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!

A Baltimore City Ordinance Fuels The Abortion Debate – Archdiocese Goes to Court To Have It Declared Unconstitutional

According to a recent article in the Baltimore Sun, a Baltimore City ordinance requires local crisis pregnancy centers to post signs in their clinics disclosing that they do not offer abortion or birth control services. Apparently, this ordinance has angered the Archdiocese of Baltimore, which has decided to file a lawsuit in the Federal District Court, seeking to have the ordinance declared unconstitutional.  Its argument is that the government should be prohibited from compelling speech by requiring the clinics to post signs.  Why would the Archdiocese want to get rid of an ordinance, which, in essence, tells the public “you cannot get an abortion here?”

It appears that the Archdiocese’s remonstration has more to do with what the clinics do separate and apart from what the ordinance requires. Because the clinics must disclose that they do not offer abortion services, some of the clinics choose to post another notice, which informs the public about clinics that do offer abortion services. The ordinance does not require such a notice.

The Archdiocese seems to assume that the clinics would not have the incentive to post information on abortion clinics in the absence of the ordinance. This assumption appears attenuated at best.  Were these notices voluntarily posted by the clinics before the ordinance was enacted? Even if the ordinance were to be repealed, would the clinics still choose to post these notices? After all, they are not compelled to post the notices under the ordinance at the present time.  Whether or not a clinic chooses to post information on abortion clinics, can a patient simply walk in and inquire about abortion clinics?  The bottom line is that these clinics disclose information on abortion services because they want to and not because they have to.

I am curious if the Archdiocese would still want to pursue a lawsuit to repeal the ordinance if the clinics did not post notices with information on abortion clinics. Would it still have a problem with an ordinance telling the public “no abortions here.” Your thoughts?

Contributing author: Jon Stefanuca

Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging

The FDA has recently launched a comprehensive new study regarding ways to reduce radiation exposure as a result of medical imaging.  The on-line article sets the background for the study, then provides comprehensive scientific and medical information for support:

Like all medical procedures, computed tomography (CT), fluoroscopy, and nuclear medicine imaging exams present both benefits and risks.  These types of imaging procedures have led to improvements in the diagnosis and treatment of numerous medical conditions.  At the same time, these types of exams expose patients to ionizing radiation, which may elevate a person’s lifetime risk of developing cancer.  As part of a balanced public health approach, the U.S. Food and Drug Administration (FDA) seeks to support the benefits of these medical imaging exams while minimizing the risks.

Through the Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging, FDA is advocating the universal adoption of two principles of radiation protection: appropriate justification for ordering each procedure, and careful optimization of the radiation dose used during each procedure.  Each patient should get the right imaging exam, at the right time, with the right radiation dose.

The related White Paper discusses types of medical imaging procedures,  factors causing the unnecessary exposure, and proposes possible solutions.  The factors include: Issues relating to Device Use, as well as Issues Relating to Clinical Decision Making.  Solutions include: Promoting Safe Use of Medical Imaging Devices, supporting informed clinical decision making, as well as increasing patient awareness.

Fat-Melting Injections (a.k.a. Lipodissolve) May Not Be As Safe As You Think

According to an article published by WebMD, the FDA reprimanded six U.S. spas (Monarch Medspa in King of Prussia, Pa., Spa 35 in Boise, Idaho, Medical Cosmetic Enhancements in Chevy Chase, Md., Innovative Directions in Health in Edina, Minn., PURE Med Spa in Boca Raton, Fla., All About You Med Spa in Madison, Ind.) and one Brazilian company for making misleading statements about the safety and side-effects of fat-melting therapy (a.k.a. mesotherapy, lipodissolve, lipozap, lipotherapy, or injection lipolysis).

FDA’s Deputy Director of the Division of New Drugs and Labeling Compliance noted:

They make it sound so good and so safe. … [They claim] it dissolves fat — melts it away with no side effects — and they have done thousands of procedures, and it really sells well. … We are really concerned because we have had reports of complications, and we have no good data that say this is safe and this is effective.

Lipodissolve is a process whereby a series of subcutaneous injections are administered (usually injections of phosphatidylcholine and deoxycholate) to a specific part of the body in an attempt to melt the subcutaneous fat. According to the article, some of the reported side-effects of this therapy have been scaring of the skin and the developments of painful subcutaneous knots.

If you are considering Lipodissolve, be aware that this treatment is yet to be approved by the FDA, and there is no medical data or scientific research demonstrating that Lipodissolve is safe for consumers.

Contributing author: Jon Stefanuca

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

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

St. Joseph tells 169 more patients they may have had unneeded surgery; total notified at now at 538

The Baltimore Sun reports today that another 169 patients have been notified by St. Joseph Medical Center in Towson, Maryland, that the coronary stent implants they received may well have been (read – were) unnecessary.  The total number of patients so far notified by the hospital has now reached 538.

Stents, mesh tubes that are threaded into damaged arteries to prop them open, are generally considered appropriate when vessels have at least a 70 percent blockage. But hospital officials say their review uncovered stents implanted by Midei in patients with insignificant blockage. And attorneys representing some patients say the amount of blockage was often overstated in their medical records.

Dr. Mark Midei, a cardiologist at the center of this storm, was terminated by St. Joseph Medical Center after the hospital came under investigation by federal authorities last year.  He at one time was an employee of one of the leading cardiology group practices in the area, MidAtlantic Cardiovascular Associates, but left that group when he was recruited by St. Joseph Medical Center to head its cardiovascular laboratory in 2008.  His departure from his group was apparently not peaceful.

[Dr. Midei’s] departure helped scuttle a deal MidAtlantic had to merge with St. Joseph rival Medstar Health, and prompted the practice’s chief executive to tell Midei: “I will spend the rest of my life trying to destroy you personally and professionally,” according to court records.  

A class action lawsuit has been filed by the the Murphy Firm in Baltimore, Maryland, working in conjunction with another Baltimore legal powerhouse, The Law Offices of Peter Angelos. These firms have been involved in many class action lawsuits across the country.  The current lawsuit has been filed in Circuit Court for Baltimore City, Maryland.  On January 28, 2010, the Murphy firm posted an announcement regarding this class action.  A similar press release detailing some of the relief being sought in the class action is posted on Peter Angelos’ firm’s website.

In February of this year, according to the Sun’s report today, “two senior members of the U.S. Senate Finance Committee called on St. Joseph to turn over records of its financial relationships with stent manufacturers, including records of how the $10,000 procedures were billed to federal and private insurers.”

“In addition to putting patients’ lives at risk, unnecessary medical procedures amount to wasteful spending of precious federal health care dollars,” they wrote in a letter to the hospital.

As for Dr. Midei’s comments or reaction to today’s article, the Sun reports:

A spokesman for Midei declined to comment. He reiterated a statement the doctor issued in January, which read: “I am confident that I have always acted in the best interest of my patients, and when all the facts are presented, I will continue providing quality medical care to my patients.”

Landmark NIH Clinical Trial Comparing Two Stroke Prevention Procedures Shows Surgery and Stenting Equally Safe and Effective

The National Institutes of Health issued a news release regarding a landmark clinical trial relating to stroke.

A stroke can be one of the most devastating medical conditions that a person can suffer. Not only can it cause immediate death (stroke is the third leading cause of death in the United States), but it can also cause severe neurologic deficits that can leave a once-healthy person with severe mental and physical limitations. Therefore, researchers are always looking at new ways to try to prevent stroke.

The National Institute of Health (NIH) recently published the results of a major nine-year clinical trial that evaluated two methods of preventing future stroke: carotid endarectomy, or CEA, which is a surgical procedure to clear blocked blood flow, and carotid artery stenting, which is a newer and less invasive procedure that implants a small, expandable device in the artery to widen the blocked area. The good news for patients is that both methods proved to be safe and effective in both men and women.

“The CREST trial results show that we now have two safe and effective methods to treat carotid artery   disease directly, the tried and true CEA, and the new kid on the block, CAS,” said Thomas G. Brott, M.D., professor of neurology and director for research at Mayo Clinic in Jacksonville, and the study’s national principal investigator. “

The study found that the two methods were not perfectly equal, however. In patients over 70 years old, for example, the surgical procedure (CEA) results were slightly superior to stenting. Also, the study noted a difference in heart attacks and strokes:

The investigators found that there were more heart attacks in the surgical group, 2.3 percent compared to 1.1 percent in the stenting group; and more strokes in the stenting group, 4.1 percent versus 2.3 percent for the surgical group in the weeks following the procedure.

What this study means to patients is that doctors now have two safe and effective means of trying to prevent future stroke, and can choose the procedure that best fits that patient.

“The CREST trial provides doctors and patients with much needed risk/benefit information to help choose the best carotid procedure based on an individual’s health history. This personalized decision making should translate into improved patient outcomes,” said Walter J. Koroshetz, M.D., deputy director of NINDS.

Added Dr. Brott, “People have some very good options for stroke prevention that we hope will not only extend the length but also the quality of their lives.”

Contributing Author: Michael Sanders

At Hearing on Radiation, Calls for Better Oversight

In an article posted by the New York Times, the dangers of radiation, specifically being over/errantly exposed in medical procedures, is graphically detailed.  The article also references an in-depth investigative report that the New York Times featured in January of this year. The tragic story of Scott Jerome-Parks, is described in both articles, with many of the sad details provided in the New York Times January investigation:

As Scott Jerome-Parks lay dying, he clung to this wish: that his fatal radiation overdose — which left him deaf, struggling to see, unable to swallow, burned, with his teeth falling out, with ulcers in his mouth and throat, nauseated, in severe pain and finally unable to breathe — be studied and talked about publicly so that others might not have to live his nightmare.

Sensing death was near, Mr. Jerome-Parks summoned his family for a final Christmas. His friends sent two buckets of sand from the beach where they had played as children so he could touch it, feel it and remember better days.

Mr. Jerome-Parks died several weeks later in 2007. He was 43.

A New York City hospital treating him for tongue cancer had failed to detect a computer error that directed a linear accelerator to blast his brain stem and neck with errant beams of radiation. Not once, but on three consecutive days.

The frequency and occurrence of radiation being utilized in medical procedures continues to be on the rise.  Many leaders from the healthcare industry agree that more needs to be done, in so far as making sure radiation continues to help, and not harm, patients.  The New York Times examined thousands of pages of records, and conducted numerous interviews with healthcare professionals.  Some of the results revealed the following:

The Times found that while this new technology allows doctors to more accurately attack tumors and reduce certain mistakes, its complexity has created new avenues for error — through software flaws, faulty programming, poor safety procedures or inadequate staffing and training. When those errors occur, they can be crippling.

“Linear accelerators and treatment planning are enormously more complex than 20 years ago,” said Dr. Howard I. Amols, chief of clinical physics at Memorial Sloan-Kettering Cancer Center in New York. But hospitals, he said, are often too trusting of the new computer systems and software, relying on them as if they had been tested over time, when in fact they have not.

Identifying radiation injuries can be difficult. Organ damage and radiation-induced cancer might not surface for years or decades, while underdosing is difficult to detect because there is no injury. For these reasons, radiation mishaps seldom result in lawsuits, a barometer of potential problems within an industry.

In 2009, the nation’s largest wound care company treated 3,000 radiation injuries, most of them serious enough to require treatment in hyperbaric oxygen chambers, which use pure, pressurized oxygen to promote healing, said Jeff Nelson, president and chief executive of the company, Diversified Clinical Services.

While the worst accidents can be devastating, most radiation therapy “is very good,” Dr. Mettler said. “And while there are accidents, you wouldn’t want to scare people to death where they don’t get needed radiation therapy.”

A good portion of the hearing last week dealt with CT Scans and the proper amount of radiation to which one should be exposed.  One of the concerning issues with CT Scans is the vast difference between exposure levels at different facilities.  Even within the same facility, doses can vary widely between patients.

CT Scans are only one example of the multitude of issues presented at the Congressional hearings last week.  The mandatory accreditation of radiologic units as well as the standardized reporting of medical errors were called for by some at the hearings.

Physicians to test new emergency treatment for traumatic brain injuries

Traumatic Brain Injuries (TBIs) occur, sadly, much more frequently than you may think.  The effects are often permanent, life-threatening and/or significant in nature.  TBIs can negatively affect many vital parts of one’s daily living, as well as the people around them.  A recent article discusses a new emergency treatment that may help combat those effects.  This treatment is spear-headed by the Emergency Department of Stanford Hospital and Clinics, as well as the Santa Clara Valley Medical Center, and is more fully detailed below:  

The Stanford team and physicians at 16 other U.S. sites want to test the efficacy of a new drug treatment. In a phase-3 clinical trial that has been approved by the U.S. Food and Drug Administration, patients with traumatic brain injuries would receive progesterone, a hormone normally found in our bodies, to determine if it helps lessen brain swelling and damage.

Animal studies and two small clinical studies have indicated that progesterone may be beneficial in treating TBI patients. Quinn, who is an associate professor of emergency medicine at the Stanford University School of Medicine, also noted that progesterone “has been around a long time, and it’s a substance we know a lot about” because it has been used for birth control and for hormone therapy.

In the trial, TBI patients who are brought to Stanford, Santa Clara Valley Medical Center and the other participating medical centers would be separated randomly into two groups. One group would get an IV mixture that has progesterone, and the other group would get an IV drip without progesterone. Everyone enrolled in the study would receive standard medical care for a brain injury — maintaining blood pressure and providing oxygen — and all patients would be contacted by telephone every month for five months, to check on their progress before returning at six months for final neurological testing.

The proposed trial is unusual because the IV treatment would have to begin within four hours of the onset of an injury — at a time when most TBI patients aren’t alert enough to give consent, and their families can’t get to the emergency department fast enough to give consent. “The people we see in the ED often come in unconscious, and we know from experience that finding family members to give consent for treatment in the emergency setting can be difficult,” Quinn said.

The consent controversy is one that will most likely not go away anytime soon.  The article states that there are federal laws in place, that allow such procedures to occur, without the patient’s informed consent.  With this in mind, Stanford has posted a link for interested individuals to take a survey, in regard to their feelings regarding such a procedure.

We leave you with some somber statistics:

Every 15 seconds, someone in the United States suffers a major traumatic brain injury. Every five minutes, someone is forever disabled as a result of a TBI. Some 52,000 deaths per year are caused by these injuries. TBIs are the leading cause of death in people aged 1 to 44.

Let’s hope these numbers decrease as time goes on, with advances in safe medical technology and innovation.