and is not worth a disgusting jar of year old cigarette butts.

The MSA had “little effect” on cigarette advertising especially that directed towards teenagers which it was intended to limit. It also appears that the big tobacco companies simply passed the costs of the MSA on to their addicted customers to the tune of about $1.28 per pack from 1998 to 2002. The net result is essentially a tax on tobacco addicts since the MSA allowed the payments to the states to be tied to sales. As tobacco product sales decline so to do the settlement payments each year. Yet, the MSA doesn’t even appear to have had any significant effect on the slow rate of decline in tobacco usage which began in the 1970s, decades before the MSA!

What the MSA did do was to let big tobacco off the hook and was a huge gift in disguise. It provided tobacco companies some protection against current and future lawsuits and gave them an excuse to raise prices to counter declining sales. The MSA created an unholy and ironic alliance between big tobacco and the states since both now have a vested interest in keeping tobacco sales up. The MSA was designed to do this by allowing the tobacco companies to essentially fix prices and reduce competition. Best of all, the MSA gave the Republican controlled Congress a great excuse to avoid any attempt to pass legislation to regulate tobacco products.

The 1998 MSA was the biggest consumer product lawsuit of all time and is one of the best examples of how litigation as a substitute for legislation fails to protect consumers or especially in this case, to compensate those injured by harmful products. The end results of the MSA are typical for this type of litigation; The states got some but not full compensation for tobacco related health costs, the tobacco companies got richer, some lawyers got massively richer, tobacco remains unregulated and dangerous, and the consumer/addict got screwed out of $1.28 a pack.

Almost a decade after the MSA and we find that cigarettes have 11% MORE nicotine in them and tobacco products continue to cause over 400,000 premature deaths each year. Tobacco remains the most dangerous and least regulated consumer product in the US. For a country obsessed with consumer product safety, this general lack of concern over the dangers of tobacco use and addiction is a glaring and bizarre omission.

Maybe it’s because tobacco has been around for so long (thousands of years) and the dangers known for so long (since the 1950s) that we don’t pay much attention given our modern 24 hour news cycle collective memories. Maybe it’s because only 2 to 3 out of every 10 of us regularly use tobacco and we have a tolerance for allowing people to do dangerous things as long as 1.) The dangers are known and 2.) It’s not dangerous to anyone else (not everyone believes in the effects of second hand smoke). Maybe it’s because tobacco takes so long to kill.

With such a high award, [Merck] will think twice before they dare introduce a drug with a side effect. That’s the theory at least.

A theory. Yea, but that’s all that is. The reality is that even such massive out of proportion awards like that seen in this case have never been proven to change corporate behavior in the development of harmful products. Case in point; the tobacco industry has been sued for millions (individual cases and class action suits) and billions ($9.8 Billion per year for 25 years to be paid out to the states to cover the health costs of smoking) but in 2001 US cigarette sales totaled about $102 Billion including about $10 Billion in net profits.

Yet tobacco remains the single deadliest consumer product causing over 400,000 deaths (1 in 5) per year in the US and producing up to $75 Billion per year in health care related costs and $82 Billion per year in economic loses. Even the massive class action suit brought by the states does not come close to covering these smoking related costs. It’s too easy for the tobacco companies to pass the costs of awards on to the consumer.

The situation is similar for Merck and Vioxx. Even though the arthritis painkiller was taken off the market in 2004 (unlike tobacco), sales of Vioxx were massive, $2.5 Billion in its last year on the market. But this represents only 11% of Merck’s total revenue. So far the total amount of jury awards (after reductions to comply with state statues on award limits) in the few cases won against Merck have been less than Merck could earn on investing the 2.5 Billion at 5%!

And it’s not clear cut that Merck intentionally covered up the increased cardiovascular risks of Vioxx from the FDA. Vioxx was approved in 1999. In November 2000 the VIGOR Study was published that compared the gastrointestinal safety of Vioxx vs Naproxen. But the hint of increased cardiac risk was already evident. From the abstract of the VIGOR study;

“The incidence of myocardial infarction was lower among patients in the naproxen group than among those in the rofecoxib group (0.1 percent vs. 0.4 percent; relative risk, 0.2; 95 percent confidence interval, 0.1 to 0.7); the overall mortality rate and the rate of death from cardiovascular causes were similar in the two groups.”

Naproxen had not previously been known to have a cardio-protective effect and so this study should have set off alarm bells at the FDA but nobody, not the FDA, not the New England Journal, and not even self appointed anti-Vioxx crusader Cardiologist Eric Topol called for a study to specifically look at the cardiovascular risks of Vioxx. In 2002, warnings about possible increased cardiovascular risks were sent out about Vioxx to patients and physicians and Merck went on to earn Billions off the drug.

Merck did not intentionally set out to make a harmful product but they did choose not to evaluate early safety concerns because they weren’t required to and obviously they didn’t feel concerned about litigation enough to do safety studies. Their primary goal was to make money and Vioxx had the potential to make them Billions.

Because of the sheer amount of potential income involved in the development of a “blockbuster” product, individual claims and even class action litigation appear to have an extremely limited (if any) effect on ethical corporate behavior. The paradox is thus; In order to be truly punitive, jury awards in product liability cases against huge corporations must be massive, like on the order of Billions, not millions. But the idea that any injury could be worth Billions in compensation is excessive even for most judges and juries in our jackpot driven system.

Ironically the one area where the threat of litigation may affect corporate behavior is in the development of niche products like medications for rare or infrequent diseases. Because the expected revenue from such medications would be limited and far less than a blockbuster like Vioxx there is the potential for litigation to damage the company far beyond the relatively small income of these specialized drugs. One of many criticisms of the pharmaceutical industry is that they concentrate too much research on potential blockbuster and “me-too” drugs instead of treatments for lesser-known conditions. The threat of litigation may be compounding this problem.

It appears massively simplistic to believe that corporations would “think twice” before developing a dangerous product. Ironically, corporations not only think twice, they have entire risk and prediction analyses about the potential liability of every consumer product. If the risk is too high then they stop. If the sales from a product are likely to exceed losses from any successful litigation then they proceed.

Companies don’t really care if a few people get hurt using their products as long as profits are not hurt as well. Ensuring that as few people get hurt as possible is not the job of a company, as bad as that sounds. It’s the job of regulatory agencies in government. But in our country we prefer as little government as possible. We prefer the lottery system. If we get injured we sue and we might win! But don’t expect the company to change.

Caveat emptor.

The recent Harvard School of Health study by professor David Studdert reviewed 1,452 closed malpractice claims and found that there is no evidence that frivolous suits are flooding the system. However it also found that over a third of the cases (37%) involving injury did not result from medical errors or malpractice and of these 28% (10% of the total) still resulted in payment to the plaintiff. Trial lawyers crowed about the results saying that the system “works” to weed out baseless claims. Yet, this spin left many of us confused. Are they saying that a 10% failure rate is a good thing? Worse yet, the system failed to compensate 27% of those cases that DID involve malpractice/errors meaning that in all, justice was denied in 20% of all cases.

The other conclusions of this study were even more damming of the current tort system. The study found that it takes on average 5 years for an injured party to receive compensation and that legal and administrative costs consume up to 50% of compensation amounts. To spin this study as proof of a successful tort system as the trial lawyers do is akin to the Black Knight’s spin about his severed arm, “It’s only a flesh wound!”

KevinMD points out that Dr. Studdert himself in his comments to the Senate believes that it is “wrong” to think that the current medical liability system “works”. Studdert references other research that shows that the majority of patients who are injured as a result of errors never seek compensation within the system. More than likely this is because of the enormous time, effort, and costs involved as well as problems with access and a general public lack of knowledge about the system.

Other problems that are mentioned by Studdert are how the current system impacts health care by inducing physicians to practice defensive medicine and because the system is so adversarial and punitive it hinders efforts to improve quality by acting as a big disincentive to the disclosure of errors. I.e. the current medical malpractice liability system focuses on the compensation of single cases and not on the medical system itself or potential inherent errors in the delivery of medical care.

Studdert proposes the following; make the medical liability system more accessible to patients injured by medical errors, shorten the time involved to obtain compensation or reach resolution, reduce the costs to all parties, improve the accuracy and reliability of judgments as well as the evaluation of actual damages, and reduce the threatening and punitive nature of the system so that physicians and hospitals are more likely to disclose data on errors in an effort to learn from individual cases and improve quality.

What is needed is a new system. Studdert says that current reforms are “tweaks” that cannot fix a system that is defective at the core. I agree. The current system is designed to be adversarial. It is designed more for win/lose than uncovering the truth and this more than anything is what necessitates enormous amounts of time, effort, and money being spent in order to “win” a case. And despite all this, the system still gets it wrong 20% of the time.

Consider what happens under the current system. Cases are litigated in front of a civil tort judge who may or may not have any experience or training in medical liability cases and the juries are made up of “peers” who are usually lay people specifically chosen for their admitted lack of any significant knowledge of modern medicine and/or the health care system. It’s like amateur hour in medical court. The only “experts” are paid hacks brought in by both sides to give their “expert [paid] opinions” which may or may not be the generally accepted standard of care. Often things degenerate into a running battle to prove which side’s expert is better and therefore “right”.

Ironically, only 1 in 5 plaintiffs win if their medical malpractice case goes to trial independent of the existence of an error or the complexity involved. Obviously the system is failing here more then not.

And only a minority of cases go to trial. 90-95% of cases are settled prior to trial! At this stage there are no standards, guidelines, or quality controls to ensure that one side or the other does not get screwed. The reasons for settling prior to trial are complex and can easily be due to greed, ignorance, fear, miscalculation, and economic considerations rather then the facts of the case. Lawyers like to talk about a person’s right to have their day in court and yet it is the inside of one that almost all defendants and plaintiffs never see!

Now consider a new system by which specialized “health courts” would see these cases. The reform minded group Common Good is one force behind the idea of health courts. Instead of a court filled with amateurs and dueling “expert” witnesses these courts would seek to reduce the costly adversarial nature of the process and introduce standardization and normalization to what is too often a hectic and unpredictable process.

“The hallmark of special health courts would be full-time judges, trained in health care issues. These judges would define and interpret standards of care in malpractice cases, relying on neutral experts paid by the court and setting precedent from one case to another. Special health courts would ensure that patients injured by mistakes would be reliably compensated, without having to pay one third or more to lawyers.”

It is my belief that everyone would be satisfied under such a health court system. Plaintiffs injured by true medical errors would be guaranteed accurate evaluation and standardized compensation in a much shorter time. True peers would judge physicians and insurance companies would enjoy the reduced costs. Everyone would be satisfied except for the trial lawyers whose role as middleman (required to navigate the current complex and dysfunctional system) could be greatly diminished. No wonder they tend to oppose such reforms!

What rhetorical crap. Can’t Leo see the effects on the health care system that he and his friends in the ATLA are having? Doctors don’t want to limit their patient’s right to compensation for injury. Doctors want to limit the perverse effects that a few obscene, overly zealous, and usually limitless judgments have had on health care and their ability to manage patients. Medpundent has a great point for point rebuttle about this article so I won’t reproduce it here. I would say however, that the funny part is that Leo’s article is almost a mirror copy ATLA’s own website that lists their positions to these exact same issues! Well, who ever said that lawyers were creative or free thinkers?

Now, don’t get me wrong. The vast majority of bloggers engage in thoughtful and intelligent discourse that is at the very heart of blogging i.e the democratic, free exchange of ideas and opinions. However, this is not to say that lawyers in this country will not use libel and defamation suits to silence opinions that go against their clients. It’s too easy for them to do. Just take an individual or organization with huge legal resources against a single private individual who publishes his or her thoughts on a single web page and you have the classic David vs Goliath scenario. Except in this case Goliath is armed with a phalanx of lawyers and millions in legal funds against David’s single family income. Nora in the above example never even got the chance to prove that the management in question were in fact “crooks”. She was manhandled by a legal system that puts the advantage on the side with the most money and power. Hardly democratic nor respective of free speech. The danger is not that cases of blatant libel will rightfully be sued but that opinions stated on blogg pages will be squelched by even the threat of legal action. These threats are nothing new to free speech. Jerry Falwell took Hustler publisher Larry Flint to court over a CARTOON that implied that Falwell had sex with his mother. Certainly not in good taste, never the less, Flint’s comical ribbing of the humorless Falwell was upheld by the US Supreme Court but it took Flint’s vast magazine empire to defend him all the way to the nation’s highest bastion of free speech. I doubt that the average blogger has a fraction of Flint’s resources. Look for this issue to become much more important in the future for bloggers and the nature of free speech online in general.

Enter Mr. Garcia stage left. It appears that he based his entire suit on this “technicality” rather than any evidence of actual negligence. Then with blood in the water the feeding frenzy began. Houston attorney Michael Caddell filed a class action lawsuit against Bracamontes, the cardiologist Dr. Urrutia, and McAllen Medical Center (MMC) on behalf of EVERY PATIENT treated by Dr. Bracamontes while he was on staff at MMC! Lawyer Garcia went suit happy and actually solicited hundreds of Dr. Bracamontes patients with a letter stating, “If you or your loved one were not accurately informed about Dr. Bracamontes’ [lack of qualifications] before consenting to heart surgery by him . . . you may have a claim for pain and suffering, mental anguish, and other personal injury or economic damages.” Keep in mind what I said about being board certified. This is not a “lack of qualifications” and I don’t believe that Dr. Bracamontes was ever proven to be any less qualified than any other cardiac surgeon. This legal blood bath was so sloppy and aggressive that several suits were dismissed when absolutely no evidence of negligence could be found and several patients had never even been treated nor seen by Dr. Urrutia and/or Dr. Bracamontes and a few never even gave their consent to sue! To my knowledge neither Raymond Garcia nor Michael Caddell have been investigated by the Texas Bar for ethics violations and both are still practicing. In fact, lawyer Garcia is running for Hidalgo county judge!

The cynical person may not care what happens in legal battles between “privileged”, rich, doctors and lawyers but cases such as these have a chilling effect on health care in general. Areas such as the RGV that are poor and rural tend to have enough trouble attracting physicians and now that the RGV has obtained a reputation for such lawsuit bombardments as these the situation can only get worse. If you think that it’s hard to get an appointment to see your doctor now just imagine what impact these suits will have on communities in the future. Insurance rates are already astronomical based on the work of Garcia and others like him. Lawyers like him seem to cast a blind eye to whatever consequences these frivolous suits will have on the quality of and access to health care of communities. Their lawsuits have the appearence of only caring about making money for themselves and their client at whatever cost. Case in point: Cardiac angioplasty is a great non-surgical treatment for coronary artery disease and heart attacks. However, because of the risks involved there needs to be nearby surgical cardiothorasic support in the case of a complication. Should Dr. Bracamontes and other cardiothorasic surgeons be driven out by these lawsuits patients in the RGV will be deprived of this valuable and often live-saving procedure and have no choice but to be transported 200 miles north to Corpus Christi for any hope of treatment. There are consequences.

America. . . . you have been warned! Thanks to my dad Lionel Rangel MD of Weslaco Texas for alerting me to this article.