Woman undergoes mastectomy only to learn a week later, she never had cancer. Now another patient of same doctor claims the same fate.

The Vancouver Sun reported that in 2001, Dr. Barbara Heartwell of the Hotel Deiu Grace Hospital in Windsor, ON performed an unneccessary mastectomy. Janice Laporte was the victim of Dr. Heartwell’s disfiguring mistake.

Ms. Laporte underwent a mastectomy in September of 2001 , and was told just one week post-operative that she never had breast cancer. Ms. Laporte’s case details are protected by a confidentiality clause; her case was settled soon after filing suit in 2002. Ms. Laporte told the Canadian Press, after a second patient came forward:

“It’s bad enough to have to be told you have cancer or to have a mastectomy,” she said.

“That is devastating enough, but then to hear that it was done for no good reason just compounds everything.”

“At least things are being looked in to now,” she said. “It’s unfortunate that this has to happen for them to look into this kind of stuff.”

The second woman who allegedly fell victim to Dr. Heartwell’s “mistaken diagnosis” is Laurie Johnston, a middle-aged single mother of a teen daughter. Ms. Johnston claims she underwent an unneccessary mastectomy in November of 2009.

Ms. Johnston has filed suit with similar accusations to those of Ms. Laporte. “Heartwell performed ‘dramatic, disfiguring and invasive surgery’…” Since filing suit, Ms. Johnston has also taken her case public.

Hotel Deiu Grace Hospital claims it became aware of the lawsuit when a reporter inquired about details of the case. The hospital has since launched an investigation into Dr. Heartwell’s cases. Dr. Kevin Tracey stated during a news conference with the Canadian Press that:

“During the course of our investigation she indicated that in our review of her past cases we would find additional cases of concern”

Apparently, these “additional cases of concern” caused the hospital to widen it’s investigation to include over 10,000 pathology reports  which were completed by Dr. Olive Williams.

Dr. Williams’ privileges were suspended in January; Dr. Heartwell voluntarily stopped operating in the early weeks of March. Both physicians have been reported to the College of Physicians and Surgeons of Ontario.

To prevent further such tragic events as happened to Ms. Laporte and ostensibly Ms. Johnston as well, a pre-surgery safety checklist was implemented into hospital practice in April. Deb Mathews, Ontario’s Health Minister, claims that of the items on the checklist, review of biopsy results are required prior to administering anesthesia.

A Windsor lawyer, Harvey Strosberg, predicts that Ms. Johnston’s case will never see the inside of a courtroom. Her case is strong and he predicts that she will likely reach a settlement agreement.

Simply put – it SHOULD never see ‘the inside of a courtroom. How tragic!

St Joseph Stent Cases and Dr. Midei Back in the News – More Cases Revealed

The Baltimore Business Journal just reported online that St. Joseph Medical Center has announced that it is now finished its review of the controversial stent procedures performed by Dr. Mark Midei between May 2007 and mid-2009.

In a statement released to the Baltimore Business Journal, hospital officials had to correct an earlier estimate provided by the hospital’s CEO, Jeff Norman, this past April 19th, when he indicated that the number of unnecessary stent implantations totaled 538. The so-called ‘final’ number, according to the report, is now 47 more than the last figure or a total of 585 patients, who have now been notified that “their blockage may not have been so severe to warrant a stent implanted by Dr. Midei.”    

We have been covering this St. Joe’s stent fiasco since February 20th, when we reported that the US Senate was launching an investigation into this matter.  The news of the congressional investigation followed lawsuits by former patients and a class action filing against the hospital.  On March 10th, we posted a story about a news release of that day in which the hospital reported an additional 169 more patients had received similar notification of unnecessary stenting by Dr. Midei, bringing the number at that time to 538.  Today’s release by the Baltimore Business Journal, as noted, adds a new 47 patients to this list.  Will more ‘review’ yield even more patients, who were, by the hospital’s own admission, subjected to implantations for blockages that “may have not been so severe to warrant a stent…”?  (What lawyer wrote that language for the hospital’s news release?).

To explain the seemingly ever-growing list of patients, the hospital stated “that an initial count of the total number of flagged stent procedures performed by Dr. Midei was “incomplete but has been corrected.

Guess it’s good that they now have the number of  patients corrected.  It would have been a lot better had they gotten the situation corrected before all these patients were submitted to unnecessary treatment with its life-long consequences.

Angina : The Efficacy of Percutaneous Coronary Intervention vs. the Efficacy of Non-Surgical Treatment

Angina is characterized by chest pain resulting from insufficient blood flow to the heart. In this context, abnormal blood flow is caused by the build up of plaque in the coronary arteries or as a result of coronary artery stenosis. Consequently, angina symptoms are usually indicative of heart disease. It is estimated that nearly seven million people in the United States have angina and that nearly 400, 000 patients present with new cases of angina each year.

A recent study published by Annals of Internal Medicine compared the efficacy of percutaneous coronary intervention vs. the efficacy of non-surgical medical care in treating angina in patients with stable coronary artery disease. Percutanious coronary intervention refers to coronary angioplasty. The study in question involved cardiac angioplasties with and without cardiac stents. Non-surgical treatment refers to drug treatment of angina symptoms.

Researchers performed a comprehensive review of 14 previous trials, which compared the efficacy of coronary angioplasty (with and without stents) vs. non-surgical medical care. In total, the 14 trials involved 7818 patients. Researchers concluded that older trials suggest that percutaneous coronary intervention was only marginally more effective in the treatment of angina. This, however, did not appear to be true in more recent trials. The study suggests that coronary angioplasty may not be necessary or recommended to treat angina in patients with stable coronary artery disease if proper evidence-based medications are employed.

Contributing author: Jon Stefanuca

Study Finds Stents as Effective as Surgery to Prevent Strokes; European Study Finds Otherwise

A few weeks ago, the NY Times published a story about a recent North American study designed to examine the efficacy of stenting versus surgery of the carotid artery for the prevention of strokes. Known as the Crest (Carotid Revascularization Endarterectomy versus Stenting Trial) Study, the project was designed to determine if the less invasive procedure known as stenting (i.e. placing a small tube inside the carotid artery) was an equally safe and effective treatment option to surgery for the prevention of stroke.  

Strokes are reported to be “the third leading cause of death in the United States and a major cause of disability among adults. Each year, almost 800,000 Americans suffer a stroke, and more than 140,000 die.”

Of concern, however, is a European study published online in the Lancet the day before the announcement of the Crest Study results.  According to Dr. Martin M. Brown, chief investigator for the European trial, the International Carotid Stenting Study, their investigation showed “dismal results” from stenting versus surgery in their study group population of 1,173 randomly selected patients (the Crest study involved 2,502 patients from more than 100 hospitals in North America).

Dr. Brown said that although differences in the groups studied might explain the disparate results, “nobody has really shown stenting is better than surgery, so why choose a stent?”

Dr. Brown added, “Even if Crest shows little difference between the two, there are three other trials that suggest surgery is safer.”

On the other side of the debate, however, are the statements of the lead author of the Crest Study, Dr. Thomas  Brott, who is quoted in the NY Times article as saying:

“We had outstanding results, and our study, we think, is representative of these treatments in the United States and Canada. Prior to the Crest trial, we really did not have the best evidence, but these results indicate that we have two very safe and effective methods to prevent stroke.” Though there are differences in risk between the two procedures and individual variations, he said, “the results from stenting are very comparable to those for carotid surgery.”

The differences in the two studies in terms of mortality and morbidity are summarized in the Times article.

What to make out of all this remains the question.  Hopefully further studies will provide a clearer answer.

I am not a doctor, and I suspect, you, the reader, are probably not either.  What I can say is this – and it is what I have been advocating throughout many of our blogs – be an educated patient.  Ask questions if you find yourself or a loved one presented with this option of surgery versus stenting and ask the right questions of your doctor.  Why is one option being suggested by your doctor over the other?  What are the risks of each procedure?  While one procedure may be “less invasive” than the other, there are still risks associated with each.  “Less invasive” is not always the answer.   I further encourage you to ask your doctor what his or her experience is in performing carotid artery stenting.  Remember, the Crest Study had one key element – “carefully screened … doctors doing the stenting procedure, including only highly skilled physicians with a lot of experience.”  Make sure your doctor fits that description.

Cardiac Catheterizations Overused

According to an article published by WebMd, a recent study suggests that almost two-thirds of patients who undergo cardiac catheterizations do not have clogged arteries.

Researchers tracked about two million patients who had the procedure at about 663 hospitals across the nation between 2004 and 2008. Of the two million patients, researchers focused on about 400, 000 patients with stable chest pain and no previous history of heart disease. The study specifically excluded patients with a history of heart disease, angina, or heart attacks.  In this population of patients, about two-thirds did not have significant arterial blockage.

Cardiac catheterization is a commonly used invasive procedure to diagnose blockage in the arteries of the heart. The procedure is performed by inserting a catheter in an artery of the arm or the leg. The catheter is then guided into the coronary arteries of the heart.  At such time, a die is injected through the catheter and its flow is analyzed to determine whether the artery is blocked.

According to Pamela S. Douglas, professor of cardiology at Duke University:

We want to be clear that if someone is having a heart attack and their doctor sends them to a cath lab, they shouldn’t argue. … But a stable patient who has not been diagnosed with heart disease and who does not need catheterization for pain control may want to ask about the risks and benefits.

Contributing author: Jon Stefanuca

Debating the Unknowns in Obesity Surgery for Children – NYTimes.com

Bariatric surgery – commonly referred to as weight-loss surgery, is apparently on the rise in the pediatric population.  A New York Times article – Debating the Unknowns in Obesity Surgery for Children – NYTimes.com – reports that these surgeries are on the rise in the United States.      

“I honestly believe that in 5 to 10 years you’ll see as many children getting weight-loss procedures as adults,” said Dr. Evan Nadler, co-director of the Obesity Institute at Children’s National Medical Center in Washington.

For those who may not be familiar with exactly what a surgeon does to the intestinal tract, there are numerous videos available on the internet that provide a good overview of this surgery – for example, here is an example showing one form of such surgery known as a by-pass.   There are a number of types of bariatric surgery, including two of the most common – Roux-en-Y gastric bypass and gastric banding procedures.

While such surgeries of often medically necessary and truly constitute a life-saving measure for some, they are not just an alternative to diet and exercise – that is, they are not without substantial risks no matter what form of bariatric surgery is being considered.

Here’s a list of just some of the potential complications -depending on the type of surgery – that are recognized risks of this surgery:

• Bleeding
• Complications due to anesthesia and medications
• Deep vein thrombosis
• Dehiscence (wound breakdown)
• Infections
• Leaks from staple line breakdown
• Marginal ulcers
• Pulmonary (lung) problems
• Spleen injury
• malabsorption
• nutritional complications
• death (reported as less than one percent)

On the other side of the equation, there is no doubt that when indicated, this surgery can certainly provide much needed restoration of health and longevity to these juvenile patients:

Obese children can suffer from a long list of problems better known in adults: insulin resistance, high blood pressure, fatty liver, a thickening of the left side of the heart, and even depression.

So far, the studies have found that the body starts to repair itself as the weight falls. For example, two years after gastric bypass, the left side of the heart has started to return to normal in most adolescents, according to cardiologists at Cincinnati Children’s. Research also suggested that for at least as long as the children have been followed, the procedure appeared safe, and about 85 to 90 percent of adolescents maintained their initial weight loss, Dr.  (Thomas H.)Inge [director of the surgical weight loss program at Cincinnati Children’s] said.

Those on the other side of this significant debate are not so confident in the long-term effects/benefits of having children undergo weight-loss surgery:

Some physicians, including Dr. Edward Livingston, chairman of gastrointestinal and endocrine surgery at the University of Texas Southwestern Medical Center at Dallas, say advocates could be drawing conclusions too early. No one can say whether the changes will translate into a health advantage later on. Dr. Livingston noted that a third of the children in the Australian gastric-banding study had to go back to the operating room over concerns about the device — and that even the children in the group that did not have surgery showed respectable improvements in blood pressure, insulin resistance and other measures. With or without surgery, he said, “both groups got better.”

The NY Times article reports: “No one knows exactly how many adolescents are turning to surgery to get thinner. One of the few studies, published in 2007, reported that bariatric surgery in teenagers was relatively rare but rising fast: from 2000 to 2003 (the last year examined), the number of operations tripled, to about 800.”

In one article, it is estimated that 220,000 bariatric procedures were performed in 2008 with an estimated increase of approximately 20,000 in 2009.

There is also an ongoing debate as to which form of weight-loss surgery is indicated for adolescents – bypass or banding.

Nor do surgeons agree on which of the two procedures used most — banding or bypass — is more appropriate for youths. Dr. Nadler, of Children’s National Medical Center, prefers banding, saying it is less radical and can be more easily undone if need be. In November, in The Journal of the American College of Surgeons, he described a study finding that among 41 teenagers followed for two years after gastric banding, their excess body weight had dropped by about half, on average, and other measures of their health had improved.

There is no doubt the debates will rage on for years to come.  What is evident, however, to those of us who have litigated many cases involving bariatric surgery performed on adults, is that this is not to be considered a ‘quick fix’ for being overweight.  It is not a form of cosmetic surgery.  This is serious stuff and reasoned considerations must be made: (1) is it medically indicated?; (2) what are the alternatives?; (3) who are the surgeons skilled in these procedures?; (4) is the adolescent properly being screened and counseled before undergoing surgery?; (5) what post-operative follow-up is needed?; (6) is the facility where the procedure is to be performed truly recognized as being capable of dealing with such patients and potential post-operative complications?; and (7) does the child and his/her parent(s) truly understand the risks associated with such procedures? – just to name a few of the many issues that must be addressed.