Posts Tagged ‘Dr. Mark Midei’

Stent Wars – The Decade Begins

Tuesday, June 22nd, 2010

On June 10th, we did the first in a series of articles regarding the basic medical issues involved in the St. Joseph Medical Center/Dr. Mark Midei stent scandal. This second installment begins in the year 2000 – a period in time the cardiology industry calls the STENT WARS.

The early part of this decade was a period when interventional cardiologists, such as Dr. Midei, were aggressively seeking to demonstrate a short and long term successful alternative to open cardiac bypass surgery for patients. While there is no doubt that these specialists were seeking better approaches for their patients by avoiding, if possible, open heart bypass surgery, it is also evident that these endovascular procedures were quite lucrative for interventional cardiologists as well.  It was reported that drug eluting stents generated a world market revenue of $5 billion annually in the early 2000′s.  In 2001, more then 500,000 procedures involving stents and balloon angioplasty were being performed in the United States annually. The “war” for market position was on. Who would win top position among manufacturers and grab this pot of gold?

The STENT WARS were also being fought around the globe and included familiar company names: Cordis, Boston Scientific, Medtronic, Abbott, Conor MedSystems, OrbusNeich, Biosensors, and Xtent.  Mergers, acquisitions, partnerships abounded.  As you can imagine, clinical trials were also proliferating throughout the medical world. Investment money was flowing. Interventional cardiologists invested in their own technology and made money on both the procedures and their investments. During this period of enormous expansion, Dr. Midei became co-founder of a large cardiology practice in the Baltimore metropolitan region. In the latter part of 2007, he was recruited away from his group practice and hired by St. Joseph Medical Center as its Director of Interventional Cardiology (Cardiac Catheterization).

So what was stent research showing?  What was the science that gave Dr. Midei an open door to placing numerous unnecessary stents at the cost of $10,000 – $15,000 a stent.

Early clinical trials were positive for the industry.  Data revealed drug-eluting stents (DES) reduced re-stenosis (i.e. re-narrowing of the cardiac blood vessel) from 20-30% to single digits and continued to show better outcomes than bare metal stents (BMS) and balloon angioplasty.  These favorable results led to the official FDA approval of two drug-eluting stents in 2003 and 2004 for use in the USA although clinical trials had been underway in major cardiac centers for several years. The stent type, coating of the stent with a particular drug, and key decisions made by the interventional cardiologist during stent placement were reportedly all factors necessary for favorable outcomes.  Using coronary angiography, the interventional cardiologist determined the proper stent length and diameter needed to repair a blocked artery and was able to ensure proper stent placement within the artery.  There was  enough new scientific research data for the American College of Cardiology and the American Heart Associated to update and publish clinical practice guidelines  for both hospitals and cardiologists in 2001.

Landmark studies during this time were also revealing more new information about progressive heart disease.  Research studies demonstrated coronary artery atherosclerosis usually affected more then one vessel and was, therefore, often a diffuse disease.

While these results led to the positive development of conjunctive drug therapies, they also opened the door for exploitation.

An interventional cardiologist, seeking to line his/her own pockets and/or gain a position of power within an organization for whom he/she worked could place many stents in multiple coronary vessels regardless of size or complexity. In other words, stents could be placed in symptomatic large blockages, and stents could also be placed in those small areas that MIGHT, in the so-called clinical judgment of the operator, develop into a blockage. Clinical practice guidelines were silent as to what should be done to lesser size lesions.  In the absence of data, the cardiologist could choose to be aggressive or conservative.  However, clearly an avenue for financial abuse and gain was opened for some interventional cardiologists to push acceptable judgment boundaries.

You might ask: weren’t there provisions and systems in hospitals to prevent such exploitation if it were to occur.  Unfortunately, nether the ACC nor AHA 2001 clinical practice guidelines contained any recommendations for peer review or oversight of this burgeoning stent industry. It was left to hospitals to establish their own monitoring guidelines to oversee the conduct of their physicians.

Join our next blog to learn more about the introduction of peer review guidelines that were finally published four years later in 2005.

St. Joseph/Midei Stent Fiasco gets predictably worse. Chief of division faces licensing charges.

Friday, June 11th, 2010

Early this afternoon, the Baltimore Sun reported that the Maryland Board of Physicians, the state’s regulatory agency for licensing doctors, filed charges against the cardiologist, Dr Mark Midei, who was the head of the cardiac catheterization lab at St. Joseph Medical Center. Essentially the 19 page charging document alleges that Midei was guilty of “gross overutilization of health care services” and “willfully making a false report on record in the practice of medicine.” (emphasis added) Efforts are underway by our firm to obtain a copy of this complaint filed against Midei by the Board. We contacted the Board of Medicine and were told that the person who handles these requests was ‘not in today.’ Since the Sun was able to obtain a copy of the charging document – notwithstanding the alleged absence of the Board’s employee – we contacted the Sun. They declined to provide it with the understandable position that they “don’t share our material beyond what we publish for everybody.” At least they were kind enough to reply to our inquiry in very timely fashion. Hey, it was worth a shot.

The Sun reports:

Midei, who ran the cardiac catheterization lab at St. Joseph Medical Center until last year, is alleged to have put stents in the arteries of patients who did not need them. He’s also accused of falsifying medical records to make it appear that the patients were candidates for the expensive — and sometimes dangerous — procedures.

These charges are referred to as the “first independent verification of complaints made more than a year ago to board members and to the staff at St. Joseph.” The first public awareness of ‘complaints against Midei’ did not occur until St. Joseph Medical Center sent letters to patients around mid-December, 2009. As you will learn later in this blog, the first complaint to the Board of Medicine was made ostensibly by a whistle-blower employee of the hospital in November 2008. What in the world took the hospital thirteen months to investigate? The agreement reached with the federal government on the Medicare fraud investigation is reported to have happened in July 2009 5 months before the letters were sent. Midei is reported to have been terminated by St. Joseph Medical Center in the summer of 2009. How long does it take to write a letter to patients and their doctors?! I guess they had to meet with their lawyers for 5 t0 13 months to ‘get it right.’

The ‘typical’ letter, written by the Head of the Department of Medicine, Daniel Hardesty, M.D.,  reads in pertinent part:

I am writing to let you know that a subsequent review [i.e. after the sent had been placed months before] of your cardiac catheterization report was different than the original reports and may be relevant to your ongoing care and treatment.

What is perhaps even more telling is the letter written by Dr. Hardesty to the treating physician for the patients who received unnecessary stents. In relevant part, they read:

You are identified as the referring cardiologist. A subsequent clinical review of this patient’s catheterization report and images were at variance with the previously reported findings. In the opinion of the reviewer, the amount of stenosis in the [coronary artery stented] was insignificant. (emphasis added). Please refer to the Clinical Guidelines attached.

Somewhat fascinating is the fact that from all currently available information it is believed that the determinations made of these 585 patients who received the letters were made by a panel of reviewers, not one reviewer, and that the panel had to agree unanimously that the stents placed by Midei were “unnecessary.” Discovery in the class action lawsuit we are involved in against St. Joseph Medical Center will let us all know just how many were involved in this process of ‘review.’

In a follow-up blog a few hours ago by the Sun’s financial columnist, Jay Hancock, we get the following information from the charging document:

– The board received its initial complaint about Midei in November 2008. An anonymous person describing him/herself as a St. Joseph employee detailed 36 cases in which stents had supposedly been improperly placed. The board received another, similar complaint in April 2009. But it didn’t launch the investigation until it was notified on July 19, 2009, that St. Joseph had revoked Midei’s privileges.

– The board charging document includes the first bits of explanation from Midei to be made public. To wit:

Midei explained the discrepancy by saying he routinely used certain percentages — 70, 80, 90 — as shorthand to signify mild, moderate or significant blockage, the document claims. But he conceded, after reviewing his cases, that there was “significantly lower percentages of stenosis than he had initially dictated at the time of the procedure.”Midei also told hospital staff that he considered other clinical symptoms aside from test results when determining whether to place a stent, according to the charging document. (emphasis added)

Wonder which defense lawyer dreamed-up the ‘shorthand’ defense? Why did I know we were also going to hear about how he used his clinical judgment to justify his conduct of putting in totally unnecessary stents. I suspect many of you don’t do medical malpractice litigation, but the legal equivalent to “the dog did it” is “I used my clinical judgment” to justify what I did.

To bring today’s news full circle, be aware that apparently the Maryland Board of Physicians was notified thirteen (13) months before the letters went to patients. Jay Hancock’s blog posting tell us the following:

– The board received its initial complaint about Midei in November 2008. An anonymous person describing him/herself as a St. Joseph employee detailed 36 cases in which stents had supposedly been improperly placed. The board received another, similar complaint in April 2009. But it didn’t launch the investigation until it was notified on July 19, 2009, that St. Joseph had revoked Midei’s privileges.

I ask again – what took so long?! How many patients were subjected to unnecessary stents by Midei while the Board was “investigating.”  How long does it take to look at a medical record that says the heart’s blood vessel was stenosed (narrowed) 90% and look at a film study and see that it’s not even 20%? Did you know that the Board of Medicine can take emergency action against a physician who poses a risk of harm to the public?

As we continue to say – if you have any questions or need additional information, please contact: The Murphy Firm’s Lisa Bennett, 410-951-8811 or 410-940-8590 Lisa.Bennett@murphypa.com

The St. Joseph Medical Center Stent Litigation: What’s It All About?

Wednesday, June 9th, 2010

As news broke in January 2010 of an investigation of unnecessary stenting procedures performed by Dr. Mark Midei, the news media quickly began their investigations into the ‘who, what, where, when and how’ of this breaking scandal involving a local area hospital, St. Joseph Medical Center.

By now, many are aware that lawsuits have been filed against the hospital. Information has been revealed about a Medicare investigation, an in-hospital review panel assigned the task of reviewing the procedures performed by the former Chief of Cardiology, Dr. Mark Midei, letters written to former patients of Midei, a senate investigation and most recently, a broadened investigation by state agencies looking into the stenting practices of others beyond Midei and St. Joseph Medical Center.

While the details of the investigations, the termination of Midei and some information about what is at the center of this storm have been revealed, what does not appear to be appreciated or at least reported is the impact on patients, who were the victims of this unnecessary stenting.

We will soon begin a series of articles on the history of angioplasty, stenting, the types of stents being used over time, the risks to patients based on the type of stent used, the implications to future care and health of patients who were subjected to this alleged fraudulent conduct. It is only with an understanding of some of these basic issues that the true impact of this alleged (but hospital-admitted) conduct is appreciated. This whole controversy is not just about lawsuits against certain healthcare providers and the reputation of those providers. It is about how the lives of many people have been impacted by the senseless conduct of these healthcare providers.

Do you really understand what angioplasty and stenting are all about? Do you know when they are indicated and when they are not? Do you appreciate what placing a piece of metal inside a coronary blood vessel means to the health and welfare of a patient, who never needed this foreign body placed in them? What does it mean to be on Plavix and aspirin for weeks, months, a year or beyond? What role does the past medical history of patient play in determining when stenting is the right choice for any given patient? What understanding do you have as to the risks associated with ‘bare metal stents’ or ‘drug eluting stents’? Are there uniform recommendations over the past years when stenting rose in popularity as a’ less-invasive, safer’ alternative to by-pass grafting? What vessels can be stented safely? What does it mean for a patient who already has a stent in place to receive a second, third or fourth stent if one or more of those additional stents were absolutely unnecessary? What mechanisms are in place, or should be in place to detect unnecessary procedures being performed in a hospital? Were those procedures in place and being used by St. Joseph Medical Center? Did Dr. Midei just happen to allegedly start performing unnecessary stent procedures after becoming employed by St. Joseph Medical Center? How far-reaching is this alleged fraud?

These are just some of the issues we will be addressing. If you already know the answers to all these questions, then you need not waste your time educating yourself by reading the information we intend to provide. Of course, if you think that this whole incident is of no real significance and just a whole lot to do about nothing – the veritable tempest in a teapot, then you need not read any further.

However, if you are at all wondering what this means to real people whose lives may now be altered or in jeopardy because of what may prove to be simple greed by healthcare providers, then we welcome you to this series. Of course, if you are at all wondering how it is conceivable that – at a bare minimum – 585 unnecessary procedures were performed by one physician in one hospital over a period of less than two years yet allegedly remained undetected by that hospital’s administrators, then you just may want to read along as the story develops. Finally, if you are now wondering in light of recent reports – was this just one doctor at one hospital over just two years? – you may definitely want to stay current with what will be revealed over time on these issues as well.

I’ll end for now with the usual disclaimer: Our law firm, Nash & Associates, has recently been invited by the principals of The Murphy Firm to join the litigation team in the class action lawsuit against St. Joseph Medical Center. While we are limited in what we may reveal to you, we are not limited in providing you with an education of those issues of medicine and law that are relevant to this entire controversy. That will be the scope of this series, which we believe will put many of the more central issues – such as the harm to real people – in better perspective.

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

Friday, April 23rd, 2010

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.

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

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.

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.”