In 2005, Guidant (now a division of Boston Scientific) admitted to knowing for three years that their Ventak Prizm heart defibrilator could short circuit, leading to both unnecessary shocks to the heart as well failures to shock when necessary, but the medical device giant did nothing to alert physicians or the public. After learning of the malfunctions, Guidant took steps to remedy the problem, but never notified the FDA. In 2005, after three physicians reported the failure of the model to revive a patient, the FDA recalled some of the faulty models and in 2007, Boston Scientific paid $240 million to settle patient lawsuits. In 2010, the Justice Department criminally charged Guidant resulting in a fine of $296 million, one of the largest penalties ever accessed to a medical device company.
Shortly thereafter, in January 2011 the government filed its civil lawsuit with James Allen named as the relator. After an eight year personal battle, the identity of the Guidant whistleblower has been revealed. Mr. Allen was implanted with one of Guidant’s faulty heart defibrillators, but after suffering severe and unnecessary shocks to his heart, he had the device removed in 2005 and launched his own investigation into Guidant, costing him personally $140,000. Allen filed his qui tam lawsuit against Guidant in 2008, alleging the medical implant device company made changes to the Ventak Prizm without FDA knowledge or approval. Allen’s lawsuit alleges more than 19,000 fraudulent claims amounting to taxpayers losses of $726 million. He also claims Guidant made changes to the device which the public is not yet aware of. The government’s suit is much more conservative, alleging 2,000 fraudulent claims to Medicare. Which figures are more accurate and how the suit will ultimately be decided is still unknown, but with such glaring differences despite the same whistleblower and similar allegations, this is certainly a case to watch.
For more information see: http://www.startribune.com/business/118677724.html