Archive for the ‘Plea Agreement’ Category

Guidant's Guilty Plea for Failure to Notify FDA of Defective Defibrillators Takes New Twist – Will Plea Agreement be Accepted by the Court?

Saturday, April 24th, 2010

Just over two weeks ago, the newswires were advising the public that Guidant LLC, a unit of Boston Scientific Corp, had been implicated in short circuiting failures of three models of their implantable cardioverter defibrillators (ICD’s). At issue in the charges brought last November by the Department of Justice were 20,146 devices identified as the Ventak Prizm 2 and Contak Renewal 1 and 2 defibrillators. It was also reported that Guidant pleaded guilty to the criminal charges. Guidant’s defibrillators became available to the public in 2005.

Dr. Ananya Mandal, the author of one of the lead articles relating to the case at that time, provided the following information about the devices:

The implantable cardioverter defibrillator (ICD) is a life saving battery operated device much like a pacemaker that is placed near the heart in a minor surgical procedure. This device detects abnormal heart rates and rhythms in the patient and delivers an electric shock to make the heart beat normally again. These save millions of people in the US and all over the world from sudden death.

As a result of the proposed plea agreement, Guidant has agreed to pay a combined criminal penalty of more than $296 million, which, according to a report in Reuters, is “the largest criminal penalty against a medical device company.”  In essence, the charges stemmed from Guidant’s withholding information from the U.S. Food and Drug Administration regarding catastrophic failures in some of the devices. According to this same Reuters report, “Boston Scientific reached a settlement with defibrillator patients in 2007 covering the 2005 product issues and additional issues the following year. It agreed to pay up to $240 million to cover up to 8,550 claims, including ones collected in a multi-district litigation case.”

This plea agreement is currently being considered by U.S. District Court Judge Donovan Frank, who announced at a hearing on April 5, 2010, that he would make his decision as to whether or not to approve the plea agreement within three weeks of that last hearing.  If he stays within the self-imposed time limit, his decision should be announced this coming week.

Photo of Ventak Prizm 2 by mindfully.org

Last week, however, a new twist to the case was reported by several news sources, including one posted by Reuters this past Thursday, April 22, 2010 – “two cardiologists who cared for a 21-year-old college student who died when his implantable defibrillator made by Guidant failed to deliver a life-saving shock are urging a federal judge to reject a plea agreement with the company.” These physicians are identified as Dr. Robert Hauser and Dr. Barry Maron.

The doctors’ comments in a letter to Judge Frank bear quoting:

“We are extremely dismayed by the U.S. Attorney General’s decision to enter into a plea agreement with Guidant LLC, rather than prosecute the company and the individuals responsible for this egregious act.

“On behalf of the patients who died or suffered pain and mental anguish as the direct result of Guidant’s illegal and unethical behavior, we urge you not to accept the plea agreement.

“To allow a repeat offender, like Guidant, to escape with a fine (that is entirely borne by the shareholders of Boston Scientific) does not hold the guilty parties fully accountable and inevitably undermines patient safety.”

Whether the judge heeds the words of these physicians or not remains to be seen. What is absolutely laudatory is the fact that these physicians have expressed their outrage as to this manufacturer’s conduct.  Are they not correct – the money paid both through civil settlements and, if approved, by virtue of the criminal charges will be “entirely borne” by the company’s shareholders? Where is the personal accountability for this outrageous conduct?  Our system of justice is one not only of compensation to the victims of such heinous conduct but also should serve to deter other individuals from taking the same life-threatening conduct in the future.  There is nothing like a good long jail sentence for those involved in this horrible scheme to deter other corporate executives from going down the same path of profit at all costs – even to human life.