Posts Tagged ‘coronary stents’

Investigation into unnecessary stent procedures broadens in scope.

Sunday, June 6th, 2010

Stent Fraud Investigation

As I notified our Facebook followers earlier today, the Baltimore Sun published an exclusive lead article on a broadening ‘stent investigation.’ What started out as a scandal involving one cardiologist (Dr. Mark Midei) at one

hospital (St. Joseph Medical Center), now has the potential to encompass the activities of other interventional cardiologists at other area hospitals.

I have been reporting on this since early in the St. Joseph investigation. Keep in mind, I have also advised our readers that our firm is now part of the class action litigation team with the Murphy firm and by extension the Angelos law firm. While I can not share with you any details of what our investigation has revealed to date, I will keep you informed of developments in our ongoing investigation and those being conducted by the news media and Maryland agencies as they progress and become public.

What is at the center of today’s report in the Baltimore Sun is the investigation by Maryland health officials.

Several cardiologists in the state have performed a suspiciously high number of the same invasive cardiac stent procedures that Dr. Mark G. Midei is accused of over-performing at St. Joseph Medical Center, according to an analysis of data from the state’s Health Services Cost Review Commission.

Investigators plan to review the work of the other cardiologists — who were not identified to The Baltimore Sun — going back five years. Sources also said they expect the investigation to eventually expand to include inquiries into other medical specialties and procedures.

Without revealing any confidential information, suffice it to say that based on our investigations to date, this news comes as no surprise. Keep in mind also that when St. Joseph conducted its own internal review and issued letters to 585 patients advising them that their stents were not medically indicated, this was based on an investigation for less than a two year period of time while Dr. Midei was a full-time employee of St. Joseph Medical Center. Dr. Midei took on this position with the hospital in January 2008. He was previously an employee of MidAtlantic Cardiovascular Associates. One might wonder if Dr. Midei’s performance of unnecessary stent procedures was isolated to his new position at St. Joseph.

For the present, let me leave you with some food for thought. These stent procedures costs usually in excess of $10,000 per procedure. As the Sun reports, in the last fiscal year alone, stent procedures brought in $220,000,000 to Maryland hospitals alone. Just how many people needed stents in one year in one state?

There were supposed to be review systems in place in-hospital and at the state agency level to guard against any fraud in the performance of unnecessary  procedures for monetary gain. How well do you think those systems worked? Hospitals have what is known as peer review committees to monitor the conduct of doctors, patient care, outcomes and the like. How did Dr. Midei’s conduct escape detection? As the Sun points out in its “St. Joseph timeline”:

May 2010: State regulatory documents indicate that Midei was able to avoid St. Joseph’s peer review process because, as a department head, he chose which cases would be reviewed. (emphasis all mine!)

Well that makes sense – sort of. We’ll see just how much attention was being paid to Dr. Midei’s (and perhaps others’) conduct by the hospital itself as the dollars came flowing in. Is this somewhat like putting the fox in charge of the hen house? We’ll just have to see. Discovery in our class action lawsuit is just starting. Stay tuned!

If you have any questions or need additional information, please contact: Lisa Bennett, 410-951-8811 or 410-940-8590
Lisa.Bennett@murphypa.com

Non-Cardiac Surgery Too Soon After Cardiac Stenting Increases Risk of Complications

Friday, May 14th, 2010

According to a recent study published in Circulation: Cardiovascular Interventions (an American Heart Association journal), patients should attempt to postpone having surgeries for at least six weeks after a coronary angioplasty procedure with stenting.  Researchers found that patients who wait at least six weeks before having another surgery are less likely to develop reduced blood flow to the heart (a.k.a. heart ischemia) and heart attacks.

The study data revealed that 42 % of patients who had other surgeries within the six-week period developed these complications. Only 13 % of patients who had surgeries beyond the six-week period developed the same complications. The study focused 1,953 patients with an average age of 64 who had cardiac angioplasty with stenting between 2003 and 2007.

According to the American Heart Association:

  • Over 70 percent of coronary angioplasty procedures in the United States also include stenting.
  • In 2006, approximately 65 percent of PCI procedures were performed on men, and approximately 50 percent were performed on people age 65 or older.
  • In 2006, an estimated 1,313,000 PCI procedures were performed in the United States.
  • In 2006, approximately 76% of stents implanted during PCI were drug-eluting, compared with 24 percent bare-metal stents.
  • In 2006, there were 652,000 PCI procedures with stents — 425,000 in men, 227,000 in women.

If you recently had cardiac stenting and require another surgery, make sure to ask your doctor about waiting to have the next surgery. This is particularly true if your next surgery is an elective one. If your doctor or surgeon is not a cardiologist, you may want to consider asking your doctor for a referral to a cardiologist.  You may also want to make sure that your physician or surgeon obtains cardiac clearance before proceeding with another surgery.   Don’t assume that your doctor will do these things for you. Be proactive; ask questions.

For related blogs, please see:

Contributing author: Jon Stefanuca

The Efficacy of Drug-Eluting Stents and Bare Metal Stents in Heart Transplant Recipients with Coronary Artery Disease

Wednesday, March 24th, 2010

A recent study published in Kardiologia Polska (Poland) compared the long-term results of drug-eluting stents and bare metal stents in heart transplant patients. Various stents are routinely used in patients post heart transplant surgery to correct blood flow abnormalities caused by coronary artery disease. Coronary artery disease is generally defined as the build-up of plaque on the interior wall of coronary arteries causing decreased or obstructed blood flow to the heart.  Despite the routine use of stents in heart transplant recipients, there is very little scientific research tracking the efficacy of drug-eluting stents vs. bare metal stents in this population.

The study in question retrospectively evaluated the long-term impact of all available coronary stents used to correct transplanted heart coronary artery disease. Researchers focused on 23 patients. The goal of the study was to identify the mortality rate and the rate of restenosis in this population of patients. Researchers found that 7% patients with drug-eluting stents had restenosis vs 61% of restenosis in patients with bare metal stents. Researchers also found that there was an 18% mortality rate in patients with drug-eluting stents vs. a 31% mortality rate in patients with bare metal stents.

Contributing author: Jon Stefanuca

St. Joseph Medical Center Stent Patients Now Face Another Risk: The FDA Requires a Black-Box Warning on Anti-Clotting Drug Plavix

Saturday, March 13th, 2010

For those of you who have been following the St. Joseph Medical Center stent fiasco, a story in the Los Angeles Times regarding the anti-clotting drug Plavix brings home a new concern for the patients who received this drug as part of the post-procedure therapy. Plavix is used “to prevent clotting of blood in patients who have stents or other prostheses or conditions that predispose them to clotting, and thus strokes and heart attacks.”

The Food and Drug Administration said Friday that it will require a new black-box warning on the label of   the popular anti-clotting drug Plavix to indicate that some patients do not metabolize the drug properly and may receive little benefit from it. The warning indicates that the drug is dangerous only in the sense that it doesn’t work in those patients and thus may leave them unprotected against heart attacks and strokes.

“The new warning appears on the label of the drug in a black box — hence the name — which is considered the most severe form of warning.”  A black box warning is the strongest warning required by the FDA.  The intent of requiring such a warning is to alert physicians and help them treat their patients correctly. “The FDA says between 2% and 14% of Plavix users don’t respond well to the drug and might benefit from alternative treatment.”

According to the FDA press release:

Plavix reduces the risk of heart attack, unstable angina, stroke, and cardiovascular death in patients with cardiovascular disease by making platelets less likely to form blood clots. Plavix does not have its anti-platelet effects until it is metabolized into its active form by the liver enzyme, CYP2C19.

People who have reduced functioning of their CYP2C19 liver enzyme cannot effectively convert Plavix to its active form. As a result, Plavix may be less effective in altering platelet activity in those people. These “poor metabolizers” may not receive the full benefit of Plavix treatment and may remain at risk for heart attack, stroke, and cardiovascular death.

A Wall Street Journal Blog suggests that this situation may actually make the physicians’ job more difficult.

Genetic testing could identify the poor responders. But most doctors aren’t well equipped to do genetic testing. They don’t have quick access to the tests. Even if they did, they might not have time in the cases of many patients to wait for results to come back.

Only one genetic test has been approved by the FDA,  Roche’s AmpliChip, “to look for the variation, but not specifically for determining treatment with Plavix. Many laboratories offer other tests, whose quality the FDA says doctors will have to assess before using. Doctors should make sure the tests are at least 98% accurate, FDA officials told reporters.”

According to Christopher Cannon, a Harvard Medical School associate professor and editor-in-chief of Cardiosource, associations involved with the cardiac-related specialties and sub-specialties “will need to develop protocols for testing and treatment. The alternatives include increasing the dose of Plavix or switching to bloodthinner Prasugrel from Lilly and Daiichi Sankyo, but Cannon says neither has been tested for that purpose.”

“Thus a real conundrum” for patients and their physicians, Cannon said. “I expect mass confusion in response to this FDA warning,” he added.

As we reported in “Eye Opener” on March 13, 2010, St. Joseph Medical Center this past week added another 169 patients to the list of those notified by letter that they had received unnecessary, expensive and potentially dangerous stent procedures.  This brought the number notified to a whopping 538 patients – at least to date.

One has to wonder in all of this, was there a single moment of thought given to the potential risks to the patients at St. Joseph Medical Center when these unnecessary stents were put in hundreds of patients?  Maybe those involved in this tragic story of despicable care were not fully versed in the genetic complication of Plavix (or maybe they were); however, they were most assuredly aware that they were exposing these unwitting patients to a risk of hemorrhage, not to mention the risks associated with having a foreign body unnecessarily placed in their coronary vessels.

Cardiac Catheterizations Overused

Thursday, March 11th, 2010

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

Wednesday, March 10th, 2010

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.”