Tuesday, July 31, 2012

AlphaWreck: The Carousel of Spine

Yesterday a CEO came out to wander, caught an aging spine in a jar
Fearful when the sky was full of thunder, and tearful at the falling of a star
And the seasons they go round and round, like Healthpoints ponies they go up and down
You're captive on the Carousel of Spine, you can't return you can only look behind
From where you came and go round and round and round in the circle game.

Yes fellow bloggers, if word on the Street is true, Dirk Kuyper became another casualty at AlphaWreck. Do I hear $1.76 per share? Are there actually any buyers?  TSB's recommendation is dump the stock and run. Ever since Les Cross was promoted to CEO and Dirk was demoted, it was just a matter of time before the old Healthpoint Sociopaths came to roost. What is it about this company? Considering that this dog has been dragging its tail for the last year or so, maybe Mr. EBITDA himself will be able to create a buzz considering this stock has underperformed (did I actually say that) ever since the underwriters pulled a fast one on the investing public. As Elias use to say, "the worm has turned." With vendors complaining about lack of payment, who knows maybe Healthpoint can lend them some money, but then on second thought, maybe not. Considering that the scuttlebutt was that they were doing business with PODS, its a wonder that the DOJ hasn't paid them a visit.  In fairness to Dirk he wasn't a bad guy, he just worked for and with some crazy people. So in closing Dirk, remember you can't return you can only look behind and go round and round and round in the circle game,

"It's a bright horizon and your awaking, you will see yourself in a brand new way
The sun is shinin' the clouds are breaking, you can't lose now, there's no game to play"

Good Luck!

Sunday, July 29, 2012

Stryker, Pomona Hospital and OP-1

Where's Steve MacMillan when you need him?  Considering that Stryker finally sold off OP-1 to Olympus in a deal that smelled fishy and included the V Brothers, once again Stryker just can't rid itself of its Albatross, also known as  OP-1. On July 25th, 2012, it was reported in various media outlets that more than a dozen patients may have be the subjects of secret medical experimentation (that sounds nefarious) alleged to have taken place at Pomona Valley Hospital, in Pomona California.  A letter dated July 24th, 2012 was issued by the attorney for the plaintiff, April C. Cabana to the Office for Human Research Protection at the United States Department of Health and Human Services.

Based on the aforementioned complaint, once again, we are revisiting the off-label use of OP-Putty and Calstrux.  Even though the complaint seems to absolve Stryker, it seems that the Almighty Stryker can't get rid of that dog OP-1. The allegations in this complaint center around the truff, as Mike Tyson would say, regarding Pomona Valley Hospital at first denying that an IRB had not been approved by the hospital.  Unfortunately for Pomona and the surgeon involved, recently obtained documents suggest that there was a "secret research project" taking place at the hospital regarding OP-1 and Calstrux. It seems that the hospital's Vice-Chair person asked the lead investigator "if efficacy is obvious should the research project and randomization be continued." 

At issue are State and Federal laws and regulations that mandate that researchers receive informed consent of subjects or patients prior to enrolling them in a research project. The complaint states that Ms. Cabana was never informed that she was going to be enrolled as a subject in this project.  As many of you are aware, surgeons can use their professional discretion for off-label use.  The smoking gun seems to be the correspondence between the hospital and Ms. Cabana's surgeon.  So how did Pomona, the surgeon, and Ms. Cabana get to this point?  OP-1 a potent bone morphogenic protein supposedly delivered the knock out blow by accelerating boney growth in and around her nerves resulting in remedial surgery that was not successful. Not only does Ms. Cabana suffer agonizing pain, she is on permanent disability. But this raises a greater concern.  If Ms. Cabana was made aware of being enrolled in the so-called "research project,"and that OP-1 and Calstrux would be used, would she had  the acumen to make an educated decision about the use of these products during her initial surgery?  Consumer Medicine?  Bah Humbug! Once again, the Cabana case brings to light the complexities that exist in modern day spine surgery, successful fusion no matter at what cost.  How many Ms. Cabana's exist that we never hear of?  Based on this complaint, there are potentially a few more to be reckoned with since Pomona had at least 16 other patients enrolled in the OP-1/Calstrux project.

So TSB must ask the proverbial question, what happens to Pomona? What happens to Dr. Famous? Does the government have the "chutzpah" to take action or will they attempt to quietly deal with this, sweeping it under the rug.  TSB doesn't know about our readers, but knowing what we know, if this was my loved one, there would be some serious ass kicking going on. 

Money, Money, Money, Money
Some people got to have it,
Hey, hey, some people really need it
Hey listen to me, y'all do thangs, do thangs, do thangs, bad things with it
Talkin' 'bout cash money, dollar bills y'all come on now.

Tuesday, July 24, 2012

Lanx: Fear and Loathing in Broomfield

"Absolute Truth is a very rare and dangerous commodity in the context of journalism."

No fellow bloggers, Hunter Thompson, aka Gonzo has been long and gone, but his spirit still lives on, at least with The Spine Blogger.  It was reported on July 23rd, in the year of the Lord, that Lanx "No Thanx" has taken it on the chin as it lost its bid to toss out a breach of contract lawsuit filed against it by "faster than a speeding cheetah, able to leap tall buildings at a single bound, it's a bird, it's a plane, no it's Alex Lukianov and Nuvasive for "allegedly" raiding its sales force.  Raiding its salesforce?  Stealing its top Bagman? Je ne said quoi!

No sympathy for the devil, keep that in mind, buy the ticket and take the ride, and if it get occasionally heavier Lanx, than what you had in mind, chalk it up to forced conscious expansion, tune in, freak out and get beaten.........Round 1 Nuvasive by a TKO.....looks like another love TKO Lanx.  TSB wants to know what our readers think?  I'll have a double shot non fat Cappuccino.


Tuesday, July 17, 2012

Spineology: Good Times, Bad Times

If there ever was a product that was slick before slick was a popular word in spine, it had to be the OptiMesh developed and marketed by Spineology. TSB remembers the first time Spineology presented its technology seeking an infusion of investment capital. The year was 2003.  Since then, the company has gone through an up and down evolution.  The OptiMesh was a deployable pouch inserted via a cannulated tube into stable vertebral defects.  The objective was to contain grafting material in place.  The material that this pouch was manufactured out of is PET which has since been used in the Dynesys System Cord.  Unfortunately for Spineology things have changed.

On July 5th, a complaint was filed for damages and demand for jury trial in the United States District Court of Indiana against Spineology.  The plaintiffs are Debra and Thomas Day and their civil action is brought on behalf of the the plaintiffs for personal injury and damages sustained as a direct result of negligent and otherwise wrongful conduct by the defendant, Spineology, Incorporated in connection with its design, development, manufacturing, testing, packaging, promotion, marketing, distribution, labeling and sale of OptiMesh what was implanted in the plaintiff.

The facts surrounding the case do not bode well for Spineology.  Based on the law, "any person who seeks to introduce a medical device into interstate commerce must prove that it is safe and efficacious for its intended use or that it is substantially equivalent." The challenge that the Spineology legal team will have will be proving that its product was not used off label rendering it adulterer and misbranded, since manufacturing adulterating or misbranding a product into interstate commerce is prohibited under the law 21 U.S.C. Sec. 331 (9-c), (g), (2003).

The Medical Device Amendment to the Food, Drug, and Cosmetic Act of 1938 require medical manufacturers to undergo premarket approval by the FDA, mandating that manufacturers must design and implement a clinical investigation.  As many of you know, the only way a device may by pass the PMA process is if there is a "substantially equivalent product," or predicated device in interstate commerce prior to May 12, 1976.  As this complaint unfolds the contentions bring to light the many challenges that companies have in properly adhering to FDA requirements. Spineology sought to market OptiMesh without conducting trials and obtained approval via a 510(K). Their submission asserted that they intended to market the product to maintain the relative position of bone grafting material and that it did not impact the stability of the vertebral body and did not include the end plates.

Spineology was warned in November of 2003 by the Office of Device Evaluation that there were reasonable concerns that the device would be used for an intended use not identified in the proposed labeling, and such use could hold harm.  Based on Spineology's labeling, the company did just that by indicating contradicted use of the OptiMesh. In August of 2007 Spineology received another warning letter for promoting OptiMesh for use in Kypho and Vertebroplasty. The complaint stated that since Spineology promoted and introduced OptiMesh into interstate commerce for uncleared indications the product was rendered adulterer under section 501(f)(1)(B) of the FDA.  It was also misbranded because Spineology did not notify the FDA of its intent to introduce the device into commercial distribution.

From June 9, 2010 thru June 30, 2010 the FDA conducted an investigation at one of Spineology's clinical investigation sites.  This investigation was performed to ensure the the Spineology data and information would be accurate and valid scientifically.  On 9/22/10 a warning letter was sent to Spineology which revealed serious violations.  The letter informed Spineology that its clinical investigator was not adhering to the study's protocol.  Despite these warnings, it is alleged that Spineology conceded this information from its physician surgeons as well as the plaintiff.

The plaintiff was treated in December of 2009 with an XLIF for instability at L4-L5 presenting with right leg pain which was resolved with the surgical procedure.  Nearly one year later, the plaintiff presented with left leg symptoms similar to her right leg pain.  The surgeon treated her conservatively unexpectedly developing a L5-S1 asymptomatic disc herniation.  On January 21, 2011, the plaintiff underwent  a surgical revision which included the partial removal of her right posterior instrumentation and a TLIF using the OptiMesh, since and XLIF procedure was not amenable to implantation at L5-S1. After 4-6 weeks the plaintiff began experiencing right buttock pain and leg pain.  A lumber CT verified extrusion of the bone graft into the right lateral recess with right nerve root compression at S1.  On 4/26/11 the plaintiff underwent exploration of the epidural space.  During the exploration it was determined that the OptiMesh had a tear posteriorly in the pouch.  The surgeon notified Spineology.  On 4/26/11 the plaintiff's pain returned. A subsequent CT on 6/7/11 demonstrated complete extrusion into the epidural space, with implant removal on 6/13/11.

There are many questions that need to be answered in order to determine whether or not Spineology acted accordingly in how they presented and marketed their product. Unfortunately, based on their track record with the FDA, Spineology may be swimming against the current. Corporations are no longer viewed as ethical or acting with integrity by juries, especially when it comes to adjudicating a product liability case involving loss of consortium. No one really knows why these events occur to some patients. Is it a quality issue? Is it a training issue? Is it an off-label issue? Is it surgical technique? But then it does raise our  defense of the importance of having a properly trained sales rep in the room. These questions will be difficult to prove because the attorneys nor the jury were in the operating room at the time of the event. Yet, off-label use is a no brainer especially when there are issues concerning structural support. The plaintiffs attorneys have a substantial amount of negative facts as to how Spineology has managed its day to day business, it will be interesting to see where everyone lands at the end.   In these types of cases no one wins, the patient suffers and the company loses credibility.  TSB wants to know what our readers think?  OptiMesh or OptiMess?  

"Good Times, Bad Times......you know I had my share"

Monday, July 16, 2012

Spine: In The Newsroom

Spineophiles, if you haven't had the opportunity to watch the Newsroom on Sunday nights, take the time to surf over to HBO and give this series a look with an objective mind. Is that possible? By now many of you are wondering, is TSB becoming a television critic?  In order to assuage your cynicism, the answer is unequivocally NO. In many respects, "The Newsroom" is an indictment of the current state of news, regardless of whether you are a liberal, conservative, or independent, but who cares about labels, hey? Just ask some of our readers. The Newsroom questions our objectivity as we transition from a nation state to a market state, more concerned about sponsors feelings rather than delivering the truth.  It questions accuracy, our insanity as a nation, along with business, politics, the media, and the government's failure in reporting the truth, even if it means offending some peoples feelings or beliefs. So how does this pertain to Spine?

The vast majority of people that work in this industry are hard working professionals. It is the 20%, a minority, that truly tarnish our industry. These are the same few individuals that snicker and sneer, while espousing free markets wrapping themselves in the American Flag, as long as it doesn't hinder their ability to game the system.  Ever read a comment and wonder how someone can go off on a tangent and introduce a topic unrelated to the blog? What does it say about that individual's ability to focus, let alone do their job? Why can't TSB challenge this unholy industry when it is warranted?  Where have all the geniuses gone from the last ten years which TSB calls the lost decade in spine.  Have we learned anything from the pitfalls of success? What began as an innovative industry led by young visionaries has mutated into an industry that is bloated and bureaucracy laden.  Spine is about as aberrant of an industry as anyone can work in. Our industry rewards executives that strangle ideas rather than reward creativity, because creativity or out-of-the box thinking may threaten the established order of things.  Today, the start-ups and early growth stage companies are mirror images of their big brothers.  Fiefdoms and internal politics have emerged as a key to ones success and longevity. God forbid you point out a deficiency or inadequacy of a system or implant, or ask why the company is spending capital with no return on their investment?  Some of our current CEO's would better meet the criteria for psychoanalysis rather than an expose in Harvard Business Review.  No one individual is bigger than the sum of its parts.

Turnover has become rampant. Rather than sustain continuity and realistic growth expectations, many of these companies go five steps backwards to go one step forward. Question my decision making, you're fired, even if the individual's decision making SUCKS. If you don't listen to your customers needs, you will never succeed. But then again, it is always easier to blame someone else than take responsibility for ones actions or decisions. Just ask Ken Lay, Jeff Skilling or better yet the former CEO's of Vertebron, Archus, CardoMedical, or IST. It was always someone else's fault. Never have I heard anyone admit, "I just wasn't prepared." Even the BOD and Investors buy into their BS. Some of our readers believe that they know TSB or our motives for this blog. Those are usually the smartest guys in the room accusing TSB of being anti-business. On the contrary, those that contribute to your blog love making money. The difference is that we do not justify making money by behaving unscrupulously with no conscience. Our response is that those few individual are entitled to their opinion, and they could keep reading OTW the mouth piece for the industry.

The industry has lost its nimbleness, it has lost its passion.  It will blame everyone else except itself.  It's the FDA's fault. It's Obama's fault. It's the sales persons fault. What about the people that truly drive the industry? What about the greed exhibited by our illustrious CEO's and our surgeon customers? "You bring no value. You are overpaid. You are the cause of the United States healthcare crisis."  But what about their own contributions to an industry once revered now loathed. Where are all the visionaries that lacked the wherewithal to properly assess where healthcare was heading?  It's churn and burn baby. What happened to all the innovation? Another pedicle screw? Another cervical plate? Another inter body device? We no longer innovate to improve clinical outcomes?  We are now focused on improving existing technology asking the question, "how are we going to use this to make more money?" Today, at day's end, you are more concerned with your stock price and whether it has gone up or down than whether you had a productive day.

The reason you read TSB is because we make you think.  We stimulate you to ask the right questions and hopefully hold your companies accountable for what they do well, and what they do poorly.  You are the engine that drives the machine on a daily basis, not the shareholders or hedge funds that play roulette with your companies shares. The reason Spine is in this state is because shareholders and BOD's place more value on bean-counters than the individuals that understand the clinical and development side of the business.  They don't want a product guy, they want a businessman or woman that can cut a deal or put another marketing spin on a me-too product.  As we enter the dog daze of summer it will be interesting to assess where we are and how we intend on adapting to an ever shrinking market place?  Vacation time is over and its back to the grind.  Have a great week, and sell something will you the investors are getting antsy.

Thursday, July 12, 2012

Spine = Easy Money? Just Ask BAXANO

The events that had transpired over the last few days validates the tension and uncertainty that exists in the spine industry. As information becomes viral, it has become apparent that the spine industry might be ready for another casulty of spine. As was posted in the comment section and verified by our sources on the Street, Baxano may be in trouble. After letting 20% of its workforce go due to inadequate funding and sales, you the readers continually validate the many issues that need to be cleaned up if the spine industry is to revitalize itself in an uncertain healthcare environment.

TSB published a blog about Baxano in early 2010 questioning the efficacy and reimbursement of this product. Your many comments in reply validate how much more knowledgeable the masses are in comparison to those that have an ability to make hoards of money and throw it around at the industry like if we were a casino.  The question must be asked, "who are these people listening to?" Who are these experts? $30 million in Series C. How much more capital in their previous rounds?  Laugh all you want, better yet, get angry at TSB, but in the end the market rules. Did anyone really believe that attempting to perform a foraminal decompression with the equivalent of a Gigli Saw was going to fly?  There were a few optomists back in 2010 that spoke about flossing their teeth and never being able to live without it.  That comment was pretty funny considering that flossing your teeth is much easier that threading a needle through a haystack. So why is it that Baxano is potentially in the initially stages of shut down?

Having spent many years fighting the insanity of our industry here are our observations;

  • Investors are no longer interested in recapitalizing companies in the spine industry
  • Reimbursement! Reimbursement! Reimbursement!  We called it in 2010
  • Improprerly trained distributors
  • Poor surgical technique (There are only that many Ozzie Smith´s out there
  • Patient Complications
The word on the Street was that Baxano generated $5 million in sales last year, and was looking for a 300% increase in sales for this fiscal calendar.  If there is any truth to that number, one must question the intent of that forecast.  Was it to appease the investors?  Considering that start ├║ps like Baxano do not possess the same fire power as a Medtronic, DePuy, Nuvasive, or Globus, time is not on their side.  So TSB wants to know what do our readers think?  $30 million plus?  Smartest guys in the room, you be the judge. In closing TSB bids our readers a good day and remember

Way down here you need a reason to move
Feel a fool running your stateside game
Lose your load, leave your mind behind
Oh Mexico, it sounds so simple I just got to go
The sun's so hot, I forgot to go home
Guess I´ll have to go now................Adios Amigos

Wednesday, July 4, 2012

Independence Day - July 4th

Today commemorates the day that these United States adopted and declared its independence from the United Kingdom, July 4th, 1776.  It would be interesting to gauge the reaction of our Founding Fathers if they could see the evolution of their Declaration. Who are we? What have we become as a Nation? How many people have actually read the Declaration in its entirety?  How many have reflected on the meaning of those words? Originally intended to declare our independence, this document is also a statement on human rights. The following words alone speak volumes,

"We hold these truths to be self evident, that all men are created equal, that they are endowed by their Creator with certain unalienable Rights, that among these are Life, Liberty, and the pursuit of happiness."

These words did not ring truth when the Declaration was signed.  The irony was  that there was contradiction in those words, "all men are created equal." Hypocrisy? Perhaps. Jefferson himself owned slaves at a that time, potentially echoing the old expression, "do as I say, not as I do." But isn't that a coat of arms that all politicians love to wear? As in the days of the American Revolution leading to the signing of the Declaration, today, we have our own kings who believe that they have inalienable rights. There should be no checks nor balances. No restrictions in doing whatever they desire. Wrapping themselves in their American Flag lapel pins, declaring their patriotism, love of God, family and money.  Yes fellow bloggers, there are many kings in our industry who believe in their own divine right. There lies the challenge in a world that is constantly changing as to what are your natural or legal rights. As the world morphs from nation states to market states, a world based purely on commerce, the founding fathers would be fascinated that we are not modifying nor amending our laws to create more checks and balances than what they intended.

In the past we depended on laws and regulation, today there is no assurance of equality but a maximization of wealth by those in power.  Globalization is screaming for a new global constitution, a global declaration to find balance and order in a chaotic world.  As market states open new opportunities, it makes everyone vulnerable. Jobs are outsourced, manufacturing is outsourced, all for the love of the Almighty Dollar and shareholder value. The financial meltdown of 2008 has been validated by the tremors that still exist on a global level, especially in the fragile European markets.  It is for this reason alone that government must adapt and create a new Declaration. As the financial sector downsizes its workforce, moving services to India, Malaysia, or the deep south, as average Americans lose confidence in the markets every time something new comes up, America loses. In many respects we have lost our integrity. We have lost our moral character, we no longer possess a code of conduct. 

So today, as you break open a cold beer, and BBQ whatever it is that you desire, and go to your local fireworks display, think of how lucky you are that we do have freedom in an imperfect world. TSB wishes everyone a Happy Fourth of July!

Tuesday, July 3, 2012

TSB Public Service Announcement

Are you tired of the way your company is treating you? Do you wake up in the morning wondering what a nuisance your regional manager is? Have you ever thought about breaking away on your own and really working for yourself?  Well, if you are, you have to start somewhere.  There are plenty of companies out there that have products that would compliment your customers needs. Why do you want to make the shareholders of your company rich?  Do you believe that they care about you or your family? Like vampires they suck the life out of everything.  If you want to explore other spine opportunities  or spine products drop an email to flhr2003@gmail.com to find out if you can add something to the your bag that will help you increase your earnings. 

Monday, July 2, 2012

Confusion? What Confusion? A Clarification of the Affordable Care Act

Based on the response our readers exhibited last week, TSB thought that there should be some clarification regarding OBAMACARE.  Before you start whining like a child it behooves those that criticize it to read all 300,000 plus words before it was amended to 900 plus pages.  So let's clarify some things.

Many people are screaming about the unconstitutionality of the law, especially about the mandate. The vast minority that scream against it wrap themselves in their cloak of freedom, claiming it will make you do things you don't want to do. Is it a penalty or tax, that my friends is left to your perception, but what we found out today is that Mitt Romney's spokesperson quoted the Governor as calling the Massachusetts Healthcare Law a penalty rather than a tax. I guess calling it a "penalty" is a kinder and gentler way. The difference? Semantics? Beauty is in the eye of whomever can BS the best, isn't it? As the general populous argues about the law, there are many things that people are claiming that the bill does, that is not true. At least get your facts straight. Are you allowed to have an opinion? Absolutely?  But you're not allowed to make up your own facts, and that's what the sheep have been fed.

Death Panels:  To our knowledge, there is no mention of a Death Panel in the bill.  The decision to approve or deny your claim will still be in the hands of your insurer.  Can you challenge it if you are denied? ABSOLUTELY, plus the government will provide oversight to ensure that you don't get screwed by the insurance industry. P.23 Section 2719

Free Insurance to Illegal Immigrants: A recipient must be a LEGAL resident of the U.S. in order to receive a tax credit. Read the language in Subpart B "Eligibility Determination" before you react. Can illegals buy healthcare? Yes indeed. Can they still go to the local ER and get care without insurance?  Nobody stopped them before, now did they? And whom do you think has been absorbing the cost if hospitals claim that they lost $45 billion in revenues last year alone.  Have you ever wondered why your pricing is getting squeezed beside the usual, that we have commoditized the market? Have you ever wondered why your insurance premiums continue to escalate? Maybe Pasterna or Lukianov will save the day, unfortunately so far neither one of them have offered a solution to our crisis.

Rationing Healthcare: There is no language in the bill that will allow anyone to ration medicine, restrict your benefits, raise your premiums, or copays for that matter.  If you have an insurance policy you will be able to keep it without having to go on a government program.  In addition there is NO PUBLIC OPTION since it was stricken from from the bill on Page 92 under 1323 Community Health Insurance Option STRICKEN.

Did The People Who Passed the Law Read It?  At least one more time than those that scream and yell about it, considering that most people formulate their opinions from the PROPGANDA BOX, excuse me the flatscreen they go home to.  Contrary to the many that don't like Nancy Pelosi, and TSB includes ourselves in that group, before you quote her, at least try not to quote her out of context.  

Is it a Penalty or Tax? Regardless of what you call it, those that bitch the most are those making over $200,000 per annum and they will be taxed by less than 1% (0.9%) by 2013.  Once again don't believe go to P.818 and read the facts.

Here is the tradeoff.  By 2014 no insurer will be able to invoke their "pre-existing condition rule." All people will be charged the same regardless of their history. (Section 2704, 2701, 1255)  If you do not have insurance, you will be charged a fee regardless whether any candidate cloaks it as a penalty or tax.  Since insurers are going to have to cover you regardless of what you have, you can't wait until you are sick to get coverage. YOU DO HAVE AN OPTION: you can determine that you will not buy insurance, but you'll have to pay the fee.  Do you pay for better schools?  Do you pay to have the police protect you?  Do you pay for public services like garbage collection or a fire department?  What is it about healthcare that makes people crazy?  A wealthy person sees no problem in buying a thoroughbred, but bitches about paying their surgeon the difference for services rendered when their insurance plan does not cover 100% of the bill and that my friends is a quote from many surgeons during our tenure in the industry.

Whether you agree with it or not, you all pay for the escalating costs of delivering healthcare.  WE DO NOT HAVE THE BEST HEALTHCARE SYSTEM IN THE WORLD, WE HAVE THE MOST EXPENSIVE. And whether you believe it or not, everyone has a right to medical care. When a two and a half year old child exhausts their lifetime healthcare benefits because of illness, the parents are told to divorce in order to qualify for aid. What's wrong with insurance companies not being able to tell people that their "lifetime" benefits have been exhausted? TSB doesn't see the insurance industry rebating those of us that don't get sick and don't use their insurance at all, because you are healthy. And if you're healthy, why do you buy insurance coverage?  For those that espouse their Machiavellian mindset that only the strong survive, you'll sing a different song when you or your loved ones are no longer healthy.

As for the medical device tax, well, let's just say that the rules of engagement are changing.  If you want to play, you're going to have to pay.  Don't like it?  I highly doubt Lukianov, Dvorak, Orsinger, Binder, Vater et al are going to stop doing business in the United States, where else will they go?  Russia? Malaysia, Israel? India? Why does everyone desire to succeed in the U.S.? Why does everyone want to sell their products in the U.S.? The behavior of some of so-called leaders is despicable.  Not only do they believe their own press clippings, the cry like little girls when the can't get their way.  You know what TSB's granddaddy use to say, "you can only milk a cow for so long, and then she runs out of milk."  That my friends is the U.S. healthcare system.