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Procedure of the Month

This is the case of a 68 year-old male suffering from severe back pain for 3 months. Patient failed conservative treatment with high doses of analgesics. MRI was performed, as shown in Figure 1 below. This T2-weighted image clearly revealed evidence of acute fracture with bone marrow edema at the L1 level. Which choice do you think best describes the patient's treatment options (click on the x-ray below to take the multiple choice/guess test)?

Figure 1: Preoperative T2-weighted sagittal MRI showed evidence of bone marrow edema indicative of acute fracture at the L1 level (arrow).

Case review and x-rays courtesy of
Dr. Bassem A Georgy.
Interventional Radiologist Valley Radiology Consultants Assistant Clinical Professor University of California, San Diego

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Procedure of the Month Sponsored by DePuy Spine, Inc.


 

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AAOS Political Action Committee
Active players in the orthopedic field know the importance of the AAOS Political Action Committee (PAC). On the cusp of hot topics affecting physicians and patients, the AAOS PAC works diligently to provide data to members of Congress and improve the present and future of orthopedics.

Who ARE These Guys?
Every 60 seconds or so a surgeon tears the cover off an Integra LifeSciences package. Quietly, this company has become the seventh largest medical implant manufacturer serving orthopedic surgeons in the world. Where to now? Would you believe $1 billion in two years? How about $2 billion by 2015?

Redemption in a Mechanism of Failure: The TOPS™ Story
Impliant’s TOPS™ System had a “squeaker” in its clinical study. After a voluntary suspension of the study by the company and finding the mechanism of failure, the FDA has approved a resumption of the study. What insider lessons were learned? Class starts here.

Who is Numero Uno in the PearlDiver Database!! Are You Surprised?
The answer may surprise you. Is it sore backs, aching hips, sore knees, fingers? PearlDiver details 3.8 million spine related complaints—complete with demographic information and charging information. But that’s not #1. PearlDiver also lists 3.5 million large joint complaints. Sorry, still not #1. What could the most common orthopedic complaint possibly be? To get the surprising answer…read on.

What the Knees Need: Baby Boomers and Their Options
Knee patients often show up at the doctor’s office with recurrent mechanical symptoms. It is up to the orthopedist, says Dr. Giles R. Scuderi, Director and orthopedic surgeon with the Insall, Scott & Kelly Institute in Manhattan, to thoroughly assess the patient and then determine if nonoperative treatment will do, or if the person needs a unicompartmental or total knee procedure.

Physician: Report Thyself
The government says its healthcare anti-fraud efforts are working and it wants to encourage physicians to self-report possible fraud. How well did the government do in 2007 and what about those deferred-prosecution deals with undisclosed evidence? Read about it here.

Revising the Statistics
The word that orthopedic patients least want to hear is “revision.” Who, in the universe of large joint patients, do we expect to see on the receiving end of this news? If you guessed “the elderly” you would have been wrong. The reality of who is hearing “revision” may come as a surprise. Read what we found when probing PearlDiver’s database.

Where Is Ben Now? Trends in Venture Capital
What is being funded by VCs and why? First of all, spine is having to share the spotlight, says Gary Stevenson, Managing Partner at MB Venture Partners, LLC. Here Stevenson outlines what constitutes an attractive investment…he also highlights issues that are affecting the distribution of VC funding.

The Hounds of Wall Street
Conventional wisdom on Wall Street is that ArthroCare is in a bare-knuckle fight to the finish with short sellers. Which leaves us with the dominating question: If ArthroCare is essentially a “lame duck” growth stock, then why are sales, earnings, and the stock price contradicting the short seller’s dire predictions and even outperforming consensus analyst forecasts? We have the answer.

The Era of “Tell Me Right Now” Dawns at FDA
The FDA wants the next phase of post-market oversight to change from self reporting to proactive surveillance. How? Through the Sentinel Initiative. Read what it means to device manufacturers here.

The Day After Tomorrow: Complication Rates and Instrumentation Trends in Posterior Lumbar Fusion
Could PearlDiver be the Nostradamus of spinal instrumentation? This most commonly performed surgery on the lumbar region of the spine increases fusion rates and improves spinal stability—but what about complications? Using PearlDiver’s database we find the answers. Are you ready for some quatrains about what happens next?

You Try It. No You Try It First: New Technology Adoption
What are the forces working for and against new technology adoption? Youth versus age, risk taking versus conservatism, and the economic realities of the day, says Dr. Rick Guyer, President of the Texas Back Institute.

Cheaper, Thinner, Faster, Stronger
In this, the second of our series of three articles on innovation, we tackle the question: How do you measure medical technology innovation? While difficult, measuring innovation is NOT impossible. Why? Well to start, and in the immortal words of Supreme Court Justice Potter Stewart, “We know it when we see it.”

SAS Crosses the Rubicon in Miami Beach
The SAS 8th Annual Global Symposium in Miami Beach may have crossed the Rubicon. How? Read about the Society’s opportunities for growth and collaboration as its new President lays out a vision for the future.

Arthroscopic Treatment for Tennis Elbow: Coming on Strong
“Tennis elbow” or lateral epicondylitis is, according to our PearlDiver database, one of the most reported diagnosis for problems with the elbow. Lately clinical evidence has shown that arthroscopic treatment for tennis elbow can provide long-term stability and, in most cases, return of the elbow to its optimal function. Check out the data from PearlDiver.

Do Republicans Make Better Orthopedic Surgeons?
A recent Nature Neuroscience journal study of the decision making differences between liberals and conservatives appears to argue in favor of Republican surgeons! Which, frankly, explains a lot—to BOTH sides and, to stretch an analogy almost to its breaking point, it may also explain why McCain’s health care plan is different from Obama’s. Read OUR take here.

"Sound of Music" Turns to Greek Tragedy for Smith & Nephew
Smith & Nephew’s Swiss (mis)adventure with Plus Orthopaedics is turning into a Greek Tragedy. The company’s whole acquisition strategy is being called into question. Read how CEO Illingworth explained it to the brutal British press.

“Dear John Letter” for Hip Resurfacing?
“Dear John H. Resurfacing: I hope this little note finds you well. We certainly have had some great times and, gosh, I’ll never forget those wonderful moments when the FDA approved your PMA. We’ve just celebrated our second anniversary together and, well, I’m just not feeling the magic anymore….” Two years after FDA approval, how happy are orthopedists with hip resurfacing? Read our analysis here.

In the Beginning, There Was the End: Manuscripts 101
Dr. Paul Manske, Professor of Orthopaedic Surgery at Washington University School of Medicine in St. Louis and Editor-in-Chief of The Journal of Hand Surgery, shares his thoughts and experience on the details of shepherding a manuscript through publication.

Did ConMed Get Re-Wired?
Ever hear about the neurosurgeon who used an $80 Bosch power drill to do brain surgery? It really happened. Surgeons like their power tools. Increasingly they also like a particular line of sterilizeable power tools from ConMed’s Linvatec unit. Did ConMed get re-wired? We have the details here.

Chan’s Sentence; Industry’s Lessons
By Walter Eisner
April 8, 2008

Dr. Patrick Chan was sentenced on April 3 after admitting to demanding and receiving kickbacks for using specific spinal devices.

What punishment did U.S. District Court Judge Susan Webber Wright dole out to the convicted felon in the 40-minute sentencing hearing?

Go to Canada to get a visa, pay $59,000 in fines and restitution, and promise to be good for three years.

Yeah, you read that right.

At a time when the entire orthopedic medical device industry is under the brightest spotlight in its history from federal prosecutions, monitors, and congressional hearings, the one surgeon who has actually been convicted of taking bribes gets sent to Canada by the judge who dismissed Paula Jones' sexual harassment lawsuit against President Bill Clinton in 1998.

Chan: “I’m Sorry”

On the other hand, Chan didn't get off unscathed. He no longer has a license to practice medicine in Arkansas, he is estranged from his family, his career is over in the U.S., and he paid over $1.5 million when the qui tam (whistleblower) lawsuit against him was settled. He has spent the last 20 months in home incarceration and the feds are keeping $2 million of his bail in the bank to make sure he comes back from Canada to comply with the terms of his probation and cooperate in continuing lawsuits and federal investigations. Chan’s current situation and past three years under the national spotlight are sure to give any surgeon pause to wonder if the benefits of a little extra cash for using a specific device are worth the cost.

Chan told the court, “I'm truly sorry for what I did, I've suffered significantly. I've lost my career.” Chan also said he hadn't seen his wife or children since his arrest in September 2006 and that there was a rift between himself and his wife.

According to the indictment, Chan received his first payment of $3,000 in January 2004 and received as much as $8,000 a month in kickbacks until June 2006. Federal agents arrested Chan in September 2006, accusing him of defrauding Medicare and Medicaid through the scheme. He put up $4 million cash and a $290,000 property bond to be released to await trial under house arrest and while wearing an ankle bracelet monitor.

Three civil suits were subsequently filed against Chan in White County, Arkansas, claiming he received $1 million in stock options. Chan reportedly said at the time of his arrest that he was worth $10 million. We don't know anything about Chan's personal finances, but after paying fines and putting up bail, that still leaves a fair chunk of change in Chan's pockets if he started with $10 million.

A Light Sentence?

The obvious question looming is: What did the feds get from Chan for the seemingly light sentence?

That question was partially answered at the sentencing.

Warren Watkins, Managing Editor of Chan's hometown newspaper, The Daily Citizen, attended the sentencing and reported that Assistant U.S. Attorney Karen Whatley told the judge, “On two occasions, Chan has had very lengthy debriefings with the FBI and office of Inspector General, and provided information to investigators.”

Chan had faced up to five years in prison, but Judge Wright noted that Chan had cooperated with federal agents after his arrest.

Chan also faces a number of civil lawsuits involving patients who claim he performed unnecessary surgeries or used devices based on his illegal kickback scheme. Michael Mitchell, who is one of whistleblower John Thomas' attorneys, told the court, "He has information for the other defendants in the kickback scheme. The case was settled for Dr. Chan, but is proceeding against Blackstone, the device manufacturer, who we contend was paying kickbacks to Chan.”

Blackstone Medical, a division of Orthofix, has told OTW that the device salesperson involved in the kickback scheme, Kelly Yielding, was not acting on behalf of the company and it is defending itself vigorously.

Deportation, Depositions, and Civil Suits

Chan is a dual citizen of Malaysia and Canada and was in the United States on a work visa. Since he's not working, his visa has expired and he is subject to deportation. If he is deported, he cannot return to the United States and fulfill the conditions of his probation or be compelled to be deposed for the civil cases. To avoid that situation, the judge, reported Watkins, said, “I will permit Dr. Chan to go home to Canada, not because I want to be lenient but because I believe if I don't, he will be deported. I'm going to direct him to leave this country immediately.”

The order for Chan to immediately leave the country made the civil case attorneys very nervous about getting his depositions.

Brandon Clark, an attorney representing one of the couples involved in a civil suit against Chan and in attendance at the sentencing, told us that Judge Wright allowed one of the attorneys for the qui tam Relator, John Thomas, to state on the record that they had received no cooperation at all from Dr. Chan and that he continued to assert the 5th Amendment in response to questions from them and requests for documents. Clark said the same had been true in their civil action on behalf of Leslie Rollins and wife, Ashley, in which Chan has consistently invoked the 5th Amendment to avoid answering any questions about his relationship with Blackstone Medical.

David Ivers, another qui tam attorney for Thomas, informed OTW that his firm had filed a motion on April 2 for court approval to amend their complaint. "The complaint," wrote Ivers, "if approved, will remove Synthes as a defendant and will provide more details about specific surgeries that were tainted by [alleged] kickbacks paid by Blackstone and their agents."

After that motion was filed, Ivers said the judge entered an order that allows the qui tam attorneys to depose Dr. Chan. They had previously requested permission from the judge to depose Dr. Chan now, without waiting on a discovery scheduling order, because of their concern that he would flee the country once he is sentenced. Dr. Chan was served with the subpoena for his deposition at his sentencing hearing.

Clark told us, "The Court's reason for not allowing the private victims of Chan's misconduct to be heard in connection with his sentencing was that the civil actions require a finding that Chan committed medical malpractice in performing unnecessary surgeries, a finding not required in the criminal proceedings where the ‘victims’ are Medicare and Medicaid, and the medical malpractice victims have not yet established through adjudication that they were in fact victims”.

“Judge Wright was clearly very attuned to the fact that there are numerous civil actions pending against Chan in state court, and that he should be required as a condition of the disposition of his criminal case to cooperate fully in returning to the United States in order to allow those various state court proceedings to go forward and be resolved," Clark concluded.

In fact, the judge noted explicit requirements of Chan’s sentencing that he:

  • Apply for an "S" Visa to enable him to return to report to his probation office, to participate in court proceedings and depositions, and to participate in meetings related to investigations and/or law enforcement.
  • Cooperate fully with opposing counsel in all pending matters, such as obtaining defendants’ depositions either in person or by telephone.

Finally, the official order noted that, “to ensure cooperation in ongoing proceedings and his appearances in the U.S. for purposes of the litigations and to meet with a probation officer, the Court will not release the $2 million on deposit with the Registry of the Court or release the lien on defendant's home and imaging machine.”

Clark said, "The Court did an admirable job of attempting to balance the competing interests of the parties to the proceeding, as well as taking account of the interests of those who were not direct parties but who would be directly affected by the terms of her decision, i.e., the civil litigants with cases against the former neurosurgeon."

Dr. Chan's civil attorneys, said Clark, have indicated that Chan “has been asked by authorities in Massachusetts investigating Blackstone Medical to testify before a grand jury in that state.”

As of April 2, however, a subpoena had not been issued to require that appearance. Clark believes that there apparently is ongoing discussion between Chan's lawyers and prosecuting authorities in Massachusetts regarding possible immunity from prosecution for Chan if he testifies.

Synthes Out – Blackstone Remains

With the possibility of Synthes being removed from the whistleblower suit, that leaves Orthofix's Blackstone as the biggest name to be allegedly linked to Chan.

Clark said that according to information provided by Blackstone, “Chan received $1,080,000 in stock less the purchase price of $225,000 for his alleged consulting services. He also paid an additional $50,000 for another 10,000 shares of stock in September of 2006, thus netting him another $40,000 in profit. All of the stock value was in addition to cash payments, royalties, honoraria, expense reimbursements and at least one study grant, creating a very handsome compensation package for Dr. Chan of well in excess of $1 million.”

Clark continued, “While continuing to deny that Dr. Chan's compensation was connected with sales of Blackstone products, [Blackstone] admitted that over the period from 2002 to 2006 while Dr. Chan was ‘consulting’ for the company, he generated sales of Blackstone spine products used in his surgeries in the total amount of $2,895,737.25. Thus, a jury will ultimately be asked in our case to determine whether at least one purpose of paying Dr. Chan over $1 million was to secure the sale of $3 million in Blackstone products.”

Industry’s Lesson

The continuing Chan saga is a long way from over if the whistleblower suit continues against Blackstone, among others, and the three civil cases in Arkansas find that Chan committed medical malpractice by performing needless surgeries and taking kickbacks to implant devices not necessarily in the best interest of his patients.

The evidence gathered from Chan’s cooperation with federal agencies, which continue to investigate Blackstone, and depositions yet to come from the civil cases will no doubt feel like Chinese water torture to the defendants in the ongoing lawsuits.

Most importantly, the bright light shining on Chan, distributors, and device companies from this case may usher in a new era of compliance and monitoring of the relationships between spine surgeons and manufacturers in the same way we’ve seen a monitoring program impact the hip and knee market. In an industry that allows a small start-up spine company to survive with only a few surgeon customers, the temptation for securing business in any way possible is powerful.

Chan didn’t go to jail or pay a huge fine. But he has become a useful tool and example to put the spine industry on notice to find ways to assure that their relationships with spine surgeons can stand the light of day.

 

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