Food and Drug Administration (FDA)
Most recent update: 1/20/11
US v. Guidant LLC formerly dba Guidant Corporation (D. Minn., 10-mj-67 DWF)
On February 25, 2010, medical device manufacturer Guidant LLC, a wholly-owned subsidiary of Boston Scientific Corporation, was charged with criminal violations of the Federal Food, Drug, and Cosmetic Act related to safety problems with some of its implantable defibrillators. Guidant LLC formerly did business as Guidant Corporation.
According to the information filed in federal district court in Minnesota, Guidant concealed information from the U.S. Food and Drug Administration (“FDA”) regarding catastrophic failures in some of its lifesaving devices. The charges were filed following a four-year investigation into Guidant’s handling of short-circuiting failures of three models of implantable cardioverter defibrillators (“ICDs”): the Ventak Prizm 2 DR (Model 1861) and the Contak Renewal (Models H135 and H155). Guidant issued safety advisories regarding the failures in June 2005.
ICDs are lifesaving devices used to detect and treat abnormal heart rhythms that can result in sudden cardiac death, one of the leading causes of mortality in the United States. The devices, once surgically implanted, constantly monitor the electrical activity in a patient’s heart for deadly electrical rhythms and deliver an electrical shock to the heart in an effort to return the heartbeat to normal. If they fail to operate properly when needed, a person can die within minutes.
The information alleges that beginning in 2002, Guidant became aware that one of its ICDs, the Ventak Prizm 2 DR, was prone to electrical arcing, rendering the device inoperative and unable to deliver life-saving therapy to the patient in whom it was implanted. Guidant changed the design of the Prizm 2 in November 2002 to correct the problem. The information charges that in August 2003, Guidant falsely told the FDA that the design changes did not affect the device’s safety or effectiveness. In fact, the device changes were made to correct this flaw, according to the information.
In early 2004, Guidant allegedly discovered a similar short-circuiting problem with its Renewal 1 and Renewal 2 devices. Following the July 2004 death of a patient associated with a shorted Renewal in Spain, the information charges that Guidant knew that the physician operating instructions for responding to a short-circuit within the device were false and misleading. In an effort to remedy this, Guidant sent a communication by overnight delivery to physicians which the company dubbed a “Product Update.” The information alleges that this communication was actually a correction to the device which attempted to mitigate the safety risk posed by the short-circuiting. Guidant was required by law to alert FDA of this action within ten days. The information charges that Guidant failed to make that notification.
Guidant issued safety advisories on the Prizm 2 and Renewal devices in June 2005. FDA classified those advisories as “Class I” recalls, the most serious classification of recall, concluding that there was a reasonable probability that the affected devices could cause serious adverse health consequences or death.
A press release dated February 25, 2010, from the U.S. Department of Justice is here. The information is here.
A corporate representative of Guidant is expected to appear at the U.S. District Court at 316 N. Robert Street, St. Paul, Minnesota on March 16, 2010 at 10:30 a.m. Central Standard Time to be formally advised of the charges against it and to enter its plea. However, this date and time could potentially change on short notice.
AMENDED NOTICE OF CHANGE OF PLEA as to Guidant LLC. Change of Plea Hearing now set for April 5, 2010, at 2:00 p.m. in Courtroom 7C, St. Paul, before Judge Donovan W. Frank. (BJS).
On March 11, 2010, the Court issued an Order (here) regarding the notification of potential victims in this matter. Individuals who are claimants in the multidistrict product liability litigation should receive the Initial Notice by mail from the lawyers in that litigation.
A copy of that Notice is here. Further notifications of court proceedings will be provided on this website.
The plea agreement, filed March 11, 2010, between Guidant and the Government is here.
On Monday, April 5, 2010, Guidant LLC pleaded guilty to both counts of the Information before U.S. District Judge Donovan Frank. Attorneys for persons who allege they are victims of these crimes have objected to the plea agreement. At the plea hearing, Judge Frank stated that he would decide whether to accept the plea agreement within three weeks.
The Objections to the Plea Agreement filed by the MDL plaintiffs is here.
The government’s response is here.
Guidant’s response is here.
The press release issued by the Department of Justice regarding Guidant’s plea of guilty to the charges is here.
On April 27, 2010, Judge Frank issued a memorandum and order (here), rejecting the plea agreement. This web page will continue to be updated with any further case developments when they occur.
The sentencing hearing for defendant, Guidant LLC, has been set for January 12, 2011, 9:00 a.m. at Courtroom 7C, Warren E. Burger U.S. Courthouse, 316 N. Robert St., St. Paul, MN before Judge Donovan Frank.
On January 4, 2011, the United States filed a memorandum setting forth its position on sentencing. The memorandum is available here.
On January 12, 2011, Guidant LLC was convicted on both counts of the Information and was sentenced to:
- Forfeit $42,079,675.00 to the United States;
- Pay a fine of $253,962,251.00;
- 3 years of probation.
The Court’s judgment, along with the conditions of Guidant’s probation, are here.