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Guidant Defribillators - Corporate Crime in the Immunity Age

By Joe Consumer

In 2005, at the encouragement of two well-respected cardiologists Dr. Robert G. Hauser and Dr. Barry J. Maron, New York Times reporter Barry Meier broke the story about a Guidant implanted defibrillator that was short-circuiting at a rate of about once a month.  Three years earlier, the company had changed its manufacturing process to correct the problem but never told doctors and continued to sell its defective inventory.  Patients died and the FDA kept this information from the public for many months.  Somebody made these corporate decisions.  (You can read a lot more about this in the Center for Justice & Democracy?s study, Heart Sick.)

Meier, Hauser and Maron never took their eye off Guidant (now part of Boston Scientific) and today, the Times reports a new story ?raising a fundamental question about medical safety and the law: who should be held accountable when a company sells a flawed product that can injure or kill patients? Is it the company or the people who run it??

Drs. Hauser and Maron are objecting to a Justice Department plea agreement ?in which the company would plead guilty to two criminal misdemeanors and pay a $296 million fine.?  Even though this is ?the largest ever paid by a medical device maker,? Hauser and Maron?s point is that  ?Nobody is being held accountable."  But as Meir points out, ?corporate executives rarely face criminal charges in such actions.?

The reason?  According to one drug and device attorney quoted in the piece, ??Prosecutors want the money ? And at least in the big money settlements they have had in pharma cases, it appears that prosecutors are willing to settle even if it means forgoing prosecutions against individuals.?

What an unbelievable point.  The government wants its cut.  Understandable.  But meanwhile, the legal system?s deterrent function becomes largely nonfunctional ? first by the failure to criminally prosecute individuals responsible for corporate crime, and second, because no civil case can go forward ? at all!  Actual patient-victims of this corporate crime, who should have recourse in the civil courts, have been left out in the frigid cold. That?s because in the 2008 case Riegel v. Medtronic, the U.S. Supreme Court immunized from liability companies that manufacture defective heart devices. This decision leaves heart patients with no legal recourse should they be injured, and removed the most significant and effective financial consequence to a company for choosing to keep a dangerous heart device on the market.

Legislation to remedy this situation is currently before Congress, called the Medical Device Safety Act.    What more is it going to take to get this law passed?!

Full post as published by ThePopTort on April 21, 2010 (boomark / email).