Recently in Bad Medicine Category

Thanks to Glenn Reynolds for pointing out this story at the Boston Globe. Apparently there's talk of banning the new clinics housed inside various Walmarts and CVS stores in Boston. As Glenn ponders, why would the lawmakers there want to eliminate affordable health care operated by the private sector? Also, Glenn links to this post which highlights how these clinics are doing things right.

That's the title of a post by Ed Silverman over at Pharalot. The issue is the use if atypical antipsychotics in children:

Florida Medicaid records show the number of children - some just months old - who were prescribed the drugs went from 9,364 seven years ago to 18,137 in 2006. No records for privately insured patients are available.

As I mentioned earlier this week, putting the blame on the pharmaceutical industry is an oversimplistic reaction to how psychiatry, psychology,and our culture have transformed childhood into a diagnostic checklist. As mentioned in Ed's post, the litigation in Florida appears to be the recommendation by agencies receiving Medicaid funds to use these drugs in children with ADHD who also had tics. While none of the atypical antipsychotics, to my knowledge, are FDA approved for this condition, it is common knowledge among mental health professionals that the most effective treatment for tics are dopaminergic antagonists such as atypical antipsychotics. True, the recent National Institute of Health's CATIE study demonstrated that most of the atypicals were no better than the older ones. But that doesn't mean that the newer atypicals aren't effective or an appropriate treatment. Perhaps, our current social construction of adolescence is partly to blame for the boom in mental health diagnosis in our children.

Ronald Bailey at Reason's blog Hit & Run discusses a recent article by Stephanie Desmon in the Baltimore Sun on the topic. Ron rightly mentions the end result of all the fuss over thimerosal in vaccines: worried parents, unvaccinated kids and more expensive vaccines. As I mentioned earlier this week, a recent study in the Archives of General Psychiatry also cast doubt on the supposed link.

Kim Severson of the New York Times has this article on the growing interest among parents of food allergies:

Record numbers of parents are heading to doctors concerned that their children are allergic to a long list of foods. States are passing laws requiring schools to have policies protecting children with food allergies. But no one knows why the number of allergies seems to be on the rise, or even if they are rising as fast as some believe.

Ms. O’Brien and leading allergy researchers agree that few reliable studies on food allergies exist. The best estimates suggest that 4 to 8 percent of young children suffer from them, though the reactions tend to grow less serious and less frequent as children grow older.

Even though the science is weak, new laws and policies are enacted under the banner of child safety. Yet as David Bernstein points out, we've been down this road before.

There's been a lot of news lately involving child psychiatry. As noted by others, the Supreme Court may grant cert in the case of Pittman v. South Carolina which has the interesting twist that the defendant, age 12 at the time of the crime, was taking antidepressants when he killed his grandparents. Yet, as I mentioned the link between antidepressants and violence is tenuous at best.

On the heels of the Pittman case, comes this weeks Frontline program which explored the explosive growth of children being diagnosed with bipolar disorder. Unlike ADHD, bipolar disorder is generally treated with antipsychotic medications which can have profound and lasting side-effects. Yet, the desire to place the blame at the foot of the pharmaceutical industry is misplaced; the psychiatric community has a long tradition of capturing behaviors within their diagnostic net and transforming them into pathologies. All of the pharmaceuticals in the world do nothing to our children without a mental health culture which favors medicine as the first line of treatment for troubled children. And that mental health culture is not just a product of myopic physicians or Big Pharma, but very much one of our own creation.

Ed Silverman reports that pharmaceutical reps will now have to be licensed in D.C. From the story in the Washington Business Journal:

The measure makes D.C. the first in the country to license pharmaceutical company sales representatives, able to revoke that license if a salesperson's activities were deemed fraudulent... The bill, dubbed SafeRx, also mandates that drug reps have a bachelor's degree, adhere to a code of ethics and refrain from giving doctors gifts."

As the Journal alludes to later in the story, the lawsuits have begun.

I'd like to thank Walter Olson for inviting me to contribute to one of my favorite blogs, Overlawyered. As an attorney and psychologist, I've worked in a number of different hospitals across the country. Health care institutions are unique places to work for in many respects because the decisions made there can directly lead to serious or even fatal outcomes. Of course this is obvious, as should be the fact that despite the best intentions of everyone involved in a patient's care, bad outcomes occur.

Alison Cowan has this article in last Friday's New York Times highlighting a recent case involving the suicide of Ruth Farrell. By all accounts Farrell had been quite depressed for a very long time. As is the case with some people who struggle with chronic depression, Ms. Ferrell was admitted to the hospital for care and observation related to her depression and suicidal ideation. Sadly, Ms. Farell hanged herself with her own pants between the standard 15 minute "checks" performed by staff on psychiatric wards. In turn, her estate sued her doctors and the hospital claiming improper care.

Greetings! Thanks to Walter Olson for allowing me the opportunity to guest blog this week at Overlawyered. I am Jason Barney and have worked for self-insured corporations as a claims investigator, a mid-sized northwest-based insurer investigating casualty and property claims, and now a large, self-insured northwest municipality as a tort claims investigator. All told, I have nearly ten years of claims and litigation management experience.

First things first: I have significant and genuine respect for attorneys and other legal professionals. I don’t take this blog as an opportunity to bash lawyers, but to “[Chronicle] the high cost of our legal system.” And, as it turns out there is a lot of that to be had.

One story that recently caught my eye and has been covered in these pages of late is a Washington Supreme Court ruling that reversed an appeals court ruling in favor of a dentist’s insurer for refusing to defend him for a practical joke gone wrong. The court’s ruling was recently criticized by The Seattle Times here and the insured’s counsel responded via letter to the editor here (scroll down to fifth letter - "The justices get it".)

In today's Journal, an article by the people behind Medical Justice:

In 2002, we launched Medical Justice, a membership-based organization designed to complement tort reform and to head off frivolous lawsuits. Medical Justice pays the bills and provides the services to file countersuits against all proponents of meritless lawsuits....

Our service has two principal components. First, we look at the quality of so-called expert-witness testimony. Behind every frivolous lawsuit there is an "expert" -- usually a physician skilled in testifying before juries and often compensated to the tune of $10,000 dollars a day. Put bluntly, many of these "experts" are frauds, as this newspaper has repeatedly shown in cases regarding asbestosis and silicosis claims....

Medical Justice's second tool is a patient-physician contract. That contract states that in a legitimate dispute, both sides will utilize only those experts who belong to such societies and who strictly follow their code of ethics. This limits the list to reputable and accountable physician experts, thus precluding the use of hired guns or medical "witnesses having other rational explanations" -- better known by their acronym.

Does it work? Yes. After five years of collecting data, we know that Medical Justice plan members are sued at a rate of under just 2% a year. The average doctor is sued at a rate of 8%-12% per year. And the company is top heavy with physicians in "high-risk" specialties.

Further, when meritless cases are filed against plan members, generally they're dropped quickly....

Finally, the system works because we back our words with deeds by taking action against proponents of frivolous suits. In a sense, Medical Justice has created a contract-based "loser-pays" paradigm. We have helped over a thousand physicians who are tired of being victimized by a system that doesn't prevent collateral damage.

Private law saves the day? Perhaps -- but how long before the plaintiffs' bar fights back with legislation?

One of the common minor medical malpractice "tort reforms" that have been proposed in recent years is the "apology law." That's the law which permits doctors to apologize to patients for bad outcomes without having those apologies thrown back in their face at trial. (Reasonable, if relatively trivial.)Rhode Island is now looking at joining the 15 or so states that have enacted such apology laws, and over at the New York Personal Injury Law Blog and crossposted at Bizarro-Overlawyered, plaintiff's attorney Eric Turkewitz endorses the bill, saying:

I've always believed, based on the manner in which calls come in to my office, that poor communication (bad bedside manner) is the primary reason patients call attorneys. They are angry, or confused, or both.

Now, the practical implication of that for doctors is clear: doctors should apologize. But he doesn't seem to reflect on the implication of that for lawyers. If med-mal cases are brought based on anger over bad bedside manner rather than wrongdoing, then our med-mal system will punish bad bedside manner rather than wrongdoing.

In any case, Turkewitz mocks an insurance company which advises doctors who apologize -- even if those apologies are protected -- to apologize for the outcome but not to admit error, claiming that this sensible advice "encourages more of the same thing that has gotten docs into trouble in the past." But Turkewitz doesn't mention that even this extremely modest reform is too much for some trial lawyers. As quoted in the same article he cites:

Providence lawyer Steven Minicucci, who handles malpractice suits, said displays of compassion are rarely useful in building such cases. But an apology and an admission of error could be key evidence. He opposes the Rhode Island legislation.

"I like to call it the `I'm-sorry-I-killed-your-mother'" bill, Minicucci said. "If a doctor comes out and says something like that, he shouldn't be able to immunize himself against statements like that by couching it in an apology."

You've got to love that "rarely," in "displays of compassion are rarely useful in building such cases." Rarely, but hey, sometimes a trial lawyer can turn compassion against the doctor. And we wouldn't want to stop that.

Speaking of apologizing (and updating an earlier story), I'm pretty sure that Mike Nifong's apology to the Duke lacrosse players ("To the extent that I made judgments that ultimately proved to be incorrect, I apologize to the three students that were wrongly accused.") is not going to cut it.

No, this case isn't going to get messy: in 2004, a Long Island couple went to a fertility clinic to help them get pregnant with a biological child. Apparently, the clinic botched the procedure by using the wrong sperm (Oops!); the couple figured it out when they noticed that the child was black and they weren't.

So they sued the clinic for malpractice and infliction of emotional distress. (Just for good measure, they sued their obstetrician, who had nothing whatsoever to do with the actual fertilization; the court dismissed that claim. Gee, I wonder why medical malpractice insurance rates are so high.) The court rejected the emotional distress claim, ruling that (as most courts do) a baby being born is not an injury to the parents, but it allowed the malpractice claim to proceed.

Speaking of emotional distress, the judge handling the case quoted the parents as saying things every child wants to hear from her parents:

"[W]e are reminded of this terrible mistake each and every time we look at her."

and

"We are conscious of and distressed by this mistake each and every time we appear in public."

A new report from Congress's Government Accountability Office — am I the only one who didn't notice that it changed its name from "General Accounting Office" over two years ago? — attempts to determine why the number of actual applications for approval of new drugs has increased at a much slower rate than the increase in pharmaceutical industry research and development expenditures.

Per the GAO panelists, "conflicting pressures of avoiding risk and producing a high return on investment" combine to curtail the development of the most innovative new drugs:

[C]ompanies prefer to produce drugs that require little risk taking but still offer the potential for high revenues.  This strategy has created an emphasis on producing 'me too' drugs — drugs which have a very similar chemical formulation to drugs already on the market.  These drugs are less risky to develop because the safety and efficacy of the drugs on which they are based have already been studied.  According to one panelist, an industry representative, because the length, complexity, and expense of developing a single drug have all increased dramatically over the last 10 to 15 years, companies must choose fewer drugs to develop.  As a result, they will often follow a business model that involves choosing drugs that are easy to develop, with a large market that will produce a large return on investment.

Another factor cited is "sponsors’ uncertainty over how they are to implement requirements for the safety and efficacy of new drugs."  The report notes

general agreement that the lack of precise FDA regulatory standards that outline what constitutes a safe and effective drug is a factor when making drug development decisions — weighing the safety of drugs against their potential therapeutic benefits.  Panelists generally agreed that because there are no precise standards for making these decisions, sponsors and FDA must address them on a case-by-case basis.  As a result, it was indicated that this uncertainty may lead a drug sponsor to abandon a drug rather than risk significant development expenditures.

While product liability litigation is not mentioned in the report by name, it clearly factors in to the industry's aversion to "risk."  Moreover, at least some of the uncertainty and extra-cautious attitudes within the FDA can be traced to highly publicized — and heavily litigated — withdrawals of drugs based on safety concerns:

* * * Some analysts have reported that safety concerns during the 1990s — which led FDA to request that manufacturers withdraw pharmaceuticals including fenfluramine and dexfenfluramine (known as Fen-Phen) in 1997, Propulsid and Rezulin in 2000, and Baycol in 2001 — impacted FDA’s review requirements.  For example, a 2004 report completed for the European Commission — the executive body of the European Union — found that the withdrawals of these pharmaceuticals from the market affected FDA’s implementation of its regulatory standards.  According to this study, FDA began to demand more complex clinical trials that called for more testing on: (1) how drugs interact with each other, (2) the effect of drugs on liver toxicity, and (3) the relationship of drugs to cardiac risk. In addition, according to several drug development experts and some industry analysts, FDA has been requiring more lengthy and complex clinical trials, which call for more patients and increased costs. . . .

Commenting on the GAO report, Ronald Bailey (Reason Magazine, Hit & Run, "What's to Blame for Fewer New Pharmaceuticals?," Dec. 20) summarizes:

Why have FDA regulators become more cautious?  Because, as Harvard Business School professor Regina Herzlinger explains in her May, 2006 article, Why Innovation in Health Care is So Hard (not online): 'Officials know they will be punished by the public and politicians more for underregulating — approving a harmful drug, say — than for tightening the approval process, even if so doing so delays a useful innovation.'

I will venture to suggest that the FDA's increased obsession with safety may be killing more people than it saves.  How about a GAO study on that question?  After all, if it takes the FDA ten years to approve a drug that saves 20,000 lives per year that means that 200,000 people died in the meantime.

The full GAO report, "New Drug Development: Science, Business, Regulatory and Intellectual Property Issues Cited as Hampering Drug Development Efforts," is available for viewing and download here [PDF].

The Oklahoma legislature, following the lead of a number of other states, attempted to limit unfounded claims for medical malpractice by mandating that all med mal suits be accompanied by an expert's affidavit stating the expert's opinion that the claim possesses merit.  The Oklahoma Supreme Court has now declared that requirement to be unconstitutional.  (See Business Insurance, "Okla. Expert Opinion Law Rules Unconstitutional", Dec. 20).

The Court states two grounds for its conclusion. First, the Oklahoma Constitution bars the legislature from adopting "special laws" in which different members of the same class are treated differently.  The Court concludes that the affidavit of merit requirement distinguishes medical negligence claims from all other negligence claims, in violation of the "special law" prohibition.  Second, the Court concludes that requiring potential med mal plaintiffs to bear the expense of obtaining a medical expert's pre-litigation opinion -- the Court estimates it to be between $500 to $5,000 -- creates an economic bar at the courthouse door that impedes less wealthy claimants' access to redress, thus depriving them of due process of law.

The court's opinion in Monica B. Zeier vs. Zimmer Inc. and Theron S. Nichols, M.D., Oklahoma Supreme Court, No. 102472 (Decided Dec. 19, 2006) -- which is not quite final and official as of this writing -- is accessible through the Court's website, here.

The "Bad Medicine" heading, which archives posts relating to medical liability, has grown so large as to be unwieldy for readers, so we're opening up a "Bad Medicine II" heading for posts from here on. The old category is here, and the new one is here.

On malpractice exposure, and reimbursement rates: "Why am I worth so little when I do my job right, and worth so much when I make a mistake?" (courtesy Cut to Cure, Aug. 25).

I've got an op-ed in this morning's Wall Street Journal (Aug. 23)(reprinted at Manhattan Institute site) examining what I term the "surprisingly conciliatory" line the Kerry/Edwards campaign has taken in recent weeks on litigation reform, and analyzing (insofar as that's possible, given the thus-far-sketchy details) the five-point plan the two offer for addressing the malpractice-suit crisis. For more, see my Aug. 9 post and links from there. Also check out this site's omnibus pages on politics, which includes many recent posts on Kerry and Edwards, and on medical liability. (Yet more: Point of Law).

Four more entries from our correspondence stack on our letters page. Topics include: why autopsies don't figure more prominently in malpractice cases, whether the legal climate deserves all the blame for the shrinkage in Philadelphia obstetrics, what happens when you tell your homeowners' insurance company that you run a controversial website, and another lawsuit challenging the 1998 tobacco settlement.

"For the first time in its history, the American College of Radiology has expelled a member for giving inaccurate expert testimony. Dr. E. James Tourje, a neuroradiologist at Cedars-Sinai Medical Center in Los Angeles, was expelled [last month] for violating the ACR code of ethics, which states that expert testimony should be nonpartisan, scientifically correct, and clinically accurate." Dr. Tourje had testified on behalf of the plaintiff in two malpractice cases, both of which resulted in defense verdicts. ("'Expert' witness gets booted from ACR", Diagnostic Imaging Online, Jul. 8; Arati Murti, "Stat Read: Election-Year Politics Push Medical Liability Skirmishes to Trenches", Imaging Economics, Aug.).

In a case several years ago, Judge Richard Posner of the Seventh Circuit gave impetus to the then-nascent trend toward professional self-regulation of expert testimony, writing in an opinion that "this kind of professional self-regulation furthers rather than impedes the cause of justice. More policing of expert testimony is required, not less." (Russell M. Pelton, "Professing Professional Conduct: AANS Raises the Bar for Expert Testimony", AANS Bulletin, Spring 2002. In the latest ABA Journal, Terry Carter discusses the controversy and in particular the formation of the Coalition and Center for Ethical Medical Testimony to promote efforts by associations to act against what Peter Huber has called malpractice by mouth. ("M.D. With a Mission", ABA Journal, Aug., reprinted at CCEMT site)(PDF). The organized plaintiff's bar is completely apoplectic about the trend: for its views, see Stephanie Mencimer, "The White Wall", Legal Affairs, Mar-Apr.; Steve Ellman, "Code of Silence", Miami Daily Business Review, Jun. 25, 2003.

This time it's the Hospital Casualty Co. of Oklahoma, a subsidiary of the Oklahoma Hospital Association founded in 1977 by 12 local hospitals, capsized by nursing-home suits and by the general Sooner-get-sued atmosphere in its home state. Must have been mismanaged, our friends in the plaintiff's bar will say. Earlier this year, the Physicians Liability Insurance Co., owned by the Oklahoma Medical Association and the state's largest med-mal insurer, "was placed under formal supervision of the Insurance Department because the company didn't have money to pay anticipated claims." Another mismanaged outfit, no doubt. More details at Point of Law, where I also discuss the anguish felt by California insurance regulators over the relative lack of interest among low-income drivers in taking advantage of a scheme to rob Peter in Pacific Palisades to pay Paul in Pico-Union.

Defensive medicine? Medblogger KevinMD winds up providing it against his better judgment when menaced by a litigious patient (Jul. 7). An anonymous post in his comments section discusses how doctors may lawfully extricate themselves from entanglement with clients who bully them with legal threats.