After reviewing a false claims lawsuit filed against Boston Scientific subsidiary Guidant and conducting additional interviews, the federal government has decided to reverse an earlier decision and join the lawsuit against the device maker, according to a MassDevice news report.
In Feb. 2002, Guidant found one of its implantable cardiac defibrillators, the Ventak Prizm, had a design flaw that resulted in device failures. In April 2002, the company had fixed the defect and began manufacturing a corrected model of the defibrillator but did not recall the older, defective models, according to the report.
The lawsuit stems from allegations and a complaint first filed by James Allen in July 2008. Under the False Claims Act, Mr. Allen accused Guidant of knowing there were problems with a Ventak Prizm that was implanted in him in Aug. 2002 but failed to disclose the defects to him. Because Guidant did not disclose the defects to him, Mr. Allen said he experienced two device failures in which the first failure caused seven unnecessary, 750-volt shocks to knock him unconscious. The second device failure caused a "storm-shocking," which caused Mr. Allen to fall down a flight of stairs, according to the report.
Following these incidences, Mr. Allen scheduled a procedure to have the device removed and replaced with a competing device, but a Guidant salesman allegedly convinced the surgeon that the Vantak Prizm was not defective and that Mr. Allen's insurance would not cover the procedure, thereby persuading the surgeon to cancel the operation. Mr. Allen allegedly went to another surgeon to have the replacement procedure done, which was covered by his insurance, according to the report.
In Sept. 2010, Boston Scientific moved to have the lawsuit dismissed, claiming the case was based on "parasitic claims" in media reports, according to the report.
Read the news report about the False Claims Act lawsuit against Guidant.
Read other coverage about device maker fraud and abuse:
- Medtronic Enters Into $268M Settlement to End Lawsuit Related to its Defibrillation Leads
- Medical Device Maker, Government Reach Tentative $10M Settlement for Alleged Kickback Scheme
In Feb. 2002, Guidant found one of its implantable cardiac defibrillators, the Ventak Prizm, had a design flaw that resulted in device failures. In April 2002, the company had fixed the defect and began manufacturing a corrected model of the defibrillator but did not recall the older, defective models, according to the report.
The lawsuit stems from allegations and a complaint first filed by James Allen in July 2008. Under the False Claims Act, Mr. Allen accused Guidant of knowing there were problems with a Ventak Prizm that was implanted in him in Aug. 2002 but failed to disclose the defects to him. Because Guidant did not disclose the defects to him, Mr. Allen said he experienced two device failures in which the first failure caused seven unnecessary, 750-volt shocks to knock him unconscious. The second device failure caused a "storm-shocking," which caused Mr. Allen to fall down a flight of stairs, according to the report.
Following these incidences, Mr. Allen scheduled a procedure to have the device removed and replaced with a competing device, but a Guidant salesman allegedly convinced the surgeon that the Vantak Prizm was not defective and that Mr. Allen's insurance would not cover the procedure, thereby persuading the surgeon to cancel the operation. Mr. Allen allegedly went to another surgeon to have the replacement procedure done, which was covered by his insurance, according to the report.
In Sept. 2010, Boston Scientific moved to have the lawsuit dismissed, claiming the case was based on "parasitic claims" in media reports, according to the report.
Read the news report about the False Claims Act lawsuit against Guidant.
Read other coverage about device maker fraud and abuse:
- Medtronic Enters Into $268M Settlement to End Lawsuit Related to its Defibrillation Leads
- Medical Device Maker, Government Reach Tentative $10M Settlement for Alleged Kickback Scheme