The Justice Department is suing Boston Scientific and its Guidant unit under the False Claims Act for conduct related to the faulty heart devices Ventak Prizm 2 and the Renewal 1 and 2. The government alleges Guidant continued to sell faulty defibrillators for years, even though it knew they were defective. Guidant pleaded guilty last February to misleading the FDA about the problems in the devices. A district court in Minnesota accepted the company's plea earlier this month.
Justice is suing the company by joining a lawsuit filed by James Allen in Minnesota. Allen says he received one of the defective devices, TheHeart.org reports.
In its complaint, the government maintains Guidant knew as early as April 2002 that an implantable cardiac Prizm 2 contained a potentially life-threatening defect. Furthermore, the company also knew as early as November 2003 that another implantable device, the Renewal 1 and 2, contained a similar defect. However, the government alleges, even after Guidant took corrective action to fix the defects, it continued to sell the stock of the old, defective versions. Moreover, instead of disclosing the problem, Guidant issued a misleading communication to doctors that misinformed them about the nature of the defect, the government further alleges.
Indeed, it wasn't until May 2005 that Guidant fully disclosed the problem after first being contacted by a reporter. The company subsequently recalled the devices shortly after a front-page article about the defects appeared in the New York Times.
In a statement, Boston Scientific expresses disappointment that the government "after reaching a criminal resolution with Guidant LLC, has chosen to seek additional money in a civil lawsuit." The company also believes the resolution of this matter should not have a significant financial impact.
- get the DOJ's release
- read Boston Scientific's release
- see the TheHeart.org report