Consumer Law

Guidant?s Government Payback

By Joe Consumer

We are in an endless, circular debate in this country about medical tests and procedures (too many and why?) and lawsuits (too many and why?).  The tale of Guidant?s Ventak Prizm 2 implanted defibrillator tells the story in many twisted ways but all with the same conclusion: if unneeded procedures are happening, ?fear of lawsuits? isn?t why, and victims are being stiffed from every angle.  

Earlier this month, a study published in the Journal of the American Medical Association said that one in five patients who receive dangerous implantable heart defibrillators, or ICDs, probably don?t need them.

Is this being done because doctors fear they?ll be sued if the don?t implant these dangerous medical devices?  Of course not.  They?re just practicing bad medicine.  In fact, the Director of the University of North Carolina McAllister Heart Institute said,  ?We know that over half of individuals who should get an ICD implanted based on guidelines actually don't receive one, for a variety of reasons. This is a far bigger problem.? 

Defibrillators are stopwatch-sized devices that can deliver a 700-volt electric shock to restore a proper heart rhythm.  Thousands of Guidant defibrillators were implanted with major defects that repeatedly shocked, injured and killed patients.  They did so much damage that last year, Guidant (now owned by Boston Scientific) pled guilty to two misdemeanors, was hit with $296 million in fines and fees and was ordered to serve three years probation.  If there?s a lawsuit problem with these devises, it?s clearly the lack of them. In 2008 the industry received immunity for making unsafe defibrillators, courtesy of the U.S. Supreme Court (Riegel v. Medtronic). 

But the government?s legal rights were never taken away, and now it wants its money back!  AP writes that yesterday, the government brought suit against Guidant ?for violat[ing] the False Claims Act by submitting false or fraudulent claims to the Medicare program. The government says roughly 2,000 false claims were submitted to Medicare for patients who had the defective models implanted.?  The Minneapolis Star-Tribune writes,

"When companies like Guidant request and receive federal dollars for products they know to be defective, the United States is committed to aggressively seeking the recovery of those payments," said John Marti, first assistant U.S. attorney in Minnesota.  In a statement, Boston Scientific spokesman Paul Donovan said the company has been "aware of the government's interest in this civil matter, and we have previously disclosed it in our regulatory filings. Guidant plans to respond to the government's allegations and claim for damages in the appropriate fashion."

That?s all great, but when the court ruled in Medtronic, it removed the most significant and effective financial consequence to a company for choosing to keep a dangerous heart device on the market.  For proof of that, check out Boston Scientific?s reassuring response to this most recent government suit, to quote, ?it doesn't expect the civil lawsuit ?  to cost the company a significant amount of money.?  Certainly not compared to all the damage it did to the victims of this disaster.  

Towards that end, here is the opening from the Center for Justice & Democracy?s study, Heart Sick. It?s a shocker (no pun intended):

As the widow [Kathleen Gohde] bent toward Allan Gohde's coffin in July [2005], she was startled by a loud beeping coming from his chest. The source of the noise was an implanted Guidant Corp. defibrillator, the same model that was linked to the death of a 21-year-old man [in] March.  Both men died after their defibrillators failed to deliver a life-saving jolt to their hearts. As it turns out, the beeping that Gohde heard was a signal of a device malfunction, and if it hadn't sounded, the family might never have known why he died.

Full post as published by ThePopTort on January 28, 2011 (boomark / email).