• Perspective: Avandia – What’s the risk?

• Washington dumps notice for malpractice lawsuits

• Conflict of interest: Can a defense attorney’s former client testify as a plaintiff expert in a later case he is defending?

• Prostate cancer and PSA: If and when to test

• The “how” matters when gauging risk after suicide attempt

• Calling plaintiff’s attorney a “slick lawyer” not enough to reverse defense verdict

• New York project seeks to cut malpractice costs, compensate victims faster.

• Judge disqualifies expert for failing to rebut claims of “hired gun.”

• Miscellaneous quick links:

Perspective: Avandia – What’s the risk?

Rosiglitazone (Avandia – GSK), an oral hypoglycemic agent (OHA) used in treating diabetes, has been in the news recently because of concern that it is associated with an excessive number of adverse events in users of the drug.

After a week of media hype with headlines such as “Avandia users experience 30% more heart attacks,” the FDA on July 14 determined that existing warnings regarding the drug are sufficient and that the drug does not need to be removed from the market.

So what’s the truth? Why the hype? Why the confusion? More ->

Washington dumps notice for malpractice lawsuits
In a July 1 ruling, the Washington State Supreme Court said that it is unconstitutional to require a 90 day notice of intent to sue in a medical malpractice case. The ruling sides with two separate plaintiffs who had medical malpractice cases thrown out by lower courts over notice issues. See Seattle Times article here.

Conflict of interest: Can a defense attorney’s former client testify as a plaintiff expert in a later case he is defending?
Ten years ago a plastic surgeon was defended by an attorney in a malpractice case. Now he is serving as a plaintiff expert. Can he do so if the current defendant’s attorney is the same one who previously defended HIM? The plastic surgeon now acting as the plaintiff’s expert submitted a declaration stating that he understood he might be subject to cross-examination in the current proceeding, and that he—as the holder of the attorney-client privilege—waived it “as it applies to any relevant information to be presented in this matter.” However, a California Court of Appeals recently ruled that the plaintiff expert must agree to sign an “unqualified waiver of attorney client privilege.” The rationale? The current case might expose the expert to cross-examination by the defense about his own case ten years previously, so an unqualified waiver is needed.

Prostate cancer and PSA: If and when to test
A great deal of controversy exists in the medical literature about the value and timing of PSA testing as a predictor or preventer of cancer of the prostate. This publication previously reported on a case in which a defendant physician lost his case because he did not do a PSA test. Here’s one in which the defendant physician won his case despite not doing a PSA test. Bottom line: Prostate cancer cases can be a crap shoot.

The “how” matters when gauging risk after suicide attempt
The method used in an unsuccessful suicide attempt may indicate the risk of a fatal attempt in the future, according to a Swedish study published in BMJ. Hanging, strangulation, or suffocation in a first attempt were associated with a 6.2 fold higher risk of later suicide completion than with poisoning

Calling plaintiff’s attorney a “slick lawyer” not enough to reverse defense verdict
An Illinois jury rendered a defense verdict after the defense attorney labeled the plaintiff attorney a “slick lawyer.” Based on this allegedly prejudicial remark, the plaintiff (or could it have been her “slick” attorney?) appealed. An appellate court affirmed the verdict.

New York project seeks to cut malpractice costs, compensate victims faster.
Five major New York City hospitals are joining a 3 year federally funded pilot program to encourage early reporting of medical errors and early settlement. The program involves the state health department and court system, and will utilize specially trained judges and health courts. The model is based on methods devised by State Supreme Court Justice Douglas McKeon of Bronx County Supreme Court. McKeon has presided over all malpractice cases involving Health and Hospital Corporation, the entity that runs New York’s municipal hospitals, which has saved HHC an estimated $50 million annually in defense fees and payouts. Settlement agreements will be mediated by judges. Victims and hospitals can still opt for a jury trial.

Judge disqualifies expert for failing to rebut claims of “hired gun.”
A Maryland judge disqualified a defense expert neuroradiologist for failing to disclose financial records, finding his testimony about those records “disingenuous” and his honesty questionable. The plaintiff had accused the expert of being a “hired gun” whose opinions were suspect. A $5.6 million verdict resulted. Reality check: The verdict might be fair if this is the best expert the defense had,

Miscellaneous quick links:

• Las Vegas Sun publishes a list of Nevada hospital medical errors, 10 years and 2.9 million inpatient visits. Pressure is on low-performing hospitals.
• CBS investigators have found that copiers remember more than we know. Many copiers have hard drives just like a computer. Tossing one out, recycling it, or trading it in can expose client records to identity theft.
• Scheduling meetings can be a pain, especially for attorneys. Take a look at “Meeting Wizard,” a free web service that is unbelievably easy to use.
• Cases against a Physician Assistant in Tennessee must utilize PA experts, not physicians, according to the Tennessee Supreme Court.
• New medical malpractice insurer in Florida bypasses brokers, claims to save physicians 20% on insurance costs by “buying direct.”

After a week of media hype with headlines such as “Avandia users experience 30% more heart attacks,” the FDA on July 14 determined that existing warnings regarding the drug are sufficient and that the drug does not need to be removed from the market.

So what’s the truth? Why the hype? Why the confusion?

On June 28, 2010, JAMA published an article by Graham et al. entitled “Risk of Acute Myocardial Infarction, Stroke, Heart Failure, and Death in Elderly Medicare Patients Treated With Rosiglitazone or Pioglitazone” (JAMA. 2010;304(4):(doi:10.1001/jama.2010.920). The authors’ research found Avandia to be more dangerous than a comparison drug pioglitazone (Actos), another OHA.

But what are the facts?

Here are some pertinent points about the study and others leading up to it:

• Included only Medicare beneficiaries age 65 and over, with 70% of the patients being 70 years of age or older.
• Compared Avandia with only one other drug, not with a placebo group who took neither drug.
• The comparison drug, Actos, actually improves outcomes in those using it, so the question is really not which drug is “dangerous,” but which drug provides the desired effect more safely.
• Previous studies on Avandia have shown inconsistent results.
• Previous studies showing a “statistically significant” difference do not necessarily mean that there is a “clinical significance” to the difference, when all mitigating factors are considered.
• The study followed patients for a maximum of 3 years.

So what did Graham and his colleagues actually find and report?

• The “danger” of Avandia is calculated based on 100 person-years of use. (How many diabetics will live another 100 years?)
• Heart attack occurs 1.83 times for Avandia vs. 1.68 times for Actos during 100 person-years of use.
• For stroke, the numbers are 1.27 vs. 0.95
• For heart failure, the numbers are 3.94 vs 3.00
• For combined heart attack, stroke and heart failure mortality, the numbers are 9.10 vs 7.42
• For mortality from all other causes, the numbers are 2.85 vs 2.40
• For combined mortality, the numbers are 9.10 vs. 7.42

This is where the hype begins. Remember that Actos, the comparison drug, actually improves mortality. Thus, presumably so does Avandia, but that argument is beyond the scope of this “Perspective.” Avandia is thus beneficial, but just associated with more potential risks.

Let’s look at relative vs. absolute risk. Suppose my chance of winning the lottery is one in a million. Suppose I develop a “system” that improves my chances of winning the lottery to one in 100,000. Do I now have a 90% better chance of winning the lottery? Yes. Do I now have a 90% chance of winning the lottery? No. My chance of winning increased from 0.000001 to 0.00001, or only 0.000099. The former number is my “relative” increased chance of winning. The number 0.000099 is my “absolute” increased chance of winning the lottery.

Based on this analysis, should I buy a lottery ticket? It depends.

The same holds true for Avandia vs. Actos. For simplicity’s sake, let’s just look at the “all cause mortality” numbers of 9.10 vs. 7.42 per 100 patient-years of use of either drug. The media reports that Avandia is “24% more likely to cause” death than Actos because 9.10 is 24% greater than 7.42. In reality, one’s chance of dying while using Avandia is only 1.78% greater (9.71 – 7.42) than with the other drug. And that’s for a person taking Avandia for 100 years.

To summarize, let’s give each patient in the study a 20 year life expectancy during which they continue to use Avandia. Five patients will make up 100 patient years of use. Accepting the authors’ numbers in this study, during their remaining 20 years, 4 of those 5 patients will be unaffected by their use of Avandia, while only one patient will have a 1.78% increased risk of dying as a result of taking the drug. The “per patient” risk is thus reduced by 80% to 0.356 (1.78 / 5) over their 20 year life expectancy.

Bottom line: Only 1 in 281 [(100 / 0.356] diabetic Medicare patients 65 year of age or older will are affected by taking the drug between age 65 and 85.

When the media blares that Avandia causes a 30% increased chance of death, many patients hear “I have a 30% chance of dying from this drug.” Not true. Nor do they have even a 30% chance of having a worse outcome.

Absolute risk is important. It puts relative risk in its proper perspective.

We have undoubtedly not heard the last of this, but the question is, “Did the FDA make the right decision.” In this author’s mind, the answer is a definite “Yes.”

• Perspective: Is a ruptured appendix evidence of malpractice?

• Do you have issues? Suggest a topic for “Perspectives”

• Florida ruling jeopardizes EMS services nationwide

• Diagnostic or screening mammogram? Whose call is it?

• Is a plaintiff expert necessary? Kentucky Supreme Courts says “Yes” — but barely.

• X-Rays of hip and pelvis miss 1/3 of fractures.

• OOPS. Nurse settles for $1 million just before jury returns defense verdict

• Fatal medication errors increase in July at teaching hospitals

• Can filing an EMTALA claim open the door to peer review documents

Perspective: Is a ruptured appendix evidence of malpractice?
By Charles A. Pilcher MD FACEP

Appendicitis is the most common acute abdominal surgical condition in medicine, yet there is probably not a single physician in practice today who hasn’t missed the diagnosis at least once. Often that results in “simple” appendicitis becoming a “ruptured” or “perforated” appendix. Attorneys are often confronted with this situation, but when is it malpractice to miss the diagnosis of appendicitis? Read more ->

Do you have issues? Suggest a topic for “Perspectives”
Reader input has led to several of the “Perspective” articles like the one above that have appeared in Medical Malpractice Bulletin over the years. If you would like to offer an essay for publication or suggest a topic for review, please contact me.

Florida ruling jeopardizes EMS services nationwide
A Volusia County, Florida, jury recently returned a $10 million verdict against the ambulance company that provided emergency transport of a pregnant woman in premature labor. The mother was being transported to a tertiary care center when she delivered a 25 week fetus 15 minutes into the trip. The baby was successfully resuscitated by the transporting EMS crew but suffered severe brain damage. The appeal of this verdict is being watched closely by EMS agencies across the country for its potential impact on transport decisions and care.

Diagnostic or screening mammogram? Whose call is it?
A patient was referred to a radiologist for a “screening mammogram” for a (presumably self-reported) lump in her breast. A lump normally requires a “diagnostic mammogram.” When the ordering physician was called by the mammography tech to change the order, the doctor declined. The radiologist claims that to override or re-write such an order would constitute Medicare fraud. Reality check: Has the radiologist ever heard of the telephone? A simple call from the radiologist explaining the standard of care to the ordering physician should clear up any misunderstanding.

Is a plaintiff expert necessary? Kentucky Supreme Courts says “Yes” — but barely.
The Kentucky Supreme Court in February agreed that an expert witness is required by a plaintiff who brings a medical malpractice suit against a physician and/or hospital. Though the facts of the case suggested it had little merit, the fact that only 4 of the Court’s 7 justices joined in the majority decision to support the trial court’s summary judgment for the defense is shocking.

X-Rays of hip and pelvis miss 1/3 of fractures.
Kirby and Spritzer in the American Journal of Roentgenology report that routine x-rays failed to detect 35 hip or pelvic fractures in 28 of 92 patients undergoing subsequent MRI. Note that the fact that these patients underwent an MRI suggests that physicians had a high clinical suspicion, despite the normal x-rays.

OOPS. Nurse settles for $1 million just before jury returns defense verdict
As the jury was deliberating, a nurse in a NY malpractice case and her attorney agreed to a $1 million settlement. Shortly thereafter the jury reported that they had reached a defense verdict, too late for the nurse. Key lesson: Juries are unpredictable.

Fatal medication errors increase in July at teaching hospitals
Researchers at the University of California San Diego report that fatal medication errors peak in July only in counties with teaching hospitals. The authors attribute the 10% increase to the influx of new resident trainees. The article in the Journal of General Internal Medicine is one of the few to substantiate the so called “July effect.” Other causes of death were not affected.

Can filing an EMTALA claim open the door to peer review documents?
This one deserves some feedback from readers. An anonymous individual blogging on malpractice issues as an “expert witness” claims that by filing an EMTALA claim, plaintiff attorneys can remove the protected status of peer reviewed material related to the case. The writer says “the federal rules of evidence allow the plaintiff attorney access to the normally off limit peer review material which then can be used in the State medical malpractice action.” I find that hard to believe/Editor. Add a comment, or Send me your thoughts.

Appendicitis is the most common acute abdominal surgical condition in medicine, yet there is probably not a single physician in practice today who hasn’t missed the diagnosis at least once. Often that results in “simple” appendicitis becoming a “ruptured” or “perforated” appendix. I have reviewed several such cases which have prompted this review.

The appendix is a tubular extension (about 1 cm diameter x 6 cm long) of the cecum, in the right lower quadrant of the abdomen at the beginning of the colon or large bowel. Because of its structure, it acts as a “catch basin” or blind pouch where a variety of bacteria and mechanical obstructions can cause problems. One can think of appendicitis as a boil or abscess. Germs get in, propagate, and cause an infection. If the infected appendix is not removed, it can swell to the point where pressure causes rupture, spilling the infection into the abdominal cavity.

Diagnosing appendicitis is easy – when it presents in classical, textbook fashion, which occurs in only about 50% of patients. The typical symptoms are:

1. A sense of being ill
2. Generalized abdominal discomfort
3. Loss of appetite
4. Nausea
5. Pain in the right lower quadrant of the abdomen
6. Fever
7. Vomiting

Classically these symptoms appear over a period of about 24 hours in the order listed. Combined with tenderness in the right lower quadrant of the abdomen on examination, further testing rarely changes the diagnosis or alters the treatment, especially in children.

But when 50% of patients with appendicitis “don’t follow the rules,” the diagnosis remains one of the most commonly missed in medicine. Nationally, about 30% of appendicitis cases progress to perforation (14.4% in Washington State) before the diagnosis is made. Sometimes that is because of delay on the part of patients in seeking medical care, and other times it is because the patient’s symptoms do not suggest to the physician a “surgical abdomen.” If the problem has not progressed to the point where  surgery is considered a reasonable option at the time of first evaluation, regardless of the diagnosis, “watchful waiting” is often the best option. The reason for that is that there is still no “gold standard” for the diagnosis. CT scans, nowadays considered our most accurate study, still fail us, leading to both missed diagnoses and unnecessary operations in between 5% and 10% of cases. The scans themselves are known to increase the risk, though marginally, of abdominal cancer in later life.

Clearly, once the diagnosis is made, surgical removal of the appendix is the treatment of choice. That said, there are numerous reported cases where non-operative management has been successful, or where a “healed appendix” was diagnosed at a subsequent surgical procedure. This shows that it’s not just that the diagnosis that can be obscure, but that the treatment is not as well-defined as we might think.

Below is an algorithm by Santacroce and Ochoa from their chapter on appendicitis in Sabiston Textbook of Surgery.

Figure 49-3 Algorithm for the evaluation and management of patients with possible acute appendicitis based on surgical assessment of clinical probability of the diagnosis.