The U.S. Department of Justice charged Guidant Corp. on Thursday with concealing critical information from federal regulators on "catastrophic" failures in several models of its heart defibrillators.
The rare filing of criminal charges culminates a four-year federal investigation that had its roots in the suspicions of two Minneapolis doctors. As the case unfolded, it rocked not only Guidant but also the rest of the medical device industry concentrated in Minnesota.
At least seven deaths have been attributed to the three models of Guidant defibrillators that were the focus of the case. Arden Hills-based Guidant's response to the short-circuiting of the implantable, stopwatch-sized devices revealed glaring weaknesses in how manufacturers of medical devices disclose defects to doctors, patients and the federal Food and Drug Administration.
The medical device industry has since become quicker to warn regulators and the public of problems with products.
Guidant is now part of Boston Scientific Corp., which said in November that it would pay $296 million on behalf of Guidant to settle the charges. The company is expected to enter a formal guilty plea in U.S. District Court in St. Paul in the coming weeks.
"The government charges that Guidant committed serious crimes by undermining the FDA's role to guard the American public against potentially dangerous medical devices," said Assistant Attorney General Tony West, who heads the Justice Department's Civil Division. "Our message is clear: We will vigorously prosecute individuals and organizations who put profit over public health and safety by violating the law."
Asked whether any individuals could still face charges related to the Guidant case, Assistant U.S. Attorney Robert Lewis said he couldn't comment.
"We are pleased to resolve this matter," Boston Scientific spokesman Paul Donovan said in a statement. "We continue to believe that Guidant and its employees acted in good faith and with the intention of complying with applicable laws and regulations."
The defibrillators cited in the investigation are the Ventak Prizm 2DR (model 1861) and the Contak Renewal (models H135 and H155). When Guidant recalled 109,000 of the devices in June 2005, seven deaths were linked to the malfunction.
It's unclear whether the number has risen since then; the company did not respond when asked Thursday.
Problems with the devices were first disclosed in May 2005 when Drs. Robert Hauser and Barry Maron of Minneapolis went public with their concerns after the death of a patient, 21-year-old Joshua Oukrop of Grand Rapids, Minn. Oukrop collapsed on a bike trip in Utah after his defibrillator failed to revive him.
Investigators discovered Guidant knew in 2002 that the Ventak Prizm device could fail and changed the design in November 2002 to correct the short-circuiting problem. But when the company alerted the FDA about the changes in August 2003, it falsely told the agency the fix did not affect the device's safety and effectiveness, according to court documents.
In early 2004, Guidant discovered similar problems in the Contak Renewal defibrillator models. In June 2004, a patient in Spain, identified only as "J.R.," visited his doctor. Electronic monitoring had detected a potential problem with the man's device but no problem could be found. The man was sent home, where he died a week later, according to court documents.
In March 2005, Guidant sent a product update to doctors "in an effort to mitigate the risk to health posed by the Renewal devices," documents state. Although the company was aware of 12 Renewal short-circuiting failures and the death in Spain, it failed to note them in the product update. Federal law required that the notice to doctors also be reported to the FDA, but it wasn't.
Boston Scientific bought Guidant for $27 billion in 2006. The company still sells a limited number of the three defibrillator models -- almost entirely outside the United States, said Annette Ruzicka, a Boston Scientific spokeswoman. She said there have been no problems since the defibrillator models were modified.
Hauser said the entire industry, which includes Fridley-based Medtronic Inc. and Little Canada-based St. Jude Medical Inc., has become more transparent as a result of the Guidant case.
Companies post product performance reports on their websites and, "when a product issue occurs, we are getting most of the information we need to make patient management decisions."
But, Hauser added, "I still think of Joshua."
Janet Moore • 612-673-7752